Feature

The U.S. Department of Health and Human Services has approved Colorado’s request to require some private insurers in the state to cover gender-affirming care.

The approval means transgender-related care must be included as part of the essential benefits offered on the state’s Affordable Care Act marketplace, which includes private individual and small group insurance plans. The coverage will start Jan. 1, 2023. Colorado is the first state in the United States to require such coverage.

The HHS notes that gender-affirming treatments to be covered include eye and lid modifications, face tightening, facial bone remodeling for facial feminization, breast/chest construction and reductions, and laser hair removal.

“I am proud to stand with Colorado to remove barriers that have historically made it difficult for transgender people to access health coverage and medical care,” said HHS Secretary Xavier Becerra in a statement.

“Colorado’s expansion of their essential health benefits to include gender-affirming surgery and other treatments is a model for other states to follow, and we invite other states to follow suit,” said Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure in the statement.

Medicaid already covers comprehensive transgender care in Colorado.

The LGBTQ+ advocacy group One Colorado estimated that, thanks to the Affordable Care Act, only 5% of the state’s LGBTQ+ community was uninsured in 2019, compared to 10% in 2011.

However, 34% of transgender respondents to a One Colorado poll in 2018 said they had been denied coverage for an LGBTQ-specific medical service, such as gender-affirming care. Sixty-two percent said that a lack of insurance or limited insurance was a barrier to care; 84% said another barrier was the lack of adequately trained mental and behavioral health professionals.
 

Mental health also covered

The Colorado plan requires individual and small group plans to cover an annual 45- to 60-minute mental health wellness exam with a qualified mental health care practitioner. The visit can include behavioral health screening, education and consultation about healthy lifestyle changes, referrals to mental health treatment, and discussion of potential medication options.

The plans also must cover an additional 15 medications as alternatives to opioids and up to six acupuncture visits annually.

“This plan expands access to mental health services for Coloradans while helping those fighting substance abuse to overcome their addiction,” said Governor Jared Polis in a statement.

“This improves care for Coloradans and ensures that even more Coloradans have access to help when they need it,” he said.

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

The U.S. Department of Health and Human Services has approved Colorado’s request to require some private insurers in the state to cover gender-affirming care.

The approval means transgender-related care must be included as part of the essential benefits offered on the state’s Affordable Care Act marketplace, which includes private individual and small group insurance plans. The coverage will start Jan. 1, 2023. Colorado is the first state in the United States to require such coverage.

The HHS notes that gender-affirming treatments to be covered include eye and lid modifications, face tightening, facial bone remodeling for facial feminization, breast/chest construction and reductions, and laser hair removal.

“I am proud to stand with Colorado to remove barriers that have historically made it difficult for transgender people to access health coverage and medical care,” said HHS Secretary Xavier Becerra in a statement.

“Colorado’s expansion of their essential health benefits to include gender-affirming surgery and other treatments is a model for other states to follow, and we invite other states to follow suit,” said Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure in the statement.

Medicaid already covers comprehensive transgender care in Colorado.

The LGBTQ+ advocacy group One Colorado estimated that, thanks to the Affordable Care Act, only 5% of the state’s LGBTQ+ community was uninsured in 2019, compared to 10% in 2011.

However, 34% of transgender respondents to a One Colorado poll in 2018 said they had been denied coverage for an LGBTQ-specific medical service, such as gender-affirming care. Sixty-two percent said that a lack of insurance or limited insurance was a barrier to care; 84% said another barrier was the lack of adequately trained mental and behavioral health professionals.
 

Mental health also covered

The Colorado plan requires individual and small group plans to cover an annual 45- to 60-minute mental health wellness exam with a qualified mental health care practitioner. The visit can include behavioral health screening, education and consultation about healthy lifestyle changes, referrals to mental health treatment, and discussion of potential medication options.

The plans also must cover an additional 15 medications as alternatives to opioids and up to six acupuncture visits annually.

“This plan expands access to mental health services for Coloradans while helping those fighting substance abuse to overcome their addiction,” said Governor Jared Polis in a statement.

“This improves care for Coloradans and ensures that even more Coloradans have access to help when they need it,” he said.

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

The U.S. Department of Health and Human Services has approved Colorado’s request to require some private insurers in the state to cover gender-affirming care.

The approval means transgender-related care must be included as part of the essential benefits offered on the state’s Affordable Care Act marketplace, which includes private individual and small group insurance plans. The coverage will start Jan. 1, 2023. Colorado is the first state in the United States to require such coverage.

The HHS notes that gender-affirming treatments to be covered include eye and lid modifications, face tightening, facial bone remodeling for facial feminization, breast/chest construction and reductions, and laser hair removal.

“I am proud to stand with Colorado to remove barriers that have historically made it difficult for transgender people to access health coverage and medical care,” said HHS Secretary Xavier Becerra in a statement.

“Colorado’s expansion of their essential health benefits to include gender-affirming surgery and other treatments is a model for other states to follow, and we invite other states to follow suit,” said Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure in the statement.

Medicaid already covers comprehensive transgender care in Colorado.

The LGBTQ+ advocacy group One Colorado estimated that, thanks to the Affordable Care Act, only 5% of the state’s LGBTQ+ community was uninsured in 2019, compared to 10% in 2011.

However, 34% of transgender respondents to a One Colorado poll in 2018 said they had been denied coverage for an LGBTQ-specific medical service, such as gender-affirming care. Sixty-two percent said that a lack of insurance or limited insurance was a barrier to care; 84% said another barrier was the lack of adequately trained mental and behavioral health professionals.
 

Mental health also covered

The Colorado plan requires individual and small group plans to cover an annual 45- to 60-minute mental health wellness exam with a qualified mental health care practitioner. The visit can include behavioral health screening, education and consultation about healthy lifestyle changes, referrals to mental health treatment, and discussion of potential medication options.

The plans also must cover an additional 15 medications as alternatives to opioids and up to six acupuncture visits annually.

“This plan expands access to mental health services for Coloradans while helping those fighting substance abuse to overcome their addiction,” said Governor Jared Polis in a statement.

“This improves care for Coloradans and ensures that even more Coloradans have access to help when they need it,” he said.

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

The World Health Organization and its partners recently released an ambitious plan, Defeating meningitis by 2030: A global road map. The goal is to reduce deaths and disabilities from bacterial meningitis, which kills about 250,000 people annually of the 1.2 million estimated to be infected.

This type of infection around the brain and spinal cord also causes long-term disabilities – deafness, learning problems, seizures, loss of limbs – in about one-quarter of survivors.

The leading causes of bacterial meningitis are Neisseria meningitidis (meningococcus), Streptococcus pneumoniae (pneumococcus), Haemophilus influenzae, and group B streptococcus. As with malaria, about half of the cases are in children under age 5 years. The most severely affected area for both infections is sub-Saharan Africa.

The main goal of the roadmap is to reduce vaccine-preventable cases of bacterial meningitis by 50% and deaths by 70% by 2030. WHO’s partners included the Centers for Disease Control and Prevention, the London School of Hygiene and Tropical Medicine, Médecins Sans Frontières (Doctors Without Borders), the Meningitis Research Foundation, PATH, UNICEF, and numerous global consultants.

For primary prevention and epidemic control, a major goal is to achieve higher vaccine coverage. Another goal is developing and deploying rapid diagnostic tests to guide treatment and prevention activities and measure the impact of vaccination. The lack of laboratory capacity to confirm the bacteria is a significant challenge. Also, patients often receive antibiotics before appropriate tests are conducted, and lumbar punctures are frequently not done.

The commitment to this project emerged in 2017. It was followed by a baseline analysis in 2018 and a draft roadmap the following year. Consultations with experts and with more than 600 patient groups in more than 90 countries followed.

Prevention through greater vaccine uptake was the top priority. Vaccination is considered the first line of defense against antibiotic resistance among the targeted bacteria.

Another goal is to quantify the decrease in antibiotic use for invasive infections or prophylaxis and the subsequent reduction in antimicrobial resistance in relation to increased vaccination.

Surveillance is weak in many regions, limiting the ability to detect epidemics and to respond appropriately. Similarly, there are limited data on the burden of sequelae, such as deafness, on meningitis survivors.

There is an inadequate supply of affordable vaccines to respond to epidemics.  Currently, routine vaccination against Neisseria meningitidis is occurring in 18 of 26 countries in the meningitis belt. Epidemics of meningococcus occur every few years in the driest time of the year and abate with the rains. Epidemics of pneumococcal meningitis are much rarer but follow a similar pattern; they have also been associated with crowding and alcohol use.

Care for those affected by meningitis is another focus, as is affirming the right to prevention and care. There’s a need for earlier recognition of the complications of meningitis and an increase in efforts to treat those complications.

WHO’s final goal in its roadmap is to boost awareness of meningitis and make it a priority for policymakers. Similarly, there is a need to educate communities about the disease, including how to access vaccines. If someone becomes ill, they need to be aware of the symptoms, the need for early treatment, and what aftercare is available.

Marie-Pierre Préziosi, MD, the core secretariat of WHO’s Technical Taskforce, told this news organization that while the roadmap looks aspirational, “it is feasible … you have strategic goals – each has milestones with time limits and who will do it.”

Regarding vaccinations, Dr. Préziosi said that “the strategy was a victim of its success. The mass campaign knocked down transmission completely.” Some countries are now waiting for multivalent vaccines. She said that vaccine hesitancy is not a significant problem in Africa “because the disease is so feared.”

Major obstacles to implementing the roadmap include the complacency of public health leaders and the COVID-19 lockdowns, which decreased vaccination coverage rates. “The second thing is also sufficient funding to do the research and innovation so that we get the affordable tools that we need globally,” Dr. Préziosi said.

Marilyn Felkner, DrPH, School of Human Ecology, University of Texas at Austin, said in an interview, “It’s very cliché, but we have often said that communicable diseases do not respect political boundaries. So to expect a country to be able to control that by themselves is a false hope.”

Regarding the roadmap, Dr. Felkner said, “I think that organizing ideas and having them in writing is always a good first step. And it can help people move forward if they’re feeling overwhelmed ... Having a written plan can certainly provide that fundamental basis. So, the important thing is not to say, ‘Oh, we have this great plan done; hope somebody picks up the plan.’ There’s got to be some momentum behind it, and hopefully some funding.”

Dr. Préziosi and Dr. Felkner have disclosed no relevant financial relationships.

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

The World Health Organization and its partners recently released an ambitious plan, Defeating meningitis by 2030: A global road map. The goal is to reduce deaths and disabilities from bacterial meningitis, which kills about 250,000 people annually of the 1.2 million estimated to be infected.

This type of infection around the brain and spinal cord also causes long-term disabilities – deafness, learning problems, seizures, loss of limbs – in about one-quarter of survivors.

The leading causes of bacterial meningitis are Neisseria meningitidis (meningococcus), Streptococcus pneumoniae (pneumococcus), Haemophilus influenzae, and group B streptococcus. As with malaria, about half of the cases are in children under age 5 years. The most severely affected area for both infections is sub-Saharan Africa.

The main goal of the roadmap is to reduce vaccine-preventable cases of bacterial meningitis by 50% and deaths by 70% by 2030. WHO’s partners included the Centers for Disease Control and Prevention, the London School of Hygiene and Tropical Medicine, Médecins Sans Frontières (Doctors Without Borders), the Meningitis Research Foundation, PATH, UNICEF, and numerous global consultants.

For primary prevention and epidemic control, a major goal is to achieve higher vaccine coverage. Another goal is developing and deploying rapid diagnostic tests to guide treatment and prevention activities and measure the impact of vaccination. The lack of laboratory capacity to confirm the bacteria is a significant challenge. Also, patients often receive antibiotics before appropriate tests are conducted, and lumbar punctures are frequently not done.

The commitment to this project emerged in 2017. It was followed by a baseline analysis in 2018 and a draft roadmap the following year. Consultations with experts and with more than 600 patient groups in more than 90 countries followed.

Prevention through greater vaccine uptake was the top priority. Vaccination is considered the first line of defense against antibiotic resistance among the targeted bacteria.

Another goal is to quantify the decrease in antibiotic use for invasive infections or prophylaxis and the subsequent reduction in antimicrobial resistance in relation to increased vaccination.

Surveillance is weak in many regions, limiting the ability to detect epidemics and to respond appropriately. Similarly, there are limited data on the burden of sequelae, such as deafness, on meningitis survivors.

There is an inadequate supply of affordable vaccines to respond to epidemics.  Currently, routine vaccination against Neisseria meningitidis is occurring in 18 of 26 countries in the meningitis belt. Epidemics of meningococcus occur every few years in the driest time of the year and abate with the rains. Epidemics of pneumococcal meningitis are much rarer but follow a similar pattern; they have also been associated with crowding and alcohol use.

Care for those affected by meningitis is another focus, as is affirming the right to prevention and care. There’s a need for earlier recognition of the complications of meningitis and an increase in efforts to treat those complications.

WHO’s final goal in its roadmap is to boost awareness of meningitis and make it a priority for policymakers. Similarly, there is a need to educate communities about the disease, including how to access vaccines. If someone becomes ill, they need to be aware of the symptoms, the need for early treatment, and what aftercare is available.

Marie-Pierre Préziosi, MD, the core secretariat of WHO’s Technical Taskforce, told this news organization that while the roadmap looks aspirational, “it is feasible … you have strategic goals – each has milestones with time limits and who will do it.”

Regarding vaccinations, Dr. Préziosi said that “the strategy was a victim of its success. The mass campaign knocked down transmission completely.” Some countries are now waiting for multivalent vaccines. She said that vaccine hesitancy is not a significant problem in Africa “because the disease is so feared.”

Major obstacles to implementing the roadmap include the complacency of public health leaders and the COVID-19 lockdowns, which decreased vaccination coverage rates. “The second thing is also sufficient funding to do the research and innovation so that we get the affordable tools that we need globally,” Dr. Préziosi said.

Marilyn Felkner, DrPH, School of Human Ecology, University of Texas at Austin, said in an interview, “It’s very cliché, but we have often said that communicable diseases do not respect political boundaries. So to expect a country to be able to control that by themselves is a false hope.”

Regarding the roadmap, Dr. Felkner said, “I think that organizing ideas and having them in writing is always a good first step. And it can help people move forward if they’re feeling overwhelmed ... Having a written plan can certainly provide that fundamental basis. So, the important thing is not to say, ‘Oh, we have this great plan done; hope somebody picks up the plan.’ There’s got to be some momentum behind it, and hopefully some funding.”

Dr. Préziosi and Dr. Felkner have disclosed no relevant financial relationships.

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

The World Health Organization and its partners recently released an ambitious plan, Defeating meningitis by 2030: A global road map. The goal is to reduce deaths and disabilities from bacterial meningitis, which kills about 250,000 people annually of the 1.2 million estimated to be infected.

This type of infection around the brain and spinal cord also causes long-term disabilities – deafness, learning problems, seizures, loss of limbs – in about one-quarter of survivors.

The leading causes of bacterial meningitis are Neisseria meningitidis (meningococcus), Streptococcus pneumoniae (pneumococcus), Haemophilus influenzae, and group B streptococcus. As with malaria, about half of the cases are in children under age 5 years. The most severely affected area for both infections is sub-Saharan Africa.

The main goal of the roadmap is to reduce vaccine-preventable cases of bacterial meningitis by 50% and deaths by 70% by 2030. WHO’s partners included the Centers for Disease Control and Prevention, the London School of Hygiene and Tropical Medicine, Médecins Sans Frontières (Doctors Without Borders), the Meningitis Research Foundation, PATH, UNICEF, and numerous global consultants.

For primary prevention and epidemic control, a major goal is to achieve higher vaccine coverage. Another goal is developing and deploying rapid diagnostic tests to guide treatment and prevention activities and measure the impact of vaccination. The lack of laboratory capacity to confirm the bacteria is a significant challenge. Also, patients often receive antibiotics before appropriate tests are conducted, and lumbar punctures are frequently not done.

The commitment to this project emerged in 2017. It was followed by a baseline analysis in 2018 and a draft roadmap the following year. Consultations with experts and with more than 600 patient groups in more than 90 countries followed.

Prevention through greater vaccine uptake was the top priority. Vaccination is considered the first line of defense against antibiotic resistance among the targeted bacteria.

Another goal is to quantify the decrease in antibiotic use for invasive infections or prophylaxis and the subsequent reduction in antimicrobial resistance in relation to increased vaccination.

Surveillance is weak in many regions, limiting the ability to detect epidemics and to respond appropriately. Similarly, there are limited data on the burden of sequelae, such as deafness, on meningitis survivors.

There is an inadequate supply of affordable vaccines to respond to epidemics.  Currently, routine vaccination against Neisseria meningitidis is occurring in 18 of 26 countries in the meningitis belt. Epidemics of meningococcus occur every few years in the driest time of the year and abate with the rains. Epidemics of pneumococcal meningitis are much rarer but follow a similar pattern; they have also been associated with crowding and alcohol use.

Care for those affected by meningitis is another focus, as is affirming the right to prevention and care. There’s a need for earlier recognition of the complications of meningitis and an increase in efforts to treat those complications.

WHO’s final goal in its roadmap is to boost awareness of meningitis and make it a priority for policymakers. Similarly, there is a need to educate communities about the disease, including how to access vaccines. If someone becomes ill, they need to be aware of the symptoms, the need for early treatment, and what aftercare is available.

Marie-Pierre Préziosi, MD, the core secretariat of WHO’s Technical Taskforce, told this news organization that while the roadmap looks aspirational, “it is feasible … you have strategic goals – each has milestones with time limits and who will do it.”

Regarding vaccinations, Dr. Préziosi said that “the strategy was a victim of its success. The mass campaign knocked down transmission completely.” Some countries are now waiting for multivalent vaccines. She said that vaccine hesitancy is not a significant problem in Africa “because the disease is so feared.”

Major obstacles to implementing the roadmap include the complacency of public health leaders and the COVID-19 lockdowns, which decreased vaccination coverage rates. “The second thing is also sufficient funding to do the research and innovation so that we get the affordable tools that we need globally,” Dr. Préziosi said.

Marilyn Felkner, DrPH, School of Human Ecology, University of Texas at Austin, said in an interview, “It’s very cliché, but we have often said that communicable diseases do not respect political boundaries. So to expect a country to be able to control that by themselves is a false hope.”

Regarding the roadmap, Dr. Felkner said, “I think that organizing ideas and having them in writing is always a good first step. And it can help people move forward if they’re feeling overwhelmed ... Having a written plan can certainly provide that fundamental basis. So, the important thing is not to say, ‘Oh, we have this great plan done; hope somebody picks up the plan.’ There’s got to be some momentum behind it, and hopefully some funding.”

Dr. Préziosi and Dr. Felkner have disclosed no relevant financial relationships.

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

In the fall of 2020, Hassane M. Zarour, MD, and colleagues began to pore over raw data from their phase 1 clinical trial designed to determine if fecal microbiota transplantation (FMT) could reprogram the gut microbiome in advanced melanoma patients who failed to respond to anti–programmed death 1immunotherapy.

Preclinical mouse studies have demonstrated that the gut microbiota could influence the response of tumors to anti–PD-1 immunotherapy, but FMT had not been previously evaluated in human patients with malignant melanoma whose disease persisted or progressed after medical therapy. Only 30%-40% of melanoma patients respond to anti–PD-1 immunotherapy, so the researchers’ sense of anticipation was palpable. “It’s a high-risk, high-reward study, so you never know,” Dr. Zarour, a dermatologist and immunologist who is coleader of the melanoma program at the University of Pittsburgh Medical Center’s Hillman Cancer Center, said in an interview.

For the study, which was funded by the National Institutes of Health and published in Science, Dr. Zarour and a team of colleagues, including Diwakar Davar, MD, a medical oncologist/hematologist at UPMC and Giorgio Trinchieri, MD, head of the cancer immunology section at the National Cancer Institute, enrolled 16 patients with advanced melanoma whose disease had persisted or progressed with anti-PD-1 drugs; donors were 7 patients with advanced melanoma who had responded to pembrolizumab, 4 with a complete response and 3 with a partial response, with a median progression-free survival of 56 months.

After donors and patients underwent serial stool sampling and studies to stamp out the potential for transmitting infectious agents, the researchers administered the donor-derived FMT to patients via colonoscopy every 14 days for 3 weeks, followed by pembrolizumab. To their delight, 6 of the 15 evaluable recipients responded to treatment, with a reduction in tumor or long-term disease stabilization. Moreover, responders also showed increased abundance of taxa that were previously associated with response to immunotherapy, increased activation of CD8+ T cells, and decreased frequency of interleukin-8–expressing myeloid cells.

“This opens new doors for the future,” Dr. Zarour said. “It’s very encouraging, but I don’t want to overstate the data. It’s a small, nonrandomized trial, but one has to keep in mind that people were skeptical about this work; they didn’t think FMT would work. Now we see many people coming into the field to investigate the role of the microbiome as a therapeutic tool, which is great.”

Teri Greiling, MD, characterized the finding as a key development in understanding the microbiome’s potential to influence the course of melanoma and other diseases. “What’s emerging over the last decade of research is that our immune system has a close, back-and-forth relationship with our microbiota,” said Dr. Greiling, associate professor of dermatology at Oregon Health & Science University, Portland. “From day 1 of birth, we’re colonized by microbes that train our immune system how to function. In response, your immune system keeps those microbes in check and shapes which ones are allowed to colonize, and which ones are a target for attack. Thus, inflammatory responses are generated. Similarly, the goal of immunotherapy is to activate the immune system to fight cancer. This study shows that the immune system continues to need the colonizing microbes in our body to function optimally.”

Immunotherapy with checkpoint inhibitors was not an option for malignant melanoma patients until 2011, she noted, so the potential for FMT to further improve outcomes is welcome news for patients and their families. “We went from a less than 5% chance of survival with metastatic melanoma to now, with the right combination of checkpoint inhibitors, we’re up over 50%, which is amazing in a decade,” Dr. Greiling said. “Still, we’re losing half of our patients. If [FMT provides] a 30% improvement over that, that would be great, but it’s hard to extrapolate from such small numbers.”
 

Positive results in an Israeli study

Results from a similar, smaller phase 1 trial of 2 FMT donors and 10 recipients with metastatic melanoma who had progressed on anti-PD-1 therapy, from the Ella Lemelbaum Institute for Immuno-Oncology at Sheba Medical Center in Tel HaShomer, Israel, yielded similar results. The FMT protocol in this study included colonoscopy and oral stool capsules, followed by the reintroduction of anti–PD-1 therapy with nivolumab. The two FMT donors had previously been treated with anti–PD-1 monotherapy for metastatic melanoma and had achieved a clinical response for at least 1 year. Of the 10 FMT recipients, 1 had a complete response and 2 had a partial response.

“We expected changes in the immune system but did not expect that 3 out of the 10 patients in our study would be turned from nonresponders to responders,” the study’s lead author, Erez N. Baruch, MD, PhD, told this news organization. “Since this was a first-in-human study, we were aiming to assess safety and not clinical responses. [We found] that microbiota modulation can change the immune infiltration within melanoma tumors and by this affect response to immunotherapy.”

Dr. Baruch, an internal medicine resident in the physician-scientist track program at the University of Texas, Houston, said that the findings create a potential new therapeutic paradigm, or a new “playing ground” for drug development that can support existing immunotherapies. “It is important for dermatologists to understand that disruptions of the gut microbiota, mainly by antibiotics, may be harmful to melanoma patients,” he said. “Antibiotics in cancer patients should be used judiciously but of course should not be avoided when there’s an indication.”

As for next steps, Dr. Zarour and colleagues are recruiting more patients to boost their sample size and conducting sequential analysis of the microbiome of study participants “to better determine what the good and bad bugs are,” he said. “There are so many variables, including diet and geography. We need more data.” The hope is to develop a “microbiome signature” to identify patients likely to respond to FMT, and maybe one day, a probiotic capsule that patients take to optimize their response to immunotherapy.

“We don’t want to say that the microbiome is responsible for everything, but it’s responsible for some of the response and some of the resistance to treatment,” Dr. Zarour said. “So, we want to identify what candidate nonresponders are more likely to respond to FMT and be able to stick the right stool in the donor. This goes to better education of the microbiome signature. We are working hard on that.”

Dr. Baruch added that performing FMT for melanoma patients requires tight collaborations between oncologists, dermatologists, GI, and infectious disease experts. “These usually can be done in the setting of large cancer centers and will probably not be available in any hospital,” he said. “This is why understanding the mechanisms and developing an FMT-like drug is important. We are focusing on studying the mechanisms behind the clinical effect in order to develop a drug with an FMT-like effect without the safety and logistic issues related to FMTs.”

Studies raise more questions

In the opinion of Dr. Greiling, results from these two studies raise more questions than they answer. “The big question ... is why and how does FMT work, and how can we make the response better?” she said. “Is there one particular gene product from one microbe that is the key magic ingredient, and we can harness this as a drug? More likely it’s a complex interplay between multiple bacterial species needed to direct the immune response. Is there a group of microbes that is the same from person to person, or is it more complex?”

Then there are pending regulatory concerns. “We know that FMT works for [Clostridioides] difficile colitis but it’s not officially [Food and Drug Administration] approved,” Dr. Greiling said. “The FDA is really struggling with how to approve or regulate using bacteria as a drug. Where is that crossover? That inhibits things moving forward, for good reason. You want to balance safety with live microbes.”

The UPMC clinical trial was supported by Merck. Dr. Zarour disclosed that he is supported by grants from the National Cancer Institute and the James W. and Frances G. McGlothlin Chair in Melanoma Immunotherapy Research at UPMC. The Israeli study was funded by the Ella Lemelbaum Institute for Immuno-Oncology. Dr. Baruch was supported by the Allen Berg Fund for Excellence in Immuno-Oncology Research. Dr. Greiling and Dr. Harris-Tryon reported having no relevant financial disclosures.

dbrunk@mdedge.com

In the fall of 2020, Hassane M. Zarour, MD, and colleagues began to pore over raw data from their phase 1 clinical trial designed to determine if fecal microbiota transplantation (FMT) could reprogram the gut microbiome in advanced melanoma patients who failed to respond to anti–programmed death 1immunotherapy.

Preclinical mouse studies have demonstrated that the gut microbiota could influence the response of tumors to anti–PD-1 immunotherapy, but FMT had not been previously evaluated in human patients with malignant melanoma whose disease persisted or progressed after medical therapy. Only 30%-40% of melanoma patients respond to anti–PD-1 immunotherapy, so the researchers’ sense of anticipation was palpable. “It’s a high-risk, high-reward study, so you never know,” Dr. Zarour, a dermatologist and immunologist who is coleader of the melanoma program at the University of Pittsburgh Medical Center’s Hillman Cancer Center, said in an interview.

For the study, which was funded by the National Institutes of Health and published in Science, Dr. Zarour and a team of colleagues, including Diwakar Davar, MD, a medical oncologist/hematologist at UPMC and Giorgio Trinchieri, MD, head of the cancer immunology section at the National Cancer Institute, enrolled 16 patients with advanced melanoma whose disease had persisted or progressed with anti-PD-1 drugs; donors were 7 patients with advanced melanoma who had responded to pembrolizumab, 4 with a complete response and 3 with a partial response, with a median progression-free survival of 56 months.

After donors and patients underwent serial stool sampling and studies to stamp out the potential for transmitting infectious agents, the researchers administered the donor-derived FMT to patients via colonoscopy every 14 days for 3 weeks, followed by pembrolizumab. To their delight, 6 of the 15 evaluable recipients responded to treatment, with a reduction in tumor or long-term disease stabilization. Moreover, responders also showed increased abundance of taxa that were previously associated with response to immunotherapy, increased activation of CD8+ T cells, and decreased frequency of interleukin-8–expressing myeloid cells.

“This opens new doors for the future,” Dr. Zarour said. “It’s very encouraging, but I don’t want to overstate the data. It’s a small, nonrandomized trial, but one has to keep in mind that people were skeptical about this work; they didn’t think FMT would work. Now we see many people coming into the field to investigate the role of the microbiome as a therapeutic tool, which is great.”

Teri Greiling, MD, characterized the finding as a key development in understanding the microbiome’s potential to influence the course of melanoma and other diseases. “What’s emerging over the last decade of research is that our immune system has a close, back-and-forth relationship with our microbiota,” said Dr. Greiling, associate professor of dermatology at Oregon Health & Science University, Portland. “From day 1 of birth, we’re colonized by microbes that train our immune system how to function. In response, your immune system keeps those microbes in check and shapes which ones are allowed to colonize, and which ones are a target for attack. Thus, inflammatory responses are generated. Similarly, the goal of immunotherapy is to activate the immune system to fight cancer. This study shows that the immune system continues to need the colonizing microbes in our body to function optimally.”

Immunotherapy with checkpoint inhibitors was not an option for malignant melanoma patients until 2011, she noted, so the potential for FMT to further improve outcomes is welcome news for patients and their families. “We went from a less than 5% chance of survival with metastatic melanoma to now, with the right combination of checkpoint inhibitors, we’re up over 50%, which is amazing in a decade,” Dr. Greiling said. “Still, we’re losing half of our patients. If [FMT provides] a 30% improvement over that, that would be great, but it’s hard to extrapolate from such small numbers.”
 

Positive results in an Israeli study

Results from a similar, smaller phase 1 trial of 2 FMT donors and 10 recipients with metastatic melanoma who had progressed on anti-PD-1 therapy, from the Ella Lemelbaum Institute for Immuno-Oncology at Sheba Medical Center in Tel HaShomer, Israel, yielded similar results. The FMT protocol in this study included colonoscopy and oral stool capsules, followed by the reintroduction of anti–PD-1 therapy with nivolumab. The two FMT donors had previously been treated with anti–PD-1 monotherapy for metastatic melanoma and had achieved a clinical response for at least 1 year. Of the 10 FMT recipients, 1 had a complete response and 2 had a partial response.

“We expected changes in the immune system but did not expect that 3 out of the 10 patients in our study would be turned from nonresponders to responders,” the study’s lead author, Erez N. Baruch, MD, PhD, told this news organization. “Since this was a first-in-human study, we were aiming to assess safety and not clinical responses. [We found] that microbiota modulation can change the immune infiltration within melanoma tumors and by this affect response to immunotherapy.”

Dr. Baruch, an internal medicine resident in the physician-scientist track program at the University of Texas, Houston, said that the findings create a potential new therapeutic paradigm, or a new “playing ground” for drug development that can support existing immunotherapies. “It is important for dermatologists to understand that disruptions of the gut microbiota, mainly by antibiotics, may be harmful to melanoma patients,” he said. “Antibiotics in cancer patients should be used judiciously but of course should not be avoided when there’s an indication.”

As for next steps, Dr. Zarour and colleagues are recruiting more patients to boost their sample size and conducting sequential analysis of the microbiome of study participants “to better determine what the good and bad bugs are,” he said. “There are so many variables, including diet and geography. We need more data.” The hope is to develop a “microbiome signature” to identify patients likely to respond to FMT, and maybe one day, a probiotic capsule that patients take to optimize their response to immunotherapy.

“We don’t want to say that the microbiome is responsible for everything, but it’s responsible for some of the response and some of the resistance to treatment,” Dr. Zarour said. “So, we want to identify what candidate nonresponders are more likely to respond to FMT and be able to stick the right stool in the donor. This goes to better education of the microbiome signature. We are working hard on that.”

Dr. Baruch added that performing FMT for melanoma patients requires tight collaborations between oncologists, dermatologists, GI, and infectious disease experts. “These usually can be done in the setting of large cancer centers and will probably not be available in any hospital,” he said. “This is why understanding the mechanisms and developing an FMT-like drug is important. We are focusing on studying the mechanisms behind the clinical effect in order to develop a drug with an FMT-like effect without the safety and logistic issues related to FMTs.”

Studies raise more questions

In the opinion of Dr. Greiling, results from these two studies raise more questions than they answer. “The big question ... is why and how does FMT work, and how can we make the response better?” she said. “Is there one particular gene product from one microbe that is the key magic ingredient, and we can harness this as a drug? More likely it’s a complex interplay between multiple bacterial species needed to direct the immune response. Is there a group of microbes that is the same from person to person, or is it more complex?”

Then there are pending regulatory concerns. “We know that FMT works for [Clostridioides] difficile colitis but it’s not officially [Food and Drug Administration] approved,” Dr. Greiling said. “The FDA is really struggling with how to approve or regulate using bacteria as a drug. Where is that crossover? That inhibits things moving forward, for good reason. You want to balance safety with live microbes.”

The UPMC clinical trial was supported by Merck. Dr. Zarour disclosed that he is supported by grants from the National Cancer Institute and the James W. and Frances G. McGlothlin Chair in Melanoma Immunotherapy Research at UPMC. The Israeli study was funded by the Ella Lemelbaum Institute for Immuno-Oncology. Dr. Baruch was supported by the Allen Berg Fund for Excellence in Immuno-Oncology Research. Dr. Greiling and Dr. Harris-Tryon reported having no relevant financial disclosures.

dbrunk@mdedge.com

In the fall of 2020, Hassane M. Zarour, MD, and colleagues began to pore over raw data from their phase 1 clinical trial designed to determine if fecal microbiota transplantation (FMT) could reprogram the gut microbiome in advanced melanoma patients who failed to respond to anti–programmed death 1immunotherapy.

Preclinical mouse studies have demonstrated that the gut microbiota could influence the response of tumors to anti–PD-1 immunotherapy, but FMT had not been previously evaluated in human patients with malignant melanoma whose disease persisted or progressed after medical therapy. Only 30%-40% of melanoma patients respond to anti–PD-1 immunotherapy, so the researchers’ sense of anticipation was palpable. “It’s a high-risk, high-reward study, so you never know,” Dr. Zarour, a dermatologist and immunologist who is coleader of the melanoma program at the University of Pittsburgh Medical Center’s Hillman Cancer Center, said in an interview.

For the study, which was funded by the National Institutes of Health and published in Science, Dr. Zarour and a team of colleagues, including Diwakar Davar, MD, a medical oncologist/hematologist at UPMC and Giorgio Trinchieri, MD, head of the cancer immunology section at the National Cancer Institute, enrolled 16 patients with advanced melanoma whose disease had persisted or progressed with anti-PD-1 drugs; donors were 7 patients with advanced melanoma who had responded to pembrolizumab, 4 with a complete response and 3 with a partial response, with a median progression-free survival of 56 months.

After donors and patients underwent serial stool sampling and studies to stamp out the potential for transmitting infectious agents, the researchers administered the donor-derived FMT to patients via colonoscopy every 14 days for 3 weeks, followed by pembrolizumab. To their delight, 6 of the 15 evaluable recipients responded to treatment, with a reduction in tumor or long-term disease stabilization. Moreover, responders also showed increased abundance of taxa that were previously associated with response to immunotherapy, increased activation of CD8+ T cells, and decreased frequency of interleukin-8–expressing myeloid cells.

“This opens new doors for the future,” Dr. Zarour said. “It’s very encouraging, but I don’t want to overstate the data. It’s a small, nonrandomized trial, but one has to keep in mind that people were skeptical about this work; they didn’t think FMT would work. Now we see many people coming into the field to investigate the role of the microbiome as a therapeutic tool, which is great.”

Teri Greiling, MD, characterized the finding as a key development in understanding the microbiome’s potential to influence the course of melanoma and other diseases. “What’s emerging over the last decade of research is that our immune system has a close, back-and-forth relationship with our microbiota,” said Dr. Greiling, associate professor of dermatology at Oregon Health & Science University, Portland. “From day 1 of birth, we’re colonized by microbes that train our immune system how to function. In response, your immune system keeps those microbes in check and shapes which ones are allowed to colonize, and which ones are a target for attack. Thus, inflammatory responses are generated. Similarly, the goal of immunotherapy is to activate the immune system to fight cancer. This study shows that the immune system continues to need the colonizing microbes in our body to function optimally.”

Immunotherapy with checkpoint inhibitors was not an option for malignant melanoma patients until 2011, she noted, so the potential for FMT to further improve outcomes is welcome news for patients and their families. “We went from a less than 5% chance of survival with metastatic melanoma to now, with the right combination of checkpoint inhibitors, we’re up over 50%, which is amazing in a decade,” Dr. Greiling said. “Still, we’re losing half of our patients. If [FMT provides] a 30% improvement over that, that would be great, but it’s hard to extrapolate from such small numbers.”
 

Positive results in an Israeli study

Results from a similar, smaller phase 1 trial of 2 FMT donors and 10 recipients with metastatic melanoma who had progressed on anti-PD-1 therapy, from the Ella Lemelbaum Institute for Immuno-Oncology at Sheba Medical Center in Tel HaShomer, Israel, yielded similar results. The FMT protocol in this study included colonoscopy and oral stool capsules, followed by the reintroduction of anti–PD-1 therapy with nivolumab. The two FMT donors had previously been treated with anti–PD-1 monotherapy for metastatic melanoma and had achieved a clinical response for at least 1 year. Of the 10 FMT recipients, 1 had a complete response and 2 had a partial response.

“We expected changes in the immune system but did not expect that 3 out of the 10 patients in our study would be turned from nonresponders to responders,” the study’s lead author, Erez N. Baruch, MD, PhD, told this news organization. “Since this was a first-in-human study, we were aiming to assess safety and not clinical responses. [We found] that microbiota modulation can change the immune infiltration within melanoma tumors and by this affect response to immunotherapy.”

Dr. Baruch, an internal medicine resident in the physician-scientist track program at the University of Texas, Houston, said that the findings create a potential new therapeutic paradigm, or a new “playing ground” for drug development that can support existing immunotherapies. “It is important for dermatologists to understand that disruptions of the gut microbiota, mainly by antibiotics, may be harmful to melanoma patients,” he said. “Antibiotics in cancer patients should be used judiciously but of course should not be avoided when there’s an indication.”

As for next steps, Dr. Zarour and colleagues are recruiting more patients to boost their sample size and conducting sequential analysis of the microbiome of study participants “to better determine what the good and bad bugs are,” he said. “There are so many variables, including diet and geography. We need more data.” The hope is to develop a “microbiome signature” to identify patients likely to respond to FMT, and maybe one day, a probiotic capsule that patients take to optimize their response to immunotherapy.

“We don’t want to say that the microbiome is responsible for everything, but it’s responsible for some of the response and some of the resistance to treatment,” Dr. Zarour said. “So, we want to identify what candidate nonresponders are more likely to respond to FMT and be able to stick the right stool in the donor. This goes to better education of the microbiome signature. We are working hard on that.”

Dr. Baruch added that performing FMT for melanoma patients requires tight collaborations between oncologists, dermatologists, GI, and infectious disease experts. “These usually can be done in the setting of large cancer centers and will probably not be available in any hospital,” he said. “This is why understanding the mechanisms and developing an FMT-like drug is important. We are focusing on studying the mechanisms behind the clinical effect in order to develop a drug with an FMT-like effect without the safety and logistic issues related to FMTs.”

Studies raise more questions

In the opinion of Dr. Greiling, results from these two studies raise more questions than they answer. “The big question ... is why and how does FMT work, and how can we make the response better?” she said. “Is there one particular gene product from one microbe that is the key magic ingredient, and we can harness this as a drug? More likely it’s a complex interplay between multiple bacterial species needed to direct the immune response. Is there a group of microbes that is the same from person to person, or is it more complex?”

Then there are pending regulatory concerns. “We know that FMT works for [Clostridioides] difficile colitis but it’s not officially [Food and Drug Administration] approved,” Dr. Greiling said. “The FDA is really struggling with how to approve or regulate using bacteria as a drug. Where is that crossover? That inhibits things moving forward, for good reason. You want to balance safety with live microbes.”

The UPMC clinical trial was supported by Merck. Dr. Zarour disclosed that he is supported by grants from the National Cancer Institute and the James W. and Frances G. McGlothlin Chair in Melanoma Immunotherapy Research at UPMC. The Israeli study was funded by the Ella Lemelbaum Institute for Immuno-Oncology. Dr. Baruch was supported by the Allen Berg Fund for Excellence in Immuno-Oncology Research. Dr. Greiling and Dr. Harris-Tryon reported having no relevant financial disclosures.

dbrunk@mdedge.com

When 23 frail elderly patients in Norway died in early 2021 shortly after they had received an mRNA-based vaccine against COVID-19, Norwegian health authorities cautioned physicians to conduct more thorough assessments of patients prior to immunization, and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).

Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.

“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”

“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.

“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
 

Potential risks

Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.

As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients

Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
 

Health authorities investigate

In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.

They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.

In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).

The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.

The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.

The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.

In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.

“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
 

Population-wide study

Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.

They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.

The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.

Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.

The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.

When 23 frail elderly patients in Norway died in early 2021 shortly after they had received an mRNA-based vaccine against COVID-19, Norwegian health authorities cautioned physicians to conduct more thorough assessments of patients prior to immunization, and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).

Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.

“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”

“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.

“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
 

Potential risks

Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.

As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients

Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
 

Health authorities investigate

In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.

They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.

In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).

The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.

The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.

The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.

In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.

“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
 

Population-wide study

Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.

They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.

The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.

Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.

The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.

When 23 frail elderly patients in Norway died in early 2021 shortly after they had received an mRNA-based vaccine against COVID-19, Norwegian health authorities cautioned physicians to conduct more thorough assessments of patients prior to immunization, and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).

Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.

“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”

“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.

“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
 

Potential risks

Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.

As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients

Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
 

Health authorities investigate

In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.

They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.

In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).

The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.

The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.

The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.

In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.

“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
 

Population-wide study

Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.

They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.

The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.

Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.

The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.

CrossFit, the widely known fitness platform and brand with thousands of affiliated gyms, is moving into primary care with the launch of its newest service, CrossFit Precision Care.

Developed by family medicine physician Julie Foucher, MD, and other CrossFit-trained doctors, the new service aims to help CrossFit members build plans to protect and improve their health, according to a statement by the company.

CrossFit Precision Care plans to meet this goal through utilizing doctors who understand the CrossFit philosophy, individualized care, data-driven recommendations, proactive lifestyle changes, and continual health optimization. Informing these plans and changes are CrossFit Precision Care’s analysis through a few different methods.

CrossFit’s partner in the endeavor, Wild Health, will provide genomic testing to determine a patient’s genetic predispositions to help optimize the health plans. Blood testing reveals many things that may affect a person’s health, such as hormone status, lipid levels, thyroid function, and cardiovascular risks. An overall lifestyle review includes exercise routines, eating habits, social life, and other patterns or behaviors.
 

Connecting with doctors who understand CrossFit

Dr. Foucher is no stranger to CrossFit. She has competed in the CrossFit Games four times and discusses the sport regularly on Twitter and Instagram. Now, she works directly with CrossFit to help it provide users with individualized data-driven plans.

“I met Eric Roza last July,” Dr. Foucher says of CrossFit’s CEO. “We talked and saw a lot of potential for CrossFit and health care providers to work together, so we started brainstorming.”

When Dr. Foucher and Mr. Roza got to know Wild Health, specifically, two of its physician cofounders, it was a natural fit, she said. Dr. Foucher says that many who train in CrossFit or go to CrossFit-affiliated gyms feel a disconnect with their family doctors: “[CrossFit is] a pretty polarizing topic, but there are also a lot of doctors who know that people are having health improvements with these programs,” she said.

Through use of Wild Health’s precision services and algorithms, CrossFit Precision Care plans to connect its users with CrossFit-trained health care practitioners. This personalized approach allows health care practitioners to build closer relationships with users of the program, who may feel more comfortable working with doctors who understand their lifestyle. Wild Health’s precision medicine approach, with trackable data such as biomarker status and risk scores, gives doctors a more complete picture of a patient’s needs and history, according to a statement on the partnership.
 

A better use of data

“To me,” Dr. Foucher says of family medicine, “that was the best option coming out of residency. It was consistent with my morals.” She says much of the current health care system is algorithm based. If a patient is experiencing certain symptoms, treatment is recommended on the basis of whatever yields the best results from the data – but this doesn’t always factor in a patient’s full history and genetics. It can be difficult for doctors to build trusting and personal relationships with patients. “In our current system, there’s not a lot of time or great tools to do that,” she says.

With the approach Wild Health and CrossFit Precision Care both use, however, Dr. Foucher says she sees a huge opportunity for optimizing patient and health care practitioner relationships.

“I see huge potential here, and I really think that this should be the standard for primary care going forwards,” Dr. Foucher explains. “The nice thing about [this approach] is that it has a really quick learning curve and is relatively easy to implement with patients. Before Wild Health optimized it, the tech and data would take about 10 hours per patient to put together. But now, we can incorporate things that work with wearable tech and track results over time and allow the patient and doctor to use this platform to create relationships. And this is something that can scale to many more patients.”

According to its website, CrossFit Precision Care is currently launching an invite-only beta test version of the program in eight states ahead of an expected national release.

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

CrossFit, the widely known fitness platform and brand with thousands of affiliated gyms, is moving into primary care with the launch of its newest service, CrossFit Precision Care.

Developed by family medicine physician Julie Foucher, MD, and other CrossFit-trained doctors, the new service aims to help CrossFit members build plans to protect and improve their health, according to a statement by the company.

CrossFit Precision Care plans to meet this goal through utilizing doctors who understand the CrossFit philosophy, individualized care, data-driven recommendations, proactive lifestyle changes, and continual health optimization. Informing these plans and changes are CrossFit Precision Care’s analysis through a few different methods.

CrossFit’s partner in the endeavor, Wild Health, will provide genomic testing to determine a patient’s genetic predispositions to help optimize the health plans. Blood testing reveals many things that may affect a person’s health, such as hormone status, lipid levels, thyroid function, and cardiovascular risks. An overall lifestyle review includes exercise routines, eating habits, social life, and other patterns or behaviors.
 

Connecting with doctors who understand CrossFit

Dr. Foucher is no stranger to CrossFit. She has competed in the CrossFit Games four times and discusses the sport regularly on Twitter and Instagram. Now, she works directly with CrossFit to help it provide users with individualized data-driven plans.

“I met Eric Roza last July,” Dr. Foucher says of CrossFit’s CEO. “We talked and saw a lot of potential for CrossFit and health care providers to work together, so we started brainstorming.”

When Dr. Foucher and Mr. Roza got to know Wild Health, specifically, two of its physician cofounders, it was a natural fit, she said. Dr. Foucher says that many who train in CrossFit or go to CrossFit-affiliated gyms feel a disconnect with their family doctors: “[CrossFit is] a pretty polarizing topic, but there are also a lot of doctors who know that people are having health improvements with these programs,” she said.

Through use of Wild Health’s precision services and algorithms, CrossFit Precision Care plans to connect its users with CrossFit-trained health care practitioners. This personalized approach allows health care practitioners to build closer relationships with users of the program, who may feel more comfortable working with doctors who understand their lifestyle. Wild Health’s precision medicine approach, with trackable data such as biomarker status and risk scores, gives doctors a more complete picture of a patient’s needs and history, according to a statement on the partnership.
 

A better use of data

“To me,” Dr. Foucher says of family medicine, “that was the best option coming out of residency. It was consistent with my morals.” She says much of the current health care system is algorithm based. If a patient is experiencing certain symptoms, treatment is recommended on the basis of whatever yields the best results from the data – but this doesn’t always factor in a patient’s full history and genetics. It can be difficult for doctors to build trusting and personal relationships with patients. “In our current system, there’s not a lot of time or great tools to do that,” she says.

With the approach Wild Health and CrossFit Precision Care both use, however, Dr. Foucher says she sees a huge opportunity for optimizing patient and health care practitioner relationships.

“I see huge potential here, and I really think that this should be the standard for primary care going forwards,” Dr. Foucher explains. “The nice thing about [this approach] is that it has a really quick learning curve and is relatively easy to implement with patients. Before Wild Health optimized it, the tech and data would take about 10 hours per patient to put together. But now, we can incorporate things that work with wearable tech and track results over time and allow the patient and doctor to use this platform to create relationships. And this is something that can scale to many more patients.”

According to its website, CrossFit Precision Care is currently launching an invite-only beta test version of the program in eight states ahead of an expected national release.

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

CrossFit, the widely known fitness platform and brand with thousands of affiliated gyms, is moving into primary care with the launch of its newest service, CrossFit Precision Care.

Developed by family medicine physician Julie Foucher, MD, and other CrossFit-trained doctors, the new service aims to help CrossFit members build plans to protect and improve their health, according to a statement by the company.

CrossFit Precision Care plans to meet this goal through utilizing doctors who understand the CrossFit philosophy, individualized care, data-driven recommendations, proactive lifestyle changes, and continual health optimization. Informing these plans and changes are CrossFit Precision Care’s analysis through a few different methods.

CrossFit’s partner in the endeavor, Wild Health, will provide genomic testing to determine a patient’s genetic predispositions to help optimize the health plans. Blood testing reveals many things that may affect a person’s health, such as hormone status, lipid levels, thyroid function, and cardiovascular risks. An overall lifestyle review includes exercise routines, eating habits, social life, and other patterns or behaviors.
 

Connecting with doctors who understand CrossFit

Dr. Foucher is no stranger to CrossFit. She has competed in the CrossFit Games four times and discusses the sport regularly on Twitter and Instagram. Now, she works directly with CrossFit to help it provide users with individualized data-driven plans.

“I met Eric Roza last July,” Dr. Foucher says of CrossFit’s CEO. “We talked and saw a lot of potential for CrossFit and health care providers to work together, so we started brainstorming.”

When Dr. Foucher and Mr. Roza got to know Wild Health, specifically, two of its physician cofounders, it was a natural fit, she said. Dr. Foucher says that many who train in CrossFit or go to CrossFit-affiliated gyms feel a disconnect with their family doctors: “[CrossFit is] a pretty polarizing topic, but there are also a lot of doctors who know that people are having health improvements with these programs,” she said.

Through use of Wild Health’s precision services and algorithms, CrossFit Precision Care plans to connect its users with CrossFit-trained health care practitioners. This personalized approach allows health care practitioners to build closer relationships with users of the program, who may feel more comfortable working with doctors who understand their lifestyle. Wild Health’s precision medicine approach, with trackable data such as biomarker status and risk scores, gives doctors a more complete picture of a patient’s needs and history, according to a statement on the partnership.
 

A better use of data

“To me,” Dr. Foucher says of family medicine, “that was the best option coming out of residency. It was consistent with my morals.” She says much of the current health care system is algorithm based. If a patient is experiencing certain symptoms, treatment is recommended on the basis of whatever yields the best results from the data – but this doesn’t always factor in a patient’s full history and genetics. It can be difficult for doctors to build trusting and personal relationships with patients. “In our current system, there’s not a lot of time or great tools to do that,” she says.

With the approach Wild Health and CrossFit Precision Care both use, however, Dr. Foucher says she sees a huge opportunity for optimizing patient and health care practitioner relationships.

“I see huge potential here, and I really think that this should be the standard for primary care going forwards,” Dr. Foucher explains. “The nice thing about [this approach] is that it has a really quick learning curve and is relatively easy to implement with patients. Before Wild Health optimized it, the tech and data would take about 10 hours per patient to put together. But now, we can incorporate things that work with wearable tech and track results over time and allow the patient and doctor to use this platform to create relationships. And this is something that can scale to many more patients.”

According to its website, CrossFit Precision Care is currently launching an invite-only beta test version of the program in eight states ahead of an expected national release.

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

In frail elderly adults with COVID-19 infections, treatment with omega-3 fatty acids may improve lipid responses and decrease levels of proinflammatory lipid mediators, results of a small randomized controlled trial suggest.

Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.

Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.

In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.

“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.

Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
 

‘Eicosanoid storm’

In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.

“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”

Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
 

Trial details

In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.

Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.

Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.

All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.

Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.

Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
 

Inflammatory markers improve

As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.

“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.

As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.

The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
 

AFib concerns

In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”

The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.

“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”

The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.

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

In frail elderly adults with COVID-19 infections, treatment with omega-3 fatty acids may improve lipid responses and decrease levels of proinflammatory lipid mediators, results of a small randomized controlled trial suggest.

Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.

Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.

In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.

“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.

Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
 

‘Eicosanoid storm’

In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.

“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”

Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
 

Trial details

In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.

Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.

Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.

All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.

Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.

Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
 

Inflammatory markers improve

As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.

“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.

As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.

The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
 

AFib concerns

In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”

The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.

“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”

The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.

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

In frail elderly adults with COVID-19 infections, treatment with omega-3 fatty acids may improve lipid responses and decrease levels of proinflammatory lipid mediators, results of a small randomized controlled trial suggest.

Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.

Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.

In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.

“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.

Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
 

‘Eicosanoid storm’

In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.

“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”

Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
 

Trial details

In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.

Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.

Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.

All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.

Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.

Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
 

Inflammatory markers improve

As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.

“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.

As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.

The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
 

AFib concerns

In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”

The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.

“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”

The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.

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

The United States just passed the 6-million mark in COVID-19 cases among children, with the last million cases taking less time to record than any of the first five, according to new data from the American Academy of Pediatrics and the Children’s Hospital Association.

The five-millionth case was reported during the week of Aug. 27 to Sept. 2, and case number 6 million came during the week of Oct. 1-7, just 5 weeks later, compared with the 6 weeks it took to go from 1 million to 2 million last November and December, the AAP and CHA said in their weekly COVID-19 report.

There were 148,222 new cases reported during the week ending Oct. 7, bringing the total case count to 6,047,371 since the pandemic started. New cases continued to drop, however, and that weekly count was down by 14.6% from the previous week and by 41.1% from the peak of almost 252,000 reached in early September, the two groups said while also noting limitations to the data, such as three states (Alabama, Nebraska, and Texas) that are no longer updating their COVID-19 dashboards.

Other metrics show similar drops in recent weeks. Among children aged 0-11 years, emergency department visits involving a COVID-19 diagnosis dropped from 4.1% of all ED visits in late August to 1.4% of ED visits on Oct. 6. ED visits with a COVID-19 diagnosis fell from a peak of 8.5% on Aug. 22 to 1.5% on Oct. 6 for 12- to 15-year-olds and from 8.5% to 1.5% in those aged 16-17 years, according to data from the Centers for Disease Control and Prevention.

The rate of new hospital admissions for children aged 0-17 years was down to 0.26 per 100,000 population on Oct. 9 after reaching 0.51 per 100,000 on Sept. 4. Hospitalizations in children totaled just over 64,000 from Aug. 1, 2020, to Oct. 9, 2021, which is just over 2% of all COVID-19–related admissions over that time period, the CDC said on its COVID Data Tracker.

That pattern, unfortunately, also applies to vaccinations. “The number of children receiving their first COVID-19 vaccine this week [Sept. 30 to Oct. 6], about 156,000, was the lowest number since vaccines were available,” the AAP said in a separate report on vaccination trends, adding that “the number of children receiving their first dose has steadily declined from 8 weeks ago when 586,000 children received their initial dose the week ending Aug. 11.”

rfranki@mdedge.com

The United States just passed the 6-million mark in COVID-19 cases among children, with the last million cases taking less time to record than any of the first five, according to new data from the American Academy of Pediatrics and the Children’s Hospital Association.

The five-millionth case was reported during the week of Aug. 27 to Sept. 2, and case number 6 million came during the week of Oct. 1-7, just 5 weeks later, compared with the 6 weeks it took to go from 1 million to 2 million last November and December, the AAP and CHA said in their weekly COVID-19 report.

There were 148,222 new cases reported during the week ending Oct. 7, bringing the total case count to 6,047,371 since the pandemic started. New cases continued to drop, however, and that weekly count was down by 14.6% from the previous week and by 41.1% from the peak of almost 252,000 reached in early September, the two groups said while also noting limitations to the data, such as three states (Alabama, Nebraska, and Texas) that are no longer updating their COVID-19 dashboards.

Other metrics show similar drops in recent weeks. Among children aged 0-11 years, emergency department visits involving a COVID-19 diagnosis dropped from 4.1% of all ED visits in late August to 1.4% of ED visits on Oct. 6. ED visits with a COVID-19 diagnosis fell from a peak of 8.5% on Aug. 22 to 1.5% on Oct. 6 for 12- to 15-year-olds and from 8.5% to 1.5% in those aged 16-17 years, according to data from the Centers for Disease Control and Prevention.

The rate of new hospital admissions for children aged 0-17 years was down to 0.26 per 100,000 population on Oct. 9 after reaching 0.51 per 100,000 on Sept. 4. Hospitalizations in children totaled just over 64,000 from Aug. 1, 2020, to Oct. 9, 2021, which is just over 2% of all COVID-19–related admissions over that time period, the CDC said on its COVID Data Tracker.

That pattern, unfortunately, also applies to vaccinations. “The number of children receiving their first COVID-19 vaccine this week [Sept. 30 to Oct. 6], about 156,000, was the lowest number since vaccines were available,” the AAP said in a separate report on vaccination trends, adding that “the number of children receiving their first dose has steadily declined from 8 weeks ago when 586,000 children received their initial dose the week ending Aug. 11.”

rfranki@mdedge.com

The United States just passed the 6-million mark in COVID-19 cases among children, with the last million cases taking less time to record than any of the first five, according to new data from the American Academy of Pediatrics and the Children’s Hospital Association.

The five-millionth case was reported during the week of Aug. 27 to Sept. 2, and case number 6 million came during the week of Oct. 1-7, just 5 weeks later, compared with the 6 weeks it took to go from 1 million to 2 million last November and December, the AAP and CHA said in their weekly COVID-19 report.

There were 148,222 new cases reported during the week ending Oct. 7, bringing the total case count to 6,047,371 since the pandemic started. New cases continued to drop, however, and that weekly count was down by 14.6% from the previous week and by 41.1% from the peak of almost 252,000 reached in early September, the two groups said while also noting limitations to the data, such as three states (Alabama, Nebraska, and Texas) that are no longer updating their COVID-19 dashboards.

Other metrics show similar drops in recent weeks. Among children aged 0-11 years, emergency department visits involving a COVID-19 diagnosis dropped from 4.1% of all ED visits in late August to 1.4% of ED visits on Oct. 6. ED visits with a COVID-19 diagnosis fell from a peak of 8.5% on Aug. 22 to 1.5% on Oct. 6 for 12- to 15-year-olds and from 8.5% to 1.5% in those aged 16-17 years, according to data from the Centers for Disease Control and Prevention.

The rate of new hospital admissions for children aged 0-17 years was down to 0.26 per 100,000 population on Oct. 9 after reaching 0.51 per 100,000 on Sept. 4. Hospitalizations in children totaled just over 64,000 from Aug. 1, 2020, to Oct. 9, 2021, which is just over 2% of all COVID-19–related admissions over that time period, the CDC said on its COVID Data Tracker.

That pattern, unfortunately, also applies to vaccinations. “The number of children receiving their first COVID-19 vaccine this week [Sept. 30 to Oct. 6], about 156,000, was the lowest number since vaccines were available,” the AAP said in a separate report on vaccination trends, adding that “the number of children receiving their first dose has steadily declined from 8 weeks ago when 586,000 children received their initial dose the week ending Aug. 11.”

rfranki@mdedge.com

A dozen workers from a psychiatric hospital near Seattle flew to Washington, D.C. to picket the National Association for Behavioral Healthcare’s annual meeting in an effort to get their employer to meet demands for a safer work environment, better staffing, and the hiring of security professionals.

They are also demanding that their employer, Cascade Behavioral Health Hospital, a private psychiatric facility owned by Acadia Healthcare and located in Tukwila, Washington, address what they call “racist harassment” by managers who have allegedly told many workers, who are primarily people of color, that they are going to be “filtered out,” Alazar Yirgu, a mental health technician at the facility, told this news organization.

The workers have been conducting a “safety strike” to protest working conditions at Cascade since early August. The protest in Tukwila began after a dozen or more workers were hurt in an August 1 incident during which they had attempted to restrain a violent patient.

“We’ve been out there for 2 months, and we will continue until our voice is heard,” said Mr. Yirgu, who was hospitalized as a result of the August patient outburst that he said has left him unable to work since the incident.

On Oct. 7, Mr. Yirgu and coworkers brought the protest to Washington, D.C., in a continued effort to voice their need for adequate personal protective equipment, increased staffing, and the hiring of security personnel.

“Any health care professional should not be fearful to do their job, because once they are in that state of mind, once they are fearful for themselves, then they are not doing their jobs; they are preoccupied with their fears,” said Mr. Yirgu, who has worked as a technician for 6 years.
 

Unsafe patient load

The workers reacted quickly after the August 1 patient outburst because there have been multiple previous incidents, Mr. Yirgu said.

In a 2019 news story by the Seattle Times, the newspaper reported there had been 65 assaults on patients or staff at Cascade from 2016 to 2018, resulting in concussions and broken bones in some instances.

Mr. Yirgu said that more recently, a patient broke a second story window, jumped to the ground, and ran off.

At the facility, workers are often assigned to as many as a dozen or more patients, he said, noting that at other psychiatric institutions, he’s cared for a maximum of five patients at once.

The Tukwila police have pushed back against the workers’ description of the incident in which Mr. Yirgu was injured, and Cascade Behavioral Health has aggressively defended its facility.

According to Mr. Yirgu, the expletive-spewing patient was clearly a danger to himself and others – especially after he stole a key card that would give him access to the entire facility, including the kitchen where knives were stored.

When more than a dozen staff answered the unit’s “Code Gray,” they were unable to subdue or restrain him. Mr. Yirgu ended up on the floor underneath the patient after the patient had jumped off a table.

As the incident unfolded, several workers called the police, who initially refused to go to the facility, saying that a new law prevented them from assisting with the restraint if there was no assault.

The Tukwila Police Department report shows that officers finally did go to the facility and determined that “a crime had not been committed based on the information presented to them, that there was no imminent threat of bodily harm, and that there was no legal grounds or authority for them to assist medical staff with physically restraining a patient.”
 

Cascade pushes back

A Service Employees International Union (SEIU) report shows about 70 workers refused to come in to work after the incident and began picketing outside the facility.

Cascade called it an illegal strike because the protesters had not given 10-days’ notice, as required by federal law, and moved to terminate those who participated. The local SEIU chapter, 1199NW, suggested the workers call their walkout a “safety strike,” because it was organized primarily to protest working conditions.

Meanwhile Cascade, which has erected a large fence so that no one in the facility can see the protesters, has said the strike is primarily about ongoing contract negotiations with the facility’s nurses and its union.

“The Union has been trying to apply unfair – and in some cases we believe unlawful – external pressures to this process, including picketing, work stoppages, smear campaigns, and false accusations,” Cascade CEO Christopher West wrote on the company’s website in mid-August.

Mr. West also claimed the union had “exaggerated stories of unfavorable work conditions to bolster its contract bargaining objectives.” He said the facility had “ample personal protective equipment” and that the “well-being and safety of our patients and staff always have been and will be our key priorities.”

In response to a request for comment, Cascade said in an emailed statement that physical confrontations had decreased by almost 50% and elopements (unauthorized leaving of the facility) by 80% from 2018 to 2021.

Cascade spokesperson Gretchen Hommrich said in the statement that the workers it has terminated “were let go for cause in violation to their employment agreement” and said the company still aimed to negotiate a new agreement with the union.

The “efforts outside of the bargaining process serve no productive purpose and have only brought harm to the residents they claim to serve,” said Ms. Hommrich.
 

‘Safety is the sole purpose’

Mr. Yirgu said it was outrageous to suggest workers were picketing over contract negotiations. “Safety is the sole purpose of this strike,” he said.

He noted that his patient care goal is to have a lot of one-on-one time with his patients, helping them navigate back to the outside world. The facility is supposed to be a safe place, Mr. Yirgu added. Violence inside the facility traumatizes the patients and may worsen their condition and delay their progress, he said.

“If I can’t keep them safe, there’s no way I’m going to be able to see them eye-to-eye when I told them I’d keep them safe and then they’re not anymore,” said Mr. Yirgu.

So far, 22 workers have been “terminated,” meaning they received a termination notice, have been taken off the work schedule by the employer, or otherwise been informed that the employer has deemed them to be separated, the SEIU reports. The organization has filed unfair labor practice (ULPs) for all 22.

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

A dozen workers from a psychiatric hospital near Seattle flew to Washington, D.C. to picket the National Association for Behavioral Healthcare’s annual meeting in an effort to get their employer to meet demands for a safer work environment, better staffing, and the hiring of security professionals.

They are also demanding that their employer, Cascade Behavioral Health Hospital, a private psychiatric facility owned by Acadia Healthcare and located in Tukwila, Washington, address what they call “racist harassment” by managers who have allegedly told many workers, who are primarily people of color, that they are going to be “filtered out,” Alazar Yirgu, a mental health technician at the facility, told this news organization.

The workers have been conducting a “safety strike” to protest working conditions at Cascade since early August. The protest in Tukwila began after a dozen or more workers were hurt in an August 1 incident during which they had attempted to restrain a violent patient.

“We’ve been out there for 2 months, and we will continue until our voice is heard,” said Mr. Yirgu, who was hospitalized as a result of the August patient outburst that he said has left him unable to work since the incident.

On Oct. 7, Mr. Yirgu and coworkers brought the protest to Washington, D.C., in a continued effort to voice their need for adequate personal protective equipment, increased staffing, and the hiring of security personnel.

“Any health care professional should not be fearful to do their job, because once they are in that state of mind, once they are fearful for themselves, then they are not doing their jobs; they are preoccupied with their fears,” said Mr. Yirgu, who has worked as a technician for 6 years.
 

Unsafe patient load

The workers reacted quickly after the August 1 patient outburst because there have been multiple previous incidents, Mr. Yirgu said.

In a 2019 news story by the Seattle Times, the newspaper reported there had been 65 assaults on patients or staff at Cascade from 2016 to 2018, resulting in concussions and broken bones in some instances.

Mr. Yirgu said that more recently, a patient broke a second story window, jumped to the ground, and ran off.

At the facility, workers are often assigned to as many as a dozen or more patients, he said, noting that at other psychiatric institutions, he’s cared for a maximum of five patients at once.

The Tukwila police have pushed back against the workers’ description of the incident in which Mr. Yirgu was injured, and Cascade Behavioral Health has aggressively defended its facility.

According to Mr. Yirgu, the expletive-spewing patient was clearly a danger to himself and others – especially after he stole a key card that would give him access to the entire facility, including the kitchen where knives were stored.

When more than a dozen staff answered the unit’s “Code Gray,” they were unable to subdue or restrain him. Mr. Yirgu ended up on the floor underneath the patient after the patient had jumped off a table.

As the incident unfolded, several workers called the police, who initially refused to go to the facility, saying that a new law prevented them from assisting with the restraint if there was no assault.

The Tukwila Police Department report shows that officers finally did go to the facility and determined that “a crime had not been committed based on the information presented to them, that there was no imminent threat of bodily harm, and that there was no legal grounds or authority for them to assist medical staff with physically restraining a patient.”
 

Cascade pushes back

A Service Employees International Union (SEIU) report shows about 70 workers refused to come in to work after the incident and began picketing outside the facility.

Cascade called it an illegal strike because the protesters had not given 10-days’ notice, as required by federal law, and moved to terminate those who participated. The local SEIU chapter, 1199NW, suggested the workers call their walkout a “safety strike,” because it was organized primarily to protest working conditions.

Meanwhile Cascade, which has erected a large fence so that no one in the facility can see the protesters, has said the strike is primarily about ongoing contract negotiations with the facility’s nurses and its union.

“The Union has been trying to apply unfair – and in some cases we believe unlawful – external pressures to this process, including picketing, work stoppages, smear campaigns, and false accusations,” Cascade CEO Christopher West wrote on the company’s website in mid-August.

Mr. West also claimed the union had “exaggerated stories of unfavorable work conditions to bolster its contract bargaining objectives.” He said the facility had “ample personal protective equipment” and that the “well-being and safety of our patients and staff always have been and will be our key priorities.”

In response to a request for comment, Cascade said in an emailed statement that physical confrontations had decreased by almost 50% and elopements (unauthorized leaving of the facility) by 80% from 2018 to 2021.

Cascade spokesperson Gretchen Hommrich said in the statement that the workers it has terminated “were let go for cause in violation to their employment agreement” and said the company still aimed to negotiate a new agreement with the union.

The “efforts outside of the bargaining process serve no productive purpose and have only brought harm to the residents they claim to serve,” said Ms. Hommrich.
 

‘Safety is the sole purpose’

Mr. Yirgu said it was outrageous to suggest workers were picketing over contract negotiations. “Safety is the sole purpose of this strike,” he said.

He noted that his patient care goal is to have a lot of one-on-one time with his patients, helping them navigate back to the outside world. The facility is supposed to be a safe place, Mr. Yirgu added. Violence inside the facility traumatizes the patients and may worsen their condition and delay their progress, he said.

“If I can’t keep them safe, there’s no way I’m going to be able to see them eye-to-eye when I told them I’d keep them safe and then they’re not anymore,” said Mr. Yirgu.

So far, 22 workers have been “terminated,” meaning they received a termination notice, have been taken off the work schedule by the employer, or otherwise been informed that the employer has deemed them to be separated, the SEIU reports. The organization has filed unfair labor practice (ULPs) for all 22.

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

A dozen workers from a psychiatric hospital near Seattle flew to Washington, D.C. to picket the National Association for Behavioral Healthcare’s annual meeting in an effort to get their employer to meet demands for a safer work environment, better staffing, and the hiring of security professionals.

They are also demanding that their employer, Cascade Behavioral Health Hospital, a private psychiatric facility owned by Acadia Healthcare and located in Tukwila, Washington, address what they call “racist harassment” by managers who have allegedly told many workers, who are primarily people of color, that they are going to be “filtered out,” Alazar Yirgu, a mental health technician at the facility, told this news organization.

The workers have been conducting a “safety strike” to protest working conditions at Cascade since early August. The protest in Tukwila began after a dozen or more workers were hurt in an August 1 incident during which they had attempted to restrain a violent patient.

“We’ve been out there for 2 months, and we will continue until our voice is heard,” said Mr. Yirgu, who was hospitalized as a result of the August patient outburst that he said has left him unable to work since the incident.

On Oct. 7, Mr. Yirgu and coworkers brought the protest to Washington, D.C., in a continued effort to voice their need for adequate personal protective equipment, increased staffing, and the hiring of security personnel.

“Any health care professional should not be fearful to do their job, because once they are in that state of mind, once they are fearful for themselves, then they are not doing their jobs; they are preoccupied with their fears,” said Mr. Yirgu, who has worked as a technician for 6 years.
 

Unsafe patient load

The workers reacted quickly after the August 1 patient outburst because there have been multiple previous incidents, Mr. Yirgu said.

In a 2019 news story by the Seattle Times, the newspaper reported there had been 65 assaults on patients or staff at Cascade from 2016 to 2018, resulting in concussions and broken bones in some instances.

Mr. Yirgu said that more recently, a patient broke a second story window, jumped to the ground, and ran off.

At the facility, workers are often assigned to as many as a dozen or more patients, he said, noting that at other psychiatric institutions, he’s cared for a maximum of five patients at once.

The Tukwila police have pushed back against the workers’ description of the incident in which Mr. Yirgu was injured, and Cascade Behavioral Health has aggressively defended its facility.

According to Mr. Yirgu, the expletive-spewing patient was clearly a danger to himself and others – especially after he stole a key card that would give him access to the entire facility, including the kitchen where knives were stored.

When more than a dozen staff answered the unit’s “Code Gray,” they were unable to subdue or restrain him. Mr. Yirgu ended up on the floor underneath the patient after the patient had jumped off a table.

As the incident unfolded, several workers called the police, who initially refused to go to the facility, saying that a new law prevented them from assisting with the restraint if there was no assault.

The Tukwila Police Department report shows that officers finally did go to the facility and determined that “a crime had not been committed based on the information presented to them, that there was no imminent threat of bodily harm, and that there was no legal grounds or authority for them to assist medical staff with physically restraining a patient.”
 

Cascade pushes back

A Service Employees International Union (SEIU) report shows about 70 workers refused to come in to work after the incident and began picketing outside the facility.

Cascade called it an illegal strike because the protesters had not given 10-days’ notice, as required by federal law, and moved to terminate those who participated. The local SEIU chapter, 1199NW, suggested the workers call their walkout a “safety strike,” because it was organized primarily to protest working conditions.

Meanwhile Cascade, which has erected a large fence so that no one in the facility can see the protesters, has said the strike is primarily about ongoing contract negotiations with the facility’s nurses and its union.

“The Union has been trying to apply unfair – and in some cases we believe unlawful – external pressures to this process, including picketing, work stoppages, smear campaigns, and false accusations,” Cascade CEO Christopher West wrote on the company’s website in mid-August.

Mr. West also claimed the union had “exaggerated stories of unfavorable work conditions to bolster its contract bargaining objectives.” He said the facility had “ample personal protective equipment” and that the “well-being and safety of our patients and staff always have been and will be our key priorities.”

In response to a request for comment, Cascade said in an emailed statement that physical confrontations had decreased by almost 50% and elopements (unauthorized leaving of the facility) by 80% from 2018 to 2021.

Cascade spokesperson Gretchen Hommrich said in the statement that the workers it has terminated “were let go for cause in violation to their employment agreement” and said the company still aimed to negotiate a new agreement with the union.

The “efforts outside of the bargaining process serve no productive purpose and have only brought harm to the residents they claim to serve,” said Ms. Hommrich.
 

‘Safety is the sole purpose’

Mr. Yirgu said it was outrageous to suggest workers were picketing over contract negotiations. “Safety is the sole purpose of this strike,” he said.

He noted that his patient care goal is to have a lot of one-on-one time with his patients, helping them navigate back to the outside world. The facility is supposed to be a safe place, Mr. Yirgu added. Violence inside the facility traumatizes the patients and may worsen their condition and delay their progress, he said.

“If I can’t keep them safe, there’s no way I’m going to be able to see them eye-to-eye when I told them I’d keep them safe and then they’re not anymore,” said Mr. Yirgu.

So far, 22 workers have been “terminated,” meaning they received a termination notice, have been taken off the work schedule by the employer, or otherwise been informed that the employer has deemed them to be separated, the SEIU reports. The organization has filed unfair labor practice (ULPs) for all 22.

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

Fear of antibiotic overuse and frustration with physicians who prescribe them too freely are key sentiments expressed by women with recurrent urinary tract infections (rUTIs), according to findings from a study involving six focus groups.

“Here in our female pelvic medicine reconstructive urology clinic at Cedars-Sinai and at UCLA, we see many women who are referred for evaluation of rUTIs who are very frustrated with their care,” Victoria Scott, MD, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“So with these focus groups, we saw an opportunity to explore why women are so frustrated and to try and improve the care delivered,” she added.

Findings from the study were published online Sept. 1 in The Journal of Urology.

“There is a need for physicians to modify management strategies ... and to devote more research efforts to improving nonantibiotic options for the prevention and treatment of recurrent urinary tract infections, as well as management strategies that better empower patients,” the authors wrote.
 

Six focus groups

Four or five participants were included in each of the six focus groups – a total of 29 women. All participants reported a history of symptomatic, culture-proven UTI episodes. They had experienced two or more infections in 6 months or three or more infections within 1 year. Women were predominantly White. Most were employed part- or full-time and held a college degree.

From a qualitative analysis of all focus group transcripts, two main themes emerged:

• The negative impact of taking antibiotics for the prevention and treatment of rUTIs.
• Resentment of the medical profession for the way it managed rUTIs.

The researchers found that participants had a good understanding of the deleterious effects from inappropriate antibiotic use, largely gleaned from media sources and the Internet. “Numerous women stated that they had reached such a level of concern about antibiotics that they would resist taking them for prevention or treatment of infections,” Dr. Scott and colleagues pointed out.

These concerns centered around the risk of developing resistance to antibiotics and the ill effects that antibiotics can have on the gastrointestinal and genitourinary microbiomes. Several women reported that they had developed Clostridium difficile infections after taking antibiotics; one of the patients required hospitalization for the infection.

Women also reported concerns that they had been given an antibiotic needlessly for symptoms that might have been caused by a genitourinary condition other than a UTI. They also reported feeling resentful toward practitioners, particularly if they felt the practitioner was overprescribing antibiotics. Some had resorted to consultations with alternative practitioners, such as herbalists. “A second concern discussed by participants was the feeling of being ignored by physicians,” the authors observed.

In this regard, the women felt that their physicians underestimated the burden that rUTIs had on their lives and the detrimental effect that repeated infections had on their relationships, work, and overall quality of life. “These perceptions led to a prevalent mistrust of physicians,” the investigators wrote. This prompted many women to insist that the medical community devote more effort to the development of nonantibiotic options for the prevention and treatment of UTIs.
 

Improved management strategies

Asked how physicians might improve their management of rUTIs, Dr. Scott shared a number of suggestions. Cardinal rule No. 1: Have the patient undergo a urinalysis to make sure she does have a UTI. “There is a subset of patients among women with rUTIs who come in with a diagnosis of an rUTI but who really have not had documentation of more than one positive urine culture,” Dr. Scott noted. Such a history suggests that they do not have an rUTI.

It’s imperative that physicians rule out commonly misdiagnosed disorders, such as overactive bladder, as a cause of the patient’s symptoms. Symptoms of overactive bladder and rUTIs often overlap. While waiting for results from the urinalysis to confirm or rule out a UTI, young and healthy women may be prescribed a nonsteroidal anti-inflammatory drug (NSAID), such as naproxen, which can help ameliorate symptoms.

Because UTIs are frequently self-limiting, Dr. Scott and others have found that for young, otherwise healthy women, NSAIDs alone can often resolve symptoms of the UTI without use of an antibiotic. For relatively severe symptoms, a urinary analgesic, such as phenazopyridine (Pyridium), may soothe the lining of the urinary tract and relieve pain. Cystex is an over-the-counter urinary analgesic that women can procure themselves, Dr. Scott added.

If an antibiotic is indicated, those most commonly prescribed for a single episode of acute cystitis are nitrofurantoin and sulfamethoxazole plus trimethoprim (Bactrim). For recurrent UTIs, “patients are a bit more complicated,” Dr. Scott admitted. “I think the best practice is to look back at a woman’s prior urine culture and select an antibiotic that showed good sensitivity in the last positive urine test,” she said.

Prevention starts with behavioral strategies, such as voiding after sexual intercourse and wiping from front to back following urination to avoid introducing fecal bacteria into the urethra. Evidence suggests that premenopausal women who drink at least 1.5 L of water a day have significantly fewer UTI episodes, Dr. Scott noted. There is also “pretty good” evidence that cranberry supplements (not juice) can prevent rUTIs. Use of cranberry supplements is supported by the American Urological Association (conditional recommendation; evidence level of grade C).

For peri- and postmenopausal women, vaginal estrogen may be effective. It’s use for UTI prevention is well supported by the literature. Although not as well supported by evidence, some women find that a supplement such as D-mannose may prevent or treat UTIs by causing bacteria to bind to it rather than to the bladder wall. Probiotics are another possibility, she noted. Empathy can’t hurt, she added.

“A common theme among satisfied women was the sentiment that their physicians understood their problems and had a system in place to allow rapid diagnosis and treatment for UTI episodes,” the authors emphasized.

“[Such attitudes] highlight the need to investigate each patient’s experience and perceptions to allow for shared decision making regarding the management of rUTIs,” they wrote.
 

Further commentary

Asked to comment on the findings, editorialist Michelle Van Kuiken, MD, assistant professor of urology, University of California, San Francisco, acknowledged that there is not a lot of good evidence to support many of the strategies recommended by the American Urological Association to prevent and treat rUTIs, but she often follows these recommendations anyway. “The one statement in the guidelines that is the most supported by evidence is the use of cranberry supplements, and I do routinely recommended daily use of some form of concentrated cranberry supplements for all of my patients with rUTIs,” she said in an interview.

Dr. Van Kuiken said that vaginal estrogen is a very good option for all postmenopausal women who suffer from rUTIs and that there is growing acceptance of its use for this and other indications. There is some evidence to support D-mannose as well, although it’s not that robust, she acknowledged.

She said the evidence supporting the use of probiotics for this indication is very thin. She does not routinely recommend them for rUTIs, although they are not inherently harmful. “I think for a lot of women who have rUTIs, it can be pretty debilitating and upsetting for them – it can impact travel plans, work, and social events,” Dr. Van Kuiken said.

“Until we develop better diagnostic and therapeutic strategies, validating women’s experiences and concerns with rUTI while limiting unnecessary antibiotics remains our best option,” she wrote.

Dr. Scott and Dr. Van Kuiken have disclosed no relevant financial relationships.

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

Fear of antibiotic overuse and frustration with physicians who prescribe them too freely are key sentiments expressed by women with recurrent urinary tract infections (rUTIs), according to findings from a study involving six focus groups.

“Here in our female pelvic medicine reconstructive urology clinic at Cedars-Sinai and at UCLA, we see many women who are referred for evaluation of rUTIs who are very frustrated with their care,” Victoria Scott, MD, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“So with these focus groups, we saw an opportunity to explore why women are so frustrated and to try and improve the care delivered,” she added.

Findings from the study were published online Sept. 1 in The Journal of Urology.

“There is a need for physicians to modify management strategies ... and to devote more research efforts to improving nonantibiotic options for the prevention and treatment of recurrent urinary tract infections, as well as management strategies that better empower patients,” the authors wrote.
 

Six focus groups

Four or five participants were included in each of the six focus groups – a total of 29 women. All participants reported a history of symptomatic, culture-proven UTI episodes. They had experienced two or more infections in 6 months or three or more infections within 1 year. Women were predominantly White. Most were employed part- or full-time and held a college degree.

From a qualitative analysis of all focus group transcripts, two main themes emerged:

• The negative impact of taking antibiotics for the prevention and treatment of rUTIs.
• Resentment of the medical profession for the way it managed rUTIs.

The researchers found that participants had a good understanding of the deleterious effects from inappropriate antibiotic use, largely gleaned from media sources and the Internet. “Numerous women stated that they had reached such a level of concern about antibiotics that they would resist taking them for prevention or treatment of infections,” Dr. Scott and colleagues pointed out.

These concerns centered around the risk of developing resistance to antibiotics and the ill effects that antibiotics can have on the gastrointestinal and genitourinary microbiomes. Several women reported that they had developed Clostridium difficile infections after taking antibiotics; one of the patients required hospitalization for the infection.

Women also reported concerns that they had been given an antibiotic needlessly for symptoms that might have been caused by a genitourinary condition other than a UTI. They also reported feeling resentful toward practitioners, particularly if they felt the practitioner was overprescribing antibiotics. Some had resorted to consultations with alternative practitioners, such as herbalists. “A second concern discussed by participants was the feeling of being ignored by physicians,” the authors observed.

In this regard, the women felt that their physicians underestimated the burden that rUTIs had on their lives and the detrimental effect that repeated infections had on their relationships, work, and overall quality of life. “These perceptions led to a prevalent mistrust of physicians,” the investigators wrote. This prompted many women to insist that the medical community devote more effort to the development of nonantibiotic options for the prevention and treatment of UTIs.
 

Improved management strategies

Asked how physicians might improve their management of rUTIs, Dr. Scott shared a number of suggestions. Cardinal rule No. 1: Have the patient undergo a urinalysis to make sure she does have a UTI. “There is a subset of patients among women with rUTIs who come in with a diagnosis of an rUTI but who really have not had documentation of more than one positive urine culture,” Dr. Scott noted. Such a history suggests that they do not have an rUTI.

It’s imperative that physicians rule out commonly misdiagnosed disorders, such as overactive bladder, as a cause of the patient’s symptoms. Symptoms of overactive bladder and rUTIs often overlap. While waiting for results from the urinalysis to confirm or rule out a UTI, young and healthy women may be prescribed a nonsteroidal anti-inflammatory drug (NSAID), such as naproxen, which can help ameliorate symptoms.

Because UTIs are frequently self-limiting, Dr. Scott and others have found that for young, otherwise healthy women, NSAIDs alone can often resolve symptoms of the UTI without use of an antibiotic. For relatively severe symptoms, a urinary analgesic, such as phenazopyridine (Pyridium), may soothe the lining of the urinary tract and relieve pain. Cystex is an over-the-counter urinary analgesic that women can procure themselves, Dr. Scott added.

If an antibiotic is indicated, those most commonly prescribed for a single episode of acute cystitis are nitrofurantoin and sulfamethoxazole plus trimethoprim (Bactrim). For recurrent UTIs, “patients are a bit more complicated,” Dr. Scott admitted. “I think the best practice is to look back at a woman’s prior urine culture and select an antibiotic that showed good sensitivity in the last positive urine test,” she said.

Prevention starts with behavioral strategies, such as voiding after sexual intercourse and wiping from front to back following urination to avoid introducing fecal bacteria into the urethra. Evidence suggests that premenopausal women who drink at least 1.5 L of water a day have significantly fewer UTI episodes, Dr. Scott noted. There is also “pretty good” evidence that cranberry supplements (not juice) can prevent rUTIs. Use of cranberry supplements is supported by the American Urological Association (conditional recommendation; evidence level of grade C).

For peri- and postmenopausal women, vaginal estrogen may be effective. It’s use for UTI prevention is well supported by the literature. Although not as well supported by evidence, some women find that a supplement such as D-mannose may prevent or treat UTIs by causing bacteria to bind to it rather than to the bladder wall. Probiotics are another possibility, she noted. Empathy can’t hurt, she added.

“A common theme among satisfied women was the sentiment that their physicians understood their problems and had a system in place to allow rapid diagnosis and treatment for UTI episodes,” the authors emphasized.

“[Such attitudes] highlight the need to investigate each patient’s experience and perceptions to allow for shared decision making regarding the management of rUTIs,” they wrote.
 

Further commentary

Asked to comment on the findings, editorialist Michelle Van Kuiken, MD, assistant professor of urology, University of California, San Francisco, acknowledged that there is not a lot of good evidence to support many of the strategies recommended by the American Urological Association to prevent and treat rUTIs, but she often follows these recommendations anyway. “The one statement in the guidelines that is the most supported by evidence is the use of cranberry supplements, and I do routinely recommended daily use of some form of concentrated cranberry supplements for all of my patients with rUTIs,” she said in an interview.

Dr. Van Kuiken said that vaginal estrogen is a very good option for all postmenopausal women who suffer from rUTIs and that there is growing acceptance of its use for this and other indications. There is some evidence to support D-mannose as well, although it’s not that robust, she acknowledged.

She said the evidence supporting the use of probiotics for this indication is very thin. She does not routinely recommend them for rUTIs, although they are not inherently harmful. “I think for a lot of women who have rUTIs, it can be pretty debilitating and upsetting for them – it can impact travel plans, work, and social events,” Dr. Van Kuiken said.

“Until we develop better diagnostic and therapeutic strategies, validating women’s experiences and concerns with rUTI while limiting unnecessary antibiotics remains our best option,” she wrote.

Dr. Scott and Dr. Van Kuiken have disclosed no relevant financial relationships.

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

Fear of antibiotic overuse and frustration with physicians who prescribe them too freely are key sentiments expressed by women with recurrent urinary tract infections (rUTIs), according to findings from a study involving six focus groups.

“Here in our female pelvic medicine reconstructive urology clinic at Cedars-Sinai and at UCLA, we see many women who are referred for evaluation of rUTIs who are very frustrated with their care,” Victoria Scott, MD, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“So with these focus groups, we saw an opportunity to explore why women are so frustrated and to try and improve the care delivered,” she added.

Findings from the study were published online Sept. 1 in The Journal of Urology.

“There is a need for physicians to modify management strategies ... and to devote more research efforts to improving nonantibiotic options for the prevention and treatment of recurrent urinary tract infections, as well as management strategies that better empower patients,” the authors wrote.
 

Six focus groups

Four or five participants were included in each of the six focus groups – a total of 29 women. All participants reported a history of symptomatic, culture-proven UTI episodes. They had experienced two or more infections in 6 months or three or more infections within 1 year. Women were predominantly White. Most were employed part- or full-time and held a college degree.

From a qualitative analysis of all focus group transcripts, two main themes emerged:

• The negative impact of taking antibiotics for the prevention and treatment of rUTIs.
• Resentment of the medical profession for the way it managed rUTIs.

The researchers found that participants had a good understanding of the deleterious effects from inappropriate antibiotic use, largely gleaned from media sources and the Internet. “Numerous women stated that they had reached such a level of concern about antibiotics that they would resist taking them for prevention or treatment of infections,” Dr. Scott and colleagues pointed out.

These concerns centered around the risk of developing resistance to antibiotics and the ill effects that antibiotics can have on the gastrointestinal and genitourinary microbiomes. Several women reported that they had developed Clostridium difficile infections after taking antibiotics; one of the patients required hospitalization for the infection.

Women also reported concerns that they had been given an antibiotic needlessly for symptoms that might have been caused by a genitourinary condition other than a UTI. They also reported feeling resentful toward practitioners, particularly if they felt the practitioner was overprescribing antibiotics. Some had resorted to consultations with alternative practitioners, such as herbalists. “A second concern discussed by participants was the feeling of being ignored by physicians,” the authors observed.

In this regard, the women felt that their physicians underestimated the burden that rUTIs had on their lives and the detrimental effect that repeated infections had on their relationships, work, and overall quality of life. “These perceptions led to a prevalent mistrust of physicians,” the investigators wrote. This prompted many women to insist that the medical community devote more effort to the development of nonantibiotic options for the prevention and treatment of UTIs.
 

Improved management strategies

Asked how physicians might improve their management of rUTIs, Dr. Scott shared a number of suggestions. Cardinal rule No. 1: Have the patient undergo a urinalysis to make sure she does have a UTI. “There is a subset of patients among women with rUTIs who come in with a diagnosis of an rUTI but who really have not had documentation of more than one positive urine culture,” Dr. Scott noted. Such a history suggests that they do not have an rUTI.

It’s imperative that physicians rule out commonly misdiagnosed disorders, such as overactive bladder, as a cause of the patient’s symptoms. Symptoms of overactive bladder and rUTIs often overlap. While waiting for results from the urinalysis to confirm or rule out a UTI, young and healthy women may be prescribed a nonsteroidal anti-inflammatory drug (NSAID), such as naproxen, which can help ameliorate symptoms.

Because UTIs are frequently self-limiting, Dr. Scott and others have found that for young, otherwise healthy women, NSAIDs alone can often resolve symptoms of the UTI without use of an antibiotic. For relatively severe symptoms, a urinary analgesic, such as phenazopyridine (Pyridium), may soothe the lining of the urinary tract and relieve pain. Cystex is an over-the-counter urinary analgesic that women can procure themselves, Dr. Scott added.

If an antibiotic is indicated, those most commonly prescribed for a single episode of acute cystitis are nitrofurantoin and sulfamethoxazole plus trimethoprim (Bactrim). For recurrent UTIs, “patients are a bit more complicated,” Dr. Scott admitted. “I think the best practice is to look back at a woman’s prior urine culture and select an antibiotic that showed good sensitivity in the last positive urine test,” she said.

Prevention starts with behavioral strategies, such as voiding after sexual intercourse and wiping from front to back following urination to avoid introducing fecal bacteria into the urethra. Evidence suggests that premenopausal women who drink at least 1.5 L of water a day have significantly fewer UTI episodes, Dr. Scott noted. There is also “pretty good” evidence that cranberry supplements (not juice) can prevent rUTIs. Use of cranberry supplements is supported by the American Urological Association (conditional recommendation; evidence level of grade C).

For peri- and postmenopausal women, vaginal estrogen may be effective. It’s use for UTI prevention is well supported by the literature. Although not as well supported by evidence, some women find that a supplement such as D-mannose may prevent or treat UTIs by causing bacteria to bind to it rather than to the bladder wall. Probiotics are another possibility, she noted. Empathy can’t hurt, she added.

“A common theme among satisfied women was the sentiment that their physicians understood their problems and had a system in place to allow rapid diagnosis and treatment for UTI episodes,” the authors emphasized.

“[Such attitudes] highlight the need to investigate each patient’s experience and perceptions to allow for shared decision making regarding the management of rUTIs,” they wrote.
 

Further commentary

Asked to comment on the findings, editorialist Michelle Van Kuiken, MD, assistant professor of urology, University of California, San Francisco, acknowledged that there is not a lot of good evidence to support many of the strategies recommended by the American Urological Association to prevent and treat rUTIs, but she often follows these recommendations anyway. “The one statement in the guidelines that is the most supported by evidence is the use of cranberry supplements, and I do routinely recommended daily use of some form of concentrated cranberry supplements for all of my patients with rUTIs,” she said in an interview.

Dr. Van Kuiken said that vaginal estrogen is a very good option for all postmenopausal women who suffer from rUTIs and that there is growing acceptance of its use for this and other indications. There is some evidence to support D-mannose as well, although it’s not that robust, she acknowledged.

She said the evidence supporting the use of probiotics for this indication is very thin. She does not routinely recommend them for rUTIs, although they are not inherently harmful. “I think for a lot of women who have rUTIs, it can be pretty debilitating and upsetting for them – it can impact travel plans, work, and social events,” Dr. Van Kuiken said.

“Until we develop better diagnostic and therapeutic strategies, validating women’s experiences and concerns with rUTI while limiting unnecessary antibiotics remains our best option,” she wrote.

Dr. Scott and Dr. Van Kuiken have disclosed no relevant financial relationships.

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

A simple caregiver education intervention reduced the use of psychotropic medications and associated drugs costs in long-term care facilities for the elderly in a new study.

The effect of the intervention was transient, possibly because of high staff turnover, according to the investigators in the new randomized, controlled trial.

The findings were presented by Ulla Aalto, MD, PhD, during a session at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

There was a significant reduction in the use of psychotropic agents at 6 months in long-term care wards where the nursing staff had undergone a short training session on drug therapy for older patients, but there was no improvement in wards that were randomly assigned to serve as controls, Dr. Aalto, from Helsinki Hospital, reported during the session.

“Future research would be investigating how we could maintain the positive effects that were gained at 6 months but not seen any more at 1 year, and how to implement the good practice in nursing homes by this kind of staff training,” she said.

Heavy drug use

Psychotropic medications are widely used in long-term care settings, but their indiscriminate use or use of the wrong drug for the wrong patient can be harmful. Inappropriate drug use in long-term care settings is also associated with higher costs, Dr. Aalto said.

To see whether a staff-training intervention could reduce drugs use and lower costs, the investigators conducted a randomized clinical trial in assisted living facilities in Helsinki in 2011, with a total of 227 patients 65 years and older.

Long-term care wards were randomly assigned to either an intervention for nursing staff consisting of two 4-hour sessions on good drug-therapy practice for older adults, or to serve as controls (10 wards in each group).

Drug use and costs were monitored at both 6 and 12 months after randomization. Psychotropic drugs included antipsychotics, antidepressants, anxiolytics, and hypnotics as classified by the World Health Organization. For the purposes of comparison, actual doses were counted and converted into relative proportions of defined daily doses.

The baseline characteristics of patients in each group were generally similar, with a mean age of around 83 years. In each study arm, nearly two-thirds of patients were on at least one psychotropic drug, and of this group, a third had been prescribed 2 or more psychotropic agents.

Nearly half of the patients were on at least one antipsychotic agent and/or antidepressant.
 

Short-term benefit

As noted before, in the wards randomized to staff training, there was a significant reduction in use of all psychotropics from baseline at 6 months after randomization (P = .045), but there was no change among the control wards.

By 12 months, however, the differences between the intervention and control arms narrowed, and drug use in the intervention arm was no longer significantly lower over baseline.

Drugs costs significantly decreased in the intervention group at 6 months (P = .027) and were numerically but not statistically lower over baseline at 12 months.

In contrast, drug costs in the control arm were numerically (but not statistically) higher at both 6 and 12 months of follow-up.

Annual drug costs in the intervention group decreased by mean of 12.3 euros ($14.22) whereas costs in the control group increased by a mean of 20.6 euros ($23.81).

“This quite light and feasible intervention succeeded in reducing overall defined daily doses of psychotropics in the short term,” Dr. Aalto said.

The waning of the intervention’s effect on drug use and costs may be caused partly by the high employee turnover rate in long-term care facilities and to the dilution effect, she said, referring to a form of judgment bias in which people tend to devalue diagnostic information when other, nondiagnostic information is also available.
 

Randomized design

In the question-and-answer session following her presentation, audience member Jesper Ryg, MD, PhD from Odense (Denmark) University Hospital and the University of Southern Denmark, also in Odense, commented: “It’s a great study, doing a [randomized, controlled trial] on deprescribing, we need more of those.”

“But what we know now is that a lot of studies show it is possible to deprescribe and get less drugs, but do we have any clinical data? Does this deprescribing lead to less falls, did it lead to lower mortality?” he asked.

Dr. Aalto replied that, in an earlier report from this study, investigators showed that harmful medication use was reduced and negative outcomes were reduced.

Another audience member asked why nursing staff were the target of the intervention, given that physicians do the actual drug prescribing.

Dr. Aalto responded: “It is the physician of course who prescribes, but in nursing homes and long-term care, nursing staff is there all the time, and the physicians are kind of consultants who just come there once in a while, so it’s important that the nurses also know about these harmful medications and can bring them to the doctor when he or she arrives there.”

Dr. Aalto and Dr. Ryg had no disclosures.

A simple caregiver education intervention reduced the use of psychotropic medications and associated drugs costs in long-term care facilities for the elderly in a new study.

The effect of the intervention was transient, possibly because of high staff turnover, according to the investigators in the new randomized, controlled trial.

The findings were presented by Ulla Aalto, MD, PhD, during a session at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

There was a significant reduction in the use of psychotropic agents at 6 months in long-term care wards where the nursing staff had undergone a short training session on drug therapy for older patients, but there was no improvement in wards that were randomly assigned to serve as controls, Dr. Aalto, from Helsinki Hospital, reported during the session.

“Future research would be investigating how we could maintain the positive effects that were gained at 6 months but not seen any more at 1 year, and how to implement the good practice in nursing homes by this kind of staff training,” she said.

Heavy drug use

Psychotropic medications are widely used in long-term care settings, but their indiscriminate use or use of the wrong drug for the wrong patient can be harmful. Inappropriate drug use in long-term care settings is also associated with higher costs, Dr. Aalto said.

To see whether a staff-training intervention could reduce drugs use and lower costs, the investigators conducted a randomized clinical trial in assisted living facilities in Helsinki in 2011, with a total of 227 patients 65 years and older.

Long-term care wards were randomly assigned to either an intervention for nursing staff consisting of two 4-hour sessions on good drug-therapy practice for older adults, or to serve as controls (10 wards in each group).

Drug use and costs were monitored at both 6 and 12 months after randomization. Psychotropic drugs included antipsychotics, antidepressants, anxiolytics, and hypnotics as classified by the World Health Organization. For the purposes of comparison, actual doses were counted and converted into relative proportions of defined daily doses.

The baseline characteristics of patients in each group were generally similar, with a mean age of around 83 years. In each study arm, nearly two-thirds of patients were on at least one psychotropic drug, and of this group, a third had been prescribed 2 or more psychotropic agents.

Nearly half of the patients were on at least one antipsychotic agent and/or antidepressant.
 

Short-term benefit

As noted before, in the wards randomized to staff training, there was a significant reduction in use of all psychotropics from baseline at 6 months after randomization (P = .045), but there was no change among the control wards.

By 12 months, however, the differences between the intervention and control arms narrowed, and drug use in the intervention arm was no longer significantly lower over baseline.

Drugs costs significantly decreased in the intervention group at 6 months (P = .027) and were numerically but not statistically lower over baseline at 12 months.

In contrast, drug costs in the control arm were numerically (but not statistically) higher at both 6 and 12 months of follow-up.

Annual drug costs in the intervention group decreased by mean of 12.3 euros ($14.22) whereas costs in the control group increased by a mean of 20.6 euros ($23.81).

“This quite light and feasible intervention succeeded in reducing overall defined daily doses of psychotropics in the short term,” Dr. Aalto said.

The waning of the intervention’s effect on drug use and costs may be caused partly by the high employee turnover rate in long-term care facilities and to the dilution effect, she said, referring to a form of judgment bias in which people tend to devalue diagnostic information when other, nondiagnostic information is also available.
 

Randomized design

In the question-and-answer session following her presentation, audience member Jesper Ryg, MD, PhD from Odense (Denmark) University Hospital and the University of Southern Denmark, also in Odense, commented: “It’s a great study, doing a [randomized, controlled trial] on deprescribing, we need more of those.”

“But what we know now is that a lot of studies show it is possible to deprescribe and get less drugs, but do we have any clinical data? Does this deprescribing lead to less falls, did it lead to lower mortality?” he asked.

Dr. Aalto replied that, in an earlier report from this study, investigators showed that harmful medication use was reduced and negative outcomes were reduced.

Another audience member asked why nursing staff were the target of the intervention, given that physicians do the actual drug prescribing.

Dr. Aalto responded: “It is the physician of course who prescribes, but in nursing homes and long-term care, nursing staff is there all the time, and the physicians are kind of consultants who just come there once in a while, so it’s important that the nurses also know about these harmful medications and can bring them to the doctor when he or she arrives there.”

Dr. Aalto and Dr. Ryg had no disclosures.

A simple caregiver education intervention reduced the use of psychotropic medications and associated drugs costs in long-term care facilities for the elderly in a new study.

The effect of the intervention was transient, possibly because of high staff turnover, according to the investigators in the new randomized, controlled trial.

The findings were presented by Ulla Aalto, MD, PhD, during a session at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

There was a significant reduction in the use of psychotropic agents at 6 months in long-term care wards where the nursing staff had undergone a short training session on drug therapy for older patients, but there was no improvement in wards that were randomly assigned to serve as controls, Dr. Aalto, from Helsinki Hospital, reported during the session.

“Future research would be investigating how we could maintain the positive effects that were gained at 6 months but not seen any more at 1 year, and how to implement the good practice in nursing homes by this kind of staff training,” she said.

Heavy drug use

Psychotropic medications are widely used in long-term care settings, but their indiscriminate use or use of the wrong drug for the wrong patient can be harmful. Inappropriate drug use in long-term care settings is also associated with higher costs, Dr. Aalto said.

To see whether a staff-training intervention could reduce drugs use and lower costs, the investigators conducted a randomized clinical trial in assisted living facilities in Helsinki in 2011, with a total of 227 patients 65 years and older.

Long-term care wards were randomly assigned to either an intervention for nursing staff consisting of two 4-hour sessions on good drug-therapy practice for older adults, or to serve as controls (10 wards in each group).

Drug use and costs were monitored at both 6 and 12 months after randomization. Psychotropic drugs included antipsychotics, antidepressants, anxiolytics, and hypnotics as classified by the World Health Organization. For the purposes of comparison, actual doses were counted and converted into relative proportions of defined daily doses.

The baseline characteristics of patients in each group were generally similar, with a mean age of around 83 years. In each study arm, nearly two-thirds of patients were on at least one psychotropic drug, and of this group, a third had been prescribed 2 or more psychotropic agents.

Nearly half of the patients were on at least one antipsychotic agent and/or antidepressant.
 

Short-term benefit

As noted before, in the wards randomized to staff training, there was a significant reduction in use of all psychotropics from baseline at 6 months after randomization (P = .045), but there was no change among the control wards.

By 12 months, however, the differences between the intervention and control arms narrowed, and drug use in the intervention arm was no longer significantly lower over baseline.

Drugs costs significantly decreased in the intervention group at 6 months (P = .027) and were numerically but not statistically lower over baseline at 12 months.

In contrast, drug costs in the control arm were numerically (but not statistically) higher at both 6 and 12 months of follow-up.

Annual drug costs in the intervention group decreased by mean of 12.3 euros ($14.22) whereas costs in the control group increased by a mean of 20.6 euros ($23.81).

“This quite light and feasible intervention succeeded in reducing overall defined daily doses of psychotropics in the short term,” Dr. Aalto said.

The waning of the intervention’s effect on drug use and costs may be caused partly by the high employee turnover rate in long-term care facilities and to the dilution effect, she said, referring to a form of judgment bias in which people tend to devalue diagnostic information when other, nondiagnostic information is also available.
 

Randomized design

In the question-and-answer session following her presentation, audience member Jesper Ryg, MD, PhD from Odense (Denmark) University Hospital and the University of Southern Denmark, also in Odense, commented: “It’s a great study, doing a [randomized, controlled trial] on deprescribing, we need more of those.”

“But what we know now is that a lot of studies show it is possible to deprescribe and get less drugs, but do we have any clinical data? Does this deprescribing lead to less falls, did it lead to lower mortality?” he asked.

Dr. Aalto replied that, in an earlier report from this study, investigators showed that harmful medication use was reduced and negative outcomes were reduced.

Another audience member asked why nursing staff were the target of the intervention, given that physicians do the actual drug prescribing.

Dr. Aalto responded: “It is the physician of course who prescribes, but in nursing homes and long-term care, nursing staff is there all the time, and the physicians are kind of consultants who just come there once in a while, so it’s important that the nurses also know about these harmful medications and can bring them to the doctor when he or she arrives there.”

Dr. Aalto and Dr. Ryg had no disclosures.