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Alcohol problems linked to legal performance-enhancement products
Adolescent alcohol use among boys was prospectively associated with use of legal performance-enhancing substances in young adulthood, based on prospective cohort data from more than 12,000 individuals, wrote Kyle T. Ganson, PhD, MSW, of the University of Toronto, and colleagues.
In addition, legal use of performance-enhancing substances (PES) among young men was associated with increased risk of alcohol use problems.
Although previous studies have shown a range of adverse effects associated with the use of anabolic-androgenic steroid derivatives (defined as illegal PES), the possible adverse effects of legal PES (defined in this report as protein powders, creatine monohydrate, dehydroepiandrostenedione, and amino acids) have not been well studied, the researchers wrote.
In a study published in Pediatrics, the researchers reviewed data from 12,133 young adults aged 18-26 years who were part of the National Longitudinal Study of Adolescent to Adult Health from 1994 to 2008.
Overall, 16% of young men and 1% of young women reported using legal PES in the past year. Among men, legal PES use was prospectively associated with increased risk of a range of alcohol-related problem behaviors including binge drinking (adjusted odds ratio, 1.35), injurious and risky behaviors (aOR, 1.78), legal problems (aOR, 1.52), reduced activities and socializing (aOR, 1.91), and problems with emotional or physical health (aOR, 1.44).
Legal PES use among young adult women was associated with an increased risk of emotional or physical health problems (aOR, 3.00).
Adolescent impact
Between adolescence and young adulthood (an average of 7 years’ follow-up), alcohol use was prospectively associated with legal PES use in young men (OR, 1.39), but neither cigarette smoking nor marijuana use in adolescence was associated with later use of legal PES. Among young women, no type of adolescent substance use was prospectively associated with later use of legal PES.
“To date, legal PES have not been largely considered as part of the spectrum of substances used among adolescents, have not been subject to the same regulatory scrutiny as other substances known to be linked to subsequent substance use and are freely available over the counter to adolescents,” Dr. Ganson and associates noted.
“Clearly, the robust reciprocal temporal relationship between substance use and legal PES suggests that each may serve as a gateway for the other,” they wrote.
The study findings were limited by several factors including the inability to identify outcomes associated with variable PES components, incomplete data collection on several drinking-related risk behaviors, and inability to analyze prospective use of illegal or other substances associated with use of legal PES, the researchers wrote.
However, “these results provide further evidence in support of the gateway theory and prospective health risk behaviors associated with legal PES and substance use,” they wrote.
The data may inform policy on the additional regulation of legal PES use in minors. In the meantime, “it is important for medical providers and clinicians to assess problematic alcohol use and drinking-related risk behaviors among young adult men who have previously used legal PES,” Dr. Ganson and associates concluded.
Challenges to clinicians
An important point to recognize is that PES is a misleading term, Steven Cuff, MD, of the Ohio State University, Columbus, and Michele LaBotz, MD, of Tufts University, Boston, wrote in an accompanying editorial. “Most legal supplements marketed for athletic performance enhancement are ineffective at increasing muscle mass or athletic performance beyond what can be achieved through appropriate nutrition and training,” they emphasized. The current study findings suggest that “legal PES should be integrated into the gateway hypothesis regarding patterns and progression of substance use through adolescence and early adulthood,” and support discouragement of any PES use among adolescents and young adults.
Even legal PES can be dangerous because of the lack of oversight of dietary supplements by the Food and Drug Administration. “There is widespread evidence that many over-the-counter dietary supplements lack stated ingredients, contain unlabeled ingredients (including potential allergens), or are contaminated with impurities or illegal or dangerous substances, such as steroids and stimulants,” the editorialists emphasized.
In addition, the association found in the study between muscle dysphoria and both PES use and substance use disorders, notably alcohol-related morbidity, highlights the need for a proactive approach by pediatricians to minimize the risk, they noted.
“For pediatricians uncomfortable with initiating discussions on PES use with their patients, an American Academy of Pediatrics–supported role-play simulation is available,” they concluded.
The study is important because “PES use is ubiquitous among adolescents and young adults,” Dr. LaBotz said in an interview. “Although it is widely believed that PES use serves as a likely ‘gateway’ to use of anabolic steroids and other substances, this is one of the very few studies that explores this relationship. Their findings that alcohol use appears to correlate with subsequent use of PES, and that PES use appears to correlate with future alcohol-related issues, suggest that this is not a simple linear progression of problematic behavior.”
Dr. LaBotz added that she was not surprised by the study findings, and emphasized that pediatric health care providers should be aware of the association between PES and alcohol use. “PES screening should be incorporated into screening done for alcohol and other substance use. This appears to be particularly true for athletes and other subpopulations who are at higher risk for problematic alcohol use.”
She said much of PES use is driven by the desire by young men for a muscular appearance, but more research is needed on young women. “In the past, this was a goal primarily associated with males, but females have become increasingly interested in achieving muscularity as well, which suggests an increasing risk of PES use among females as compared to earlier reports. We need updated data on patterns, prevalence and consequences of PES use in females.”
In addition, “although preparticipation physical examination forms include screening questions for PES use among athletes, further information is needed on how to incorporate PES into substance use screening that is performed in a general pediatric population, such as including athletes and nonathletes,” Dr. LaBotz said.
The study was supported by the National Institutes of Health and by grants to one of the coauthors from the Pediatric Scientist Development Program funded by the American Academy of Pediatrics and the American Pediatric Society, as well as the American Heart Association Career Development Award. The researchers had no financial conflicts to disclose. Dr. Cuff and Dr. LaBotz had no financial conflicts to disclose.
SOURCE: Ganson KT et al. Pediatrics. 2020 Sep. doi: 10.1542/peds.2020-0409.
Adolescent alcohol use among boys was prospectively associated with use of legal performance-enhancing substances in young adulthood, based on prospective cohort data from more than 12,000 individuals, wrote Kyle T. Ganson, PhD, MSW, of the University of Toronto, and colleagues.
In addition, legal use of performance-enhancing substances (PES) among young men was associated with increased risk of alcohol use problems.
Although previous studies have shown a range of adverse effects associated with the use of anabolic-androgenic steroid derivatives (defined as illegal PES), the possible adverse effects of legal PES (defined in this report as protein powders, creatine monohydrate, dehydroepiandrostenedione, and amino acids) have not been well studied, the researchers wrote.
In a study published in Pediatrics, the researchers reviewed data from 12,133 young adults aged 18-26 years who were part of the National Longitudinal Study of Adolescent to Adult Health from 1994 to 2008.
Overall, 16% of young men and 1% of young women reported using legal PES in the past year. Among men, legal PES use was prospectively associated with increased risk of a range of alcohol-related problem behaviors including binge drinking (adjusted odds ratio, 1.35), injurious and risky behaviors (aOR, 1.78), legal problems (aOR, 1.52), reduced activities and socializing (aOR, 1.91), and problems with emotional or physical health (aOR, 1.44).
Legal PES use among young adult women was associated with an increased risk of emotional or physical health problems (aOR, 3.00).
Adolescent impact
Between adolescence and young adulthood (an average of 7 years’ follow-up), alcohol use was prospectively associated with legal PES use in young men (OR, 1.39), but neither cigarette smoking nor marijuana use in adolescence was associated with later use of legal PES. Among young women, no type of adolescent substance use was prospectively associated with later use of legal PES.
“To date, legal PES have not been largely considered as part of the spectrum of substances used among adolescents, have not been subject to the same regulatory scrutiny as other substances known to be linked to subsequent substance use and are freely available over the counter to adolescents,” Dr. Ganson and associates noted.
“Clearly, the robust reciprocal temporal relationship between substance use and legal PES suggests that each may serve as a gateway for the other,” they wrote.
The study findings were limited by several factors including the inability to identify outcomes associated with variable PES components, incomplete data collection on several drinking-related risk behaviors, and inability to analyze prospective use of illegal or other substances associated with use of legal PES, the researchers wrote.
However, “these results provide further evidence in support of the gateway theory and prospective health risk behaviors associated with legal PES and substance use,” they wrote.
The data may inform policy on the additional regulation of legal PES use in minors. In the meantime, “it is important for medical providers and clinicians to assess problematic alcohol use and drinking-related risk behaviors among young adult men who have previously used legal PES,” Dr. Ganson and associates concluded.
Challenges to clinicians
An important point to recognize is that PES is a misleading term, Steven Cuff, MD, of the Ohio State University, Columbus, and Michele LaBotz, MD, of Tufts University, Boston, wrote in an accompanying editorial. “Most legal supplements marketed for athletic performance enhancement are ineffective at increasing muscle mass or athletic performance beyond what can be achieved through appropriate nutrition and training,” they emphasized. The current study findings suggest that “legal PES should be integrated into the gateway hypothesis regarding patterns and progression of substance use through adolescence and early adulthood,” and support discouragement of any PES use among adolescents and young adults.
Even legal PES can be dangerous because of the lack of oversight of dietary supplements by the Food and Drug Administration. “There is widespread evidence that many over-the-counter dietary supplements lack stated ingredients, contain unlabeled ingredients (including potential allergens), or are contaminated with impurities or illegal or dangerous substances, such as steroids and stimulants,” the editorialists emphasized.
In addition, the association found in the study between muscle dysphoria and both PES use and substance use disorders, notably alcohol-related morbidity, highlights the need for a proactive approach by pediatricians to minimize the risk, they noted.
“For pediatricians uncomfortable with initiating discussions on PES use with their patients, an American Academy of Pediatrics–supported role-play simulation is available,” they concluded.
The study is important because “PES use is ubiquitous among adolescents and young adults,” Dr. LaBotz said in an interview. “Although it is widely believed that PES use serves as a likely ‘gateway’ to use of anabolic steroids and other substances, this is one of the very few studies that explores this relationship. Their findings that alcohol use appears to correlate with subsequent use of PES, and that PES use appears to correlate with future alcohol-related issues, suggest that this is not a simple linear progression of problematic behavior.”
Dr. LaBotz added that she was not surprised by the study findings, and emphasized that pediatric health care providers should be aware of the association between PES and alcohol use. “PES screening should be incorporated into screening done for alcohol and other substance use. This appears to be particularly true for athletes and other subpopulations who are at higher risk for problematic alcohol use.”
She said much of PES use is driven by the desire by young men for a muscular appearance, but more research is needed on young women. “In the past, this was a goal primarily associated with males, but females have become increasingly interested in achieving muscularity as well, which suggests an increasing risk of PES use among females as compared to earlier reports. We need updated data on patterns, prevalence and consequences of PES use in females.”
In addition, “although preparticipation physical examination forms include screening questions for PES use among athletes, further information is needed on how to incorporate PES into substance use screening that is performed in a general pediatric population, such as including athletes and nonathletes,” Dr. LaBotz said.
The study was supported by the National Institutes of Health and by grants to one of the coauthors from the Pediatric Scientist Development Program funded by the American Academy of Pediatrics and the American Pediatric Society, as well as the American Heart Association Career Development Award. The researchers had no financial conflicts to disclose. Dr. Cuff and Dr. LaBotz had no financial conflicts to disclose.
SOURCE: Ganson KT et al. Pediatrics. 2020 Sep. doi: 10.1542/peds.2020-0409.
Adolescent alcohol use among boys was prospectively associated with use of legal performance-enhancing substances in young adulthood, based on prospective cohort data from more than 12,000 individuals, wrote Kyle T. Ganson, PhD, MSW, of the University of Toronto, and colleagues.
In addition, legal use of performance-enhancing substances (PES) among young men was associated with increased risk of alcohol use problems.
Although previous studies have shown a range of adverse effects associated with the use of anabolic-androgenic steroid derivatives (defined as illegal PES), the possible adverse effects of legal PES (defined in this report as protein powders, creatine monohydrate, dehydroepiandrostenedione, and amino acids) have not been well studied, the researchers wrote.
In a study published in Pediatrics, the researchers reviewed data from 12,133 young adults aged 18-26 years who were part of the National Longitudinal Study of Adolescent to Adult Health from 1994 to 2008.
Overall, 16% of young men and 1% of young women reported using legal PES in the past year. Among men, legal PES use was prospectively associated with increased risk of a range of alcohol-related problem behaviors including binge drinking (adjusted odds ratio, 1.35), injurious and risky behaviors (aOR, 1.78), legal problems (aOR, 1.52), reduced activities and socializing (aOR, 1.91), and problems with emotional or physical health (aOR, 1.44).
Legal PES use among young adult women was associated with an increased risk of emotional or physical health problems (aOR, 3.00).
Adolescent impact
Between adolescence and young adulthood (an average of 7 years’ follow-up), alcohol use was prospectively associated with legal PES use in young men (OR, 1.39), but neither cigarette smoking nor marijuana use in adolescence was associated with later use of legal PES. Among young women, no type of adolescent substance use was prospectively associated with later use of legal PES.
“To date, legal PES have not been largely considered as part of the spectrum of substances used among adolescents, have not been subject to the same regulatory scrutiny as other substances known to be linked to subsequent substance use and are freely available over the counter to adolescents,” Dr. Ganson and associates noted.
“Clearly, the robust reciprocal temporal relationship between substance use and legal PES suggests that each may serve as a gateway for the other,” they wrote.
The study findings were limited by several factors including the inability to identify outcomes associated with variable PES components, incomplete data collection on several drinking-related risk behaviors, and inability to analyze prospective use of illegal or other substances associated with use of legal PES, the researchers wrote.
However, “these results provide further evidence in support of the gateway theory and prospective health risk behaviors associated with legal PES and substance use,” they wrote.
The data may inform policy on the additional regulation of legal PES use in minors. In the meantime, “it is important for medical providers and clinicians to assess problematic alcohol use and drinking-related risk behaviors among young adult men who have previously used legal PES,” Dr. Ganson and associates concluded.
Challenges to clinicians
An important point to recognize is that PES is a misleading term, Steven Cuff, MD, of the Ohio State University, Columbus, and Michele LaBotz, MD, of Tufts University, Boston, wrote in an accompanying editorial. “Most legal supplements marketed for athletic performance enhancement are ineffective at increasing muscle mass or athletic performance beyond what can be achieved through appropriate nutrition and training,” they emphasized. The current study findings suggest that “legal PES should be integrated into the gateway hypothesis regarding patterns and progression of substance use through adolescence and early adulthood,” and support discouragement of any PES use among adolescents and young adults.
Even legal PES can be dangerous because of the lack of oversight of dietary supplements by the Food and Drug Administration. “There is widespread evidence that many over-the-counter dietary supplements lack stated ingredients, contain unlabeled ingredients (including potential allergens), or are contaminated with impurities or illegal or dangerous substances, such as steroids and stimulants,” the editorialists emphasized.
In addition, the association found in the study between muscle dysphoria and both PES use and substance use disorders, notably alcohol-related morbidity, highlights the need for a proactive approach by pediatricians to minimize the risk, they noted.
“For pediatricians uncomfortable with initiating discussions on PES use with their patients, an American Academy of Pediatrics–supported role-play simulation is available,” they concluded.
The study is important because “PES use is ubiquitous among adolescents and young adults,” Dr. LaBotz said in an interview. “Although it is widely believed that PES use serves as a likely ‘gateway’ to use of anabolic steroids and other substances, this is one of the very few studies that explores this relationship. Their findings that alcohol use appears to correlate with subsequent use of PES, and that PES use appears to correlate with future alcohol-related issues, suggest that this is not a simple linear progression of problematic behavior.”
Dr. LaBotz added that she was not surprised by the study findings, and emphasized that pediatric health care providers should be aware of the association between PES and alcohol use. “PES screening should be incorporated into screening done for alcohol and other substance use. This appears to be particularly true for athletes and other subpopulations who are at higher risk for problematic alcohol use.”
She said much of PES use is driven by the desire by young men for a muscular appearance, but more research is needed on young women. “In the past, this was a goal primarily associated with males, but females have become increasingly interested in achieving muscularity as well, which suggests an increasing risk of PES use among females as compared to earlier reports. We need updated data on patterns, prevalence and consequences of PES use in females.”
In addition, “although preparticipation physical examination forms include screening questions for PES use among athletes, further information is needed on how to incorporate PES into substance use screening that is performed in a general pediatric population, such as including athletes and nonathletes,” Dr. LaBotz said.
The study was supported by the National Institutes of Health and by grants to one of the coauthors from the Pediatric Scientist Development Program funded by the American Academy of Pediatrics and the American Pediatric Society, as well as the American Heart Association Career Development Award. The researchers had no financial conflicts to disclose. Dr. Cuff and Dr. LaBotz had no financial conflicts to disclose.
SOURCE: Ganson KT et al. Pediatrics. 2020 Sep. doi: 10.1542/peds.2020-0409.
FROM PEDIATRICS
Surgeon general pushes for improved hypertension control
Roughly half of American adults have hypertension, and about 71% of these cases are uncontrolled, according to data from the American Heart Association.
If left uncontrolled, hypertension can increase risk for conditions including heart disease, stroke, kidney disease, pregnancy complications, and cognitive decline, surgeon general Vice Adm. Jerome M. Adams, MD, said in a teleconference on Oct. 7. Hispanic and Black individuals are disproportionately affected, he added.
“We cannot wait to deal with this epidemic of uncontrolled high blood pressure,” even in the midst of the ongoing COVID-19 pandemic, said Dr. Adams. “We know what works” to help control hypertension, he added, citing his own use of a blood pressure monitoring device at home.
The Department of Health & Human Services has issued a Call to Action to Control Hypertension based on the latest science and research.
Dr. Adams outlined three goals to improve hypertension control, starting with making it a national priority. The Call to Action supports increasing awareness of the health risks associated with hypertension, recognizing the economic impact, overcoming barriers to controlling hypertension, and promoting health equity.
“In 2020, disparities in the burden of disease – especially among minority populations – have been recognized during the COVID-19 pandemic. A growing body of evidence has shown that people with underlying health conditions, including cardiovascular disease, are at increased risk of worse outcomes related to COVID-19 infection,” according to the Call to Action.
A second goal is to build and sustain communities that support individuals in taking responsibility for their health and blood pressure control, Dr. Adams said. He cited the need to create places for safe physical activity, access to healthy food, and opportunities to connect to resources to support lifestyle changes.
Finally, clinicians should continue to use standardized treatment approaches and promote team-based care to maximize outcomes for patients, Dr. Adams said.
Success starts with making hypertension control a priority across the leadership team, regardless of the size, location, or demographic population at a health care setting, he said. Dr. Adams cited the Million Hearts 2022 program, an ongoing initiative to prevent 1 million heart attacks in the United States over 5 years, as a way that HHS is recognizing and rewarding success stories in hypertension control from across the country.
Empowering patients and equipping them to take charge of their hypertension essential to reducing the epidemic of high blood pressure, especially during the ongoing pandemic, Dr. Adams said. His message to clinicians to extend to patients is that it is safe to visit their doctors. Hospitals have worked to create a safe environment, however, patients can and should monitor their blood pressure regularly at home, using a self-measured blood pressure monitoring (SMBP) device, which may be covered by some insurers.
“I would encourage people to know their numbers,” and that 130/80 mm Hg is considered high and a risk factor for poor health outcomes, Dr. Adams said. Clinicians also should continue to support patients in lifestyle changes such as healthy eating and exercising regularly to help control high blood pressure.
The AHA expressed support for the surgeon general’s Call to Action. “Today’s call to action references updated hypertension guidelines the AHA and the American College of Cardiology issued in 2017 that apply the latest science to help clinicians work with patients to control their blood pressure,” the AHA said in a statement. The AHA also called on the Centers for Medicare & Medicaid Services and other insurance providers “to include coverage of SMBP devices for treatment and management of hypertension.”
The Call to Action was accompanied by a Viewpoint from Dr. Adams and Janet S. Wright, MD, also of the HHS, published in JAMA. Dr. Adams and Dr. Wright emphasized that the timing of the Call to Action recognizes that many of the same social factors that support or impede successful high blood pressure control are factors in worse outcomes from COVID-19 infections as well.
“When coupled with widespread implementation of best practices in clinical settings and empowering individuals to actively manage their blood pressure, acknowledging and addressing a community’s social conditions may generate sustained improvements in control of both hypertension and COVID-19,” they said.
Read and download the full Call to Action here, and read the Executive Summary at hhs.gov.
Roughly half of American adults have hypertension, and about 71% of these cases are uncontrolled, according to data from the American Heart Association.
If left uncontrolled, hypertension can increase risk for conditions including heart disease, stroke, kidney disease, pregnancy complications, and cognitive decline, surgeon general Vice Adm. Jerome M. Adams, MD, said in a teleconference on Oct. 7. Hispanic and Black individuals are disproportionately affected, he added.
“We cannot wait to deal with this epidemic of uncontrolled high blood pressure,” even in the midst of the ongoing COVID-19 pandemic, said Dr. Adams. “We know what works” to help control hypertension, he added, citing his own use of a blood pressure monitoring device at home.
The Department of Health & Human Services has issued a Call to Action to Control Hypertension based on the latest science and research.
Dr. Adams outlined three goals to improve hypertension control, starting with making it a national priority. The Call to Action supports increasing awareness of the health risks associated with hypertension, recognizing the economic impact, overcoming barriers to controlling hypertension, and promoting health equity.
“In 2020, disparities in the burden of disease – especially among minority populations – have been recognized during the COVID-19 pandemic. A growing body of evidence has shown that people with underlying health conditions, including cardiovascular disease, are at increased risk of worse outcomes related to COVID-19 infection,” according to the Call to Action.
A second goal is to build and sustain communities that support individuals in taking responsibility for their health and blood pressure control, Dr. Adams said. He cited the need to create places for safe physical activity, access to healthy food, and opportunities to connect to resources to support lifestyle changes.
Finally, clinicians should continue to use standardized treatment approaches and promote team-based care to maximize outcomes for patients, Dr. Adams said.
Success starts with making hypertension control a priority across the leadership team, regardless of the size, location, or demographic population at a health care setting, he said. Dr. Adams cited the Million Hearts 2022 program, an ongoing initiative to prevent 1 million heart attacks in the United States over 5 years, as a way that HHS is recognizing and rewarding success stories in hypertension control from across the country.
Empowering patients and equipping them to take charge of their hypertension essential to reducing the epidemic of high blood pressure, especially during the ongoing pandemic, Dr. Adams said. His message to clinicians to extend to patients is that it is safe to visit their doctors. Hospitals have worked to create a safe environment, however, patients can and should monitor their blood pressure regularly at home, using a self-measured blood pressure monitoring (SMBP) device, which may be covered by some insurers.
“I would encourage people to know their numbers,” and that 130/80 mm Hg is considered high and a risk factor for poor health outcomes, Dr. Adams said. Clinicians also should continue to support patients in lifestyle changes such as healthy eating and exercising regularly to help control high blood pressure.
The AHA expressed support for the surgeon general’s Call to Action. “Today’s call to action references updated hypertension guidelines the AHA and the American College of Cardiology issued in 2017 that apply the latest science to help clinicians work with patients to control their blood pressure,” the AHA said in a statement. The AHA also called on the Centers for Medicare & Medicaid Services and other insurance providers “to include coverage of SMBP devices for treatment and management of hypertension.”
The Call to Action was accompanied by a Viewpoint from Dr. Adams and Janet S. Wright, MD, also of the HHS, published in JAMA. Dr. Adams and Dr. Wright emphasized that the timing of the Call to Action recognizes that many of the same social factors that support or impede successful high blood pressure control are factors in worse outcomes from COVID-19 infections as well.
“When coupled with widespread implementation of best practices in clinical settings and empowering individuals to actively manage their blood pressure, acknowledging and addressing a community’s social conditions may generate sustained improvements in control of both hypertension and COVID-19,” they said.
Read and download the full Call to Action here, and read the Executive Summary at hhs.gov.
Roughly half of American adults have hypertension, and about 71% of these cases are uncontrolled, according to data from the American Heart Association.
If left uncontrolled, hypertension can increase risk for conditions including heart disease, stroke, kidney disease, pregnancy complications, and cognitive decline, surgeon general Vice Adm. Jerome M. Adams, MD, said in a teleconference on Oct. 7. Hispanic and Black individuals are disproportionately affected, he added.
“We cannot wait to deal with this epidemic of uncontrolled high blood pressure,” even in the midst of the ongoing COVID-19 pandemic, said Dr. Adams. “We know what works” to help control hypertension, he added, citing his own use of a blood pressure monitoring device at home.
The Department of Health & Human Services has issued a Call to Action to Control Hypertension based on the latest science and research.
Dr. Adams outlined three goals to improve hypertension control, starting with making it a national priority. The Call to Action supports increasing awareness of the health risks associated with hypertension, recognizing the economic impact, overcoming barriers to controlling hypertension, and promoting health equity.
“In 2020, disparities in the burden of disease – especially among minority populations – have been recognized during the COVID-19 pandemic. A growing body of evidence has shown that people with underlying health conditions, including cardiovascular disease, are at increased risk of worse outcomes related to COVID-19 infection,” according to the Call to Action.
A second goal is to build and sustain communities that support individuals in taking responsibility for their health and blood pressure control, Dr. Adams said. He cited the need to create places for safe physical activity, access to healthy food, and opportunities to connect to resources to support lifestyle changes.
Finally, clinicians should continue to use standardized treatment approaches and promote team-based care to maximize outcomes for patients, Dr. Adams said.
Success starts with making hypertension control a priority across the leadership team, regardless of the size, location, or demographic population at a health care setting, he said. Dr. Adams cited the Million Hearts 2022 program, an ongoing initiative to prevent 1 million heart attacks in the United States over 5 years, as a way that HHS is recognizing and rewarding success stories in hypertension control from across the country.
Empowering patients and equipping them to take charge of their hypertension essential to reducing the epidemic of high blood pressure, especially during the ongoing pandemic, Dr. Adams said. His message to clinicians to extend to patients is that it is safe to visit their doctors. Hospitals have worked to create a safe environment, however, patients can and should monitor their blood pressure regularly at home, using a self-measured blood pressure monitoring (SMBP) device, which may be covered by some insurers.
“I would encourage people to know their numbers,” and that 130/80 mm Hg is considered high and a risk factor for poor health outcomes, Dr. Adams said. Clinicians also should continue to support patients in lifestyle changes such as healthy eating and exercising regularly to help control high blood pressure.
The AHA expressed support for the surgeon general’s Call to Action. “Today’s call to action references updated hypertension guidelines the AHA and the American College of Cardiology issued in 2017 that apply the latest science to help clinicians work with patients to control their blood pressure,” the AHA said in a statement. The AHA also called on the Centers for Medicare & Medicaid Services and other insurance providers “to include coverage of SMBP devices for treatment and management of hypertension.”
The Call to Action was accompanied by a Viewpoint from Dr. Adams and Janet S. Wright, MD, also of the HHS, published in JAMA. Dr. Adams and Dr. Wright emphasized that the timing of the Call to Action recognizes that many of the same social factors that support or impede successful high blood pressure control are factors in worse outcomes from COVID-19 infections as well.
“When coupled with widespread implementation of best practices in clinical settings and empowering individuals to actively manage their blood pressure, acknowledging and addressing a community’s social conditions may generate sustained improvements in control of both hypertension and COVID-19,” they said.
Read and download the full Call to Action here, and read the Executive Summary at hhs.gov.
MI recurrences drop, but women underestimate disease risk
The number of heart attack survivors in the United States who experienced repeat attacks within a year decreased between 2008 and 2017, especially among women, yet women’s awareness of their risk of death from heart disease also decreased, according to data from a pair of studies published in Circulation.
Recurrent MI rates drop, but not enough
Although the overall morbidity and mortality from coronary heart disease (CHD) in the United States has been on the decline for decades, CHD remains the leading cause of death and disability in both sexes, wrote Sanne A.E. Peters, PhD, of Imperial College London, and colleagues.
To better assess the rates of recurrent CHD by sex, the researchers reviewed data from 770,408 women and 700,477 men younger than 65 years with commercial health insurance or aged 66 years and older with Medicare who were hospitalized for myocardial infarction between 2008 and 2017. The patients were followed for 1 year for recurrent MIs, recurrent CHD events, heart failure hospitalization, and all-cause mortality.
In the study of recurrent heart disease, the rate of recurrent heart attacks per 1,000 person-years declined from 89.2 to 72.3 in women and from 94.2 to 81.3 in men. In addition, the rate of recurrent heart disease events (defined as either an MI or an artery-opening procedure), dropped per 1,000 person-years from 166.3 to 133.3 in women and from 198.1 to 176.8 in men. The reduction was significantly greater among women compared with men (P < .001 for both recurrent MIs and recurrent CHD events) and the differences by sex were consistent throughout the study period.
However, no significant difference occurred in recurrent MI rates among younger women (aged 21-54 years), or men aged 55-79 years, the researchers noted.
Heart failure rates per 1,000 person-years decreased from 177.4 to 158.1 in women and from 162.9 to 156.1 in men during the study period, and all-cause mortality decreased per 1,000 person-years from 403.2 to 389.5 for women and from 436.1 to 417.9 in men.
Potential contributing factors to the reductions in rates of recurrent events after a heart attack may include improved acute cardiac procedures, in-hospital therapy, and secondary prevention, the researchers noted. In addition, “changes in the type and definition of MI may also have contributed to the decline in recurrent events,” they said. “Also, the introduction and increasing sensitivity of cardiac biomarkers assays, especially cardiac troponin, may have contributed to an increased detection of less severe MIs over time, which, in turn, could have resulted in artifactual reductions in the consequences of MI,” they said.
The study findings were limited by several factors including the use of claims data, lack of information on the severity of heart attacks, and inability to analyze population subgroups, but the results were strengthened by the use of a large, multicultural database.
Despite the decline seen in this study, overall rates of recurrent MI, recurrent CHD events, heart failure hospitalization, and mortality remain high, the researchers said, and the results “highlight the need for interventions to ensure men and women receive guideline recommended treatment to lower the risk for recurrent MI, recurrent CHD, heart failure, and mortality after hospital discharge for MI,” they concluded.
Many women don’t recognize heart disease risk
Although women showed a greater reduction in recurrent MI and recurrent CHD events compared with men, the awareness of heart disease as the No. 1 killer of women has declined, according to a special report from the American Heart Association.
Based on survey data from 2009, 65% of women were aware that heart disease was their leading cause of death (LCOD); by 2019 the number dropped to 44%. The 10-year decline occurred across all races and ethnicities, as well as ages, with the exception of women aged 65 years and older.
The American Heart Association has conducted national surveys since 1997 to monitor awareness of cardiovascular disease among U.S. women. Data from earlier surveys showed increased awareness of heart disease as LCOD and increased awareness of heart attack symptoms between 1997 and 2012, wrote Mary Cushman, MD, of the University of Vermont, Burlington, chair of the writing group for the statement, and colleagues.
However, overall awareness and knowledge of heart disease among women remains poor, they wrote.
“Awareness programs designed to educate the public about CVD among women in the United States include Go Red for Women by the American Heart Association; The Heart Truth by the National Heart, Lung, and Blood Institute; and Make the Call, Don’t Miss a Beat by the U.S. Department of Health and Human Services,” the researchers noted. To determine the change in awareness of heart disease as the LCOD among women, the researchers conducted a multivariate analysis of 1,158 women who completed the 2009 survey and 1,345 who completed the 2019 survey. The average age was 50 years; roughly 70% of the participants in the 2009 survey and 62% in the 2019 survey were non-Hispanic White.
The greatest declines in awareness of heart disease as LCOD occurred among Hispanics and non-Hispanic Blacks and among all respondents aged 25-34 years.
Awareness of heart disease as LCOD was 30% lower among women with high blood pressure compared with women overall, the researchers noted.
“In both surveys, higher educational attainment was strongly related to awareness that heart disease is the LCOD,” the researchers said. However, the results highlight the need for renewed efforts to educate younger women, Hispanic women, and non-Hispanic Black women, they emphasized. Unpublished data from the AHA survey showed that “younger women were less likely to report leading a heart-healthy lifestyle and were more likely to identify multiple barriers to leading a heart-healthy lifestyle, including lack of time, stress, and lack of confidence,” they wrote.
In addition, awareness of heart attack warning signs declined overall and within each ethnic group between 2009 and 2019.
The survey results were limited by several factors including the use of an online-only model that might limit generalizability to populations without online access, and was conducted only in English, the researchers wrote.
Heart disease needs new PR plan
The study of heart disease risk awareness among women was an important update to understand how well the message about women’s risk is getting out, said Martha Gulati, MD, president-elect of the American Society of Preventive Cardiology, in an interview.
The issue remains that heart disease is the No. 1 killer of women, and the decrease in awareness “means we need to amplify our message,” she said.
“I also question whether the symbol of the red dress [for women’s heart disease] is working, and it seems that now is the time to change this symbol,” she emphasized. “I wear a red dress pin on my lab coat and every day someone asks what it means, and no one recognizes it,” she said. “I think ‘Go Red for Women’ is great and part of our outward campaign, but our symbol needs to change to increase the connection and awareness in women,” she said.
What might be a better symbol? Simply, a heart, said Dr. Gulati. But “we need to study whatever is next to really connect with women and make them understand their risk for heart disease,” she added.
“Additionally, we really need to get to minority women,” she said. “We are lagging there, and the survey was conducted in English so it missed many people,” she noted.
Dr. Gulati said she was shocked at how much awareness of heart disease risk has fallen among women, even in those with risk factors such as hypertension, who were 30% less likely to be aware that heart disease remains their leading cause of death. “Younger women as well as very unaware; what this means to me is that our public education efforts need to be amplified,” Dr. Gulati said.
Barriers to educating women about heart disease risk include language and access to affordable screening, Dr. Gulati emphasized. “We need to ensure screening for heart disease is always included as a covered cost for a preventive service,” she said.
“Research needs to be done to identify what works toward educating women about cardiac risk. We need to identify a marketing tool to increase awareness in women. It might be something different for one race versus another,” Dr. Gulati said. “Our messaging needs to improve, but how we improve it needs more than just health care professionals,” she said.
Focus on prevention to reduce MI recurrence
“The study regarding recurrent events after MI is important because we really don’t know much about recurrent coronary heart disease after a MI over time,” said Dr. Gulati. These data can be helpful in managing surviving patients and understanding future risk, she said. “But I was surprised to see fewer recurrent events in women, as women still have more heart failure than men even if it has declined with time,” she noted.
Dr. Gulati questioned several aspects of the study and highlighted some of the limitations. “These are claims data, so do they accurately reflect the U.S. population?” she asked. “Remember, this is a study of people who survived a heart attack; those who didn’t survive aren’t included, and that group is more likely to be women, especially women younger than 55 years,” she said.
In addition, Dr. Gulati noted the lack of data on type of heart attack and on treatment adherence or referral to cardiac rehab, as well as lack of data on long-term medication adherence or follow-up care.
Prevention is the key take-home message from both studies, “whether we are talking primary prevention for the heart disease awareness study or secondary prevention for the recurrent heart attack study,” Dr. Gulati said.
The recurrent heart disease study was supported in part by Amgen and the University of Alabama at Birmingham. Lead author Dr. Peters disclosed support from a UK Medical Research Council Skills Development Fellowship with no financial conflicts. Dr. Cushman had no financial conflicts to disclose; several coauthors on the writing committee disclosed relationships with companies including Amarin and Boehringer Ingelheim. Dr. Gulati had no financial conflicts to disclose.
SOURCE: Peters SAE et al. Circulation. 2020 Sep 21. doi: 10.1161/CIRCULATIONAHA.120.047065; Cushman M et al. Circulation. 2020 Sep 21. doi: 10.1161/CIR.0000000000000907.
The number of heart attack survivors in the United States who experienced repeat attacks within a year decreased between 2008 and 2017, especially among women, yet women’s awareness of their risk of death from heart disease also decreased, according to data from a pair of studies published in Circulation.
Recurrent MI rates drop, but not enough
Although the overall morbidity and mortality from coronary heart disease (CHD) in the United States has been on the decline for decades, CHD remains the leading cause of death and disability in both sexes, wrote Sanne A.E. Peters, PhD, of Imperial College London, and colleagues.
To better assess the rates of recurrent CHD by sex, the researchers reviewed data from 770,408 women and 700,477 men younger than 65 years with commercial health insurance or aged 66 years and older with Medicare who were hospitalized for myocardial infarction between 2008 and 2017. The patients were followed for 1 year for recurrent MIs, recurrent CHD events, heart failure hospitalization, and all-cause mortality.
In the study of recurrent heart disease, the rate of recurrent heart attacks per 1,000 person-years declined from 89.2 to 72.3 in women and from 94.2 to 81.3 in men. In addition, the rate of recurrent heart disease events (defined as either an MI or an artery-opening procedure), dropped per 1,000 person-years from 166.3 to 133.3 in women and from 198.1 to 176.8 in men. The reduction was significantly greater among women compared with men (P < .001 for both recurrent MIs and recurrent CHD events) and the differences by sex were consistent throughout the study period.
However, no significant difference occurred in recurrent MI rates among younger women (aged 21-54 years), or men aged 55-79 years, the researchers noted.
Heart failure rates per 1,000 person-years decreased from 177.4 to 158.1 in women and from 162.9 to 156.1 in men during the study period, and all-cause mortality decreased per 1,000 person-years from 403.2 to 389.5 for women and from 436.1 to 417.9 in men.
Potential contributing factors to the reductions in rates of recurrent events after a heart attack may include improved acute cardiac procedures, in-hospital therapy, and secondary prevention, the researchers noted. In addition, “changes in the type and definition of MI may also have contributed to the decline in recurrent events,” they said. “Also, the introduction and increasing sensitivity of cardiac biomarkers assays, especially cardiac troponin, may have contributed to an increased detection of less severe MIs over time, which, in turn, could have resulted in artifactual reductions in the consequences of MI,” they said.
The study findings were limited by several factors including the use of claims data, lack of information on the severity of heart attacks, and inability to analyze population subgroups, but the results were strengthened by the use of a large, multicultural database.
Despite the decline seen in this study, overall rates of recurrent MI, recurrent CHD events, heart failure hospitalization, and mortality remain high, the researchers said, and the results “highlight the need for interventions to ensure men and women receive guideline recommended treatment to lower the risk for recurrent MI, recurrent CHD, heart failure, and mortality after hospital discharge for MI,” they concluded.
Many women don’t recognize heart disease risk
Although women showed a greater reduction in recurrent MI and recurrent CHD events compared with men, the awareness of heart disease as the No. 1 killer of women has declined, according to a special report from the American Heart Association.
Based on survey data from 2009, 65% of women were aware that heart disease was their leading cause of death (LCOD); by 2019 the number dropped to 44%. The 10-year decline occurred across all races and ethnicities, as well as ages, with the exception of women aged 65 years and older.
The American Heart Association has conducted national surveys since 1997 to monitor awareness of cardiovascular disease among U.S. women. Data from earlier surveys showed increased awareness of heart disease as LCOD and increased awareness of heart attack symptoms between 1997 and 2012, wrote Mary Cushman, MD, of the University of Vermont, Burlington, chair of the writing group for the statement, and colleagues.
However, overall awareness and knowledge of heart disease among women remains poor, they wrote.
“Awareness programs designed to educate the public about CVD among women in the United States include Go Red for Women by the American Heart Association; The Heart Truth by the National Heart, Lung, and Blood Institute; and Make the Call, Don’t Miss a Beat by the U.S. Department of Health and Human Services,” the researchers noted. To determine the change in awareness of heart disease as the LCOD among women, the researchers conducted a multivariate analysis of 1,158 women who completed the 2009 survey and 1,345 who completed the 2019 survey. The average age was 50 years; roughly 70% of the participants in the 2009 survey and 62% in the 2019 survey were non-Hispanic White.
The greatest declines in awareness of heart disease as LCOD occurred among Hispanics and non-Hispanic Blacks and among all respondents aged 25-34 years.
Awareness of heart disease as LCOD was 30% lower among women with high blood pressure compared with women overall, the researchers noted.
“In both surveys, higher educational attainment was strongly related to awareness that heart disease is the LCOD,” the researchers said. However, the results highlight the need for renewed efforts to educate younger women, Hispanic women, and non-Hispanic Black women, they emphasized. Unpublished data from the AHA survey showed that “younger women were less likely to report leading a heart-healthy lifestyle and were more likely to identify multiple barriers to leading a heart-healthy lifestyle, including lack of time, stress, and lack of confidence,” they wrote.
In addition, awareness of heart attack warning signs declined overall and within each ethnic group between 2009 and 2019.
The survey results were limited by several factors including the use of an online-only model that might limit generalizability to populations without online access, and was conducted only in English, the researchers wrote.
Heart disease needs new PR plan
The study of heart disease risk awareness among women was an important update to understand how well the message about women’s risk is getting out, said Martha Gulati, MD, president-elect of the American Society of Preventive Cardiology, in an interview.
The issue remains that heart disease is the No. 1 killer of women, and the decrease in awareness “means we need to amplify our message,” she said.
“I also question whether the symbol of the red dress [for women’s heart disease] is working, and it seems that now is the time to change this symbol,” she emphasized. “I wear a red dress pin on my lab coat and every day someone asks what it means, and no one recognizes it,” she said. “I think ‘Go Red for Women’ is great and part of our outward campaign, but our symbol needs to change to increase the connection and awareness in women,” she said.
What might be a better symbol? Simply, a heart, said Dr. Gulati. But “we need to study whatever is next to really connect with women and make them understand their risk for heart disease,” she added.
“Additionally, we really need to get to minority women,” she said. “We are lagging there, and the survey was conducted in English so it missed many people,” she noted.
Dr. Gulati said she was shocked at how much awareness of heart disease risk has fallen among women, even in those with risk factors such as hypertension, who were 30% less likely to be aware that heart disease remains their leading cause of death. “Younger women as well as very unaware; what this means to me is that our public education efforts need to be amplified,” Dr. Gulati said.
Barriers to educating women about heart disease risk include language and access to affordable screening, Dr. Gulati emphasized. “We need to ensure screening for heart disease is always included as a covered cost for a preventive service,” she said.
“Research needs to be done to identify what works toward educating women about cardiac risk. We need to identify a marketing tool to increase awareness in women. It might be something different for one race versus another,” Dr. Gulati said. “Our messaging needs to improve, but how we improve it needs more than just health care professionals,” she said.
Focus on prevention to reduce MI recurrence
“The study regarding recurrent events after MI is important because we really don’t know much about recurrent coronary heart disease after a MI over time,” said Dr. Gulati. These data can be helpful in managing surviving patients and understanding future risk, she said. “But I was surprised to see fewer recurrent events in women, as women still have more heart failure than men even if it has declined with time,” she noted.
Dr. Gulati questioned several aspects of the study and highlighted some of the limitations. “These are claims data, so do they accurately reflect the U.S. population?” she asked. “Remember, this is a study of people who survived a heart attack; those who didn’t survive aren’t included, and that group is more likely to be women, especially women younger than 55 years,” she said.
In addition, Dr. Gulati noted the lack of data on type of heart attack and on treatment adherence or referral to cardiac rehab, as well as lack of data on long-term medication adherence or follow-up care.
Prevention is the key take-home message from both studies, “whether we are talking primary prevention for the heart disease awareness study or secondary prevention for the recurrent heart attack study,” Dr. Gulati said.
The recurrent heart disease study was supported in part by Amgen and the University of Alabama at Birmingham. Lead author Dr. Peters disclosed support from a UK Medical Research Council Skills Development Fellowship with no financial conflicts. Dr. Cushman had no financial conflicts to disclose; several coauthors on the writing committee disclosed relationships with companies including Amarin and Boehringer Ingelheim. Dr. Gulati had no financial conflicts to disclose.
SOURCE: Peters SAE et al. Circulation. 2020 Sep 21. doi: 10.1161/CIRCULATIONAHA.120.047065; Cushman M et al. Circulation. 2020 Sep 21. doi: 10.1161/CIR.0000000000000907.
The number of heart attack survivors in the United States who experienced repeat attacks within a year decreased between 2008 and 2017, especially among women, yet women’s awareness of their risk of death from heart disease also decreased, according to data from a pair of studies published in Circulation.
Recurrent MI rates drop, but not enough
Although the overall morbidity and mortality from coronary heart disease (CHD) in the United States has been on the decline for decades, CHD remains the leading cause of death and disability in both sexes, wrote Sanne A.E. Peters, PhD, of Imperial College London, and colleagues.
To better assess the rates of recurrent CHD by sex, the researchers reviewed data from 770,408 women and 700,477 men younger than 65 years with commercial health insurance or aged 66 years and older with Medicare who were hospitalized for myocardial infarction between 2008 and 2017. The patients were followed for 1 year for recurrent MIs, recurrent CHD events, heart failure hospitalization, and all-cause mortality.
In the study of recurrent heart disease, the rate of recurrent heart attacks per 1,000 person-years declined from 89.2 to 72.3 in women and from 94.2 to 81.3 in men. In addition, the rate of recurrent heart disease events (defined as either an MI or an artery-opening procedure), dropped per 1,000 person-years from 166.3 to 133.3 in women and from 198.1 to 176.8 in men. The reduction was significantly greater among women compared with men (P < .001 for both recurrent MIs and recurrent CHD events) and the differences by sex were consistent throughout the study period.
However, no significant difference occurred in recurrent MI rates among younger women (aged 21-54 years), or men aged 55-79 years, the researchers noted.
Heart failure rates per 1,000 person-years decreased from 177.4 to 158.1 in women and from 162.9 to 156.1 in men during the study period, and all-cause mortality decreased per 1,000 person-years from 403.2 to 389.5 for women and from 436.1 to 417.9 in men.
Potential contributing factors to the reductions in rates of recurrent events after a heart attack may include improved acute cardiac procedures, in-hospital therapy, and secondary prevention, the researchers noted. In addition, “changes in the type and definition of MI may also have contributed to the decline in recurrent events,” they said. “Also, the introduction and increasing sensitivity of cardiac biomarkers assays, especially cardiac troponin, may have contributed to an increased detection of less severe MIs over time, which, in turn, could have resulted in artifactual reductions in the consequences of MI,” they said.
The study findings were limited by several factors including the use of claims data, lack of information on the severity of heart attacks, and inability to analyze population subgroups, but the results were strengthened by the use of a large, multicultural database.
Despite the decline seen in this study, overall rates of recurrent MI, recurrent CHD events, heart failure hospitalization, and mortality remain high, the researchers said, and the results “highlight the need for interventions to ensure men and women receive guideline recommended treatment to lower the risk for recurrent MI, recurrent CHD, heart failure, and mortality after hospital discharge for MI,” they concluded.
Many women don’t recognize heart disease risk
Although women showed a greater reduction in recurrent MI and recurrent CHD events compared with men, the awareness of heart disease as the No. 1 killer of women has declined, according to a special report from the American Heart Association.
Based on survey data from 2009, 65% of women were aware that heart disease was their leading cause of death (LCOD); by 2019 the number dropped to 44%. The 10-year decline occurred across all races and ethnicities, as well as ages, with the exception of women aged 65 years and older.
The American Heart Association has conducted national surveys since 1997 to monitor awareness of cardiovascular disease among U.S. women. Data from earlier surveys showed increased awareness of heart disease as LCOD and increased awareness of heart attack symptoms between 1997 and 2012, wrote Mary Cushman, MD, of the University of Vermont, Burlington, chair of the writing group for the statement, and colleagues.
However, overall awareness and knowledge of heart disease among women remains poor, they wrote.
“Awareness programs designed to educate the public about CVD among women in the United States include Go Red for Women by the American Heart Association; The Heart Truth by the National Heart, Lung, and Blood Institute; and Make the Call, Don’t Miss a Beat by the U.S. Department of Health and Human Services,” the researchers noted. To determine the change in awareness of heart disease as the LCOD among women, the researchers conducted a multivariate analysis of 1,158 women who completed the 2009 survey and 1,345 who completed the 2019 survey. The average age was 50 years; roughly 70% of the participants in the 2009 survey and 62% in the 2019 survey were non-Hispanic White.
The greatest declines in awareness of heart disease as LCOD occurred among Hispanics and non-Hispanic Blacks and among all respondents aged 25-34 years.
Awareness of heart disease as LCOD was 30% lower among women with high blood pressure compared with women overall, the researchers noted.
“In both surveys, higher educational attainment was strongly related to awareness that heart disease is the LCOD,” the researchers said. However, the results highlight the need for renewed efforts to educate younger women, Hispanic women, and non-Hispanic Black women, they emphasized. Unpublished data from the AHA survey showed that “younger women were less likely to report leading a heart-healthy lifestyle and were more likely to identify multiple barriers to leading a heart-healthy lifestyle, including lack of time, stress, and lack of confidence,” they wrote.
In addition, awareness of heart attack warning signs declined overall and within each ethnic group between 2009 and 2019.
The survey results were limited by several factors including the use of an online-only model that might limit generalizability to populations without online access, and was conducted only in English, the researchers wrote.
Heart disease needs new PR plan
The study of heart disease risk awareness among women was an important update to understand how well the message about women’s risk is getting out, said Martha Gulati, MD, president-elect of the American Society of Preventive Cardiology, in an interview.
The issue remains that heart disease is the No. 1 killer of women, and the decrease in awareness “means we need to amplify our message,” she said.
“I also question whether the symbol of the red dress [for women’s heart disease] is working, and it seems that now is the time to change this symbol,” she emphasized. “I wear a red dress pin on my lab coat and every day someone asks what it means, and no one recognizes it,” she said. “I think ‘Go Red for Women’ is great and part of our outward campaign, but our symbol needs to change to increase the connection and awareness in women,” she said.
What might be a better symbol? Simply, a heart, said Dr. Gulati. But “we need to study whatever is next to really connect with women and make them understand their risk for heart disease,” she added.
“Additionally, we really need to get to minority women,” she said. “We are lagging there, and the survey was conducted in English so it missed many people,” she noted.
Dr. Gulati said she was shocked at how much awareness of heart disease risk has fallen among women, even in those with risk factors such as hypertension, who were 30% less likely to be aware that heart disease remains their leading cause of death. “Younger women as well as very unaware; what this means to me is that our public education efforts need to be amplified,” Dr. Gulati said.
Barriers to educating women about heart disease risk include language and access to affordable screening, Dr. Gulati emphasized. “We need to ensure screening for heart disease is always included as a covered cost for a preventive service,” she said.
“Research needs to be done to identify what works toward educating women about cardiac risk. We need to identify a marketing tool to increase awareness in women. It might be something different for one race versus another,” Dr. Gulati said. “Our messaging needs to improve, but how we improve it needs more than just health care professionals,” she said.
Focus on prevention to reduce MI recurrence
“The study regarding recurrent events after MI is important because we really don’t know much about recurrent coronary heart disease after a MI over time,” said Dr. Gulati. These data can be helpful in managing surviving patients and understanding future risk, she said. “But I was surprised to see fewer recurrent events in women, as women still have more heart failure than men even if it has declined with time,” she noted.
Dr. Gulati questioned several aspects of the study and highlighted some of the limitations. “These are claims data, so do they accurately reflect the U.S. population?” she asked. “Remember, this is a study of people who survived a heart attack; those who didn’t survive aren’t included, and that group is more likely to be women, especially women younger than 55 years,” she said.
In addition, Dr. Gulati noted the lack of data on type of heart attack and on treatment adherence or referral to cardiac rehab, as well as lack of data on long-term medication adherence or follow-up care.
Prevention is the key take-home message from both studies, “whether we are talking primary prevention for the heart disease awareness study or secondary prevention for the recurrent heart attack study,” Dr. Gulati said.
The recurrent heart disease study was supported in part by Amgen and the University of Alabama at Birmingham. Lead author Dr. Peters disclosed support from a UK Medical Research Council Skills Development Fellowship with no financial conflicts. Dr. Cushman had no financial conflicts to disclose; several coauthors on the writing committee disclosed relationships with companies including Amarin and Boehringer Ingelheim. Dr. Gulati had no financial conflicts to disclose.
SOURCE: Peters SAE et al. Circulation. 2020 Sep 21. doi: 10.1161/CIRCULATIONAHA.120.047065; Cushman M et al. Circulation. 2020 Sep 21. doi: 10.1161/CIR.0000000000000907.
FROM CIRCULATION
Minorities bear brunt of pediatric COVID-19 cases
Black and Hispanic children comprised significantly more cases of COVID-19, compared with White children, based on data from a large, cross-sectional study of 1,000 cases.
“Data regarding disparities in SARS-CoV-2 infection and outcomes have been, thus far, mostly limited to adults,” wrote Monika K. Goyal, MD, of Children’s National Hospital, Washington, and colleagues. “Additional data further suggest that low socioeconomic status may further exacerbate health outcomes for racial and ethnic minorities.”
In a study published in Pediatrics, the researchers conducted a cross-sectional analysis of 1,000 children from a registry of non–acutely ill pediatric patients seen at a drive-through and walk-up COVID-19 test site.
Minority, socioeconomic status affect pediatric outcomes too
The median age of the study population was 8 years, and approximately half were male.
The researchers also examined the association of median family income (MFI) using census block group estimates data from the American Community Survey (2014–2018) to represent socioeconomic status.
Infection rates were significantly higher among children in the lowest three quartiles of MFI (24%, 27%, and 38% for quartiles 3, 2, and 1, respectively), compared with the highest quartile of MFI (9%).
After adjusting for age, sex, and MFI, Hispanic children were six times more likely and non-Hispanic Black children were twice as likely to test positive for COVID-19 than non-Hispanic White children (adjusted odds ratios, 6.3 and 2.3, respectively).
The study findings were limited by several factors including the use of clinician-reported ethnicity and thus potential for misclassification, the researchers noted. In addition, the socioeconomic and racial disparities may be underestimated because these groups have less access to primary care, and the study did not allow for confounding variables including housing conditions or occupancy.
“Although it was beyond the scope of this study to understand the causes for these differential rates of infection, the causes may be multifactorial, including, but not limited to, structural factors, poorer access to health care, limited resources, and bias and discrimination,” the researchers noted. In addition, the high infection rate among minority children may be impacted by parents who are less able to telework, find child care, or avoid public transportation, Dr. Goyal and associates wrote.
Future research should address “the modifiable reasons for these observed disparities as well as their differential impact in terms of SARS-CoV-2–related morbidity and mortality outcomes to mitigate the spread of infection and its health effects,” they concluded.
How to help
“This study is important because we need to understand which groups of children are at highest risk for SARS-CoV-2 infection in order to maximize efforts for screening, allocating resources, and prioritizing vaccine administration,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was not surprised at the higher infection rates in general in minorities and low socioeconomic groups. “We already knew that adult COVID-19 rates were higher for people in certain racial/ethnic groups and those with socioeconomic disadvantages; however, I was shocked by the percentages. That is a huge burden for a population that already has disparities in health outcomes.”
“As the authors cite, this was not a research study of why these groups were more likely to be COVID-19 positive, but they speculated that crowded living conditions, multigenerational families living together, and many minorities being essential workers unable to work from home,” said Dr. Kinsella. Additional factors contributing to higher infection rates may include limited access to care, transportation issues, insurance coverage, schedule challenges, and fear of deportation. Some of these problems might be addressed by coming into communities in mobile vans, visiting community health centers and schools with free educational materials, using masks and hand sanitizer, and offering free access to testing.
“Future studies could confirm the cause of this discrepancy, as well as study community-based interventions and their outcomes,” Dr. Kinsella said. In the meantime, a take-home message for clinicians is the need to prioritize screening, resources, and vaccines to reflect the higher rates of SARS-CoV-2 infections in children from disadvantaged racial and socioeconomic backgrounds.
The study received no outside funding. The researchers had no financial conflicts to disclose, but lead author Dr. Goyal is a member of the Pediatrics editorial board. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News editorial advisory board.
SOURCE: Goyal MK et al. Pediatrics. 2020 Sep 24. doi: 10.1542/peds.2020-009951.
Black and Hispanic children comprised significantly more cases of COVID-19, compared with White children, based on data from a large, cross-sectional study of 1,000 cases.
“Data regarding disparities in SARS-CoV-2 infection and outcomes have been, thus far, mostly limited to adults,” wrote Monika K. Goyal, MD, of Children’s National Hospital, Washington, and colleagues. “Additional data further suggest that low socioeconomic status may further exacerbate health outcomes for racial and ethnic minorities.”
In a study published in Pediatrics, the researchers conducted a cross-sectional analysis of 1,000 children from a registry of non–acutely ill pediatric patients seen at a drive-through and walk-up COVID-19 test site.
Minority, socioeconomic status affect pediatric outcomes too
The median age of the study population was 8 years, and approximately half were male.
The researchers also examined the association of median family income (MFI) using census block group estimates data from the American Community Survey (2014–2018) to represent socioeconomic status.
Infection rates were significantly higher among children in the lowest three quartiles of MFI (24%, 27%, and 38% for quartiles 3, 2, and 1, respectively), compared with the highest quartile of MFI (9%).
After adjusting for age, sex, and MFI, Hispanic children were six times more likely and non-Hispanic Black children were twice as likely to test positive for COVID-19 than non-Hispanic White children (adjusted odds ratios, 6.3 and 2.3, respectively).
The study findings were limited by several factors including the use of clinician-reported ethnicity and thus potential for misclassification, the researchers noted. In addition, the socioeconomic and racial disparities may be underestimated because these groups have less access to primary care, and the study did not allow for confounding variables including housing conditions or occupancy.
“Although it was beyond the scope of this study to understand the causes for these differential rates of infection, the causes may be multifactorial, including, but not limited to, structural factors, poorer access to health care, limited resources, and bias and discrimination,” the researchers noted. In addition, the high infection rate among minority children may be impacted by parents who are less able to telework, find child care, or avoid public transportation, Dr. Goyal and associates wrote.
Future research should address “the modifiable reasons for these observed disparities as well as their differential impact in terms of SARS-CoV-2–related morbidity and mortality outcomes to mitigate the spread of infection and its health effects,” they concluded.
How to help
“This study is important because we need to understand which groups of children are at highest risk for SARS-CoV-2 infection in order to maximize efforts for screening, allocating resources, and prioritizing vaccine administration,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was not surprised at the higher infection rates in general in minorities and low socioeconomic groups. “We already knew that adult COVID-19 rates were higher for people in certain racial/ethnic groups and those with socioeconomic disadvantages; however, I was shocked by the percentages. That is a huge burden for a population that already has disparities in health outcomes.”
“As the authors cite, this was not a research study of why these groups were more likely to be COVID-19 positive, but they speculated that crowded living conditions, multigenerational families living together, and many minorities being essential workers unable to work from home,” said Dr. Kinsella. Additional factors contributing to higher infection rates may include limited access to care, transportation issues, insurance coverage, schedule challenges, and fear of deportation. Some of these problems might be addressed by coming into communities in mobile vans, visiting community health centers and schools with free educational materials, using masks and hand sanitizer, and offering free access to testing.
“Future studies could confirm the cause of this discrepancy, as well as study community-based interventions and their outcomes,” Dr. Kinsella said. In the meantime, a take-home message for clinicians is the need to prioritize screening, resources, and vaccines to reflect the higher rates of SARS-CoV-2 infections in children from disadvantaged racial and socioeconomic backgrounds.
The study received no outside funding. The researchers had no financial conflicts to disclose, but lead author Dr. Goyal is a member of the Pediatrics editorial board. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News editorial advisory board.
SOURCE: Goyal MK et al. Pediatrics. 2020 Sep 24. doi: 10.1542/peds.2020-009951.
Black and Hispanic children comprised significantly more cases of COVID-19, compared with White children, based on data from a large, cross-sectional study of 1,000 cases.
“Data regarding disparities in SARS-CoV-2 infection and outcomes have been, thus far, mostly limited to adults,” wrote Monika K. Goyal, MD, of Children’s National Hospital, Washington, and colleagues. “Additional data further suggest that low socioeconomic status may further exacerbate health outcomes for racial and ethnic minorities.”
In a study published in Pediatrics, the researchers conducted a cross-sectional analysis of 1,000 children from a registry of non–acutely ill pediatric patients seen at a drive-through and walk-up COVID-19 test site.
Minority, socioeconomic status affect pediatric outcomes too
The median age of the study population was 8 years, and approximately half were male.
The researchers also examined the association of median family income (MFI) using census block group estimates data from the American Community Survey (2014–2018) to represent socioeconomic status.
Infection rates were significantly higher among children in the lowest three quartiles of MFI (24%, 27%, and 38% for quartiles 3, 2, and 1, respectively), compared with the highest quartile of MFI (9%).
After adjusting for age, sex, and MFI, Hispanic children were six times more likely and non-Hispanic Black children were twice as likely to test positive for COVID-19 than non-Hispanic White children (adjusted odds ratios, 6.3 and 2.3, respectively).
The study findings were limited by several factors including the use of clinician-reported ethnicity and thus potential for misclassification, the researchers noted. In addition, the socioeconomic and racial disparities may be underestimated because these groups have less access to primary care, and the study did not allow for confounding variables including housing conditions or occupancy.
“Although it was beyond the scope of this study to understand the causes for these differential rates of infection, the causes may be multifactorial, including, but not limited to, structural factors, poorer access to health care, limited resources, and bias and discrimination,” the researchers noted. In addition, the high infection rate among minority children may be impacted by parents who are less able to telework, find child care, or avoid public transportation, Dr. Goyal and associates wrote.
Future research should address “the modifiable reasons for these observed disparities as well as their differential impact in terms of SARS-CoV-2–related morbidity and mortality outcomes to mitigate the spread of infection and its health effects,” they concluded.
How to help
“This study is important because we need to understand which groups of children are at highest risk for SARS-CoV-2 infection in order to maximize efforts for screening, allocating resources, and prioritizing vaccine administration,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was not surprised at the higher infection rates in general in minorities and low socioeconomic groups. “We already knew that adult COVID-19 rates were higher for people in certain racial/ethnic groups and those with socioeconomic disadvantages; however, I was shocked by the percentages. That is a huge burden for a population that already has disparities in health outcomes.”
“As the authors cite, this was not a research study of why these groups were more likely to be COVID-19 positive, but they speculated that crowded living conditions, multigenerational families living together, and many minorities being essential workers unable to work from home,” said Dr. Kinsella. Additional factors contributing to higher infection rates may include limited access to care, transportation issues, insurance coverage, schedule challenges, and fear of deportation. Some of these problems might be addressed by coming into communities in mobile vans, visiting community health centers and schools with free educational materials, using masks and hand sanitizer, and offering free access to testing.
“Future studies could confirm the cause of this discrepancy, as well as study community-based interventions and their outcomes,” Dr. Kinsella said. In the meantime, a take-home message for clinicians is the need to prioritize screening, resources, and vaccines to reflect the higher rates of SARS-CoV-2 infections in children from disadvantaged racial and socioeconomic backgrounds.
The study received no outside funding. The researchers had no financial conflicts to disclose, but lead author Dr. Goyal is a member of the Pediatrics editorial board. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News editorial advisory board.
SOURCE: Goyal MK et al. Pediatrics. 2020 Sep 24. doi: 10.1542/peds.2020-009951.
FROM PEDIATRICS
COVID-19 may discourage pediatric flu vaccination
Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.
“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.
Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.
To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.
“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
Pandemic changes some parents’ plans
Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).
Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.
“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.
The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”
The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
Potential for ‘twindemic’ is real
The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.
“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.
Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.
“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.
“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.
Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”
Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”
However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.
The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.
“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”
Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.
“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.
In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.
Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.
SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.
Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.
“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.
Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.
To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.
“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
Pandemic changes some parents’ plans
Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).
Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.
“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.
The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”
The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
Potential for ‘twindemic’ is real
The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.
“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.
Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.
“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.
“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.
Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”
Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”
However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.
The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.
“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”
Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.
“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.
In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.
Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.
SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.
Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.
“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.
Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.
To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.
“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
Pandemic changes some parents’ plans
Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).
Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.
“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.
The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”
The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
Potential for ‘twindemic’ is real
The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.
“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.
Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.
“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.
“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.
Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”
Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”
However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.
The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.
“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”
Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.
“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.
In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.
Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.
SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.
FROM PEDIATRICS
Identifying pancreatitis etiology may help prevent progression
Pancreatitis remains the third most common gastroenterological cause of hospital admission, and staying on top of the latest quality indicators is important for the care and safety of patients, said Jamie S. Barkin, MD, professor of medicine in the division of gastroenterology at the University of Miami, in a virtual presentation at the annual Digestive Diseases: New Advances conference jointly provided by Rutgers and Global Academy for Medical Education.
The basics of treatment have changed, said Dr. Barkin. “A large volume of ringers lactate intravenous fluids given within the first 24 hours of admission, as opposed to normal saline, may decrease the inflammatory response in patients with acute pancreatitis.” The preferred diagnostic method remains clinical evaluation along with use of serum lipase, which is more sensitive than serum amylase (97%) but with similar specificity (99%), and current wisdom does not support the need for an early CT for diagnosis unless there is a diagnostic dilemma.
Early establishment of disease etiology and its therapy is imperative to attempt to prevent recurrent episodes and progression to chronic pancreatitis, Dr. Barkin said. Genetic testing studies suggest that approximately 10% of acute pancreatitis cases are the result of genetic factors, and Dr. Barkin recommended performing genetic testing after a first attack of idiopathic acute pancreatitis, especially in younger patients.
There is an extensive list of medications that may cause acute pancreatitis, according to a recent study published in PLOS One, the most common of which include acetaminophen, amiodarone, azathioprine, and angiotensin-converting enzyme inhibitors, Dr. Barkin said. In addition, acute pancreatitis can be caused by isonicotinic acid hydrazide (INH), cannabis, L-asparaginase, metronidazole, mesalamine, simvastatin, sulindac, sitagliptin, thiazides, tigecycline, trans-retinoic acid, and valproic acid, among others.
Current recommendations for hospital treatment of acute pancreatitis include early large volume fluid replacement and initiation of per-oral nutrition as soon as able to be tolerated, as well as pain control, Dr. Barkin said. In addition, management includes strict glycemic and triglyceride control and performance of cholecystectomy for mild and or moderate biliary pancreatitis or endoscopic retrograde cholangiopancreatography (ERCP) if the patient is not an operative candidate during the same hospital stay.
Current recommendations for the prevention of acute pancreatitis include avoidance of irritants such as alcohol, nicotine, and drugs known to cause acute pancreatitis, including marijuana, said Dr. Barkin. In addition, controlling metabolic factors such as obesity, diabetes, and triglycerides can help reduce risk of recurrent episodes in susceptible patients. Several of these factors are also linked to increased risk for progression of acute pancreatitis to chronic pancreatitis.
For patients with biliary pancreatitis, Dr. Barkin noted that cholecystectomy should be performed prior to discharge during the index hospitalization. “In patients who cannot undergo surgery, endoscopic sphincterotomy should be performed to allow spontaneous passage of any stones still in the gallbladder,” he noted.
In addition, patients who have experienced an attack of acute pancreatitis should be screened long-term for development of pancreatic exocrine insufficiency, which may be present in approximately one-quarter of patients following an acute pancreatitis episode, and diabetes, Dr. Barkin said. He cited a population-based study published in the American Journal of Gastroenterology in 2019 in which individuals with postpancreatitis diabetes had significantly higher rates of all-cause mortality, as well as hospitalization for conditions including chronic pulmonary disease, severe renal disease, and infectious disease.
Finally, at the time of discharge, it is essential to evaluate acute pancreatitis patients for risk of readmission, Dr. Barkin said. In addition to severe disease and systemic inflammatory response syndrome at the time of patient discharge, several factors increase the likelihood of readmission including ongoing abdominal pain requiring use of pain medicine, obesity, and inability to tolerate solid food, he noted.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Barkin had no relevant financial conflicts to disclose.
Share AGA GI Patient Center education on pancreatitis to help your patients understand testing and treatment options and possible complications at http://ow.ly/nsdn30rcz5A.
Pancreatitis remains the third most common gastroenterological cause of hospital admission, and staying on top of the latest quality indicators is important for the care and safety of patients, said Jamie S. Barkin, MD, professor of medicine in the division of gastroenterology at the University of Miami, in a virtual presentation at the annual Digestive Diseases: New Advances conference jointly provided by Rutgers and Global Academy for Medical Education.
The basics of treatment have changed, said Dr. Barkin. “A large volume of ringers lactate intravenous fluids given within the first 24 hours of admission, as opposed to normal saline, may decrease the inflammatory response in patients with acute pancreatitis.” The preferred diagnostic method remains clinical evaluation along with use of serum lipase, which is more sensitive than serum amylase (97%) but with similar specificity (99%), and current wisdom does not support the need for an early CT for diagnosis unless there is a diagnostic dilemma.
Early establishment of disease etiology and its therapy is imperative to attempt to prevent recurrent episodes and progression to chronic pancreatitis, Dr. Barkin said. Genetic testing studies suggest that approximately 10% of acute pancreatitis cases are the result of genetic factors, and Dr. Barkin recommended performing genetic testing after a first attack of idiopathic acute pancreatitis, especially in younger patients.
There is an extensive list of medications that may cause acute pancreatitis, according to a recent study published in PLOS One, the most common of which include acetaminophen, amiodarone, azathioprine, and angiotensin-converting enzyme inhibitors, Dr. Barkin said. In addition, acute pancreatitis can be caused by isonicotinic acid hydrazide (INH), cannabis, L-asparaginase, metronidazole, mesalamine, simvastatin, sulindac, sitagliptin, thiazides, tigecycline, trans-retinoic acid, and valproic acid, among others.
Current recommendations for hospital treatment of acute pancreatitis include early large volume fluid replacement and initiation of per-oral nutrition as soon as able to be tolerated, as well as pain control, Dr. Barkin said. In addition, management includes strict glycemic and triglyceride control and performance of cholecystectomy for mild and or moderate biliary pancreatitis or endoscopic retrograde cholangiopancreatography (ERCP) if the patient is not an operative candidate during the same hospital stay.
Current recommendations for the prevention of acute pancreatitis include avoidance of irritants such as alcohol, nicotine, and drugs known to cause acute pancreatitis, including marijuana, said Dr. Barkin. In addition, controlling metabolic factors such as obesity, diabetes, and triglycerides can help reduce risk of recurrent episodes in susceptible patients. Several of these factors are also linked to increased risk for progression of acute pancreatitis to chronic pancreatitis.
For patients with biliary pancreatitis, Dr. Barkin noted that cholecystectomy should be performed prior to discharge during the index hospitalization. “In patients who cannot undergo surgery, endoscopic sphincterotomy should be performed to allow spontaneous passage of any stones still in the gallbladder,” he noted.
In addition, patients who have experienced an attack of acute pancreatitis should be screened long-term for development of pancreatic exocrine insufficiency, which may be present in approximately one-quarter of patients following an acute pancreatitis episode, and diabetes, Dr. Barkin said. He cited a population-based study published in the American Journal of Gastroenterology in 2019 in which individuals with postpancreatitis diabetes had significantly higher rates of all-cause mortality, as well as hospitalization for conditions including chronic pulmonary disease, severe renal disease, and infectious disease.
Finally, at the time of discharge, it is essential to evaluate acute pancreatitis patients for risk of readmission, Dr. Barkin said. In addition to severe disease and systemic inflammatory response syndrome at the time of patient discharge, several factors increase the likelihood of readmission including ongoing abdominal pain requiring use of pain medicine, obesity, and inability to tolerate solid food, he noted.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Barkin had no relevant financial conflicts to disclose.
Share AGA GI Patient Center education on pancreatitis to help your patients understand testing and treatment options and possible complications at http://ow.ly/nsdn30rcz5A.
Pancreatitis remains the third most common gastroenterological cause of hospital admission, and staying on top of the latest quality indicators is important for the care and safety of patients, said Jamie S. Barkin, MD, professor of medicine in the division of gastroenterology at the University of Miami, in a virtual presentation at the annual Digestive Diseases: New Advances conference jointly provided by Rutgers and Global Academy for Medical Education.
The basics of treatment have changed, said Dr. Barkin. “A large volume of ringers lactate intravenous fluids given within the first 24 hours of admission, as opposed to normal saline, may decrease the inflammatory response in patients with acute pancreatitis.” The preferred diagnostic method remains clinical evaluation along with use of serum lipase, which is more sensitive than serum amylase (97%) but with similar specificity (99%), and current wisdom does not support the need for an early CT for diagnosis unless there is a diagnostic dilemma.
Early establishment of disease etiology and its therapy is imperative to attempt to prevent recurrent episodes and progression to chronic pancreatitis, Dr. Barkin said. Genetic testing studies suggest that approximately 10% of acute pancreatitis cases are the result of genetic factors, and Dr. Barkin recommended performing genetic testing after a first attack of idiopathic acute pancreatitis, especially in younger patients.
There is an extensive list of medications that may cause acute pancreatitis, according to a recent study published in PLOS One, the most common of which include acetaminophen, amiodarone, azathioprine, and angiotensin-converting enzyme inhibitors, Dr. Barkin said. In addition, acute pancreatitis can be caused by isonicotinic acid hydrazide (INH), cannabis, L-asparaginase, metronidazole, mesalamine, simvastatin, sulindac, sitagliptin, thiazides, tigecycline, trans-retinoic acid, and valproic acid, among others.
Current recommendations for hospital treatment of acute pancreatitis include early large volume fluid replacement and initiation of per-oral nutrition as soon as able to be tolerated, as well as pain control, Dr. Barkin said. In addition, management includes strict glycemic and triglyceride control and performance of cholecystectomy for mild and or moderate biliary pancreatitis or endoscopic retrograde cholangiopancreatography (ERCP) if the patient is not an operative candidate during the same hospital stay.
Current recommendations for the prevention of acute pancreatitis include avoidance of irritants such as alcohol, nicotine, and drugs known to cause acute pancreatitis, including marijuana, said Dr. Barkin. In addition, controlling metabolic factors such as obesity, diabetes, and triglycerides can help reduce risk of recurrent episodes in susceptible patients. Several of these factors are also linked to increased risk for progression of acute pancreatitis to chronic pancreatitis.
For patients with biliary pancreatitis, Dr. Barkin noted that cholecystectomy should be performed prior to discharge during the index hospitalization. “In patients who cannot undergo surgery, endoscopic sphincterotomy should be performed to allow spontaneous passage of any stones still in the gallbladder,” he noted.
In addition, patients who have experienced an attack of acute pancreatitis should be screened long-term for development of pancreatic exocrine insufficiency, which may be present in approximately one-quarter of patients following an acute pancreatitis episode, and diabetes, Dr. Barkin said. He cited a population-based study published in the American Journal of Gastroenterology in 2019 in which individuals with postpancreatitis diabetes had significantly higher rates of all-cause mortality, as well as hospitalization for conditions including chronic pulmonary disease, severe renal disease, and infectious disease.
Finally, at the time of discharge, it is essential to evaluate acute pancreatitis patients for risk of readmission, Dr. Barkin said. In addition to severe disease and systemic inflammatory response syndrome at the time of patient discharge, several factors increase the likelihood of readmission including ongoing abdominal pain requiring use of pain medicine, obesity, and inability to tolerate solid food, he noted.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Barkin had no relevant financial conflicts to disclose.
Share AGA GI Patient Center education on pancreatitis to help your patients understand testing and treatment options and possible complications at http://ow.ly/nsdn30rcz5A.
FROM DIGESTIVE DISEASES: NEW ADVANCES
Pandemic drives demand for self-managed abortions
Requests for self-managed abortion via a telemedicine service increased by 27% from March 20, 2020, to April 11, 2020, in the United States in the wake of widespread lockdowns and shelter-in-place directives because of the COVID-19 pandemic, based on data from a provider of such services.
Access to abortion care is challenging in many areas under ordinary circumstances, but the disruption of the COVID-19 pandemic led to many states suspending or limiting in-clinic services, wrote Abigail R.A. Aiken, MD, PhD, of the University of Texas at Austin and colleagues.
“As a result, people may increasingly be seeking self-managed abortion outside the formal health care system,” they said.
In a research letter published in Obstetrics & Gynecology, the investigators reviewed request data from Aid Access, a telemedicine service that provides medication for abortion at up to 10 weeks’ gestation for users who complete an online consultation form. They also collected data on the implementation and scope of COVID-19–related abortion restrictions by state.
The analysis included all 49,935 requests made between January 1, 2019, and April 11, 2020.
Overall, the rate of requests for self-managed medical abortions increased significantly, by 27%, during the period from March 20, 2020, to April 11, 2020, which reflected the average period after clinic restrictions or closures at the state level. A total of 11 states showed individually significant increases in requests for self-managed medical abortions, with the highest of 94% in Texas and the lowest of 22% in Ohio. In these 11 states, the median time spent at home was 5% higher than in states without significant increases in requests for self-managed medical abortions during the same period. These states also had “particularly high COVID-19 rates or more severe COVID-19–related restrictions on in-clinic abortion access,” the researchers noted.
Patients want alternatives to in-person care
“Our results may reflect two distinct phenomena,” Dr. Aiken and associates wrote. “First, more people may be seeking abortion through all channels, whether due to COVID-19 risks during pregnancy, reduced access to prenatal care, or the pandemic-related economic downturn. Second, there may be shift in demand from in-clinic to self-managed abortion during the pandemic, possibly owing to fear of infection during in-person care or inability to get to a clinic because of childcare and transit disruptions,” they explained.
The study findings were limited by the inability to measure all options for women to achieve self-managed abortions and a lack of power to detect changes in states with low request numbers or where restrictions were implemented at later dates, the researchers noted. However, the results suggest that telemedicine services for medication abortion should be a policy priority because patients may continue to seek alternatives while in-clinic services remain restricted, they said.
In fact, “the World Health Organization recommends telemedicine and self-management abortion-care models during the pandemic, and the United Kingdom has temporarily implemented fully remote provision of abortion medications,” the researchers wrote. However, similar strategies in the United States “would depend on sustained changes to the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategy, which requires patients to collect mifepristone at a hospital or medical facility, as well as changes to state-specific laws that prohibit remote provider consultation,” Dr. Aiken and associates concluded.
Lift barriers to protect patients
Eve Espey, MD, of the University of New Mexico, Albuquerque, said in an interview.
“As background, state abortion restrictions have increased exponentially over the last decade, while research over the same time period has demonstrated the safety of telemedicine abortion – a form of self-managed abortion – with no in-person visit for appropriate candidates,” she said.
“Enter the coronavirus pandemic with safety concerns related to in-person medical visits and certain states leveraging the opportunity to enact even more stringent abortion restrictions. Unsurprisingly, the result, as documented in this excellent research report, is a significant increase in requests for telemedicine abortion in many states, particularly the most restrictive, from the single online service in the United States, Aid Access,” said Dr. Espey.
“Barriers to self-managed abortion include the [FDA] Risk Evaluation and Mitigation Strategy for mifepristone, a set of unnecessary restrictions requiring that providers meet certain qualifications and dispense the medication only in a clinic, office, or hospital,” she said. “The REMS precludes the use of telemedicine abortion; Aid Access and the FDA are in legal proceedings,” she noted.
“Most recently, the [American Civil Liberties Union] sued the FDA on behalf of a coalition of medical experts led by [American College of Obstetricians and Gynecologists] to suspend the REMS for mifepristone during the COVID public health emergency, to allow patients to receive the medications for early abortion without a visit to a health care provider,” Dr. Espey said. “Fortunately, a federal district court required the temporary suspension of the in-person dispensing restriction. Although this is a great step to improve abortion access during the pandemic, a permanent removal of the REMS would pave the way for ongoing safe, effective, and patient-centered early abortion care,” noted Dr. Espey, who was asked to comment on the research letter.
Dr. Aiken disclosed serving as a consultant for Agile Therapeutics, and a coauthor is the founder and director of Aid Access. Dr. Espey had no financial conflicts to disclose. She is a member of the Ob.Gyn. News Editorial Advisory Board.
SOURCE: Aiken ARA et al. Obstet Gynecol. 2020 Jul 21. doi: 10.1097/AOG.0000000000004081.
Requests for self-managed abortion via a telemedicine service increased by 27% from March 20, 2020, to April 11, 2020, in the United States in the wake of widespread lockdowns and shelter-in-place directives because of the COVID-19 pandemic, based on data from a provider of such services.
Access to abortion care is challenging in many areas under ordinary circumstances, but the disruption of the COVID-19 pandemic led to many states suspending or limiting in-clinic services, wrote Abigail R.A. Aiken, MD, PhD, of the University of Texas at Austin and colleagues.
“As a result, people may increasingly be seeking self-managed abortion outside the formal health care system,” they said.
In a research letter published in Obstetrics & Gynecology, the investigators reviewed request data from Aid Access, a telemedicine service that provides medication for abortion at up to 10 weeks’ gestation for users who complete an online consultation form. They also collected data on the implementation and scope of COVID-19–related abortion restrictions by state.
The analysis included all 49,935 requests made between January 1, 2019, and April 11, 2020.
Overall, the rate of requests for self-managed medical abortions increased significantly, by 27%, during the period from March 20, 2020, to April 11, 2020, which reflected the average period after clinic restrictions or closures at the state level. A total of 11 states showed individually significant increases in requests for self-managed medical abortions, with the highest of 94% in Texas and the lowest of 22% in Ohio. In these 11 states, the median time spent at home was 5% higher than in states without significant increases in requests for self-managed medical abortions during the same period. These states also had “particularly high COVID-19 rates or more severe COVID-19–related restrictions on in-clinic abortion access,” the researchers noted.
Patients want alternatives to in-person care
“Our results may reflect two distinct phenomena,” Dr. Aiken and associates wrote. “First, more people may be seeking abortion through all channels, whether due to COVID-19 risks during pregnancy, reduced access to prenatal care, or the pandemic-related economic downturn. Second, there may be shift in demand from in-clinic to self-managed abortion during the pandemic, possibly owing to fear of infection during in-person care or inability to get to a clinic because of childcare and transit disruptions,” they explained.
The study findings were limited by the inability to measure all options for women to achieve self-managed abortions and a lack of power to detect changes in states with low request numbers or where restrictions were implemented at later dates, the researchers noted. However, the results suggest that telemedicine services for medication abortion should be a policy priority because patients may continue to seek alternatives while in-clinic services remain restricted, they said.
In fact, “the World Health Organization recommends telemedicine and self-management abortion-care models during the pandemic, and the United Kingdom has temporarily implemented fully remote provision of abortion medications,” the researchers wrote. However, similar strategies in the United States “would depend on sustained changes to the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategy, which requires patients to collect mifepristone at a hospital or medical facility, as well as changes to state-specific laws that prohibit remote provider consultation,” Dr. Aiken and associates concluded.
Lift barriers to protect patients
Eve Espey, MD, of the University of New Mexico, Albuquerque, said in an interview.
“As background, state abortion restrictions have increased exponentially over the last decade, while research over the same time period has demonstrated the safety of telemedicine abortion – a form of self-managed abortion – with no in-person visit for appropriate candidates,” she said.
“Enter the coronavirus pandemic with safety concerns related to in-person medical visits and certain states leveraging the opportunity to enact even more stringent abortion restrictions. Unsurprisingly, the result, as documented in this excellent research report, is a significant increase in requests for telemedicine abortion in many states, particularly the most restrictive, from the single online service in the United States, Aid Access,” said Dr. Espey.
“Barriers to self-managed abortion include the [FDA] Risk Evaluation and Mitigation Strategy for mifepristone, a set of unnecessary restrictions requiring that providers meet certain qualifications and dispense the medication only in a clinic, office, or hospital,” she said. “The REMS precludes the use of telemedicine abortion; Aid Access and the FDA are in legal proceedings,” she noted.
“Most recently, the [American Civil Liberties Union] sued the FDA on behalf of a coalition of medical experts led by [American College of Obstetricians and Gynecologists] to suspend the REMS for mifepristone during the COVID public health emergency, to allow patients to receive the medications for early abortion without a visit to a health care provider,” Dr. Espey said. “Fortunately, a federal district court required the temporary suspension of the in-person dispensing restriction. Although this is a great step to improve abortion access during the pandemic, a permanent removal of the REMS would pave the way for ongoing safe, effective, and patient-centered early abortion care,” noted Dr. Espey, who was asked to comment on the research letter.
Dr. Aiken disclosed serving as a consultant for Agile Therapeutics, and a coauthor is the founder and director of Aid Access. Dr. Espey had no financial conflicts to disclose. She is a member of the Ob.Gyn. News Editorial Advisory Board.
SOURCE: Aiken ARA et al. Obstet Gynecol. 2020 Jul 21. doi: 10.1097/AOG.0000000000004081.
Requests for self-managed abortion via a telemedicine service increased by 27% from March 20, 2020, to April 11, 2020, in the United States in the wake of widespread lockdowns and shelter-in-place directives because of the COVID-19 pandemic, based on data from a provider of such services.
Access to abortion care is challenging in many areas under ordinary circumstances, but the disruption of the COVID-19 pandemic led to many states suspending or limiting in-clinic services, wrote Abigail R.A. Aiken, MD, PhD, of the University of Texas at Austin and colleagues.
“As a result, people may increasingly be seeking self-managed abortion outside the formal health care system,” they said.
In a research letter published in Obstetrics & Gynecology, the investigators reviewed request data from Aid Access, a telemedicine service that provides medication for abortion at up to 10 weeks’ gestation for users who complete an online consultation form. They also collected data on the implementation and scope of COVID-19–related abortion restrictions by state.
The analysis included all 49,935 requests made between January 1, 2019, and April 11, 2020.
Overall, the rate of requests for self-managed medical abortions increased significantly, by 27%, during the period from March 20, 2020, to April 11, 2020, which reflected the average period after clinic restrictions or closures at the state level. A total of 11 states showed individually significant increases in requests for self-managed medical abortions, with the highest of 94% in Texas and the lowest of 22% in Ohio. In these 11 states, the median time spent at home was 5% higher than in states without significant increases in requests for self-managed medical abortions during the same period. These states also had “particularly high COVID-19 rates or more severe COVID-19–related restrictions on in-clinic abortion access,” the researchers noted.
Patients want alternatives to in-person care
“Our results may reflect two distinct phenomena,” Dr. Aiken and associates wrote. “First, more people may be seeking abortion through all channels, whether due to COVID-19 risks during pregnancy, reduced access to prenatal care, or the pandemic-related economic downturn. Second, there may be shift in demand from in-clinic to self-managed abortion during the pandemic, possibly owing to fear of infection during in-person care or inability to get to a clinic because of childcare and transit disruptions,” they explained.
The study findings were limited by the inability to measure all options for women to achieve self-managed abortions and a lack of power to detect changes in states with low request numbers or where restrictions were implemented at later dates, the researchers noted. However, the results suggest that telemedicine services for medication abortion should be a policy priority because patients may continue to seek alternatives while in-clinic services remain restricted, they said.
In fact, “the World Health Organization recommends telemedicine and self-management abortion-care models during the pandemic, and the United Kingdom has temporarily implemented fully remote provision of abortion medications,” the researchers wrote. However, similar strategies in the United States “would depend on sustained changes to the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategy, which requires patients to collect mifepristone at a hospital or medical facility, as well as changes to state-specific laws that prohibit remote provider consultation,” Dr. Aiken and associates concluded.
Lift barriers to protect patients
Eve Espey, MD, of the University of New Mexico, Albuquerque, said in an interview.
“As background, state abortion restrictions have increased exponentially over the last decade, while research over the same time period has demonstrated the safety of telemedicine abortion – a form of self-managed abortion – with no in-person visit for appropriate candidates,” she said.
“Enter the coronavirus pandemic with safety concerns related to in-person medical visits and certain states leveraging the opportunity to enact even more stringent abortion restrictions. Unsurprisingly, the result, as documented in this excellent research report, is a significant increase in requests for telemedicine abortion in many states, particularly the most restrictive, from the single online service in the United States, Aid Access,” said Dr. Espey.
“Barriers to self-managed abortion include the [FDA] Risk Evaluation and Mitigation Strategy for mifepristone, a set of unnecessary restrictions requiring that providers meet certain qualifications and dispense the medication only in a clinic, office, or hospital,” she said. “The REMS precludes the use of telemedicine abortion; Aid Access and the FDA are in legal proceedings,” she noted.
“Most recently, the [American Civil Liberties Union] sued the FDA on behalf of a coalition of medical experts led by [American College of Obstetricians and Gynecologists] to suspend the REMS for mifepristone during the COVID public health emergency, to allow patients to receive the medications for early abortion without a visit to a health care provider,” Dr. Espey said. “Fortunately, a federal district court required the temporary suspension of the in-person dispensing restriction. Although this is a great step to improve abortion access during the pandemic, a permanent removal of the REMS would pave the way for ongoing safe, effective, and patient-centered early abortion care,” noted Dr. Espey, who was asked to comment on the research letter.
Dr. Aiken disclosed serving as a consultant for Agile Therapeutics, and a coauthor is the founder and director of Aid Access. Dr. Espey had no financial conflicts to disclose. She is a member of the Ob.Gyn. News Editorial Advisory Board.
SOURCE: Aiken ARA et al. Obstet Gynecol. 2020 Jul 21. doi: 10.1097/AOG.0000000000004081.
FROM OBSTETRICS & GYNECOLOGY
Dr. Brian Mandell gives his take on ACR’s newest gout guideline
Guidance on the initiation and use of urate-lowering therapies was among the strong recommendations in the updated gout guideline recently issued by the American College of Rheumatology, said Brian F. Mandell, MD, PhD, in a virtual presentation at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.
The 2020 American College of Rheumatology Guideline for the Management of Gout is “intended to provide guidance for particular patterns of practice and not to dictate the care of a particular patient,” said Dr. Mandell, chair of academic medicine at the Cleveland Clinic in Ohio and cochair of the conference. However, “there was a hope that, with additional evidence since the previous guideline issued in 2012, the recommendations are more firmly based and will improve care,” he said.
Of 42 recommendations, 16 were strong, and these included guidance on several points: when to initiate urate-lowering therapy and using a treat-to-target strategy for lowering serum uric acid to less than 6 mg/dL; prophylaxis against attacks; the use of allopurinol as the first-choice drug and how to avoid hypersensitivity reactions; the use of pegloticase (Krystexxa); and treating flares.
Hyperuricemia does not automatically equal gout, Dr. Mandell said. A 2018 published analysis of data from several large cohorts including 18,889 adults who were gout-free at baseline showed that serum uric acid levels could not accurately predict an initial gout attack. Therefore, the guideline conditionally recommends against initiating any pharmacologic urate-lowering therapy in patients with asymptomatic hyperuricemia. The guideline authors intentionally did not include the presence of comorbidities or deposits of uric acid in making their recommendation. But when advising an individual patient, these factors plus the patient’s age and family history should be considered, he said. “Individualize the decision to use ULT [urate-lowering therapy] to prevent possible future flares,” he advised, with consideration of age, the effects of the flare on the patient’s life, and challenges in treating flares.
For patients who are being treated with urate-lowering therapy, a published study indicated that if treatment is discontinued, “gout attacks will recur, depending on the new serum urate level,” Dr. Mandell said. “Maintenance of low SUA [serum uric acid] must be lifelong to stop attacks,” he emphasized, noting that this is counter to a management guideline published by the American College of Physicians in 2017.
“For patients starting any ULT, we strongly recommend allopurinol over all other urate-lowering therapies as the preferred first-line agent for all patients, including those with CKD [chronic kidney disease] stage 3 or higher,” according to the new guideline, which also recommends starting at a low dose followed by dose titration to target versus starting at a higher dose.
Two reasons in support of a slow up-titration of urate-lowering therapy are a lower frequency of mobilization flares and a possibly lower chance of allopurinol hypersensitivity reactions, Dr. Mandell said.
Although the guideline recommends allopurinol over probenecid, “probenecid works well as monotherapy and effectively as add-on therapy to a xanthine oxidase inhibitor, and it is cheap,” Dr. Mandell said.
Allopurinol can be associated with life-threatening hypersensitivity reactions, but most of these have been associated with a higher-than-recommended starting dose, according to the literature, he noted. The new guideline suggests checking for the HLA-B*5801 haplotype in high-risk demographic groups, and if it is present, to use an alternative to allopurinol if possible
The updated guideline also carries a strong recommendation for the use of pegloticase for patients with frequent gout flares and nonresolving subcutaneous tophi, but it strongly recommends against switching to pegloticase for patients with infrequent gout flares and no tophi.
However, Dr. Mandell said that he will consider off-label treatment of gout with pegloticase “in patients where a shorter time to response really matters,” which is consistent with his belief that, within these treatment principles, the management of gout must be individualized to the specific patient.
For treating acute gout flares, the guideline recommendations strongly supports the use of oral colchicine, NSAIDs, or glucocorticoids as an appropriate first-line therapy, based on patient factors and preferences, instead of using interleukin-1 inhibitors or adrenocorticotropic hormone. However, the interleukin-1 inhibitor anakinra has shown relatively rapid and successful response in treating patients hospitalized with acute gout, Dr. Mandell said. No large, randomized, trials have been conducted, but he cited his experience at the Cleveland Clinic in Ohio, where anakinra is the most common treatment for acute gout on inpatient consults, and he cited a representative small study of 26 patients in which 73% showed “significant response” within 5 days of treatment, which meant that they were able to move and bear weight without pain. In addition, a more recent study of 100 hospitalized patients in the Journal of Rheumatology, found that 75% showed a rapid response to anakinra and improvement or resolution of flares within 4 days, Dr. Mandell said.
Dr. Mandell disclosed relationships with companies including Horizon, Ardea/AstraZeneca/Ironwood, and Takeda. He served as coauthor on the 2012 American College of Rheumatology gout guideline.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Guidance on the initiation and use of urate-lowering therapies was among the strong recommendations in the updated gout guideline recently issued by the American College of Rheumatology, said Brian F. Mandell, MD, PhD, in a virtual presentation at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.
The 2020 American College of Rheumatology Guideline for the Management of Gout is “intended to provide guidance for particular patterns of practice and not to dictate the care of a particular patient,” said Dr. Mandell, chair of academic medicine at the Cleveland Clinic in Ohio and cochair of the conference. However, “there was a hope that, with additional evidence since the previous guideline issued in 2012, the recommendations are more firmly based and will improve care,” he said.
Of 42 recommendations, 16 were strong, and these included guidance on several points: when to initiate urate-lowering therapy and using a treat-to-target strategy for lowering serum uric acid to less than 6 mg/dL; prophylaxis against attacks; the use of allopurinol as the first-choice drug and how to avoid hypersensitivity reactions; the use of pegloticase (Krystexxa); and treating flares.
Hyperuricemia does not automatically equal gout, Dr. Mandell said. A 2018 published analysis of data from several large cohorts including 18,889 adults who were gout-free at baseline showed that serum uric acid levels could not accurately predict an initial gout attack. Therefore, the guideline conditionally recommends against initiating any pharmacologic urate-lowering therapy in patients with asymptomatic hyperuricemia. The guideline authors intentionally did not include the presence of comorbidities or deposits of uric acid in making their recommendation. But when advising an individual patient, these factors plus the patient’s age and family history should be considered, he said. “Individualize the decision to use ULT [urate-lowering therapy] to prevent possible future flares,” he advised, with consideration of age, the effects of the flare on the patient’s life, and challenges in treating flares.
For patients who are being treated with urate-lowering therapy, a published study indicated that if treatment is discontinued, “gout attacks will recur, depending on the new serum urate level,” Dr. Mandell said. “Maintenance of low SUA [serum uric acid] must be lifelong to stop attacks,” he emphasized, noting that this is counter to a management guideline published by the American College of Physicians in 2017.
“For patients starting any ULT, we strongly recommend allopurinol over all other urate-lowering therapies as the preferred first-line agent for all patients, including those with CKD [chronic kidney disease] stage 3 or higher,” according to the new guideline, which also recommends starting at a low dose followed by dose titration to target versus starting at a higher dose.
Two reasons in support of a slow up-titration of urate-lowering therapy are a lower frequency of mobilization flares and a possibly lower chance of allopurinol hypersensitivity reactions, Dr. Mandell said.
Although the guideline recommends allopurinol over probenecid, “probenecid works well as monotherapy and effectively as add-on therapy to a xanthine oxidase inhibitor, and it is cheap,” Dr. Mandell said.
Allopurinol can be associated with life-threatening hypersensitivity reactions, but most of these have been associated with a higher-than-recommended starting dose, according to the literature, he noted. The new guideline suggests checking for the HLA-B*5801 haplotype in high-risk demographic groups, and if it is present, to use an alternative to allopurinol if possible
The updated guideline also carries a strong recommendation for the use of pegloticase for patients with frequent gout flares and nonresolving subcutaneous tophi, but it strongly recommends against switching to pegloticase for patients with infrequent gout flares and no tophi.
However, Dr. Mandell said that he will consider off-label treatment of gout with pegloticase “in patients where a shorter time to response really matters,” which is consistent with his belief that, within these treatment principles, the management of gout must be individualized to the specific patient.
For treating acute gout flares, the guideline recommendations strongly supports the use of oral colchicine, NSAIDs, or glucocorticoids as an appropriate first-line therapy, based on patient factors and preferences, instead of using interleukin-1 inhibitors or adrenocorticotropic hormone. However, the interleukin-1 inhibitor anakinra has shown relatively rapid and successful response in treating patients hospitalized with acute gout, Dr. Mandell said. No large, randomized, trials have been conducted, but he cited his experience at the Cleveland Clinic in Ohio, where anakinra is the most common treatment for acute gout on inpatient consults, and he cited a representative small study of 26 patients in which 73% showed “significant response” within 5 days of treatment, which meant that they were able to move and bear weight without pain. In addition, a more recent study of 100 hospitalized patients in the Journal of Rheumatology, found that 75% showed a rapid response to anakinra and improvement or resolution of flares within 4 days, Dr. Mandell said.
Dr. Mandell disclosed relationships with companies including Horizon, Ardea/AstraZeneca/Ironwood, and Takeda. He served as coauthor on the 2012 American College of Rheumatology gout guideline.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Guidance on the initiation and use of urate-lowering therapies was among the strong recommendations in the updated gout guideline recently issued by the American College of Rheumatology, said Brian F. Mandell, MD, PhD, in a virtual presentation at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.
The 2020 American College of Rheumatology Guideline for the Management of Gout is “intended to provide guidance for particular patterns of practice and not to dictate the care of a particular patient,” said Dr. Mandell, chair of academic medicine at the Cleveland Clinic in Ohio and cochair of the conference. However, “there was a hope that, with additional evidence since the previous guideline issued in 2012, the recommendations are more firmly based and will improve care,” he said.
Of 42 recommendations, 16 were strong, and these included guidance on several points: when to initiate urate-lowering therapy and using a treat-to-target strategy for lowering serum uric acid to less than 6 mg/dL; prophylaxis against attacks; the use of allopurinol as the first-choice drug and how to avoid hypersensitivity reactions; the use of pegloticase (Krystexxa); and treating flares.
Hyperuricemia does not automatically equal gout, Dr. Mandell said. A 2018 published analysis of data from several large cohorts including 18,889 adults who were gout-free at baseline showed that serum uric acid levels could not accurately predict an initial gout attack. Therefore, the guideline conditionally recommends against initiating any pharmacologic urate-lowering therapy in patients with asymptomatic hyperuricemia. The guideline authors intentionally did not include the presence of comorbidities or deposits of uric acid in making their recommendation. But when advising an individual patient, these factors plus the patient’s age and family history should be considered, he said. “Individualize the decision to use ULT [urate-lowering therapy] to prevent possible future flares,” he advised, with consideration of age, the effects of the flare on the patient’s life, and challenges in treating flares.
For patients who are being treated with urate-lowering therapy, a published study indicated that if treatment is discontinued, “gout attacks will recur, depending on the new serum urate level,” Dr. Mandell said. “Maintenance of low SUA [serum uric acid] must be lifelong to stop attacks,” he emphasized, noting that this is counter to a management guideline published by the American College of Physicians in 2017.
“For patients starting any ULT, we strongly recommend allopurinol over all other urate-lowering therapies as the preferred first-line agent for all patients, including those with CKD [chronic kidney disease] stage 3 or higher,” according to the new guideline, which also recommends starting at a low dose followed by dose titration to target versus starting at a higher dose.
Two reasons in support of a slow up-titration of urate-lowering therapy are a lower frequency of mobilization flares and a possibly lower chance of allopurinol hypersensitivity reactions, Dr. Mandell said.
Although the guideline recommends allopurinol over probenecid, “probenecid works well as monotherapy and effectively as add-on therapy to a xanthine oxidase inhibitor, and it is cheap,” Dr. Mandell said.
Allopurinol can be associated with life-threatening hypersensitivity reactions, but most of these have been associated with a higher-than-recommended starting dose, according to the literature, he noted. The new guideline suggests checking for the HLA-B*5801 haplotype in high-risk demographic groups, and if it is present, to use an alternative to allopurinol if possible
The updated guideline also carries a strong recommendation for the use of pegloticase for patients with frequent gout flares and nonresolving subcutaneous tophi, but it strongly recommends against switching to pegloticase for patients with infrequent gout flares and no tophi.
However, Dr. Mandell said that he will consider off-label treatment of gout with pegloticase “in patients where a shorter time to response really matters,” which is consistent with his belief that, within these treatment principles, the management of gout must be individualized to the specific patient.
For treating acute gout flares, the guideline recommendations strongly supports the use of oral colchicine, NSAIDs, or glucocorticoids as an appropriate first-line therapy, based on patient factors and preferences, instead of using interleukin-1 inhibitors or adrenocorticotropic hormone. However, the interleukin-1 inhibitor anakinra has shown relatively rapid and successful response in treating patients hospitalized with acute gout, Dr. Mandell said. No large, randomized, trials have been conducted, but he cited his experience at the Cleveland Clinic in Ohio, where anakinra is the most common treatment for acute gout on inpatient consults, and he cited a representative small study of 26 patients in which 73% showed “significant response” within 5 days of treatment, which meant that they were able to move and bear weight without pain. In addition, a more recent study of 100 hospitalized patients in the Journal of Rheumatology, found that 75% showed a rapid response to anakinra and improvement or resolution of flares within 4 days, Dr. Mandell said.
Dr. Mandell disclosed relationships with companies including Horizon, Ardea/AstraZeneca/Ironwood, and Takeda. He served as coauthor on the 2012 American College of Rheumatology gout guideline.
Global Academy for Medical Education and this news organization are owned by the same parent company.
FROM PRD 2020
Identify the dominant symptom in IBS
Many factors can prompt individuals with irritable bowel syndrome (IBS) to seek consultation with a specialist said Anthony Lembo, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, in a virtual presentation at the conference jointly provided by Rutgers and Global Academy for Medical Education.
Most patients with IBS suffer with symptoms for years before seeking care, he said.
Common reasons to cause an individual with IBS to seek care include severity of abdominal pain, psychological disturbance such as anxiety, and concerns about organic disease such as colon cancer, perhaps because they know someone who was recently diagnosed with it,” he said.
Our understanding of the pathophysiology of IBS has expanded dramatically over the past decade, Dr. Lembo said. IBS was once thought to be primarily a motility disorder, but currently the many interacting factors include not only motility but also diet, gut microflora, visceral hypersensitivity, immune dysregulation, and brain-gut interactions, he said.
The pathophysiology of postinfectious IBS has been particularly well described and includes the role of anti-CdtB and antivinculin antibodies, and low-grade inflammation in the lining of the intestines, Dr. Lembo explained.
These cases of postinfection IBS can linger for up to a year in approximately 10% of patients, he said.
IBS can affect anyone, anywhere, but it tends to be more common in younger individuals than older adults, and more common in women than men, Dr. Lembo said.
When diagnosing IBS in the clinic setting, a history should include a timeline and triggers for symptoms, he advised. A detailed dietary history, review of medications, and an assessment for alarm features (such as family history of colon cancer or celiac disease, weight loss, anemia, blood in stools, nocturnal awakening, or an onset of symptoms at age older than 50 years) should also be included he said.
Physical signs of systemic and local disease, and a digital rectal exam to assess patients for dyssynergia, especially those with constipation should also be performed, Dr. Lembo added.
In some cases, consider a colonoscopy for patients with IBS, namely those with alarm features, age-appropriate screening criteria, the presence of persistent and frequent watery diarrhea, or in patients who don’t respond to therapy, he added.
Treatment strategies for IBS should start with diet and lifestyle modifications when appropriate, Dr. Lembo said. Encourage patients to pursue moderate to vigorous exercise or some physical activity 3-5 times a week, to get enough sleep, and to start with a traditional IBS diet. Such a diet involves three meals a day, with three or fewer snacks, and not overeating at any of these times, he said. Other diet tips include reducing consumption of fatty or spicy foods, as well as coffee, alcohol, onions, beans, and cabbage. He also advised encouraging patients to avoid gum and soft drinks, as well as artificial sweeteners, and to use soluble rather than insoluble fiber. The low-FODMAP (fermentable oligo-, di-, monosaccharides and polyols) diet has shown benefit in some patients. For those who respond to the low-FODMAP diet it is important to reintroduce foods into their diet. Nutrition consultation should be considered for most patients.
Follow a stepwise approach to treatment, Dr. Lembo emphasized that, if IBS patients with constipation are not improving with diet and lifestyle, over-the-counter medications such as polyethylene glycol can be considered to improve bowel consistency, although the drug’s effect on pain is limited. Prescription options include secretogogues (linaclotide, plenecatide, lubiprostone), and prokinetics (tegaserod, a 5-HT4 partial agonist that was recently reapproved by the FDA for women < 65 years without cardiovascular risk factors). In general, prescription drugs for IBS-C have similar efficacy in most endpoints though differences in their mechanisms of action and side effects should be considered when prescribing a particular agent, he said.
Other perspectives on managing IBS include cognitive behavior therapy and fecal microbiota transplant, Dr. Lembo said. Cognitive behavior therapy improves IBS symptoms after 12 weeks in patients who had weekly sessions compared with controls who received 4 weeks of basic patient education, he noted. As for fecal microbiota transplant, the jury is still out and it is important to note that FMT is not currently approved for clinical practice for patients with IBS, he noted.
Dr. Lembo disclosed relationships with Allergan, Ardelyx, Bayer, Bioamerica, Ironwood, Mylan and Takeda.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Many factors can prompt individuals with irritable bowel syndrome (IBS) to seek consultation with a specialist said Anthony Lembo, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, in a virtual presentation at the conference jointly provided by Rutgers and Global Academy for Medical Education.
Most patients with IBS suffer with symptoms for years before seeking care, he said.
Common reasons to cause an individual with IBS to seek care include severity of abdominal pain, psychological disturbance such as anxiety, and concerns about organic disease such as colon cancer, perhaps because they know someone who was recently diagnosed with it,” he said.
Our understanding of the pathophysiology of IBS has expanded dramatically over the past decade, Dr. Lembo said. IBS was once thought to be primarily a motility disorder, but currently the many interacting factors include not only motility but also diet, gut microflora, visceral hypersensitivity, immune dysregulation, and brain-gut interactions, he said.
The pathophysiology of postinfectious IBS has been particularly well described and includes the role of anti-CdtB and antivinculin antibodies, and low-grade inflammation in the lining of the intestines, Dr. Lembo explained.
These cases of postinfection IBS can linger for up to a year in approximately 10% of patients, he said.
IBS can affect anyone, anywhere, but it tends to be more common in younger individuals than older adults, and more common in women than men, Dr. Lembo said.
When diagnosing IBS in the clinic setting, a history should include a timeline and triggers for symptoms, he advised. A detailed dietary history, review of medications, and an assessment for alarm features (such as family history of colon cancer or celiac disease, weight loss, anemia, blood in stools, nocturnal awakening, or an onset of symptoms at age older than 50 years) should also be included he said.
Physical signs of systemic and local disease, and a digital rectal exam to assess patients for dyssynergia, especially those with constipation should also be performed, Dr. Lembo added.
In some cases, consider a colonoscopy for patients with IBS, namely those with alarm features, age-appropriate screening criteria, the presence of persistent and frequent watery diarrhea, or in patients who don’t respond to therapy, he added.
Treatment strategies for IBS should start with diet and lifestyle modifications when appropriate, Dr. Lembo said. Encourage patients to pursue moderate to vigorous exercise or some physical activity 3-5 times a week, to get enough sleep, and to start with a traditional IBS diet. Such a diet involves three meals a day, with three or fewer snacks, and not overeating at any of these times, he said. Other diet tips include reducing consumption of fatty or spicy foods, as well as coffee, alcohol, onions, beans, and cabbage. He also advised encouraging patients to avoid gum and soft drinks, as well as artificial sweeteners, and to use soluble rather than insoluble fiber. The low-FODMAP (fermentable oligo-, di-, monosaccharides and polyols) diet has shown benefit in some patients. For those who respond to the low-FODMAP diet it is important to reintroduce foods into their diet. Nutrition consultation should be considered for most patients.
Follow a stepwise approach to treatment, Dr. Lembo emphasized that, if IBS patients with constipation are not improving with diet and lifestyle, over-the-counter medications such as polyethylene glycol can be considered to improve bowel consistency, although the drug’s effect on pain is limited. Prescription options include secretogogues (linaclotide, plenecatide, lubiprostone), and prokinetics (tegaserod, a 5-HT4 partial agonist that was recently reapproved by the FDA for women < 65 years without cardiovascular risk factors). In general, prescription drugs for IBS-C have similar efficacy in most endpoints though differences in their mechanisms of action and side effects should be considered when prescribing a particular agent, he said.
Other perspectives on managing IBS include cognitive behavior therapy and fecal microbiota transplant, Dr. Lembo said. Cognitive behavior therapy improves IBS symptoms after 12 weeks in patients who had weekly sessions compared with controls who received 4 weeks of basic patient education, he noted. As for fecal microbiota transplant, the jury is still out and it is important to note that FMT is not currently approved for clinical practice for patients with IBS, he noted.
Dr. Lembo disclosed relationships with Allergan, Ardelyx, Bayer, Bioamerica, Ironwood, Mylan and Takeda.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Many factors can prompt individuals with irritable bowel syndrome (IBS) to seek consultation with a specialist said Anthony Lembo, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, in a virtual presentation at the conference jointly provided by Rutgers and Global Academy for Medical Education.
Most patients with IBS suffer with symptoms for years before seeking care, he said.
Common reasons to cause an individual with IBS to seek care include severity of abdominal pain, psychological disturbance such as anxiety, and concerns about organic disease such as colon cancer, perhaps because they know someone who was recently diagnosed with it,” he said.
Our understanding of the pathophysiology of IBS has expanded dramatically over the past decade, Dr. Lembo said. IBS was once thought to be primarily a motility disorder, but currently the many interacting factors include not only motility but also diet, gut microflora, visceral hypersensitivity, immune dysregulation, and brain-gut interactions, he said.
The pathophysiology of postinfectious IBS has been particularly well described and includes the role of anti-CdtB and antivinculin antibodies, and low-grade inflammation in the lining of the intestines, Dr. Lembo explained.
These cases of postinfection IBS can linger for up to a year in approximately 10% of patients, he said.
IBS can affect anyone, anywhere, but it tends to be more common in younger individuals than older adults, and more common in women than men, Dr. Lembo said.
When diagnosing IBS in the clinic setting, a history should include a timeline and triggers for symptoms, he advised. A detailed dietary history, review of medications, and an assessment for alarm features (such as family history of colon cancer or celiac disease, weight loss, anemia, blood in stools, nocturnal awakening, or an onset of symptoms at age older than 50 years) should also be included he said.
Physical signs of systemic and local disease, and a digital rectal exam to assess patients for dyssynergia, especially those with constipation should also be performed, Dr. Lembo added.
In some cases, consider a colonoscopy for patients with IBS, namely those with alarm features, age-appropriate screening criteria, the presence of persistent and frequent watery diarrhea, or in patients who don’t respond to therapy, he added.
Treatment strategies for IBS should start with diet and lifestyle modifications when appropriate, Dr. Lembo said. Encourage patients to pursue moderate to vigorous exercise or some physical activity 3-5 times a week, to get enough sleep, and to start with a traditional IBS diet. Such a diet involves three meals a day, with three or fewer snacks, and not overeating at any of these times, he said. Other diet tips include reducing consumption of fatty or spicy foods, as well as coffee, alcohol, onions, beans, and cabbage. He also advised encouraging patients to avoid gum and soft drinks, as well as artificial sweeteners, and to use soluble rather than insoluble fiber. The low-FODMAP (fermentable oligo-, di-, monosaccharides and polyols) diet has shown benefit in some patients. For those who respond to the low-FODMAP diet it is important to reintroduce foods into their diet. Nutrition consultation should be considered for most patients.
Follow a stepwise approach to treatment, Dr. Lembo emphasized that, if IBS patients with constipation are not improving with diet and lifestyle, over-the-counter medications such as polyethylene glycol can be considered to improve bowel consistency, although the drug’s effect on pain is limited. Prescription options include secretogogues (linaclotide, plenecatide, lubiprostone), and prokinetics (tegaserod, a 5-HT4 partial agonist that was recently reapproved by the FDA for women < 65 years without cardiovascular risk factors). In general, prescription drugs for IBS-C have similar efficacy in most endpoints though differences in their mechanisms of action and side effects should be considered when prescribing a particular agent, he said.
Other perspectives on managing IBS include cognitive behavior therapy and fecal microbiota transplant, Dr. Lembo said. Cognitive behavior therapy improves IBS symptoms after 12 weeks in patients who had weekly sessions compared with controls who received 4 weeks of basic patient education, he noted. As for fecal microbiota transplant, the jury is still out and it is important to note that FMT is not currently approved for clinical practice for patients with IBS, he noted.
Dr. Lembo disclosed relationships with Allergan, Ardelyx, Bayer, Bioamerica, Ironwood, Mylan and Takeda.
Global Academy for Medical Education and this news organization are owned by the same parent company.
FROM Digestive Diseases: New Advances
Combination beats misoprostol monotherapy on cost effectiveness
A combination of mifepristone followed by misoprostol was significantly more cost effective for the medical management of miscarriage than misoprostol alone, based on a decision-tree model and simulations using a range of patient income levels, cost variables, and practice patterns.
Although the American College of Obstetricians and Gynecologists recommends a combination of mifepristone and misoprostol for the medical management of miscarriage, some physicians may hesitate because of the high cost of mifepristone, wrote Holly H. Berkley, MD, of the Naval Medical Center, San Diego, and colleagues.
Previous research has supported the cost effectiveness of combination therapy, but the data came from a secondary analysis that limited the generalizability of the findings, they wrote. In a study published in Obstetrics & Gynecology, the researchers created a decision-tree model using two standard practice patterns.
In the first, patients received mifepristone and one dose of misoprostol (combination therapy) or one dose of misoprostol alone (monotherapy) at their initial visit with follow-up within 3 days. Combination therapy was defined as 200 mg of oral mifepristone followed by one or two doses of 800 micrograms of vaginal misoprostol; monotherapy was defined as one or two doses of 800 micrograms of vaginal misoprostol.
“If miscarriage is not completed, a second dose of misoprostol is given, and the patient will have a second follow-up visit 8 days after initiation of treatment. If miscarriage is not complete at the second follow-up visit, surgical management is prescribed,” Dr. Berkley and associates reported.
In the second pattern, patients receive two doses of misoprostol at the first visit and an initial follow-up visit 8 days later.
Patient hourly income was based on the wages of three employment levels of the military patient population, estimated at $7.25/hour, $15.90/hour, and $35.10 per hour. “For clinicians outside of the military health system, these wage categories may also serve as an estimate of earnings for low-income, low-middle income, and middle-income patients across the United States,” Dr. Berkley and colleagues noted.
The researchers also considered costs for time of work, transportation, and the costs of the medical visits. Costs also were computed for surgical management with in–operating room dilation and curettage or in-office manual vacuum aspiration, if needed.
The greatest difference in favor of combination therapy resulted in a savings of $190.20 per patient, compared with monotherapy, in the first practice pattern and the lowest wage group (19.5%).
“In every scenario, and for every wage level, the average cost of combination therapy is less than that of monotherapy,” Dr. Berkley and associates noted. In addition, the differences in cost between combination therapy and monotherapy increased with patients’ wages, “reflecting wage differences as well as the net savings owing to increased completion rates.”
Completion rates are key to cost effectiveness
“The higher completion rate of combination therapy leads to decreased time spent on treatment and therefore decreased time off work, decreased office visits, and a decreased need for surgical management for persistent pregnancy, which significantly reduces cost,” they noted.
The model shows that the cost of mifepristone, which some clinicians may see as a barrier, contributes little to the overall treatment costs, Dr. Berkley and colleagues emphasized.
The study findings were limited by several factors including the large ranges in costs for office visits and procedures and the inability to replicate all clinical settings and variables, the researchers noted. However, the results were strengthened by the use of current practice patterns and costs, and they support the mifepristone/misoprostol combination as being the most cost effective for medical management of miscarriage, they said.
The findings of the current study, combined with higher effectiveness reported in recent randomized controlled trials and the endorsement of the American College of Obstetricians and Gynecologists “make a strong case for mifepristone followed by misoprostol to become the standard, first-line treatment regimen for the medical management of miscarriage,” Dr. Berkley and associates concluded.
Research is clear, policy needs to catch up
“There is clear research showing that using mifepristone with misoprostol to medically manage early pregnancy loss is significantly more effective than misoprostol alone,” Sarah Prager, MD, of the University of Washington, Seattle, said in an interview. “The combination protocol does include an expensive medication, so it’s important to evaluate if the cost of this more effective method is ‘worth it,’ ” she said. “ including fewer projected days off work and fewer patients needing procedures to complete their miscarriage.”
Dr. Prager said she was not surprised by the study findings because similar results have been found in other studies evaluating treatment of abortion with misoprostol alone versus mifepristone and misoprostol. “When something is significantly more effective, it usually will also come with a cost benefit.”
Potential barriers to the use of combination therapy are related to policy rather than drug safety or effectiveness, according to Dr. Prager.
“The primary barrier is that mifepristone use is regulated by a REMS [Risk Evaluation and Mitigation Strategy] restriction which requires that providers dispense the medication directly to patients, rather than being able to prescribe it and have patients then pick it up at a pharmacy,” she said. “This restriction is typically used for medications that are dangerous and need to be closely controlled. In the case of mifepristone, the restriction does not serve a safety purpose; it simply limits access to the medication which is still primarily used to medically treat abortion.
“The secondary barrier is stigma against using a medication that is seen as an abortion medication. I fear many providers or practices may avoid putting it on formulary due to this stigma,” Dr. Prager noted.
“There is already sufficient evidence that the combination therapy is superior to monotherapy, and there is also evidence that mifepristone can be safely prescribed [not dispensed] and does not need the REMS requirement,” Dr. Prager said. “I don’t believe more research is needed; just policy change.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose.
SOURCE: Berkley HH et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004063.
A combination of mifepristone followed by misoprostol was significantly more cost effective for the medical management of miscarriage than misoprostol alone, based on a decision-tree model and simulations using a range of patient income levels, cost variables, and practice patterns.
Although the American College of Obstetricians and Gynecologists recommends a combination of mifepristone and misoprostol for the medical management of miscarriage, some physicians may hesitate because of the high cost of mifepristone, wrote Holly H. Berkley, MD, of the Naval Medical Center, San Diego, and colleagues.
Previous research has supported the cost effectiveness of combination therapy, but the data came from a secondary analysis that limited the generalizability of the findings, they wrote. In a study published in Obstetrics & Gynecology, the researchers created a decision-tree model using two standard practice patterns.
In the first, patients received mifepristone and one dose of misoprostol (combination therapy) or one dose of misoprostol alone (monotherapy) at their initial visit with follow-up within 3 days. Combination therapy was defined as 200 mg of oral mifepristone followed by one or two doses of 800 micrograms of vaginal misoprostol; monotherapy was defined as one or two doses of 800 micrograms of vaginal misoprostol.
“If miscarriage is not completed, a second dose of misoprostol is given, and the patient will have a second follow-up visit 8 days after initiation of treatment. If miscarriage is not complete at the second follow-up visit, surgical management is prescribed,” Dr. Berkley and associates reported.
In the second pattern, patients receive two doses of misoprostol at the first visit and an initial follow-up visit 8 days later.
Patient hourly income was based on the wages of three employment levels of the military patient population, estimated at $7.25/hour, $15.90/hour, and $35.10 per hour. “For clinicians outside of the military health system, these wage categories may also serve as an estimate of earnings for low-income, low-middle income, and middle-income patients across the United States,” Dr. Berkley and colleagues noted.
The researchers also considered costs for time of work, transportation, and the costs of the medical visits. Costs also were computed for surgical management with in–operating room dilation and curettage or in-office manual vacuum aspiration, if needed.
The greatest difference in favor of combination therapy resulted in a savings of $190.20 per patient, compared with monotherapy, in the first practice pattern and the lowest wage group (19.5%).
“In every scenario, and for every wage level, the average cost of combination therapy is less than that of monotherapy,” Dr. Berkley and associates noted. In addition, the differences in cost between combination therapy and monotherapy increased with patients’ wages, “reflecting wage differences as well as the net savings owing to increased completion rates.”
Completion rates are key to cost effectiveness
“The higher completion rate of combination therapy leads to decreased time spent on treatment and therefore decreased time off work, decreased office visits, and a decreased need for surgical management for persistent pregnancy, which significantly reduces cost,” they noted.
The model shows that the cost of mifepristone, which some clinicians may see as a barrier, contributes little to the overall treatment costs, Dr. Berkley and colleagues emphasized.
The study findings were limited by several factors including the large ranges in costs for office visits and procedures and the inability to replicate all clinical settings and variables, the researchers noted. However, the results were strengthened by the use of current practice patterns and costs, and they support the mifepristone/misoprostol combination as being the most cost effective for medical management of miscarriage, they said.
The findings of the current study, combined with higher effectiveness reported in recent randomized controlled trials and the endorsement of the American College of Obstetricians and Gynecologists “make a strong case for mifepristone followed by misoprostol to become the standard, first-line treatment regimen for the medical management of miscarriage,” Dr. Berkley and associates concluded.
Research is clear, policy needs to catch up
“There is clear research showing that using mifepristone with misoprostol to medically manage early pregnancy loss is significantly more effective than misoprostol alone,” Sarah Prager, MD, of the University of Washington, Seattle, said in an interview. “The combination protocol does include an expensive medication, so it’s important to evaluate if the cost of this more effective method is ‘worth it,’ ” she said. “ including fewer projected days off work and fewer patients needing procedures to complete their miscarriage.”
Dr. Prager said she was not surprised by the study findings because similar results have been found in other studies evaluating treatment of abortion with misoprostol alone versus mifepristone and misoprostol. “When something is significantly more effective, it usually will also come with a cost benefit.”
Potential barriers to the use of combination therapy are related to policy rather than drug safety or effectiveness, according to Dr. Prager.
“The primary barrier is that mifepristone use is regulated by a REMS [Risk Evaluation and Mitigation Strategy] restriction which requires that providers dispense the medication directly to patients, rather than being able to prescribe it and have patients then pick it up at a pharmacy,” she said. “This restriction is typically used for medications that are dangerous and need to be closely controlled. In the case of mifepristone, the restriction does not serve a safety purpose; it simply limits access to the medication which is still primarily used to medically treat abortion.
“The secondary barrier is stigma against using a medication that is seen as an abortion medication. I fear many providers or practices may avoid putting it on formulary due to this stigma,” Dr. Prager noted.
“There is already sufficient evidence that the combination therapy is superior to monotherapy, and there is also evidence that mifepristone can be safely prescribed [not dispensed] and does not need the REMS requirement,” Dr. Prager said. “I don’t believe more research is needed; just policy change.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose.
SOURCE: Berkley HH et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004063.
A combination of mifepristone followed by misoprostol was significantly more cost effective for the medical management of miscarriage than misoprostol alone, based on a decision-tree model and simulations using a range of patient income levels, cost variables, and practice patterns.
Although the American College of Obstetricians and Gynecologists recommends a combination of mifepristone and misoprostol for the medical management of miscarriage, some physicians may hesitate because of the high cost of mifepristone, wrote Holly H. Berkley, MD, of the Naval Medical Center, San Diego, and colleagues.
Previous research has supported the cost effectiveness of combination therapy, but the data came from a secondary analysis that limited the generalizability of the findings, they wrote. In a study published in Obstetrics & Gynecology, the researchers created a decision-tree model using two standard practice patterns.
In the first, patients received mifepristone and one dose of misoprostol (combination therapy) or one dose of misoprostol alone (monotherapy) at their initial visit with follow-up within 3 days. Combination therapy was defined as 200 mg of oral mifepristone followed by one or two doses of 800 micrograms of vaginal misoprostol; monotherapy was defined as one or two doses of 800 micrograms of vaginal misoprostol.
“If miscarriage is not completed, a second dose of misoprostol is given, and the patient will have a second follow-up visit 8 days after initiation of treatment. If miscarriage is not complete at the second follow-up visit, surgical management is prescribed,” Dr. Berkley and associates reported.
In the second pattern, patients receive two doses of misoprostol at the first visit and an initial follow-up visit 8 days later.
Patient hourly income was based on the wages of three employment levels of the military patient population, estimated at $7.25/hour, $15.90/hour, and $35.10 per hour. “For clinicians outside of the military health system, these wage categories may also serve as an estimate of earnings for low-income, low-middle income, and middle-income patients across the United States,” Dr. Berkley and colleagues noted.
The researchers also considered costs for time of work, transportation, and the costs of the medical visits. Costs also were computed for surgical management with in–operating room dilation and curettage or in-office manual vacuum aspiration, if needed.
The greatest difference in favor of combination therapy resulted in a savings of $190.20 per patient, compared with monotherapy, in the first practice pattern and the lowest wage group (19.5%).
“In every scenario, and for every wage level, the average cost of combination therapy is less than that of monotherapy,” Dr. Berkley and associates noted. In addition, the differences in cost between combination therapy and monotherapy increased with patients’ wages, “reflecting wage differences as well as the net savings owing to increased completion rates.”
Completion rates are key to cost effectiveness
“The higher completion rate of combination therapy leads to decreased time spent on treatment and therefore decreased time off work, decreased office visits, and a decreased need for surgical management for persistent pregnancy, which significantly reduces cost,” they noted.
The model shows that the cost of mifepristone, which some clinicians may see as a barrier, contributes little to the overall treatment costs, Dr. Berkley and colleagues emphasized.
The study findings were limited by several factors including the large ranges in costs for office visits and procedures and the inability to replicate all clinical settings and variables, the researchers noted. However, the results were strengthened by the use of current practice patterns and costs, and they support the mifepristone/misoprostol combination as being the most cost effective for medical management of miscarriage, they said.
The findings of the current study, combined with higher effectiveness reported in recent randomized controlled trials and the endorsement of the American College of Obstetricians and Gynecologists “make a strong case for mifepristone followed by misoprostol to become the standard, first-line treatment regimen for the medical management of miscarriage,” Dr. Berkley and associates concluded.
Research is clear, policy needs to catch up
“There is clear research showing that using mifepristone with misoprostol to medically manage early pregnancy loss is significantly more effective than misoprostol alone,” Sarah Prager, MD, of the University of Washington, Seattle, said in an interview. “The combination protocol does include an expensive medication, so it’s important to evaluate if the cost of this more effective method is ‘worth it,’ ” she said. “ including fewer projected days off work and fewer patients needing procedures to complete their miscarriage.”
Dr. Prager said she was not surprised by the study findings because similar results have been found in other studies evaluating treatment of abortion with misoprostol alone versus mifepristone and misoprostol. “When something is significantly more effective, it usually will also come with a cost benefit.”
Potential barriers to the use of combination therapy are related to policy rather than drug safety or effectiveness, according to Dr. Prager.
“The primary barrier is that mifepristone use is regulated by a REMS [Risk Evaluation and Mitigation Strategy] restriction which requires that providers dispense the medication directly to patients, rather than being able to prescribe it and have patients then pick it up at a pharmacy,” she said. “This restriction is typically used for medications that are dangerous and need to be closely controlled. In the case of mifepristone, the restriction does not serve a safety purpose; it simply limits access to the medication which is still primarily used to medically treat abortion.
“The secondary barrier is stigma against using a medication that is seen as an abortion medication. I fear many providers or practices may avoid putting it on formulary due to this stigma,” Dr. Prager noted.
“There is already sufficient evidence that the combination therapy is superior to monotherapy, and there is also evidence that mifepristone can be safely prescribed [not dispensed] and does not need the REMS requirement,” Dr. Prager said. “I don’t believe more research is needed; just policy change.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose.
SOURCE: Berkley HH et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004063.
FROM OBSTETRICS & GYNECOLOGY