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Updates in clinical practice guidelines for Lyme disease
According to the Centers for Disease Control and Prevention, Lyme disease is the fastest growing vector-borne disease, affecting approximately 300,000 Americans every year. It is caused by the spirochete, Borrelia burgdorferi which is transmitted to humans by the deer tick. Lyme disease is often an overlooked diagnosis for myriad reasons, including inaccurate test results.
Recent guidelines for the prevention, diagnosis, and treatment of Lyme disease have been developed by a panel from the Infectious Disease Society of America (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR) using evidence-based recommendations.
Infection prevention
We all know that the best way to treat any disease is by preventing it. The following measures are recommended as tools to prevent infection: personal protective wear, repellents, and removal of the attached tick. Recommended repellents include DEET, picaridin, IR3535, oil of lemon, eucalyptus, para-Menthane-3,8-diol (PMD), 2-undecanone, and permethrin. If a tick is found, it should be removed promptly by mechanical measures, such as with tweezers. The tweezers should be inserted between the tick body and skin to ensure removal of the entire tick. Burning an attached tick or applying a noxious chemical to the tick is not recommended.
Diagnosis
Diagnosing Lyme disease is often difficult given that tests can be negative for some time after a tick bite, even when the infection is present. There is good evidence to show that submitting the removed tick for identification is good practice. However, there is no evidence supporting testing the removed tick for the presence of Borrelia burgdorferi as it does not reliably predict infection in humans. It also is recommended to avoid testing asymptomatic people following a tick bite.
Following a high-risk tick bite, adults and children can be given prophylactic antibiotics within 72 hours. It is not helpful for low-risk bites. If the risk level is uncertain, it is better to observe before giving antibiotics. For adults, a single 200-mg dose of doxycycline can be given. In children, 4.4 mg per kg of body weight, up to 200 mg max, can be used for those under 45 kg.
For patients with a tick exposure and erythema migrans, a clinical diagnosis of Lyme disease can be made without further testing. If the clinical presentation is not typical, it is recommended to do an antibody test on an acute phase serum sample followed by a convalescent serum sample in 2-3 weeks if the initial test is negative. Recommended antibiotics for treatment include doxycycline for 10 days or amoxicillin or cefuroxime for 14 days. If a patient is unable to take these, azithromycin may be used for 7 days.
The guidelines also make recommendations regarding testing for Lyme neuroborreliosis, for which neurologic presentations, for adults with psychiatric illnesses, and for children with developmental/behavioral/psychiatric disorders. They further make recommendations for treatment of Lyme disease involving the brain or spinal column, facial nerve palsy, carditis, cardiomyopathy, and arthritis, which are beyond the scope of this discussion.
As family doctors, we are often the first ones patients call upon after a tick bite. We are the ones who diagnosis and treat Lyme disease, so it is imperative that we stay up to date with current clinical guidelines and practice evidence-based medicine. These most recent guidelines from several specialty societies can provide the answers to many of our patients’ questions. They also serve as a great tool to help with our clinical decision-making regarding tick bites. Lyme disease can be a scary infection for patients but, if we offer them the recommended measures, it doesn’t have to be.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].
According to the Centers for Disease Control and Prevention, Lyme disease is the fastest growing vector-borne disease, affecting approximately 300,000 Americans every year. It is caused by the spirochete, Borrelia burgdorferi which is transmitted to humans by the deer tick. Lyme disease is often an overlooked diagnosis for myriad reasons, including inaccurate test results.
Recent guidelines for the prevention, diagnosis, and treatment of Lyme disease have been developed by a panel from the Infectious Disease Society of America (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR) using evidence-based recommendations.
Infection prevention
We all know that the best way to treat any disease is by preventing it. The following measures are recommended as tools to prevent infection: personal protective wear, repellents, and removal of the attached tick. Recommended repellents include DEET, picaridin, IR3535, oil of lemon, eucalyptus, para-Menthane-3,8-diol (PMD), 2-undecanone, and permethrin. If a tick is found, it should be removed promptly by mechanical measures, such as with tweezers. The tweezers should be inserted between the tick body and skin to ensure removal of the entire tick. Burning an attached tick or applying a noxious chemical to the tick is not recommended.
Diagnosis
Diagnosing Lyme disease is often difficult given that tests can be negative for some time after a tick bite, even when the infection is present. There is good evidence to show that submitting the removed tick for identification is good practice. However, there is no evidence supporting testing the removed tick for the presence of Borrelia burgdorferi as it does not reliably predict infection in humans. It also is recommended to avoid testing asymptomatic people following a tick bite.
Following a high-risk tick bite, adults and children can be given prophylactic antibiotics within 72 hours. It is not helpful for low-risk bites. If the risk level is uncertain, it is better to observe before giving antibiotics. For adults, a single 200-mg dose of doxycycline can be given. In children, 4.4 mg per kg of body weight, up to 200 mg max, can be used for those under 45 kg.
For patients with a tick exposure and erythema migrans, a clinical diagnosis of Lyme disease can be made without further testing. If the clinical presentation is not typical, it is recommended to do an antibody test on an acute phase serum sample followed by a convalescent serum sample in 2-3 weeks if the initial test is negative. Recommended antibiotics for treatment include doxycycline for 10 days or amoxicillin or cefuroxime for 14 days. If a patient is unable to take these, azithromycin may be used for 7 days.
The guidelines also make recommendations regarding testing for Lyme neuroborreliosis, for which neurologic presentations, for adults with psychiatric illnesses, and for children with developmental/behavioral/psychiatric disorders. They further make recommendations for treatment of Lyme disease involving the brain or spinal column, facial nerve palsy, carditis, cardiomyopathy, and arthritis, which are beyond the scope of this discussion.
As family doctors, we are often the first ones patients call upon after a tick bite. We are the ones who diagnosis and treat Lyme disease, so it is imperative that we stay up to date with current clinical guidelines and practice evidence-based medicine. These most recent guidelines from several specialty societies can provide the answers to many of our patients’ questions. They also serve as a great tool to help with our clinical decision-making regarding tick bites. Lyme disease can be a scary infection for patients but, if we offer them the recommended measures, it doesn’t have to be.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].
According to the Centers for Disease Control and Prevention, Lyme disease is the fastest growing vector-borne disease, affecting approximately 300,000 Americans every year. It is caused by the spirochete, Borrelia burgdorferi which is transmitted to humans by the deer tick. Lyme disease is often an overlooked diagnosis for myriad reasons, including inaccurate test results.
Recent guidelines for the prevention, diagnosis, and treatment of Lyme disease have been developed by a panel from the Infectious Disease Society of America (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR) using evidence-based recommendations.
Infection prevention
We all know that the best way to treat any disease is by preventing it. The following measures are recommended as tools to prevent infection: personal protective wear, repellents, and removal of the attached tick. Recommended repellents include DEET, picaridin, IR3535, oil of lemon, eucalyptus, para-Menthane-3,8-diol (PMD), 2-undecanone, and permethrin. If a tick is found, it should be removed promptly by mechanical measures, such as with tweezers. The tweezers should be inserted between the tick body and skin to ensure removal of the entire tick. Burning an attached tick or applying a noxious chemical to the tick is not recommended.
Diagnosis
Diagnosing Lyme disease is often difficult given that tests can be negative for some time after a tick bite, even when the infection is present. There is good evidence to show that submitting the removed tick for identification is good practice. However, there is no evidence supporting testing the removed tick for the presence of Borrelia burgdorferi as it does not reliably predict infection in humans. It also is recommended to avoid testing asymptomatic people following a tick bite.
Following a high-risk tick bite, adults and children can be given prophylactic antibiotics within 72 hours. It is not helpful for low-risk bites. If the risk level is uncertain, it is better to observe before giving antibiotics. For adults, a single 200-mg dose of doxycycline can be given. In children, 4.4 mg per kg of body weight, up to 200 mg max, can be used for those under 45 kg.
For patients with a tick exposure and erythema migrans, a clinical diagnosis of Lyme disease can be made without further testing. If the clinical presentation is not typical, it is recommended to do an antibody test on an acute phase serum sample followed by a convalescent serum sample in 2-3 weeks if the initial test is negative. Recommended antibiotics for treatment include doxycycline for 10 days or amoxicillin or cefuroxime for 14 days. If a patient is unable to take these, azithromycin may be used for 7 days.
The guidelines also make recommendations regarding testing for Lyme neuroborreliosis, for which neurologic presentations, for adults with psychiatric illnesses, and for children with developmental/behavioral/psychiatric disorders. They further make recommendations for treatment of Lyme disease involving the brain or spinal column, facial nerve palsy, carditis, cardiomyopathy, and arthritis, which are beyond the scope of this discussion.
As family doctors, we are often the first ones patients call upon after a tick bite. We are the ones who diagnosis and treat Lyme disease, so it is imperative that we stay up to date with current clinical guidelines and practice evidence-based medicine. These most recent guidelines from several specialty societies can provide the answers to many of our patients’ questions. They also serve as a great tool to help with our clinical decision-making regarding tick bites. Lyme disease can be a scary infection for patients but, if we offer them the recommended measures, it doesn’t have to be.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].
Benzene was found in some sunscreens. Now what?
Just before Memorial Day, which include batches from Neutrogena, Banana Boat, CVS Health, and other brands. More than three-quarters of the products are sprays.
“We’re asking our patients to put sunscreen on from 6 months of age, telling them to do it their entire life, their whole body, multiple times a day,” Christopher G. Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Conn., said in an interview. If benzene-contaminated sunscreen proves to be a widespread problem, he said, “the benzene amounts can add up to a significant chronic exposure over a lifetime.”
In the Valisure statement announcing the findings, Dr. Bunick, who is also quoted in the petition, said that “it is critical that regulatory agencies address benzene contamination in sunscreens, and all topical medications at the manufacturing and final product level, so that all individuals feel safe using sunscreen products.”
The list of products that tested positive is included in the citizen petition, and a full list of products that did not show any contamination is available in an attachment.
Benzene is not an ingredient in sunscreen, and Valisure’s petition suggests that the findings are a result of contamination somewhere in the manufacturing process, not of product degradation.
“This isn’t a sunscreen issue, it’s a manufacturing issue,” said Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington. “We don’t want those things to be blurred.”
When asked to comment on Valisure’s findings, an FDA spokesperson said, “The FDA takes seriously any safety concerns raised about products we regulate, including sunscreen. While the agency evaluates the submitted citizen petition, we will continue to monitor the sunscreen marketplace and manufacturing efforts to help ensure the availability of safe sunscreens for U.S. consumers.”
Both Johnson & Johnson, Neutrogena’s parent company, and Banana Boat issued statements reiterating that benzene is not an ingredient in their products.
Assessing the risks
There is a risk of patients taking away the wrong message from these findings.
“People already have ambivalence about sunscreen, and this is just going to make that worse,” Dr. Friedman said in an interview. He pointed out that benzene is present in car exhaust, second-hand smoke, and elsewhere. Inhalation exposure has been the primary focus of toxicology investigations, as has exposure from ingesting things such as contaminated drinking water – not via topical application. “We don’t know how effectively [benzene] gets through the skin, if it gets absorbed systemically, and how that then behaves downstream,” he noted.
On the other hand, ultraviolet radiation is a well-established carcinogen. Avoiding an effective preventive measure such as sunscreen could prove more harmful than exposure to trace amounts of benzene, ultimately to be determined by the FDA.
“Just because those particular products do pose a risk, that doesn’t erase the message that sunscreens are safe and should be used,” Dr. Bunick said. “It’s not mutually exclusive.”
And then there’s the fact that the benzene contamination appears to be fairly limited. “The majority of products we tested, over 200 of them, had no detectable amounts of benzene, and uncontaminated sunscreen should certainly continue to be used,” David Light, CEO of Valisure, told this news organization.
Advising patients
With headlines blaring the news about a carcinogen in sunscreen, patients will be reaching out for advice.
“The number one question patients will have is, ‘What sunscreen do you recommend?’” said Dr. Bunick. “The answer should be to pick a sunscreen that we know wasn’t contaminated. Reassure your patient the ingredients themselves are effective and safe, and that’s not what’s leading to the contamination.”
Dr. Friedman agrees. “We need to be mindful. Dermatologists need to be armed with the facts in order to counsel patients: Sunscreen is still a very important, effective, and safe, scientifically based way to prevent the harmful effects of the sun, in addition to things like sun protective clothing and seeking shade between 10 a.m. and 4 p.m.”
As alarming as Valisure’s findings may seem initially, Dr. Bunick noted a silver lining. “The consumer, the public should feel reassured this report is out there. It shows that someone’s watching out. That’s an important safety message: These things aren’t going undetected.”
Just before Memorial Day, which include batches from Neutrogena, Banana Boat, CVS Health, and other brands. More than three-quarters of the products are sprays.
“We’re asking our patients to put sunscreen on from 6 months of age, telling them to do it their entire life, their whole body, multiple times a day,” Christopher G. Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Conn., said in an interview. If benzene-contaminated sunscreen proves to be a widespread problem, he said, “the benzene amounts can add up to a significant chronic exposure over a lifetime.”
In the Valisure statement announcing the findings, Dr. Bunick, who is also quoted in the petition, said that “it is critical that regulatory agencies address benzene contamination in sunscreens, and all topical medications at the manufacturing and final product level, so that all individuals feel safe using sunscreen products.”
The list of products that tested positive is included in the citizen petition, and a full list of products that did not show any contamination is available in an attachment.
Benzene is not an ingredient in sunscreen, and Valisure’s petition suggests that the findings are a result of contamination somewhere in the manufacturing process, not of product degradation.
“This isn’t a sunscreen issue, it’s a manufacturing issue,” said Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington. “We don’t want those things to be blurred.”
When asked to comment on Valisure’s findings, an FDA spokesperson said, “The FDA takes seriously any safety concerns raised about products we regulate, including sunscreen. While the agency evaluates the submitted citizen petition, we will continue to monitor the sunscreen marketplace and manufacturing efforts to help ensure the availability of safe sunscreens for U.S. consumers.”
Both Johnson & Johnson, Neutrogena’s parent company, and Banana Boat issued statements reiterating that benzene is not an ingredient in their products.
Assessing the risks
There is a risk of patients taking away the wrong message from these findings.
“People already have ambivalence about sunscreen, and this is just going to make that worse,” Dr. Friedman said in an interview. He pointed out that benzene is present in car exhaust, second-hand smoke, and elsewhere. Inhalation exposure has been the primary focus of toxicology investigations, as has exposure from ingesting things such as contaminated drinking water – not via topical application. “We don’t know how effectively [benzene] gets through the skin, if it gets absorbed systemically, and how that then behaves downstream,” he noted.
On the other hand, ultraviolet radiation is a well-established carcinogen. Avoiding an effective preventive measure such as sunscreen could prove more harmful than exposure to trace amounts of benzene, ultimately to be determined by the FDA.
“Just because those particular products do pose a risk, that doesn’t erase the message that sunscreens are safe and should be used,” Dr. Bunick said. “It’s not mutually exclusive.”
And then there’s the fact that the benzene contamination appears to be fairly limited. “The majority of products we tested, over 200 of them, had no detectable amounts of benzene, and uncontaminated sunscreen should certainly continue to be used,” David Light, CEO of Valisure, told this news organization.
Advising patients
With headlines blaring the news about a carcinogen in sunscreen, patients will be reaching out for advice.
“The number one question patients will have is, ‘What sunscreen do you recommend?’” said Dr. Bunick. “The answer should be to pick a sunscreen that we know wasn’t contaminated. Reassure your patient the ingredients themselves are effective and safe, and that’s not what’s leading to the contamination.”
Dr. Friedman agrees. “We need to be mindful. Dermatologists need to be armed with the facts in order to counsel patients: Sunscreen is still a very important, effective, and safe, scientifically based way to prevent the harmful effects of the sun, in addition to things like sun protective clothing and seeking shade between 10 a.m. and 4 p.m.”
As alarming as Valisure’s findings may seem initially, Dr. Bunick noted a silver lining. “The consumer, the public should feel reassured this report is out there. It shows that someone’s watching out. That’s an important safety message: These things aren’t going undetected.”
Just before Memorial Day, which include batches from Neutrogena, Banana Boat, CVS Health, and other brands. More than three-quarters of the products are sprays.
“We’re asking our patients to put sunscreen on from 6 months of age, telling them to do it their entire life, their whole body, multiple times a day,” Christopher G. Bunick, MD, PhD, associate professor of dermatology at Yale University, New Haven, Conn., said in an interview. If benzene-contaminated sunscreen proves to be a widespread problem, he said, “the benzene amounts can add up to a significant chronic exposure over a lifetime.”
In the Valisure statement announcing the findings, Dr. Bunick, who is also quoted in the petition, said that “it is critical that regulatory agencies address benzene contamination in sunscreens, and all topical medications at the manufacturing and final product level, so that all individuals feel safe using sunscreen products.”
The list of products that tested positive is included in the citizen petition, and a full list of products that did not show any contamination is available in an attachment.
Benzene is not an ingredient in sunscreen, and Valisure’s petition suggests that the findings are a result of contamination somewhere in the manufacturing process, not of product degradation.
“This isn’t a sunscreen issue, it’s a manufacturing issue,” said Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington. “We don’t want those things to be blurred.”
When asked to comment on Valisure’s findings, an FDA spokesperson said, “The FDA takes seriously any safety concerns raised about products we regulate, including sunscreen. While the agency evaluates the submitted citizen petition, we will continue to monitor the sunscreen marketplace and manufacturing efforts to help ensure the availability of safe sunscreens for U.S. consumers.”
Both Johnson & Johnson, Neutrogena’s parent company, and Banana Boat issued statements reiterating that benzene is not an ingredient in their products.
Assessing the risks
There is a risk of patients taking away the wrong message from these findings.
“People already have ambivalence about sunscreen, and this is just going to make that worse,” Dr. Friedman said in an interview. He pointed out that benzene is present in car exhaust, second-hand smoke, and elsewhere. Inhalation exposure has been the primary focus of toxicology investigations, as has exposure from ingesting things such as contaminated drinking water – not via topical application. “We don’t know how effectively [benzene] gets through the skin, if it gets absorbed systemically, and how that then behaves downstream,” he noted.
On the other hand, ultraviolet radiation is a well-established carcinogen. Avoiding an effective preventive measure such as sunscreen could prove more harmful than exposure to trace amounts of benzene, ultimately to be determined by the FDA.
“Just because those particular products do pose a risk, that doesn’t erase the message that sunscreens are safe and should be used,” Dr. Bunick said. “It’s not mutually exclusive.”
And then there’s the fact that the benzene contamination appears to be fairly limited. “The majority of products we tested, over 200 of them, had no detectable amounts of benzene, and uncontaminated sunscreen should certainly continue to be used,” David Light, CEO of Valisure, told this news organization.
Advising patients
With headlines blaring the news about a carcinogen in sunscreen, patients will be reaching out for advice.
“The number one question patients will have is, ‘What sunscreen do you recommend?’” said Dr. Bunick. “The answer should be to pick a sunscreen that we know wasn’t contaminated. Reassure your patient the ingredients themselves are effective and safe, and that’s not what’s leading to the contamination.”
Dr. Friedman agrees. “We need to be mindful. Dermatologists need to be armed with the facts in order to counsel patients: Sunscreen is still a very important, effective, and safe, scientifically based way to prevent the harmful effects of the sun, in addition to things like sun protective clothing and seeking shade between 10 a.m. and 4 p.m.”
As alarming as Valisure’s findings may seem initially, Dr. Bunick noted a silver lining. “The consumer, the public should feel reassured this report is out there. It shows that someone’s watching out. That’s an important safety message: These things aren’t going undetected.”
Mistrust and Mandates: COVID-19 Vaccination in the Military
It is June and most of us are looking forward to a more normal summer than the one we had in 2020. Many Americans have been vaccinated and states are rolling back some (or all) masking requirements and restrictions on gatherings. In many sectors, including the US Department of Defense (DoD) and the US Department of Veterans Affairs (VA), worries from public health officials about vaccine supply and how to ethically allocate demand have given way to a new set of concerns: We have the shots, but for widespread protection we have to get them into arms.
The reluctance to roll up the sleeve is known as vaccine hesitancy. The National Academies of Science comments on vaccine hesitancy in its report on COVID-19 vaccination allocation. “Potential consequences of vaccine hesitancy—which the committee views as an attitude, preference, or motivational state—are the behaviors of vaccine refusal or delay.”2
On that count, there was encouraging albeit unexpected news in waning days of May. Media reported a sharp increase in the COVID-vaccination of military personnel. Unnamed DoD officials indicated, they had seen a 55% increase in the vaccination of active-duty service members over the previous month. This news represents a dramatic turnaround in a trend of vaccine hesitancy among military members that has persisted since the vaccine became available.3 Even last month, this would have been a very different column. The DoD has not disclosed the exact number of service members who have declined COVID-19 vaccination but multiple news outlets have documented that there was widespread and significant vaccine hesitancy among military personnel. In February, Military News reported that one-third of troops who were offered the vaccine declined it; and in April, USA Today stated that 40% of Marines had refused vaccination.4,5
Still, it is worth examining the data on vaccination among active duty service members. From December 2020 through March 2021, the military conducted the first study to evaluate rates of vaccine initiation and completion in the military in general and for service members from racial/ethnic minorities in particular. Black military personnel were 28% less likely than non-Hispanic White service members to initiate vaccination against coronavirus even after adjusting for other possible confounders. Just 29% of White, 25.5% of Hispanic, and 18.7% of Black service members had initiated the vaccine process in the survey.6
The authors suggest that in part, vaccine hesitancy explains the findings.4 Vaccine hesitancy among racial and ethnic minorities is even more tragic because these same already disadvantaged cohorts have disproportionately suffered from COVID-19 throughout the pandemic with higher rates of infection, serious illness requiring hospitalization, and infection-related morbidity.7
Vaccine hesitancy, delay, or refusal in Black Americans whether military or civilian often is attributed to the historical abuses like the Tuskegee syphilis experiments or the more recent example of cancer cell lines taken from Henrietta Lacks without consent.8 Such government sponsored betrayals no doubt are the soil in which hesitancy grows but recent commentators have opined that focusing solely on these infamous examples may ignore current systemic racism that is pervasively feeding Black Americans reluctance to consider or accept COVID-19 vaccination.9 Blaming infamous research also provides a convenient excuse for confronting contemporary racial discrimination in health care and taking responsibility as health care practitioners for reversing it. “Framing the conversation about distrust in COVID vaccines in terms of everyday racism rather than historical atrocities may increase underserved communities’ willingness to be vaccinated,” Bajaj and Stanford wrote in a recent recent New England Journal of Medicine commentary. “When we hyperfocus on Sims, Lacks, and Tuskegee, we ascribe the current Black health experience to past racism, rooting our present in immovable historical occurrences and undermining efforts to combat mistrust. Everyday racism, by contrast, can be tackled in the present.”9
The study of racial/ethnic disparities in COVID-19 vaccination in active-duty service members was a work product of the Armed Forces Health Surveillance Division. The authors underscore several factors that support the connection between discrimination and vaccine hesitancy in the military. Lack of access to and ability to obtain COVID-19 vaccination continues to be a major barrier that disadvantaged populations must overcome.10 The COVID-19 vaccine is widely available, easily obtained, and free of charge for all military personnel. Yet the vaccine hesitancy in the military parallels that of the civilian sector. This led the study authors to opine that, “forces external to the U.S. Military, such as interpersonal and societal factors also contribute to vaccine hesitancy among military service members.”6
Obviously, any unvaccinated active-duty service member reduces the combat readiness of the fighting force a consideration that led some in Congress to call for mandating vaccination. The vaccine is currently being administered under an emergency use authorization (EUA), which prevents even the military from mandating it.11 Even if President Joseph Biden obtained a waiver to make the vaccine mandatory, the implications of forcing service members who have volunteered to serve their country is ethically problematic. Those problems are exponentially amplified when applied to members of ethnic and racial minorities who have a past and present of health disparities and discrimination. Respecting the decision of those in uniform to decline COVID-19 vaccination is the first and perhaps most important step to rebuilding the trust that is the most promising means of reducing vaccine hesitancy.
Part of the accountability we all bear for health care inequity and racism is to continue the work of this landmark study to better understand vaccine hesitancy among military and veteran cohorts, develop counseling and education that target those attitudes, beliefs, and motivations with education, counseling, and support. All of us can in some small measure follow the ethical mandate “to dispel rumors and provide facts to people” of Secretary Austin, a Black retired 4-star Army general.1
1. Garmone J. Secretary of Defense Addresses Vaccine Hesitancy in the Military. Published February 25, 2021. Accessed May 26, 2021. https://www.defense.gov/Explore/News/Article/Article/2516511/secretary-of-defense-addresses-vaccine-hesitancy-in-military/
2. National Academies of Sciences, Engineering, and Medicine. Framework for Equitable Allocation of COVID-19 Vaccine . The National Academies of Science; 2020:188. doi:10.17226/25917
3. Liebermann O. US military sees 55% jump in COVID-19 vaccinations over last month. Published May 20, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/05/20/politics/us-military-covid-vaccinations/index.html
4. Kime P. Almost one-third of us troops are refusing COVID-19 vaccines, officials Say. Published February 17, 2021. Accessed May 26, 2021. https://www.military.com/daily-news/2021/02/17/almost-one-third-of-us-troops-are-refusing-covid-vaccines-officials-say.html
5. Elbeshbishi S. Nearly 40% of Marines decline COVID-19 vaccine, prompting some Democrats to urge Biden to set mandate for the military. USA Today. April 10, 2021. Accessed May 26, 2021. https://www.usatoday.com/story/news/politics/2021/04/10/covid-vaccine-nearly-forty-percent-us-marines-decline/7173918002/
6. Lang MA, Stahlman S, Wells NY, et al. Disparities in COVID-19 vaccine initiation and completion among active component service members and health care personnel, 11 December 2020-12 March 2021. MSMR. 2021;28(4):2-9.
7. Webb Hooper M, Nápoles AM, Pérez-Stable EJ. COVID-19 and racial/ethnic disparities. JAMA . 2020;323(24):2466-2467. doi:10.1001/jama.2020.8598
8. Kum D. Fueled by a history of mistreatment, Black Americans distrust the new COVID-19 vaccines. TIME. December 8, 2020. Accessed May 26, 2021.https://time.com/5925074/black-americans-covid-19-vaccine-distrust/
9. Bajaj SS, Stanford FC. Beyond Tuskegee - Vaccine Distrust and Everyday Racism. N Engl J Med. 2021;384(5):e12. doi:10.1056/NEJMpv2035827
10. Feldman N. Why Black and Latino people still lag on COVID-19 vaccines-and how to fix it. NPR. April 26, 2021. Accessed May 26, 2021. https://www.npr.org/sections/health-shots/2021/04/26/989962041/why-black-and-latino-people-still-lag-on-covid-vaccines-and-how-to-fix-it
11. Kaufman E. Lawmakers ask Biden to issue waiver to make COVID-19 vaccination mandatory of members of the military. Updated March 24, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/03/24/politics/congress-letter-military-vaccine/index.html
It is June and most of us are looking forward to a more normal summer than the one we had in 2020. Many Americans have been vaccinated and states are rolling back some (or all) masking requirements and restrictions on gatherings. In many sectors, including the US Department of Defense (DoD) and the US Department of Veterans Affairs (VA), worries from public health officials about vaccine supply and how to ethically allocate demand have given way to a new set of concerns: We have the shots, but for widespread protection we have to get them into arms.
The reluctance to roll up the sleeve is known as vaccine hesitancy. The National Academies of Science comments on vaccine hesitancy in its report on COVID-19 vaccination allocation. “Potential consequences of vaccine hesitancy—which the committee views as an attitude, preference, or motivational state—are the behaviors of vaccine refusal or delay.”2
On that count, there was encouraging albeit unexpected news in waning days of May. Media reported a sharp increase in the COVID-vaccination of military personnel. Unnamed DoD officials indicated, they had seen a 55% increase in the vaccination of active-duty service members over the previous month. This news represents a dramatic turnaround in a trend of vaccine hesitancy among military members that has persisted since the vaccine became available.3 Even last month, this would have been a very different column. The DoD has not disclosed the exact number of service members who have declined COVID-19 vaccination but multiple news outlets have documented that there was widespread and significant vaccine hesitancy among military personnel. In February, Military News reported that one-third of troops who were offered the vaccine declined it; and in April, USA Today stated that 40% of Marines had refused vaccination.4,5
Still, it is worth examining the data on vaccination among active duty service members. From December 2020 through March 2021, the military conducted the first study to evaluate rates of vaccine initiation and completion in the military in general and for service members from racial/ethnic minorities in particular. Black military personnel were 28% less likely than non-Hispanic White service members to initiate vaccination against coronavirus even after adjusting for other possible confounders. Just 29% of White, 25.5% of Hispanic, and 18.7% of Black service members had initiated the vaccine process in the survey.6
The authors suggest that in part, vaccine hesitancy explains the findings.4 Vaccine hesitancy among racial and ethnic minorities is even more tragic because these same already disadvantaged cohorts have disproportionately suffered from COVID-19 throughout the pandemic with higher rates of infection, serious illness requiring hospitalization, and infection-related morbidity.7
Vaccine hesitancy, delay, or refusal in Black Americans whether military or civilian often is attributed to the historical abuses like the Tuskegee syphilis experiments or the more recent example of cancer cell lines taken from Henrietta Lacks without consent.8 Such government sponsored betrayals no doubt are the soil in which hesitancy grows but recent commentators have opined that focusing solely on these infamous examples may ignore current systemic racism that is pervasively feeding Black Americans reluctance to consider or accept COVID-19 vaccination.9 Blaming infamous research also provides a convenient excuse for confronting contemporary racial discrimination in health care and taking responsibility as health care practitioners for reversing it. “Framing the conversation about distrust in COVID vaccines in terms of everyday racism rather than historical atrocities may increase underserved communities’ willingness to be vaccinated,” Bajaj and Stanford wrote in a recent recent New England Journal of Medicine commentary. “When we hyperfocus on Sims, Lacks, and Tuskegee, we ascribe the current Black health experience to past racism, rooting our present in immovable historical occurrences and undermining efforts to combat mistrust. Everyday racism, by contrast, can be tackled in the present.”9
The study of racial/ethnic disparities in COVID-19 vaccination in active-duty service members was a work product of the Armed Forces Health Surveillance Division. The authors underscore several factors that support the connection between discrimination and vaccine hesitancy in the military. Lack of access to and ability to obtain COVID-19 vaccination continues to be a major barrier that disadvantaged populations must overcome.10 The COVID-19 vaccine is widely available, easily obtained, and free of charge for all military personnel. Yet the vaccine hesitancy in the military parallels that of the civilian sector. This led the study authors to opine that, “forces external to the U.S. Military, such as interpersonal and societal factors also contribute to vaccine hesitancy among military service members.”6
Obviously, any unvaccinated active-duty service member reduces the combat readiness of the fighting force a consideration that led some in Congress to call for mandating vaccination. The vaccine is currently being administered under an emergency use authorization (EUA), which prevents even the military from mandating it.11 Even if President Joseph Biden obtained a waiver to make the vaccine mandatory, the implications of forcing service members who have volunteered to serve their country is ethically problematic. Those problems are exponentially amplified when applied to members of ethnic and racial minorities who have a past and present of health disparities and discrimination. Respecting the decision of those in uniform to decline COVID-19 vaccination is the first and perhaps most important step to rebuilding the trust that is the most promising means of reducing vaccine hesitancy.
Part of the accountability we all bear for health care inequity and racism is to continue the work of this landmark study to better understand vaccine hesitancy among military and veteran cohorts, develop counseling and education that target those attitudes, beliefs, and motivations with education, counseling, and support. All of us can in some small measure follow the ethical mandate “to dispel rumors and provide facts to people” of Secretary Austin, a Black retired 4-star Army general.1
It is June and most of us are looking forward to a more normal summer than the one we had in 2020. Many Americans have been vaccinated and states are rolling back some (or all) masking requirements and restrictions on gatherings. In many sectors, including the US Department of Defense (DoD) and the US Department of Veterans Affairs (VA), worries from public health officials about vaccine supply and how to ethically allocate demand have given way to a new set of concerns: We have the shots, but for widespread protection we have to get them into arms.
The reluctance to roll up the sleeve is known as vaccine hesitancy. The National Academies of Science comments on vaccine hesitancy in its report on COVID-19 vaccination allocation. “Potential consequences of vaccine hesitancy—which the committee views as an attitude, preference, or motivational state—are the behaviors of vaccine refusal or delay.”2
On that count, there was encouraging albeit unexpected news in waning days of May. Media reported a sharp increase in the COVID-vaccination of military personnel. Unnamed DoD officials indicated, they had seen a 55% increase in the vaccination of active-duty service members over the previous month. This news represents a dramatic turnaround in a trend of vaccine hesitancy among military members that has persisted since the vaccine became available.3 Even last month, this would have been a very different column. The DoD has not disclosed the exact number of service members who have declined COVID-19 vaccination but multiple news outlets have documented that there was widespread and significant vaccine hesitancy among military personnel. In February, Military News reported that one-third of troops who were offered the vaccine declined it; and in April, USA Today stated that 40% of Marines had refused vaccination.4,5
Still, it is worth examining the data on vaccination among active duty service members. From December 2020 through March 2021, the military conducted the first study to evaluate rates of vaccine initiation and completion in the military in general and for service members from racial/ethnic minorities in particular. Black military personnel were 28% less likely than non-Hispanic White service members to initiate vaccination against coronavirus even after adjusting for other possible confounders. Just 29% of White, 25.5% of Hispanic, and 18.7% of Black service members had initiated the vaccine process in the survey.6
The authors suggest that in part, vaccine hesitancy explains the findings.4 Vaccine hesitancy among racial and ethnic minorities is even more tragic because these same already disadvantaged cohorts have disproportionately suffered from COVID-19 throughout the pandemic with higher rates of infection, serious illness requiring hospitalization, and infection-related morbidity.7
Vaccine hesitancy, delay, or refusal in Black Americans whether military or civilian often is attributed to the historical abuses like the Tuskegee syphilis experiments or the more recent example of cancer cell lines taken from Henrietta Lacks without consent.8 Such government sponsored betrayals no doubt are the soil in which hesitancy grows but recent commentators have opined that focusing solely on these infamous examples may ignore current systemic racism that is pervasively feeding Black Americans reluctance to consider or accept COVID-19 vaccination.9 Blaming infamous research also provides a convenient excuse for confronting contemporary racial discrimination in health care and taking responsibility as health care practitioners for reversing it. “Framing the conversation about distrust in COVID vaccines in terms of everyday racism rather than historical atrocities may increase underserved communities’ willingness to be vaccinated,” Bajaj and Stanford wrote in a recent recent New England Journal of Medicine commentary. “When we hyperfocus on Sims, Lacks, and Tuskegee, we ascribe the current Black health experience to past racism, rooting our present in immovable historical occurrences and undermining efforts to combat mistrust. Everyday racism, by contrast, can be tackled in the present.”9
The study of racial/ethnic disparities in COVID-19 vaccination in active-duty service members was a work product of the Armed Forces Health Surveillance Division. The authors underscore several factors that support the connection between discrimination and vaccine hesitancy in the military. Lack of access to and ability to obtain COVID-19 vaccination continues to be a major barrier that disadvantaged populations must overcome.10 The COVID-19 vaccine is widely available, easily obtained, and free of charge for all military personnel. Yet the vaccine hesitancy in the military parallels that of the civilian sector. This led the study authors to opine that, “forces external to the U.S. Military, such as interpersonal and societal factors also contribute to vaccine hesitancy among military service members.”6
Obviously, any unvaccinated active-duty service member reduces the combat readiness of the fighting force a consideration that led some in Congress to call for mandating vaccination. The vaccine is currently being administered under an emergency use authorization (EUA), which prevents even the military from mandating it.11 Even if President Joseph Biden obtained a waiver to make the vaccine mandatory, the implications of forcing service members who have volunteered to serve their country is ethically problematic. Those problems are exponentially amplified when applied to members of ethnic and racial minorities who have a past and present of health disparities and discrimination. Respecting the decision of those in uniform to decline COVID-19 vaccination is the first and perhaps most important step to rebuilding the trust that is the most promising means of reducing vaccine hesitancy.
Part of the accountability we all bear for health care inequity and racism is to continue the work of this landmark study to better understand vaccine hesitancy among military and veteran cohorts, develop counseling and education that target those attitudes, beliefs, and motivations with education, counseling, and support. All of us can in some small measure follow the ethical mandate “to dispel rumors and provide facts to people” of Secretary Austin, a Black retired 4-star Army general.1
1. Garmone J. Secretary of Defense Addresses Vaccine Hesitancy in the Military. Published February 25, 2021. Accessed May 26, 2021. https://www.defense.gov/Explore/News/Article/Article/2516511/secretary-of-defense-addresses-vaccine-hesitancy-in-military/
2. National Academies of Sciences, Engineering, and Medicine. Framework for Equitable Allocation of COVID-19 Vaccine . The National Academies of Science; 2020:188. doi:10.17226/25917
3. Liebermann O. US military sees 55% jump in COVID-19 vaccinations over last month. Published May 20, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/05/20/politics/us-military-covid-vaccinations/index.html
4. Kime P. Almost one-third of us troops are refusing COVID-19 vaccines, officials Say. Published February 17, 2021. Accessed May 26, 2021. https://www.military.com/daily-news/2021/02/17/almost-one-third-of-us-troops-are-refusing-covid-vaccines-officials-say.html
5. Elbeshbishi S. Nearly 40% of Marines decline COVID-19 vaccine, prompting some Democrats to urge Biden to set mandate for the military. USA Today. April 10, 2021. Accessed May 26, 2021. https://www.usatoday.com/story/news/politics/2021/04/10/covid-vaccine-nearly-forty-percent-us-marines-decline/7173918002/
6. Lang MA, Stahlman S, Wells NY, et al. Disparities in COVID-19 vaccine initiation and completion among active component service members and health care personnel, 11 December 2020-12 March 2021. MSMR. 2021;28(4):2-9.
7. Webb Hooper M, Nápoles AM, Pérez-Stable EJ. COVID-19 and racial/ethnic disparities. JAMA . 2020;323(24):2466-2467. doi:10.1001/jama.2020.8598
8. Kum D. Fueled by a history of mistreatment, Black Americans distrust the new COVID-19 vaccines. TIME. December 8, 2020. Accessed May 26, 2021.https://time.com/5925074/black-americans-covid-19-vaccine-distrust/
9. Bajaj SS, Stanford FC. Beyond Tuskegee - Vaccine Distrust and Everyday Racism. N Engl J Med. 2021;384(5):e12. doi:10.1056/NEJMpv2035827
10. Feldman N. Why Black and Latino people still lag on COVID-19 vaccines-and how to fix it. NPR. April 26, 2021. Accessed May 26, 2021. https://www.npr.org/sections/health-shots/2021/04/26/989962041/why-black-and-latino-people-still-lag-on-covid-vaccines-and-how-to-fix-it
11. Kaufman E. Lawmakers ask Biden to issue waiver to make COVID-19 vaccination mandatory of members of the military. Updated March 24, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/03/24/politics/congress-letter-military-vaccine/index.html
1. Garmone J. Secretary of Defense Addresses Vaccine Hesitancy in the Military. Published February 25, 2021. Accessed May 26, 2021. https://www.defense.gov/Explore/News/Article/Article/2516511/secretary-of-defense-addresses-vaccine-hesitancy-in-military/
2. National Academies of Sciences, Engineering, and Medicine. Framework for Equitable Allocation of COVID-19 Vaccine . The National Academies of Science; 2020:188. doi:10.17226/25917
3. Liebermann O. US military sees 55% jump in COVID-19 vaccinations over last month. Published May 20, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/05/20/politics/us-military-covid-vaccinations/index.html
4. Kime P. Almost one-third of us troops are refusing COVID-19 vaccines, officials Say. Published February 17, 2021. Accessed May 26, 2021. https://www.military.com/daily-news/2021/02/17/almost-one-third-of-us-troops-are-refusing-covid-vaccines-officials-say.html
5. Elbeshbishi S. Nearly 40% of Marines decline COVID-19 vaccine, prompting some Democrats to urge Biden to set mandate for the military. USA Today. April 10, 2021. Accessed May 26, 2021. https://www.usatoday.com/story/news/politics/2021/04/10/covid-vaccine-nearly-forty-percent-us-marines-decline/7173918002/
6. Lang MA, Stahlman S, Wells NY, et al. Disparities in COVID-19 vaccine initiation and completion among active component service members and health care personnel, 11 December 2020-12 March 2021. MSMR. 2021;28(4):2-9.
7. Webb Hooper M, Nápoles AM, Pérez-Stable EJ. COVID-19 and racial/ethnic disparities. JAMA . 2020;323(24):2466-2467. doi:10.1001/jama.2020.8598
8. Kum D. Fueled by a history of mistreatment, Black Americans distrust the new COVID-19 vaccines. TIME. December 8, 2020. Accessed May 26, 2021.https://time.com/5925074/black-americans-covid-19-vaccine-distrust/
9. Bajaj SS, Stanford FC. Beyond Tuskegee - Vaccine Distrust and Everyday Racism. N Engl J Med. 2021;384(5):e12. doi:10.1056/NEJMpv2035827
10. Feldman N. Why Black and Latino people still lag on COVID-19 vaccines-and how to fix it. NPR. April 26, 2021. Accessed May 26, 2021. https://www.npr.org/sections/health-shots/2021/04/26/989962041/why-black-and-latino-people-still-lag-on-covid-vaccines-and-how-to-fix-it
11. Kaufman E. Lawmakers ask Biden to issue waiver to make COVID-19 vaccination mandatory of members of the military. Updated March 24, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/03/24/politics/congress-letter-military-vaccine/index.html
Hospital acquisition had no significant change in the rate of readmission or mortality
Background: Prior studies have examined the impact of hospital system mergers on health care costs, but few studies have previously examined impact on quality and patient experience.
Study design: Retrospective, difference-in-difference analysis.
Setting: 2,232 U.S. hospitals during 2007-2016.
Synopsis: The authors identified 2,232 hospitals, including 246 hospitals that were acquired between 2009 and 2013 and 1,986 control hospitals that were not acquired during this period. They used a difference-in-difference analysis to compare hospital performance on quality and patient experience measures from before and after an acquisition to concurrent changes in control hospitals. Hospital acquisition was associated with a significant decline in measured patient experience. There was no significant differential change in 30-day readmission or mortality. Although there was an association between acquisition and significant improvement in clinical process metrics, the authors found that this improvement occurred almost entirely prior to acquisition.
Bottom line: Hospital acquisition was associated with worse experience for patients and had no significant impact on readmission or mortality rates.
Citation: Beaulieu ND et al. Changes in quality of care after hospital mergers and acquisitions. N Engl J Med. 2020 Jan 2;382:51-9.
Dr. Midha is a hospitalist at Beth Israel Deaconess Medical Center, instructor of medicine, Boston University, and part-time instructor in medicine, Harvard Medical School, all in Boston.
Background: Prior studies have examined the impact of hospital system mergers on health care costs, but few studies have previously examined impact on quality and patient experience.
Study design: Retrospective, difference-in-difference analysis.
Setting: 2,232 U.S. hospitals during 2007-2016.
Synopsis: The authors identified 2,232 hospitals, including 246 hospitals that were acquired between 2009 and 2013 and 1,986 control hospitals that were not acquired during this period. They used a difference-in-difference analysis to compare hospital performance on quality and patient experience measures from before and after an acquisition to concurrent changes in control hospitals. Hospital acquisition was associated with a significant decline in measured patient experience. There was no significant differential change in 30-day readmission or mortality. Although there was an association between acquisition and significant improvement in clinical process metrics, the authors found that this improvement occurred almost entirely prior to acquisition.
Bottom line: Hospital acquisition was associated with worse experience for patients and had no significant impact on readmission or mortality rates.
Citation: Beaulieu ND et al. Changes in quality of care after hospital mergers and acquisitions. N Engl J Med. 2020 Jan 2;382:51-9.
Dr. Midha is a hospitalist at Beth Israel Deaconess Medical Center, instructor of medicine, Boston University, and part-time instructor in medicine, Harvard Medical School, all in Boston.
Background: Prior studies have examined the impact of hospital system mergers on health care costs, but few studies have previously examined impact on quality and patient experience.
Study design: Retrospective, difference-in-difference analysis.
Setting: 2,232 U.S. hospitals during 2007-2016.
Synopsis: The authors identified 2,232 hospitals, including 246 hospitals that were acquired between 2009 and 2013 and 1,986 control hospitals that were not acquired during this period. They used a difference-in-difference analysis to compare hospital performance on quality and patient experience measures from before and after an acquisition to concurrent changes in control hospitals. Hospital acquisition was associated with a significant decline in measured patient experience. There was no significant differential change in 30-day readmission or mortality. Although there was an association between acquisition and significant improvement in clinical process metrics, the authors found that this improvement occurred almost entirely prior to acquisition.
Bottom line: Hospital acquisition was associated with worse experience for patients and had no significant impact on readmission or mortality rates.
Citation: Beaulieu ND et al. Changes in quality of care after hospital mergers and acquisitions. N Engl J Med. 2020 Jan 2;382:51-9.
Dr. Midha is a hospitalist at Beth Israel Deaconess Medical Center, instructor of medicine, Boston University, and part-time instructor in medicine, Harvard Medical School, all in Boston.
New obesity target? Dopamine circuit in brainstem affects satiety
Researchers have discovered a new dopaminergic neural circuit leading to the hindbrain that is involved in satiety (feeling full and eating cessation) in mice, which may eventually lead to new ways to treat obesity.
Moreover, when mice were given methylphenidate (Ritalin, Concerta) – a stimulant approved to treat attention deficit hyperactivity disorder (ADHD) with a well-known side effect of decreasing appetite – signals in this dopaminergic pathway were enhanced and the mice ate less.
The study by Yong Han, PhD, a postdoctoral associate at Baylor College of Medicine, Houston, and colleagues was published online May 27 in Science Advances.
“We identified a new dopamine neural circuit from the midbrain to the hindbrain (brainstem) that regulates feeding behavior through an enhanced satiation response,” senior author Qi Wu, PhD, assistant professor in pediatrics-nutrition at Baylor College of Medicine, summarized in an interview.
The findings suggest that “people with obesity have a compromised dopaminergic neural pathway, presumably in ways that delay the satiation response, which makes them eat more, have a larger meal,” he explained.
Newly identified brain circuit plays a key role in satiety response
The study is about a circuit in the brain that helps precisely regulate the size of food portion consumed, Dr. Wu emphasized in a statement from the university, adding that the satiation response is as important as appetite.
Importantly, the results also provide clues about how methylphenidate can lead to weight loss.
Regulators have deemed that methylphenidate, a controlled substance with other side effects such as anxiety and a fast heart rate, is safe and effective for ADHD, Dr. Wu noted.
He speculated that, “If researchers want to do clinical trials of methylphenidate for obesity, it ultimately could evolve to be an anti-obesity drug, alone or combined with other drugs, or possibly derivatives of methylphenidate could be tested.”
The brain circuit “we discovered is the first to be fully described to regulate portion size via dopamine signaling,” Dr. Han stressed in the statement.
“Our new study shows that a circuit connecting neurons that produce dopamine, a chemical messenger previously known for the regulation of motivation and pleasure, has a new [critical] role in the control of feeding through dynamically regulating the satiety response,” he explained.
Brain signals that control portion size
Earlier studies that investigated how the dopaminergic system may regulate food intake, appetite, and body weight, have produced conflicting results, Dr. Wu said.
The researchers performed several experiments in mice that included the use of cell-specific circuitry mapping, optogenetics, and real-time recordings of brain activity.
They identified a new dopaminergic neural circuit comprised of dopaminergic neurons in the caudal ventral tegmental area (DA-VTA neurons) in the midbrain that directly innervate dopamine receptor D1-expressing neurons within the lateral parabrachial nucleus (DRD1-LPBN neurons) in the hindbrain.
There were four main findings:
- DA-VTA neurons were activated immediately before the cessation of each feeding bout.
- Actively inhibiting DA-VTA neurons before the end of each feeding bout prolonged the feeding.
- Activating DRD1-LPBN neurons inhibited feeding.
- Mice that lacked the DRD1 gene ate much more and gained weight.
“Our study illuminates a hindbrain dopaminergic circuit that controls feeding through dynamic regulation in satiety response and meal structure,” the researchers reiterate.
The study was supported by grants from the National Institutes of Health, NIH Digestive Diseases Center, Pew Charitable Trust, American Diabetes Association, Baylor Collaborative Faculty Research Investment Program, USDA/CRIS, USDA/ARS, American Heart Association, and NIH Centers of Biomedical Research Excellence, and by Pew and Kavli scholarships. The researchers have reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Researchers have discovered a new dopaminergic neural circuit leading to the hindbrain that is involved in satiety (feeling full and eating cessation) in mice, which may eventually lead to new ways to treat obesity.
Moreover, when mice were given methylphenidate (Ritalin, Concerta) – a stimulant approved to treat attention deficit hyperactivity disorder (ADHD) with a well-known side effect of decreasing appetite – signals in this dopaminergic pathway were enhanced and the mice ate less.
The study by Yong Han, PhD, a postdoctoral associate at Baylor College of Medicine, Houston, and colleagues was published online May 27 in Science Advances.
“We identified a new dopamine neural circuit from the midbrain to the hindbrain (brainstem) that regulates feeding behavior through an enhanced satiation response,” senior author Qi Wu, PhD, assistant professor in pediatrics-nutrition at Baylor College of Medicine, summarized in an interview.
The findings suggest that “people with obesity have a compromised dopaminergic neural pathway, presumably in ways that delay the satiation response, which makes them eat more, have a larger meal,” he explained.
Newly identified brain circuit plays a key role in satiety response
The study is about a circuit in the brain that helps precisely regulate the size of food portion consumed, Dr. Wu emphasized in a statement from the university, adding that the satiation response is as important as appetite.
Importantly, the results also provide clues about how methylphenidate can lead to weight loss.
Regulators have deemed that methylphenidate, a controlled substance with other side effects such as anxiety and a fast heart rate, is safe and effective for ADHD, Dr. Wu noted.
He speculated that, “If researchers want to do clinical trials of methylphenidate for obesity, it ultimately could evolve to be an anti-obesity drug, alone or combined with other drugs, or possibly derivatives of methylphenidate could be tested.”
The brain circuit “we discovered is the first to be fully described to regulate portion size via dopamine signaling,” Dr. Han stressed in the statement.
“Our new study shows that a circuit connecting neurons that produce dopamine, a chemical messenger previously known for the regulation of motivation and pleasure, has a new [critical] role in the control of feeding through dynamically regulating the satiety response,” he explained.
Brain signals that control portion size
Earlier studies that investigated how the dopaminergic system may regulate food intake, appetite, and body weight, have produced conflicting results, Dr. Wu said.
The researchers performed several experiments in mice that included the use of cell-specific circuitry mapping, optogenetics, and real-time recordings of brain activity.
They identified a new dopaminergic neural circuit comprised of dopaminergic neurons in the caudal ventral tegmental area (DA-VTA neurons) in the midbrain that directly innervate dopamine receptor D1-expressing neurons within the lateral parabrachial nucleus (DRD1-LPBN neurons) in the hindbrain.
There were four main findings:
- DA-VTA neurons were activated immediately before the cessation of each feeding bout.
- Actively inhibiting DA-VTA neurons before the end of each feeding bout prolonged the feeding.
- Activating DRD1-LPBN neurons inhibited feeding.
- Mice that lacked the DRD1 gene ate much more and gained weight.
“Our study illuminates a hindbrain dopaminergic circuit that controls feeding through dynamic regulation in satiety response and meal structure,” the researchers reiterate.
The study was supported by grants from the National Institutes of Health, NIH Digestive Diseases Center, Pew Charitable Trust, American Diabetes Association, Baylor Collaborative Faculty Research Investment Program, USDA/CRIS, USDA/ARS, American Heart Association, and NIH Centers of Biomedical Research Excellence, and by Pew and Kavli scholarships. The researchers have reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Researchers have discovered a new dopaminergic neural circuit leading to the hindbrain that is involved in satiety (feeling full and eating cessation) in mice, which may eventually lead to new ways to treat obesity.
Moreover, when mice were given methylphenidate (Ritalin, Concerta) – a stimulant approved to treat attention deficit hyperactivity disorder (ADHD) with a well-known side effect of decreasing appetite – signals in this dopaminergic pathway were enhanced and the mice ate less.
The study by Yong Han, PhD, a postdoctoral associate at Baylor College of Medicine, Houston, and colleagues was published online May 27 in Science Advances.
“We identified a new dopamine neural circuit from the midbrain to the hindbrain (brainstem) that regulates feeding behavior through an enhanced satiation response,” senior author Qi Wu, PhD, assistant professor in pediatrics-nutrition at Baylor College of Medicine, summarized in an interview.
The findings suggest that “people with obesity have a compromised dopaminergic neural pathway, presumably in ways that delay the satiation response, which makes them eat more, have a larger meal,” he explained.
Newly identified brain circuit plays a key role in satiety response
The study is about a circuit in the brain that helps precisely regulate the size of food portion consumed, Dr. Wu emphasized in a statement from the university, adding that the satiation response is as important as appetite.
Importantly, the results also provide clues about how methylphenidate can lead to weight loss.
Regulators have deemed that methylphenidate, a controlled substance with other side effects such as anxiety and a fast heart rate, is safe and effective for ADHD, Dr. Wu noted.
He speculated that, “If researchers want to do clinical trials of methylphenidate for obesity, it ultimately could evolve to be an anti-obesity drug, alone or combined with other drugs, or possibly derivatives of methylphenidate could be tested.”
The brain circuit “we discovered is the first to be fully described to regulate portion size via dopamine signaling,” Dr. Han stressed in the statement.
“Our new study shows that a circuit connecting neurons that produce dopamine, a chemical messenger previously known for the regulation of motivation and pleasure, has a new [critical] role in the control of feeding through dynamically regulating the satiety response,” he explained.
Brain signals that control portion size
Earlier studies that investigated how the dopaminergic system may regulate food intake, appetite, and body weight, have produced conflicting results, Dr. Wu said.
The researchers performed several experiments in mice that included the use of cell-specific circuitry mapping, optogenetics, and real-time recordings of brain activity.
They identified a new dopaminergic neural circuit comprised of dopaminergic neurons in the caudal ventral tegmental area (DA-VTA neurons) in the midbrain that directly innervate dopamine receptor D1-expressing neurons within the lateral parabrachial nucleus (DRD1-LPBN neurons) in the hindbrain.
There were four main findings:
- DA-VTA neurons were activated immediately before the cessation of each feeding bout.
- Actively inhibiting DA-VTA neurons before the end of each feeding bout prolonged the feeding.
- Activating DRD1-LPBN neurons inhibited feeding.
- Mice that lacked the DRD1 gene ate much more and gained weight.
“Our study illuminates a hindbrain dopaminergic circuit that controls feeding through dynamic regulation in satiety response and meal structure,” the researchers reiterate.
The study was supported by grants from the National Institutes of Health, NIH Digestive Diseases Center, Pew Charitable Trust, American Diabetes Association, Baylor Collaborative Faculty Research Investment Program, USDA/CRIS, USDA/ARS, American Heart Association, and NIH Centers of Biomedical Research Excellence, and by Pew and Kavli scholarships. The researchers have reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Electronic frailty index based on routine blood tests may help identify at-risk seniors
Background: Accurate identification of frail older patients at hospital admission may help target interventions; however, the extent to which risk prediction tools such as the frailty index can be utilized in the acute setting remains unclear.
Study design: Single-center prospective cohort study, during April 2015–January 2017.
Setting: A tertiary care, academic medical center in the United Kingdom.
Synopsis: This study enrolled 1,750 older adults, comprising 2,552 hospital admissions. For each admission, the authors generated a frailty index, called FI-Laboratory, based on the proportion of abnormal results from 27 of the most common admission laboratory tests. The authors found that an increase in the FI-Lab was significantly associated, independent of an existing chronic frailty score, with increased proportion of inpatient days, discharge to a higher level of care, readmission rates, and mortality. Notably, researchers were unable to calculate the FI-Lab score in 11.6% of cases because of insufficient laboratory information. The single-center design of this study may limit its generalizability.
Bottom line: The FI-Laboratory may provide information, complementary to existing frailty assessments, to help identify older adults at increased risk of inpatient adverse outcomes.
Citation: Logan Ellis H et al. Complementing chronic frailty assessment at hospital admission with an electronic frailty index (FI-Laboratory) comprising routine blood test results. CMAJ. 2020;192(1)e3-8.
Dr. Hu is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.
Background: Accurate identification of frail older patients at hospital admission may help target interventions; however, the extent to which risk prediction tools such as the frailty index can be utilized in the acute setting remains unclear.
Study design: Single-center prospective cohort study, during April 2015–January 2017.
Setting: A tertiary care, academic medical center in the United Kingdom.
Synopsis: This study enrolled 1,750 older adults, comprising 2,552 hospital admissions. For each admission, the authors generated a frailty index, called FI-Laboratory, based on the proportion of abnormal results from 27 of the most common admission laboratory tests. The authors found that an increase in the FI-Lab was significantly associated, independent of an existing chronic frailty score, with increased proportion of inpatient days, discharge to a higher level of care, readmission rates, and mortality. Notably, researchers were unable to calculate the FI-Lab score in 11.6% of cases because of insufficient laboratory information. The single-center design of this study may limit its generalizability.
Bottom line: The FI-Laboratory may provide information, complementary to existing frailty assessments, to help identify older adults at increased risk of inpatient adverse outcomes.
Citation: Logan Ellis H et al. Complementing chronic frailty assessment at hospital admission with an electronic frailty index (FI-Laboratory) comprising routine blood test results. CMAJ. 2020;192(1)e3-8.
Dr. Hu is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.
Background: Accurate identification of frail older patients at hospital admission may help target interventions; however, the extent to which risk prediction tools such as the frailty index can be utilized in the acute setting remains unclear.
Study design: Single-center prospective cohort study, during April 2015–January 2017.
Setting: A tertiary care, academic medical center in the United Kingdom.
Synopsis: This study enrolled 1,750 older adults, comprising 2,552 hospital admissions. For each admission, the authors generated a frailty index, called FI-Laboratory, based on the proportion of abnormal results from 27 of the most common admission laboratory tests. The authors found that an increase in the FI-Lab was significantly associated, independent of an existing chronic frailty score, with increased proportion of inpatient days, discharge to a higher level of care, readmission rates, and mortality. Notably, researchers were unable to calculate the FI-Lab score in 11.6% of cases because of insufficient laboratory information. The single-center design of this study may limit its generalizability.
Bottom line: The FI-Laboratory may provide information, complementary to existing frailty assessments, to help identify older adults at increased risk of inpatient adverse outcomes.
Citation: Logan Ellis H et al. Complementing chronic frailty assessment at hospital admission with an electronic frailty index (FI-Laboratory) comprising routine blood test results. CMAJ. 2020;192(1)e3-8.
Dr. Hu is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.
FDA approves ‘game changer’ semaglutide for weight loss
The U.S. Food and Drug Administration has approved a 2.4 mg/week subcutaneous dose of the glucagonlike peptide–1 (GLP-1) receptor agonist semaglutide (Wegovy, Novo Nordisk) for weight loss.
Specifically, this drug format and dosage are approved as an adjunct to a reduced-calorie diet and increased physical activity to treat adults who have obesity (body mass index [BMI] ≥ 30 kg/m2) or are overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity.
Semaglutide “induces weight loss by reducing hunger, increasing feelings of fullness, and thereby helping people eat less and reduce their calorie intake,” according to a company statement.
Novo Nordisk plans to launch Wegovy later this month in the United States. The prescribing information can be found here.
This weight-loss drug is currently under review by the European Medicines Agency.
Several experts told Medscape that they believe the approval of this drug – as long as it is reimbursed – has the potential to change the paradigm of care when it comes to weight loss.
‘Game changer’ drug tested in STEP clinical trial program
The favorable FDA ruling is based on results from the Semaglutide Treatment Effect in People With Obesity (STEP) program of four phase 3 clinical trials that tested the drug’s safety and efficacy in more than 4,500 adults with overweight or obesity obesity who were randomized to receive a reduced a calorie meal plan and increased physical activity (placebo) or this lifestyle intervention plus semaglutide.
The four 68-week trials of subcutaneous semaglutide 2.4 mg/week versus placebo were published in February and March 2021.
As previously reported by this news organization, all trials were in adults with overweight or obesity:
- was in 1,961 adults (N Engl J Med. 2021 March 18;384:989-1002).
- was in 1,210 adults who also had diabetes (Lancet. 2021 Mar 13;397;971-84).
- was in 611 adults, where those in the treatment group also underwent an intensive lifestyle intervention (JAMA. 2021 Feb 24;325:1403-13.
- was in 803 adults who had reached a target dose of 2.4 mg semaglutide after a 20-week run-in (and the trial examined further weight loss in the subsequent 48 weeks) (JAMA 2021 Mar 23;325:1414-25).
In the STEP 1, 2, and 4 trials of individuals with overweight and obesity, those in the semaglutide groups attained a 15%-18% weight loss over 68 weeks.
The dosage was well-tolerated. The most common side effects were gastrointestinal, and they were transient and mild or moderate in severity.
The side effects, contraindications, and a black box warning about thyroid C-cell tumors are spelled out in the prescribing information.
A coauthor of the STEP 1 trial, Rachel Batterham, MBBS, PhD, of the Centre for Obesity Research at University College London, said at the time of publication: “The findings of this study represent a major breakthrough for improving the health of people with obesity.”
“No other drug has come close to producing this level of weight loss – this really is a gamechanger. For the first time, people can achieve through drugs what was only possible through weight-loss surgery,” she added.
Welcome Addition, But Will Insurance Coverage, Price Thwart Access?
Thomas A. Wadden, PhD, from the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, and lead author of STEP 3, commented in an email to this news organization that “semaglutide 2.4 mg appears to be the breakthrough in weight management that healthcare providers and their patients with obesity have been waiting for.”
The mean 15% weight loss at 68 weeks is nearly twice what is seen with other FDA-approved anti-obesity medications, he noted, and moreover, 70% of patients taking semaglutide lost at least 10% of their initial weight, which is associated with clinically meaningful improvements in obesity-related type 2 diabetes, hypertension, obstructive sleep apnea, and impaired quality of life.
And “nearly one-third of users are likely to lose 20% or more of their starting weight, an outcome which eludes traditional diet and exercise interventions and which approaches weight losses produced by the most widely performed bariatric surgery, sleeve gastrectomy (with mean losses of 25% of initial weight at 1 year).” Dr. Wadden stressed.
Thus “the efficacy of semaglutide 2.4 mg, combined with its favorable safety profile, makes this medication a potential game changer,” he summarized, echoing Dr. Batterham.
However, insurance coverage and price could block uptake.
“I hope that the millions of people – in the U.S. and worldwide – who could benefit from this medication eventually will have access to it,” said Dr. Wadden. “In the U.S., the coverage of anti-obesity medications by insurers and employers will need to improve to ensure this happens, and the medication must be reasonably priced. These changes are critical to making this medication the game changer it could be.”
“This approval is an important development,” Scott Kahan, MD, director of the National Center for Weight and Wellness, Washington, who was not involved in the clinical trials of this drug, similarly wrote in an email.
“In a field with relatively few medication options, the availability of additional obesity pharmacotherapy agents is welcome,” he said. “In particular, semaglutide has shown impressive efficacy and safety data; as such it should be a valuable clinical option for many patients.”
However, it is concerning that “access to obesity treatments has traditionally been a challenge,” Dr. Kahan warned. “Novo Nordisk’s other obesity medication, Saxenda, has been a valuable tool, but one that exceedingly few patients are able to utilize due to minimal insurance reimbursement and very high cost.”
“It remains to be seen how accessible semaglutide will be for patients,” according to Dr. Kahan, “Still, if the challenge of limited coverage and high cost can be mitigated, this medication has a chance to significantly change the current paradigm of care, which until till now has included minimal use of pharmacotherapy outside specialty clinics,” he maintains.
Lower-dose injectable and pill already approved for diabetes
Subcutaneous semaglutide at doses up to 1 mg/week (Ozempic, Novo Nordisk), which comes as prefilled pens at doses of 0.5 mg or 1.0 mg, is already approved for the treatment of type 2 diabetes.
The company is also applying for approval for a higher dose of semaglutide, 2 mg/week, for use in type 2 diabetes, and has just resubmitted its label expansion application to the FDA, after the agency issued a refusal to file letter in March.
And in September 2019, the FDA approved oral semaglutide (Rybelsus, Novo Nordisk), in doses of 7 and 14 mg/day, to improve glycemic control in type 2 diabetes, making it the first GLP-1 receptor agonist available in tablet form.
CVOT and oral format trials for obesity on the horizon
The ongoing Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT) trial will shed light on cardiovascular outcomes after 2.5-5 years in patients with cardiovascular disease and overweight or obesity but without type 2 diabetes. Participants will receive semaglutide in doses up to a maximum of 2.4 mg/week, or placebo, as an adjunct to lifestyle recommendations focused on cardiovascular risk reduction. The study is expected to complete in 2023.
And Novo Nordisk plans to initiate a global 68-week phase 3 trial in the second half of 2021 on the efficacy and safety of oral semaglutide 50 mg compared with placebo in 1000 people with obesity or overweight and comorbidities.
A version of this article first appeared on Medscape.com.
This article was updated 6/7/21.
The U.S. Food and Drug Administration has approved a 2.4 mg/week subcutaneous dose of the glucagonlike peptide–1 (GLP-1) receptor agonist semaglutide (Wegovy, Novo Nordisk) for weight loss.
Specifically, this drug format and dosage are approved as an adjunct to a reduced-calorie diet and increased physical activity to treat adults who have obesity (body mass index [BMI] ≥ 30 kg/m2) or are overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity.
Semaglutide “induces weight loss by reducing hunger, increasing feelings of fullness, and thereby helping people eat less and reduce their calorie intake,” according to a company statement.
Novo Nordisk plans to launch Wegovy later this month in the United States. The prescribing information can be found here.
This weight-loss drug is currently under review by the European Medicines Agency.
Several experts told Medscape that they believe the approval of this drug – as long as it is reimbursed – has the potential to change the paradigm of care when it comes to weight loss.
‘Game changer’ drug tested in STEP clinical trial program
The favorable FDA ruling is based on results from the Semaglutide Treatment Effect in People With Obesity (STEP) program of four phase 3 clinical trials that tested the drug’s safety and efficacy in more than 4,500 adults with overweight or obesity obesity who were randomized to receive a reduced a calorie meal plan and increased physical activity (placebo) or this lifestyle intervention plus semaglutide.
The four 68-week trials of subcutaneous semaglutide 2.4 mg/week versus placebo were published in February and March 2021.
As previously reported by this news organization, all trials were in adults with overweight or obesity:
- was in 1,961 adults (N Engl J Med. 2021 March 18;384:989-1002).
- was in 1,210 adults who also had diabetes (Lancet. 2021 Mar 13;397;971-84).
- was in 611 adults, where those in the treatment group also underwent an intensive lifestyle intervention (JAMA. 2021 Feb 24;325:1403-13.
- was in 803 adults who had reached a target dose of 2.4 mg semaglutide after a 20-week run-in (and the trial examined further weight loss in the subsequent 48 weeks) (JAMA 2021 Mar 23;325:1414-25).
In the STEP 1, 2, and 4 trials of individuals with overweight and obesity, those in the semaglutide groups attained a 15%-18% weight loss over 68 weeks.
The dosage was well-tolerated. The most common side effects were gastrointestinal, and they were transient and mild or moderate in severity.
The side effects, contraindications, and a black box warning about thyroid C-cell tumors are spelled out in the prescribing information.
A coauthor of the STEP 1 trial, Rachel Batterham, MBBS, PhD, of the Centre for Obesity Research at University College London, said at the time of publication: “The findings of this study represent a major breakthrough for improving the health of people with obesity.”
“No other drug has come close to producing this level of weight loss – this really is a gamechanger. For the first time, people can achieve through drugs what was only possible through weight-loss surgery,” she added.
Welcome Addition, But Will Insurance Coverage, Price Thwart Access?
Thomas A. Wadden, PhD, from the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, and lead author of STEP 3, commented in an email to this news organization that “semaglutide 2.4 mg appears to be the breakthrough in weight management that healthcare providers and their patients with obesity have been waiting for.”
The mean 15% weight loss at 68 weeks is nearly twice what is seen with other FDA-approved anti-obesity medications, he noted, and moreover, 70% of patients taking semaglutide lost at least 10% of their initial weight, which is associated with clinically meaningful improvements in obesity-related type 2 diabetes, hypertension, obstructive sleep apnea, and impaired quality of life.
And “nearly one-third of users are likely to lose 20% or more of their starting weight, an outcome which eludes traditional diet and exercise interventions and which approaches weight losses produced by the most widely performed bariatric surgery, sleeve gastrectomy (with mean losses of 25% of initial weight at 1 year).” Dr. Wadden stressed.
Thus “the efficacy of semaglutide 2.4 mg, combined with its favorable safety profile, makes this medication a potential game changer,” he summarized, echoing Dr. Batterham.
However, insurance coverage and price could block uptake.
“I hope that the millions of people – in the U.S. and worldwide – who could benefit from this medication eventually will have access to it,” said Dr. Wadden. “In the U.S., the coverage of anti-obesity medications by insurers and employers will need to improve to ensure this happens, and the medication must be reasonably priced. These changes are critical to making this medication the game changer it could be.”
“This approval is an important development,” Scott Kahan, MD, director of the National Center for Weight and Wellness, Washington, who was not involved in the clinical trials of this drug, similarly wrote in an email.
“In a field with relatively few medication options, the availability of additional obesity pharmacotherapy agents is welcome,” he said. “In particular, semaglutide has shown impressive efficacy and safety data; as such it should be a valuable clinical option for many patients.”
However, it is concerning that “access to obesity treatments has traditionally been a challenge,” Dr. Kahan warned. “Novo Nordisk’s other obesity medication, Saxenda, has been a valuable tool, but one that exceedingly few patients are able to utilize due to minimal insurance reimbursement and very high cost.”
“It remains to be seen how accessible semaglutide will be for patients,” according to Dr. Kahan, “Still, if the challenge of limited coverage and high cost can be mitigated, this medication has a chance to significantly change the current paradigm of care, which until till now has included minimal use of pharmacotherapy outside specialty clinics,” he maintains.
Lower-dose injectable and pill already approved for diabetes
Subcutaneous semaglutide at doses up to 1 mg/week (Ozempic, Novo Nordisk), which comes as prefilled pens at doses of 0.5 mg or 1.0 mg, is already approved for the treatment of type 2 diabetes.
The company is also applying for approval for a higher dose of semaglutide, 2 mg/week, for use in type 2 diabetes, and has just resubmitted its label expansion application to the FDA, after the agency issued a refusal to file letter in March.
And in September 2019, the FDA approved oral semaglutide (Rybelsus, Novo Nordisk), in doses of 7 and 14 mg/day, to improve glycemic control in type 2 diabetes, making it the first GLP-1 receptor agonist available in tablet form.
CVOT and oral format trials for obesity on the horizon
The ongoing Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT) trial will shed light on cardiovascular outcomes after 2.5-5 years in patients with cardiovascular disease and overweight or obesity but without type 2 diabetes. Participants will receive semaglutide in doses up to a maximum of 2.4 mg/week, or placebo, as an adjunct to lifestyle recommendations focused on cardiovascular risk reduction. The study is expected to complete in 2023.
And Novo Nordisk plans to initiate a global 68-week phase 3 trial in the second half of 2021 on the efficacy and safety of oral semaglutide 50 mg compared with placebo in 1000 people with obesity or overweight and comorbidities.
A version of this article first appeared on Medscape.com.
This article was updated 6/7/21.
The U.S. Food and Drug Administration has approved a 2.4 mg/week subcutaneous dose of the glucagonlike peptide–1 (GLP-1) receptor agonist semaglutide (Wegovy, Novo Nordisk) for weight loss.
Specifically, this drug format and dosage are approved as an adjunct to a reduced-calorie diet and increased physical activity to treat adults who have obesity (body mass index [BMI] ≥ 30 kg/m2) or are overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity.
Semaglutide “induces weight loss by reducing hunger, increasing feelings of fullness, and thereby helping people eat less and reduce their calorie intake,” according to a company statement.
Novo Nordisk plans to launch Wegovy later this month in the United States. The prescribing information can be found here.
This weight-loss drug is currently under review by the European Medicines Agency.
Several experts told Medscape that they believe the approval of this drug – as long as it is reimbursed – has the potential to change the paradigm of care when it comes to weight loss.
‘Game changer’ drug tested in STEP clinical trial program
The favorable FDA ruling is based on results from the Semaglutide Treatment Effect in People With Obesity (STEP) program of four phase 3 clinical trials that tested the drug’s safety and efficacy in more than 4,500 adults with overweight or obesity obesity who were randomized to receive a reduced a calorie meal plan and increased physical activity (placebo) or this lifestyle intervention plus semaglutide.
The four 68-week trials of subcutaneous semaglutide 2.4 mg/week versus placebo were published in February and March 2021.
As previously reported by this news organization, all trials were in adults with overweight or obesity:
- was in 1,961 adults (N Engl J Med. 2021 March 18;384:989-1002).
- was in 1,210 adults who also had diabetes (Lancet. 2021 Mar 13;397;971-84).
- was in 611 adults, where those in the treatment group also underwent an intensive lifestyle intervention (JAMA. 2021 Feb 24;325:1403-13.
- was in 803 adults who had reached a target dose of 2.4 mg semaglutide after a 20-week run-in (and the trial examined further weight loss in the subsequent 48 weeks) (JAMA 2021 Mar 23;325:1414-25).
In the STEP 1, 2, and 4 trials of individuals with overweight and obesity, those in the semaglutide groups attained a 15%-18% weight loss over 68 weeks.
The dosage was well-tolerated. The most common side effects were gastrointestinal, and they were transient and mild or moderate in severity.
The side effects, contraindications, and a black box warning about thyroid C-cell tumors are spelled out in the prescribing information.
A coauthor of the STEP 1 trial, Rachel Batterham, MBBS, PhD, of the Centre for Obesity Research at University College London, said at the time of publication: “The findings of this study represent a major breakthrough for improving the health of people with obesity.”
“No other drug has come close to producing this level of weight loss – this really is a gamechanger. For the first time, people can achieve through drugs what was only possible through weight-loss surgery,” she added.
Welcome Addition, But Will Insurance Coverage, Price Thwart Access?
Thomas A. Wadden, PhD, from the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, and lead author of STEP 3, commented in an email to this news organization that “semaglutide 2.4 mg appears to be the breakthrough in weight management that healthcare providers and their patients with obesity have been waiting for.”
The mean 15% weight loss at 68 weeks is nearly twice what is seen with other FDA-approved anti-obesity medications, he noted, and moreover, 70% of patients taking semaglutide lost at least 10% of their initial weight, which is associated with clinically meaningful improvements in obesity-related type 2 diabetes, hypertension, obstructive sleep apnea, and impaired quality of life.
And “nearly one-third of users are likely to lose 20% or more of their starting weight, an outcome which eludes traditional diet and exercise interventions and which approaches weight losses produced by the most widely performed bariatric surgery, sleeve gastrectomy (with mean losses of 25% of initial weight at 1 year).” Dr. Wadden stressed.
Thus “the efficacy of semaglutide 2.4 mg, combined with its favorable safety profile, makes this medication a potential game changer,” he summarized, echoing Dr. Batterham.
However, insurance coverage and price could block uptake.
“I hope that the millions of people – in the U.S. and worldwide – who could benefit from this medication eventually will have access to it,” said Dr. Wadden. “In the U.S., the coverage of anti-obesity medications by insurers and employers will need to improve to ensure this happens, and the medication must be reasonably priced. These changes are critical to making this medication the game changer it could be.”
“This approval is an important development,” Scott Kahan, MD, director of the National Center for Weight and Wellness, Washington, who was not involved in the clinical trials of this drug, similarly wrote in an email.
“In a field with relatively few medication options, the availability of additional obesity pharmacotherapy agents is welcome,” he said. “In particular, semaglutide has shown impressive efficacy and safety data; as such it should be a valuable clinical option for many patients.”
However, it is concerning that “access to obesity treatments has traditionally been a challenge,” Dr. Kahan warned. “Novo Nordisk’s other obesity medication, Saxenda, has been a valuable tool, but one that exceedingly few patients are able to utilize due to minimal insurance reimbursement and very high cost.”
“It remains to be seen how accessible semaglutide will be for patients,” according to Dr. Kahan, “Still, if the challenge of limited coverage and high cost can be mitigated, this medication has a chance to significantly change the current paradigm of care, which until till now has included minimal use of pharmacotherapy outside specialty clinics,” he maintains.
Lower-dose injectable and pill already approved for diabetes
Subcutaneous semaglutide at doses up to 1 mg/week (Ozempic, Novo Nordisk), which comes as prefilled pens at doses of 0.5 mg or 1.0 mg, is already approved for the treatment of type 2 diabetes.
The company is also applying for approval for a higher dose of semaglutide, 2 mg/week, for use in type 2 diabetes, and has just resubmitted its label expansion application to the FDA, after the agency issued a refusal to file letter in March.
And in September 2019, the FDA approved oral semaglutide (Rybelsus, Novo Nordisk), in doses of 7 and 14 mg/day, to improve glycemic control in type 2 diabetes, making it the first GLP-1 receptor agonist available in tablet form.
CVOT and oral format trials for obesity on the horizon
The ongoing Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT) trial will shed light on cardiovascular outcomes after 2.5-5 years in patients with cardiovascular disease and overweight or obesity but without type 2 diabetes. Participants will receive semaglutide in doses up to a maximum of 2.4 mg/week, or placebo, as an adjunct to lifestyle recommendations focused on cardiovascular risk reduction. The study is expected to complete in 2023.
And Novo Nordisk plans to initiate a global 68-week phase 3 trial in the second half of 2021 on the efficacy and safety of oral semaglutide 50 mg compared with placebo in 1000 people with obesity or overweight and comorbidities.
A version of this article first appeared on Medscape.com.
This article was updated 6/7/21.
Better ways to handle in-hospital conflicts
Imagine a hospitalist, part of a group with 35 hospitalists, is in her second year of practice and is caring for a 55-year-old woman with a history of congestive heart failure and cirrhosis from hepatitis C due to heroin use. The patient was hospitalized with acute back pain and found to have vertebral osteomyelitis confirmed on MRI.
The hospitalist calls a surgeon to get a biopsy so that antibiotic therapy can be chosen. The surgeon says it’s the second time the patient has been hospitalized for this condition, and asks, “Why do you need me to see this patient?” He says the hospitalist should just give IV antibiotics and consult infectious disease.
The hospitalist says, “The patient needs this biopsy. I’ll just call your chair.”
In the course of a busy day, conflicts arise all the time in the hospital – between clinicians, between patients and clinicians, and as internal battles when clinicians face uncertain situations. There are ways to make these conflicts less tense and more in tune with patient care, panelists said recently during a session at SHM Converge, the annual conference of the Society of Hospital Medicine.
In the case of vertebral osteomyelitis, for instance, the hospitalist was using a “position-based” strategy to deal with the conflict with the surgeon – she came in knowing she wanted a biopsy – rather than an “interest-based” strategy, or what is in the patient’s interest, said Patrick Rendon, MD, FHM, assistant professor in the hospital medicine division at the University of New Mexico, Albuquerque.
“What we really need to do is realign the thinking from both the hospitalist as well as the consult perspective,” Dr. Rendon said. “It is not us versus the consultant or the consult versus us. It should be both, together, versus the problem.”
Instead of saying something like, “I need this biopsy,” it might be better to ask for an evaluation, he said.
Handling conflicts better can improve patient care but can also benefit the clinicians themselves. While hospitalists say they routinely experience “pushback” when making a request of a consultant, they also say that they prefer to receive instruction when consulting about a case. Dr. Rendon said that hospitalists also say they want this teaching done “in the right way,” and consultants routinely say that their instruction, when they give it, is often met with resistance.
“The idea here is to open up perspectives,” Dr. Rendon said.
Emily Gottenborg, MD, hospitalist and assistant professor of medicine at the University of Colorado, discussed the case of an intern caring for a patient who says something offensive.
Conflicts, she said, come in all sorts – intimidation, harassment, bias. And they can be based on race, gender, disability, and hierarchy, she said. When on the receiving end of offensive remarks from patients, it’s important for a clinician to set boundaries and quickly move on, with responses such as, “I care about you as a person, but I will not tolerate offensive behavior. Let’s focus on how I can help you today.”
“Practice that behavior so that you have a script in your mind and then use it when needed so that you can nip this behavior in the bud,” Dr. Gottenborg said.
In her hypothetical case, the intern asks for help from her program, and monthly morbidity and mortality workshops on bias and harassment are scheduled. She also receives counseling, and faculty and staff receive discrimination and bias training. Getting help from the institution can help systematically reduce these problems, Dr. Gottenborg said.
Ernie Esquivel, MD, SFHM, hospitalist and assistant professor of clinical medicine at Weill Cornell Medicine, New York, said internal conflicts test physicians routinely – and this has been especially true during the COVID-19 pandemic, in which urgent clinical situations arose with no clear answers.
“In the past year, physicians have experienced an incredible amount of anxiety and stress,” he said. “Tolerating uncertainty is probably one of the most mature skills that we need to learn as a physician.”
The culture of medicine, to a large degree, promotes the opposite tendency: value is placed on nailing down the diagnosis or achieving certainty. Confidence levels of physicians tend not to waver, even in the face of difficult cases full of uncertainty, Dr. Esquivel said.
He urged physicians to practice “deliberate clinical inertia” – to resist a quick response and to think more deeply and systematically about a situation. To show the importance of this, he asks residents to rank diagnoses, using sticky notes, as information about a case is provided. By the fourth round, when much more information is available, the diagnoses have changed dramatically.
Dr. Esquivel suggested physicians switch from thinking in terms of “diagnoses” to thinking in terms of “hypotheses.” That approach can help clinicians tolerate uncertainty, because it reinforces the idea that they are dealing with an “iterative process.”
“There may not be one diagnosis to consider,” he said, “but several in play at once.”
A version of this article first appeared on Medscape.com.
Imagine a hospitalist, part of a group with 35 hospitalists, is in her second year of practice and is caring for a 55-year-old woman with a history of congestive heart failure and cirrhosis from hepatitis C due to heroin use. The patient was hospitalized with acute back pain and found to have vertebral osteomyelitis confirmed on MRI.
The hospitalist calls a surgeon to get a biopsy so that antibiotic therapy can be chosen. The surgeon says it’s the second time the patient has been hospitalized for this condition, and asks, “Why do you need me to see this patient?” He says the hospitalist should just give IV antibiotics and consult infectious disease.
The hospitalist says, “The patient needs this biopsy. I’ll just call your chair.”
In the course of a busy day, conflicts arise all the time in the hospital – between clinicians, between patients and clinicians, and as internal battles when clinicians face uncertain situations. There are ways to make these conflicts less tense and more in tune with patient care, panelists said recently during a session at SHM Converge, the annual conference of the Society of Hospital Medicine.
In the case of vertebral osteomyelitis, for instance, the hospitalist was using a “position-based” strategy to deal with the conflict with the surgeon – she came in knowing she wanted a biopsy – rather than an “interest-based” strategy, or what is in the patient’s interest, said Patrick Rendon, MD, FHM, assistant professor in the hospital medicine division at the University of New Mexico, Albuquerque.
“What we really need to do is realign the thinking from both the hospitalist as well as the consult perspective,” Dr. Rendon said. “It is not us versus the consultant or the consult versus us. It should be both, together, versus the problem.”
Instead of saying something like, “I need this biopsy,” it might be better to ask for an evaluation, he said.
Handling conflicts better can improve patient care but can also benefit the clinicians themselves. While hospitalists say they routinely experience “pushback” when making a request of a consultant, they also say that they prefer to receive instruction when consulting about a case. Dr. Rendon said that hospitalists also say they want this teaching done “in the right way,” and consultants routinely say that their instruction, when they give it, is often met with resistance.
“The idea here is to open up perspectives,” Dr. Rendon said.
Emily Gottenborg, MD, hospitalist and assistant professor of medicine at the University of Colorado, discussed the case of an intern caring for a patient who says something offensive.
Conflicts, she said, come in all sorts – intimidation, harassment, bias. And they can be based on race, gender, disability, and hierarchy, she said. When on the receiving end of offensive remarks from patients, it’s important for a clinician to set boundaries and quickly move on, with responses such as, “I care about you as a person, but I will not tolerate offensive behavior. Let’s focus on how I can help you today.”
“Practice that behavior so that you have a script in your mind and then use it when needed so that you can nip this behavior in the bud,” Dr. Gottenborg said.
In her hypothetical case, the intern asks for help from her program, and monthly morbidity and mortality workshops on bias and harassment are scheduled. She also receives counseling, and faculty and staff receive discrimination and bias training. Getting help from the institution can help systematically reduce these problems, Dr. Gottenborg said.
Ernie Esquivel, MD, SFHM, hospitalist and assistant professor of clinical medicine at Weill Cornell Medicine, New York, said internal conflicts test physicians routinely – and this has been especially true during the COVID-19 pandemic, in which urgent clinical situations arose with no clear answers.
“In the past year, physicians have experienced an incredible amount of anxiety and stress,” he said. “Tolerating uncertainty is probably one of the most mature skills that we need to learn as a physician.”
The culture of medicine, to a large degree, promotes the opposite tendency: value is placed on nailing down the diagnosis or achieving certainty. Confidence levels of physicians tend not to waver, even in the face of difficult cases full of uncertainty, Dr. Esquivel said.
He urged physicians to practice “deliberate clinical inertia” – to resist a quick response and to think more deeply and systematically about a situation. To show the importance of this, he asks residents to rank diagnoses, using sticky notes, as information about a case is provided. By the fourth round, when much more information is available, the diagnoses have changed dramatically.
Dr. Esquivel suggested physicians switch from thinking in terms of “diagnoses” to thinking in terms of “hypotheses.” That approach can help clinicians tolerate uncertainty, because it reinforces the idea that they are dealing with an “iterative process.”
“There may not be one diagnosis to consider,” he said, “but several in play at once.”
A version of this article first appeared on Medscape.com.
Imagine a hospitalist, part of a group with 35 hospitalists, is in her second year of practice and is caring for a 55-year-old woman with a history of congestive heart failure and cirrhosis from hepatitis C due to heroin use. The patient was hospitalized with acute back pain and found to have vertebral osteomyelitis confirmed on MRI.
The hospitalist calls a surgeon to get a biopsy so that antibiotic therapy can be chosen. The surgeon says it’s the second time the patient has been hospitalized for this condition, and asks, “Why do you need me to see this patient?” He says the hospitalist should just give IV antibiotics and consult infectious disease.
The hospitalist says, “The patient needs this biopsy. I’ll just call your chair.”
In the course of a busy day, conflicts arise all the time in the hospital – between clinicians, between patients and clinicians, and as internal battles when clinicians face uncertain situations. There are ways to make these conflicts less tense and more in tune with patient care, panelists said recently during a session at SHM Converge, the annual conference of the Society of Hospital Medicine.
In the case of vertebral osteomyelitis, for instance, the hospitalist was using a “position-based” strategy to deal with the conflict with the surgeon – she came in knowing she wanted a biopsy – rather than an “interest-based” strategy, or what is in the patient’s interest, said Patrick Rendon, MD, FHM, assistant professor in the hospital medicine division at the University of New Mexico, Albuquerque.
“What we really need to do is realign the thinking from both the hospitalist as well as the consult perspective,” Dr. Rendon said. “It is not us versus the consultant or the consult versus us. It should be both, together, versus the problem.”
Instead of saying something like, “I need this biopsy,” it might be better to ask for an evaluation, he said.
Handling conflicts better can improve patient care but can also benefit the clinicians themselves. While hospitalists say they routinely experience “pushback” when making a request of a consultant, they also say that they prefer to receive instruction when consulting about a case. Dr. Rendon said that hospitalists also say they want this teaching done “in the right way,” and consultants routinely say that their instruction, when they give it, is often met with resistance.
“The idea here is to open up perspectives,” Dr. Rendon said.
Emily Gottenborg, MD, hospitalist and assistant professor of medicine at the University of Colorado, discussed the case of an intern caring for a patient who says something offensive.
Conflicts, she said, come in all sorts – intimidation, harassment, bias. And they can be based on race, gender, disability, and hierarchy, she said. When on the receiving end of offensive remarks from patients, it’s important for a clinician to set boundaries and quickly move on, with responses such as, “I care about you as a person, but I will not tolerate offensive behavior. Let’s focus on how I can help you today.”
“Practice that behavior so that you have a script in your mind and then use it when needed so that you can nip this behavior in the bud,” Dr. Gottenborg said.
In her hypothetical case, the intern asks for help from her program, and monthly morbidity and mortality workshops on bias and harassment are scheduled. She also receives counseling, and faculty and staff receive discrimination and bias training. Getting help from the institution can help systematically reduce these problems, Dr. Gottenborg said.
Ernie Esquivel, MD, SFHM, hospitalist and assistant professor of clinical medicine at Weill Cornell Medicine, New York, said internal conflicts test physicians routinely – and this has been especially true during the COVID-19 pandemic, in which urgent clinical situations arose with no clear answers.
“In the past year, physicians have experienced an incredible amount of anxiety and stress,” he said. “Tolerating uncertainty is probably one of the most mature skills that we need to learn as a physician.”
The culture of medicine, to a large degree, promotes the opposite tendency: value is placed on nailing down the diagnosis or achieving certainty. Confidence levels of physicians tend not to waver, even in the face of difficult cases full of uncertainty, Dr. Esquivel said.
He urged physicians to practice “deliberate clinical inertia” – to resist a quick response and to think more deeply and systematically about a situation. To show the importance of this, he asks residents to rank diagnoses, using sticky notes, as information about a case is provided. By the fourth round, when much more information is available, the diagnoses have changed dramatically.
Dr. Esquivel suggested physicians switch from thinking in terms of “diagnoses” to thinking in terms of “hypotheses.” That approach can help clinicians tolerate uncertainty, because it reinforces the idea that they are dealing with an “iterative process.”
“There may not be one diagnosis to consider,” he said, “but several in play at once.”
A version of this article first appeared on Medscape.com.
FROM SHM CONVERGE 2021
Adding daily steps linked to longer life
Taking more steps each day, in short spurts or longer bouts, was associated with a longer life in women older than 60 years, according to data from more than 16,000 participants in the ongoing Women’s Health Study.
The American Heart Association recommends at least 150 minutes per week of moderate physical activity, 75 minutes of vigorous physical activity, or a combination of both as fitness guidelines for adults. Walking is a safe and easy way for many adults to follow these guidelines, according to Christopher C. Moore, MS, a PhD candidate at the University of North Carolina at Chapel Hill.
The popularity of step counts reflect that they are simple and objective, and “focusing on steps can help promote an active lifestyle,” he said. Data on the impact of sporadic steps accumulated outside of longer bouts of activity on health outcomes are limited; however, technology advances in the form of fitness apps and wearable devices make it possible for researchers to track and measure the benefits of short periods of activity as well as longer periods.
In a study presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the AHA, Mr. Moore and colleagues assessed data from women older than 60 years who used wearable step-counting devices to measure their daily steps and walking patterns.
The study population included 16,732 women enrolled in the Women’s Health Study, a longstanding study of heart disease, cancer, and disease prevention among women in the United States. The participants wore waist step counters 4-7 days a week during 2011-2015. The average of the women was 72 years; 96% were non-Hispanic White, and the average BMI was 26 kg/m2.
The researchers divided the total number of steps for each study participant into two groups: “bouted” steps, defined as 10 minutes or longer bouts of walking with few interruptions; and “sporadic” steps, defined as short spurts of walking during regular daily activities such as housework, taking the stairs, or walking to or from a car.
A total of 804 deaths occurred during an average of 6 years of follow-up. Each initial increase of 1,000 steps including sporadic or bouted steps was associated with a 28% decrease in death, compared with no daily steps (hazard ratio, 0.72).
Each increasing quartile of sporadic steps was linked with higher total steps per day, Mr. Moore said. “Initial increase in sporadic steps corresponded to the greatest reductions in mortality,” with a HR of 0.69 per additional sporadic steps below 3,200 per day, and the impact on reduced mortality plateaued at about 4,500 sporadic steps per day.
In further analysis, the researchers also found a roughly 32% decrease in death in participants who took more than 2,000 steps daily in uninterrupted bouts (HR, 0.69).
The study findings were limited by several factors, including the relatively short follow-up period and number of events, the assessment of steps at a single time point, and the mostly homogeneous population, Mr. Moore noted. Additional research is needed to assess whether the results are generalizable to men, younger women, and diverse racial and ethnic groups.
However, the results may have implications for public health messaging, he emphasized. The message is that, to impact longevity, the total volume of steps is more important than the type of activity through which they are accumulated.
“You can accumulate your steps through longer bouts of purposeful activity or through everyday behaviors such as walking to your car, taking the stairs, and doing housework,” Mr. Moore concluded.
Find a friend, both of you benefit
On the basis of this study and other available evidence, more steps daily are recommended for everyone, Nieca Goldberg, MD, a cardiologist at New York University Langone Health, said in an interview.
“You can increase minutes of walking and frequency of walking,” she said.
Dr. Goldberg emphasized that you don’t need a fancy app or wearable device to up your steps. She offered some tips to help overcome barriers to putting one foot in front of the other. “Take the steps instead of the elevator. Park your car farther from your destination so you can walk.” Also, you can help yourself and help a friend to better health. “Get a walking buddy so you can encourage each other to walk,” Dr. Goldberg added.
Mr. Moore and Dr. Goldberg had no financial conflicts to disclose. The Women’s Health Study is funded by Brigham and Women’s Hospital; the National Heart, Lung, and Blood Institute; and the National Cancer Institute. Mr. Moore was funded by a grant from the NHLBI but had no other financial conflicts to disclose.
Taking more steps each day, in short spurts or longer bouts, was associated with a longer life in women older than 60 years, according to data from more than 16,000 participants in the ongoing Women’s Health Study.
The American Heart Association recommends at least 150 minutes per week of moderate physical activity, 75 minutes of vigorous physical activity, or a combination of both as fitness guidelines for adults. Walking is a safe and easy way for many adults to follow these guidelines, according to Christopher C. Moore, MS, a PhD candidate at the University of North Carolina at Chapel Hill.
The popularity of step counts reflect that they are simple and objective, and “focusing on steps can help promote an active lifestyle,” he said. Data on the impact of sporadic steps accumulated outside of longer bouts of activity on health outcomes are limited; however, technology advances in the form of fitness apps and wearable devices make it possible for researchers to track and measure the benefits of short periods of activity as well as longer periods.
In a study presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the AHA, Mr. Moore and colleagues assessed data from women older than 60 years who used wearable step-counting devices to measure their daily steps and walking patterns.
The study population included 16,732 women enrolled in the Women’s Health Study, a longstanding study of heart disease, cancer, and disease prevention among women in the United States. The participants wore waist step counters 4-7 days a week during 2011-2015. The average of the women was 72 years; 96% were non-Hispanic White, and the average BMI was 26 kg/m2.
The researchers divided the total number of steps for each study participant into two groups: “bouted” steps, defined as 10 minutes or longer bouts of walking with few interruptions; and “sporadic” steps, defined as short spurts of walking during regular daily activities such as housework, taking the stairs, or walking to or from a car.
A total of 804 deaths occurred during an average of 6 years of follow-up. Each initial increase of 1,000 steps including sporadic or bouted steps was associated with a 28% decrease in death, compared with no daily steps (hazard ratio, 0.72).
Each increasing quartile of sporadic steps was linked with higher total steps per day, Mr. Moore said. “Initial increase in sporadic steps corresponded to the greatest reductions in mortality,” with a HR of 0.69 per additional sporadic steps below 3,200 per day, and the impact on reduced mortality plateaued at about 4,500 sporadic steps per day.
In further analysis, the researchers also found a roughly 32% decrease in death in participants who took more than 2,000 steps daily in uninterrupted bouts (HR, 0.69).
The study findings were limited by several factors, including the relatively short follow-up period and number of events, the assessment of steps at a single time point, and the mostly homogeneous population, Mr. Moore noted. Additional research is needed to assess whether the results are generalizable to men, younger women, and diverse racial and ethnic groups.
However, the results may have implications for public health messaging, he emphasized. The message is that, to impact longevity, the total volume of steps is more important than the type of activity through which they are accumulated.
“You can accumulate your steps through longer bouts of purposeful activity or through everyday behaviors such as walking to your car, taking the stairs, and doing housework,” Mr. Moore concluded.
Find a friend, both of you benefit
On the basis of this study and other available evidence, more steps daily are recommended for everyone, Nieca Goldberg, MD, a cardiologist at New York University Langone Health, said in an interview.
“You can increase minutes of walking and frequency of walking,” she said.
Dr. Goldberg emphasized that you don’t need a fancy app or wearable device to up your steps. She offered some tips to help overcome barriers to putting one foot in front of the other. “Take the steps instead of the elevator. Park your car farther from your destination so you can walk.” Also, you can help yourself and help a friend to better health. “Get a walking buddy so you can encourage each other to walk,” Dr. Goldberg added.
Mr. Moore and Dr. Goldberg had no financial conflicts to disclose. The Women’s Health Study is funded by Brigham and Women’s Hospital; the National Heart, Lung, and Blood Institute; and the National Cancer Institute. Mr. Moore was funded by a grant from the NHLBI but had no other financial conflicts to disclose.
Taking more steps each day, in short spurts or longer bouts, was associated with a longer life in women older than 60 years, according to data from more than 16,000 participants in the ongoing Women’s Health Study.
The American Heart Association recommends at least 150 minutes per week of moderate physical activity, 75 minutes of vigorous physical activity, or a combination of both as fitness guidelines for adults. Walking is a safe and easy way for many adults to follow these guidelines, according to Christopher C. Moore, MS, a PhD candidate at the University of North Carolina at Chapel Hill.
The popularity of step counts reflect that they are simple and objective, and “focusing on steps can help promote an active lifestyle,” he said. Data on the impact of sporadic steps accumulated outside of longer bouts of activity on health outcomes are limited; however, technology advances in the form of fitness apps and wearable devices make it possible for researchers to track and measure the benefits of short periods of activity as well as longer periods.
In a study presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the AHA, Mr. Moore and colleagues assessed data from women older than 60 years who used wearable step-counting devices to measure their daily steps and walking patterns.
The study population included 16,732 women enrolled in the Women’s Health Study, a longstanding study of heart disease, cancer, and disease prevention among women in the United States. The participants wore waist step counters 4-7 days a week during 2011-2015. The average of the women was 72 years; 96% were non-Hispanic White, and the average BMI was 26 kg/m2.
The researchers divided the total number of steps for each study participant into two groups: “bouted” steps, defined as 10 minutes or longer bouts of walking with few interruptions; and “sporadic” steps, defined as short spurts of walking during regular daily activities such as housework, taking the stairs, or walking to or from a car.
A total of 804 deaths occurred during an average of 6 years of follow-up. Each initial increase of 1,000 steps including sporadic or bouted steps was associated with a 28% decrease in death, compared with no daily steps (hazard ratio, 0.72).
Each increasing quartile of sporadic steps was linked with higher total steps per day, Mr. Moore said. “Initial increase in sporadic steps corresponded to the greatest reductions in mortality,” with a HR of 0.69 per additional sporadic steps below 3,200 per day, and the impact on reduced mortality plateaued at about 4,500 sporadic steps per day.
In further analysis, the researchers also found a roughly 32% decrease in death in participants who took more than 2,000 steps daily in uninterrupted bouts (HR, 0.69).
The study findings were limited by several factors, including the relatively short follow-up period and number of events, the assessment of steps at a single time point, and the mostly homogeneous population, Mr. Moore noted. Additional research is needed to assess whether the results are generalizable to men, younger women, and diverse racial and ethnic groups.
However, the results may have implications for public health messaging, he emphasized. The message is that, to impact longevity, the total volume of steps is more important than the type of activity through which they are accumulated.
“You can accumulate your steps through longer bouts of purposeful activity or through everyday behaviors such as walking to your car, taking the stairs, and doing housework,” Mr. Moore concluded.
Find a friend, both of you benefit
On the basis of this study and other available evidence, more steps daily are recommended for everyone, Nieca Goldberg, MD, a cardiologist at New York University Langone Health, said in an interview.
“You can increase minutes of walking and frequency of walking,” she said.
Dr. Goldberg emphasized that you don’t need a fancy app or wearable device to up your steps. She offered some tips to help overcome barriers to putting one foot in front of the other. “Take the steps instead of the elevator. Park your car farther from your destination so you can walk.” Also, you can help yourself and help a friend to better health. “Get a walking buddy so you can encourage each other to walk,” Dr. Goldberg added.
Mr. Moore and Dr. Goldberg had no financial conflicts to disclose. The Women’s Health Study is funded by Brigham and Women’s Hospital; the National Heart, Lung, and Blood Institute; and the National Cancer Institute. Mr. Moore was funded by a grant from the NHLBI but had no other financial conflicts to disclose.
FROM EPI LIFESTYLE 2021
Hospitalists play key role in advance care planning
Advance care planning (ACP) is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences for future medical care, according to Meredith A. MacMartin, MD, director of inpatient palliative care at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H.
ACP “is really about planning for care in advance,” and in many ways, the inpatient setting is uniquely suited to this process, Dr. MacMartin said in a presentation at SHM Converge 2021, the annual conference of the Society of Hospital Medicine. “The key part is the advance part. You want conversations to happen before the care is actually needed,” she said.
Dr. MacMartin emphasized the importance of distinguishing between ACP and advance directives (ADs). ACP is a process, whereas ADs are documentation, “ideally of the content of advance care planning discussions,” she explained. ACP involves discussion about what is important to the patients, their goals, what information is helpful for them, and whether their current care is aligned with their goals, Dr. MacMartin said. ADs might involve a designated power of attorney for health care, a living will, and, in some states, specific clinician-signed orders regarding resuscitation or transport to hospital.
ACP is “more than whether a patient wants CPR [cardiopulmonary resuscitation] or not,” said Dr. MacMartin. ACP matters because it helps ensure that the care a patient receives aligns with the patient’s wishes and values, she said. ACP increases the likelihood that patients will die in their preferred locations, it allows them to discuss their wishes and prepare for decline, and it relieves family members of the burden of decision making, she said. From a hospital perspective, data show that use of an ACP can decrease intensive care unit (ICU) utilization and overall health care costs. “Often, when people are given the opportunity to express their wishes, they get less unnecessary care,” Dr. MacMartin noted.
Although ACP often takes place in an outpatient setting, hospitalists are in a unique position to conduct some ACP conversations with their patients, Dr. MacMartin said. “Hospitalists are available” and are physically present at least once a day, so there is a pragmatic advantage. Also, some data suggest that patients may feel more comfortable having ACP conversations with a hospitalist than with a primary care provider with whom they have a long-standing relationship, Dr. MacMartin added.
Another important advantage of ACP in the hospital setting is that, “as hospitalists, you are the expert on inpatient illness; you know what sick looks like, and you have a unique perspective on prognostication that may be harder to recreate in the outpatient setting,” Dr. MacMartin said.
Barriers to ACP include patient identification, logistics, attitudes
Settings in which ACP is appropriate include those in which a patient is undergoing “sentinel hospitalization,” meaning that the patient is at a transition point in the disease course. Examples are a patient newly diagnosed with metastatic solid cancer, a patient with progressive chronic kidney disease who is considering hemodialysis, or a patient who receives treatment in the ICU for longer than 7 days, Dr. MacMartin said.
Guidelines for identifying patients who might benefit from ACP include the use of the “surprise question” (“would you be surprised if this patient dies in the next year?”) as well as functional status assessments using tools such as the Australia-modified Karnofsky Performance Status or the Eastern Cooperative Oncology Group score, said Dr. MacMartin. Some studies suggest that any hospitalized patient older than 65 years should have an ACP discussion, she added.
Time pressure remains a significant barrier to ACP conversations. Some strategies to overcome this problem include enlisting help from other specialists, particularly social workers, Dr. MacMartin said. Social workers report a higher comfort level for talking to patients about death than any other medical specialty; “this is something they want to be doing,” she said. Also, the possibility of reimbursement may act as a buffer to create more time to have ACP conversations with patients, she noted.
Addressing clinicians’ discomfort with ACP conversations can be “a tougher nut to crack,” Dr. MacMartin acknowledged. Clinicians report that they don’t want to cause their patients distress, and some report that having conversations about end-of-life care is distressing for them as well. Some of these barriers can be overcome with skills training, including use of a prepared guideline or framework to help increase the comfort level for both clinicians and patients, said Dr. MacMartin.
A look ahead: Training strategies and COVID-19 impact
“For hospitalists interested in developing their ACP skills, I highly recommend two resources,” Dr. MacMartin said in an interview. “The Serious Illness Conversation Guide, from Ariadne Labs, is an excellent tool for any clinician to guide discussion about a patient’s goals and values,” she said.
“For clinicians wanting to build or improve their communication, including advance care planning discussions but also topics like responding to patient’s emotions, VitalTalk training offers a deeper dive into core communications skills,” she added.
“If your hospital has a palliative care team, they may also have more local resources available to you. To learn more about billing for ACP discussions, I recommend starting with your institutional billing and coding group, as these practices vary some between practices, and they will be able to provide the best guidance for clinicians. These are new codes that aren’t yet being very widely used so it’s a chance to innovate,” Dr. MacMartin noted.
“The hospital setting is an opportunity for patients to reflect on their health, both present and in the future, with a physician who has expertise in acute illness and prognostication and who is available for discussion on a daily basis during the hospitalization,” Dr. MacMartin emphasized.
As for whether the COVID-19 pandemic has affected ACP in the inpatient setting, the data are limited, but more information is forthcoming, Dr. MacMartin said. “In my personal experience and in talking to colleagues elsewhere, the pandemic has highlighted the need for ACP in some ways, as we have tried to ensure that people who wouldn’t want things like intensive care are identified early,” she said. “I hope that some of the workflows developed to identify patients who should get ACP in the hospital stay in practice and are strengthened over time,” she added.
Dr. MacMartin has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Advance care planning (ACP) is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences for future medical care, according to Meredith A. MacMartin, MD, director of inpatient palliative care at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H.
ACP “is really about planning for care in advance,” and in many ways, the inpatient setting is uniquely suited to this process, Dr. MacMartin said in a presentation at SHM Converge 2021, the annual conference of the Society of Hospital Medicine. “The key part is the advance part. You want conversations to happen before the care is actually needed,” she said.
Dr. MacMartin emphasized the importance of distinguishing between ACP and advance directives (ADs). ACP is a process, whereas ADs are documentation, “ideally of the content of advance care planning discussions,” she explained. ACP involves discussion about what is important to the patients, their goals, what information is helpful for them, and whether their current care is aligned with their goals, Dr. MacMartin said. ADs might involve a designated power of attorney for health care, a living will, and, in some states, specific clinician-signed orders regarding resuscitation or transport to hospital.
ACP is “more than whether a patient wants CPR [cardiopulmonary resuscitation] or not,” said Dr. MacMartin. ACP matters because it helps ensure that the care a patient receives aligns with the patient’s wishes and values, she said. ACP increases the likelihood that patients will die in their preferred locations, it allows them to discuss their wishes and prepare for decline, and it relieves family members of the burden of decision making, she said. From a hospital perspective, data show that use of an ACP can decrease intensive care unit (ICU) utilization and overall health care costs. “Often, when people are given the opportunity to express their wishes, they get less unnecessary care,” Dr. MacMartin noted.
Although ACP often takes place in an outpatient setting, hospitalists are in a unique position to conduct some ACP conversations with their patients, Dr. MacMartin said. “Hospitalists are available” and are physically present at least once a day, so there is a pragmatic advantage. Also, some data suggest that patients may feel more comfortable having ACP conversations with a hospitalist than with a primary care provider with whom they have a long-standing relationship, Dr. MacMartin added.
Another important advantage of ACP in the hospital setting is that, “as hospitalists, you are the expert on inpatient illness; you know what sick looks like, and you have a unique perspective on prognostication that may be harder to recreate in the outpatient setting,” Dr. MacMartin said.
Barriers to ACP include patient identification, logistics, attitudes
Settings in which ACP is appropriate include those in which a patient is undergoing “sentinel hospitalization,” meaning that the patient is at a transition point in the disease course. Examples are a patient newly diagnosed with metastatic solid cancer, a patient with progressive chronic kidney disease who is considering hemodialysis, or a patient who receives treatment in the ICU for longer than 7 days, Dr. MacMartin said.
Guidelines for identifying patients who might benefit from ACP include the use of the “surprise question” (“would you be surprised if this patient dies in the next year?”) as well as functional status assessments using tools such as the Australia-modified Karnofsky Performance Status or the Eastern Cooperative Oncology Group score, said Dr. MacMartin. Some studies suggest that any hospitalized patient older than 65 years should have an ACP discussion, she added.
Time pressure remains a significant barrier to ACP conversations. Some strategies to overcome this problem include enlisting help from other specialists, particularly social workers, Dr. MacMartin said. Social workers report a higher comfort level for talking to patients about death than any other medical specialty; “this is something they want to be doing,” she said. Also, the possibility of reimbursement may act as a buffer to create more time to have ACP conversations with patients, she noted.
Addressing clinicians’ discomfort with ACP conversations can be “a tougher nut to crack,” Dr. MacMartin acknowledged. Clinicians report that they don’t want to cause their patients distress, and some report that having conversations about end-of-life care is distressing for them as well. Some of these barriers can be overcome with skills training, including use of a prepared guideline or framework to help increase the comfort level for both clinicians and patients, said Dr. MacMartin.
A look ahead: Training strategies and COVID-19 impact
“For hospitalists interested in developing their ACP skills, I highly recommend two resources,” Dr. MacMartin said in an interview. “The Serious Illness Conversation Guide, from Ariadne Labs, is an excellent tool for any clinician to guide discussion about a patient’s goals and values,” she said.
“For clinicians wanting to build or improve their communication, including advance care planning discussions but also topics like responding to patient’s emotions, VitalTalk training offers a deeper dive into core communications skills,” she added.
“If your hospital has a palliative care team, they may also have more local resources available to you. To learn more about billing for ACP discussions, I recommend starting with your institutional billing and coding group, as these practices vary some between practices, and they will be able to provide the best guidance for clinicians. These are new codes that aren’t yet being very widely used so it’s a chance to innovate,” Dr. MacMartin noted.
“The hospital setting is an opportunity for patients to reflect on their health, both present and in the future, with a physician who has expertise in acute illness and prognostication and who is available for discussion on a daily basis during the hospitalization,” Dr. MacMartin emphasized.
As for whether the COVID-19 pandemic has affected ACP in the inpatient setting, the data are limited, but more information is forthcoming, Dr. MacMartin said. “In my personal experience and in talking to colleagues elsewhere, the pandemic has highlighted the need for ACP in some ways, as we have tried to ensure that people who wouldn’t want things like intensive care are identified early,” she said. “I hope that some of the workflows developed to identify patients who should get ACP in the hospital stay in practice and are strengthened over time,” she added.
Dr. MacMartin has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Advance care planning (ACP) is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences for future medical care, according to Meredith A. MacMartin, MD, director of inpatient palliative care at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H.
ACP “is really about planning for care in advance,” and in many ways, the inpatient setting is uniquely suited to this process, Dr. MacMartin said in a presentation at SHM Converge 2021, the annual conference of the Society of Hospital Medicine. “The key part is the advance part. You want conversations to happen before the care is actually needed,” she said.
Dr. MacMartin emphasized the importance of distinguishing between ACP and advance directives (ADs). ACP is a process, whereas ADs are documentation, “ideally of the content of advance care planning discussions,” she explained. ACP involves discussion about what is important to the patients, their goals, what information is helpful for them, and whether their current care is aligned with their goals, Dr. MacMartin said. ADs might involve a designated power of attorney for health care, a living will, and, in some states, specific clinician-signed orders regarding resuscitation or transport to hospital.
ACP is “more than whether a patient wants CPR [cardiopulmonary resuscitation] or not,” said Dr. MacMartin. ACP matters because it helps ensure that the care a patient receives aligns with the patient’s wishes and values, she said. ACP increases the likelihood that patients will die in their preferred locations, it allows them to discuss their wishes and prepare for decline, and it relieves family members of the burden of decision making, she said. From a hospital perspective, data show that use of an ACP can decrease intensive care unit (ICU) utilization and overall health care costs. “Often, when people are given the opportunity to express their wishes, they get less unnecessary care,” Dr. MacMartin noted.
Although ACP often takes place in an outpatient setting, hospitalists are in a unique position to conduct some ACP conversations with their patients, Dr. MacMartin said. “Hospitalists are available” and are physically present at least once a day, so there is a pragmatic advantage. Also, some data suggest that patients may feel more comfortable having ACP conversations with a hospitalist than with a primary care provider with whom they have a long-standing relationship, Dr. MacMartin added.
Another important advantage of ACP in the hospital setting is that, “as hospitalists, you are the expert on inpatient illness; you know what sick looks like, and you have a unique perspective on prognostication that may be harder to recreate in the outpatient setting,” Dr. MacMartin said.
Barriers to ACP include patient identification, logistics, attitudes
Settings in which ACP is appropriate include those in which a patient is undergoing “sentinel hospitalization,” meaning that the patient is at a transition point in the disease course. Examples are a patient newly diagnosed with metastatic solid cancer, a patient with progressive chronic kidney disease who is considering hemodialysis, or a patient who receives treatment in the ICU for longer than 7 days, Dr. MacMartin said.
Guidelines for identifying patients who might benefit from ACP include the use of the “surprise question” (“would you be surprised if this patient dies in the next year?”) as well as functional status assessments using tools such as the Australia-modified Karnofsky Performance Status or the Eastern Cooperative Oncology Group score, said Dr. MacMartin. Some studies suggest that any hospitalized patient older than 65 years should have an ACP discussion, she added.
Time pressure remains a significant barrier to ACP conversations. Some strategies to overcome this problem include enlisting help from other specialists, particularly social workers, Dr. MacMartin said. Social workers report a higher comfort level for talking to patients about death than any other medical specialty; “this is something they want to be doing,” she said. Also, the possibility of reimbursement may act as a buffer to create more time to have ACP conversations with patients, she noted.
Addressing clinicians’ discomfort with ACP conversations can be “a tougher nut to crack,” Dr. MacMartin acknowledged. Clinicians report that they don’t want to cause their patients distress, and some report that having conversations about end-of-life care is distressing for them as well. Some of these barriers can be overcome with skills training, including use of a prepared guideline or framework to help increase the comfort level for both clinicians and patients, said Dr. MacMartin.
A look ahead: Training strategies and COVID-19 impact
“For hospitalists interested in developing their ACP skills, I highly recommend two resources,” Dr. MacMartin said in an interview. “The Serious Illness Conversation Guide, from Ariadne Labs, is an excellent tool for any clinician to guide discussion about a patient’s goals and values,” she said.
“For clinicians wanting to build or improve their communication, including advance care planning discussions but also topics like responding to patient’s emotions, VitalTalk training offers a deeper dive into core communications skills,” she added.
“If your hospital has a palliative care team, they may also have more local resources available to you. To learn more about billing for ACP discussions, I recommend starting with your institutional billing and coding group, as these practices vary some between practices, and they will be able to provide the best guidance for clinicians. These are new codes that aren’t yet being very widely used so it’s a chance to innovate,” Dr. MacMartin noted.
“The hospital setting is an opportunity for patients to reflect on their health, both present and in the future, with a physician who has expertise in acute illness and prognostication and who is available for discussion on a daily basis during the hospitalization,” Dr. MacMartin emphasized.
As for whether the COVID-19 pandemic has affected ACP in the inpatient setting, the data are limited, but more information is forthcoming, Dr. MacMartin said. “In my personal experience and in talking to colleagues elsewhere, the pandemic has highlighted the need for ACP in some ways, as we have tried to ensure that people who wouldn’t want things like intensive care are identified early,” she said. “I hope that some of the workflows developed to identify patients who should get ACP in the hospital stay in practice and are strengthened over time,” she added.
Dr. MacMartin has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM SHM CONVERGE 2021