Mixed Topics

Biopsy for this patient revealed folliculitis with Demodex mites visualized on histology. Direct immunofluorescence was negative. A KOH preparation was performed and was positive for large numbers of Demodex. Bacterial cultures were negative. The patient was started on a course of submicrobial doxycycline and ivermectin and showed marked improvement 1 month following treatment.

Demodex folliculorum and Demodex brevis (collectively referred to as Demodex) are microscopic parasitic mites that commonly live on human skin.1 Typically, the mite remains asymptomatic. However, in higher numbers, the infestation may cause dermatoses, called demodicosis. Demodex folliculitis is caused by high numbers of Demodex folliculorum, which lives in follicles and sebaceous glands. Lesions often present as itchy papules, pustules, and erythematous scaling on the face, ears, and scalp. Blepharitis may be present. Demodex folliculitis is more common in immunocompromised patients.2

Demodex may have a causative role in rosacea and present similarly, with a key difference being that Demodex-type rosacea is more scaly/dry and pustular than common rosacea.1 In Demodex folliculitis, bacterial cultures are often negative. A skin scraping for KOH will reveal increased mite colonization. The Demodex mite may also be seen in histologic slides.

Treatment of Demodex folliculitis includes crotamiton cream, permethrin cream, oral tetracyclines, topical or systemic metronidazole, and topical or oral ivermectin.

This case and photos were submitted by Susannah McClain, MD, Three Rivers Dermatology, Pittsburgh.
 

References

1. Rather PA and Hassan I. Indian J Dermatol. 2014 Jan;59(1):60-6.

2. Bachmeyer C and Moreno-Sabater A. CMAJ. 2017 Jun 26;189(25):E865.

Biopsy for this patient revealed folliculitis with Demodex mites visualized on histology. Direct immunofluorescence was negative. A KOH preparation was performed and was positive for large numbers of Demodex. Bacterial cultures were negative. The patient was started on a course of submicrobial doxycycline and ivermectin and showed marked improvement 1 month following treatment.

Demodex folliculorum and Demodex brevis (collectively referred to as Demodex) are microscopic parasitic mites that commonly live on human skin.1 Typically, the mite remains asymptomatic. However, in higher numbers, the infestation may cause dermatoses, called demodicosis. Demodex folliculitis is caused by high numbers of Demodex folliculorum, which lives in follicles and sebaceous glands. Lesions often present as itchy papules, pustules, and erythematous scaling on the face, ears, and scalp. Blepharitis may be present. Demodex folliculitis is more common in immunocompromised patients.2

Demodex may have a causative role in rosacea and present similarly, with a key difference being that Demodex-type rosacea is more scaly/dry and pustular than common rosacea.1 In Demodex folliculitis, bacterial cultures are often negative. A skin scraping for KOH will reveal increased mite colonization. The Demodex mite may also be seen in histologic slides.

Treatment of Demodex folliculitis includes crotamiton cream, permethrin cream, oral tetracyclines, topical or systemic metronidazole, and topical or oral ivermectin.

This case and photos were submitted by Susannah McClain, MD, Three Rivers Dermatology, Pittsburgh.
 

References

1. Rather PA and Hassan I. Indian J Dermatol. 2014 Jan;59(1):60-6.

2. Bachmeyer C and Moreno-Sabater A. CMAJ. 2017 Jun 26;189(25):E865.

Biopsy for this patient revealed folliculitis with Demodex mites visualized on histology. Direct immunofluorescence was negative. A KOH preparation was performed and was positive for large numbers of Demodex. Bacterial cultures were negative. The patient was started on a course of submicrobial doxycycline and ivermectin and showed marked improvement 1 month following treatment.

Demodex folliculorum and Demodex brevis (collectively referred to as Demodex) are microscopic parasitic mites that commonly live on human skin.1 Typically, the mite remains asymptomatic. However, in higher numbers, the infestation may cause dermatoses, called demodicosis. Demodex folliculitis is caused by high numbers of Demodex folliculorum, which lives in follicles and sebaceous glands. Lesions often present as itchy papules, pustules, and erythematous scaling on the face, ears, and scalp. Blepharitis may be present. Demodex folliculitis is more common in immunocompromised patients.2

Demodex may have a causative role in rosacea and present similarly, with a key difference being that Demodex-type rosacea is more scaly/dry and pustular than common rosacea.1 In Demodex folliculitis, bacterial cultures are often negative. A skin scraping for KOH will reveal increased mite colonization. The Demodex mite may also be seen in histologic slides.

Treatment of Demodex folliculitis includes crotamiton cream, permethrin cream, oral tetracyclines, topical or systemic metronidazole, and topical or oral ivermectin.

This case and photos were submitted by Susannah McClain, MD, Three Rivers Dermatology, Pittsburgh.
 

References

1. Rather PA and Hassan I. Indian J Dermatol. 2014 Jan;59(1):60-6.

2. Bachmeyer C and Moreno-Sabater A. CMAJ. 2017 Jun 26;189(25):E865.

The use of e-cigarettes is linked to a higher frequency of self-reported wheezing and shortness of breath in adolescents and young adults, according to an online survey. The association was present even after controlling for cigarette and cannabis use.

Previous studies of adolescents and young adults have shown associations between e-cigarette use and wheeze, shortness of breath, and asthma. The Youth Risk Behavior Surveillance (YRBS) survey by the Centers for Disease Control and Prevention and other health agencies, conducted from 2015 to 2017, found that 63.5% of youth who used e-cigarettes also used some combination of cigarettes and cannabis. Combined use was associated with a 55%-65% increased odds of self-reported asthma.

The Population Assessment of Tobacco and Health (PATH) study, which was published in October 2020, had similar findings, though it did not find an association between e-cigarette use alone and wheezing.

“The findings from the current study highlight that we need to keep asking young people about respiratory symptoms, couse of other tobacco products, as well as cannabis use. As more products, including cannabis and various e-cigarette devices, enter the market, assessing respiratory health will be important both where adolescents and young adults receive their health care and in research,” Alayna Tackett, PhD, said in an interview. Dr. Tackett presented the study at the American Thoracic Society’s virtual international conference. She is an assistant professor of preventive medicine at the University of Southern California, Los Angeles.

“I found [the study] very interesting because it seems to be identifying a physiologic response to these e-cigarettes,” said Christopher Pascoe, MD, who was asked to comment. “And they were so young [age 14-21 years]. The fact that these symptoms of wheezing and shortness of breath are coming from people who are this young suggests that there may be chronic problems showing up later with continued use of these devices.”

Dr. Pascoe is an assistant professor of physiology and pathophysiology at the University of Manitoba, Winnipeg, where he also works with the Children’s Hospital Research Institute of Manitoba. His own research examines lung tissue harvested from pneumothorax surgeries in smokers and e-cigarette users to identify markers of inflammation.

He called the research a “good start” at unraveling the impacts of e-cigarettes and smoking, since some people use both products. “The fact that there was still a twofold increase in odds for wheezing, shortness of breath among people who use these e-cigarettes, but weren’t using cannabis and weren’t using cigarettes. I think it’s novel, and it suggests that there is an effect [of e-cigarettes alone].”

The study is based on a self-reported data, which is a significant limitation, especially considering that asthma is often overreported. “Self-report can be fraught with things, but I think it’s an interesting starting point for trying to recruit people who are just e-cigarette users and following them up further,” said Dr. Pascoe.

The researchers surveyed 2,931 individuals aged 14-21 years between Aug. 6 and Aug.30, 2020, with an average age of 18.9 years. Of the respondents, 80% were women and girls, and 75% were White. The high percentage of women and girls was unusual. Dr. Tackett provided no explanation for the atypical demographic but noted that the current study used convenience sampling.

The survey asked about use of e-cigarettes, cigarettes, and cannabis in the past 30 days, as well as asthma diagnosis and respiratory symptoms over the same period. The methodology employed survey management company Lucid, which recruited, collected data from, and provided compensation to participants.

A total of 24% of participants reported asthma, 13% reported wheeze, and 20% reported shortness of breath. Among 1,414 respondents who reported e-cigarette use in the past 30 days, 15% also said they had used cigarettes, and 37% said they had used cannabis.

After controlling for age, birth sex, and race/ethnicity, compared with self-reported never e-cigarette users, there was an association between past 30-day e-cigarette use and self-reported asthma (odds ratio, 1.4; 95% CI, 1.1-1.7), wheeze (OR, 3.1; 95% CI, 2.3-4.2), and shortness of breath (OR, 2.9; 95% CI, 2.3-3.6). After the researchers controlled for past 30-day cigarette cannabis use, the association with asthma was no longer statistically significant (OR, 1.11; 95% CI, 0.87-1.41), but the association with wheeze (OR, 2.3; 95% CI, 1.6-3.0) and shortness of breath (OR, 2.1; 95% CI, 1.6-2.8) remained.

Dr. Tackett noted that wheeze and shortness of breath are only two indicators of respiratory health, and more research needs to be done. Her team is conducting follow-up studies using objective measurement tools such as home-based spirometry in adolescents and young adults who exclusively use e-cigarettes and who have never used e-cigarettes.

“We need to better understand the complex relationships between use of these products and whether multiple product use is associated with worse respiratory outcomes,” said Dr. Tackett.

Dr. Pascoe and Dr. Tackett disclosed no relevant financial relationships.

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

The use of e-cigarettes is linked to a higher frequency of self-reported wheezing and shortness of breath in adolescents and young adults, according to an online survey. The association was present even after controlling for cigarette and cannabis use.

Previous studies of adolescents and young adults have shown associations between e-cigarette use and wheeze, shortness of breath, and asthma. The Youth Risk Behavior Surveillance (YRBS) survey by the Centers for Disease Control and Prevention and other health agencies, conducted from 2015 to 2017, found that 63.5% of youth who used e-cigarettes also used some combination of cigarettes and cannabis. Combined use was associated with a 55%-65% increased odds of self-reported asthma.

The Population Assessment of Tobacco and Health (PATH) study, which was published in October 2020, had similar findings, though it did not find an association between e-cigarette use alone and wheezing.

“The findings from the current study highlight that we need to keep asking young people about respiratory symptoms, couse of other tobacco products, as well as cannabis use. As more products, including cannabis and various e-cigarette devices, enter the market, assessing respiratory health will be important both where adolescents and young adults receive their health care and in research,” Alayna Tackett, PhD, said in an interview. Dr. Tackett presented the study at the American Thoracic Society’s virtual international conference. She is an assistant professor of preventive medicine at the University of Southern California, Los Angeles.

“I found [the study] very interesting because it seems to be identifying a physiologic response to these e-cigarettes,” said Christopher Pascoe, MD, who was asked to comment. “And they were so young [age 14-21 years]. The fact that these symptoms of wheezing and shortness of breath are coming from people who are this young suggests that there may be chronic problems showing up later with continued use of these devices.”

Dr. Pascoe is an assistant professor of physiology and pathophysiology at the University of Manitoba, Winnipeg, where he also works with the Children’s Hospital Research Institute of Manitoba. His own research examines lung tissue harvested from pneumothorax surgeries in smokers and e-cigarette users to identify markers of inflammation.

He called the research a “good start” at unraveling the impacts of e-cigarettes and smoking, since some people use both products. “The fact that there was still a twofold increase in odds for wheezing, shortness of breath among people who use these e-cigarettes, but weren’t using cannabis and weren’t using cigarettes. I think it’s novel, and it suggests that there is an effect [of e-cigarettes alone].”

The study is based on a self-reported data, which is a significant limitation, especially considering that asthma is often overreported. “Self-report can be fraught with things, but I think it’s an interesting starting point for trying to recruit people who are just e-cigarette users and following them up further,” said Dr. Pascoe.

The researchers surveyed 2,931 individuals aged 14-21 years between Aug. 6 and Aug.30, 2020, with an average age of 18.9 years. Of the respondents, 80% were women and girls, and 75% were White. The high percentage of women and girls was unusual. Dr. Tackett provided no explanation for the atypical demographic but noted that the current study used convenience sampling.

The survey asked about use of e-cigarettes, cigarettes, and cannabis in the past 30 days, as well as asthma diagnosis and respiratory symptoms over the same period. The methodology employed survey management company Lucid, which recruited, collected data from, and provided compensation to participants.

A total of 24% of participants reported asthma, 13% reported wheeze, and 20% reported shortness of breath. Among 1,414 respondents who reported e-cigarette use in the past 30 days, 15% also said they had used cigarettes, and 37% said they had used cannabis.

After controlling for age, birth sex, and race/ethnicity, compared with self-reported never e-cigarette users, there was an association between past 30-day e-cigarette use and self-reported asthma (odds ratio, 1.4; 95% CI, 1.1-1.7), wheeze (OR, 3.1; 95% CI, 2.3-4.2), and shortness of breath (OR, 2.9; 95% CI, 2.3-3.6). After the researchers controlled for past 30-day cigarette cannabis use, the association with asthma was no longer statistically significant (OR, 1.11; 95% CI, 0.87-1.41), but the association with wheeze (OR, 2.3; 95% CI, 1.6-3.0) and shortness of breath (OR, 2.1; 95% CI, 1.6-2.8) remained.

Dr. Tackett noted that wheeze and shortness of breath are only two indicators of respiratory health, and more research needs to be done. Her team is conducting follow-up studies using objective measurement tools such as home-based spirometry in adolescents and young adults who exclusively use e-cigarettes and who have never used e-cigarettes.

“We need to better understand the complex relationships between use of these products and whether multiple product use is associated with worse respiratory outcomes,” said Dr. Tackett.

Dr. Pascoe and Dr. Tackett disclosed no relevant financial relationships.

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

The use of e-cigarettes is linked to a higher frequency of self-reported wheezing and shortness of breath in adolescents and young adults, according to an online survey. The association was present even after controlling for cigarette and cannabis use.

Previous studies of adolescents and young adults have shown associations between e-cigarette use and wheeze, shortness of breath, and asthma. The Youth Risk Behavior Surveillance (YRBS) survey by the Centers for Disease Control and Prevention and other health agencies, conducted from 2015 to 2017, found that 63.5% of youth who used e-cigarettes also used some combination of cigarettes and cannabis. Combined use was associated with a 55%-65% increased odds of self-reported asthma.

The Population Assessment of Tobacco and Health (PATH) study, which was published in October 2020, had similar findings, though it did not find an association between e-cigarette use alone and wheezing.

“The findings from the current study highlight that we need to keep asking young people about respiratory symptoms, couse of other tobacco products, as well as cannabis use. As more products, including cannabis and various e-cigarette devices, enter the market, assessing respiratory health will be important both where adolescents and young adults receive their health care and in research,” Alayna Tackett, PhD, said in an interview. Dr. Tackett presented the study at the American Thoracic Society’s virtual international conference. She is an assistant professor of preventive medicine at the University of Southern California, Los Angeles.

“I found [the study] very interesting because it seems to be identifying a physiologic response to these e-cigarettes,” said Christopher Pascoe, MD, who was asked to comment. “And they were so young [age 14-21 years]. The fact that these symptoms of wheezing and shortness of breath are coming from people who are this young suggests that there may be chronic problems showing up later with continued use of these devices.”

Dr. Pascoe is an assistant professor of physiology and pathophysiology at the University of Manitoba, Winnipeg, where he also works with the Children’s Hospital Research Institute of Manitoba. His own research examines lung tissue harvested from pneumothorax surgeries in smokers and e-cigarette users to identify markers of inflammation.

He called the research a “good start” at unraveling the impacts of e-cigarettes and smoking, since some people use both products. “The fact that there was still a twofold increase in odds for wheezing, shortness of breath among people who use these e-cigarettes, but weren’t using cannabis and weren’t using cigarettes. I think it’s novel, and it suggests that there is an effect [of e-cigarettes alone].”

The study is based on a self-reported data, which is a significant limitation, especially considering that asthma is often overreported. “Self-report can be fraught with things, but I think it’s an interesting starting point for trying to recruit people who are just e-cigarette users and following them up further,” said Dr. Pascoe.

The researchers surveyed 2,931 individuals aged 14-21 years between Aug. 6 and Aug.30, 2020, with an average age of 18.9 years. Of the respondents, 80% were women and girls, and 75% were White. The high percentage of women and girls was unusual. Dr. Tackett provided no explanation for the atypical demographic but noted that the current study used convenience sampling.

The survey asked about use of e-cigarettes, cigarettes, and cannabis in the past 30 days, as well as asthma diagnosis and respiratory symptoms over the same period. The methodology employed survey management company Lucid, which recruited, collected data from, and provided compensation to participants.

A total of 24% of participants reported asthma, 13% reported wheeze, and 20% reported shortness of breath. Among 1,414 respondents who reported e-cigarette use in the past 30 days, 15% also said they had used cigarettes, and 37% said they had used cannabis.

After controlling for age, birth sex, and race/ethnicity, compared with self-reported never e-cigarette users, there was an association between past 30-day e-cigarette use and self-reported asthma (odds ratio, 1.4; 95% CI, 1.1-1.7), wheeze (OR, 3.1; 95% CI, 2.3-4.2), and shortness of breath (OR, 2.9; 95% CI, 2.3-3.6). After the researchers controlled for past 30-day cigarette cannabis use, the association with asthma was no longer statistically significant (OR, 1.11; 95% CI, 0.87-1.41), but the association with wheeze (OR, 2.3; 95% CI, 1.6-3.0) and shortness of breath (OR, 2.1; 95% CI, 1.6-2.8) remained.

Dr. Tackett noted that wheeze and shortness of breath are only two indicators of respiratory health, and more research needs to be done. Her team is conducting follow-up studies using objective measurement tools such as home-based spirometry in adolescents and young adults who exclusively use e-cigarettes and who have never used e-cigarettes.

“We need to better understand the complex relationships between use of these products and whether multiple product use is associated with worse respiratory outcomes,” said Dr. Tackett.

Dr. Pascoe and Dr. Tackett disclosed no relevant financial relationships.

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

A hospitalist for 18 years and Annual Conference Committee (ACC) member for the last 4 years, I have always felt immense pride in this meeting. This year, we experienced constant evolution and adapted in ways unimaginable; frameshifts, detours, course corrections, wearing out words like “pivot” and “unprecedented,” whilst contending with virus lulls and surges at hospitals across the country. And SHM Converge 2021 was a landmark success despite it all.

Our SHM community successfully connected through the marvels of modern technology and enjoyed a snappy new logo and name to mark the occasion. Our unflappable course director Dan Steinberg, MD, SFHM, led an intrepid and creative team through uncertainty and produced an extraordinary educational event truly worthy of the term “unprecedented.” ACC members, talented in so many ways, each brought a unique perspective to the planning table to craft a balanced, relevant, and cutting-edge program. The only thing harder than planning a conference for thousands of hospitalists is planning TWO CONFERENCES – one in person, then one virtually.

For their facilitation of virtual adaptation of everything from clinical talks to hot dog sales, our SHM administrative staff deserve a medal. Industry sponsors likewise performed pretzel maneuvers for the virtual interface, and we thank them for their creativity and support. Freshly minted SHM CEO Eric Howell, MD, MHM, kicked off Converge by adeptly filling some very large shoes with aplomb, humor, and humility – telegraphing that our society is in good hands indeed (and that 2020 was NOT the ‘final frontier’). And, finally, each of you, in the suspended reality of a conference hall, tapped into session after session from the comfort of your hometown chairs, indefatigably learning and networking during a pandemic year.

So, beyond adaptability, what did we learn? We renewed our commitment to resilience and wellness in medicine, and reemphasized how critical diversity, equity, and inclusion are in both the workplace and in clinical practice. These topics were complemented by the usual standing-room-only clinical updates and rapid-fire sessions – where everyone could enjoy a front row seat. We talked about parenting in the pandemic, compared clinical approaches in friendly debates – for patients big and small – and deeply dived into leadership strategies for a sustainable workforce.

Here are some SHM Converge 2021 nuggets (Apologies for so few ... there were thousands!):
 

Plenaries

Eric Howell, MD, MHM

• Make the world a better place, be transparent and act with integrity, invest in others, do what you love.
• SHM has been leading the pack in providing e-learning options, promoting clinician self-care, and intensifying diversity, equity, and inclusion efforts before and throughout the pandemic.
• SHM has 18,000 members, 68 chapters, 26 special interest groups, 15 committees, 12 board of directors, 50 staff – growing and getting stronger every day.
• Rainbows need both rain and sunshine to form.

Gen. Mark Hertling

• Our COVID experience as hospitalists shared many features with active combat, including post-COVID combat fog.
• Use your ears, eyes, and mouth in that order: Listen more, see more, speak less.

Vineet Arora, MD, MHM

• Don’t pass up your “career gates.”
• Find “zero-gravity thinkers” – not innovation killers.
• Keep track of your state of mind using the “Bob Wachter scale.”

U.S. Surgeon Gen. Vivek Murthy, MD, and Danielle Scheurer, MD, SFHM

• Mental health and well-being of clinicians is imperative; “heal thyself” doesn’t work. Culture must support policies to truly craft a more sustaining and rewarding environment.
• We are a nation hyperfocused on episodic and salvage care (and are good at it) but must move the needle toward continuity and prevention. Sadly, nobody celebrates the heart attack that was prevented.
• What can hospitalists do about social determinants of health? Advocate for policies individually or through SHM – if you don’t know how, receive training – this is invaluable. More lobbying as a profession may yield legislation and funding aimed at such determinants and improve healthcare.

Larry Wellikson, MD, MHM

• New models hospitalists may soon inhabit: Hospital at Home, ED+, Micro-Hospitals.
• More than 50% of revenue comes from “vertical” services (outside the hospital) rather than horizontal services (in hospital) – trend to increase efforts in population health initiatives.
• Emphasis on value must go from looking at episodes of care to outcomes.
• Hospitalists Complexologists? Be relevant, add value – survive, thrive, and prosper.
   

   

Other sessions

Stroke

• Mobile stroke units are a thing!
• Neurologists are not great at predictions after stroke – but scoring tools are!
• Focus on patient-centered outcomes (100% disability free vs. able to walk vs. happy to be alive).

Drug allergies

• Penicillin allergy: 2% cross-reactivity for cephalosporins – not 10%.

Navigating work/life balance

• Have two phones for work/home – church and state – keep them separate!

Becoming an expert

• Avoid “analysis paralysis”: “Better a good decision quickly than the best decision too late” – H. Geneen

Misc. revelations

• It’s pretty cool to know the Surgeon General is a hospitalist!
• Our SHM community rocks!
• Eric Howell is an avid Star Trek and overalls enthusiast!
• It’s exceedingly difficult to become a MHM – 35 total, 3 this year.
• Danielle Scheurer is a warm and natural interviewer, sensational leader, and closet REM-rapper.
• No matter how hard I try, I’ll always be a social media Luddite: “Am I hashtagging?”

Convenience notwithstanding, this year’s conference-from-home luxury is one we hope to dispense with for SHM Converge 2022, in exchange for wandering of halls, jockeying to be closer to the front of the room, collecting freebies in exhibit halls, and seeing 50 old friends on the way to the session for which you’re already late.

Nashville, Tenn., aka Music City, will be the site of our first in-person meeting in 3 years in April 2022. I will be there with my guitar for SHM’s open mic and I hope you too bring your diverse talents from across the country to spend a week learning and energizing with us, making hospital medicine music in “Honky Tonk Hall,” “Elvis Lives Lounge,” or the “Grand Ol’ Opry-ation Suite.” The band is getting back together! Be a part of the excitement. Bring your voice, bring your talent, and let’s do Nashville in numbers!

Planning is now underway ... and we need your ideas and suggestions! Share thoughts on topics and speakers through the OPEN CALL site through June 1st ... and don’t forget to watch on-demand talks you missed from SHM Converge 2021 – a veritable treasure trove of learning.

Dr. Nye is a hospitalist and professor of medicine at the University of California, San Francisco. She is the course director of SHM Converge 2022.

A hospitalist for 18 years and Annual Conference Committee (ACC) member for the last 4 years, I have always felt immense pride in this meeting. This year, we experienced constant evolution and adapted in ways unimaginable; frameshifts, detours, course corrections, wearing out words like “pivot” and “unprecedented,” whilst contending with virus lulls and surges at hospitals across the country. And SHM Converge 2021 was a landmark success despite it all.

Our SHM community successfully connected through the marvels of modern technology and enjoyed a snappy new logo and name to mark the occasion. Our unflappable course director Dan Steinberg, MD, SFHM, led an intrepid and creative team through uncertainty and produced an extraordinary educational event truly worthy of the term “unprecedented.” ACC members, talented in so many ways, each brought a unique perspective to the planning table to craft a balanced, relevant, and cutting-edge program. The only thing harder than planning a conference for thousands of hospitalists is planning TWO CONFERENCES – one in person, then one virtually.

For their facilitation of virtual adaptation of everything from clinical talks to hot dog sales, our SHM administrative staff deserve a medal. Industry sponsors likewise performed pretzel maneuvers for the virtual interface, and we thank them for their creativity and support. Freshly minted SHM CEO Eric Howell, MD, MHM, kicked off Converge by adeptly filling some very large shoes with aplomb, humor, and humility – telegraphing that our society is in good hands indeed (and that 2020 was NOT the ‘final frontier’). And, finally, each of you, in the suspended reality of a conference hall, tapped into session after session from the comfort of your hometown chairs, indefatigably learning and networking during a pandemic year.

So, beyond adaptability, what did we learn? We renewed our commitment to resilience and wellness in medicine, and reemphasized how critical diversity, equity, and inclusion are in both the workplace and in clinical practice. These topics were complemented by the usual standing-room-only clinical updates and rapid-fire sessions – where everyone could enjoy a front row seat. We talked about parenting in the pandemic, compared clinical approaches in friendly debates – for patients big and small – and deeply dived into leadership strategies for a sustainable workforce.

Here are some SHM Converge 2021 nuggets (Apologies for so few ... there were thousands!):
 

Plenaries

Eric Howell, MD, MHM

• Make the world a better place, be transparent and act with integrity, invest in others, do what you love.
• SHM has been leading the pack in providing e-learning options, promoting clinician self-care, and intensifying diversity, equity, and inclusion efforts before and throughout the pandemic.
• SHM has 18,000 members, 68 chapters, 26 special interest groups, 15 committees, 12 board of directors, 50 staff – growing and getting stronger every day.
• Rainbows need both rain and sunshine to form.

Gen. Mark Hertling

• Our COVID experience as hospitalists shared many features with active combat, including post-COVID combat fog.
• Use your ears, eyes, and mouth in that order: Listen more, see more, speak less.

Vineet Arora, MD, MHM

• Don’t pass up your “career gates.”
• Find “zero-gravity thinkers” – not innovation killers.
• Keep track of your state of mind using the “Bob Wachter scale.”

U.S. Surgeon Gen. Vivek Murthy, MD, and Danielle Scheurer, MD, SFHM

• Mental health and well-being of clinicians is imperative; “heal thyself” doesn’t work. Culture must support policies to truly craft a more sustaining and rewarding environment.
• We are a nation hyperfocused on episodic and salvage care (and are good at it) but must move the needle toward continuity and prevention. Sadly, nobody celebrates the heart attack that was prevented.
• What can hospitalists do about social determinants of health? Advocate for policies individually or through SHM – if you don’t know how, receive training – this is invaluable. More lobbying as a profession may yield legislation and funding aimed at such determinants and improve healthcare.

Larry Wellikson, MD, MHM

• New models hospitalists may soon inhabit: Hospital at Home, ED+, Micro-Hospitals.
• More than 50% of revenue comes from “vertical” services (outside the hospital) rather than horizontal services (in hospital) – trend to increase efforts in population health initiatives.
• Emphasis on value must go from looking at episodes of care to outcomes.
• Hospitalists Complexologists? Be relevant, add value – survive, thrive, and prosper.
   

   

Other sessions

Stroke

• Mobile stroke units are a thing!
• Neurologists are not great at predictions after stroke – but scoring tools are!
• Focus on patient-centered outcomes (100% disability free vs. able to walk vs. happy to be alive).

Drug allergies

• Penicillin allergy: 2% cross-reactivity for cephalosporins – not 10%.

Navigating work/life balance

• Have two phones for work/home – church and state – keep them separate!

Becoming an expert

• Avoid “analysis paralysis”: “Better a good decision quickly than the best decision too late” – H. Geneen

Misc. revelations

• It’s pretty cool to know the Surgeon General is a hospitalist!
• Our SHM community rocks!
• Eric Howell is an avid Star Trek and overalls enthusiast!
• It’s exceedingly difficult to become a MHM – 35 total, 3 this year.
• Danielle Scheurer is a warm and natural interviewer, sensational leader, and closet REM-rapper.
• No matter how hard I try, I’ll always be a social media Luddite: “Am I hashtagging?”

Convenience notwithstanding, this year’s conference-from-home luxury is one we hope to dispense with for SHM Converge 2022, in exchange for wandering of halls, jockeying to be closer to the front of the room, collecting freebies in exhibit halls, and seeing 50 old friends on the way to the session for which you’re already late.

Nashville, Tenn., aka Music City, will be the site of our first in-person meeting in 3 years in April 2022. I will be there with my guitar for SHM’s open mic and I hope you too bring your diverse talents from across the country to spend a week learning and energizing with us, making hospital medicine music in “Honky Tonk Hall,” “Elvis Lives Lounge,” or the “Grand Ol’ Opry-ation Suite.” The band is getting back together! Be a part of the excitement. Bring your voice, bring your talent, and let’s do Nashville in numbers!

Planning is now underway ... and we need your ideas and suggestions! Share thoughts on topics and speakers through the OPEN CALL site through June 1st ... and don’t forget to watch on-demand talks you missed from SHM Converge 2021 – a veritable treasure trove of learning.

Dr. Nye is a hospitalist and professor of medicine at the University of California, San Francisco. She is the course director of SHM Converge 2022.

A hospitalist for 18 years and Annual Conference Committee (ACC) member for the last 4 years, I have always felt immense pride in this meeting. This year, we experienced constant evolution and adapted in ways unimaginable; frameshifts, detours, course corrections, wearing out words like “pivot” and “unprecedented,” whilst contending with virus lulls and surges at hospitals across the country. And SHM Converge 2021 was a landmark success despite it all.

Our SHM community successfully connected through the marvels of modern technology and enjoyed a snappy new logo and name to mark the occasion. Our unflappable course director Dan Steinberg, MD, SFHM, led an intrepid and creative team through uncertainty and produced an extraordinary educational event truly worthy of the term “unprecedented.” ACC members, talented in so many ways, each brought a unique perspective to the planning table to craft a balanced, relevant, and cutting-edge program. The only thing harder than planning a conference for thousands of hospitalists is planning TWO CONFERENCES – one in person, then one virtually.

For their facilitation of virtual adaptation of everything from clinical talks to hot dog sales, our SHM administrative staff deserve a medal. Industry sponsors likewise performed pretzel maneuvers for the virtual interface, and we thank them for their creativity and support. Freshly minted SHM CEO Eric Howell, MD, MHM, kicked off Converge by adeptly filling some very large shoes with aplomb, humor, and humility – telegraphing that our society is in good hands indeed (and that 2020 was NOT the ‘final frontier’). And, finally, each of you, in the suspended reality of a conference hall, tapped into session after session from the comfort of your hometown chairs, indefatigably learning and networking during a pandemic year.

So, beyond adaptability, what did we learn? We renewed our commitment to resilience and wellness in medicine, and reemphasized how critical diversity, equity, and inclusion are in both the workplace and in clinical practice. These topics were complemented by the usual standing-room-only clinical updates and rapid-fire sessions – where everyone could enjoy a front row seat. We talked about parenting in the pandemic, compared clinical approaches in friendly debates – for patients big and small – and deeply dived into leadership strategies for a sustainable workforce.

Here are some SHM Converge 2021 nuggets (Apologies for so few ... there were thousands!):
 

Plenaries

Eric Howell, MD, MHM

• Make the world a better place, be transparent and act with integrity, invest in others, do what you love.
• SHM has been leading the pack in providing e-learning options, promoting clinician self-care, and intensifying diversity, equity, and inclusion efforts before and throughout the pandemic.
• SHM has 18,000 members, 68 chapters, 26 special interest groups, 15 committees, 12 board of directors, 50 staff – growing and getting stronger every day.
• Rainbows need both rain and sunshine to form.

Gen. Mark Hertling

• Our COVID experience as hospitalists shared many features with active combat, including post-COVID combat fog.
• Use your ears, eyes, and mouth in that order: Listen more, see more, speak less.

Vineet Arora, MD, MHM

• Don’t pass up your “career gates.”
• Find “zero-gravity thinkers” – not innovation killers.
• Keep track of your state of mind using the “Bob Wachter scale.”

U.S. Surgeon Gen. Vivek Murthy, MD, and Danielle Scheurer, MD, SFHM

• Mental health and well-being of clinicians is imperative; “heal thyself” doesn’t work. Culture must support policies to truly craft a more sustaining and rewarding environment.
• We are a nation hyperfocused on episodic and salvage care (and are good at it) but must move the needle toward continuity and prevention. Sadly, nobody celebrates the heart attack that was prevented.
• What can hospitalists do about social determinants of health? Advocate for policies individually or through SHM – if you don’t know how, receive training – this is invaluable. More lobbying as a profession may yield legislation and funding aimed at such determinants and improve healthcare.

Larry Wellikson, MD, MHM

• New models hospitalists may soon inhabit: Hospital at Home, ED+, Micro-Hospitals.
• More than 50% of revenue comes from “vertical” services (outside the hospital) rather than horizontal services (in hospital) – trend to increase efforts in population health initiatives.
• Emphasis on value must go from looking at episodes of care to outcomes.
• Hospitalists Complexologists? Be relevant, add value – survive, thrive, and prosper.
   

   

Other sessions

Stroke

• Mobile stroke units are a thing!
• Neurologists are not great at predictions after stroke – but scoring tools are!
• Focus on patient-centered outcomes (100% disability free vs. able to walk vs. happy to be alive).

Drug allergies

• Penicillin allergy: 2% cross-reactivity for cephalosporins – not 10%.

Navigating work/life balance

• Have two phones for work/home – church and state – keep them separate!

Becoming an expert

• Avoid “analysis paralysis”: “Better a good decision quickly than the best decision too late” – H. Geneen

Misc. revelations

• It’s pretty cool to know the Surgeon General is a hospitalist!
• Our SHM community rocks!
• Eric Howell is an avid Star Trek and overalls enthusiast!
• It’s exceedingly difficult to become a MHM – 35 total, 3 this year.
• Danielle Scheurer is a warm and natural interviewer, sensational leader, and closet REM-rapper.
• No matter how hard I try, I’ll always be a social media Luddite: “Am I hashtagging?”

Convenience notwithstanding, this year’s conference-from-home luxury is one we hope to dispense with for SHM Converge 2022, in exchange for wandering of halls, jockeying to be closer to the front of the room, collecting freebies in exhibit halls, and seeing 50 old friends on the way to the session for which you’re already late.

Nashville, Tenn., aka Music City, will be the site of our first in-person meeting in 3 years in April 2022. I will be there with my guitar for SHM’s open mic and I hope you too bring your diverse talents from across the country to spend a week learning and energizing with us, making hospital medicine music in “Honky Tonk Hall,” “Elvis Lives Lounge,” or the “Grand Ol’ Opry-ation Suite.” The band is getting back together! Be a part of the excitement. Bring your voice, bring your talent, and let’s do Nashville in numbers!

Planning is now underway ... and we need your ideas and suggestions! Share thoughts on topics and speakers through the OPEN CALL site through June 1st ... and don’t forget to watch on-demand talks you missed from SHM Converge 2021 – a veritable treasure trove of learning.

Dr. Nye is a hospitalist and professor of medicine at the University of California, San Francisco. She is the course director of SHM Converge 2022.

The Food and Drug Administration is launching a process to prepare an environmental impact statement (EIS) regarding the use oxybenzone and octinoxate in over-the-counter sunscreen products.

mark wragg/iStockphoto.com

According to the “Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use,” which was published in the Federal Register on May 13, 2021, the FDA will prepare an EIS “when data or information in an environmental assessment or otherwise available to the Agency leads to a finding that the proposed agency action may significantly affect the quality of the human environment.” The first step in this effort involves a “public scoping process” to evaluate any potential environmental impacts associated with the use of oxybenzone and octinoxate in sunscreens so that an EIS, if required, “can be completed prior to issuance of a final sunscreen order addressing sunscreens containing these ingredients.”

The American Academy of Dermatology Association weighed in on the FDA’s announcement, noting that it “appreciates the efforts of the agency to thoroughly examine all relevant science before issuing a final sunscreen order on these ingredients,” according to a statement released by the AADA on May 13, 2021.

The statement added: “Skin cancer is the most common cancer in the U.S., and unprotected exposure to the sun’s harmful ultraviolet rays is a major risk factor. The AADA continues to focus on encouraging members of the public to protect themselves by seeking shade, wearing protective clothing – including a lightweight and long-sleeved shirt, pants, a wide-brimmed hat and sunglasses – and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all exposed skin.”

According to the FDA document, a series of developments regarding oxybenzone and octinoxate prompted the agency to take this step, including comments the agency received in response to the 2019 proposed rule titled “Sunscreen Drug Products for Over-The-Counter Human Use,” which raised concern about the potential effects of the two ingredients on coral and/or coral reefs, as well as research efforts by the National Oceanic and Atmospheric Administration Coral Reef Conservation Programs on the potential impacts of sunscreen products that include oxybenzone and octinoxate on coral reefs and other aquatic systems. Hawaii’s 2018 state law prohibiting the sale, offer of sale, and distribution of sunscreens that contain oxybenzone and/or octinoxate also influenced the agency’s decision to further evaluate the topic.

“The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including potential alternatives and the extent to which those issues and impacts will be analyzed,” the FDA document states. “At this initial stage of the scoping process, we have identified the following four alternatives: FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA [new drug application] is impermissible; FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA is permissible; FDA will conclude that inclusion of oxybenzone in sunscreens marketed without an NDA is permissible but that the inclusion of octinoxate in sunscreens marketed without an NDA is impermissible; or FDA will conclude that inclusion of octinoxate in sunscreens marketed without an NDA is permissible but that the inclusion of oxybenzone in sunscreens marketed without an NDA is impermissible.”

Until June 14, the FDA is accepting comments from the public electronically via the Federal eRulemaking Portal at www.regulations.gov (search for Docket No. FDA-2021-N-0352) or by mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852. Refer to Docket No. FDA-2021-N-0352.

[email protected]

The Food and Drug Administration is launching a process to prepare an environmental impact statement (EIS) regarding the use oxybenzone and octinoxate in over-the-counter sunscreen products.

mark wragg/iStockphoto.com

According to the “Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use,” which was published in the Federal Register on May 13, 2021, the FDA will prepare an EIS “when data or information in an environmental assessment or otherwise available to the Agency leads to a finding that the proposed agency action may significantly affect the quality of the human environment.” The first step in this effort involves a “public scoping process” to evaluate any potential environmental impacts associated with the use of oxybenzone and octinoxate in sunscreens so that an EIS, if required, “can be completed prior to issuance of a final sunscreen order addressing sunscreens containing these ingredients.”

The American Academy of Dermatology Association weighed in on the FDA’s announcement, noting that it “appreciates the efforts of the agency to thoroughly examine all relevant science before issuing a final sunscreen order on these ingredients,” according to a statement released by the AADA on May 13, 2021.

The statement added: “Skin cancer is the most common cancer in the U.S., and unprotected exposure to the sun’s harmful ultraviolet rays is a major risk factor. The AADA continues to focus on encouraging members of the public to protect themselves by seeking shade, wearing protective clothing – including a lightweight and long-sleeved shirt, pants, a wide-brimmed hat and sunglasses – and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all exposed skin.”

According to the FDA document, a series of developments regarding oxybenzone and octinoxate prompted the agency to take this step, including comments the agency received in response to the 2019 proposed rule titled “Sunscreen Drug Products for Over-The-Counter Human Use,” which raised concern about the potential effects of the two ingredients on coral and/or coral reefs, as well as research efforts by the National Oceanic and Atmospheric Administration Coral Reef Conservation Programs on the potential impacts of sunscreen products that include oxybenzone and octinoxate on coral reefs and other aquatic systems. Hawaii’s 2018 state law prohibiting the sale, offer of sale, and distribution of sunscreens that contain oxybenzone and/or octinoxate also influenced the agency’s decision to further evaluate the topic.

“The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including potential alternatives and the extent to which those issues and impacts will be analyzed,” the FDA document states. “At this initial stage of the scoping process, we have identified the following four alternatives: FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA [new drug application] is impermissible; FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA is permissible; FDA will conclude that inclusion of oxybenzone in sunscreens marketed without an NDA is permissible but that the inclusion of octinoxate in sunscreens marketed without an NDA is impermissible; or FDA will conclude that inclusion of octinoxate in sunscreens marketed without an NDA is permissible but that the inclusion of oxybenzone in sunscreens marketed without an NDA is impermissible.”

Until June 14, the FDA is accepting comments from the public electronically via the Federal eRulemaking Portal at www.regulations.gov (search for Docket No. FDA-2021-N-0352) or by mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852. Refer to Docket No. FDA-2021-N-0352.

[email protected]

The Food and Drug Administration is launching a process to prepare an environmental impact statement (EIS) regarding the use oxybenzone and octinoxate in over-the-counter sunscreen products.

mark wragg/iStockphoto.com

According to the “Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use,” which was published in the Federal Register on May 13, 2021, the FDA will prepare an EIS “when data or information in an environmental assessment or otherwise available to the Agency leads to a finding that the proposed agency action may significantly affect the quality of the human environment.” The first step in this effort involves a “public scoping process” to evaluate any potential environmental impacts associated with the use of oxybenzone and octinoxate in sunscreens so that an EIS, if required, “can be completed prior to issuance of a final sunscreen order addressing sunscreens containing these ingredients.”

The American Academy of Dermatology Association weighed in on the FDA’s announcement, noting that it “appreciates the efforts of the agency to thoroughly examine all relevant science before issuing a final sunscreen order on these ingredients,” according to a statement released by the AADA on May 13, 2021.

The statement added: “Skin cancer is the most common cancer in the U.S., and unprotected exposure to the sun’s harmful ultraviolet rays is a major risk factor. The AADA continues to focus on encouraging members of the public to protect themselves by seeking shade, wearing protective clothing – including a lightweight and long-sleeved shirt, pants, a wide-brimmed hat and sunglasses – and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all exposed skin.”

According to the FDA document, a series of developments regarding oxybenzone and octinoxate prompted the agency to take this step, including comments the agency received in response to the 2019 proposed rule titled “Sunscreen Drug Products for Over-The-Counter Human Use,” which raised concern about the potential effects of the two ingredients on coral and/or coral reefs, as well as research efforts by the National Oceanic and Atmospheric Administration Coral Reef Conservation Programs on the potential impacts of sunscreen products that include oxybenzone and octinoxate on coral reefs and other aquatic systems. Hawaii’s 2018 state law prohibiting the sale, offer of sale, and distribution of sunscreens that contain oxybenzone and/or octinoxate also influenced the agency’s decision to further evaluate the topic.

“The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including potential alternatives and the extent to which those issues and impacts will be analyzed,” the FDA document states. “At this initial stage of the scoping process, we have identified the following four alternatives: FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA [new drug application] is impermissible; FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA is permissible; FDA will conclude that inclusion of oxybenzone in sunscreens marketed without an NDA is permissible but that the inclusion of octinoxate in sunscreens marketed without an NDA is impermissible; or FDA will conclude that inclusion of octinoxate in sunscreens marketed without an NDA is permissible but that the inclusion of oxybenzone in sunscreens marketed without an NDA is impermissible.”

Until June 14, the FDA is accepting comments from the public electronically via the Federal eRulemaking Portal at www.regulations.gov (search for Docket No. FDA-2021-N-0352) or by mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852. Refer to Docket No. FDA-2021-N-0352.

[email protected]

The Food and Drug Administration is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Terry Rudd/MDedge News

The warning, published on May 13, comes on the heels of recent research reporting that high–field strength magnets in newer smartphones may cause some implanted medical devices to switch to “magnet mode” and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

“The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact,” it said. “The FDA also conducted its own testing on some products that use the high–field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter defibrillators and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

• Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.
• Do not carry consumer electronics in a pocket over the medical device.
• Check your device using your home monitoring system, if you have one.
• Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

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

The Food and Drug Administration is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Terry Rudd/MDedge News

The warning, published on May 13, comes on the heels of recent research reporting that high–field strength magnets in newer smartphones may cause some implanted medical devices to switch to “magnet mode” and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

“The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact,” it said. “The FDA also conducted its own testing on some products that use the high–field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter defibrillators and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

• Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.
• Do not carry consumer electronics in a pocket over the medical device.
• Check your device using your home monitoring system, if you have one.
• Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

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

The Food and Drug Administration is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Terry Rudd/MDedge News

The warning, published on May 13, comes on the heels of recent research reporting that high–field strength magnets in newer smartphones may cause some implanted medical devices to switch to “magnet mode” and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

“The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact,” it said. “The FDA also conducted its own testing on some products that use the high–field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter defibrillators and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

• Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.
• Do not carry consumer electronics in a pocket over the medical device.
• Check your device using your home monitoring system, if you have one.
• Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

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

What a year it has been in the world of hospital medicine with all the changes, challenges, and uncertainties surrounding the COVID-19 pandemic. Some hospitalist programs were hit hard early on with an early surge, when little was known about COVID-19, and other programs have had more time to plan and adapt to later surges.

As many readers of The Hospitalist know, the Society of Hospital Medicine publishes a biennial State of Hospital Medicine (SoHM) Report – last published in September 2020 using data from 2019. The SoHM Report contains a wealth of information that many groups find useful in evaluating their programs, with topics ranging from compensation to staffing to scheduling. As some prior months’ Survey Insights columns have alluded to, with the rapid pace of change in 2020 because of the COVID-19 pandemic, the Society of Hospital Medicine made the decision to publish an addendum highlighting the myriad of adjustments and adaptations that have occurred in such a short period of time. The COVID-19 Addendum is available to all purchasers of the SoHM Report and contains data from survey responses submitted in September 2020.

Let’s take a look at what transpired in 2020, starting with staffing – no doubt a challenge for many groups. During some periods of time, patient volumes may have fallen below historical averages with stay-at-home orders, canceled procedures, and a reluctance by patients to seek medical care. In contrast, for many groups, other parts of the year were all-hands-on-deck scenarios to care for extraordinary surges in patient volume. To compound this, many hospitalist groups had physicians and staff facing quarantine or isolation requirements because of exposures or contracting COVID-19, and locums positions may have been difficult to fill because of travel restrictions and extreme demand.

What operational changes were made in response to these staffing challenges? Perhaps one notable finding from the COVID-19 Addendum was the need for contingency planning and backup systems. From the 2020 SoHM, prior to the pandemic, 47.4% of adult hospital medicine groups had backup systems in place. In our recently published addendum, we found that 61.9% of groups instituted a backup system where none previously existed. In addition, 54.2% of groups modified their existing backup system. Some 39.6% of hospital medicine groups also utilized clinicians from other service lines to help cover service needs.

Aside from staffing, hospitals faced unprecedented financial challenges, and these effects rippled through to hospitalists. Our addendum found that 42.0% of hospitalist groups faced reductions in salary or bonuses, and 35.5% of hospital medicine groups reduced provider compensation by a reduction of work hours or shifts. I’ve personally been struck by these findings – that many hospitalists at the front-lines of COVID-19 received salary reductions, albeit temporary for many groups, during one of the most challenging years of their professional careers. Our addendum, interestingly, also found that a smaller 10.7% of groups instituted hazard pay for clinicians caring for COVID-19 patients.

So, are the changes and challenges your group faced similar to what was experienced by other hospital medicine programs? These findings and many more interesting and useful pieces of data are available in the full COVID-19 Addendum. Perhaps my biggest takeaway is that hospitalists have been perhaps the most uniquely positioned specialty to tackle the challenges of the COVID-19 pandemic. We have always been a dynamic, changing field, ready to lead and tackle change – and while change may have happened more quickly and in ways that were unforeseen just a year ago, hospitalists have undoubtedly demonstrated their strengths as leaders ready to adapt and rise to the occasion.

I am optimistic that, as we move beyond the pandemic in the coming months and years, the value that hospitalists have proven yet again will yield long-term recognition and benefits to our programs and our specialty.

Dr. Huang is a physician adviser and clinical professor of medicine in the division of hospital medicine at the University of California, San Diego. He is a member of SHM’s Practice Analysis Committee.

What a year it has been in the world of hospital medicine with all the changes, challenges, and uncertainties surrounding the COVID-19 pandemic. Some hospitalist programs were hit hard early on with an early surge, when little was known about COVID-19, and other programs have had more time to plan and adapt to later surges.

As many readers of The Hospitalist know, the Society of Hospital Medicine publishes a biennial State of Hospital Medicine (SoHM) Report – last published in September 2020 using data from 2019. The SoHM Report contains a wealth of information that many groups find useful in evaluating their programs, with topics ranging from compensation to staffing to scheduling. As some prior months’ Survey Insights columns have alluded to, with the rapid pace of change in 2020 because of the COVID-19 pandemic, the Society of Hospital Medicine made the decision to publish an addendum highlighting the myriad of adjustments and adaptations that have occurred in such a short period of time. The COVID-19 Addendum is available to all purchasers of the SoHM Report and contains data from survey responses submitted in September 2020.

Let’s take a look at what transpired in 2020, starting with staffing – no doubt a challenge for many groups. During some periods of time, patient volumes may have fallen below historical averages with stay-at-home orders, canceled procedures, and a reluctance by patients to seek medical care. In contrast, for many groups, other parts of the year were all-hands-on-deck scenarios to care for extraordinary surges in patient volume. To compound this, many hospitalist groups had physicians and staff facing quarantine or isolation requirements because of exposures or contracting COVID-19, and locums positions may have been difficult to fill because of travel restrictions and extreme demand.

What operational changes were made in response to these staffing challenges? Perhaps one notable finding from the COVID-19 Addendum was the need for contingency planning and backup systems. From the 2020 SoHM, prior to the pandemic, 47.4% of adult hospital medicine groups had backup systems in place. In our recently published addendum, we found that 61.9% of groups instituted a backup system where none previously existed. In addition, 54.2% of groups modified their existing backup system. Some 39.6% of hospital medicine groups also utilized clinicians from other service lines to help cover service needs.

Aside from staffing, hospitals faced unprecedented financial challenges, and these effects rippled through to hospitalists. Our addendum found that 42.0% of hospitalist groups faced reductions in salary or bonuses, and 35.5% of hospital medicine groups reduced provider compensation by a reduction of work hours or shifts. I’ve personally been struck by these findings – that many hospitalists at the front-lines of COVID-19 received salary reductions, albeit temporary for many groups, during one of the most challenging years of their professional careers. Our addendum, interestingly, also found that a smaller 10.7% of groups instituted hazard pay for clinicians caring for COVID-19 patients.

So, are the changes and challenges your group faced similar to what was experienced by other hospital medicine programs? These findings and many more interesting and useful pieces of data are available in the full COVID-19 Addendum. Perhaps my biggest takeaway is that hospitalists have been perhaps the most uniquely positioned specialty to tackle the challenges of the COVID-19 pandemic. We have always been a dynamic, changing field, ready to lead and tackle change – and while change may have happened more quickly and in ways that were unforeseen just a year ago, hospitalists have undoubtedly demonstrated their strengths as leaders ready to adapt and rise to the occasion.

I am optimistic that, as we move beyond the pandemic in the coming months and years, the value that hospitalists have proven yet again will yield long-term recognition and benefits to our programs and our specialty.

Dr. Huang is a physician adviser and clinical professor of medicine in the division of hospital medicine at the University of California, San Diego. He is a member of SHM’s Practice Analysis Committee.

What a year it has been in the world of hospital medicine with all the changes, challenges, and uncertainties surrounding the COVID-19 pandemic. Some hospitalist programs were hit hard early on with an early surge, when little was known about COVID-19, and other programs have had more time to plan and adapt to later surges.

As many readers of The Hospitalist know, the Society of Hospital Medicine publishes a biennial State of Hospital Medicine (SoHM) Report – last published in September 2020 using data from 2019. The SoHM Report contains a wealth of information that many groups find useful in evaluating their programs, with topics ranging from compensation to staffing to scheduling. As some prior months’ Survey Insights columns have alluded to, with the rapid pace of change in 2020 because of the COVID-19 pandemic, the Society of Hospital Medicine made the decision to publish an addendum highlighting the myriad of adjustments and adaptations that have occurred in such a short period of time. The COVID-19 Addendum is available to all purchasers of the SoHM Report and contains data from survey responses submitted in September 2020.

Let’s take a look at what transpired in 2020, starting with staffing – no doubt a challenge for many groups. During some periods of time, patient volumes may have fallen below historical averages with stay-at-home orders, canceled procedures, and a reluctance by patients to seek medical care. In contrast, for many groups, other parts of the year were all-hands-on-deck scenarios to care for extraordinary surges in patient volume. To compound this, many hospitalist groups had physicians and staff facing quarantine or isolation requirements because of exposures or contracting COVID-19, and locums positions may have been difficult to fill because of travel restrictions and extreme demand.

What operational changes were made in response to these staffing challenges? Perhaps one notable finding from the COVID-19 Addendum was the need for contingency planning and backup systems. From the 2020 SoHM, prior to the pandemic, 47.4% of adult hospital medicine groups had backup systems in place. In our recently published addendum, we found that 61.9% of groups instituted a backup system where none previously existed. In addition, 54.2% of groups modified their existing backup system. Some 39.6% of hospital medicine groups also utilized clinicians from other service lines to help cover service needs.

Aside from staffing, hospitals faced unprecedented financial challenges, and these effects rippled through to hospitalists. Our addendum found that 42.0% of hospitalist groups faced reductions in salary or bonuses, and 35.5% of hospital medicine groups reduced provider compensation by a reduction of work hours or shifts. I’ve personally been struck by these findings – that many hospitalists at the front-lines of COVID-19 received salary reductions, albeit temporary for many groups, during one of the most challenging years of their professional careers. Our addendum, interestingly, also found that a smaller 10.7% of groups instituted hazard pay for clinicians caring for COVID-19 patients.

So, are the changes and challenges your group faced similar to what was experienced by other hospital medicine programs? These findings and many more interesting and useful pieces of data are available in the full COVID-19 Addendum. Perhaps my biggest takeaway is that hospitalists have been perhaps the most uniquely positioned specialty to tackle the challenges of the COVID-19 pandemic. We have always been a dynamic, changing field, ready to lead and tackle change – and while change may have happened more quickly and in ways that were unforeseen just a year ago, hospitalists have undoubtedly demonstrated their strengths as leaders ready to adapt and rise to the occasion.

I am optimistic that, as we move beyond the pandemic in the coming months and years, the value that hospitalists have proven yet again will yield long-term recognition and benefits to our programs and our specialty.

Dr. Huang is a physician adviser and clinical professor of medicine in the division of hospital medicine at the University of California, San Diego. He is a member of SHM’s Practice Analysis Committee.

Your mentor has been looking for someone to help lead a new project in your division, and tells you she’s been having a hard time finding someone – but that you would be great. The project isn’t something you are very interested in doing and you’re already swamped with other projects, but the mentor seems to need the help. What do you do?

Mentor-mentee relationships can be deeply beneficial, but the dynamics – in this situation and many others – can be complex. At SHM Converge, the annual conference of the Society of Hospital Medicine, panelists offered guidance on how best to navigate this terrain.

Vineet Arora, MD, MAPP, MHM, associate chief medical officer for clinical learning environment at the University of Chicago, suggested that, in the situation involving the mentor’s request to an uncertain mentee, the mentee should not give an immediate answer, but consider the pros and cons.

“It’s tough when it’s somebody who’s directly overseeing you,” she said. “If you’re really truly the best person, they’re going to want you in the job, and maybe they’ll make it work for you.” She said it would be important to find out why the mentor is having trouble finding someone, and suggested the mentee could find someone with whom to discuss it.

Calling mentoring a “team sport,” Dr. Arora described several types: the traditional mentor who helps many aspects of a mentee’s career, a “coach” who helps on a specific project or topic, a “sponsor” that can help elevate a mentee to a bigger opportunity, and a “connector” who can help a mentee begin new career relationships.

“Don’t invest in just one person,” she said. “Try to get that personal board of directors.”

She mentioned six things all mentors should do: Choose mentees carefully, establish a mentorship team, run a tight ship, head off rifts or resolve them, prepare for transitions when they take a new position and might have a new relationship with a mentee, and don’t commit “mentorship malpractice.”

Mentoring is a two-way street, with both people benefiting and learning, but mentoring can have its troubles, either through active, dysfunctional behavior that’s easy to spot, or passive behavior, such as the “bottleneck” problem when a mentor is too preoccupied with his or her own priorities to mentor well, the “country clubber” who mentors only for popularity and social capital but doesn’t do the work required, and the “world traveler” who is sought after but has little time for day-to-day mentoring.

Valerie Vaughan, MD, MSc, assistant professor of medicine at the University of Utah, described four “golden rules” of being a mentee. First, find a CAPE mentor (for capable, availability, projects of interest, and easy to get along with). Then, be respectful of a mentor’s time, communicate effectively, and be engaged and energizing.

“Mentors typically don’t get paid to mentor and so a lot of them are doing it because they find joy for doing it,” Dr. Vaughan said. “So as much as you can as a mentee, try to be the person who brings energy to the mentor-mentee relationship. It’s up to you to drive projects forward.”

Valerie Press, MD, MPH, SFHM, associate professor of medicine at the University of Chicago, offered tips for men who are mentoring women. She said that, while cross-gender mentorship is common and important, gender-based stereotypes and “unconscious assumptions” are alive and well. Women, she noted, have less access to mentorship and sponsorship, are paid less for the same work, and have high rates of attrition.

Male mentors have to meet the challenge of thinking outside of their own lived experience, combating stereotypes, and addressing these gender-based career disparities, she said.

She suggested that male mentors, for one thing, “rewrite gender scripts,” with comments such as, “This is a difficult situation, but I have confidence in you! What do you think your next move should be?” They should also “learn from each other on how to change the power dynamic,” and start and participate in conversations involving emotions, since they can be clues to what a mentee is experiencing.

When it comes to pushing for better policies, “be an upstander, not a bystander,” Dr. Press said.

“Use your organizational power and your social capital,” she said. “Use your voice to help make more equitable policies. Don’t just leave it to the women’s committee to come up with solutions to lack of lactation rooms, or paternity and maternity leave, or better daycare. These are family issues and everybody issues.”

Maylyn S. Martinez, MD, clinical associate professor of medicine at the University of Chicago, suggested that mentors for physicians from minority groups should resist the tendency to view their interests narrowly.

“Don’t assume that their interests are going to center on their gender or minority status – invite them to be on projects that have nothing to do with that,” she said. They should also not be encouraged to do projects that won’t help with career advancement any more than others would be encouraged to take on such projects.

“Be the solution,” she said. “Not the problem.”
 

Your mentor has been looking for someone to help lead a new project in your division, and tells you she’s been having a hard time finding someone – but that you would be great. The project isn’t something you are very interested in doing and you’re already swamped with other projects, but the mentor seems to need the help. What do you do?

Mentor-mentee relationships can be deeply beneficial, but the dynamics – in this situation and many others – can be complex. At SHM Converge, the annual conference of the Society of Hospital Medicine, panelists offered guidance on how best to navigate this terrain.

Vineet Arora, MD, MAPP, MHM, associate chief medical officer for clinical learning environment at the University of Chicago, suggested that, in the situation involving the mentor’s request to an uncertain mentee, the mentee should not give an immediate answer, but consider the pros and cons.

“It’s tough when it’s somebody who’s directly overseeing you,” she said. “If you’re really truly the best person, they’re going to want you in the job, and maybe they’ll make it work for you.” She said it would be important to find out why the mentor is having trouble finding someone, and suggested the mentee could find someone with whom to discuss it.

Calling mentoring a “team sport,” Dr. Arora described several types: the traditional mentor who helps many aspects of a mentee’s career, a “coach” who helps on a specific project or topic, a “sponsor” that can help elevate a mentee to a bigger opportunity, and a “connector” who can help a mentee begin new career relationships.

“Don’t invest in just one person,” she said. “Try to get that personal board of directors.”

She mentioned six things all mentors should do: Choose mentees carefully, establish a mentorship team, run a tight ship, head off rifts or resolve them, prepare for transitions when they take a new position and might have a new relationship with a mentee, and don’t commit “mentorship malpractice.”

Mentoring is a two-way street, with both people benefiting and learning, but mentoring can have its troubles, either through active, dysfunctional behavior that’s easy to spot, or passive behavior, such as the “bottleneck” problem when a mentor is too preoccupied with his or her own priorities to mentor well, the “country clubber” who mentors only for popularity and social capital but doesn’t do the work required, and the “world traveler” who is sought after but has little time for day-to-day mentoring.

Valerie Vaughan, MD, MSc, assistant professor of medicine at the University of Utah, described four “golden rules” of being a mentee. First, find a CAPE mentor (for capable, availability, projects of interest, and easy to get along with). Then, be respectful of a mentor’s time, communicate effectively, and be engaged and energizing.

“Mentors typically don’t get paid to mentor and so a lot of them are doing it because they find joy for doing it,” Dr. Vaughan said. “So as much as you can as a mentee, try to be the person who brings energy to the mentor-mentee relationship. It’s up to you to drive projects forward.”

Valerie Press, MD, MPH, SFHM, associate professor of medicine at the University of Chicago, offered tips for men who are mentoring women. She said that, while cross-gender mentorship is common and important, gender-based stereotypes and “unconscious assumptions” are alive and well. Women, she noted, have less access to mentorship and sponsorship, are paid less for the same work, and have high rates of attrition.

Male mentors have to meet the challenge of thinking outside of their own lived experience, combating stereotypes, and addressing these gender-based career disparities, she said.

She suggested that male mentors, for one thing, “rewrite gender scripts,” with comments such as, “This is a difficult situation, but I have confidence in you! What do you think your next move should be?” They should also “learn from each other on how to change the power dynamic,” and start and participate in conversations involving emotions, since they can be clues to what a mentee is experiencing.

When it comes to pushing for better policies, “be an upstander, not a bystander,” Dr. Press said.

“Use your organizational power and your social capital,” she said. “Use your voice to help make more equitable policies. Don’t just leave it to the women’s committee to come up with solutions to lack of lactation rooms, or paternity and maternity leave, or better daycare. These are family issues and everybody issues.”

Maylyn S. Martinez, MD, clinical associate professor of medicine at the University of Chicago, suggested that mentors for physicians from minority groups should resist the tendency to view their interests narrowly.

“Don’t assume that their interests are going to center on their gender or minority status – invite them to be on projects that have nothing to do with that,” she said. They should also not be encouraged to do projects that won’t help with career advancement any more than others would be encouraged to take on such projects.

“Be the solution,” she said. “Not the problem.”
 

Your mentor has been looking for someone to help lead a new project in your division, and tells you she’s been having a hard time finding someone – but that you would be great. The project isn’t something you are very interested in doing and you’re already swamped with other projects, but the mentor seems to need the help. What do you do?

Mentor-mentee relationships can be deeply beneficial, but the dynamics – in this situation and many others – can be complex. At SHM Converge, the annual conference of the Society of Hospital Medicine, panelists offered guidance on how best to navigate this terrain.

Vineet Arora, MD, MAPP, MHM, associate chief medical officer for clinical learning environment at the University of Chicago, suggested that, in the situation involving the mentor’s request to an uncertain mentee, the mentee should not give an immediate answer, but consider the pros and cons.

“It’s tough when it’s somebody who’s directly overseeing you,” she said. “If you’re really truly the best person, they’re going to want you in the job, and maybe they’ll make it work for you.” She said it would be important to find out why the mentor is having trouble finding someone, and suggested the mentee could find someone with whom to discuss it.

Calling mentoring a “team sport,” Dr. Arora described several types: the traditional mentor who helps many aspects of a mentee’s career, a “coach” who helps on a specific project or topic, a “sponsor” that can help elevate a mentee to a bigger opportunity, and a “connector” who can help a mentee begin new career relationships.

“Don’t invest in just one person,” she said. “Try to get that personal board of directors.”

She mentioned six things all mentors should do: Choose mentees carefully, establish a mentorship team, run a tight ship, head off rifts or resolve them, prepare for transitions when they take a new position and might have a new relationship with a mentee, and don’t commit “mentorship malpractice.”

Mentoring is a two-way street, with both people benefiting and learning, but mentoring can have its troubles, either through active, dysfunctional behavior that’s easy to spot, or passive behavior, such as the “bottleneck” problem when a mentor is too preoccupied with his or her own priorities to mentor well, the “country clubber” who mentors only for popularity and social capital but doesn’t do the work required, and the “world traveler” who is sought after but has little time for day-to-day mentoring.

Valerie Vaughan, MD, MSc, assistant professor of medicine at the University of Utah, described four “golden rules” of being a mentee. First, find a CAPE mentor (for capable, availability, projects of interest, and easy to get along with). Then, be respectful of a mentor’s time, communicate effectively, and be engaged and energizing.

“Mentors typically don’t get paid to mentor and so a lot of them are doing it because they find joy for doing it,” Dr. Vaughan said. “So as much as you can as a mentee, try to be the person who brings energy to the mentor-mentee relationship. It’s up to you to drive projects forward.”

Valerie Press, MD, MPH, SFHM, associate professor of medicine at the University of Chicago, offered tips for men who are mentoring women. She said that, while cross-gender mentorship is common and important, gender-based stereotypes and “unconscious assumptions” are alive and well. Women, she noted, have less access to mentorship and sponsorship, are paid less for the same work, and have high rates of attrition.

Male mentors have to meet the challenge of thinking outside of their own lived experience, combating stereotypes, and addressing these gender-based career disparities, she said.

She suggested that male mentors, for one thing, “rewrite gender scripts,” with comments such as, “This is a difficult situation, but I have confidence in you! What do you think your next move should be?” They should also “learn from each other on how to change the power dynamic,” and start and participate in conversations involving emotions, since they can be clues to what a mentee is experiencing.

When it comes to pushing for better policies, “be an upstander, not a bystander,” Dr. Press said.

“Use your organizational power and your social capital,” she said. “Use your voice to help make more equitable policies. Don’t just leave it to the women’s committee to come up with solutions to lack of lactation rooms, or paternity and maternity leave, or better daycare. These are family issues and everybody issues.”

Maylyn S. Martinez, MD, clinical associate professor of medicine at the University of Chicago, suggested that mentors for physicians from minority groups should resist the tendency to view their interests narrowly.

“Don’t assume that their interests are going to center on their gender or minority status – invite them to be on projects that have nothing to do with that,” she said. They should also not be encouraged to do projects that won’t help with career advancement any more than others would be encouraged to take on such projects.

“Be the solution,” she said. “Not the problem.”
 

An examination of coffee consumption habits of almost 400,000 people suggests that those habits are largely driven by a person’s cardiovascular health.

©Elena Moiseeva/fotolia.com

Data from a large population database showed that people with essential hypertension, angina, or cardiac arrhythmias drank less coffee than people who had none of these conditions. When they did drink coffee, it tended to be decaffeinated.

The investigators, led by Elina Hyppönen, PhD, director of the Australian Centre for Precision Health at the University of South Australia, Adelaide, say that this predilection for avoiding coffee, which is known to produce jitteriness and heart palpitations, is based on genetics.

“If your body is telling you not to drink that extra cup of coffee, there’s likely a reason why,” Dr. Hyppönen said in an interview.

The study was published online in the American Journal of Clinical Nutrition.

“People drink coffee as a pick-me-up when they’re feeling tired, or because it tastes good, or simply because it’s part of their daily routine, but what we don’t recognize is that people subconsciously self-regulate safe levels of caffeine based on how high their blood pressure is, and this is likely a result of a protective genetic mechanism, [meaning] that someone who drinks a lot of coffee is likely more genetically tolerant of caffeine, as compared to someone who drinks very little,” Dr. Hyppönen said.

“In addition, we’ve known from past research that when people feel unwell, they tend to drink less coffee. This type of phenomenon, where disease drives behavior, is called reverse causality,” Dr. Hyppönen said.

For this analysis, she and her team used information on 390,435 individuals of European ancestry from the UK Biobank, a large epidemiologic database. Habitual coffee consumption was self-reported, and systolic and diastolic blood pressure and heart rate were measured at baseline. Cardiovascular symptoms at baseline were gleaned from hospital diagnoses, primary care records, and/or self report, the authors note.

To look at the relationship of systolic BP, diastolic BP, and heart rate with coffee consumption, they used a strategy called Mendelian randomization, which allows genetic information such as variants reflecting higher blood pressures and heart rate to be used to provide evidence for a causal association.

Results showed that participants with essential hypertension, angina, or arrhythmia were “all more likely to drink less caffeinated coffee and to be nonhabitual or decaffeinated coffee drinkers compared with those who did not report related symptoms,” the authors write.

Those with higher systolic and diastolic BP based on their genetics tended to drink less caffeinated coffee at baseline, “with consistent genetic evidence to support a causal explanation across all methods,” they noted.

They also found that those people who have a higher resting heart rate due to their genes were more likely to choose decaffeinated coffee.

“These results have two major implications,” Dr. Hyppönen said. “Firstly, they show that our bodies can regulate behavior in ways that we may not realize, and that if something does not feel good to us, there is a likely to be a reason why.”

“Second, our results show that our health status in part regulates the amount of coffee we drink. This is important, because when disease drives behavior, it can lead to misleading health associations in observational studies, and indeed, create a false impression for health benefits if the group of people who do not drink coffee also includes more people who are unwell,” she said.

For now, doctors can tell their patients that this study provides an explanation as to why research on the health effects of habitual coffee consumption has been conflicting, Dr. Hyppönen said.

“Our study also highlights the uncertainty that underlies the claimed health benefits of coffee, but at the same time, it gives a positive message about the ability of our body to regulate our level of coffee consumption in a way that helps us avoid adverse effects.”

“The most common symptoms of excessive coffee consumption are palpitations and rapid heartbeat, also known as tachycardia,” Nieca Goldberg, MD, medical director of the NYU Women’s Heart Program at NYU Langone Health, said in an interview.

“This study was designed to see if cardiac symptoms affect coffee consumption, and it showed that people with hypertension, angina, history of arrhythmias, and poor health tend to be decaffeinated coffee drinkers or no coffee drinkers,” Dr. Goldberg said.

“People naturally alter their coffee intake base on their blood pressure and symptoms of palpitations and/or rapid heart rate,” she said.

The results also suggest that, “we cannot infer health benefit or harm based on the available coffee studies,” Dr. Goldberg added.

The study was funded by the National Health and Medical Research Council, Australia. Dr. Hyppönen and Dr. Goldberg have disclosed no relevant financial relationships.

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

An examination of coffee consumption habits of almost 400,000 people suggests that those habits are largely driven by a person’s cardiovascular health.

©Elena Moiseeva/fotolia.com

Data from a large population database showed that people with essential hypertension, angina, or cardiac arrhythmias drank less coffee than people who had none of these conditions. When they did drink coffee, it tended to be decaffeinated.

The investigators, led by Elina Hyppönen, PhD, director of the Australian Centre for Precision Health at the University of South Australia, Adelaide, say that this predilection for avoiding coffee, which is known to produce jitteriness and heart palpitations, is based on genetics.

“If your body is telling you not to drink that extra cup of coffee, there’s likely a reason why,” Dr. Hyppönen said in an interview.

The study was published online in the American Journal of Clinical Nutrition.

“People drink coffee as a pick-me-up when they’re feeling tired, or because it tastes good, or simply because it’s part of their daily routine, but what we don’t recognize is that people subconsciously self-regulate safe levels of caffeine based on how high their blood pressure is, and this is likely a result of a protective genetic mechanism, [meaning] that someone who drinks a lot of coffee is likely more genetically tolerant of caffeine, as compared to someone who drinks very little,” Dr. Hyppönen said.

“In addition, we’ve known from past research that when people feel unwell, they tend to drink less coffee. This type of phenomenon, where disease drives behavior, is called reverse causality,” Dr. Hyppönen said.

For this analysis, she and her team used information on 390,435 individuals of European ancestry from the UK Biobank, a large epidemiologic database. Habitual coffee consumption was self-reported, and systolic and diastolic blood pressure and heart rate were measured at baseline. Cardiovascular symptoms at baseline were gleaned from hospital diagnoses, primary care records, and/or self report, the authors note.

To look at the relationship of systolic BP, diastolic BP, and heart rate with coffee consumption, they used a strategy called Mendelian randomization, which allows genetic information such as variants reflecting higher blood pressures and heart rate to be used to provide evidence for a causal association.

Results showed that participants with essential hypertension, angina, or arrhythmia were “all more likely to drink less caffeinated coffee and to be nonhabitual or decaffeinated coffee drinkers compared with those who did not report related symptoms,” the authors write.

Those with higher systolic and diastolic BP based on their genetics tended to drink less caffeinated coffee at baseline, “with consistent genetic evidence to support a causal explanation across all methods,” they noted.

They also found that those people who have a higher resting heart rate due to their genes were more likely to choose decaffeinated coffee.

“These results have two major implications,” Dr. Hyppönen said. “Firstly, they show that our bodies can regulate behavior in ways that we may not realize, and that if something does not feel good to us, there is a likely to be a reason why.”

“Second, our results show that our health status in part regulates the amount of coffee we drink. This is important, because when disease drives behavior, it can lead to misleading health associations in observational studies, and indeed, create a false impression for health benefits if the group of people who do not drink coffee also includes more people who are unwell,” she said.

For now, doctors can tell their patients that this study provides an explanation as to why research on the health effects of habitual coffee consumption has been conflicting, Dr. Hyppönen said.

“Our study also highlights the uncertainty that underlies the claimed health benefits of coffee, but at the same time, it gives a positive message about the ability of our body to regulate our level of coffee consumption in a way that helps us avoid adverse effects.”

“The most common symptoms of excessive coffee consumption are palpitations and rapid heartbeat, also known as tachycardia,” Nieca Goldberg, MD, medical director of the NYU Women’s Heart Program at NYU Langone Health, said in an interview.

“This study was designed to see if cardiac symptoms affect coffee consumption, and it showed that people with hypertension, angina, history of arrhythmias, and poor health tend to be decaffeinated coffee drinkers or no coffee drinkers,” Dr. Goldberg said.

“People naturally alter their coffee intake base on their blood pressure and symptoms of palpitations and/or rapid heart rate,” she said.

The results also suggest that, “we cannot infer health benefit or harm based on the available coffee studies,” Dr. Goldberg added.

The study was funded by the National Health and Medical Research Council, Australia. Dr. Hyppönen and Dr. Goldberg have disclosed no relevant financial relationships.

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

An examination of coffee consumption habits of almost 400,000 people suggests that those habits are largely driven by a person’s cardiovascular health.

©Elena Moiseeva/fotolia.com

Data from a large population database showed that people with essential hypertension, angina, or cardiac arrhythmias drank less coffee than people who had none of these conditions. When they did drink coffee, it tended to be decaffeinated.

The investigators, led by Elina Hyppönen, PhD, director of the Australian Centre for Precision Health at the University of South Australia, Adelaide, say that this predilection for avoiding coffee, which is known to produce jitteriness and heart palpitations, is based on genetics.

“If your body is telling you not to drink that extra cup of coffee, there’s likely a reason why,” Dr. Hyppönen said in an interview.

The study was published online in the American Journal of Clinical Nutrition.

“People drink coffee as a pick-me-up when they’re feeling tired, or because it tastes good, or simply because it’s part of their daily routine, but what we don’t recognize is that people subconsciously self-regulate safe levels of caffeine based on how high their blood pressure is, and this is likely a result of a protective genetic mechanism, [meaning] that someone who drinks a lot of coffee is likely more genetically tolerant of caffeine, as compared to someone who drinks very little,” Dr. Hyppönen said.

“In addition, we’ve known from past research that when people feel unwell, they tend to drink less coffee. This type of phenomenon, where disease drives behavior, is called reverse causality,” Dr. Hyppönen said.

For this analysis, she and her team used information on 390,435 individuals of European ancestry from the UK Biobank, a large epidemiologic database. Habitual coffee consumption was self-reported, and systolic and diastolic blood pressure and heart rate were measured at baseline. Cardiovascular symptoms at baseline were gleaned from hospital diagnoses, primary care records, and/or self report, the authors note.

To look at the relationship of systolic BP, diastolic BP, and heart rate with coffee consumption, they used a strategy called Mendelian randomization, which allows genetic information such as variants reflecting higher blood pressures and heart rate to be used to provide evidence for a causal association.

Results showed that participants with essential hypertension, angina, or arrhythmia were “all more likely to drink less caffeinated coffee and to be nonhabitual or decaffeinated coffee drinkers compared with those who did not report related symptoms,” the authors write.

Those with higher systolic and diastolic BP based on their genetics tended to drink less caffeinated coffee at baseline, “with consistent genetic evidence to support a causal explanation across all methods,” they noted.

They also found that those people who have a higher resting heart rate due to their genes were more likely to choose decaffeinated coffee.

“These results have two major implications,” Dr. Hyppönen said. “Firstly, they show that our bodies can regulate behavior in ways that we may not realize, and that if something does not feel good to us, there is a likely to be a reason why.”

“Second, our results show that our health status in part regulates the amount of coffee we drink. This is important, because when disease drives behavior, it can lead to misleading health associations in observational studies, and indeed, create a false impression for health benefits if the group of people who do not drink coffee also includes more people who are unwell,” she said.

For now, doctors can tell their patients that this study provides an explanation as to why research on the health effects of habitual coffee consumption has been conflicting, Dr. Hyppönen said.

“Our study also highlights the uncertainty that underlies the claimed health benefits of coffee, but at the same time, it gives a positive message about the ability of our body to regulate our level of coffee consumption in a way that helps us avoid adverse effects.”

“The most common symptoms of excessive coffee consumption are palpitations and rapid heartbeat, also known as tachycardia,” Nieca Goldberg, MD, medical director of the NYU Women’s Heart Program at NYU Langone Health, said in an interview.

“This study was designed to see if cardiac symptoms affect coffee consumption, and it showed that people with hypertension, angina, history of arrhythmias, and poor health tend to be decaffeinated coffee drinkers or no coffee drinkers,” Dr. Goldberg said.

“People naturally alter their coffee intake base on their blood pressure and symptoms of palpitations and/or rapid heart rate,” she said.

The results also suggest that, “we cannot infer health benefit or harm based on the available coffee studies,” Dr. Goldberg added.

The study was funded by the National Health and Medical Research Council, Australia. Dr. Hyppönen and Dr. Goldberg have disclosed no relevant financial relationships.

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

William of Ockham would have been proud because, at this year’s American Gastroenterological Association’s Shark Tank pitch competition, one product clearly demonstrated Ockham’s razor – that sometimes the simplest solution is best – and came away as the winner at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Courtesy Dr. Toufic Kachaamy

Out of five innovative products, ranging from an educational app to a high-tech anorectal sensor, all aimed at improving outcomes in patients with gastrointestinal disorders, the winner was ... drumroll please ...

A needle.

That’s it. A needle. But not like any other needle.


 

Winner: Toufic Kachaamy, MD, FASGE, AGAF – An EUS-guided access needle

This EUS-guided access needle, invented by Dr. Kachaamy, enterprise clinical leader at Cancer Treatment Centers of America, Phoenix, is a simple device that overcomes a longstanding challenge presented by endoscopic retrograde cholangiopancreatography (ERCP): biliary access.

Many “ERCPs are considered difficult, and sometimes fail, depending on the center and the endoscopist,” Dr. Kachaamy said during a virtual presentation. “Most failures are due to failed initial access to the bile duct.”

Indeed, one study cited a failure rate in ductal cannulation of 5%-15% even among experienced hands.

Failure can have several consequences, Dr. Kachaamy noted, including increased complications, higher cost, delayed care, longer hospitalization, and greater likelihood of patient transfer.

He went on to explain why biliary access can be so challenging and how this EUS-guided access needle helps address these issues.

“[The] two main limitations [during endoscopic ultrasound–guided biliary access] are directing the wire into the narrowed areas and the wire shearing as we are manipulating the wire to get it to where we want it,” Dr. Kachaamy said. “[This EUS-guided access needle] is a 19-22 gauge, rotatable needle with a smooth, side exit for the wire to allow wire manipulation and direction without shearing.”

Dr. Kachaamy highlighted the simple design, which will keep the production cost below $300 per unit, and suggested that failed ERCPs are just the first potential indication of many. Future uses may include gallbladder access, peri-GI collection, gastrojejunostomy, and others.

In an interview, Dr. Kachaamy reacted to the win, which follows 2 years of collaborative development with Cancer Treatment Centers of America.

“For people who are innovators, there’s nothing that feels more rewarding than their ideas being recognized as adding something to the field and potentially helping people and patients,” Dr. Kachaamy said. “So [this is] very, very, very exciting. Very rewarding. Pride would probably be the best way I’d describe it.”

Dr. Kachaamy anticipates that this EUS-guided access needle will be commercially available within 1-2 years, pending regulatory approval. In the meantime, he and his colleagues are seeking a strategic partner.


 

A shark speaks

V. Raman Muthusamy, MD, AGAF, immediate past chair of the AGA Center for GI Innovation and Technology and director of endoscopy at UCLA Health System, moderated the Shark Tank session, calling it “the highlight” of the AGA Tech Summit.

Dr. Muthusamy and four other “sharks,” including a gastroenterologist, venture capitalist, regulatory device reviewer, and entrepreneur, scored the pitches using three equally weighted categories: the quality of the pitch, the level of innovation and impact on the field, and the quality of the business plan and overall feasibility.

“We saw a full spectrum [of innovations],” Dr. Muthusamy said. “I think it was an enjoyable session.”

Behind closed doors, the sharks narrowed the field to two top contenders. Ultimately, however, there could be only one winner: Dr. Kachaamy. Their decision aligned with a “Fan Favorite” audience poll.

“A lot of [Dr. Kachaamy’s win] had to do with the potential applications and commonality of the problem,” Dr. Muthusamy said in an interview. He highlighted how the EUS-guided access needle allows for an immediate response to ERCP failure without the need for a second procedure.

Dr. Muthusamy also noted that several product designs previously failed to achieve what the EUS-guided access needle has the potential to do.

“I think the feeling was that this seemed to be a way that may address some of the limitations and challenges that we’ve had with earlier [attempts at solving this problem],” Dr. Muthusamy said.

For innovators who didn’t make the cut this year, or those with products still in development, Dr. Muthusamy suggested applying next year.

“We encourage our colleagues and members of the AGA to continue to apply to this program,” Dr. Muthusamy said.
 

Other fish in the sea

Four other innovators entered the AGA Shark Tank this year. Here are snippets of their pitches:

Hans Gregersen, MD, PhD, MPH – Fecobionics
“Fecobionics is a simulated electronic stool with the consistency and shape of normal stool,” Dr. Gregersen said.

The balloon device, which contains multiple sensors, provides “real-time, quantitative, and mechanistic insights by simulating defecation.”

“It ... is inserted into the rectum,” Dr. Gregersen said. “It measures multiple pressures; it has gyroscopes that measure orientation; we can compute the bending of the device; and we can calculate the shape of the device.”

According to Dr. Gregersen, Fecobionics has “diagnostic potential for patients with fecal incontinence and for subtyping patients with constipation.” He highlighted fewer false-positives than current technology, alongside greater efficiency and lower cost.

Dr. Gregersen is a research professor at California Medical Innovations Institute, San Diego.

Mary J. Pattison, RN – Trans-Abdominal Gastric Surgical System (TAGSS)
TAGSS is a trans-abdominal gastric access device that “represents a novel and exciting means to address multiple gastrointestinal conditions that are without a standardized approach,” Ms. Pattison said. “Placed as simply as a [percutaneous endoscopic gastrostomy tube], TAGSS offers disruptive technology to address [gastroesophageal reflux disease], fundoplication, achalasia, gastroparesis, gastric tumors, and even obesity in a safe, efficient, and cost effective manner. TAGSS offers the first true hybrid approach for endoscopic/laparoscopic collaboration.”

Ms. Pattison is a nurse clinician and endoscopy assistant at WestGlen GI Consultants, Weston, Mo.

Pankaj Rajvanshi, MD, FAASLD – Healthswim App
“At this time, most patient education is provided by Dr. Google,” Dr. Rajvanshi said, “and we want to change that. We have built a platform which allows you, the physician, to create custom, curated, credible content that can be delivered seamlessly to your patients on an ongoing basis.”

Through the Healthswim app, patients subscribe to their providers, allowing access physician-approved content. Subscribers also receive provider updates through their social media feeds.

Dr. Rajvanshi is a gastroenterologist at Swedish Medical Center, Seattle.

Ali S. Karakurum, MD, FACP, FACG – A Device for Removal of Esophageal Food Impactions
“I would like to propose a device which consists of a clear overtube, a collapsible plastic cylindrical basket secured to the distal end of the overtube ... and a snare wire attached to the distal end of the basket which is controlled by the snare handle externally,” Dr. Karakurum said. “The device is ... gradually advanced over the scope for the basket to encompass the food bolus under direct visualization. Once the food bolus is within the basket, the wire loop at the end of the basket is closed via the external handle, securing the food bolus in the basket for safe removal.”

Dr. Karakurum is a gastroenterologist at Advanced Gastroenterology & Endoscopy, Port Jefferson, N.Y.

This article was updated 5/14/21.

William of Ockham would have been proud because, at this year’s American Gastroenterological Association’s Shark Tank pitch competition, one product clearly demonstrated Ockham’s razor – that sometimes the simplest solution is best – and came away as the winner at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Courtesy Dr. Toufic Kachaamy

Out of five innovative products, ranging from an educational app to a high-tech anorectal sensor, all aimed at improving outcomes in patients with gastrointestinal disorders, the winner was ... drumroll please ...

A needle.

That’s it. A needle. But not like any other needle.


 

Winner: Toufic Kachaamy, MD, FASGE, AGAF – An EUS-guided access needle

This EUS-guided access needle, invented by Dr. Kachaamy, enterprise clinical leader at Cancer Treatment Centers of America, Phoenix, is a simple device that overcomes a longstanding challenge presented by endoscopic retrograde cholangiopancreatography (ERCP): biliary access.

Many “ERCPs are considered difficult, and sometimes fail, depending on the center and the endoscopist,” Dr. Kachaamy said during a virtual presentation. “Most failures are due to failed initial access to the bile duct.”

Indeed, one study cited a failure rate in ductal cannulation of 5%-15% even among experienced hands.

Failure can have several consequences, Dr. Kachaamy noted, including increased complications, higher cost, delayed care, longer hospitalization, and greater likelihood of patient transfer.

He went on to explain why biliary access can be so challenging and how this EUS-guided access needle helps address these issues.

“[The] two main limitations [during endoscopic ultrasound–guided biliary access] are directing the wire into the narrowed areas and the wire shearing as we are manipulating the wire to get it to where we want it,” Dr. Kachaamy said. “[This EUS-guided access needle] is a 19-22 gauge, rotatable needle with a smooth, side exit for the wire to allow wire manipulation and direction without shearing.”

Dr. Kachaamy highlighted the simple design, which will keep the production cost below $300 per unit, and suggested that failed ERCPs are just the first potential indication of many. Future uses may include gallbladder access, peri-GI collection, gastrojejunostomy, and others.

In an interview, Dr. Kachaamy reacted to the win, which follows 2 years of collaborative development with Cancer Treatment Centers of America.

“For people who are innovators, there’s nothing that feels more rewarding than their ideas being recognized as adding something to the field and potentially helping people and patients,” Dr. Kachaamy said. “So [this is] very, very, very exciting. Very rewarding. Pride would probably be the best way I’d describe it.”

Dr. Kachaamy anticipates that this EUS-guided access needle will be commercially available within 1-2 years, pending regulatory approval. In the meantime, he and his colleagues are seeking a strategic partner.


 

A shark speaks

V. Raman Muthusamy, MD, AGAF, immediate past chair of the AGA Center for GI Innovation and Technology and director of endoscopy at UCLA Health System, moderated the Shark Tank session, calling it “the highlight” of the AGA Tech Summit.

Dr. Muthusamy and four other “sharks,” including a gastroenterologist, venture capitalist, regulatory device reviewer, and entrepreneur, scored the pitches using three equally weighted categories: the quality of the pitch, the level of innovation and impact on the field, and the quality of the business plan and overall feasibility.

“We saw a full spectrum [of innovations],” Dr. Muthusamy said. “I think it was an enjoyable session.”

Behind closed doors, the sharks narrowed the field to two top contenders. Ultimately, however, there could be only one winner: Dr. Kachaamy. Their decision aligned with a “Fan Favorite” audience poll.

“A lot of [Dr. Kachaamy’s win] had to do with the potential applications and commonality of the problem,” Dr. Muthusamy said in an interview. He highlighted how the EUS-guided access needle allows for an immediate response to ERCP failure without the need for a second procedure.

Dr. Muthusamy also noted that several product designs previously failed to achieve what the EUS-guided access needle has the potential to do.

“I think the feeling was that this seemed to be a way that may address some of the limitations and challenges that we’ve had with earlier [attempts at solving this problem],” Dr. Muthusamy said.

For innovators who didn’t make the cut this year, or those with products still in development, Dr. Muthusamy suggested applying next year.

“We encourage our colleagues and members of the AGA to continue to apply to this program,” Dr. Muthusamy said.
 

Other fish in the sea

Four other innovators entered the AGA Shark Tank this year. Here are snippets of their pitches:

Hans Gregersen, MD, PhD, MPH – Fecobionics
“Fecobionics is a simulated electronic stool with the consistency and shape of normal stool,” Dr. Gregersen said.

The balloon device, which contains multiple sensors, provides “real-time, quantitative, and mechanistic insights by simulating defecation.”

“It ... is inserted into the rectum,” Dr. Gregersen said. “It measures multiple pressures; it has gyroscopes that measure orientation; we can compute the bending of the device; and we can calculate the shape of the device.”

According to Dr. Gregersen, Fecobionics has “diagnostic potential for patients with fecal incontinence and for subtyping patients with constipation.” He highlighted fewer false-positives than current technology, alongside greater efficiency and lower cost.

Dr. Gregersen is a research professor at California Medical Innovations Institute, San Diego.

Mary J. Pattison, RN – Trans-Abdominal Gastric Surgical System (TAGSS)
TAGSS is a trans-abdominal gastric access device that “represents a novel and exciting means to address multiple gastrointestinal conditions that are without a standardized approach,” Ms. Pattison said. “Placed as simply as a [percutaneous endoscopic gastrostomy tube], TAGSS offers disruptive technology to address [gastroesophageal reflux disease], fundoplication, achalasia, gastroparesis, gastric tumors, and even obesity in a safe, efficient, and cost effective manner. TAGSS offers the first true hybrid approach for endoscopic/laparoscopic collaboration.”

Ms. Pattison is a nurse clinician and endoscopy assistant at WestGlen GI Consultants, Weston, Mo.

Pankaj Rajvanshi, MD, FAASLD – Healthswim App
“At this time, most patient education is provided by Dr. Google,” Dr. Rajvanshi said, “and we want to change that. We have built a platform which allows you, the physician, to create custom, curated, credible content that can be delivered seamlessly to your patients on an ongoing basis.”

Through the Healthswim app, patients subscribe to their providers, allowing access physician-approved content. Subscribers also receive provider updates through their social media feeds.

Dr. Rajvanshi is a gastroenterologist at Swedish Medical Center, Seattle.

Ali S. Karakurum, MD, FACP, FACG – A Device for Removal of Esophageal Food Impactions
“I would like to propose a device which consists of a clear overtube, a collapsible plastic cylindrical basket secured to the distal end of the overtube ... and a snare wire attached to the distal end of the basket which is controlled by the snare handle externally,” Dr. Karakurum said. “The device is ... gradually advanced over the scope for the basket to encompass the food bolus under direct visualization. Once the food bolus is within the basket, the wire loop at the end of the basket is closed via the external handle, securing the food bolus in the basket for safe removal.”

Dr. Karakurum is a gastroenterologist at Advanced Gastroenterology & Endoscopy, Port Jefferson, N.Y.

This article was updated 5/14/21.

William of Ockham would have been proud because, at this year’s American Gastroenterological Association’s Shark Tank pitch competition, one product clearly demonstrated Ockham’s razor – that sometimes the simplest solution is best – and came away as the winner at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Courtesy Dr. Toufic Kachaamy

Out of five innovative products, ranging from an educational app to a high-tech anorectal sensor, all aimed at improving outcomes in patients with gastrointestinal disorders, the winner was ... drumroll please ...

A needle.

That’s it. A needle. But not like any other needle.


 

Winner: Toufic Kachaamy, MD, FASGE, AGAF – An EUS-guided access needle

This EUS-guided access needle, invented by Dr. Kachaamy, enterprise clinical leader at Cancer Treatment Centers of America, Phoenix, is a simple device that overcomes a longstanding challenge presented by endoscopic retrograde cholangiopancreatography (ERCP): biliary access.

Many “ERCPs are considered difficult, and sometimes fail, depending on the center and the endoscopist,” Dr. Kachaamy said during a virtual presentation. “Most failures are due to failed initial access to the bile duct.”

Indeed, one study cited a failure rate in ductal cannulation of 5%-15% even among experienced hands.

Failure can have several consequences, Dr. Kachaamy noted, including increased complications, higher cost, delayed care, longer hospitalization, and greater likelihood of patient transfer.

He went on to explain why biliary access can be so challenging and how this EUS-guided access needle helps address these issues.

“[The] two main limitations [during endoscopic ultrasound–guided biliary access] are directing the wire into the narrowed areas and the wire shearing as we are manipulating the wire to get it to where we want it,” Dr. Kachaamy said. “[This EUS-guided access needle] is a 19-22 gauge, rotatable needle with a smooth, side exit for the wire to allow wire manipulation and direction without shearing.”

Dr. Kachaamy highlighted the simple design, which will keep the production cost below $300 per unit, and suggested that failed ERCPs are just the first potential indication of many. Future uses may include gallbladder access, peri-GI collection, gastrojejunostomy, and others.

In an interview, Dr. Kachaamy reacted to the win, which follows 2 years of collaborative development with Cancer Treatment Centers of America.

“For people who are innovators, there’s nothing that feels more rewarding than their ideas being recognized as adding something to the field and potentially helping people and patients,” Dr. Kachaamy said. “So [this is] very, very, very exciting. Very rewarding. Pride would probably be the best way I’d describe it.”

Dr. Kachaamy anticipates that this EUS-guided access needle will be commercially available within 1-2 years, pending regulatory approval. In the meantime, he and his colleagues are seeking a strategic partner.


 

A shark speaks

V. Raman Muthusamy, MD, AGAF, immediate past chair of the AGA Center for GI Innovation and Technology and director of endoscopy at UCLA Health System, moderated the Shark Tank session, calling it “the highlight” of the AGA Tech Summit.

Dr. Muthusamy and four other “sharks,” including a gastroenterologist, venture capitalist, regulatory device reviewer, and entrepreneur, scored the pitches using three equally weighted categories: the quality of the pitch, the level of innovation and impact on the field, and the quality of the business plan and overall feasibility.

“We saw a full spectrum [of innovations],” Dr. Muthusamy said. “I think it was an enjoyable session.”

Behind closed doors, the sharks narrowed the field to two top contenders. Ultimately, however, there could be only one winner: Dr. Kachaamy. Their decision aligned with a “Fan Favorite” audience poll.

“A lot of [Dr. Kachaamy’s win] had to do with the potential applications and commonality of the problem,” Dr. Muthusamy said in an interview. He highlighted how the EUS-guided access needle allows for an immediate response to ERCP failure without the need for a second procedure.

Dr. Muthusamy also noted that several product designs previously failed to achieve what the EUS-guided access needle has the potential to do.

“I think the feeling was that this seemed to be a way that may address some of the limitations and challenges that we’ve had with earlier [attempts at solving this problem],” Dr. Muthusamy said.

For innovators who didn’t make the cut this year, or those with products still in development, Dr. Muthusamy suggested applying next year.

“We encourage our colleagues and members of the AGA to continue to apply to this program,” Dr. Muthusamy said.
 

Other fish in the sea

Four other innovators entered the AGA Shark Tank this year. Here are snippets of their pitches:

Hans Gregersen, MD, PhD, MPH – Fecobionics
“Fecobionics is a simulated electronic stool with the consistency and shape of normal stool,” Dr. Gregersen said.

The balloon device, which contains multiple sensors, provides “real-time, quantitative, and mechanistic insights by simulating defecation.”

“It ... is inserted into the rectum,” Dr. Gregersen said. “It measures multiple pressures; it has gyroscopes that measure orientation; we can compute the bending of the device; and we can calculate the shape of the device.”

According to Dr. Gregersen, Fecobionics has “diagnostic potential for patients with fecal incontinence and for subtyping patients with constipation.” He highlighted fewer false-positives than current technology, alongside greater efficiency and lower cost.

Dr. Gregersen is a research professor at California Medical Innovations Institute, San Diego.

Mary J. Pattison, RN – Trans-Abdominal Gastric Surgical System (TAGSS)
TAGSS is a trans-abdominal gastric access device that “represents a novel and exciting means to address multiple gastrointestinal conditions that are without a standardized approach,” Ms. Pattison said. “Placed as simply as a [percutaneous endoscopic gastrostomy tube], TAGSS offers disruptive technology to address [gastroesophageal reflux disease], fundoplication, achalasia, gastroparesis, gastric tumors, and even obesity in a safe, efficient, and cost effective manner. TAGSS offers the first true hybrid approach for endoscopic/laparoscopic collaboration.”

Ms. Pattison is a nurse clinician and endoscopy assistant at WestGlen GI Consultants, Weston, Mo.

Pankaj Rajvanshi, MD, FAASLD – Healthswim App
“At this time, most patient education is provided by Dr. Google,” Dr. Rajvanshi said, “and we want to change that. We have built a platform which allows you, the physician, to create custom, curated, credible content that can be delivered seamlessly to your patients on an ongoing basis.”

Through the Healthswim app, patients subscribe to their providers, allowing access physician-approved content. Subscribers also receive provider updates through their social media feeds.

Dr. Rajvanshi is a gastroenterologist at Swedish Medical Center, Seattle.

Ali S. Karakurum, MD, FACP, FACG – A Device for Removal of Esophageal Food Impactions
“I would like to propose a device which consists of a clear overtube, a collapsible plastic cylindrical basket secured to the distal end of the overtube ... and a snare wire attached to the distal end of the basket which is controlled by the snare handle externally,” Dr. Karakurum said. “The device is ... gradually advanced over the scope for the basket to encompass the food bolus under direct visualization. Once the food bolus is within the basket, the wire loop at the end of the basket is closed via the external handle, securing the food bolus in the basket for safe removal.”

Dr. Karakurum is a gastroenterologist at Advanced Gastroenterology & Endoscopy, Port Jefferson, N.Y.

This article was updated 5/14/21.

The American Heart Association, the American College of Cardiology, and the Obesity Society define overweight as a body mass index (BMI) of 25 to 29.9 and obesity as a BMI ≥ 30. Morbid obesity is defined as a BMI ≥ 35 or 40.^2,3 Based on these BMI cutoffs, the Endocrine Society recommends diet and lifestyle as the foundation of weight management and pharmacotherapy for those with a BMI ≥ 30 without comorbidities. In patients with a BMI ≥ 27, weight management medications may be considered if a patient has comorbid hypertension, T2DM, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or nonalcoholic fatty liver disease. Patients with BMI > 40 are eligible for weight loss surgery.⁴

Lifestyle and dietary interventions are the foundation of current weight management guidelines from the Endocrine Society.⁴ At a minimum, guidelines recommended enrolling motivated patients in a high-intensity lifestyle intervention class of at least 14 sessions in the first 6 months to reach a goal weight loss of 5 to 10% from baseline and to maintain a reduction of 3 to 5% from baseline.³ Medications are recommended as an adjunct to lifestyle and dietary changes. Most weight management medications work in the brain to stimulate satiety signaling, which helps motivated patients adhere to their dietary interventions, assist those who have been unsuccessful in earlier weight loss attempts, and help maintain weight.^3,4

Guidelines recommend 7 weight management medications, including orlistat (both prescription strength and over-the-counter), liraglutide, phentermine, phentermine/topiramate, lorcaserin, and naltrexone/bupropion. Using medications to assist with weight loss increases likelihood that patients will achieve 5 to 10% weight loss from baseline.^5,6 Studies looking at long-term effects of these medications on weight loss have found improvements in blood pressure (BP), biomarkers for cardiovascular disease, and T2DM-related comorbidities.^3,5,7

Positive effects on comorbidities have been found to be related to drug class and mechanism of action (MOA); those that also are approved for T2DM have demonstrated the most favorable cardiovascular effects.⁷ Other medications that work as stimulants or as modulators of serotonin pathways are associated with increased risks, prompting the US Food and Drug Administration (FDA) to remove some medications from the market.^7,8 In January 2020, lorcaserin was taken off the market because of increased risk of cancer found in postmarketing surveillance.⁹ The benefit of weight loss must be weighed against the risk of medication use.

Monthly follow-up is recommended with weight management medications in the beginning to assess safety and efficacy; medications should be discontinued if weight loss is inadequate in the first 3 months.^1,3,4 Limited studies have assessed the long-term use of weight management medications in a real-world setting. Medications are prescribed for weight management at Veteran Health Indiana (VHI) in outpatient clinics, including primary care, endocrinology, and gastrointestinal (GI) specialties. However, prescribing practices, outcomes, and adherence to guideline recommendations have not been studied. Data from this study will be used to better understand how VHI can serve its veterans through diet, lifestyle, and pharmacologic interventions.

Methods

We conducted a single-center, retrospective chart review for patients started on weight management medications at VHI. A patient list was generated based on prescription fills from June 1, 2017 to June 30, 2019. All data were obtained using the Computerized Patient Record System and patients were not contacted. This study was approved by the Indiana University Health Institutional Review Board and the VHI Research and Development Committee.

At the time of study, orlistat, liraglutide, phentermine/topiramate, lorcaserin, and naltrexone/bupropion were available at VHI for patients who met the criteria. All patients must have been enrolled in dietary and lifestyle management to be approved for these medications. The US Department of Veterans Affairs (VA) MOVE! weight management program, designed by the VA National Center for Health Promotion and Disease Promotion, is available at VA sites throughout the country. After MOVE! orientation, patients can participate in group or individual 12-week programs that include weigh ins, goal-setting strategies, meal planning, and habit modification support. If patients are unable to meet in person, phone and other telehealth opportunities are available.

Patients were included in the study if they received a prescription of any 1 of the 5 available medications during the enrollment period. Patients were excluded if they received a prescription from or were treated by a civilian health care provider, if they never used the medication, or if their weight loss was attributed to a cancer diagnosis. These criteria produced 86 patients of whom 96 unique weight loss prescriptions were generated. Data were collected for each instance of medication use so that some patients were included multiple times. In this case, data collection for the failed medication ended when failure was documented, and new data points began when new medication was prescribed; all data collected were per medication, not per patient. This method was used to account for medication failure and provide accurate weight loss results based on medication choice within this institution.

The primary outcomes included total weight loss and weight loss as a percentage of baseline weight at 3, 6, 12, and > 12 months of therapy. Secondary outcomes included weight loss of 5% from baseline, rate of successful weight maintenance after initial weight loss of 5% from baseline, adverse drug reaction (ADR) monitoring, and use of weight management medications across clinics at VHI.

Demographic data included race, age, sex, baseline weight, BMI, and comorbid medical conditions. Comorbidities were collected based on the most recent primary care clinical note before initiating medication. Medication data collected included medications used to manage comorbidities. Data related to weight management medication included prescribing clinic, reason for medication discontinuation, or bariatric surgery intervention if applicable.

Efficacy outcome data included weight and BMI across therapy duration. Safety outcomes data included heart rate, BP, and ADRs that resulted in medication discontinuation as documented in the electronic health record (EHR).

Results

A total of 86 patients were identified based on prescription fills, which produced 99 unique instances of medication use. Of the 99 identified, 3 met exclusion criteria and were not included in the final analysis. Among included veterans, 16 were female and 80 were male (Table 1). Most of those included identified as White race (86%), male (83%), and mean age 53 years. At baseline, mean weight was 130 kg and mean BMI 41.

Comorbidities and Medication Use

Hypertension (66%), hyperlipidemia (64%), and psychiatric diagnoses (50%) were most common comorbid conditions. Substance use (23%) and T2DM (40%) were the most common comorbidities influencing medication choice. Substance use evaluation included amphetamines and cocaine for this analysis.

Phentermine/topiramate is the preferred first-line agent unless patients have contraindications for use, in which case naltrexone/bupropion is recommended, based on guidelines for weight management medications within the VHI system. However, for patients with comorbid T2DM, liraglutide is preferred because of its beneficial effects for both weight loss and blood glucose control.² Most patients at VHI were started on liraglutide (44%) or phentermine/topiramate (42%), which was in line with recommendations. Our sample included ≥ 1 prescription for each medication available at our facility, although the number of patients on each medication was not equal. Of note, the one patient taking lorcaserin at the time of study discontinued therapy in response to recent FDA guidance.⁹

Medications for comorbid conditions could contribute to weight gain. Of the patient sample, β blockers (n = 24) and anticonvulsants, including gabapentin and pregabalin (n = 22) were the most common Other medications that could have contributed to weight gain included sulfonylureas (n = 5), antipsychotics (n = 4), tricyclic antidepressants (n = 2), and hormone replacement therapies (n = 2).

Primary Outcomes

The mean weight of participants dropped from 129.9 to 114.2 kg over the 12 months of weight management medication therapy for a absolute difference of 15.8 kg (Figure 1 and eTable 1 available at doi:10.12788/fp.0117). Weight loss was recorded at 3, 6, 12, and > 12 months of weight management therapy. At each time point, weight loss was statistically significant (P < .001) compared with baseline (Table 2), even though not every patient had weight loss records at each time point.

When classified by medication choice, mean change in weight was orlistat −25.9 kg (n = 5); lorcaserin −22.5 kg (n = 1); liraglutide −10.3 kg (n = 43); phentermine/topiramate −5.0 kg (n = 42); and naltrexone/ bupropion +2.1 kg (n = 5) over the duration of the study (eTable 2 available at doi:10.12788/fp.0117). Patients receiving orlistat and liraglutide had increasing weight loss across the duration of treatment compared with those on lorcaserin who had initial weight gain before weight loss. Phentermine/topiramate showed initial weight loss that tapered off, and naltrexone/bupropion demonstrated initial weight loss with eventual weight gain at study end point.

Secondary Outcomes

More than one-half of the patients analyzed lost 5 to 10% from baseline while taking weight management medication. Fifty-six (59%) patients lost 5% at any point while on therapy (Table 3). Among those patients, 31 (32%) lost ≥ 10% from baseline. When looking at success related to guideline recommendations, 32 (38%) patients lost 5% from baseline in the first 3 months of medication therapy.

Among patients who lost at least 5% from baseline, we performed further analysis to assess weight maintenance of 3 to 5% from baseline for 12 months. In the 12 months after initial weight loss, the number of patients who were able to maintain their weight loss steadily declined (Figure 2). In the end, 17 (30%) of patients who achieved 5 to 10% weight loss at baseline were able to maintain weight loss. Only 18% of study patients were able to achieve guideline-directed weight loss and maintain that weight for 12 months.

Discussion

This study evaluated the use and outcomes of weight management medication among veterans at VHI. The study aimed to better understand the efficacy and safety of these medications while exposing potential weaknesses in care and to promote avenues to improve weight loss and maintenance.

Clinical trials for weight management medications reported weight loss of 8 to 10 kg over 56 weeks: 21 to 63% of patients losing at least 5% from baseline weight.^10-14 The findings from our study found a higher average weight loss (−15.8 kg) than that reported in trials and a consistent percentage of patients (58.3%) who achieved at least 5% weight loss. It is promising to see that when used in a noncontrolled setting, these medications were able to produce weight loss consistent with results seen in large, controlled trials.

Pi-Sunyer and colleagues found continued weight loss after the initial 5% weight loss to an eventual 10% weight loss in many patients.¹⁰ Additionally, Smith and colleagues found that nearly 68% of their participants who took lorcaserin were able to maintain 3 to 5% weight loss over 12 months.¹³ Sjöström and colleagues acknowledged that many patients taking orlistat for an extended period began to gain weight, although at one-half the rate than that seen in the placebo group.¹² This study found that fewer patients were able to maintain their weight loss over 12 months, with only 30% of patients maintaining 3 to 5% weight loss from baseline. This difference in weight maintenance likely was because of the uncontrolled nature of this study. Once patients reach their initial weight loss goal, even the most motivated patients will have trouble maintaining that weight.⁴ Despite the challenges associated with maintaining weight loss, the quality of life benefits patients gained and potential reductions in health care spending support using resources to improve these outcomes.^2,14,15

Pi-Sunyer and colleagues reported high incidences of nausea (40%), vomiting (16%), diarrhea (21%), and constipation (20%) with liraglutide.¹⁰ Sjöström and colleagues reported 7% of patients experienced GI upset with orlistat.¹² Comparatively, only 17% of our patients reported AEs that required discontinuation, including GI upset. One patient in our study discontinued naltrexone/bupropion because of a significant change in mental status and suicide attempt. Clinical trials did not report a greater risk of depression or suicidality compared with placebo; however, there is a warning on the labeling of naltrexone/bupropion for increased suicidality with the use of antidepressant agents.^16,17 The neurologic AE that required discontinuation of phentermine/topiramate at our institution is unique based on published information.^11,18

The data from this study reinforced the observation that weight maintenance is the most challenging aspect of weight loss. Although our data showed clinically meaningful weight loss from baseline, many patients regained their weight, and some exceeded their baseline weight. Beyond providing these medications, this evidence suggests the need for close, continued follow-up through patients’ weight loss journey.

Limitations

Because this is a retrospective chart review, data collection was influenced by and limited to information that had been recorded in the EHR. AEs that resulted in medication discontinuation were assessed from the patient’s chart, which might not be correct if providers did not update the records. Follow-up was not always scheduled at regular intervals after medication initiation, resulting in varying sample numbers at each time point, potentially interfering with true weight loss averages. Although not included in this analysis, it might be beneficial to evaluate adherence to recommendations for follow-up with laboratory and weight monitoring to better capture where future monitoring can be improved. Second, there was an unbalanced number of patients taking each medication. Specifically, we saw a change in weight with orlistat that exceeded what is consistently seen in larger, more controlled trials. Although this is an effect of the real world, small sample sizes cannot be generalized to the larger population and might result in data reflecting that of an outlier. Last, there is a lack of generalizability because of the veteran population demographic, which is more male and lacks ethnic diversity. This study also was carried out at a single, educational tertiary medical center, which might not apply to all populations.

Conclusions

Despite the limitations discussed, this study shows that the use of weight management medications in a general veteran population produces initial weight loss consistent with previous studies. However, there is room for continued improvement in follow-up strategies to promote greater weight maintenance after initial weight loss. Considering the high health care costs, personal burden, and potential long-term complications associated with obesity, efforts to promote development of programs that support weight management and maintenance are imperative.

Acknowledgment
This material is the result of work supported with resources and the use of facilities at Veteran Health Indiana.

The American Heart Association, the American College of Cardiology, and the Obesity Society define overweight as a body mass index (BMI) of 25 to 29.9 and obesity as a BMI ≥ 30. Morbid obesity is defined as a BMI ≥ 35 or 40.^2,3 Based on these BMI cutoffs, the Endocrine Society recommends diet and lifestyle as the foundation of weight management and pharmacotherapy for those with a BMI ≥ 30 without comorbidities. In patients with a BMI ≥ 27, weight management medications may be considered if a patient has comorbid hypertension, T2DM, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or nonalcoholic fatty liver disease. Patients with BMI > 40 are eligible for weight loss surgery.⁴

Lifestyle and dietary interventions are the foundation of current weight management guidelines from the Endocrine Society.⁴ At a minimum, guidelines recommended enrolling motivated patients in a high-intensity lifestyle intervention class of at least 14 sessions in the first 6 months to reach a goal weight loss of 5 to 10% from baseline and to maintain a reduction of 3 to 5% from baseline.³ Medications are recommended as an adjunct to lifestyle and dietary changes. Most weight management medications work in the brain to stimulate satiety signaling, which helps motivated patients adhere to their dietary interventions, assist those who have been unsuccessful in earlier weight loss attempts, and help maintain weight.^3,4

Guidelines recommend 7 weight management medications, including orlistat (both prescription strength and over-the-counter), liraglutide, phentermine, phentermine/topiramate, lorcaserin, and naltrexone/bupropion. Using medications to assist with weight loss increases likelihood that patients will achieve 5 to 10% weight loss from baseline.^5,6 Studies looking at long-term effects of these medications on weight loss have found improvements in blood pressure (BP), biomarkers for cardiovascular disease, and T2DM-related comorbidities.^3,5,7

Positive effects on comorbidities have been found to be related to drug class and mechanism of action (MOA); those that also are approved for T2DM have demonstrated the most favorable cardiovascular effects.⁷ Other medications that work as stimulants or as modulators of serotonin pathways are associated with increased risks, prompting the US Food and Drug Administration (FDA) to remove some medications from the market.^7,8 In January 2020, lorcaserin was taken off the market because of increased risk of cancer found in postmarketing surveillance.⁹ The benefit of weight loss must be weighed against the risk of medication use.

Monthly follow-up is recommended with weight management medications in the beginning to assess safety and efficacy; medications should be discontinued if weight loss is inadequate in the first 3 months.^1,3,4 Limited studies have assessed the long-term use of weight management medications in a real-world setting. Medications are prescribed for weight management at Veteran Health Indiana (VHI) in outpatient clinics, including primary care, endocrinology, and gastrointestinal (GI) specialties. However, prescribing practices, outcomes, and adherence to guideline recommendations have not been studied. Data from this study will be used to better understand how VHI can serve its veterans through diet, lifestyle, and pharmacologic interventions.

Methods

We conducted a single-center, retrospective chart review for patients started on weight management medications at VHI. A patient list was generated based on prescription fills from June 1, 2017 to June 30, 2019. All data were obtained using the Computerized Patient Record System and patients were not contacted. This study was approved by the Indiana University Health Institutional Review Board and the VHI Research and Development Committee.

At the time of study, orlistat, liraglutide, phentermine/topiramate, lorcaserin, and naltrexone/bupropion were available at VHI for patients who met the criteria. All patients must have been enrolled in dietary and lifestyle management to be approved for these medications. The US Department of Veterans Affairs (VA) MOVE! weight management program, designed by the VA National Center for Health Promotion and Disease Promotion, is available at VA sites throughout the country. After MOVE! orientation, patients can participate in group or individual 12-week programs that include weigh ins, goal-setting strategies, meal planning, and habit modification support. If patients are unable to meet in person, phone and other telehealth opportunities are available.

Patients were included in the study if they received a prescription of any 1 of the 5 available medications during the enrollment period. Patients were excluded if they received a prescription from or were treated by a civilian health care provider, if they never used the medication, or if their weight loss was attributed to a cancer diagnosis. These criteria produced 86 patients of whom 96 unique weight loss prescriptions were generated. Data were collected for each instance of medication use so that some patients were included multiple times. In this case, data collection for the failed medication ended when failure was documented, and new data points began when new medication was prescribed; all data collected were per medication, not per patient. This method was used to account for medication failure and provide accurate weight loss results based on medication choice within this institution.

The primary outcomes included total weight loss and weight loss as a percentage of baseline weight at 3, 6, 12, and > 12 months of therapy. Secondary outcomes included weight loss of 5% from baseline, rate of successful weight maintenance after initial weight loss of 5% from baseline, adverse drug reaction (ADR) monitoring, and use of weight management medications across clinics at VHI.

Demographic data included race, age, sex, baseline weight, BMI, and comorbid medical conditions. Comorbidities were collected based on the most recent primary care clinical note before initiating medication. Medication data collected included medications used to manage comorbidities. Data related to weight management medication included prescribing clinic, reason for medication discontinuation, or bariatric surgery intervention if applicable.

Efficacy outcome data included weight and BMI across therapy duration. Safety outcomes data included heart rate, BP, and ADRs that resulted in medication discontinuation as documented in the electronic health record (EHR).

Results

A total of 86 patients were identified based on prescription fills, which produced 99 unique instances of medication use. Of the 99 identified, 3 met exclusion criteria and were not included in the final analysis. Among included veterans, 16 were female and 80 were male (Table 1). Most of those included identified as White race (86%), male (83%), and mean age 53 years. At baseline, mean weight was 130 kg and mean BMI 41.

Comorbidities and Medication Use

Hypertension (66%), hyperlipidemia (64%), and psychiatric diagnoses (50%) were most common comorbid conditions. Substance use (23%) and T2DM (40%) were the most common comorbidities influencing medication choice. Substance use evaluation included amphetamines and cocaine for this analysis.

Phentermine/topiramate is the preferred first-line agent unless patients have contraindications for use, in which case naltrexone/bupropion is recommended, based on guidelines for weight management medications within the VHI system. However, for patients with comorbid T2DM, liraglutide is preferred because of its beneficial effects for both weight loss and blood glucose control.² Most patients at VHI were started on liraglutide (44%) or phentermine/topiramate (42%), which was in line with recommendations. Our sample included ≥ 1 prescription for each medication available at our facility, although the number of patients on each medication was not equal. Of note, the one patient taking lorcaserin at the time of study discontinued therapy in response to recent FDA guidance.⁹

Medications for comorbid conditions could contribute to weight gain. Of the patient sample, β blockers (n = 24) and anticonvulsants, including gabapentin and pregabalin (n = 22) were the most common Other medications that could have contributed to weight gain included sulfonylureas (n = 5), antipsychotics (n = 4), tricyclic antidepressants (n = 2), and hormone replacement therapies (n = 2).

Primary Outcomes

The mean weight of participants dropped from 129.9 to 114.2 kg over the 12 months of weight management medication therapy for a absolute difference of 15.8 kg (Figure 1 and eTable 1 available at doi:10.12788/fp.0117). Weight loss was recorded at 3, 6, 12, and > 12 months of weight management therapy. At each time point, weight loss was statistically significant (P < .001) compared with baseline (Table 2), even though not every patient had weight loss records at each time point.

When classified by medication choice, mean change in weight was orlistat −25.9 kg (n = 5); lorcaserin −22.5 kg (n = 1); liraglutide −10.3 kg (n = 43); phentermine/topiramate −5.0 kg (n = 42); and naltrexone/ bupropion +2.1 kg (n = 5) over the duration of the study (eTable 2 available at doi:10.12788/fp.0117). Patients receiving orlistat and liraglutide had increasing weight loss across the duration of treatment compared with those on lorcaserin who had initial weight gain before weight loss. Phentermine/topiramate showed initial weight loss that tapered off, and naltrexone/bupropion demonstrated initial weight loss with eventual weight gain at study end point.

Secondary Outcomes

More than one-half of the patients analyzed lost 5 to 10% from baseline while taking weight management medication. Fifty-six (59%) patients lost 5% at any point while on therapy (Table 3). Among those patients, 31 (32%) lost ≥ 10% from baseline. When looking at success related to guideline recommendations, 32 (38%) patients lost 5% from baseline in the first 3 months of medication therapy.

Among patients who lost at least 5% from baseline, we performed further analysis to assess weight maintenance of 3 to 5% from baseline for 12 months. In the 12 months after initial weight loss, the number of patients who were able to maintain their weight loss steadily declined (Figure 2). In the end, 17 (30%) of patients who achieved 5 to 10% weight loss at baseline were able to maintain weight loss. Only 18% of study patients were able to achieve guideline-directed weight loss and maintain that weight for 12 months.

Discussion

This study evaluated the use and outcomes of weight management medication among veterans at VHI. The study aimed to better understand the efficacy and safety of these medications while exposing potential weaknesses in care and to promote avenues to improve weight loss and maintenance.

Clinical trials for weight management medications reported weight loss of 8 to 10 kg over 56 weeks: 21 to 63% of patients losing at least 5% from baseline weight.^10-14 The findings from our study found a higher average weight loss (−15.8 kg) than that reported in trials and a consistent percentage of patients (58.3%) who achieved at least 5% weight loss. It is promising to see that when used in a noncontrolled setting, these medications were able to produce weight loss consistent with results seen in large, controlled trials.

Pi-Sunyer and colleagues found continued weight loss after the initial 5% weight loss to an eventual 10% weight loss in many patients.¹⁰ Additionally, Smith and colleagues found that nearly 68% of their participants who took lorcaserin were able to maintain 3 to 5% weight loss over 12 months.¹³ Sjöström and colleagues acknowledged that many patients taking orlistat for an extended period began to gain weight, although at one-half the rate than that seen in the placebo group.¹² This study found that fewer patients were able to maintain their weight loss over 12 months, with only 30% of patients maintaining 3 to 5% weight loss from baseline. This difference in weight maintenance likely was because of the uncontrolled nature of this study. Once patients reach their initial weight loss goal, even the most motivated patients will have trouble maintaining that weight.⁴ Despite the challenges associated with maintaining weight loss, the quality of life benefits patients gained and potential reductions in health care spending support using resources to improve these outcomes.^2,14,15

Pi-Sunyer and colleagues reported high incidences of nausea (40%), vomiting (16%), diarrhea (21%), and constipation (20%) with liraglutide.¹⁰ Sjöström and colleagues reported 7% of patients experienced GI upset with orlistat.¹² Comparatively, only 17% of our patients reported AEs that required discontinuation, including GI upset. One patient in our study discontinued naltrexone/bupropion because of a significant change in mental status and suicide attempt. Clinical trials did not report a greater risk of depression or suicidality compared with placebo; however, there is a warning on the labeling of naltrexone/bupropion for increased suicidality with the use of antidepressant agents.^16,17 The neurologic AE that required discontinuation of phentermine/topiramate at our institution is unique based on published information.^11,18

The data from this study reinforced the observation that weight maintenance is the most challenging aspect of weight loss. Although our data showed clinically meaningful weight loss from baseline, many patients regained their weight, and some exceeded their baseline weight. Beyond providing these medications, this evidence suggests the need for close, continued follow-up through patients’ weight loss journey.

Limitations

Because this is a retrospective chart review, data collection was influenced by and limited to information that had been recorded in the EHR. AEs that resulted in medication discontinuation were assessed from the patient’s chart, which might not be correct if providers did not update the records. Follow-up was not always scheduled at regular intervals after medication initiation, resulting in varying sample numbers at each time point, potentially interfering with true weight loss averages. Although not included in this analysis, it might be beneficial to evaluate adherence to recommendations for follow-up with laboratory and weight monitoring to better capture where future monitoring can be improved. Second, there was an unbalanced number of patients taking each medication. Specifically, we saw a change in weight with orlistat that exceeded what is consistently seen in larger, more controlled trials. Although this is an effect of the real world, small sample sizes cannot be generalized to the larger population and might result in data reflecting that of an outlier. Last, there is a lack of generalizability because of the veteran population demographic, which is more male and lacks ethnic diversity. This study also was carried out at a single, educational tertiary medical center, which might not apply to all populations.

Conclusions

Despite the limitations discussed, this study shows that the use of weight management medications in a general veteran population produces initial weight loss consistent with previous studies. However, there is room for continued improvement in follow-up strategies to promote greater weight maintenance after initial weight loss. Considering the high health care costs, personal burden, and potential long-term complications associated with obesity, efforts to promote development of programs that support weight management and maintenance are imperative.

Acknowledgment
This material is the result of work supported with resources and the use of facilities at Veteran Health Indiana.

The American Heart Association, the American College of Cardiology, and the Obesity Society define overweight as a body mass index (BMI) of 25 to 29.9 and obesity as a BMI ≥ 30. Morbid obesity is defined as a BMI ≥ 35 or 40.^2,3 Based on these BMI cutoffs, the Endocrine Society recommends diet and lifestyle as the foundation of weight management and pharmacotherapy for those with a BMI ≥ 30 without comorbidities. In patients with a BMI ≥ 27, weight management medications may be considered if a patient has comorbid hypertension, T2DM, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or nonalcoholic fatty liver disease. Patients with BMI > 40 are eligible for weight loss surgery.⁴

Lifestyle and dietary interventions are the foundation of current weight management guidelines from the Endocrine Society.⁴ At a minimum, guidelines recommended enrolling motivated patients in a high-intensity lifestyle intervention class of at least 14 sessions in the first 6 months to reach a goal weight loss of 5 to 10% from baseline and to maintain a reduction of 3 to 5% from baseline.³ Medications are recommended as an adjunct to lifestyle and dietary changes. Most weight management medications work in the brain to stimulate satiety signaling, which helps motivated patients adhere to their dietary interventions, assist those who have been unsuccessful in earlier weight loss attempts, and help maintain weight.^3,4

Guidelines recommend 7 weight management medications, including orlistat (both prescription strength and over-the-counter), liraglutide, phentermine, phentermine/topiramate, lorcaserin, and naltrexone/bupropion. Using medications to assist with weight loss increases likelihood that patients will achieve 5 to 10% weight loss from baseline.^5,6 Studies looking at long-term effects of these medications on weight loss have found improvements in blood pressure (BP), biomarkers for cardiovascular disease, and T2DM-related comorbidities.^3,5,7

Positive effects on comorbidities have been found to be related to drug class and mechanism of action (MOA); those that also are approved for T2DM have demonstrated the most favorable cardiovascular effects.⁷ Other medications that work as stimulants or as modulators of serotonin pathways are associated with increased risks, prompting the US Food and Drug Administration (FDA) to remove some medications from the market.^7,8 In January 2020, lorcaserin was taken off the market because of increased risk of cancer found in postmarketing surveillance.⁹ The benefit of weight loss must be weighed against the risk of medication use.

Monthly follow-up is recommended with weight management medications in the beginning to assess safety and efficacy; medications should be discontinued if weight loss is inadequate in the first 3 months.^1,3,4 Limited studies have assessed the long-term use of weight management medications in a real-world setting. Medications are prescribed for weight management at Veteran Health Indiana (VHI) in outpatient clinics, including primary care, endocrinology, and gastrointestinal (GI) specialties. However, prescribing practices, outcomes, and adherence to guideline recommendations have not been studied. Data from this study will be used to better understand how VHI can serve its veterans through diet, lifestyle, and pharmacologic interventions.

Methods

We conducted a single-center, retrospective chart review for patients started on weight management medications at VHI. A patient list was generated based on prescription fills from June 1, 2017 to June 30, 2019. All data were obtained using the Computerized Patient Record System and patients were not contacted. This study was approved by the Indiana University Health Institutional Review Board and the VHI Research and Development Committee.

At the time of study, orlistat, liraglutide, phentermine/topiramate, lorcaserin, and naltrexone/bupropion were available at VHI for patients who met the criteria. All patients must have been enrolled in dietary and lifestyle management to be approved for these medications. The US Department of Veterans Affairs (VA) MOVE! weight management program, designed by the VA National Center for Health Promotion and Disease Promotion, is available at VA sites throughout the country. After MOVE! orientation, patients can participate in group or individual 12-week programs that include weigh ins, goal-setting strategies, meal planning, and habit modification support. If patients are unable to meet in person, phone and other telehealth opportunities are available.

Patients were included in the study if they received a prescription of any 1 of the 5 available medications during the enrollment period. Patients were excluded if they received a prescription from or were treated by a civilian health care provider, if they never used the medication, or if their weight loss was attributed to a cancer diagnosis. These criteria produced 86 patients of whom 96 unique weight loss prescriptions were generated. Data were collected for each instance of medication use so that some patients were included multiple times. In this case, data collection for the failed medication ended when failure was documented, and new data points began when new medication was prescribed; all data collected were per medication, not per patient. This method was used to account for medication failure and provide accurate weight loss results based on medication choice within this institution.

The primary outcomes included total weight loss and weight loss as a percentage of baseline weight at 3, 6, 12, and > 12 months of therapy. Secondary outcomes included weight loss of 5% from baseline, rate of successful weight maintenance after initial weight loss of 5% from baseline, adverse drug reaction (ADR) monitoring, and use of weight management medications across clinics at VHI.

Demographic data included race, age, sex, baseline weight, BMI, and comorbid medical conditions. Comorbidities were collected based on the most recent primary care clinical note before initiating medication. Medication data collected included medications used to manage comorbidities. Data related to weight management medication included prescribing clinic, reason for medication discontinuation, or bariatric surgery intervention if applicable.

Efficacy outcome data included weight and BMI across therapy duration. Safety outcomes data included heart rate, BP, and ADRs that resulted in medication discontinuation as documented in the electronic health record (EHR).

Results

A total of 86 patients were identified based on prescription fills, which produced 99 unique instances of medication use. Of the 99 identified, 3 met exclusion criteria and were not included in the final analysis. Among included veterans, 16 were female and 80 were male (Table 1). Most of those included identified as White race (86%), male (83%), and mean age 53 years. At baseline, mean weight was 130 kg and mean BMI 41.

Comorbidities and Medication Use

Hypertension (66%), hyperlipidemia (64%), and psychiatric diagnoses (50%) were most common comorbid conditions. Substance use (23%) and T2DM (40%) were the most common comorbidities influencing medication choice. Substance use evaluation included amphetamines and cocaine for this analysis.

Phentermine/topiramate is the preferred first-line agent unless patients have contraindications for use, in which case naltrexone/bupropion is recommended, based on guidelines for weight management medications within the VHI system. However, for patients with comorbid T2DM, liraglutide is preferred because of its beneficial effects for both weight loss and blood glucose control.² Most patients at VHI were started on liraglutide (44%) or phentermine/topiramate (42%), which was in line with recommendations. Our sample included ≥ 1 prescription for each medication available at our facility, although the number of patients on each medication was not equal. Of note, the one patient taking lorcaserin at the time of study discontinued therapy in response to recent FDA guidance.⁹

Medications for comorbid conditions could contribute to weight gain. Of the patient sample, β blockers (n = 24) and anticonvulsants, including gabapentin and pregabalin (n = 22) were the most common Other medications that could have contributed to weight gain included sulfonylureas (n = 5), antipsychotics (n = 4), tricyclic antidepressants (n = 2), and hormone replacement therapies (n = 2).

Primary Outcomes

The mean weight of participants dropped from 129.9 to 114.2 kg over the 12 months of weight management medication therapy for a absolute difference of 15.8 kg (Figure 1 and eTable 1 available at doi:10.12788/fp.0117). Weight loss was recorded at 3, 6, 12, and > 12 months of weight management therapy. At each time point, weight loss was statistically significant (P < .001) compared with baseline (Table 2), even though not every patient had weight loss records at each time point.

When classified by medication choice, mean change in weight was orlistat −25.9 kg (n = 5); lorcaserin −22.5 kg (n = 1); liraglutide −10.3 kg (n = 43); phentermine/topiramate −5.0 kg (n = 42); and naltrexone/ bupropion +2.1 kg (n = 5) over the duration of the study (eTable 2 available at doi:10.12788/fp.0117). Patients receiving orlistat and liraglutide had increasing weight loss across the duration of treatment compared with those on lorcaserin who had initial weight gain before weight loss. Phentermine/topiramate showed initial weight loss that tapered off, and naltrexone/bupropion demonstrated initial weight loss with eventual weight gain at study end point.

Secondary Outcomes

More than one-half of the patients analyzed lost 5 to 10% from baseline while taking weight management medication. Fifty-six (59%) patients lost 5% at any point while on therapy (Table 3). Among those patients, 31 (32%) lost ≥ 10% from baseline. When looking at success related to guideline recommendations, 32 (38%) patients lost 5% from baseline in the first 3 months of medication therapy.

Among patients who lost at least 5% from baseline, we performed further analysis to assess weight maintenance of 3 to 5% from baseline for 12 months. In the 12 months after initial weight loss, the number of patients who were able to maintain their weight loss steadily declined (Figure 2). In the end, 17 (30%) of patients who achieved 5 to 10% weight loss at baseline were able to maintain weight loss. Only 18% of study patients were able to achieve guideline-directed weight loss and maintain that weight for 12 months.

Discussion

This study evaluated the use and outcomes of weight management medication among veterans at VHI. The study aimed to better understand the efficacy and safety of these medications while exposing potential weaknesses in care and to promote avenues to improve weight loss and maintenance.

Clinical trials for weight management medications reported weight loss of 8 to 10 kg over 56 weeks: 21 to 63% of patients losing at least 5% from baseline weight.^10-14 The findings from our study found a higher average weight loss (−15.8 kg) than that reported in trials and a consistent percentage of patients (58.3%) who achieved at least 5% weight loss. It is promising to see that when used in a noncontrolled setting, these medications were able to produce weight loss consistent with results seen in large, controlled trials.

Pi-Sunyer and colleagues found continued weight loss after the initial 5% weight loss to an eventual 10% weight loss in many patients.¹⁰ Additionally, Smith and colleagues found that nearly 68% of their participants who took lorcaserin were able to maintain 3 to 5% weight loss over 12 months.¹³ Sjöström and colleagues acknowledged that many patients taking orlistat for an extended period began to gain weight, although at one-half the rate than that seen in the placebo group.¹² This study found that fewer patients were able to maintain their weight loss over 12 months, with only 30% of patients maintaining 3 to 5% weight loss from baseline. This difference in weight maintenance likely was because of the uncontrolled nature of this study. Once patients reach their initial weight loss goal, even the most motivated patients will have trouble maintaining that weight.⁴ Despite the challenges associated with maintaining weight loss, the quality of life benefits patients gained and potential reductions in health care spending support using resources to improve these outcomes.^2,14,15

Pi-Sunyer and colleagues reported high incidences of nausea (40%), vomiting (16%), diarrhea (21%), and constipation (20%) with liraglutide.¹⁰ Sjöström and colleagues reported 7% of patients experienced GI upset with orlistat.¹² Comparatively, only 17% of our patients reported AEs that required discontinuation, including GI upset. One patient in our study discontinued naltrexone/bupropion because of a significant change in mental status and suicide attempt. Clinical trials did not report a greater risk of depression or suicidality compared with placebo; however, there is a warning on the labeling of naltrexone/bupropion for increased suicidality with the use of antidepressant agents.^16,17 The neurologic AE that required discontinuation of phentermine/topiramate at our institution is unique based on published information.^11,18

The data from this study reinforced the observation that weight maintenance is the most challenging aspect of weight loss. Although our data showed clinically meaningful weight loss from baseline, many patients regained their weight, and some exceeded their baseline weight. Beyond providing these medications, this evidence suggests the need for close, continued follow-up through patients’ weight loss journey.

Limitations

Because this is a retrospective chart review, data collection was influenced by and limited to information that had been recorded in the EHR. AEs that resulted in medication discontinuation were assessed from the patient’s chart, which might not be correct if providers did not update the records. Follow-up was not always scheduled at regular intervals after medication initiation, resulting in varying sample numbers at each time point, potentially interfering with true weight loss averages. Although not included in this analysis, it might be beneficial to evaluate adherence to recommendations for follow-up with laboratory and weight monitoring to better capture where future monitoring can be improved. Second, there was an unbalanced number of patients taking each medication. Specifically, we saw a change in weight with orlistat that exceeded what is consistently seen in larger, more controlled trials. Although this is an effect of the real world, small sample sizes cannot be generalized to the larger population and might result in data reflecting that of an outlier. Last, there is a lack of generalizability because of the veteran population demographic, which is more male and lacks ethnic diversity. This study also was carried out at a single, educational tertiary medical center, which might not apply to all populations.

Conclusions

Despite the limitations discussed, this study shows that the use of weight management medications in a general veteran population produces initial weight loss consistent with previous studies. However, there is room for continued improvement in follow-up strategies to promote greater weight maintenance after initial weight loss. Considering the high health care costs, personal burden, and potential long-term complications associated with obesity, efforts to promote development of programs that support weight management and maintenance are imperative.

Acknowledgment
This material is the result of work supported with resources and the use of facilities at Veteran Health Indiana.