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Most men with low-risk prostate tumors now forgoing treatment
, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.
Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.
Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.
Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.
In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.
Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.
Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”
In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.
Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.
“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”
The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.
In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.
In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
Aiming higher
William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”
Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.
However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.
Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”
Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.
“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”
Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”
Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.
Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.
Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.
Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.
In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.
Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.
Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”
In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.
Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.
“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”
The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.
In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.
In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
Aiming higher
William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”
Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.
However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.
Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”
Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.
“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”
Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”
Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.
Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.
Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.
Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.
In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.
Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.
Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”
In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.
Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.
“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”
The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.
In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.
In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
Aiming higher
William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”
Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.
However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.
Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”
Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.
“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”
Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”
Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AUA ANNUAL MEETING
Metformin use linked to birth defects in boys
researchers have found.
The association appears to involve the effects of metformin on the development of sperm during a critical window prior to conception. Female offspring were not affected. Although previous studies have linked diabetes with fertility problems in men, the latest study is the first to show that these problems can result from treatment rather than the disease itself, according to the researchers, whose findings appear in Annals of Internal Medicine.
“This is the first data to suggest that paternal metformin [use] may be associated with birth defects in children. As such, it would be early to begin to alter clinical practice,” Michael Eisenberg, MD, director of male reproductive medicine and surgery, department of urology, Stanford (Calif.) University, who is a coauthor of the study, said in an interview. “However, if it is confirmed in other populations, then it may begin to enter counseling discussions.”
Dr. Eisenberg added that eating a nutritious diet, exercising, and maintaining a healthy body weight “can improve a man’s health and likely his fertility as well.”
For the new study, Dr. Eisenberg and colleagues analyzed records in a registry of all 1.25 million births that occurred in Denmark between 1997 and 2016. The registry included information on birth defects and parental drug prescriptions.
Offspring were considered exposed to a diabetes drug if a father had filled one or more prescriptions for the medications during the 3 months prior to conception, when the fertilizing sperm would have been produced.
The final analysis included 1,116,779 offspring – all singleton births to women without a history of diabetes or essential hypertension – of whom 7,029 were exposed to diabetes drugs via the father, and 3.3% (n = 36,585) had one or more major birth defects.
Among male offspring whose fathers had taken metformin (n = 1,451), there was a 3.4-fold greater incidence of major genitourinary birth defects, according to the researchers. The study failed to find associations between birth defects and the use of insulin. Although a signal did emerge for sulfonylurea-based drugs, it did not reach statistical significance.
The risk associated with metformin did not appear for men who were prescribed the drug in the year before or after sperm development. Nor was it evident in siblings of the boys with birth defects who were not considered to have been exposed to the medication, the researchers reported.
In an editorial accompanying the journal article, Germaine Buck Louis, PhD, a reproductive and perinatal epidemiologist, wrote: “Given the prevalence of metformin use as first-line therapy for type 2 diabetes, corroboration of these findings is urgently needed.”
Dr. Louis, dean of the College of Health and Human Services at George Mason University, Washington, said a key limitation of the research is the lack of data on how well men in the study adhered to their diabetes treatment. Nevertheless, “clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal metformin use relative to other medications.”
The researchers received funding from the National Institutes of Health and the Centers for Disease Control and Prevention.
A version of this article first appeared on Medscape.com.
researchers have found.
The association appears to involve the effects of metformin on the development of sperm during a critical window prior to conception. Female offspring were not affected. Although previous studies have linked diabetes with fertility problems in men, the latest study is the first to show that these problems can result from treatment rather than the disease itself, according to the researchers, whose findings appear in Annals of Internal Medicine.
“This is the first data to suggest that paternal metformin [use] may be associated with birth defects in children. As such, it would be early to begin to alter clinical practice,” Michael Eisenberg, MD, director of male reproductive medicine and surgery, department of urology, Stanford (Calif.) University, who is a coauthor of the study, said in an interview. “However, if it is confirmed in other populations, then it may begin to enter counseling discussions.”
Dr. Eisenberg added that eating a nutritious diet, exercising, and maintaining a healthy body weight “can improve a man’s health and likely his fertility as well.”
For the new study, Dr. Eisenberg and colleagues analyzed records in a registry of all 1.25 million births that occurred in Denmark between 1997 and 2016. The registry included information on birth defects and parental drug prescriptions.
Offspring were considered exposed to a diabetes drug if a father had filled one or more prescriptions for the medications during the 3 months prior to conception, when the fertilizing sperm would have been produced.
The final analysis included 1,116,779 offspring – all singleton births to women without a history of diabetes or essential hypertension – of whom 7,029 were exposed to diabetes drugs via the father, and 3.3% (n = 36,585) had one or more major birth defects.
Among male offspring whose fathers had taken metformin (n = 1,451), there was a 3.4-fold greater incidence of major genitourinary birth defects, according to the researchers. The study failed to find associations between birth defects and the use of insulin. Although a signal did emerge for sulfonylurea-based drugs, it did not reach statistical significance.
The risk associated with metformin did not appear for men who were prescribed the drug in the year before or after sperm development. Nor was it evident in siblings of the boys with birth defects who were not considered to have been exposed to the medication, the researchers reported.
In an editorial accompanying the journal article, Germaine Buck Louis, PhD, a reproductive and perinatal epidemiologist, wrote: “Given the prevalence of metformin use as first-line therapy for type 2 diabetes, corroboration of these findings is urgently needed.”
Dr. Louis, dean of the College of Health and Human Services at George Mason University, Washington, said a key limitation of the research is the lack of data on how well men in the study adhered to their diabetes treatment. Nevertheless, “clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal metformin use relative to other medications.”
The researchers received funding from the National Institutes of Health and the Centers for Disease Control and Prevention.
A version of this article first appeared on Medscape.com.
researchers have found.
The association appears to involve the effects of metformin on the development of sperm during a critical window prior to conception. Female offspring were not affected. Although previous studies have linked diabetes with fertility problems in men, the latest study is the first to show that these problems can result from treatment rather than the disease itself, according to the researchers, whose findings appear in Annals of Internal Medicine.
“This is the first data to suggest that paternal metformin [use] may be associated with birth defects in children. As such, it would be early to begin to alter clinical practice,” Michael Eisenberg, MD, director of male reproductive medicine and surgery, department of urology, Stanford (Calif.) University, who is a coauthor of the study, said in an interview. “However, if it is confirmed in other populations, then it may begin to enter counseling discussions.”
Dr. Eisenberg added that eating a nutritious diet, exercising, and maintaining a healthy body weight “can improve a man’s health and likely his fertility as well.”
For the new study, Dr. Eisenberg and colleagues analyzed records in a registry of all 1.25 million births that occurred in Denmark between 1997 and 2016. The registry included information on birth defects and parental drug prescriptions.
Offspring were considered exposed to a diabetes drug if a father had filled one or more prescriptions for the medications during the 3 months prior to conception, when the fertilizing sperm would have been produced.
The final analysis included 1,116,779 offspring – all singleton births to women without a history of diabetes or essential hypertension – of whom 7,029 were exposed to diabetes drugs via the father, and 3.3% (n = 36,585) had one or more major birth defects.
Among male offspring whose fathers had taken metformin (n = 1,451), there was a 3.4-fold greater incidence of major genitourinary birth defects, according to the researchers. The study failed to find associations between birth defects and the use of insulin. Although a signal did emerge for sulfonylurea-based drugs, it did not reach statistical significance.
The risk associated with metformin did not appear for men who were prescribed the drug in the year before or after sperm development. Nor was it evident in siblings of the boys with birth defects who were not considered to have been exposed to the medication, the researchers reported.
In an editorial accompanying the journal article, Germaine Buck Louis, PhD, a reproductive and perinatal epidemiologist, wrote: “Given the prevalence of metformin use as first-line therapy for type 2 diabetes, corroboration of these findings is urgently needed.”
Dr. Louis, dean of the College of Health and Human Services at George Mason University, Washington, said a key limitation of the research is the lack of data on how well men in the study adhered to their diabetes treatment. Nevertheless, “clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal metformin use relative to other medications.”
The researchers received funding from the National Institutes of Health and the Centers for Disease Control and Prevention.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
U.S. primary care seen lagging in key markers
In delivery of primary care, including access and coordination, the U.S. trails well behind 10 other wealthy countries, according to a new report from the Commonwealth Fund.
The document, released March 15, concludes that the shortcomings in the U.S. system – from a lack of a relationship with a primary care physician to unequal access to after-hours care – “disproportionately affect Black and Latinx communities and rural areas, exacerbating disparities that have widened during the COVID-19 pandemic.”
“This report really shows that the U.S. is falling behind. We know that a strong primary care system yields better health outcomes. We have a lot to learn from other high-income countries,” coauthor Munira Z. Gunja, MPH, a senior researcher for the Commonwealth Fund’s International Program in Health Policy and Practice Innovations, told this news organization. “At baseline, we really need to make sure that everyone has health insurance in this country so they can actually use primary care services, and we need to increase the supply of those services.”
The report draws from the Commonwealth Fund’s 2019 and 2020 International Health Policy Surveys and the 2020 International Profiles of Health Care Systems. Among the main points:
- U.S. adults are the least likely to have a regular physician or place of care or a long-standing relationship with a primary care provider: 43% of American adults have a long-term relationship with a primary care doctor, compared with highs of 71% in Germany and the Netherlands.
- Access to home visits or after-hours care – excluding emergency department visits – is lowest in the United States (45%). In the Netherlands, Norway, New Zealand, and Germany, the rate is 90% to 96%.
- Half of primary care providers in the United States report adequate coordination with specialists and hospitals – around the average for the 11 countries studied.
‘Dismal mess’
Experts reacted to the report with a mix of concern and frustration – but not surprise.
“The results in this report are not surprising, and we have known them all for a number of years now,” Timothy Hoff, PhD, a health policy expert at Northeastern University, Boston, said. “Primary care doctors remain the backbone of our primary care system. But there are too few of them in the United States, and there likely will remain too few of them in the future. This opens the door to other and more diverse forms of innovation that will be required to help complement the work they do.”
Dr. Hoff, author of Searching for the Family Doctor: Primary Care on the Brink, added that comparing the United States to smaller countries like Norway or the United Kingdom is “somewhat problematic.”
“Our system has to take care of several hundred million people, trapped in a fragmented and market-based delivery system focused on specialty care, each of whom may have a different insurance plan,” he said. “Doing some of the things very small countries with government-funded insurance and a history of strong primary care delivery do in taking care of far fewer citizens is not realistic.”
Jeffrey Borkan, MD, PhD, chair and professor in the department of family medicine at the Alpert Medical School of Brown University, Providence, R.I., said the most shocking finding in the report is that despite spending far more on health care than any other country, “we cannot manage to provide one of the least expensive and most efficacious services: a relationship with a primary care doctor.”
Arthur Caplan, PhD, director of the Division of Medical Ethics at New York University Langone Medical Center, called primary care in this country “a dismal mess. It has been for many years. This is especially so in mental health. Access in many counties is nonexistent, and many primary care physicians are opting into boutique care.”
R. Shawn Martin, CEO of the 133,000-member American Academy of Family Physicians, said, “None of this surprises me. I think these are trendlines; we have been following this for many, many years here at the Academy.”
Mr. Martin added that he was disappointed that the recent, large investments in sharing and digitizing information have not closed the gaps that hinder the efficient and widespread delivery of primary care.
The findings in the report weren’t all bad. More primary care providers in the United States (30%) screen their patients for social needs such as housing, food security, and transportation – the highest among all 11 nations studied.
Also, Commonwealth Fund said the proportion of patients who said they received information on meeting their social needs and screening for domestic violence or social isolation was low everywhere. However, the percentage in the United States, Canada, and Norway was the highest, at 9%. Sweden had the lowest rate for such screenings, at 1%.
The researchers noted that social determinants of health account for as much as 55% of health outcomes. “In some countries, like the United States, the higher rates of receiving such information may be a response to the higher rates of material hardship, along with a weaker safety net,” the report states.
Ms. Gunja and her colleagues suggested several options for changes in policies, including narrowing the wage gap between primary care providers and higher-paid specialists; subsidizing medical school tuition to give students incentives to enter primary care; investing in telehealth to make primary care more accessible; and rewarding and holding providers accountable for continuity of care.
“The U.S. had the largest wage gap and highest tuition fees among the countries we studied,” Ms. Gunja told this news organization..
Researchers noted that U.S. patients could benefit from the introduction of incentives such as those paid in New Zealand to primary health organizations, which receive additional funding per capita to promote health and coordinate care.
But Dr. Caplan was skeptical that those measures would do much to correct the problems.
“We have no will to fix this ongoing, scandalous situation,” he said. “Specialist care still pays inordinately large salaries. Nurses and physician extenders are underused. Academic prestige does little to reward primary care. Plus, patients are not pressing for better access. Sorry, but I see no solutions pending in the current climate. Obamacare barely survived.”
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In delivery of primary care, including access and coordination, the U.S. trails well behind 10 other wealthy countries, according to a new report from the Commonwealth Fund.
The document, released March 15, concludes that the shortcomings in the U.S. system – from a lack of a relationship with a primary care physician to unequal access to after-hours care – “disproportionately affect Black and Latinx communities and rural areas, exacerbating disparities that have widened during the COVID-19 pandemic.”
“This report really shows that the U.S. is falling behind. We know that a strong primary care system yields better health outcomes. We have a lot to learn from other high-income countries,” coauthor Munira Z. Gunja, MPH, a senior researcher for the Commonwealth Fund’s International Program in Health Policy and Practice Innovations, told this news organization. “At baseline, we really need to make sure that everyone has health insurance in this country so they can actually use primary care services, and we need to increase the supply of those services.”
The report draws from the Commonwealth Fund’s 2019 and 2020 International Health Policy Surveys and the 2020 International Profiles of Health Care Systems. Among the main points:
- U.S. adults are the least likely to have a regular physician or place of care or a long-standing relationship with a primary care provider: 43% of American adults have a long-term relationship with a primary care doctor, compared with highs of 71% in Germany and the Netherlands.
- Access to home visits or after-hours care – excluding emergency department visits – is lowest in the United States (45%). In the Netherlands, Norway, New Zealand, and Germany, the rate is 90% to 96%.
- Half of primary care providers in the United States report adequate coordination with specialists and hospitals – around the average for the 11 countries studied.
‘Dismal mess’
Experts reacted to the report with a mix of concern and frustration – but not surprise.
“The results in this report are not surprising, and we have known them all for a number of years now,” Timothy Hoff, PhD, a health policy expert at Northeastern University, Boston, said. “Primary care doctors remain the backbone of our primary care system. But there are too few of them in the United States, and there likely will remain too few of them in the future. This opens the door to other and more diverse forms of innovation that will be required to help complement the work they do.”
Dr. Hoff, author of Searching for the Family Doctor: Primary Care on the Brink, added that comparing the United States to smaller countries like Norway or the United Kingdom is “somewhat problematic.”
“Our system has to take care of several hundred million people, trapped in a fragmented and market-based delivery system focused on specialty care, each of whom may have a different insurance plan,” he said. “Doing some of the things very small countries with government-funded insurance and a history of strong primary care delivery do in taking care of far fewer citizens is not realistic.”
Jeffrey Borkan, MD, PhD, chair and professor in the department of family medicine at the Alpert Medical School of Brown University, Providence, R.I., said the most shocking finding in the report is that despite spending far more on health care than any other country, “we cannot manage to provide one of the least expensive and most efficacious services: a relationship with a primary care doctor.”
Arthur Caplan, PhD, director of the Division of Medical Ethics at New York University Langone Medical Center, called primary care in this country “a dismal mess. It has been for many years. This is especially so in mental health. Access in many counties is nonexistent, and many primary care physicians are opting into boutique care.”
R. Shawn Martin, CEO of the 133,000-member American Academy of Family Physicians, said, “None of this surprises me. I think these are trendlines; we have been following this for many, many years here at the Academy.”
Mr. Martin added that he was disappointed that the recent, large investments in sharing and digitizing information have not closed the gaps that hinder the efficient and widespread delivery of primary care.
The findings in the report weren’t all bad. More primary care providers in the United States (30%) screen their patients for social needs such as housing, food security, and transportation – the highest among all 11 nations studied.
Also, Commonwealth Fund said the proportion of patients who said they received information on meeting their social needs and screening for domestic violence or social isolation was low everywhere. However, the percentage in the United States, Canada, and Norway was the highest, at 9%. Sweden had the lowest rate for such screenings, at 1%.
The researchers noted that social determinants of health account for as much as 55% of health outcomes. “In some countries, like the United States, the higher rates of receiving such information may be a response to the higher rates of material hardship, along with a weaker safety net,” the report states.
Ms. Gunja and her colleagues suggested several options for changes in policies, including narrowing the wage gap between primary care providers and higher-paid specialists; subsidizing medical school tuition to give students incentives to enter primary care; investing in telehealth to make primary care more accessible; and rewarding and holding providers accountable for continuity of care.
“The U.S. had the largest wage gap and highest tuition fees among the countries we studied,” Ms. Gunja told this news organization..
Researchers noted that U.S. patients could benefit from the introduction of incentives such as those paid in New Zealand to primary health organizations, which receive additional funding per capita to promote health and coordinate care.
But Dr. Caplan was skeptical that those measures would do much to correct the problems.
“We have no will to fix this ongoing, scandalous situation,” he said. “Specialist care still pays inordinately large salaries. Nurses and physician extenders are underused. Academic prestige does little to reward primary care. Plus, patients are not pressing for better access. Sorry, but I see no solutions pending in the current climate. Obamacare barely survived.”
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In delivery of primary care, including access and coordination, the U.S. trails well behind 10 other wealthy countries, according to a new report from the Commonwealth Fund.
The document, released March 15, concludes that the shortcomings in the U.S. system – from a lack of a relationship with a primary care physician to unequal access to after-hours care – “disproportionately affect Black and Latinx communities and rural areas, exacerbating disparities that have widened during the COVID-19 pandemic.”
“This report really shows that the U.S. is falling behind. We know that a strong primary care system yields better health outcomes. We have a lot to learn from other high-income countries,” coauthor Munira Z. Gunja, MPH, a senior researcher for the Commonwealth Fund’s International Program in Health Policy and Practice Innovations, told this news organization. “At baseline, we really need to make sure that everyone has health insurance in this country so they can actually use primary care services, and we need to increase the supply of those services.”
The report draws from the Commonwealth Fund’s 2019 and 2020 International Health Policy Surveys and the 2020 International Profiles of Health Care Systems. Among the main points:
- U.S. adults are the least likely to have a regular physician or place of care or a long-standing relationship with a primary care provider: 43% of American adults have a long-term relationship with a primary care doctor, compared with highs of 71% in Germany and the Netherlands.
- Access to home visits or after-hours care – excluding emergency department visits – is lowest in the United States (45%). In the Netherlands, Norway, New Zealand, and Germany, the rate is 90% to 96%.
- Half of primary care providers in the United States report adequate coordination with specialists and hospitals – around the average for the 11 countries studied.
‘Dismal mess’
Experts reacted to the report with a mix of concern and frustration – but not surprise.
“The results in this report are not surprising, and we have known them all for a number of years now,” Timothy Hoff, PhD, a health policy expert at Northeastern University, Boston, said. “Primary care doctors remain the backbone of our primary care system. But there are too few of them in the United States, and there likely will remain too few of them in the future. This opens the door to other and more diverse forms of innovation that will be required to help complement the work they do.”
Dr. Hoff, author of Searching for the Family Doctor: Primary Care on the Brink, added that comparing the United States to smaller countries like Norway or the United Kingdom is “somewhat problematic.”
“Our system has to take care of several hundred million people, trapped in a fragmented and market-based delivery system focused on specialty care, each of whom may have a different insurance plan,” he said. “Doing some of the things very small countries with government-funded insurance and a history of strong primary care delivery do in taking care of far fewer citizens is not realistic.”
Jeffrey Borkan, MD, PhD, chair and professor in the department of family medicine at the Alpert Medical School of Brown University, Providence, R.I., said the most shocking finding in the report is that despite spending far more on health care than any other country, “we cannot manage to provide one of the least expensive and most efficacious services: a relationship with a primary care doctor.”
Arthur Caplan, PhD, director of the Division of Medical Ethics at New York University Langone Medical Center, called primary care in this country “a dismal mess. It has been for many years. This is especially so in mental health. Access in many counties is nonexistent, and many primary care physicians are opting into boutique care.”
R. Shawn Martin, CEO of the 133,000-member American Academy of Family Physicians, said, “None of this surprises me. I think these are trendlines; we have been following this for many, many years here at the Academy.”
Mr. Martin added that he was disappointed that the recent, large investments in sharing and digitizing information have not closed the gaps that hinder the efficient and widespread delivery of primary care.
The findings in the report weren’t all bad. More primary care providers in the United States (30%) screen their patients for social needs such as housing, food security, and transportation – the highest among all 11 nations studied.
Also, Commonwealth Fund said the proportion of patients who said they received information on meeting their social needs and screening for domestic violence or social isolation was low everywhere. However, the percentage in the United States, Canada, and Norway was the highest, at 9%. Sweden had the lowest rate for such screenings, at 1%.
The researchers noted that social determinants of health account for as much as 55% of health outcomes. “In some countries, like the United States, the higher rates of receiving such information may be a response to the higher rates of material hardship, along with a weaker safety net,” the report states.
Ms. Gunja and her colleagues suggested several options for changes in policies, including narrowing the wage gap between primary care providers and higher-paid specialists; subsidizing medical school tuition to give students incentives to enter primary care; investing in telehealth to make primary care more accessible; and rewarding and holding providers accountable for continuity of care.
“The U.S. had the largest wage gap and highest tuition fees among the countries we studied,” Ms. Gunja told this news organization..
Researchers noted that U.S. patients could benefit from the introduction of incentives such as those paid in New Zealand to primary health organizations, which receive additional funding per capita to promote health and coordinate care.
But Dr. Caplan was skeptical that those measures would do much to correct the problems.
“We have no will to fix this ongoing, scandalous situation,” he said. “Specialist care still pays inordinately large salaries. Nurses and physician extenders are underused. Academic prestige does little to reward primary care. Plus, patients are not pressing for better access. Sorry, but I see no solutions pending in the current climate. Obamacare barely survived.”
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Handheld ECGs ease AFib screening in the very elderly
The use of handheld, single-lead electrocardiograms (ECGs) did not increase diagnoses of AFib overall in patients aged 65 and older, but it did in patients 85 and up, researchers reported in Circulation.
“Incorporating single-lead ECGs into routine medical assessments as a new vital sign was widely feasible. Over 90% of people who were offered screening agreed to it and underwent screening,” said Steven Lubitz, MD, of the Cardiac Arrhythmia Service and Cardiovascular Research Center at Massachusetts General Hospital, Boston, who led the study.
Because advanced age is associated with a substantially increased risk of both AFib and stroke, point-of-care screening might be an efficient use of handheld ECGs, Dr. Lubitz said.
“The technology simply requires patients to place their fingers on the device to record an electrocardiogram and can be easily embedded in the routine clinical practice of primary care physicians,” he said in an interview.
The typical person has a 30% lifetime risk of developing AFib, and the chances of experiencing a stroke associated with the arrhythmia can be reduced significantly with anticoagulants, Dr. Lubitz said.
Professional organizations are split about the utility of screening for AFib. The European Society of Cardiology recommends opportunistic screening with either pulse palpation or ECG rhythm strip at clinic visits for patients 65 and older. The National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand have issued similar guidelines.
However, screening for AFib is not considered standard of care in the United States – although Dr. Lubitz predicted that that would change.
“I think the guidelines in the United States will evolve in the next few years, because I think we’re getting closer to understanding who we should be screening for atrial fibrillation and how we should be screening,” Dr. Lubitz told this news organization.
‘Very reassuring’ results
The randomized controlled trial found that for patients 85 and older, use of handheld ECGs led to a nearly 2% increase in new diagnoses of AFib in the screening group compared to conventional care.
The researchers also demonstrated an increased likelihood of diagnosing AFib during the patient’s primary-care encounter than at other sites, such as the emergency department or inpatient settings that might be more costly and resource-intensive. Moreover, the study reported that point-of-care screening was associated with high rates of oral anticoagulation prescriptions written for patients with newly diagnosed AFib, a finding Dr. Lubitz called “very reassuring.”
The Mass General researchers used single-lead devices attached to a tablet computer to screen more than 35,000 men and women from 16 primary care sites affiliated with the hospital’s practice-based research network.
Half the sites were randomly selected to include the screening intervention, where medical assistants used handheld ECGs at the start of the visit while checking routine vital signs.
The 1-year study screened 91% of eligible patients, demonstrating that single-lead rhythm assessment is feasible as part of routine primary care practice, Dr. Lubitz said. This finding supports other studies suggesting that handheld devices can enable rapid and scalable mass screening.
“We demonstrated that integration into routine practice by clinical personnel – in this case, medical assistants – is feasible. No study has measured and demonstrated such a high integration with routine care, reflecting both patient interest in screening and feasibility of incorporating screening into busy clinical practices,” Dr. Lubitz said.
Mobile ECGs with the handheld device take about 30 seconds to perform. In contrast, standard ECGs used in outpatient practices are bulky, and recording the ECG can take roughly 10 minutes.
Anthony Leazzo, DO, chairman of family practice at Northwestern Medicine Delnor Hospital, in Geneva, Ill., noted that smartwatches provide an alternative technology for detecting AFib.
But “a handheld, one-lead device would be more beneficial and should be more sensitive by measuring electrical activity similar to a normal ECG,” he said.
However, Dr. Leazzo said using such technology would need to be cost-effective because the patients at highest risk for AFib usually are on fixed incomes. Consumer versions of the devices can cost under $100. Dr. Lubitz said the actual cost for devices and a software platform used for a medical enterprise may differ.
Handheld ECGs are gradually being integrated into clinical practices, a trend driven by the rapid growth of telemedicine to remotely assess patients, Dr. Lubitz said.
“Our work affirmed that single-lead devices generate information for the physician that is actionable, though the proportion of newly detected AFib cases using a point-of-care ECG screening approach is likely to be very small,” Dr. Lubitz said in an interview. “For that reason, we think handheld devices are best deployed for people at the highest risk of AFib and stroke, and age is an excellent surrogate for that determination.”
The study was funded by Bristol-Myers Squibb–Pfizer Alliance.
A version of this article first appeared on Medscape.com.
The use of handheld, single-lead electrocardiograms (ECGs) did not increase diagnoses of AFib overall in patients aged 65 and older, but it did in patients 85 and up, researchers reported in Circulation.
“Incorporating single-lead ECGs into routine medical assessments as a new vital sign was widely feasible. Over 90% of people who were offered screening agreed to it and underwent screening,” said Steven Lubitz, MD, of the Cardiac Arrhythmia Service and Cardiovascular Research Center at Massachusetts General Hospital, Boston, who led the study.
Because advanced age is associated with a substantially increased risk of both AFib and stroke, point-of-care screening might be an efficient use of handheld ECGs, Dr. Lubitz said.
“The technology simply requires patients to place their fingers on the device to record an electrocardiogram and can be easily embedded in the routine clinical practice of primary care physicians,” he said in an interview.
The typical person has a 30% lifetime risk of developing AFib, and the chances of experiencing a stroke associated with the arrhythmia can be reduced significantly with anticoagulants, Dr. Lubitz said.
Professional organizations are split about the utility of screening for AFib. The European Society of Cardiology recommends opportunistic screening with either pulse palpation or ECG rhythm strip at clinic visits for patients 65 and older. The National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand have issued similar guidelines.
However, screening for AFib is not considered standard of care in the United States – although Dr. Lubitz predicted that that would change.
“I think the guidelines in the United States will evolve in the next few years, because I think we’re getting closer to understanding who we should be screening for atrial fibrillation and how we should be screening,” Dr. Lubitz told this news organization.
‘Very reassuring’ results
The randomized controlled trial found that for patients 85 and older, use of handheld ECGs led to a nearly 2% increase in new diagnoses of AFib in the screening group compared to conventional care.
The researchers also demonstrated an increased likelihood of diagnosing AFib during the patient’s primary-care encounter than at other sites, such as the emergency department or inpatient settings that might be more costly and resource-intensive. Moreover, the study reported that point-of-care screening was associated with high rates of oral anticoagulation prescriptions written for patients with newly diagnosed AFib, a finding Dr. Lubitz called “very reassuring.”
The Mass General researchers used single-lead devices attached to a tablet computer to screen more than 35,000 men and women from 16 primary care sites affiliated with the hospital’s practice-based research network.
Half the sites were randomly selected to include the screening intervention, where medical assistants used handheld ECGs at the start of the visit while checking routine vital signs.
The 1-year study screened 91% of eligible patients, demonstrating that single-lead rhythm assessment is feasible as part of routine primary care practice, Dr. Lubitz said. This finding supports other studies suggesting that handheld devices can enable rapid and scalable mass screening.
“We demonstrated that integration into routine practice by clinical personnel – in this case, medical assistants – is feasible. No study has measured and demonstrated such a high integration with routine care, reflecting both patient interest in screening and feasibility of incorporating screening into busy clinical practices,” Dr. Lubitz said.
Mobile ECGs with the handheld device take about 30 seconds to perform. In contrast, standard ECGs used in outpatient practices are bulky, and recording the ECG can take roughly 10 minutes.
Anthony Leazzo, DO, chairman of family practice at Northwestern Medicine Delnor Hospital, in Geneva, Ill., noted that smartwatches provide an alternative technology for detecting AFib.
But “a handheld, one-lead device would be more beneficial and should be more sensitive by measuring electrical activity similar to a normal ECG,” he said.
However, Dr. Leazzo said using such technology would need to be cost-effective because the patients at highest risk for AFib usually are on fixed incomes. Consumer versions of the devices can cost under $100. Dr. Lubitz said the actual cost for devices and a software platform used for a medical enterprise may differ.
Handheld ECGs are gradually being integrated into clinical practices, a trend driven by the rapid growth of telemedicine to remotely assess patients, Dr. Lubitz said.
“Our work affirmed that single-lead devices generate information for the physician that is actionable, though the proportion of newly detected AFib cases using a point-of-care ECG screening approach is likely to be very small,” Dr. Lubitz said in an interview. “For that reason, we think handheld devices are best deployed for people at the highest risk of AFib and stroke, and age is an excellent surrogate for that determination.”
The study was funded by Bristol-Myers Squibb–Pfizer Alliance.
A version of this article first appeared on Medscape.com.
The use of handheld, single-lead electrocardiograms (ECGs) did not increase diagnoses of AFib overall in patients aged 65 and older, but it did in patients 85 and up, researchers reported in Circulation.
“Incorporating single-lead ECGs into routine medical assessments as a new vital sign was widely feasible. Over 90% of people who were offered screening agreed to it and underwent screening,” said Steven Lubitz, MD, of the Cardiac Arrhythmia Service and Cardiovascular Research Center at Massachusetts General Hospital, Boston, who led the study.
Because advanced age is associated with a substantially increased risk of both AFib and stroke, point-of-care screening might be an efficient use of handheld ECGs, Dr. Lubitz said.
“The technology simply requires patients to place their fingers on the device to record an electrocardiogram and can be easily embedded in the routine clinical practice of primary care physicians,” he said in an interview.
The typical person has a 30% lifetime risk of developing AFib, and the chances of experiencing a stroke associated with the arrhythmia can be reduced significantly with anticoagulants, Dr. Lubitz said.
Professional organizations are split about the utility of screening for AFib. The European Society of Cardiology recommends opportunistic screening with either pulse palpation or ECG rhythm strip at clinic visits for patients 65 and older. The National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand have issued similar guidelines.
However, screening for AFib is not considered standard of care in the United States – although Dr. Lubitz predicted that that would change.
“I think the guidelines in the United States will evolve in the next few years, because I think we’re getting closer to understanding who we should be screening for atrial fibrillation and how we should be screening,” Dr. Lubitz told this news organization.
‘Very reassuring’ results
The randomized controlled trial found that for patients 85 and older, use of handheld ECGs led to a nearly 2% increase in new diagnoses of AFib in the screening group compared to conventional care.
The researchers also demonstrated an increased likelihood of diagnosing AFib during the patient’s primary-care encounter than at other sites, such as the emergency department or inpatient settings that might be more costly and resource-intensive. Moreover, the study reported that point-of-care screening was associated with high rates of oral anticoagulation prescriptions written for patients with newly diagnosed AFib, a finding Dr. Lubitz called “very reassuring.”
The Mass General researchers used single-lead devices attached to a tablet computer to screen more than 35,000 men and women from 16 primary care sites affiliated with the hospital’s practice-based research network.
Half the sites were randomly selected to include the screening intervention, where medical assistants used handheld ECGs at the start of the visit while checking routine vital signs.
The 1-year study screened 91% of eligible patients, demonstrating that single-lead rhythm assessment is feasible as part of routine primary care practice, Dr. Lubitz said. This finding supports other studies suggesting that handheld devices can enable rapid and scalable mass screening.
“We demonstrated that integration into routine practice by clinical personnel – in this case, medical assistants – is feasible. No study has measured and demonstrated such a high integration with routine care, reflecting both patient interest in screening and feasibility of incorporating screening into busy clinical practices,” Dr. Lubitz said.
Mobile ECGs with the handheld device take about 30 seconds to perform. In contrast, standard ECGs used in outpatient practices are bulky, and recording the ECG can take roughly 10 minutes.
Anthony Leazzo, DO, chairman of family practice at Northwestern Medicine Delnor Hospital, in Geneva, Ill., noted that smartwatches provide an alternative technology for detecting AFib.
But “a handheld, one-lead device would be more beneficial and should be more sensitive by measuring electrical activity similar to a normal ECG,” he said.
However, Dr. Leazzo said using such technology would need to be cost-effective because the patients at highest risk for AFib usually are on fixed incomes. Consumer versions of the devices can cost under $100. Dr. Lubitz said the actual cost for devices and a software platform used for a medical enterprise may differ.
Handheld ECGs are gradually being integrated into clinical practices, a trend driven by the rapid growth of telemedicine to remotely assess patients, Dr. Lubitz said.
“Our work affirmed that single-lead devices generate information for the physician that is actionable, though the proportion of newly detected AFib cases using a point-of-care ECG screening approach is likely to be very small,” Dr. Lubitz said in an interview. “For that reason, we think handheld devices are best deployed for people at the highest risk of AFib and stroke, and age is an excellent surrogate for that determination.”
The study was funded by Bristol-Myers Squibb–Pfizer Alliance.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Spanish-speaking navigators show Hispanic patients path to CRC screening
A Spanish-speaking patient navigator dramatically increased the percentage of Hispanics undergoing colorectal screening with colonoscopies in Providence, R.I.
Screening colonoscopies are a well-established approach to reducing colorectal cancer mortality by identifying and removing polyps. However, Hispanics in the United States lag behind the general population in completion rates for screening colonoscopies.
“Starting colorectal cancer colonoscopy screening at age 45 saves lives. But this life-saving procedure is underutilized by certain populations, not only because of limited access to care but because of cultural, language, and educational barriers that exist,” Abdul Saied Calvino, MD, MPH, program director of the Complex General Surgical Oncology Fellowship at Roger Williams Medical Center, Providence, R.I., told this news organization.
Tailored patient navigation is effective but has not been widely adopted. The new study is one of the first to look at the ‘real-life’ impact of these types of programs in the Hispanic population, Dr. Calvino and his colleagues reported in the journal Cancer.
Colorectal cancer is the second leading cause of cancer-related death in the United States overall and the third-most diagnosed cancer site, according to the American Cancer Society. Among Hispanics, colorectal cancer is the second leading cause of cancer mortality and the second-most diagnosed site of malignancy.
Dr. Calvino and his colleagues sought to learn if a culturally tailored patient navigation program could improve rates of screening colonoscopies among Hispanic residents in Providence.
The hospital hired a dedicated Spanish-speaking navigator/coordinator and enrolled 698 men and women into the program.
The navigator sent introductory letters in Spanish to study participants, made phone calls to educate patients about the importance of cancer screening, and called again to ensure that all potential barriers to colonoscopy were overcome, Dr. Calvino said. Colonoscopy completion, cancellations, and no-shows were recorded. Participants were followed for 28 months.
The program proved highly successful, according to the researchers. At the end of the study period, 85% of patients – exceeding the national goal of 80% set by the National Colorectal Cancer Roundtable – had completed testing, with no differences between men and women; the cancellation rate was 9% and only 6% of patients failed to show up for endoscopy.
Among the group that underwent colonoscopy, 254 (43%) had polyps removed and eight (1.3%) required colectomy, the researchers reported. Five patients (0.8%) were diagnosed with malignancy.
Dr. Calvino attributed the 15% combined rate of no-shows and cancellations to the cost of the procedure (copayment, out-of-pocket expense, and loss of wages) and the inability to follow-up with those patients. He added that 90% of those who completed the procedure said that without the patient navigation program they would not have completed the screening colonoscopies.
Aimee Afable, PhD, MPH, an expert on health disparities and immigrant health at Downstate Health Science University, New York, called the new study small but “important.”
Dr. Afable said strong evidence supports the ability of patient navigation programs to improve the reach and impact of screening programs aimed at the underserved. However, hospitals typically do not adequately fund such initiatives. (Dr. Calvino said the program at Roger Williams started with a grant from the OLDCO Foundation and is now supported by his institution.)
“In 2022, post-COVID, it is common to see health care support staff leaving institutions, hospitals because they’re not being paid well, and they are overburdened,” Dr. Afable told this news organization. “Patient navigation is not, unfortunately, a routine part of health care in the U.S. despite its central role in ensuring continuity of care.”
Funding for the study was provided by a grant from the OLDCO Foundation. Coauthor John C. Hardaway, MD, PhD, reports being a cancer liaison physician for the American College of Surgeons. The other authors have disclosed no relevant financial relationships.
Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.
A version of this article first appeared on Medscape.com.
A Spanish-speaking patient navigator dramatically increased the percentage of Hispanics undergoing colorectal screening with colonoscopies in Providence, R.I.
Screening colonoscopies are a well-established approach to reducing colorectal cancer mortality by identifying and removing polyps. However, Hispanics in the United States lag behind the general population in completion rates for screening colonoscopies.
“Starting colorectal cancer colonoscopy screening at age 45 saves lives. But this life-saving procedure is underutilized by certain populations, not only because of limited access to care but because of cultural, language, and educational barriers that exist,” Abdul Saied Calvino, MD, MPH, program director of the Complex General Surgical Oncology Fellowship at Roger Williams Medical Center, Providence, R.I., told this news organization.
Tailored patient navigation is effective but has not been widely adopted. The new study is one of the first to look at the ‘real-life’ impact of these types of programs in the Hispanic population, Dr. Calvino and his colleagues reported in the journal Cancer.
Colorectal cancer is the second leading cause of cancer-related death in the United States overall and the third-most diagnosed cancer site, according to the American Cancer Society. Among Hispanics, colorectal cancer is the second leading cause of cancer mortality and the second-most diagnosed site of malignancy.
Dr. Calvino and his colleagues sought to learn if a culturally tailored patient navigation program could improve rates of screening colonoscopies among Hispanic residents in Providence.
The hospital hired a dedicated Spanish-speaking navigator/coordinator and enrolled 698 men and women into the program.
The navigator sent introductory letters in Spanish to study participants, made phone calls to educate patients about the importance of cancer screening, and called again to ensure that all potential barriers to colonoscopy were overcome, Dr. Calvino said. Colonoscopy completion, cancellations, and no-shows were recorded. Participants were followed for 28 months.
The program proved highly successful, according to the researchers. At the end of the study period, 85% of patients – exceeding the national goal of 80% set by the National Colorectal Cancer Roundtable – had completed testing, with no differences between men and women; the cancellation rate was 9% and only 6% of patients failed to show up for endoscopy.
Among the group that underwent colonoscopy, 254 (43%) had polyps removed and eight (1.3%) required colectomy, the researchers reported. Five patients (0.8%) were diagnosed with malignancy.
Dr. Calvino attributed the 15% combined rate of no-shows and cancellations to the cost of the procedure (copayment, out-of-pocket expense, and loss of wages) and the inability to follow-up with those patients. He added that 90% of those who completed the procedure said that without the patient navigation program they would not have completed the screening colonoscopies.
Aimee Afable, PhD, MPH, an expert on health disparities and immigrant health at Downstate Health Science University, New York, called the new study small but “important.”
Dr. Afable said strong evidence supports the ability of patient navigation programs to improve the reach and impact of screening programs aimed at the underserved. However, hospitals typically do not adequately fund such initiatives. (Dr. Calvino said the program at Roger Williams started with a grant from the OLDCO Foundation and is now supported by his institution.)
“In 2022, post-COVID, it is common to see health care support staff leaving institutions, hospitals because they’re not being paid well, and they are overburdened,” Dr. Afable told this news organization. “Patient navigation is not, unfortunately, a routine part of health care in the U.S. despite its central role in ensuring continuity of care.”
Funding for the study was provided by a grant from the OLDCO Foundation. Coauthor John C. Hardaway, MD, PhD, reports being a cancer liaison physician for the American College of Surgeons. The other authors have disclosed no relevant financial relationships.
Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.
A version of this article first appeared on Medscape.com.
A Spanish-speaking patient navigator dramatically increased the percentage of Hispanics undergoing colorectal screening with colonoscopies in Providence, R.I.
Screening colonoscopies are a well-established approach to reducing colorectal cancer mortality by identifying and removing polyps. However, Hispanics in the United States lag behind the general population in completion rates for screening colonoscopies.
“Starting colorectal cancer colonoscopy screening at age 45 saves lives. But this life-saving procedure is underutilized by certain populations, not only because of limited access to care but because of cultural, language, and educational barriers that exist,” Abdul Saied Calvino, MD, MPH, program director of the Complex General Surgical Oncology Fellowship at Roger Williams Medical Center, Providence, R.I., told this news organization.
Tailored patient navigation is effective but has not been widely adopted. The new study is one of the first to look at the ‘real-life’ impact of these types of programs in the Hispanic population, Dr. Calvino and his colleagues reported in the journal Cancer.
Colorectal cancer is the second leading cause of cancer-related death in the United States overall and the third-most diagnosed cancer site, according to the American Cancer Society. Among Hispanics, colorectal cancer is the second leading cause of cancer mortality and the second-most diagnosed site of malignancy.
Dr. Calvino and his colleagues sought to learn if a culturally tailored patient navigation program could improve rates of screening colonoscopies among Hispanic residents in Providence.
The hospital hired a dedicated Spanish-speaking navigator/coordinator and enrolled 698 men and women into the program.
The navigator sent introductory letters in Spanish to study participants, made phone calls to educate patients about the importance of cancer screening, and called again to ensure that all potential barriers to colonoscopy were overcome, Dr. Calvino said. Colonoscopy completion, cancellations, and no-shows were recorded. Participants were followed for 28 months.
The program proved highly successful, according to the researchers. At the end of the study period, 85% of patients – exceeding the national goal of 80% set by the National Colorectal Cancer Roundtable – had completed testing, with no differences between men and women; the cancellation rate was 9% and only 6% of patients failed to show up for endoscopy.
Among the group that underwent colonoscopy, 254 (43%) had polyps removed and eight (1.3%) required colectomy, the researchers reported. Five patients (0.8%) were diagnosed with malignancy.
Dr. Calvino attributed the 15% combined rate of no-shows and cancellations to the cost of the procedure (copayment, out-of-pocket expense, and loss of wages) and the inability to follow-up with those patients. He added that 90% of those who completed the procedure said that without the patient navigation program they would not have completed the screening colonoscopies.
Aimee Afable, PhD, MPH, an expert on health disparities and immigrant health at Downstate Health Science University, New York, called the new study small but “important.”
Dr. Afable said strong evidence supports the ability of patient navigation programs to improve the reach and impact of screening programs aimed at the underserved. However, hospitals typically do not adequately fund such initiatives. (Dr. Calvino said the program at Roger Williams started with a grant from the OLDCO Foundation and is now supported by his institution.)
“In 2022, post-COVID, it is common to see health care support staff leaving institutions, hospitals because they’re not being paid well, and they are overburdened,” Dr. Afable told this news organization. “Patient navigation is not, unfortunately, a routine part of health care in the U.S. despite its central role in ensuring continuity of care.”
Funding for the study was provided by a grant from the OLDCO Foundation. Coauthor John C. Hardaway, MD, PhD, reports being a cancer liaison physician for the American College of Surgeons. The other authors have disclosed no relevant financial relationships.
Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.
A version of this article first appeared on Medscape.com.
Spanish-speaking navigators show Hispanic patients path to CRC screening
A Spanish-speaking patient navigator dramatically increased the percentage of Hispanics undergoing colorectal screening with colonoscopies in Providence, R.I.
Screening colonoscopies are a well-established approach to reducing colorectal cancer mortality by identifying and removing polyps. However, Hispanics in the United States lag behind the general population in completion rates for screening colonoscopies.
“Starting colorectal cancer colonoscopy screening at age 45 saves lives. But this life-saving procedure is underutilized by certain populations, not only because of limited access to care but because of cultural, language, and educational barriers that exist,” Abdul Saied Calvino, MD, MPH, program director of the Complex General Surgical Oncology Fellowship at Roger Williams Medical Center, Providence, R.I., told this news organization.
Tailored patient navigation is effective but has not been widely adopted. The new study is one of the first to look at the ‘real-life’ impact of these types of programs in the Hispanic population, Dr. Calvino and his colleagues reported in the journal Cancer.
Colorectal cancer is the second leading cause of cancer-related death in the United States overall and the third-most diagnosed cancer site, according to the American Cancer Society. Among Hispanics, colorectal cancer is the second leading cause of cancer mortality and the second-most diagnosed site of malignancy.
Dr. Calvino and his colleagues sought to learn if a culturally tailored patient navigation program could improve rates of screening colonoscopies among Hispanic residents in Providence.
The hospital hired a dedicated Spanish-speaking navigator/coordinator and enrolled 698 men and women into the program.
The navigator sent introductory letters in Spanish to study participants, made phone calls to educate patients about the importance of cancer screening, and called again to ensure that all potential barriers to colonoscopy were overcome, Dr. Calvino said. Colonoscopy completion, cancellations, and no-shows were recorded. Participants were followed for 28 months.
The program proved highly successful, according to the researchers. At the end of the study period, 85% of patients – exceeding the national goal of 80% set by the National Colorectal Cancer Roundtable – had completed testing, with no differences between men and women; the cancellation rate was 9% and only 6% of patients failed to show up for endoscopy.*
Among the group that underwent colonoscopy, 254 (43%) had polyps removed and eight (1.3%) required colectomy, the researchers reported. Five patients (0.8%) were diagnosed with malignancy.
Dr. Calvino attributed the 15% combined rate of no-shows and cancellations to the cost of the procedure (copayment, out-of-pocket expense, and loss of wages) and the inability to follow-up with those patients. He added that 90% of those who completed the procedure said that without the patient navigation program they would not have completed the screening colonoscopies.
Aimee Afable, PhD, MPH, an expert on health disparities and immigrant health at Downstate Health Science University, New York, called the new study small but “important.”
Dr. Afable said strong evidence supports the ability of patient navigation programs to improve the reach and impact of screening programs aimed at the underserved. However, hospitals typically do not adequately fund such initiatives. (Dr. Calvino said the program at Roger Williams started with a grant from the OLDCO Foundation and is now supported by his institution.)
“In 2022, post-COVID, it is common to see health care support staff leaving institutions, hospitals because they’re not being paid well, and they are overburdened,” Dr. Afable told this news organization. “Patient navigation is not, unfortunately, a routine part of health care in the U.S. despite its central role in ensuring continuity of care.”
Funding for the study was provided by a grant from the OLDCO Foundation. Coauthor John C. Hardaway, MD, PhD, reports being a cancer liaison physician for the American College of Surgeons. The other authors have disclosed no relevant financial relationships. Dr. Afable has no disclosures.
A version of this article first appeared on Medscape.com.
*Correction, 2/9/22: An earlier version of this article misidentified the group that set the national screening goal.
This article was updated 2/18/22.
A Spanish-speaking patient navigator dramatically increased the percentage of Hispanics undergoing colorectal screening with colonoscopies in Providence, R.I.
Screening colonoscopies are a well-established approach to reducing colorectal cancer mortality by identifying and removing polyps. However, Hispanics in the United States lag behind the general population in completion rates for screening colonoscopies.
“Starting colorectal cancer colonoscopy screening at age 45 saves lives. But this life-saving procedure is underutilized by certain populations, not only because of limited access to care but because of cultural, language, and educational barriers that exist,” Abdul Saied Calvino, MD, MPH, program director of the Complex General Surgical Oncology Fellowship at Roger Williams Medical Center, Providence, R.I., told this news organization.
Tailored patient navigation is effective but has not been widely adopted. The new study is one of the first to look at the ‘real-life’ impact of these types of programs in the Hispanic population, Dr. Calvino and his colleagues reported in the journal Cancer.
Colorectal cancer is the second leading cause of cancer-related death in the United States overall and the third-most diagnosed cancer site, according to the American Cancer Society. Among Hispanics, colorectal cancer is the second leading cause of cancer mortality and the second-most diagnosed site of malignancy.
Dr. Calvino and his colleagues sought to learn if a culturally tailored patient navigation program could improve rates of screening colonoscopies among Hispanic residents in Providence.
The hospital hired a dedicated Spanish-speaking navigator/coordinator and enrolled 698 men and women into the program.
The navigator sent introductory letters in Spanish to study participants, made phone calls to educate patients about the importance of cancer screening, and called again to ensure that all potential barriers to colonoscopy were overcome, Dr. Calvino said. Colonoscopy completion, cancellations, and no-shows were recorded. Participants were followed for 28 months.
The program proved highly successful, according to the researchers. At the end of the study period, 85% of patients – exceeding the national goal of 80% set by the National Colorectal Cancer Roundtable – had completed testing, with no differences between men and women; the cancellation rate was 9% and only 6% of patients failed to show up for endoscopy.*
Among the group that underwent colonoscopy, 254 (43%) had polyps removed and eight (1.3%) required colectomy, the researchers reported. Five patients (0.8%) were diagnosed with malignancy.
Dr. Calvino attributed the 15% combined rate of no-shows and cancellations to the cost of the procedure (copayment, out-of-pocket expense, and loss of wages) and the inability to follow-up with those patients. He added that 90% of those who completed the procedure said that without the patient navigation program they would not have completed the screening colonoscopies.
Aimee Afable, PhD, MPH, an expert on health disparities and immigrant health at Downstate Health Science University, New York, called the new study small but “important.”
Dr. Afable said strong evidence supports the ability of patient navigation programs to improve the reach and impact of screening programs aimed at the underserved. However, hospitals typically do not adequately fund such initiatives. (Dr. Calvino said the program at Roger Williams started with a grant from the OLDCO Foundation and is now supported by his institution.)
“In 2022, post-COVID, it is common to see health care support staff leaving institutions, hospitals because they’re not being paid well, and they are overburdened,” Dr. Afable told this news organization. “Patient navigation is not, unfortunately, a routine part of health care in the U.S. despite its central role in ensuring continuity of care.”
Funding for the study was provided by a grant from the OLDCO Foundation. Coauthor John C. Hardaway, MD, PhD, reports being a cancer liaison physician for the American College of Surgeons. The other authors have disclosed no relevant financial relationships. Dr. Afable has no disclosures.
A version of this article first appeared on Medscape.com.
*Correction, 2/9/22: An earlier version of this article misidentified the group that set the national screening goal.
This article was updated 2/18/22.
A Spanish-speaking patient navigator dramatically increased the percentage of Hispanics undergoing colorectal screening with colonoscopies in Providence, R.I.
Screening colonoscopies are a well-established approach to reducing colorectal cancer mortality by identifying and removing polyps. However, Hispanics in the United States lag behind the general population in completion rates for screening colonoscopies.
“Starting colorectal cancer colonoscopy screening at age 45 saves lives. But this life-saving procedure is underutilized by certain populations, not only because of limited access to care but because of cultural, language, and educational barriers that exist,” Abdul Saied Calvino, MD, MPH, program director of the Complex General Surgical Oncology Fellowship at Roger Williams Medical Center, Providence, R.I., told this news organization.
Tailored patient navigation is effective but has not been widely adopted. The new study is one of the first to look at the ‘real-life’ impact of these types of programs in the Hispanic population, Dr. Calvino and his colleagues reported in the journal Cancer.
Colorectal cancer is the second leading cause of cancer-related death in the United States overall and the third-most diagnosed cancer site, according to the American Cancer Society. Among Hispanics, colorectal cancer is the second leading cause of cancer mortality and the second-most diagnosed site of malignancy.
Dr. Calvino and his colleagues sought to learn if a culturally tailored patient navigation program could improve rates of screening colonoscopies among Hispanic residents in Providence.
The hospital hired a dedicated Spanish-speaking navigator/coordinator and enrolled 698 men and women into the program.
The navigator sent introductory letters in Spanish to study participants, made phone calls to educate patients about the importance of cancer screening, and called again to ensure that all potential barriers to colonoscopy were overcome, Dr. Calvino said. Colonoscopy completion, cancellations, and no-shows were recorded. Participants were followed for 28 months.
The program proved highly successful, according to the researchers. At the end of the study period, 85% of patients – exceeding the national goal of 80% set by the National Colorectal Cancer Roundtable – had completed testing, with no differences between men and women; the cancellation rate was 9% and only 6% of patients failed to show up for endoscopy.*
Among the group that underwent colonoscopy, 254 (43%) had polyps removed and eight (1.3%) required colectomy, the researchers reported. Five patients (0.8%) were diagnosed with malignancy.
Dr. Calvino attributed the 15% combined rate of no-shows and cancellations to the cost of the procedure (copayment, out-of-pocket expense, and loss of wages) and the inability to follow-up with those patients. He added that 90% of those who completed the procedure said that without the patient navigation program they would not have completed the screening colonoscopies.
Aimee Afable, PhD, MPH, an expert on health disparities and immigrant health at Downstate Health Science University, New York, called the new study small but “important.”
Dr. Afable said strong evidence supports the ability of patient navigation programs to improve the reach and impact of screening programs aimed at the underserved. However, hospitals typically do not adequately fund such initiatives. (Dr. Calvino said the program at Roger Williams started with a grant from the OLDCO Foundation and is now supported by his institution.)
“In 2022, post-COVID, it is common to see health care support staff leaving institutions, hospitals because they’re not being paid well, and they are overburdened,” Dr. Afable told this news organization. “Patient navigation is not, unfortunately, a routine part of health care in the U.S. despite its central role in ensuring continuity of care.”
Funding for the study was provided by a grant from the OLDCO Foundation. Coauthor John C. Hardaway, MD, PhD, reports being a cancer liaison physician for the American College of Surgeons. The other authors have disclosed no relevant financial relationships. Dr. Afable has no disclosures.
A version of this article first appeared on Medscape.com.
*Correction, 2/9/22: An earlier version of this article misidentified the group that set the national screening goal.
This article was updated 2/18/22.
Prophylactic meds may prevent cesarean bleeding
Methylergonovine is often used to control severe bleeding immediately after cesarean deliveries. But a new study suggests that the ergot alkaloid agent could benefit these women if administered before delivery, researchers from the University of Iowa Hospitals, Iowa City, reported in the January edition of the American Journal of Obstetrics and Gynecology. The data were presented Feb. 4 at the 2022 virtual Pregnancy Meeting of the Society of Maternal-Fetal Medicine.
The findings have prompted the institution to begin administering prophylactic methylergonovine in addition to oxytocin at the time of cesarean deliveries, according to the researchers.
“The addition of prophylactic methylergonovine improved uterine tone, decreased the requirement of additional uterotonic agents, decreased the risk of postpartum hemorrhage, and decreased the need for blood transfusions,” lead author Nicole Masse, MD, assistant professor of maternal-fetal medicine at the University of Iowa, said in an interview.
Abnormal uterine tone is the leading cause of postpartum hemorrhage, Dr. Masse said. “Satisfactory uterine tone following delivery is essential. This study found a decreased need for blood transfusions in patients who received prophylactic methylergonovine. Given the risks of blood transfusions, which can include disease transmission and allergic reactions, transfusions should be avoided whenever possible.”
Conducted between June 2019 and February 2021, the single-center, randomized controlled trial of 160 women undergoing an intrapartum cesarean birth is the largest of its kind to date, Dr. Masse said. Women received either intravenous oxytocin at a dose of 300 mU per minute plus 1 mL of intramuscular normal saline (n = 80) or intravenous oxytocin at a dose of 300 mU per minute plus 0.2 mg (1 mL) of intramuscular methylergonovine (n = 80).
Women who received prophylactic methylergonovine required significantly less additional uterotonic agents than those who received oxytocin alone (20% vs. 55%; relative risk, 0.36; 95% confidence interval 0.22-0.59), according to the researchers. Those receiving methylergonovine were more likely to experience improved uterine tone (80% vs. 41.2%; RR, 1.94; 95% CI, 1.46-2.56), a lower incidence of postpartum hemorrhage (35% vs. 58.8%; RR, 0.6; 95% CI, 0.42-0.85), decreased need for a blood transfusion (5% vs. 22.5%; RR, 0.22; 95% CI, 0.08-0.63), and lower mean quantitative blood loss (996 mL vs. 1,315 mL; P = .004), they reported.
“As the majority of postpartum hemorrhages are preventable, this study is clinically relevant and can serve to decrease the morbidity associated with postpartum hemorrhage,” Dr. Masse said.
Jennifer Choi, DO, clinical assistant professor of maternal-fetal medicine at Stony Brook University Hospital, New York, said the Iowa team’s results are contrary to prior studies showing no benefit with simultaneous use of oxytocin and ergot alkaloids.
“It would be interesting to see long-term benefits across a diverse population,” she said. “But as methylergonovine is a known contraindication to hypertensive and cardiovascular disorders, including pre-eclampsia, patients would have to be carefully screened.”
Kecia Gaither, MD, MPH, associate professor of clinical obstetrics and gynecology at Weill Cornell Medicine, New York, called the study “a novel idea, but more research and higher numbers are needed for a substantive conclusion.”
Additional studies should look at variables such as the number of prior cesarean deliveries, body mass index, presence of uterine myomas, presence of abnormal placentation (placenta accreta, increta, percreta), and presence of multiple gestation, said Dr. Gaither, who also is director of perinatal services at NYC Health + Hospitals/Lincoln.
“Methergine [methylergonovine] use is contraindicated in women with hypertension/pre-eclampsia spectrum, mitral valve prolapse, history of coronary artery disease, and liver pathology,” she noted.
The researchers reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Methylergonovine is often used to control severe bleeding immediately after cesarean deliveries. But a new study suggests that the ergot alkaloid agent could benefit these women if administered before delivery, researchers from the University of Iowa Hospitals, Iowa City, reported in the January edition of the American Journal of Obstetrics and Gynecology. The data were presented Feb. 4 at the 2022 virtual Pregnancy Meeting of the Society of Maternal-Fetal Medicine.
The findings have prompted the institution to begin administering prophylactic methylergonovine in addition to oxytocin at the time of cesarean deliveries, according to the researchers.
“The addition of prophylactic methylergonovine improved uterine tone, decreased the requirement of additional uterotonic agents, decreased the risk of postpartum hemorrhage, and decreased the need for blood transfusions,” lead author Nicole Masse, MD, assistant professor of maternal-fetal medicine at the University of Iowa, said in an interview.
Abnormal uterine tone is the leading cause of postpartum hemorrhage, Dr. Masse said. “Satisfactory uterine tone following delivery is essential. This study found a decreased need for blood transfusions in patients who received prophylactic methylergonovine. Given the risks of blood transfusions, which can include disease transmission and allergic reactions, transfusions should be avoided whenever possible.”
Conducted between June 2019 and February 2021, the single-center, randomized controlled trial of 160 women undergoing an intrapartum cesarean birth is the largest of its kind to date, Dr. Masse said. Women received either intravenous oxytocin at a dose of 300 mU per minute plus 1 mL of intramuscular normal saline (n = 80) or intravenous oxytocin at a dose of 300 mU per minute plus 0.2 mg (1 mL) of intramuscular methylergonovine (n = 80).
Women who received prophylactic methylergonovine required significantly less additional uterotonic agents than those who received oxytocin alone (20% vs. 55%; relative risk, 0.36; 95% confidence interval 0.22-0.59), according to the researchers. Those receiving methylergonovine were more likely to experience improved uterine tone (80% vs. 41.2%; RR, 1.94; 95% CI, 1.46-2.56), a lower incidence of postpartum hemorrhage (35% vs. 58.8%; RR, 0.6; 95% CI, 0.42-0.85), decreased need for a blood transfusion (5% vs. 22.5%; RR, 0.22; 95% CI, 0.08-0.63), and lower mean quantitative blood loss (996 mL vs. 1,315 mL; P = .004), they reported.
“As the majority of postpartum hemorrhages are preventable, this study is clinically relevant and can serve to decrease the morbidity associated with postpartum hemorrhage,” Dr. Masse said.
Jennifer Choi, DO, clinical assistant professor of maternal-fetal medicine at Stony Brook University Hospital, New York, said the Iowa team’s results are contrary to prior studies showing no benefit with simultaneous use of oxytocin and ergot alkaloids.
“It would be interesting to see long-term benefits across a diverse population,” she said. “But as methylergonovine is a known contraindication to hypertensive and cardiovascular disorders, including pre-eclampsia, patients would have to be carefully screened.”
Kecia Gaither, MD, MPH, associate professor of clinical obstetrics and gynecology at Weill Cornell Medicine, New York, called the study “a novel idea, but more research and higher numbers are needed for a substantive conclusion.”
Additional studies should look at variables such as the number of prior cesarean deliveries, body mass index, presence of uterine myomas, presence of abnormal placentation (placenta accreta, increta, percreta), and presence of multiple gestation, said Dr. Gaither, who also is director of perinatal services at NYC Health + Hospitals/Lincoln.
“Methergine [methylergonovine] use is contraindicated in women with hypertension/pre-eclampsia spectrum, mitral valve prolapse, history of coronary artery disease, and liver pathology,” she noted.
The researchers reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Methylergonovine is often used to control severe bleeding immediately after cesarean deliveries. But a new study suggests that the ergot alkaloid agent could benefit these women if administered before delivery, researchers from the University of Iowa Hospitals, Iowa City, reported in the January edition of the American Journal of Obstetrics and Gynecology. The data were presented Feb. 4 at the 2022 virtual Pregnancy Meeting of the Society of Maternal-Fetal Medicine.
The findings have prompted the institution to begin administering prophylactic methylergonovine in addition to oxytocin at the time of cesarean deliveries, according to the researchers.
“The addition of prophylactic methylergonovine improved uterine tone, decreased the requirement of additional uterotonic agents, decreased the risk of postpartum hemorrhage, and decreased the need for blood transfusions,” lead author Nicole Masse, MD, assistant professor of maternal-fetal medicine at the University of Iowa, said in an interview.
Abnormal uterine tone is the leading cause of postpartum hemorrhage, Dr. Masse said. “Satisfactory uterine tone following delivery is essential. This study found a decreased need for blood transfusions in patients who received prophylactic methylergonovine. Given the risks of blood transfusions, which can include disease transmission and allergic reactions, transfusions should be avoided whenever possible.”
Conducted between June 2019 and February 2021, the single-center, randomized controlled trial of 160 women undergoing an intrapartum cesarean birth is the largest of its kind to date, Dr. Masse said. Women received either intravenous oxytocin at a dose of 300 mU per minute plus 1 mL of intramuscular normal saline (n = 80) or intravenous oxytocin at a dose of 300 mU per minute plus 0.2 mg (1 mL) of intramuscular methylergonovine (n = 80).
Women who received prophylactic methylergonovine required significantly less additional uterotonic agents than those who received oxytocin alone (20% vs. 55%; relative risk, 0.36; 95% confidence interval 0.22-0.59), according to the researchers. Those receiving methylergonovine were more likely to experience improved uterine tone (80% vs. 41.2%; RR, 1.94; 95% CI, 1.46-2.56), a lower incidence of postpartum hemorrhage (35% vs. 58.8%; RR, 0.6; 95% CI, 0.42-0.85), decreased need for a blood transfusion (5% vs. 22.5%; RR, 0.22; 95% CI, 0.08-0.63), and lower mean quantitative blood loss (996 mL vs. 1,315 mL; P = .004), they reported.
“As the majority of postpartum hemorrhages are preventable, this study is clinically relevant and can serve to decrease the morbidity associated with postpartum hemorrhage,” Dr. Masse said.
Jennifer Choi, DO, clinical assistant professor of maternal-fetal medicine at Stony Brook University Hospital, New York, said the Iowa team’s results are contrary to prior studies showing no benefit with simultaneous use of oxytocin and ergot alkaloids.
“It would be interesting to see long-term benefits across a diverse population,” she said. “But as methylergonovine is a known contraindication to hypertensive and cardiovascular disorders, including pre-eclampsia, patients would have to be carefully screened.”
Kecia Gaither, MD, MPH, associate professor of clinical obstetrics and gynecology at Weill Cornell Medicine, New York, called the study “a novel idea, but more research and higher numbers are needed for a substantive conclusion.”
Additional studies should look at variables such as the number of prior cesarean deliveries, body mass index, presence of uterine myomas, presence of abnormal placentation (placenta accreta, increta, percreta), and presence of multiple gestation, said Dr. Gaither, who also is director of perinatal services at NYC Health + Hospitals/Lincoln.
“Methergine [methylergonovine] use is contraindicated in women with hypertension/pre-eclampsia spectrum, mitral valve prolapse, history of coronary artery disease, and liver pathology,” she noted.
The researchers reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Study questions reliability of maternal drug testing
A new study finding that samples from maternal urine and the meconium of their newborn babies frequently produce different results is raising more questions about drug testing of pregnant women.
The study found concerningly high rates of disagreement (or “discordance”) in biochemical testing between maternal urine in women with a documented history of or active drug use and the meconium in their newborns. In some cases, such discordance might be triggering the inappropriate intervention of childcare protective services, including the separation of infants from their mothers, according to the researchers, who presented their findings Feb. 4 at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“There’s a very big debate right now in the obstetrics and perinatology communities about the utility of biochemical testing and the identification of high-risk women,” lead author Cassandra Heiselman, DO, MPH, clinical assistant professor in the department of obstetrics, gynecology and reproductive medicine at Stony Brook (N.Y.) University, said in an interview. “We know that each biochemical test has limitations, which can include basically the inability to detect all substances, especially synthetic opioids like fentanyl, [and] the possibility for false results.”
Inaccuracies in testing can potentially result in inappropriate separation of mother and baby. “Careful scrutiny of results is needed,” Dr. Heiselman said.
The Stony Brook team conducted a retrospective cohort study that identified women presenting for delivery from January 2017 to March 2021 with indications for drug testing, including a known history of or current substance use disorder/misuse, and late or no prenatal care. A standardized panel was used for testing maternal urine and newborn meconium.
Urine tests of 327 women resulted in 187 (57%) positive and 98 (30%) negative results, along with 42 (13%) samples with incomplete data, the researchers reported. In contrast, drug testing of newborn meconium was positive in 273 (83%) cases, negative in 42 (13%), and was not performed in 12 (4%) – for a rate of concordance of 41%.
Concordance of urine/meconium occurred more frequently in male newborns (65%), compared with females (35%). “It is unclear biologically why there is such a difference based on the sex of the infants’ test and is an area that needs further investigation,” Dr. Heiselman said.
Comparing urine and meconium tests for 11 substances resulted in 195/483 (40%) concordance, the researchers said; 18% were discordant with positive maternal urine, and 41% were discordant with newborn positive meconium.
Oxycodone and fentanyl were significantly discordant with positive maternal urine. Cannabis use was the most common factor associated with a positive test of meconium, according to the researchers.
“Some studies have shown cannabis use in the second trimester can show up in meconium testing even if the mother has stopped that behavior,” Dr. Heiselman said. “Then there is also cross-reactivity with other substances that can lead to higher false positive results, especially in the urine toxicology.”
The reasons for the discordant results are not clear and vary by substance, Dr. Heiselman said.
“Cannabis and methadone were the significant factors leading to discordance with positive newborn meconium, which may reflect prior use earlier in pregnancy without recent use before delivery,” she said in an interview. “Urine and meconium reflect potentially different timing in perinatal exposure and the potential differences in windows of detection for different substances. Therefore, we would expect some discordance in our comparisons, just not the extent that we saw.”
Some test results might also have been false positives. Many commonly used medications, from cough syrups to proton pump inhibitors, have the potential to generate positive results for illicit drugs, Dr. Heiselman said.
“The issue of discordance is a complex one, where there are limitations of the tests being performed, possible cross-reactivity with false positives, and the difference in what test reflects as far as timing of prenatal exposure. Furthermore, a negative test does not rule out sporadic use, nor does a positive result diagnose substance use disorder or its severity,” she said.
Lack of standards
Dr. Heiselman said states and the federal government lack standards to biochemically evaluate women at risk for drug abuse and their newborns.
“My institution uses a risk-based protocol. Basically, we test cases where we have a known history of substance use disorder or active use, a history in the last 3 years of any kind of substance use, initiation of late prenatal care after 20 weeks, or no prenatal care at all,” she said. “And then the pediatricians on the other side will test neonates if the mother has any of that history or if the neonates themselves have unexplained complications or drug withdrawal symptoms.”
High rates of discordance can result in the inappropriate intervention by childcare protective service agencies when the mother may not have a substance use disorder, she noted.
Perinatologist Kecia Gaither, MD, MPH, associate professor of clinical obstetrics and gynecology at Weill Cornell Medicine, New York, called the findings “no surprise,” but added that negative findings in neonates “do not exclude the possibility of substance abuse by the mother. It is important to recognize the limitations inherent with screening tests for illicit substances in neonates from substance-abusing mothers.”
Dr. Heiselman added that understanding what maternal and infant drug tests truly reflect “can help us as clinicians in deciding when we test, whether it’s medically necessary, instead of just thinking biochemical tests are the best screening tool, because we know that we are screening. We must engage these women in empathetic and nonjudgmental discussions, which often will elucidate a substance use disorder history more so than just biochemical testing, negative or positive.”
The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study finding that samples from maternal urine and the meconium of their newborn babies frequently produce different results is raising more questions about drug testing of pregnant women.
The study found concerningly high rates of disagreement (or “discordance”) in biochemical testing between maternal urine in women with a documented history of or active drug use and the meconium in their newborns. In some cases, such discordance might be triggering the inappropriate intervention of childcare protective services, including the separation of infants from their mothers, according to the researchers, who presented their findings Feb. 4 at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“There’s a very big debate right now in the obstetrics and perinatology communities about the utility of biochemical testing and the identification of high-risk women,” lead author Cassandra Heiselman, DO, MPH, clinical assistant professor in the department of obstetrics, gynecology and reproductive medicine at Stony Brook (N.Y.) University, said in an interview. “We know that each biochemical test has limitations, which can include basically the inability to detect all substances, especially synthetic opioids like fentanyl, [and] the possibility for false results.”
Inaccuracies in testing can potentially result in inappropriate separation of mother and baby. “Careful scrutiny of results is needed,” Dr. Heiselman said.
The Stony Brook team conducted a retrospective cohort study that identified women presenting for delivery from January 2017 to March 2021 with indications for drug testing, including a known history of or current substance use disorder/misuse, and late or no prenatal care. A standardized panel was used for testing maternal urine and newborn meconium.
Urine tests of 327 women resulted in 187 (57%) positive and 98 (30%) negative results, along with 42 (13%) samples with incomplete data, the researchers reported. In contrast, drug testing of newborn meconium was positive in 273 (83%) cases, negative in 42 (13%), and was not performed in 12 (4%) – for a rate of concordance of 41%.
Concordance of urine/meconium occurred more frequently in male newborns (65%), compared with females (35%). “It is unclear biologically why there is such a difference based on the sex of the infants’ test and is an area that needs further investigation,” Dr. Heiselman said.
Comparing urine and meconium tests for 11 substances resulted in 195/483 (40%) concordance, the researchers said; 18% were discordant with positive maternal urine, and 41% were discordant with newborn positive meconium.
Oxycodone and fentanyl were significantly discordant with positive maternal urine. Cannabis use was the most common factor associated with a positive test of meconium, according to the researchers.
“Some studies have shown cannabis use in the second trimester can show up in meconium testing even if the mother has stopped that behavior,” Dr. Heiselman said. “Then there is also cross-reactivity with other substances that can lead to higher false positive results, especially in the urine toxicology.”
The reasons for the discordant results are not clear and vary by substance, Dr. Heiselman said.
“Cannabis and methadone were the significant factors leading to discordance with positive newborn meconium, which may reflect prior use earlier in pregnancy without recent use before delivery,” she said in an interview. “Urine and meconium reflect potentially different timing in perinatal exposure and the potential differences in windows of detection for different substances. Therefore, we would expect some discordance in our comparisons, just not the extent that we saw.”
Some test results might also have been false positives. Many commonly used medications, from cough syrups to proton pump inhibitors, have the potential to generate positive results for illicit drugs, Dr. Heiselman said.
“The issue of discordance is a complex one, where there are limitations of the tests being performed, possible cross-reactivity with false positives, and the difference in what test reflects as far as timing of prenatal exposure. Furthermore, a negative test does not rule out sporadic use, nor does a positive result diagnose substance use disorder or its severity,” she said.
Lack of standards
Dr. Heiselman said states and the federal government lack standards to biochemically evaluate women at risk for drug abuse and their newborns.
“My institution uses a risk-based protocol. Basically, we test cases where we have a known history of substance use disorder or active use, a history in the last 3 years of any kind of substance use, initiation of late prenatal care after 20 weeks, or no prenatal care at all,” she said. “And then the pediatricians on the other side will test neonates if the mother has any of that history or if the neonates themselves have unexplained complications or drug withdrawal symptoms.”
High rates of discordance can result in the inappropriate intervention by childcare protective service agencies when the mother may not have a substance use disorder, she noted.
Perinatologist Kecia Gaither, MD, MPH, associate professor of clinical obstetrics and gynecology at Weill Cornell Medicine, New York, called the findings “no surprise,” but added that negative findings in neonates “do not exclude the possibility of substance abuse by the mother. It is important to recognize the limitations inherent with screening tests for illicit substances in neonates from substance-abusing mothers.”
Dr. Heiselman added that understanding what maternal and infant drug tests truly reflect “can help us as clinicians in deciding when we test, whether it’s medically necessary, instead of just thinking biochemical tests are the best screening tool, because we know that we are screening. We must engage these women in empathetic and nonjudgmental discussions, which often will elucidate a substance use disorder history more so than just biochemical testing, negative or positive.”
The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study finding that samples from maternal urine and the meconium of their newborn babies frequently produce different results is raising more questions about drug testing of pregnant women.
The study found concerningly high rates of disagreement (or “discordance”) in biochemical testing between maternal urine in women with a documented history of or active drug use and the meconium in their newborns. In some cases, such discordance might be triggering the inappropriate intervention of childcare protective services, including the separation of infants from their mothers, according to the researchers, who presented their findings Feb. 4 at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“There’s a very big debate right now in the obstetrics and perinatology communities about the utility of biochemical testing and the identification of high-risk women,” lead author Cassandra Heiselman, DO, MPH, clinical assistant professor in the department of obstetrics, gynecology and reproductive medicine at Stony Brook (N.Y.) University, said in an interview. “We know that each biochemical test has limitations, which can include basically the inability to detect all substances, especially synthetic opioids like fentanyl, [and] the possibility for false results.”
Inaccuracies in testing can potentially result in inappropriate separation of mother and baby. “Careful scrutiny of results is needed,” Dr. Heiselman said.
The Stony Brook team conducted a retrospective cohort study that identified women presenting for delivery from January 2017 to March 2021 with indications for drug testing, including a known history of or current substance use disorder/misuse, and late or no prenatal care. A standardized panel was used for testing maternal urine and newborn meconium.
Urine tests of 327 women resulted in 187 (57%) positive and 98 (30%) negative results, along with 42 (13%) samples with incomplete data, the researchers reported. In contrast, drug testing of newborn meconium was positive in 273 (83%) cases, negative in 42 (13%), and was not performed in 12 (4%) – for a rate of concordance of 41%.
Concordance of urine/meconium occurred more frequently in male newborns (65%), compared with females (35%). “It is unclear biologically why there is such a difference based on the sex of the infants’ test and is an area that needs further investigation,” Dr. Heiselman said.
Comparing urine and meconium tests for 11 substances resulted in 195/483 (40%) concordance, the researchers said; 18% were discordant with positive maternal urine, and 41% were discordant with newborn positive meconium.
Oxycodone and fentanyl were significantly discordant with positive maternal urine. Cannabis use was the most common factor associated with a positive test of meconium, according to the researchers.
“Some studies have shown cannabis use in the second trimester can show up in meconium testing even if the mother has stopped that behavior,” Dr. Heiselman said. “Then there is also cross-reactivity with other substances that can lead to higher false positive results, especially in the urine toxicology.”
The reasons for the discordant results are not clear and vary by substance, Dr. Heiselman said.
“Cannabis and methadone were the significant factors leading to discordance with positive newborn meconium, which may reflect prior use earlier in pregnancy without recent use before delivery,” she said in an interview. “Urine and meconium reflect potentially different timing in perinatal exposure and the potential differences in windows of detection for different substances. Therefore, we would expect some discordance in our comparisons, just not the extent that we saw.”
Some test results might also have been false positives. Many commonly used medications, from cough syrups to proton pump inhibitors, have the potential to generate positive results for illicit drugs, Dr. Heiselman said.
“The issue of discordance is a complex one, where there are limitations of the tests being performed, possible cross-reactivity with false positives, and the difference in what test reflects as far as timing of prenatal exposure. Furthermore, a negative test does not rule out sporadic use, nor does a positive result diagnose substance use disorder or its severity,” she said.
Lack of standards
Dr. Heiselman said states and the federal government lack standards to biochemically evaluate women at risk for drug abuse and their newborns.
“My institution uses a risk-based protocol. Basically, we test cases where we have a known history of substance use disorder or active use, a history in the last 3 years of any kind of substance use, initiation of late prenatal care after 20 weeks, or no prenatal care at all,” she said. “And then the pediatricians on the other side will test neonates if the mother has any of that history or if the neonates themselves have unexplained complications or drug withdrawal symptoms.”
High rates of discordance can result in the inappropriate intervention by childcare protective service agencies when the mother may not have a substance use disorder, she noted.
Perinatologist Kecia Gaither, MD, MPH, associate professor of clinical obstetrics and gynecology at Weill Cornell Medicine, New York, called the findings “no surprise,” but added that negative findings in neonates “do not exclude the possibility of substance abuse by the mother. It is important to recognize the limitations inherent with screening tests for illicit substances in neonates from substance-abusing mothers.”
Dr. Heiselman added that understanding what maternal and infant drug tests truly reflect “can help us as clinicians in deciding when we test, whether it’s medically necessary, instead of just thinking biochemical tests are the best screening tool, because we know that we are screening. We must engage these women in empathetic and nonjudgmental discussions, which often will elucidate a substance use disorder history more so than just biochemical testing, negative or positive.”
The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE PREGNANCY MEETING
Routine vaginal cleansing seen ineffective for unscheduled cesareans
Vaginal cleansing showed no reduction in morbidity when performed before unscheduled cesarean deliveries, researchers reported at the 2022 Pregnancy Meeting of the Society for Maternal-Fetal Medicine.
Several studies have evaluated vaginal cleansing prior to cesarean delivery, with mixed results. The American College of Obstetricians and Gynecologists recommends clinicians consider cleansing prior to unscheduled cesareans, but that advice appears not to be widely heeded.
The new findings, from what the researchers called the single largest study of vaginal cleansing prior to cesarean delivery in the United States, showed no difference in post-cesarean infections when the vagina was cleansed with povidone-iodine prior to unscheduled cesarean delivery.
“These findings do not support routine vaginal cleansing prior to unscheduled cesarean deliveries,” lead author Lorene Atkins Temming, MD, medical director of labor and delivery at Atrium Health Wake Forest School of Medicine, Charlotte, North Carolina, told this news organization. The research was conducted at and sponsored by Washington University School of Medicine, St. Louis, where Dr. Temming did her fellowship.
Dr. Temming’s group compared vaginal cleansing with povidone-iodine in addition to routine abdominal cleansing to abdominal cleansing alone. Among the primary outcomes of the study was the effect of cleansing on post-cesarean infectious morbidity.
“There is a higher risk of infectious complications after cesarean delivery than other gynecologic surgeries,” Dr. Temming told this news organization. “While the reason for this isn’t entirely clear, it is thought to be because cesareans are often performed after a patient’s cervix is dilated. This dilation can allow normal bacteria that live in the vagina to ascend into the uterus and can increase the risk of infections.”
Patients undergoing cesarean delivery after labor were randomly assigned to undergo preoperative abdominal cleansing only (n = 304) or preoperative abdominal cleansing plus vaginal cleansing with povidone-iodine (n = 304). Women were included in the analysis if they underwent cesareans after regular contractions and any cervical dilation, if their membranes ruptured, or if they had the procedure performed when they were more than 4 cm dilated.
The primary outcome was composite infectious morbidity, a catchall that included surgical-site infection, maternal fever, endometritis, and wound complications within 30 days after cesarean delivery. The secondary outcomes were hospital readmission, visits to the emergency department, and treatment for neonatal sepsis.
The researchers observed no significant difference in the primary composite outcome between the two groups (11.7% vs. 11.7%, P = .98; 95% confidence interval, 0.6-1.5). “Vaginal cleansing appears to be unnecessary when preoperative antibiotics and skin antisepsis are performed,” Dr. Temming said.
Jennifer L. Lew, MD, an ob/gyn at Northwestern Medicine Kishwaukee Hospital in Dekalb, Illinois, said current practice regarding preparation for unscheduled cesarean surgery includes chlorhexidine on the abdomen and povidone-iodine for introducing a Foley catheter into the urethra.
“Many patients may already have a catheter in place due to labor and epidural, so they would not need” vaginal prep, Dr. Lew said. “Currently, the standard does not require doing a vaginal prep for any cesarean sections, those in labor or not.”
The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Vaginal cleansing showed no reduction in morbidity when performed before unscheduled cesarean deliveries, researchers reported at the 2022 Pregnancy Meeting of the Society for Maternal-Fetal Medicine.
Several studies have evaluated vaginal cleansing prior to cesarean delivery, with mixed results. The American College of Obstetricians and Gynecologists recommends clinicians consider cleansing prior to unscheduled cesareans, but that advice appears not to be widely heeded.
The new findings, from what the researchers called the single largest study of vaginal cleansing prior to cesarean delivery in the United States, showed no difference in post-cesarean infections when the vagina was cleansed with povidone-iodine prior to unscheduled cesarean delivery.
“These findings do not support routine vaginal cleansing prior to unscheduled cesarean deliveries,” lead author Lorene Atkins Temming, MD, medical director of labor and delivery at Atrium Health Wake Forest School of Medicine, Charlotte, North Carolina, told this news organization. The research was conducted at and sponsored by Washington University School of Medicine, St. Louis, where Dr. Temming did her fellowship.
Dr. Temming’s group compared vaginal cleansing with povidone-iodine in addition to routine abdominal cleansing to abdominal cleansing alone. Among the primary outcomes of the study was the effect of cleansing on post-cesarean infectious morbidity.
“There is a higher risk of infectious complications after cesarean delivery than other gynecologic surgeries,” Dr. Temming told this news organization. “While the reason for this isn’t entirely clear, it is thought to be because cesareans are often performed after a patient’s cervix is dilated. This dilation can allow normal bacteria that live in the vagina to ascend into the uterus and can increase the risk of infections.”
Patients undergoing cesarean delivery after labor were randomly assigned to undergo preoperative abdominal cleansing only (n = 304) or preoperative abdominal cleansing plus vaginal cleansing with povidone-iodine (n = 304). Women were included in the analysis if they underwent cesareans after regular contractions and any cervical dilation, if their membranes ruptured, or if they had the procedure performed when they were more than 4 cm dilated.
The primary outcome was composite infectious morbidity, a catchall that included surgical-site infection, maternal fever, endometritis, and wound complications within 30 days after cesarean delivery. The secondary outcomes were hospital readmission, visits to the emergency department, and treatment for neonatal sepsis.
The researchers observed no significant difference in the primary composite outcome between the two groups (11.7% vs. 11.7%, P = .98; 95% confidence interval, 0.6-1.5). “Vaginal cleansing appears to be unnecessary when preoperative antibiotics and skin antisepsis are performed,” Dr. Temming said.
Jennifer L. Lew, MD, an ob/gyn at Northwestern Medicine Kishwaukee Hospital in Dekalb, Illinois, said current practice regarding preparation for unscheduled cesarean surgery includes chlorhexidine on the abdomen and povidone-iodine for introducing a Foley catheter into the urethra.
“Many patients may already have a catheter in place due to labor and epidural, so they would not need” vaginal prep, Dr. Lew said. “Currently, the standard does not require doing a vaginal prep for any cesarean sections, those in labor or not.”
The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Vaginal cleansing showed no reduction in morbidity when performed before unscheduled cesarean deliveries, researchers reported at the 2022 Pregnancy Meeting of the Society for Maternal-Fetal Medicine.
Several studies have evaluated vaginal cleansing prior to cesarean delivery, with mixed results. The American College of Obstetricians and Gynecologists recommends clinicians consider cleansing prior to unscheduled cesareans, but that advice appears not to be widely heeded.
The new findings, from what the researchers called the single largest study of vaginal cleansing prior to cesarean delivery in the United States, showed no difference in post-cesarean infections when the vagina was cleansed with povidone-iodine prior to unscheduled cesarean delivery.
“These findings do not support routine vaginal cleansing prior to unscheduled cesarean deliveries,” lead author Lorene Atkins Temming, MD, medical director of labor and delivery at Atrium Health Wake Forest School of Medicine, Charlotte, North Carolina, told this news organization. The research was conducted at and sponsored by Washington University School of Medicine, St. Louis, where Dr. Temming did her fellowship.
Dr. Temming’s group compared vaginal cleansing with povidone-iodine in addition to routine abdominal cleansing to abdominal cleansing alone. Among the primary outcomes of the study was the effect of cleansing on post-cesarean infectious morbidity.
“There is a higher risk of infectious complications after cesarean delivery than other gynecologic surgeries,” Dr. Temming told this news organization. “While the reason for this isn’t entirely clear, it is thought to be because cesareans are often performed after a patient’s cervix is dilated. This dilation can allow normal bacteria that live in the vagina to ascend into the uterus and can increase the risk of infections.”
Patients undergoing cesarean delivery after labor were randomly assigned to undergo preoperative abdominal cleansing only (n = 304) or preoperative abdominal cleansing plus vaginal cleansing with povidone-iodine (n = 304). Women were included in the analysis if they underwent cesareans after regular contractions and any cervical dilation, if their membranes ruptured, or if they had the procedure performed when they were more than 4 cm dilated.
The primary outcome was composite infectious morbidity, a catchall that included surgical-site infection, maternal fever, endometritis, and wound complications within 30 days after cesarean delivery. The secondary outcomes were hospital readmission, visits to the emergency department, and treatment for neonatal sepsis.
The researchers observed no significant difference in the primary composite outcome between the two groups (11.7% vs. 11.7%, P = .98; 95% confidence interval, 0.6-1.5). “Vaginal cleansing appears to be unnecessary when preoperative antibiotics and skin antisepsis are performed,” Dr. Temming said.
Jennifer L. Lew, MD, an ob/gyn at Northwestern Medicine Kishwaukee Hospital in Dekalb, Illinois, said current practice regarding preparation for unscheduled cesarean surgery includes chlorhexidine on the abdomen and povidone-iodine for introducing a Foley catheter into the urethra.
“Many patients may already have a catheter in place due to labor and epidural, so they would not need” vaginal prep, Dr. Lew said. “Currently, the standard does not require doing a vaginal prep for any cesarean sections, those in labor or not.”
The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Negative home COVID test no ‘free pass’ for kids, study finds
With the country looking increasingly to rapid testing as an off-ramp from the COVID-19 pandemic, a new study shows that the performance of the tests in children falls below standards set by regulatory agencies in the United States and elsewhere for diagnostic accuracy.
Experts said the findings, from a meta-analysis by researchers in the United Kingdom and Germany, underscore that, while a positive result on a rapid test is almost certainly an indicator of infection, negative results often are unreliable and can lead to a false sense of security.
“Real-life performance of current antigen tests for professional use in pediatric populations is below the minimum performance criteria set by WHO, the United States Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency (U.K.),” according to Naomi Fujita-Rohwerder, PhD, a research associate at the Cologne-based German Institute for Quality and Efficiency in Health Care (IQWiG), and her colleagues, whose study appears in BMJ Evidence-Based Medicine.
The researchers said that the study suggests that performance of rapid testing in a pediatric population is comparable to that in adults. However, they said they could not identify any studies investigating self-testing in children, which also could affect test performance.
Egon Ozer, MD, PhD, director of the center for pathogen genomics and microbial evolution at Northwestern University in Chicago, said the finding that specificity was high but sensitivity was middling “suggests that we should be very careful about interpreting negative antigen test results in children and recognize that there is a fair amount of uncertainty in the tests in this situation.”
Researchers from IQWiG, which examines the advantages and disadvantages of medical interventions, and the University of Manchester (England), conducted the systematic review and meta-analysis, which they described as the first of its kind to evaluate the diagnostic accuracy of rapid point-of-care tests for current SARS-CoV-2 infections in children.
They compiled information from 17 studies with a total 6,355 participants. They compared all antigen tests to reverse-transcription polymerase chain reaction (PCR). The studies compared eight antigen tests from six different brands. The rapid antigen tests, available from pharmacies and online stores, are widely used for self-testing in schools and testing toddlers before kindergarten.
The pooled diagnostic sensitivity of antigen tests was 64.2% and specificity was 99.1%.
Dr. Ozer noted that the analysis “was not able to address important outstanding questions such as the likelihood of transmitting infection with a false-negative antigen test versus a true-negative antigen test or how much repeated testing can increase the sensitivity.”
“In Europe, we don’t know how most tests perform in real life,” Dr. Fujita-Rohwerder said. “And even in countries like the United States, where market access is more stringent, we don’t know whether self-testing performed by children or sample collection in toddlers by laypersons has a significant impact on the diagnostic accuracy. Also, diagnostic accuracy estimates reported in our study may not apply to the current omicron or future variants of SARS-CoV-2 or vaccinated children. Hopefully, these essential gaps in the evidence will get addressed soon.”
Dr. Ozer said one takeaway from this study is negative antigen tests should not be considered a “free pass” in children, especially if the child is symptomatic, has been recently exposed to COVID-19, or is planning to spend time with individuals with conditions that place them at high risk for complications of COVID-19 infection. “In such cases, consider getting PCR testing or at least performing a repeat antigen test 36-48 hours after the first negative,” he said.
Dr. Fujita-Rohwerder said the low diagnostic sensitivity may affect the use of the tests. The gaps in evidence her group found in their study point to research needed to support evidence-based decision-making. “In particular, evidence is needed on real-life performance of tests in schools, self-testing performed by children, and kindergarten, [particularly] sample collection in toddlers by laypersons,” she said.
However, she stressed, testing is only a single measure. “Effectively reducing the spread of SARS-CoV-2 during the current pandemic requires multilayered mitigation measures,” she said. “Rapid testing represents one single layer. It can have its use at the population level, even though the sensitivity of antigen tests is lower than expected. However, antigen-based rapid testing is not a magic bullet: If your kid tests negative, do not disregard other mitigation measures.”
Edward Campbell, PhD, a virologist at Loyola University of Chicago, who serves on the board of LaGrange Elementary School District 102 outside Chicago, said the findings were unsurprising.
“This study generally looks consistent with what is known for adults. These rapid antigen tests are less sensitive than other tests,” said Dr. Campbell, who also runs a testing company for private schools in the Chicago area using reverse transcription-loop-mediated isothermal amplification technology. Even so, he said, “These tests are still effective at identifying people who are infectious to some degree. Never miss an opportunity to test.”
Dr. Fujita-Rohwerder disclosed no relevant financial conflicts of interest. Dr. Campbell owns Safeguard Surveillance.
With the country looking increasingly to rapid testing as an off-ramp from the COVID-19 pandemic, a new study shows that the performance of the tests in children falls below standards set by regulatory agencies in the United States and elsewhere for diagnostic accuracy.
Experts said the findings, from a meta-analysis by researchers in the United Kingdom and Germany, underscore that, while a positive result on a rapid test is almost certainly an indicator of infection, negative results often are unreliable and can lead to a false sense of security.
“Real-life performance of current antigen tests for professional use in pediatric populations is below the minimum performance criteria set by WHO, the United States Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency (U.K.),” according to Naomi Fujita-Rohwerder, PhD, a research associate at the Cologne-based German Institute for Quality and Efficiency in Health Care (IQWiG), and her colleagues, whose study appears in BMJ Evidence-Based Medicine.
The researchers said that the study suggests that performance of rapid testing in a pediatric population is comparable to that in adults. However, they said they could not identify any studies investigating self-testing in children, which also could affect test performance.
Egon Ozer, MD, PhD, director of the center for pathogen genomics and microbial evolution at Northwestern University in Chicago, said the finding that specificity was high but sensitivity was middling “suggests that we should be very careful about interpreting negative antigen test results in children and recognize that there is a fair amount of uncertainty in the tests in this situation.”
Researchers from IQWiG, which examines the advantages and disadvantages of medical interventions, and the University of Manchester (England), conducted the systematic review and meta-analysis, which they described as the first of its kind to evaluate the diagnostic accuracy of rapid point-of-care tests for current SARS-CoV-2 infections in children.
They compiled information from 17 studies with a total 6,355 participants. They compared all antigen tests to reverse-transcription polymerase chain reaction (PCR). The studies compared eight antigen tests from six different brands. The rapid antigen tests, available from pharmacies and online stores, are widely used for self-testing in schools and testing toddlers before kindergarten.
The pooled diagnostic sensitivity of antigen tests was 64.2% and specificity was 99.1%.
Dr. Ozer noted that the analysis “was not able to address important outstanding questions such as the likelihood of transmitting infection with a false-negative antigen test versus a true-negative antigen test or how much repeated testing can increase the sensitivity.”
“In Europe, we don’t know how most tests perform in real life,” Dr. Fujita-Rohwerder said. “And even in countries like the United States, where market access is more stringent, we don’t know whether self-testing performed by children or sample collection in toddlers by laypersons has a significant impact on the diagnostic accuracy. Also, diagnostic accuracy estimates reported in our study may not apply to the current omicron or future variants of SARS-CoV-2 or vaccinated children. Hopefully, these essential gaps in the evidence will get addressed soon.”
Dr. Ozer said one takeaway from this study is negative antigen tests should not be considered a “free pass” in children, especially if the child is symptomatic, has been recently exposed to COVID-19, or is planning to spend time with individuals with conditions that place them at high risk for complications of COVID-19 infection. “In such cases, consider getting PCR testing or at least performing a repeat antigen test 36-48 hours after the first negative,” he said.
Dr. Fujita-Rohwerder said the low diagnostic sensitivity may affect the use of the tests. The gaps in evidence her group found in their study point to research needed to support evidence-based decision-making. “In particular, evidence is needed on real-life performance of tests in schools, self-testing performed by children, and kindergarten, [particularly] sample collection in toddlers by laypersons,” she said.
However, she stressed, testing is only a single measure. “Effectively reducing the spread of SARS-CoV-2 during the current pandemic requires multilayered mitigation measures,” she said. “Rapid testing represents one single layer. It can have its use at the population level, even though the sensitivity of antigen tests is lower than expected. However, antigen-based rapid testing is not a magic bullet: If your kid tests negative, do not disregard other mitigation measures.”
Edward Campbell, PhD, a virologist at Loyola University of Chicago, who serves on the board of LaGrange Elementary School District 102 outside Chicago, said the findings were unsurprising.
“This study generally looks consistent with what is known for adults. These rapid antigen tests are less sensitive than other tests,” said Dr. Campbell, who also runs a testing company for private schools in the Chicago area using reverse transcription-loop-mediated isothermal amplification technology. Even so, he said, “These tests are still effective at identifying people who are infectious to some degree. Never miss an opportunity to test.”
Dr. Fujita-Rohwerder disclosed no relevant financial conflicts of interest. Dr. Campbell owns Safeguard Surveillance.
With the country looking increasingly to rapid testing as an off-ramp from the COVID-19 pandemic, a new study shows that the performance of the tests in children falls below standards set by regulatory agencies in the United States and elsewhere for diagnostic accuracy.
Experts said the findings, from a meta-analysis by researchers in the United Kingdom and Germany, underscore that, while a positive result on a rapid test is almost certainly an indicator of infection, negative results often are unreliable and can lead to a false sense of security.
“Real-life performance of current antigen tests for professional use in pediatric populations is below the minimum performance criteria set by WHO, the United States Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency (U.K.),” according to Naomi Fujita-Rohwerder, PhD, a research associate at the Cologne-based German Institute for Quality and Efficiency in Health Care (IQWiG), and her colleagues, whose study appears in BMJ Evidence-Based Medicine.
The researchers said that the study suggests that performance of rapid testing in a pediatric population is comparable to that in adults. However, they said they could not identify any studies investigating self-testing in children, which also could affect test performance.
Egon Ozer, MD, PhD, director of the center for pathogen genomics and microbial evolution at Northwestern University in Chicago, said the finding that specificity was high but sensitivity was middling “suggests that we should be very careful about interpreting negative antigen test results in children and recognize that there is a fair amount of uncertainty in the tests in this situation.”
Researchers from IQWiG, which examines the advantages and disadvantages of medical interventions, and the University of Manchester (England), conducted the systematic review and meta-analysis, which they described as the first of its kind to evaluate the diagnostic accuracy of rapid point-of-care tests for current SARS-CoV-2 infections in children.
They compiled information from 17 studies with a total 6,355 participants. They compared all antigen tests to reverse-transcription polymerase chain reaction (PCR). The studies compared eight antigen tests from six different brands. The rapid antigen tests, available from pharmacies and online stores, are widely used for self-testing in schools and testing toddlers before kindergarten.
The pooled diagnostic sensitivity of antigen tests was 64.2% and specificity was 99.1%.
Dr. Ozer noted that the analysis “was not able to address important outstanding questions such as the likelihood of transmitting infection with a false-negative antigen test versus a true-negative antigen test or how much repeated testing can increase the sensitivity.”
“In Europe, we don’t know how most tests perform in real life,” Dr. Fujita-Rohwerder said. “And even in countries like the United States, where market access is more stringent, we don’t know whether self-testing performed by children or sample collection in toddlers by laypersons has a significant impact on the diagnostic accuracy. Also, diagnostic accuracy estimates reported in our study may not apply to the current omicron or future variants of SARS-CoV-2 or vaccinated children. Hopefully, these essential gaps in the evidence will get addressed soon.”
Dr. Ozer said one takeaway from this study is negative antigen tests should not be considered a “free pass” in children, especially if the child is symptomatic, has been recently exposed to COVID-19, or is planning to spend time with individuals with conditions that place them at high risk for complications of COVID-19 infection. “In such cases, consider getting PCR testing or at least performing a repeat antigen test 36-48 hours after the first negative,” he said.
Dr. Fujita-Rohwerder said the low diagnostic sensitivity may affect the use of the tests. The gaps in evidence her group found in their study point to research needed to support evidence-based decision-making. “In particular, evidence is needed on real-life performance of tests in schools, self-testing performed by children, and kindergarten, [particularly] sample collection in toddlers by laypersons,” she said.
However, she stressed, testing is only a single measure. “Effectively reducing the spread of SARS-CoV-2 during the current pandemic requires multilayered mitigation measures,” she said. “Rapid testing represents one single layer. It can have its use at the population level, even though the sensitivity of antigen tests is lower than expected. However, antigen-based rapid testing is not a magic bullet: If your kid tests negative, do not disregard other mitigation measures.”
Edward Campbell, PhD, a virologist at Loyola University of Chicago, who serves on the board of LaGrange Elementary School District 102 outside Chicago, said the findings were unsurprising.
“This study generally looks consistent with what is known for adults. These rapid antigen tests are less sensitive than other tests,” said Dr. Campbell, who also runs a testing company for private schools in the Chicago area using reverse transcription-loop-mediated isothermal amplification technology. Even so, he said, “These tests are still effective at identifying people who are infectious to some degree. Never miss an opportunity to test.”
Dr. Fujita-Rohwerder disclosed no relevant financial conflicts of interest. Dr. Campbell owns Safeguard Surveillance.
BMJ EVIDENCE-BASED MEDICINE