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Premenopausal women benefit from ovarian conservation with benign hysterectomies
Although bilateral salpingo-oophorectomy (BSO) with hysterectomy has been shown to reduce the risk for ovarian cancer in women at increased risk, current guidelines are touting ovarian conservation, especially in premenopausal women, wrote Mathilde Gottschau, MD, of the Danish Cancer Society Research Center, Copenhagen, and colleagues. However, post-hysterectomy outcomes in women with and without BSO have not been well examined.
In a study published in the Annals of Internal Medicine, the researchers reviewed data from a nationwide registry of women in Denmark aged 20 years and older who underwent benign hysterectomies with BSO (22,974 women) and without BSO (120,011 women) between 1977 and 2017. The women were divided into subgroups based on age; those younger than 45 years were defined as premenopausal, those aged 45-54 years were defined as perimenopausal, those aged 55-64 were defined as early postmenopausal, and those aged 65 and older were defined as late menopausal.
The primary outcomes were hospitalization for cardiovascular disease, cancer incidence, and all-cause mortality over a median follow-up period of 22 years.
For women younger than 45 years, the 10-year cumulative risk for all cancer was lower with BSO than without, but the risk of overall cardiovascular disease was higher with BSO, with higher levels of ischemic heart disease and stroke, compared with women without BSO. The 10-year cumulative mortality was higher with BSO than without (2.16% vs. 1.94%).
For women aged 45-54 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO (risk difference, 0.73 percentage points) associated mainly with nonbreast cancer, and both 10-year and 20-year mortality were higher in those with BSO than those without.
For women aged 55-65 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO. Cumulative overall mortality was higher at 10 years for those with BSO, but lower at 20 years.
For women aged 65 years and older, both 10-year and 20-year cumulative overall cancer risk was higher with BSO than without (RD, 2.54 and 4.57 percentage points, respectively). Cumulative mortality was higher in the BSO group at 10 years, but lower at 20 years.
The study findings were limited by several factors including the use of age to determine menopausal status and the lack of genetic predisposition data, and the focus only on a relatively homogeneous population that may not be generalizable to other populations, the researchers noted.
However, the results were strengthened by the use of a nationwide registry and the long-term follow-up period, they said. The current study indicates that the health risks outweigh the potential benefits of BSO with benign hysterectomy for premenopausal women and supports the current guidelines for ovarian conservation in these women with low lifetime ovarian cancer risk, they said. For postmenopausal women, the data support a cautious approach to BSO given the lack of a clear survival benefit and cancer excess, they concluded.
Delayed diagnosis of ovarian cancers favors BSO
“The question of removing ovaries at the time of benign hysterectomy to prevent ovarian cancer in low-risk women has been widely debated,” which has contributed to the variation in incidence rates of unilateral and bilateral oophorectomy over time, wrote Elizabeth Casiano Evans, MD, of the University of Texas, San Antonio, and Deslyn T.G. Hobson, MD, of Wayne State University, Detroit, in an accompanying editorial.
Ovarian cancer often goes undiagnosed until an advanced stage, and BSO can significantly reduce risk in women with BRCA1 and BRCA2 mutations, they noted.
For women without increased risk, those who are premenopausal may wish to preserve ovarian function, but women also may benefit from improvements in a range of menopause-related symptoms including vasomotor and urogenital symptoms, sexual dysfunction, and psychiatric and cognitive symptoms, they said.
“In addition, salpingectomy alone has a role in significantly reducing ovarian cancer incidence without compromising ovarian function because the fallopian tube has been found to be at the origin of many ovarian cancer cases,” they noted. In the current study, “the crude ovarian cancer risk was lower with BSO” across all age groups, the editorialists said.
The choice of whether to include BSO at the time of benign hysterectomy is complicated, with many factors to consider, the editorialists wrote, and the current study supports the need for informed, shared decision-making between clinicians and patients.
The study was supported by the Danish Cancer Society’s Scientific Committee and the Mermaid Project. The researchers had no financial conflicts to disclose. The editorial authors had no financial conflicts to disclose.
Although bilateral salpingo-oophorectomy (BSO) with hysterectomy has been shown to reduce the risk for ovarian cancer in women at increased risk, current guidelines are touting ovarian conservation, especially in premenopausal women, wrote Mathilde Gottschau, MD, of the Danish Cancer Society Research Center, Copenhagen, and colleagues. However, post-hysterectomy outcomes in women with and without BSO have not been well examined.
In a study published in the Annals of Internal Medicine, the researchers reviewed data from a nationwide registry of women in Denmark aged 20 years and older who underwent benign hysterectomies with BSO (22,974 women) and without BSO (120,011 women) between 1977 and 2017. The women were divided into subgroups based on age; those younger than 45 years were defined as premenopausal, those aged 45-54 years were defined as perimenopausal, those aged 55-64 were defined as early postmenopausal, and those aged 65 and older were defined as late menopausal.
The primary outcomes were hospitalization for cardiovascular disease, cancer incidence, and all-cause mortality over a median follow-up period of 22 years.
For women younger than 45 years, the 10-year cumulative risk for all cancer was lower with BSO than without, but the risk of overall cardiovascular disease was higher with BSO, with higher levels of ischemic heart disease and stroke, compared with women without BSO. The 10-year cumulative mortality was higher with BSO than without (2.16% vs. 1.94%).
For women aged 45-54 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO (risk difference, 0.73 percentage points) associated mainly with nonbreast cancer, and both 10-year and 20-year mortality were higher in those with BSO than those without.
For women aged 55-65 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO. Cumulative overall mortality was higher at 10 years for those with BSO, but lower at 20 years.
For women aged 65 years and older, both 10-year and 20-year cumulative overall cancer risk was higher with BSO than without (RD, 2.54 and 4.57 percentage points, respectively). Cumulative mortality was higher in the BSO group at 10 years, but lower at 20 years.
The study findings were limited by several factors including the use of age to determine menopausal status and the lack of genetic predisposition data, and the focus only on a relatively homogeneous population that may not be generalizable to other populations, the researchers noted.
However, the results were strengthened by the use of a nationwide registry and the long-term follow-up period, they said. The current study indicates that the health risks outweigh the potential benefits of BSO with benign hysterectomy for premenopausal women and supports the current guidelines for ovarian conservation in these women with low lifetime ovarian cancer risk, they said. For postmenopausal women, the data support a cautious approach to BSO given the lack of a clear survival benefit and cancer excess, they concluded.
Delayed diagnosis of ovarian cancers favors BSO
“The question of removing ovaries at the time of benign hysterectomy to prevent ovarian cancer in low-risk women has been widely debated,” which has contributed to the variation in incidence rates of unilateral and bilateral oophorectomy over time, wrote Elizabeth Casiano Evans, MD, of the University of Texas, San Antonio, and Deslyn T.G. Hobson, MD, of Wayne State University, Detroit, in an accompanying editorial.
Ovarian cancer often goes undiagnosed until an advanced stage, and BSO can significantly reduce risk in women with BRCA1 and BRCA2 mutations, they noted.
For women without increased risk, those who are premenopausal may wish to preserve ovarian function, but women also may benefit from improvements in a range of menopause-related symptoms including vasomotor and urogenital symptoms, sexual dysfunction, and psychiatric and cognitive symptoms, they said.
“In addition, salpingectomy alone has a role in significantly reducing ovarian cancer incidence without compromising ovarian function because the fallopian tube has been found to be at the origin of many ovarian cancer cases,” they noted. In the current study, “the crude ovarian cancer risk was lower with BSO” across all age groups, the editorialists said.
The choice of whether to include BSO at the time of benign hysterectomy is complicated, with many factors to consider, the editorialists wrote, and the current study supports the need for informed, shared decision-making between clinicians and patients.
The study was supported by the Danish Cancer Society’s Scientific Committee and the Mermaid Project. The researchers had no financial conflicts to disclose. The editorial authors had no financial conflicts to disclose.
Although bilateral salpingo-oophorectomy (BSO) with hysterectomy has been shown to reduce the risk for ovarian cancer in women at increased risk, current guidelines are touting ovarian conservation, especially in premenopausal women, wrote Mathilde Gottschau, MD, of the Danish Cancer Society Research Center, Copenhagen, and colleagues. However, post-hysterectomy outcomes in women with and without BSO have not been well examined.
In a study published in the Annals of Internal Medicine, the researchers reviewed data from a nationwide registry of women in Denmark aged 20 years and older who underwent benign hysterectomies with BSO (22,974 women) and without BSO (120,011 women) between 1977 and 2017. The women were divided into subgroups based on age; those younger than 45 years were defined as premenopausal, those aged 45-54 years were defined as perimenopausal, those aged 55-64 were defined as early postmenopausal, and those aged 65 and older were defined as late menopausal.
The primary outcomes were hospitalization for cardiovascular disease, cancer incidence, and all-cause mortality over a median follow-up period of 22 years.
For women younger than 45 years, the 10-year cumulative risk for all cancer was lower with BSO than without, but the risk of overall cardiovascular disease was higher with BSO, with higher levels of ischemic heart disease and stroke, compared with women without BSO. The 10-year cumulative mortality was higher with BSO than without (2.16% vs. 1.94%).
For women aged 45-54 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO (risk difference, 0.73 percentage points) associated mainly with nonbreast cancer, and both 10-year and 20-year mortality were higher in those with BSO than those without.
For women aged 55-65 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO. Cumulative overall mortality was higher at 10 years for those with BSO, but lower at 20 years.
For women aged 65 years and older, both 10-year and 20-year cumulative overall cancer risk was higher with BSO than without (RD, 2.54 and 4.57 percentage points, respectively). Cumulative mortality was higher in the BSO group at 10 years, but lower at 20 years.
The study findings were limited by several factors including the use of age to determine menopausal status and the lack of genetic predisposition data, and the focus only on a relatively homogeneous population that may not be generalizable to other populations, the researchers noted.
However, the results were strengthened by the use of a nationwide registry and the long-term follow-up period, they said. The current study indicates that the health risks outweigh the potential benefits of BSO with benign hysterectomy for premenopausal women and supports the current guidelines for ovarian conservation in these women with low lifetime ovarian cancer risk, they said. For postmenopausal women, the data support a cautious approach to BSO given the lack of a clear survival benefit and cancer excess, they concluded.
Delayed diagnosis of ovarian cancers favors BSO
“The question of removing ovaries at the time of benign hysterectomy to prevent ovarian cancer in low-risk women has been widely debated,” which has contributed to the variation in incidence rates of unilateral and bilateral oophorectomy over time, wrote Elizabeth Casiano Evans, MD, of the University of Texas, San Antonio, and Deslyn T.G. Hobson, MD, of Wayne State University, Detroit, in an accompanying editorial.
Ovarian cancer often goes undiagnosed until an advanced stage, and BSO can significantly reduce risk in women with BRCA1 and BRCA2 mutations, they noted.
For women without increased risk, those who are premenopausal may wish to preserve ovarian function, but women also may benefit from improvements in a range of menopause-related symptoms including vasomotor and urogenital symptoms, sexual dysfunction, and psychiatric and cognitive symptoms, they said.
“In addition, salpingectomy alone has a role in significantly reducing ovarian cancer incidence without compromising ovarian function because the fallopian tube has been found to be at the origin of many ovarian cancer cases,” they noted. In the current study, “the crude ovarian cancer risk was lower with BSO” across all age groups, the editorialists said.
The choice of whether to include BSO at the time of benign hysterectomy is complicated, with many factors to consider, the editorialists wrote, and the current study supports the need for informed, shared decision-making between clinicians and patients.
The study was supported by the Danish Cancer Society’s Scientific Committee and the Mermaid Project. The researchers had no financial conflicts to disclose. The editorial authors had no financial conflicts to disclose.
FROM THE ANNALS OF INTERNAL MEDICINE
Cardiovascular disease deaths rise on and after high-pollution days
Cardiovascular disease deaths were significantly more common on days of high pollution and for the following 2 days, compared with other days, based on data from nearly 88,000 deaths over a 5-year period.
Previous research has shown the harmful effect of air pollution on human health in highly polluted areas, but Eastern Poland, a region with so-called “Polish smog” has exceptionally high levels of pollution. However, the specific impact of Polish smog, caused primarily by burning coal, on cardiovascular disease (CVD) mortality has not been well studied, said Michal Swieczkowski, MD, of the Medical University of Bialystok (Poland) in a presentation at the annual congress of the European Association of Preventive Cardiology.
Dr. Swieczkowski and colleagues reviewed all-cause deaths from five main cities in Eastern Poland during 2016-2020 for associations with pollution levels and days when deaths occurred. Mortality data were obtained from the Central Statistical Office. Air pollution concentrations for two types of particulate matter (PM2.5, PM10) and nitrogen oxide were collected from the Voivodeship Inspectorate for Environmental Protection. The main sources of the pollutants were road traffic and household heaters using coal or wood.
The final analysis included nearly 6 million person-years of follow-up. The researchers used a time-stratified case-crossover design. For each participant, the researchers compared levels of each pollutant on the day of the week a death occurred (such as a Wednesday) with pollutant levels on the same day of the week without any deaths in the same month (the remaining Wednesdays of that month). This design eliminated the potential confounding effects of participant characteristics, including other cardiovascular risk factors such as smoking and hyperlipidemia, and time trends. Essentially, participants “served as their own controls,” Dr. Swieczkowski said. The researchers conducted similar analyses for pollution levels 1 day and 2 days before a death occurred.
Overall, 87,990 deaths were identified during the study period; of these, 34,907 were from CVD, 9,688 from acute coronary syndromes, and 3,776 from ischemic stroke.
“Exposure to PM2.5 and PM10 was associated with increased mortality on the day of exposure, the next day, and up to 2 days after exposure,” said Dr. Swieczkowski.
Overall, an increase of 10 mcg/m3 in the three pollutants was significantly associated with increase in CVD mortality on the day of exposure to the increased pollution levels, with odds ratios of 1.034, 1.033, and 1.083 for PM2.5, PM10, and NO2, respectively (all P < .001).
The risks of dying from CVD were similar 1 and 2 days after the polluted day.
An increase in PM levels, but not NO2, was significantly associated with acute coronary syndrome (ACS) on the day of exposure to increased pollutants (ORs, 1.029 for PM2.5 [P = .002] and 1.015 [P = .049] for PM10). Both ischemic stroke and ACS mortality were significantly higher at 1 day after exposure, compared with other days. Ischemic stroke was associated with increases in PM2.5 and PM10, while ACS was associated with increases in PM2.5, PM10, and NO2.
When stratified by gender, the effects were more noticeable in women, Dr. Swieczkowski said. “Exposure to both types of particulate caused increased mortality due to acute coronary syndrome as well as ischemic stroke.” Among men, only death from acute coronary syndrome was significantly associated with exposure to increased particulate matter.
In a head-to-head comparison, women were more vulnerable to air pollution by up to 2.5%, he added.
When stratified by age, the effects of all three pollutants were associated with increased risk of death from ischemic stroke and ACS in participants older than 65 years. For those aged 65 years and younger, the only significant association was between ACS-associated mortality and ischemic stroke.
The results suggest “a special need for developing calculators to estimate the risk of CVD incidence depending on the place of residence that could be used for everyday practice,” said Dr. Swieczkowski. “Systemic changes should become a priority for policy makers, and, simultaneously, we as physicians should educate and protect our patients, especially those with high risk of cardiovascular disease,” he said.
Gender differences rooted in anatomy
When asked for an explanation of the difference in the impact of pollution on mortality between men and women, Dr. Swieczkowski explained that women are likely more vulnerable because of differences in anatomy of the pharynx and larynx, and breathing patterns. Previous studies have shown that air pollution causes more oxidative stress in women. Also, in the current study, the mean age of the women was 8 to 9 years older, he said.
The study design was an “elegant way to take away the impact of other cardiovascular risk factors,” noted session moderator Maryam Kavousi, MD, of Erasmus University Medical Center, Rotterdam, the Netherlands.
The study was supported by the National Science Centre, Poland. The researchers had no financial conflicts to disclose.
Cardiovascular disease deaths were significantly more common on days of high pollution and for the following 2 days, compared with other days, based on data from nearly 88,000 deaths over a 5-year period.
Previous research has shown the harmful effect of air pollution on human health in highly polluted areas, but Eastern Poland, a region with so-called “Polish smog” has exceptionally high levels of pollution. However, the specific impact of Polish smog, caused primarily by burning coal, on cardiovascular disease (CVD) mortality has not been well studied, said Michal Swieczkowski, MD, of the Medical University of Bialystok (Poland) in a presentation at the annual congress of the European Association of Preventive Cardiology.
Dr. Swieczkowski and colleagues reviewed all-cause deaths from five main cities in Eastern Poland during 2016-2020 for associations with pollution levels and days when deaths occurred. Mortality data were obtained from the Central Statistical Office. Air pollution concentrations for two types of particulate matter (PM2.5, PM10) and nitrogen oxide were collected from the Voivodeship Inspectorate for Environmental Protection. The main sources of the pollutants were road traffic and household heaters using coal or wood.
The final analysis included nearly 6 million person-years of follow-up. The researchers used a time-stratified case-crossover design. For each participant, the researchers compared levels of each pollutant on the day of the week a death occurred (such as a Wednesday) with pollutant levels on the same day of the week without any deaths in the same month (the remaining Wednesdays of that month). This design eliminated the potential confounding effects of participant characteristics, including other cardiovascular risk factors such as smoking and hyperlipidemia, and time trends. Essentially, participants “served as their own controls,” Dr. Swieczkowski said. The researchers conducted similar analyses for pollution levels 1 day and 2 days before a death occurred.
Overall, 87,990 deaths were identified during the study period; of these, 34,907 were from CVD, 9,688 from acute coronary syndromes, and 3,776 from ischemic stroke.
“Exposure to PM2.5 and PM10 was associated with increased mortality on the day of exposure, the next day, and up to 2 days after exposure,” said Dr. Swieczkowski.
Overall, an increase of 10 mcg/m3 in the three pollutants was significantly associated with increase in CVD mortality on the day of exposure to the increased pollution levels, with odds ratios of 1.034, 1.033, and 1.083 for PM2.5, PM10, and NO2, respectively (all P < .001).
The risks of dying from CVD were similar 1 and 2 days after the polluted day.
An increase in PM levels, but not NO2, was significantly associated with acute coronary syndrome (ACS) on the day of exposure to increased pollutants (ORs, 1.029 for PM2.5 [P = .002] and 1.015 [P = .049] for PM10). Both ischemic stroke and ACS mortality were significantly higher at 1 day after exposure, compared with other days. Ischemic stroke was associated with increases in PM2.5 and PM10, while ACS was associated with increases in PM2.5, PM10, and NO2.
When stratified by gender, the effects were more noticeable in women, Dr. Swieczkowski said. “Exposure to both types of particulate caused increased mortality due to acute coronary syndrome as well as ischemic stroke.” Among men, only death from acute coronary syndrome was significantly associated with exposure to increased particulate matter.
In a head-to-head comparison, women were more vulnerable to air pollution by up to 2.5%, he added.
When stratified by age, the effects of all three pollutants were associated with increased risk of death from ischemic stroke and ACS in participants older than 65 years. For those aged 65 years and younger, the only significant association was between ACS-associated mortality and ischemic stroke.
The results suggest “a special need for developing calculators to estimate the risk of CVD incidence depending on the place of residence that could be used for everyday practice,” said Dr. Swieczkowski. “Systemic changes should become a priority for policy makers, and, simultaneously, we as physicians should educate and protect our patients, especially those with high risk of cardiovascular disease,” he said.
Gender differences rooted in anatomy
When asked for an explanation of the difference in the impact of pollution on mortality between men and women, Dr. Swieczkowski explained that women are likely more vulnerable because of differences in anatomy of the pharynx and larynx, and breathing patterns. Previous studies have shown that air pollution causes more oxidative stress in women. Also, in the current study, the mean age of the women was 8 to 9 years older, he said.
The study design was an “elegant way to take away the impact of other cardiovascular risk factors,” noted session moderator Maryam Kavousi, MD, of Erasmus University Medical Center, Rotterdam, the Netherlands.
The study was supported by the National Science Centre, Poland. The researchers had no financial conflicts to disclose.
Cardiovascular disease deaths were significantly more common on days of high pollution and for the following 2 days, compared with other days, based on data from nearly 88,000 deaths over a 5-year period.
Previous research has shown the harmful effect of air pollution on human health in highly polluted areas, but Eastern Poland, a region with so-called “Polish smog” has exceptionally high levels of pollution. However, the specific impact of Polish smog, caused primarily by burning coal, on cardiovascular disease (CVD) mortality has not been well studied, said Michal Swieczkowski, MD, of the Medical University of Bialystok (Poland) in a presentation at the annual congress of the European Association of Preventive Cardiology.
Dr. Swieczkowski and colleagues reviewed all-cause deaths from five main cities in Eastern Poland during 2016-2020 for associations with pollution levels and days when deaths occurred. Mortality data were obtained from the Central Statistical Office. Air pollution concentrations for two types of particulate matter (PM2.5, PM10) and nitrogen oxide were collected from the Voivodeship Inspectorate for Environmental Protection. The main sources of the pollutants were road traffic and household heaters using coal or wood.
The final analysis included nearly 6 million person-years of follow-up. The researchers used a time-stratified case-crossover design. For each participant, the researchers compared levels of each pollutant on the day of the week a death occurred (such as a Wednesday) with pollutant levels on the same day of the week without any deaths in the same month (the remaining Wednesdays of that month). This design eliminated the potential confounding effects of participant characteristics, including other cardiovascular risk factors such as smoking and hyperlipidemia, and time trends. Essentially, participants “served as their own controls,” Dr. Swieczkowski said. The researchers conducted similar analyses for pollution levels 1 day and 2 days before a death occurred.
Overall, 87,990 deaths were identified during the study period; of these, 34,907 were from CVD, 9,688 from acute coronary syndromes, and 3,776 from ischemic stroke.
“Exposure to PM2.5 and PM10 was associated with increased mortality on the day of exposure, the next day, and up to 2 days after exposure,” said Dr. Swieczkowski.
Overall, an increase of 10 mcg/m3 in the three pollutants was significantly associated with increase in CVD mortality on the day of exposure to the increased pollution levels, with odds ratios of 1.034, 1.033, and 1.083 for PM2.5, PM10, and NO2, respectively (all P < .001).
The risks of dying from CVD were similar 1 and 2 days after the polluted day.
An increase in PM levels, but not NO2, was significantly associated with acute coronary syndrome (ACS) on the day of exposure to increased pollutants (ORs, 1.029 for PM2.5 [P = .002] and 1.015 [P = .049] for PM10). Both ischemic stroke and ACS mortality were significantly higher at 1 day after exposure, compared with other days. Ischemic stroke was associated with increases in PM2.5 and PM10, while ACS was associated with increases in PM2.5, PM10, and NO2.
When stratified by gender, the effects were more noticeable in women, Dr. Swieczkowski said. “Exposure to both types of particulate caused increased mortality due to acute coronary syndrome as well as ischemic stroke.” Among men, only death from acute coronary syndrome was significantly associated with exposure to increased particulate matter.
In a head-to-head comparison, women were more vulnerable to air pollution by up to 2.5%, he added.
When stratified by age, the effects of all three pollutants were associated with increased risk of death from ischemic stroke and ACS in participants older than 65 years. For those aged 65 years and younger, the only significant association was between ACS-associated mortality and ischemic stroke.
The results suggest “a special need for developing calculators to estimate the risk of CVD incidence depending on the place of residence that could be used for everyday practice,” said Dr. Swieczkowski. “Systemic changes should become a priority for policy makers, and, simultaneously, we as physicians should educate and protect our patients, especially those with high risk of cardiovascular disease,” he said.
Gender differences rooted in anatomy
When asked for an explanation of the difference in the impact of pollution on mortality between men and women, Dr. Swieczkowski explained that women are likely more vulnerable because of differences in anatomy of the pharynx and larynx, and breathing patterns. Previous studies have shown that air pollution causes more oxidative stress in women. Also, in the current study, the mean age of the women was 8 to 9 years older, he said.
The study design was an “elegant way to take away the impact of other cardiovascular risk factors,” noted session moderator Maryam Kavousi, MD, of Erasmus University Medical Center, Rotterdam, the Netherlands.
The study was supported by the National Science Centre, Poland. The researchers had no financial conflicts to disclose.
FROM ESC CONGRESS 2023
Sentinel events in hospitals continue to rise, driven by increase in falls
Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.
The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).
Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.
Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.
A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).
Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.
The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).
Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).
“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
Increased reporting may not reflect increased occurrence
“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.
“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.
Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.
However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”
Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”
The review authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.
The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).
Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.
Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.
A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).
Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.
The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).
Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).
“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
Increased reporting may not reflect increased occurrence
“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.
“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.
Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.
However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”
Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”
The review authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.
The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).
Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.
Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.
A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).
Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.
The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).
Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).
“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
Increased reporting may not reflect increased occurrence
“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.
“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.
Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.
However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”
Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”
The review authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adherence to oral contraceptive protocols prevents pregnancy
Combined oral contraceptives (COCs) remain a popular method of pregnancy prevention worldwide, but efficacy and failure rates can be difficult to determine, as real-word use does not always mirror clinical trials, wrote Mitchell D. Creinin, MD, of the University of California, Davis, and colleagues. Clinical trials include perfect use or method-failure rates, but data on pregnancy risk based on reported adherence alone are lacking, they said.
To assess the effects of missed pills on COC efficacy, the researchers reviewed data from a pair of parallel phase 3 trials, focusing only on adherence to the pill dosing regimen. The findings were published in Obstetrics & Gynecology.
The study population included 1,864 individuals from the United States and Canada, and 1,553 from Europe and Russia.
The participants were healthy, sexually active adults aged 16-50 years in monogamous relationships from 2016 through 2018 who agreed to used estetrol 15 mg and drospirenone 3 mg for up to 13 28-day cycles as their only contraceptive method. Condom use was permitted for protection against sexually transmitted infections if needed. The 28-day COCs included 24 hormonal tablets and 4 placebo tablets. Participants received written instructions for what to do it they missed pills.
The primary outcome was the relationship between missed pills and pregnancies.
A total of 31 pregnancies occurred across both studies; none of these occurred during cycles in which other contraception was used. Of 22 pregnancies in participants who reported taking all pills, 21 reported daily pill use during the cycle in which pregnancy occurred. One participant reported not taking one pill and one participant reported not taking two pills; neither correctly followed the instructions for missed pills.
Pregnancies occurred in .09% of cycles in which participants reported taking all pills, and in 0.25%, 0.83%, and 1.6% of cycles in which participants reported missing one pill, two pills, or more than two pills, respectively.
“Pregnancy rates exceeded 1% only in participants who did not correctly follow missed-pill instructions,” the researchers noted.
Pregnancy rates per cycle ranged from 0% to 0.21%, and 48.4% of the pregnancies occurred during the first four cycles of COC use. Approximately one-third (32.3%) of pregnancies occurred within the first week of a new pill pack.
“Fertilization does not appear to be related to the timing of missed pills within the cycle because pregnancy did not occur more frequently earlier in the cycle (after the placebo pills),” the researchers wrote in their discussion. This finding contradicts previous research suggesting that contraceptive failure rates decrease over the first year of use, they said. In addition, the formulation of the pill used may affect pregnancy rates when pills are missed, as some hormones have longer half-lives, they noted.
The study findings were limited by several factors, including the lack of adjustment for outcomes based on reported sexual activity per cycle, and by the reliance on self-reports.
However, the results were strengthened by the use of the clinical outcomes of pregnancy as the primary outcome, rather than characteristics and predictors of participants who missed pills, the researchers said.
The cycle-based methodology used in the current study may provide insight on the relationship between COC adherence and pregnancy risk that can inform future studies, they concluded.
Findings highlight the importance of options
“With increasing restrictions on abortion care, offering more contraceptive options for people is critical,” Lauren Owens, MD, associate professor of obstetrics and gynecology at the University of Washington, Seattle, said in an interview. “That’s not to say that having another pill option makes up for the harm people are experiencing as they navigate abortion bans and legal interference in their health care, but no one pill works for all people, and having more options is helpful,” she said.
Dr. Owens noted that the rates of pregnancy in the current study were lower than she traditionally associates with COCs, “although I usually discuss annual failure rates with patients, not failure rates per cycle, and the latter will clearly be lower.” In the current study, “The authors hypothesize some of this may be due to the longer half-life that estetrol has compared to ethinyl estradiol, the estrogen form more commonly found in oral contraceptive pills,” she said.
From a clinical standpoint, “I appreciated the linkage between number of missed pills and pregnancies occurring,” Dr. Owens said. “This is a good reminder to clinicians to talk to patients ahead of time about what to do when missed pills occur and to provide resources in advance that patients can reference when needed,” she said.
“The authors published other studies on this pill in the last year and it seems to work well and have a reasonable safety profile,” Dr. Owens told this news organization. However, “We still need to broaden the methods available to patients, particularly methods that people producing sperm can use. In the face of ongoing and escalating attacks on access to contraceptive care and abortion care, it’s more important than ever to do what we can to improve options for patients,” she said.
The study was supported by Estetra SRL, an affiliate company of Mithra Pharmaceuticals. Dr. Creinin disclosed relationships with multiple companies including Gedeon Richter, Mayne, and Organon. He disclosed serving on the advisory boards for Evofem, Fuji Pharma, Gedeon Richter, GlaxoSmithKline, Mayne, Merck, OLIC, Organon, and Searchlight, and serving as a consultant for Estetra SRL (including the current study), Libbs, Mayne, and Medicines360; his university department receives contraceptive research funding from Chemo Research SL, Evofem, HRA Pharma, Medicines360, Merck, and Sebela. Dr. Owens had no relevant financial conflicts to disclose.
Combined oral contraceptives (COCs) remain a popular method of pregnancy prevention worldwide, but efficacy and failure rates can be difficult to determine, as real-word use does not always mirror clinical trials, wrote Mitchell D. Creinin, MD, of the University of California, Davis, and colleagues. Clinical trials include perfect use or method-failure rates, but data on pregnancy risk based on reported adherence alone are lacking, they said.
To assess the effects of missed pills on COC efficacy, the researchers reviewed data from a pair of parallel phase 3 trials, focusing only on adherence to the pill dosing regimen. The findings were published in Obstetrics & Gynecology.
The study population included 1,864 individuals from the United States and Canada, and 1,553 from Europe and Russia.
The participants were healthy, sexually active adults aged 16-50 years in monogamous relationships from 2016 through 2018 who agreed to used estetrol 15 mg and drospirenone 3 mg for up to 13 28-day cycles as their only contraceptive method. Condom use was permitted for protection against sexually transmitted infections if needed. The 28-day COCs included 24 hormonal tablets and 4 placebo tablets. Participants received written instructions for what to do it they missed pills.
The primary outcome was the relationship between missed pills and pregnancies.
A total of 31 pregnancies occurred across both studies; none of these occurred during cycles in which other contraception was used. Of 22 pregnancies in participants who reported taking all pills, 21 reported daily pill use during the cycle in which pregnancy occurred. One participant reported not taking one pill and one participant reported not taking two pills; neither correctly followed the instructions for missed pills.
Pregnancies occurred in .09% of cycles in which participants reported taking all pills, and in 0.25%, 0.83%, and 1.6% of cycles in which participants reported missing one pill, two pills, or more than two pills, respectively.
“Pregnancy rates exceeded 1% only in participants who did not correctly follow missed-pill instructions,” the researchers noted.
Pregnancy rates per cycle ranged from 0% to 0.21%, and 48.4% of the pregnancies occurred during the first four cycles of COC use. Approximately one-third (32.3%) of pregnancies occurred within the first week of a new pill pack.
“Fertilization does not appear to be related to the timing of missed pills within the cycle because pregnancy did not occur more frequently earlier in the cycle (after the placebo pills),” the researchers wrote in their discussion. This finding contradicts previous research suggesting that contraceptive failure rates decrease over the first year of use, they said. In addition, the formulation of the pill used may affect pregnancy rates when pills are missed, as some hormones have longer half-lives, they noted.
The study findings were limited by several factors, including the lack of adjustment for outcomes based on reported sexual activity per cycle, and by the reliance on self-reports.
However, the results were strengthened by the use of the clinical outcomes of pregnancy as the primary outcome, rather than characteristics and predictors of participants who missed pills, the researchers said.
The cycle-based methodology used in the current study may provide insight on the relationship between COC adherence and pregnancy risk that can inform future studies, they concluded.
Findings highlight the importance of options
“With increasing restrictions on abortion care, offering more contraceptive options for people is critical,” Lauren Owens, MD, associate professor of obstetrics and gynecology at the University of Washington, Seattle, said in an interview. “That’s not to say that having another pill option makes up for the harm people are experiencing as they navigate abortion bans and legal interference in their health care, but no one pill works for all people, and having more options is helpful,” she said.
Dr. Owens noted that the rates of pregnancy in the current study were lower than she traditionally associates with COCs, “although I usually discuss annual failure rates with patients, not failure rates per cycle, and the latter will clearly be lower.” In the current study, “The authors hypothesize some of this may be due to the longer half-life that estetrol has compared to ethinyl estradiol, the estrogen form more commonly found in oral contraceptive pills,” she said.
From a clinical standpoint, “I appreciated the linkage between number of missed pills and pregnancies occurring,” Dr. Owens said. “This is a good reminder to clinicians to talk to patients ahead of time about what to do when missed pills occur and to provide resources in advance that patients can reference when needed,” she said.
“The authors published other studies on this pill in the last year and it seems to work well and have a reasonable safety profile,” Dr. Owens told this news organization. However, “We still need to broaden the methods available to patients, particularly methods that people producing sperm can use. In the face of ongoing and escalating attacks on access to contraceptive care and abortion care, it’s more important than ever to do what we can to improve options for patients,” she said.
The study was supported by Estetra SRL, an affiliate company of Mithra Pharmaceuticals. Dr. Creinin disclosed relationships with multiple companies including Gedeon Richter, Mayne, and Organon. He disclosed serving on the advisory boards for Evofem, Fuji Pharma, Gedeon Richter, GlaxoSmithKline, Mayne, Merck, OLIC, Organon, and Searchlight, and serving as a consultant for Estetra SRL (including the current study), Libbs, Mayne, and Medicines360; his university department receives contraceptive research funding from Chemo Research SL, Evofem, HRA Pharma, Medicines360, Merck, and Sebela. Dr. Owens had no relevant financial conflicts to disclose.
Combined oral contraceptives (COCs) remain a popular method of pregnancy prevention worldwide, but efficacy and failure rates can be difficult to determine, as real-word use does not always mirror clinical trials, wrote Mitchell D. Creinin, MD, of the University of California, Davis, and colleagues. Clinical trials include perfect use or method-failure rates, but data on pregnancy risk based on reported adherence alone are lacking, they said.
To assess the effects of missed pills on COC efficacy, the researchers reviewed data from a pair of parallel phase 3 trials, focusing only on adherence to the pill dosing regimen. The findings were published in Obstetrics & Gynecology.
The study population included 1,864 individuals from the United States and Canada, and 1,553 from Europe and Russia.
The participants were healthy, sexually active adults aged 16-50 years in monogamous relationships from 2016 through 2018 who agreed to used estetrol 15 mg and drospirenone 3 mg for up to 13 28-day cycles as their only contraceptive method. Condom use was permitted for protection against sexually transmitted infections if needed. The 28-day COCs included 24 hormonal tablets and 4 placebo tablets. Participants received written instructions for what to do it they missed pills.
The primary outcome was the relationship between missed pills and pregnancies.
A total of 31 pregnancies occurred across both studies; none of these occurred during cycles in which other contraception was used. Of 22 pregnancies in participants who reported taking all pills, 21 reported daily pill use during the cycle in which pregnancy occurred. One participant reported not taking one pill and one participant reported not taking two pills; neither correctly followed the instructions for missed pills.
Pregnancies occurred in .09% of cycles in which participants reported taking all pills, and in 0.25%, 0.83%, and 1.6% of cycles in which participants reported missing one pill, two pills, or more than two pills, respectively.
“Pregnancy rates exceeded 1% only in participants who did not correctly follow missed-pill instructions,” the researchers noted.
Pregnancy rates per cycle ranged from 0% to 0.21%, and 48.4% of the pregnancies occurred during the first four cycles of COC use. Approximately one-third (32.3%) of pregnancies occurred within the first week of a new pill pack.
“Fertilization does not appear to be related to the timing of missed pills within the cycle because pregnancy did not occur more frequently earlier in the cycle (after the placebo pills),” the researchers wrote in their discussion. This finding contradicts previous research suggesting that contraceptive failure rates decrease over the first year of use, they said. In addition, the formulation of the pill used may affect pregnancy rates when pills are missed, as some hormones have longer half-lives, they noted.
The study findings were limited by several factors, including the lack of adjustment for outcomes based on reported sexual activity per cycle, and by the reliance on self-reports.
However, the results were strengthened by the use of the clinical outcomes of pregnancy as the primary outcome, rather than characteristics and predictors of participants who missed pills, the researchers said.
The cycle-based methodology used in the current study may provide insight on the relationship between COC adherence and pregnancy risk that can inform future studies, they concluded.
Findings highlight the importance of options
“With increasing restrictions on abortion care, offering more contraceptive options for people is critical,” Lauren Owens, MD, associate professor of obstetrics and gynecology at the University of Washington, Seattle, said in an interview. “That’s not to say that having another pill option makes up for the harm people are experiencing as they navigate abortion bans and legal interference in their health care, but no one pill works for all people, and having more options is helpful,” she said.
Dr. Owens noted that the rates of pregnancy in the current study were lower than she traditionally associates with COCs, “although I usually discuss annual failure rates with patients, not failure rates per cycle, and the latter will clearly be lower.” In the current study, “The authors hypothesize some of this may be due to the longer half-life that estetrol has compared to ethinyl estradiol, the estrogen form more commonly found in oral contraceptive pills,” she said.
From a clinical standpoint, “I appreciated the linkage between number of missed pills and pregnancies occurring,” Dr. Owens said. “This is a good reminder to clinicians to talk to patients ahead of time about what to do when missed pills occur and to provide resources in advance that patients can reference when needed,” she said.
“The authors published other studies on this pill in the last year and it seems to work well and have a reasonable safety profile,” Dr. Owens told this news organization. However, “We still need to broaden the methods available to patients, particularly methods that people producing sperm can use. In the face of ongoing and escalating attacks on access to contraceptive care and abortion care, it’s more important than ever to do what we can to improve options for patients,” she said.
The study was supported by Estetra SRL, an affiliate company of Mithra Pharmaceuticals. Dr. Creinin disclosed relationships with multiple companies including Gedeon Richter, Mayne, and Organon. He disclosed serving on the advisory boards for Evofem, Fuji Pharma, Gedeon Richter, GlaxoSmithKline, Mayne, Merck, OLIC, Organon, and Searchlight, and serving as a consultant for Estetra SRL (including the current study), Libbs, Mayne, and Medicines360; his university department receives contraceptive research funding from Chemo Research SL, Evofem, HRA Pharma, Medicines360, Merck, and Sebela. Dr. Owens had no relevant financial conflicts to disclose.
FROM OBSTETRICS & GYNECOLOGY
Oophorectomies continue to dominate torsion treatment
Prompt surgical management is essential in cases of ovarian torsion in order to salvage ovarian function, and recent studies have shown that conservative management with detorsion does not increase postoperative complications, compared with oophorectomy, wrote Hannah Ryles, MD, of the University of Pennsylvania, Philadelphia, and colleagues.
The American College of Obstetricians and Gynecologists issued practice guidelines in November 2016 that recommended ovarian conservation rather than oophorectomy to manage adnexal torsion in women wishing to preserve fertility. However, the impact of this guideline on clinical practice and surgical patterns remains unclear, the researchers said.
In a study published in Obstetrics and Gynecology, the researchers reviewed data from 402 patients who underwent surgeries before the updated ACOG guidelines (2008-2016) and 1,389 who underwent surgeries after the guidelines (2017-2020). Surgery data came from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. The study population included women aged 18-50 years who underwent adnexal torsion surgery and were identified as having either oophorectomy or ovarian conservation surgery.
A total of 1,791 surgeries performed for adnexal torsion were included in the study; 542 (30.3%) involved ovarian conservation and 1,249 (69.7%) involved oophorectomy.
The proportion of oophorectomies was similar during the periods before and after the guidelines (71.9% vs. 69.1%; P = .16). However, the proportion of oophorectomies changed significantly across the entire study period, by approximately –1.6% each year.
Factors significantly associated with oophorectomy compared with ovarian conservation included older age (35 years vs. 28 years), higher body mass index (29.2 kg/m2 vs. 27.5 kg/m2), anemia (12.2% vs. 7.2%), hypertension (10.4% vs. 3.1%), and higher American Society of Anesthesiologists classification.
“There remains no defined acceptable rate of oophorectomy; this decision involves multiple factors, such as fertility and other patient desires after a risk and benefit discussion, menopausal status, concern for malignancy, and safety and feasibility of conservative procedures,” the researchers wrote in their discussion. However, in emergency situations, it may be difficult to determine a patient’s preferences, and a lack of desire for future fertility may be presumed, which may contribute to the relatively high oophorectomy rates over time, they said.
The findings were limited by several factors including the retrospective design and lack of data on surgical history, histopathology, and intraoperative appearance of the ovary, as well as lack of clinical data including the time from presentation to diagnosis or surgery, the researchers noted. “Although we were also unable to determine obstetric history and fertility desires, our median age of 32 years reflects a young cohort that was limited to women of reproductive age,” they added.
However, the results reflect studies suggesting that clinical practice often lags behind updated guidelines, and the findings were strengthened by the use of the NSQIP database and reflect a need for greater efforts to promote ovarian conservation in accordance with the current guidelines, the researchers concluded.
Consider unilateral oophorectomy
The current study highlights the discrepancy between the ACOG guidelines and clinical practice, with “disappointingly low” rates of ovarian preservation in the adult population, wrote Riley J. Young, MD, and Kimberly A. Kho, MD, both of the University of Texas Southwestern Medical Center, Dallas, in an accompanying editorial. The reasons for the discrepancy include clinical concerns for conserving a torsed ovary and the difficulty of assessing fertility desires in an emergency situation, they said.
However, consideration of unilateral oophorectomy as an option should be part of clinical decision-making, according to the editorialists. Previous studies suggest that retention of a single ovarian may still allow for a successful pregnancy, and the effects of unilateral oophorectomy have been studied in infertility and assisted reproductive technology settings.
Women with a single ovary have fewer eggs and require higher amounts of gonadotropins, but pregnancy is possible, the editorialists said. However, the long-term effects of unilateral oophorectomy are uncertain, and potential detrimental outcomes include increased mortality and cognitive impairment; therefore “we aim for premenopausal ovaries simply to be conserved, whether fertility is the stated goal or not,” they noted. This may include consideration of unilateral oophorectomy. “Each ovary conserved at midnight moves us closer to a more acceptable ovarian conservation rate,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kho disclosed funding to her institution from Hologic for being on an investigator-initiated study, Dr. Young had no financial conflicts to disclose.
Prompt surgical management is essential in cases of ovarian torsion in order to salvage ovarian function, and recent studies have shown that conservative management with detorsion does not increase postoperative complications, compared with oophorectomy, wrote Hannah Ryles, MD, of the University of Pennsylvania, Philadelphia, and colleagues.
The American College of Obstetricians and Gynecologists issued practice guidelines in November 2016 that recommended ovarian conservation rather than oophorectomy to manage adnexal torsion in women wishing to preserve fertility. However, the impact of this guideline on clinical practice and surgical patterns remains unclear, the researchers said.
In a study published in Obstetrics and Gynecology, the researchers reviewed data from 402 patients who underwent surgeries before the updated ACOG guidelines (2008-2016) and 1,389 who underwent surgeries after the guidelines (2017-2020). Surgery data came from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. The study population included women aged 18-50 years who underwent adnexal torsion surgery and were identified as having either oophorectomy or ovarian conservation surgery.
A total of 1,791 surgeries performed for adnexal torsion were included in the study; 542 (30.3%) involved ovarian conservation and 1,249 (69.7%) involved oophorectomy.
The proportion of oophorectomies was similar during the periods before and after the guidelines (71.9% vs. 69.1%; P = .16). However, the proportion of oophorectomies changed significantly across the entire study period, by approximately –1.6% each year.
Factors significantly associated with oophorectomy compared with ovarian conservation included older age (35 years vs. 28 years), higher body mass index (29.2 kg/m2 vs. 27.5 kg/m2), anemia (12.2% vs. 7.2%), hypertension (10.4% vs. 3.1%), and higher American Society of Anesthesiologists classification.
“There remains no defined acceptable rate of oophorectomy; this decision involves multiple factors, such as fertility and other patient desires after a risk and benefit discussion, menopausal status, concern for malignancy, and safety and feasibility of conservative procedures,” the researchers wrote in their discussion. However, in emergency situations, it may be difficult to determine a patient’s preferences, and a lack of desire for future fertility may be presumed, which may contribute to the relatively high oophorectomy rates over time, they said.
The findings were limited by several factors including the retrospective design and lack of data on surgical history, histopathology, and intraoperative appearance of the ovary, as well as lack of clinical data including the time from presentation to diagnosis or surgery, the researchers noted. “Although we were also unable to determine obstetric history and fertility desires, our median age of 32 years reflects a young cohort that was limited to women of reproductive age,” they added.
However, the results reflect studies suggesting that clinical practice often lags behind updated guidelines, and the findings were strengthened by the use of the NSQIP database and reflect a need for greater efforts to promote ovarian conservation in accordance with the current guidelines, the researchers concluded.
Consider unilateral oophorectomy
The current study highlights the discrepancy between the ACOG guidelines and clinical practice, with “disappointingly low” rates of ovarian preservation in the adult population, wrote Riley J. Young, MD, and Kimberly A. Kho, MD, both of the University of Texas Southwestern Medical Center, Dallas, in an accompanying editorial. The reasons for the discrepancy include clinical concerns for conserving a torsed ovary and the difficulty of assessing fertility desires in an emergency situation, they said.
However, consideration of unilateral oophorectomy as an option should be part of clinical decision-making, according to the editorialists. Previous studies suggest that retention of a single ovarian may still allow for a successful pregnancy, and the effects of unilateral oophorectomy have been studied in infertility and assisted reproductive technology settings.
Women with a single ovary have fewer eggs and require higher amounts of gonadotropins, but pregnancy is possible, the editorialists said. However, the long-term effects of unilateral oophorectomy are uncertain, and potential detrimental outcomes include increased mortality and cognitive impairment; therefore “we aim for premenopausal ovaries simply to be conserved, whether fertility is the stated goal or not,” they noted. This may include consideration of unilateral oophorectomy. “Each ovary conserved at midnight moves us closer to a more acceptable ovarian conservation rate,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kho disclosed funding to her institution from Hologic for being on an investigator-initiated study, Dr. Young had no financial conflicts to disclose.
Prompt surgical management is essential in cases of ovarian torsion in order to salvage ovarian function, and recent studies have shown that conservative management with detorsion does not increase postoperative complications, compared with oophorectomy, wrote Hannah Ryles, MD, of the University of Pennsylvania, Philadelphia, and colleagues.
The American College of Obstetricians and Gynecologists issued practice guidelines in November 2016 that recommended ovarian conservation rather than oophorectomy to manage adnexal torsion in women wishing to preserve fertility. However, the impact of this guideline on clinical practice and surgical patterns remains unclear, the researchers said.
In a study published in Obstetrics and Gynecology, the researchers reviewed data from 402 patients who underwent surgeries before the updated ACOG guidelines (2008-2016) and 1,389 who underwent surgeries after the guidelines (2017-2020). Surgery data came from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. The study population included women aged 18-50 years who underwent adnexal torsion surgery and were identified as having either oophorectomy or ovarian conservation surgery.
A total of 1,791 surgeries performed for adnexal torsion were included in the study; 542 (30.3%) involved ovarian conservation and 1,249 (69.7%) involved oophorectomy.
The proportion of oophorectomies was similar during the periods before and after the guidelines (71.9% vs. 69.1%; P = .16). However, the proportion of oophorectomies changed significantly across the entire study period, by approximately –1.6% each year.
Factors significantly associated with oophorectomy compared with ovarian conservation included older age (35 years vs. 28 years), higher body mass index (29.2 kg/m2 vs. 27.5 kg/m2), anemia (12.2% vs. 7.2%), hypertension (10.4% vs. 3.1%), and higher American Society of Anesthesiologists classification.
“There remains no defined acceptable rate of oophorectomy; this decision involves multiple factors, such as fertility and other patient desires after a risk and benefit discussion, menopausal status, concern for malignancy, and safety and feasibility of conservative procedures,” the researchers wrote in their discussion. However, in emergency situations, it may be difficult to determine a patient’s preferences, and a lack of desire for future fertility may be presumed, which may contribute to the relatively high oophorectomy rates over time, they said.
The findings were limited by several factors including the retrospective design and lack of data on surgical history, histopathology, and intraoperative appearance of the ovary, as well as lack of clinical data including the time from presentation to diagnosis or surgery, the researchers noted. “Although we were also unable to determine obstetric history and fertility desires, our median age of 32 years reflects a young cohort that was limited to women of reproductive age,” they added.
However, the results reflect studies suggesting that clinical practice often lags behind updated guidelines, and the findings were strengthened by the use of the NSQIP database and reflect a need for greater efforts to promote ovarian conservation in accordance with the current guidelines, the researchers concluded.
Consider unilateral oophorectomy
The current study highlights the discrepancy between the ACOG guidelines and clinical practice, with “disappointingly low” rates of ovarian preservation in the adult population, wrote Riley J. Young, MD, and Kimberly A. Kho, MD, both of the University of Texas Southwestern Medical Center, Dallas, in an accompanying editorial. The reasons for the discrepancy include clinical concerns for conserving a torsed ovary and the difficulty of assessing fertility desires in an emergency situation, they said.
However, consideration of unilateral oophorectomy as an option should be part of clinical decision-making, according to the editorialists. Previous studies suggest that retention of a single ovarian may still allow for a successful pregnancy, and the effects of unilateral oophorectomy have been studied in infertility and assisted reproductive technology settings.
Women with a single ovary have fewer eggs and require higher amounts of gonadotropins, but pregnancy is possible, the editorialists said. However, the long-term effects of unilateral oophorectomy are uncertain, and potential detrimental outcomes include increased mortality and cognitive impairment; therefore “we aim for premenopausal ovaries simply to be conserved, whether fertility is the stated goal or not,” they noted. This may include consideration of unilateral oophorectomy. “Each ovary conserved at midnight moves us closer to a more acceptable ovarian conservation rate,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kho disclosed funding to her institution from Hologic for being on an investigator-initiated study, Dr. Young had no financial conflicts to disclose.
FROM OBSTETRICS & GYNECOLOGY
Noisy incubators could stunt infant hearing
Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies’ hearing and language development skills at risk.
Previous studies have shown that the neonatal intensive care unit is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, and colleagues.
“By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants,” and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say.
In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels to describe the sound characteristics and to identify resonance characteristics inside an incubator.
The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannequin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care.
Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency); and blood pressure measurement.
The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.
The researchers reported that the incubator tended to dampen most sounds but also that some sounds resonated inside the incubator, which raised the interior noise level by as much as 28 decibels.
Most of the measures using both A-weighted decibels (dBA) and sound pressure level decibels (dBSPL) were above the 45-decibel level for neonatal sound exposure recommended by the American Academy of Pediatrics. The measurements (dBA) versus unweighted (dBSPL) are limited in that they are designed to measure low levels of sound and therefore might underestimate proportions of high and low frequencies at stronger levels, the researchers acknowledge.
Overall, most measures were clustered in the 55-75 decibel range, although some sound levels for incubator handling, while below levels previously reported in the literature, reached approximately 100 decibels.
The noise involved inside the incubator was not perceived as loud by those working with the incubator, the researchers note.
As for resonance inside the incubator, the researchers measured a low-frequency main resonance of 97 Hz, but they write that this resonance can be hard to capture in weighted measurements. However, the resonance means that “noises from the outside sound more tonal inside the incubator, booming and muffled as well as less rough or noisy,” and sounds inside the incubator are similarly affected, the researchers say.
“Most of the noise situations described in this manuscript far exceed not only the recommendation of the AAP but also international guidelines provided by the World Health Organization and the U.S. Environmental Protection Agency,” which recommend, respectively, maximum dBA levels of 35 dBA and 45 dBA for daytime and 30 dBA and 35 dBA for night, the researchers indicate.
Potential long-term implications are that babies who spend time in the NICU are at risk for hearing impairment, which could lead to delays in language acquisition, they say.
The findings were limited by several factors, including the variance among the incubators, which prevents generalizability, the researchers note. Other limitations include the use of a simulation room rather than everyday conditions, in which the environmental sounds would likely be even louder.
However, the results provide insights into the specifics of incubator and NICU noise and suggest that sound be a consideration in the development and promotion of incubators to help protect the hearing of the infants inside them, the researchers conclude.
A generalist’s take
“This is an interesting study looking at the level and character of the sound experienced by preterm infants inside an incubator and how it may compare to sounds experienced within the mother’s womb,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
In society at large, “there has been more focus lately on the general environment and its effect on health, and this study is a unique take on this concept,” he said. “Although in general the incubators work to dampen external sounds, low-frequency sounds may actually resonate more inside the incubators, and taps on the outside or inside of the incubator itself are amplified within the incubator,” he noted. “It is sad but not surprising that the decibel levels experienced by the infants in the incubators exceed the recommended levels recommended by AAP.”
As for additional research, “it would be interesting to see the results of trials looking at various short- or long-term outcomes experienced by infants exposed to a lower-level noise compared to the current levels,” Dr. Joos told this news organization.
A neonatologist’s perspective
“As the field of neonatology advances, we are caring for an ever-growing number of extremely preterm infants,” said Caitlin M. Drumm, MD, of Walter Reed National Military Medical Center, Bethesda, Md., in an interview.
“These infants will spend the first few months of their lives within an incubator in the neonatal intensive care unit, so it is important to understand the potential long-term implications of environmental effects on these vulnerable patients,” she said.
“As in prior studies, it was not surprising that essentially every environmental, handling, or respiratory intervention led to noise levels higher than the limit recommended by the American Academy of Pediatrics,” Dr. Drumm said. “What was surprising was just how high above the 45-dB recommended noise limit many environmental stimuli are. For example, the authors cite respiratory flow rates of 8 L/min or higher as risky for hearing health at 84.72 dBSPL, “ she said.
The key message for clinicians is to be aware of noise levels in the NICU, Dr. Drumm said. “Environmental stimuli as simple as putting a stethoscope on the incubator lead to noise levels well above the limit recommended by the American Academy of Pediatrics. The entire NICU care team has a role to play in minimizing environmental sound hazards for our most critically ill patients.”
Looking ahead, “future research should focus on providing more information correlating neonatal environmental sound exposure to long-term hearing and neurodevelopmental outcomes,” she said.
The study received no outside funding. The researchers report no relevant financial relationships. Dr. Joos serves on the editorial advisory board of Pediatric News. Dr. Drumm has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies’ hearing and language development skills at risk.
Previous studies have shown that the neonatal intensive care unit is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, and colleagues.
“By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants,” and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say.
In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels to describe the sound characteristics and to identify resonance characteristics inside an incubator.
The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannequin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care.
Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency); and blood pressure measurement.
The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.
The researchers reported that the incubator tended to dampen most sounds but also that some sounds resonated inside the incubator, which raised the interior noise level by as much as 28 decibels.
Most of the measures using both A-weighted decibels (dBA) and sound pressure level decibels (dBSPL) were above the 45-decibel level for neonatal sound exposure recommended by the American Academy of Pediatrics. The measurements (dBA) versus unweighted (dBSPL) are limited in that they are designed to measure low levels of sound and therefore might underestimate proportions of high and low frequencies at stronger levels, the researchers acknowledge.
Overall, most measures were clustered in the 55-75 decibel range, although some sound levels for incubator handling, while below levels previously reported in the literature, reached approximately 100 decibels.
The noise involved inside the incubator was not perceived as loud by those working with the incubator, the researchers note.
As for resonance inside the incubator, the researchers measured a low-frequency main resonance of 97 Hz, but they write that this resonance can be hard to capture in weighted measurements. However, the resonance means that “noises from the outside sound more tonal inside the incubator, booming and muffled as well as less rough or noisy,” and sounds inside the incubator are similarly affected, the researchers say.
“Most of the noise situations described in this manuscript far exceed not only the recommendation of the AAP but also international guidelines provided by the World Health Organization and the U.S. Environmental Protection Agency,” which recommend, respectively, maximum dBA levels of 35 dBA and 45 dBA for daytime and 30 dBA and 35 dBA for night, the researchers indicate.
Potential long-term implications are that babies who spend time in the NICU are at risk for hearing impairment, which could lead to delays in language acquisition, they say.
The findings were limited by several factors, including the variance among the incubators, which prevents generalizability, the researchers note. Other limitations include the use of a simulation room rather than everyday conditions, in which the environmental sounds would likely be even louder.
However, the results provide insights into the specifics of incubator and NICU noise and suggest that sound be a consideration in the development and promotion of incubators to help protect the hearing of the infants inside them, the researchers conclude.
A generalist’s take
“This is an interesting study looking at the level and character of the sound experienced by preterm infants inside an incubator and how it may compare to sounds experienced within the mother’s womb,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
In society at large, “there has been more focus lately on the general environment and its effect on health, and this study is a unique take on this concept,” he said. “Although in general the incubators work to dampen external sounds, low-frequency sounds may actually resonate more inside the incubators, and taps on the outside or inside of the incubator itself are amplified within the incubator,” he noted. “It is sad but not surprising that the decibel levels experienced by the infants in the incubators exceed the recommended levels recommended by AAP.”
As for additional research, “it would be interesting to see the results of trials looking at various short- or long-term outcomes experienced by infants exposed to a lower-level noise compared to the current levels,” Dr. Joos told this news organization.
A neonatologist’s perspective
“As the field of neonatology advances, we are caring for an ever-growing number of extremely preterm infants,” said Caitlin M. Drumm, MD, of Walter Reed National Military Medical Center, Bethesda, Md., in an interview.
“These infants will spend the first few months of their lives within an incubator in the neonatal intensive care unit, so it is important to understand the potential long-term implications of environmental effects on these vulnerable patients,” she said.
“As in prior studies, it was not surprising that essentially every environmental, handling, or respiratory intervention led to noise levels higher than the limit recommended by the American Academy of Pediatrics,” Dr. Drumm said. “What was surprising was just how high above the 45-dB recommended noise limit many environmental stimuli are. For example, the authors cite respiratory flow rates of 8 L/min or higher as risky for hearing health at 84.72 dBSPL, “ she said.
The key message for clinicians is to be aware of noise levels in the NICU, Dr. Drumm said. “Environmental stimuli as simple as putting a stethoscope on the incubator lead to noise levels well above the limit recommended by the American Academy of Pediatrics. The entire NICU care team has a role to play in minimizing environmental sound hazards for our most critically ill patients.”
Looking ahead, “future research should focus on providing more information correlating neonatal environmental sound exposure to long-term hearing and neurodevelopmental outcomes,” she said.
The study received no outside funding. The researchers report no relevant financial relationships. Dr. Joos serves on the editorial advisory board of Pediatric News. Dr. Drumm has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies’ hearing and language development skills at risk.
Previous studies have shown that the neonatal intensive care unit is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, and colleagues.
“By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants,” and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say.
In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels to describe the sound characteristics and to identify resonance characteristics inside an incubator.
The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannequin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care.
Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency); and blood pressure measurement.
The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.
The researchers reported that the incubator tended to dampen most sounds but also that some sounds resonated inside the incubator, which raised the interior noise level by as much as 28 decibels.
Most of the measures using both A-weighted decibels (dBA) and sound pressure level decibels (dBSPL) were above the 45-decibel level for neonatal sound exposure recommended by the American Academy of Pediatrics. The measurements (dBA) versus unweighted (dBSPL) are limited in that they are designed to measure low levels of sound and therefore might underestimate proportions of high and low frequencies at stronger levels, the researchers acknowledge.
Overall, most measures were clustered in the 55-75 decibel range, although some sound levels for incubator handling, while below levels previously reported in the literature, reached approximately 100 decibels.
The noise involved inside the incubator was not perceived as loud by those working with the incubator, the researchers note.
As for resonance inside the incubator, the researchers measured a low-frequency main resonance of 97 Hz, but they write that this resonance can be hard to capture in weighted measurements. However, the resonance means that “noises from the outside sound more tonal inside the incubator, booming and muffled as well as less rough or noisy,” and sounds inside the incubator are similarly affected, the researchers say.
“Most of the noise situations described in this manuscript far exceed not only the recommendation of the AAP but also international guidelines provided by the World Health Organization and the U.S. Environmental Protection Agency,” which recommend, respectively, maximum dBA levels of 35 dBA and 45 dBA for daytime and 30 dBA and 35 dBA for night, the researchers indicate.
Potential long-term implications are that babies who spend time in the NICU are at risk for hearing impairment, which could lead to delays in language acquisition, they say.
The findings were limited by several factors, including the variance among the incubators, which prevents generalizability, the researchers note. Other limitations include the use of a simulation room rather than everyday conditions, in which the environmental sounds would likely be even louder.
However, the results provide insights into the specifics of incubator and NICU noise and suggest that sound be a consideration in the development and promotion of incubators to help protect the hearing of the infants inside them, the researchers conclude.
A generalist’s take
“This is an interesting study looking at the level and character of the sound experienced by preterm infants inside an incubator and how it may compare to sounds experienced within the mother’s womb,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
In society at large, “there has been more focus lately on the general environment and its effect on health, and this study is a unique take on this concept,” he said. “Although in general the incubators work to dampen external sounds, low-frequency sounds may actually resonate more inside the incubators, and taps on the outside or inside of the incubator itself are amplified within the incubator,” he noted. “It is sad but not surprising that the decibel levels experienced by the infants in the incubators exceed the recommended levels recommended by AAP.”
As for additional research, “it would be interesting to see the results of trials looking at various short- or long-term outcomes experienced by infants exposed to a lower-level noise compared to the current levels,” Dr. Joos told this news organization.
A neonatologist’s perspective
“As the field of neonatology advances, we are caring for an ever-growing number of extremely preterm infants,” said Caitlin M. Drumm, MD, of Walter Reed National Military Medical Center, Bethesda, Md., in an interview.
“These infants will spend the first few months of their lives within an incubator in the neonatal intensive care unit, so it is important to understand the potential long-term implications of environmental effects on these vulnerable patients,” she said.
“As in prior studies, it was not surprising that essentially every environmental, handling, or respiratory intervention led to noise levels higher than the limit recommended by the American Academy of Pediatrics,” Dr. Drumm said. “What was surprising was just how high above the 45-dB recommended noise limit many environmental stimuli are. For example, the authors cite respiratory flow rates of 8 L/min or higher as risky for hearing health at 84.72 dBSPL, “ she said.
The key message for clinicians is to be aware of noise levels in the NICU, Dr. Drumm said. “Environmental stimuli as simple as putting a stethoscope on the incubator lead to noise levels well above the limit recommended by the American Academy of Pediatrics. The entire NICU care team has a role to play in minimizing environmental sound hazards for our most critically ill patients.”
Looking ahead, “future research should focus on providing more information correlating neonatal environmental sound exposure to long-term hearing and neurodevelopmental outcomes,” she said.
The study received no outside funding. The researchers report no relevant financial relationships. Dr. Joos serves on the editorial advisory board of Pediatric News. Dr. Drumm has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Low-dose olanzapine improves appetite in chemotherapy patients
Anorexia is a problem in approximately 50% of newly-diagnosed cancer patients, and can compromise survival, wrote study author Lakshmi Sandhya, MD, of Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India, and colleagues. In particular, patients with lung and gastrointestinal tract cancers are prone to anorexia during chemotherapy, they said. Olanzapine is a demonstrated appetite stimulant and has been used in cancer patients as a short-term antiemetic, but its use for long-term appetite stimulation has not been well-studied, they said.
In the study, published in the Journal of Clinical Oncology, the researchers randomized 124 adults aged 18 years and older to a 2.5 grams of olanzapine or placebo for 12 weeks. The participants had untreated, locally advanced, or metastatic gastric, hepatopancreaticobiliary (HPB), or lung cancers.
The median age of the participants was 55 years. The primary outcome was a weight gain greater than 5% and improved appetite based on the visual analog scale (VAS) and questionnaires. A change in nutritional status, quality of life (QOL), and chemotherapy toxicity, were secondary endpoints.
After 12 weeks, complete data were available for 58 patients in the olanzapine group and 54 in the placebo group. Of these, 60% of the olanzapine group and 9% of the placebo group met the primary endpoint of a weight gain greater than 5%. The proportion of patients with improved appetite based on VAS scores and questionnaire scores was significantly higher in olanzapine patients vs. placebo patients (43% vs. 13% and 22% vs. 4%, respectively).
In addition, 52% of the olanzapine group vs. 18% of the placebo group achieved more than 75% intake of recommended daily calories.
Most of the reported toxicities were not hematological and similar between the groups (85% for olanzapine vs. 88% for placebo). The proportion of patients with toxicities of grade 3 or higher was lower in the olanzapine group vs. the placebo group (12% vs. 37%, P = .002). Patients in the olanzapine group also reported significantly improved quality of life from baseline compared to the placebo patients.
The findings were limited by several factors including the heterogeneous cancers and treatment regimens, the lack of data on weight beyond 12 weeks, the relatively small study population, and the subjective nature of anorexia measurements, the researchers noted.
However, the results suggest that low-dose olanzapine is an effective and well-tolerated add-on intervention for the subset of patients at risk for anorexia at the start of chemotherapy, they said.
“Future studies could look at various cancers in a multicentric setting and long-term endpoints such as patient survival,” they concluded.
The study drug and placebo were funded by an intramural grant from Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER). The researchers had no financial conflicts to disclose.
Anorexia is a problem in approximately 50% of newly-diagnosed cancer patients, and can compromise survival, wrote study author Lakshmi Sandhya, MD, of Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India, and colleagues. In particular, patients with lung and gastrointestinal tract cancers are prone to anorexia during chemotherapy, they said. Olanzapine is a demonstrated appetite stimulant and has been used in cancer patients as a short-term antiemetic, but its use for long-term appetite stimulation has not been well-studied, they said.
In the study, published in the Journal of Clinical Oncology, the researchers randomized 124 adults aged 18 years and older to a 2.5 grams of olanzapine or placebo for 12 weeks. The participants had untreated, locally advanced, or metastatic gastric, hepatopancreaticobiliary (HPB), or lung cancers.
The median age of the participants was 55 years. The primary outcome was a weight gain greater than 5% and improved appetite based on the visual analog scale (VAS) and questionnaires. A change in nutritional status, quality of life (QOL), and chemotherapy toxicity, were secondary endpoints.
After 12 weeks, complete data were available for 58 patients in the olanzapine group and 54 in the placebo group. Of these, 60% of the olanzapine group and 9% of the placebo group met the primary endpoint of a weight gain greater than 5%. The proportion of patients with improved appetite based on VAS scores and questionnaire scores was significantly higher in olanzapine patients vs. placebo patients (43% vs. 13% and 22% vs. 4%, respectively).
In addition, 52% of the olanzapine group vs. 18% of the placebo group achieved more than 75% intake of recommended daily calories.
Most of the reported toxicities were not hematological and similar between the groups (85% for olanzapine vs. 88% for placebo). The proportion of patients with toxicities of grade 3 or higher was lower in the olanzapine group vs. the placebo group (12% vs. 37%, P = .002). Patients in the olanzapine group also reported significantly improved quality of life from baseline compared to the placebo patients.
The findings were limited by several factors including the heterogeneous cancers and treatment regimens, the lack of data on weight beyond 12 weeks, the relatively small study population, and the subjective nature of anorexia measurements, the researchers noted.
However, the results suggest that low-dose olanzapine is an effective and well-tolerated add-on intervention for the subset of patients at risk for anorexia at the start of chemotherapy, they said.
“Future studies could look at various cancers in a multicentric setting and long-term endpoints such as patient survival,” they concluded.
The study drug and placebo were funded by an intramural grant from Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER). The researchers had no financial conflicts to disclose.
Anorexia is a problem in approximately 50% of newly-diagnosed cancer patients, and can compromise survival, wrote study author Lakshmi Sandhya, MD, of Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India, and colleagues. In particular, patients with lung and gastrointestinal tract cancers are prone to anorexia during chemotherapy, they said. Olanzapine is a demonstrated appetite stimulant and has been used in cancer patients as a short-term antiemetic, but its use for long-term appetite stimulation has not been well-studied, they said.
In the study, published in the Journal of Clinical Oncology, the researchers randomized 124 adults aged 18 years and older to a 2.5 grams of olanzapine or placebo for 12 weeks. The participants had untreated, locally advanced, or metastatic gastric, hepatopancreaticobiliary (HPB), or lung cancers.
The median age of the participants was 55 years. The primary outcome was a weight gain greater than 5% and improved appetite based on the visual analog scale (VAS) and questionnaires. A change in nutritional status, quality of life (QOL), and chemotherapy toxicity, were secondary endpoints.
After 12 weeks, complete data were available for 58 patients in the olanzapine group and 54 in the placebo group. Of these, 60% of the olanzapine group and 9% of the placebo group met the primary endpoint of a weight gain greater than 5%. The proportion of patients with improved appetite based on VAS scores and questionnaire scores was significantly higher in olanzapine patients vs. placebo patients (43% vs. 13% and 22% vs. 4%, respectively).
In addition, 52% of the olanzapine group vs. 18% of the placebo group achieved more than 75% intake of recommended daily calories.
Most of the reported toxicities were not hematological and similar between the groups (85% for olanzapine vs. 88% for placebo). The proportion of patients with toxicities of grade 3 or higher was lower in the olanzapine group vs. the placebo group (12% vs. 37%, P = .002). Patients in the olanzapine group also reported significantly improved quality of life from baseline compared to the placebo patients.
The findings were limited by several factors including the heterogeneous cancers and treatment regimens, the lack of data on weight beyond 12 weeks, the relatively small study population, and the subjective nature of anorexia measurements, the researchers noted.
However, the results suggest that low-dose olanzapine is an effective and well-tolerated add-on intervention for the subset of patients at risk for anorexia at the start of chemotherapy, they said.
“Future studies could look at various cancers in a multicentric setting and long-term endpoints such as patient survival,” they concluded.
The study drug and placebo were funded by an intramural grant from Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER). The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Children ate more fruits and vegetables during longer meals: Study
Adding 10 minutes to family mealtimes increased children’s consumption of fruits and vegetables by approximately one portion, based on data from 50 parent-child dyads.
Family meals are known to affect children’s food choices and preferences and can be an effective setting for improving children’s nutrition, wrote Mattea Dallacker, PhD, of the University of Mannheim, Germany, and colleagues.
However, the effect of extending meal duration on increasing fruit and vegetable intake in particular has not been examined, they said.
In a study published in JAMA Network Open, the researchers provided two free evening meals to 50 parent-child dyads under each of two different conditions. The control condition was defined by the families as a regular family mealtime duration (an average meal was 20.83 minutes), while the intervention was an average meal time 10 minutes (50%) longer. The age of the parents ranged from 22 to 55 years, with a mean of 43 years; 72% of the parent participants were mothers. The children’s ages ranged from 6 to 11 years, with a mean of 8 years, with approximately equal numbers of boys and girls.
The study was conducted in a family meal laboratory setting in Berlin, and groups were randomized to the longer or shorter meal setting first. The primary outcome was the total number of pieces of fruit and vegetables eaten by the child as part of each of the two meals.
Both meals were the “typical German evening meal of sliced bread, cold cuts of cheese and meat, and bite-sized pieces of fruits and vegetables,” followed by a dessert course of chocolate pudding or fruit yogurt and cookies, the researchers wrote. Beverages were water and one sugar-sweetened beverage; the specific foods and beverages were based on the child’s preferences, reported in an online preassessment, and the foods were consistent for the longer and shorter meals. All participants were asked not to eat for 2 hours prior to arriving for their meals at the laboratory.
During longer meals, children ate an average of seven additional bite-sized pieces of fruits and vegetables, which translates to approximately a full portion (defined as 100 g, such as a medium apple), the researchers wrote. The difference was significant compared with the shorter meals for fruits (P = .01) and vegetables (P < .001).
A piece of fruit was approximately 10 grams (6-10 g for grapes and tangerine segments; 10-14 g for cherry tomatoes; and 9-11 g for apple, banana, carrot, or cucumber). Other foods served with the meals included cheese, meats, butter, and sweet spreads.
Children also ate more slowly (defined as fewer bites per minute) during the longer meals, and they reported significantly greater satiety after the longer meals (P < .001 for both). The consumption of bread and cold cuts was similar for the two meal settings.
“Higher intake of fruits and vegetables during longer meals cannot be explained by longer exposure to food alone; otherwise, an increased intake of bread and cold cuts would have occurred,” the researchers wrote in their discussion. “One possible explanation is that the fruits and vegetables were cut into bite-sized pieces, making them convenient to eat.”
Further analysis showed that during the longer meals, more fruits and vegetables were consumed overall, but more vegetables were eaten from the start of the meal, while the additional fruit was eaten during the additional time at the end.
The findings were limited by several factors, primarily use of a laboratory setting that does not generalize to natural eating environments, the researchers noted. Other potential limitations included the effect of a video cameras on desirable behaviors and the limited ethnic and socioeconomic diversity of the study population, they said. The results were strengthened by the within-dyad study design that allowed for control of factors such as video observation, but more research is needed with more diverse groups and across longer time frames, the researchers said.
However, the results suggest that adding 10 minutes to a family mealtime can yield significant improvements in children’s diets, they said. They suggested strategies including playing music chosen by the child/children and setting rules that everyone must remain at the table for a certain length of time, with fruits and vegetables available on the table.
“If the effects of this simple, inexpensive, and low-threshold intervention prove stable over time, it could contribute to addressing a major public health problem,” the researchers concluded.
Findings intriguing, more data needed
The current study is important because food and vegetable intake in the majority of children falls below the recommended daily allowance, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
The key take-home message for clinicians is the continued need to stress the importance of family meals, said Dr. Kinsella. “Many children continue to be overbooked with activities, and it may be rare for many families to sit down together for a meal for any length of time.”
Don’t discount the potential effect of a longer school lunch on children’s fruit and vegetable consumption as well, she added. “Advocating for longer lunch time is important, as many kids report not being able to finish their lunch at school.”
The current study was limited by being conducted in a lab setting, which may have influenced children’s desire for different foods, “also they had fewer distractions, and were being offered favorite foods,” said Dr. Kinsella.
Looking ahead, “it would be interesting to see if this result carried over to nonpreferred fruits and veggies and made any difference for picky eaters,” she said.
The study received no outside funding. The open-access publication of the study (but not the study itself) was supported by the Max Planck Institute for Human Development Library Open Access Fund. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Adding 10 minutes to family mealtimes increased children’s consumption of fruits and vegetables by approximately one portion, based on data from 50 parent-child dyads.
Family meals are known to affect children’s food choices and preferences and can be an effective setting for improving children’s nutrition, wrote Mattea Dallacker, PhD, of the University of Mannheim, Germany, and colleagues.
However, the effect of extending meal duration on increasing fruit and vegetable intake in particular has not been examined, they said.
In a study published in JAMA Network Open, the researchers provided two free evening meals to 50 parent-child dyads under each of two different conditions. The control condition was defined by the families as a regular family mealtime duration (an average meal was 20.83 minutes), while the intervention was an average meal time 10 minutes (50%) longer. The age of the parents ranged from 22 to 55 years, with a mean of 43 years; 72% of the parent participants were mothers. The children’s ages ranged from 6 to 11 years, with a mean of 8 years, with approximately equal numbers of boys and girls.
The study was conducted in a family meal laboratory setting in Berlin, and groups were randomized to the longer or shorter meal setting first. The primary outcome was the total number of pieces of fruit and vegetables eaten by the child as part of each of the two meals.
Both meals were the “typical German evening meal of sliced bread, cold cuts of cheese and meat, and bite-sized pieces of fruits and vegetables,” followed by a dessert course of chocolate pudding or fruit yogurt and cookies, the researchers wrote. Beverages were water and one sugar-sweetened beverage; the specific foods and beverages were based on the child’s preferences, reported in an online preassessment, and the foods were consistent for the longer and shorter meals. All participants were asked not to eat for 2 hours prior to arriving for their meals at the laboratory.
During longer meals, children ate an average of seven additional bite-sized pieces of fruits and vegetables, which translates to approximately a full portion (defined as 100 g, such as a medium apple), the researchers wrote. The difference was significant compared with the shorter meals for fruits (P = .01) and vegetables (P < .001).
A piece of fruit was approximately 10 grams (6-10 g for grapes and tangerine segments; 10-14 g for cherry tomatoes; and 9-11 g for apple, banana, carrot, or cucumber). Other foods served with the meals included cheese, meats, butter, and sweet spreads.
Children also ate more slowly (defined as fewer bites per minute) during the longer meals, and they reported significantly greater satiety after the longer meals (P < .001 for both). The consumption of bread and cold cuts was similar for the two meal settings.
“Higher intake of fruits and vegetables during longer meals cannot be explained by longer exposure to food alone; otherwise, an increased intake of bread and cold cuts would have occurred,” the researchers wrote in their discussion. “One possible explanation is that the fruits and vegetables were cut into bite-sized pieces, making them convenient to eat.”
Further analysis showed that during the longer meals, more fruits and vegetables were consumed overall, but more vegetables were eaten from the start of the meal, while the additional fruit was eaten during the additional time at the end.
The findings were limited by several factors, primarily use of a laboratory setting that does not generalize to natural eating environments, the researchers noted. Other potential limitations included the effect of a video cameras on desirable behaviors and the limited ethnic and socioeconomic diversity of the study population, they said. The results were strengthened by the within-dyad study design that allowed for control of factors such as video observation, but more research is needed with more diverse groups and across longer time frames, the researchers said.
However, the results suggest that adding 10 minutes to a family mealtime can yield significant improvements in children’s diets, they said. They suggested strategies including playing music chosen by the child/children and setting rules that everyone must remain at the table for a certain length of time, with fruits and vegetables available on the table.
“If the effects of this simple, inexpensive, and low-threshold intervention prove stable over time, it could contribute to addressing a major public health problem,” the researchers concluded.
Findings intriguing, more data needed
The current study is important because food and vegetable intake in the majority of children falls below the recommended daily allowance, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
The key take-home message for clinicians is the continued need to stress the importance of family meals, said Dr. Kinsella. “Many children continue to be overbooked with activities, and it may be rare for many families to sit down together for a meal for any length of time.”
Don’t discount the potential effect of a longer school lunch on children’s fruit and vegetable consumption as well, she added. “Advocating for longer lunch time is important, as many kids report not being able to finish their lunch at school.”
The current study was limited by being conducted in a lab setting, which may have influenced children’s desire for different foods, “also they had fewer distractions, and were being offered favorite foods,” said Dr. Kinsella.
Looking ahead, “it would be interesting to see if this result carried over to nonpreferred fruits and veggies and made any difference for picky eaters,” she said.
The study received no outside funding. The open-access publication of the study (but not the study itself) was supported by the Max Planck Institute for Human Development Library Open Access Fund. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Adding 10 minutes to family mealtimes increased children’s consumption of fruits and vegetables by approximately one portion, based on data from 50 parent-child dyads.
Family meals are known to affect children’s food choices and preferences and can be an effective setting for improving children’s nutrition, wrote Mattea Dallacker, PhD, of the University of Mannheim, Germany, and colleagues.
However, the effect of extending meal duration on increasing fruit and vegetable intake in particular has not been examined, they said.
In a study published in JAMA Network Open, the researchers provided two free evening meals to 50 parent-child dyads under each of two different conditions. The control condition was defined by the families as a regular family mealtime duration (an average meal was 20.83 minutes), while the intervention was an average meal time 10 minutes (50%) longer. The age of the parents ranged from 22 to 55 years, with a mean of 43 years; 72% of the parent participants were mothers. The children’s ages ranged from 6 to 11 years, with a mean of 8 years, with approximately equal numbers of boys and girls.
The study was conducted in a family meal laboratory setting in Berlin, and groups were randomized to the longer or shorter meal setting first. The primary outcome was the total number of pieces of fruit and vegetables eaten by the child as part of each of the two meals.
Both meals were the “typical German evening meal of sliced bread, cold cuts of cheese and meat, and bite-sized pieces of fruits and vegetables,” followed by a dessert course of chocolate pudding or fruit yogurt and cookies, the researchers wrote. Beverages were water and one sugar-sweetened beverage; the specific foods and beverages were based on the child’s preferences, reported in an online preassessment, and the foods were consistent for the longer and shorter meals. All participants were asked not to eat for 2 hours prior to arriving for their meals at the laboratory.
During longer meals, children ate an average of seven additional bite-sized pieces of fruits and vegetables, which translates to approximately a full portion (defined as 100 g, such as a medium apple), the researchers wrote. The difference was significant compared with the shorter meals for fruits (P = .01) and vegetables (P < .001).
A piece of fruit was approximately 10 grams (6-10 g for grapes and tangerine segments; 10-14 g for cherry tomatoes; and 9-11 g for apple, banana, carrot, or cucumber). Other foods served with the meals included cheese, meats, butter, and sweet spreads.
Children also ate more slowly (defined as fewer bites per minute) during the longer meals, and they reported significantly greater satiety after the longer meals (P < .001 for both). The consumption of bread and cold cuts was similar for the two meal settings.
“Higher intake of fruits and vegetables during longer meals cannot be explained by longer exposure to food alone; otherwise, an increased intake of bread and cold cuts would have occurred,” the researchers wrote in their discussion. “One possible explanation is that the fruits and vegetables were cut into bite-sized pieces, making them convenient to eat.”
Further analysis showed that during the longer meals, more fruits and vegetables were consumed overall, but more vegetables were eaten from the start of the meal, while the additional fruit was eaten during the additional time at the end.
The findings were limited by several factors, primarily use of a laboratory setting that does not generalize to natural eating environments, the researchers noted. Other potential limitations included the effect of a video cameras on desirable behaviors and the limited ethnic and socioeconomic diversity of the study population, they said. The results were strengthened by the within-dyad study design that allowed for control of factors such as video observation, but more research is needed with more diverse groups and across longer time frames, the researchers said.
However, the results suggest that adding 10 minutes to a family mealtime can yield significant improvements in children’s diets, they said. They suggested strategies including playing music chosen by the child/children and setting rules that everyone must remain at the table for a certain length of time, with fruits and vegetables available on the table.
“If the effects of this simple, inexpensive, and low-threshold intervention prove stable over time, it could contribute to addressing a major public health problem,” the researchers concluded.
Findings intriguing, more data needed
The current study is important because food and vegetable intake in the majority of children falls below the recommended daily allowance, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
The key take-home message for clinicians is the continued need to stress the importance of family meals, said Dr. Kinsella. “Many children continue to be overbooked with activities, and it may be rare for many families to sit down together for a meal for any length of time.”
Don’t discount the potential effect of a longer school lunch on children’s fruit and vegetable consumption as well, she added. “Advocating for longer lunch time is important, as many kids report not being able to finish their lunch at school.”
The current study was limited by being conducted in a lab setting, which may have influenced children’s desire for different foods, “also they had fewer distractions, and were being offered favorite foods,” said Dr. Kinsella.
Looking ahead, “it would be interesting to see if this result carried over to nonpreferred fruits and veggies and made any difference for picky eaters,” she said.
The study received no outside funding. The open-access publication of the study (but not the study itself) was supported by the Max Planck Institute for Human Development Library Open Access Fund. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM JAMA NETWORK OPEN
Cesarean deliveries drop in women at low risk
Although clinically indicated cesarean deliveries may improve outcomes for mothers and infants, “when not clinically indicated, cesarean delivery is a major surgical intervention that increases risk for adverse outcomes,” wrote Anna M. Frappaolo of Columbia University College of Physicians and Surgeons, New York, and colleagues.
The Healthy People 2030 campaign includes the reduction of cesarean deliveries, but trends in these procedures, especially with regard to diagnoses of labor arrest, have not been well studied, the researchers said.
In an analysis published in JAMA Network Open, the researchers reviewed delivery hospitalizations using data from the National Inpatient Sample from 2000 to 2019.
Births deemed low risk for cesarean delivery were identified by using criteria of the Society for Maternal-Fetal Medicine and additional criteria, and joinpoint regression analysis was used to estimate changes.
The researchers examined overall trends in cesarean deliveries as well as trends for three specific diagnoses: nonreassuring fetal status, labor arrest, and obstructed labor.
The final analysis included 40,517,867 deliveries; of these, 4,885,716 (12.1%) were cesarean deliveries.
Overall, cesarean deliveries in patients deemed at low risk increased from 9.7% in 2000 to 13.9% in 2009, then plateaued and decreased from 13.0% in 2012 to 11.1% in 2019. The average annual percentage change (AAPC) for cesarean delivery was 6.4% for the years from 2000 to 2005, 1.2% from 2005 to 2009, and −2.2% from 2009 to 2019.
Cesarean delivery for nonreassuring fetal status increased over the entire study period, from 3.4% in 2000 to 5.1% in 2019. By contrast, overall cesarean delivery for labor arrest increased from 3.6% in 2000 to a high of 4.8% in 2009, then decreased to 2.7% in 2019. Cesarean deliveries with a diagnosis of obstructed labor decreased from 0.9% in 2008 to 0.3% in 2019.
More specifically, cesarean deliveries for labor arrest in the active phase, latent phase, and second stage of labor increased from 1.5% to 2.1%, 1.1% to 1.5%, and 0.9% to 1.3%, respectively, from 2000 to 2009, and decreased from 2.1% to 1.7% for the active phase, from 1.5% to 1.2% for the latent phase, and from 1.2% to 0.9% for the second stage between 2010 and 2019.
Patients with increased odds of cesarean delivery were older (aged 35-39 years vs. 25-29 years, adjusted odds ratio 1.27), delivered in a hospital in the South vs. the Northeast of the United States (aOR 1.11), and were more likely to be non-Hispanic Black vs. non-Hispanic White (OR 1.23).
Notably, changes in nomenclature and interpretation of intrapartum electronic fetal heart monitoring occurred during the study period, with recommendations for the adoption of a three-tiered system for fetal heart rate patterns in 2008. “It is possible that current evidence and nomenclature related to intrapartum FHR interpretation may result in identification of a larger number of fetuses deemed at indeterminate risk for abnormal acid-base status,” the researchers wrote in their discussion.
The study findings were limited by several factors including the use of administrative discharge data rather than clinical records, the exclusion of patients with chronic conditions associated with cesarean delivery, changes in billing codes during the study period, and the inability to account for the effect of health factors, maternal age, and use of assisted reproductive technology, the researchers noted.
However, the results were strengthened by the large sample size and 20-year study period, as well as the stratification of labor arrest by stage, and suggest uptake of newer recommendations, they said. “Future reductions in cesarean deliveries among patients at low risk for cesarean delivery may be dependent on improved assessment of intrapartum fetal status,” they concluded.
Consider populations and outcomes in cesarean risk assessment
The decreasing rates of cesarean deliveries in the current study can be seen as positive, but more research is needed to examine maternal and neonatal outcomes, and to consider other conditions that affect risk for cesarean delivery, Paolo Ivo Cavoretto, MD, and Massimo Candiani, MD, of IRCCS San Raffaele Scientific Institute, and Antonio Farina, MD, of the University of Bologna, Italy, wrote in an accompanying editorial.
Notably, the study authors identified a population aged 15-39 years as low risk, and an increased risk for cesarean delivery within this range increased with age. “Maternal age remains a major risk factor associated with the risk of cesarean delivery, both from results of this study and those of previous analyses assessing its independence from other related risk factors,” the editorialists said.
The study findings also reflect the changes in standards for labor duration during the study period, they noted. The longer duration of labor may reduce cesarean delivery rates, but it is not without maternal and fetal-neonatal risks, they wrote.
“To be sure that the described trend of cesarean delivery rate reduction can be considered positive, there would be the theoretical need to analyze other maternal-fetal-neonatal outcomes (e.g., rates of operative deliveries, neonatal acidemia, intensive care unit use, maternal hemorrhage, pelvic floor trauma and dysfunction, and psychological distress),” the editorialists concluded.
More research needed to explore clinical decisions
“Reducing the cesarean delivery rate is a top priority, but evidence is lacking on an optimal rate that improves maternal and neonatal outcomes,” Iris Krishna, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Hospital quality and safety committees have been working to decrease cesarean deliveries amongst low-risk women, and identifying contemporary trends gives us insight on whether some of these efforts have translated to a lower cesarean delivery rate,” she said.
Dr. Krishna said she was not surprised by the higher cesarean section rate in the South. “The decision for cesarean delivery is multifaceted, and although this study was not able to assess clinical indications for cesarean delivery or maternal and fetal outcomes, we cannot ignore that social determinants of health contribute greatly to overall health outcomes,” she said. The trends in the current study further underscore the geographic disparities in access to health care present in the South, she added.
“This study notes that cesarean delivery for nonreassuring fetal status increased; however, nonreassuring fetal status as an indication for cesarean delivery can be subjective,” Dr. Krishna said. “Hospital quality and safety committees should consider reviewing the clinical scenarios that led to this decision to identify opportunities for improvement and further education,” she said.
“Defining contemporary trends in cesarean delivery for low-risk patients has merit, but the study findings should be interpreted with caution,” said Dr. Krishna, who is a member of the Ob.Gyn. News advisory board. More research is needed to define an optimal cesarean section rate that promotes positive maternal and fetal outcomes, and to determine whether identifying an optimal rate should be based on patient risk profiles, she said.
The study received no outside funding. Lead author Ms. Frappaolo had no financial conflicts to disclose; nor did the editorial authors or Dr. Krishna.
Although clinically indicated cesarean deliveries may improve outcomes for mothers and infants, “when not clinically indicated, cesarean delivery is a major surgical intervention that increases risk for adverse outcomes,” wrote Anna M. Frappaolo of Columbia University College of Physicians and Surgeons, New York, and colleagues.
The Healthy People 2030 campaign includes the reduction of cesarean deliveries, but trends in these procedures, especially with regard to diagnoses of labor arrest, have not been well studied, the researchers said.
In an analysis published in JAMA Network Open, the researchers reviewed delivery hospitalizations using data from the National Inpatient Sample from 2000 to 2019.
Births deemed low risk for cesarean delivery were identified by using criteria of the Society for Maternal-Fetal Medicine and additional criteria, and joinpoint regression analysis was used to estimate changes.
The researchers examined overall trends in cesarean deliveries as well as trends for three specific diagnoses: nonreassuring fetal status, labor arrest, and obstructed labor.
The final analysis included 40,517,867 deliveries; of these, 4,885,716 (12.1%) were cesarean deliveries.
Overall, cesarean deliveries in patients deemed at low risk increased from 9.7% in 2000 to 13.9% in 2009, then plateaued and decreased from 13.0% in 2012 to 11.1% in 2019. The average annual percentage change (AAPC) for cesarean delivery was 6.4% for the years from 2000 to 2005, 1.2% from 2005 to 2009, and −2.2% from 2009 to 2019.
Cesarean delivery for nonreassuring fetal status increased over the entire study period, from 3.4% in 2000 to 5.1% in 2019. By contrast, overall cesarean delivery for labor arrest increased from 3.6% in 2000 to a high of 4.8% in 2009, then decreased to 2.7% in 2019. Cesarean deliveries with a diagnosis of obstructed labor decreased from 0.9% in 2008 to 0.3% in 2019.
More specifically, cesarean deliveries for labor arrest in the active phase, latent phase, and second stage of labor increased from 1.5% to 2.1%, 1.1% to 1.5%, and 0.9% to 1.3%, respectively, from 2000 to 2009, and decreased from 2.1% to 1.7% for the active phase, from 1.5% to 1.2% for the latent phase, and from 1.2% to 0.9% for the second stage between 2010 and 2019.
Patients with increased odds of cesarean delivery were older (aged 35-39 years vs. 25-29 years, adjusted odds ratio 1.27), delivered in a hospital in the South vs. the Northeast of the United States (aOR 1.11), and were more likely to be non-Hispanic Black vs. non-Hispanic White (OR 1.23).
Notably, changes in nomenclature and interpretation of intrapartum electronic fetal heart monitoring occurred during the study period, with recommendations for the adoption of a three-tiered system for fetal heart rate patterns in 2008. “It is possible that current evidence and nomenclature related to intrapartum FHR interpretation may result in identification of a larger number of fetuses deemed at indeterminate risk for abnormal acid-base status,” the researchers wrote in their discussion.
The study findings were limited by several factors including the use of administrative discharge data rather than clinical records, the exclusion of patients with chronic conditions associated with cesarean delivery, changes in billing codes during the study period, and the inability to account for the effect of health factors, maternal age, and use of assisted reproductive technology, the researchers noted.
However, the results were strengthened by the large sample size and 20-year study period, as well as the stratification of labor arrest by stage, and suggest uptake of newer recommendations, they said. “Future reductions in cesarean deliveries among patients at low risk for cesarean delivery may be dependent on improved assessment of intrapartum fetal status,” they concluded.
Consider populations and outcomes in cesarean risk assessment
The decreasing rates of cesarean deliveries in the current study can be seen as positive, but more research is needed to examine maternal and neonatal outcomes, and to consider other conditions that affect risk for cesarean delivery, Paolo Ivo Cavoretto, MD, and Massimo Candiani, MD, of IRCCS San Raffaele Scientific Institute, and Antonio Farina, MD, of the University of Bologna, Italy, wrote in an accompanying editorial.
Notably, the study authors identified a population aged 15-39 years as low risk, and an increased risk for cesarean delivery within this range increased with age. “Maternal age remains a major risk factor associated with the risk of cesarean delivery, both from results of this study and those of previous analyses assessing its independence from other related risk factors,” the editorialists said.
The study findings also reflect the changes in standards for labor duration during the study period, they noted. The longer duration of labor may reduce cesarean delivery rates, but it is not without maternal and fetal-neonatal risks, they wrote.
“To be sure that the described trend of cesarean delivery rate reduction can be considered positive, there would be the theoretical need to analyze other maternal-fetal-neonatal outcomes (e.g., rates of operative deliveries, neonatal acidemia, intensive care unit use, maternal hemorrhage, pelvic floor trauma and dysfunction, and psychological distress),” the editorialists concluded.
More research needed to explore clinical decisions
“Reducing the cesarean delivery rate is a top priority, but evidence is lacking on an optimal rate that improves maternal and neonatal outcomes,” Iris Krishna, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Hospital quality and safety committees have been working to decrease cesarean deliveries amongst low-risk women, and identifying contemporary trends gives us insight on whether some of these efforts have translated to a lower cesarean delivery rate,” she said.
Dr. Krishna said she was not surprised by the higher cesarean section rate in the South. “The decision for cesarean delivery is multifaceted, and although this study was not able to assess clinical indications for cesarean delivery or maternal and fetal outcomes, we cannot ignore that social determinants of health contribute greatly to overall health outcomes,” she said. The trends in the current study further underscore the geographic disparities in access to health care present in the South, she added.
“This study notes that cesarean delivery for nonreassuring fetal status increased; however, nonreassuring fetal status as an indication for cesarean delivery can be subjective,” Dr. Krishna said. “Hospital quality and safety committees should consider reviewing the clinical scenarios that led to this decision to identify opportunities for improvement and further education,” she said.
“Defining contemporary trends in cesarean delivery for low-risk patients has merit, but the study findings should be interpreted with caution,” said Dr. Krishna, who is a member of the Ob.Gyn. News advisory board. More research is needed to define an optimal cesarean section rate that promotes positive maternal and fetal outcomes, and to determine whether identifying an optimal rate should be based on patient risk profiles, she said.
The study received no outside funding. Lead author Ms. Frappaolo had no financial conflicts to disclose; nor did the editorial authors or Dr. Krishna.
Although clinically indicated cesarean deliveries may improve outcomes for mothers and infants, “when not clinically indicated, cesarean delivery is a major surgical intervention that increases risk for adverse outcomes,” wrote Anna M. Frappaolo of Columbia University College of Physicians and Surgeons, New York, and colleagues.
The Healthy People 2030 campaign includes the reduction of cesarean deliveries, but trends in these procedures, especially with regard to diagnoses of labor arrest, have not been well studied, the researchers said.
In an analysis published in JAMA Network Open, the researchers reviewed delivery hospitalizations using data from the National Inpatient Sample from 2000 to 2019.
Births deemed low risk for cesarean delivery were identified by using criteria of the Society for Maternal-Fetal Medicine and additional criteria, and joinpoint regression analysis was used to estimate changes.
The researchers examined overall trends in cesarean deliveries as well as trends for three specific diagnoses: nonreassuring fetal status, labor arrest, and obstructed labor.
The final analysis included 40,517,867 deliveries; of these, 4,885,716 (12.1%) were cesarean deliveries.
Overall, cesarean deliveries in patients deemed at low risk increased from 9.7% in 2000 to 13.9% in 2009, then plateaued and decreased from 13.0% in 2012 to 11.1% in 2019. The average annual percentage change (AAPC) for cesarean delivery was 6.4% for the years from 2000 to 2005, 1.2% from 2005 to 2009, and −2.2% from 2009 to 2019.
Cesarean delivery for nonreassuring fetal status increased over the entire study period, from 3.4% in 2000 to 5.1% in 2019. By contrast, overall cesarean delivery for labor arrest increased from 3.6% in 2000 to a high of 4.8% in 2009, then decreased to 2.7% in 2019. Cesarean deliveries with a diagnosis of obstructed labor decreased from 0.9% in 2008 to 0.3% in 2019.
More specifically, cesarean deliveries for labor arrest in the active phase, latent phase, and second stage of labor increased from 1.5% to 2.1%, 1.1% to 1.5%, and 0.9% to 1.3%, respectively, from 2000 to 2009, and decreased from 2.1% to 1.7% for the active phase, from 1.5% to 1.2% for the latent phase, and from 1.2% to 0.9% for the second stage between 2010 and 2019.
Patients with increased odds of cesarean delivery were older (aged 35-39 years vs. 25-29 years, adjusted odds ratio 1.27), delivered in a hospital in the South vs. the Northeast of the United States (aOR 1.11), and were more likely to be non-Hispanic Black vs. non-Hispanic White (OR 1.23).
Notably, changes in nomenclature and interpretation of intrapartum electronic fetal heart monitoring occurred during the study period, with recommendations for the adoption of a three-tiered system for fetal heart rate patterns in 2008. “It is possible that current evidence and nomenclature related to intrapartum FHR interpretation may result in identification of a larger number of fetuses deemed at indeterminate risk for abnormal acid-base status,” the researchers wrote in their discussion.
The study findings were limited by several factors including the use of administrative discharge data rather than clinical records, the exclusion of patients with chronic conditions associated with cesarean delivery, changes in billing codes during the study period, and the inability to account for the effect of health factors, maternal age, and use of assisted reproductive technology, the researchers noted.
However, the results were strengthened by the large sample size and 20-year study period, as well as the stratification of labor arrest by stage, and suggest uptake of newer recommendations, they said. “Future reductions in cesarean deliveries among patients at low risk for cesarean delivery may be dependent on improved assessment of intrapartum fetal status,” they concluded.
Consider populations and outcomes in cesarean risk assessment
The decreasing rates of cesarean deliveries in the current study can be seen as positive, but more research is needed to examine maternal and neonatal outcomes, and to consider other conditions that affect risk for cesarean delivery, Paolo Ivo Cavoretto, MD, and Massimo Candiani, MD, of IRCCS San Raffaele Scientific Institute, and Antonio Farina, MD, of the University of Bologna, Italy, wrote in an accompanying editorial.
Notably, the study authors identified a population aged 15-39 years as low risk, and an increased risk for cesarean delivery within this range increased with age. “Maternal age remains a major risk factor associated with the risk of cesarean delivery, both from results of this study and those of previous analyses assessing its independence from other related risk factors,” the editorialists said.
The study findings also reflect the changes in standards for labor duration during the study period, they noted. The longer duration of labor may reduce cesarean delivery rates, but it is not without maternal and fetal-neonatal risks, they wrote.
“To be sure that the described trend of cesarean delivery rate reduction can be considered positive, there would be the theoretical need to analyze other maternal-fetal-neonatal outcomes (e.g., rates of operative deliveries, neonatal acidemia, intensive care unit use, maternal hemorrhage, pelvic floor trauma and dysfunction, and psychological distress),” the editorialists concluded.
More research needed to explore clinical decisions
“Reducing the cesarean delivery rate is a top priority, but evidence is lacking on an optimal rate that improves maternal and neonatal outcomes,” Iris Krishna, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Hospital quality and safety committees have been working to decrease cesarean deliveries amongst low-risk women, and identifying contemporary trends gives us insight on whether some of these efforts have translated to a lower cesarean delivery rate,” she said.
Dr. Krishna said she was not surprised by the higher cesarean section rate in the South. “The decision for cesarean delivery is multifaceted, and although this study was not able to assess clinical indications for cesarean delivery or maternal and fetal outcomes, we cannot ignore that social determinants of health contribute greatly to overall health outcomes,” she said. The trends in the current study further underscore the geographic disparities in access to health care present in the South, she added.
“This study notes that cesarean delivery for nonreassuring fetal status increased; however, nonreassuring fetal status as an indication for cesarean delivery can be subjective,” Dr. Krishna said. “Hospital quality and safety committees should consider reviewing the clinical scenarios that led to this decision to identify opportunities for improvement and further education,” she said.
“Defining contemporary trends in cesarean delivery for low-risk patients has merit, but the study findings should be interpreted with caution,” said Dr. Krishna, who is a member of the Ob.Gyn. News advisory board. More research is needed to define an optimal cesarean section rate that promotes positive maternal and fetal outcomes, and to determine whether identifying an optimal rate should be based on patient risk profiles, she said.
The study received no outside funding. Lead author Ms. Frappaolo had no financial conflicts to disclose; nor did the editorial authors or Dr. Krishna.
FROM JAMA NETWORK OPEN
High-dose prophylactic anticoagulation benefits patients with COVID-19 pneumonia
High-dose prophylactic anticoagulation or therapeutic anticoagulation reduced de novo thrombosis in patients with hypoxemic COVID-19 pneumonia, based on data from 334 adults.
Patients with hypoxemic COVID-19 pneumonia are at increased risk of thrombosis and anticoagulation-related bleeding, therefore data to identify the lowest effective anticoagulant dose are needed, wrote Vincent Labbé, MD, of Sorbonne University, Paris, and colleagues.
Previous studies of different anticoagulation strategies for noncritically ill and critically ill patients with COVID-19 pneumonia have shown contrasting results, but some institutions recommend a high-dose regimen in the wake of data showing macrovascular thrombosis in patients with COVID-19 who were treated with standard anticoagulation, the authors wrote.
However, no previously published studies have compared the effectiveness of the three anticoagulation strategies: high-dose prophylactic anticoagulation (HD-PA), standard dose prophylactic anticoagulation (SD-PA), and therapeutic anticoagulation (TA), they said.
In the open-label Anticoagulation COVID-19 (ANTICOVID) trial, published in JAMA Internal Medicine, the researchers identified consecutively hospitalized adults aged 18 years and older being treated for hypoxemic COVID-19 pneumonia in 23 centers in France between April 2021 and December 2021.
The patients were randomly assigned to SD-PA (116 patients), HD-PA (111 patients), and TA (112 patients) using low-molecular-weight heparin for 14 days, or until either hospital discharge or weaning from supplemental oxygen for 48 consecutive hours, whichever outcome occurred first. The HD-PA patients received two times the SD-PA dose. The mean age of the patients was 58.3 years, and approximately two-thirds were men; race and ethnicity data were not collected. Participants had no macrovascular thrombosis at the start of the study.
The primary outcomes were all-cause mortality and time to clinical improvement (defined as the time from randomization to a 2-point improvement on a 7-category respiratory function scale).
The secondary outcome was a combination of safety and efficacy at day 28 that included a composite of thrombosis (ischemic stroke, noncerebrovascular arterial thrombosis, deep venous thrombosis, pulmonary artery thrombosis, and central venous catheter–related deep venous thrombosis), major bleeding, or all-cause death.
For the primary outcome, results were similar among the groups; HD-PA had no significant benefit over SD-PA or TA. All-cause death rates for SD-PA, HD-PA, and TA patients were 14%, 12%, and 13%, respectively. The time to clinical improvement for the three groups was approximately 8 days, 9 days, and 8 days, respectively. Results for the primary outcome were consistent across all prespecified subgroups.
However, HD-PA was associated with a significant fourfold reduced risk of de novo thrombosis compared with SD-PA (5.5% vs. 20.2%) with no observed increase in major bleeding. TA was not associated with any significant improvement in primary or secondary outcomes compared with HD-PA or SD-PA.
The current study findings of no improvement in survival or disease resolution in patients with a higher anticoagulant dose reflects data from previous studies, the researchers wrote in their discussion. “Our study results together with those of previous RCTs support the premise that the role of microvascular thrombosis in worsening organ dysfunction may be narrower than estimated,” they said.
The findings were limited by several factors including the open-label design and the relatively small sample size, the lack of data on microvascular (vs. macrovascular) thrombosis at baseline, and the predominance of the Delta variant of COVID-19 among the study participants, which may have contributed to a lower mortality rate, the researchers noted.
However, given the significant reduction in de novo thrombosis, the results support the routine use of HD-PA in patients with severe hypoxemic COVID-19 pneumonia, they concluded.
Results inform current clinical practice
Over the course of the COVID-19 pandemic, “Patients hospitalized with COVID-19 manifested the highest risk for thromboembolic complications, especially patients in the intensive care setting,” and early reports suggested that standard prophylactic doses of anticoagulant therapy might be insufficient to prevent thrombotic events, Richard C. Becker, MD, of the University of Cincinnati, and Thomas L. Ortel, MD, of Duke University, Durham, N.C., wrote in an accompanying editorial.
“Although there have been several studies that have investigated the role of anticoagulant therapy in hospitalized patients with COVID-19, this is the first study that specifically compared a standard, prophylactic dose of low-molecular-weight heparin to a ‘high-dose’ prophylactic regimen and to a full therapeutic dose regimen,” Dr. Ortel said in an interview.
“Given the concerns about an increased thrombotic risk with prophylactic dose anticoagulation, and the potential bleeding risk associated with a full therapeutic dose of anticoagulation, this approach enabled the investigators to explore the efficacy and safety of an intermediate dose between these two extremes,” he said.
In the current study, , a finding that was not observed in other studies investigating anticoagulant therapy in hospitalized patients with severe COVID-19,” Dr. Ortel told this news organization. “Much initial concern about progression of disease in patients hospitalized with severe COVID-19 focused on the role of microvascular thrombosis, which appears to be less important in this process, or, alternatively, less responsive to anticoagulant therapy.”
The clinical takeaway from the study, Dr. Ortel said, is the decreased risk for venous thromboembolism with a high-dose prophylactic anticoagulation strategy compared with a standard-dose prophylactic regimen for patients hospitalized with hypoxemic COVID-19 pneumonia, “leading to an improved net clinical outcome.”
Looking ahead, “Additional research is needed to determine whether a higher dose of prophylactic anticoagulation would be beneficial for patients hospitalized with COVID-19 pneumonia who are not in an intensive care unit setting,” Dr. Ortel said. Studies are needed to determine whether therapeutic interventions are equally beneficial in patients with different coronavirus variants, since most patients in the current study were infected with the Delta variant, he added.
The study was supported by LEO Pharma. Dr. Labbé disclosed grants from LEO Pharma during the study and fees from AOP Health unrelated to the current study.
Dr. Becker disclosed personal fees from Novartis Data Safety Monitoring Board, Ionis Data Safety Monitoring Board, and Basking Biosciences Scientific Advisory Board unrelated to the current study. Dr. Ortel disclosed grants from the National Institutes of Health, Instrumentation Laboratory, Stago, and Siemens; contract fees from the Centers for Disease Control and Prevention; and honoraria from UpToDate unrelated to the current study.
A version of this article originally appeared on Medscape.com.
High-dose prophylactic anticoagulation or therapeutic anticoagulation reduced de novo thrombosis in patients with hypoxemic COVID-19 pneumonia, based on data from 334 adults.
Patients with hypoxemic COVID-19 pneumonia are at increased risk of thrombosis and anticoagulation-related bleeding, therefore data to identify the lowest effective anticoagulant dose are needed, wrote Vincent Labbé, MD, of Sorbonne University, Paris, and colleagues.
Previous studies of different anticoagulation strategies for noncritically ill and critically ill patients with COVID-19 pneumonia have shown contrasting results, but some institutions recommend a high-dose regimen in the wake of data showing macrovascular thrombosis in patients with COVID-19 who were treated with standard anticoagulation, the authors wrote.
However, no previously published studies have compared the effectiveness of the three anticoagulation strategies: high-dose prophylactic anticoagulation (HD-PA), standard dose prophylactic anticoagulation (SD-PA), and therapeutic anticoagulation (TA), they said.
In the open-label Anticoagulation COVID-19 (ANTICOVID) trial, published in JAMA Internal Medicine, the researchers identified consecutively hospitalized adults aged 18 years and older being treated for hypoxemic COVID-19 pneumonia in 23 centers in France between April 2021 and December 2021.
The patients were randomly assigned to SD-PA (116 patients), HD-PA (111 patients), and TA (112 patients) using low-molecular-weight heparin for 14 days, or until either hospital discharge or weaning from supplemental oxygen for 48 consecutive hours, whichever outcome occurred first. The HD-PA patients received two times the SD-PA dose. The mean age of the patients was 58.3 years, and approximately two-thirds were men; race and ethnicity data were not collected. Participants had no macrovascular thrombosis at the start of the study.
The primary outcomes were all-cause mortality and time to clinical improvement (defined as the time from randomization to a 2-point improvement on a 7-category respiratory function scale).
The secondary outcome was a combination of safety and efficacy at day 28 that included a composite of thrombosis (ischemic stroke, noncerebrovascular arterial thrombosis, deep venous thrombosis, pulmonary artery thrombosis, and central venous catheter–related deep venous thrombosis), major bleeding, or all-cause death.
For the primary outcome, results were similar among the groups; HD-PA had no significant benefit over SD-PA or TA. All-cause death rates for SD-PA, HD-PA, and TA patients were 14%, 12%, and 13%, respectively. The time to clinical improvement for the three groups was approximately 8 days, 9 days, and 8 days, respectively. Results for the primary outcome were consistent across all prespecified subgroups.
However, HD-PA was associated with a significant fourfold reduced risk of de novo thrombosis compared with SD-PA (5.5% vs. 20.2%) with no observed increase in major bleeding. TA was not associated with any significant improvement in primary or secondary outcomes compared with HD-PA or SD-PA.
The current study findings of no improvement in survival or disease resolution in patients with a higher anticoagulant dose reflects data from previous studies, the researchers wrote in their discussion. “Our study results together with those of previous RCTs support the premise that the role of microvascular thrombosis in worsening organ dysfunction may be narrower than estimated,” they said.
The findings were limited by several factors including the open-label design and the relatively small sample size, the lack of data on microvascular (vs. macrovascular) thrombosis at baseline, and the predominance of the Delta variant of COVID-19 among the study participants, which may have contributed to a lower mortality rate, the researchers noted.
However, given the significant reduction in de novo thrombosis, the results support the routine use of HD-PA in patients with severe hypoxemic COVID-19 pneumonia, they concluded.
Results inform current clinical practice
Over the course of the COVID-19 pandemic, “Patients hospitalized with COVID-19 manifested the highest risk for thromboembolic complications, especially patients in the intensive care setting,” and early reports suggested that standard prophylactic doses of anticoagulant therapy might be insufficient to prevent thrombotic events, Richard C. Becker, MD, of the University of Cincinnati, and Thomas L. Ortel, MD, of Duke University, Durham, N.C., wrote in an accompanying editorial.
“Although there have been several studies that have investigated the role of anticoagulant therapy in hospitalized patients with COVID-19, this is the first study that specifically compared a standard, prophylactic dose of low-molecular-weight heparin to a ‘high-dose’ prophylactic regimen and to a full therapeutic dose regimen,” Dr. Ortel said in an interview.
“Given the concerns about an increased thrombotic risk with prophylactic dose anticoagulation, and the potential bleeding risk associated with a full therapeutic dose of anticoagulation, this approach enabled the investigators to explore the efficacy and safety of an intermediate dose between these two extremes,” he said.
In the current study, , a finding that was not observed in other studies investigating anticoagulant therapy in hospitalized patients with severe COVID-19,” Dr. Ortel told this news organization. “Much initial concern about progression of disease in patients hospitalized with severe COVID-19 focused on the role of microvascular thrombosis, which appears to be less important in this process, or, alternatively, less responsive to anticoagulant therapy.”
The clinical takeaway from the study, Dr. Ortel said, is the decreased risk for venous thromboembolism with a high-dose prophylactic anticoagulation strategy compared with a standard-dose prophylactic regimen for patients hospitalized with hypoxemic COVID-19 pneumonia, “leading to an improved net clinical outcome.”
Looking ahead, “Additional research is needed to determine whether a higher dose of prophylactic anticoagulation would be beneficial for patients hospitalized with COVID-19 pneumonia who are not in an intensive care unit setting,” Dr. Ortel said. Studies are needed to determine whether therapeutic interventions are equally beneficial in patients with different coronavirus variants, since most patients in the current study were infected with the Delta variant, he added.
The study was supported by LEO Pharma. Dr. Labbé disclosed grants from LEO Pharma during the study and fees from AOP Health unrelated to the current study.
Dr. Becker disclosed personal fees from Novartis Data Safety Monitoring Board, Ionis Data Safety Monitoring Board, and Basking Biosciences Scientific Advisory Board unrelated to the current study. Dr. Ortel disclosed grants from the National Institutes of Health, Instrumentation Laboratory, Stago, and Siemens; contract fees from the Centers for Disease Control and Prevention; and honoraria from UpToDate unrelated to the current study.
A version of this article originally appeared on Medscape.com.
High-dose prophylactic anticoagulation or therapeutic anticoagulation reduced de novo thrombosis in patients with hypoxemic COVID-19 pneumonia, based on data from 334 adults.
Patients with hypoxemic COVID-19 pneumonia are at increased risk of thrombosis and anticoagulation-related bleeding, therefore data to identify the lowest effective anticoagulant dose are needed, wrote Vincent Labbé, MD, of Sorbonne University, Paris, and colleagues.
Previous studies of different anticoagulation strategies for noncritically ill and critically ill patients with COVID-19 pneumonia have shown contrasting results, but some institutions recommend a high-dose regimen in the wake of data showing macrovascular thrombosis in patients with COVID-19 who were treated with standard anticoagulation, the authors wrote.
However, no previously published studies have compared the effectiveness of the three anticoagulation strategies: high-dose prophylactic anticoagulation (HD-PA), standard dose prophylactic anticoagulation (SD-PA), and therapeutic anticoagulation (TA), they said.
In the open-label Anticoagulation COVID-19 (ANTICOVID) trial, published in JAMA Internal Medicine, the researchers identified consecutively hospitalized adults aged 18 years and older being treated for hypoxemic COVID-19 pneumonia in 23 centers in France between April 2021 and December 2021.
The patients were randomly assigned to SD-PA (116 patients), HD-PA (111 patients), and TA (112 patients) using low-molecular-weight heparin for 14 days, or until either hospital discharge or weaning from supplemental oxygen for 48 consecutive hours, whichever outcome occurred first. The HD-PA patients received two times the SD-PA dose. The mean age of the patients was 58.3 years, and approximately two-thirds were men; race and ethnicity data were not collected. Participants had no macrovascular thrombosis at the start of the study.
The primary outcomes were all-cause mortality and time to clinical improvement (defined as the time from randomization to a 2-point improvement on a 7-category respiratory function scale).
The secondary outcome was a combination of safety and efficacy at day 28 that included a composite of thrombosis (ischemic stroke, noncerebrovascular arterial thrombosis, deep venous thrombosis, pulmonary artery thrombosis, and central venous catheter–related deep venous thrombosis), major bleeding, or all-cause death.
For the primary outcome, results were similar among the groups; HD-PA had no significant benefit over SD-PA or TA. All-cause death rates for SD-PA, HD-PA, and TA patients were 14%, 12%, and 13%, respectively. The time to clinical improvement for the three groups was approximately 8 days, 9 days, and 8 days, respectively. Results for the primary outcome were consistent across all prespecified subgroups.
However, HD-PA was associated with a significant fourfold reduced risk of de novo thrombosis compared with SD-PA (5.5% vs. 20.2%) with no observed increase in major bleeding. TA was not associated with any significant improvement in primary or secondary outcomes compared with HD-PA or SD-PA.
The current study findings of no improvement in survival or disease resolution in patients with a higher anticoagulant dose reflects data from previous studies, the researchers wrote in their discussion. “Our study results together with those of previous RCTs support the premise that the role of microvascular thrombosis in worsening organ dysfunction may be narrower than estimated,” they said.
The findings were limited by several factors including the open-label design and the relatively small sample size, the lack of data on microvascular (vs. macrovascular) thrombosis at baseline, and the predominance of the Delta variant of COVID-19 among the study participants, which may have contributed to a lower mortality rate, the researchers noted.
However, given the significant reduction in de novo thrombosis, the results support the routine use of HD-PA in patients with severe hypoxemic COVID-19 pneumonia, they concluded.
Results inform current clinical practice
Over the course of the COVID-19 pandemic, “Patients hospitalized with COVID-19 manifested the highest risk for thromboembolic complications, especially patients in the intensive care setting,” and early reports suggested that standard prophylactic doses of anticoagulant therapy might be insufficient to prevent thrombotic events, Richard C. Becker, MD, of the University of Cincinnati, and Thomas L. Ortel, MD, of Duke University, Durham, N.C., wrote in an accompanying editorial.
“Although there have been several studies that have investigated the role of anticoagulant therapy in hospitalized patients with COVID-19, this is the first study that specifically compared a standard, prophylactic dose of low-molecular-weight heparin to a ‘high-dose’ prophylactic regimen and to a full therapeutic dose regimen,” Dr. Ortel said in an interview.
“Given the concerns about an increased thrombotic risk with prophylactic dose anticoagulation, and the potential bleeding risk associated with a full therapeutic dose of anticoagulation, this approach enabled the investigators to explore the efficacy and safety of an intermediate dose between these two extremes,” he said.
In the current study, , a finding that was not observed in other studies investigating anticoagulant therapy in hospitalized patients with severe COVID-19,” Dr. Ortel told this news organization. “Much initial concern about progression of disease in patients hospitalized with severe COVID-19 focused on the role of microvascular thrombosis, which appears to be less important in this process, or, alternatively, less responsive to anticoagulant therapy.”
The clinical takeaway from the study, Dr. Ortel said, is the decreased risk for venous thromboembolism with a high-dose prophylactic anticoagulation strategy compared with a standard-dose prophylactic regimen for patients hospitalized with hypoxemic COVID-19 pneumonia, “leading to an improved net clinical outcome.”
Looking ahead, “Additional research is needed to determine whether a higher dose of prophylactic anticoagulation would be beneficial for patients hospitalized with COVID-19 pneumonia who are not in an intensive care unit setting,” Dr. Ortel said. Studies are needed to determine whether therapeutic interventions are equally beneficial in patients with different coronavirus variants, since most patients in the current study were infected with the Delta variant, he added.
The study was supported by LEO Pharma. Dr. Labbé disclosed grants from LEO Pharma during the study and fees from AOP Health unrelated to the current study.
Dr. Becker disclosed personal fees from Novartis Data Safety Monitoring Board, Ionis Data Safety Monitoring Board, and Basking Biosciences Scientific Advisory Board unrelated to the current study. Dr. Ortel disclosed grants from the National Institutes of Health, Instrumentation Laboratory, Stago, and Siemens; contract fees from the Centers for Disease Control and Prevention; and honoraria from UpToDate unrelated to the current study.
A version of this article originally appeared on Medscape.com.