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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Systematic review of radiofrequency microneedling studies unveiled
Of the according to results from a new systematic review.
“Most devices for aesthetic purposes induce denaturation and remodeling of collagen, elastin, and other dermal structures through tissue injury and stimulating the body’s wound-healing response,” lead study author Marcus G. Tan, MD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “Radiofrequency microneedling is no exception in this regard. RFMN creates perforations in the skin and delivers radiofrequency-generated thermal energy into the underlying tissue. However, RFMN is unique in that thermal energy is delivered in a fashion that produces a reverse temperature gradient to most ablative lasers.”
When using ablative lasers, which target water as its chromophore through selective photothermolysis, the temperature gradient is highest at the epidermis and papillary dermis, and decreases as it penetrates the deeper structures of the skin. In RFMN, radiofrequency energy is delivered directly to the target depth through the microneedle electrodes, thus creating a temperature gradient that is highest in the deep, target structures and cooler at the superficial structures. “This results in less unwanted epidermal heating and reduces the risk of postinflammatory hyperpigmentation,” explained Dr. Tan, a resident in the division of dermatology at the University of Ottawa.
“Because RFMN is unaffected by skin chromophores, it is essentially a ‘color-blind’ technology and safe for use in patients of all skin phototypes. In comparison to lasers, radiofrequency energy can also be delivered to deeper structures of the skin by increasing the length of microneedle electrodes. Despite these advantages of RFMN, this technology remains utilized less frequently compared to ablative lasers for its skin rejuvenating effects.”
To review high-quality medical literature related to RFMN, Dr. Tan and colleagues searched EMBASE and MEDLINE from inception to May 13, 2020, by using the terms “radiofrequency microneedling,” “fractional radiofrequency,” “radiofrequency needling,” or “radiofrequency percutaneous collagen induction.” They limited the analysis to dermatology-related randomized, split-body, or blinded studies with original data in humans. Of the 42 studies included in the final analysis, there were 14 studies of skin rejuvenation, 7 of acne scars, 6 of acne vulgaris, 5 each of striae and axillary hyperhidrosis, 2 of melasma, and 1 each of rosacea, cellulite, and androgenetic alopecia.
After reviewing the 42 studies, the study authors proposed that a strong recommendation for RFMN be made for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis, and a weak recommendation for the technology to be used for papulopustular rosacea, striae, and male-pattern androgenetic alopecia when used in conjunction with topical 5% minoxidil. There was insufficient evidence to make recommendations for its use in cellulite and melasma.
One finding that Dr. Tan described as “interesting” was the observation that RFMN was superior to Er:YAG fractional ablative lasers for treatment of rhytides on the lower face (i.e., the nasolabial, perioral, jawline and neck regions). “Secondly, we observed that one session of RFMN was able to achieve 37% efficacy of a surgical face-lift, but without any adverse effects,” Dr. Tan said. “Two-thirds of the patients who received surgical face-lift developed hypertrophic scarring requiring further scar management, compared to none of the patients receiving RFMN.”
Based on their review, Dr. Tan and colleagues recommend that RFMN be offered as one of the therapeutic options for patients seeking treatment for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis. “It is usually tolerable with just topical anesthesia applied 30-60 minutes before treatment, and its side effects are transient and usually resolve after 5 days,” he said. “Patients should be counseled that the benefits of RFMN may have a slower onset, compared to other treatments, but it is progressive, durable, and can be used repeatedly and safely in all skin types including darker-skin phenotypes with minimal risk of adverse events.”
One of the abstract section chairs, Fernanda H. Sakamoto, MD, PhD, said that RFMN devices have become increasingly popular in recent years. “The paper presented by Tan et al. is very relevant, as it compares clinical indications, parameters, and results in search for evidence of efficacy and appropriate settings,” said Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, told this news organization. “The paper provides long-needed guidelines to clinicians and helps manage patients’ expectations.”
Dr. Tan acknowledged certain limitations of the study, including the lack of head-to-head studies comparing specific RFMN devices. “There are many RFMN devices available commercially, each with different capabilities and degrees of effectiveness,” he said. “With more research and technological advancements since the first radiofrequency device was approved in 2002, RFMN has made significant improvements. In general, the newer generation devices produce markedly better results.”
Dr. Tan reported having no financial disclosures. Dr. Sakamoto disclosed that she holds intellectual property rights with Accure Acne, Massachusetts General Hospital, and Lightwater Biosciences.
Of the according to results from a new systematic review.
“Most devices for aesthetic purposes induce denaturation and remodeling of collagen, elastin, and other dermal structures through tissue injury and stimulating the body’s wound-healing response,” lead study author Marcus G. Tan, MD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “Radiofrequency microneedling is no exception in this regard. RFMN creates perforations in the skin and delivers radiofrequency-generated thermal energy into the underlying tissue. However, RFMN is unique in that thermal energy is delivered in a fashion that produces a reverse temperature gradient to most ablative lasers.”
When using ablative lasers, which target water as its chromophore through selective photothermolysis, the temperature gradient is highest at the epidermis and papillary dermis, and decreases as it penetrates the deeper structures of the skin. In RFMN, radiofrequency energy is delivered directly to the target depth through the microneedle electrodes, thus creating a temperature gradient that is highest in the deep, target structures and cooler at the superficial structures. “This results in less unwanted epidermal heating and reduces the risk of postinflammatory hyperpigmentation,” explained Dr. Tan, a resident in the division of dermatology at the University of Ottawa.
“Because RFMN is unaffected by skin chromophores, it is essentially a ‘color-blind’ technology and safe for use in patients of all skin phototypes. In comparison to lasers, radiofrequency energy can also be delivered to deeper structures of the skin by increasing the length of microneedle electrodes. Despite these advantages of RFMN, this technology remains utilized less frequently compared to ablative lasers for its skin rejuvenating effects.”
To review high-quality medical literature related to RFMN, Dr. Tan and colleagues searched EMBASE and MEDLINE from inception to May 13, 2020, by using the terms “radiofrequency microneedling,” “fractional radiofrequency,” “radiofrequency needling,” or “radiofrequency percutaneous collagen induction.” They limited the analysis to dermatology-related randomized, split-body, or blinded studies with original data in humans. Of the 42 studies included in the final analysis, there were 14 studies of skin rejuvenation, 7 of acne scars, 6 of acne vulgaris, 5 each of striae and axillary hyperhidrosis, 2 of melasma, and 1 each of rosacea, cellulite, and androgenetic alopecia.
After reviewing the 42 studies, the study authors proposed that a strong recommendation for RFMN be made for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis, and a weak recommendation for the technology to be used for papulopustular rosacea, striae, and male-pattern androgenetic alopecia when used in conjunction with topical 5% minoxidil. There was insufficient evidence to make recommendations for its use in cellulite and melasma.
One finding that Dr. Tan described as “interesting” was the observation that RFMN was superior to Er:YAG fractional ablative lasers for treatment of rhytides on the lower face (i.e., the nasolabial, perioral, jawline and neck regions). “Secondly, we observed that one session of RFMN was able to achieve 37% efficacy of a surgical face-lift, but without any adverse effects,” Dr. Tan said. “Two-thirds of the patients who received surgical face-lift developed hypertrophic scarring requiring further scar management, compared to none of the patients receiving RFMN.”
Based on their review, Dr. Tan and colleagues recommend that RFMN be offered as one of the therapeutic options for patients seeking treatment for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis. “It is usually tolerable with just topical anesthesia applied 30-60 minutes before treatment, and its side effects are transient and usually resolve after 5 days,” he said. “Patients should be counseled that the benefits of RFMN may have a slower onset, compared to other treatments, but it is progressive, durable, and can be used repeatedly and safely in all skin types including darker-skin phenotypes with minimal risk of adverse events.”
One of the abstract section chairs, Fernanda H. Sakamoto, MD, PhD, said that RFMN devices have become increasingly popular in recent years. “The paper presented by Tan et al. is very relevant, as it compares clinical indications, parameters, and results in search for evidence of efficacy and appropriate settings,” said Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, told this news organization. “The paper provides long-needed guidelines to clinicians and helps manage patients’ expectations.”
Dr. Tan acknowledged certain limitations of the study, including the lack of head-to-head studies comparing specific RFMN devices. “There are many RFMN devices available commercially, each with different capabilities and degrees of effectiveness,” he said. “With more research and technological advancements since the first radiofrequency device was approved in 2002, RFMN has made significant improvements. In general, the newer generation devices produce markedly better results.”
Dr. Tan reported having no financial disclosures. Dr. Sakamoto disclosed that she holds intellectual property rights with Accure Acne, Massachusetts General Hospital, and Lightwater Biosciences.
Of the according to results from a new systematic review.
“Most devices for aesthetic purposes induce denaturation and remodeling of collagen, elastin, and other dermal structures through tissue injury and stimulating the body’s wound-healing response,” lead study author Marcus G. Tan, MD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “Radiofrequency microneedling is no exception in this regard. RFMN creates perforations in the skin and delivers radiofrequency-generated thermal energy into the underlying tissue. However, RFMN is unique in that thermal energy is delivered in a fashion that produces a reverse temperature gradient to most ablative lasers.”
When using ablative lasers, which target water as its chromophore through selective photothermolysis, the temperature gradient is highest at the epidermis and papillary dermis, and decreases as it penetrates the deeper structures of the skin. In RFMN, radiofrequency energy is delivered directly to the target depth through the microneedle electrodes, thus creating a temperature gradient that is highest in the deep, target structures and cooler at the superficial structures. “This results in less unwanted epidermal heating and reduces the risk of postinflammatory hyperpigmentation,” explained Dr. Tan, a resident in the division of dermatology at the University of Ottawa.
“Because RFMN is unaffected by skin chromophores, it is essentially a ‘color-blind’ technology and safe for use in patients of all skin phototypes. In comparison to lasers, radiofrequency energy can also be delivered to deeper structures of the skin by increasing the length of microneedle electrodes. Despite these advantages of RFMN, this technology remains utilized less frequently compared to ablative lasers for its skin rejuvenating effects.”
To review high-quality medical literature related to RFMN, Dr. Tan and colleagues searched EMBASE and MEDLINE from inception to May 13, 2020, by using the terms “radiofrequency microneedling,” “fractional radiofrequency,” “radiofrequency needling,” or “radiofrequency percutaneous collagen induction.” They limited the analysis to dermatology-related randomized, split-body, or blinded studies with original data in humans. Of the 42 studies included in the final analysis, there were 14 studies of skin rejuvenation, 7 of acne scars, 6 of acne vulgaris, 5 each of striae and axillary hyperhidrosis, 2 of melasma, and 1 each of rosacea, cellulite, and androgenetic alopecia.
After reviewing the 42 studies, the study authors proposed that a strong recommendation for RFMN be made for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis, and a weak recommendation for the technology to be used for papulopustular rosacea, striae, and male-pattern androgenetic alopecia when used in conjunction with topical 5% minoxidil. There was insufficient evidence to make recommendations for its use in cellulite and melasma.
One finding that Dr. Tan described as “interesting” was the observation that RFMN was superior to Er:YAG fractional ablative lasers for treatment of rhytides on the lower face (i.e., the nasolabial, perioral, jawline and neck regions). “Secondly, we observed that one session of RFMN was able to achieve 37% efficacy of a surgical face-lift, but without any adverse effects,” Dr. Tan said. “Two-thirds of the patients who received surgical face-lift developed hypertrophic scarring requiring further scar management, compared to none of the patients receiving RFMN.”
Based on their review, Dr. Tan and colleagues recommend that RFMN be offered as one of the therapeutic options for patients seeking treatment for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis. “It is usually tolerable with just topical anesthesia applied 30-60 minutes before treatment, and its side effects are transient and usually resolve after 5 days,” he said. “Patients should be counseled that the benefits of RFMN may have a slower onset, compared to other treatments, but it is progressive, durable, and can be used repeatedly and safely in all skin types including darker-skin phenotypes with minimal risk of adverse events.”
One of the abstract section chairs, Fernanda H. Sakamoto, MD, PhD, said that RFMN devices have become increasingly popular in recent years. “The paper presented by Tan et al. is very relevant, as it compares clinical indications, parameters, and results in search for evidence of efficacy and appropriate settings,” said Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, told this news organization. “The paper provides long-needed guidelines to clinicians and helps manage patients’ expectations.”
Dr. Tan acknowledged certain limitations of the study, including the lack of head-to-head studies comparing specific RFMN devices. “There are many RFMN devices available commercially, each with different capabilities and degrees of effectiveness,” he said. “With more research and technological advancements since the first radiofrequency device was approved in 2002, RFMN has made significant improvements. In general, the newer generation devices produce markedly better results.”
Dr. Tan reported having no financial disclosures. Dr. Sakamoto disclosed that she holds intellectual property rights with Accure Acne, Massachusetts General Hospital, and Lightwater Biosciences.
FROM ASLMS 2021
Photobiomodulation reduced acute radiodermatitis severity in head and neck cancer patients
The delivery of , according to results from the first randomized study of its kind.
“The use of light therapy-based applications for cancer therapy-related adverse events has steadily increased in the past 40 years,” lead study author Jolien Robijns, MSc, PhD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “The most well-known and studied indication of photobiomodulation therapy in supportive cancer care is oral mucositis,” she said, referring to a recent systematic review, which found that based on the available evidence, PBMT is an effective therapy for the prevention of oral mucositis, using well-defined PBM parameters in specific patient populations. “Various internationally well-recognized health organizations in oncology recommend PBMT to prevent and manage oral mucositis,” she added.
Based on the wound-healing and anti-inflammatory properties of PBMT, several studies have investigated its use for the prevention and management of acute radiodermatitis (ARD) since the 1990s, said Dr. Robijns, a postdoctoral researcher at Limburg Clinical Research Center in Hasselt, Belgium. Under the supervision of Jeroen Mebis, MD, PhD, at the Limburg Oncologic Laser Institute, she and her colleagues have been conducting clinical research on PBMT and ARD since 2014, with successful results. In 2020 they published a narrative review, which showed that based on nine clinical trials, PBMT could effectively reduce the incidence of severe ARD, decrease accompanying pain, and improve patients’ quality of life.
For the current study, known as the DERMISHEAD trial and published online March 9, 2021, in Radiotherapy and Oncology, investigators at Limburg Oncology Center at Jessa Hospital in Hasselt, and Hasselt University, recruited head and neck cancer patients who underwent bilateral radiotherapy with or without chemotherapy, for a total dose of 30-35 x 2 Gy . All patients received standard skin care combined with two PBMT or sham sessions twice per week during the complete course of RT, which resulted in 14 total sessions.
As described in the Radiotherapy and Oncology study, the commercially available device used for PBMT “consists of two laser diodes with different wavelengths (808-905 nm), peak powers (1.1-25 W), and emission modes (continuous and pulsed). Both diodes work simultaneously and synchronously with coincident propagation axes (average radiant power 3.3 W). The energy density (fluence) was set at 4 J/cm2 based on earlier recommendations and on our clinical experience.” A blinded study nurse used Radiation Therapy Oncology Group criteria to evaluate the skin reactions.
After 303 patients were initially assessed for eligibility, 46 patients were enrolled in DERMISHEAD (18 in the placebo group and 28 in the PBMT group). At the end of radiotherapy, 77.8% of patients in the placebo group had a grade 2 or 3 skin reaction, compared with 28.6% of patients in the PBMT group (P = .001).
“The DERMISHEAD trial proved that PBMT significantly reduces the severity of ARD,” Dr. Robijns said. “Thereby, it improves the patients’ quality of life during their radiotherapy course. The trial supports the further implementation of PBM in the supportive care of cancer patients undergoing radiotherapy.”
The results are similar to those in the TRANSDERMIS trial, in which Dr. Robijns and her colleagues used PMBT to treat breast cancer patients.
“However, an interesting difference is that the percentage decrease in severe ARD was higher in the DERMISHEAD trial than in the TRANSDERMIS trial: 49% vs. 23%, respectively,” she noted. “This difference can be rationalized because in total, more control head and neck cancer patients developed grade 3 ARD than did control breast cancer patients (17% vs. 5%). A possible explanation of this finding can be related to the difference in treatment regimens and radiotherapy parameters between the two trials.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was asked to comment on the study, said that acute radiation dermatitis “can be very painful and distressing to patients, and over time, the skin changes can create long-term problems. Prevention of acute and chronic radiation dermatitis is worthwhile, particularly for patients at risk.”
This study, she added, “shows a benefit of photobiomodulation therapy as a potential preventative treatment. Notably, patients did not always follow up appropriately for the therapy, and the authors said that it is yet another thing that patients need to keep track of, in addition to their cancer therapy visits. Thus, optimally, it would be useful to have a biomarker of which patients would most benefit from treatments that prevent/potentiate radiation dermatitis.”
Dr. Robijns acknowledged certain limitations of the trial, including its small sample size and the scarcity of clinical trials on PBM and acute radiation dermatitis. “More studies are needed,” she said. “Future studies should focus on randomized controlled study designs with well-described and complete PBMT parameters in a larger and more diverse patient population. This would enable the implementation of PBM in the field of ARD and supportive cancer care, which would enhance wound care management and improve the patient’s quality of life.”
This work won a “best of clinical applications” abstract award from the ASLMS.
The research is part of the Limburg Clinical Research Center UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. The research is also funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl. Dr. Robijns reported having no financial disclosures.
The delivery of , according to results from the first randomized study of its kind.
“The use of light therapy-based applications for cancer therapy-related adverse events has steadily increased in the past 40 years,” lead study author Jolien Robijns, MSc, PhD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “The most well-known and studied indication of photobiomodulation therapy in supportive cancer care is oral mucositis,” she said, referring to a recent systematic review, which found that based on the available evidence, PBMT is an effective therapy for the prevention of oral mucositis, using well-defined PBM parameters in specific patient populations. “Various internationally well-recognized health organizations in oncology recommend PBMT to prevent and manage oral mucositis,” she added.
Based on the wound-healing and anti-inflammatory properties of PBMT, several studies have investigated its use for the prevention and management of acute radiodermatitis (ARD) since the 1990s, said Dr. Robijns, a postdoctoral researcher at Limburg Clinical Research Center in Hasselt, Belgium. Under the supervision of Jeroen Mebis, MD, PhD, at the Limburg Oncologic Laser Institute, she and her colleagues have been conducting clinical research on PBMT and ARD since 2014, with successful results. In 2020 they published a narrative review, which showed that based on nine clinical trials, PBMT could effectively reduce the incidence of severe ARD, decrease accompanying pain, and improve patients’ quality of life.
For the current study, known as the DERMISHEAD trial and published online March 9, 2021, in Radiotherapy and Oncology, investigators at Limburg Oncology Center at Jessa Hospital in Hasselt, and Hasselt University, recruited head and neck cancer patients who underwent bilateral radiotherapy with or without chemotherapy, for a total dose of 30-35 x 2 Gy . All patients received standard skin care combined with two PBMT or sham sessions twice per week during the complete course of RT, which resulted in 14 total sessions.
As described in the Radiotherapy and Oncology study, the commercially available device used for PBMT “consists of two laser diodes with different wavelengths (808-905 nm), peak powers (1.1-25 W), and emission modes (continuous and pulsed). Both diodes work simultaneously and synchronously with coincident propagation axes (average radiant power 3.3 W). The energy density (fluence) was set at 4 J/cm2 based on earlier recommendations and on our clinical experience.” A blinded study nurse used Radiation Therapy Oncology Group criteria to evaluate the skin reactions.
After 303 patients were initially assessed for eligibility, 46 patients were enrolled in DERMISHEAD (18 in the placebo group and 28 in the PBMT group). At the end of radiotherapy, 77.8% of patients in the placebo group had a grade 2 or 3 skin reaction, compared with 28.6% of patients in the PBMT group (P = .001).
“The DERMISHEAD trial proved that PBMT significantly reduces the severity of ARD,” Dr. Robijns said. “Thereby, it improves the patients’ quality of life during their radiotherapy course. The trial supports the further implementation of PBM in the supportive care of cancer patients undergoing radiotherapy.”
The results are similar to those in the TRANSDERMIS trial, in which Dr. Robijns and her colleagues used PMBT to treat breast cancer patients.
“However, an interesting difference is that the percentage decrease in severe ARD was higher in the DERMISHEAD trial than in the TRANSDERMIS trial: 49% vs. 23%, respectively,” she noted. “This difference can be rationalized because in total, more control head and neck cancer patients developed grade 3 ARD than did control breast cancer patients (17% vs. 5%). A possible explanation of this finding can be related to the difference in treatment regimens and radiotherapy parameters between the two trials.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was asked to comment on the study, said that acute radiation dermatitis “can be very painful and distressing to patients, and over time, the skin changes can create long-term problems. Prevention of acute and chronic radiation dermatitis is worthwhile, particularly for patients at risk.”
This study, she added, “shows a benefit of photobiomodulation therapy as a potential preventative treatment. Notably, patients did not always follow up appropriately for the therapy, and the authors said that it is yet another thing that patients need to keep track of, in addition to their cancer therapy visits. Thus, optimally, it would be useful to have a biomarker of which patients would most benefit from treatments that prevent/potentiate radiation dermatitis.”
Dr. Robijns acknowledged certain limitations of the trial, including its small sample size and the scarcity of clinical trials on PBM and acute radiation dermatitis. “More studies are needed,” she said. “Future studies should focus on randomized controlled study designs with well-described and complete PBMT parameters in a larger and more diverse patient population. This would enable the implementation of PBM in the field of ARD and supportive cancer care, which would enhance wound care management and improve the patient’s quality of life.”
This work won a “best of clinical applications” abstract award from the ASLMS.
The research is part of the Limburg Clinical Research Center UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. The research is also funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl. Dr. Robijns reported having no financial disclosures.
The delivery of , according to results from the first randomized study of its kind.
“The use of light therapy-based applications for cancer therapy-related adverse events has steadily increased in the past 40 years,” lead study author Jolien Robijns, MSc, PhD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “The most well-known and studied indication of photobiomodulation therapy in supportive cancer care is oral mucositis,” she said, referring to a recent systematic review, which found that based on the available evidence, PBMT is an effective therapy for the prevention of oral mucositis, using well-defined PBM parameters in specific patient populations. “Various internationally well-recognized health organizations in oncology recommend PBMT to prevent and manage oral mucositis,” she added.
Based on the wound-healing and anti-inflammatory properties of PBMT, several studies have investigated its use for the prevention and management of acute radiodermatitis (ARD) since the 1990s, said Dr. Robijns, a postdoctoral researcher at Limburg Clinical Research Center in Hasselt, Belgium. Under the supervision of Jeroen Mebis, MD, PhD, at the Limburg Oncologic Laser Institute, she and her colleagues have been conducting clinical research on PBMT and ARD since 2014, with successful results. In 2020 they published a narrative review, which showed that based on nine clinical trials, PBMT could effectively reduce the incidence of severe ARD, decrease accompanying pain, and improve patients’ quality of life.
For the current study, known as the DERMISHEAD trial and published online March 9, 2021, in Radiotherapy and Oncology, investigators at Limburg Oncology Center at Jessa Hospital in Hasselt, and Hasselt University, recruited head and neck cancer patients who underwent bilateral radiotherapy with or without chemotherapy, for a total dose of 30-35 x 2 Gy . All patients received standard skin care combined with two PBMT or sham sessions twice per week during the complete course of RT, which resulted in 14 total sessions.
As described in the Radiotherapy and Oncology study, the commercially available device used for PBMT “consists of two laser diodes with different wavelengths (808-905 nm), peak powers (1.1-25 W), and emission modes (continuous and pulsed). Both diodes work simultaneously and synchronously with coincident propagation axes (average radiant power 3.3 W). The energy density (fluence) was set at 4 J/cm2 based on earlier recommendations and on our clinical experience.” A blinded study nurse used Radiation Therapy Oncology Group criteria to evaluate the skin reactions.
After 303 patients were initially assessed for eligibility, 46 patients were enrolled in DERMISHEAD (18 in the placebo group and 28 in the PBMT group). At the end of radiotherapy, 77.8% of patients in the placebo group had a grade 2 or 3 skin reaction, compared with 28.6% of patients in the PBMT group (P = .001).
“The DERMISHEAD trial proved that PBMT significantly reduces the severity of ARD,” Dr. Robijns said. “Thereby, it improves the patients’ quality of life during their radiotherapy course. The trial supports the further implementation of PBM in the supportive care of cancer patients undergoing radiotherapy.”
The results are similar to those in the TRANSDERMIS trial, in which Dr. Robijns and her colleagues used PMBT to treat breast cancer patients.
“However, an interesting difference is that the percentage decrease in severe ARD was higher in the DERMISHEAD trial than in the TRANSDERMIS trial: 49% vs. 23%, respectively,” she noted. “This difference can be rationalized because in total, more control head and neck cancer patients developed grade 3 ARD than did control breast cancer patients (17% vs. 5%). A possible explanation of this finding can be related to the difference in treatment regimens and radiotherapy parameters between the two trials.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was asked to comment on the study, said that acute radiation dermatitis “can be very painful and distressing to patients, and over time, the skin changes can create long-term problems. Prevention of acute and chronic radiation dermatitis is worthwhile, particularly for patients at risk.”
This study, she added, “shows a benefit of photobiomodulation therapy as a potential preventative treatment. Notably, patients did not always follow up appropriately for the therapy, and the authors said that it is yet another thing that patients need to keep track of, in addition to their cancer therapy visits. Thus, optimally, it would be useful to have a biomarker of which patients would most benefit from treatments that prevent/potentiate radiation dermatitis.”
Dr. Robijns acknowledged certain limitations of the trial, including its small sample size and the scarcity of clinical trials on PBM and acute radiation dermatitis. “More studies are needed,” she said. “Future studies should focus on randomized controlled study designs with well-described and complete PBMT parameters in a larger and more diverse patient population. This would enable the implementation of PBM in the field of ARD and supportive cancer care, which would enhance wound care management and improve the patient’s quality of life.”
This work won a “best of clinical applications” abstract award from the ASLMS.
The research is part of the Limburg Clinical Research Center UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. The research is also funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl. Dr. Robijns reported having no financial disclosures.
FROM ASLMS 2021
FDA preparing an environmental impact statement for 2 sunscreen ingredients
The Food and Drug Administration is launching a process to prepare an environmental impact statement (EIS) regarding the use oxybenzone and octinoxate in over-the-counter sunscreen products.
According to the “Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use,” which was published in the Federal Register on May 13, 2021, the FDA will prepare an EIS “when data or information in an environmental assessment or otherwise available to the Agency leads to a finding that the proposed agency action may significantly affect the quality of the human environment.” The first step in this effort involves a “public scoping process” to evaluate any potential environmental impacts associated with the use of oxybenzone and octinoxate in sunscreens so that an EIS, if required, “can be completed prior to issuance of a final sunscreen order addressing sunscreens containing these ingredients.”
The American Academy of Dermatology Association weighed in on the FDA’s announcement, noting that it “appreciates the efforts of the agency to thoroughly examine all relevant science before issuing a final sunscreen order on these ingredients,” according to a statement released by the AADA on May 13, 2021.
The statement added: “Skin cancer is the most common cancer in the U.S., and unprotected exposure to the sun’s harmful ultraviolet rays is a major risk factor. The AADA continues to focus on encouraging members of the public to protect themselves by seeking shade, wearing protective clothing – including a lightweight and long-sleeved shirt, pants, a wide-brimmed hat and sunglasses – and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all exposed skin.”
According to the FDA document, a series of developments regarding oxybenzone and octinoxate prompted the agency to take this step, including comments the agency received in response to the 2019 proposed rule titled “Sunscreen Drug Products for Over-The-Counter Human Use,” which raised concern about the potential effects of the two ingredients on coral and/or coral reefs, as well as research efforts by the National Oceanic and Atmospheric Administration Coral Reef Conservation Programs on the potential impacts of sunscreen products that include oxybenzone and octinoxate on coral reefs and other aquatic systems. Hawaii’s 2018 state law prohibiting the sale, offer of sale, and distribution of sunscreens that contain oxybenzone and/or octinoxate also influenced the agency’s decision to further evaluate the topic.
“The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including potential alternatives and the extent to which those issues and impacts will be analyzed,” the FDA document states. “At this initial stage of the scoping process, we have identified the following four alternatives: FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA [new drug application] is impermissible; FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA is permissible; FDA will conclude that inclusion of oxybenzone in sunscreens marketed without an NDA is permissible but that the inclusion of octinoxate in sunscreens marketed without an NDA is impermissible; or FDA will conclude that inclusion of octinoxate in sunscreens marketed without an NDA is permissible but that the inclusion of oxybenzone in sunscreens marketed without an NDA is impermissible.”
Until June 14, the FDA is accepting comments from the public electronically via the Federal eRulemaking Portal at www.regulations.gov (search for Docket No. FDA-2021-N-0352) or by mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852. Refer to Docket No. FDA-2021-N-0352.
The Food and Drug Administration is launching a process to prepare an environmental impact statement (EIS) regarding the use oxybenzone and octinoxate in over-the-counter sunscreen products.
According to the “Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use,” which was published in the Federal Register on May 13, 2021, the FDA will prepare an EIS “when data or information in an environmental assessment or otherwise available to the Agency leads to a finding that the proposed agency action may significantly affect the quality of the human environment.” The first step in this effort involves a “public scoping process” to evaluate any potential environmental impacts associated with the use of oxybenzone and octinoxate in sunscreens so that an EIS, if required, “can be completed prior to issuance of a final sunscreen order addressing sunscreens containing these ingredients.”
The American Academy of Dermatology Association weighed in on the FDA’s announcement, noting that it “appreciates the efforts of the agency to thoroughly examine all relevant science before issuing a final sunscreen order on these ingredients,” according to a statement released by the AADA on May 13, 2021.
The statement added: “Skin cancer is the most common cancer in the U.S., and unprotected exposure to the sun’s harmful ultraviolet rays is a major risk factor. The AADA continues to focus on encouraging members of the public to protect themselves by seeking shade, wearing protective clothing – including a lightweight and long-sleeved shirt, pants, a wide-brimmed hat and sunglasses – and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all exposed skin.”
According to the FDA document, a series of developments regarding oxybenzone and octinoxate prompted the agency to take this step, including comments the agency received in response to the 2019 proposed rule titled “Sunscreen Drug Products for Over-The-Counter Human Use,” which raised concern about the potential effects of the two ingredients on coral and/or coral reefs, as well as research efforts by the National Oceanic and Atmospheric Administration Coral Reef Conservation Programs on the potential impacts of sunscreen products that include oxybenzone and octinoxate on coral reefs and other aquatic systems. Hawaii’s 2018 state law prohibiting the sale, offer of sale, and distribution of sunscreens that contain oxybenzone and/or octinoxate also influenced the agency’s decision to further evaluate the topic.
“The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including potential alternatives and the extent to which those issues and impacts will be analyzed,” the FDA document states. “At this initial stage of the scoping process, we have identified the following four alternatives: FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA [new drug application] is impermissible; FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA is permissible; FDA will conclude that inclusion of oxybenzone in sunscreens marketed without an NDA is permissible but that the inclusion of octinoxate in sunscreens marketed without an NDA is impermissible; or FDA will conclude that inclusion of octinoxate in sunscreens marketed without an NDA is permissible but that the inclusion of oxybenzone in sunscreens marketed without an NDA is impermissible.”
Until June 14, the FDA is accepting comments from the public electronically via the Federal eRulemaking Portal at www.regulations.gov (search for Docket No. FDA-2021-N-0352) or by mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852. Refer to Docket No. FDA-2021-N-0352.
The Food and Drug Administration is launching a process to prepare an environmental impact statement (EIS) regarding the use oxybenzone and octinoxate in over-the-counter sunscreen products.
According to the “Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use,” which was published in the Federal Register on May 13, 2021, the FDA will prepare an EIS “when data or information in an environmental assessment or otherwise available to the Agency leads to a finding that the proposed agency action may significantly affect the quality of the human environment.” The first step in this effort involves a “public scoping process” to evaluate any potential environmental impacts associated with the use of oxybenzone and octinoxate in sunscreens so that an EIS, if required, “can be completed prior to issuance of a final sunscreen order addressing sunscreens containing these ingredients.”
The American Academy of Dermatology Association weighed in on the FDA’s announcement, noting that it “appreciates the efforts of the agency to thoroughly examine all relevant science before issuing a final sunscreen order on these ingredients,” according to a statement released by the AADA on May 13, 2021.
The statement added: “Skin cancer is the most common cancer in the U.S., and unprotected exposure to the sun’s harmful ultraviolet rays is a major risk factor. The AADA continues to focus on encouraging members of the public to protect themselves by seeking shade, wearing protective clothing – including a lightweight and long-sleeved shirt, pants, a wide-brimmed hat and sunglasses – and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all exposed skin.”
According to the FDA document, a series of developments regarding oxybenzone and octinoxate prompted the agency to take this step, including comments the agency received in response to the 2019 proposed rule titled “Sunscreen Drug Products for Over-The-Counter Human Use,” which raised concern about the potential effects of the two ingredients on coral and/or coral reefs, as well as research efforts by the National Oceanic and Atmospheric Administration Coral Reef Conservation Programs on the potential impacts of sunscreen products that include oxybenzone and octinoxate on coral reefs and other aquatic systems. Hawaii’s 2018 state law prohibiting the sale, offer of sale, and distribution of sunscreens that contain oxybenzone and/or octinoxate also influenced the agency’s decision to further evaluate the topic.
“The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including potential alternatives and the extent to which those issues and impacts will be analyzed,” the FDA document states. “At this initial stage of the scoping process, we have identified the following four alternatives: FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA [new drug application] is impermissible; FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA is permissible; FDA will conclude that inclusion of oxybenzone in sunscreens marketed without an NDA is permissible but that the inclusion of octinoxate in sunscreens marketed without an NDA is impermissible; or FDA will conclude that inclusion of octinoxate in sunscreens marketed without an NDA is permissible but that the inclusion of oxybenzone in sunscreens marketed without an NDA is impermissible.”
Until June 14, the FDA is accepting comments from the public electronically via the Federal eRulemaking Portal at www.regulations.gov (search for Docket No. FDA-2021-N-0352) or by mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852. Refer to Docket No. FDA-2021-N-0352.
Photoprotection recommended for people of color
and applying a tinted sunscreen with an SPF of 30 or greater to exposed areas, according to Henry W. Lim, MD.
In addition, “with rigorous photoprotection, vitamin D supplementation should be advised to patients,” Dr. Lim, a former chair of the department of dermatology at Henry Ford Health System, Detroit, said during the Society for Pediatric Dermatology pre-AAD meeting. “One multivitamin a day should be sufficient for most patients. This is especially relevant because we do know that skin of color patients tend to have lower vitamin D levels to start with.”
Photoprotection for people of color helps minimize the development of photodermatoses, postinflammatory hyperpigmentation, polymorphous light eruption, and chronic actinic dermatitis, he said. In a retrospective chart review of 1,080 people conducted at four academic medical centers in the United States, Dr. Lim and colleagues found a higher proportion of polymorphous light eruption and chronic actinic dermatitis in Black individuals, and a higher proportion of photoallergic contact dermatitis, phototoxic drug eruptions, phytophotodermatitis, porphyria, and solar urticaria in White individuals.
“Another pediatric photodermatosis, actinic prurigo, tends to occur most often in Mestizo individuals, patients of American Indian heritage,” he added. “This is a significant issue, especially in Latin America.”
In a systematic review of 20 studies in the medical literature, researchers assessed the quality of life and psychological impact of photodermatoses in affected patients. Studies included in the review drew from 2,487 adults and 119 children. Among adults, the self-administered Dermatology Life Quality Index (DLQI) revealed that photodermatoses adversely affected employment, education, and leisure activities in adults. Among children, the condition adversely affected outdoor activities and exacerbated symptoms in those with erythropoietic protoporphyria (EPP).
As for skin cancer risk, the association between UV light exposure and the development of melanoma is not as strong in people with skin of color, compared with light-skinned individuals. In a recent systematic review of 13 studies on the topic, 11 showed no association, one showed a small positive relationship in Black males and 1 showed a weak association in Hispanic males.
“The conclusion from this review is that UV protection for melanoma prevention in people of color is not supported by most studies,” said Dr. Lim, who was not affiliated with the review. “The authors also noted, however, that the evidence is of moderate to low quality. Larger studies should be done.”
The association between UV exposure and the development to squamous cell cancer in skin of color is also not strong. “However, we do know that sun exposure is associated with the development of basal cell carcinoma in this population,” he said.
Sunscreen ingredient studies
Dr. Lim also highlighted findings from two studies related to the effect of sunscreen application on plasma concentration of sunscreen active ingredients, both in adults. In the most recent analysis, scientists at the Food and Drug Administration and colleagues conducted a randomized clinical trial in 48 individuals with skin types II-IV.
Participants applied sunscreen at 2 mg/cm2 to 75% of body surface area at 0 hours on day 1 and 4 times on day 2 through day 4 at 2-hour intervals. Over the course of 21 days, the researchers collected 34 blood samples from each participant, and evaluated six active ingredients in four sunscreen products: avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate.
For all active ingredients, levels of greater than 0.5 ng/mL were detected after a single application on day 1. Levels of greater than 0.5 ng/mL were detected up to day 7, and up to day 21 for oxybenzone. All were detected in skin on days 7 and 14 via tape stripping. The authors called for further studies to determine the clinical significance of these findings and emphasized that the results “do not indicate that individuals should refrain from the use of sunscreen.”
The FDA is asking for additional studies on the safety of these 12 filters, noted Dr. Lim, who is a past president of the American Academy of Dermatology. On Feb. 26, 2019, the FDA issued a proposed rule regarding sunscreen drug products for over-the-counter human use. It proposes that the 16 UV filters be classified into one of 3 categories. Category I would include zinc oxide and titanium dioxide, which are generally recognized as safe and effective (GRASE). Category II would include PABA and trolamine salicylate, which are not used in the United States and are not GRASE. Category III would include 12 filters that lack insufficient safety data to make a determination regarding GRASE.
The final FDA rule was scheduled to be released in September of 2020, but a result of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the FDA “will be moving from a laborious rulemaking process to an administrative order process, which means it should not take as long to implement a monograph,” Dr. Lim said. “The FDA has decided that there will not be a final rule regarding sunscreen drug products,” but is required to issue a proposed administrative order by Sept. 27, 2021, he said.
When the final administrative order has been issued, manufacturers would have at least 1 year to comply with sunscreen products offered in the United States. “The approximate timeline is probably going to be 2023,” he said.
Dr. Lim disclosed that he is an investigator for Incyte, L’Oreal, Pfizer, and the Patient-centered Outcomes Research Institute, and a consultant for Pierre Fabre, ISDIN, Ferndale, La Roche–Posay, and Beiersdorf. He has been a speaker at general educational sessions sponsored by La Roche–Posay and Cantabria Labs.
and applying a tinted sunscreen with an SPF of 30 or greater to exposed areas, according to Henry W. Lim, MD.
In addition, “with rigorous photoprotection, vitamin D supplementation should be advised to patients,” Dr. Lim, a former chair of the department of dermatology at Henry Ford Health System, Detroit, said during the Society for Pediatric Dermatology pre-AAD meeting. “One multivitamin a day should be sufficient for most patients. This is especially relevant because we do know that skin of color patients tend to have lower vitamin D levels to start with.”
Photoprotection for people of color helps minimize the development of photodermatoses, postinflammatory hyperpigmentation, polymorphous light eruption, and chronic actinic dermatitis, he said. In a retrospective chart review of 1,080 people conducted at four academic medical centers in the United States, Dr. Lim and colleagues found a higher proportion of polymorphous light eruption and chronic actinic dermatitis in Black individuals, and a higher proportion of photoallergic contact dermatitis, phototoxic drug eruptions, phytophotodermatitis, porphyria, and solar urticaria in White individuals.
“Another pediatric photodermatosis, actinic prurigo, tends to occur most often in Mestizo individuals, patients of American Indian heritage,” he added. “This is a significant issue, especially in Latin America.”
In a systematic review of 20 studies in the medical literature, researchers assessed the quality of life and psychological impact of photodermatoses in affected patients. Studies included in the review drew from 2,487 adults and 119 children. Among adults, the self-administered Dermatology Life Quality Index (DLQI) revealed that photodermatoses adversely affected employment, education, and leisure activities in adults. Among children, the condition adversely affected outdoor activities and exacerbated symptoms in those with erythropoietic protoporphyria (EPP).
As for skin cancer risk, the association between UV light exposure and the development of melanoma is not as strong in people with skin of color, compared with light-skinned individuals. In a recent systematic review of 13 studies on the topic, 11 showed no association, one showed a small positive relationship in Black males and 1 showed a weak association in Hispanic males.
“The conclusion from this review is that UV protection for melanoma prevention in people of color is not supported by most studies,” said Dr. Lim, who was not affiliated with the review. “The authors also noted, however, that the evidence is of moderate to low quality. Larger studies should be done.”
The association between UV exposure and the development to squamous cell cancer in skin of color is also not strong. “However, we do know that sun exposure is associated with the development of basal cell carcinoma in this population,” he said.
Sunscreen ingredient studies
Dr. Lim also highlighted findings from two studies related to the effect of sunscreen application on plasma concentration of sunscreen active ingredients, both in adults. In the most recent analysis, scientists at the Food and Drug Administration and colleagues conducted a randomized clinical trial in 48 individuals with skin types II-IV.
Participants applied sunscreen at 2 mg/cm2 to 75% of body surface area at 0 hours on day 1 and 4 times on day 2 through day 4 at 2-hour intervals. Over the course of 21 days, the researchers collected 34 blood samples from each participant, and evaluated six active ingredients in four sunscreen products: avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate.
For all active ingredients, levels of greater than 0.5 ng/mL were detected after a single application on day 1. Levels of greater than 0.5 ng/mL were detected up to day 7, and up to day 21 for oxybenzone. All were detected in skin on days 7 and 14 via tape stripping. The authors called for further studies to determine the clinical significance of these findings and emphasized that the results “do not indicate that individuals should refrain from the use of sunscreen.”
The FDA is asking for additional studies on the safety of these 12 filters, noted Dr. Lim, who is a past president of the American Academy of Dermatology. On Feb. 26, 2019, the FDA issued a proposed rule regarding sunscreen drug products for over-the-counter human use. It proposes that the 16 UV filters be classified into one of 3 categories. Category I would include zinc oxide and titanium dioxide, which are generally recognized as safe and effective (GRASE). Category II would include PABA and trolamine salicylate, which are not used in the United States and are not GRASE. Category III would include 12 filters that lack insufficient safety data to make a determination regarding GRASE.
The final FDA rule was scheduled to be released in September of 2020, but a result of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the FDA “will be moving from a laborious rulemaking process to an administrative order process, which means it should not take as long to implement a monograph,” Dr. Lim said. “The FDA has decided that there will not be a final rule regarding sunscreen drug products,” but is required to issue a proposed administrative order by Sept. 27, 2021, he said.
When the final administrative order has been issued, manufacturers would have at least 1 year to comply with sunscreen products offered in the United States. “The approximate timeline is probably going to be 2023,” he said.
Dr. Lim disclosed that he is an investigator for Incyte, L’Oreal, Pfizer, and the Patient-centered Outcomes Research Institute, and a consultant for Pierre Fabre, ISDIN, Ferndale, La Roche–Posay, and Beiersdorf. He has been a speaker at general educational sessions sponsored by La Roche–Posay and Cantabria Labs.
and applying a tinted sunscreen with an SPF of 30 or greater to exposed areas, according to Henry W. Lim, MD.
In addition, “with rigorous photoprotection, vitamin D supplementation should be advised to patients,” Dr. Lim, a former chair of the department of dermatology at Henry Ford Health System, Detroit, said during the Society for Pediatric Dermatology pre-AAD meeting. “One multivitamin a day should be sufficient for most patients. This is especially relevant because we do know that skin of color patients tend to have lower vitamin D levels to start with.”
Photoprotection for people of color helps minimize the development of photodermatoses, postinflammatory hyperpigmentation, polymorphous light eruption, and chronic actinic dermatitis, he said. In a retrospective chart review of 1,080 people conducted at four academic medical centers in the United States, Dr. Lim and colleagues found a higher proportion of polymorphous light eruption and chronic actinic dermatitis in Black individuals, and a higher proportion of photoallergic contact dermatitis, phototoxic drug eruptions, phytophotodermatitis, porphyria, and solar urticaria in White individuals.
“Another pediatric photodermatosis, actinic prurigo, tends to occur most often in Mestizo individuals, patients of American Indian heritage,” he added. “This is a significant issue, especially in Latin America.”
In a systematic review of 20 studies in the medical literature, researchers assessed the quality of life and psychological impact of photodermatoses in affected patients. Studies included in the review drew from 2,487 adults and 119 children. Among adults, the self-administered Dermatology Life Quality Index (DLQI) revealed that photodermatoses adversely affected employment, education, and leisure activities in adults. Among children, the condition adversely affected outdoor activities and exacerbated symptoms in those with erythropoietic protoporphyria (EPP).
As for skin cancer risk, the association between UV light exposure and the development of melanoma is not as strong in people with skin of color, compared with light-skinned individuals. In a recent systematic review of 13 studies on the topic, 11 showed no association, one showed a small positive relationship in Black males and 1 showed a weak association in Hispanic males.
“The conclusion from this review is that UV protection for melanoma prevention in people of color is not supported by most studies,” said Dr. Lim, who was not affiliated with the review. “The authors also noted, however, that the evidence is of moderate to low quality. Larger studies should be done.”
The association between UV exposure and the development to squamous cell cancer in skin of color is also not strong. “However, we do know that sun exposure is associated with the development of basal cell carcinoma in this population,” he said.
Sunscreen ingredient studies
Dr. Lim also highlighted findings from two studies related to the effect of sunscreen application on plasma concentration of sunscreen active ingredients, both in adults. In the most recent analysis, scientists at the Food and Drug Administration and colleagues conducted a randomized clinical trial in 48 individuals with skin types II-IV.
Participants applied sunscreen at 2 mg/cm2 to 75% of body surface area at 0 hours on day 1 and 4 times on day 2 through day 4 at 2-hour intervals. Over the course of 21 days, the researchers collected 34 blood samples from each participant, and evaluated six active ingredients in four sunscreen products: avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate.
For all active ingredients, levels of greater than 0.5 ng/mL were detected after a single application on day 1. Levels of greater than 0.5 ng/mL were detected up to day 7, and up to day 21 for oxybenzone. All were detected in skin on days 7 and 14 via tape stripping. The authors called for further studies to determine the clinical significance of these findings and emphasized that the results “do not indicate that individuals should refrain from the use of sunscreen.”
The FDA is asking for additional studies on the safety of these 12 filters, noted Dr. Lim, who is a past president of the American Academy of Dermatology. On Feb. 26, 2019, the FDA issued a proposed rule regarding sunscreen drug products for over-the-counter human use. It proposes that the 16 UV filters be classified into one of 3 categories. Category I would include zinc oxide and titanium dioxide, which are generally recognized as safe and effective (GRASE). Category II would include PABA and trolamine salicylate, which are not used in the United States and are not GRASE. Category III would include 12 filters that lack insufficient safety data to make a determination regarding GRASE.
The final FDA rule was scheduled to be released in September of 2020, but a result of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the FDA “will be moving from a laborious rulemaking process to an administrative order process, which means it should not take as long to implement a monograph,” Dr. Lim said. “The FDA has decided that there will not be a final rule regarding sunscreen drug products,” but is required to issue a proposed administrative order by Sept. 27, 2021, he said.
When the final administrative order has been issued, manufacturers would have at least 1 year to comply with sunscreen products offered in the United States. “The approximate timeline is probably going to be 2023,” he said.
Dr. Lim disclosed that he is an investigator for Incyte, L’Oreal, Pfizer, and the Patient-centered Outcomes Research Institute, and a consultant for Pierre Fabre, ISDIN, Ferndale, La Roche–Posay, and Beiersdorf. He has been a speaker at general educational sessions sponsored by La Roche–Posay and Cantabria Labs.
FROM THE SPD PRE-AAD MEETING
The case for molecular classification of vascular anomalies presented
according to Beth Drolet, MD.
“We now know that 75%-80% of vascular malformations have gene mutations that make the cells either live longer, grow faster, or make them bigger in size,” Dr. Drolet, professor and chair of dermatology at the University of Wisconsin–Madison, said during the Society for Pediatric Dermatology pre-AAD meeting. “The basic binary premise of the current ISSVA [International Society for the Study of Vascular Anomalies] classification dividing vascular anomalies into tumors and malformations is wrong; the biology is not that straightforward. It may be helpful to differentiate between an infantile hemangioma and a capillary malformation during infancy as the hemangioma will grow in the next month, but we now know that patients with capillary malformations also have significant overgrowth of their tissue. We’ve all seen that; it just takes years, not months for us to notice it.”
The change in thinking about the root causes of vascular anomalies, she noted, stems from scientific advances in the understanding of embryonic mosaicism, DNA variation that happens after the zygote is formed, but before birth. “We know that each cell in a zygote will undergo 40 cell divisions before a baby is born,” she said. “Those cell divisions are not as neat as we thought they were. That cell and DNA duplication is actually quite messy, so there are mutations that happen purely because of embryonic cell division.”
Everyone is born with 120 somatic mutations per cell, she continued, “so we have multiple genomes in one human. Not all of those mutations are going to cause disease. Not all of those are going to be functional. About 10% of those mutations will actually be in a coding region of the gene and have the potential to change the function of the protein. If it changes the function of the protein so that the cell can’t survive, that cell dies off, but it gives the cell an advantage. It grows a little bit faster, let’s say. That cell survives, divides, producing a line of cells that can cause disease.”
In 2011, Dr. Drolet and colleagues from the Hemangioma Investigator Group and the Pediatric Dermatology Research Alliance (PeDRA) launched a multisite collaborative group to investigate the role of mosaic genetics in patients with vascular anomalies and discrepancy of growth. To date, 365 patients are enrolled, and the researchers have sequenced 97 of 165 affected tissue samples collected. “What’s nice about the registry is that we enrolled a wide spectrum of diseases: very mild diseases that might be treated by dermatologists to complex, syndromic diseases that might end up in an interdisciplinary vascular anomalies clinic,” she said.
For gene sequencing, the researchers drew from solid tumor biology and used next-generation sequencing with semi-target hybrid capture, “so we’re only looking at a subset of genes,” she said. “Right now, the chip we’re using has 180 cancer-related genes. It sequences the entire exome of the gene with a high depth of coverage, usually over 1,000 X. We use a specific pipeline that can detect very low allele frequency mutation: down to 1%, and robust criteria to determine variant pathogenicity.”
In 75% of tissue samples so far, the researchers have found a gene mutation in one of 13 genes: AKT1, AKT3, BRAF, GNA11, GNAQ, KRAS, MAP2K1, NRAS, PIK3CA, PIK3R1, PTPN11, RASA1, and TEK. According to Dr. Drolet, the common thread in these 13 genes is that they are implicated in cancer and have direct control over the cell cycle. “They’re intracellular proteins that control the cell cycle,” she explained. “These are proteins that are in the cell but interact with transmembrane proteins that receive extracellular messengers of cell growth”.
Understanding and recognizing genetic conditions is complicated, she said, because it involves determining which gene is altered, where in the DNA the gene is altered, how the gene variation will influence the function of the protein, and what tissue expresses that gene. “Then you get your phenotype,” Dr. Drolet said. “If you add mosaicism onto that, you have several additional variables. You need to know: When in embryogenesis did the mutation occur? What region of the body is affected? What cell lineage is affected? That predicts what phenotype you’re going to have.”
While molecular classification efforts continue to be refined, Dr. Drolet incorporates genotyping at every opportunity, like when she counsels parents of a baby born with a vascular stain on its face. “What can we tell them about what else might be wrong? What can we tell them about how this will change over time? What can we tell them about how we can treat it? I think genotyping absolutely helps to clarify that for me,” she said. “I can’t use that alone, but it gives me another piece of evidence to help do a better job in predicting when I need to screen, what I need to screen for, and what might happen in the future. If you combine your genotype with your clinical exam, I really do believe we can start to offer some prognostication for our families, to say, ‘this is the degree of overgrowth we may see over time; these are the complications I predict that you might have.’ ”
Even the vascular stain can give you a clue. “If it’s light and lacey, you probably don’t have a lot of cell cycle activation,” Dr. Drolet said. “If it’s dark and there’s blebs and you’ve got some bleeding at a young age, you’ve got a highly activated mutation, and there’s everything in between.”
Dr. Drolet disclosed that she is a consultant for Venthera and Novartis and is a board member for the Isthmus Project. She also holds intellectual property rights in and is a patent holder for Peds Derm Development Group. Dr. Drolet has also received funding from the Spirit Foundation, Kayleigh’s Crew Endowment, the SPD, PeDRA, and the National Institutes of Health.
according to Beth Drolet, MD.
“We now know that 75%-80% of vascular malformations have gene mutations that make the cells either live longer, grow faster, or make them bigger in size,” Dr. Drolet, professor and chair of dermatology at the University of Wisconsin–Madison, said during the Society for Pediatric Dermatology pre-AAD meeting. “The basic binary premise of the current ISSVA [International Society for the Study of Vascular Anomalies] classification dividing vascular anomalies into tumors and malformations is wrong; the biology is not that straightforward. It may be helpful to differentiate between an infantile hemangioma and a capillary malformation during infancy as the hemangioma will grow in the next month, but we now know that patients with capillary malformations also have significant overgrowth of their tissue. We’ve all seen that; it just takes years, not months for us to notice it.”
The change in thinking about the root causes of vascular anomalies, she noted, stems from scientific advances in the understanding of embryonic mosaicism, DNA variation that happens after the zygote is formed, but before birth. “We know that each cell in a zygote will undergo 40 cell divisions before a baby is born,” she said. “Those cell divisions are not as neat as we thought they were. That cell and DNA duplication is actually quite messy, so there are mutations that happen purely because of embryonic cell division.”
Everyone is born with 120 somatic mutations per cell, she continued, “so we have multiple genomes in one human. Not all of those mutations are going to cause disease. Not all of those are going to be functional. About 10% of those mutations will actually be in a coding region of the gene and have the potential to change the function of the protein. If it changes the function of the protein so that the cell can’t survive, that cell dies off, but it gives the cell an advantage. It grows a little bit faster, let’s say. That cell survives, divides, producing a line of cells that can cause disease.”
In 2011, Dr. Drolet and colleagues from the Hemangioma Investigator Group and the Pediatric Dermatology Research Alliance (PeDRA) launched a multisite collaborative group to investigate the role of mosaic genetics in patients with vascular anomalies and discrepancy of growth. To date, 365 patients are enrolled, and the researchers have sequenced 97 of 165 affected tissue samples collected. “What’s nice about the registry is that we enrolled a wide spectrum of diseases: very mild diseases that might be treated by dermatologists to complex, syndromic diseases that might end up in an interdisciplinary vascular anomalies clinic,” she said.
For gene sequencing, the researchers drew from solid tumor biology and used next-generation sequencing with semi-target hybrid capture, “so we’re only looking at a subset of genes,” she said. “Right now, the chip we’re using has 180 cancer-related genes. It sequences the entire exome of the gene with a high depth of coverage, usually over 1,000 X. We use a specific pipeline that can detect very low allele frequency mutation: down to 1%, and robust criteria to determine variant pathogenicity.”
In 75% of tissue samples so far, the researchers have found a gene mutation in one of 13 genes: AKT1, AKT3, BRAF, GNA11, GNAQ, KRAS, MAP2K1, NRAS, PIK3CA, PIK3R1, PTPN11, RASA1, and TEK. According to Dr. Drolet, the common thread in these 13 genes is that they are implicated in cancer and have direct control over the cell cycle. “They’re intracellular proteins that control the cell cycle,” she explained. “These are proteins that are in the cell but interact with transmembrane proteins that receive extracellular messengers of cell growth”.
Understanding and recognizing genetic conditions is complicated, she said, because it involves determining which gene is altered, where in the DNA the gene is altered, how the gene variation will influence the function of the protein, and what tissue expresses that gene. “Then you get your phenotype,” Dr. Drolet said. “If you add mosaicism onto that, you have several additional variables. You need to know: When in embryogenesis did the mutation occur? What region of the body is affected? What cell lineage is affected? That predicts what phenotype you’re going to have.”
While molecular classification efforts continue to be refined, Dr. Drolet incorporates genotyping at every opportunity, like when she counsels parents of a baby born with a vascular stain on its face. “What can we tell them about what else might be wrong? What can we tell them about how this will change over time? What can we tell them about how we can treat it? I think genotyping absolutely helps to clarify that for me,” she said. “I can’t use that alone, but it gives me another piece of evidence to help do a better job in predicting when I need to screen, what I need to screen for, and what might happen in the future. If you combine your genotype with your clinical exam, I really do believe we can start to offer some prognostication for our families, to say, ‘this is the degree of overgrowth we may see over time; these are the complications I predict that you might have.’ ”
Even the vascular stain can give you a clue. “If it’s light and lacey, you probably don’t have a lot of cell cycle activation,” Dr. Drolet said. “If it’s dark and there’s blebs and you’ve got some bleeding at a young age, you’ve got a highly activated mutation, and there’s everything in between.”
Dr. Drolet disclosed that she is a consultant for Venthera and Novartis and is a board member for the Isthmus Project. She also holds intellectual property rights in and is a patent holder for Peds Derm Development Group. Dr. Drolet has also received funding from the Spirit Foundation, Kayleigh’s Crew Endowment, the SPD, PeDRA, and the National Institutes of Health.
according to Beth Drolet, MD.
“We now know that 75%-80% of vascular malformations have gene mutations that make the cells either live longer, grow faster, or make them bigger in size,” Dr. Drolet, professor and chair of dermatology at the University of Wisconsin–Madison, said during the Society for Pediatric Dermatology pre-AAD meeting. “The basic binary premise of the current ISSVA [International Society for the Study of Vascular Anomalies] classification dividing vascular anomalies into tumors and malformations is wrong; the biology is not that straightforward. It may be helpful to differentiate between an infantile hemangioma and a capillary malformation during infancy as the hemangioma will grow in the next month, but we now know that patients with capillary malformations also have significant overgrowth of their tissue. We’ve all seen that; it just takes years, not months for us to notice it.”
The change in thinking about the root causes of vascular anomalies, she noted, stems from scientific advances in the understanding of embryonic mosaicism, DNA variation that happens after the zygote is formed, but before birth. “We know that each cell in a zygote will undergo 40 cell divisions before a baby is born,” she said. “Those cell divisions are not as neat as we thought they were. That cell and DNA duplication is actually quite messy, so there are mutations that happen purely because of embryonic cell division.”
Everyone is born with 120 somatic mutations per cell, she continued, “so we have multiple genomes in one human. Not all of those mutations are going to cause disease. Not all of those are going to be functional. About 10% of those mutations will actually be in a coding region of the gene and have the potential to change the function of the protein. If it changes the function of the protein so that the cell can’t survive, that cell dies off, but it gives the cell an advantage. It grows a little bit faster, let’s say. That cell survives, divides, producing a line of cells that can cause disease.”
In 2011, Dr. Drolet and colleagues from the Hemangioma Investigator Group and the Pediatric Dermatology Research Alliance (PeDRA) launched a multisite collaborative group to investigate the role of mosaic genetics in patients with vascular anomalies and discrepancy of growth. To date, 365 patients are enrolled, and the researchers have sequenced 97 of 165 affected tissue samples collected. “What’s nice about the registry is that we enrolled a wide spectrum of diseases: very mild diseases that might be treated by dermatologists to complex, syndromic diseases that might end up in an interdisciplinary vascular anomalies clinic,” she said.
For gene sequencing, the researchers drew from solid tumor biology and used next-generation sequencing with semi-target hybrid capture, “so we’re only looking at a subset of genes,” she said. “Right now, the chip we’re using has 180 cancer-related genes. It sequences the entire exome of the gene with a high depth of coverage, usually over 1,000 X. We use a specific pipeline that can detect very low allele frequency mutation: down to 1%, and robust criteria to determine variant pathogenicity.”
In 75% of tissue samples so far, the researchers have found a gene mutation in one of 13 genes: AKT1, AKT3, BRAF, GNA11, GNAQ, KRAS, MAP2K1, NRAS, PIK3CA, PIK3R1, PTPN11, RASA1, and TEK. According to Dr. Drolet, the common thread in these 13 genes is that they are implicated in cancer and have direct control over the cell cycle. “They’re intracellular proteins that control the cell cycle,” she explained. “These are proteins that are in the cell but interact with transmembrane proteins that receive extracellular messengers of cell growth”.
Understanding and recognizing genetic conditions is complicated, she said, because it involves determining which gene is altered, where in the DNA the gene is altered, how the gene variation will influence the function of the protein, and what tissue expresses that gene. “Then you get your phenotype,” Dr. Drolet said. “If you add mosaicism onto that, you have several additional variables. You need to know: When in embryogenesis did the mutation occur? What region of the body is affected? What cell lineage is affected? That predicts what phenotype you’re going to have.”
While molecular classification efforts continue to be refined, Dr. Drolet incorporates genotyping at every opportunity, like when she counsels parents of a baby born with a vascular stain on its face. “What can we tell them about what else might be wrong? What can we tell them about how this will change over time? What can we tell them about how we can treat it? I think genotyping absolutely helps to clarify that for me,” she said. “I can’t use that alone, but it gives me another piece of evidence to help do a better job in predicting when I need to screen, what I need to screen for, and what might happen in the future. If you combine your genotype with your clinical exam, I really do believe we can start to offer some prognostication for our families, to say, ‘this is the degree of overgrowth we may see over time; these are the complications I predict that you might have.’ ”
Even the vascular stain can give you a clue. “If it’s light and lacey, you probably don’t have a lot of cell cycle activation,” Dr. Drolet said. “If it’s dark and there’s blebs and you’ve got some bleeding at a young age, you’ve got a highly activated mutation, and there’s everything in between.”
Dr. Drolet disclosed that she is a consultant for Venthera and Novartis and is a board member for the Isthmus Project. She also holds intellectual property rights in and is a patent holder for Peds Derm Development Group. Dr. Drolet has also received funding from the Spirit Foundation, Kayleigh’s Crew Endowment, the SPD, PeDRA, and the National Institutes of Health.
FROM THE SPD PRE-AAD MEETING
Trends in the management of pulmonary embolism
One of the newest trends in pulmonary embolism management is treatment of cancer associated venous thromboembolism (VTE) which encompasses deep vein thrombosis (DVT) and PE. Following the clinical management of cancer-associated venous thromboembolism in the hospital, direct oral anticoagulant therapy at discharge is your starting point, except in cases of intact luminal cancers, Scott Kaatz, DO, MSc, FACP, SFHM, said during SHM Converge, the annual conference of the Society of Hospital Medicine.
Dr. Kaatz, of the division of hospital medicine at Henry Ford Hospital, Detroit, based his remarks on emerging recommendations from leading medical societies on the topic, as well as a one-page algorithm from the Anticoagulation Forum that can be accessed at https://acforum-excellence.org/Resource-Center/resource_files/1638-2020-11-30-121425.pdf.
For the short-term treatment of VTE (3-6 months) for patients with active cancer, the American Society of Hematology guideline panel suggests direct oral anticoagulants, such as apixaban, edoxaban, or rivaroxaban, over low-molecular-weight heparin (LMWH) – a conditional recommendation based on low certainty in the evidence of effects.
Dr. Kaatz also discussed the latest recommendations regarding length of VTE treatment. After completion of primary treatment for patients with DVT and/or PE provoked by a chronic risk factor such as a surgery, pregnancy, or having a leg in a cast, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “On the other hand, patients with DVT and/or PE provoked by a transient factor typically do not require antithrombotic therapy after completion of primary treatment,” said Dr. Kaatz, who is also a clinical professor of medicine at Wayne State University, Detroit.
After completion of primary treatment for patients with unprovoked DVT and/or PE, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “The recommendation does not apply to patients who have a high risk for bleeding complications,” he noted.
Transient or reversible risk factors should be also considered in length of VTE treatment. For example, according to guidelines from the European Society of Cardiology, the estimated risk for long-term VTE recurrence is high (defined as greater than 8% per year) for patients with active cancer, for patients with one or more previous episodes of VTE in the absence of a major transient or reversible factor, and for those with antiphospholipid antibody syndrome.
Dr. Kaatz also highlighted recommendations for the acute treatment of intermediate risk, or submassive PE. The ESC guidelines state that if anticoagulation is initiated parenterally, LMWH or fondaparinux is recommended over unfractionated heparin (UFH) for most patients. “The reason for that is, one drug-use evaluation study found that, after 24 hours using UFH, only about 24% of patients had reached their therapeutic goal,” Dr. Kaatz said. Guidelines for intermediate risk patients from ASH recommend anticoagulation as your starting point, while thrombolysis is reasonable to consider for submassive PE and low risk for bleeding in selected younger patients or for patients at high risk for decompensation because of concomitant cardiopulmonary disease. “The bleeding rates get much higher in patients over age 65,” he said.
Another resource Dr. Kaatz mentioned is the Pulmonary Embolism Response Team (PERT) Consortium, which was developed after initial efforts of a multidisciplinary team of physicians at Massachusetts General Hospital. The first PERT sought to coordinate and expedite the treatment of pulmonary embolus with a team of physicians from a variety of specialties. In 2019 the PERT Consortium published guidelines on the diagnosis, treatment, and follow-up of acute PE. “It includes detailed algorithms that are a little different from the ASH and ESC guidelines,” Dr. Kaatz said.
Dr. Kaatz disclosed that he is a consultant for Janssen, Pfizer, Portola/Alexion, Bristol-Myers Squibb, Novartis, and CSL Behring. He has also received research funding from Janssen, Bristol-Myers Squibb, and Osmosis. He also holds board positions with the AC Forum and the National Blood Clot Alliance Medical and Scientific Advisory Board.
One of the newest trends in pulmonary embolism management is treatment of cancer associated venous thromboembolism (VTE) which encompasses deep vein thrombosis (DVT) and PE. Following the clinical management of cancer-associated venous thromboembolism in the hospital, direct oral anticoagulant therapy at discharge is your starting point, except in cases of intact luminal cancers, Scott Kaatz, DO, MSc, FACP, SFHM, said during SHM Converge, the annual conference of the Society of Hospital Medicine.
Dr. Kaatz, of the division of hospital medicine at Henry Ford Hospital, Detroit, based his remarks on emerging recommendations from leading medical societies on the topic, as well as a one-page algorithm from the Anticoagulation Forum that can be accessed at https://acforum-excellence.org/Resource-Center/resource_files/1638-2020-11-30-121425.pdf.
For the short-term treatment of VTE (3-6 months) for patients with active cancer, the American Society of Hematology guideline panel suggests direct oral anticoagulants, such as apixaban, edoxaban, or rivaroxaban, over low-molecular-weight heparin (LMWH) – a conditional recommendation based on low certainty in the evidence of effects.
Dr. Kaatz also discussed the latest recommendations regarding length of VTE treatment. After completion of primary treatment for patients with DVT and/or PE provoked by a chronic risk factor such as a surgery, pregnancy, or having a leg in a cast, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “On the other hand, patients with DVT and/or PE provoked by a transient factor typically do not require antithrombotic therapy after completion of primary treatment,” said Dr. Kaatz, who is also a clinical professor of medicine at Wayne State University, Detroit.
After completion of primary treatment for patients with unprovoked DVT and/or PE, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “The recommendation does not apply to patients who have a high risk for bleeding complications,” he noted.
Transient or reversible risk factors should be also considered in length of VTE treatment. For example, according to guidelines from the European Society of Cardiology, the estimated risk for long-term VTE recurrence is high (defined as greater than 8% per year) for patients with active cancer, for patients with one or more previous episodes of VTE in the absence of a major transient or reversible factor, and for those with antiphospholipid antibody syndrome.
Dr. Kaatz also highlighted recommendations for the acute treatment of intermediate risk, or submassive PE. The ESC guidelines state that if anticoagulation is initiated parenterally, LMWH or fondaparinux is recommended over unfractionated heparin (UFH) for most patients. “The reason for that is, one drug-use evaluation study found that, after 24 hours using UFH, only about 24% of patients had reached their therapeutic goal,” Dr. Kaatz said. Guidelines for intermediate risk patients from ASH recommend anticoagulation as your starting point, while thrombolysis is reasonable to consider for submassive PE and low risk for bleeding in selected younger patients or for patients at high risk for decompensation because of concomitant cardiopulmonary disease. “The bleeding rates get much higher in patients over age 65,” he said.
Another resource Dr. Kaatz mentioned is the Pulmonary Embolism Response Team (PERT) Consortium, which was developed after initial efforts of a multidisciplinary team of physicians at Massachusetts General Hospital. The first PERT sought to coordinate and expedite the treatment of pulmonary embolus with a team of physicians from a variety of specialties. In 2019 the PERT Consortium published guidelines on the diagnosis, treatment, and follow-up of acute PE. “It includes detailed algorithms that are a little different from the ASH and ESC guidelines,” Dr. Kaatz said.
Dr. Kaatz disclosed that he is a consultant for Janssen, Pfizer, Portola/Alexion, Bristol-Myers Squibb, Novartis, and CSL Behring. He has also received research funding from Janssen, Bristol-Myers Squibb, and Osmosis. He also holds board positions with the AC Forum and the National Blood Clot Alliance Medical and Scientific Advisory Board.
One of the newest trends in pulmonary embolism management is treatment of cancer associated venous thromboembolism (VTE) which encompasses deep vein thrombosis (DVT) and PE. Following the clinical management of cancer-associated venous thromboembolism in the hospital, direct oral anticoagulant therapy at discharge is your starting point, except in cases of intact luminal cancers, Scott Kaatz, DO, MSc, FACP, SFHM, said during SHM Converge, the annual conference of the Society of Hospital Medicine.
Dr. Kaatz, of the division of hospital medicine at Henry Ford Hospital, Detroit, based his remarks on emerging recommendations from leading medical societies on the topic, as well as a one-page algorithm from the Anticoagulation Forum that can be accessed at https://acforum-excellence.org/Resource-Center/resource_files/1638-2020-11-30-121425.pdf.
For the short-term treatment of VTE (3-6 months) for patients with active cancer, the American Society of Hematology guideline panel suggests direct oral anticoagulants, such as apixaban, edoxaban, or rivaroxaban, over low-molecular-weight heparin (LMWH) – a conditional recommendation based on low certainty in the evidence of effects.
Dr. Kaatz also discussed the latest recommendations regarding length of VTE treatment. After completion of primary treatment for patients with DVT and/or PE provoked by a chronic risk factor such as a surgery, pregnancy, or having a leg in a cast, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “On the other hand, patients with DVT and/or PE provoked by a transient factor typically do not require antithrombotic therapy after completion of primary treatment,” said Dr. Kaatz, who is also a clinical professor of medicine at Wayne State University, Detroit.
After completion of primary treatment for patients with unprovoked DVT and/or PE, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “The recommendation does not apply to patients who have a high risk for bleeding complications,” he noted.
Transient or reversible risk factors should be also considered in length of VTE treatment. For example, according to guidelines from the European Society of Cardiology, the estimated risk for long-term VTE recurrence is high (defined as greater than 8% per year) for patients with active cancer, for patients with one or more previous episodes of VTE in the absence of a major transient or reversible factor, and for those with antiphospholipid antibody syndrome.
Dr. Kaatz also highlighted recommendations for the acute treatment of intermediate risk, or submassive PE. The ESC guidelines state that if anticoagulation is initiated parenterally, LMWH or fondaparinux is recommended over unfractionated heparin (UFH) for most patients. “The reason for that is, one drug-use evaluation study found that, after 24 hours using UFH, only about 24% of patients had reached their therapeutic goal,” Dr. Kaatz said. Guidelines for intermediate risk patients from ASH recommend anticoagulation as your starting point, while thrombolysis is reasonable to consider for submassive PE and low risk for bleeding in selected younger patients or for patients at high risk for decompensation because of concomitant cardiopulmonary disease. “The bleeding rates get much higher in patients over age 65,” he said.
Another resource Dr. Kaatz mentioned is the Pulmonary Embolism Response Team (PERT) Consortium, which was developed after initial efforts of a multidisciplinary team of physicians at Massachusetts General Hospital. The first PERT sought to coordinate and expedite the treatment of pulmonary embolus with a team of physicians from a variety of specialties. In 2019 the PERT Consortium published guidelines on the diagnosis, treatment, and follow-up of acute PE. “It includes detailed algorithms that are a little different from the ASH and ESC guidelines,” Dr. Kaatz said.
Dr. Kaatz disclosed that he is a consultant for Janssen, Pfizer, Portola/Alexion, Bristol-Myers Squibb, Novartis, and CSL Behring. He has also received research funding from Janssen, Bristol-Myers Squibb, and Osmosis. He also holds board positions with the AC Forum and the National Blood Clot Alliance Medical and Scientific Advisory Board.
FROM SHM CONVERGE 2021
AAD unveils new guidelines for actinic keratosis management
. They also conditionally recommend the use of photodynamic therapy (PDT) and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens.
Those are two of 18 recommendations made by 14 members of the multidisciplinary work group that convened to assemble the AAD’s first-ever guidelines on the management of AKs, which were published online April 2 in the Journal of the American Academy of Dermatology. The group, cochaired by Daniel B. Eisen, MD, professor of clinical dermatology at the University of California, Davis, and Todd E. Schlesinger, MD, medical director of the Dermatology and Laser Center of Charleston, S.C., conducted a systematic review to address five clinical questions on the management of AKs in adults. The questions were: What are the efficacy, effectiveness, and adverse effects of surgical and chemical peel treatments for AK; of topically applied agents for AK; of energy devices and other miscellaneous treatments for AK; and of combination therapy for the treatment of AK? And what are the special considerations to be taken into account when treating AK in immunocompromised individuals?
Next, the work group applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence and formulating and grading clinical recommendations based on relevant randomized trials in the medical literature.
“As a participant in the work group, I was impressed by the level of care and detail and the involvement of relevant stakeholders, including a patient advocate, as well as having the draft guidelines go out to the AAD membership at large, and evaluating every comment that came in,” Maryam Asgari, MD, MPH, professor of dermatology at Harvard University, Boston, said in an interview. “The academy sought stakeholder and leadership input in revising and revamping the guidelines. The AAD also made sure the work group had minimal conflicts of interest by requiring that the majority of experts convened did not have relevant financial conflicts of interest. That might not be the case in a publication such as a systematic review, where no threshold for financial conflict of interest for coauthorship is set.”
Of the 18 recommendations the work group made for patients with AKs, only four were ranked as “strong” based on the evidence reviewed, while the rest were ranked as “conditional.”
The strong recommendations include the use of UV protection, field treatment with 5-FU, field treatment with imiquimod, and the use of cryosurgery.
The first four conditional recommendations for patients with AKs include the use of diclofenac, treatment with cryosurgery over CO2 laser ablation, aminolevulinic acid (ALA)–red-light PDT, and 1- to 4-hour 5-ALA incubation time to enhance complete clearance with red-light PDT. The work group also conditionally recommends ALA-daylight PDT as less painful than but equally effective as ALA–red-light PDT.
In the clinical experience of Catherine M. DiGiorgio, MD, who was not involved in the guidelines, daylight PDT with ALA is a viable, cost-effective option. “Patients can come into the office, apply the ALA and then they go outside for 2 hours – not in direct sunlight but in a shady area,” Dr. DiGiorgio, a dermatologist who practices at the Boston Center for Facial Rejuvenation, said in an interview. “That’s a cost-effective treatment for patients who perhaps can’t afford some of the chemotherapy creams. I don’t think we’ve adopted ALA-daylight PDT here in the U.S. very much.”
The work group noted that topical 1% tirbanibulin ointment, a novel microtubule inhibitor, was approved for treatment of AKs on the face and scalp by the Food and Drug Administration after the guidelines had been put together.
Several trials of combination therapy were included in the review of evidence, prompting several recommendations. For example, the work group conditionally recommends combined 5-FU cream and cryosurgery over cryosurgery alone, based on moderate-quality evidence and conditionally recommends combined imiquimod and cryosurgery over cryosurgery alone based on low-quality evidence. In addition, the work group conditionally recommends against the use of 3% diclofenac in addition to cryosurgery, favoring cryosurgery alone based on low-quality evidence, and conditionally recommends against the use of imiquimod typically after ALA–blue-light PDT, based on moderate-quality data.
“The additional treatment with imiquimod was thought to add both expense and burden to the patient, which negates much of the perceived convenience of using PDT as a stand-alone treatment modality and which is not mitigated by the modest increase in lesion reduction,” the authors wrote.
The guidelines emphasize the importance of shared decision-making between patients and clinicians on the choice of therapy, a point that resonates with Dr. DiGiorgio. Success of a treatment can depend on whether a patient is willing to go through with it, she said. “Some patients don’t want to do a therapeutic topical like 5-FU. They prefer to come in and have cryotherapy done. Others prefer to not come in and have the cream at home and treat themselves.”
Assembling the guidelines exposed certain gaps in research, according to the work group. Of the 18 recommendations, seven were based on low-quality evidence, and there were not enough data to make guidelines for the treatment of AKs in immunocompromised individuals.
“I can’t tell you the number of times we in the committee sat back and said, ‘we need to have a randomized trial that looks at this, or compares this to that head on,’” Dr. Asgari said. Such limitations “give researchers direction for where the areas of study need to go to help us answer some of these management conundrums.”
She added that the new guidelines “give clinicians a leg to stand on” when an insurer pushes back on a recommended treatment for AK. “It gives you a way to have dialogue with insurers if you’re prescribing some of these treatments.”
The guidelines authors write that there is “strong theoretic rationale for the treatment of AK to prevent skin cancers” but acknowledge that only a few studies in the review “report the incidence of skin cancer as an outcome measure or have sufficient follow-up to viably measure carcinoma development.” In addition, “more long-term research is needed to validate our current understanding of skin cancer progression from AKs to keratinocyte carcinoma.”
Dr. DiGiorgio thinks about this differently. “I think treatment of AKs does prevent skin cancers,” she said. “We call them precancers as we’re treating our patients because we know a certain percentage of them can develop into skin cancers over time.”
The study was funded by internal funds from the AAD. Dr. Asgari disclosed that she serves as an investigator for Pfizer. Several of the other authors reported having financial disclosures.
Dr. DiGiorgio reported having no financial disclosures.
. They also conditionally recommend the use of photodynamic therapy (PDT) and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens.
Those are two of 18 recommendations made by 14 members of the multidisciplinary work group that convened to assemble the AAD’s first-ever guidelines on the management of AKs, which were published online April 2 in the Journal of the American Academy of Dermatology. The group, cochaired by Daniel B. Eisen, MD, professor of clinical dermatology at the University of California, Davis, and Todd E. Schlesinger, MD, medical director of the Dermatology and Laser Center of Charleston, S.C., conducted a systematic review to address five clinical questions on the management of AKs in adults. The questions were: What are the efficacy, effectiveness, and adverse effects of surgical and chemical peel treatments for AK; of topically applied agents for AK; of energy devices and other miscellaneous treatments for AK; and of combination therapy for the treatment of AK? And what are the special considerations to be taken into account when treating AK in immunocompromised individuals?
Next, the work group applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence and formulating and grading clinical recommendations based on relevant randomized trials in the medical literature.
“As a participant in the work group, I was impressed by the level of care and detail and the involvement of relevant stakeholders, including a patient advocate, as well as having the draft guidelines go out to the AAD membership at large, and evaluating every comment that came in,” Maryam Asgari, MD, MPH, professor of dermatology at Harvard University, Boston, said in an interview. “The academy sought stakeholder and leadership input in revising and revamping the guidelines. The AAD also made sure the work group had minimal conflicts of interest by requiring that the majority of experts convened did not have relevant financial conflicts of interest. That might not be the case in a publication such as a systematic review, where no threshold for financial conflict of interest for coauthorship is set.”
Of the 18 recommendations the work group made for patients with AKs, only four were ranked as “strong” based on the evidence reviewed, while the rest were ranked as “conditional.”
The strong recommendations include the use of UV protection, field treatment with 5-FU, field treatment with imiquimod, and the use of cryosurgery.
The first four conditional recommendations for patients with AKs include the use of diclofenac, treatment with cryosurgery over CO2 laser ablation, aminolevulinic acid (ALA)–red-light PDT, and 1- to 4-hour 5-ALA incubation time to enhance complete clearance with red-light PDT. The work group also conditionally recommends ALA-daylight PDT as less painful than but equally effective as ALA–red-light PDT.
In the clinical experience of Catherine M. DiGiorgio, MD, who was not involved in the guidelines, daylight PDT with ALA is a viable, cost-effective option. “Patients can come into the office, apply the ALA and then they go outside for 2 hours – not in direct sunlight but in a shady area,” Dr. DiGiorgio, a dermatologist who practices at the Boston Center for Facial Rejuvenation, said in an interview. “That’s a cost-effective treatment for patients who perhaps can’t afford some of the chemotherapy creams. I don’t think we’ve adopted ALA-daylight PDT here in the U.S. very much.”
The work group noted that topical 1% tirbanibulin ointment, a novel microtubule inhibitor, was approved for treatment of AKs on the face and scalp by the Food and Drug Administration after the guidelines had been put together.
Several trials of combination therapy were included in the review of evidence, prompting several recommendations. For example, the work group conditionally recommends combined 5-FU cream and cryosurgery over cryosurgery alone, based on moderate-quality evidence and conditionally recommends combined imiquimod and cryosurgery over cryosurgery alone based on low-quality evidence. In addition, the work group conditionally recommends against the use of 3% diclofenac in addition to cryosurgery, favoring cryosurgery alone based on low-quality evidence, and conditionally recommends against the use of imiquimod typically after ALA–blue-light PDT, based on moderate-quality data.
“The additional treatment with imiquimod was thought to add both expense and burden to the patient, which negates much of the perceived convenience of using PDT as a stand-alone treatment modality and which is not mitigated by the modest increase in lesion reduction,” the authors wrote.
The guidelines emphasize the importance of shared decision-making between patients and clinicians on the choice of therapy, a point that resonates with Dr. DiGiorgio. Success of a treatment can depend on whether a patient is willing to go through with it, she said. “Some patients don’t want to do a therapeutic topical like 5-FU. They prefer to come in and have cryotherapy done. Others prefer to not come in and have the cream at home and treat themselves.”
Assembling the guidelines exposed certain gaps in research, according to the work group. Of the 18 recommendations, seven were based on low-quality evidence, and there were not enough data to make guidelines for the treatment of AKs in immunocompromised individuals.
“I can’t tell you the number of times we in the committee sat back and said, ‘we need to have a randomized trial that looks at this, or compares this to that head on,’” Dr. Asgari said. Such limitations “give researchers direction for where the areas of study need to go to help us answer some of these management conundrums.”
She added that the new guidelines “give clinicians a leg to stand on” when an insurer pushes back on a recommended treatment for AK. “It gives you a way to have dialogue with insurers if you’re prescribing some of these treatments.”
The guidelines authors write that there is “strong theoretic rationale for the treatment of AK to prevent skin cancers” but acknowledge that only a few studies in the review “report the incidence of skin cancer as an outcome measure or have sufficient follow-up to viably measure carcinoma development.” In addition, “more long-term research is needed to validate our current understanding of skin cancer progression from AKs to keratinocyte carcinoma.”
Dr. DiGiorgio thinks about this differently. “I think treatment of AKs does prevent skin cancers,” she said. “We call them precancers as we’re treating our patients because we know a certain percentage of them can develop into skin cancers over time.”
The study was funded by internal funds from the AAD. Dr. Asgari disclosed that she serves as an investigator for Pfizer. Several of the other authors reported having financial disclosures.
Dr. DiGiorgio reported having no financial disclosures.
. They also conditionally recommend the use of photodynamic therapy (PDT) and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens.
Those are two of 18 recommendations made by 14 members of the multidisciplinary work group that convened to assemble the AAD’s first-ever guidelines on the management of AKs, which were published online April 2 in the Journal of the American Academy of Dermatology. The group, cochaired by Daniel B. Eisen, MD, professor of clinical dermatology at the University of California, Davis, and Todd E. Schlesinger, MD, medical director of the Dermatology and Laser Center of Charleston, S.C., conducted a systematic review to address five clinical questions on the management of AKs in adults. The questions were: What are the efficacy, effectiveness, and adverse effects of surgical and chemical peel treatments for AK; of topically applied agents for AK; of energy devices and other miscellaneous treatments for AK; and of combination therapy for the treatment of AK? And what are the special considerations to be taken into account when treating AK in immunocompromised individuals?
Next, the work group applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence and formulating and grading clinical recommendations based on relevant randomized trials in the medical literature.
“As a participant in the work group, I was impressed by the level of care and detail and the involvement of relevant stakeholders, including a patient advocate, as well as having the draft guidelines go out to the AAD membership at large, and evaluating every comment that came in,” Maryam Asgari, MD, MPH, professor of dermatology at Harvard University, Boston, said in an interview. “The academy sought stakeholder and leadership input in revising and revamping the guidelines. The AAD also made sure the work group had minimal conflicts of interest by requiring that the majority of experts convened did not have relevant financial conflicts of interest. That might not be the case in a publication such as a systematic review, where no threshold for financial conflict of interest for coauthorship is set.”
Of the 18 recommendations the work group made for patients with AKs, only four were ranked as “strong” based on the evidence reviewed, while the rest were ranked as “conditional.”
The strong recommendations include the use of UV protection, field treatment with 5-FU, field treatment with imiquimod, and the use of cryosurgery.
The first four conditional recommendations for patients with AKs include the use of diclofenac, treatment with cryosurgery over CO2 laser ablation, aminolevulinic acid (ALA)–red-light PDT, and 1- to 4-hour 5-ALA incubation time to enhance complete clearance with red-light PDT. The work group also conditionally recommends ALA-daylight PDT as less painful than but equally effective as ALA–red-light PDT.
In the clinical experience of Catherine M. DiGiorgio, MD, who was not involved in the guidelines, daylight PDT with ALA is a viable, cost-effective option. “Patients can come into the office, apply the ALA and then they go outside for 2 hours – not in direct sunlight but in a shady area,” Dr. DiGiorgio, a dermatologist who practices at the Boston Center for Facial Rejuvenation, said in an interview. “That’s a cost-effective treatment for patients who perhaps can’t afford some of the chemotherapy creams. I don’t think we’ve adopted ALA-daylight PDT here in the U.S. very much.”
The work group noted that topical 1% tirbanibulin ointment, a novel microtubule inhibitor, was approved for treatment of AKs on the face and scalp by the Food and Drug Administration after the guidelines had been put together.
Several trials of combination therapy were included in the review of evidence, prompting several recommendations. For example, the work group conditionally recommends combined 5-FU cream and cryosurgery over cryosurgery alone, based on moderate-quality evidence and conditionally recommends combined imiquimod and cryosurgery over cryosurgery alone based on low-quality evidence. In addition, the work group conditionally recommends against the use of 3% diclofenac in addition to cryosurgery, favoring cryosurgery alone based on low-quality evidence, and conditionally recommends against the use of imiquimod typically after ALA–blue-light PDT, based on moderate-quality data.
“The additional treatment with imiquimod was thought to add both expense and burden to the patient, which negates much of the perceived convenience of using PDT as a stand-alone treatment modality and which is not mitigated by the modest increase in lesion reduction,” the authors wrote.
The guidelines emphasize the importance of shared decision-making between patients and clinicians on the choice of therapy, a point that resonates with Dr. DiGiorgio. Success of a treatment can depend on whether a patient is willing to go through with it, she said. “Some patients don’t want to do a therapeutic topical like 5-FU. They prefer to come in and have cryotherapy done. Others prefer to not come in and have the cream at home and treat themselves.”
Assembling the guidelines exposed certain gaps in research, according to the work group. Of the 18 recommendations, seven were based on low-quality evidence, and there were not enough data to make guidelines for the treatment of AKs in immunocompromised individuals.
“I can’t tell you the number of times we in the committee sat back and said, ‘we need to have a randomized trial that looks at this, or compares this to that head on,’” Dr. Asgari said. Such limitations “give researchers direction for where the areas of study need to go to help us answer some of these management conundrums.”
She added that the new guidelines “give clinicians a leg to stand on” when an insurer pushes back on a recommended treatment for AK. “It gives you a way to have dialogue with insurers if you’re prescribing some of these treatments.”
The guidelines authors write that there is “strong theoretic rationale for the treatment of AK to prevent skin cancers” but acknowledge that only a few studies in the review “report the incidence of skin cancer as an outcome measure or have sufficient follow-up to viably measure carcinoma development.” In addition, “more long-term research is needed to validate our current understanding of skin cancer progression from AKs to keratinocyte carcinoma.”
Dr. DiGiorgio thinks about this differently. “I think treatment of AKs does prevent skin cancers,” she said. “We call them precancers as we’re treating our patients because we know a certain percentage of them can develop into skin cancers over time.”
The study was funded by internal funds from the AAD. Dr. Asgari disclosed that she serves as an investigator for Pfizer. Several of the other authors reported having financial disclosures.
Dr. DiGiorgio reported having no financial disclosures.
FROM JAAD
Expert emphasizes importance of screening for OSA prior to surgery
If you don’t have a standardized process for obstructive sleep apnea screening of all patients heading into the operating room at your hospital you should, because perioperative pulmonary complications can occur, according to Efren C. Manjarrez MD, SFHM, FACP.
If OSA is not documented in the patient’s chart, you may find yourself making a bedside assessment. “I usually don’t ask the patients this because they can’t necessarily answer the questions,” Dr. Manjarrez, associate professor in the division of hospital medicine at the University of Miami, said at SHM Converge, the annual conference of the Society of Hospital Medicine. “So, I ask their partner: ‘Does your partner snore loudly? Are they sleepy during the daytime, or are they gasping or choking in the middle of the night?’”
The following factors have a relatively high specificity for OSA: a STOP-Bang score of 5 or greater, a STOP-Bang score of 2 or greater plus male gender, and a STOP-Bang score of 2 or greater plus a body mass index greater than 35 kg/m2. Clinicians can also check the Mallampati score on their patients by having them tilt their heads back and stick out their tongues.
“If the uvula is not touching the tongue, that’s a Mallampati score of 1; that’s a pretty wide-open airway,” Dr. Manjarrez said. “However, when you do not have any form of an airway and the palate is touching the tongue, that is a Mallampati score of 4, which indicates OSA.”
Other objective data suggestive of OSA include high blood pressure, a BMI over 35 kg/m2, a neck circumference of greater than 40 cm, and male gender. In a study of patients who presented for surgery who did not have a diagnosis of sleep apnea, a high STOP-Bang score indicated a high probability of moderate to severe sleep apnea (Br J. Anaesth 2012;108[5]:768-75).
“If the STOP-Bang score is 0-2, your workup stops,” Dr. Manjarrez said. “If your STOP-Bang score is 5 or above, there’s a high likelihood they have moderate or severe sleep apnea. Patients who have a STOP-Bang of 3-4, calculate their STOP score. If the STOP score is 2 or more and they’re male, obese, and have a neck circumference of greater than 40 cm, there’s a pretty good chance they’ve got OSA.”
Screening for OSA prior to surgery matters, because the potential pulmonary complications are fairly high, “anywhere from postoperative respiratory failure to COPD exacerbation and hypoxia to pneumonia,” he continued. “These patients very commonly desaturate and are difficult for the anesthesiologists to intubate. Fortunately, we have not found significant cardiac complications in the medical literature, but we do know that patients with OSA commonly get postoperative atrial fibrillation. There are also combined complications like desaturation and AFib and difficult intubations. Patients with sleep apnea do have a higher resource utilization perioperatively. Fortunately, at this point in time the data does not show that patients with OSA going in for surgery have an increased mortality.”
To optimize the care of these patients prior to surgery, Dr. Manjarrez recommends that hospitalists document that a patient either has known OSA or suspected OSA. “If possible, obtain their sleep study results and recommended PAP settings,” he said. “Ask patients to bring their PAP device to the hospital or to assure the hospital has appropriate surrogate devices available. You also want to advise the patient and the perioperative care team of the increased risk of complications in patients at high risk for OSA and optimize other conditions that may impair cardiorespiratory function.”
Perioperative risk reduction strategies include planning for difficult intubation and mask ventilation, using regional anesthesia and analgesia, using sedatives with caution, minimizing the use of opioids and anticipating variable opioid responses. “When I have a patient with suspected sleep apnea and no red flags I write down ‘OSA precautions,’ in the chart, which means elevate the head of the bed, perform continuous pulse oximetry, and cautiously supply supplemental oxygen as needed,” he said.
Postoperatively, he continued, minimize sedative agents and opioids, use regional and nonopioid analgesics when possible, provide supplemental oxygen until the patient is able to maintain baseline SaO2 on room air in a monitored setting, maintain the patient in nonsupine position when feasible, and continuously monitor pulse oximetry.
Consider delay of elective surgery and referral to a sleep medicine specialist in cases of uncontrolled systemic conditions or impaired gas exchange, including hypoventilation syndromes (a clue being a serum HC03 of 28 or higher), severe pulmonary hypertension (a clue being right ventricular systolic blood pressure or pulmonary systolic pressure of 70 mm Hg or above, or right ventricular dilatation/dysfunction), and hypoxemia not explained by cardiac disease.
A systematic review and meta-analysis of six studies that included 904 patients with sleep apnea found that there was no significant difference in the postoperative adverse events between CPAP and no-CPAP treatment (Anesth Analg 2015;120:1013-23). However, there was a significant reduction in the Apnea-Hypopnea Index postoperatively among those who used CPAP (37 vs. 12 events per hour; P less than .001), as well as a significant reduction in hospital length of stay 4 vs. 4.4 days; P = .05).
Dr. Manjarrez reported having no financial disclosures.
If you don’t have a standardized process for obstructive sleep apnea screening of all patients heading into the operating room at your hospital you should, because perioperative pulmonary complications can occur, according to Efren C. Manjarrez MD, SFHM, FACP.
If OSA is not documented in the patient’s chart, you may find yourself making a bedside assessment. “I usually don’t ask the patients this because they can’t necessarily answer the questions,” Dr. Manjarrez, associate professor in the division of hospital medicine at the University of Miami, said at SHM Converge, the annual conference of the Society of Hospital Medicine. “So, I ask their partner: ‘Does your partner snore loudly? Are they sleepy during the daytime, or are they gasping or choking in the middle of the night?’”
The following factors have a relatively high specificity for OSA: a STOP-Bang score of 5 or greater, a STOP-Bang score of 2 or greater plus male gender, and a STOP-Bang score of 2 or greater plus a body mass index greater than 35 kg/m2. Clinicians can also check the Mallampati score on their patients by having them tilt their heads back and stick out their tongues.
“If the uvula is not touching the tongue, that’s a Mallampati score of 1; that’s a pretty wide-open airway,” Dr. Manjarrez said. “However, when you do not have any form of an airway and the palate is touching the tongue, that is a Mallampati score of 4, which indicates OSA.”
Other objective data suggestive of OSA include high blood pressure, a BMI over 35 kg/m2, a neck circumference of greater than 40 cm, and male gender. In a study of patients who presented for surgery who did not have a diagnosis of sleep apnea, a high STOP-Bang score indicated a high probability of moderate to severe sleep apnea (Br J. Anaesth 2012;108[5]:768-75).
“If the STOP-Bang score is 0-2, your workup stops,” Dr. Manjarrez said. “If your STOP-Bang score is 5 or above, there’s a high likelihood they have moderate or severe sleep apnea. Patients who have a STOP-Bang of 3-4, calculate their STOP score. If the STOP score is 2 or more and they’re male, obese, and have a neck circumference of greater than 40 cm, there’s a pretty good chance they’ve got OSA.”
Screening for OSA prior to surgery matters, because the potential pulmonary complications are fairly high, “anywhere from postoperative respiratory failure to COPD exacerbation and hypoxia to pneumonia,” he continued. “These patients very commonly desaturate and are difficult for the anesthesiologists to intubate. Fortunately, we have not found significant cardiac complications in the medical literature, but we do know that patients with OSA commonly get postoperative atrial fibrillation. There are also combined complications like desaturation and AFib and difficult intubations. Patients with sleep apnea do have a higher resource utilization perioperatively. Fortunately, at this point in time the data does not show that patients with OSA going in for surgery have an increased mortality.”
To optimize the care of these patients prior to surgery, Dr. Manjarrez recommends that hospitalists document that a patient either has known OSA or suspected OSA. “If possible, obtain their sleep study results and recommended PAP settings,” he said. “Ask patients to bring their PAP device to the hospital or to assure the hospital has appropriate surrogate devices available. You also want to advise the patient and the perioperative care team of the increased risk of complications in patients at high risk for OSA and optimize other conditions that may impair cardiorespiratory function.”
Perioperative risk reduction strategies include planning for difficult intubation and mask ventilation, using regional anesthesia and analgesia, using sedatives with caution, minimizing the use of opioids and anticipating variable opioid responses. “When I have a patient with suspected sleep apnea and no red flags I write down ‘OSA precautions,’ in the chart, which means elevate the head of the bed, perform continuous pulse oximetry, and cautiously supply supplemental oxygen as needed,” he said.
Postoperatively, he continued, minimize sedative agents and opioids, use regional and nonopioid analgesics when possible, provide supplemental oxygen until the patient is able to maintain baseline SaO2 on room air in a monitored setting, maintain the patient in nonsupine position when feasible, and continuously monitor pulse oximetry.
Consider delay of elective surgery and referral to a sleep medicine specialist in cases of uncontrolled systemic conditions or impaired gas exchange, including hypoventilation syndromes (a clue being a serum HC03 of 28 or higher), severe pulmonary hypertension (a clue being right ventricular systolic blood pressure or pulmonary systolic pressure of 70 mm Hg or above, or right ventricular dilatation/dysfunction), and hypoxemia not explained by cardiac disease.
A systematic review and meta-analysis of six studies that included 904 patients with sleep apnea found that there was no significant difference in the postoperative adverse events between CPAP and no-CPAP treatment (Anesth Analg 2015;120:1013-23). However, there was a significant reduction in the Apnea-Hypopnea Index postoperatively among those who used CPAP (37 vs. 12 events per hour; P less than .001), as well as a significant reduction in hospital length of stay 4 vs. 4.4 days; P = .05).
Dr. Manjarrez reported having no financial disclosures.
If you don’t have a standardized process for obstructive sleep apnea screening of all patients heading into the operating room at your hospital you should, because perioperative pulmonary complications can occur, according to Efren C. Manjarrez MD, SFHM, FACP.
If OSA is not documented in the patient’s chart, you may find yourself making a bedside assessment. “I usually don’t ask the patients this because they can’t necessarily answer the questions,” Dr. Manjarrez, associate professor in the division of hospital medicine at the University of Miami, said at SHM Converge, the annual conference of the Society of Hospital Medicine. “So, I ask their partner: ‘Does your partner snore loudly? Are they sleepy during the daytime, or are they gasping or choking in the middle of the night?’”
The following factors have a relatively high specificity for OSA: a STOP-Bang score of 5 or greater, a STOP-Bang score of 2 or greater plus male gender, and a STOP-Bang score of 2 or greater plus a body mass index greater than 35 kg/m2. Clinicians can also check the Mallampati score on their patients by having them tilt their heads back and stick out their tongues.
“If the uvula is not touching the tongue, that’s a Mallampati score of 1; that’s a pretty wide-open airway,” Dr. Manjarrez said. “However, when you do not have any form of an airway and the palate is touching the tongue, that is a Mallampati score of 4, which indicates OSA.”
Other objective data suggestive of OSA include high blood pressure, a BMI over 35 kg/m2, a neck circumference of greater than 40 cm, and male gender. In a study of patients who presented for surgery who did not have a diagnosis of sleep apnea, a high STOP-Bang score indicated a high probability of moderate to severe sleep apnea (Br J. Anaesth 2012;108[5]:768-75).
“If the STOP-Bang score is 0-2, your workup stops,” Dr. Manjarrez said. “If your STOP-Bang score is 5 or above, there’s a high likelihood they have moderate or severe sleep apnea. Patients who have a STOP-Bang of 3-4, calculate their STOP score. If the STOP score is 2 or more and they’re male, obese, and have a neck circumference of greater than 40 cm, there’s a pretty good chance they’ve got OSA.”
Screening for OSA prior to surgery matters, because the potential pulmonary complications are fairly high, “anywhere from postoperative respiratory failure to COPD exacerbation and hypoxia to pneumonia,” he continued. “These patients very commonly desaturate and are difficult for the anesthesiologists to intubate. Fortunately, we have not found significant cardiac complications in the medical literature, but we do know that patients with OSA commonly get postoperative atrial fibrillation. There are also combined complications like desaturation and AFib and difficult intubations. Patients with sleep apnea do have a higher resource utilization perioperatively. Fortunately, at this point in time the data does not show that patients with OSA going in for surgery have an increased mortality.”
To optimize the care of these patients prior to surgery, Dr. Manjarrez recommends that hospitalists document that a patient either has known OSA or suspected OSA. “If possible, obtain their sleep study results and recommended PAP settings,” he said. “Ask patients to bring their PAP device to the hospital or to assure the hospital has appropriate surrogate devices available. You also want to advise the patient and the perioperative care team of the increased risk of complications in patients at high risk for OSA and optimize other conditions that may impair cardiorespiratory function.”
Perioperative risk reduction strategies include planning for difficult intubation and mask ventilation, using regional anesthesia and analgesia, using sedatives with caution, minimizing the use of opioids and anticipating variable opioid responses. “When I have a patient with suspected sleep apnea and no red flags I write down ‘OSA precautions,’ in the chart, which means elevate the head of the bed, perform continuous pulse oximetry, and cautiously supply supplemental oxygen as needed,” he said.
Postoperatively, he continued, minimize sedative agents and opioids, use regional and nonopioid analgesics when possible, provide supplemental oxygen until the patient is able to maintain baseline SaO2 on room air in a monitored setting, maintain the patient in nonsupine position when feasible, and continuously monitor pulse oximetry.
Consider delay of elective surgery and referral to a sleep medicine specialist in cases of uncontrolled systemic conditions or impaired gas exchange, including hypoventilation syndromes (a clue being a serum HC03 of 28 or higher), severe pulmonary hypertension (a clue being right ventricular systolic blood pressure or pulmonary systolic pressure of 70 mm Hg or above, or right ventricular dilatation/dysfunction), and hypoxemia not explained by cardiac disease.
A systematic review and meta-analysis of six studies that included 904 patients with sleep apnea found that there was no significant difference in the postoperative adverse events between CPAP and no-CPAP treatment (Anesth Analg 2015;120:1013-23). However, there was a significant reduction in the Apnea-Hypopnea Index postoperatively among those who used CPAP (37 vs. 12 events per hour; P less than .001), as well as a significant reduction in hospital length of stay 4 vs. 4.4 days; P = .05).
Dr. Manjarrez reported having no financial disclosures.
FROM SHM CONVERGE 2021
Survey offers a snapshot of nationwide COVID-19 discharge practices
Discharge practices for COVID-19 patients vary widely at the nation’s academic medical centers, but there are some areas of strong concordance, especially related to procedures for isolation and mitigating transmission of COVID-19.
In addition, most sites use some form of clinical criteria to determine discharge readiness, S. Ryan Greysen, MD, MHS, SFHM, said on May 5 at SHM Converge, the annual conference of the Society of Hospital Medicine.
Those rank among the key findings from of a survey of 22 academic medical centers conducted by the Hospital Medicine Re-engineering Network (HOMERuN), which was launched in 2011 as a way to advance hospital medicine through rigorous research to improve the care of hospitalized patients.
“When COVID came and changed all of our lives, HOMERuN was well positioned to examine the state of practices in member hospitals, and we set out some key principles,” Dr. Greysen said. “First, we wanted to respect the challenges and needs of sites during this extraordinary time. We wanted to support speed and flexibility from our study design to get results to the front lines as quickly as possible. Therefore, we used lightweight research methods such as cross-sectional surveys, periodic evaluations, and we use the data to support operational needs. We have developed linkages to more granular datasets such as electronic health records, but our focus to date has been mostly on the frontline experience of hospitalists and gathering consensus around clinical practice, especially in the early stages of the pandemic.”
In March and April of 2020, Dr. Greysen and colleagues collected and analyzed any discharge protocols, policies, or other documents from 22 academic medical centers. From this they created a follow-up survey containing 21 different domains that was administered to the same institutions in May and June of 2020. “It’s not meant to be a completely comprehensive list, but these 21 domains were the themes we saw coming out of these discharge practice documents,” explained Dr. Greysen, chief of hospital medicine at the University of Pennsylvania, Philadelphia, which is one of the participating sites.
Next, the researchers used a concordance table to help them keep track of which institution responded in which way for which domain, and they bundled the discharge criteria into five higher order domains: procedures for isolation and mitigating transmission; clinical criteria for discharge; nonclinical/nonisolation issues; discharge to settings other than home, and postdischarge instructions, monitoring, and follow-up.
In the procedures for isolation and mitigating transmission domain, Dr. Greysen reported that the use of isolation guidelines was the area of greatest consensus in the study, with 19 of 22 sites (86%) citing the Centers for Disease Control and Prevention and 7 (32%) also citing state department of health guidance. “Specifically, most sites included the ability to socially isolate at home (until no longer necessary per CDC guidance) as part of the criteria,” he said. Most sites (73%) required use of personal protective equipment (PPE) in transportation from the hospital and 73% gave masks and other PPE for use at home.
Session copresenter Maralyssa A. Bann, MD, a hospitalist at the University of Washington/Harborview Medical Center, Seattle, another participating site, pointed out that the institutions surveyed look to the CDC as being “the single source of truth on discharge practices,” specifically material for health care workers related to discharging COVID-19 patients. “Notable specific recent updates include the recommendation that meeting criteria for discontinuation of Transmission-Based Precautions is not a prerequisite for discharge from a health care facility,” Dr. Bann said. “Also, as of August 2020, use of symptom-based strategy for discontinuation of isolation precautions instead of repeat testing is recommended for most patients. This is a rapidly evolving area.”
Practices in the clinical criteria for discharge domain varied by site. Slightly more than one-quarter of sites (27%) gave little or no guidance by using terms like “use clinical judgment,” while 14% gave very specific detailed algorithms. “Most sites fell in between and gave some parameters, usually along the lines of symptom improvement, temperature, and oxygen requirement, but the criteria were variable,” Dr. Greysen said. “For example, in terms of temperature, many sites said that patients should be afebrile for a specific length of time, 24-72 hours, while other sites simply said afebrile at discharge.” Meanwhile, the following criteria for discharge were addressed by relatively few sites: lab criteria (36%), age (36%), high-risk comorbidities (32%), or ID consultation (18%).
In the nonclinical/nonisolation domain, 73% of sites assessed for level of support available, though this was variably defined. Slightly more than half (55%) specifically assessed activities of daily living or the presence of a caregiver to assist, while 18% reported addressing durable medical equipment such as beds and toilets and access to food or medication supplies in ways that were specific for COVID-19 patients.
In the discharge to settings other than home domain, 77% of sites addressed discharge to skilled nursing facilities, inpatient rehabilitation, or long-term care, although specific requirements were often set by the accepting facilities. In addition, 65% of sites gave specific guidance for patients experiencing unstable housing/homelessness, usually recommending a respite facility or similar, and 59% addressed congregate/shared living spaces such as assisted living facilities. “Often the strictest criteria [two negative COVID tests] were applied to discharge to these types of settings,” he said.
In the postdischarge instructions, monitoring, and follow-up domain, 73% of sites reported providing home monitoring and/or virtual follow-up care. Programs ranged from daily texting via SMS or patient portals, RN phone calls, home pulse oximeters, and/or thermometers. In addition, 55% of sites had created COVID-specific brochures, discharge instructions, and other materials to standardize content such as use of PPE, travel restrictions, social distancing, signs and symptoms to watch out for, and what to do if worsening clinically.
Dr. Bann predicted future trends on the heels of the HOMERuN survey, including the development of more evidence and consensus related to discharge criteria. “Clarity is needed specifically around hypoxemia at rest/on ambulation, as well as more flexible criteria for oxygen supplementation,” she said. “We also think there will be a considerable amount of growth in posthospitalization monitoring and support, in particular home-based and virtual/remote monitoring.”
HOMERuN is supported by the Gordon and Betty Moore Foundation, the AAMC, the Patient-Centered Outcomes Research Institute, the Clinical Data Research Networks, the Patient-Powered Research Networks, and Agency for Healthcare Research and Quality. Dr. Greysen and Dr. Bann reported having no financial disclosures.
Discharge practices for COVID-19 patients vary widely at the nation’s academic medical centers, but there are some areas of strong concordance, especially related to procedures for isolation and mitigating transmission of COVID-19.
In addition, most sites use some form of clinical criteria to determine discharge readiness, S. Ryan Greysen, MD, MHS, SFHM, said on May 5 at SHM Converge, the annual conference of the Society of Hospital Medicine.
Those rank among the key findings from of a survey of 22 academic medical centers conducted by the Hospital Medicine Re-engineering Network (HOMERuN), which was launched in 2011 as a way to advance hospital medicine through rigorous research to improve the care of hospitalized patients.
“When COVID came and changed all of our lives, HOMERuN was well positioned to examine the state of practices in member hospitals, and we set out some key principles,” Dr. Greysen said. “First, we wanted to respect the challenges and needs of sites during this extraordinary time. We wanted to support speed and flexibility from our study design to get results to the front lines as quickly as possible. Therefore, we used lightweight research methods such as cross-sectional surveys, periodic evaluations, and we use the data to support operational needs. We have developed linkages to more granular datasets such as electronic health records, but our focus to date has been mostly on the frontline experience of hospitalists and gathering consensus around clinical practice, especially in the early stages of the pandemic.”
In March and April of 2020, Dr. Greysen and colleagues collected and analyzed any discharge protocols, policies, or other documents from 22 academic medical centers. From this they created a follow-up survey containing 21 different domains that was administered to the same institutions in May and June of 2020. “It’s not meant to be a completely comprehensive list, but these 21 domains were the themes we saw coming out of these discharge practice documents,” explained Dr. Greysen, chief of hospital medicine at the University of Pennsylvania, Philadelphia, which is one of the participating sites.
Next, the researchers used a concordance table to help them keep track of which institution responded in which way for which domain, and they bundled the discharge criteria into five higher order domains: procedures for isolation and mitigating transmission; clinical criteria for discharge; nonclinical/nonisolation issues; discharge to settings other than home, and postdischarge instructions, monitoring, and follow-up.
In the procedures for isolation and mitigating transmission domain, Dr. Greysen reported that the use of isolation guidelines was the area of greatest consensus in the study, with 19 of 22 sites (86%) citing the Centers for Disease Control and Prevention and 7 (32%) also citing state department of health guidance. “Specifically, most sites included the ability to socially isolate at home (until no longer necessary per CDC guidance) as part of the criteria,” he said. Most sites (73%) required use of personal protective equipment (PPE) in transportation from the hospital and 73% gave masks and other PPE for use at home.
Session copresenter Maralyssa A. Bann, MD, a hospitalist at the University of Washington/Harborview Medical Center, Seattle, another participating site, pointed out that the institutions surveyed look to the CDC as being “the single source of truth on discharge practices,” specifically material for health care workers related to discharging COVID-19 patients. “Notable specific recent updates include the recommendation that meeting criteria for discontinuation of Transmission-Based Precautions is not a prerequisite for discharge from a health care facility,” Dr. Bann said. “Also, as of August 2020, use of symptom-based strategy for discontinuation of isolation precautions instead of repeat testing is recommended for most patients. This is a rapidly evolving area.”
Practices in the clinical criteria for discharge domain varied by site. Slightly more than one-quarter of sites (27%) gave little or no guidance by using terms like “use clinical judgment,” while 14% gave very specific detailed algorithms. “Most sites fell in between and gave some parameters, usually along the lines of symptom improvement, temperature, and oxygen requirement, but the criteria were variable,” Dr. Greysen said. “For example, in terms of temperature, many sites said that patients should be afebrile for a specific length of time, 24-72 hours, while other sites simply said afebrile at discharge.” Meanwhile, the following criteria for discharge were addressed by relatively few sites: lab criteria (36%), age (36%), high-risk comorbidities (32%), or ID consultation (18%).
In the nonclinical/nonisolation domain, 73% of sites assessed for level of support available, though this was variably defined. Slightly more than half (55%) specifically assessed activities of daily living or the presence of a caregiver to assist, while 18% reported addressing durable medical equipment such as beds and toilets and access to food or medication supplies in ways that were specific for COVID-19 patients.
In the discharge to settings other than home domain, 77% of sites addressed discharge to skilled nursing facilities, inpatient rehabilitation, or long-term care, although specific requirements were often set by the accepting facilities. In addition, 65% of sites gave specific guidance for patients experiencing unstable housing/homelessness, usually recommending a respite facility or similar, and 59% addressed congregate/shared living spaces such as assisted living facilities. “Often the strictest criteria [two negative COVID tests] were applied to discharge to these types of settings,” he said.
In the postdischarge instructions, monitoring, and follow-up domain, 73% of sites reported providing home monitoring and/or virtual follow-up care. Programs ranged from daily texting via SMS or patient portals, RN phone calls, home pulse oximeters, and/or thermometers. In addition, 55% of sites had created COVID-specific brochures, discharge instructions, and other materials to standardize content such as use of PPE, travel restrictions, social distancing, signs and symptoms to watch out for, and what to do if worsening clinically.
Dr. Bann predicted future trends on the heels of the HOMERuN survey, including the development of more evidence and consensus related to discharge criteria. “Clarity is needed specifically around hypoxemia at rest/on ambulation, as well as more flexible criteria for oxygen supplementation,” she said. “We also think there will be a considerable amount of growth in posthospitalization monitoring and support, in particular home-based and virtual/remote monitoring.”
HOMERuN is supported by the Gordon and Betty Moore Foundation, the AAMC, the Patient-Centered Outcomes Research Institute, the Clinical Data Research Networks, the Patient-Powered Research Networks, and Agency for Healthcare Research and Quality. Dr. Greysen and Dr. Bann reported having no financial disclosures.
Discharge practices for COVID-19 patients vary widely at the nation’s academic medical centers, but there are some areas of strong concordance, especially related to procedures for isolation and mitigating transmission of COVID-19.
In addition, most sites use some form of clinical criteria to determine discharge readiness, S. Ryan Greysen, MD, MHS, SFHM, said on May 5 at SHM Converge, the annual conference of the Society of Hospital Medicine.
Those rank among the key findings from of a survey of 22 academic medical centers conducted by the Hospital Medicine Re-engineering Network (HOMERuN), which was launched in 2011 as a way to advance hospital medicine through rigorous research to improve the care of hospitalized patients.
“When COVID came and changed all of our lives, HOMERuN was well positioned to examine the state of practices in member hospitals, and we set out some key principles,” Dr. Greysen said. “First, we wanted to respect the challenges and needs of sites during this extraordinary time. We wanted to support speed and flexibility from our study design to get results to the front lines as quickly as possible. Therefore, we used lightweight research methods such as cross-sectional surveys, periodic evaluations, and we use the data to support operational needs. We have developed linkages to more granular datasets such as electronic health records, but our focus to date has been mostly on the frontline experience of hospitalists and gathering consensus around clinical practice, especially in the early stages of the pandemic.”
In March and April of 2020, Dr. Greysen and colleagues collected and analyzed any discharge protocols, policies, or other documents from 22 academic medical centers. From this they created a follow-up survey containing 21 different domains that was administered to the same institutions in May and June of 2020. “It’s not meant to be a completely comprehensive list, but these 21 domains were the themes we saw coming out of these discharge practice documents,” explained Dr. Greysen, chief of hospital medicine at the University of Pennsylvania, Philadelphia, which is one of the participating sites.
Next, the researchers used a concordance table to help them keep track of which institution responded in which way for which domain, and they bundled the discharge criteria into five higher order domains: procedures for isolation and mitigating transmission; clinical criteria for discharge; nonclinical/nonisolation issues; discharge to settings other than home, and postdischarge instructions, monitoring, and follow-up.
In the procedures for isolation and mitigating transmission domain, Dr. Greysen reported that the use of isolation guidelines was the area of greatest consensus in the study, with 19 of 22 sites (86%) citing the Centers for Disease Control and Prevention and 7 (32%) also citing state department of health guidance. “Specifically, most sites included the ability to socially isolate at home (until no longer necessary per CDC guidance) as part of the criteria,” he said. Most sites (73%) required use of personal protective equipment (PPE) in transportation from the hospital and 73% gave masks and other PPE for use at home.
Session copresenter Maralyssa A. Bann, MD, a hospitalist at the University of Washington/Harborview Medical Center, Seattle, another participating site, pointed out that the institutions surveyed look to the CDC as being “the single source of truth on discharge practices,” specifically material for health care workers related to discharging COVID-19 patients. “Notable specific recent updates include the recommendation that meeting criteria for discontinuation of Transmission-Based Precautions is not a prerequisite for discharge from a health care facility,” Dr. Bann said. “Also, as of August 2020, use of symptom-based strategy for discontinuation of isolation precautions instead of repeat testing is recommended for most patients. This is a rapidly evolving area.”
Practices in the clinical criteria for discharge domain varied by site. Slightly more than one-quarter of sites (27%) gave little or no guidance by using terms like “use clinical judgment,” while 14% gave very specific detailed algorithms. “Most sites fell in between and gave some parameters, usually along the lines of symptom improvement, temperature, and oxygen requirement, but the criteria were variable,” Dr. Greysen said. “For example, in terms of temperature, many sites said that patients should be afebrile for a specific length of time, 24-72 hours, while other sites simply said afebrile at discharge.” Meanwhile, the following criteria for discharge were addressed by relatively few sites: lab criteria (36%), age (36%), high-risk comorbidities (32%), or ID consultation (18%).
In the nonclinical/nonisolation domain, 73% of sites assessed for level of support available, though this was variably defined. Slightly more than half (55%) specifically assessed activities of daily living or the presence of a caregiver to assist, while 18% reported addressing durable medical equipment such as beds and toilets and access to food or medication supplies in ways that were specific for COVID-19 patients.
In the discharge to settings other than home domain, 77% of sites addressed discharge to skilled nursing facilities, inpatient rehabilitation, or long-term care, although specific requirements were often set by the accepting facilities. In addition, 65% of sites gave specific guidance for patients experiencing unstable housing/homelessness, usually recommending a respite facility or similar, and 59% addressed congregate/shared living spaces such as assisted living facilities. “Often the strictest criteria [two negative COVID tests] were applied to discharge to these types of settings,” he said.
In the postdischarge instructions, monitoring, and follow-up domain, 73% of sites reported providing home monitoring and/or virtual follow-up care. Programs ranged from daily texting via SMS or patient portals, RN phone calls, home pulse oximeters, and/or thermometers. In addition, 55% of sites had created COVID-specific brochures, discharge instructions, and other materials to standardize content such as use of PPE, travel restrictions, social distancing, signs and symptoms to watch out for, and what to do if worsening clinically.
Dr. Bann predicted future trends on the heels of the HOMERuN survey, including the development of more evidence and consensus related to discharge criteria. “Clarity is needed specifically around hypoxemia at rest/on ambulation, as well as more flexible criteria for oxygen supplementation,” she said. “We also think there will be a considerable amount of growth in posthospitalization monitoring and support, in particular home-based and virtual/remote monitoring.”
HOMERuN is supported by the Gordon and Betty Moore Foundation, the AAMC, the Patient-Centered Outcomes Research Institute, the Clinical Data Research Networks, the Patient-Powered Research Networks, and Agency for Healthcare Research and Quality. Dr. Greysen and Dr. Bann reported having no financial disclosures.
FROM SHM CONVERGE 2021
Strategies to turn the tide on racial and gender inequity
Working to mitigate racial and gender inequity in hospital medicine may seem like a daunting task, but every physician can play a role in turning the tide toward equity, according to Jorge Ganem, MD, FAAP.
“Talking about bias, racism, sexism, gender inequity, and health disparities is difficult,” Dr. Ganem, associate professor of pediatrics at the University of Texas at Austin and director of pediatric hospital medicine at Dell Children’s Medical Center in Austin, said May 5 at SHM Converge, the annual conference of the Society of Hospital Medicine. “There certainly comes a heavy weight and responsibility that we all feel. But I believe that we should approach gender inequities and racial disparities through a quality and patient safety lens, and looking through that lens.”
Dr. Ganem – along with Vanessa Durand, DO, FAAP, of St. Christopher’s Hospital for Children in Philadelphia, and Yemisi O. Jones, MD, FAAP, FHM, of Cincinnati Children’s Hospital – devised the concept of “functional allyship” as one way to improve representation in hospital medicine. The approach consists of three categories: listeners, amplifiers, and champions. Listeners are “those who take the time to listen and give space to the voices who are oppressed and disadvantaged,” Dr. Ganem said. “Action may not always be possible, but the space gives those who are marginalized validation to the feelings that the oppression produces.”
He described amplifiers as those who use their position of privilege to spread the message by educating their colleagues and other peers. “This includes elevating those from marginalized communities to speak on their own behalf and giving them the spotlight, given their expertise,” he said.
Champions are those who actively work to dismantle the oppression within systems. Dr. Ganem cited organizations such as ADVANCE PHM, FEMinEM and HeForShe as examples of national and global efforts, “but this also includes those working in committees that are addressing diversity and inclusion in their workplace and coming up with policies and procedures to increase equity,” he said.
Finding opportunities to practice mentorship and sponsorship are also important. “Positive mentorship relationships are key in avoiding burnout and decreasing attrition,” he said. “The development of successful mentorship programs are a must in order to retain women physicians and ‘underrepresented in medicine’ physicians in your organization.” He described a “sponsor” as someone who is in a position of influence and power who actively supports the career of a “protégé” whom they have identified as having high potential. “The sponsor may advance a protégé’s career by nominating them for leadership opportunities and introducing them into career networks,” he said.
Dr. Durand discussed additional ways to improve disparities of gender, race, and ethnicity. “It can all start with measuring the data,” said Dr. Durand, also an assistant professor of pediatrics at Drexel University, Philadelphia. “This means looking at gender and race and ethnicity data by unit or section at your institution, as well as leadership positions.” In 2017, authors led by Hilary Sanfey, MBBBCh, MHPE, FACS, published an article addressing strategies to identify and close the gender salary gap in surgery (J Am Coll Surg. 2017;225[2]:333-8). Their recommendations included changing policies, transparency, oversight of metrics, promoting women to senior leadership positions, and evaluating the organizational culture. “It goes back to culture, because it leads to accountability,” Dr. Durand said. “Behavior change comes with accountability.”
Part of holding people accountable within a culture change includes addressing microaggressions, or indirect expressions of prejudice. In 2016, authors led by Floyd Cheung, PhD., established a framework using the acronym A.C.T.I.O.N., which identifies a microaggression without being aggressive or evoking defensiveness towards the person communicating the microaggression. A.C.T.I.O.N. stands for Ask clarifying questions; Come from curiosity, not judgment; Tell what you observed in a factual manner; Impact exploration – discuss what the impact was; Own your own thoughts and feelings around the situation; and discuss Next steps.
“Granted, this might take a little time, but when we state microaggressions, most of us don’t realize that those statements could be hurtful or uncomfortable for the person receiving them,” Dr. Durand said.
Another strategy to address disparities involves partially blinding the interview process for trainees. “You can do this by not giving any ‘cognitive information’ to your interviewers – such as United States Medical Licensing Examination Step scores – that may anchor their position prior to the interview taking place,” she explained. “You can also standardize one or two questions that all interviewees have to answer, to have a more objective way to compare answers horizontally rather than vertically.”
This complements the notion of the Association of American Medical Colleges’ “holistic review,” a principle that it describes as allowing admissions committees “to consider the ‘whole’ applicant, rather than disproportionately focusing on any one factor.”
“The overall concept is to evaluate what are criteria of the position you are hiring for,” Dr. Durand said. “Different criteria will have different levels of importance. You would take into consideration the values of the group or the institution and make sure those criteria are most important for selection, at the forefront.”
Dr. Ganem and Dr. Durand reported having no financial disclosures.
Working to mitigate racial and gender inequity in hospital medicine may seem like a daunting task, but every physician can play a role in turning the tide toward equity, according to Jorge Ganem, MD, FAAP.
“Talking about bias, racism, sexism, gender inequity, and health disparities is difficult,” Dr. Ganem, associate professor of pediatrics at the University of Texas at Austin and director of pediatric hospital medicine at Dell Children’s Medical Center in Austin, said May 5 at SHM Converge, the annual conference of the Society of Hospital Medicine. “There certainly comes a heavy weight and responsibility that we all feel. But I believe that we should approach gender inequities and racial disparities through a quality and patient safety lens, and looking through that lens.”
Dr. Ganem – along with Vanessa Durand, DO, FAAP, of St. Christopher’s Hospital for Children in Philadelphia, and Yemisi O. Jones, MD, FAAP, FHM, of Cincinnati Children’s Hospital – devised the concept of “functional allyship” as one way to improve representation in hospital medicine. The approach consists of three categories: listeners, amplifiers, and champions. Listeners are “those who take the time to listen and give space to the voices who are oppressed and disadvantaged,” Dr. Ganem said. “Action may not always be possible, but the space gives those who are marginalized validation to the feelings that the oppression produces.”
He described amplifiers as those who use their position of privilege to spread the message by educating their colleagues and other peers. “This includes elevating those from marginalized communities to speak on their own behalf and giving them the spotlight, given their expertise,” he said.
Champions are those who actively work to dismantle the oppression within systems. Dr. Ganem cited organizations such as ADVANCE PHM, FEMinEM and HeForShe as examples of national and global efforts, “but this also includes those working in committees that are addressing diversity and inclusion in their workplace and coming up with policies and procedures to increase equity,” he said.
Finding opportunities to practice mentorship and sponsorship are also important. “Positive mentorship relationships are key in avoiding burnout and decreasing attrition,” he said. “The development of successful mentorship programs are a must in order to retain women physicians and ‘underrepresented in medicine’ physicians in your organization.” He described a “sponsor” as someone who is in a position of influence and power who actively supports the career of a “protégé” whom they have identified as having high potential. “The sponsor may advance a protégé’s career by nominating them for leadership opportunities and introducing them into career networks,” he said.
Dr. Durand discussed additional ways to improve disparities of gender, race, and ethnicity. “It can all start with measuring the data,” said Dr. Durand, also an assistant professor of pediatrics at Drexel University, Philadelphia. “This means looking at gender and race and ethnicity data by unit or section at your institution, as well as leadership positions.” In 2017, authors led by Hilary Sanfey, MBBBCh, MHPE, FACS, published an article addressing strategies to identify and close the gender salary gap in surgery (J Am Coll Surg. 2017;225[2]:333-8). Their recommendations included changing policies, transparency, oversight of metrics, promoting women to senior leadership positions, and evaluating the organizational culture. “It goes back to culture, because it leads to accountability,” Dr. Durand said. “Behavior change comes with accountability.”
Part of holding people accountable within a culture change includes addressing microaggressions, or indirect expressions of prejudice. In 2016, authors led by Floyd Cheung, PhD., established a framework using the acronym A.C.T.I.O.N., which identifies a microaggression without being aggressive or evoking defensiveness towards the person communicating the microaggression. A.C.T.I.O.N. stands for Ask clarifying questions; Come from curiosity, not judgment; Tell what you observed in a factual manner; Impact exploration – discuss what the impact was; Own your own thoughts and feelings around the situation; and discuss Next steps.
“Granted, this might take a little time, but when we state microaggressions, most of us don’t realize that those statements could be hurtful or uncomfortable for the person receiving them,” Dr. Durand said.
Another strategy to address disparities involves partially blinding the interview process for trainees. “You can do this by not giving any ‘cognitive information’ to your interviewers – such as United States Medical Licensing Examination Step scores – that may anchor their position prior to the interview taking place,” she explained. “You can also standardize one or two questions that all interviewees have to answer, to have a more objective way to compare answers horizontally rather than vertically.”
This complements the notion of the Association of American Medical Colleges’ “holistic review,” a principle that it describes as allowing admissions committees “to consider the ‘whole’ applicant, rather than disproportionately focusing on any one factor.”
“The overall concept is to evaluate what are criteria of the position you are hiring for,” Dr. Durand said. “Different criteria will have different levels of importance. You would take into consideration the values of the group or the institution and make sure those criteria are most important for selection, at the forefront.”
Dr. Ganem and Dr. Durand reported having no financial disclosures.
Working to mitigate racial and gender inequity in hospital medicine may seem like a daunting task, but every physician can play a role in turning the tide toward equity, according to Jorge Ganem, MD, FAAP.
“Talking about bias, racism, sexism, gender inequity, and health disparities is difficult,” Dr. Ganem, associate professor of pediatrics at the University of Texas at Austin and director of pediatric hospital medicine at Dell Children’s Medical Center in Austin, said May 5 at SHM Converge, the annual conference of the Society of Hospital Medicine. “There certainly comes a heavy weight and responsibility that we all feel. But I believe that we should approach gender inequities and racial disparities through a quality and patient safety lens, and looking through that lens.”
Dr. Ganem – along with Vanessa Durand, DO, FAAP, of St. Christopher’s Hospital for Children in Philadelphia, and Yemisi O. Jones, MD, FAAP, FHM, of Cincinnati Children’s Hospital – devised the concept of “functional allyship” as one way to improve representation in hospital medicine. The approach consists of three categories: listeners, amplifiers, and champions. Listeners are “those who take the time to listen and give space to the voices who are oppressed and disadvantaged,” Dr. Ganem said. “Action may not always be possible, but the space gives those who are marginalized validation to the feelings that the oppression produces.”
He described amplifiers as those who use their position of privilege to spread the message by educating their colleagues and other peers. “This includes elevating those from marginalized communities to speak on their own behalf and giving them the spotlight, given their expertise,” he said.
Champions are those who actively work to dismantle the oppression within systems. Dr. Ganem cited organizations such as ADVANCE PHM, FEMinEM and HeForShe as examples of national and global efforts, “but this also includes those working in committees that are addressing diversity and inclusion in their workplace and coming up with policies and procedures to increase equity,” he said.
Finding opportunities to practice mentorship and sponsorship are also important. “Positive mentorship relationships are key in avoiding burnout and decreasing attrition,” he said. “The development of successful mentorship programs are a must in order to retain women physicians and ‘underrepresented in medicine’ physicians in your organization.” He described a “sponsor” as someone who is in a position of influence and power who actively supports the career of a “protégé” whom they have identified as having high potential. “The sponsor may advance a protégé’s career by nominating them for leadership opportunities and introducing them into career networks,” he said.
Dr. Durand discussed additional ways to improve disparities of gender, race, and ethnicity. “It can all start with measuring the data,” said Dr. Durand, also an assistant professor of pediatrics at Drexel University, Philadelphia. “This means looking at gender and race and ethnicity data by unit or section at your institution, as well as leadership positions.” In 2017, authors led by Hilary Sanfey, MBBBCh, MHPE, FACS, published an article addressing strategies to identify and close the gender salary gap in surgery (J Am Coll Surg. 2017;225[2]:333-8). Their recommendations included changing policies, transparency, oversight of metrics, promoting women to senior leadership positions, and evaluating the organizational culture. “It goes back to culture, because it leads to accountability,” Dr. Durand said. “Behavior change comes with accountability.”
Part of holding people accountable within a culture change includes addressing microaggressions, or indirect expressions of prejudice. In 2016, authors led by Floyd Cheung, PhD., established a framework using the acronym A.C.T.I.O.N., which identifies a microaggression without being aggressive or evoking defensiveness towards the person communicating the microaggression. A.C.T.I.O.N. stands for Ask clarifying questions; Come from curiosity, not judgment; Tell what you observed in a factual manner; Impact exploration – discuss what the impact was; Own your own thoughts and feelings around the situation; and discuss Next steps.
“Granted, this might take a little time, but when we state microaggressions, most of us don’t realize that those statements could be hurtful or uncomfortable for the person receiving them,” Dr. Durand said.
Another strategy to address disparities involves partially blinding the interview process for trainees. “You can do this by not giving any ‘cognitive information’ to your interviewers – such as United States Medical Licensing Examination Step scores – that may anchor their position prior to the interview taking place,” she explained. “You can also standardize one or two questions that all interviewees have to answer, to have a more objective way to compare answers horizontally rather than vertically.”
This complements the notion of the Association of American Medical Colleges’ “holistic review,” a principle that it describes as allowing admissions committees “to consider the ‘whole’ applicant, rather than disproportionately focusing on any one factor.”
“The overall concept is to evaluate what are criteria of the position you are hiring for,” Dr. Durand said. “Different criteria will have different levels of importance. You would take into consideration the values of the group or the institution and make sure those criteria are most important for selection, at the forefront.”
Dr. Ganem and Dr. Durand reported having no financial disclosures.
FROM SHM CONVERGE 2021