Original Research

Extramammary Paget disease (EMPD) is an insidious intraepithelial neoplasm that occurs in areas with a high density of apocrine glands such as the penoscrotal area, the vulva, and occasionally the axillae. It mainly affects patients aged 50 to 80 years.¹ Clinically, EMPD presents as pruritic, nonhealing, red plaques that can be mistaken for eczema. On histology, characteristic Paget cells have abundant pale cytoplasm and atypical nuclear lobuli and are adenocarcinomatous,^1,2 usually infiltrating the epidermis.² In approximately 25% of cases, EMPD is associated with neoplastic disease in adnexal structures or organs with a contiguous epithelial lining.² Therefore, screening for an underlying malignancy when EMPD is first diagnosed is indispensable.

Because EMPD tends to be multifocal, presents in elderly patients, and affects functionally important areas such as the anal canal or genitals, treatment often is difficult.^3,4 Surgery generally is considered as a first-line treatment⁵; however, the rate of positive margins ranges from 36% to 67%, and local recurrence is common.¹

Radiotherapy has been used in EMPD patients mainly when surgery was not an option or was not effective, but several reports have indicated that it should play a more important role in the treatment of EMPD. Luk et al¹ described 6 patients who were treated with different types of radiotherapy. Similar to the results of prior studies,^3,5,6 they concluded that it was an effective treatment of EMPD.¹

We conducted a retrospective study to analyze long-term outcomes in 7 patients who were treated with external beam radiotherapy (EBRT) for EMPD.

Methods

Seven patients (6 men and 1 woman) who had been diagnosed with EMPD and were treated with EBRT at the Department of Dermatology at the University Hospital Zurich in Switzerland (1988-2004) were evaluated. The diagnosis was confirmed by a dermatopathologist or pathologist via histology. Data regarding clinical presentation, EBRT regimen, and side effects were retrieved from the medical records. Long-term outcomes were evaluated by an attending dermatologist (1 case), a general practitioner (5 cases), or the hospital’s outpatient department (1 case). None of the patients showed an associated malignancy at the time of treatment; however, patient 5 had been diagnosed with and treated for a sigmoid colon adenocarcinoma 6 years prior to undergoing EBRT for EMPD. Three patients (patients 3, 5, and 7) received EBRT for local relapse after prior treatment of EMPD (ie, CO₂ laser, multiple local treatments). One patient (patient 2) underwent surgical excision prior to EBRT. The remaining 3 patients had not undergone any prior treatment of EMPD. All patients underwent EBRT with the goal of complete remission.

Six patients received low-energy radiotherapy of 20 to 30 kV at doses of 200 to 400 cGy per day for 2 to 5 days per week until a total dose of 4000 to 5600 cGy was completed. A 0.4- to 0.5-mm aluminum filter was used, and the focus-skin distance (FSD) was 20 cm. One patient was treated with a radiograph of 40 kV at 400 cGy per day for 2 days per week until a total dose of 4800 cGy was completed. A 1.0-mm aluminum filter was used, and the FSD was 10 cm. The field of EBRT included 2-cm margins clear of all visible disease. The treatment parameters for all patients are outlined in the Table.

Results

Complete remission was initially obtained in 6 of 7 patients. In patient 3, an erosive perianal plaque remained following treatment with EBRT that was locally treated with imiquimod cream 3%. The patient relapsed 2.5 years later with a lesion in the vaginal area that was treated with imiquimod cream 3% and later via surgical excision. Complete remission was never achieved, and the patient died 7 years after EBRT treatment due to unrelated causes. Patient 5 relapsed after 6 years of remission following treatment with EBRT and also was treated with imiquimod.

At the time of this study, 1 patient remained in full remission (patient 1: 12 years) and 2 had died while in remission (patient 2: 14 years; patient 4: 6.5 years). Two patients were lost to follow-up while in remision (patient 6: 6 months; patient 7: 3 years); however, they did not show any signs of relapse. The Figure shows patient 6 at baseline and at 4 and 8 months after starting treatment with ERBT.
 

A 73-year-old man with extramammary Paget disease in the inguinal region at baseline (A) and 4 (B) and 8 (C) months after starting treatment with electron beam radiotherapy.

The most commonly reported side effect was mild dermatitis with reddening and desquamation. Patient 2 developed erosive radiodermatitis 4 days after the first treatment with EBRT. All acute reactions resolved with local treatment. Late side effects of EBRT were hyperpigmentation (patients 1 and 4) and mild skin atrophy (patient 4).

Comment

Because EMPD is such a rare disease, data regarding long-term treatment outcomes are mostly from small studies and case reports; evidence in the literature regarding treatment of EMPD with EBRT is especially limited. However, the good initial healing in most reported cases, the relatively low and late relapse rate, and the mild side effects reported in most cases make EBRT an effective treatment of EMPD. In the current study, initial complete remission was achieved in 6 of 7 patients. Patient 3 did not show complete macroscopic remission following EBRT but had a poor response to treatment in general, as she had already been unsuccessfully treated with several local treatments prior to EBRT; also, surgical and topical intervention following EBRT was not successful. Patient 5 relapsed after 6 years, but this case exceeds the follow-up period of many cases of EMPD found in the literature.

Overall, EBRT was well tolerated by the patients included in our study. All patients showed mild dermatitis following treatment as an acute reaction to EBRT. In most cases, these reactions resolved on their own or with topical treatment. Two patients developed late hyperpigmentation and one developed mild skin atrophy in the treatment area. One patient who was treated until a total dose of 5600 cGy was achieved developed erosive radiodermatitis, whereas the other patients were only treated 2 to 5 times per week. Side effects can therefore be considered as mild and/or easily controlled.

Luk et al¹ also observed a low rate of long-term relapse in patients with EMPD, but consistent EBRT with similar doses and settings were applied in our study. The following parameters showed the best results in treatment response, low side effects, and relapse rate: total dose of 4000 to 4800 cGy; 20 to 30 kV; electron current of 10 to 20 mA; 0.4- to 0.5-mm aluminum filter; 20-cm FSD. This dose is at the low end of those for the standard fractionation regimen, which is a total dose of 4200 to 7000 cGy using 200-cGy fractions.¹ The dose we used was slightly lower than the total dose recommended by Besa et al⁵ who treated 65 patients with radiotherapy for EMPD in 1992 (>50 Gy). It is equivalent to the doses used by Burrows et al⁶ and by Moreno-Arias et al³ (40–50 Gy). Lower radiograph doses may put treatment outcome at risk.⁷

Surgery is considered the first-line therapy for EMPD. Positive margin rates vary from 36% to 67% depending on the size of the lesion and the type of surgery that is used.⁵ Positive margin rates lead to a significant increase in recurrence rate (P<.001).⁸ Relapse rates for surgical intervention vary in the literature from 19% to 44%⁸ and 40% to 45% within 4 years of surgery.⁴ Wang et al⁸ reviewed long-term outcomes of surgical treatment in 130 Chinese patients with penoscrotal EMPD. They recommended 3-cm surgical margins and frozen section pathological examination for complicated conditions. A local recurrence rate of 9.9% was reported, which is remarkably lower than in many other studies in the literature.⁸ Nevertheless, the severe possible side effects of surgery cannot be easily put aside.

Electron beam radiotherapy should be considered as an alternate therapy in EMPD given its low risks and moderate side effects. In our study, the relapse rate was 28.6% (2/7), which is not remarkably higher than reports in the literature of relapse rates associated with surgical excision. Electron beam radiotherapy should be especially considered when extensive margin-controlled surgery is not an option, such as EMPD in sensitive areas or for an extensive circumference of the lesion, as surgery might then produce functional disfiguring results. Adequate limiting ray (grenz ray) or low-energy radiograph treatment has proved to preserve function, especially in the area of the vulva and glans penis.⁹ Furthermore, EBRT may be the treatment of choice in patients with an increased risk for morbidity from surgery, such as elderly patients⁵ or those with wound healing disorders (eg, diabetes mellitus).

Conclusion

Given that EMPD patients typically are elderly with multimorbidities, surgery should be carefully considered in this patient population, particularly because EMPD without underlying malignancies has an excellent survival rate.⁵ Highly invasive treatments should therefore be thoughtfully considered. Because of the inconsistent data on relapse rates and the small number of patients with EMPD who have been studied, further study with more cases is needed.

Extramammary Paget disease (EMPD) is an insidious intraepithelial neoplasm that occurs in areas with a high density of apocrine glands such as the penoscrotal area, the vulva, and occasionally the axillae. It mainly affects patients aged 50 to 80 years.¹ Clinically, EMPD presents as pruritic, nonhealing, red plaques that can be mistaken for eczema. On histology, characteristic Paget cells have abundant pale cytoplasm and atypical nuclear lobuli and are adenocarcinomatous,^1,2 usually infiltrating the epidermis.² In approximately 25% of cases, EMPD is associated with neoplastic disease in adnexal structures or organs with a contiguous epithelial lining.² Therefore, screening for an underlying malignancy when EMPD is first diagnosed is indispensable.

Because EMPD tends to be multifocal, presents in elderly patients, and affects functionally important areas such as the anal canal or genitals, treatment often is difficult.^3,4 Surgery generally is considered as a first-line treatment⁵; however, the rate of positive margins ranges from 36% to 67%, and local recurrence is common.¹

Radiotherapy has been used in EMPD patients mainly when surgery was not an option or was not effective, but several reports have indicated that it should play a more important role in the treatment of EMPD. Luk et al¹ described 6 patients who were treated with different types of radiotherapy. Similar to the results of prior studies,^3,5,6 they concluded that it was an effective treatment of EMPD.¹

We conducted a retrospective study to analyze long-term outcomes in 7 patients who were treated with external beam radiotherapy (EBRT) for EMPD.

Methods

Seven patients (6 men and 1 woman) who had been diagnosed with EMPD and were treated with EBRT at the Department of Dermatology at the University Hospital Zurich in Switzerland (1988-2004) were evaluated. The diagnosis was confirmed by a dermatopathologist or pathologist via histology. Data regarding clinical presentation, EBRT regimen, and side effects were retrieved from the medical records. Long-term outcomes were evaluated by an attending dermatologist (1 case), a general practitioner (5 cases), or the hospital’s outpatient department (1 case). None of the patients showed an associated malignancy at the time of treatment; however, patient 5 had been diagnosed with and treated for a sigmoid colon adenocarcinoma 6 years prior to undergoing EBRT for EMPD. Three patients (patients 3, 5, and 7) received EBRT for local relapse after prior treatment of EMPD (ie, CO₂ laser, multiple local treatments). One patient (patient 2) underwent surgical excision prior to EBRT. The remaining 3 patients had not undergone any prior treatment of EMPD. All patients underwent EBRT with the goal of complete remission.

Six patients received low-energy radiotherapy of 20 to 30 kV at doses of 200 to 400 cGy per day for 2 to 5 days per week until a total dose of 4000 to 5600 cGy was completed. A 0.4- to 0.5-mm aluminum filter was used, and the focus-skin distance (FSD) was 20 cm. One patient was treated with a radiograph of 40 kV at 400 cGy per day for 2 days per week until a total dose of 4800 cGy was completed. A 1.0-mm aluminum filter was used, and the FSD was 10 cm. The field of EBRT included 2-cm margins clear of all visible disease. The treatment parameters for all patients are outlined in the Table.

Results

Complete remission was initially obtained in 6 of 7 patients. In patient 3, an erosive perianal plaque remained following treatment with EBRT that was locally treated with imiquimod cream 3%. The patient relapsed 2.5 years later with a lesion in the vaginal area that was treated with imiquimod cream 3% and later via surgical excision. Complete remission was never achieved, and the patient died 7 years after EBRT treatment due to unrelated causes. Patient 5 relapsed after 6 years of remission following treatment with EBRT and also was treated with imiquimod.

At the time of this study, 1 patient remained in full remission (patient 1: 12 years) and 2 had died while in remission (patient 2: 14 years; patient 4: 6.5 years). Two patients were lost to follow-up while in remision (patient 6: 6 months; patient 7: 3 years); however, they did not show any signs of relapse. The Figure shows patient 6 at baseline and at 4 and 8 months after starting treatment with ERBT.
 

A 73-year-old man with extramammary Paget disease in the inguinal region at baseline (A) and 4 (B) and 8 (C) months after starting treatment with electron beam radiotherapy.

The most commonly reported side effect was mild dermatitis with reddening and desquamation. Patient 2 developed erosive radiodermatitis 4 days after the first treatment with EBRT. All acute reactions resolved with local treatment. Late side effects of EBRT were hyperpigmentation (patients 1 and 4) and mild skin atrophy (patient 4).

Comment

Because EMPD is such a rare disease, data regarding long-term treatment outcomes are mostly from small studies and case reports; evidence in the literature regarding treatment of EMPD with EBRT is especially limited. However, the good initial healing in most reported cases, the relatively low and late relapse rate, and the mild side effects reported in most cases make EBRT an effective treatment of EMPD. In the current study, initial complete remission was achieved in 6 of 7 patients. Patient 3 did not show complete macroscopic remission following EBRT but had a poor response to treatment in general, as she had already been unsuccessfully treated with several local treatments prior to EBRT; also, surgical and topical intervention following EBRT was not successful. Patient 5 relapsed after 6 years, but this case exceeds the follow-up period of many cases of EMPD found in the literature.

Overall, EBRT was well tolerated by the patients included in our study. All patients showed mild dermatitis following treatment as an acute reaction to EBRT. In most cases, these reactions resolved on their own or with topical treatment. Two patients developed late hyperpigmentation and one developed mild skin atrophy in the treatment area. One patient who was treated until a total dose of 5600 cGy was achieved developed erosive radiodermatitis, whereas the other patients were only treated 2 to 5 times per week. Side effects can therefore be considered as mild and/or easily controlled.

Luk et al¹ also observed a low rate of long-term relapse in patients with EMPD, but consistent EBRT with similar doses and settings were applied in our study. The following parameters showed the best results in treatment response, low side effects, and relapse rate: total dose of 4000 to 4800 cGy; 20 to 30 kV; electron current of 10 to 20 mA; 0.4- to 0.5-mm aluminum filter; 20-cm FSD. This dose is at the low end of those for the standard fractionation regimen, which is a total dose of 4200 to 7000 cGy using 200-cGy fractions.¹ The dose we used was slightly lower than the total dose recommended by Besa et al⁵ who treated 65 patients with radiotherapy for EMPD in 1992 (>50 Gy). It is equivalent to the doses used by Burrows et al⁶ and by Moreno-Arias et al³ (40–50 Gy). Lower radiograph doses may put treatment outcome at risk.⁷

Surgery is considered the first-line therapy for EMPD. Positive margin rates vary from 36% to 67% depending on the size of the lesion and the type of surgery that is used.⁵ Positive margin rates lead to a significant increase in recurrence rate (P<.001).⁸ Relapse rates for surgical intervention vary in the literature from 19% to 44%⁸ and 40% to 45% within 4 years of surgery.⁴ Wang et al⁸ reviewed long-term outcomes of surgical treatment in 130 Chinese patients with penoscrotal EMPD. They recommended 3-cm surgical margins and frozen section pathological examination for complicated conditions. A local recurrence rate of 9.9% was reported, which is remarkably lower than in many other studies in the literature.⁸ Nevertheless, the severe possible side effects of surgery cannot be easily put aside.

Electron beam radiotherapy should be considered as an alternate therapy in EMPD given its low risks and moderate side effects. In our study, the relapse rate was 28.6% (2/7), which is not remarkably higher than reports in the literature of relapse rates associated with surgical excision. Electron beam radiotherapy should be especially considered when extensive margin-controlled surgery is not an option, such as EMPD in sensitive areas or for an extensive circumference of the lesion, as surgery might then produce functional disfiguring results. Adequate limiting ray (grenz ray) or low-energy radiograph treatment has proved to preserve function, especially in the area of the vulva and glans penis.⁹ Furthermore, EBRT may be the treatment of choice in patients with an increased risk for morbidity from surgery, such as elderly patients⁵ or those with wound healing disorders (eg, diabetes mellitus).

Conclusion

Given that EMPD patients typically are elderly with multimorbidities, surgery should be carefully considered in this patient population, particularly because EMPD without underlying malignancies has an excellent survival rate.⁵ Highly invasive treatments should therefore be thoughtfully considered. Because of the inconsistent data on relapse rates and the small number of patients with EMPD who have been studied, further study with more cases is needed.

Extramammary Paget disease (EMPD) is an insidious intraepithelial neoplasm that occurs in areas with a high density of apocrine glands such as the penoscrotal area, the vulva, and occasionally the axillae. It mainly affects patients aged 50 to 80 years.¹ Clinically, EMPD presents as pruritic, nonhealing, red plaques that can be mistaken for eczema. On histology, characteristic Paget cells have abundant pale cytoplasm and atypical nuclear lobuli and are adenocarcinomatous,^1,2 usually infiltrating the epidermis.² In approximately 25% of cases, EMPD is associated with neoplastic disease in adnexal structures or organs with a contiguous epithelial lining.² Therefore, screening for an underlying malignancy when EMPD is first diagnosed is indispensable.

Because EMPD tends to be multifocal, presents in elderly patients, and affects functionally important areas such as the anal canal or genitals, treatment often is difficult.^3,4 Surgery generally is considered as a first-line treatment⁵; however, the rate of positive margins ranges from 36% to 67%, and local recurrence is common.¹

Radiotherapy has been used in EMPD patients mainly when surgery was not an option or was not effective, but several reports have indicated that it should play a more important role in the treatment of EMPD. Luk et al¹ described 6 patients who were treated with different types of radiotherapy. Similar to the results of prior studies,^3,5,6 they concluded that it was an effective treatment of EMPD.¹

We conducted a retrospective study to analyze long-term outcomes in 7 patients who were treated with external beam radiotherapy (EBRT) for EMPD.

Methods

Seven patients (6 men and 1 woman) who had been diagnosed with EMPD and were treated with EBRT at the Department of Dermatology at the University Hospital Zurich in Switzerland (1988-2004) were evaluated. The diagnosis was confirmed by a dermatopathologist or pathologist via histology. Data regarding clinical presentation, EBRT regimen, and side effects were retrieved from the medical records. Long-term outcomes were evaluated by an attending dermatologist (1 case), a general practitioner (5 cases), or the hospital’s outpatient department (1 case). None of the patients showed an associated malignancy at the time of treatment; however, patient 5 had been diagnosed with and treated for a sigmoid colon adenocarcinoma 6 years prior to undergoing EBRT for EMPD. Three patients (patients 3, 5, and 7) received EBRT for local relapse after prior treatment of EMPD (ie, CO₂ laser, multiple local treatments). One patient (patient 2) underwent surgical excision prior to EBRT. The remaining 3 patients had not undergone any prior treatment of EMPD. All patients underwent EBRT with the goal of complete remission.

Six patients received low-energy radiotherapy of 20 to 30 kV at doses of 200 to 400 cGy per day for 2 to 5 days per week until a total dose of 4000 to 5600 cGy was completed. A 0.4- to 0.5-mm aluminum filter was used, and the focus-skin distance (FSD) was 20 cm. One patient was treated with a radiograph of 40 kV at 400 cGy per day for 2 days per week until a total dose of 4800 cGy was completed. A 1.0-mm aluminum filter was used, and the FSD was 10 cm. The field of EBRT included 2-cm margins clear of all visible disease. The treatment parameters for all patients are outlined in the Table.

Results

Complete remission was initially obtained in 6 of 7 patients. In patient 3, an erosive perianal plaque remained following treatment with EBRT that was locally treated with imiquimod cream 3%. The patient relapsed 2.5 years later with a lesion in the vaginal area that was treated with imiquimod cream 3% and later via surgical excision. Complete remission was never achieved, and the patient died 7 years after EBRT treatment due to unrelated causes. Patient 5 relapsed after 6 years of remission following treatment with EBRT and also was treated with imiquimod.

At the time of this study, 1 patient remained in full remission (patient 1: 12 years) and 2 had died while in remission (patient 2: 14 years; patient 4: 6.5 years). Two patients were lost to follow-up while in remision (patient 6: 6 months; patient 7: 3 years); however, they did not show any signs of relapse. The Figure shows patient 6 at baseline and at 4 and 8 months after starting treatment with ERBT.
 

A 73-year-old man with extramammary Paget disease in the inguinal region at baseline (A) and 4 (B) and 8 (C) months after starting treatment with electron beam radiotherapy.

The most commonly reported side effect was mild dermatitis with reddening and desquamation. Patient 2 developed erosive radiodermatitis 4 days after the first treatment with EBRT. All acute reactions resolved with local treatment. Late side effects of EBRT were hyperpigmentation (patients 1 and 4) and mild skin atrophy (patient 4).

Comment

Because EMPD is such a rare disease, data regarding long-term treatment outcomes are mostly from small studies and case reports; evidence in the literature regarding treatment of EMPD with EBRT is especially limited. However, the good initial healing in most reported cases, the relatively low and late relapse rate, and the mild side effects reported in most cases make EBRT an effective treatment of EMPD. In the current study, initial complete remission was achieved in 6 of 7 patients. Patient 3 did not show complete macroscopic remission following EBRT but had a poor response to treatment in general, as she had already been unsuccessfully treated with several local treatments prior to EBRT; also, surgical and topical intervention following EBRT was not successful. Patient 5 relapsed after 6 years, but this case exceeds the follow-up period of many cases of EMPD found in the literature.

Overall, EBRT was well tolerated by the patients included in our study. All patients showed mild dermatitis following treatment as an acute reaction to EBRT. In most cases, these reactions resolved on their own or with topical treatment. Two patients developed late hyperpigmentation and one developed mild skin atrophy in the treatment area. One patient who was treated until a total dose of 5600 cGy was achieved developed erosive radiodermatitis, whereas the other patients were only treated 2 to 5 times per week. Side effects can therefore be considered as mild and/or easily controlled.

Luk et al¹ also observed a low rate of long-term relapse in patients with EMPD, but consistent EBRT with similar doses and settings were applied in our study. The following parameters showed the best results in treatment response, low side effects, and relapse rate: total dose of 4000 to 4800 cGy; 20 to 30 kV; electron current of 10 to 20 mA; 0.4- to 0.5-mm aluminum filter; 20-cm FSD. This dose is at the low end of those for the standard fractionation regimen, which is a total dose of 4200 to 7000 cGy using 200-cGy fractions.¹ The dose we used was slightly lower than the total dose recommended by Besa et al⁵ who treated 65 patients with radiotherapy for EMPD in 1992 (>50 Gy). It is equivalent to the doses used by Burrows et al⁶ and by Moreno-Arias et al³ (40–50 Gy). Lower radiograph doses may put treatment outcome at risk.⁷

Surgery is considered the first-line therapy for EMPD. Positive margin rates vary from 36% to 67% depending on the size of the lesion and the type of surgery that is used.⁵ Positive margin rates lead to a significant increase in recurrence rate (P<.001).⁸ Relapse rates for surgical intervention vary in the literature from 19% to 44%⁸ and 40% to 45% within 4 years of surgery.⁴ Wang et al⁸ reviewed long-term outcomes of surgical treatment in 130 Chinese patients with penoscrotal EMPD. They recommended 3-cm surgical margins and frozen section pathological examination for complicated conditions. A local recurrence rate of 9.9% was reported, which is remarkably lower than in many other studies in the literature.⁸ Nevertheless, the severe possible side effects of surgery cannot be easily put aside.

Electron beam radiotherapy should be considered as an alternate therapy in EMPD given its low risks and moderate side effects. In our study, the relapse rate was 28.6% (2/7), which is not remarkably higher than reports in the literature of relapse rates associated with surgical excision. Electron beam radiotherapy should be especially considered when extensive margin-controlled surgery is not an option, such as EMPD in sensitive areas or for an extensive circumference of the lesion, as surgery might then produce functional disfiguring results. Adequate limiting ray (grenz ray) or low-energy radiograph treatment has proved to preserve function, especially in the area of the vulva and glans penis.⁹ Furthermore, EBRT may be the treatment of choice in patients with an increased risk for morbidity from surgery, such as elderly patients⁵ or those with wound healing disorders (eg, diabetes mellitus).

Conclusion

Given that EMPD patients typically are elderly with multimorbidities, surgery should be carefully considered in this patient population, particularly because EMPD without underlying malignancies has an excellent survival rate.⁵ Highly invasive treatments should therefore be thoughtfully considered. Because of the inconsistent data on relapse rates and the small number of patients with EMPD who have been studied, further study with more cases is needed.

The VHA cares for 170,000 patients with chronic hepatitis C virus (HCV) infection, making it the largest single provider of medical care to chronic HCV patients in the U.S.¹ Although HCV treatment rates within the VHA outpace those of the private sector, only half of patients with HCV infection within the VHA have accessed a liver specialist and less than a quarter have received antiviral medication.^2-4

Newer HCV treatment regimens promise treatment sustained virologic response (SVR) rates—a marker of viral clearance posttreatment—of ≥ 90% in most cases but require careful patient selection and management.⁵  In particular, the estimated 24% of patients with HCV infection with advanced liver disease require more rapid consideration for therapy to reduce complications of cirrhosis such as liver failure, hepatocellular carcinoma, and death.⁶ With the advent of promising HCV therapies and rising rates of cirrhosis, there is an urgent need for population health management approach to deliver HCV care more widely and effectively.^5,7

Rationale for Clinical Dashboards

Although the VHA hosts the largest integrated electronic medical record (EMR) system in the U.S., an EMR on its own does not guarantee improved patient care or access.⁸ EMRs can be used to document health care delivery, but they do not routinely provide information about the burden of disease in a population, nor do they identify patients most in need of care.

Clinical dashboards are tools that are geared to provide clinicians with relevant data to improve patient care. Early clinical dashboard development across the VHA was primary care focused, targeting patients with diabetes, ischemic heart disease, and hypertension. This national primary care dashboard provides clinically relevant, actionable data and enables the clinical provider to track patient progress. In addition, regional data can be aggregated for use by VISN managers.
While the impact of dashboards on quality of care is not well investigated, it remains a vital tool with the potential to transform care.⁹

HCV dashboards have been developed by individual VISNs and facilities across the VHA. HCV dashboards serve to identify patients most in need of antiviral therapy, expand outreach to those previously unseen by specialty care, sort patients by severity of liver disease, track treatment status, and calculate SVR.

Current HCV dashboards incorporate elements derived from the VA Corporate Data Warehouse (CDW), a national VA data repository consisting of data from all facilities’ electronic medical record systems. Updated information from the previous day is made available in VISN data warehouses and is refreshed nightly. The final result is user-friendly clinical data available in near-real time to dashboard users.

VISN 21 HCV Dashboard

Purpose and Elements

The VISN 21 HCV dashboard will be discussed as a prototype. Graphics of the VISN 21 dashboard interface are presented in Figure 1 and Figure 2. The VISN 21 HCV dashboard was developed by pharmacists with specialty training in medical informatics, health care analytics, and data management. The dashboard addresses 3 previously unmet needs in HCV care: population management, patient treatment outcome tracking, and administrative planning.

Population management. The VISN 21 HCV dashboard allows for a centralized approach to care across a large geographic area containing multiple facilities. One important function is to identify patients with advanced liver disease as well as those who have not been seen in specialty care within the previous 2 years. It also allows for pretreatment screening through identification of HCV viral characteristics (eg, genotype, viral load) and selected comorbidities (eg, renal function, mental health conditions) that may influence candidacy for specific antiviral therapies. Individual patient reports can be stratified by facility (eg, clinic or VAMC) to identify the burden of disease within a specific location.

Patient treatment outcome tracking. The HCV dashboard allows tracking of the numbers and characteristics of patients who have previously received antiviral therapy. The number of patients achieving virologic cure may be tracked at the VISN and station levels, or displayed based on user-selected parameters, such as treatment history.

Administrative planning. The high costs of HCV antiviral medication requires careful budgetary planning and close communication with local and regional leadership. The VISN 21 HCV dashboard provides information crucial to assessing future treatment needs. Specifically, it allows administrators to view the number of patients actively being treated. The dashboard also allows for comparison of treatment rates among different facilities and help allocate resources where needed.

Design Architecture

To construct the source data for the dashboards, relevant data elements are pulled into a base table using Structured Query Language (SQL) code. Subsequently, SQL Server Reporting Services (SSRS) (Microsoft, Redmond, WA) compiles the dashboard output into an interactive and user-friendly interface that can be tailored to individual end users’ needs.

Dashboard development process. Through collaboration and survey of clinical providers, clinical factors necessary to decide patient and treatment readiness were identified. Relevant data elements include HCV genotype, selected medical and psychiatric comorbidities, prior receipt of treatment, and presence of advanced liver disease. While liver disease severity may be determined by invasive means, such as liver biopsy, the dashboard offers a noninvasive assessment using laboratory values (eg, calculated Fibrosis 4 score, Model for End Stage Liver Disease score).^10,11

Once dashboard elements were selected, the variables were operationalized using data available in the CDW within the prescription, diagnostic, and laboratory data tables. As code was written, output was validated through chart review to ensure accuracy. Further validation was performed through comparison of the dashboard data with the clinical case registry, a registry of HCV viremic confirmed patients. Throughout dashboard development, the product was presented to end users to solicit requests for modifications. The code was refined over time to incorporate end user input.

Dashboard user interface. SSRS allows users to customize reports based on any variables defined within the data set including facility, severity of disease, HCV genotype, and prior antiviral treatment history among others. Results are displayed with summary information, including the total number of patients in the selected cohort, the number of patients who have been referred to a specialty liver clinic, and the number of patients who have been determined to achieve SVR. The end user has the option to export the results to excel for further use (eg, patient lists for telephone follow-up).

User recruitment. After piloting, the VISN 21 HCV dashboard was introduced during monthly pharmacy meetings and clinical telehealth encounters with providers. Feedback was solicited during the presentations and through postdevelopment surveys. In particular, providers requested spreadsheet-friendly formatting, additional informational fields consisting of mental health and substance abuse diagnoses, and identification of all patients with HCV regardless
of disease severity. A key element of dashboard refinement includes enhancing usability by solicitation of user feedback with subsequent tailoring of the user interface.¹²

Challenges

Many challenges exist in clinical dashboard development, expansion, and implementation including data integrity, workflow, and work culture. Data elements are often variable within a single facility, and this variation increases when identifying the same elements across facilities. For example, a laboratory test name (eg, “serum creatinine”) may exist with 2 to 3 different labels (eg, “creat,” “SCr,” “serum Cr”) within a single facility. As the variation increases, potential for inappropriate laboratory tests may be increased. Specialty clinic names also vary within and between facilities.

Local nomenclature for HCV clinic names may include “liver,” “infectious disease,” “hepatitis c,” or some variation, making it crucial for the dashboard developer to work closely with clinical staff to accurately matchspecialty clinic names being pulled from the data warehouse. Given the complexities of naming nomenclature within VA data, dashboard development requires a substantial investment of code customization and validation.

Ongoing dashboard maintenance is another important challenge due to the need for staff trained in SQL coding and familiarity with VA data warehouse architecture. Consequently, until the VHA dedicates resources to maintain such dashboards, only VISNs with existing technical knowledge and staffing will benefit from dashboards.

Usability, typically defined as “…effectiveness, efficiency and satisfaction with which the intended users can achieve their tasks in the intended context of product use,” is an additional consideration as the HCV clinical dashboard disseminates nationally.¹³ Standard clinic workflow is not always conducive to the use of dashboards. VHA providers use the Computerized Patient Record System (CPRS) to review and document patient notes. However, accessing the HCV dashboard involves a site hosted outside of CPRS, thereby requiring the user to take several extra steps. These and other usability factors will need to be considered as the dashboard disseminates more widely.

Finally, data describing the effectiveness of clinical dashboards is very limited. VISN 21 is tracking the number of users accessing the dashboard. However, further study is needed to determine if clinical dashboards improve patient access and quality of care as well as factors to enhance usability

Conclusion

Clinical dashboards have the ability to transform each clinical provider into a population health manager who can readily identify patients most in need of care within their facility catchment area and beyond. As HCV dashboard development and implementation grows across the VHA, there is a need to pair clinical and technological advancements with greater patient outreach and shared best practices. Understanding the factors that tie improved quality of care with usability as well as investment in dashboard development and related efforts will likely keep the VHA in the forefront of chronic care delivery.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

The VHA cares for 170,000 patients with chronic hepatitis C virus (HCV) infection, making it the largest single provider of medical care to chronic HCV patients in the U.S.¹ Although HCV treatment rates within the VHA outpace those of the private sector, only half of patients with HCV infection within the VHA have accessed a liver specialist and less than a quarter have received antiviral medication.^2-4

Newer HCV treatment regimens promise treatment sustained virologic response (SVR) rates—a marker of viral clearance posttreatment—of ≥ 90% in most cases but require careful patient selection and management.⁵  In particular, the estimated 24% of patients with HCV infection with advanced liver disease require more rapid consideration for therapy to reduce complications of cirrhosis such as liver failure, hepatocellular carcinoma, and death.⁶ With the advent of promising HCV therapies and rising rates of cirrhosis, there is an urgent need for population health management approach to deliver HCV care more widely and effectively.^5,7

Rationale for Clinical Dashboards

Although the VHA hosts the largest integrated electronic medical record (EMR) system in the U.S., an EMR on its own does not guarantee improved patient care or access.⁸ EMRs can be used to document health care delivery, but they do not routinely provide information about the burden of disease in a population, nor do they identify patients most in need of care.

Clinical dashboards are tools that are geared to provide clinicians with relevant data to improve patient care. Early clinical dashboard development across the VHA was primary care focused, targeting patients with diabetes, ischemic heart disease, and hypertension. This national primary care dashboard provides clinically relevant, actionable data and enables the clinical provider to track patient progress. In addition, regional data can be aggregated for use by VISN managers.
While the impact of dashboards on quality of care is not well investigated, it remains a vital tool with the potential to transform care.⁹

HCV dashboards have been developed by individual VISNs and facilities across the VHA. HCV dashboards serve to identify patients most in need of antiviral therapy, expand outreach to those previously unseen by specialty care, sort patients by severity of liver disease, track treatment status, and calculate SVR.

Current HCV dashboards incorporate elements derived from the VA Corporate Data Warehouse (CDW), a national VA data repository consisting of data from all facilities’ electronic medical record systems. Updated information from the previous day is made available in VISN data warehouses and is refreshed nightly. The final result is user-friendly clinical data available in near-real time to dashboard users.

VISN 21 HCV Dashboard

Purpose and Elements

The VISN 21 HCV dashboard will be discussed as a prototype. Graphics of the VISN 21 dashboard interface are presented in Figure 1 and Figure 2. The VISN 21 HCV dashboard was developed by pharmacists with specialty training in medical informatics, health care analytics, and data management. The dashboard addresses 3 previously unmet needs in HCV care: population management, patient treatment outcome tracking, and administrative planning.

Population management. The VISN 21 HCV dashboard allows for a centralized approach to care across a large geographic area containing multiple facilities. One important function is to identify patients with advanced liver disease as well as those who have not been seen in specialty care within the previous 2 years. It also allows for pretreatment screening through identification of HCV viral characteristics (eg, genotype, viral load) and selected comorbidities (eg, renal function, mental health conditions) that may influence candidacy for specific antiviral therapies. Individual patient reports can be stratified by facility (eg, clinic or VAMC) to identify the burden of disease within a specific location.

Patient treatment outcome tracking. The HCV dashboard allows tracking of the numbers and characteristics of patients who have previously received antiviral therapy. The number of patients achieving virologic cure may be tracked at the VISN and station levels, or displayed based on user-selected parameters, such as treatment history.

Administrative planning. The high costs of HCV antiviral medication requires careful budgetary planning and close communication with local and regional leadership. The VISN 21 HCV dashboard provides information crucial to assessing future treatment needs. Specifically, it allows administrators to view the number of patients actively being treated. The dashboard also allows for comparison of treatment rates among different facilities and help allocate resources where needed.

Design Architecture

To construct the source data for the dashboards, relevant data elements are pulled into a base table using Structured Query Language (SQL) code. Subsequently, SQL Server Reporting Services (SSRS) (Microsoft, Redmond, WA) compiles the dashboard output into an interactive and user-friendly interface that can be tailored to individual end users’ needs.

Dashboard development process. Through collaboration and survey of clinical providers, clinical factors necessary to decide patient and treatment readiness were identified. Relevant data elements include HCV genotype, selected medical and psychiatric comorbidities, prior receipt of treatment, and presence of advanced liver disease. While liver disease severity may be determined by invasive means, such as liver biopsy, the dashboard offers a noninvasive assessment using laboratory values (eg, calculated Fibrosis 4 score, Model for End Stage Liver Disease score).^10,11

Once dashboard elements were selected, the variables were operationalized using data available in the CDW within the prescription, diagnostic, and laboratory data tables. As code was written, output was validated through chart review to ensure accuracy. Further validation was performed through comparison of the dashboard data with the clinical case registry, a registry of HCV viremic confirmed patients. Throughout dashboard development, the product was presented to end users to solicit requests for modifications. The code was refined over time to incorporate end user input.

Dashboard user interface. SSRS allows users to customize reports based on any variables defined within the data set including facility, severity of disease, HCV genotype, and prior antiviral treatment history among others. Results are displayed with summary information, including the total number of patients in the selected cohort, the number of patients who have been referred to a specialty liver clinic, and the number of patients who have been determined to achieve SVR. The end user has the option to export the results to excel for further use (eg, patient lists for telephone follow-up).

User recruitment. After piloting, the VISN 21 HCV dashboard was introduced during monthly pharmacy meetings and clinical telehealth encounters with providers. Feedback was solicited during the presentations and through postdevelopment surveys. In particular, providers requested spreadsheet-friendly formatting, additional informational fields consisting of mental health and substance abuse diagnoses, and identification of all patients with HCV regardless
of disease severity. A key element of dashboard refinement includes enhancing usability by solicitation of user feedback with subsequent tailoring of the user interface.¹²

Challenges

Many challenges exist in clinical dashboard development, expansion, and implementation including data integrity, workflow, and work culture. Data elements are often variable within a single facility, and this variation increases when identifying the same elements across facilities. For example, a laboratory test name (eg, “serum creatinine”) may exist with 2 to 3 different labels (eg, “creat,” “SCr,” “serum Cr”) within a single facility. As the variation increases, potential for inappropriate laboratory tests may be increased. Specialty clinic names also vary within and between facilities.

Local nomenclature for HCV clinic names may include “liver,” “infectious disease,” “hepatitis c,” or some variation, making it crucial for the dashboard developer to work closely with clinical staff to accurately matchspecialty clinic names being pulled from the data warehouse. Given the complexities of naming nomenclature within VA data, dashboard development requires a substantial investment of code customization and validation.

Ongoing dashboard maintenance is another important challenge due to the need for staff trained in SQL coding and familiarity with VA data warehouse architecture. Consequently, until the VHA dedicates resources to maintain such dashboards, only VISNs with existing technical knowledge and staffing will benefit from dashboards.

Usability, typically defined as “…effectiveness, efficiency and satisfaction with which the intended users can achieve their tasks in the intended context of product use,” is an additional consideration as the HCV clinical dashboard disseminates nationally.¹³ Standard clinic workflow is not always conducive to the use of dashboards. VHA providers use the Computerized Patient Record System (CPRS) to review and document patient notes. However, accessing the HCV dashboard involves a site hosted outside of CPRS, thereby requiring the user to take several extra steps. These and other usability factors will need to be considered as the dashboard disseminates more widely.

Finally, data describing the effectiveness of clinical dashboards is very limited. VISN 21 is tracking the number of users accessing the dashboard. However, further study is needed to determine if clinical dashboards improve patient access and quality of care as well as factors to enhance usability

Conclusion

Clinical dashboards have the ability to transform each clinical provider into a population health manager who can readily identify patients most in need of care within their facility catchment area and beyond. As HCV dashboard development and implementation grows across the VHA, there is a need to pair clinical and technological advancements with greater patient outreach and shared best practices. Understanding the factors that tie improved quality of care with usability as well as investment in dashboard development and related efforts will likely keep the VHA in the forefront of chronic care delivery.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

The VHA cares for 170,000 patients with chronic hepatitis C virus (HCV) infection, making it the largest single provider of medical care to chronic HCV patients in the U.S.¹ Although HCV treatment rates within the VHA outpace those of the private sector, only half of patients with HCV infection within the VHA have accessed a liver specialist and less than a quarter have received antiviral medication.^2-4

Newer HCV treatment regimens promise treatment sustained virologic response (SVR) rates—a marker of viral clearance posttreatment—of ≥ 90% in most cases but require careful patient selection and management.⁵  In particular, the estimated 24% of patients with HCV infection with advanced liver disease require more rapid consideration for therapy to reduce complications of cirrhosis such as liver failure, hepatocellular carcinoma, and death.⁶ With the advent of promising HCV therapies and rising rates of cirrhosis, there is an urgent need for population health management approach to deliver HCV care more widely and effectively.^5,7

Rationale for Clinical Dashboards

Although the VHA hosts the largest integrated electronic medical record (EMR) system in the U.S., an EMR on its own does not guarantee improved patient care or access.⁸ EMRs can be used to document health care delivery, but they do not routinely provide information about the burden of disease in a population, nor do they identify patients most in need of care.

Clinical dashboards are tools that are geared to provide clinicians with relevant data to improve patient care. Early clinical dashboard development across the VHA was primary care focused, targeting patients with diabetes, ischemic heart disease, and hypertension. This national primary care dashboard provides clinically relevant, actionable data and enables the clinical provider to track patient progress. In addition, regional data can be aggregated for use by VISN managers.
While the impact of dashboards on quality of care is not well investigated, it remains a vital tool with the potential to transform care.⁹

HCV dashboards have been developed by individual VISNs and facilities across the VHA. HCV dashboards serve to identify patients most in need of antiviral therapy, expand outreach to those previously unseen by specialty care, sort patients by severity of liver disease, track treatment status, and calculate SVR.

Current HCV dashboards incorporate elements derived from the VA Corporate Data Warehouse (CDW), a national VA data repository consisting of data from all facilities’ electronic medical record systems. Updated information from the previous day is made available in VISN data warehouses and is refreshed nightly. The final result is user-friendly clinical data available in near-real time to dashboard users.

VISN 21 HCV Dashboard

Purpose and Elements

The VISN 21 HCV dashboard will be discussed as a prototype. Graphics of the VISN 21 dashboard interface are presented in Figure 1 and Figure 2. The VISN 21 HCV dashboard was developed by pharmacists with specialty training in medical informatics, health care analytics, and data management. The dashboard addresses 3 previously unmet needs in HCV care: population management, patient treatment outcome tracking, and administrative planning.

Population management. The VISN 21 HCV dashboard allows for a centralized approach to care across a large geographic area containing multiple facilities. One important function is to identify patients with advanced liver disease as well as those who have not been seen in specialty care within the previous 2 years. It also allows for pretreatment screening through identification of HCV viral characteristics (eg, genotype, viral load) and selected comorbidities (eg, renal function, mental health conditions) that may influence candidacy for specific antiviral therapies. Individual patient reports can be stratified by facility (eg, clinic or VAMC) to identify the burden of disease within a specific location.

Patient treatment outcome tracking. The HCV dashboard allows tracking of the numbers and characteristics of patients who have previously received antiviral therapy. The number of patients achieving virologic cure may be tracked at the VISN and station levels, or displayed based on user-selected parameters, such as treatment history.

Administrative planning. The high costs of HCV antiviral medication requires careful budgetary planning and close communication with local and regional leadership. The VISN 21 HCV dashboard provides information crucial to assessing future treatment needs. Specifically, it allows administrators to view the number of patients actively being treated. The dashboard also allows for comparison of treatment rates among different facilities and help allocate resources where needed.

Design Architecture

To construct the source data for the dashboards, relevant data elements are pulled into a base table using Structured Query Language (SQL) code. Subsequently, SQL Server Reporting Services (SSRS) (Microsoft, Redmond, WA) compiles the dashboard output into an interactive and user-friendly interface that can be tailored to individual end users’ needs.

Dashboard development process. Through collaboration and survey of clinical providers, clinical factors necessary to decide patient and treatment readiness were identified. Relevant data elements include HCV genotype, selected medical and psychiatric comorbidities, prior receipt of treatment, and presence of advanced liver disease. While liver disease severity may be determined by invasive means, such as liver biopsy, the dashboard offers a noninvasive assessment using laboratory values (eg, calculated Fibrosis 4 score, Model for End Stage Liver Disease score).^10,11

Once dashboard elements were selected, the variables were operationalized using data available in the CDW within the prescription, diagnostic, and laboratory data tables. As code was written, output was validated through chart review to ensure accuracy. Further validation was performed through comparison of the dashboard data with the clinical case registry, a registry of HCV viremic confirmed patients. Throughout dashboard development, the product was presented to end users to solicit requests for modifications. The code was refined over time to incorporate end user input.

Dashboard user interface. SSRS allows users to customize reports based on any variables defined within the data set including facility, severity of disease, HCV genotype, and prior antiviral treatment history among others. Results are displayed with summary information, including the total number of patients in the selected cohort, the number of patients who have been referred to a specialty liver clinic, and the number of patients who have been determined to achieve SVR. The end user has the option to export the results to excel for further use (eg, patient lists for telephone follow-up).

User recruitment. After piloting, the VISN 21 HCV dashboard was introduced during monthly pharmacy meetings and clinical telehealth encounters with providers. Feedback was solicited during the presentations and through postdevelopment surveys. In particular, providers requested spreadsheet-friendly formatting, additional informational fields consisting of mental health and substance abuse diagnoses, and identification of all patients with HCV regardless
of disease severity. A key element of dashboard refinement includes enhancing usability by solicitation of user feedback with subsequent tailoring of the user interface.¹²

Challenges

Many challenges exist in clinical dashboard development, expansion, and implementation including data integrity, workflow, and work culture. Data elements are often variable within a single facility, and this variation increases when identifying the same elements across facilities. For example, a laboratory test name (eg, “serum creatinine”) may exist with 2 to 3 different labels (eg, “creat,” “SCr,” “serum Cr”) within a single facility. As the variation increases, potential for inappropriate laboratory tests may be increased. Specialty clinic names also vary within and between facilities.

Local nomenclature for HCV clinic names may include “liver,” “infectious disease,” “hepatitis c,” or some variation, making it crucial for the dashboard developer to work closely with clinical staff to accurately matchspecialty clinic names being pulled from the data warehouse. Given the complexities of naming nomenclature within VA data, dashboard development requires a substantial investment of code customization and validation.

Ongoing dashboard maintenance is another important challenge due to the need for staff trained in SQL coding and familiarity with VA data warehouse architecture. Consequently, until the VHA dedicates resources to maintain such dashboards, only VISNs with existing technical knowledge and staffing will benefit from dashboards.

Usability, typically defined as “…effectiveness, efficiency and satisfaction with which the intended users can achieve their tasks in the intended context of product use,” is an additional consideration as the HCV clinical dashboard disseminates nationally.¹³ Standard clinic workflow is not always conducive to the use of dashboards. VHA providers use the Computerized Patient Record System (CPRS) to review and document patient notes. However, accessing the HCV dashboard involves a site hosted outside of CPRS, thereby requiring the user to take several extra steps. These and other usability factors will need to be considered as the dashboard disseminates more widely.

Finally, data describing the effectiveness of clinical dashboards is very limited. VISN 21 is tracking the number of users accessing the dashboard. However, further study is needed to determine if clinical dashboards improve patient access and quality of care as well as factors to enhance usability

Conclusion

Clinical dashboards have the ability to transform each clinical provider into a population health manager who can readily identify patients most in need of care within their facility catchment area and beyond. As HCV dashboard development and implementation grows across the VHA, there is a need to pair clinical and technological advancements with greater patient outreach and shared best practices. Understanding the factors that tie improved quality of care with usability as well as investment in dashboard development and related efforts will likely keep the VHA in the forefront of chronic care delivery.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

There are a variety of well-established methods for diagnosing dermatophyte infections, including potassium hydroxide (KOH) preparations, fungal cultures, and skin biopsies. Each modality has its place in clinical practice, but they also have drawbacks. Reflectance confocal microscopy (RCM) is an emerging in vivo technology that could potentially serve as a sensitive, rapid, and noninvasive method of diagnosing dermatophytosis. Using near-infrared laser light scanning, RCM provides a quick noninvasive method of generating black-and-white, horizontal, quasipathology images that allow for the identification of cells and other structures similar to dermoscopy and histopathology.¹ The images are obtained in a fully noninvasive fashion, as the device is placed in contact with the skin using a liquid medium. The process takes 5 to 15 minutes depending on the number of images obtained, and the images can then be displayed in real time on a computer screen or transmitted to a pathologist for evaluation.

Most initial applications of RCM focused on evaluating melanocytic lesions with the primary goal of differentiating between benign nevi and melanomas, thus reducing the need for skin biopsies.^2-4 Efforts to develop RCM diagnostic criteria for identification of other skin cancers^5,6 as well as to aid in the diagnosis of nonneoplastic skin conditions are ongoing.⁷ The potential applications of RCM are virtually limitless, as this modality can (at least partially) take the place of biopsies in a variety of clinical scenarios.^2,8 Few reports have documented the utility of RCM as a diagnostic tool for onychomycosis^9,10 and dermatophytic infections of the skin.^11,12 Hui et al¹³ reported use for RCM for microscopic evaluation of mycelium features. Turan et al¹⁴ found that RCM could not replace the current diagnostic standards for tinea incognito but may be successfully used as an in vivo noninvasive screening tool to facilitate diagnosis. Because it provides high-resolution horizontal images extending from the surface of the stratum corneum to the superficial reticular dermis, RCM could be an effective tool in the diagnosis of cutaneous dermatophyte infections, as organisms usually are located in the stratum corneum of the epidermis in this infection. Branching hyphae are readily visible in the stratum corneum on RCM (Figure).

Branching hyphae (red arrows) seen in the epidermis on reflectance confocal microscopy.

We reviewed a series of 9 cases from a private practice setting in which RCM was used to diagnose dermatophytosis. We compared the diagnostic accuracy of RCM to results from other diagnostic methods and the ultimate clinical outcome to determine the usefulness of this new technology.

Methods

Our retrospective chart review included all cases in which RCM was used and the clinical differential diagnosis included tinea corporis over a 4-month period in a private, single-specialty dermatology practice. All patients were treated by the same dermatologist. The RCM images were taken using an imaging system that had a horizontal optical resolution of less than 1.25 μm and a vertical optical resolution of less than 5.0 μm. The imaging was performed by medical assistants who were trained by the device manufacturer.

The sample sites were cleaned with isopropyl alcohol and a translucent contact ring was affixed to the skin using a liquid medium. The imaging head of the device was connected to the imaging ring and the images were taken. Identical imaging protocol was used in all patients. Multiple sets of horizontal images and one stack of vertical images were obtained. Patients reported no discomfort during the procedure, and the entire process was usually completed within 15 minutes. The images were sent to the pathologist for evaluation using the manufacturer’s telepathology system and were returned with a diagnosis within 24 hours. (On-site, real-time diagnosis also is possible if the dermatologist is trained in interpreting the images.)

In the chart review we looked for other diagnostic methods used as well as clinical outcomes. A case was considered to be positive for dermatophytic infection if any of the other diagnostic modalities yielded positive results or if a definitive resolution of the condition could be achieved using antifungal treatments alone.

Results

Ten patients (mean age, 43.1 years; age range, 16–76 years) with lesions that presented as possible dermatophytic infections underwent RCM analysis. In addition to RCM imaging, 5 patients underwent KOH testing of skin scrapings, 3 underwent analysis by fungal culture utilizing dermatophyte test medium (DTM), and 5 underwent biopsies. The findings are further summarized in the Table. One patient (patient 5) was excluded from the study because the RCM could not be evaluated due to the poor quality of the confocal images. Additionally, 2 patients (patients 2 and 7) had suboptimal imaging, which limited the evaluation.

Of the 9 evaluable cases, 4 (patients 1–4) were determined to be positive for the presence of dermatophytic infection through the fulfillment of criteria independent of RCM imaging. In each of those 4 cases, RCM images revealed the presence of hyphae, which indicated the presence of dermato-phytic infection. In these 4 cases, RCM and other diagnostic methods reached the same diagnosis.

In the other 5 cases (patients 6–10), the final diagnosis was not a dermatophytic infection. In 4 of those cases (patients 7–10), there were no signs of any structure resembling hyphae on the RCM images; however, in 1 case (patient 6), the RCM images showed structures that were consistent with the appearance of hyphae to the extent that the investigators, based solely on analysis of the RCM images, deemed a diagnosis indicating presence of a dermatophytic infection to be valid. In this case, a 38-year-old man presented with extensive scaly patches on the back of several months’ duration. Repeated skin biopsies showed hyperkeratosis and occasionally minimal spongiosis, while periodic acid–Schiff staining did not reveal fungal elements. Fungal cultures and KOH preparations were negative. Prior treatments with topical antifungals and steroids failed to improve the condition, which resolved rapidly with urea cream 40%. The interpretation of the RCM images in this patient did not match up with the results obtained from other methods of diagnosis and the clinical outcome; thus, we classified it as an incorrect diagnosis based on RCM analysis alone. In total, successful diagnosis using RCM imaging was achieved in 8 of 9 cases included in the analysis.

Comment

In this chart review, we evaluated the utility of using RCM in the diagnosis of dermatophytic infections of the skin by comparing findings noted on confocal imaging with those of other methods of diagnosis (Table). We included cases in which the clinical presentation raised the possibility of dermatophytic infection. Cases were considered positive for dermatophytes if KOH preparation, fungal culture, or skin biopsy (with or without periodic acid–Schiff staining) were positive or if there was a complete response to antifungal treatment alone. In this small number of cases, we found that RCM was 100% sensitive, as hyphae were readily seen in all cases of dermatophytic infections. In 1 RCM-positive case (patient 3), fungal culture with DTM was negative, but antifungal therapy was nonetheless given. Because the lesion resolved promptly with econazole, RCM proved to be true positive and DTM proved to be false negative (Table). Reflectance confocal microscopy imaging, however, was less specific. Of the 5 cases that showed no presence of dermatophytic infection, there was 1 case (patient 6) in which the pathologist could recognize structures that resembled fungal hyphae. There are various possible sources of structures masquerading as dermatophytes on confocal imaging, including the edges of nonnucleated loose keratinocytes, keratin fragments, and other foreign fibers. Evaluation by an experienced investigator can certainly help in limiting false-positive analyses, but a larger case study would be useful to develop a set of specific criteria to aid in the differentiation of fungal hyphae from other artifacts as well as to further define the sensitivity and specificity of RCM.

We also encountered difficulties with the technical aspects of RCM. One case (patient 5) was excluded from the analysis because the images were poor quality and could not be interpreted, and 2 cases (patients 2 and 7) had suboptimal images, in part due to operator error and in part due to equipment error that was recognized later on. The technical difficulties were problematic because no immediate review of image quality was available while patients were still present for possible reimaging. All of the images evaluated in this study were captured shortly after the RCM device was introduced to the practice. It is possible that with more training and a quick, on-site review of image quality, these technical problems could be avoided. Imaging protocols (ie, numbers and levels of scans taken by the confocal microscope) also could be adjusted so they include a large enough range to compensate for potential operator errors; however, these adjustments also could increase overall imaging time.

Conclusion

Based on our chart review of a small number of cases, we found that RCM can be a useful tool in diagnosing dermatophytic infections of the skin. With adequate training, dermatologists may be able to use RCM as an in-office tool to capture and evaluate images and subsequently diagnose or exclude dermatophytosis in a quick and noninvasive manner. However, further research and controlled studies of more cases will be required to develop accurate criteria for diagnosing fungal structures by RCM as well as to help determine the role of RCM in our diagnostic armamentarium.

There are a variety of well-established methods for diagnosing dermatophyte infections, including potassium hydroxide (KOH) preparations, fungal cultures, and skin biopsies. Each modality has its place in clinical practice, but they also have drawbacks. Reflectance confocal microscopy (RCM) is an emerging in vivo technology that could potentially serve as a sensitive, rapid, and noninvasive method of diagnosing dermatophytosis. Using near-infrared laser light scanning, RCM provides a quick noninvasive method of generating black-and-white, horizontal, quasipathology images that allow for the identification of cells and other structures similar to dermoscopy and histopathology.¹ The images are obtained in a fully noninvasive fashion, as the device is placed in contact with the skin using a liquid medium. The process takes 5 to 15 minutes depending on the number of images obtained, and the images can then be displayed in real time on a computer screen or transmitted to a pathologist for evaluation.

Most initial applications of RCM focused on evaluating melanocytic lesions with the primary goal of differentiating between benign nevi and melanomas, thus reducing the need for skin biopsies.^2-4 Efforts to develop RCM diagnostic criteria for identification of other skin cancers^5,6 as well as to aid in the diagnosis of nonneoplastic skin conditions are ongoing.⁷ The potential applications of RCM are virtually limitless, as this modality can (at least partially) take the place of biopsies in a variety of clinical scenarios.^2,8 Few reports have documented the utility of RCM as a diagnostic tool for onychomycosis^9,10 and dermatophytic infections of the skin.^11,12 Hui et al¹³ reported use for RCM for microscopic evaluation of mycelium features. Turan et al¹⁴ found that RCM could not replace the current diagnostic standards for tinea incognito but may be successfully used as an in vivo noninvasive screening tool to facilitate diagnosis. Because it provides high-resolution horizontal images extending from the surface of the stratum corneum to the superficial reticular dermis, RCM could be an effective tool in the diagnosis of cutaneous dermatophyte infections, as organisms usually are located in the stratum corneum of the epidermis in this infection. Branching hyphae are readily visible in the stratum corneum on RCM (Figure).

Branching hyphae (red arrows) seen in the epidermis on reflectance confocal microscopy.

We reviewed a series of 9 cases from a private practice setting in which RCM was used to diagnose dermatophytosis. We compared the diagnostic accuracy of RCM to results from other diagnostic methods and the ultimate clinical outcome to determine the usefulness of this new technology.

Methods

Our retrospective chart review included all cases in which RCM was used and the clinical differential diagnosis included tinea corporis over a 4-month period in a private, single-specialty dermatology practice. All patients were treated by the same dermatologist. The RCM images were taken using an imaging system that had a horizontal optical resolution of less than 1.25 μm and a vertical optical resolution of less than 5.0 μm. The imaging was performed by medical assistants who were trained by the device manufacturer.

The sample sites were cleaned with isopropyl alcohol and a translucent contact ring was affixed to the skin using a liquid medium. The imaging head of the device was connected to the imaging ring and the images were taken. Identical imaging protocol was used in all patients. Multiple sets of horizontal images and one stack of vertical images were obtained. Patients reported no discomfort during the procedure, and the entire process was usually completed within 15 minutes. The images were sent to the pathologist for evaluation using the manufacturer’s telepathology system and were returned with a diagnosis within 24 hours. (On-site, real-time diagnosis also is possible if the dermatologist is trained in interpreting the images.)

In the chart review we looked for other diagnostic methods used as well as clinical outcomes. A case was considered to be positive for dermatophytic infection if any of the other diagnostic modalities yielded positive results or if a definitive resolution of the condition could be achieved using antifungal treatments alone.

Results

Ten patients (mean age, 43.1 years; age range, 16–76 years) with lesions that presented as possible dermatophytic infections underwent RCM analysis. In addition to RCM imaging, 5 patients underwent KOH testing of skin scrapings, 3 underwent analysis by fungal culture utilizing dermatophyte test medium (DTM), and 5 underwent biopsies. The findings are further summarized in the Table. One patient (patient 5) was excluded from the study because the RCM could not be evaluated due to the poor quality of the confocal images. Additionally, 2 patients (patients 2 and 7) had suboptimal imaging, which limited the evaluation.

Of the 9 evaluable cases, 4 (patients 1–4) were determined to be positive for the presence of dermatophytic infection through the fulfillment of criteria independent of RCM imaging. In each of those 4 cases, RCM images revealed the presence of hyphae, which indicated the presence of dermato-phytic infection. In these 4 cases, RCM and other diagnostic methods reached the same diagnosis.

In the other 5 cases (patients 6–10), the final diagnosis was not a dermatophytic infection. In 4 of those cases (patients 7–10), there were no signs of any structure resembling hyphae on the RCM images; however, in 1 case (patient 6), the RCM images showed structures that were consistent with the appearance of hyphae to the extent that the investigators, based solely on analysis of the RCM images, deemed a diagnosis indicating presence of a dermatophytic infection to be valid. In this case, a 38-year-old man presented with extensive scaly patches on the back of several months’ duration. Repeated skin biopsies showed hyperkeratosis and occasionally minimal spongiosis, while periodic acid–Schiff staining did not reveal fungal elements. Fungal cultures and KOH preparations were negative. Prior treatments with topical antifungals and steroids failed to improve the condition, which resolved rapidly with urea cream 40%. The interpretation of the RCM images in this patient did not match up with the results obtained from other methods of diagnosis and the clinical outcome; thus, we classified it as an incorrect diagnosis based on RCM analysis alone. In total, successful diagnosis using RCM imaging was achieved in 8 of 9 cases included in the analysis.

Comment

In this chart review, we evaluated the utility of using RCM in the diagnosis of dermatophytic infections of the skin by comparing findings noted on confocal imaging with those of other methods of diagnosis (Table). We included cases in which the clinical presentation raised the possibility of dermatophytic infection. Cases were considered positive for dermatophytes if KOH preparation, fungal culture, or skin biopsy (with or without periodic acid–Schiff staining) were positive or if there was a complete response to antifungal treatment alone. In this small number of cases, we found that RCM was 100% sensitive, as hyphae were readily seen in all cases of dermatophytic infections. In 1 RCM-positive case (patient 3), fungal culture with DTM was negative, but antifungal therapy was nonetheless given. Because the lesion resolved promptly with econazole, RCM proved to be true positive and DTM proved to be false negative (Table). Reflectance confocal microscopy imaging, however, was less specific. Of the 5 cases that showed no presence of dermatophytic infection, there was 1 case (patient 6) in which the pathologist could recognize structures that resembled fungal hyphae. There are various possible sources of structures masquerading as dermatophytes on confocal imaging, including the edges of nonnucleated loose keratinocytes, keratin fragments, and other foreign fibers. Evaluation by an experienced investigator can certainly help in limiting false-positive analyses, but a larger case study would be useful to develop a set of specific criteria to aid in the differentiation of fungal hyphae from other artifacts as well as to further define the sensitivity and specificity of RCM.

We also encountered difficulties with the technical aspects of RCM. One case (patient 5) was excluded from the analysis because the images were poor quality and could not be interpreted, and 2 cases (patients 2 and 7) had suboptimal images, in part due to operator error and in part due to equipment error that was recognized later on. The technical difficulties were problematic because no immediate review of image quality was available while patients were still present for possible reimaging. All of the images evaluated in this study were captured shortly after the RCM device was introduced to the practice. It is possible that with more training and a quick, on-site review of image quality, these technical problems could be avoided. Imaging protocols (ie, numbers and levels of scans taken by the confocal microscope) also could be adjusted so they include a large enough range to compensate for potential operator errors; however, these adjustments also could increase overall imaging time.

Conclusion

Based on our chart review of a small number of cases, we found that RCM can be a useful tool in diagnosing dermatophytic infections of the skin. With adequate training, dermatologists may be able to use RCM as an in-office tool to capture and evaluate images and subsequently diagnose or exclude dermatophytosis in a quick and noninvasive manner. However, further research and controlled studies of more cases will be required to develop accurate criteria for diagnosing fungal structures by RCM as well as to help determine the role of RCM in our diagnostic armamentarium.

There are a variety of well-established methods for diagnosing dermatophyte infections, including potassium hydroxide (KOH) preparations, fungal cultures, and skin biopsies. Each modality has its place in clinical practice, but they also have drawbacks. Reflectance confocal microscopy (RCM) is an emerging in vivo technology that could potentially serve as a sensitive, rapid, and noninvasive method of diagnosing dermatophytosis. Using near-infrared laser light scanning, RCM provides a quick noninvasive method of generating black-and-white, horizontal, quasipathology images that allow for the identification of cells and other structures similar to dermoscopy and histopathology.¹ The images are obtained in a fully noninvasive fashion, as the device is placed in contact with the skin using a liquid medium. The process takes 5 to 15 minutes depending on the number of images obtained, and the images can then be displayed in real time on a computer screen or transmitted to a pathologist for evaluation.

Most initial applications of RCM focused on evaluating melanocytic lesions with the primary goal of differentiating between benign nevi and melanomas, thus reducing the need for skin biopsies.^2-4 Efforts to develop RCM diagnostic criteria for identification of other skin cancers^5,6 as well as to aid in the diagnosis of nonneoplastic skin conditions are ongoing.⁷ The potential applications of RCM are virtually limitless, as this modality can (at least partially) take the place of biopsies in a variety of clinical scenarios.^2,8 Few reports have documented the utility of RCM as a diagnostic tool for onychomycosis^9,10 and dermatophytic infections of the skin.^11,12 Hui et al¹³ reported use for RCM for microscopic evaluation of mycelium features. Turan et al¹⁴ found that RCM could not replace the current diagnostic standards for tinea incognito but may be successfully used as an in vivo noninvasive screening tool to facilitate diagnosis. Because it provides high-resolution horizontal images extending from the surface of the stratum corneum to the superficial reticular dermis, RCM could be an effective tool in the diagnosis of cutaneous dermatophyte infections, as organisms usually are located in the stratum corneum of the epidermis in this infection. Branching hyphae are readily visible in the stratum corneum on RCM (Figure).

Branching hyphae (red arrows) seen in the epidermis on reflectance confocal microscopy.

We reviewed a series of 9 cases from a private practice setting in which RCM was used to diagnose dermatophytosis. We compared the diagnostic accuracy of RCM to results from other diagnostic methods and the ultimate clinical outcome to determine the usefulness of this new technology.

Methods

Our retrospective chart review included all cases in which RCM was used and the clinical differential diagnosis included tinea corporis over a 4-month period in a private, single-specialty dermatology practice. All patients were treated by the same dermatologist. The RCM images were taken using an imaging system that had a horizontal optical resolution of less than 1.25 μm and a vertical optical resolution of less than 5.0 μm. The imaging was performed by medical assistants who were trained by the device manufacturer.

The sample sites were cleaned with isopropyl alcohol and a translucent contact ring was affixed to the skin using a liquid medium. The imaging head of the device was connected to the imaging ring and the images were taken. Identical imaging protocol was used in all patients. Multiple sets of horizontal images and one stack of vertical images were obtained. Patients reported no discomfort during the procedure, and the entire process was usually completed within 15 minutes. The images were sent to the pathologist for evaluation using the manufacturer’s telepathology system and were returned with a diagnosis within 24 hours. (On-site, real-time diagnosis also is possible if the dermatologist is trained in interpreting the images.)

In the chart review we looked for other diagnostic methods used as well as clinical outcomes. A case was considered to be positive for dermatophytic infection if any of the other diagnostic modalities yielded positive results or if a definitive resolution of the condition could be achieved using antifungal treatments alone.

Results

Ten patients (mean age, 43.1 years; age range, 16–76 years) with lesions that presented as possible dermatophytic infections underwent RCM analysis. In addition to RCM imaging, 5 patients underwent KOH testing of skin scrapings, 3 underwent analysis by fungal culture utilizing dermatophyte test medium (DTM), and 5 underwent biopsies. The findings are further summarized in the Table. One patient (patient 5) was excluded from the study because the RCM could not be evaluated due to the poor quality of the confocal images. Additionally, 2 patients (patients 2 and 7) had suboptimal imaging, which limited the evaluation.

Of the 9 evaluable cases, 4 (patients 1–4) were determined to be positive for the presence of dermatophytic infection through the fulfillment of criteria independent of RCM imaging. In each of those 4 cases, RCM images revealed the presence of hyphae, which indicated the presence of dermato-phytic infection. In these 4 cases, RCM and other diagnostic methods reached the same diagnosis.

In the other 5 cases (patients 6–10), the final diagnosis was not a dermatophytic infection. In 4 of those cases (patients 7–10), there were no signs of any structure resembling hyphae on the RCM images; however, in 1 case (patient 6), the RCM images showed structures that were consistent with the appearance of hyphae to the extent that the investigators, based solely on analysis of the RCM images, deemed a diagnosis indicating presence of a dermatophytic infection to be valid. In this case, a 38-year-old man presented with extensive scaly patches on the back of several months’ duration. Repeated skin biopsies showed hyperkeratosis and occasionally minimal spongiosis, while periodic acid–Schiff staining did not reveal fungal elements. Fungal cultures and KOH preparations were negative. Prior treatments with topical antifungals and steroids failed to improve the condition, which resolved rapidly with urea cream 40%. The interpretation of the RCM images in this patient did not match up with the results obtained from other methods of diagnosis and the clinical outcome; thus, we classified it as an incorrect diagnosis based on RCM analysis alone. In total, successful diagnosis using RCM imaging was achieved in 8 of 9 cases included in the analysis.

Comment

In this chart review, we evaluated the utility of using RCM in the diagnosis of dermatophytic infections of the skin by comparing findings noted on confocal imaging with those of other methods of diagnosis (Table). We included cases in which the clinical presentation raised the possibility of dermatophytic infection. Cases were considered positive for dermatophytes if KOH preparation, fungal culture, or skin biopsy (with or without periodic acid–Schiff staining) were positive or if there was a complete response to antifungal treatment alone. In this small number of cases, we found that RCM was 100% sensitive, as hyphae were readily seen in all cases of dermatophytic infections. In 1 RCM-positive case (patient 3), fungal culture with DTM was negative, but antifungal therapy was nonetheless given. Because the lesion resolved promptly with econazole, RCM proved to be true positive and DTM proved to be false negative (Table). Reflectance confocal microscopy imaging, however, was less specific. Of the 5 cases that showed no presence of dermatophytic infection, there was 1 case (patient 6) in which the pathologist could recognize structures that resembled fungal hyphae. There are various possible sources of structures masquerading as dermatophytes on confocal imaging, including the edges of nonnucleated loose keratinocytes, keratin fragments, and other foreign fibers. Evaluation by an experienced investigator can certainly help in limiting false-positive analyses, but a larger case study would be useful to develop a set of specific criteria to aid in the differentiation of fungal hyphae from other artifacts as well as to further define the sensitivity and specificity of RCM.

We also encountered difficulties with the technical aspects of RCM. One case (patient 5) was excluded from the analysis because the images were poor quality and could not be interpreted, and 2 cases (patients 2 and 7) had suboptimal images, in part due to operator error and in part due to equipment error that was recognized later on. The technical difficulties were problematic because no immediate review of image quality was available while patients were still present for possible reimaging. All of the images evaluated in this study were captured shortly after the RCM device was introduced to the practice. It is possible that with more training and a quick, on-site review of image quality, these technical problems could be avoided. Imaging protocols (ie, numbers and levels of scans taken by the confocal microscope) also could be adjusted so they include a large enough range to compensate for potential operator errors; however, these adjustments also could increase overall imaging time.

Conclusion

Based on our chart review of a small number of cases, we found that RCM can be a useful tool in diagnosing dermatophytic infections of the skin. With adequate training, dermatologists may be able to use RCM as an in-office tool to capture and evaluate images and subsequently diagnose or exclude dermatophytosis in a quick and noninvasive manner. However, further research and controlled studies of more cases will be required to develop accurate criteria for diagnosing fungal structures by RCM as well as to help determine the role of RCM in our diagnostic armamentarium.