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HIV services are bouncing back from COVID-19 disruptions, data suggest, but recovery is ‘precarious’
Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.
These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
COVID-19 and HIV services
Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.
New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.
However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.
The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.
PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
Longer-term outcomes still unclear
Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”
Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”
Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.
Need for equitable vaccine access
For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.
Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.
A version of this article first appeared on Medscape.com.
Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.
These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
COVID-19 and HIV services
Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.
New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.
However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.
The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.
PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
Longer-term outcomes still unclear
Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”
Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”
Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.
Need for equitable vaccine access
For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.
Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.
A version of this article first appeared on Medscape.com.
Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.
These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
COVID-19 and HIV services
Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.
New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.
However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.
The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.
PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
Longer-term outcomes still unclear
Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”
Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”
Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.
Need for equitable vaccine access
For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.
Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.
A version of this article first appeared on Medscape.com.
Sociocultural stigmas provide barriers to sexual health in gay and bisexual Hispanic men
Religion and masculine ideology remain significant social cultural barriers to sexual health in Hispanic gay or bisexual men, according to new qualitative research presented at the 2021 Association of Nurses in AIDS Care conference. The pilot study also found that these men learned more sexual health information from friends and social networks than from their health care professionals.
“There’s still so much we do not know about cultural factors and the different levels of influence that shape sexual health promotion beliefs among Latinos, but moreover in Latino same-gender–loving men,” lead author Lisvel Matos, MSN, FNP-C, WHNP-BC, a PhD candidate at Duke University’s School of Nursing, Durham, N.C., said in an interview. Ms. Matos prefers the term same-gender–loving men (SGLM) over men who have sex with men, as the latter term is more clinical and can be stigmatizing.
In Ms. Matos’ 10 years of working in nursing, she noticed that this lack of understanding about sexual health in Hispanic SGLM impeded culturally relevant interventions in this population. “When we don’t have the evidence to show what’s effective for these populations,” she said, “then we’re kind of working blind.”
To get a better sense of social cultural barriers that influence sexual health, Ms. Matos and colleagues conducted 60- to 75-minute interviews with Hispanic SGLM through the secure web conferencing app WebEx from October 2020 to October 2021. The study used the World Health Organization’s definition of sexual health: “a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.” The pilot study included 15 individuals, 8 of whom were born outside of the United States. The mean age of participants was 31.4 years, and 47% reported being single and sexually active. 93% of participants said they were aware of pre-exposure prophylaxis (PrEP), and 47% reported using PrEP.
Ms. Matos identified three common themes in barriers to sexual health in these men: sexual silence, religion, and machismo, a term meaning aggressive masculine pride and patriarchal ideas of manhood. “Because of social constructs, because of what it meant to be a man, [sexual health] was a very difficult subject in adolescence,” said one participant in a quote included on the poster. “I definitely believe in Christianity, and I think that has affected my sexual preference,” said another quoted individual. “It came into that Catholic guilt where you always feel bad.”
More than half of the study participants reported not having access to health care at one time in their life, because of lack of insurance or other factors such as feeling uncomfortable or even dehumanized by health care professionals. Most men said they learned about sexual health, including PrEP, from dating apps like Grindr or friend-based social media platforms rather than in care settings. Ms. Matos, who presented the study at the conference, received the Student Poster Research Award for her work.
The findings are “a good reminder for providers” that these barriers, which have been identified for decades, are still major impediments to sexual health in Hispanic SGLM, both individually and at the clinic level, Dalmacio Dennis Flores, PhD, ACRN, an assistant professor at the University of Pennsylvania School of Nursing, Philadelphia, said in an interview. He was not involved with the work. “We need to be in a space to normalize their attractions, behaviors, and identities and then help them to be more confident about it,” he noted.
Self-confidence as well as trust in sexual partners and health providers were factors that helped these men overcome this negative messaging and sociocultural stigmas, Ms. Matos found.
“The fact that [the researchers] have individual level data about the experiences of this group of men can inform how we develop clinic-level structures that can, for example, promote trust with the provider,” added Kamila Alexander, PhD, MPH, RN, an assistant professor and associate director of PhD and postdoctoral programs at Johns Hopkins University’s School of Nursing, Baltimore.
Dr. Alexander, who was not involved with the research, added that the small study is a good starting point to better inform culturally relevant care for populations marginalized by society, like Hispanic SGLM, and to challenge ingrained stereotypes around religion, masculinity, and sexuality. The researchers “highlighted these intersectional stigmas that have a lot to do with structural factors,” she said, “and those things are really ripe for intervention.”
Ms. Matos, Dr. Flores, and Dr. Alexander disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Religion and masculine ideology remain significant social cultural barriers to sexual health in Hispanic gay or bisexual men, according to new qualitative research presented at the 2021 Association of Nurses in AIDS Care conference. The pilot study also found that these men learned more sexual health information from friends and social networks than from their health care professionals.
“There’s still so much we do not know about cultural factors and the different levels of influence that shape sexual health promotion beliefs among Latinos, but moreover in Latino same-gender–loving men,” lead author Lisvel Matos, MSN, FNP-C, WHNP-BC, a PhD candidate at Duke University’s School of Nursing, Durham, N.C., said in an interview. Ms. Matos prefers the term same-gender–loving men (SGLM) over men who have sex with men, as the latter term is more clinical and can be stigmatizing.
In Ms. Matos’ 10 years of working in nursing, she noticed that this lack of understanding about sexual health in Hispanic SGLM impeded culturally relevant interventions in this population. “When we don’t have the evidence to show what’s effective for these populations,” she said, “then we’re kind of working blind.”
To get a better sense of social cultural barriers that influence sexual health, Ms. Matos and colleagues conducted 60- to 75-minute interviews with Hispanic SGLM through the secure web conferencing app WebEx from October 2020 to October 2021. The study used the World Health Organization’s definition of sexual health: “a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.” The pilot study included 15 individuals, 8 of whom were born outside of the United States. The mean age of participants was 31.4 years, and 47% reported being single and sexually active. 93% of participants said they were aware of pre-exposure prophylaxis (PrEP), and 47% reported using PrEP.
Ms. Matos identified three common themes in barriers to sexual health in these men: sexual silence, religion, and machismo, a term meaning aggressive masculine pride and patriarchal ideas of manhood. “Because of social constructs, because of what it meant to be a man, [sexual health] was a very difficult subject in adolescence,” said one participant in a quote included on the poster. “I definitely believe in Christianity, and I think that has affected my sexual preference,” said another quoted individual. “It came into that Catholic guilt where you always feel bad.”
More than half of the study participants reported not having access to health care at one time in their life, because of lack of insurance or other factors such as feeling uncomfortable or even dehumanized by health care professionals. Most men said they learned about sexual health, including PrEP, from dating apps like Grindr or friend-based social media platforms rather than in care settings. Ms. Matos, who presented the study at the conference, received the Student Poster Research Award for her work.
The findings are “a good reminder for providers” that these barriers, which have been identified for decades, are still major impediments to sexual health in Hispanic SGLM, both individually and at the clinic level, Dalmacio Dennis Flores, PhD, ACRN, an assistant professor at the University of Pennsylvania School of Nursing, Philadelphia, said in an interview. He was not involved with the work. “We need to be in a space to normalize their attractions, behaviors, and identities and then help them to be more confident about it,” he noted.
Self-confidence as well as trust in sexual partners and health providers were factors that helped these men overcome this negative messaging and sociocultural stigmas, Ms. Matos found.
“The fact that [the researchers] have individual level data about the experiences of this group of men can inform how we develop clinic-level structures that can, for example, promote trust with the provider,” added Kamila Alexander, PhD, MPH, RN, an assistant professor and associate director of PhD and postdoctoral programs at Johns Hopkins University’s School of Nursing, Baltimore.
Dr. Alexander, who was not involved with the research, added that the small study is a good starting point to better inform culturally relevant care for populations marginalized by society, like Hispanic SGLM, and to challenge ingrained stereotypes around religion, masculinity, and sexuality. The researchers “highlighted these intersectional stigmas that have a lot to do with structural factors,” she said, “and those things are really ripe for intervention.”
Ms. Matos, Dr. Flores, and Dr. Alexander disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Religion and masculine ideology remain significant social cultural barriers to sexual health in Hispanic gay or bisexual men, according to new qualitative research presented at the 2021 Association of Nurses in AIDS Care conference. The pilot study also found that these men learned more sexual health information from friends and social networks than from their health care professionals.
“There’s still so much we do not know about cultural factors and the different levels of influence that shape sexual health promotion beliefs among Latinos, but moreover in Latino same-gender–loving men,” lead author Lisvel Matos, MSN, FNP-C, WHNP-BC, a PhD candidate at Duke University’s School of Nursing, Durham, N.C., said in an interview. Ms. Matos prefers the term same-gender–loving men (SGLM) over men who have sex with men, as the latter term is more clinical and can be stigmatizing.
In Ms. Matos’ 10 years of working in nursing, she noticed that this lack of understanding about sexual health in Hispanic SGLM impeded culturally relevant interventions in this population. “When we don’t have the evidence to show what’s effective for these populations,” she said, “then we’re kind of working blind.”
To get a better sense of social cultural barriers that influence sexual health, Ms. Matos and colleagues conducted 60- to 75-minute interviews with Hispanic SGLM through the secure web conferencing app WebEx from October 2020 to October 2021. The study used the World Health Organization’s definition of sexual health: “a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.” The pilot study included 15 individuals, 8 of whom were born outside of the United States. The mean age of participants was 31.4 years, and 47% reported being single and sexually active. 93% of participants said they were aware of pre-exposure prophylaxis (PrEP), and 47% reported using PrEP.
Ms. Matos identified three common themes in barriers to sexual health in these men: sexual silence, religion, and machismo, a term meaning aggressive masculine pride and patriarchal ideas of manhood. “Because of social constructs, because of what it meant to be a man, [sexual health] was a very difficult subject in adolescence,” said one participant in a quote included on the poster. “I definitely believe in Christianity, and I think that has affected my sexual preference,” said another quoted individual. “It came into that Catholic guilt where you always feel bad.”
More than half of the study participants reported not having access to health care at one time in their life, because of lack of insurance or other factors such as feeling uncomfortable or even dehumanized by health care professionals. Most men said they learned about sexual health, including PrEP, from dating apps like Grindr or friend-based social media platforms rather than in care settings. Ms. Matos, who presented the study at the conference, received the Student Poster Research Award for her work.
The findings are “a good reminder for providers” that these barriers, which have been identified for decades, are still major impediments to sexual health in Hispanic SGLM, both individually and at the clinic level, Dalmacio Dennis Flores, PhD, ACRN, an assistant professor at the University of Pennsylvania School of Nursing, Philadelphia, said in an interview. He was not involved with the work. “We need to be in a space to normalize their attractions, behaviors, and identities and then help them to be more confident about it,” he noted.
Self-confidence as well as trust in sexual partners and health providers were factors that helped these men overcome this negative messaging and sociocultural stigmas, Ms. Matos found.
“The fact that [the researchers] have individual level data about the experiences of this group of men can inform how we develop clinic-level structures that can, for example, promote trust with the provider,” added Kamila Alexander, PhD, MPH, RN, an assistant professor and associate director of PhD and postdoctoral programs at Johns Hopkins University’s School of Nursing, Baltimore.
Dr. Alexander, who was not involved with the research, added that the small study is a good starting point to better inform culturally relevant care for populations marginalized by society, like Hispanic SGLM, and to challenge ingrained stereotypes around religion, masculinity, and sexuality. The researchers “highlighted these intersectional stigmas that have a lot to do with structural factors,” she said, “and those things are really ripe for intervention.”
Ms. Matos, Dr. Flores, and Dr. Alexander disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ANAC 2021
Is ERCP indicated in gallstone pancreatitis without cholangitis?
Background: The timing and need for ERCP in the setting of gallstone pancreatitis without acute cholangitis has been debated widely. Guidelines recommend urgent ERCP for patients with gallstone pancreatitis with concurrent cholangitis, severe cholestasis, or a visualized stone in the duct, but it is unclear if ERCP benefits those with gallstone pancreatitis without those clear indicators.
Study design: Prospective randomized controlled superiority trial.
Setting: 26 hospitals in the Netherlands.
Synopsis: Of patients with severe gallstone pancreatitis without cholangitis, 232 were randomized 1:1 to undergo urgent ERCP with biliary sphincterotomy (less than 24 hours after presentation) or conservative therapy (analgesia, intravenous fluids, with selective ERCP for cholangitis or persistent cholestasis). The primary endpoint was a composite score of mortality or major complications within 6 months of randomization. There was no difference in the primary endpoint, which occurred in 38% of the urgent-ERCP group and 44% of the conservative-therapy group (P = .37). In a subgroup of patients with cholestasis suggestive of biliary obstruction, the primary endpoint occurred in 32% of the urgent-ERCP group and 42% in the conservative group (P = .18). Similar rates of adverse events were observed between both groups. Limitations included difficulty in diagnosis of cholangitis, moderate positive predictive value of scoring tools to isolate those with severe pancreatitis, and lack of endoscopic ultrasound to determine the presence of ductal stones or sludge.
Bottom line: Conservative management was equal to ERCP with sphincterotomy in patients with severe gallstone pancreatitis without cholangitis, and ERCP may be best reserved for patients with persistent cholestasis or later-developed cholangitis.
Citation: Schepers NJ et al. Urgent endoscopic retrograde cholangiopancreatography with sphincterotomy versus conservative treatment in predicted severe acute gallstone pancreatitis (APEC): A multicentre randomised controlled trial. Lancet. 2020;396:167-76. doi: 10.1016/S0140-6736(20)30539-0.
Dr. Reddy is a hospitalist at Northwestern Memorial Hospital and instructor of medicine, Feinberg School of Medicine, both in Chicago.
Background: The timing and need for ERCP in the setting of gallstone pancreatitis without acute cholangitis has been debated widely. Guidelines recommend urgent ERCP for patients with gallstone pancreatitis with concurrent cholangitis, severe cholestasis, or a visualized stone in the duct, but it is unclear if ERCP benefits those with gallstone pancreatitis without those clear indicators.
Study design: Prospective randomized controlled superiority trial.
Setting: 26 hospitals in the Netherlands.
Synopsis: Of patients with severe gallstone pancreatitis without cholangitis, 232 were randomized 1:1 to undergo urgent ERCP with biliary sphincterotomy (less than 24 hours after presentation) or conservative therapy (analgesia, intravenous fluids, with selective ERCP for cholangitis or persistent cholestasis). The primary endpoint was a composite score of mortality or major complications within 6 months of randomization. There was no difference in the primary endpoint, which occurred in 38% of the urgent-ERCP group and 44% of the conservative-therapy group (P = .37). In a subgroup of patients with cholestasis suggestive of biliary obstruction, the primary endpoint occurred in 32% of the urgent-ERCP group and 42% in the conservative group (P = .18). Similar rates of adverse events were observed between both groups. Limitations included difficulty in diagnosis of cholangitis, moderate positive predictive value of scoring tools to isolate those with severe pancreatitis, and lack of endoscopic ultrasound to determine the presence of ductal stones or sludge.
Bottom line: Conservative management was equal to ERCP with sphincterotomy in patients with severe gallstone pancreatitis without cholangitis, and ERCP may be best reserved for patients with persistent cholestasis or later-developed cholangitis.
Citation: Schepers NJ et al. Urgent endoscopic retrograde cholangiopancreatography with sphincterotomy versus conservative treatment in predicted severe acute gallstone pancreatitis (APEC): A multicentre randomised controlled trial. Lancet. 2020;396:167-76. doi: 10.1016/S0140-6736(20)30539-0.
Dr. Reddy is a hospitalist at Northwestern Memorial Hospital and instructor of medicine, Feinberg School of Medicine, both in Chicago.
Background: The timing and need for ERCP in the setting of gallstone pancreatitis without acute cholangitis has been debated widely. Guidelines recommend urgent ERCP for patients with gallstone pancreatitis with concurrent cholangitis, severe cholestasis, or a visualized stone in the duct, but it is unclear if ERCP benefits those with gallstone pancreatitis without those clear indicators.
Study design: Prospective randomized controlled superiority trial.
Setting: 26 hospitals in the Netherlands.
Synopsis: Of patients with severe gallstone pancreatitis without cholangitis, 232 were randomized 1:1 to undergo urgent ERCP with biliary sphincterotomy (less than 24 hours after presentation) or conservative therapy (analgesia, intravenous fluids, with selective ERCP for cholangitis or persistent cholestasis). The primary endpoint was a composite score of mortality or major complications within 6 months of randomization. There was no difference in the primary endpoint, which occurred in 38% of the urgent-ERCP group and 44% of the conservative-therapy group (P = .37). In a subgroup of patients with cholestasis suggestive of biliary obstruction, the primary endpoint occurred in 32% of the urgent-ERCP group and 42% in the conservative group (P = .18). Similar rates of adverse events were observed between both groups. Limitations included difficulty in diagnosis of cholangitis, moderate positive predictive value of scoring tools to isolate those with severe pancreatitis, and lack of endoscopic ultrasound to determine the presence of ductal stones or sludge.
Bottom line: Conservative management was equal to ERCP with sphincterotomy in patients with severe gallstone pancreatitis without cholangitis, and ERCP may be best reserved for patients with persistent cholestasis or later-developed cholangitis.
Citation: Schepers NJ et al. Urgent endoscopic retrograde cholangiopancreatography with sphincterotomy versus conservative treatment in predicted severe acute gallstone pancreatitis (APEC): A multicentre randomised controlled trial. Lancet. 2020;396:167-76. doi: 10.1016/S0140-6736(20)30539-0.
Dr. Reddy is a hospitalist at Northwestern Memorial Hospital and instructor of medicine, Feinberg School of Medicine, both in Chicago.
In pill or food form, healthy fatty acids reduce liver fat
For patients with nonalcoholic fatty liver disease (NAFLD) who supplement their diets with polyunsaturated fatty acids (PUFA), liver and metabolic parameters improve, results of a systematic review and meta-analysis suggest.
Data from randomized clinical trials show that, for participants with NAFLD who used PUFA supplements with or without additional dietary interventions, hepatic steatosis and lobular inflammation decreased, and in one study, fibrosis decreased. There were also improvements in liver enzyme levels, said Saleh Alqahtani, MBChB, associate professor of medicine at Johns Hopkins University, Baltimore, during a presentation at the annual meeting of the American Association for the Study of Liver Diseases.
“Since there’s no effective medical therapy for NAFLD, weight loss through lifestyle modifications becomes the most important focused intervention for patients with NAFLD,” he said. “However, the majority of patients fail to achieve or to maintain weight loss for long-term therapy. Therefore, dietary intervention or supplementation might help reduce the prevalence of NAFLD and decrease the progression of nonalcoholic steatohepatitis [NASH] and liver cirrhosis.
“More clinical trials are warranted to determine the long-term efficacy of the Mediterranean diet and polyunsaturated fatty acid supplementation among adult patients with NAFLD,” he added.
RCTs and case-control studies
It’s well documented that consumption of PUFAs, found in fatty fish and in canola, grapeseed, corn, and soybean oils, as well as monounsaturated fatty acids, found in olive oil and peanut oil, can contribute to improvement of NALFD, Dr. Alqahtani said.
In contrast, foods high in saturated fatty acids, such as butter, as well as trans fats and cholesterol can contribute to NAFLD progression, he said.
In their studies of intrahepatic triglyceride content, Dr. Alqahtani and colleagues found that fatty acids in the liver come from three major sources: dietary fatty acids, which account for about 15% of liver fat, tissue lipolysis, and de novo hepatic lipogenesis.
Previous systematic reviews and meta-analyses of the relationship between diet and NAFLD have focused on marine-based (n-3) PUFAs, but “the data regarding the evidence of unsaturated fatty acids through supplements or monounsaturated fatty acids through dietary supplementation are lacking,” he said.
To summarize the effects of dietary or supplemental fatty acids on liver and metabolic parameters in adults with NAFLD, Dr. Alqahtani and colleagues conducted a systematic review and meta-analysis, concentrating on studies that included specifics about interventions and outcomes.
They identified a total of 18 randomized controlled trials and 4 case-control studies that met their criteria. The studies were published from 2008 to 2020.
Regarding the effects of interventions on the components of NASH, they found that, in 1 or more of 12 randomized trials of PUFA supplementation with or without dietary interventions, there were associations with decreased hepatic steatosis, lobular inflammation, and fibrosis and declines in ALT and AST levels.
In three trials of dietary-only interventions, there were decreases in hepatic steatosis and ALT and/or AST levels. In two studies of the effects of healthy cooking oils only, hepatic steatosis decreased, but there was no effect on ALT or AST levels.
All three interventions were associated with improvements in fasting glucose levels and insulin metabolism, as well as decreases in total cholesterol, triglycerides, and LDL cholesterol and increases in HDL cholesterol.
Better understanding of dietary composition
“We’ve known for a while that dietary composition may impact NAFLD and NASH,” said Manal F. Abdelmalek, MD, professor of medicine at Duke University, Durham, N.C., who commented on the study.
“What [Dr. Alqahtani and colleagues] have shown is that supplementation with healthy fatty acids improves fatty liver. This really does extend our knowledge of what we understand about dietary composition, particularly the recommendations that support higher fish consumption and a Mediterranean-style diet,” she said.
“It’s not just about the fat but the type of fat that’s consumed, and drilling down to the particulars of dietary composition beyond calories alone,” she added.
No source of funding for the study has been disclosed. Dr. Alqahtani and Dr. Abdelmalek have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For patients with nonalcoholic fatty liver disease (NAFLD) who supplement their diets with polyunsaturated fatty acids (PUFA), liver and metabolic parameters improve, results of a systematic review and meta-analysis suggest.
Data from randomized clinical trials show that, for participants with NAFLD who used PUFA supplements with or without additional dietary interventions, hepatic steatosis and lobular inflammation decreased, and in one study, fibrosis decreased. There were also improvements in liver enzyme levels, said Saleh Alqahtani, MBChB, associate professor of medicine at Johns Hopkins University, Baltimore, during a presentation at the annual meeting of the American Association for the Study of Liver Diseases.
“Since there’s no effective medical therapy for NAFLD, weight loss through lifestyle modifications becomes the most important focused intervention for patients with NAFLD,” he said. “However, the majority of patients fail to achieve or to maintain weight loss for long-term therapy. Therefore, dietary intervention or supplementation might help reduce the prevalence of NAFLD and decrease the progression of nonalcoholic steatohepatitis [NASH] and liver cirrhosis.
“More clinical trials are warranted to determine the long-term efficacy of the Mediterranean diet and polyunsaturated fatty acid supplementation among adult patients with NAFLD,” he added.
RCTs and case-control studies
It’s well documented that consumption of PUFAs, found in fatty fish and in canola, grapeseed, corn, and soybean oils, as well as monounsaturated fatty acids, found in olive oil and peanut oil, can contribute to improvement of NALFD, Dr. Alqahtani said.
In contrast, foods high in saturated fatty acids, such as butter, as well as trans fats and cholesterol can contribute to NAFLD progression, he said.
In their studies of intrahepatic triglyceride content, Dr. Alqahtani and colleagues found that fatty acids in the liver come from three major sources: dietary fatty acids, which account for about 15% of liver fat, tissue lipolysis, and de novo hepatic lipogenesis.
Previous systematic reviews and meta-analyses of the relationship between diet and NAFLD have focused on marine-based (n-3) PUFAs, but “the data regarding the evidence of unsaturated fatty acids through supplements or monounsaturated fatty acids through dietary supplementation are lacking,” he said.
To summarize the effects of dietary or supplemental fatty acids on liver and metabolic parameters in adults with NAFLD, Dr. Alqahtani and colleagues conducted a systematic review and meta-analysis, concentrating on studies that included specifics about interventions and outcomes.
They identified a total of 18 randomized controlled trials and 4 case-control studies that met their criteria. The studies were published from 2008 to 2020.
Regarding the effects of interventions on the components of NASH, they found that, in 1 or more of 12 randomized trials of PUFA supplementation with or without dietary interventions, there were associations with decreased hepatic steatosis, lobular inflammation, and fibrosis and declines in ALT and AST levels.
In three trials of dietary-only interventions, there were decreases in hepatic steatosis and ALT and/or AST levels. In two studies of the effects of healthy cooking oils only, hepatic steatosis decreased, but there was no effect on ALT or AST levels.
All three interventions were associated with improvements in fasting glucose levels and insulin metabolism, as well as decreases in total cholesterol, triglycerides, and LDL cholesterol and increases in HDL cholesterol.
Better understanding of dietary composition
“We’ve known for a while that dietary composition may impact NAFLD and NASH,” said Manal F. Abdelmalek, MD, professor of medicine at Duke University, Durham, N.C., who commented on the study.
“What [Dr. Alqahtani and colleagues] have shown is that supplementation with healthy fatty acids improves fatty liver. This really does extend our knowledge of what we understand about dietary composition, particularly the recommendations that support higher fish consumption and a Mediterranean-style diet,” she said.
“It’s not just about the fat but the type of fat that’s consumed, and drilling down to the particulars of dietary composition beyond calories alone,” she added.
No source of funding for the study has been disclosed. Dr. Alqahtani and Dr. Abdelmalek have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For patients with nonalcoholic fatty liver disease (NAFLD) who supplement their diets with polyunsaturated fatty acids (PUFA), liver and metabolic parameters improve, results of a systematic review and meta-analysis suggest.
Data from randomized clinical trials show that, for participants with NAFLD who used PUFA supplements with or without additional dietary interventions, hepatic steatosis and lobular inflammation decreased, and in one study, fibrosis decreased. There were also improvements in liver enzyme levels, said Saleh Alqahtani, MBChB, associate professor of medicine at Johns Hopkins University, Baltimore, during a presentation at the annual meeting of the American Association for the Study of Liver Diseases.
“Since there’s no effective medical therapy for NAFLD, weight loss through lifestyle modifications becomes the most important focused intervention for patients with NAFLD,” he said. “However, the majority of patients fail to achieve or to maintain weight loss for long-term therapy. Therefore, dietary intervention or supplementation might help reduce the prevalence of NAFLD and decrease the progression of nonalcoholic steatohepatitis [NASH] and liver cirrhosis.
“More clinical trials are warranted to determine the long-term efficacy of the Mediterranean diet and polyunsaturated fatty acid supplementation among adult patients with NAFLD,” he added.
RCTs and case-control studies
It’s well documented that consumption of PUFAs, found in fatty fish and in canola, grapeseed, corn, and soybean oils, as well as monounsaturated fatty acids, found in olive oil and peanut oil, can contribute to improvement of NALFD, Dr. Alqahtani said.
In contrast, foods high in saturated fatty acids, such as butter, as well as trans fats and cholesterol can contribute to NAFLD progression, he said.
In their studies of intrahepatic triglyceride content, Dr. Alqahtani and colleagues found that fatty acids in the liver come from three major sources: dietary fatty acids, which account for about 15% of liver fat, tissue lipolysis, and de novo hepatic lipogenesis.
Previous systematic reviews and meta-analyses of the relationship between diet and NAFLD have focused on marine-based (n-3) PUFAs, but “the data regarding the evidence of unsaturated fatty acids through supplements or monounsaturated fatty acids through dietary supplementation are lacking,” he said.
To summarize the effects of dietary or supplemental fatty acids on liver and metabolic parameters in adults with NAFLD, Dr. Alqahtani and colleagues conducted a systematic review and meta-analysis, concentrating on studies that included specifics about interventions and outcomes.
They identified a total of 18 randomized controlled trials and 4 case-control studies that met their criteria. The studies were published from 2008 to 2020.
Regarding the effects of interventions on the components of NASH, they found that, in 1 or more of 12 randomized trials of PUFA supplementation with or without dietary interventions, there were associations with decreased hepatic steatosis, lobular inflammation, and fibrosis and declines in ALT and AST levels.
In three trials of dietary-only interventions, there were decreases in hepatic steatosis and ALT and/or AST levels. In two studies of the effects of healthy cooking oils only, hepatic steatosis decreased, but there was no effect on ALT or AST levels.
All three interventions were associated with improvements in fasting glucose levels and insulin metabolism, as well as decreases in total cholesterol, triglycerides, and LDL cholesterol and increases in HDL cholesterol.
Better understanding of dietary composition
“We’ve known for a while that dietary composition may impact NAFLD and NASH,” said Manal F. Abdelmalek, MD, professor of medicine at Duke University, Durham, N.C., who commented on the study.
“What [Dr. Alqahtani and colleagues] have shown is that supplementation with healthy fatty acids improves fatty liver. This really does extend our knowledge of what we understand about dietary composition, particularly the recommendations that support higher fish consumption and a Mediterranean-style diet,” she said.
“It’s not just about the fat but the type of fat that’s consumed, and drilling down to the particulars of dietary composition beyond calories alone,” she added.
No source of funding for the study has been disclosed. Dr. Alqahtani and Dr. Abdelmalek have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LIVER MEETING 2021
Immunotherapies for children with r/r ALL face off
It’s possible to compare apples and oranges – both are fruits, after all; likewise, in the absence of head-to-head trials, it’s possible to make an indirect comparison of two immunotherapy strategies for treating relapsed or refractory pediatric acute lymphoblastic leukemia (r/r ALL): chimeric antigen receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah), and immunotherapy with the bi-specific T-cell engager (BiTE) blinatumomab (Blincyto).
Michael Verneris, MD, of the University of Colorado Anschutz Medical Center in Aurora, and associates carried out the first such indirect, patient-level comparison of these two immunotherapies.
“The large differences in CR and OS outcomes across multiple differing assessments suggest that our findings describe a true treatment impact. Although the current analysis is retrospective and limited by cross-study comparison, these findings support the growing body of clinical trial and real-world evidence demonstrating that tisagenlecleucel is an important treatment option for children and young adults with r/r ALL,” they wrote in an article published in Blood Advances.
However, as two pediatric leukemia experts uninvolved in the study noted, the comparison may be of limited use because the two immunotherapy agents can have different indications and applications, depending on the clinical situation.
Trial data compared
Dr. Verneris and colleagues looked at patient-level data from two clinical trials: the phase 2 single-arm ELIANA trial evaluating tisagenlecleucel in patients with relapsed and refractory B-cell lineage ALL (79 patients), and the efficacy phase of the MT103-205 trial assessing blinatumomab in a similar population (70 patients).
To account for differences between the studies, the investigators used five different statistical approaches, including propensity score weighting and adjustment for prognostic factors.
Regardless of the analytical method they used, results showed that patients treated with tisagenlecleucel were significantly more likely to have complete remissions than were patients treated with blinatumomab, with odds ratios favoring the CAR T-cell construct ranging from 6.71 to 9.76.
Similarly, treatment with tisagenlecleucel was associated with lower risk for death, with hazard ratios ranging from 68% to 74%.
The authors acknowledged that some prognostic variables such as bone marrow blast count, remission duration, and performance status were not recorded in the patient level data from the blinatumomab trial and therefore they could not be used in the analyses. They also conceded that selection bias could account for some of the differences in outcomes between the trials.
Patient characteristics drive choice
The comparison of the two agents “is something we as treating physicians often think about, because we are faced with a choice often of tisagenlecleucel or blinatumomab when we have a relapsed/refractory patient, ” Melinda Pauly, MD, medical director of oncology at the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, said in an interview.
Dr. Pauly, who was not involved in the study, said that the choice of therapy is based primarily on patient characteristics and the specific clinical situation.
“For patients who have prior toxicity with bone marrow transplant or don’t have a good donor option for bone marrow transplant, those are certainly patients that we are looking for a therapy that would be more sustained, and that would definitely be the tisagenlecleucel,” she said.
CAR T-cell therapy may not be an immediate option for patients for whom time is critical, however, due to the requirements of apheresis for T-cell harvesting, cell transduction, expansion, and infusion, and for such patients who have disease refractory to chemotherapy, blinatumomab may be an option.
Blinatumomab may also serve as a bridge to transplant, she said.
Dr. Pauly, who has a special interest in the care of infants with ALL, noted that apheresis can be difficult to accomplish in very young patients and may not yield T-cells sufficient for CAR T therapy, and for these patients blinatumomab may be the better option.
Howard Weinstein, MD, unit chief of the division of pediatric hematology/oncology at Mass General Hospital for Children in Boston, noted that “there are all kinds of statistical methodologies to try to balance the two populations in the studies, and they did as best as you can at balancing the risk factors, such as the number of patients with relapses after prior bone marrow transplants.”
“But there are so many genetic subtypes of acute lymphoblastic leukemia that have differing prognoses, it’s hard to do this kind of retrospective analysis when it’s not a randomized head-to-head trial,” he said in an interview.
Novartis Pharmaceuticals, maker of tisagenlecleucel, sponsored the study. Dr. Verneris disclosed serving on advisory boards for Novartis, and five of the study coauthors are employees of the company. Dr. Pauly and Dr. Weinstein reported having no conflicts of interest.
It’s possible to compare apples and oranges – both are fruits, after all; likewise, in the absence of head-to-head trials, it’s possible to make an indirect comparison of two immunotherapy strategies for treating relapsed or refractory pediatric acute lymphoblastic leukemia (r/r ALL): chimeric antigen receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah), and immunotherapy with the bi-specific T-cell engager (BiTE) blinatumomab (Blincyto).
Michael Verneris, MD, of the University of Colorado Anschutz Medical Center in Aurora, and associates carried out the first such indirect, patient-level comparison of these two immunotherapies.
“The large differences in CR and OS outcomes across multiple differing assessments suggest that our findings describe a true treatment impact. Although the current analysis is retrospective and limited by cross-study comparison, these findings support the growing body of clinical trial and real-world evidence demonstrating that tisagenlecleucel is an important treatment option for children and young adults with r/r ALL,” they wrote in an article published in Blood Advances.
However, as two pediatric leukemia experts uninvolved in the study noted, the comparison may be of limited use because the two immunotherapy agents can have different indications and applications, depending on the clinical situation.
Trial data compared
Dr. Verneris and colleagues looked at patient-level data from two clinical trials: the phase 2 single-arm ELIANA trial evaluating tisagenlecleucel in patients with relapsed and refractory B-cell lineage ALL (79 patients), and the efficacy phase of the MT103-205 trial assessing blinatumomab in a similar population (70 patients).
To account for differences between the studies, the investigators used five different statistical approaches, including propensity score weighting and adjustment for prognostic factors.
Regardless of the analytical method they used, results showed that patients treated with tisagenlecleucel were significantly more likely to have complete remissions than were patients treated with blinatumomab, with odds ratios favoring the CAR T-cell construct ranging from 6.71 to 9.76.
Similarly, treatment with tisagenlecleucel was associated with lower risk for death, with hazard ratios ranging from 68% to 74%.
The authors acknowledged that some prognostic variables such as bone marrow blast count, remission duration, and performance status were not recorded in the patient level data from the blinatumomab trial and therefore they could not be used in the analyses. They also conceded that selection bias could account for some of the differences in outcomes between the trials.
Patient characteristics drive choice
The comparison of the two agents “is something we as treating physicians often think about, because we are faced with a choice often of tisagenlecleucel or blinatumomab when we have a relapsed/refractory patient, ” Melinda Pauly, MD, medical director of oncology at the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, said in an interview.
Dr. Pauly, who was not involved in the study, said that the choice of therapy is based primarily on patient characteristics and the specific clinical situation.
“For patients who have prior toxicity with bone marrow transplant or don’t have a good donor option for bone marrow transplant, those are certainly patients that we are looking for a therapy that would be more sustained, and that would definitely be the tisagenlecleucel,” she said.
CAR T-cell therapy may not be an immediate option for patients for whom time is critical, however, due to the requirements of apheresis for T-cell harvesting, cell transduction, expansion, and infusion, and for such patients who have disease refractory to chemotherapy, blinatumomab may be an option.
Blinatumomab may also serve as a bridge to transplant, she said.
Dr. Pauly, who has a special interest in the care of infants with ALL, noted that apheresis can be difficult to accomplish in very young patients and may not yield T-cells sufficient for CAR T therapy, and for these patients blinatumomab may be the better option.
Howard Weinstein, MD, unit chief of the division of pediatric hematology/oncology at Mass General Hospital for Children in Boston, noted that “there are all kinds of statistical methodologies to try to balance the two populations in the studies, and they did as best as you can at balancing the risk factors, such as the number of patients with relapses after prior bone marrow transplants.”
“But there are so many genetic subtypes of acute lymphoblastic leukemia that have differing prognoses, it’s hard to do this kind of retrospective analysis when it’s not a randomized head-to-head trial,” he said in an interview.
Novartis Pharmaceuticals, maker of tisagenlecleucel, sponsored the study. Dr. Verneris disclosed serving on advisory boards for Novartis, and five of the study coauthors are employees of the company. Dr. Pauly and Dr. Weinstein reported having no conflicts of interest.
It’s possible to compare apples and oranges – both are fruits, after all; likewise, in the absence of head-to-head trials, it’s possible to make an indirect comparison of two immunotherapy strategies for treating relapsed or refractory pediatric acute lymphoblastic leukemia (r/r ALL): chimeric antigen receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah), and immunotherapy with the bi-specific T-cell engager (BiTE) blinatumomab (Blincyto).
Michael Verneris, MD, of the University of Colorado Anschutz Medical Center in Aurora, and associates carried out the first such indirect, patient-level comparison of these two immunotherapies.
“The large differences in CR and OS outcomes across multiple differing assessments suggest that our findings describe a true treatment impact. Although the current analysis is retrospective and limited by cross-study comparison, these findings support the growing body of clinical trial and real-world evidence demonstrating that tisagenlecleucel is an important treatment option for children and young adults with r/r ALL,” they wrote in an article published in Blood Advances.
However, as two pediatric leukemia experts uninvolved in the study noted, the comparison may be of limited use because the two immunotherapy agents can have different indications and applications, depending on the clinical situation.
Trial data compared
Dr. Verneris and colleagues looked at patient-level data from two clinical trials: the phase 2 single-arm ELIANA trial evaluating tisagenlecleucel in patients with relapsed and refractory B-cell lineage ALL (79 patients), and the efficacy phase of the MT103-205 trial assessing blinatumomab in a similar population (70 patients).
To account for differences between the studies, the investigators used five different statistical approaches, including propensity score weighting and adjustment for prognostic factors.
Regardless of the analytical method they used, results showed that patients treated with tisagenlecleucel were significantly more likely to have complete remissions than were patients treated with blinatumomab, with odds ratios favoring the CAR T-cell construct ranging from 6.71 to 9.76.
Similarly, treatment with tisagenlecleucel was associated with lower risk for death, with hazard ratios ranging from 68% to 74%.
The authors acknowledged that some prognostic variables such as bone marrow blast count, remission duration, and performance status were not recorded in the patient level data from the blinatumomab trial and therefore they could not be used in the analyses. They also conceded that selection bias could account for some of the differences in outcomes between the trials.
Patient characteristics drive choice
The comparison of the two agents “is something we as treating physicians often think about, because we are faced with a choice often of tisagenlecleucel or blinatumomab when we have a relapsed/refractory patient, ” Melinda Pauly, MD, medical director of oncology at the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, said in an interview.
Dr. Pauly, who was not involved in the study, said that the choice of therapy is based primarily on patient characteristics and the specific clinical situation.
“For patients who have prior toxicity with bone marrow transplant or don’t have a good donor option for bone marrow transplant, those are certainly patients that we are looking for a therapy that would be more sustained, and that would definitely be the tisagenlecleucel,” she said.
CAR T-cell therapy may not be an immediate option for patients for whom time is critical, however, due to the requirements of apheresis for T-cell harvesting, cell transduction, expansion, and infusion, and for such patients who have disease refractory to chemotherapy, blinatumomab may be an option.
Blinatumomab may also serve as a bridge to transplant, she said.
Dr. Pauly, who has a special interest in the care of infants with ALL, noted that apheresis can be difficult to accomplish in very young patients and may not yield T-cells sufficient for CAR T therapy, and for these patients blinatumomab may be the better option.
Howard Weinstein, MD, unit chief of the division of pediatric hematology/oncology at Mass General Hospital for Children in Boston, noted that “there are all kinds of statistical methodologies to try to balance the two populations in the studies, and they did as best as you can at balancing the risk factors, such as the number of patients with relapses after prior bone marrow transplants.”
“But there are so many genetic subtypes of acute lymphoblastic leukemia that have differing prognoses, it’s hard to do this kind of retrospective analysis when it’s not a randomized head-to-head trial,” he said in an interview.
Novartis Pharmaceuticals, maker of tisagenlecleucel, sponsored the study. Dr. Verneris disclosed serving on advisory boards for Novartis, and five of the study coauthors are employees of the company. Dr. Pauly and Dr. Weinstein reported having no conflicts of interest.
FROM BLOOD ADVANCES
Topical options for acne patients continue to expand
yet they are likely underused in today’s clinical practice.
A study of prescribing practices from 2012 to 2014 indicated that dermatologists prescribed retinoids for just 58.8% of acne cases, while nondermatologists prescribed them for only 32.4% of cases. “If the guidelines are telling us that we should use topical retinoids for almost all of our acne patients, why are we using them for half of the patients?” Emmy Graber, MD, MBA, asked during MedscapeLive’s annual Las Vegas Dermatology Seminar. “We have a lot of options today for topical retinoids,” she added, noting that, in the past few years, trifarotene cream 0.005% and new formulations of tazarotene lotion (0.045%) and tretinoin lotion (0.05%) have become available.
According to Dr. Graber, president of The Dermatology Institute of Boston, tazarotene has been considered the most efficacious topical retinoid but is generally the least well tolerated, while adapalene has often been considered to be one of the better-tolerated topical retinoids. “This is a broad generalization,” she said. “One should also take into account the concentration and formulation of the retinoid. Cutaneous adverse events increase in severity as the concentration increases regardless of the vehicle.” There are no studies comparing trifarotene with other topical retinoids, she added.
In two phase 2, double-blind, vehicle-controlled studies (PERFECT 1 and PERFECT 2), researchers randomized more than 2,400 patients with moderate facial or truncal acne to receive trifarotene cream or a vehicle for 12 weeks. The mean percent change from baseline in facial inflammatory lesions in the trifarotene-treated group was –54.4% and –66.2% in PERFECT 1, and PERFECT 2, respectively, while the mean percent change from baseline in facial noninflammatory lesions was –49.7% and –57.7%, respectively.
In addition, the mean percent change from baseline in truncal inflammatory lesions in the trifarotene-treated groups was –57.4% and –65.4%, respectively, while the mean percent change from baseline in truncal noninflammatory lesions was –49.1% and –55.2%, respectively.
The choice of vehicle may affect absorption of topical retinoids, and some formulations may increase skin hydration and decrease transepidermal water loss, “which is a good thing,” Dr. Graber said. “Also, vehicles aim to slow drug delivery over time while also making sure that the drug penetrates into the pilosebaceous unit.”
One recent advance is the honeycomb-like polymeric emulsion technology found in tretinoin 0.05% lotion and tazarotene 0.045% lotion. These formulations contain droplets of the tretinoin and tazarotene embedded in a honeycomb matrix with hydrating agents. “I think this is exciting and could enhance our patient compliance and tolerability,” she said. Another unique feature about these two products, especially the tretinoin product, is the very small particle size with this new formulation. “It’s small enough that it can penetrate down into the pilosebaceous unit,” which is different than with older formulations, in which the tretinoin “largely just sat on the surface of the skin and didn’t penetrate into the pilosebaceous unit.” In addition, she said, “there’s only 9% degradation of the tretinoin in UV light, compared to 72% degradation of standard tretinoin 0.025% gel, and with the new tretinoin formulation, there’s no degradation when used with benzoyl peroxide.”
Another new topical retinoid to consider is a fixed-dose combination of encapsulated benzoyl peroxide 3% and encapsulated tretinoin 0.1% cream (Twyneo), which was approved by the Food and Drug Administration in July 2021 for the treatment of acne in adults and children aged 9 years and older. “Typically, benzoyl peroxide and tretinoin cannot be mixed in the same tube to stability issues,” she said. “Here, each product is individually encapsulated in a silica shell so that they can be applied together.”
The approval was supported by positive results from two phase 3, randomized, double-blind, vehicle-controlled, multicenter studies (NCT03761784 and NCT03761810), in which Twyneo demonstrated efficacy and a favorable tolerability profile in patients aged 9 years and older with facial acne.
Another topical treatment option, dapsone, is now FDA approved for ages 9 and up, expanded from its initial indication for ages 12 and up. The new indication is based on a phase 4, multicenter, open-label study in which acne patients aged 9-11 years applied dapsone 7.5% gel once daily to the face and acne-affected areas on the upper chest, upper back, and shoulders for 12 weeks. After 12 weeks, facial acne was clear or almost clear in about 47% of patients. “Inflammatory, noninflammatory, and total lesions decreased from baseline, but there was a greater reduction in noninflammatory lesions, so if you have a very young patient with acne, now you can consider dapsone gel,” Dr. Graber said.
In August 2020, clascoterone cream became the first topical androgen receptor inhibitor approved for the treatment of acne in patients 12 years of age and older. It is a drug believed to address sebum and inflammation directly in the sebaceous gland and is structurally similar to dihydrotestosterone and spironolactone.
“This is a completely new drug category in acne,” she said. “Unlike all oral antiandrogen therapies, clascoterone cream can be used in both males and females with acne. It’s the first acne drug to have a new mechanism of action in almost 40 years, since isotretinoin was approved in 1982.”
In vitro, she continued, clascoterone competes with dihydrotestosterone for binding to the androgen receptor, inhibiting downstream signaling and leading to inhibited sebum production, reduced secretion of inflammatory cytokines, and inhibition of inflammatory pathways. Two phase 3 studies that led to its approval involved 1,440 patients with moderate to severe facial acne aged 9-58 years. The cream was applied twice a day for 12 weeks and treatment adherence was approximately 90%. The researchers found that clascoterone cream was significantly more effective than vehicle cream at achieving Investigator’s Global Assessment scores of 0 (clear) or 1 (almost clear), the definition of treatment success in the study, and reducing noninflammatory lesion and inflammatory lesion counts at week 12. “There were no safety issues noted during these studies, and clascoterone cream was well tolerated,” Dr. Graber said.
Dr. Graber disclosed that she is a consultant/adviser for Digital Diagnostics, Almirall, Hovione, Keratin Biosciences, La Roche Posay, Ortho Dermatologics, Sebacia, Sol-Gel, Verrica, and WebMD. She is also a research investigator for Hovione, Ortho Dermatologics, Sebacia, and she receives royalties from Wolters Kluwer Health.
MedscapeLive and this news organization are owned by the same parent company.
Commentary by Lawrence W. Eichenfield, MD
Acne vulgaris remains an issue of tremendous importance to preteens, teens, and young adults, with approximately 85% of individuals aged 12-24 being affected. Expanding options for topical treatments may help bring effective disease control. Dr. Graber pointed out that historically, pediatricians and other primary care practitioners utilize topical retinoids less often for acne care as compared with dermatologists or guidelines recommendations (either the AAP’s or AAD’s). There are now expanded options, including over-the-counter retinoids (adapalene 0.1% gel), generic and trade brand topical tretinoin products, prescription adapalene medications, older and recently approved tazarotene products, and a newer type of topical retinoid, trifarotene. Novel formulations and emulsion technology, as well as retinoid developed in combination products, give more options in patients down to 9 years of age. A novel topical anti-androgen, clascoterone, is in its own category, as the first topical “hormonal agent,” allowing hormonal therapy to be used for males as well as females (aged 12 years and up). A recent review in JAMA (2021 Nov 23;326[20]:2055-67) incorporates many of these newer medications into management suggestions, emphasizing that first-line therapies are topical retinoids, benzoyl peroxide, azelaic acid, or combinations of topicals, whereas in more severe disease, oral antibiotics such as doxycycline or minocycline, hormonal therapies such as combination oral conceptive agents or spironolactone, or isotretinoin are most effective.
Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.
A version of this article first appeared on Medscape.com.
This article was updated 6/18/22.
yet they are likely underused in today’s clinical practice.
A study of prescribing practices from 2012 to 2014 indicated that dermatologists prescribed retinoids for just 58.8% of acne cases, while nondermatologists prescribed them for only 32.4% of cases. “If the guidelines are telling us that we should use topical retinoids for almost all of our acne patients, why are we using them for half of the patients?” Emmy Graber, MD, MBA, asked during MedscapeLive’s annual Las Vegas Dermatology Seminar. “We have a lot of options today for topical retinoids,” she added, noting that, in the past few years, trifarotene cream 0.005% and new formulations of tazarotene lotion (0.045%) and tretinoin lotion (0.05%) have become available.
According to Dr. Graber, president of The Dermatology Institute of Boston, tazarotene has been considered the most efficacious topical retinoid but is generally the least well tolerated, while adapalene has often been considered to be one of the better-tolerated topical retinoids. “This is a broad generalization,” she said. “One should also take into account the concentration and formulation of the retinoid. Cutaneous adverse events increase in severity as the concentration increases regardless of the vehicle.” There are no studies comparing trifarotene with other topical retinoids, she added.
In two phase 2, double-blind, vehicle-controlled studies (PERFECT 1 and PERFECT 2), researchers randomized more than 2,400 patients with moderate facial or truncal acne to receive trifarotene cream or a vehicle for 12 weeks. The mean percent change from baseline in facial inflammatory lesions in the trifarotene-treated group was –54.4% and –66.2% in PERFECT 1, and PERFECT 2, respectively, while the mean percent change from baseline in facial noninflammatory lesions was –49.7% and –57.7%, respectively.
In addition, the mean percent change from baseline in truncal inflammatory lesions in the trifarotene-treated groups was –57.4% and –65.4%, respectively, while the mean percent change from baseline in truncal noninflammatory lesions was –49.1% and –55.2%, respectively.
The choice of vehicle may affect absorption of topical retinoids, and some formulations may increase skin hydration and decrease transepidermal water loss, “which is a good thing,” Dr. Graber said. “Also, vehicles aim to slow drug delivery over time while also making sure that the drug penetrates into the pilosebaceous unit.”
One recent advance is the honeycomb-like polymeric emulsion technology found in tretinoin 0.05% lotion and tazarotene 0.045% lotion. These formulations contain droplets of the tretinoin and tazarotene embedded in a honeycomb matrix with hydrating agents. “I think this is exciting and could enhance our patient compliance and tolerability,” she said. Another unique feature about these two products, especially the tretinoin product, is the very small particle size with this new formulation. “It’s small enough that it can penetrate down into the pilosebaceous unit,” which is different than with older formulations, in which the tretinoin “largely just sat on the surface of the skin and didn’t penetrate into the pilosebaceous unit.” In addition, she said, “there’s only 9% degradation of the tretinoin in UV light, compared to 72% degradation of standard tretinoin 0.025% gel, and with the new tretinoin formulation, there’s no degradation when used with benzoyl peroxide.”
Another new topical retinoid to consider is a fixed-dose combination of encapsulated benzoyl peroxide 3% and encapsulated tretinoin 0.1% cream (Twyneo), which was approved by the Food and Drug Administration in July 2021 for the treatment of acne in adults and children aged 9 years and older. “Typically, benzoyl peroxide and tretinoin cannot be mixed in the same tube to stability issues,” she said. “Here, each product is individually encapsulated in a silica shell so that they can be applied together.”
The approval was supported by positive results from two phase 3, randomized, double-blind, vehicle-controlled, multicenter studies (NCT03761784 and NCT03761810), in which Twyneo demonstrated efficacy and a favorable tolerability profile in patients aged 9 years and older with facial acne.
Another topical treatment option, dapsone, is now FDA approved for ages 9 and up, expanded from its initial indication for ages 12 and up. The new indication is based on a phase 4, multicenter, open-label study in which acne patients aged 9-11 years applied dapsone 7.5% gel once daily to the face and acne-affected areas on the upper chest, upper back, and shoulders for 12 weeks. After 12 weeks, facial acne was clear or almost clear in about 47% of patients. “Inflammatory, noninflammatory, and total lesions decreased from baseline, but there was a greater reduction in noninflammatory lesions, so if you have a very young patient with acne, now you can consider dapsone gel,” Dr. Graber said.
In August 2020, clascoterone cream became the first topical androgen receptor inhibitor approved for the treatment of acne in patients 12 years of age and older. It is a drug believed to address sebum and inflammation directly in the sebaceous gland and is structurally similar to dihydrotestosterone and spironolactone.
“This is a completely new drug category in acne,” she said. “Unlike all oral antiandrogen therapies, clascoterone cream can be used in both males and females with acne. It’s the first acne drug to have a new mechanism of action in almost 40 years, since isotretinoin was approved in 1982.”
In vitro, she continued, clascoterone competes with dihydrotestosterone for binding to the androgen receptor, inhibiting downstream signaling and leading to inhibited sebum production, reduced secretion of inflammatory cytokines, and inhibition of inflammatory pathways. Two phase 3 studies that led to its approval involved 1,440 patients with moderate to severe facial acne aged 9-58 years. The cream was applied twice a day for 12 weeks and treatment adherence was approximately 90%. The researchers found that clascoterone cream was significantly more effective than vehicle cream at achieving Investigator’s Global Assessment scores of 0 (clear) or 1 (almost clear), the definition of treatment success in the study, and reducing noninflammatory lesion and inflammatory lesion counts at week 12. “There were no safety issues noted during these studies, and clascoterone cream was well tolerated,” Dr. Graber said.
Dr. Graber disclosed that she is a consultant/adviser for Digital Diagnostics, Almirall, Hovione, Keratin Biosciences, La Roche Posay, Ortho Dermatologics, Sebacia, Sol-Gel, Verrica, and WebMD. She is also a research investigator for Hovione, Ortho Dermatologics, Sebacia, and she receives royalties from Wolters Kluwer Health.
MedscapeLive and this news organization are owned by the same parent company.
Commentary by Lawrence W. Eichenfield, MD
Acne vulgaris remains an issue of tremendous importance to preteens, teens, and young adults, with approximately 85% of individuals aged 12-24 being affected. Expanding options for topical treatments may help bring effective disease control. Dr. Graber pointed out that historically, pediatricians and other primary care practitioners utilize topical retinoids less often for acne care as compared with dermatologists or guidelines recommendations (either the AAP’s or AAD’s). There are now expanded options, including over-the-counter retinoids (adapalene 0.1% gel), generic and trade brand topical tretinoin products, prescription adapalene medications, older and recently approved tazarotene products, and a newer type of topical retinoid, trifarotene. Novel formulations and emulsion technology, as well as retinoid developed in combination products, give more options in patients down to 9 years of age. A novel topical anti-androgen, clascoterone, is in its own category, as the first topical “hormonal agent,” allowing hormonal therapy to be used for males as well as females (aged 12 years and up). A recent review in JAMA (2021 Nov 23;326[20]:2055-67) incorporates many of these newer medications into management suggestions, emphasizing that first-line therapies are topical retinoids, benzoyl peroxide, azelaic acid, or combinations of topicals, whereas in more severe disease, oral antibiotics such as doxycycline or minocycline, hormonal therapies such as combination oral conceptive agents or spironolactone, or isotretinoin are most effective.
Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.
A version of this article first appeared on Medscape.com.
This article was updated 6/18/22.
yet they are likely underused in today’s clinical practice.
A study of prescribing practices from 2012 to 2014 indicated that dermatologists prescribed retinoids for just 58.8% of acne cases, while nondermatologists prescribed them for only 32.4% of cases. “If the guidelines are telling us that we should use topical retinoids for almost all of our acne patients, why are we using them for half of the patients?” Emmy Graber, MD, MBA, asked during MedscapeLive’s annual Las Vegas Dermatology Seminar. “We have a lot of options today for topical retinoids,” she added, noting that, in the past few years, trifarotene cream 0.005% and new formulations of tazarotene lotion (0.045%) and tretinoin lotion (0.05%) have become available.
According to Dr. Graber, president of The Dermatology Institute of Boston, tazarotene has been considered the most efficacious topical retinoid but is generally the least well tolerated, while adapalene has often been considered to be one of the better-tolerated topical retinoids. “This is a broad generalization,” she said. “One should also take into account the concentration and formulation of the retinoid. Cutaneous adverse events increase in severity as the concentration increases regardless of the vehicle.” There are no studies comparing trifarotene with other topical retinoids, she added.
In two phase 2, double-blind, vehicle-controlled studies (PERFECT 1 and PERFECT 2), researchers randomized more than 2,400 patients with moderate facial or truncal acne to receive trifarotene cream or a vehicle for 12 weeks. The mean percent change from baseline in facial inflammatory lesions in the trifarotene-treated group was –54.4% and –66.2% in PERFECT 1, and PERFECT 2, respectively, while the mean percent change from baseline in facial noninflammatory lesions was –49.7% and –57.7%, respectively.
In addition, the mean percent change from baseline in truncal inflammatory lesions in the trifarotene-treated groups was –57.4% and –65.4%, respectively, while the mean percent change from baseline in truncal noninflammatory lesions was –49.1% and –55.2%, respectively.
The choice of vehicle may affect absorption of topical retinoids, and some formulations may increase skin hydration and decrease transepidermal water loss, “which is a good thing,” Dr. Graber said. “Also, vehicles aim to slow drug delivery over time while also making sure that the drug penetrates into the pilosebaceous unit.”
One recent advance is the honeycomb-like polymeric emulsion technology found in tretinoin 0.05% lotion and tazarotene 0.045% lotion. These formulations contain droplets of the tretinoin and tazarotene embedded in a honeycomb matrix with hydrating agents. “I think this is exciting and could enhance our patient compliance and tolerability,” she said. Another unique feature about these two products, especially the tretinoin product, is the very small particle size with this new formulation. “It’s small enough that it can penetrate down into the pilosebaceous unit,” which is different than with older formulations, in which the tretinoin “largely just sat on the surface of the skin and didn’t penetrate into the pilosebaceous unit.” In addition, she said, “there’s only 9% degradation of the tretinoin in UV light, compared to 72% degradation of standard tretinoin 0.025% gel, and with the new tretinoin formulation, there’s no degradation when used with benzoyl peroxide.”
Another new topical retinoid to consider is a fixed-dose combination of encapsulated benzoyl peroxide 3% and encapsulated tretinoin 0.1% cream (Twyneo), which was approved by the Food and Drug Administration in July 2021 for the treatment of acne in adults and children aged 9 years and older. “Typically, benzoyl peroxide and tretinoin cannot be mixed in the same tube to stability issues,” she said. “Here, each product is individually encapsulated in a silica shell so that they can be applied together.”
The approval was supported by positive results from two phase 3, randomized, double-blind, vehicle-controlled, multicenter studies (NCT03761784 and NCT03761810), in which Twyneo demonstrated efficacy and a favorable tolerability profile in patients aged 9 years and older with facial acne.
Another topical treatment option, dapsone, is now FDA approved for ages 9 and up, expanded from its initial indication for ages 12 and up. The new indication is based on a phase 4, multicenter, open-label study in which acne patients aged 9-11 years applied dapsone 7.5% gel once daily to the face and acne-affected areas on the upper chest, upper back, and shoulders for 12 weeks. After 12 weeks, facial acne was clear or almost clear in about 47% of patients. “Inflammatory, noninflammatory, and total lesions decreased from baseline, but there was a greater reduction in noninflammatory lesions, so if you have a very young patient with acne, now you can consider dapsone gel,” Dr. Graber said.
In August 2020, clascoterone cream became the first topical androgen receptor inhibitor approved for the treatment of acne in patients 12 years of age and older. It is a drug believed to address sebum and inflammation directly in the sebaceous gland and is structurally similar to dihydrotestosterone and spironolactone.
“This is a completely new drug category in acne,” she said. “Unlike all oral antiandrogen therapies, clascoterone cream can be used in both males and females with acne. It’s the first acne drug to have a new mechanism of action in almost 40 years, since isotretinoin was approved in 1982.”
In vitro, she continued, clascoterone competes with dihydrotestosterone for binding to the androgen receptor, inhibiting downstream signaling and leading to inhibited sebum production, reduced secretion of inflammatory cytokines, and inhibition of inflammatory pathways. Two phase 3 studies that led to its approval involved 1,440 patients with moderate to severe facial acne aged 9-58 years. The cream was applied twice a day for 12 weeks and treatment adherence was approximately 90%. The researchers found that clascoterone cream was significantly more effective than vehicle cream at achieving Investigator’s Global Assessment scores of 0 (clear) or 1 (almost clear), the definition of treatment success in the study, and reducing noninflammatory lesion and inflammatory lesion counts at week 12. “There were no safety issues noted during these studies, and clascoterone cream was well tolerated,” Dr. Graber said.
Dr. Graber disclosed that she is a consultant/adviser for Digital Diagnostics, Almirall, Hovione, Keratin Biosciences, La Roche Posay, Ortho Dermatologics, Sebacia, Sol-Gel, Verrica, and WebMD. She is also a research investigator for Hovione, Ortho Dermatologics, Sebacia, and she receives royalties from Wolters Kluwer Health.
MedscapeLive and this news organization are owned by the same parent company.
Commentary by Lawrence W. Eichenfield, MD
Acne vulgaris remains an issue of tremendous importance to preteens, teens, and young adults, with approximately 85% of individuals aged 12-24 being affected. Expanding options for topical treatments may help bring effective disease control. Dr. Graber pointed out that historically, pediatricians and other primary care practitioners utilize topical retinoids less often for acne care as compared with dermatologists or guidelines recommendations (either the AAP’s or AAD’s). There are now expanded options, including over-the-counter retinoids (adapalene 0.1% gel), generic and trade brand topical tretinoin products, prescription adapalene medications, older and recently approved tazarotene products, and a newer type of topical retinoid, trifarotene. Novel formulations and emulsion technology, as well as retinoid developed in combination products, give more options in patients down to 9 years of age. A novel topical anti-androgen, clascoterone, is in its own category, as the first topical “hormonal agent,” allowing hormonal therapy to be used for males as well as females (aged 12 years and up). A recent review in JAMA (2021 Nov 23;326[20]:2055-67) incorporates many of these newer medications into management suggestions, emphasizing that first-line therapies are topical retinoids, benzoyl peroxide, azelaic acid, or combinations of topicals, whereas in more severe disease, oral antibiotics such as doxycycline or minocycline, hormonal therapies such as combination oral conceptive agents or spironolactone, or isotretinoin are most effective.
Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.
A version of this article first appeared on Medscape.com.
This article was updated 6/18/22.
FROM THE MEDSCAPELIVE LAS VEGAS DERMATOLOGY SEMINAR
Cirrhosis comorbidities tied to worse outcomes
Multiple comorbidities appear to worsen mortality outcomes in patients with cirrhosis: Those with compensated cirrhosis and three comorbid conditions have a mortality rate similar to patients with decompensated cirrhosis, according to a new analysis of a population-based cohort in the Dallas-Fort Worth metroplex.
“I think it’s a pretty strong message that just the presence of these chronic diseases has such a strong effect in the long run. They at least contribute to mortality to some extent. It’s really important to focus on these chronic diseases as targets early during the care that we provide to these to cirrhotic patients to make sure that we control them so that, in the long run, we can decrease the premature death and mortality in these patients,” said Mohammad Amin Fallahzadeh, MD, MPH, who presented the results at the annual meeting of the American Association for the Study of Liver Diseases.
The study included 35,361 patients with cirrhosis. The mean age of participants was 59.5 years, 41.8% were female, 29.7% were non-White, and 17.5% were Hispanic. Comorbidities were common, occurring in about 25% of patients. Forty-five percent of comorbidities were cardiovascular diseases (CVD); 28.9% of subjects had one comorbidity, 17.5% had two comorbidities, and 12.6% had three comorbidities.
A Kaplan-Meier curve showed that patients with compensated cirrhosis and no comorbidities had the highest survival over time, while decompensated patients with comorbidities had the lowest survival (P = .01). The curve showed similar survival between patients with compensated cirrhosis and three comorbidities and decompensated patients with no comorbidities.
The risk of death increased with one comorbidity (hazard ratio, 2.5; 95% confidence interval, 2.23-2.8), two comorbidities (HR, 3.27; 95% CI, 2.9-3.69), and three comorbidities (HR, 4.52; 95% CI, 3.99-5.12).
Mortality increased with the number of comorbidities in both compensated and decompensated patients; patients with hepatitis C, alcoholic liver disease, and nonalcoholic fatty liver disease; by race (White, Black, and other); and in different age groups. A stronger effect of comorbidities was seen in compensated patients (HR, 6.4 vs. 4.1), female patients (HR, 5.2 vs. 4.1), and in patients older than age 65 years (HR, 7.2 vs. 3.7 in those aged 45-64 years and 5.0 in those younger than age 45 years).
The researchers also found an apparent synergistic effect of chronic kidney disease (CKD) and CVD. Both conditions were associated with increased risk on their own, but when a patient had both CVD and CKD, mortality was higher than just the added risk of the two conditions.
The findings confirm that patients with cirrhosis and comorbidities seem to have worse quality of life and higher mortality. “I didn’t expect that it would have such a major effect, to make a compensated patient as if they are decompensated, but we definitely see that in our daily practice,” said Dr. Fallahzadeh, who is a 2nd-year internal medicine resident at Baylor University Medical Center, Dallas.
“When a hepatologist or an internist has a visit with a patient who is diagnosed with cirrhosis, they need to screen them for the other chronic diseases like diabetes, CKD, and cardiovascular disease to make sure that if they have any of these conditions, they’ll be under control, or if they need any referral for better management. For example, if they need a nephrology referral, it [should] be done as early as possible so that we can minimize the burden of these diseases in the long run for these patients. And we need to educate the patients as well about controlling these chronic problems,” said Dr. Fallahzadeh.
The findings might make researchers reconsider how to classify compensated and decompensated cirrhosis. “When we talk about decompensated liver disease, we’re talking about variceal hemorrhage, ascites, and encephalopathy. In this case, they’re saying that if you’re compensated and you [have] three of these associated medical conditions, that you could be worse off than decompensated cirrhosis. It’s really challenging the status quo and how we think about these two disease entities. They’re thought of a lot differently in terms of the mortality. That needs to be further elucidated,” said Mayur Brahmania, MD, assistant professor of medicine at Western University, London, Ont., who moderated the session.
A key limitation to the study was that the researchers did not have access to data about medication use, so it could not be determined if comorbidities were being controlled. Body mass index and most lifestyle factors were also uncontrolled.
Dr. Fallahzadeh and Dr. Brahmania have no relevant financial disclosures.
Multiple comorbidities appear to worsen mortality outcomes in patients with cirrhosis: Those with compensated cirrhosis and three comorbid conditions have a mortality rate similar to patients with decompensated cirrhosis, according to a new analysis of a population-based cohort in the Dallas-Fort Worth metroplex.
“I think it’s a pretty strong message that just the presence of these chronic diseases has such a strong effect in the long run. They at least contribute to mortality to some extent. It’s really important to focus on these chronic diseases as targets early during the care that we provide to these to cirrhotic patients to make sure that we control them so that, in the long run, we can decrease the premature death and mortality in these patients,” said Mohammad Amin Fallahzadeh, MD, MPH, who presented the results at the annual meeting of the American Association for the Study of Liver Diseases.
The study included 35,361 patients with cirrhosis. The mean age of participants was 59.5 years, 41.8% were female, 29.7% were non-White, and 17.5% were Hispanic. Comorbidities were common, occurring in about 25% of patients. Forty-five percent of comorbidities were cardiovascular diseases (CVD); 28.9% of subjects had one comorbidity, 17.5% had two comorbidities, and 12.6% had three comorbidities.
A Kaplan-Meier curve showed that patients with compensated cirrhosis and no comorbidities had the highest survival over time, while decompensated patients with comorbidities had the lowest survival (P = .01). The curve showed similar survival between patients with compensated cirrhosis and three comorbidities and decompensated patients with no comorbidities.
The risk of death increased with one comorbidity (hazard ratio, 2.5; 95% confidence interval, 2.23-2.8), two comorbidities (HR, 3.27; 95% CI, 2.9-3.69), and three comorbidities (HR, 4.52; 95% CI, 3.99-5.12).
Mortality increased with the number of comorbidities in both compensated and decompensated patients; patients with hepatitis C, alcoholic liver disease, and nonalcoholic fatty liver disease; by race (White, Black, and other); and in different age groups. A stronger effect of comorbidities was seen in compensated patients (HR, 6.4 vs. 4.1), female patients (HR, 5.2 vs. 4.1), and in patients older than age 65 years (HR, 7.2 vs. 3.7 in those aged 45-64 years and 5.0 in those younger than age 45 years).
The researchers also found an apparent synergistic effect of chronic kidney disease (CKD) and CVD. Both conditions were associated with increased risk on their own, but when a patient had both CVD and CKD, mortality was higher than just the added risk of the two conditions.
The findings confirm that patients with cirrhosis and comorbidities seem to have worse quality of life and higher mortality. “I didn’t expect that it would have such a major effect, to make a compensated patient as if they are decompensated, but we definitely see that in our daily practice,” said Dr. Fallahzadeh, who is a 2nd-year internal medicine resident at Baylor University Medical Center, Dallas.
“When a hepatologist or an internist has a visit with a patient who is diagnosed with cirrhosis, they need to screen them for the other chronic diseases like diabetes, CKD, and cardiovascular disease to make sure that if they have any of these conditions, they’ll be under control, or if they need any referral for better management. For example, if they need a nephrology referral, it [should] be done as early as possible so that we can minimize the burden of these diseases in the long run for these patients. And we need to educate the patients as well about controlling these chronic problems,” said Dr. Fallahzadeh.
The findings might make researchers reconsider how to classify compensated and decompensated cirrhosis. “When we talk about decompensated liver disease, we’re talking about variceal hemorrhage, ascites, and encephalopathy. In this case, they’re saying that if you’re compensated and you [have] three of these associated medical conditions, that you could be worse off than decompensated cirrhosis. It’s really challenging the status quo and how we think about these two disease entities. They’re thought of a lot differently in terms of the mortality. That needs to be further elucidated,” said Mayur Brahmania, MD, assistant professor of medicine at Western University, London, Ont., who moderated the session.
A key limitation to the study was that the researchers did not have access to data about medication use, so it could not be determined if comorbidities were being controlled. Body mass index and most lifestyle factors were also uncontrolled.
Dr. Fallahzadeh and Dr. Brahmania have no relevant financial disclosures.
Multiple comorbidities appear to worsen mortality outcomes in patients with cirrhosis: Those with compensated cirrhosis and three comorbid conditions have a mortality rate similar to patients with decompensated cirrhosis, according to a new analysis of a population-based cohort in the Dallas-Fort Worth metroplex.
“I think it’s a pretty strong message that just the presence of these chronic diseases has such a strong effect in the long run. They at least contribute to mortality to some extent. It’s really important to focus on these chronic diseases as targets early during the care that we provide to these to cirrhotic patients to make sure that we control them so that, in the long run, we can decrease the premature death and mortality in these patients,” said Mohammad Amin Fallahzadeh, MD, MPH, who presented the results at the annual meeting of the American Association for the Study of Liver Diseases.
The study included 35,361 patients with cirrhosis. The mean age of participants was 59.5 years, 41.8% were female, 29.7% were non-White, and 17.5% were Hispanic. Comorbidities were common, occurring in about 25% of patients. Forty-five percent of comorbidities were cardiovascular diseases (CVD); 28.9% of subjects had one comorbidity, 17.5% had two comorbidities, and 12.6% had three comorbidities.
A Kaplan-Meier curve showed that patients with compensated cirrhosis and no comorbidities had the highest survival over time, while decompensated patients with comorbidities had the lowest survival (P = .01). The curve showed similar survival between patients with compensated cirrhosis and three comorbidities and decompensated patients with no comorbidities.
The risk of death increased with one comorbidity (hazard ratio, 2.5; 95% confidence interval, 2.23-2.8), two comorbidities (HR, 3.27; 95% CI, 2.9-3.69), and three comorbidities (HR, 4.52; 95% CI, 3.99-5.12).
Mortality increased with the number of comorbidities in both compensated and decompensated patients; patients with hepatitis C, alcoholic liver disease, and nonalcoholic fatty liver disease; by race (White, Black, and other); and in different age groups. A stronger effect of comorbidities was seen in compensated patients (HR, 6.4 vs. 4.1), female patients (HR, 5.2 vs. 4.1), and in patients older than age 65 years (HR, 7.2 vs. 3.7 in those aged 45-64 years and 5.0 in those younger than age 45 years).
The researchers also found an apparent synergistic effect of chronic kidney disease (CKD) and CVD. Both conditions were associated with increased risk on their own, but when a patient had both CVD and CKD, mortality was higher than just the added risk of the two conditions.
The findings confirm that patients with cirrhosis and comorbidities seem to have worse quality of life and higher mortality. “I didn’t expect that it would have such a major effect, to make a compensated patient as if they are decompensated, but we definitely see that in our daily practice,” said Dr. Fallahzadeh, who is a 2nd-year internal medicine resident at Baylor University Medical Center, Dallas.
“When a hepatologist or an internist has a visit with a patient who is diagnosed with cirrhosis, they need to screen them for the other chronic diseases like diabetes, CKD, and cardiovascular disease to make sure that if they have any of these conditions, they’ll be under control, or if they need any referral for better management. For example, if they need a nephrology referral, it [should] be done as early as possible so that we can minimize the burden of these diseases in the long run for these patients. And we need to educate the patients as well about controlling these chronic problems,” said Dr. Fallahzadeh.
The findings might make researchers reconsider how to classify compensated and decompensated cirrhosis. “When we talk about decompensated liver disease, we’re talking about variceal hemorrhage, ascites, and encephalopathy. In this case, they’re saying that if you’re compensated and you [have] three of these associated medical conditions, that you could be worse off than decompensated cirrhosis. It’s really challenging the status quo and how we think about these two disease entities. They’re thought of a lot differently in terms of the mortality. That needs to be further elucidated,” said Mayur Brahmania, MD, assistant professor of medicine at Western University, London, Ont., who moderated the session.
A key limitation to the study was that the researchers did not have access to data about medication use, so it could not be determined if comorbidities were being controlled. Body mass index and most lifestyle factors were also uncontrolled.
Dr. Fallahzadeh and Dr. Brahmania have no relevant financial disclosures.
FROM THE LIVER MEETING
Patient whips out smartphone and starts recording: Trouble ahead?
Joe Lindsey, a 48-year old Colorado-based journalist, has dealt with complex hearing loss for about 15 years. which has led to countless doctor’s visits, treatments, and even surgery in hopes of finding improvement. As time went on and Mr. Lindsey’s hearing deteriorated, he began recording his appointments in order to retain important information.
Mr. Lindsey had positive intentions, but not every patient does.
With smartphones everywhere, recording medical appointments can be fraught with downsides too. While there are clear-cut reasons for recording doctor visits, patients’ goals and how they carry out the taping are key. Audio only? Or also video? With the physician’s knowledge and permission, or without?
These are the legal and ethical weeds doctors find themselves in today, so it’s important to understand all sides of the issue.
The medical world is divided on its sentiments about patients recording their visits. The American Medical Association, in fact, failed to make progress on a recent policy (resolution 007) proposal to encourage that any “audio or video recording made during a medical encounter should require both physician and patient notification and consent.” Rather than voting on the resolution, the AMA house of delegates tabled it and chose to gather more information on the issue.
In most cases, patients are recording their visits in good faith, says Jeffrey Segal, MD, JD, the CEO and founder of Medical Justice, a risk mitigation and reputation management firm for healthcare clinicians. “When it comes to ‘Team, let’s record this,’ I’m a fan,” he says. “The most common reason patients record visits is that there’s a lot of information transferred from the doctor to the patient, and there’s just not enough time to absorb it all.”
While the option is there for patients to take notes, in the give-and-take nature of conversation, this can get difficult. “If they record the visit, they can then digest it all down the road,” says Dr. Segal. “A compliant patient is one who understands what’s expected. That’s the charitable explanation for recording, and I support it.”
It’s that question of good intent, however, that concerns some physicians in today’s highly litigious society. “The worry is that there’s a small subset of patients with an ulterior motive,” says Dr. Segal.
“Some patients do record in case of an event down the road,” he adds. “They want the recording to potentially talk to a lawyer, or to file a board complaint.”
Laws in the United States surrounding recordings are confusing, with variations from state to state. Currently, 39 U.S. states allow for one-party consent — meaning a patient can record a visit without consenting with the physician.
Monica Verduzco-Gutierrez, MD, professor and chair of rehabilitation medicine at University of Texas Health, San Antonio, resides in Texas, which is one of the 39 one-consent states. “Physicians must be aware of this fact and consider how it might be used against them,” she says. “A good practice is to set expectations with the patient from the start. Also, know your hospital’s policy — some may have boundaries surrounding recordings.”
The first step is to know what type of state you practice in. Regardless of whether you are in a one- or two-party consent state — but especially a one-party state — it’s a smart move to add a sign at your office saying that you support the recording of visits, provided the patient is open and transparent about it. “Let the patient know that if they plan to record, they should ask your permission,” says Dr. Segal. “Let them know it’s not appropriate if they haven’t received your permission.”
There are, of course, the occasional horror stories involving surreptitious recordings. “I remember a case where a patient left a phone actively recording in his bag of clothing, which went into the OR with him,” he says. “The background conversation was not flattering to the patient, who happened to be an employee of the hospital. When he came to and listened to the recording, he sued, winning his case.”
The age of video and telehealth
What about the rare situation when a patient pulls out a phone and begins to videotape a conversation? It can be a big slippery slope. “Patients can abuse a video recording with editing, and the recording becomes one-dimensional, which is unfair to the physician,” adds Dr. Segal.
Patients sometimes have other motives as well. “I’m aware of occasions where a doctor/patient visit got heated and the patient took out the phone to video record, sharing it to social media,” says Dr. Segal. “Once someone uses a phone to take video, just stop the conversation. Tell the patient, ‘We’re having a disagreement,’ and that it’s time to put an end to it.”
He adds that from the physician side, a video can be a protagonist in a conversation. “Frankly, a camera on your face changes the nature of things,” Dr. Segal says. “It’s much easier to have the phone sitting in a corner, quietly recording.”
Other scenarios might involve a patient’s family member accompanying the patient and bringing out their phone to record. “Doctors should consider how this might be used against them — it can blow up,” says Dr. Verduzco-Gutierrez. “Draw boundaries on this behavior, using your hospital’s policy if it has one.”
In today’s pandemic landscape, this is particularly important, she adds. “There’s generally more mistrust in the medical system right now,” says Dr. Verduzco-Gutierrez. “People are getting misinformation from sources that aren’t credible, and then want to record their visits because they aren’t receiving the treatment they want, for instance.”
COVID has also added the tricky element of telehealth, which has exploded since 2020. “You don’t know what a patient is doing on the other side of the screen,” Dr. Verduzco-Gutierrez explains. “Face-to-face, you might see them with their phones out, but anything goes with telehealth. You have to be open and communicative with your patients about your policies from the start to avoid any negative connotations.”
How taping can help patients
Mr. Lindsey, the Colorado journalist, is far from alone in his desire to use visit recordings in order to retain valuable information — and with good reason. According to the Dartmouth Institute for Health Policy and Clinical Practice’s Open Recordings Project, at least 1 in 10 patients records their doctor’s visits.
“I realized I was missing things and in a medical setting, that matters,” Mr. Lindsey says. “Last year, once COVID hit and we all began wearing masks, I lost my ability to read lips, one of my coping mechanisms. It became even more important that I had a backup recording to ensure I understood everything.”
Even if a patient doesn’t have hearing loss like Mr. Lindsey, having an audio record of a visit can be useful. According to a 2018 study on patient recall of key information 1 week out from their visits, 49% of decisions and recommendations were recalled accurately without prompting; 36% recalled with a prompt; and 15% recalled erroneously or not at all.
This squares with the personal experiences of Dr. Verduzco-Gutierrez. “I even see this with my mom, who doesn’t remember many details of her doctor’s visits when I ask her,” she says. “This can definitely impact treatment.”
For better or worse
Dr. Verduzco-Gutierrez says that often it comes down to how a patient learns best. “I teach my residents to keep this in mind and to ask the patient in advance what works best for them,” she says. “If a patient is a visual learner, they might want to take notes or have access to the appointment notes after the visit. If they will learn and retain the information best with an audio recording, then offer that option.”
Mr. Lindsey makes it a habit to inform his physicians that he will be making an audio recording of his visits. “I always let them know that I’m recording for accuracy and not to catch them in some sort of falsehood,” he says. “I can get the doctor’s notes, but those are often short and to the point; I can get more information by going back over the recording.”
To date, Mr. Lindsey hasn’t experienced any pushback from his physicians. “No one has balked at the idea or acted surprised that I want to do it,” he explains. “I think most doctors appreciate that we have a tool we can make use of for better care.”
In past coverage of the topic, some healthcare providers weighed in with support for recordings, usually citing personal reasons. “I am so very grateful for the physicians that allowed me to record the medical appointments that I attended with my parents,” said one. “As their adult daughter, I was painfully aware that my parents struggled to process and understand all of the new information coming their way.”
Another expressed support as well, stating that as a patient, he prefers recordings to notes, because the latter “bears little resemblance to the content of the meeting and discussion with the physician. If the patient straightforwardly asks for permission to record, then why not honor the good intent expressed thereby?”
More often than not, patients have good intentions when they decide to hit the record button in a medical visit. A little preparation goes a long way, however, says Dr. Segal: “Assume you’re being recorded, and act accordingly.”
A version of this article first appeared on Medscape.com.
Joe Lindsey, a 48-year old Colorado-based journalist, has dealt with complex hearing loss for about 15 years. which has led to countless doctor’s visits, treatments, and even surgery in hopes of finding improvement. As time went on and Mr. Lindsey’s hearing deteriorated, he began recording his appointments in order to retain important information.
Mr. Lindsey had positive intentions, but not every patient does.
With smartphones everywhere, recording medical appointments can be fraught with downsides too. While there are clear-cut reasons for recording doctor visits, patients’ goals and how they carry out the taping are key. Audio only? Or also video? With the physician’s knowledge and permission, or without?
These are the legal and ethical weeds doctors find themselves in today, so it’s important to understand all sides of the issue.
The medical world is divided on its sentiments about patients recording their visits. The American Medical Association, in fact, failed to make progress on a recent policy (resolution 007) proposal to encourage that any “audio or video recording made during a medical encounter should require both physician and patient notification and consent.” Rather than voting on the resolution, the AMA house of delegates tabled it and chose to gather more information on the issue.
In most cases, patients are recording their visits in good faith, says Jeffrey Segal, MD, JD, the CEO and founder of Medical Justice, a risk mitigation and reputation management firm for healthcare clinicians. “When it comes to ‘Team, let’s record this,’ I’m a fan,” he says. “The most common reason patients record visits is that there’s a lot of information transferred from the doctor to the patient, and there’s just not enough time to absorb it all.”
While the option is there for patients to take notes, in the give-and-take nature of conversation, this can get difficult. “If they record the visit, they can then digest it all down the road,” says Dr. Segal. “A compliant patient is one who understands what’s expected. That’s the charitable explanation for recording, and I support it.”
It’s that question of good intent, however, that concerns some physicians in today’s highly litigious society. “The worry is that there’s a small subset of patients with an ulterior motive,” says Dr. Segal.
“Some patients do record in case of an event down the road,” he adds. “They want the recording to potentially talk to a lawyer, or to file a board complaint.”
Laws in the United States surrounding recordings are confusing, with variations from state to state. Currently, 39 U.S. states allow for one-party consent — meaning a patient can record a visit without consenting with the physician.
Monica Verduzco-Gutierrez, MD, professor and chair of rehabilitation medicine at University of Texas Health, San Antonio, resides in Texas, which is one of the 39 one-consent states. “Physicians must be aware of this fact and consider how it might be used against them,” she says. “A good practice is to set expectations with the patient from the start. Also, know your hospital’s policy — some may have boundaries surrounding recordings.”
The first step is to know what type of state you practice in. Regardless of whether you are in a one- or two-party consent state — but especially a one-party state — it’s a smart move to add a sign at your office saying that you support the recording of visits, provided the patient is open and transparent about it. “Let the patient know that if they plan to record, they should ask your permission,” says Dr. Segal. “Let them know it’s not appropriate if they haven’t received your permission.”
There are, of course, the occasional horror stories involving surreptitious recordings. “I remember a case where a patient left a phone actively recording in his bag of clothing, which went into the OR with him,” he says. “The background conversation was not flattering to the patient, who happened to be an employee of the hospital. When he came to and listened to the recording, he sued, winning his case.”
The age of video and telehealth
What about the rare situation when a patient pulls out a phone and begins to videotape a conversation? It can be a big slippery slope. “Patients can abuse a video recording with editing, and the recording becomes one-dimensional, which is unfair to the physician,” adds Dr. Segal.
Patients sometimes have other motives as well. “I’m aware of occasions where a doctor/patient visit got heated and the patient took out the phone to video record, sharing it to social media,” says Dr. Segal. “Once someone uses a phone to take video, just stop the conversation. Tell the patient, ‘We’re having a disagreement,’ and that it’s time to put an end to it.”
He adds that from the physician side, a video can be a protagonist in a conversation. “Frankly, a camera on your face changes the nature of things,” Dr. Segal says. “It’s much easier to have the phone sitting in a corner, quietly recording.”
Other scenarios might involve a patient’s family member accompanying the patient and bringing out their phone to record. “Doctors should consider how this might be used against them — it can blow up,” says Dr. Verduzco-Gutierrez. “Draw boundaries on this behavior, using your hospital’s policy if it has one.”
In today’s pandemic landscape, this is particularly important, she adds. “There’s generally more mistrust in the medical system right now,” says Dr. Verduzco-Gutierrez. “People are getting misinformation from sources that aren’t credible, and then want to record their visits because they aren’t receiving the treatment they want, for instance.”
COVID has also added the tricky element of telehealth, which has exploded since 2020. “You don’t know what a patient is doing on the other side of the screen,” Dr. Verduzco-Gutierrez explains. “Face-to-face, you might see them with their phones out, but anything goes with telehealth. You have to be open and communicative with your patients about your policies from the start to avoid any negative connotations.”
How taping can help patients
Mr. Lindsey, the Colorado journalist, is far from alone in his desire to use visit recordings in order to retain valuable information — and with good reason. According to the Dartmouth Institute for Health Policy and Clinical Practice’s Open Recordings Project, at least 1 in 10 patients records their doctor’s visits.
“I realized I was missing things and in a medical setting, that matters,” Mr. Lindsey says. “Last year, once COVID hit and we all began wearing masks, I lost my ability to read lips, one of my coping mechanisms. It became even more important that I had a backup recording to ensure I understood everything.”
Even if a patient doesn’t have hearing loss like Mr. Lindsey, having an audio record of a visit can be useful. According to a 2018 study on patient recall of key information 1 week out from their visits, 49% of decisions and recommendations were recalled accurately without prompting; 36% recalled with a prompt; and 15% recalled erroneously or not at all.
This squares with the personal experiences of Dr. Verduzco-Gutierrez. “I even see this with my mom, who doesn’t remember many details of her doctor’s visits when I ask her,” she says. “This can definitely impact treatment.”
For better or worse
Dr. Verduzco-Gutierrez says that often it comes down to how a patient learns best. “I teach my residents to keep this in mind and to ask the patient in advance what works best for them,” she says. “If a patient is a visual learner, they might want to take notes or have access to the appointment notes after the visit. If they will learn and retain the information best with an audio recording, then offer that option.”
Mr. Lindsey makes it a habit to inform his physicians that he will be making an audio recording of his visits. “I always let them know that I’m recording for accuracy and not to catch them in some sort of falsehood,” he says. “I can get the doctor’s notes, but those are often short and to the point; I can get more information by going back over the recording.”
To date, Mr. Lindsey hasn’t experienced any pushback from his physicians. “No one has balked at the idea or acted surprised that I want to do it,” he explains. “I think most doctors appreciate that we have a tool we can make use of for better care.”
In past coverage of the topic, some healthcare providers weighed in with support for recordings, usually citing personal reasons. “I am so very grateful for the physicians that allowed me to record the medical appointments that I attended with my parents,” said one. “As their adult daughter, I was painfully aware that my parents struggled to process and understand all of the new information coming their way.”
Another expressed support as well, stating that as a patient, he prefers recordings to notes, because the latter “bears little resemblance to the content of the meeting and discussion with the physician. If the patient straightforwardly asks for permission to record, then why not honor the good intent expressed thereby?”
More often than not, patients have good intentions when they decide to hit the record button in a medical visit. A little preparation goes a long way, however, says Dr. Segal: “Assume you’re being recorded, and act accordingly.”
A version of this article first appeared on Medscape.com.
Joe Lindsey, a 48-year old Colorado-based journalist, has dealt with complex hearing loss for about 15 years. which has led to countless doctor’s visits, treatments, and even surgery in hopes of finding improvement. As time went on and Mr. Lindsey’s hearing deteriorated, he began recording his appointments in order to retain important information.
Mr. Lindsey had positive intentions, but not every patient does.
With smartphones everywhere, recording medical appointments can be fraught with downsides too. While there are clear-cut reasons for recording doctor visits, patients’ goals and how they carry out the taping are key. Audio only? Or also video? With the physician’s knowledge and permission, or without?
These are the legal and ethical weeds doctors find themselves in today, so it’s important to understand all sides of the issue.
The medical world is divided on its sentiments about patients recording their visits. The American Medical Association, in fact, failed to make progress on a recent policy (resolution 007) proposal to encourage that any “audio or video recording made during a medical encounter should require both physician and patient notification and consent.” Rather than voting on the resolution, the AMA house of delegates tabled it and chose to gather more information on the issue.
In most cases, patients are recording their visits in good faith, says Jeffrey Segal, MD, JD, the CEO and founder of Medical Justice, a risk mitigation and reputation management firm for healthcare clinicians. “When it comes to ‘Team, let’s record this,’ I’m a fan,” he says. “The most common reason patients record visits is that there’s a lot of information transferred from the doctor to the patient, and there’s just not enough time to absorb it all.”
While the option is there for patients to take notes, in the give-and-take nature of conversation, this can get difficult. “If they record the visit, they can then digest it all down the road,” says Dr. Segal. “A compliant patient is one who understands what’s expected. That’s the charitable explanation for recording, and I support it.”
It’s that question of good intent, however, that concerns some physicians in today’s highly litigious society. “The worry is that there’s a small subset of patients with an ulterior motive,” says Dr. Segal.
“Some patients do record in case of an event down the road,” he adds. “They want the recording to potentially talk to a lawyer, or to file a board complaint.”
Laws in the United States surrounding recordings are confusing, with variations from state to state. Currently, 39 U.S. states allow for one-party consent — meaning a patient can record a visit without consenting with the physician.
Monica Verduzco-Gutierrez, MD, professor and chair of rehabilitation medicine at University of Texas Health, San Antonio, resides in Texas, which is one of the 39 one-consent states. “Physicians must be aware of this fact and consider how it might be used against them,” she says. “A good practice is to set expectations with the patient from the start. Also, know your hospital’s policy — some may have boundaries surrounding recordings.”
The first step is to know what type of state you practice in. Regardless of whether you are in a one- or two-party consent state — but especially a one-party state — it’s a smart move to add a sign at your office saying that you support the recording of visits, provided the patient is open and transparent about it. “Let the patient know that if they plan to record, they should ask your permission,” says Dr. Segal. “Let them know it’s not appropriate if they haven’t received your permission.”
There are, of course, the occasional horror stories involving surreptitious recordings. “I remember a case where a patient left a phone actively recording in his bag of clothing, which went into the OR with him,” he says. “The background conversation was not flattering to the patient, who happened to be an employee of the hospital. When he came to and listened to the recording, he sued, winning his case.”
The age of video and telehealth
What about the rare situation when a patient pulls out a phone and begins to videotape a conversation? It can be a big slippery slope. “Patients can abuse a video recording with editing, and the recording becomes one-dimensional, which is unfair to the physician,” adds Dr. Segal.
Patients sometimes have other motives as well. “I’m aware of occasions where a doctor/patient visit got heated and the patient took out the phone to video record, sharing it to social media,” says Dr. Segal. “Once someone uses a phone to take video, just stop the conversation. Tell the patient, ‘We’re having a disagreement,’ and that it’s time to put an end to it.”
He adds that from the physician side, a video can be a protagonist in a conversation. “Frankly, a camera on your face changes the nature of things,” Dr. Segal says. “It’s much easier to have the phone sitting in a corner, quietly recording.”
Other scenarios might involve a patient’s family member accompanying the patient and bringing out their phone to record. “Doctors should consider how this might be used against them — it can blow up,” says Dr. Verduzco-Gutierrez. “Draw boundaries on this behavior, using your hospital’s policy if it has one.”
In today’s pandemic landscape, this is particularly important, she adds. “There’s generally more mistrust in the medical system right now,” says Dr. Verduzco-Gutierrez. “People are getting misinformation from sources that aren’t credible, and then want to record their visits because they aren’t receiving the treatment they want, for instance.”
COVID has also added the tricky element of telehealth, which has exploded since 2020. “You don’t know what a patient is doing on the other side of the screen,” Dr. Verduzco-Gutierrez explains. “Face-to-face, you might see them with their phones out, but anything goes with telehealth. You have to be open and communicative with your patients about your policies from the start to avoid any negative connotations.”
How taping can help patients
Mr. Lindsey, the Colorado journalist, is far from alone in his desire to use visit recordings in order to retain valuable information — and with good reason. According to the Dartmouth Institute for Health Policy and Clinical Practice’s Open Recordings Project, at least 1 in 10 patients records their doctor’s visits.
“I realized I was missing things and in a medical setting, that matters,” Mr. Lindsey says. “Last year, once COVID hit and we all began wearing masks, I lost my ability to read lips, one of my coping mechanisms. It became even more important that I had a backup recording to ensure I understood everything.”
Even if a patient doesn’t have hearing loss like Mr. Lindsey, having an audio record of a visit can be useful. According to a 2018 study on patient recall of key information 1 week out from their visits, 49% of decisions and recommendations were recalled accurately without prompting; 36% recalled with a prompt; and 15% recalled erroneously or not at all.
This squares with the personal experiences of Dr. Verduzco-Gutierrez. “I even see this with my mom, who doesn’t remember many details of her doctor’s visits when I ask her,” she says. “This can definitely impact treatment.”
For better or worse
Dr. Verduzco-Gutierrez says that often it comes down to how a patient learns best. “I teach my residents to keep this in mind and to ask the patient in advance what works best for them,” she says. “If a patient is a visual learner, they might want to take notes or have access to the appointment notes after the visit. If they will learn and retain the information best with an audio recording, then offer that option.”
Mr. Lindsey makes it a habit to inform his physicians that he will be making an audio recording of his visits. “I always let them know that I’m recording for accuracy and not to catch them in some sort of falsehood,” he says. “I can get the doctor’s notes, but those are often short and to the point; I can get more information by going back over the recording.”
To date, Mr. Lindsey hasn’t experienced any pushback from his physicians. “No one has balked at the idea or acted surprised that I want to do it,” he explains. “I think most doctors appreciate that we have a tool we can make use of for better care.”
In past coverage of the topic, some healthcare providers weighed in with support for recordings, usually citing personal reasons. “I am so very grateful for the physicians that allowed me to record the medical appointments that I attended with my parents,” said one. “As their adult daughter, I was painfully aware that my parents struggled to process and understand all of the new information coming their way.”
Another expressed support as well, stating that as a patient, he prefers recordings to notes, because the latter “bears little resemblance to the content of the meeting and discussion with the physician. If the patient straightforwardly asks for permission to record, then why not honor the good intent expressed thereby?”
More often than not, patients have good intentions when they decide to hit the record button in a medical visit. A little preparation goes a long way, however, says Dr. Segal: “Assume you’re being recorded, and act accordingly.”
A version of this article first appeared on Medscape.com.
CDC unveils mental health protection plan for health care workers
Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.
“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.
“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
Burnout is not selective
There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.
He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.
Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.
Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. , Dr. Howard said.
Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data.
“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.
Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.
“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
Primary prevention approach
To tackle the burnout crisis, NIOSH plans to:
- Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
- Assimilate the evidence and create a repository of best practices, resources, and interventions.
- Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
- Identify and adapt tools for the health care workplace that emphasize stress reduction.
NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.
This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.
Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.
A version of this article first appeared on Medscape.com.
Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.
“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.
“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
Burnout is not selective
There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.
He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.
Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.
Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. , Dr. Howard said.
Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data.
“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.
Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.
“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
Primary prevention approach
To tackle the burnout crisis, NIOSH plans to:
- Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
- Assimilate the evidence and create a repository of best practices, resources, and interventions.
- Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
- Identify and adapt tools for the health care workplace that emphasize stress reduction.
NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.
This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.
Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.
A version of this article first appeared on Medscape.com.
Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.
“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.
“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
Burnout is not selective
There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.
He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.
Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.
Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. , Dr. Howard said.
Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data.
“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.
Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.
“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
Primary prevention approach
To tackle the burnout crisis, NIOSH plans to:
- Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
- Assimilate the evidence and create a repository of best practices, resources, and interventions.
- Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
- Identify and adapt tools for the health care workplace that emphasize stress reduction.
NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.
This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.
Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.
A version of this article first appeared on Medscape.com.
Beware of private equity–owned nursing homes: study
When you have to help a parent choose a nursing home or you need nursing home care yourself, you can consult a health care professional, talk to friends, or look at the Nursing Home Compare website of the Centers for Medicare and Medicaid Services (CMS). The CMS website includes star ratings for each nursing home, both overall and on health inspections, staffing and certain quality measures.
But what you might not know is what financial incentives a particular nursing home might have to provide high-quality care, depending on what kind of entity owns the facility.
According to the study, you can expect a somewhat lower level of quality in a PE-owned nursing home than in other for-profit facilities.
The researchers compared CMS data on 302 nursing homes owned by 79 PE firms to data on 9,562 for-profit facilities not owned by such companies from 2013 to 2017. Among fee-for-service Medicare patients in long-term care, private equity acquisitions of nursing homes were associated with an 11.1% increase in ambulatory-care-sensitive (ACS) visits to the emergency department (ED) and an 8.7% increase in ACS hospitalizations per quarter, compared to the changes that occurred in the non-PE-owned facilities, they found.
What’s more, Medicare costs per beneficiary increased 3.9% more – or about $1,000 a year – in the PE-owned nursing homes than they did in the other cohort during the study period.
And when the acquired nursing homes were compared to the nursing homes prior to their acquisition by PE firms, there were no statistically significant differences in unadjusted outcomes, the researchers found. That means the two cohorts were broadly comparable.
The researchers adjusted the numbers in their study for various characteristics of the facilities and their residents. For example, the PE-acquired nursing homes were likely to have a higher percentage of patients covered by Medicare and a lower percentage covered by Medicaid than their non-PE counterparts.
The mean percentages of Black residents, female residents, and residents aged 85 or older were 12.4%, 65.4%, and 36.2%, respectively, for the PE-owned nursing homes and 15.7%, 67.8%, and 39%, respectively, for the non–PE-owned facilities.
Less than optimal outcomes
On average, the residents of non–PE-owned nursing homes had better outcomes than did the patients in the PE-owned facilities. But that doesn’t mean that the average for-profit nursing home had terrific outcomes.
For all the nursing homes in the study, the mean quarterly rate of ACS emergency department visits was 14.1%, and the mean quarterly rate of ACS hospitalizations was 17.3%.
“These events should be largely, although not completely, preventable with appropriate care,” the researchers pointed out.
To date, PE firms have invested about $750 billion in U.S. health care, with nursing homes being a major target of these companies, which currently own 5% of skilled nursing facilities, per the study. PE companies seek annual returns of 20% or more, the paper says, and thus feel pressure to generate high short-term profits. That could lead to reduced staffing, services, supplies, or equipment in their facilities.
Some nursing homes purchased by PE firms may be responsible for the debt incurred in their own leveraged buyouts, the researchers noted. There is also concern that PE firms may focus their properties disproportionately on short-term post-acute care, which is reimbursed at a higher rate than long-term care, the study says.
For all these reasons, some health policy makers are concerned about the long-term impact of private-equity nursing home acquisitions, according to the study.
A version of this article first appeared on WebMD.com.
When you have to help a parent choose a nursing home or you need nursing home care yourself, you can consult a health care professional, talk to friends, or look at the Nursing Home Compare website of the Centers for Medicare and Medicaid Services (CMS). The CMS website includes star ratings for each nursing home, both overall and on health inspections, staffing and certain quality measures.
But what you might not know is what financial incentives a particular nursing home might have to provide high-quality care, depending on what kind of entity owns the facility.
According to the study, you can expect a somewhat lower level of quality in a PE-owned nursing home than in other for-profit facilities.
The researchers compared CMS data on 302 nursing homes owned by 79 PE firms to data on 9,562 for-profit facilities not owned by such companies from 2013 to 2017. Among fee-for-service Medicare patients in long-term care, private equity acquisitions of nursing homes were associated with an 11.1% increase in ambulatory-care-sensitive (ACS) visits to the emergency department (ED) and an 8.7% increase in ACS hospitalizations per quarter, compared to the changes that occurred in the non-PE-owned facilities, they found.
What’s more, Medicare costs per beneficiary increased 3.9% more – or about $1,000 a year – in the PE-owned nursing homes than they did in the other cohort during the study period.
And when the acquired nursing homes were compared to the nursing homes prior to their acquisition by PE firms, there were no statistically significant differences in unadjusted outcomes, the researchers found. That means the two cohorts were broadly comparable.
The researchers adjusted the numbers in their study for various characteristics of the facilities and their residents. For example, the PE-acquired nursing homes were likely to have a higher percentage of patients covered by Medicare and a lower percentage covered by Medicaid than their non-PE counterparts.
The mean percentages of Black residents, female residents, and residents aged 85 or older were 12.4%, 65.4%, and 36.2%, respectively, for the PE-owned nursing homes and 15.7%, 67.8%, and 39%, respectively, for the non–PE-owned facilities.
Less than optimal outcomes
On average, the residents of non–PE-owned nursing homes had better outcomes than did the patients in the PE-owned facilities. But that doesn’t mean that the average for-profit nursing home had terrific outcomes.
For all the nursing homes in the study, the mean quarterly rate of ACS emergency department visits was 14.1%, and the mean quarterly rate of ACS hospitalizations was 17.3%.
“These events should be largely, although not completely, preventable with appropriate care,” the researchers pointed out.
To date, PE firms have invested about $750 billion in U.S. health care, with nursing homes being a major target of these companies, which currently own 5% of skilled nursing facilities, per the study. PE companies seek annual returns of 20% or more, the paper says, and thus feel pressure to generate high short-term profits. That could lead to reduced staffing, services, supplies, or equipment in their facilities.
Some nursing homes purchased by PE firms may be responsible for the debt incurred in their own leveraged buyouts, the researchers noted. There is also concern that PE firms may focus their properties disproportionately on short-term post-acute care, which is reimbursed at a higher rate than long-term care, the study says.
For all these reasons, some health policy makers are concerned about the long-term impact of private-equity nursing home acquisitions, according to the study.
A version of this article first appeared on WebMD.com.
When you have to help a parent choose a nursing home or you need nursing home care yourself, you can consult a health care professional, talk to friends, or look at the Nursing Home Compare website of the Centers for Medicare and Medicaid Services (CMS). The CMS website includes star ratings for each nursing home, both overall and on health inspections, staffing and certain quality measures.
But what you might not know is what financial incentives a particular nursing home might have to provide high-quality care, depending on what kind of entity owns the facility.
According to the study, you can expect a somewhat lower level of quality in a PE-owned nursing home than in other for-profit facilities.
The researchers compared CMS data on 302 nursing homes owned by 79 PE firms to data on 9,562 for-profit facilities not owned by such companies from 2013 to 2017. Among fee-for-service Medicare patients in long-term care, private equity acquisitions of nursing homes were associated with an 11.1% increase in ambulatory-care-sensitive (ACS) visits to the emergency department (ED) and an 8.7% increase in ACS hospitalizations per quarter, compared to the changes that occurred in the non-PE-owned facilities, they found.
What’s more, Medicare costs per beneficiary increased 3.9% more – or about $1,000 a year – in the PE-owned nursing homes than they did in the other cohort during the study period.
And when the acquired nursing homes were compared to the nursing homes prior to their acquisition by PE firms, there were no statistically significant differences in unadjusted outcomes, the researchers found. That means the two cohorts were broadly comparable.
The researchers adjusted the numbers in their study for various characteristics of the facilities and their residents. For example, the PE-acquired nursing homes were likely to have a higher percentage of patients covered by Medicare and a lower percentage covered by Medicaid than their non-PE counterparts.
The mean percentages of Black residents, female residents, and residents aged 85 or older were 12.4%, 65.4%, and 36.2%, respectively, for the PE-owned nursing homes and 15.7%, 67.8%, and 39%, respectively, for the non–PE-owned facilities.
Less than optimal outcomes
On average, the residents of non–PE-owned nursing homes had better outcomes than did the patients in the PE-owned facilities. But that doesn’t mean that the average for-profit nursing home had terrific outcomes.
For all the nursing homes in the study, the mean quarterly rate of ACS emergency department visits was 14.1%, and the mean quarterly rate of ACS hospitalizations was 17.3%.
“These events should be largely, although not completely, preventable with appropriate care,” the researchers pointed out.
To date, PE firms have invested about $750 billion in U.S. health care, with nursing homes being a major target of these companies, which currently own 5% of skilled nursing facilities, per the study. PE companies seek annual returns of 20% or more, the paper says, and thus feel pressure to generate high short-term profits. That could lead to reduced staffing, services, supplies, or equipment in their facilities.
Some nursing homes purchased by PE firms may be responsible for the debt incurred in their own leveraged buyouts, the researchers noted. There is also concern that PE firms may focus their properties disproportionately on short-term post-acute care, which is reimbursed at a higher rate than long-term care, the study says.
For all these reasons, some health policy makers are concerned about the long-term impact of private-equity nursing home acquisitions, according to the study.
A version of this article first appeared on WebMD.com.