Practice Gap

Nail matrix and nail bed injections with triamcinolone acetonide are used to treat trachyonychia and inflammatory nail conditions, including nail psoriasis and nail lichen planus. The procedure should be quick in well-trained hands, with each nail injection taking only seconds to perform. Typically, patients have multiple nails involved, requiring at least 1 injection into the nail matrix or the nail bed (or both) in each nail at each visit. Patients often are anxious when undergoing nail injections; the nail unit is highly innervated and vascular, which can cause notable transient discomfort during the procedure^1,2 as well as postoperative pain.³

Nail injections must be repeated every 4 to 6 weeks to sustain clinical benefit and maximize outcomes, which can lead to heightened anxiety and apprehension before and during the visit. Furthermore, pain and anxiety associated with the procedure may deter patients from returning for follow-up injections, which can impact treatment adherence and clinical outcomes.

Dermatologists should implement strategies to decrease periprocedural anxiety to improve the nail injection experience. In our practice, we routinely incorporate stress-reducing techniques—music, talkesthesia, a sleep mask, cool air, ethyl chloride, and squeezing a stress ball—into the clinical workflow of the procedure. The goal of these techniques is to divert attention away from painful stimuli. Most patients, however, receive injections in both hands, making it impractical to employ some of these techniques, particularly squeezing a stress ball. We employed a unique method involving polyurethane tubing to reduce stress and anxiety during nail procedures.

The Technique

A patient was receiving treatment with intralesional triamcinolone injections to the nail matrix for trachyonychia involving all of the fingernails. He worked as an equipment and facilities manager, giving him access to polyurethane tubing, which is routinely used in the manufacture of some medical devices that require gas or liquid to operate. He found the nail injections to be painful but was motivated to proceed with treatment. He brought in a piece of polyurethane tubing to a subsequent visit to bite on during the injections (Figure) and reported considerable relief of pain.

What you were not taught in United States history class was that this method—clenching an object orally—dates to the era before the Civil War, before appropriate anesthetics and analgesics were developed, when patients and soldiers bit on a bullet or leather strap during surgical procedures.⁴ Clenching and chewing have been shown to promote relaxation and reduce acute pain and stress.⁵

Practical Implications

Polyurethane tubing can be purchased in bulk, is inexpensive ($0.30/foot on Amazon), and unlikely to damage teeth due to its flexibility. It can be cut into 6-inch pieces and given to the patient at their first nail injection appointment. The patient can then bring the tubing to subsequent appointments to use as a mastication tool during nail injections.

We instruct the patient to disinfect the dedicated piece of tubing after the initial visit and each subsequent visit by soaking it for 15 minutes in either a 3% hydrogen peroxide solution, antibacterial mouthwash, a solution of baking soda (bicarbonate of soda) and water (1 cup of water to 2 teaspoons of baking soda), or white vinegar. We instruct them to thoroughly dry the disinfected polyurethane tube and store it in a clean, reusable, resealable zipper storage bag between appointments.

In addition to reducing anxiety and pain, this method also distracts the patient and therefore promotes patient and physician safety. Patients are less likely to jump or startle during the injection, thereby reducing the risk of physically interfering with the nail surgeon or making an unanticipated advance into the surgical field.

Although frustrated patients with nail disease may need to “bite the bullet” when they accept treatment with nail injections, lessons from our patient and from United States history offer a safe and cost-effective pain management strategy. Minimizing discomfort and anxiety during the first nail injection is crucial because doing so is likely to promote adherence with follow-up injections and therefore improve clinical outcomes.

Future clinical studies should validate the clinical utility of oral mastication and clenching during nail procedures compared to other perioperative stress- and anxiety-reducing techniques.

Practice Gap

Nail matrix and nail bed injections with triamcinolone acetonide are used to treat trachyonychia and inflammatory nail conditions, including nail psoriasis and nail lichen planus. The procedure should be quick in well-trained hands, with each nail injection taking only seconds to perform. Typically, patients have multiple nails involved, requiring at least 1 injection into the nail matrix or the nail bed (or both) in each nail at each visit. Patients often are anxious when undergoing nail injections; the nail unit is highly innervated and vascular, which can cause notable transient discomfort during the procedure^1,2 as well as postoperative pain.³

Nail injections must be repeated every 4 to 6 weeks to sustain clinical benefit and maximize outcomes, which can lead to heightened anxiety and apprehension before and during the visit. Furthermore, pain and anxiety associated with the procedure may deter patients from returning for follow-up injections, which can impact treatment adherence and clinical outcomes.

Dermatologists should implement strategies to decrease periprocedural anxiety to improve the nail injection experience. In our practice, we routinely incorporate stress-reducing techniques—music, talkesthesia, a sleep mask, cool air, ethyl chloride, and squeezing a stress ball—into the clinical workflow of the procedure. The goal of these techniques is to divert attention away from painful stimuli. Most patients, however, receive injections in both hands, making it impractical to employ some of these techniques, particularly squeezing a stress ball. We employed a unique method involving polyurethane tubing to reduce stress and anxiety during nail procedures.

The Technique

A patient was receiving treatment with intralesional triamcinolone injections to the nail matrix for trachyonychia involving all of the fingernails. He worked as an equipment and facilities manager, giving him access to polyurethane tubing, which is routinely used in the manufacture of some medical devices that require gas or liquid to operate. He found the nail injections to be painful but was motivated to proceed with treatment. He brought in a piece of polyurethane tubing to a subsequent visit to bite on during the injections (Figure) and reported considerable relief of pain.

What you were not taught in United States history class was that this method—clenching an object orally—dates to the era before the Civil War, before appropriate anesthetics and analgesics were developed, when patients and soldiers bit on a bullet or leather strap during surgical procedures.⁴ Clenching and chewing have been shown to promote relaxation and reduce acute pain and stress.⁵

Practical Implications

Polyurethane tubing can be purchased in bulk, is inexpensive ($0.30/foot on Amazon), and unlikely to damage teeth due to its flexibility. It can be cut into 6-inch pieces and given to the patient at their first nail injection appointment. The patient can then bring the tubing to subsequent appointments to use as a mastication tool during nail injections.

We instruct the patient to disinfect the dedicated piece of tubing after the initial visit and each subsequent visit by soaking it for 15 minutes in either a 3% hydrogen peroxide solution, antibacterial mouthwash, a solution of baking soda (bicarbonate of soda) and water (1 cup of water to 2 teaspoons of baking soda), or white vinegar. We instruct them to thoroughly dry the disinfected polyurethane tube and store it in a clean, reusable, resealable zipper storage bag between appointments.

In addition to reducing anxiety and pain, this method also distracts the patient and therefore promotes patient and physician safety. Patients are less likely to jump or startle during the injection, thereby reducing the risk of physically interfering with the nail surgeon or making an unanticipated advance into the surgical field.

Although frustrated patients with nail disease may need to “bite the bullet” when they accept treatment with nail injections, lessons from our patient and from United States history offer a safe and cost-effective pain management strategy. Minimizing discomfort and anxiety during the first nail injection is crucial because doing so is likely to promote adherence with follow-up injections and therefore improve clinical outcomes.

Future clinical studies should validate the clinical utility of oral mastication and clenching during nail procedures compared to other perioperative stress- and anxiety-reducing techniques.

Practice Gap

Nail matrix and nail bed injections with triamcinolone acetonide are used to treat trachyonychia and inflammatory nail conditions, including nail psoriasis and nail lichen planus. The procedure should be quick in well-trained hands, with each nail injection taking only seconds to perform. Typically, patients have multiple nails involved, requiring at least 1 injection into the nail matrix or the nail bed (or both) in each nail at each visit. Patients often are anxious when undergoing nail injections; the nail unit is highly innervated and vascular, which can cause notable transient discomfort during the procedure^1,2 as well as postoperative pain.³

Nail injections must be repeated every 4 to 6 weeks to sustain clinical benefit and maximize outcomes, which can lead to heightened anxiety and apprehension before and during the visit. Furthermore, pain and anxiety associated with the procedure may deter patients from returning for follow-up injections, which can impact treatment adherence and clinical outcomes.

Dermatologists should implement strategies to decrease periprocedural anxiety to improve the nail injection experience. In our practice, we routinely incorporate stress-reducing techniques—music, talkesthesia, a sleep mask, cool air, ethyl chloride, and squeezing a stress ball—into the clinical workflow of the procedure. The goal of these techniques is to divert attention away from painful stimuli. Most patients, however, receive injections in both hands, making it impractical to employ some of these techniques, particularly squeezing a stress ball. We employed a unique method involving polyurethane tubing to reduce stress and anxiety during nail procedures.

The Technique

A patient was receiving treatment with intralesional triamcinolone injections to the nail matrix for trachyonychia involving all of the fingernails. He worked as an equipment and facilities manager, giving him access to polyurethane tubing, which is routinely used in the manufacture of some medical devices that require gas or liquid to operate. He found the nail injections to be painful but was motivated to proceed with treatment. He brought in a piece of polyurethane tubing to a subsequent visit to bite on during the injections (Figure) and reported considerable relief of pain.

What you were not taught in United States history class was that this method—clenching an object orally—dates to the era before the Civil War, before appropriate anesthetics and analgesics were developed, when patients and soldiers bit on a bullet or leather strap during surgical procedures.⁴ Clenching and chewing have been shown to promote relaxation and reduce acute pain and stress.⁵

Practical Implications

Polyurethane tubing can be purchased in bulk, is inexpensive ($0.30/foot on Amazon), and unlikely to damage teeth due to its flexibility. It can be cut into 6-inch pieces and given to the patient at their first nail injection appointment. The patient can then bring the tubing to subsequent appointments to use as a mastication tool during nail injections.

We instruct the patient to disinfect the dedicated piece of tubing after the initial visit and each subsequent visit by soaking it for 15 minutes in either a 3% hydrogen peroxide solution, antibacterial mouthwash, a solution of baking soda (bicarbonate of soda) and water (1 cup of water to 2 teaspoons of baking soda), or white vinegar. We instruct them to thoroughly dry the disinfected polyurethane tube and store it in a clean, reusable, resealable zipper storage bag between appointments.

In addition to reducing anxiety and pain, this method also distracts the patient and therefore promotes patient and physician safety. Patients are less likely to jump or startle during the injection, thereby reducing the risk of physically interfering with the nail surgeon or making an unanticipated advance into the surgical field.

Although frustrated patients with nail disease may need to “bite the bullet” when they accept treatment with nail injections, lessons from our patient and from United States history offer a safe and cost-effective pain management strategy. Minimizing discomfort and anxiety during the first nail injection is crucial because doing so is likely to promote adherence with follow-up injections and therefore improve clinical outcomes.

Future clinical studies should validate the clinical utility of oral mastication and clenching during nail procedures compared to other perioperative stress- and anxiety-reducing techniques.

The incidence of skin cancer continues to increase, and it is by far the most common malignancy in the United States. Based on the sheer incidence and prevalence of skin cancer, early detection and treatment are critical. Looking at melanoma alone, the 5-year survival rate is greater than 99% when detected early but falls to 71% when the disease reaches the lymph nodes and 32% with metastasis to distant organs.¹ Furthermore, a 2018 study found stage I melanoma patients who were treated 4 months after biopsy had a 41% increased risk of death compared with those treated within the first month.² However, many patients are not seen by a dermatologist first for examination of suspicious skin lesions and instead are referred by a general practitioner or primary care mid-level provider. Therefore, many patients experience a longer time to diagnosis or treatment, which directly correlates with survival rate.

Dermoscopy is a noninvasive diagnostic tool for skin lesions, including melanoma. Using a handheld dermoscope (or dermatoscope), a transilluminating light source magnifies skin lesions and allows for the visualization of subsurface skin structures within the epidermis, dermoepidermal junction, and papillary dermis.³ Dermoscopy has been shown to improve a dermatologist’s accuracy in diagnosing malignant melanoma vs clinical evaluation with the unaided eye.^4,5 More recently, dermoscopy has been digitized, allowing for the collection and documentation of case photographs. Dermoscopy also has expanded past the scope of dermatologists and has become increasingly useful in primary care.⁶ Among family physicians, dermoscopy also has been shown to have a higher sensitivity for melanoma detection compared to gross examination.⁷ Therefore, both the increased diagnostic performance of malignant melanoma using a dermoscope and the expanded use of dermoscopy in medical care validate the evaluation of an artificial intelligence (AI) algorithm in diagnosing malignant melanoma using dermoscopic images.

Triage (Triage Technologies Inc) is an AI application that uses a web interface and combines a pretrained convolutional neural network (CNN) with a reinforcement learning agent as a question-answering model. The CNN algorithm can classify 133 different skin diseases, 7 of which it is able to classify using dermoscopic images. This study sought to evaluate the performance of Triage’s dermoscopic classifier in identifying lesions as benign or malignant to determine whether AI could assist in the triage of skin cancer cases to shorten time to diagnosis.

Materials and Methods

The MClass-D test set from the International Skin Imaging Collaboration was assessed by both AI and practicing medical providers. The set was composed of 80 benign nevi and 20 biopsy-verified malignant melanomas. Board-certified US dermatologists (n=23), family physicians (n=7), and primary care mid-level providers (n=12)(ie, nurse practitioners, physician assistants) were asked to label the images as benign or malignant. The results from the medical providers were then compared to the performance of the AI application by looking at the sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV). Statistical significance was determined with a 1 sample t test run through RStudio (Posit Software, PBC), and P<.05 was considered significant.

Results

The AI application performed extremely well in differentiating between benign nevi and malignant melanomas, with a sensitivity of 80%, specificity of 95%, accuracy of 92%, PPV of 80%, and NPV of 95% (Table 1). When compared with practicing medical providers, the AI performed significantly better in almost all categories (P<.05)(Figure 1). With all medical providers combined, the AI had significantly higher accuracy, sensitivity, and specificity (P<.05). The accuracy of the individual medical providers ranged from 32% to 78%.

Compared with dermatologists, the AI was significantly more specific and accurate and demonstrated a higher PPV and NPV (P<.05). There was no significant difference between the AI and dermatologists in sensitivity or labeling the true malignant lesions as malignant. The dermatologists who participated had been practicing from 1.5 years to 44 years, with an average of 16 years of dermatologic experience. There was no correlation between years practicing and performance in determining the malignancy of lesions. Of 14 dermatologists, dermoscopy was used daily by 10 and occasionally by 3, but only 6 dermatologists had any formal training. Dermatologists who used dermoscopy averaged 11 years of use.

The AI also performed significantly better than the primary care providers, including both family physicians and mid-level providers (P<.05). With the family physicians and mid-level provider scores combined, the AI showed a statistically significantly better performance in all categories examined, including sensitivity, specificity, accuracy, PPV, and NPV (P<.05). However, when compared with family physicians alone, the AI did not demonstrate a statistically significant difference in sensitivity.

Automatic Visual Recognition Development—The AI application we studied was developed by dermatologists as a tool to assist in the screening of skin lesions suspicious for melanoma or a benign neoplasm.⁸ Developing AI applications that can reliably recognize objects in photographs has been the subject of considerable research. Notable progress in automatic visual recognition was shown in 2012 when a deep learning model won the ImageNet object recognition challenge and outperformed competing approaches by a large margin.^9,10 The ImageNet competition, which has been held annually since 2010, required participants to build a visual classification system that distinguished among 1000 object categories using 1.2 million labeled images as training data. In 2017, participants developed automated visual systems that surpassed the estimated human performance.¹¹ Given this success, the organization decided to deliver a more challenging competition involving 3D imaging—Medical ImageNet, a petabyte-scale, cloud-based, open repository project—with goals including image classification and annotation.¹²

Convolutional Neural Networks—Convolutional neural networks are computer system architectures commonly employed for making predictions from images.¹³ Convolutional neural networks are based on a set of layers of learned filters that perform convolution, a mathematical operation that reflects the relationship between the 2 functions. The main algorithm that makes the learning possible is called backpropagation, wherein an error is computed at the output and distributed backward through the neural network’s layers.¹⁴ Although CNNs and backpropagation methods have existed since 1989, recent technologic advances have allowed for deep learning–based algorithms to be widely integrated with everyday applications.¹⁵ Advances in computational power in the form of graphics processing units and parallelization, the existence of large data sets such as the ImageNet database, and the rise of software frameworks have allowed for quick prototyping and deployment of deep learning models.^16,17

Convolutional neural networks have demonstrated potential to excel at a wide range of visual tasks. In dermatology, visual recognition methods often rely on using either a pretrained CNN as a feature extractor for further classification or fine-tuning a pretrained network on dermoscopic images.^18-20 In 2017, a model was trained on 130,000 clinical images of benign and malignant skin lesions. Its performance was found to be in line with that of 21 US board-certified dermatology experts when diagnosing skin cancers from clinical images confirmed by biopsy.²¹

Triage—The AI application Triage is composed of several components contained in a web interface (Figure 2). To use the interface, the user must sign up and upload a photograph to the website. The image first passes through a gated-logic visual classifier that rejects any images that do not contain a visible skin condition. If the image contains a skin condition, the image is passed to a skin classifier that predicts the probability of the image containing 1 of 133 classes of skin conditions, 7 of which the application can diagnose with a dermoscopic image.

Image courtesy of Triage Technologies Inc and Izhaar Tejani, BA (Toronto, Ontario, Canada).

The AI application uses several techniques when training a CNN model. To address skin condition class imbalances (when more examples exist for 1 class than the others) in the training data, additional weights are applied to mistakes made on underrepresented classes, which encourages the model to better detect cases with low prevalence in the data set. Data augmentation techniques such as rotating, zooming, and flipping the training images are applied to allow the model to become more familiar with variability in the input images. Convolutional neural networks are trained using a well-known neural network optimization method called Stochastic gradient descent with momentum.²²

The final predictions are refined by a question-and-answer system that encodes dermatology knowledge and is currently under active development. Finally, the top k most probable conditions are displayed to the user, where k≤5. An initial prototype of the system was described in a published research paper in the 2019 medical imaging workshop of the Neural Information Systems conference.²³

The prototype demonstrated that combining a pretrained CNN with a reinforcement learning agent as a question-answering model increased the classification confidence and accuracy of its visual symptom checker and decreased the average number of questions asked to narrow down the differential diagnosis. The reinforcement learning approach increases the accuracy more than 20% compared with the CNN-only approach, which only uses visual information to predict the condition.²³

This application’s current visual question-answering system is trained on a diverse set of data that includes more than 20 years of clinical encounters and user-uploaded cases submitted by more than 150,000 patients and 10,000 clinicians in more than 150 countries. All crowdsourced images used for training the dermoscopy classifier are biopsy-verified images contributed by dermatologists. These data are made up of case photographs that are tagged with metadata around the patient’s age, sex, symptoms, and diagnoses. The CNN algorithm used covers 133 skin disease classes, representing 588 clinical conditions. It also can automatically detect 7 malignant, premalignant, and benign dermoscopic categories, which is the focus of this study (Table 2). Diagnoses are verified by patient response to treatment, biopsy results, and dermatologist consensus.

In addition to having improved performance, supporting more than 130 disease classes, and having a diverse data set, the application used has beat competing technologies.^20,24 The application currently is available on the internet in more than 30 countries after it received Health Canada Class I medical device approval and the CE mark in Europe.

Can AI Reliably Detect Melanoma?—In our study, of the lesions labeled benign, the higher PPV and NPV of the AI algorithm means that the lesions were more reliably true benign lesions, and the lesions labeled as malignant were more likely to be true malignant lesions. Therefore, the diagnosis given by the AI compared with the medical provider was significantly more likely to be correct. These findings demonstrate that this AI application can reliably detect malignant melanoma using dermoscopic images. However, this study was limited by the small sample size of medical providers. Further studies are necessary to assess whether the high diagnostic accuracy of the application translates to expedited referrals and a decrease in unnecessary biopsies.

Dermoscopy Training—This study looked at dermoscopic images instead of gross examination, as is often done in clinic, which draws into question the dermoscopic training dermatologists receive. The diagnostic accuracy using dermoscopic images has been shown to be higher than evaluation with the naked eye.^5,6 However, there currently is no standard for dermoscopic training in dermatology residencies, and education varies widely.²⁵ These data suggest that there may be a lack of dermoscopic training among dermatologists, which could accentuate the difference in performance between dermatologists and AI. Most primary care providers also lack formal dermoscopy training. Although dermoscopy has been shown to increase the diagnostic efficacy of primary care providers, this increase does not become apparent until the medical provider has had years of formal training in addition to clinical experience, which is not commonly provided in the medical training that primary care providers receive.^8,26

Conclusion

It is anticipated that AI will shape the future of medicine and become incorporated into daily practice.²⁷ Artificial intelligence will not replace physicians but rather assist clinicians and help to streamline medical care. Clinicians will take on the role of interpreting AI output and integrate it into patient care. With this advancement, it is important to highlight that for AI to improve the quality, efficiency, and accessibility of health care, clinicians must be equipped with the right training.^27-29

The incidence of skin cancer continues to increase, and it is by far the most common malignancy in the United States. Based on the sheer incidence and prevalence of skin cancer, early detection and treatment are critical. Looking at melanoma alone, the 5-year survival rate is greater than 99% when detected early but falls to 71% when the disease reaches the lymph nodes and 32% with metastasis to distant organs.¹ Furthermore, a 2018 study found stage I melanoma patients who were treated 4 months after biopsy had a 41% increased risk of death compared with those treated within the first month.² However, many patients are not seen by a dermatologist first for examination of suspicious skin lesions and instead are referred by a general practitioner or primary care mid-level provider. Therefore, many patients experience a longer time to diagnosis or treatment, which directly correlates with survival rate.

Dermoscopy is a noninvasive diagnostic tool for skin lesions, including melanoma. Using a handheld dermoscope (or dermatoscope), a transilluminating light source magnifies skin lesions and allows for the visualization of subsurface skin structures within the epidermis, dermoepidermal junction, and papillary dermis.³ Dermoscopy has been shown to improve a dermatologist’s accuracy in diagnosing malignant melanoma vs clinical evaluation with the unaided eye.^4,5 More recently, dermoscopy has been digitized, allowing for the collection and documentation of case photographs. Dermoscopy also has expanded past the scope of dermatologists and has become increasingly useful in primary care.⁶ Among family physicians, dermoscopy also has been shown to have a higher sensitivity for melanoma detection compared to gross examination.⁷ Therefore, both the increased diagnostic performance of malignant melanoma using a dermoscope and the expanded use of dermoscopy in medical care validate the evaluation of an artificial intelligence (AI) algorithm in diagnosing malignant melanoma using dermoscopic images.

Triage (Triage Technologies Inc) is an AI application that uses a web interface and combines a pretrained convolutional neural network (CNN) with a reinforcement learning agent as a question-answering model. The CNN algorithm can classify 133 different skin diseases, 7 of which it is able to classify using dermoscopic images. This study sought to evaluate the performance of Triage’s dermoscopic classifier in identifying lesions as benign or malignant to determine whether AI could assist in the triage of skin cancer cases to shorten time to diagnosis.

Materials and Methods

The MClass-D test set from the International Skin Imaging Collaboration was assessed by both AI and practicing medical providers. The set was composed of 80 benign nevi and 20 biopsy-verified malignant melanomas. Board-certified US dermatologists (n=23), family physicians (n=7), and primary care mid-level providers (n=12)(ie, nurse practitioners, physician assistants) were asked to label the images as benign or malignant. The results from the medical providers were then compared to the performance of the AI application by looking at the sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV). Statistical significance was determined with a 1 sample t test run through RStudio (Posit Software, PBC), and P<.05 was considered significant.

Results

The AI application performed extremely well in differentiating between benign nevi and malignant melanomas, with a sensitivity of 80%, specificity of 95%, accuracy of 92%, PPV of 80%, and NPV of 95% (Table 1). When compared with practicing medical providers, the AI performed significantly better in almost all categories (P<.05)(Figure 1). With all medical providers combined, the AI had significantly higher accuracy, sensitivity, and specificity (P<.05). The accuracy of the individual medical providers ranged from 32% to 78%.

Compared with dermatologists, the AI was significantly more specific and accurate and demonstrated a higher PPV and NPV (P<.05). There was no significant difference between the AI and dermatologists in sensitivity or labeling the true malignant lesions as malignant. The dermatologists who participated had been practicing from 1.5 years to 44 years, with an average of 16 years of dermatologic experience. There was no correlation between years practicing and performance in determining the malignancy of lesions. Of 14 dermatologists, dermoscopy was used daily by 10 and occasionally by 3, but only 6 dermatologists had any formal training. Dermatologists who used dermoscopy averaged 11 years of use.

The AI also performed significantly better than the primary care providers, including both family physicians and mid-level providers (P<.05). With the family physicians and mid-level provider scores combined, the AI showed a statistically significantly better performance in all categories examined, including sensitivity, specificity, accuracy, PPV, and NPV (P<.05). However, when compared with family physicians alone, the AI did not demonstrate a statistically significant difference in sensitivity.

Automatic Visual Recognition Development—The AI application we studied was developed by dermatologists as a tool to assist in the screening of skin lesions suspicious for melanoma or a benign neoplasm.⁸ Developing AI applications that can reliably recognize objects in photographs has been the subject of considerable research. Notable progress in automatic visual recognition was shown in 2012 when a deep learning model won the ImageNet object recognition challenge and outperformed competing approaches by a large margin.^9,10 The ImageNet competition, which has been held annually since 2010, required participants to build a visual classification system that distinguished among 1000 object categories using 1.2 million labeled images as training data. In 2017, participants developed automated visual systems that surpassed the estimated human performance.¹¹ Given this success, the organization decided to deliver a more challenging competition involving 3D imaging—Medical ImageNet, a petabyte-scale, cloud-based, open repository project—with goals including image classification and annotation.¹²

Convolutional Neural Networks—Convolutional neural networks are computer system architectures commonly employed for making predictions from images.¹³ Convolutional neural networks are based on a set of layers of learned filters that perform convolution, a mathematical operation that reflects the relationship between the 2 functions. The main algorithm that makes the learning possible is called backpropagation, wherein an error is computed at the output and distributed backward through the neural network’s layers.¹⁴ Although CNNs and backpropagation methods have existed since 1989, recent technologic advances have allowed for deep learning–based algorithms to be widely integrated with everyday applications.¹⁵ Advances in computational power in the form of graphics processing units and parallelization, the existence of large data sets such as the ImageNet database, and the rise of software frameworks have allowed for quick prototyping and deployment of deep learning models.^16,17

Convolutional neural networks have demonstrated potential to excel at a wide range of visual tasks. In dermatology, visual recognition methods often rely on using either a pretrained CNN as a feature extractor for further classification or fine-tuning a pretrained network on dermoscopic images.^18-20 In 2017, a model was trained on 130,000 clinical images of benign and malignant skin lesions. Its performance was found to be in line with that of 21 US board-certified dermatology experts when diagnosing skin cancers from clinical images confirmed by biopsy.²¹

Triage—The AI application Triage is composed of several components contained in a web interface (Figure 2). To use the interface, the user must sign up and upload a photograph to the website. The image first passes through a gated-logic visual classifier that rejects any images that do not contain a visible skin condition. If the image contains a skin condition, the image is passed to a skin classifier that predicts the probability of the image containing 1 of 133 classes of skin conditions, 7 of which the application can diagnose with a dermoscopic image.

Image courtesy of Triage Technologies Inc and Izhaar Tejani, BA (Toronto, Ontario, Canada).

The AI application uses several techniques when training a CNN model. To address skin condition class imbalances (when more examples exist for 1 class than the others) in the training data, additional weights are applied to mistakes made on underrepresented classes, which encourages the model to better detect cases with low prevalence in the data set. Data augmentation techniques such as rotating, zooming, and flipping the training images are applied to allow the model to become more familiar with variability in the input images. Convolutional neural networks are trained using a well-known neural network optimization method called Stochastic gradient descent with momentum.²²

The final predictions are refined by a question-and-answer system that encodes dermatology knowledge and is currently under active development. Finally, the top k most probable conditions are displayed to the user, where k≤5. An initial prototype of the system was described in a published research paper in the 2019 medical imaging workshop of the Neural Information Systems conference.²³

The prototype demonstrated that combining a pretrained CNN with a reinforcement learning agent as a question-answering model increased the classification confidence and accuracy of its visual symptom checker and decreased the average number of questions asked to narrow down the differential diagnosis. The reinforcement learning approach increases the accuracy more than 20% compared with the CNN-only approach, which only uses visual information to predict the condition.²³

This application’s current visual question-answering system is trained on a diverse set of data that includes more than 20 years of clinical encounters and user-uploaded cases submitted by more than 150,000 patients and 10,000 clinicians in more than 150 countries. All crowdsourced images used for training the dermoscopy classifier are biopsy-verified images contributed by dermatologists. These data are made up of case photographs that are tagged with metadata around the patient’s age, sex, symptoms, and diagnoses. The CNN algorithm used covers 133 skin disease classes, representing 588 clinical conditions. It also can automatically detect 7 malignant, premalignant, and benign dermoscopic categories, which is the focus of this study (Table 2). Diagnoses are verified by patient response to treatment, biopsy results, and dermatologist consensus.

In addition to having improved performance, supporting more than 130 disease classes, and having a diverse data set, the application used has beat competing technologies.^20,24 The application currently is available on the internet in more than 30 countries after it received Health Canada Class I medical device approval and the CE mark in Europe.

Can AI Reliably Detect Melanoma?—In our study, of the lesions labeled benign, the higher PPV and NPV of the AI algorithm means that the lesions were more reliably true benign lesions, and the lesions labeled as malignant were more likely to be true malignant lesions. Therefore, the diagnosis given by the AI compared with the medical provider was significantly more likely to be correct. These findings demonstrate that this AI application can reliably detect malignant melanoma using dermoscopic images. However, this study was limited by the small sample size of medical providers. Further studies are necessary to assess whether the high diagnostic accuracy of the application translates to expedited referrals and a decrease in unnecessary biopsies.

Dermoscopy Training—This study looked at dermoscopic images instead of gross examination, as is often done in clinic, which draws into question the dermoscopic training dermatologists receive. The diagnostic accuracy using dermoscopic images has been shown to be higher than evaluation with the naked eye.^5,6 However, there currently is no standard for dermoscopic training in dermatology residencies, and education varies widely.²⁵ These data suggest that there may be a lack of dermoscopic training among dermatologists, which could accentuate the difference in performance between dermatologists and AI. Most primary care providers also lack formal dermoscopy training. Although dermoscopy has been shown to increase the diagnostic efficacy of primary care providers, this increase does not become apparent until the medical provider has had years of formal training in addition to clinical experience, which is not commonly provided in the medical training that primary care providers receive.^8,26

Conclusion

It is anticipated that AI will shape the future of medicine and become incorporated into daily practice.²⁷ Artificial intelligence will not replace physicians but rather assist clinicians and help to streamline medical care. Clinicians will take on the role of interpreting AI output and integrate it into patient care. With this advancement, it is important to highlight that for AI to improve the quality, efficiency, and accessibility of health care, clinicians must be equipped with the right training.^27-29

The incidence of skin cancer continues to increase, and it is by far the most common malignancy in the United States. Based on the sheer incidence and prevalence of skin cancer, early detection and treatment are critical. Looking at melanoma alone, the 5-year survival rate is greater than 99% when detected early but falls to 71% when the disease reaches the lymph nodes and 32% with metastasis to distant organs.¹ Furthermore, a 2018 study found stage I melanoma patients who were treated 4 months after biopsy had a 41% increased risk of death compared with those treated within the first month.² However, many patients are not seen by a dermatologist first for examination of suspicious skin lesions and instead are referred by a general practitioner or primary care mid-level provider. Therefore, many patients experience a longer time to diagnosis or treatment, which directly correlates with survival rate.

Dermoscopy is a noninvasive diagnostic tool for skin lesions, including melanoma. Using a handheld dermoscope (or dermatoscope), a transilluminating light source magnifies skin lesions and allows for the visualization of subsurface skin structures within the epidermis, dermoepidermal junction, and papillary dermis.³ Dermoscopy has been shown to improve a dermatologist’s accuracy in diagnosing malignant melanoma vs clinical evaluation with the unaided eye.^4,5 More recently, dermoscopy has been digitized, allowing for the collection and documentation of case photographs. Dermoscopy also has expanded past the scope of dermatologists and has become increasingly useful in primary care.⁶ Among family physicians, dermoscopy also has been shown to have a higher sensitivity for melanoma detection compared to gross examination.⁷ Therefore, both the increased diagnostic performance of malignant melanoma using a dermoscope and the expanded use of dermoscopy in medical care validate the evaluation of an artificial intelligence (AI) algorithm in diagnosing malignant melanoma using dermoscopic images.

Triage (Triage Technologies Inc) is an AI application that uses a web interface and combines a pretrained convolutional neural network (CNN) with a reinforcement learning agent as a question-answering model. The CNN algorithm can classify 133 different skin diseases, 7 of which it is able to classify using dermoscopic images. This study sought to evaluate the performance of Triage’s dermoscopic classifier in identifying lesions as benign or malignant to determine whether AI could assist in the triage of skin cancer cases to shorten time to diagnosis.

Materials and Methods

The MClass-D test set from the International Skin Imaging Collaboration was assessed by both AI and practicing medical providers. The set was composed of 80 benign nevi and 20 biopsy-verified malignant melanomas. Board-certified US dermatologists (n=23), family physicians (n=7), and primary care mid-level providers (n=12)(ie, nurse practitioners, physician assistants) were asked to label the images as benign or malignant. The results from the medical providers were then compared to the performance of the AI application by looking at the sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV). Statistical significance was determined with a 1 sample t test run through RStudio (Posit Software, PBC), and P<.05 was considered significant.

Results

The AI application performed extremely well in differentiating between benign nevi and malignant melanomas, with a sensitivity of 80%, specificity of 95%, accuracy of 92%, PPV of 80%, and NPV of 95% (Table 1). When compared with practicing medical providers, the AI performed significantly better in almost all categories (P<.05)(Figure 1). With all medical providers combined, the AI had significantly higher accuracy, sensitivity, and specificity (P<.05). The accuracy of the individual medical providers ranged from 32% to 78%.

Compared with dermatologists, the AI was significantly more specific and accurate and demonstrated a higher PPV and NPV (P<.05). There was no significant difference between the AI and dermatologists in sensitivity or labeling the true malignant lesions as malignant. The dermatologists who participated had been practicing from 1.5 years to 44 years, with an average of 16 years of dermatologic experience. There was no correlation between years practicing and performance in determining the malignancy of lesions. Of 14 dermatologists, dermoscopy was used daily by 10 and occasionally by 3, but only 6 dermatologists had any formal training. Dermatologists who used dermoscopy averaged 11 years of use.

The AI also performed significantly better than the primary care providers, including both family physicians and mid-level providers (P<.05). With the family physicians and mid-level provider scores combined, the AI showed a statistically significantly better performance in all categories examined, including sensitivity, specificity, accuracy, PPV, and NPV (P<.05). However, when compared with family physicians alone, the AI did not demonstrate a statistically significant difference in sensitivity.

Automatic Visual Recognition Development—The AI application we studied was developed by dermatologists as a tool to assist in the screening of skin lesions suspicious for melanoma or a benign neoplasm.⁸ Developing AI applications that can reliably recognize objects in photographs has been the subject of considerable research. Notable progress in automatic visual recognition was shown in 2012 when a deep learning model won the ImageNet object recognition challenge and outperformed competing approaches by a large margin.^9,10 The ImageNet competition, which has been held annually since 2010, required participants to build a visual classification system that distinguished among 1000 object categories using 1.2 million labeled images as training data. In 2017, participants developed automated visual systems that surpassed the estimated human performance.¹¹ Given this success, the organization decided to deliver a more challenging competition involving 3D imaging—Medical ImageNet, a petabyte-scale, cloud-based, open repository project—with goals including image classification and annotation.¹²

Convolutional Neural Networks—Convolutional neural networks are computer system architectures commonly employed for making predictions from images.¹³ Convolutional neural networks are based on a set of layers of learned filters that perform convolution, a mathematical operation that reflects the relationship between the 2 functions. The main algorithm that makes the learning possible is called backpropagation, wherein an error is computed at the output and distributed backward through the neural network’s layers.¹⁴ Although CNNs and backpropagation methods have existed since 1989, recent technologic advances have allowed for deep learning–based algorithms to be widely integrated with everyday applications.¹⁵ Advances in computational power in the form of graphics processing units and parallelization, the existence of large data sets such as the ImageNet database, and the rise of software frameworks have allowed for quick prototyping and deployment of deep learning models.^16,17

Convolutional neural networks have demonstrated potential to excel at a wide range of visual tasks. In dermatology, visual recognition methods often rely on using either a pretrained CNN as a feature extractor for further classification or fine-tuning a pretrained network on dermoscopic images.^18-20 In 2017, a model was trained on 130,000 clinical images of benign and malignant skin lesions. Its performance was found to be in line with that of 21 US board-certified dermatology experts when diagnosing skin cancers from clinical images confirmed by biopsy.²¹

Triage—The AI application Triage is composed of several components contained in a web interface (Figure 2). To use the interface, the user must sign up and upload a photograph to the website. The image first passes through a gated-logic visual classifier that rejects any images that do not contain a visible skin condition. If the image contains a skin condition, the image is passed to a skin classifier that predicts the probability of the image containing 1 of 133 classes of skin conditions, 7 of which the application can diagnose with a dermoscopic image.

Image courtesy of Triage Technologies Inc and Izhaar Tejani, BA (Toronto, Ontario, Canada).

The AI application uses several techniques when training a CNN model. To address skin condition class imbalances (when more examples exist for 1 class than the others) in the training data, additional weights are applied to mistakes made on underrepresented classes, which encourages the model to better detect cases with low prevalence in the data set. Data augmentation techniques such as rotating, zooming, and flipping the training images are applied to allow the model to become more familiar with variability in the input images. Convolutional neural networks are trained using a well-known neural network optimization method called Stochastic gradient descent with momentum.²²

The final predictions are refined by a question-and-answer system that encodes dermatology knowledge and is currently under active development. Finally, the top k most probable conditions are displayed to the user, where k≤5. An initial prototype of the system was described in a published research paper in the 2019 medical imaging workshop of the Neural Information Systems conference.²³

The prototype demonstrated that combining a pretrained CNN with a reinforcement learning agent as a question-answering model increased the classification confidence and accuracy of its visual symptom checker and decreased the average number of questions asked to narrow down the differential diagnosis. The reinforcement learning approach increases the accuracy more than 20% compared with the CNN-only approach, which only uses visual information to predict the condition.²³

This application’s current visual question-answering system is trained on a diverse set of data that includes more than 20 years of clinical encounters and user-uploaded cases submitted by more than 150,000 patients and 10,000 clinicians in more than 150 countries. All crowdsourced images used for training the dermoscopy classifier are biopsy-verified images contributed by dermatologists. These data are made up of case photographs that are tagged with metadata around the patient’s age, sex, symptoms, and diagnoses. The CNN algorithm used covers 133 skin disease classes, representing 588 clinical conditions. It also can automatically detect 7 malignant, premalignant, and benign dermoscopic categories, which is the focus of this study (Table 2). Diagnoses are verified by patient response to treatment, biopsy results, and dermatologist consensus.

In addition to having improved performance, supporting more than 130 disease classes, and having a diverse data set, the application used has beat competing technologies.^20,24 The application currently is available on the internet in more than 30 countries after it received Health Canada Class I medical device approval and the CE mark in Europe.

Can AI Reliably Detect Melanoma?—In our study, of the lesions labeled benign, the higher PPV and NPV of the AI algorithm means that the lesions were more reliably true benign lesions, and the lesions labeled as malignant were more likely to be true malignant lesions. Therefore, the diagnosis given by the AI compared with the medical provider was significantly more likely to be correct. These findings demonstrate that this AI application can reliably detect malignant melanoma using dermoscopic images. However, this study was limited by the small sample size of medical providers. Further studies are necessary to assess whether the high diagnostic accuracy of the application translates to expedited referrals and a decrease in unnecessary biopsies.

Dermoscopy Training—This study looked at dermoscopic images instead of gross examination, as is often done in clinic, which draws into question the dermoscopic training dermatologists receive. The diagnostic accuracy using dermoscopic images has been shown to be higher than evaluation with the naked eye.^5,6 However, there currently is no standard for dermoscopic training in dermatology residencies, and education varies widely.²⁵ These data suggest that there may be a lack of dermoscopic training among dermatologists, which could accentuate the difference in performance between dermatologists and AI. Most primary care providers also lack formal dermoscopy training. Although dermoscopy has been shown to increase the diagnostic efficacy of primary care providers, this increase does not become apparent until the medical provider has had years of formal training in addition to clinical experience, which is not commonly provided in the medical training that primary care providers receive.^8,26

Conclusion

It is anticipated that AI will shape the future of medicine and become incorporated into daily practice.²⁷ Artificial intelligence will not replace physicians but rather assist clinicians and help to streamline medical care. Clinicians will take on the role of interpreting AI output and integrate it into patient care. With this advancement, it is important to highlight that for AI to improve the quality, efficiency, and accessibility of health care, clinicians must be equipped with the right training.^27-29

Cutaneous angiosarcoma (cAS) is a rare malignancy arising from vascular or lymphatic tissue. It classically presents during the sixth or seventh decades of life as a raised purple papule or plaque on the head and neck areas.¹ Primary cAS frequently mimics benign conditions, leading to delays in care. Such delays coupled with the aggressive nature of angiosarcomas leads to a poor prognosis. Five-year survival rates range from 11% to 50%, and more than half of patients die within 1 year of diagnosis.^2-7

Currently, there is no consensus on the most effective treatments, as the rare nature of cAS has made the development of controlled clinical trials difficult. Wide local excision (WLE) is most frequently employed; however, the tumor’s infiltrative growth makes complete resection and negative surgical margins difficult to achieve.⁸ Recently, Mohs micrographic surgery (MMS) has been postulated as a treatment option. The tissue-sparing nature and intraoperative margin control of MMS may provide tumor eradication and cosmesis benefits reported with other cutaneous malignancies.⁹

Nearly all localized cASs are treated with surgical excision with or without adjuvant treatment modalities; however, it is unclear which of these modalities provide a survival benefit. We conducted a systematic review of the literature to compare treatment modalities for localized cAS of the head and neck regions and to compare treatments based on tumor stage.

METHODS

A literature search was performed to identify published studies indexed by MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and PubMed from January 1, 1977, to May 8, 2020, reporting on cAS and treatment modalities used. The search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines.⁵ Data extracted included patient demographics, tumor characteristics (including T1 [≤5 cm] and T2 [>5 cm and ≤10 cm] based on the American Joint Committee on Cancer soft tissue sarcoma staging criteria), treatments used, follow-up time, overall survival (OS) rates, and complications.^10,11

Studies were required to (1) include participants with head and neck cAS; (2) report original patient data following cAS treatment with surgical (WLE or MMS) and/or nonsurgical modalities (chemotherapy [CT], radiotherapy [RT], immunotherapy [IT]); (3) report outcome data related to OS rates following treatment; and (4) have articles published in English. Given the rare nature of cAS, there was no limitation on the number of participants needed.

The Newcastle-Ottawa scale for observational studies was used to assess the quality of studies.¹² Higher scores indicate low risk of bias, while lower scores represent high risk of bias.

Continuous data were reported with means and SDs, while categorical variables were reported as percentages. Overall survival means and SDs were compared between treatment modalities using an independent sample t test with P<.05 considered statistically significant. Due to the heterogeneity of the data, a meta-analysis was not reported.

RESULTS

Literature Search and Risk of Bias Assessment

There were 283 manuscripts identified, 56 articles read in full, and 40 articles included in the review (Figure). Among the 16 studies not meeting inclusion criteria, 7 did not provide enough data to isolate head and neck cAS cases,^1,13-18 6 did not report outcomes related to the current review,^19-24 and 3 did not provide enough data to isolate different treatment outcomes.^25-27 Among the included studies, 32 reported use of WLE: WLE alone (n=21)^2,7,11,28-45; WLE with RT (n=24)^{2,3,11,28-31,33-36,38-41,43-51}; WLE with CT (n=7)^{2,31,35,39,41,48,52}; WLE with RT and CT (n=11)^{2,29,31,33-35,39,40,48,52,53}; WLE with RT and IT (n=3)^35,54,55; and WLE with RT, CT, and IT (n=1).⁵³ Nine studies reported MMS: MMS alone (n=5)^39,56-59; MMS with RT (n=3)^32,50,60,61; and MMS with RT and CT (n=1).⁵¹

Risk of bias assessment identified low risk in 3 articles. High risk was identified in 5 case reports,^57-61 and 1 study did not describe patient selection.⁴³ Clayton et al⁵⁶ showed intermediate risk, given the study controlled for 1 factor.

Patient Demographics

A total of 1295 patients were included. The pooled mean age of the patients was 67.5 years (range, 3–88 years), and 64.7% were male. There were 79 cases identified as T1 and 105 as T2. A total of 825 cases were treated using WLE with or without adjuvant therapy, while a total of 9 cases were treated using MMS with and without adjuvant therapies (Table). There were 461 cases treated without surgical excision: RT alone (n=261), CT alone (n=38), IT alone (n=35), RT with CT (n=81), RT with IT (n=34), and RT with CT and IT (n=12)(Table). The median follow-up period across all studies was 23.5 months (range, 1–228 months).

Comparison Between Surgical and Nonsurgical Modalities

Wide Local Excision—Wide local excision (n=825; 63.7%) alone or in combination with other therapies was the most frequently used treatment modality. The mean (SD) OS was longest for WLE with RT, CT, and IT (n=3; 39.3 [24.1]), followed by WLE with RT (n=447; 35.9 [34.3] months), WLE with CT (n=13; 32.4 [30.2] months), WLE alone (n=324; 29.6 [34.1] months), WLE with RT and IT (n=11; 23.5 [4.9] months), and WLE with RT and CT (n=27; 20.7 [13.1] months).

Nonsurgical Modalities—Nonsurgical methods were used less frequently than surgical methods (n=461; 35.6%). The mean (SD) OS time in descending order was as follows: RT with CT and IT (n=12; 34.9 [1.2] months), RT with CT (n=81; 30.4 [37.8] months), IT alone (n=35; 25.7 [no SD reported] months), RT with IT (n=34; 20.5 [8.6] months), CT alone (n=38; 20.1 [15.9] months), and RT alone (n=261; 12.8 [8.3] months).

When comparing mean (SD) OS outcomes between surgical and nonsurgical treatment modalities, only the addition of WLE to RT significantly increased OS when compared with RT alone (WLE, 35.9 [34.3] months; RT alone, 12.8 [8.3] months; P=.001). When WLE was added to CT or both RT and CT, there was no significant difference with OS when compared with CT alone (WLE with CT, 32.4 [30.2] months; CT alone, 20.1 [15.9] months; P=.065); or both RT and CT in combination (WLE with RT and CT, 20.7 [13.1] months; RT and CT, 30.4 [37.8] months; P=.204).

Comparison Between T1 and T2 cAS

T1 Angiosarcoma—There were 79 patients identified as having T1 tumors across 16 studies.^{2,31,32,34,39-41,46,48-50,53,58-60,62} The mean (SD) OS was longest for WLE with RT, CT, and IT (n=2; 56.0 [6.0] months), followed by WLE with CT (n=4; 54.5 [41.0] months); WLE with RT (n=30; 39.7 [41.2] months); WLE alone (n=22; 37.2 [37.3] months); WLE with both RT and CT (n=7; 25.5 [18.7] months); RT with IT (n=2; 20.0 [11.0] months); RT with CT (n=6; 15.7 [6.8] months); and RT alone (n=1; 13 [no SD]) months)(eTable).

T2 Angiosarcoma—There were 105 patients with T2 tumors in 15 studies.^{2,31,32,34,39-41,46,48-50,52,53,57,62} The mean (SD) OS for each treatment modality in descending order was as follows: RT with CT and IT (n=1; 36 [no SD reported] months); RT with CT (n=23; 34.3 [46.3] months); WLE with RT (n=21; 26.3 [23.8] months); WLE with CT (n=8; 21.5 [16.6] months); WLE alone (n=16; 19.8 [15.6] months); WLE with RT and CT (n=14; 19.2 [10.5] months); RT alone (n=17; 10.1 [5.5] months); CT alone (n=2; 6.7 [3.7] months); and WLE with RT, CT, and IT (n=1; 6.0 [no SD] months)(eTable).

Mohs Micrographic Surgery—The use of MMS was only identified in case reports or small observational studies for a total of 9 patients. Five cASs were treated with MMS alone for a mean (SD) OS of 37 (21.5) months, with 4 reporting cAS staging: 2 were T1^58,59 (mean [SD] OS, 37.0 [17.0] months) and 2 were T2 tumors^39,57 (mean [SD] OS, 44.5 [26.5] months). Mohs micrographic surgery with RT was used for 3 tumors (mean [SD] OS, 34.0 [26.9] months); 2 were T1^50,60 (mean [SD] OS, 42.0 [30.0] months) and 1 unreported staging (eTable).⁵⁶ Mohs micrographic surgery with both RT and CT was used in 1 patient (unreported staging; OS, 82 months).⁵¹

Complications

Complications were rare and mainly associated with CT and RT. Four studies reported radiation dermatitis with RT.^53,55,62,63 Two studies reported peripheral neuropathy and myelotoxicity with CT.^35,51 Only 1 study reported poor wound healing due to surgical complications.²⁹

COMMENT

Cutaneous angiosarcomas are rare and have limited treatment guidelines. Surgical excision does appear to be an effective adjunct to nonsurgical treatments, particularly WLE combined with RT, CT, and IT. Although MMS ultimately may be useful for cAS, the limited number and substantial heterogeneity of reported cases precludes definitive conclusions at this time.

Achieving margin control during WLE is associated with higher OS when treating angiosarcoma,^36,46 which is particularly true for T1 tumors where margin control is imperative, and many cases are treated with a combination of WLE and RT. Overall survival times are lower for T2 tumors, as these tumors are larger and most likely have spread; therefore, more aggressive combination treatments were more prevalent. In these cases, complete margin control may be difficult to achieve and may not be as critical to the outcome if another form of adjuvant therapy can be administered promptly.^24,64

When surgery is contraindicated, RT with or without CT was the most commonly reported treatment modality. However, these treatments were notably less effective than when used in combination with surgical resection. The use of RT alone has a recurrence rate reported up to 100% in certain studies, suggesting the need to utilize RT in combination with other modalities.^23,39 It is important to note that RT often is used as monotherapy in palliative treatment, which may indirectly skew survival rates.²

Limitations of the study include a lack of randomized controlled trials. Most reports were retrospective reviews or case series, and tumor staging was sparsely reported. Finally, although MMS may provide utility in the treatment of cAS, the sample size of 9 precluded definitive conclusions from being formed about its efficacy.

CONCLUSION

Cutaneous angiosarcoma is rare and has limited data comparing different treatment modalities. The paucity of data currently limits definitive recommendations; however, both surgical and nonsurgical modalities have demonstrated potential efficacy in the treatment of cAS and may benefit from additional research. Clinicians should consider a multidisciplinary approach for patients with a diagnosis of cAS to tailor treatments on a case-by-case basis.

Cutaneous angiosarcoma (cAS) is a rare malignancy arising from vascular or lymphatic tissue. It classically presents during the sixth or seventh decades of life as a raised purple papule or plaque on the head and neck areas.¹ Primary cAS frequently mimics benign conditions, leading to delays in care. Such delays coupled with the aggressive nature of angiosarcomas leads to a poor prognosis. Five-year survival rates range from 11% to 50%, and more than half of patients die within 1 year of diagnosis.^2-7

Currently, there is no consensus on the most effective treatments, as the rare nature of cAS has made the development of controlled clinical trials difficult. Wide local excision (WLE) is most frequently employed; however, the tumor’s infiltrative growth makes complete resection and negative surgical margins difficult to achieve.⁸ Recently, Mohs micrographic surgery (MMS) has been postulated as a treatment option. The tissue-sparing nature and intraoperative margin control of MMS may provide tumor eradication and cosmesis benefits reported with other cutaneous malignancies.⁹

Nearly all localized cASs are treated with surgical excision with or without adjuvant treatment modalities; however, it is unclear which of these modalities provide a survival benefit. We conducted a systematic review of the literature to compare treatment modalities for localized cAS of the head and neck regions and to compare treatments based on tumor stage.

METHODS

A literature search was performed to identify published studies indexed by MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and PubMed from January 1, 1977, to May 8, 2020, reporting on cAS and treatment modalities used. The search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines.⁵ Data extracted included patient demographics, tumor characteristics (including T1 [≤5 cm] and T2 [>5 cm and ≤10 cm] based on the American Joint Committee on Cancer soft tissue sarcoma staging criteria), treatments used, follow-up time, overall survival (OS) rates, and complications.^10,11

Studies were required to (1) include participants with head and neck cAS; (2) report original patient data following cAS treatment with surgical (WLE or MMS) and/or nonsurgical modalities (chemotherapy [CT], radiotherapy [RT], immunotherapy [IT]); (3) report outcome data related to OS rates following treatment; and (4) have articles published in English. Given the rare nature of cAS, there was no limitation on the number of participants needed.

The Newcastle-Ottawa scale for observational studies was used to assess the quality of studies.¹² Higher scores indicate low risk of bias, while lower scores represent high risk of bias.

Continuous data were reported with means and SDs, while categorical variables were reported as percentages. Overall survival means and SDs were compared between treatment modalities using an independent sample t test with P<.05 considered statistically significant. Due to the heterogeneity of the data, a meta-analysis was not reported.

RESULTS

Literature Search and Risk of Bias Assessment

There were 283 manuscripts identified, 56 articles read in full, and 40 articles included in the review (Figure). Among the 16 studies not meeting inclusion criteria, 7 did not provide enough data to isolate head and neck cAS cases,^1,13-18 6 did not report outcomes related to the current review,^19-24 and 3 did not provide enough data to isolate different treatment outcomes.^25-27 Among the included studies, 32 reported use of WLE: WLE alone (n=21)^2,7,11,28-45; WLE with RT (n=24)^{2,3,11,28-31,33-36,38-41,43-51}; WLE with CT (n=7)^{2,31,35,39,41,48,52}; WLE with RT and CT (n=11)^{2,29,31,33-35,39,40,48,52,53}; WLE with RT and IT (n=3)^35,54,55; and WLE with RT, CT, and IT (n=1).⁵³ Nine studies reported MMS: MMS alone (n=5)^39,56-59; MMS with RT (n=3)^32,50,60,61; and MMS with RT and CT (n=1).⁵¹

Risk of bias assessment identified low risk in 3 articles. High risk was identified in 5 case reports,^57-61 and 1 study did not describe patient selection.⁴³ Clayton et al⁵⁶ showed intermediate risk, given the study controlled for 1 factor.

Patient Demographics

A total of 1295 patients were included. The pooled mean age of the patients was 67.5 years (range, 3–88 years), and 64.7% were male. There were 79 cases identified as T1 and 105 as T2. A total of 825 cases were treated using WLE with or without adjuvant therapy, while a total of 9 cases were treated using MMS with and without adjuvant therapies (Table). There were 461 cases treated without surgical excision: RT alone (n=261), CT alone (n=38), IT alone (n=35), RT with CT (n=81), RT with IT (n=34), and RT with CT and IT (n=12)(Table). The median follow-up period across all studies was 23.5 months (range, 1–228 months).

Comparison Between Surgical and Nonsurgical Modalities

Wide Local Excision—Wide local excision (n=825; 63.7%) alone or in combination with other therapies was the most frequently used treatment modality. The mean (SD) OS was longest for WLE with RT, CT, and IT (n=3; 39.3 [24.1]), followed by WLE with RT (n=447; 35.9 [34.3] months), WLE with CT (n=13; 32.4 [30.2] months), WLE alone (n=324; 29.6 [34.1] months), WLE with RT and IT (n=11; 23.5 [4.9] months), and WLE with RT and CT (n=27; 20.7 [13.1] months).

Nonsurgical Modalities—Nonsurgical methods were used less frequently than surgical methods (n=461; 35.6%). The mean (SD) OS time in descending order was as follows: RT with CT and IT (n=12; 34.9 [1.2] months), RT with CT (n=81; 30.4 [37.8] months), IT alone (n=35; 25.7 [no SD reported] months), RT with IT (n=34; 20.5 [8.6] months), CT alone (n=38; 20.1 [15.9] months), and RT alone (n=261; 12.8 [8.3] months).

When comparing mean (SD) OS outcomes between surgical and nonsurgical treatment modalities, only the addition of WLE to RT significantly increased OS when compared with RT alone (WLE, 35.9 [34.3] months; RT alone, 12.8 [8.3] months; P=.001). When WLE was added to CT or both RT and CT, there was no significant difference with OS when compared with CT alone (WLE with CT, 32.4 [30.2] months; CT alone, 20.1 [15.9] months; P=.065); or both RT and CT in combination (WLE with RT and CT, 20.7 [13.1] months; RT and CT, 30.4 [37.8] months; P=.204).

Comparison Between T1 and T2 cAS

T1 Angiosarcoma—There were 79 patients identified as having T1 tumors across 16 studies.^{2,31,32,34,39-41,46,48-50,53,58-60,62} The mean (SD) OS was longest for WLE with RT, CT, and IT (n=2; 56.0 [6.0] months), followed by WLE with CT (n=4; 54.5 [41.0] months); WLE with RT (n=30; 39.7 [41.2] months); WLE alone (n=22; 37.2 [37.3] months); WLE with both RT and CT (n=7; 25.5 [18.7] months); RT with IT (n=2; 20.0 [11.0] months); RT with CT (n=6; 15.7 [6.8] months); and RT alone (n=1; 13 [no SD]) months)(eTable).

T2 Angiosarcoma—There were 105 patients with T2 tumors in 15 studies.^{2,31,32,34,39-41,46,48-50,52,53,57,62} The mean (SD) OS for each treatment modality in descending order was as follows: RT with CT and IT (n=1; 36 [no SD reported] months); RT with CT (n=23; 34.3 [46.3] months); WLE with RT (n=21; 26.3 [23.8] months); WLE with CT (n=8; 21.5 [16.6] months); WLE alone (n=16; 19.8 [15.6] months); WLE with RT and CT (n=14; 19.2 [10.5] months); RT alone (n=17; 10.1 [5.5] months); CT alone (n=2; 6.7 [3.7] months); and WLE with RT, CT, and IT (n=1; 6.0 [no SD] months)(eTable).

Mohs Micrographic Surgery—The use of MMS was only identified in case reports or small observational studies for a total of 9 patients. Five cASs were treated with MMS alone for a mean (SD) OS of 37 (21.5) months, with 4 reporting cAS staging: 2 were T1^58,59 (mean [SD] OS, 37.0 [17.0] months) and 2 were T2 tumors^39,57 (mean [SD] OS, 44.5 [26.5] months). Mohs micrographic surgery with RT was used for 3 tumors (mean [SD] OS, 34.0 [26.9] months); 2 were T1^50,60 (mean [SD] OS, 42.0 [30.0] months) and 1 unreported staging (eTable).⁵⁶ Mohs micrographic surgery with both RT and CT was used in 1 patient (unreported staging; OS, 82 months).⁵¹

Complications

Complications were rare and mainly associated with CT and RT. Four studies reported radiation dermatitis with RT.^53,55,62,63 Two studies reported peripheral neuropathy and myelotoxicity with CT.^35,51 Only 1 study reported poor wound healing due to surgical complications.²⁹

COMMENT

Cutaneous angiosarcomas are rare and have limited treatment guidelines. Surgical excision does appear to be an effective adjunct to nonsurgical treatments, particularly WLE combined with RT, CT, and IT. Although MMS ultimately may be useful for cAS, the limited number and substantial heterogeneity of reported cases precludes definitive conclusions at this time.

Achieving margin control during WLE is associated with higher OS when treating angiosarcoma,^36,46 which is particularly true for T1 tumors where margin control is imperative, and many cases are treated with a combination of WLE and RT. Overall survival times are lower for T2 tumors, as these tumors are larger and most likely have spread; therefore, more aggressive combination treatments were more prevalent. In these cases, complete margin control may be difficult to achieve and may not be as critical to the outcome if another form of adjuvant therapy can be administered promptly.^24,64

When surgery is contraindicated, RT with or without CT was the most commonly reported treatment modality. However, these treatments were notably less effective than when used in combination with surgical resection. The use of RT alone has a recurrence rate reported up to 100% in certain studies, suggesting the need to utilize RT in combination with other modalities.^23,39 It is important to note that RT often is used as monotherapy in palliative treatment, which may indirectly skew survival rates.²

Limitations of the study include a lack of randomized controlled trials. Most reports were retrospective reviews or case series, and tumor staging was sparsely reported. Finally, although MMS may provide utility in the treatment of cAS, the sample size of 9 precluded definitive conclusions from being formed about its efficacy.

CONCLUSION

Cutaneous angiosarcoma is rare and has limited data comparing different treatment modalities. The paucity of data currently limits definitive recommendations; however, both surgical and nonsurgical modalities have demonstrated potential efficacy in the treatment of cAS and may benefit from additional research. Clinicians should consider a multidisciplinary approach for patients with a diagnosis of cAS to tailor treatments on a case-by-case basis.

Cutaneous angiosarcoma (cAS) is a rare malignancy arising from vascular or lymphatic tissue. It classically presents during the sixth or seventh decades of life as a raised purple papule or plaque on the head and neck areas.¹ Primary cAS frequently mimics benign conditions, leading to delays in care. Such delays coupled with the aggressive nature of angiosarcomas leads to a poor prognosis. Five-year survival rates range from 11% to 50%, and more than half of patients die within 1 year of diagnosis.^2-7

Currently, there is no consensus on the most effective treatments, as the rare nature of cAS has made the development of controlled clinical trials difficult. Wide local excision (WLE) is most frequently employed; however, the tumor’s infiltrative growth makes complete resection and negative surgical margins difficult to achieve.⁸ Recently, Mohs micrographic surgery (MMS) has been postulated as a treatment option. The tissue-sparing nature and intraoperative margin control of MMS may provide tumor eradication and cosmesis benefits reported with other cutaneous malignancies.⁹

Nearly all localized cASs are treated with surgical excision with or without adjuvant treatment modalities; however, it is unclear which of these modalities provide a survival benefit. We conducted a systematic review of the literature to compare treatment modalities for localized cAS of the head and neck regions and to compare treatments based on tumor stage.

METHODS

A literature search was performed to identify published studies indexed by MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and PubMed from January 1, 1977, to May 8, 2020, reporting on cAS and treatment modalities used. The search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines.⁵ Data extracted included patient demographics, tumor characteristics (including T1 [≤5 cm] and T2 [>5 cm and ≤10 cm] based on the American Joint Committee on Cancer soft tissue sarcoma staging criteria), treatments used, follow-up time, overall survival (OS) rates, and complications.^10,11

Studies were required to (1) include participants with head and neck cAS; (2) report original patient data following cAS treatment with surgical (WLE or MMS) and/or nonsurgical modalities (chemotherapy [CT], radiotherapy [RT], immunotherapy [IT]); (3) report outcome data related to OS rates following treatment; and (4) have articles published in English. Given the rare nature of cAS, there was no limitation on the number of participants needed.

The Newcastle-Ottawa scale for observational studies was used to assess the quality of studies.¹² Higher scores indicate low risk of bias, while lower scores represent high risk of bias.

Continuous data were reported with means and SDs, while categorical variables were reported as percentages. Overall survival means and SDs were compared between treatment modalities using an independent sample t test with P<.05 considered statistically significant. Due to the heterogeneity of the data, a meta-analysis was not reported.

RESULTS

Literature Search and Risk of Bias Assessment

There were 283 manuscripts identified, 56 articles read in full, and 40 articles included in the review (Figure). Among the 16 studies not meeting inclusion criteria, 7 did not provide enough data to isolate head and neck cAS cases,^1,13-18 6 did not report outcomes related to the current review,^19-24 and 3 did not provide enough data to isolate different treatment outcomes.^25-27 Among the included studies, 32 reported use of WLE: WLE alone (n=21)^2,7,11,28-45; WLE with RT (n=24)^{2,3,11,28-31,33-36,38-41,43-51}; WLE with CT (n=7)^{2,31,35,39,41,48,52}; WLE with RT and CT (n=11)^{2,29,31,33-35,39,40,48,52,53}; WLE with RT and IT (n=3)^35,54,55; and WLE with RT, CT, and IT (n=1).⁵³ Nine studies reported MMS: MMS alone (n=5)^39,56-59; MMS with RT (n=3)^32,50,60,61; and MMS with RT and CT (n=1).⁵¹

Risk of bias assessment identified low risk in 3 articles. High risk was identified in 5 case reports,^57-61 and 1 study did not describe patient selection.⁴³ Clayton et al⁵⁶ showed intermediate risk, given the study controlled for 1 factor.

Patient Demographics

A total of 1295 patients were included. The pooled mean age of the patients was 67.5 years (range, 3–88 years), and 64.7% were male. There were 79 cases identified as T1 and 105 as T2. A total of 825 cases were treated using WLE with or without adjuvant therapy, while a total of 9 cases were treated using MMS with and without adjuvant therapies (Table). There were 461 cases treated without surgical excision: RT alone (n=261), CT alone (n=38), IT alone (n=35), RT with CT (n=81), RT with IT (n=34), and RT with CT and IT (n=12)(Table). The median follow-up period across all studies was 23.5 months (range, 1–228 months).

Comparison Between Surgical and Nonsurgical Modalities

Wide Local Excision—Wide local excision (n=825; 63.7%) alone or in combination with other therapies was the most frequently used treatment modality. The mean (SD) OS was longest for WLE with RT, CT, and IT (n=3; 39.3 [24.1]), followed by WLE with RT (n=447; 35.9 [34.3] months), WLE with CT (n=13; 32.4 [30.2] months), WLE alone (n=324; 29.6 [34.1] months), WLE with RT and IT (n=11; 23.5 [4.9] months), and WLE with RT and CT (n=27; 20.7 [13.1] months).

Nonsurgical Modalities—Nonsurgical methods were used less frequently than surgical methods (n=461; 35.6%). The mean (SD) OS time in descending order was as follows: RT with CT and IT (n=12; 34.9 [1.2] months), RT with CT (n=81; 30.4 [37.8] months), IT alone (n=35; 25.7 [no SD reported] months), RT with IT (n=34; 20.5 [8.6] months), CT alone (n=38; 20.1 [15.9] months), and RT alone (n=261; 12.8 [8.3] months).

When comparing mean (SD) OS outcomes between surgical and nonsurgical treatment modalities, only the addition of WLE to RT significantly increased OS when compared with RT alone (WLE, 35.9 [34.3] months; RT alone, 12.8 [8.3] months; P=.001). When WLE was added to CT or both RT and CT, there was no significant difference with OS when compared with CT alone (WLE with CT, 32.4 [30.2] months; CT alone, 20.1 [15.9] months; P=.065); or both RT and CT in combination (WLE with RT and CT, 20.7 [13.1] months; RT and CT, 30.4 [37.8] months; P=.204).

Comparison Between T1 and T2 cAS

T1 Angiosarcoma—There were 79 patients identified as having T1 tumors across 16 studies.^{2,31,32,34,39-41,46,48-50,53,58-60,62} The mean (SD) OS was longest for WLE with RT, CT, and IT (n=2; 56.0 [6.0] months), followed by WLE with CT (n=4; 54.5 [41.0] months); WLE with RT (n=30; 39.7 [41.2] months); WLE alone (n=22; 37.2 [37.3] months); WLE with both RT and CT (n=7; 25.5 [18.7] months); RT with IT (n=2; 20.0 [11.0] months); RT with CT (n=6; 15.7 [6.8] months); and RT alone (n=1; 13 [no SD]) months)(eTable).

T2 Angiosarcoma—There were 105 patients with T2 tumors in 15 studies.^{2,31,32,34,39-41,46,48-50,52,53,57,62} The mean (SD) OS for each treatment modality in descending order was as follows: RT with CT and IT (n=1; 36 [no SD reported] months); RT with CT (n=23; 34.3 [46.3] months); WLE with RT (n=21; 26.3 [23.8] months); WLE with CT (n=8; 21.5 [16.6] months); WLE alone (n=16; 19.8 [15.6] months); WLE with RT and CT (n=14; 19.2 [10.5] months); RT alone (n=17; 10.1 [5.5] months); CT alone (n=2; 6.7 [3.7] months); and WLE with RT, CT, and IT (n=1; 6.0 [no SD] months)(eTable).

Mohs Micrographic Surgery—The use of MMS was only identified in case reports or small observational studies for a total of 9 patients. Five cASs were treated with MMS alone for a mean (SD) OS of 37 (21.5) months, with 4 reporting cAS staging: 2 were T1^58,59 (mean [SD] OS, 37.0 [17.0] months) and 2 were T2 tumors^39,57 (mean [SD] OS, 44.5 [26.5] months). Mohs micrographic surgery with RT was used for 3 tumors (mean [SD] OS, 34.0 [26.9] months); 2 were T1^50,60 (mean [SD] OS, 42.0 [30.0] months) and 1 unreported staging (eTable).⁵⁶ Mohs micrographic surgery with both RT and CT was used in 1 patient (unreported staging; OS, 82 months).⁵¹

Complications

Complications were rare and mainly associated with CT and RT. Four studies reported radiation dermatitis with RT.^53,55,62,63 Two studies reported peripheral neuropathy and myelotoxicity with CT.^35,51 Only 1 study reported poor wound healing due to surgical complications.²⁹

COMMENT

Cutaneous angiosarcomas are rare and have limited treatment guidelines. Surgical excision does appear to be an effective adjunct to nonsurgical treatments, particularly WLE combined with RT, CT, and IT. Although MMS ultimately may be useful for cAS, the limited number and substantial heterogeneity of reported cases precludes definitive conclusions at this time.

Achieving margin control during WLE is associated with higher OS when treating angiosarcoma,^36,46 which is particularly true for T1 tumors where margin control is imperative, and many cases are treated with a combination of WLE and RT. Overall survival times are lower for T2 tumors, as these tumors are larger and most likely have spread; therefore, more aggressive combination treatments were more prevalent. In these cases, complete margin control may be difficult to achieve and may not be as critical to the outcome if another form of adjuvant therapy can be administered promptly.^24,64

When surgery is contraindicated, RT with or without CT was the most commonly reported treatment modality. However, these treatments were notably less effective than when used in combination with surgical resection. The use of RT alone has a recurrence rate reported up to 100% in certain studies, suggesting the need to utilize RT in combination with other modalities.^23,39 It is important to note that RT often is used as monotherapy in palliative treatment, which may indirectly skew survival rates.²

Limitations of the study include a lack of randomized controlled trials. Most reports were retrospective reviews or case series, and tumor staging was sparsely reported. Finally, although MMS may provide utility in the treatment of cAS, the sample size of 9 precluded definitive conclusions from being formed about its efficacy.

CONCLUSION

Cutaneous angiosarcoma is rare and has limited data comparing different treatment modalities. The paucity of data currently limits definitive recommendations; however, both surgical and nonsurgical modalities have demonstrated potential efficacy in the treatment of cAS and may benefit from additional research. Clinicians should consider a multidisciplinary approach for patients with a diagnosis of cAS to tailor treatments on a case-by-case basis.

The landscape of breast cancer care and how we're working on pushing the targeted treatment movement forward is rapidly changing, especially with antibody drug conjugates (ADCs). 

I like to think of ADCs as targeted missiles. They're essentially composed of antibodies against specific antigens, or targets of interest, and then they're combined with a linker to a chemotherapy payload. It's a way to deliver the chemotherapy in a more targeted manner than traditional chemotherapy, which is an exciting opportunity to allow us to target those patients who otherwise prefer agents that were more difficult to tolerate before this technology was invented. 

This field has grown exponentially in the last 5 to 10 years and has presented multiple new opportunities for research. What is most exciting is that we have new targets for these treatments—new antigens that we can target with novel ADCs.

The NeoSTAR trial evaluated the ADC sacituzumab govitecan (SG), which is used for patients who have earlier stage triple negative breast cancer before surgery. The idea of this is to hopefully spare patients from many of the more toxic effects of traditional chemotherapy, while still providing them precision in terms of the treatment that we're targeting in the body. 

I was involved in the ASCENT trial, which is also notable for precise treatment. It demonstrated the superiority of SG in metastatic triple negative breast cancer, and more recently the US Food and Drug Administration label has been expanded to the metastatic hormone-positive space as well. As we're developing these ADCs and broadening their use, we're able to reach larger patient populations. It's really exciting because we know there's such an appetite among our patients to use these agents, given how effective they can be and, in some situations, less toxic than the standard chemotherapy they would have otherwise gotten. 

The other big category of trials involves another ADC called trastuzumab deruxtecan (TD). Trastuzumab is conjugated against HER2, a breast cancer specific agent, and is combined with the linker, deruxtecan—a very potent chemotherapy payload. TD was initially used in patients who had HER2-positive breast cancer. In fact, trastuzumab, the first half of the drug, was used as an antibody in and of itself in a lot of earlier stage and metastatic cancer for years. We've known about that for a long time. But more recently, with the series of DESTINY trials, we have seen the major impact that TD in HER2 can have compared to other chemotherapy agents and against other ADCs as well. 

What was so exciting about the trials presented in 2022 is that they created a new category of patients called HER2-low. Before, we had always considered patients as HER2-positive or HER2-negative. We now know it's not that binary. We had already known by the way we do the pathology that people can have levels of HER2 expression. HER2-low patients are people who would have been considered HER2-negative before this—but have some HER2 expression. They have what we consider low on a scale of 0 to 3+, typically. Therefore, they're 1+ or 2+, not 0, and not 3+, because that would be considered HER2-positive. It's a little more complicated because when it's triple 2-positive, they could also do a back-up test, if a patient is positive on that, they are considered as HER2-positive. 

There is now a new category of HER2-low patients who were also shown to have a tremendous improvement benefit with TD; this new category of patients could be candidates for this treatment, although they would never have been used for HER2 targeting before. These agents can be so effective that it's even causing us to rethink our classifications of disease. 

Some of what we're working on right now is specifically looking at how patients are resistant to these agents; that's one of our major focuses as Mass General. We know these treatments are highly effective, but unfortunately, they don't last forever. Very few of these cancer treatments do, because as we know, cancer has this remarkable ability to evolve resistance to agents that we use. The amazing thing about ADCs is they've extended (in some cases) overall survival for patients, which is fantastic. But as I said, we know that they are not lasting forever. Part of what we're involved in with that clinical and research setting is to look at patients who've had success with these agents and ultimately progressed, and then figure out what changed before and after treatment (down to the single cell or genetic level) in order to continue expanding use of these treatments, extending use of the treatments, and making them more effective for more patients. 

The landscape of breast cancer care and how we're working on pushing the targeted treatment movement forward is rapidly changing, especially with antibody drug conjugates (ADCs). 

I like to think of ADCs as targeted missiles. They're essentially composed of antibodies against specific antigens, or targets of interest, and then they're combined with a linker to a chemotherapy payload. It's a way to deliver the chemotherapy in a more targeted manner than traditional chemotherapy, which is an exciting opportunity to allow us to target those patients who otherwise prefer agents that were more difficult to tolerate before this technology was invented. 

This field has grown exponentially in the last 5 to 10 years and has presented multiple new opportunities for research. What is most exciting is that we have new targets for these treatments—new antigens that we can target with novel ADCs.

The NeoSTAR trial evaluated the ADC sacituzumab govitecan (SG), which is used for patients who have earlier stage triple negative breast cancer before surgery. The idea of this is to hopefully spare patients from many of the more toxic effects of traditional chemotherapy, while still providing them precision in terms of the treatment that we're targeting in the body. 

I was involved in the ASCENT trial, which is also notable for precise treatment. It demonstrated the superiority of SG in metastatic triple negative breast cancer, and more recently the US Food and Drug Administration label has been expanded to the metastatic hormone-positive space as well. As we're developing these ADCs and broadening their use, we're able to reach larger patient populations. It's really exciting because we know there's such an appetite among our patients to use these agents, given how effective they can be and, in some situations, less toxic than the standard chemotherapy they would have otherwise gotten. 

The other big category of trials involves another ADC called trastuzumab deruxtecan (TD). Trastuzumab is conjugated against HER2, a breast cancer specific agent, and is combined with the linker, deruxtecan—a very potent chemotherapy payload. TD was initially used in patients who had HER2-positive breast cancer. In fact, trastuzumab, the first half of the drug, was used as an antibody in and of itself in a lot of earlier stage and metastatic cancer for years. We've known about that for a long time. But more recently, with the series of DESTINY trials, we have seen the major impact that TD in HER2 can have compared to other chemotherapy agents and against other ADCs as well. 

What was so exciting about the trials presented in 2022 is that they created a new category of patients called HER2-low. Before, we had always considered patients as HER2-positive or HER2-negative. We now know it's not that binary. We had already known by the way we do the pathology that people can have levels of HER2 expression. HER2-low patients are people who would have been considered HER2-negative before this—but have some HER2 expression. They have what we consider low on a scale of 0 to 3+, typically. Therefore, they're 1+ or 2+, not 0, and not 3+, because that would be considered HER2-positive. It's a little more complicated because when it's triple 2-positive, they could also do a back-up test, if a patient is positive on that, they are considered as HER2-positive. 

There is now a new category of HER2-low patients who were also shown to have a tremendous improvement benefit with TD; this new category of patients could be candidates for this treatment, although they would never have been used for HER2 targeting before. These agents can be so effective that it's even causing us to rethink our classifications of disease. 

Some of what we're working on right now is specifically looking at how patients are resistant to these agents; that's one of our major focuses as Mass General. We know these treatments are highly effective, but unfortunately, they don't last forever. Very few of these cancer treatments do, because as we know, cancer has this remarkable ability to evolve resistance to agents that we use. The amazing thing about ADCs is they've extended (in some cases) overall survival for patients, which is fantastic. But as I said, we know that they are not lasting forever. Part of what we're involved in with that clinical and research setting is to look at patients who've had success with these agents and ultimately progressed, and then figure out what changed before and after treatment (down to the single cell or genetic level) in order to continue expanding use of these treatments, extending use of the treatments, and making them more effective for more patients. 

The landscape of breast cancer care and how we're working on pushing the targeted treatment movement forward is rapidly changing, especially with antibody drug conjugates (ADCs). 

I like to think of ADCs as targeted missiles. They're essentially composed of antibodies against specific antigens, or targets of interest, and then they're combined with a linker to a chemotherapy payload. It's a way to deliver the chemotherapy in a more targeted manner than traditional chemotherapy, which is an exciting opportunity to allow us to target those patients who otherwise prefer agents that were more difficult to tolerate before this technology was invented. 

This field has grown exponentially in the last 5 to 10 years and has presented multiple new opportunities for research. What is most exciting is that we have new targets for these treatments—new antigens that we can target with novel ADCs.

The NeoSTAR trial evaluated the ADC sacituzumab govitecan (SG), which is used for patients who have earlier stage triple negative breast cancer before surgery. The idea of this is to hopefully spare patients from many of the more toxic effects of traditional chemotherapy, while still providing them precision in terms of the treatment that we're targeting in the body. 

I was involved in the ASCENT trial, which is also notable for precise treatment. It demonstrated the superiority of SG in metastatic triple negative breast cancer, and more recently the US Food and Drug Administration label has been expanded to the metastatic hormone-positive space as well. As we're developing these ADCs and broadening their use, we're able to reach larger patient populations. It's really exciting because we know there's such an appetite among our patients to use these agents, given how effective they can be and, in some situations, less toxic than the standard chemotherapy they would have otherwise gotten. 

The other big category of trials involves another ADC called trastuzumab deruxtecan (TD). Trastuzumab is conjugated against HER2, a breast cancer specific agent, and is combined with the linker, deruxtecan—a very potent chemotherapy payload. TD was initially used in patients who had HER2-positive breast cancer. In fact, trastuzumab, the first half of the drug, was used as an antibody in and of itself in a lot of earlier stage and metastatic cancer for years. We've known about that for a long time. But more recently, with the series of DESTINY trials, we have seen the major impact that TD in HER2 can have compared to other chemotherapy agents and against other ADCs as well. 

What was so exciting about the trials presented in 2022 is that they created a new category of patients called HER2-low. Before, we had always considered patients as HER2-positive or HER2-negative. We now know it's not that binary. We had already known by the way we do the pathology that people can have levels of HER2 expression. HER2-low patients are people who would have been considered HER2-negative before this—but have some HER2 expression. They have what we consider low on a scale of 0 to 3+, typically. Therefore, they're 1+ or 2+, not 0, and not 3+, because that would be considered HER2-positive. It's a little more complicated because when it's triple 2-positive, they could also do a back-up test, if a patient is positive on that, they are considered as HER2-positive. 

There is now a new category of HER2-low patients who were also shown to have a tremendous improvement benefit with TD; this new category of patients could be candidates for this treatment, although they would never have been used for HER2 targeting before. These agents can be so effective that it's even causing us to rethink our classifications of disease. 

Some of what we're working on right now is specifically looking at how patients are resistant to these agents; that's one of our major focuses as Mass General. We know these treatments are highly effective, but unfortunately, they don't last forever. Very few of these cancer treatments do, because as we know, cancer has this remarkable ability to evolve resistance to agents that we use. The amazing thing about ADCs is they've extended (in some cases) overall survival for patients, which is fantastic. But as I said, we know that they are not lasting forever. Part of what we're involved in with that clinical and research setting is to look at patients who've had success with these agents and ultimately progressed, and then figure out what changed before and after treatment (down to the single cell or genetic level) in order to continue expanding use of these treatments, extending use of the treatments, and making them more effective for more patients. 

Initiation of buprenorphine in hospitals in the United States has plateaued since 2018, with low retention rates of less than 25%, based on data from more than 3 million individuals who began buprenorphine between January 2016 and October 2022.

University of Michigan

Opioid overdose deaths are at a record high in the United States, and many of these deaths can be prevented with medications such as buprenorphine, said lead author Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, in an interview. “However, buprenorphine cannot prevent opioid overdose deaths if patients are never started on the medication or only stay on the medication for a short time. For that reason, rates of buprenorphine initiation and retention are critical metrics for measuring how well the U.S. health care system is responding to the opioid epidemic,” he said.

“At the time we started our study, several other research groups had evaluated U.S. rates of buprenorphine initiation and retention using data through 2020. However, more recent national data were lacking,” Dr. Chua told this news organization. “We felt that this was an important knowledge gap given the many changes in society that have occurred since 2020,” he noted. “For example, it was possible that the relaxation of social distancing measures during 2021 and 2022 might have reduced barriers to health care visits, thereby increasing opportunities to initiate treatment for opioid addiction with buprenorphine,” he said.

Dr. Chua and colleagues used data from the IQVIA Longitudinal Prescription Database, which reports 92% of prescriptions dispensed from retail pharmacies in the United States. “Buprenorphine products included immediate-release and extended-release formulations approved for opioid use disorder but not formulations primarily used to treat pain,” they write.

Monthly buprenorphine initiation was defined as the number of patients initiating therapy per 100,000 individuals. For retention, the researchers used a National Quality Forum-endorsed quality measure that defined retention as continuous use of buprenorphine for at least 180 days.

A total of 3,006,629 patients began buprenorphine therapy during the study period; approximately 43% were female.

During the first years of the study period, from January 2016 through September 2018, the monthly buprenorphine initiation rate increased from 12.5 per 100,000 to 15.9 per 100,000, with a statistically significant monthly percentage change of 0.62% (P < .001).

However, from October 2018 through October 2022, the monthly percentage remained essentially the same (P = .62) with a monthly percentage change of −0.03%.

From March 2020 through December 2020, the median monthly buprenorphine initiation rate was 14.4 per 100,000, only slightly lower than the rates from January 2019 through February 2020 and from January 2021 through October 2022 (15.5 per 100,000 and 15.0 per 100,000, respectively).

Over the entire study period from January 2016 through October 2022, the median monthly retention rate for buprenorphine use was 22.2%. This rate increased minimally, with no significant changes in slope and a monthly percentage change of 0.08% (P = .04).

The study findings were limited by several factors, including a lack of data on race and ethnicity, in-clinic administration of buprenorphine, and buprenorphine dispensing through methadone outpatient programs, the researchers note. Also, data did not indicate whether some patients began buprenorphine to treat pain, they say. The timing of the flattening of buprenorphine use also suggests the influence of factors beyond the COVID-19 pandemic, they write.

However, the results were strengthened by the large sample size and suggest that efforts to date to increase buprenorphine use have been unsuccessful, the researchers write. “A comprehensive approach is needed to eliminate barriers to buprenorphine initiation and retention, such as stigma and uneven access to prescribers,” they conclude.
 

Study highlights underuse of buprenorphine option

“Our study shows that buprenorphine initiation rates have been flat since the end of 2018 and that rates of 180-day retention in buprenorphine therapy have remained low throughout 2016-2022,” Dr. Chua told this news organization. “Neither of these findings are particularly surprising, but they are disappointing,” he said. “There were a lot of policy and clinical efforts to maintain and expand access to buprenorphine during the COVID-19 pandemic, such as allowing buprenorphine to be prescribed via telehealth without an in-person visit and eliminating training requirements for the waiver that previously was required to prescribe buprenorphine.

“The fact that buprenorphine initiation and retention did not rise after these efforts were implemented suggests that they were insufficient to meet the rising need for this medication,” he said.

The current study “adds to a growing body of research suggesting that clinicians are not maximizing opportunities to initiate buprenorphine treatment among patients with opioid addiction,” Dr. Chua said. He cited another of his recent studies in which 1 in 12 patients were prescribed buprenorphine within 30 days of an emergency department visit for opioid overdose from August 2019 to April 2021, but half of patients with emergency department visits with anaphylaxis were prescribed anepinephrine auto-injector.

“My hope is that our new study will further underscore to clinicians how much the health care system is underusing a critical tool to prevent opioid overdose deaths,” he said.

The federal government’s recent elimination of the waiver needed to prescribe buprenorphine may move the needle, but to what degree remains to be seen, Dr. Chua added. “It is possible this intervention will be insufficient to overcome the many other barriers to buprenorphine initiation and retention, such as stigma about the drug among clinicians, patients, and pharmacists,” he said.
 

Lack of education remains a barrier to buprenorphine use

The current study is important to determine whether attempts to increase buprenorphine initiation and treatment retention are working, said Reuben J. Strayer, MD, director of addiction medicine in the emergency medicine department at Maimonides Medical Center, New York, in an interview.

Dr. Strayer was not involved in the current study, but said he was surprised that initiation of buprenorphine didn’t decrease more dramatically during the pandemic, given the significant barriers to accessing care during that time.

However, “efforts to increase buprenorphine initiation and retention have not been sufficiently effective,” Dr. Strayer said. “The rise of fentanyl as a primary street opioid, replacing heroin, has dissuaded both patients and providers from initiating buprenorphine for fear of precipitated withdrawal.”

The elimination of the DATA 2000 (X) waiver was the removal of a potential barrier to increased buprenorphine use, said Dr. Strayer. “Now that the DATA 2000 (X) waiver has been eliminated, the focus of buprenorphine access is educating primary care and inpatient providers on its use, so that patients with OUD [opioid use disorder] can be treated, regardless of the venue at which they seek care,” he said.

Looking ahead, “The priority in buprenorphine research is determining the most effective way to initiate buprenorphine without the risk of precipitated withdrawal,” Dr. Strayer added.

The study was supported in part by the Benter Foundation, the Michigan Department of Health and Human Services, and the Susan B. Meister Child Health Evaluation and Research Center in the department of pediatrics at the University of Michigan. Dr. Chua was supported by the National Institute on Drug Abuse. Dr. Strayer has disclosed no relevant financial relationships.

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

Initiation of buprenorphine in hospitals in the United States has plateaued since 2018, with low retention rates of less than 25%, based on data from more than 3 million individuals who began buprenorphine between January 2016 and October 2022.

University of Michigan

Opioid overdose deaths are at a record high in the United States, and many of these deaths can be prevented with medications such as buprenorphine, said lead author Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, in an interview. “However, buprenorphine cannot prevent opioid overdose deaths if patients are never started on the medication or only stay on the medication for a short time. For that reason, rates of buprenorphine initiation and retention are critical metrics for measuring how well the U.S. health care system is responding to the opioid epidemic,” he said.

“At the time we started our study, several other research groups had evaluated U.S. rates of buprenorphine initiation and retention using data through 2020. However, more recent national data were lacking,” Dr. Chua told this news organization. “We felt that this was an important knowledge gap given the many changes in society that have occurred since 2020,” he noted. “For example, it was possible that the relaxation of social distancing measures during 2021 and 2022 might have reduced barriers to health care visits, thereby increasing opportunities to initiate treatment for opioid addiction with buprenorphine,” he said.

Dr. Chua and colleagues used data from the IQVIA Longitudinal Prescription Database, which reports 92% of prescriptions dispensed from retail pharmacies in the United States. “Buprenorphine products included immediate-release and extended-release formulations approved for opioid use disorder but not formulations primarily used to treat pain,” they write.

Monthly buprenorphine initiation was defined as the number of patients initiating therapy per 100,000 individuals. For retention, the researchers used a National Quality Forum-endorsed quality measure that defined retention as continuous use of buprenorphine for at least 180 days.

A total of 3,006,629 patients began buprenorphine therapy during the study period; approximately 43% were female.

During the first years of the study period, from January 2016 through September 2018, the monthly buprenorphine initiation rate increased from 12.5 per 100,000 to 15.9 per 100,000, with a statistically significant monthly percentage change of 0.62% (P < .001).

However, from October 2018 through October 2022, the monthly percentage remained essentially the same (P = .62) with a monthly percentage change of −0.03%.

From March 2020 through December 2020, the median monthly buprenorphine initiation rate was 14.4 per 100,000, only slightly lower than the rates from January 2019 through February 2020 and from January 2021 through October 2022 (15.5 per 100,000 and 15.0 per 100,000, respectively).

Over the entire study period from January 2016 through October 2022, the median monthly retention rate for buprenorphine use was 22.2%. This rate increased minimally, with no significant changes in slope and a monthly percentage change of 0.08% (P = .04).

The study findings were limited by several factors, including a lack of data on race and ethnicity, in-clinic administration of buprenorphine, and buprenorphine dispensing through methadone outpatient programs, the researchers note. Also, data did not indicate whether some patients began buprenorphine to treat pain, they say. The timing of the flattening of buprenorphine use also suggests the influence of factors beyond the COVID-19 pandemic, they write.

However, the results were strengthened by the large sample size and suggest that efforts to date to increase buprenorphine use have been unsuccessful, the researchers write. “A comprehensive approach is needed to eliminate barriers to buprenorphine initiation and retention, such as stigma and uneven access to prescribers,” they conclude.
 

Study highlights underuse of buprenorphine option

“Our study shows that buprenorphine initiation rates have been flat since the end of 2018 and that rates of 180-day retention in buprenorphine therapy have remained low throughout 2016-2022,” Dr. Chua told this news organization. “Neither of these findings are particularly surprising, but they are disappointing,” he said. “There were a lot of policy and clinical efforts to maintain and expand access to buprenorphine during the COVID-19 pandemic, such as allowing buprenorphine to be prescribed via telehealth without an in-person visit and eliminating training requirements for the waiver that previously was required to prescribe buprenorphine.

“The fact that buprenorphine initiation and retention did not rise after these efforts were implemented suggests that they were insufficient to meet the rising need for this medication,” he said.

The current study “adds to a growing body of research suggesting that clinicians are not maximizing opportunities to initiate buprenorphine treatment among patients with opioid addiction,” Dr. Chua said. He cited another of his recent studies in which 1 in 12 patients were prescribed buprenorphine within 30 days of an emergency department visit for opioid overdose from August 2019 to April 2021, but half of patients with emergency department visits with anaphylaxis were prescribed anepinephrine auto-injector.

“My hope is that our new study will further underscore to clinicians how much the health care system is underusing a critical tool to prevent opioid overdose deaths,” he said.

The federal government’s recent elimination of the waiver needed to prescribe buprenorphine may move the needle, but to what degree remains to be seen, Dr. Chua added. “It is possible this intervention will be insufficient to overcome the many other barriers to buprenorphine initiation and retention, such as stigma about the drug among clinicians, patients, and pharmacists,” he said.
 

Lack of education remains a barrier to buprenorphine use

The current study is important to determine whether attempts to increase buprenorphine initiation and treatment retention are working, said Reuben J. Strayer, MD, director of addiction medicine in the emergency medicine department at Maimonides Medical Center, New York, in an interview.

Dr. Strayer was not involved in the current study, but said he was surprised that initiation of buprenorphine didn’t decrease more dramatically during the pandemic, given the significant barriers to accessing care during that time.

However, “efforts to increase buprenorphine initiation and retention have not been sufficiently effective,” Dr. Strayer said. “The rise of fentanyl as a primary street opioid, replacing heroin, has dissuaded both patients and providers from initiating buprenorphine for fear of precipitated withdrawal.”

The elimination of the DATA 2000 (X) waiver was the removal of a potential barrier to increased buprenorphine use, said Dr. Strayer. “Now that the DATA 2000 (X) waiver has been eliminated, the focus of buprenorphine access is educating primary care and inpatient providers on its use, so that patients with OUD [opioid use disorder] can be treated, regardless of the venue at which they seek care,” he said.

Looking ahead, “The priority in buprenorphine research is determining the most effective way to initiate buprenorphine without the risk of precipitated withdrawal,” Dr. Strayer added.

The study was supported in part by the Benter Foundation, the Michigan Department of Health and Human Services, and the Susan B. Meister Child Health Evaluation and Research Center in the department of pediatrics at the University of Michigan. Dr. Chua was supported by the National Institute on Drug Abuse. Dr. Strayer has disclosed no relevant financial relationships.

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

Initiation of buprenorphine in hospitals in the United States has plateaued since 2018, with low retention rates of less than 25%, based on data from more than 3 million individuals who began buprenorphine between January 2016 and October 2022.

University of Michigan

Opioid overdose deaths are at a record high in the United States, and many of these deaths can be prevented with medications such as buprenorphine, said lead author Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, in an interview. “However, buprenorphine cannot prevent opioid overdose deaths if patients are never started on the medication or only stay on the medication for a short time. For that reason, rates of buprenorphine initiation and retention are critical metrics for measuring how well the U.S. health care system is responding to the opioid epidemic,” he said.

“At the time we started our study, several other research groups had evaluated U.S. rates of buprenorphine initiation and retention using data through 2020. However, more recent national data were lacking,” Dr. Chua told this news organization. “We felt that this was an important knowledge gap given the many changes in society that have occurred since 2020,” he noted. “For example, it was possible that the relaxation of social distancing measures during 2021 and 2022 might have reduced barriers to health care visits, thereby increasing opportunities to initiate treatment for opioid addiction with buprenorphine,” he said.

Dr. Chua and colleagues used data from the IQVIA Longitudinal Prescription Database, which reports 92% of prescriptions dispensed from retail pharmacies in the United States. “Buprenorphine products included immediate-release and extended-release formulations approved for opioid use disorder but not formulations primarily used to treat pain,” they write.

Monthly buprenorphine initiation was defined as the number of patients initiating therapy per 100,000 individuals. For retention, the researchers used a National Quality Forum-endorsed quality measure that defined retention as continuous use of buprenorphine for at least 180 days.

A total of 3,006,629 patients began buprenorphine therapy during the study period; approximately 43% were female.

During the first years of the study period, from January 2016 through September 2018, the monthly buprenorphine initiation rate increased from 12.5 per 100,000 to 15.9 per 100,000, with a statistically significant monthly percentage change of 0.62% (P < .001).

However, from October 2018 through October 2022, the monthly percentage remained essentially the same (P = .62) with a monthly percentage change of −0.03%.

From March 2020 through December 2020, the median monthly buprenorphine initiation rate was 14.4 per 100,000, only slightly lower than the rates from January 2019 through February 2020 and from January 2021 through October 2022 (15.5 per 100,000 and 15.0 per 100,000, respectively).

Over the entire study period from January 2016 through October 2022, the median monthly retention rate for buprenorphine use was 22.2%. This rate increased minimally, with no significant changes in slope and a monthly percentage change of 0.08% (P = .04).

The study findings were limited by several factors, including a lack of data on race and ethnicity, in-clinic administration of buprenorphine, and buprenorphine dispensing through methadone outpatient programs, the researchers note. Also, data did not indicate whether some patients began buprenorphine to treat pain, they say. The timing of the flattening of buprenorphine use also suggests the influence of factors beyond the COVID-19 pandemic, they write.

However, the results were strengthened by the large sample size and suggest that efforts to date to increase buprenorphine use have been unsuccessful, the researchers write. “A comprehensive approach is needed to eliminate barriers to buprenorphine initiation and retention, such as stigma and uneven access to prescribers,” they conclude.
 

Study highlights underuse of buprenorphine option

“Our study shows that buprenorphine initiation rates have been flat since the end of 2018 and that rates of 180-day retention in buprenorphine therapy have remained low throughout 2016-2022,” Dr. Chua told this news organization. “Neither of these findings are particularly surprising, but they are disappointing,” he said. “There were a lot of policy and clinical efforts to maintain and expand access to buprenorphine during the COVID-19 pandemic, such as allowing buprenorphine to be prescribed via telehealth without an in-person visit and eliminating training requirements for the waiver that previously was required to prescribe buprenorphine.

“The fact that buprenorphine initiation and retention did not rise after these efforts were implemented suggests that they were insufficient to meet the rising need for this medication,” he said.

The current study “adds to a growing body of research suggesting that clinicians are not maximizing opportunities to initiate buprenorphine treatment among patients with opioid addiction,” Dr. Chua said. He cited another of his recent studies in which 1 in 12 patients were prescribed buprenorphine within 30 days of an emergency department visit for opioid overdose from August 2019 to April 2021, but half of patients with emergency department visits with anaphylaxis were prescribed anepinephrine auto-injector.

“My hope is that our new study will further underscore to clinicians how much the health care system is underusing a critical tool to prevent opioid overdose deaths,” he said.

The federal government’s recent elimination of the waiver needed to prescribe buprenorphine may move the needle, but to what degree remains to be seen, Dr. Chua added. “It is possible this intervention will be insufficient to overcome the many other barriers to buprenorphine initiation and retention, such as stigma about the drug among clinicians, patients, and pharmacists,” he said.
 

Lack of education remains a barrier to buprenorphine use

The current study is important to determine whether attempts to increase buprenorphine initiation and treatment retention are working, said Reuben J. Strayer, MD, director of addiction medicine in the emergency medicine department at Maimonides Medical Center, New York, in an interview.

Dr. Strayer was not involved in the current study, but said he was surprised that initiation of buprenorphine didn’t decrease more dramatically during the pandemic, given the significant barriers to accessing care during that time.

However, “efforts to increase buprenorphine initiation and retention have not been sufficiently effective,” Dr. Strayer said. “The rise of fentanyl as a primary street opioid, replacing heroin, has dissuaded both patients and providers from initiating buprenorphine for fear of precipitated withdrawal.”

The elimination of the DATA 2000 (X) waiver was the removal of a potential barrier to increased buprenorphine use, said Dr. Strayer. “Now that the DATA 2000 (X) waiver has been eliminated, the focus of buprenorphine access is educating primary care and inpatient providers on its use, so that patients with OUD [opioid use disorder] can be treated, regardless of the venue at which they seek care,” he said.

Looking ahead, “The priority in buprenorphine research is determining the most effective way to initiate buprenorphine without the risk of precipitated withdrawal,” Dr. Strayer added.

The study was supported in part by the Benter Foundation, the Michigan Department of Health and Human Services, and the Susan B. Meister Child Health Evaluation and Research Center in the department of pediatrics at the University of Michigan. Dr. Chua was supported by the National Institute on Drug Abuse. Dr. Strayer has disclosed no relevant financial relationships.

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

Newly diagnosed type 2 diabetes has steadily risen by 4%-5% annually in the United States over the past 20 years; However, during the first year of the pandemic, the Journal of Pediatrics reported a possible 77% increase in youth-reported cases. Coupled with nearly 1 in 3 children being overweight, treatment for this patient population has recently evolved. 

Dr Amy S. Shah of the Cincinnati Children's Hospital Medical Center reports on the current therapeutic and lifestyle modifications guidelines for this patient population, including the consideration of prescribing glucagon-like peptide 1 receptor agonists such as liraglutide, dulaglutide, and exenatide.

--

Amy S. Shah, MD, MS, Professor of Pediatrics, Division of Endocrinology, Director of the Adolescents Type 2 Diabetes Program, Cincinnati Children's Hospital Medical Center, The University of Cincinnati, Cincinnati, Ohio

Amy S. Shah, MD, MS, has disclosed the following relevant financial relationships:

Received research grant from: National Institutes of Health

Received income in an amount equal to or greater than $250 from: Journal of the American Medical Association (Associate Editor)

Newly diagnosed type 2 diabetes has steadily risen by 4%-5% annually in the United States over the past 20 years; However, during the first year of the pandemic, the Journal of Pediatrics reported a possible 77% increase in youth-reported cases. Coupled with nearly 1 in 3 children being overweight, treatment for this patient population has recently evolved. 

Dr Amy S. Shah of the Cincinnati Children's Hospital Medical Center reports on the current therapeutic and lifestyle modifications guidelines for this patient population, including the consideration of prescribing glucagon-like peptide 1 receptor agonists such as liraglutide, dulaglutide, and exenatide.

--

Amy S. Shah, MD, MS, Professor of Pediatrics, Division of Endocrinology, Director of the Adolescents Type 2 Diabetes Program, Cincinnati Children's Hospital Medical Center, The University of Cincinnati, Cincinnati, Ohio

Amy S. Shah, MD, MS, has disclosed the following relevant financial relationships:

Received research grant from: National Institutes of Health

Received income in an amount equal to or greater than $250 from: Journal of the American Medical Association (Associate Editor)

Newly diagnosed type 2 diabetes has steadily risen by 4%-5% annually in the United States over the past 20 years; However, during the first year of the pandemic, the Journal of Pediatrics reported a possible 77% increase in youth-reported cases. Coupled with nearly 1 in 3 children being overweight, treatment for this patient population has recently evolved. 

Dr Amy S. Shah of the Cincinnati Children's Hospital Medical Center reports on the current therapeutic and lifestyle modifications guidelines for this patient population, including the consideration of prescribing glucagon-like peptide 1 receptor agonists such as liraglutide, dulaglutide, and exenatide.

--

Amy S. Shah, MD, MS, Professor of Pediatrics, Division of Endocrinology, Director of the Adolescents Type 2 Diabetes Program, Cincinnati Children's Hospital Medical Center, The University of Cincinnati, Cincinnati, Ohio

Amy S. Shah, MD, MS, has disclosed the following relevant financial relationships:

Received research grant from: National Institutes of Health

Received income in an amount equal to or greater than $250 from: Journal of the American Medical Association (Associate Editor)

The Diagnosis: Alopecic and Aseptic Nodule of the Scalp

Alopecic and aseptic nodule of the scalp (AANS) is an underdiagnosed condition presenting with one or few inflammatory nodules on the scalp with overlying nonscarring alopecia. The nodules can be soft, fluctuant, or firm and are characterized by negative fungal and bacterial stains as well as cultures.¹ Trichoscopic features such as black or yellow dots, fine vellus hairs, and broken hairs have been reported.^1-3 Dilated follicular openings may be seen and are termed the Eastern pancake sign, as they resemble the bubble cavities formed during the cooking of atayef.² The histologic features of AANS often are nonspecific but show a nodular or pseudocystic, lymphohistiocytic to acute inflammatory component centered in the dermis.¹ Granulomatous inflammation or isolated giant cells have been reported within the deep dermis.^1,4 In our patient, histopathology revealed admixed acute and granulomatous inflammation within the deep dermis (Figure). Treatment of AANS includes oral antibiotics such as doxycycline, intralesional corticosteroids, or excision.¹

Although the etiology of AANS currently is unclear, a process of follicular plugging or a deep folliculitis sparing the bulge stem cells has been theorized. Young males are disproportionately affected.¹ It is uncertain how much overlap there is, if any, between AANS and pseudocyst of the scalp, the latter of which primarily is reported in the Japanese literature and demonstrates alopecic nodules between the forehead and vertex of the scalp with pseudocystic architecture and granulomatous infiltration on histopathology.^4-7

There are several clinical and histologic differences between AANS and other diagnoses in the differential. Dermoid cysts tend to present at birth, with 70% of cases presenting before the age of 6 years, and without overlying skin changes.⁸ They represent a benign entrapment of ectoderm along embryonic closure lines during development.⁹ Histologic examination typically will show a squamous-lined cyst within the dermis with associated adnexal structures.¹⁰ Cylindromas are benign neoplasms of eccrine sweat glands named after the histologic presentation of cylinder-shaped basaloid cell populations when cross-sectioned.^11,12 When cylindromas coalesce on the scalp, they form a distinctive morphology sometimes loosely resembling a turban, giving them the previously more common name turban tumors.^11,13 Cylindromas appear as slow-growing protuberant tumors that are erythematous or flesh colored. Cylindromas are 9 times more common in females.13 Pilar cysts have a stratified squamous epithelium lining with a palisaded outer layer and are derived from the outer root sheath of hair follicles.¹⁴ Clinically, pilar cysts are smooth mobile cysts that favor skin with a dense concentration of hair follicles.^14,15 On palpation, pilar cysts are firm due to their keratinous contents and typically are nontender unless inflamed.¹⁵ Lipomas are benign mesenchymal tumors with mature adipocytes that often appear as subcutaneous nodules without overlying skin changes, though they can involve deep fascia. On palpation, lipomas generally are soft, mobile, and nontender.¹⁶

The Diagnosis: Alopecic and Aseptic Nodule of the Scalp

Alopecic and aseptic nodule of the scalp (AANS) is an underdiagnosed condition presenting with one or few inflammatory nodules on the scalp with overlying nonscarring alopecia. The nodules can be soft, fluctuant, or firm and are characterized by negative fungal and bacterial stains as well as cultures.¹ Trichoscopic features such as black or yellow dots, fine vellus hairs, and broken hairs have been reported.^1-3 Dilated follicular openings may be seen and are termed the Eastern pancake sign, as they resemble the bubble cavities formed during the cooking of atayef.² The histologic features of AANS often are nonspecific but show a nodular or pseudocystic, lymphohistiocytic to acute inflammatory component centered in the dermis.¹ Granulomatous inflammation or isolated giant cells have been reported within the deep dermis.^1,4 In our patient, histopathology revealed admixed acute and granulomatous inflammation within the deep dermis (Figure). Treatment of AANS includes oral antibiotics such as doxycycline, intralesional corticosteroids, or excision.¹

Although the etiology of AANS currently is unclear, a process of follicular plugging or a deep folliculitis sparing the bulge stem cells has been theorized. Young males are disproportionately affected.¹ It is uncertain how much overlap there is, if any, between AANS and pseudocyst of the scalp, the latter of which primarily is reported in the Japanese literature and demonstrates alopecic nodules between the forehead and vertex of the scalp with pseudocystic architecture and granulomatous infiltration on histopathology.^4-7

There are several clinical and histologic differences between AANS and other diagnoses in the differential. Dermoid cysts tend to present at birth, with 70% of cases presenting before the age of 6 years, and without overlying skin changes.⁸ They represent a benign entrapment of ectoderm along embryonic closure lines during development.⁹ Histologic examination typically will show a squamous-lined cyst within the dermis with associated adnexal structures.¹⁰ Cylindromas are benign neoplasms of eccrine sweat glands named after the histologic presentation of cylinder-shaped basaloid cell populations when cross-sectioned.^11,12 When cylindromas coalesce on the scalp, they form a distinctive morphology sometimes loosely resembling a turban, giving them the previously more common name turban tumors.^11,13 Cylindromas appear as slow-growing protuberant tumors that are erythematous or flesh colored. Cylindromas are 9 times more common in females.13 Pilar cysts have a stratified squamous epithelium lining with a palisaded outer layer and are derived from the outer root sheath of hair follicles.¹⁴ Clinically, pilar cysts are smooth mobile cysts that favor skin with a dense concentration of hair follicles.^14,15 On palpation, pilar cysts are firm due to their keratinous contents and typically are nontender unless inflamed.¹⁵ Lipomas are benign mesenchymal tumors with mature adipocytes that often appear as subcutaneous nodules without overlying skin changes, though they can involve deep fascia. On palpation, lipomas generally are soft, mobile, and nontender.¹⁶

The Diagnosis: Alopecic and Aseptic Nodule of the Scalp

Alopecic and aseptic nodule of the scalp (AANS) is an underdiagnosed condition presenting with one or few inflammatory nodules on the scalp with overlying nonscarring alopecia. The nodules can be soft, fluctuant, or firm and are characterized by negative fungal and bacterial stains as well as cultures.¹ Trichoscopic features such as black or yellow dots, fine vellus hairs, and broken hairs have been reported.^1-3 Dilated follicular openings may be seen and are termed the Eastern pancake sign, as they resemble the bubble cavities formed during the cooking of atayef.² The histologic features of AANS often are nonspecific but show a nodular or pseudocystic, lymphohistiocytic to acute inflammatory component centered in the dermis.¹ Granulomatous inflammation or isolated giant cells have been reported within the deep dermis.^1,4 In our patient, histopathology revealed admixed acute and granulomatous inflammation within the deep dermis (Figure). Treatment of AANS includes oral antibiotics such as doxycycline, intralesional corticosteroids, or excision.¹

Although the etiology of AANS currently is unclear, a process of follicular plugging or a deep folliculitis sparing the bulge stem cells has been theorized. Young males are disproportionately affected.¹ It is uncertain how much overlap there is, if any, between AANS and pseudocyst of the scalp, the latter of which primarily is reported in the Japanese literature and demonstrates alopecic nodules between the forehead and vertex of the scalp with pseudocystic architecture and granulomatous infiltration on histopathology.^4-7

There are several clinical and histologic differences between AANS and other diagnoses in the differential. Dermoid cysts tend to present at birth, with 70% of cases presenting before the age of 6 years, and without overlying skin changes.⁸ They represent a benign entrapment of ectoderm along embryonic closure lines during development.⁹ Histologic examination typically will show a squamous-lined cyst within the dermis with associated adnexal structures.¹⁰ Cylindromas are benign neoplasms of eccrine sweat glands named after the histologic presentation of cylinder-shaped basaloid cell populations when cross-sectioned.^11,12 When cylindromas coalesce on the scalp, they form a distinctive morphology sometimes loosely resembling a turban, giving them the previously more common name turban tumors.^11,13 Cylindromas appear as slow-growing protuberant tumors that are erythematous or flesh colored. Cylindromas are 9 times more common in females.13 Pilar cysts have a stratified squamous epithelium lining with a palisaded outer layer and are derived from the outer root sheath of hair follicles.¹⁴ Clinically, pilar cysts are smooth mobile cysts that favor skin with a dense concentration of hair follicles.^14,15 On palpation, pilar cysts are firm due to their keratinous contents and typically are nontender unless inflamed.¹⁵ Lipomas are benign mesenchymal tumors with mature adipocytes that often appear as subcutaneous nodules without overlying skin changes, though they can involve deep fascia. On palpation, lipomas generally are soft, mobile, and nontender.¹⁶

Seven months after Lahavah Wallace’s weight-loss operation, a New York bariatric surgery practice sued her, accusing her of “intentionally” failing to pay nearly $18,000 of her bill.

Long Island Minimally Invasive Surgery, which does business as the New York Bariatric Group, went on to accuse Ms. Wallace of “embezzlement,” alleging she kept insurance payments that should have been turned over to the practice.

Ms. Wallace denies the allegations, which the bariatric practice has leveled against patients in hundreds of debt-collection lawsuits filed over the past 4 years, court records in New York state show.

In about 60 cases, the lawsuits demanded $100,000 or more from patients. Some patients were found liable for tens of thousands of dollars in interest charges or wound up shackled with debt that could take a decade or more to shake. Others are facing the likely prospect of six-figure financial penalties, court records show.

Backed by a major private equity firm, the bariatric practice spends millions each year on advertisements featuring patients who have dropped 100 pounds or more after bariatric procedures, sometimes having had a portion of their stomachs removed. The ads have run on TV, online, and on New York City subway posters.

The online ads, often showcasing the slogan “Stop obesity for life,” appealed to Ms. Wallace, who lives in Brooklyn and works as a legal assistant for the state of New York. She said she turned over checks from her insurer to the bariatric group and was stunned when the medical practice hauled her into court citing an “out-of-network payment agreement” she had signed before her surgery.

“I really didn’t know what I was signing,” Ms. Wallace told KFF Health News. “I didn’t pay enough attention.”

Shawn Garber, MD, a bariatric surgeon who founded the practice in 2000 on Long Island and serves as its CEO, said that “prior to rendering services” his office staff advises patients of the costs and their responsibility to pay the bill.

The bariatric group has cited these out-of-network payment agreements in at least 300 lawsuits filed against patients from January 2019 to 2022 demanding nearly $19 million to cover medical bills, interest charges, and attorney’s fees, a KFF Health News review of New York state court records found.

Danny De Voe, a partner at Sahn Ward Braff Koblenz law firm in Uniondale, N.Y., who filed many of those suits, declined to comment, citing attorney-client privilege.

In most cases, the medical practice had agreed to accept an insurance company’s out-of-network rate as full payment for its services – with caveats, according to court filings.

In the agreements they signed, patients promised to pay any coinsurance, meeting any deductible, and pass on to the medical practice any reimbursement checks they received from their health plans within 7 days.

Patients who fail to do so “will be held responsible for the full amount charged for your surgery, plus the cost of legal fees,” the agreement states.

That “full amount” can be thousands of dollars higher than what insurers would likely pay, KFF Health News found – while legal fees and other costs can layer on thousands more.

Elisabeth Benjamin, a lawyer with the Community Service Society of New York, said conflicts can arise when insurers send checks to pay for out-of-network medical services to patients rather than reimbursing a medical provider directly.

“We would prefer to see regulators step in and stop that practice,” she said, adding it “causes tension between providers and patients.”

That’s certainly true for Ms. Wallace. The surgery practice sued her in August 2022demanding $17,981 in fees it said remained unpaid after her January 2022 laparoscopic sleeve gastrectomy, an operation in which much of the stomach is removed to assist weight loss.

The lawsuit also tacked on a demand for $5,993 in attorney’s fees, court records show.

The suit alleges Ms. Wallace signed the contract even though she “had no intention” of paying her bills. The complaint goes on to accuse her of “committing embezzlement” by “willfully, intentionally, deliberately and maliciously” depositing checks from her health plan into her personal account.

The suit doesn’t include details to substantiate these claims, and Ms. Wallace said in her court response they are not true. Ms. Wallace said she turned over checks for the charges.

“They billed the insurance for everything they possibly could,” Ms. Wallace said.

In September, Ms. Wallace filed for bankruptcy, hoping to discharge the bariatric care debt along with about $4,700 in unrelated credit card charges.

The medical practice fired back in November by filing an “adversary complaint” in her Brooklyn bankruptcy court proceeding that argues her medical debt should not be forgiven because Ms. Wallace committed fraud.

The adversary complaint, which is pending in the bankruptcy case, accuses Ms. Wallace of “fraudulently” inducing the surgery center to perform “elective medical procedures” without requiring payment up front.

Both the harsh wording and claims of wrongdoing have infuriated Ms. Wallace and her attorney, Jacob Silver, of Brooklyn.

Mr. Silver wants the medical practice to turn over records of the payments received from Ms. Wallace. “There is no fraud here,” he said. “This is frivolous. We are taking a no-settlement position.”
 

Gaining debt

Few patients sued by the bariatric practice mount a defense in court and those who do fight often lose, court records show.

The medical practice won default judgments totaling nearly $6 million in about 90 of the 300 cases in the sample reviewed by KFF Health News. Default judgments are entered when the defendant fails to respond.

Many cases either are pending, or it is not clear from court filings how they were resolved.

Some patients tried to argue that the fees were too high or that they didn’t understand going in how much they could owe. One woman, trying to push back against a demand for more than $100,000, said in a legal filing that she “was given numerous papers to sign without anyone of the staff members explaining to me what it actually meant.” Another patient, who was sued for more than $40,000, wrote: “I don’t have the means to pay this bill.”

Among the cases described in court records:

• A Westchester County, N.Y., woman was sued for $102,556 and settled for $72,000 in May 2021. She agreed to pay $7,500 upon signing the settlement and $500 a month from September 2021 to May 2032.
• A Peekskill, N.Y., woman in a December 2019 judgment was held liable for $384,092, which included $94,047 in interest.
• A Newburgh, N.Y., man was sued in 2021 for $252,309 in medical bills, 12% interest, and $84,103 in attorneys’ fees. The case is pending.

Robert Cohen, a longtime attorney for the bariatric practice, testified in a November 2021 hearing that the lawyers take “a contingency fee of one-third of our recovery” in these cases. In that case, Mr. Cohen had requested $13,578 based on his contingency fee arrangement. He testified that he spent 7.3 hours on the case and that his customary billing rate was $475 per hour, which came to $3,467.50. The judge awarded the lower amount, according to a transcript of the hearing.

Teresa LaMasters, MD, president of the American Society for Metabolic and Bariatric Surgery, said suing patients for large sums “is not a common practice” among bariatric surgeons.

“This is not what the vast majority in the field would espouse,” she said.

But Dr. Garber, the NYBG’s chief executive, suggested patients deserve blame.

“These lawsuits stem from these patients stealing the insurance money rather than forwarding it onto NYBG as they are morally and contractually obligated to do,” Dr. Garber wrote in an email to KFF Health News.

Dr. Garber added: “The issue is not with what we bill, but rather with the fact that the insurance companies refuse to send payment directly to us.”
 

‘A kooky system’

Defense attorneys argue that many patients don’t fully comprehend the perils of failing to pay on time – for whatever reason.

In a few cases, patients admitted pocketing checks they were obligated to turn over to the medical practice. But for the most part, court records don’t specify how many such checks were issued and for what amounts – or whether the patient improperly cashed them.

“It’s a kooky system,” said Paul Brite, an attorney who has faced off against the bariatric practice in court.

“You sign these documents that could cost you tons of money. It shouldn’t be that way,” he said. “This can ruin their financial life.”

New York lawmakers have acted to limit the damage from medical debt, including “surprise bills.”

In November, Democratic Gov. Kathy Hochul signed legislation that prohibits health care providers from slapping liens on a primary residence or garnishing wages.

But contracts with onerous repayment terms represent an “evolving area of law” and an alarming “new twist” on concerns over medical debt, said Ms. Benjamin, the community service society lawyer.

She said contract “accelerator clauses” that trigger severe penalties if patients miss payments should not be permitted for medical debt.

“If you default, the full amount is due,” she said. “This is really a bummer.”
 

‘Fair market value’

The debt collection lawsuits argue that weight-loss patients had agreed to pay “fair market value” for services – and the doctors are only trying to secure money they are due.

But some prices far exceed typical insurance payments for obesity treatments across the country, according to a medical billing data registry. Surgeons performed about 200,000 bariatric operations in 2020, according to the bariatric surgery society.

Ms. Wallace, the Brooklyn legal assistant, was billed $60,500 for her lap sleeve gastrectomy, though how much her insurance actually paid remains to be hashed out in court.

Michael Arrigo, a California medical billing expert at No World Borders, called the prices “outrageous” and “unreasonable and, in fact, likely unconscionable.”

“I disagree that these are fair market charges,” he said.

Dr. LaMasters called the gastrectomy price billed to Ms. Wallace “really expensive” and “a severe outlier.” While charges vary by region, she quoted a typical price of around $22,000.

Dr. Garber said NYBG “bills at usual and customary rates” determined by Fair Health, a New York City-based repository of insurance claims data. Fair Health “sets these rates based upon the acceptable price for our geographic location,” he said.

But Rachel Kent, Fair Health’s senior director of marketing, told KFF Health News that the group “does not set rates, nor determine or take any position on what constitutes ‘usual and customary rates.’ ” Instead, it reports the prices providers are charging in a given area.

Overall, Fair Health data shows huge price variations even in adjacent ZIP codes in the metro area. In Long Island’s Roslyn Heights neighborhood, where NYBG is based, Fair Health lists the out-of-network price charged by providers in the area as $60,500, the figure Ms. Wallace was billed.

But in several other New York City–area ZIP codes the price charged for the gastrectomy procedure hovers around $20,000, according to the data bank. The price in Manhattan is $17,500, for instance, according to Fair Health.

Nationwide, the average cost in 2021 for bariatric surgery done in a hospital was $32,868, according to a KFF analysis of health insurance claims.
 

Private equity arrives

Dr. Garber said in a court affidavit in May 2022 that he founded the bariatric practice “with a singular focus: providing safe, effective care to patients suffering from obesity and its resulting complications.”

Under his leadership, the practice has “developed into New York’s elite institution for obesity treatment,” Dr. Garber said. He said the group’s surgeons are “highly sought after to train other bariatric surgeons throughout the country and are active in the development of new, cutting-edge bariatric surgery techniques.”

In 2017, Dr. Garber and partners agreed on a business plan to help spur growth and “attract private equity investment,” according to the affidavit.

They formed a separate company to handle the bariatric practice’s business side. Known as management services organizations, such companies provide a way for private equity investors to circumvent laws in some states that prohibit nonphysicians from owning a stake in a medical practice.

In August 2019, the private equity firm Sentinel Capital Partners bought 65% of the MSO for $156.5 million, according to Dr. Garber’s affidavit. The management company is now known as New You Bariatric Group. The private equity firm did not respond to requests for comment.

Dr. Garber, in a September 2021 American Society for Metabolic and Bariatric Surgery webinar viewable online, said the weight-loss practice spends $6 million a year on media and marketing directly to patients – and is on a roll. Nationally, bariatric surgery is growing 6% annually, he said. NYBG boasts two dozen offices in the tri-state area of New York, New Jersey, and Connecticut and is poised to expand into more states.

“Since private equity, we’ve been growing at 30%-40% year over year,” Dr. Garber said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Seven months after Lahavah Wallace’s weight-loss operation, a New York bariatric surgery practice sued her, accusing her of “intentionally” failing to pay nearly $18,000 of her bill.

Long Island Minimally Invasive Surgery, which does business as the New York Bariatric Group, went on to accuse Ms. Wallace of “embezzlement,” alleging she kept insurance payments that should have been turned over to the practice.

Ms. Wallace denies the allegations, which the bariatric practice has leveled against patients in hundreds of debt-collection lawsuits filed over the past 4 years, court records in New York state show.

In about 60 cases, the lawsuits demanded $100,000 or more from patients. Some patients were found liable for tens of thousands of dollars in interest charges or wound up shackled with debt that could take a decade or more to shake. Others are facing the likely prospect of six-figure financial penalties, court records show.

Backed by a major private equity firm, the bariatric practice spends millions each year on advertisements featuring patients who have dropped 100 pounds or more after bariatric procedures, sometimes having had a portion of their stomachs removed. The ads have run on TV, online, and on New York City subway posters.

The online ads, often showcasing the slogan “Stop obesity for life,” appealed to Ms. Wallace, who lives in Brooklyn and works as a legal assistant for the state of New York. She said she turned over checks from her insurer to the bariatric group and was stunned when the medical practice hauled her into court citing an “out-of-network payment agreement” she had signed before her surgery.

“I really didn’t know what I was signing,” Ms. Wallace told KFF Health News. “I didn’t pay enough attention.”

Shawn Garber, MD, a bariatric surgeon who founded the practice in 2000 on Long Island and serves as its CEO, said that “prior to rendering services” his office staff advises patients of the costs and their responsibility to pay the bill.

The bariatric group has cited these out-of-network payment agreements in at least 300 lawsuits filed against patients from January 2019 to 2022 demanding nearly $19 million to cover medical bills, interest charges, and attorney’s fees, a KFF Health News review of New York state court records found.

Danny De Voe, a partner at Sahn Ward Braff Koblenz law firm in Uniondale, N.Y., who filed many of those suits, declined to comment, citing attorney-client privilege.

In most cases, the medical practice had agreed to accept an insurance company’s out-of-network rate as full payment for its services – with caveats, according to court filings.

In the agreements they signed, patients promised to pay any coinsurance, meeting any deductible, and pass on to the medical practice any reimbursement checks they received from their health plans within 7 days.

Patients who fail to do so “will be held responsible for the full amount charged for your surgery, plus the cost of legal fees,” the agreement states.

That “full amount” can be thousands of dollars higher than what insurers would likely pay, KFF Health News found – while legal fees and other costs can layer on thousands more.

Elisabeth Benjamin, a lawyer with the Community Service Society of New York, said conflicts can arise when insurers send checks to pay for out-of-network medical services to patients rather than reimbursing a medical provider directly.

“We would prefer to see regulators step in and stop that practice,” she said, adding it “causes tension between providers and patients.”

That’s certainly true for Ms. Wallace. The surgery practice sued her in August 2022demanding $17,981 in fees it said remained unpaid after her January 2022 laparoscopic sleeve gastrectomy, an operation in which much of the stomach is removed to assist weight loss.

The lawsuit also tacked on a demand for $5,993 in attorney’s fees, court records show.

The suit alleges Ms. Wallace signed the contract even though she “had no intention” of paying her bills. The complaint goes on to accuse her of “committing embezzlement” by “willfully, intentionally, deliberately and maliciously” depositing checks from her health plan into her personal account.

The suit doesn’t include details to substantiate these claims, and Ms. Wallace said in her court response they are not true. Ms. Wallace said she turned over checks for the charges.

“They billed the insurance for everything they possibly could,” Ms. Wallace said.

In September, Ms. Wallace filed for bankruptcy, hoping to discharge the bariatric care debt along with about $4,700 in unrelated credit card charges.

The medical practice fired back in November by filing an “adversary complaint” in her Brooklyn bankruptcy court proceeding that argues her medical debt should not be forgiven because Ms. Wallace committed fraud.

The adversary complaint, which is pending in the bankruptcy case, accuses Ms. Wallace of “fraudulently” inducing the surgery center to perform “elective medical procedures” without requiring payment up front.

Both the harsh wording and claims of wrongdoing have infuriated Ms. Wallace and her attorney, Jacob Silver, of Brooklyn.

Mr. Silver wants the medical practice to turn over records of the payments received from Ms. Wallace. “There is no fraud here,” he said. “This is frivolous. We are taking a no-settlement position.”
 

Gaining debt

Few patients sued by the bariatric practice mount a defense in court and those who do fight often lose, court records show.

The medical practice won default judgments totaling nearly $6 million in about 90 of the 300 cases in the sample reviewed by KFF Health News. Default judgments are entered when the defendant fails to respond.

Many cases either are pending, or it is not clear from court filings how they were resolved.

Some patients tried to argue that the fees were too high or that they didn’t understand going in how much they could owe. One woman, trying to push back against a demand for more than $100,000, said in a legal filing that she “was given numerous papers to sign without anyone of the staff members explaining to me what it actually meant.” Another patient, who was sued for more than $40,000, wrote: “I don’t have the means to pay this bill.”

Among the cases described in court records:

• A Westchester County, N.Y., woman was sued for $102,556 and settled for $72,000 in May 2021. She agreed to pay $7,500 upon signing the settlement and $500 a month from September 2021 to May 2032.
• A Peekskill, N.Y., woman in a December 2019 judgment was held liable for $384,092, which included $94,047 in interest.
• A Newburgh, N.Y., man was sued in 2021 for $252,309 in medical bills, 12% interest, and $84,103 in attorneys’ fees. The case is pending.

Robert Cohen, a longtime attorney for the bariatric practice, testified in a November 2021 hearing that the lawyers take “a contingency fee of one-third of our recovery” in these cases. In that case, Mr. Cohen had requested $13,578 based on his contingency fee arrangement. He testified that he spent 7.3 hours on the case and that his customary billing rate was $475 per hour, which came to $3,467.50. The judge awarded the lower amount, according to a transcript of the hearing.

Teresa LaMasters, MD, president of the American Society for Metabolic and Bariatric Surgery, said suing patients for large sums “is not a common practice” among bariatric surgeons.

“This is not what the vast majority in the field would espouse,” she said.

But Dr. Garber, the NYBG’s chief executive, suggested patients deserve blame.

“These lawsuits stem from these patients stealing the insurance money rather than forwarding it onto NYBG as they are morally and contractually obligated to do,” Dr. Garber wrote in an email to KFF Health News.

Dr. Garber added: “The issue is not with what we bill, but rather with the fact that the insurance companies refuse to send payment directly to us.”
 

‘A kooky system’

Defense attorneys argue that many patients don’t fully comprehend the perils of failing to pay on time – for whatever reason.

In a few cases, patients admitted pocketing checks they were obligated to turn over to the medical practice. But for the most part, court records don’t specify how many such checks were issued and for what amounts – or whether the patient improperly cashed them.

“It’s a kooky system,” said Paul Brite, an attorney who has faced off against the bariatric practice in court.

“You sign these documents that could cost you tons of money. It shouldn’t be that way,” he said. “This can ruin their financial life.”

New York lawmakers have acted to limit the damage from medical debt, including “surprise bills.”

In November, Democratic Gov. Kathy Hochul signed legislation that prohibits health care providers from slapping liens on a primary residence or garnishing wages.

But contracts with onerous repayment terms represent an “evolving area of law” and an alarming “new twist” on concerns over medical debt, said Ms. Benjamin, the community service society lawyer.

She said contract “accelerator clauses” that trigger severe penalties if patients miss payments should not be permitted for medical debt.

“If you default, the full amount is due,” she said. “This is really a bummer.”
 

‘Fair market value’

The debt collection lawsuits argue that weight-loss patients had agreed to pay “fair market value” for services – and the doctors are only trying to secure money they are due.

But some prices far exceed typical insurance payments for obesity treatments across the country, according to a medical billing data registry. Surgeons performed about 200,000 bariatric operations in 2020, according to the bariatric surgery society.

Ms. Wallace, the Brooklyn legal assistant, was billed $60,500 for her lap sleeve gastrectomy, though how much her insurance actually paid remains to be hashed out in court.

Michael Arrigo, a California medical billing expert at No World Borders, called the prices “outrageous” and “unreasonable and, in fact, likely unconscionable.”

“I disagree that these are fair market charges,” he said.

Dr. LaMasters called the gastrectomy price billed to Ms. Wallace “really expensive” and “a severe outlier.” While charges vary by region, she quoted a typical price of around $22,000.

Dr. Garber said NYBG “bills at usual and customary rates” determined by Fair Health, a New York City-based repository of insurance claims data. Fair Health “sets these rates based upon the acceptable price for our geographic location,” he said.

But Rachel Kent, Fair Health’s senior director of marketing, told KFF Health News that the group “does not set rates, nor determine or take any position on what constitutes ‘usual and customary rates.’ ” Instead, it reports the prices providers are charging in a given area.

Overall, Fair Health data shows huge price variations even in adjacent ZIP codes in the metro area. In Long Island’s Roslyn Heights neighborhood, where NYBG is based, Fair Health lists the out-of-network price charged by providers in the area as $60,500, the figure Ms. Wallace was billed.

But in several other New York City–area ZIP codes the price charged for the gastrectomy procedure hovers around $20,000, according to the data bank. The price in Manhattan is $17,500, for instance, according to Fair Health.

Nationwide, the average cost in 2021 for bariatric surgery done in a hospital was $32,868, according to a KFF analysis of health insurance claims.
 

Private equity arrives

Dr. Garber said in a court affidavit in May 2022 that he founded the bariatric practice “with a singular focus: providing safe, effective care to patients suffering from obesity and its resulting complications.”

Under his leadership, the practice has “developed into New York’s elite institution for obesity treatment,” Dr. Garber said. He said the group’s surgeons are “highly sought after to train other bariatric surgeons throughout the country and are active in the development of new, cutting-edge bariatric surgery techniques.”

In 2017, Dr. Garber and partners agreed on a business plan to help spur growth and “attract private equity investment,” according to the affidavit.

They formed a separate company to handle the bariatric practice’s business side. Known as management services organizations, such companies provide a way for private equity investors to circumvent laws in some states that prohibit nonphysicians from owning a stake in a medical practice.

In August 2019, the private equity firm Sentinel Capital Partners bought 65% of the MSO for $156.5 million, according to Dr. Garber’s affidavit. The management company is now known as New You Bariatric Group. The private equity firm did not respond to requests for comment.

Dr. Garber, in a September 2021 American Society for Metabolic and Bariatric Surgery webinar viewable online, said the weight-loss practice spends $6 million a year on media and marketing directly to patients – and is on a roll. Nationally, bariatric surgery is growing 6% annually, he said. NYBG boasts two dozen offices in the tri-state area of New York, New Jersey, and Connecticut and is poised to expand into more states.

“Since private equity, we’ve been growing at 30%-40% year over year,” Dr. Garber said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Seven months after Lahavah Wallace’s weight-loss operation, a New York bariatric surgery practice sued her, accusing her of “intentionally” failing to pay nearly $18,000 of her bill.

Long Island Minimally Invasive Surgery, which does business as the New York Bariatric Group, went on to accuse Ms. Wallace of “embezzlement,” alleging she kept insurance payments that should have been turned over to the practice.

Ms. Wallace denies the allegations, which the bariatric practice has leveled against patients in hundreds of debt-collection lawsuits filed over the past 4 years, court records in New York state show.

In about 60 cases, the lawsuits demanded $100,000 or more from patients. Some patients were found liable for tens of thousands of dollars in interest charges or wound up shackled with debt that could take a decade or more to shake. Others are facing the likely prospect of six-figure financial penalties, court records show.

Backed by a major private equity firm, the bariatric practice spends millions each year on advertisements featuring patients who have dropped 100 pounds or more after bariatric procedures, sometimes having had a portion of their stomachs removed. The ads have run on TV, online, and on New York City subway posters.

The online ads, often showcasing the slogan “Stop obesity for life,” appealed to Ms. Wallace, who lives in Brooklyn and works as a legal assistant for the state of New York. She said she turned over checks from her insurer to the bariatric group and was stunned when the medical practice hauled her into court citing an “out-of-network payment agreement” she had signed before her surgery.

“I really didn’t know what I was signing,” Ms. Wallace told KFF Health News. “I didn’t pay enough attention.”

Shawn Garber, MD, a bariatric surgeon who founded the practice in 2000 on Long Island and serves as its CEO, said that “prior to rendering services” his office staff advises patients of the costs and their responsibility to pay the bill.

The bariatric group has cited these out-of-network payment agreements in at least 300 lawsuits filed against patients from January 2019 to 2022 demanding nearly $19 million to cover medical bills, interest charges, and attorney’s fees, a KFF Health News review of New York state court records found.

Danny De Voe, a partner at Sahn Ward Braff Koblenz law firm in Uniondale, N.Y., who filed many of those suits, declined to comment, citing attorney-client privilege.

In most cases, the medical practice had agreed to accept an insurance company’s out-of-network rate as full payment for its services – with caveats, according to court filings.

In the agreements they signed, patients promised to pay any coinsurance, meeting any deductible, and pass on to the medical practice any reimbursement checks they received from their health plans within 7 days.

Patients who fail to do so “will be held responsible for the full amount charged for your surgery, plus the cost of legal fees,” the agreement states.

That “full amount” can be thousands of dollars higher than what insurers would likely pay, KFF Health News found – while legal fees and other costs can layer on thousands more.

Elisabeth Benjamin, a lawyer with the Community Service Society of New York, said conflicts can arise when insurers send checks to pay for out-of-network medical services to patients rather than reimbursing a medical provider directly.

“We would prefer to see regulators step in and stop that practice,” she said, adding it “causes tension between providers and patients.”

That’s certainly true for Ms. Wallace. The surgery practice sued her in August 2022demanding $17,981 in fees it said remained unpaid after her January 2022 laparoscopic sleeve gastrectomy, an operation in which much of the stomach is removed to assist weight loss.

The lawsuit also tacked on a demand for $5,993 in attorney’s fees, court records show.

The suit alleges Ms. Wallace signed the contract even though she “had no intention” of paying her bills. The complaint goes on to accuse her of “committing embezzlement” by “willfully, intentionally, deliberately and maliciously” depositing checks from her health plan into her personal account.

The suit doesn’t include details to substantiate these claims, and Ms. Wallace said in her court response they are not true. Ms. Wallace said she turned over checks for the charges.

“They billed the insurance for everything they possibly could,” Ms. Wallace said.

In September, Ms. Wallace filed for bankruptcy, hoping to discharge the bariatric care debt along with about $4,700 in unrelated credit card charges.

The medical practice fired back in November by filing an “adversary complaint” in her Brooklyn bankruptcy court proceeding that argues her medical debt should not be forgiven because Ms. Wallace committed fraud.

The adversary complaint, which is pending in the bankruptcy case, accuses Ms. Wallace of “fraudulently” inducing the surgery center to perform “elective medical procedures” without requiring payment up front.

Both the harsh wording and claims of wrongdoing have infuriated Ms. Wallace and her attorney, Jacob Silver, of Brooklyn.

Mr. Silver wants the medical practice to turn over records of the payments received from Ms. Wallace. “There is no fraud here,” he said. “This is frivolous. We are taking a no-settlement position.”
 

Gaining debt

Few patients sued by the bariatric practice mount a defense in court and those who do fight often lose, court records show.

The medical practice won default judgments totaling nearly $6 million in about 90 of the 300 cases in the sample reviewed by KFF Health News. Default judgments are entered when the defendant fails to respond.

Many cases either are pending, or it is not clear from court filings how they were resolved.

Some patients tried to argue that the fees were too high or that they didn’t understand going in how much they could owe. One woman, trying to push back against a demand for more than $100,000, said in a legal filing that she “was given numerous papers to sign without anyone of the staff members explaining to me what it actually meant.” Another patient, who was sued for more than $40,000, wrote: “I don’t have the means to pay this bill.”

Among the cases described in court records:

• A Westchester County, N.Y., woman was sued for $102,556 and settled for $72,000 in May 2021. She agreed to pay $7,500 upon signing the settlement and $500 a month from September 2021 to May 2032.
• A Peekskill, N.Y., woman in a December 2019 judgment was held liable for $384,092, which included $94,047 in interest.
• A Newburgh, N.Y., man was sued in 2021 for $252,309 in medical bills, 12% interest, and $84,103 in attorneys’ fees. The case is pending.

Robert Cohen, a longtime attorney for the bariatric practice, testified in a November 2021 hearing that the lawyers take “a contingency fee of one-third of our recovery” in these cases. In that case, Mr. Cohen had requested $13,578 based on his contingency fee arrangement. He testified that he spent 7.3 hours on the case and that his customary billing rate was $475 per hour, which came to $3,467.50. The judge awarded the lower amount, according to a transcript of the hearing.

Teresa LaMasters, MD, president of the American Society for Metabolic and Bariatric Surgery, said suing patients for large sums “is not a common practice” among bariatric surgeons.

“This is not what the vast majority in the field would espouse,” she said.

But Dr. Garber, the NYBG’s chief executive, suggested patients deserve blame.

“These lawsuits stem from these patients stealing the insurance money rather than forwarding it onto NYBG as they are morally and contractually obligated to do,” Dr. Garber wrote in an email to KFF Health News.

Dr. Garber added: “The issue is not with what we bill, but rather with the fact that the insurance companies refuse to send payment directly to us.”
 

‘A kooky system’

Defense attorneys argue that many patients don’t fully comprehend the perils of failing to pay on time – for whatever reason.

In a few cases, patients admitted pocketing checks they were obligated to turn over to the medical practice. But for the most part, court records don’t specify how many such checks were issued and for what amounts – or whether the patient improperly cashed them.

“It’s a kooky system,” said Paul Brite, an attorney who has faced off against the bariatric practice in court.

“You sign these documents that could cost you tons of money. It shouldn’t be that way,” he said. “This can ruin their financial life.”

New York lawmakers have acted to limit the damage from medical debt, including “surprise bills.”

In November, Democratic Gov. Kathy Hochul signed legislation that prohibits health care providers from slapping liens on a primary residence or garnishing wages.

But contracts with onerous repayment terms represent an “evolving area of law” and an alarming “new twist” on concerns over medical debt, said Ms. Benjamin, the community service society lawyer.

She said contract “accelerator clauses” that trigger severe penalties if patients miss payments should not be permitted for medical debt.

“If you default, the full amount is due,” she said. “This is really a bummer.”
 

‘Fair market value’

The debt collection lawsuits argue that weight-loss patients had agreed to pay “fair market value” for services – and the doctors are only trying to secure money they are due.

But some prices far exceed typical insurance payments for obesity treatments across the country, according to a medical billing data registry. Surgeons performed about 200,000 bariatric operations in 2020, according to the bariatric surgery society.

Ms. Wallace, the Brooklyn legal assistant, was billed $60,500 for her lap sleeve gastrectomy, though how much her insurance actually paid remains to be hashed out in court.

Michael Arrigo, a California medical billing expert at No World Borders, called the prices “outrageous” and “unreasonable and, in fact, likely unconscionable.”

“I disagree that these are fair market charges,” he said.

Dr. LaMasters called the gastrectomy price billed to Ms. Wallace “really expensive” and “a severe outlier.” While charges vary by region, she quoted a typical price of around $22,000.

Dr. Garber said NYBG “bills at usual and customary rates” determined by Fair Health, a New York City-based repository of insurance claims data. Fair Health “sets these rates based upon the acceptable price for our geographic location,” he said.

But Rachel Kent, Fair Health’s senior director of marketing, told KFF Health News that the group “does not set rates, nor determine or take any position on what constitutes ‘usual and customary rates.’ ” Instead, it reports the prices providers are charging in a given area.

Overall, Fair Health data shows huge price variations even in adjacent ZIP codes in the metro area. In Long Island’s Roslyn Heights neighborhood, where NYBG is based, Fair Health lists the out-of-network price charged by providers in the area as $60,500, the figure Ms. Wallace was billed.

But in several other New York City–area ZIP codes the price charged for the gastrectomy procedure hovers around $20,000, according to the data bank. The price in Manhattan is $17,500, for instance, according to Fair Health.

Nationwide, the average cost in 2021 for bariatric surgery done in a hospital was $32,868, according to a KFF analysis of health insurance claims.
 

Private equity arrives

Dr. Garber said in a court affidavit in May 2022 that he founded the bariatric practice “with a singular focus: providing safe, effective care to patients suffering from obesity and its resulting complications.”

Under his leadership, the practice has “developed into New York’s elite institution for obesity treatment,” Dr. Garber said. He said the group’s surgeons are “highly sought after to train other bariatric surgeons throughout the country and are active in the development of new, cutting-edge bariatric surgery techniques.”

In 2017, Dr. Garber and partners agreed on a business plan to help spur growth and “attract private equity investment,” according to the affidavit.

They formed a separate company to handle the bariatric practice’s business side. Known as management services organizations, such companies provide a way for private equity investors to circumvent laws in some states that prohibit nonphysicians from owning a stake in a medical practice.

In August 2019, the private equity firm Sentinel Capital Partners bought 65% of the MSO for $156.5 million, according to Dr. Garber’s affidavit. The management company is now known as New You Bariatric Group. The private equity firm did not respond to requests for comment.

Dr. Garber, in a September 2021 American Society for Metabolic and Bariatric Surgery webinar viewable online, said the weight-loss practice spends $6 million a year on media and marketing directly to patients – and is on a roll. Nationally, bariatric surgery is growing 6% annually, he said. NYBG boasts two dozen offices in the tri-state area of New York, New Jersey, and Connecticut and is poised to expand into more states.

“Since private equity, we’ve been growing at 30%-40% year over year,” Dr. Garber said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

WASHINGTON – Approximately 70% of children with febrile urinary tract infections receive guideline-adherent follow-up imaging from primary care, based on data from 118 individuals.

“Timely imaging is recommended after febrile UTI (fUTI) in young children to identify treatable urologic conditions,” wrote Jonathan Hatoun, MD, of Boston Children’s Hospital, and colleagues in a poster presented at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics (AAP) currently recommends renal-bladder ultrasound (RBUS) after fUTI with voiding cystourethrogram (VCUG) after abnormal RBUS or second fUTI, but data on clinician adherence to these recommendations are limited, the researchers said.

To characterize practice patterns regarding fUTI, the researchers reviewed data from children younger than 24 months of age with fUTI who were treated at a primary care network in Massachusetts in 2019. The definition of fUTI was temperature of 38° C or higher, positive urinalysis, and more than 50,000 CFU on urine culture. The median age of the patients was 9 months; 84% were female.

In a multivariate analysis, post-UTI imaging followed the AAP guidelines in 82 cases (69.5%). The main reasons for nonadherence were lack of RBUS in 21 patients, VCUG despite normal RBUS in 9 patients, no VCUG after abnormal RBUS in 4 patients, and no VCUG after a second fUTI in 2 patients.

Overall, nonadherence was a result of not ordering a recommended study in 23% of cases (errors of omission) and ordering an unnecessary study in 8% of cases (errors of commission).

Commercial insurance, larger number of providers in practice, and younger provider age were significant independent predictors of adherence (odds ratios 2.82, 1.38, and 0.96, respectively).

The findings were limited by the use of data from a single center; however, the results suggest that targeted training may improve guideline adherence, the researchers wrote. Additional research and quality improvement studies are needed to understand and address the impact of insurance on guideline adherence for imaging after febrile UTIs, they noted.
 

Provider education is essential to continued quality of care

When it comes to febrile UTIs, “it is important to stay focused on the quality of care being provided, as opposed to the usual benchmark of quantity of care,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“This is a very simple but interesting study on provider compliance with practice guidelines,” said Dr. Joos, who was not involved in the study. “I was surprised that the providers did so well in ordering the correct imaging in 70% of the cases,” he said.

 Of particular interest, Dr. Joos noted, was that “the authors also showed that older providers and those working in smaller practices are less likely to comply with this particular imaging guideline. This can be summed up as the ‘I didn’t know the guideline’ effect.”

To improve quality of care, “more research and effort should be directed at updating providers when strong new evidence changes previous practices and guidelines,” Dr. Joos told this news organization.

The study received no outside funding. The researchers and Dr. Joos had no financial conflicts to disclose.

WASHINGTON – Approximately 70% of children with febrile urinary tract infections receive guideline-adherent follow-up imaging from primary care, based on data from 118 individuals.

“Timely imaging is recommended after febrile UTI (fUTI) in young children to identify treatable urologic conditions,” wrote Jonathan Hatoun, MD, of Boston Children’s Hospital, and colleagues in a poster presented at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics (AAP) currently recommends renal-bladder ultrasound (RBUS) after fUTI with voiding cystourethrogram (VCUG) after abnormal RBUS or second fUTI, but data on clinician adherence to these recommendations are limited, the researchers said.

To characterize practice patterns regarding fUTI, the researchers reviewed data from children younger than 24 months of age with fUTI who were treated at a primary care network in Massachusetts in 2019. The definition of fUTI was temperature of 38° C or higher, positive urinalysis, and more than 50,000 CFU on urine culture. The median age of the patients was 9 months; 84% were female.

In a multivariate analysis, post-UTI imaging followed the AAP guidelines in 82 cases (69.5%). The main reasons for nonadherence were lack of RBUS in 21 patients, VCUG despite normal RBUS in 9 patients, no VCUG after abnormal RBUS in 4 patients, and no VCUG after a second fUTI in 2 patients.

Overall, nonadherence was a result of not ordering a recommended study in 23% of cases (errors of omission) and ordering an unnecessary study in 8% of cases (errors of commission).

Commercial insurance, larger number of providers in practice, and younger provider age were significant independent predictors of adherence (odds ratios 2.82, 1.38, and 0.96, respectively).

The findings were limited by the use of data from a single center; however, the results suggest that targeted training may improve guideline adherence, the researchers wrote. Additional research and quality improvement studies are needed to understand and address the impact of insurance on guideline adherence for imaging after febrile UTIs, they noted.
 

Provider education is essential to continued quality of care

When it comes to febrile UTIs, “it is important to stay focused on the quality of care being provided, as opposed to the usual benchmark of quantity of care,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“This is a very simple but interesting study on provider compliance with practice guidelines,” said Dr. Joos, who was not involved in the study. “I was surprised that the providers did so well in ordering the correct imaging in 70% of the cases,” he said.

 Of particular interest, Dr. Joos noted, was that “the authors also showed that older providers and those working in smaller practices are less likely to comply with this particular imaging guideline. This can be summed up as the ‘I didn’t know the guideline’ effect.”

To improve quality of care, “more research and effort should be directed at updating providers when strong new evidence changes previous practices and guidelines,” Dr. Joos told this news organization.

The study received no outside funding. The researchers and Dr. Joos had no financial conflicts to disclose.

WASHINGTON – Approximately 70% of children with febrile urinary tract infections receive guideline-adherent follow-up imaging from primary care, based on data from 118 individuals.

“Timely imaging is recommended after febrile UTI (fUTI) in young children to identify treatable urologic conditions,” wrote Jonathan Hatoun, MD, of Boston Children’s Hospital, and colleagues in a poster presented at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics (AAP) currently recommends renal-bladder ultrasound (RBUS) after fUTI with voiding cystourethrogram (VCUG) after abnormal RBUS or second fUTI, but data on clinician adherence to these recommendations are limited, the researchers said.

To characterize practice patterns regarding fUTI, the researchers reviewed data from children younger than 24 months of age with fUTI who were treated at a primary care network in Massachusetts in 2019. The definition of fUTI was temperature of 38° C or higher, positive urinalysis, and more than 50,000 CFU on urine culture. The median age of the patients was 9 months; 84% were female.

In a multivariate analysis, post-UTI imaging followed the AAP guidelines in 82 cases (69.5%). The main reasons for nonadherence were lack of RBUS in 21 patients, VCUG despite normal RBUS in 9 patients, no VCUG after abnormal RBUS in 4 patients, and no VCUG after a second fUTI in 2 patients.

Overall, nonadherence was a result of not ordering a recommended study in 23% of cases (errors of omission) and ordering an unnecessary study in 8% of cases (errors of commission).

Commercial insurance, larger number of providers in practice, and younger provider age were significant independent predictors of adherence (odds ratios 2.82, 1.38, and 0.96, respectively).

The findings were limited by the use of data from a single center; however, the results suggest that targeted training may improve guideline adherence, the researchers wrote. Additional research and quality improvement studies are needed to understand and address the impact of insurance on guideline adherence for imaging after febrile UTIs, they noted.
 

Provider education is essential to continued quality of care

When it comes to febrile UTIs, “it is important to stay focused on the quality of care being provided, as opposed to the usual benchmark of quantity of care,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“This is a very simple but interesting study on provider compliance with practice guidelines,” said Dr. Joos, who was not involved in the study. “I was surprised that the providers did so well in ordering the correct imaging in 70% of the cases,” he said.

 Of particular interest, Dr. Joos noted, was that “the authors also showed that older providers and those working in smaller practices are less likely to comply with this particular imaging guideline. This can be summed up as the ‘I didn’t know the guideline’ effect.”

To improve quality of care, “more research and effort should be directed at updating providers when strong new evidence changes previous practices and guidelines,” Dr. Joos told this news organization.

The study received no outside funding. The researchers and Dr. Joos had no financial conflicts to disclose.

Hoping to lure U.S. physicians northward, the Canadian provinces of Nova Scotia and Ontario are now allowing those who are board certified to start practicing medicine immediately with full licensure. They’ll no longer have to start with a limited license and take additional exams or be supervised for up to a year to become fully licensed.

Canada is experiencing an acute shortage of licensed physicians that’s expected to intensify over the next decade. The shortfall is estimated to be about 44,000 physicians by 2028, with family doctors accounting for 72% of the deficit.

“Reducing licensing barriers should make Canada a more attractive option for U.S. doctors who may be considering a move north,” said Tom Florence, president of AMN Healthcare’s Physician Solutions division, which recruits American physicians to work in Canada.

“Canada also has a truly expedited work visa process for qualifying physicians who have a job offer and wish to practice there,” said Mr. Florence. It usually takes about 6 months compared with at least 18 months for Canadian physicians who want to work in the United States, he said.

Few U.S.-trained physicians work in Canada, which has a population of nearly 39 million. Just 812 of them practiced in Canada in 2019, the last year data was collected, according to the Canadian Medical Association.

But Canada may attract American physicians who find U.S. medicine to be fraught with ethical dilemmas and restrictions from insurance companies and elected officials, said Theresa Rohr-Kirchgraber, MD, an internist and immediate past president of the American Medical Women’s Association.

“Rather than give up practicing medicine, a move to Canada may be a welcome respite for some U.S. physicians,” she said.

Physician recruiters in Ontario and Nova Scotia welcomed the news. About 13% of the population is without a family doctor, according to news reports.

A number of U.S. physicians have started practices in Nova Scotia in recent years, said Katrina Philopoulos, Nova Scotia Health’s director of physician recruitment. “I think this momentum will help us,” she said.

Other Canadian provinces with physician shortages are also considering making similar changes. Alberta recently announced a 5-year pilot project to waive some licensing requirements for family doctors and general practitioners trained in Australia, Ireland, United Kingdom, and the United States.
 

What are the pros and cons of working in Canada?

“Some U.S. physicians may be attracted by a single-payer system in which all patients have access to coverage, but there are a range of drawbacks and benefits to consider in both systems,” said Mr. Florence.

U.S. physicians generally earn more than their Canadian counterparts, so income is not likely to be a draw, he said.

That appears to be the case for both family medicine physicians and specialists when comparing average net annual salaries. (To obtain Canadian salaries, 2021 gross income data from the Canadian Institute for Health Information were used; 20% was deducted for operation costs; and Canadian dollars were converted into U.S. dollars based on the current exchange rate.)

A family medicine doctor in Canada will earn an annual average salary of $195,853 USD compared with $236,000 in the United States. A cardiologist in Canada will earn $314,051 USD annually compared with $459,000 in the United States. A dermatologist in Canada will earn $270,018 annually compared with $394,000 in the United States.

Everett Fuller, MD, an emergency medicine physician who moved from Texas to Nova Scotia in 2015 for his Canadian wife, recently wrote about the pros and cons of working there compared with the United States. For him, it was a worthwhile move.

“It’s getting back to making medicine and patient care the priority instead of the business of medicine,” Dr. Fuller wrote.

“I have the comfort of knowing that a patient and their family will not go bankrupt trying to pay medical bills if I make a catastrophic diagnosis. There’s no out-of-pocket cost, other than prescriptions (depending on their drug plan).”

Dr. Fuller also doesn’t have to fight insurers for reimbursement or preapprovals, and he pays much less for medical malpractice premiums in a less litigious environment, he said.

But he mentioned a few negatives. Some treatment is rationed, which can lead to long wait times for patients to get appointments. Also, “hospitals aren’t in it for the profit, so you’re not going to get a CT, MRI, and cath lab in every hospital,” he noted.

Mr. Florence doesn’t think either system “offers a panacea for many of the challenges physicians face today. Even with reduced barriers to licensure, we do not anticipate an exodus to U.S. physicians to the north.”
 

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

Hoping to lure U.S. physicians northward, the Canadian provinces of Nova Scotia and Ontario are now allowing those who are board certified to start practicing medicine immediately with full licensure. They’ll no longer have to start with a limited license and take additional exams or be supervised for up to a year to become fully licensed.

Canada is experiencing an acute shortage of licensed physicians that’s expected to intensify over the next decade. The shortfall is estimated to be about 44,000 physicians by 2028, with family doctors accounting for 72% of the deficit.

“Reducing licensing barriers should make Canada a more attractive option for U.S. doctors who may be considering a move north,” said Tom Florence, president of AMN Healthcare’s Physician Solutions division, which recruits American physicians to work in Canada.

“Canada also has a truly expedited work visa process for qualifying physicians who have a job offer and wish to practice there,” said Mr. Florence. It usually takes about 6 months compared with at least 18 months for Canadian physicians who want to work in the United States, he said.

Few U.S.-trained physicians work in Canada, which has a population of nearly 39 million. Just 812 of them practiced in Canada in 2019, the last year data was collected, according to the Canadian Medical Association.

But Canada may attract American physicians who find U.S. medicine to be fraught with ethical dilemmas and restrictions from insurance companies and elected officials, said Theresa Rohr-Kirchgraber, MD, an internist and immediate past president of the American Medical Women’s Association.

“Rather than give up practicing medicine, a move to Canada may be a welcome respite for some U.S. physicians,” she said.

Physician recruiters in Ontario and Nova Scotia welcomed the news. About 13% of the population is without a family doctor, according to news reports.

A number of U.S. physicians have started practices in Nova Scotia in recent years, said Katrina Philopoulos, Nova Scotia Health’s director of physician recruitment. “I think this momentum will help us,” she said.

Other Canadian provinces with physician shortages are also considering making similar changes. Alberta recently announced a 5-year pilot project to waive some licensing requirements for family doctors and general practitioners trained in Australia, Ireland, United Kingdom, and the United States.
 

What are the pros and cons of working in Canada?

“Some U.S. physicians may be attracted by a single-payer system in which all patients have access to coverage, but there are a range of drawbacks and benefits to consider in both systems,” said Mr. Florence.

U.S. physicians generally earn more than their Canadian counterparts, so income is not likely to be a draw, he said.

That appears to be the case for both family medicine physicians and specialists when comparing average net annual salaries. (To obtain Canadian salaries, 2021 gross income data from the Canadian Institute for Health Information were used; 20% was deducted for operation costs; and Canadian dollars were converted into U.S. dollars based on the current exchange rate.)

A family medicine doctor in Canada will earn an annual average salary of $195,853 USD compared with $236,000 in the United States. A cardiologist in Canada will earn $314,051 USD annually compared with $459,000 in the United States. A dermatologist in Canada will earn $270,018 annually compared with $394,000 in the United States.

Everett Fuller, MD, an emergency medicine physician who moved from Texas to Nova Scotia in 2015 for his Canadian wife, recently wrote about the pros and cons of working there compared with the United States. For him, it was a worthwhile move.

“It’s getting back to making medicine and patient care the priority instead of the business of medicine,” Dr. Fuller wrote.

“I have the comfort of knowing that a patient and their family will not go bankrupt trying to pay medical bills if I make a catastrophic diagnosis. There’s no out-of-pocket cost, other than prescriptions (depending on their drug plan).”

Dr. Fuller also doesn’t have to fight insurers for reimbursement or preapprovals, and he pays much less for medical malpractice premiums in a less litigious environment, he said.

But he mentioned a few negatives. Some treatment is rationed, which can lead to long wait times for patients to get appointments. Also, “hospitals aren’t in it for the profit, so you’re not going to get a CT, MRI, and cath lab in every hospital,” he noted.

Mr. Florence doesn’t think either system “offers a panacea for many of the challenges physicians face today. Even with reduced barriers to licensure, we do not anticipate an exodus to U.S. physicians to the north.”
 

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

Hoping to lure U.S. physicians northward, the Canadian provinces of Nova Scotia and Ontario are now allowing those who are board certified to start practicing medicine immediately with full licensure. They’ll no longer have to start with a limited license and take additional exams or be supervised for up to a year to become fully licensed.

Canada is experiencing an acute shortage of licensed physicians that’s expected to intensify over the next decade. The shortfall is estimated to be about 44,000 physicians by 2028, with family doctors accounting for 72% of the deficit.

“Reducing licensing barriers should make Canada a more attractive option for U.S. doctors who may be considering a move north,” said Tom Florence, president of AMN Healthcare’s Physician Solutions division, which recruits American physicians to work in Canada.

“Canada also has a truly expedited work visa process for qualifying physicians who have a job offer and wish to practice there,” said Mr. Florence. It usually takes about 6 months compared with at least 18 months for Canadian physicians who want to work in the United States, he said.

Few U.S.-trained physicians work in Canada, which has a population of nearly 39 million. Just 812 of them practiced in Canada in 2019, the last year data was collected, according to the Canadian Medical Association.

But Canada may attract American physicians who find U.S. medicine to be fraught with ethical dilemmas and restrictions from insurance companies and elected officials, said Theresa Rohr-Kirchgraber, MD, an internist and immediate past president of the American Medical Women’s Association.

“Rather than give up practicing medicine, a move to Canada may be a welcome respite for some U.S. physicians,” she said.

Physician recruiters in Ontario and Nova Scotia welcomed the news. About 13% of the population is without a family doctor, according to news reports.

A number of U.S. physicians have started practices in Nova Scotia in recent years, said Katrina Philopoulos, Nova Scotia Health’s director of physician recruitment. “I think this momentum will help us,” she said.

Other Canadian provinces with physician shortages are also considering making similar changes. Alberta recently announced a 5-year pilot project to waive some licensing requirements for family doctors and general practitioners trained in Australia, Ireland, United Kingdom, and the United States.
 

What are the pros and cons of working in Canada?

“Some U.S. physicians may be attracted by a single-payer system in which all patients have access to coverage, but there are a range of drawbacks and benefits to consider in both systems,” said Mr. Florence.

U.S. physicians generally earn more than their Canadian counterparts, so income is not likely to be a draw, he said.

That appears to be the case for both family medicine physicians and specialists when comparing average net annual salaries. (To obtain Canadian salaries, 2021 gross income data from the Canadian Institute for Health Information were used; 20% was deducted for operation costs; and Canadian dollars were converted into U.S. dollars based on the current exchange rate.)

A family medicine doctor in Canada will earn an annual average salary of $195,853 USD compared with $236,000 in the United States. A cardiologist in Canada will earn $314,051 USD annually compared with $459,000 in the United States. A dermatologist in Canada will earn $270,018 annually compared with $394,000 in the United States.

Everett Fuller, MD, an emergency medicine physician who moved from Texas to Nova Scotia in 2015 for his Canadian wife, recently wrote about the pros and cons of working there compared with the United States. For him, it was a worthwhile move.

“It’s getting back to making medicine and patient care the priority instead of the business of medicine,” Dr. Fuller wrote.

“I have the comfort of knowing that a patient and their family will not go bankrupt trying to pay medical bills if I make a catastrophic diagnosis. There’s no out-of-pocket cost, other than prescriptions (depending on their drug plan).”

Dr. Fuller also doesn’t have to fight insurers for reimbursement or preapprovals, and he pays much less for medical malpractice premiums in a less litigious environment, he said.

But he mentioned a few negatives. Some treatment is rationed, which can lead to long wait times for patients to get appointments. Also, “hospitals aren’t in it for the profit, so you’re not going to get a CT, MRI, and cath lab in every hospital,” he noted.

Mr. Florence doesn’t think either system “offers a panacea for many of the challenges physicians face today. Even with reduced barriers to licensure, we do not anticipate an exodus to U.S. physicians to the north.”
 

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