Mohs micrographic surgery (MMS) entails multiple time-consuming surgical and histological examinations for each patient. As surgical stages are performed and histological sections are processed, an efficient communication method among providers, medical assistants, histotechnologists, and patients is necessary to avoid delays. To address these and other communication issues, providers have focused on ways to increase clinic efficiency and improve patient-reported outcomes by utilizing new or repurposed communication technologies in their Mohs practice. 

Prior reports have highlighted the utility of hands-free headsets that allow real-time communication among staff members as a means of increasing clinic efficiency and decreasing patient wait times.^1-4 These systems may mediate a more rapid turnover between stages by mitigating the need for surgeons and support staff to assemble within a designated workspace.^1,3,4 However, there is no single or standardized communication method that best suits all surgical suites and MMS practices. Our study aimed to identify the current communication strategies employed by Mohs surgeons and thereby ascertain which method(s) portend(s) the highest benefit in average daily time savings and provider-perceived patient satisfaction.

Materials and Methods

Survey Instrument
A new 10-question electronic survey was published on the SurveyMonkey website, and a link to the survey was provided in a quarterly email that originated from the American College of Mohs Surgery and was distributed to all 1735 active members. Responses were obtained from January 2019 to February 2019.

Statistical Analysis
A statistical analysis was done to determine any significant associations among the providers’ responses. P<.05 was used to determine statistical significance. A Cochran-Armitage test for trend was used to identify significant associations between the number of rooms and the communication systems that were used. Thus, 7 total tests—1 for each device (whiteboard, light system, flag system, wired intercom, wireless intercom, walkie-talkie, or headset)—were conducted. The Cochran-Armitage test also was used to determine whether the probability of using the device was affected by the number of stations/surgical rooms that were attended by the Mohs surgeons. To determine whether the communication devices used were associated with higher patient satisfaction, a χ² test was conducted for each device (7 total tests), testing the categories of using that device (yes/no) and patient satisfaction (yes/no). A Fisher exact test of independence was used in any case where the proportion for the device and patient satisfaction was 25% or higher. To determine whether the communication method was associated with increased time savings, 7 total Cochran-Armitage tests were conducted, 1 for each device. A logistic regression model was used to determine whether there was a significant association between the number of stations and the likelihood of reporting patient satisfaction.

Results

Eighty-eight surgeons responded to the survey, with a response rate of 5% (88/1735). A total of 55 surgeons completed the survey in its entirety and were included in the data analysis. The most commonly used communication mediums were whiteboards (29/55 [53%]), followed by a flag system (16/55 [29%]) and a light system (13/55 [24%]). Most Mohs surgeons (52/55 [95%]) used the communication media to communicate with their staff only, and 76% (42/55) of Mohs surgeons believed that their communication media contributed to higher patient satisfaction. Overall, 58% (32/55) of Mohs surgeons stated that their communication media saved more than 15 minutes (on average) per day. The use of a whiteboard and/or flag system was reported as the least efficient method, with average daily time savings of 13 minutes. With the introduction of newer technology (wired or wireless intercoms, headsets, walkie-talkies, or internal messaging systems such as Skype) to the whiteboard and/or flag system, the time savings increased by 10 minutes per day. Nearly 25% (14/55) of surgeons utilized more than 1 communication system.

As the number of stations in an MMS suite increased, the probability of using a whiteboard to track the progress of the cases decreased. There were no statistically significant associations identified between the number of stations and the use of other communication devices (ie, flag system, light system, wireless intercom, wired intercom, walkie-talkie, headset). The stratified percentages of the amount of time savings for each communication modality are presented in the Figure (whiteboards and headsets were excluded because they did not increase time savings). The use of a light system was the only communication modality found to be statistically associated with an increase in provider-reported time savings (P=.0482; Figure). In addition, our analysis did not show an improvement in provider-reported patient satisfaction with any of the current systems used in MMS clinics.

Comment

The process of transmitting information among the medical team during MMS is a complex interplay involving the relay of crucial information, with many opportunities for the introduction of distraction and error. Despite numerous improvements in the efficiency of the preparation of histological specimens and implementation of various time-saving and tissue-saving surgical interventions, relatively little attention has been given to address the sometimes chaotic and challenging process of organizing results from each stage of multiple patients in an MMS surgical suite.⁵

As demonstrated by our survey, incorporation of a light-based system into an MMS clinic may improve workplace efficiency by decreasing the redundant use of support staff and allowing Mohs surgeons to transition from one station to the next seamlessly. Light-based communication systems provide an immediate notification for support staff via color-coded and/or numerically coded indicators on input switches located outside and inside the examination/surgery rooms. The switch indicators can be depressed with minimal disruption from station to station, thereby foregoing the need to interrupt an ongoing excision or closure to convey the status of the case. These systems may then permit enhanced clinic and workflow efficiency, which may help to shorten patient wait times.

Conclusion

Our study supports the use of light-based communication systems in MMS suites to improve efficiency in the clinic. Based on our analysis, light-based communication methods were significantly associated with improved time savings (P=.0482). Our study did not show an improvement in provider-reported satisfaction with any of the current systems used in MMS clinics. We hope that this information will help guide providers in implementing new communication techniques to improve clinic efficiency. 



Acknowledgments
The authors would like to thank Ms. Kathy Kyler (Oklahoma City, Oklahoma) for her assistance in preparing this manuscript. Support for Dr. Chen and Mr. Stubblefield was provided through National Institutes of Health, National Institute of General Medical Sciences [Grant 2U54GM104938-06, PI Judith James].

Mohs micrographic surgery (MMS) entails multiple time-consuming surgical and histological examinations for each patient. As surgical stages are performed and histological sections are processed, an efficient communication method among providers, medical assistants, histotechnologists, and patients is necessary to avoid delays. To address these and other communication issues, providers have focused on ways to increase clinic efficiency and improve patient-reported outcomes by utilizing new or repurposed communication technologies in their Mohs practice. 

Prior reports have highlighted the utility of hands-free headsets that allow real-time communication among staff members as a means of increasing clinic efficiency and decreasing patient wait times.^1-4 These systems may mediate a more rapid turnover between stages by mitigating the need for surgeons and support staff to assemble within a designated workspace.^1,3,4 However, there is no single or standardized communication method that best suits all surgical suites and MMS practices. Our study aimed to identify the current communication strategies employed by Mohs surgeons and thereby ascertain which method(s) portend(s) the highest benefit in average daily time savings and provider-perceived patient satisfaction.

Materials and Methods

Survey Instrument
A new 10-question electronic survey was published on the SurveyMonkey website, and a link to the survey was provided in a quarterly email that originated from the American College of Mohs Surgery and was distributed to all 1735 active members. Responses were obtained from January 2019 to February 2019.

Statistical Analysis
A statistical analysis was done to determine any significant associations among the providers’ responses. P<.05 was used to determine statistical significance. A Cochran-Armitage test for trend was used to identify significant associations between the number of rooms and the communication systems that were used. Thus, 7 total tests—1 for each device (whiteboard, light system, flag system, wired intercom, wireless intercom, walkie-talkie, or headset)—were conducted. The Cochran-Armitage test also was used to determine whether the probability of using the device was affected by the number of stations/surgical rooms that were attended by the Mohs surgeons. To determine whether the communication devices used were associated with higher patient satisfaction, a χ² test was conducted for each device (7 total tests), testing the categories of using that device (yes/no) and patient satisfaction (yes/no). A Fisher exact test of independence was used in any case where the proportion for the device and patient satisfaction was 25% or higher. To determine whether the communication method was associated with increased time savings, 7 total Cochran-Armitage tests were conducted, 1 for each device. A logistic regression model was used to determine whether there was a significant association between the number of stations and the likelihood of reporting patient satisfaction.

Results

Eighty-eight surgeons responded to the survey, with a response rate of 5% (88/1735). A total of 55 surgeons completed the survey in its entirety and were included in the data analysis. The most commonly used communication mediums were whiteboards (29/55 [53%]), followed by a flag system (16/55 [29%]) and a light system (13/55 [24%]). Most Mohs surgeons (52/55 [95%]) used the communication media to communicate with their staff only, and 76% (42/55) of Mohs surgeons believed that their communication media contributed to higher patient satisfaction. Overall, 58% (32/55) of Mohs surgeons stated that their communication media saved more than 15 minutes (on average) per day. The use of a whiteboard and/or flag system was reported as the least efficient method, with average daily time savings of 13 minutes. With the introduction of newer technology (wired or wireless intercoms, headsets, walkie-talkies, or internal messaging systems such as Skype) to the whiteboard and/or flag system, the time savings increased by 10 minutes per day. Nearly 25% (14/55) of surgeons utilized more than 1 communication system.

As the number of stations in an MMS suite increased, the probability of using a whiteboard to track the progress of the cases decreased. There were no statistically significant associations identified between the number of stations and the use of other communication devices (ie, flag system, light system, wireless intercom, wired intercom, walkie-talkie, headset). The stratified percentages of the amount of time savings for each communication modality are presented in the Figure (whiteboards and headsets were excluded because they did not increase time savings). The use of a light system was the only communication modality found to be statistically associated with an increase in provider-reported time savings (P=.0482; Figure). In addition, our analysis did not show an improvement in provider-reported patient satisfaction with any of the current systems used in MMS clinics.

Comment

The process of transmitting information among the medical team during MMS is a complex interplay involving the relay of crucial information, with many opportunities for the introduction of distraction and error. Despite numerous improvements in the efficiency of the preparation of histological specimens and implementation of various time-saving and tissue-saving surgical interventions, relatively little attention has been given to address the sometimes chaotic and challenging process of organizing results from each stage of multiple patients in an MMS surgical suite.⁵

As demonstrated by our survey, incorporation of a light-based system into an MMS clinic may improve workplace efficiency by decreasing the redundant use of support staff and allowing Mohs surgeons to transition from one station to the next seamlessly. Light-based communication systems provide an immediate notification for support staff via color-coded and/or numerically coded indicators on input switches located outside and inside the examination/surgery rooms. The switch indicators can be depressed with minimal disruption from station to station, thereby foregoing the need to interrupt an ongoing excision or closure to convey the status of the case. These systems may then permit enhanced clinic and workflow efficiency, which may help to shorten patient wait times.

Conclusion

Our study supports the use of light-based communication systems in MMS suites to improve efficiency in the clinic. Based on our analysis, light-based communication methods were significantly associated with improved time savings (P=.0482). Our study did not show an improvement in provider-reported satisfaction with any of the current systems used in MMS clinics. We hope that this information will help guide providers in implementing new communication techniques to improve clinic efficiency. 



Acknowledgments
The authors would like to thank Ms. Kathy Kyler (Oklahoma City, Oklahoma) for her assistance in preparing this manuscript. Support for Dr. Chen and Mr. Stubblefield was provided through National Institutes of Health, National Institute of General Medical Sciences [Grant 2U54GM104938-06, PI Judith James].

Mohs micrographic surgery (MMS) entails multiple time-consuming surgical and histological examinations for each patient. As surgical stages are performed and histological sections are processed, an efficient communication method among providers, medical assistants, histotechnologists, and patients is necessary to avoid delays. To address these and other communication issues, providers have focused on ways to increase clinic efficiency and improve patient-reported outcomes by utilizing new or repurposed communication technologies in their Mohs practice. 

Prior reports have highlighted the utility of hands-free headsets that allow real-time communication among staff members as a means of increasing clinic efficiency and decreasing patient wait times.^1-4 These systems may mediate a more rapid turnover between stages by mitigating the need for surgeons and support staff to assemble within a designated workspace.^1,3,4 However, there is no single or standardized communication method that best suits all surgical suites and MMS practices. Our study aimed to identify the current communication strategies employed by Mohs surgeons and thereby ascertain which method(s) portend(s) the highest benefit in average daily time savings and provider-perceived patient satisfaction.

Materials and Methods

Survey Instrument
A new 10-question electronic survey was published on the SurveyMonkey website, and a link to the survey was provided in a quarterly email that originated from the American College of Mohs Surgery and was distributed to all 1735 active members. Responses were obtained from January 2019 to February 2019.

Statistical Analysis
A statistical analysis was done to determine any significant associations among the providers’ responses. P<.05 was used to determine statistical significance. A Cochran-Armitage test for trend was used to identify significant associations between the number of rooms and the communication systems that were used. Thus, 7 total tests—1 for each device (whiteboard, light system, flag system, wired intercom, wireless intercom, walkie-talkie, or headset)—were conducted. The Cochran-Armitage test also was used to determine whether the probability of using the device was affected by the number of stations/surgical rooms that were attended by the Mohs surgeons. To determine whether the communication devices used were associated with higher patient satisfaction, a χ² test was conducted for each device (7 total tests), testing the categories of using that device (yes/no) and patient satisfaction (yes/no). A Fisher exact test of independence was used in any case where the proportion for the device and patient satisfaction was 25% or higher. To determine whether the communication method was associated with increased time savings, 7 total Cochran-Armitage tests were conducted, 1 for each device. A logistic regression model was used to determine whether there was a significant association between the number of stations and the likelihood of reporting patient satisfaction.

Results

Eighty-eight surgeons responded to the survey, with a response rate of 5% (88/1735). A total of 55 surgeons completed the survey in its entirety and were included in the data analysis. The most commonly used communication mediums were whiteboards (29/55 [53%]), followed by a flag system (16/55 [29%]) and a light system (13/55 [24%]). Most Mohs surgeons (52/55 [95%]) used the communication media to communicate with their staff only, and 76% (42/55) of Mohs surgeons believed that their communication media contributed to higher patient satisfaction. Overall, 58% (32/55) of Mohs surgeons stated that their communication media saved more than 15 minutes (on average) per day. The use of a whiteboard and/or flag system was reported as the least efficient method, with average daily time savings of 13 minutes. With the introduction of newer technology (wired or wireless intercoms, headsets, walkie-talkies, or internal messaging systems such as Skype) to the whiteboard and/or flag system, the time savings increased by 10 minutes per day. Nearly 25% (14/55) of surgeons utilized more than 1 communication system.

As the number of stations in an MMS suite increased, the probability of using a whiteboard to track the progress of the cases decreased. There were no statistically significant associations identified between the number of stations and the use of other communication devices (ie, flag system, light system, wireless intercom, wired intercom, walkie-talkie, headset). The stratified percentages of the amount of time savings for each communication modality are presented in the Figure (whiteboards and headsets were excluded because they did not increase time savings). The use of a light system was the only communication modality found to be statistically associated with an increase in provider-reported time savings (P=.0482; Figure). In addition, our analysis did not show an improvement in provider-reported patient satisfaction with any of the current systems used in MMS clinics.

Comment

The process of transmitting information among the medical team during MMS is a complex interplay involving the relay of crucial information, with many opportunities for the introduction of distraction and error. Despite numerous improvements in the efficiency of the preparation of histological specimens and implementation of various time-saving and tissue-saving surgical interventions, relatively little attention has been given to address the sometimes chaotic and challenging process of organizing results from each stage of multiple patients in an MMS surgical suite.⁵

As demonstrated by our survey, incorporation of a light-based system into an MMS clinic may improve workplace efficiency by decreasing the redundant use of support staff and allowing Mohs surgeons to transition from one station to the next seamlessly. Light-based communication systems provide an immediate notification for support staff via color-coded and/or numerically coded indicators on input switches located outside and inside the examination/surgery rooms. The switch indicators can be depressed with minimal disruption from station to station, thereby foregoing the need to interrupt an ongoing excision or closure to convey the status of the case. These systems may then permit enhanced clinic and workflow efficiency, which may help to shorten patient wait times.

Conclusion

Our study supports the use of light-based communication systems in MMS suites to improve efficiency in the clinic. Based on our analysis, light-based communication methods were significantly associated with improved time savings (P=.0482). Our study did not show an improvement in provider-reported satisfaction with any of the current systems used in MMS clinics. We hope that this information will help guide providers in implementing new communication techniques to improve clinic efficiency. 



Acknowledgments
The authors would like to thank Ms. Kathy Kyler (Oklahoma City, Oklahoma) for her assistance in preparing this manuscript. Support for Dr. Chen and Mr. Stubblefield was provided through National Institutes of Health, National Institute of General Medical Sciences [Grant 2U54GM104938-06, PI Judith James].

New guidelines from the American Academy of Dermatology strongly recommend the use of either 5-fluorouracil (5-FU) or imiquimod for the field treatment of actinic keratosis (AK). 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.

New guidelines from the American Academy of Dermatology strongly recommend the use of either 5-fluorouracil (5-FU) or imiquimod for the field treatment of actinic keratosis (AK). 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.

New guidelines from the American Academy of Dermatology strongly recommend the use of either 5-fluorouracil (5-FU) or imiquimod for the field treatment of actinic keratosis (AK). 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.

The decline in the number of cosmetic procedures performed in 2020, compared with 2019, very closely matched the amount of the time lost to physicians because of the COVID-19 pandemic, according to the American Society of Plastic Surgeons.

There were an estimated 15.6 million cosmetic procedures performed in 2020, compared with 18.4 million in 2019, a drop of 15.2%. Meanwhile, society members reported that they stopped performing elective surgery for an average of 8.1 weeks, which works out to 15.6% of a 52-week year, the ASPS said in its annual statistics report.

“The pandemic isn’t over, but thanks to vaccines, a new normal is starting to define itself – and some surgeons’ offices that were closed or offered only limited services within the last year are seeing higher demand,” Lynn Jeffers, MD, MBA, immediate past president of the ASPS, said in a written statement.

Minimally invasive procedures, which made up the majority of cosmetic procedures in 2020, dropped by a slightly higher 16%, compared with 14% on the surgical side. “Injectables continued to be the most sought-after treatments in 2020,” the ASPS said, with survey respondents citing “a significant uptick in demand during the coronavirus pandemic.”

OnabotuliumtoxinA injection, the most popular form of minimally invasive procedure, was down by 13% from 2019, while use of soft-tissue fillers fell by 11%. Laser skin resurfacing was third in popularity and had the smallest drop, just 8%, among the top five from 2019 to 2020, the ASPS data show.

The drop in volume for chemical peels was large enough (33%), to move it from third place in 2019 to fourth in 2020, and a slightly less than average drop of 12% moved intense pulsed-light treatments from sixth place in 2019 to fifth in 2020, switching places with laser hair removal (down 28%), the ASPS reported.

Among the surgical procedures, rhinoplasty was the most popular in 2020, as it was in 2019, after dropping by just 3%. Blepharoplasty was down by 8% from 2019, but two other common procedures, liposuction and breast augmentation, fell by 20% and 33%, respectively, the ASPS said.

rfranki@mdedge.com

The decline in the number of cosmetic procedures performed in 2020, compared with 2019, very closely matched the amount of the time lost to physicians because of the COVID-19 pandemic, according to the American Society of Plastic Surgeons.

There were an estimated 15.6 million cosmetic procedures performed in 2020, compared with 18.4 million in 2019, a drop of 15.2%. Meanwhile, society members reported that they stopped performing elective surgery for an average of 8.1 weeks, which works out to 15.6% of a 52-week year, the ASPS said in its annual statistics report.

“The pandemic isn’t over, but thanks to vaccines, a new normal is starting to define itself – and some surgeons’ offices that were closed or offered only limited services within the last year are seeing higher demand,” Lynn Jeffers, MD, MBA, immediate past president of the ASPS, said in a written statement.

Minimally invasive procedures, which made up the majority of cosmetic procedures in 2020, dropped by a slightly higher 16%, compared with 14% on the surgical side. “Injectables continued to be the most sought-after treatments in 2020,” the ASPS said, with survey respondents citing “a significant uptick in demand during the coronavirus pandemic.”

OnabotuliumtoxinA injection, the most popular form of minimally invasive procedure, was down by 13% from 2019, while use of soft-tissue fillers fell by 11%. Laser skin resurfacing was third in popularity and had the smallest drop, just 8%, among the top five from 2019 to 2020, the ASPS data show.

The drop in volume for chemical peels was large enough (33%), to move it from third place in 2019 to fourth in 2020, and a slightly less than average drop of 12% moved intense pulsed-light treatments from sixth place in 2019 to fifth in 2020, switching places with laser hair removal (down 28%), the ASPS reported.

Among the surgical procedures, rhinoplasty was the most popular in 2020, as it was in 2019, after dropping by just 3%. Blepharoplasty was down by 8% from 2019, but two other common procedures, liposuction and breast augmentation, fell by 20% and 33%, respectively, the ASPS said.

rfranki@mdedge.com

The decline in the number of cosmetic procedures performed in 2020, compared with 2019, very closely matched the amount of the time lost to physicians because of the COVID-19 pandemic, according to the American Society of Plastic Surgeons.

There were an estimated 15.6 million cosmetic procedures performed in 2020, compared with 18.4 million in 2019, a drop of 15.2%. Meanwhile, society members reported that they stopped performing elective surgery for an average of 8.1 weeks, which works out to 15.6% of a 52-week year, the ASPS said in its annual statistics report.

“The pandemic isn’t over, but thanks to vaccines, a new normal is starting to define itself – and some surgeons’ offices that were closed or offered only limited services within the last year are seeing higher demand,” Lynn Jeffers, MD, MBA, immediate past president of the ASPS, said in a written statement.

Minimally invasive procedures, which made up the majority of cosmetic procedures in 2020, dropped by a slightly higher 16%, compared with 14% on the surgical side. “Injectables continued to be the most sought-after treatments in 2020,” the ASPS said, with survey respondents citing “a significant uptick in demand during the coronavirus pandemic.”

OnabotuliumtoxinA injection, the most popular form of minimally invasive procedure, was down by 13% from 2019, while use of soft-tissue fillers fell by 11%. Laser skin resurfacing was third in popularity and had the smallest drop, just 8%, among the top five from 2019 to 2020, the ASPS data show.

The drop in volume for chemical peels was large enough (33%), to move it from third place in 2019 to fourth in 2020, and a slightly less than average drop of 12% moved intense pulsed-light treatments from sixth place in 2019 to fifth in 2020, switching places with laser hair removal (down 28%), the ASPS reported.

Among the surgical procedures, rhinoplasty was the most popular in 2020, as it was in 2019, after dropping by just 3%. Blepharoplasty was down by 8% from 2019, but two other common procedures, liposuction and breast augmentation, fell by 20% and 33%, respectively, the ASPS said.

rfranki@mdedge.com

The serious infection risk associated with rituximab treatment for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is high but can be offset by co-prescribing co-trimoxazole, data from a single-center, retrospective study reaffirm.

Over the course of a 3-year study period, 14 (28%) of 50 patients with AAV treated with rituximab experienced at latest one severe infection defined as a grade 3 or higher event. The incidence of severe infections was 15.4 per 100 person-years.

However, a lower rate of infections was seen in patients who had been co-prescribed co-trimoxazole (trimethoprim and sulfamethoxazole), Francesco Dernie, a fifth-year medical student at the University of Oxford (England), reported at the British Society for Rheumatology annual conference.

“In the case of rituximab, the depletion of B cells and associated immune suppression is a double-edged sword, allowing effective disease control, but also leaving the body vulnerable to opportunistic and severe infections,” Mr. Dernie said at the meeting.

Of the patients who developed a severe infection on rituximab, just 7% had been treated with co-trimoxazole. In comparison, 44% of those who did not get a severe infection had received co-trimoxazole. Multivariate analysis confirmed that co-trimoxazole use was an influencing factor, with an odds ratio (OR) of 0.096 (95% confidence interval, 0.009–0.996; P = .05).

Another finding was that patients with low immunoglobulin G levels (less than 6 g/L) were more likely to develop a severe infection than were those with higher IgG levels. Indeed, the OR for hypogammaglobulinemia and the risk for infection was 8.782 (95% CI, 1.19–64.6; P = .033).

“Our results support the monitoring of IgG levels to identify patients who may be more susceptible to infection, as well as the prescription of prophylactic co-trimoxazole to reduce overall severe infection risk,” Mr. Dernie and associates concluded in their abstract.

It’s a “really important message around co-trimoxazole,” observed Neil Basu, MBChB, a clinical senior lecturer and honorary consultant at the Institute of Infection, Immunity & Inflammation, University of Glasgow (Scotland).

“It still frustrates me when I see that patients haven’t received that while receiving rituximab. Of course, co-trimoxazole can have its problems,” said Dr. Basu, who was not involved in the study. “It’s not uncommon for patients to develop reactions or be intolerant to the drug.”

Raashid Luqmani, DM, a senior coauthor of the work and professor of rheumatology at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, said: “The tolerance of co-trimoxazole has been remarkably good in this cohort.” If there was a problem with using co-trimoxazole, then “our standard would be to go with trimethoprim alone as the next in line and follow that with inhaled pentamidine. So, it’s kind of following what we would all generally do,” Dr. Luqmani said.

Study details

To look at the characteristics of and risk factors for serious infections associated with rituximab use in AAV, Mr. Dernie and associates retrospectively examined the electronic records of patients who had been treated between August 2016 and August 2019. Follow-up was until August 2020.

Of the 50 patients identified, nearly half (48%) were men. The average age was 60 years, ranging from 25 to 90 years. Most (n = 36; 72%) patients had a diagnosis of granulomatosis with polyangiitis, while another 2 (4%) had microscopic polyangiitis, 1 (2%) had eosinophilic granulomatosis with polyangiitis, and 11 (22%) had an overlapping type of vasculitis or undefined AAV.

Of the 18 severe infection events recorded, most (56%) involved the respiratory tract. Less than one-third (28%) were sepsis or neutropenic sepsis events, and there was one case each (6%) of cellulitis, complicated urinary tract infection, and recurrent wound infection.

There were “small numbers of individual comorbidities that were not sufficient to enter into our regression analysis,” Mr. Dernie noted. “It’s likely that comorbid conditions such as COPD [chronic obstructive pulmonary disease] also contribute to an individual’s risk of developing severe infections, and thus should factor into their individualized management.”

Mr. Dernie acknowledged in discussion: “One of the limitations of the study was we just looked at patients in a time when they were receiving rituximab, so they may have historically been exposed to other treatment options.” However, he added, “they weren’t having any other major DMARDs or immunosuppressive treatments at the time.”

Dr. Luqmani observed: “If you look at Francesco’s data on the hypogammaglobulinemia at the start of rituximab, that probably gives you a good idea of just how immunosuppressed these patients were already before we got to this point.”

Dr. Luqmani added: “I suspect that’s in keeping with a lot of other centers that have started using rituximab an awful lot for patients who previously had episodes of vasculitis treated with other disease-modifying therapies, particularly cyclophosphamide.”

But for how long should co-trimoxazole be given after the last rituximab dose? asked the chair of the session, Richard Watts, DM, of Norwich (England) Medical School. These data are purely observational, so it’s not possible to say, Mr. Dernie noted: “The patients that we included as having co-trimoxazole seem to be on it more or less consistently, permanently,” he said.

What about the best dose? “It’s a tricky one,” Dr. Luqmani said, as “we not only use co-trimoxazole for prophylaxis, but we often also want to use it for treatment of the vasculitis itself.”

It’s very likely that there was a mix of patients in the analysis that had received co-trimoxazole as either a treatment or prophylaxis, which means different doses, he said.

“It might be interesting to know whether there was a difference” between doses used and the prevention of infection, added Dr. Luqmani, “but I suspect the numbers are too small to tell.”

Mr. Dernie, Dr. Luqmani, and the other coauthors had no disclosures.

The serious infection risk associated with rituximab treatment for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is high but can be offset by co-prescribing co-trimoxazole, data from a single-center, retrospective study reaffirm.

Over the course of a 3-year study period, 14 (28%) of 50 patients with AAV treated with rituximab experienced at latest one severe infection defined as a grade 3 or higher event. The incidence of severe infections was 15.4 per 100 person-years.

However, a lower rate of infections was seen in patients who had been co-prescribed co-trimoxazole (trimethoprim and sulfamethoxazole), Francesco Dernie, a fifth-year medical student at the University of Oxford (England), reported at the British Society for Rheumatology annual conference.

“In the case of rituximab, the depletion of B cells and associated immune suppression is a double-edged sword, allowing effective disease control, but also leaving the body vulnerable to opportunistic and severe infections,” Mr. Dernie said at the meeting.

Of the patients who developed a severe infection on rituximab, just 7% had been treated with co-trimoxazole. In comparison, 44% of those who did not get a severe infection had received co-trimoxazole. Multivariate analysis confirmed that co-trimoxazole use was an influencing factor, with an odds ratio (OR) of 0.096 (95% confidence interval, 0.009–0.996; P = .05).

Another finding was that patients with low immunoglobulin G levels (less than 6 g/L) were more likely to develop a severe infection than were those with higher IgG levels. Indeed, the OR for hypogammaglobulinemia and the risk for infection was 8.782 (95% CI, 1.19–64.6; P = .033).

“Our results support the monitoring of IgG levels to identify patients who may be more susceptible to infection, as well as the prescription of prophylactic co-trimoxazole to reduce overall severe infection risk,” Mr. Dernie and associates concluded in their abstract.

It’s a “really important message around co-trimoxazole,” observed Neil Basu, MBChB, a clinical senior lecturer and honorary consultant at the Institute of Infection, Immunity & Inflammation, University of Glasgow (Scotland).

“It still frustrates me when I see that patients haven’t received that while receiving rituximab. Of course, co-trimoxazole can have its problems,” said Dr. Basu, who was not involved in the study. “It’s not uncommon for patients to develop reactions or be intolerant to the drug.”

Raashid Luqmani, DM, a senior coauthor of the work and professor of rheumatology at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, said: “The tolerance of co-trimoxazole has been remarkably good in this cohort.” If there was a problem with using co-trimoxazole, then “our standard would be to go with trimethoprim alone as the next in line and follow that with inhaled pentamidine. So, it’s kind of following what we would all generally do,” Dr. Luqmani said.

Study details

To look at the characteristics of and risk factors for serious infections associated with rituximab use in AAV, Mr. Dernie and associates retrospectively examined the electronic records of patients who had been treated between August 2016 and August 2019. Follow-up was until August 2020.

Of the 50 patients identified, nearly half (48%) were men. The average age was 60 years, ranging from 25 to 90 years. Most (n = 36; 72%) patients had a diagnosis of granulomatosis with polyangiitis, while another 2 (4%) had microscopic polyangiitis, 1 (2%) had eosinophilic granulomatosis with polyangiitis, and 11 (22%) had an overlapping type of vasculitis or undefined AAV.

Of the 18 severe infection events recorded, most (56%) involved the respiratory tract. Less than one-third (28%) were sepsis or neutropenic sepsis events, and there was one case each (6%) of cellulitis, complicated urinary tract infection, and recurrent wound infection.

There were “small numbers of individual comorbidities that were not sufficient to enter into our regression analysis,” Mr. Dernie noted. “It’s likely that comorbid conditions such as COPD [chronic obstructive pulmonary disease] also contribute to an individual’s risk of developing severe infections, and thus should factor into their individualized management.”

Mr. Dernie acknowledged in discussion: “One of the limitations of the study was we just looked at patients in a time when they were receiving rituximab, so they may have historically been exposed to other treatment options.” However, he added, “they weren’t having any other major DMARDs or immunosuppressive treatments at the time.”

Dr. Luqmani observed: “If you look at Francesco’s data on the hypogammaglobulinemia at the start of rituximab, that probably gives you a good idea of just how immunosuppressed these patients were already before we got to this point.”

Dr. Luqmani added: “I suspect that’s in keeping with a lot of other centers that have started using rituximab an awful lot for patients who previously had episodes of vasculitis treated with other disease-modifying therapies, particularly cyclophosphamide.”

But for how long should co-trimoxazole be given after the last rituximab dose? asked the chair of the session, Richard Watts, DM, of Norwich (England) Medical School. These data are purely observational, so it’s not possible to say, Mr. Dernie noted: “The patients that we included as having co-trimoxazole seem to be on it more or less consistently, permanently,” he said.

What about the best dose? “It’s a tricky one,” Dr. Luqmani said, as “we not only use co-trimoxazole for prophylaxis, but we often also want to use it for treatment of the vasculitis itself.”

It’s very likely that there was a mix of patients in the analysis that had received co-trimoxazole as either a treatment or prophylaxis, which means different doses, he said.

“It might be interesting to know whether there was a difference” between doses used and the prevention of infection, added Dr. Luqmani, “but I suspect the numbers are too small to tell.”

Mr. Dernie, Dr. Luqmani, and the other coauthors had no disclosures.

The serious infection risk associated with rituximab treatment for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is high but can be offset by co-prescribing co-trimoxazole, data from a single-center, retrospective study reaffirm.

Over the course of a 3-year study period, 14 (28%) of 50 patients with AAV treated with rituximab experienced at latest one severe infection defined as a grade 3 or higher event. The incidence of severe infections was 15.4 per 100 person-years.

However, a lower rate of infections was seen in patients who had been co-prescribed co-trimoxazole (trimethoprim and sulfamethoxazole), Francesco Dernie, a fifth-year medical student at the University of Oxford (England), reported at the British Society for Rheumatology annual conference.

“In the case of rituximab, the depletion of B cells and associated immune suppression is a double-edged sword, allowing effective disease control, but also leaving the body vulnerable to opportunistic and severe infections,” Mr. Dernie said at the meeting.

Of the patients who developed a severe infection on rituximab, just 7% had been treated with co-trimoxazole. In comparison, 44% of those who did not get a severe infection had received co-trimoxazole. Multivariate analysis confirmed that co-trimoxazole use was an influencing factor, with an odds ratio (OR) of 0.096 (95% confidence interval, 0.009–0.996; P = .05).

Another finding was that patients with low immunoglobulin G levels (less than 6 g/L) were more likely to develop a severe infection than were those with higher IgG levels. Indeed, the OR for hypogammaglobulinemia and the risk for infection was 8.782 (95% CI, 1.19–64.6; P = .033).

“Our results support the monitoring of IgG levels to identify patients who may be more susceptible to infection, as well as the prescription of prophylactic co-trimoxazole to reduce overall severe infection risk,” Mr. Dernie and associates concluded in their abstract.

It’s a “really important message around co-trimoxazole,” observed Neil Basu, MBChB, a clinical senior lecturer and honorary consultant at the Institute of Infection, Immunity & Inflammation, University of Glasgow (Scotland).

“It still frustrates me when I see that patients haven’t received that while receiving rituximab. Of course, co-trimoxazole can have its problems,” said Dr. Basu, who was not involved in the study. “It’s not uncommon for patients to develop reactions or be intolerant to the drug.”

Raashid Luqmani, DM, a senior coauthor of the work and professor of rheumatology at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, said: “The tolerance of co-trimoxazole has been remarkably good in this cohort.” If there was a problem with using co-trimoxazole, then “our standard would be to go with trimethoprim alone as the next in line and follow that with inhaled pentamidine. So, it’s kind of following what we would all generally do,” Dr. Luqmani said.

Study details

To look at the characteristics of and risk factors for serious infections associated with rituximab use in AAV, Mr. Dernie and associates retrospectively examined the electronic records of patients who had been treated between August 2016 and August 2019. Follow-up was until August 2020.

Of the 50 patients identified, nearly half (48%) were men. The average age was 60 years, ranging from 25 to 90 years. Most (n = 36; 72%) patients had a diagnosis of granulomatosis with polyangiitis, while another 2 (4%) had microscopic polyangiitis, 1 (2%) had eosinophilic granulomatosis with polyangiitis, and 11 (22%) had an overlapping type of vasculitis or undefined AAV.

Of the 18 severe infection events recorded, most (56%) involved the respiratory tract. Less than one-third (28%) were sepsis or neutropenic sepsis events, and there was one case each (6%) of cellulitis, complicated urinary tract infection, and recurrent wound infection.

There were “small numbers of individual comorbidities that were not sufficient to enter into our regression analysis,” Mr. Dernie noted. “It’s likely that comorbid conditions such as COPD [chronic obstructive pulmonary disease] also contribute to an individual’s risk of developing severe infections, and thus should factor into their individualized management.”

Mr. Dernie acknowledged in discussion: “One of the limitations of the study was we just looked at patients in a time when they were receiving rituximab, so they may have historically been exposed to other treatment options.” However, he added, “they weren’t having any other major DMARDs or immunosuppressive treatments at the time.”

Dr. Luqmani observed: “If you look at Francesco’s data on the hypogammaglobulinemia at the start of rituximab, that probably gives you a good idea of just how immunosuppressed these patients were already before we got to this point.”

Dr. Luqmani added: “I suspect that’s in keeping with a lot of other centers that have started using rituximab an awful lot for patients who previously had episodes of vasculitis treated with other disease-modifying therapies, particularly cyclophosphamide.”

But for how long should co-trimoxazole be given after the last rituximab dose? asked the chair of the session, Richard Watts, DM, of Norwich (England) Medical School. These data are purely observational, so it’s not possible to say, Mr. Dernie noted: “The patients that we included as having co-trimoxazole seem to be on it more or less consistently, permanently,” he said.

What about the best dose? “It’s a tricky one,” Dr. Luqmani said, as “we not only use co-trimoxazole for prophylaxis, but we often also want to use it for treatment of the vasculitis itself.”

It’s very likely that there was a mix of patients in the analysis that had received co-trimoxazole as either a treatment or prophylaxis, which means different doses, he said.

“It might be interesting to know whether there was a difference” between doses used and the prevention of infection, added Dr. Luqmani, “but I suspect the numbers are too small to tell.”

Mr. Dernie, Dr. Luqmani, and the other coauthors had no disclosures.

Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the annual meeting of the American College of Physicians.

Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.

However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.

“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.

He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.

Restricted sleep is a good place to start for chronic insomnia, he continued.

Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.

Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.

“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
 

Sleep specialists in short supply

Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.

He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.

CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.

However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.

Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.

“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
 

Insomnia among older patients

Interest in helping older patients with insomnia dominated the chat session associated with the talk.

Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.

Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.

If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.

“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.

Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.

Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.

He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.

He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.

Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.

“It has no measurable effect in a third of patients and at least unacceptable side effects in another third.  Right off the bat, it’s not efficacious in two thirds of patients.”

Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”

Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.

Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.

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

Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the annual meeting of the American College of Physicians.

Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.

However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.

“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.

He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.

Restricted sleep is a good place to start for chronic insomnia, he continued.

Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.

Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.

“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
 

Sleep specialists in short supply

Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.

He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.

CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.

However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.

Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.

“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
 

Insomnia among older patients

Interest in helping older patients with insomnia dominated the chat session associated with the talk.

Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.

Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.

If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.

“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.

Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.

Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.

He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.

He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.

Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.

“It has no measurable effect in a third of patients and at least unacceptable side effects in another third.  Right off the bat, it’s not efficacious in two thirds of patients.”

Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”

Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.

Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.

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

Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the annual meeting of the American College of Physicians.

Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.

However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.

“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.

He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.

Restricted sleep is a good place to start for chronic insomnia, he continued.

Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.

Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.

“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
 

Sleep specialists in short supply

Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.

He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.

CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.

However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.

Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.

“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
 

Insomnia among older patients

Interest in helping older patients with insomnia dominated the chat session associated with the talk.

Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.

Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.

If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.

“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.

Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.

Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.

He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.

He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.

Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.

“It has no measurable effect in a third of patients and at least unacceptable side effects in another third.  Right off the bat, it’s not efficacious in two thirds of patients.”

Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”

Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.

Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.

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

Converge 2021 session

Making The Pediatric Hospital Medicine Core Competencies Work for You

Presenters

Erin Fisher, MD, MHM, FAAP; Sandra Gage, MD, PhD, SFHM, FAAP; Jennifer Maniscalco, MD, MPH, MAcM, FAAP; Sofia Teferi, MD, SFHM, FAAP

Session summary

The Pediatric Hospital Medicine (PHM) Core Competencies were originally published in the Journal of Hospital Medicine in 2010, and created a framework for graduate and continuing medical education, reflecting the roles and expectations for all pediatric hospitalists in the United States. Since that time, the field of PHM, scope of practice, and roles of hospitalists has evolved, making a substantial update to this dossier necessary.

The 2020 PHM Core Competencies consist of four sections, including common clinical diagnoses and conditions, specialized services, core skills, and the health care system. The four topics are covered in 66 chapters, which were updated or created for the present version.

The Core Competencies have many practical applications, including teaching or curriculum development, which may be used by trainees as well as PHM providers. The speakers gave real-world examples of the competencies’ application to evaluations, and the continuum of knowledge, skills, attitudes, and system implementation in the development of a trainee from student to practicing hospitalist. Trainees’ knowledge gaps can be identified using the competencies, and utilization of the provided compendium will help identify sources that can aid in teaching.

Professional development is an excellent way to utilize the Core Competencies. Division directors may identify a needed area for improvement and the competencies can serve as a road map for establishing goals, plan development, and analysis of results of the intervention. They are also a great resource for PHM board prep. Although the competencies were not developed specifically for the PHM boards, they do contain all 13 PHM content domains set forth by the American Board of Pediatrics for PHM.

The Core Competencies can also be used to justify service line needs and resources in discussions with administration. For instance, if one is a pediatric hospitalist at a community hospital and asked to take over the newborn nursery, the competencies can be used to get buy-in from the group, as a guide for additional training, to provide a framework for development of practice pathways, and to request resources needed.

The Pediatric Core Competencies are a great resource for pediatric hospitalists and group leaders with many uses, from board preparation to education and professional development. They provide a framework for improvement of knowledge, skills, and attitudes within an organization.
 

Key takeaways

• Given a change in scope of practice of pediatric hospitalists over the past 10 years, the PHM Core Competencies were updated and published in the Journal of Hospital Medicine in 2020.
• The Core Competencies have many practical applications including education, curriculum development, professional development, and PHM board preparation.
• The Core Competencies provide a framework for improvement of knowledge, skills, and attitudes within an organization.

Dr. Schwenk is a pediatric hospitalist at Norton Children’s Hospital in Louisville, Ky., where he serves as a medical director of inpatient services. He is an associate professor of pediatrics at the University of Louisville School of Medicine. He is a Senior Fellow of Hospital Medicine and has served on the executive council of the Pediatrics Special Interest Group and the Annual Meeting Committee for SHM Converge.

Converge 2021 session

Making The Pediatric Hospital Medicine Core Competencies Work for You

Presenters

Erin Fisher, MD, MHM, FAAP; Sandra Gage, MD, PhD, SFHM, FAAP; Jennifer Maniscalco, MD, MPH, MAcM, FAAP; Sofia Teferi, MD, SFHM, FAAP

Session summary

The Pediatric Hospital Medicine (PHM) Core Competencies were originally published in the Journal of Hospital Medicine in 2010, and created a framework for graduate and continuing medical education, reflecting the roles and expectations for all pediatric hospitalists in the United States. Since that time, the field of PHM, scope of practice, and roles of hospitalists has evolved, making a substantial update to this dossier necessary.

The 2020 PHM Core Competencies consist of four sections, including common clinical diagnoses and conditions, specialized services, core skills, and the health care system. The four topics are covered in 66 chapters, which were updated or created for the present version.

The Core Competencies have many practical applications, including teaching or curriculum development, which may be used by trainees as well as PHM providers. The speakers gave real-world examples of the competencies’ application to evaluations, and the continuum of knowledge, skills, attitudes, and system implementation in the development of a trainee from student to practicing hospitalist. Trainees’ knowledge gaps can be identified using the competencies, and utilization of the provided compendium will help identify sources that can aid in teaching.

Professional development is an excellent way to utilize the Core Competencies. Division directors may identify a needed area for improvement and the competencies can serve as a road map for establishing goals, plan development, and analysis of results of the intervention. They are also a great resource for PHM board prep. Although the competencies were not developed specifically for the PHM boards, they do contain all 13 PHM content domains set forth by the American Board of Pediatrics for PHM.

The Core Competencies can also be used to justify service line needs and resources in discussions with administration. For instance, if one is a pediatric hospitalist at a community hospital and asked to take over the newborn nursery, the competencies can be used to get buy-in from the group, as a guide for additional training, to provide a framework for development of practice pathways, and to request resources needed.

The Pediatric Core Competencies are a great resource for pediatric hospitalists and group leaders with many uses, from board preparation to education and professional development. They provide a framework for improvement of knowledge, skills, and attitudes within an organization.
 

Key takeaways

• Given a change in scope of practice of pediatric hospitalists over the past 10 years, the PHM Core Competencies were updated and published in the Journal of Hospital Medicine in 2020.
• The Core Competencies have many practical applications including education, curriculum development, professional development, and PHM board preparation.
• The Core Competencies provide a framework for improvement of knowledge, skills, and attitudes within an organization.

Dr. Schwenk is a pediatric hospitalist at Norton Children’s Hospital in Louisville, Ky., where he serves as a medical director of inpatient services. He is an associate professor of pediatrics at the University of Louisville School of Medicine. He is a Senior Fellow of Hospital Medicine and has served on the executive council of the Pediatrics Special Interest Group and the Annual Meeting Committee for SHM Converge.

Converge 2021 session

Making The Pediatric Hospital Medicine Core Competencies Work for You

Presenters

Erin Fisher, MD, MHM, FAAP; Sandra Gage, MD, PhD, SFHM, FAAP; Jennifer Maniscalco, MD, MPH, MAcM, FAAP; Sofia Teferi, MD, SFHM, FAAP

Session summary

The Pediatric Hospital Medicine (PHM) Core Competencies were originally published in the Journal of Hospital Medicine in 2010, and created a framework for graduate and continuing medical education, reflecting the roles and expectations for all pediatric hospitalists in the United States. Since that time, the field of PHM, scope of practice, and roles of hospitalists has evolved, making a substantial update to this dossier necessary.

The 2020 PHM Core Competencies consist of four sections, including common clinical diagnoses and conditions, specialized services, core skills, and the health care system. The four topics are covered in 66 chapters, which were updated or created for the present version.

The Core Competencies have many practical applications, including teaching or curriculum development, which may be used by trainees as well as PHM providers. The speakers gave real-world examples of the competencies’ application to evaluations, and the continuum of knowledge, skills, attitudes, and system implementation in the development of a trainee from student to practicing hospitalist. Trainees’ knowledge gaps can be identified using the competencies, and utilization of the provided compendium will help identify sources that can aid in teaching.

Professional development is an excellent way to utilize the Core Competencies. Division directors may identify a needed area for improvement and the competencies can serve as a road map for establishing goals, plan development, and analysis of results of the intervention. They are also a great resource for PHM board prep. Although the competencies were not developed specifically for the PHM boards, they do contain all 13 PHM content domains set forth by the American Board of Pediatrics for PHM.

The Core Competencies can also be used to justify service line needs and resources in discussions with administration. For instance, if one is a pediatric hospitalist at a community hospital and asked to take over the newborn nursery, the competencies can be used to get buy-in from the group, as a guide for additional training, to provide a framework for development of practice pathways, and to request resources needed.

The Pediatric Core Competencies are a great resource for pediatric hospitalists and group leaders with many uses, from board preparation to education and professional development. They provide a framework for improvement of knowledge, skills, and attitudes within an organization.
 

Key takeaways

• Given a change in scope of practice of pediatric hospitalists over the past 10 years, the PHM Core Competencies were updated and published in the Journal of Hospital Medicine in 2020.
• The Core Competencies have many practical applications including education, curriculum development, professional development, and PHM board preparation.
• The Core Competencies provide a framework for improvement of knowledge, skills, and attitudes within an organization.

Dr. Schwenk is a pediatric hospitalist at Norton Children’s Hospital in Louisville, Ky., where he serves as a medical director of inpatient services. He is an associate professor of pediatrics at the University of Louisville School of Medicine. He is a Senior Fellow of Hospital Medicine and has served on the executive council of the Pediatrics Special Interest Group and the Annual Meeting Committee for SHM Converge.

The newly updated Valve Academic Research Consortium 3 (VARC-3) definitions and endpoints proposed for transcatheter and surgical aortic valve replacement (TAVR/SAVR) research aim to add more granularity and a patient focus to a rapidly evolving field, the authors say.

Work began in 2016 to update definitions in the document to be more contemporary, as TAVR matured over the last 10 years to include younger, lower-risk patients and began moving to long-term outcomes, lead author Philippe Généreux, MD, said in an interview.

“The main change in VARC-3 is really that we tried to define not only procedural outcome, both for TAVR and aortic valve replacement performed by surgery, but also more the long-term outcomes mainly based on the patient – so quality of life, bioprosthetic valve failure, how do we define a valve failure, and also the need for rehospitalization,” he said.

However, soon after the VARC-3 document was published on April 19, 2021, in the European Heart Journal and Journal of the American College of Cardiology, surgeons took to social media to highlight the writing committee’s financial ties to industry and to suggest some definitions were shaped to favor transcatheter approaches.

“There’s no doubt that the coauthors who participated in these guidelines are experts; nobody would argue about that but what we can argue, and I’m 100% sure about, is that we have experts outside the payroll of industry who are excellent and can be part of this guideline drafting in an unbiased way,” Victor Dayan, MD, adjunct professor of cardiac surgery, National Institute of Cardiac Surgery, Montevideo, Uruguay, said in an interview.

Although the American College of Physicians recommends guideline committee members with moderate- or high-level conflicts of interest recuse themselves from authorship, he noted that one author has received more than $2 million in fees from industry in the past 4-5 years.

In all, 20 of 23 authors were involved in PARTNER, SURTAVI, and PORTICO, and several also write clinical guidelines for the American College of Cardiology and American Heart Association. “So we have the same authors that are judge, jury, and attorney for these issues,” Dr. Dayan said.

In a comment, J. Rafael Sádaba, MD, PhD, interim secretary general for the European Association for Cardio-Thoracic Surgery, pointed out that only three committee members are surgeons and that author disclosures took up nearly a full page of the document. “Surely they would be able to find very capable physicians with far less conflicts of interest.”

Dr. Sádaba said the question to him is why professional societies like ACC and AHA don’t define the endpoints for the clinical trials that will inform their guidelines.

“One could say these people are there because they’re good scientists, trialists, but one at least has to ask why is this happening. Why are these people setting the rules for the trials they’re running?” said Dr. Sádaba, of the Royal Navarre Hospital, Pamplona, Spain.

Dr. Généreux dismissed the Twitter comments as coming from a handful of people who engage in conspiracy theories. The VARC-3 document, he said, was created with input from 75 experts, including Food and Drug Administration officials, and the final document was reviewed by the FDA and underwent rigorous peer review prior to publication.

“The question is: do you believe there is bias when people are involved in studies driven by the industry? Well, this is where we derive our science in this field,” he said. “We are very transparent and disclose our conflicts of interest [COI].”

Commenting further, Dr. Généreux added, “this was a very well-balanced group and to imply that because we work with industry, we don’t have the best interest of the patient in mind is wrong.”

Editor in chief of the EHJ, Filippo Crea, MD, PhD, Catholic University, Rome, said in an comment that “it is not surprising that most of the authors have experience in TAVR trials. All of the authors have carefully disclosed their COIs.”

He noted that the EHJ and JACC copublished the first VARC consensus in 2011, VARC-2 1 year later, and that VARC-3 was reviewed by four external reviewers and two editors and was accepted for publication after two revisions.

Asked about a shot on social media that the EHJ had long ago “sold its soul” to be the scientific “arm” of industry, Dr. Crea said allegations need to be substantiated by facts.

“The wide adoption of VARC definitions implies that they have been well accepted by the scientific community and that they have stood the test of time,” Dr. Crea said. “EHJ has a history of publishing high-quality science. We welcome robust arguments that may challenge previously published work. Readers who perceive gaps are encouraged to provide a detailed challenge and engage with the journal.”
 

Defining hospitalizations

One of the surgeons’ biggest concerns is that VARC-3 now defines hospitalization or rehospitalization as “any admission after the index hospitalization or study enrollment” for at least 24 hours, including an ED stay.

VARC-2 and SURTAVI defined hospitalizations as those for valve-related symptoms or worsening heart failure, whereas the newly reformulated definition of hospitalization was part of the main composite endpoint in the PARTNER-3 trial, along with stroke and mortality, that drove the superiority of TAVR over SAVR at 1 year for low-risk patients, Dr. Dayan noted.

“It’s not uncommon for patients who have cardiac surgery to come back for issues related to wound healing or mild pulmonary edema for a day or 2, and if you include these hospitalizations in the primary endpoint, it will dilute the real benefit of SAVR versus TAVR, which is mortality and stroke,” he added.

In choosing the broader definition, Dr. Généreux said they borrowed from heart failure studies that take a granular approach and account for every hospitalization, be it for a medication change or adjustment. “We cannot pick and choose which hospitalization we are going to consider or ignore.”

VARC-3 proposes criteria for identifying and diagnosing hypoattenuated leaflet thickening (HALT) and reduced leaflet motion and features a detailed chart of the new classification scheme for bioprosthetic valve dysfunction and failure.

Bioprosthetic valve dysfunction includes structural valve deterioration, nonstructural valve dysfunction (including abnormalities not intrinsic to the valve such as paravalvular regurgitation or prosthesis-patient mismatch), thrombosis, and endocarditis. VARC-3 proposes a five-class grading system for paravalvular regurgitation (mild, mild-moderate, moderate, moderate-severe, severe).

The document updates what the authors called a “previously vague definition” of valve thrombosis proposed in 2011 to now include “clinically significant” prosthetic valve thrombosis. This requires clinical sequelae of a thromboembolic event (stroke, transient ischemic attack, retinal occlusion, or other evidence of thromboembolism) or worsening valve stenosis/regurgitation and either hemodynamic valve deterioration stage 2 or 3 or confirmatory imaging (CT evidence of HALT or transesophageal echocardiographic findings). In the absence of symptoms/clinical sequelae, valve thrombosis (subclinical) can be diagnosed if there is hemodynamic valve deterioration stage 3 and confirmatory imaging.

Bioprosthetic valve failure is divided into three stages, with stage 1 taking into account clinical factors along with valve dysfunction, stage 2 being reintervention, and stage 3 being valve-related death.

“For us, bioprosthesis valve failure is not only the need for reintervention, but it’s also mortality, it’s also a significant increase in gradient or the occurrence of paravalvular leak,” said Dr. Généreux, of the Morristown (N.J.) Medical Center. “So it’s much more clinical.”
 

Stroke, myocardial infarction

VARC-3 provides detailed definitions of neurologic events and, in an attempt to harmonize with the Neurologic Academic Research Consortium, recommends combining assessment of neurologic symptoms with tissue-based criteria (pathology or neuroimaging, ideally diffusion-weighted MRI) to define stroke and other central nervous system injury.

It also recommends that assessment be performed 30-90 days after a neurologic event and that assessment of neurologic deficits for cerebral embolic protection trials be performed by a neurologist.

VARC-3 endorses the fourth Universal Definition of Myocardial Infarction for MI types 1-3, 4B, and 4C.

For periprocedural MI after percutaneous coronary intervention (PCI), coronary bypass graft surgery, TAVR, and SAVR, however, it endorses the modified Society for Cardiovascular Angiography and Interventions and Academic Research Consortium-2 definition, which uses troponin or creatine kinase-MB thresholds.

“Given that most current and future studies related to AVR strategies will involve long-term follow-up, with patients frequently suffering from coronary artery disease, VARC-3 believes that these definitions will allow the most appropriate characterization and classification of types of MI occurring in this population,” the committee wrote.

The decision comes after last year’s controversy surrounding the Abbott-sponsored EXCEL trial, which used a modified version of the SCAI definition for periprocedural MI as part of its primary composite endpoint of death, stroke, and MI.

Initial reports showed nearly twice the rate of periprocedural MI with cardiac surgery as with PCI, but after a BBC investigation involving leaked data and an onslaught of criticism from surgeons, later results using the third universal definition showed surgery had the advantage.

The debacle frayed relations between surgeons and interventionalists and prompted EACTS to withdraw its support for treatment recommendations for left main coronary artery disease.

Dr. Dayan applauded VARC-3 for incorporating more detailed information on stroke and neurologic events, but said the use of the SCAI definition in the final published document is in “total disregard” to the controversy generated among surgeons and interventionalists.

“The main concern for surgeons is defining periprocedural MI just by biochemical definitions, without any additional criteria like ECG, angiographic,” he said. “This is totally new and goes against what surgeons have been advocating for years around EXCEL.”

Dr. Sádaba was troubled by the definitions of MI and hospitalization, but also questioned other changes, like lumping vascular complications together with access-related complications. “The sense is a lot of what they’ve put here favors one type of intervention over the other.”

Dr. Généreux reported receiving consultant fees from Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular System, Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, Tryton Medical, and has equity in Pi-Cardia, Sig.Num, SoundBite Medical Solutions, Saranas, and Puzzle Medical. Dr. Crea reported receiving personal fees from Novartis, Bristol-Myers Squibb, Amgen, and AstraZeneca, and is a member of the advisory board of GlyCardial Diagnostics. Dr. Dayan and Dr. Sádaba reported no relevant conflicts of interest.

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

The newly updated Valve Academic Research Consortium 3 (VARC-3) definitions and endpoints proposed for transcatheter and surgical aortic valve replacement (TAVR/SAVR) research aim to add more granularity and a patient focus to a rapidly evolving field, the authors say.

Work began in 2016 to update definitions in the document to be more contemporary, as TAVR matured over the last 10 years to include younger, lower-risk patients and began moving to long-term outcomes, lead author Philippe Généreux, MD, said in an interview.

“The main change in VARC-3 is really that we tried to define not only procedural outcome, both for TAVR and aortic valve replacement performed by surgery, but also more the long-term outcomes mainly based on the patient – so quality of life, bioprosthetic valve failure, how do we define a valve failure, and also the need for rehospitalization,” he said.

However, soon after the VARC-3 document was published on April 19, 2021, in the European Heart Journal and Journal of the American College of Cardiology, surgeons took to social media to highlight the writing committee’s financial ties to industry and to suggest some definitions were shaped to favor transcatheter approaches.

“There’s no doubt that the coauthors who participated in these guidelines are experts; nobody would argue about that but what we can argue, and I’m 100% sure about, is that we have experts outside the payroll of industry who are excellent and can be part of this guideline drafting in an unbiased way,” Victor Dayan, MD, adjunct professor of cardiac surgery, National Institute of Cardiac Surgery, Montevideo, Uruguay, said in an interview.

Although the American College of Physicians recommends guideline committee members with moderate- or high-level conflicts of interest recuse themselves from authorship, he noted that one author has received more than $2 million in fees from industry in the past 4-5 years.

In all, 20 of 23 authors were involved in PARTNER, SURTAVI, and PORTICO, and several also write clinical guidelines for the American College of Cardiology and American Heart Association. “So we have the same authors that are judge, jury, and attorney for these issues,” Dr. Dayan said.

In a comment, J. Rafael Sádaba, MD, PhD, interim secretary general for the European Association for Cardio-Thoracic Surgery, pointed out that only three committee members are surgeons and that author disclosures took up nearly a full page of the document. “Surely they would be able to find very capable physicians with far less conflicts of interest.”

Dr. Sádaba said the question to him is why professional societies like ACC and AHA don’t define the endpoints for the clinical trials that will inform their guidelines.

“One could say these people are there because they’re good scientists, trialists, but one at least has to ask why is this happening. Why are these people setting the rules for the trials they’re running?” said Dr. Sádaba, of the Royal Navarre Hospital, Pamplona, Spain.

Dr. Généreux dismissed the Twitter comments as coming from a handful of people who engage in conspiracy theories. The VARC-3 document, he said, was created with input from 75 experts, including Food and Drug Administration officials, and the final document was reviewed by the FDA and underwent rigorous peer review prior to publication.

“The question is: do you believe there is bias when people are involved in studies driven by the industry? Well, this is where we derive our science in this field,” he said. “We are very transparent and disclose our conflicts of interest [COI].”

Commenting further, Dr. Généreux added, “this was a very well-balanced group and to imply that because we work with industry, we don’t have the best interest of the patient in mind is wrong.”

Editor in chief of the EHJ, Filippo Crea, MD, PhD, Catholic University, Rome, said in an comment that “it is not surprising that most of the authors have experience in TAVR trials. All of the authors have carefully disclosed their COIs.”

He noted that the EHJ and JACC copublished the first VARC consensus in 2011, VARC-2 1 year later, and that VARC-3 was reviewed by four external reviewers and two editors and was accepted for publication after two revisions.

Asked about a shot on social media that the EHJ had long ago “sold its soul” to be the scientific “arm” of industry, Dr. Crea said allegations need to be substantiated by facts.

“The wide adoption of VARC definitions implies that they have been well accepted by the scientific community and that they have stood the test of time,” Dr. Crea said. “EHJ has a history of publishing high-quality science. We welcome robust arguments that may challenge previously published work. Readers who perceive gaps are encouraged to provide a detailed challenge and engage with the journal.”
 

Defining hospitalizations

One of the surgeons’ biggest concerns is that VARC-3 now defines hospitalization or rehospitalization as “any admission after the index hospitalization or study enrollment” for at least 24 hours, including an ED stay.

VARC-2 and SURTAVI defined hospitalizations as those for valve-related symptoms or worsening heart failure, whereas the newly reformulated definition of hospitalization was part of the main composite endpoint in the PARTNER-3 trial, along with stroke and mortality, that drove the superiority of TAVR over SAVR at 1 year for low-risk patients, Dr. Dayan noted.

“It’s not uncommon for patients who have cardiac surgery to come back for issues related to wound healing or mild pulmonary edema for a day or 2, and if you include these hospitalizations in the primary endpoint, it will dilute the real benefit of SAVR versus TAVR, which is mortality and stroke,” he added.

In choosing the broader definition, Dr. Généreux said they borrowed from heart failure studies that take a granular approach and account for every hospitalization, be it for a medication change or adjustment. “We cannot pick and choose which hospitalization we are going to consider or ignore.”

VARC-3 proposes criteria for identifying and diagnosing hypoattenuated leaflet thickening (HALT) and reduced leaflet motion and features a detailed chart of the new classification scheme for bioprosthetic valve dysfunction and failure.

Bioprosthetic valve dysfunction includes structural valve deterioration, nonstructural valve dysfunction (including abnormalities not intrinsic to the valve such as paravalvular regurgitation or prosthesis-patient mismatch), thrombosis, and endocarditis. VARC-3 proposes a five-class grading system for paravalvular regurgitation (mild, mild-moderate, moderate, moderate-severe, severe).

The document updates what the authors called a “previously vague definition” of valve thrombosis proposed in 2011 to now include “clinically significant” prosthetic valve thrombosis. This requires clinical sequelae of a thromboembolic event (stroke, transient ischemic attack, retinal occlusion, or other evidence of thromboembolism) or worsening valve stenosis/regurgitation and either hemodynamic valve deterioration stage 2 or 3 or confirmatory imaging (CT evidence of HALT or transesophageal echocardiographic findings). In the absence of symptoms/clinical sequelae, valve thrombosis (subclinical) can be diagnosed if there is hemodynamic valve deterioration stage 3 and confirmatory imaging.

Bioprosthetic valve failure is divided into three stages, with stage 1 taking into account clinical factors along with valve dysfunction, stage 2 being reintervention, and stage 3 being valve-related death.

“For us, bioprosthesis valve failure is not only the need for reintervention, but it’s also mortality, it’s also a significant increase in gradient or the occurrence of paravalvular leak,” said Dr. Généreux, of the Morristown (N.J.) Medical Center. “So it’s much more clinical.”
 

Stroke, myocardial infarction

VARC-3 provides detailed definitions of neurologic events and, in an attempt to harmonize with the Neurologic Academic Research Consortium, recommends combining assessment of neurologic symptoms with tissue-based criteria (pathology or neuroimaging, ideally diffusion-weighted MRI) to define stroke and other central nervous system injury.

It also recommends that assessment be performed 30-90 days after a neurologic event and that assessment of neurologic deficits for cerebral embolic protection trials be performed by a neurologist.

VARC-3 endorses the fourth Universal Definition of Myocardial Infarction for MI types 1-3, 4B, and 4C.

For periprocedural MI after percutaneous coronary intervention (PCI), coronary bypass graft surgery, TAVR, and SAVR, however, it endorses the modified Society for Cardiovascular Angiography and Interventions and Academic Research Consortium-2 definition, which uses troponin or creatine kinase-MB thresholds.

“Given that most current and future studies related to AVR strategies will involve long-term follow-up, with patients frequently suffering from coronary artery disease, VARC-3 believes that these definitions will allow the most appropriate characterization and classification of types of MI occurring in this population,” the committee wrote.

The decision comes after last year’s controversy surrounding the Abbott-sponsored EXCEL trial, which used a modified version of the SCAI definition for periprocedural MI as part of its primary composite endpoint of death, stroke, and MI.

Initial reports showed nearly twice the rate of periprocedural MI with cardiac surgery as with PCI, but after a BBC investigation involving leaked data and an onslaught of criticism from surgeons, later results using the third universal definition showed surgery had the advantage.

The debacle frayed relations between surgeons and interventionalists and prompted EACTS to withdraw its support for treatment recommendations for left main coronary artery disease.

Dr. Dayan applauded VARC-3 for incorporating more detailed information on stroke and neurologic events, but said the use of the SCAI definition in the final published document is in “total disregard” to the controversy generated among surgeons and interventionalists.

“The main concern for surgeons is defining periprocedural MI just by biochemical definitions, without any additional criteria like ECG, angiographic,” he said. “This is totally new and goes against what surgeons have been advocating for years around EXCEL.”

Dr. Sádaba was troubled by the definitions of MI and hospitalization, but also questioned other changes, like lumping vascular complications together with access-related complications. “The sense is a lot of what they’ve put here favors one type of intervention over the other.”

Dr. Généreux reported receiving consultant fees from Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular System, Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, Tryton Medical, and has equity in Pi-Cardia, Sig.Num, SoundBite Medical Solutions, Saranas, and Puzzle Medical. Dr. Crea reported receiving personal fees from Novartis, Bristol-Myers Squibb, Amgen, and AstraZeneca, and is a member of the advisory board of GlyCardial Diagnostics. Dr. Dayan and Dr. Sádaba reported no relevant conflicts of interest.

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

The newly updated Valve Academic Research Consortium 3 (VARC-3) definitions and endpoints proposed for transcatheter and surgical aortic valve replacement (TAVR/SAVR) research aim to add more granularity and a patient focus to a rapidly evolving field, the authors say.

Work began in 2016 to update definitions in the document to be more contemporary, as TAVR matured over the last 10 years to include younger, lower-risk patients and began moving to long-term outcomes, lead author Philippe Généreux, MD, said in an interview.

“The main change in VARC-3 is really that we tried to define not only procedural outcome, both for TAVR and aortic valve replacement performed by surgery, but also more the long-term outcomes mainly based on the patient – so quality of life, bioprosthetic valve failure, how do we define a valve failure, and also the need for rehospitalization,” he said.

However, soon after the VARC-3 document was published on April 19, 2021, in the European Heart Journal and Journal of the American College of Cardiology, surgeons took to social media to highlight the writing committee’s financial ties to industry and to suggest some definitions were shaped to favor transcatheter approaches.

“There’s no doubt that the coauthors who participated in these guidelines are experts; nobody would argue about that but what we can argue, and I’m 100% sure about, is that we have experts outside the payroll of industry who are excellent and can be part of this guideline drafting in an unbiased way,” Victor Dayan, MD, adjunct professor of cardiac surgery, National Institute of Cardiac Surgery, Montevideo, Uruguay, said in an interview.

Although the American College of Physicians recommends guideline committee members with moderate- or high-level conflicts of interest recuse themselves from authorship, he noted that one author has received more than $2 million in fees from industry in the past 4-5 years.

In all, 20 of 23 authors were involved in PARTNER, SURTAVI, and PORTICO, and several also write clinical guidelines for the American College of Cardiology and American Heart Association. “So we have the same authors that are judge, jury, and attorney for these issues,” Dr. Dayan said.

In a comment, J. Rafael Sádaba, MD, PhD, interim secretary general for the European Association for Cardio-Thoracic Surgery, pointed out that only three committee members are surgeons and that author disclosures took up nearly a full page of the document. “Surely they would be able to find very capable physicians with far less conflicts of interest.”

Dr. Sádaba said the question to him is why professional societies like ACC and AHA don’t define the endpoints for the clinical trials that will inform their guidelines.

“One could say these people are there because they’re good scientists, trialists, but one at least has to ask why is this happening. Why are these people setting the rules for the trials they’re running?” said Dr. Sádaba, of the Royal Navarre Hospital, Pamplona, Spain.

Dr. Généreux dismissed the Twitter comments as coming from a handful of people who engage in conspiracy theories. The VARC-3 document, he said, was created with input from 75 experts, including Food and Drug Administration officials, and the final document was reviewed by the FDA and underwent rigorous peer review prior to publication.

“The question is: do you believe there is bias when people are involved in studies driven by the industry? Well, this is where we derive our science in this field,” he said. “We are very transparent and disclose our conflicts of interest [COI].”

Commenting further, Dr. Généreux added, “this was a very well-balanced group and to imply that because we work with industry, we don’t have the best interest of the patient in mind is wrong.”

Editor in chief of the EHJ, Filippo Crea, MD, PhD, Catholic University, Rome, said in an comment that “it is not surprising that most of the authors have experience in TAVR trials. All of the authors have carefully disclosed their COIs.”

He noted that the EHJ and JACC copublished the first VARC consensus in 2011, VARC-2 1 year later, and that VARC-3 was reviewed by four external reviewers and two editors and was accepted for publication after two revisions.

Asked about a shot on social media that the EHJ had long ago “sold its soul” to be the scientific “arm” of industry, Dr. Crea said allegations need to be substantiated by facts.

“The wide adoption of VARC definitions implies that they have been well accepted by the scientific community and that they have stood the test of time,” Dr. Crea said. “EHJ has a history of publishing high-quality science. We welcome robust arguments that may challenge previously published work. Readers who perceive gaps are encouraged to provide a detailed challenge and engage with the journal.”
 

Defining hospitalizations

One of the surgeons’ biggest concerns is that VARC-3 now defines hospitalization or rehospitalization as “any admission after the index hospitalization or study enrollment” for at least 24 hours, including an ED stay.

VARC-2 and SURTAVI defined hospitalizations as those for valve-related symptoms or worsening heart failure, whereas the newly reformulated definition of hospitalization was part of the main composite endpoint in the PARTNER-3 trial, along with stroke and mortality, that drove the superiority of TAVR over SAVR at 1 year for low-risk patients, Dr. Dayan noted.

“It’s not uncommon for patients who have cardiac surgery to come back for issues related to wound healing or mild pulmonary edema for a day or 2, and if you include these hospitalizations in the primary endpoint, it will dilute the real benefit of SAVR versus TAVR, which is mortality and stroke,” he added.

In choosing the broader definition, Dr. Généreux said they borrowed from heart failure studies that take a granular approach and account for every hospitalization, be it for a medication change or adjustment. “We cannot pick and choose which hospitalization we are going to consider or ignore.”

VARC-3 proposes criteria for identifying and diagnosing hypoattenuated leaflet thickening (HALT) and reduced leaflet motion and features a detailed chart of the new classification scheme for bioprosthetic valve dysfunction and failure.

Bioprosthetic valve dysfunction includes structural valve deterioration, nonstructural valve dysfunction (including abnormalities not intrinsic to the valve such as paravalvular regurgitation or prosthesis-patient mismatch), thrombosis, and endocarditis. VARC-3 proposes a five-class grading system for paravalvular regurgitation (mild, mild-moderate, moderate, moderate-severe, severe).

The document updates what the authors called a “previously vague definition” of valve thrombosis proposed in 2011 to now include “clinically significant” prosthetic valve thrombosis. This requires clinical sequelae of a thromboembolic event (stroke, transient ischemic attack, retinal occlusion, or other evidence of thromboembolism) or worsening valve stenosis/regurgitation and either hemodynamic valve deterioration stage 2 or 3 or confirmatory imaging (CT evidence of HALT or transesophageal echocardiographic findings). In the absence of symptoms/clinical sequelae, valve thrombosis (subclinical) can be diagnosed if there is hemodynamic valve deterioration stage 3 and confirmatory imaging.

Bioprosthetic valve failure is divided into three stages, with stage 1 taking into account clinical factors along with valve dysfunction, stage 2 being reintervention, and stage 3 being valve-related death.

“For us, bioprosthesis valve failure is not only the need for reintervention, but it’s also mortality, it’s also a significant increase in gradient or the occurrence of paravalvular leak,” said Dr. Généreux, of the Morristown (N.J.) Medical Center. “So it’s much more clinical.”
 

Stroke, myocardial infarction

VARC-3 provides detailed definitions of neurologic events and, in an attempt to harmonize with the Neurologic Academic Research Consortium, recommends combining assessment of neurologic symptoms with tissue-based criteria (pathology or neuroimaging, ideally diffusion-weighted MRI) to define stroke and other central nervous system injury.

It also recommends that assessment be performed 30-90 days after a neurologic event and that assessment of neurologic deficits for cerebral embolic protection trials be performed by a neurologist.

VARC-3 endorses the fourth Universal Definition of Myocardial Infarction for MI types 1-3, 4B, and 4C.

For periprocedural MI after percutaneous coronary intervention (PCI), coronary bypass graft surgery, TAVR, and SAVR, however, it endorses the modified Society for Cardiovascular Angiography and Interventions and Academic Research Consortium-2 definition, which uses troponin or creatine kinase-MB thresholds.

“Given that most current and future studies related to AVR strategies will involve long-term follow-up, with patients frequently suffering from coronary artery disease, VARC-3 believes that these definitions will allow the most appropriate characterization and classification of types of MI occurring in this population,” the committee wrote.

The decision comes after last year’s controversy surrounding the Abbott-sponsored EXCEL trial, which used a modified version of the SCAI definition for periprocedural MI as part of its primary composite endpoint of death, stroke, and MI.

Initial reports showed nearly twice the rate of periprocedural MI with cardiac surgery as with PCI, but after a BBC investigation involving leaked data and an onslaught of criticism from surgeons, later results using the third universal definition showed surgery had the advantage.

The debacle frayed relations between surgeons and interventionalists and prompted EACTS to withdraw its support for treatment recommendations for left main coronary artery disease.

Dr. Dayan applauded VARC-3 for incorporating more detailed information on stroke and neurologic events, but said the use of the SCAI definition in the final published document is in “total disregard” to the controversy generated among surgeons and interventionalists.

“The main concern for surgeons is defining periprocedural MI just by biochemical definitions, without any additional criteria like ECG, angiographic,” he said. “This is totally new and goes against what surgeons have been advocating for years around EXCEL.”

Dr. Sádaba was troubled by the definitions of MI and hospitalization, but also questioned other changes, like lumping vascular complications together with access-related complications. “The sense is a lot of what they’ve put here favors one type of intervention over the other.”

Dr. Généreux reported receiving consultant fees from Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular System, Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, Tryton Medical, and has equity in Pi-Cardia, Sig.Num, SoundBite Medical Solutions, Saranas, and Puzzle Medical. Dr. Crea reported receiving personal fees from Novartis, Bristol-Myers Squibb, Amgen, and AstraZeneca, and is a member of the advisory board of GlyCardial Diagnostics. Dr. Dayan and Dr. Sádaba reported no relevant conflicts of interest.

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

Key clinical point: Eptinezumab, particularly at a dosage of 300 mg, has significant efficacy and an acceptable safety profile for treatment of migraine.

Major finding: Eptinezumab significantly reduced the mean monthly migraine days (MMDs) compared with placebo at week 12 at a dosage of 30 mg (change in MMDs, −0.29; P = .0001), 100 mg (change in MMDs, −0.31; P less than .00001), and 300 mg (change in MMDs, −0.41; P less than .00001). Treatment-emergent adverse events were not significantly different between eptinezumab and placebo.

Study details: This was a meta-analysis of 4 randomized controlled trials including 2,739 patients with migraine.

Disclosures: This work was supported by the Suzhou Health Talents Training Project. The authors declared no competing interests.

Source: Yan Z et al. J Headache Pain. 2021 Mar 6. doi: 10.1186/s10194-021-01220-y.

Key clinical point: Eptinezumab, particularly at a dosage of 300 mg, has significant efficacy and an acceptable safety profile for treatment of migraine.

Major finding: Eptinezumab significantly reduced the mean monthly migraine days (MMDs) compared with placebo at week 12 at a dosage of 30 mg (change in MMDs, −0.29; P = .0001), 100 mg (change in MMDs, −0.31; P less than .00001), and 300 mg (change in MMDs, −0.41; P less than .00001). Treatment-emergent adverse events were not significantly different between eptinezumab and placebo.

Study details: This was a meta-analysis of 4 randomized controlled trials including 2,739 patients with migraine.

Disclosures: This work was supported by the Suzhou Health Talents Training Project. The authors declared no competing interests.

Source: Yan Z et al. J Headache Pain. 2021 Mar 6. doi: 10.1186/s10194-021-01220-y.

Key clinical point: Eptinezumab, particularly at a dosage of 300 mg, has significant efficacy and an acceptable safety profile for treatment of migraine.

Major finding: Eptinezumab significantly reduced the mean monthly migraine days (MMDs) compared with placebo at week 12 at a dosage of 30 mg (change in MMDs, −0.29; P = .0001), 100 mg (change in MMDs, −0.31; P less than .00001), and 300 mg (change in MMDs, −0.41; P less than .00001). Treatment-emergent adverse events were not significantly different between eptinezumab and placebo.

Study details: This was a meta-analysis of 4 randomized controlled trials including 2,739 patients with migraine.

Disclosures: This work was supported by the Suzhou Health Talents Training Project. The authors declared no competing interests.

Source: Yan Z et al. J Headache Pain. 2021 Mar 6. doi: 10.1186/s10194-021-01220-y.

Key clinical point: Components of nonpharmacological interventions are effective for treatment of pediatric migraine.

Major finding: Short-term self-administered treatments (standardized mean difference [SMD], 1.44; 95% confidence interval [95% CI], 0.26-2.62), biofeedback (SMD, 1.41; 95% CI, 0.64-2.17), relaxation (SMD, 1.38; 95% CI, 0.61-2.14), and psychological treatments (SMD, 1.36; 95% CI, 0.15-2.57) were more effective than the waiting list, with findings being similar for long-term treatments.

Study details: A network meta-analysis of 12 randomized clinical trials that evaluated nonpharmacological treatments for pediatric migraine in 576 children and adolescents with episodic migraine.

Disclosures: The study was supported in part by the Sara Page Mayo Endowment for Pediatric Pain Research, Education, and Treatment. The authors reported no potential conflicts of interest.

Source: Koechlin H et al. Pediatrics. 2021 Mar 9. doi: 10.1542/peds.2019-4107.

Key clinical point: Components of nonpharmacological interventions are effective for treatment of pediatric migraine.

Major finding: Short-term self-administered treatments (standardized mean difference [SMD], 1.44; 95% confidence interval [95% CI], 0.26-2.62), biofeedback (SMD, 1.41; 95% CI, 0.64-2.17), relaxation (SMD, 1.38; 95% CI, 0.61-2.14), and psychological treatments (SMD, 1.36; 95% CI, 0.15-2.57) were more effective than the waiting list, with findings being similar for long-term treatments.

Study details: A network meta-analysis of 12 randomized clinical trials that evaluated nonpharmacological treatments for pediatric migraine in 576 children and adolescents with episodic migraine.

Disclosures: The study was supported in part by the Sara Page Mayo Endowment for Pediatric Pain Research, Education, and Treatment. The authors reported no potential conflicts of interest.

Source: Koechlin H et al. Pediatrics. 2021 Mar 9. doi: 10.1542/peds.2019-4107.

Key clinical point: Components of nonpharmacological interventions are effective for treatment of pediatric migraine.

Major finding: Short-term self-administered treatments (standardized mean difference [SMD], 1.44; 95% confidence interval [95% CI], 0.26-2.62), biofeedback (SMD, 1.41; 95% CI, 0.64-2.17), relaxation (SMD, 1.38; 95% CI, 0.61-2.14), and psychological treatments (SMD, 1.36; 95% CI, 0.15-2.57) were more effective than the waiting list, with findings being similar for long-term treatments.

Study details: A network meta-analysis of 12 randomized clinical trials that evaluated nonpharmacological treatments for pediatric migraine in 576 children and adolescents with episodic migraine.

Disclosures: The study was supported in part by the Sara Page Mayo Endowment for Pediatric Pain Research, Education, and Treatment. The authors reported no potential conflicts of interest.

Source: Koechlin H et al. Pediatrics. 2021 Mar 9. doi: 10.1542/peds.2019-4107.

Every spring, I look forward to attending the American Psychiatric Association’s annual meeting. It has become a ritual that starts many months before the actual conference.

Submissions for presentations are due in September, so the planning often starts in the late summer. Hotel and plane reservations are made in January, and the meeting itself begins in May.

The city that hosts the event changes each year but, for me, many things do not. The Clinical Psychiatry News editorial board meeting takes place on Monday morning at 7 a.m., and I scour the program for what sessions to attend. In recent years, I have made a point of writing an article for about one of the sessions while still at the meeting – in 2019 I wrote about the improv-acting workshops I attended – something that just doesn’t translate to a Zoom experience.

I go with the same friend every year, I always attend the Hopkins alumni reception, and I organize dinner at a nice restaurant for friends. I have collected so many funny stories and memories over the years that it would be hard to catalog them all. There was the time in Toronto that I set up a meal at a restaurant named Susur – a meal like no other I’ve ever had – and the check arrived with a jaw-dropping sum that I had not anticipated. In San Diego, we watched a gorgeous sunset over the Pacific Ocean from the veranda of the Hotel Coronado. There was the time I sunbathed on the beach in Waikiki with my book editor, and the notable distress when my colleague’s husband called from the airport to say he was not permitted to board his plane in Baltimore to join us in California! There are funny stories, but there is the sadness that one friend who joined us for so many of these events has died.

I always find the program options to be overwhelming: There is so much going on at once that it can be hard to decide what to go to. I try to attend a mix of sessions, some that are inspiring or entertaining, and others that will be informative for clinical issues.

The speakers have been incredible and over the years I’ve heard then-Vice President Joseph Biden, retired quarterback Terry Bradshaw, Oliver Sacks, Alan Alda, Archbishop Desmond Tutu, and perhaps my favorite – Lorraine Bracco, the actress who played Dr. Melfi on “The Sopranos” – to name just a few. And, of course, the opportunity to get the continuing medical education credits I need for licensing is just one more reason to attend.

Last year in May I was still adjusting to my “new” career from home with a computer screen. I had been scheduled to participate in several panels for the meeting in Philadelphia, but extra computer hours had no appeal. And while the fatigue of doing telemental health has eased, I still avoid extra hours interacting with my computer screen and I did not attend this year’s meeting. Without the lure of friends, fun, and the novelty of being somewhere new, my APA experience would have to wait for real life.

Virtual APA has had a drop in participation. In 2019, the last real-life convention in San Francisco, there were 700 scientific sessions and 11,000 professionals in attendance. This year’s virtual conference hosted 135 sessions with more than 7,000 attendees. Attendance was down, but so were costs associated with live conventions and the APA is considering the addition of a virtual component when the annual meeting returns to the in-person venue.

Tom Abdallah is a medical student at Weill Cornell Medicine–Qatar in Education City. He has never attended an in-person APA annual meeting, but he joined for this year’s virtual sessions. “The scientific sessions were fantastic and diverse. Networking was limited in comparison to in-person conferences. The meeting was very well organized, and it gave me the opportunity to attend without worrying about travel.”

Steven Daviss, MD, a psychiatrist in Maryland, also commented on the ease and financial benefit of attending the meeting from his home office. He calculated that the cost was much less: $350 for virtual APA, compared with approximately $3,500 for the real thing, allowing for transportation, hotels, meals out, and lost income. “But,” said Dr. Daviss, “engagement with colleagues was minimal.”

APA Assembly member Annette Hanson, MD, has continued to go into work throughout the pandemic. Still, she noted that meetings and committee work have made sure she does not miss out on the “Zoom fatigue” that everyone else is feeling. The virtual APA was tiring for her.

“It was brutal. There was the APA Assembly 1 weekend, right after evening Zoom reference committee meetings the week before. Then virtual APA the next weekend. By the end of the week, I had worked every day for 3 weeks straight, including my more-than-full-time job!”

It has been a challenging time, to say the least, and it has certainly helped that videoconferencing has allowed us to be there for our patients and for each other in so many different circumstances. Former APA President Paul Summergrad, MD, talked about how virtual meetings can be very good as educational tools, but he conveyed what I have been feeling in a sentence: “I miss the social aspect of meetings.”

Please get your vaccine, and I hope to see you in New Orleans next May!

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

Every spring, I look forward to attending the American Psychiatric Association’s annual meeting. It has become a ritual that starts many months before the actual conference.

Submissions for presentations are due in September, so the planning often starts in the late summer. Hotel and plane reservations are made in January, and the meeting itself begins in May.

The city that hosts the event changes each year but, for me, many things do not. The Clinical Psychiatry News editorial board meeting takes place on Monday morning at 7 a.m., and I scour the program for what sessions to attend. In recent years, I have made a point of writing an article for about one of the sessions while still at the meeting – in 2019 I wrote about the improv-acting workshops I attended – something that just doesn’t translate to a Zoom experience.

I go with the same friend every year, I always attend the Hopkins alumni reception, and I organize dinner at a nice restaurant for friends. I have collected so many funny stories and memories over the years that it would be hard to catalog them all. There was the time in Toronto that I set up a meal at a restaurant named Susur – a meal like no other I’ve ever had – and the check arrived with a jaw-dropping sum that I had not anticipated. In San Diego, we watched a gorgeous sunset over the Pacific Ocean from the veranda of the Hotel Coronado. There was the time I sunbathed on the beach in Waikiki with my book editor, and the notable distress when my colleague’s husband called from the airport to say he was not permitted to board his plane in Baltimore to join us in California! There are funny stories, but there is the sadness that one friend who joined us for so many of these events has died.

I always find the program options to be overwhelming: There is so much going on at once that it can be hard to decide what to go to. I try to attend a mix of sessions, some that are inspiring or entertaining, and others that will be informative for clinical issues.

The speakers have been incredible and over the years I’ve heard then-Vice President Joseph Biden, retired quarterback Terry Bradshaw, Oliver Sacks, Alan Alda, Archbishop Desmond Tutu, and perhaps my favorite – Lorraine Bracco, the actress who played Dr. Melfi on “The Sopranos” – to name just a few. And, of course, the opportunity to get the continuing medical education credits I need for licensing is just one more reason to attend.

Last year in May I was still adjusting to my “new” career from home with a computer screen. I had been scheduled to participate in several panels for the meeting in Philadelphia, but extra computer hours had no appeal. And while the fatigue of doing telemental health has eased, I still avoid extra hours interacting with my computer screen and I did not attend this year’s meeting. Without the lure of friends, fun, and the novelty of being somewhere new, my APA experience would have to wait for real life.

Virtual APA has had a drop in participation. In 2019, the last real-life convention in San Francisco, there were 700 scientific sessions and 11,000 professionals in attendance. This year’s virtual conference hosted 135 sessions with more than 7,000 attendees. Attendance was down, but so were costs associated with live conventions and the APA is considering the addition of a virtual component when the annual meeting returns to the in-person venue.

Tom Abdallah is a medical student at Weill Cornell Medicine–Qatar in Education City. He has never attended an in-person APA annual meeting, but he joined for this year’s virtual sessions. “The scientific sessions were fantastic and diverse. Networking was limited in comparison to in-person conferences. The meeting was very well organized, and it gave me the opportunity to attend without worrying about travel.”

Steven Daviss, MD, a psychiatrist in Maryland, also commented on the ease and financial benefit of attending the meeting from his home office. He calculated that the cost was much less: $350 for virtual APA, compared with approximately $3,500 for the real thing, allowing for transportation, hotels, meals out, and lost income. “But,” said Dr. Daviss, “engagement with colleagues was minimal.”

APA Assembly member Annette Hanson, MD, has continued to go into work throughout the pandemic. Still, she noted that meetings and committee work have made sure she does not miss out on the “Zoom fatigue” that everyone else is feeling. The virtual APA was tiring for her.

“It was brutal. There was the APA Assembly 1 weekend, right after evening Zoom reference committee meetings the week before. Then virtual APA the next weekend. By the end of the week, I had worked every day for 3 weeks straight, including my more-than-full-time job!”

It has been a challenging time, to say the least, and it has certainly helped that videoconferencing has allowed us to be there for our patients and for each other in so many different circumstances. Former APA President Paul Summergrad, MD, talked about how virtual meetings can be very good as educational tools, but he conveyed what I have been feeling in a sentence: “I miss the social aspect of meetings.”

Please get your vaccine, and I hope to see you in New Orleans next May!

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

Every spring, I look forward to attending the American Psychiatric Association’s annual meeting. It has become a ritual that starts many months before the actual conference.

Submissions for presentations are due in September, so the planning often starts in the late summer. Hotel and plane reservations are made in January, and the meeting itself begins in May.

The city that hosts the event changes each year but, for me, many things do not. The Clinical Psychiatry News editorial board meeting takes place on Monday morning at 7 a.m., and I scour the program for what sessions to attend. In recent years, I have made a point of writing an article for about one of the sessions while still at the meeting – in 2019 I wrote about the improv-acting workshops I attended – something that just doesn’t translate to a Zoom experience.

I go with the same friend every year, I always attend the Hopkins alumni reception, and I organize dinner at a nice restaurant for friends. I have collected so many funny stories and memories over the years that it would be hard to catalog them all. There was the time in Toronto that I set up a meal at a restaurant named Susur – a meal like no other I’ve ever had – and the check arrived with a jaw-dropping sum that I had not anticipated. In San Diego, we watched a gorgeous sunset over the Pacific Ocean from the veranda of the Hotel Coronado. There was the time I sunbathed on the beach in Waikiki with my book editor, and the notable distress when my colleague’s husband called from the airport to say he was not permitted to board his plane in Baltimore to join us in California! There are funny stories, but there is the sadness that one friend who joined us for so many of these events has died.

I always find the program options to be overwhelming: There is so much going on at once that it can be hard to decide what to go to. I try to attend a mix of sessions, some that are inspiring or entertaining, and others that will be informative for clinical issues.

The speakers have been incredible and over the years I’ve heard then-Vice President Joseph Biden, retired quarterback Terry Bradshaw, Oliver Sacks, Alan Alda, Archbishop Desmond Tutu, and perhaps my favorite – Lorraine Bracco, the actress who played Dr. Melfi on “The Sopranos” – to name just a few. And, of course, the opportunity to get the continuing medical education credits I need for licensing is just one more reason to attend.

Last year in May I was still adjusting to my “new” career from home with a computer screen. I had been scheduled to participate in several panels for the meeting in Philadelphia, but extra computer hours had no appeal. And while the fatigue of doing telemental health has eased, I still avoid extra hours interacting with my computer screen and I did not attend this year’s meeting. Without the lure of friends, fun, and the novelty of being somewhere new, my APA experience would have to wait for real life.

Virtual APA has had a drop in participation. In 2019, the last real-life convention in San Francisco, there were 700 scientific sessions and 11,000 professionals in attendance. This year’s virtual conference hosted 135 sessions with more than 7,000 attendees. Attendance was down, but so were costs associated with live conventions and the APA is considering the addition of a virtual component when the annual meeting returns to the in-person venue.

Tom Abdallah is a medical student at Weill Cornell Medicine–Qatar in Education City. He has never attended an in-person APA annual meeting, but he joined for this year’s virtual sessions. “The scientific sessions were fantastic and diverse. Networking was limited in comparison to in-person conferences. The meeting was very well organized, and it gave me the opportunity to attend without worrying about travel.”

Steven Daviss, MD, a psychiatrist in Maryland, also commented on the ease and financial benefit of attending the meeting from his home office. He calculated that the cost was much less: $350 for virtual APA, compared with approximately $3,500 for the real thing, allowing for transportation, hotels, meals out, and lost income. “But,” said Dr. Daviss, “engagement with colleagues was minimal.”

APA Assembly member Annette Hanson, MD, has continued to go into work throughout the pandemic. Still, she noted that meetings and committee work have made sure she does not miss out on the “Zoom fatigue” that everyone else is feeling. The virtual APA was tiring for her.

“It was brutal. There was the APA Assembly 1 weekend, right after evening Zoom reference committee meetings the week before. Then virtual APA the next weekend. By the end of the week, I had worked every day for 3 weeks straight, including my more-than-full-time job!”

It has been a challenging time, to say the least, and it has certainly helped that videoconferencing has allowed us to be there for our patients and for each other in so many different circumstances. Former APA President Paul Summergrad, MD, talked about how virtual meetings can be very good as educational tools, but he conveyed what I have been feeling in a sentence: “I miss the social aspect of meetings.”

Please get your vaccine, and I hope to see you in New Orleans next May!

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.