Heidi Splete

Maternal mortality is a public health crisis for all women, said Elizabeth A. Howell, MD, of the University of Pennsylvania, Philadelphia, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

The maternal mortality rate in the United States in 2018 was 17.4 maternal deaths per 100,000 live births, according to data from the Centers for Disease Control and Prevention, Dr. Howell said. Maternal mortality is defined as death during pregnancy or within 42 days of delivery; pregnancy-related mortality includes death during pregnancy or within 1 year of pregnancy, from pregnancy or as a result of any cause related to, or aggravated by, pregnancy, according to the CDC.

However, “Black women are two to three times more likely than White women to die from a pregnancy-related cause,” Dr. Howell said. These disparities are even more marked in some cities; data show that Black women in New York City are eight times more likely than White women to die from a pregnancy-related cause, she noted.

Pregnancy-related mortality persists regardless of education level, and remains significantly higher in Black women, compared with White women with at least a college degree, Dr. Howell added.

In her presentation, Dr. Howell reviewed some top causes of maternal mortality overall, and potential factors driving disparities. Data from the CDC show cardiomyopathy, cardiovascular conditions, and preeclampsia/eclampsia as the top three underlying causes of pregnancy-related deaths among non-Hispanic Black women, compared with mental health conditions, cardiovascular conditions, and hemorrhage in non-Hispanic White women, Dr. Howell said.

To help prevent maternal mortality across all populations, “It is important for us to think about the timing of deaths so we can better understand the causes,” said Dr. Howell.

CDC Vital Signs data show that approximately one-third of pregnancy-related deaths occur during pregnancy, but approximately 20% occur between 43 and 365 days postpartum, she said.

Although cardiovascular conditions top the list of clinical causes of pregnancy-related maternal mortality, maternal self-harm should not be discounted, and is likely underreported, Dr. Howell said. Data show that the peak incidence of maternal suicide occurs between 9 and 12 months’ postpartum, and risk factors include major depression, substance use disorder, and intimate partner violence, she noted.

Dr. Howell then shared the results of studies she conducted in 2020 and 2016 on racial disparities, hospital quality, and maternal mortality. One of her key findings in the 2020 study, presented at this year’s virtual meeting of the American College of Obstetricians and Gynecologists, showed that women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity, and an accompanying simulation/thought exercise showed that the hospital of delivery accounted for approximately half of the disparity in severe maternal morbidity between Black and White women. An earlier study she published in 2016 of between-hospital differences in New York City showed that Black and Latina women were significantly more likely than White women to deliver in hospitals with higher rates of severe maternal mortality.

These findings illustrate that “racial segregation in neighborhoods is also part of the story,” of maternal mortality, Dr. Howell said.

Dr. Howell outlined ways the health care community can reduce severe maternal morbidity and mortality for all women, including promoting contraception and preconception health, improving postpartum management, eliminating bias, and using patient navigators as needed to enhance communication among the care team,

“Think about ways to engage the community,” in support of women’s pregnancy health, Dr. Howell said. She also emphasized the need to enroll more pregnant women in clinical trials.
 

Don’t exclude pregnant women from trials

In a follow-up session, Cynthia Gyamfi-Bannerman, MD, of the University of California, San Diego, expanded on opportunities to include pregnant women in clinical research.

Clinical trials for pregnant people fall into two categories, she noted; those studying interventions to improve pregnancy outcomes and those studying interventions for common medical conditions that coexist with pregnancy. These trials are either initiated by the investigators, conducted under contract, or federally funded, Dr. Gyamfi-Bannerman said. Currently, the only obstetric clinical trials research network is the Maternal-Fetal Medicine Units Network, established in 1986 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The MFMU has conducted significant and life-saving research, but “we need more networks to focus on researching pregnancy complications,” Dr. Gyamfi-Bannerman said. Once the infrastructure exists in multiple settings, the ability to conduct trials will improve, she said.

Dr. Gyamfi-Bannerman stressed the need to engage and involve community-based physicians in clinical trials; using those relationships to enroll a more diverse population for whom working with their local physician would be more feasible than traveling to a larger clinical trial center.

She also commented on the need to include pregnant women in nonobstetric clinical trials. The exclusion of pregnant women from COVID-19 vaccine trials left clinicians with no information for guiding pregnant patients, she said. “It is important to think about why we are excluding pregnant women,” she said.

Finally, Dr. Gyamfi-Bannerman recommended a national effort to coordinate and leverage EHR data, which could have an effect on reducing maternal morbidity by facilitating the study of nonobstetric interventions in pregnancy, such as behavior interventions and mental health care.

Dr. Howell and Dr. Gyamfi-Bannerman had no financial conflicts to disclose.
 

Maternal mortality is a public health crisis for all women, said Elizabeth A. Howell, MD, of the University of Pennsylvania, Philadelphia, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

The maternal mortality rate in the United States in 2018 was 17.4 maternal deaths per 100,000 live births, according to data from the Centers for Disease Control and Prevention, Dr. Howell said. Maternal mortality is defined as death during pregnancy or within 42 days of delivery; pregnancy-related mortality includes death during pregnancy or within 1 year of pregnancy, from pregnancy or as a result of any cause related to, or aggravated by, pregnancy, according to the CDC.

However, “Black women are two to three times more likely than White women to die from a pregnancy-related cause,” Dr. Howell said. These disparities are even more marked in some cities; data show that Black women in New York City are eight times more likely than White women to die from a pregnancy-related cause, she noted.

Pregnancy-related mortality persists regardless of education level, and remains significantly higher in Black women, compared with White women with at least a college degree, Dr. Howell added.

In her presentation, Dr. Howell reviewed some top causes of maternal mortality overall, and potential factors driving disparities. Data from the CDC show cardiomyopathy, cardiovascular conditions, and preeclampsia/eclampsia as the top three underlying causes of pregnancy-related deaths among non-Hispanic Black women, compared with mental health conditions, cardiovascular conditions, and hemorrhage in non-Hispanic White women, Dr. Howell said.

To help prevent maternal mortality across all populations, “It is important for us to think about the timing of deaths so we can better understand the causes,” said Dr. Howell.

CDC Vital Signs data show that approximately one-third of pregnancy-related deaths occur during pregnancy, but approximately 20% occur between 43 and 365 days postpartum, she said.

Although cardiovascular conditions top the list of clinical causes of pregnancy-related maternal mortality, maternal self-harm should not be discounted, and is likely underreported, Dr. Howell said. Data show that the peak incidence of maternal suicide occurs between 9 and 12 months’ postpartum, and risk factors include major depression, substance use disorder, and intimate partner violence, she noted.

Dr. Howell then shared the results of studies she conducted in 2020 and 2016 on racial disparities, hospital quality, and maternal mortality. One of her key findings in the 2020 study, presented at this year’s virtual meeting of the American College of Obstetricians and Gynecologists, showed that women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity, and an accompanying simulation/thought exercise showed that the hospital of delivery accounted for approximately half of the disparity in severe maternal morbidity between Black and White women. An earlier study she published in 2016 of between-hospital differences in New York City showed that Black and Latina women were significantly more likely than White women to deliver in hospitals with higher rates of severe maternal mortality.

These findings illustrate that “racial segregation in neighborhoods is also part of the story,” of maternal mortality, Dr. Howell said.

Dr. Howell outlined ways the health care community can reduce severe maternal morbidity and mortality for all women, including promoting contraception and preconception health, improving postpartum management, eliminating bias, and using patient navigators as needed to enhance communication among the care team,

“Think about ways to engage the community,” in support of women’s pregnancy health, Dr. Howell said. She also emphasized the need to enroll more pregnant women in clinical trials.
 

Don’t exclude pregnant women from trials

In a follow-up session, Cynthia Gyamfi-Bannerman, MD, of the University of California, San Diego, expanded on opportunities to include pregnant women in clinical research.

Clinical trials for pregnant people fall into two categories, she noted; those studying interventions to improve pregnancy outcomes and those studying interventions for common medical conditions that coexist with pregnancy. These trials are either initiated by the investigators, conducted under contract, or federally funded, Dr. Gyamfi-Bannerman said. Currently, the only obstetric clinical trials research network is the Maternal-Fetal Medicine Units Network, established in 1986 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The MFMU has conducted significant and life-saving research, but “we need more networks to focus on researching pregnancy complications,” Dr. Gyamfi-Bannerman said. Once the infrastructure exists in multiple settings, the ability to conduct trials will improve, she said.

Dr. Gyamfi-Bannerman stressed the need to engage and involve community-based physicians in clinical trials; using those relationships to enroll a more diverse population for whom working with their local physician would be more feasible than traveling to a larger clinical trial center.

She also commented on the need to include pregnant women in nonobstetric clinical trials. The exclusion of pregnant women from COVID-19 vaccine trials left clinicians with no information for guiding pregnant patients, she said. “It is important to think about why we are excluding pregnant women,” she said.

Finally, Dr. Gyamfi-Bannerman recommended a national effort to coordinate and leverage EHR data, which could have an effect on reducing maternal morbidity by facilitating the study of nonobstetric interventions in pregnancy, such as behavior interventions and mental health care.

Dr. Howell and Dr. Gyamfi-Bannerman had no financial conflicts to disclose.
 

Maternal mortality is a public health crisis for all women, said Elizabeth A. Howell, MD, of the University of Pennsylvania, Philadelphia, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

The maternal mortality rate in the United States in 2018 was 17.4 maternal deaths per 100,000 live births, according to data from the Centers for Disease Control and Prevention, Dr. Howell said. Maternal mortality is defined as death during pregnancy or within 42 days of delivery; pregnancy-related mortality includes death during pregnancy or within 1 year of pregnancy, from pregnancy or as a result of any cause related to, or aggravated by, pregnancy, according to the CDC.

However, “Black women are two to three times more likely than White women to die from a pregnancy-related cause,” Dr. Howell said. These disparities are even more marked in some cities; data show that Black women in New York City are eight times more likely than White women to die from a pregnancy-related cause, she noted.

Pregnancy-related mortality persists regardless of education level, and remains significantly higher in Black women, compared with White women with at least a college degree, Dr. Howell added.

In her presentation, Dr. Howell reviewed some top causes of maternal mortality overall, and potential factors driving disparities. Data from the CDC show cardiomyopathy, cardiovascular conditions, and preeclampsia/eclampsia as the top three underlying causes of pregnancy-related deaths among non-Hispanic Black women, compared with mental health conditions, cardiovascular conditions, and hemorrhage in non-Hispanic White women, Dr. Howell said.

To help prevent maternal mortality across all populations, “It is important for us to think about the timing of deaths so we can better understand the causes,” said Dr. Howell.

CDC Vital Signs data show that approximately one-third of pregnancy-related deaths occur during pregnancy, but approximately 20% occur between 43 and 365 days postpartum, she said.

Although cardiovascular conditions top the list of clinical causes of pregnancy-related maternal mortality, maternal self-harm should not be discounted, and is likely underreported, Dr. Howell said. Data show that the peak incidence of maternal suicide occurs between 9 and 12 months’ postpartum, and risk factors include major depression, substance use disorder, and intimate partner violence, she noted.

Dr. Howell then shared the results of studies she conducted in 2020 and 2016 on racial disparities, hospital quality, and maternal mortality. One of her key findings in the 2020 study, presented at this year’s virtual meeting of the American College of Obstetricians and Gynecologists, showed that women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity, and an accompanying simulation/thought exercise showed that the hospital of delivery accounted for approximately half of the disparity in severe maternal morbidity between Black and White women. An earlier study she published in 2016 of between-hospital differences in New York City showed that Black and Latina women were significantly more likely than White women to deliver in hospitals with higher rates of severe maternal mortality.

These findings illustrate that “racial segregation in neighborhoods is also part of the story,” of maternal mortality, Dr. Howell said.

Dr. Howell outlined ways the health care community can reduce severe maternal morbidity and mortality for all women, including promoting contraception and preconception health, improving postpartum management, eliminating bias, and using patient navigators as needed to enhance communication among the care team,

“Think about ways to engage the community,” in support of women’s pregnancy health, Dr. Howell said. She also emphasized the need to enroll more pregnant women in clinical trials.
 

Don’t exclude pregnant women from trials

In a follow-up session, Cynthia Gyamfi-Bannerman, MD, of the University of California, San Diego, expanded on opportunities to include pregnant women in clinical research.

Clinical trials for pregnant people fall into two categories, she noted; those studying interventions to improve pregnancy outcomes and those studying interventions for common medical conditions that coexist with pregnancy. These trials are either initiated by the investigators, conducted under contract, or federally funded, Dr. Gyamfi-Bannerman said. Currently, the only obstetric clinical trials research network is the Maternal-Fetal Medicine Units Network, established in 1986 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The MFMU has conducted significant and life-saving research, but “we need more networks to focus on researching pregnancy complications,” Dr. Gyamfi-Bannerman said. Once the infrastructure exists in multiple settings, the ability to conduct trials will improve, she said.

Dr. Gyamfi-Bannerman stressed the need to engage and involve community-based physicians in clinical trials; using those relationships to enroll a more diverse population for whom working with their local physician would be more feasible than traveling to a larger clinical trial center.

She also commented on the need to include pregnant women in nonobstetric clinical trials. The exclusion of pregnant women from COVID-19 vaccine trials left clinicians with no information for guiding pregnant patients, she said. “It is important to think about why we are excluding pregnant women,” she said.

Finally, Dr. Gyamfi-Bannerman recommended a national effort to coordinate and leverage EHR data, which could have an effect on reducing maternal morbidity by facilitating the study of nonobstetric interventions in pregnancy, such as behavior interventions and mental health care.

Dr. Howell and Dr. Gyamfi-Bannerman had no financial conflicts to disclose.
 

Adenoma miss rates were significantly lower with the use of an artificial intelligence (AI)–based computer-aided detection (CADe) system than with high-definition white light (HDWL), according to a new prospective, multicenter, single-blind randomized study based on data from more than 200 colonoscopies.

Missed adenomas can be generally categorized as adenomas fully obscured from the visual field or those appearing partly or fully in the visual field but missed by an endoscopist, wrote Jeremy R. Glissen Brown, MD, of Harvard Medical School, Boston, and colleagues. While retrospective and prospective studies in China, Italy, and Japan have shown that deep-learning CADe improves adenoma identification during colonoscopy, there have been no prospective U.S. studies on CADe in a diverse population, they noted.

In the study published in Clinical Gastroenterology and Hepatology, the researchers reviewed data from 223 adults aged 22 years and older who underwent screening colonoscopies across four U.S. academic medical centers between 2019 and 2020. The procedure indication was primary colorectal cancer screening for 59.6% of the patients and postpolypectomy surveillance for 40.4%. Among this cohort, 45.3% (101) were female, 67.7% (151) were White, and 21% (133) were African American. Participants were randomized to receive either CADe colonoscopy first or HDWL colonoscopy first; the patients immediately underwent the other procedure in tandem fashion from the same endoscopist.

The primary outcome of the study was adenoma miss rate (AMR), defined as “the number of histologically confirmed adenomas detected during the second colonoscopy in either arm divided by the total number of adenomas detected during both procedures.” Sessile serrated lesion (SSL) miss rates and adenomas per colonoscopy (APC) were secondary outcomes.

Overall, the primary outcome of AMR was significantly lower in the CADe-first group, compared with the HDWL-first group (20.12% vs. 31.25%; P = .0247), with an odds ratio of 1.8048 (95% CI, 1.0780-3.0217). The CADe-first group yielded a lower SSL miss rate, compared with the HDLW-first group (7.14% vs. 42.11%; P = .0482), as well as a lower polyp miss rate (20.70% vs. 33.71%; P = .0007). The first-pass number of APC was significantly higher in the CADe-first group, compared with the HDWL-first group (1.19 [SD 2.03] vs. 0.90 [SD 1.55]; P = .0323). In addition, the first-pass adenoma detection rate (ADR) was not significantly different in the CADe-first group, compared with the HDWL-first group (50.44% vs. 43.64%; P = .3091), and the median withdrawal time was significantly shorter with CADe, compared with HDWL (9.5 minutes vs. 8.5 minutes; P = .0098).

There were no significant observable differences between the two groups regarding missed adenomas arranged by size or location. Moreover, there were no significant differences in miss rates for hyperplastic polyps or advanced adenomas. Factors significantly associated with missed adenomas included being in the HDLW-first group, age 65 years or younger, and the right colon vs. other locations. No immediate adverse events occurred in either group.

According to the researchers, while previous studies in China and Italy have shown increased ADR using CADe systems, these results are not generalizable to the U.S. population for several reasons, notably the studies’ inclusion of colonoscopy indications other than colorectal cancer screening and surveillance. Though the present study showed a significantly lower AMR with CADe, it still represents missed adenomas. The researchers note: “In the present study, in which CADe detected 285 polyps, there were only three false negatives (defined as polyps that were visualized by the endoscopist but not by the CADe system). Overall, this suggests that the ‘missed polyps’ in the CADe arm may have been obscured behind folds rather than in the visual field.” They added, “Further research is needed on combining CADe technologies with mucosal exposure devices, as the benefits of these tools for polyp detection may be additive.”

The study findings were limited by several factors, including the inability to detect a difference in overall ADR, the limited generalizability of the tandem study design to real-world practice, the inclusion of only experienced endoscopists, and the use of a second monitor that may have impacted gaze patterns, the researchers noted. However, the results represent the first examination of deep-learning CADe in a diverse U.S. population and showed a decrease in adenoma miss rates and decreased miss rates for polyps and SSLs, compared with HDWL. Based on these findings, the authors concluded CADe “has the potential to decrease inter-provider variability in colonoscopy quality by reducing adenoma miss rate even in experienced providers.”
 

Reducing miss rates matters

“Missed adenomas can be associated with the development of interval colorectal cancer, so whether novel technologies such as artificial intelligence-based computer-aided polyp detection system can decrease adenoma miss rate is of interest,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr Sakuraba said he was not surprised by the current study findings, as several pilot and randomized studies have shown the benefits of AI-based polyp detection systems. As for how the AI-assisted technology might improve practice, he said it may be a valuable addition. “Adenoma miss rate was significantly lower with an AI-based polyp detection system, so it might lead to decreased colorectal cancer,” he explained. “Various methods to improve adenoma detection should complement each other. 

Dr. Sakuraba also commented that additional research is needed outside of academic centers, noting “further studies in the community setting involving various endoscopists are required to confirm generalizability.”

Lead author Dr. Glissen Brown had no financial conflicts to disclose. This was an investigator-initiated study, with research software and study funding provided by Wision. Dr. Sakuraba disclosed collaborative research with Fuji film, which was not involved in this study.

Adenoma miss rates were significantly lower with the use of an artificial intelligence (AI)–based computer-aided detection (CADe) system than with high-definition white light (HDWL), according to a new prospective, multicenter, single-blind randomized study based on data from more than 200 colonoscopies.

Missed adenomas can be generally categorized as adenomas fully obscured from the visual field or those appearing partly or fully in the visual field but missed by an endoscopist, wrote Jeremy R. Glissen Brown, MD, of Harvard Medical School, Boston, and colleagues. While retrospective and prospective studies in China, Italy, and Japan have shown that deep-learning CADe improves adenoma identification during colonoscopy, there have been no prospective U.S. studies on CADe in a diverse population, they noted.

In the study published in Clinical Gastroenterology and Hepatology, the researchers reviewed data from 223 adults aged 22 years and older who underwent screening colonoscopies across four U.S. academic medical centers between 2019 and 2020. The procedure indication was primary colorectal cancer screening for 59.6% of the patients and postpolypectomy surveillance for 40.4%. Among this cohort, 45.3% (101) were female, 67.7% (151) were White, and 21% (133) were African American. Participants were randomized to receive either CADe colonoscopy first or HDWL colonoscopy first; the patients immediately underwent the other procedure in tandem fashion from the same endoscopist.

The primary outcome of the study was adenoma miss rate (AMR), defined as “the number of histologically confirmed adenomas detected during the second colonoscopy in either arm divided by the total number of adenomas detected during both procedures.” Sessile serrated lesion (SSL) miss rates and adenomas per colonoscopy (APC) were secondary outcomes.

Overall, the primary outcome of AMR was significantly lower in the CADe-first group, compared with the HDWL-first group (20.12% vs. 31.25%; P = .0247), with an odds ratio of 1.8048 (95% CI, 1.0780-3.0217). The CADe-first group yielded a lower SSL miss rate, compared with the HDLW-first group (7.14% vs. 42.11%; P = .0482), as well as a lower polyp miss rate (20.70% vs. 33.71%; P = .0007). The first-pass number of APC was significantly higher in the CADe-first group, compared with the HDWL-first group (1.19 [SD 2.03] vs. 0.90 [SD 1.55]; P = .0323). In addition, the first-pass adenoma detection rate (ADR) was not significantly different in the CADe-first group, compared with the HDWL-first group (50.44% vs. 43.64%; P = .3091), and the median withdrawal time was significantly shorter with CADe, compared with HDWL (9.5 minutes vs. 8.5 minutes; P = .0098).

There were no significant observable differences between the two groups regarding missed adenomas arranged by size or location. Moreover, there were no significant differences in miss rates for hyperplastic polyps or advanced adenomas. Factors significantly associated with missed adenomas included being in the HDLW-first group, age 65 years or younger, and the right colon vs. other locations. No immediate adverse events occurred in either group.

According to the researchers, while previous studies in China and Italy have shown increased ADR using CADe systems, these results are not generalizable to the U.S. population for several reasons, notably the studies’ inclusion of colonoscopy indications other than colorectal cancer screening and surveillance. Though the present study showed a significantly lower AMR with CADe, it still represents missed adenomas. The researchers note: “In the present study, in which CADe detected 285 polyps, there were only three false negatives (defined as polyps that were visualized by the endoscopist but not by the CADe system). Overall, this suggests that the ‘missed polyps’ in the CADe arm may have been obscured behind folds rather than in the visual field.” They added, “Further research is needed on combining CADe technologies with mucosal exposure devices, as the benefits of these tools for polyp detection may be additive.”

The study findings were limited by several factors, including the inability to detect a difference in overall ADR, the limited generalizability of the tandem study design to real-world practice, the inclusion of only experienced endoscopists, and the use of a second monitor that may have impacted gaze patterns, the researchers noted. However, the results represent the first examination of deep-learning CADe in a diverse U.S. population and showed a decrease in adenoma miss rates and decreased miss rates for polyps and SSLs, compared with HDWL. Based on these findings, the authors concluded CADe “has the potential to decrease inter-provider variability in colonoscopy quality by reducing adenoma miss rate even in experienced providers.”
 

Reducing miss rates matters

“Missed adenomas can be associated with the development of interval colorectal cancer, so whether novel technologies such as artificial intelligence-based computer-aided polyp detection system can decrease adenoma miss rate is of interest,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr Sakuraba said he was not surprised by the current study findings, as several pilot and randomized studies have shown the benefits of AI-based polyp detection systems. As for how the AI-assisted technology might improve practice, he said it may be a valuable addition. “Adenoma miss rate was significantly lower with an AI-based polyp detection system, so it might lead to decreased colorectal cancer,” he explained. “Various methods to improve adenoma detection should complement each other. 

Dr. Sakuraba also commented that additional research is needed outside of academic centers, noting “further studies in the community setting involving various endoscopists are required to confirm generalizability.”

Lead author Dr. Glissen Brown had no financial conflicts to disclose. This was an investigator-initiated study, with research software and study funding provided by Wision. Dr. Sakuraba disclosed collaborative research with Fuji film, which was not involved in this study.

Adenoma miss rates were significantly lower with the use of an artificial intelligence (AI)–based computer-aided detection (CADe) system than with high-definition white light (HDWL), according to a new prospective, multicenter, single-blind randomized study based on data from more than 200 colonoscopies.

Missed adenomas can be generally categorized as adenomas fully obscured from the visual field or those appearing partly or fully in the visual field but missed by an endoscopist, wrote Jeremy R. Glissen Brown, MD, of Harvard Medical School, Boston, and colleagues. While retrospective and prospective studies in China, Italy, and Japan have shown that deep-learning CADe improves adenoma identification during colonoscopy, there have been no prospective U.S. studies on CADe in a diverse population, they noted.

In the study published in Clinical Gastroenterology and Hepatology, the researchers reviewed data from 223 adults aged 22 years and older who underwent screening colonoscopies across four U.S. academic medical centers between 2019 and 2020. The procedure indication was primary colorectal cancer screening for 59.6% of the patients and postpolypectomy surveillance for 40.4%. Among this cohort, 45.3% (101) were female, 67.7% (151) were White, and 21% (133) were African American. Participants were randomized to receive either CADe colonoscopy first or HDWL colonoscopy first; the patients immediately underwent the other procedure in tandem fashion from the same endoscopist.

The primary outcome of the study was adenoma miss rate (AMR), defined as “the number of histologically confirmed adenomas detected during the second colonoscopy in either arm divided by the total number of adenomas detected during both procedures.” Sessile serrated lesion (SSL) miss rates and adenomas per colonoscopy (APC) were secondary outcomes.

Overall, the primary outcome of AMR was significantly lower in the CADe-first group, compared with the HDWL-first group (20.12% vs. 31.25%; P = .0247), with an odds ratio of 1.8048 (95% CI, 1.0780-3.0217). The CADe-first group yielded a lower SSL miss rate, compared with the HDLW-first group (7.14% vs. 42.11%; P = .0482), as well as a lower polyp miss rate (20.70% vs. 33.71%; P = .0007). The first-pass number of APC was significantly higher in the CADe-first group, compared with the HDWL-first group (1.19 [SD 2.03] vs. 0.90 [SD 1.55]; P = .0323). In addition, the first-pass adenoma detection rate (ADR) was not significantly different in the CADe-first group, compared with the HDWL-first group (50.44% vs. 43.64%; P = .3091), and the median withdrawal time was significantly shorter with CADe, compared with HDWL (9.5 minutes vs. 8.5 minutes; P = .0098).

There were no significant observable differences between the two groups regarding missed adenomas arranged by size or location. Moreover, there were no significant differences in miss rates for hyperplastic polyps or advanced adenomas. Factors significantly associated with missed adenomas included being in the HDLW-first group, age 65 years or younger, and the right colon vs. other locations. No immediate adverse events occurred in either group.

According to the researchers, while previous studies in China and Italy have shown increased ADR using CADe systems, these results are not generalizable to the U.S. population for several reasons, notably the studies’ inclusion of colonoscopy indications other than colorectal cancer screening and surveillance. Though the present study showed a significantly lower AMR with CADe, it still represents missed adenomas. The researchers note: “In the present study, in which CADe detected 285 polyps, there were only three false negatives (defined as polyps that were visualized by the endoscopist but not by the CADe system). Overall, this suggests that the ‘missed polyps’ in the CADe arm may have been obscured behind folds rather than in the visual field.” They added, “Further research is needed on combining CADe technologies with mucosal exposure devices, as the benefits of these tools for polyp detection may be additive.”

The study findings were limited by several factors, including the inability to detect a difference in overall ADR, the limited generalizability of the tandem study design to real-world practice, the inclusion of only experienced endoscopists, and the use of a second monitor that may have impacted gaze patterns, the researchers noted. However, the results represent the first examination of deep-learning CADe in a diverse U.S. population and showed a decrease in adenoma miss rates and decreased miss rates for polyps and SSLs, compared with HDWL. Based on these findings, the authors concluded CADe “has the potential to decrease inter-provider variability in colonoscopy quality by reducing adenoma miss rate even in experienced providers.”
 

Reducing miss rates matters

“Missed adenomas can be associated with the development of interval colorectal cancer, so whether novel technologies such as artificial intelligence-based computer-aided polyp detection system can decrease adenoma miss rate is of interest,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr Sakuraba said he was not surprised by the current study findings, as several pilot and randomized studies have shown the benefits of AI-based polyp detection systems. As for how the AI-assisted technology might improve practice, he said it may be a valuable addition. “Adenoma miss rate was significantly lower with an AI-based polyp detection system, so it might lead to decreased colorectal cancer,” he explained. “Various methods to improve adenoma detection should complement each other. 

Dr. Sakuraba also commented that additional research is needed outside of academic centers, noting “further studies in the community setting involving various endoscopists are required to confirm generalizability.”

Lead author Dr. Glissen Brown had no financial conflicts to disclose. This was an investigator-initiated study, with research software and study funding provided by Wision. Dr. Sakuraba disclosed collaborative research with Fuji film, which was not involved in this study.

Women who had a preterm delivery were at least 1.6 times as likely to develop hypertension over the next decade as those who had full-term deliveries, based on data from a national cohort study of more than 2 million women.

Pregnancy complications such as preeclampsia and other hypertensive disorders of pregnancy have been associated with chronic hypertension as well as with preterm delivery, but the independent role of preterm delivery in chronic hypertension risk remains unclear, Casey Crump, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote. “A better understanding of the long-term hypertension risks associated with preterm delivery is needed to improve risk stratification, clinical monitoring, and CVD [cardiovascular disease] prevention in women.”

In a study published in JAMA Cardiology, the researchers reviewed data from 2,195,989 women with 4,308,286 singleton deliveries in Sweden from Jan. 1, 1973, to Dec. 31, 2015. Women with preexisting hypertension before their first pregnancy were excluded. Pregnancy duration was based on maternal reports of the last menstrual period for patients in the 1970s, and based on ultrasound estimates in the 1980s and beyond. Pregnancy duration was divided into six groups in terms of completed weeks of gestation: extremely preterm (22-27 weeks), moderately preterm (28-33 weeks), late preterm (34-36 weeks), early term (37-38 weeks), full term (39-41 weeks), and post term (≥42 weeks). Full-term delivery was used as the reference, and the three preterm groups were combined for summaries of preterm delivery (less than 37 weeks).

Overall, women who delivered at less than 37 weeks’ gestation had a 1.6-fold increased risk of hypertension (adjusted hazard ratio, 1.67) within the next 10 years, compared with women who delivered full term after controlling for preeclampsia, other hypertensive disorders of pregnancy, and maternal factors.

When further stratified by pregnancy duration, the aHRs for extremely preterm, moderately preterm, late preterm, and early term, compared with full-term deliveries were 2.23, 1.85, 1.55, and 1.26, respectively, in the first decade after delivery. Each additional week of pregnancy was associated with a mean 7% reduction in hypertension risk (a HR, 0.93).

The increased hypertension risk following preterm delivery (less than 37 weeks) persisted at 10-19 years, 20-29 years, and 30-43 years, with aHRs of 1.40, 1.20, and 1.12, respectively. Early-term delivery at 37-38 weeks also carried an increased risk of long-term hypertension compared with full-term delivery, with aHRs of 1.12 and 1.06 at 20-29 years and 30-43 years, respectively.

“Cosibling analyses suggested that these findings were only partially explained by familial (genetic and/or early-life environmental) factors that are shared determinants of both preterm delivery and hypertension,” the researchers noted. The findings suggest that preterm delivery itself may contribute to or affect the pathophysiology that leads to cardiovascular disease, they added, hypothesizing that endothelial dysfunction caused by preterm delivery may cause functional impairments in the microvasculature.

The study findings were limited by several factors including the lack of detailed records to verify hypertension and the use of data from a single country, the researchers noted. However, the results were strengthened by the large study population, the use of highly complete prenatal and birth records to minimize selection bias, and the long-term follow-up.

The results are consistent with those from previous studies, and support the recognition of preterm delivery as a lifetime risk factor for hypertension, but future studies should focus on racial and ethnic subgroups already at increased risk for both preterm delivery and hypertension, they added.

“Additional follow-up will be needed to examine these associations in older adulthood when hypertension increasingly and disproportionately affects women,” they concluded.

Data highlight the need for patient and provider education

“This study furthers our knowledge regarding long-term complications associated with the frequent pregnancy complication of preterm delivery,” Stephen S. Crane, MD, an ob.gyn. and maternal-fetal medicine specialist in private practice in Orlando, said in an interview. “Cardiovascular disease is the leading cause of death and often goes unrecognized in women. There are shared risk factors among women and men for developing CVD, the most common being hypertension. However, women have the unique risk factor of pregnancy and its attendant complications including preeclampsia, glucose intolerance, and preterm delivery. Hypertensive disorders in pregnancy often lead to indicated premature delivery, and are associated with development of chronic hypertension and subsequent CVD. However, prior data suggest that preterm delivery itself is a risk factor for developing chronic hypertension later in life.

“The current study, which evaluates one of the most complete population data sets with up to 43 years of follow-up, is the first to assess for familial determinants by cosibling analysis, and supports preterm delivery as an independent risk factor for the development of hypertension,” he said. The study results illustrate that this risk is longstanding, and that recurrent preterm birth further increases the risk of developing hypertension.

Dr. Crane said he was not surprised by the study findings, given that inflammatory processes have been linked to the development of hypertension and CVD. “Similarly, inflammatory processes have been implicated in the pathophysiology of preterm labor and inflammatory cytokines may also play a role in normal term labor. Therefore, it is not surprising that preterm delivery would be a marker for the risk of development of hypertension, as both may be responses to underlying inflammatory processes. Identification of these underlying inflammatory processes and methods for prevention will be critical if we are to decrease both the incidence of preterm birth and CVD.

“As prenatal care may be the only medical care women obtain, it is important to take this opportunity to educate patients regarding their long-term risks of developing hypertension and the need for long-term follow up. Interventions that may help reduce the risk for recurrent preterm birth and long-term risks for developing hypertension and CVD include weight loss, increased activity, and smoking cessation; the resources to achieve these goals need to be shared with patients,” he said.

“Knowledge deficits both on the part of the provider and patient may be a significant barrier to intervention that may be overcome with improved education,” said Dr. Crane. “Care providers need education regarding the long-term risks associated with a history of preterm delivery in order to better educate their patients regarding both prevention of recurrent preterm birth and the development of hypertension and CVD.” However, socioeconomic status, education level, and the inability to obtain further health care remain common barriers to intervention for many women.

“Additional research is needed to identify the causes of inflammatory processes leading to preterm delivery and risks for hypertension and CVD,” said Dr. Crane. “Only after the causes are identified can treatments be sought to successfully treat these conditions.”

The study was supported by the National Heart, Lung, and Blood Institute at the National Institutes of Health; the Swedish Research Council; the Swedish Heart-Lung Foundation; and an Avtal om Läkarutbildning och Forskning (Agreement on Medical Training and Research) (ALF) project grant from Region Skåne/Lund University. Neither the researchers nor Dr. Crane had any financial conflicts to disclose.

Women who had a preterm delivery were at least 1.6 times as likely to develop hypertension over the next decade as those who had full-term deliveries, based on data from a national cohort study of more than 2 million women.

Pregnancy complications such as preeclampsia and other hypertensive disorders of pregnancy have been associated with chronic hypertension as well as with preterm delivery, but the independent role of preterm delivery in chronic hypertension risk remains unclear, Casey Crump, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote. “A better understanding of the long-term hypertension risks associated with preterm delivery is needed to improve risk stratification, clinical monitoring, and CVD [cardiovascular disease] prevention in women.”

In a study published in JAMA Cardiology, the researchers reviewed data from 2,195,989 women with 4,308,286 singleton deliveries in Sweden from Jan. 1, 1973, to Dec. 31, 2015. Women with preexisting hypertension before their first pregnancy were excluded. Pregnancy duration was based on maternal reports of the last menstrual period for patients in the 1970s, and based on ultrasound estimates in the 1980s and beyond. Pregnancy duration was divided into six groups in terms of completed weeks of gestation: extremely preterm (22-27 weeks), moderately preterm (28-33 weeks), late preterm (34-36 weeks), early term (37-38 weeks), full term (39-41 weeks), and post term (≥42 weeks). Full-term delivery was used as the reference, and the three preterm groups were combined for summaries of preterm delivery (less than 37 weeks).

Overall, women who delivered at less than 37 weeks’ gestation had a 1.6-fold increased risk of hypertension (adjusted hazard ratio, 1.67) within the next 10 years, compared with women who delivered full term after controlling for preeclampsia, other hypertensive disorders of pregnancy, and maternal factors.

When further stratified by pregnancy duration, the aHRs for extremely preterm, moderately preterm, late preterm, and early term, compared with full-term deliveries were 2.23, 1.85, 1.55, and 1.26, respectively, in the first decade after delivery. Each additional week of pregnancy was associated with a mean 7% reduction in hypertension risk (a HR, 0.93).

The increased hypertension risk following preterm delivery (less than 37 weeks) persisted at 10-19 years, 20-29 years, and 30-43 years, with aHRs of 1.40, 1.20, and 1.12, respectively. Early-term delivery at 37-38 weeks also carried an increased risk of long-term hypertension compared with full-term delivery, with aHRs of 1.12 and 1.06 at 20-29 years and 30-43 years, respectively.

“Cosibling analyses suggested that these findings were only partially explained by familial (genetic and/or early-life environmental) factors that are shared determinants of both preterm delivery and hypertension,” the researchers noted. The findings suggest that preterm delivery itself may contribute to or affect the pathophysiology that leads to cardiovascular disease, they added, hypothesizing that endothelial dysfunction caused by preterm delivery may cause functional impairments in the microvasculature.

The study findings were limited by several factors including the lack of detailed records to verify hypertension and the use of data from a single country, the researchers noted. However, the results were strengthened by the large study population, the use of highly complete prenatal and birth records to minimize selection bias, and the long-term follow-up.

The results are consistent with those from previous studies, and support the recognition of preterm delivery as a lifetime risk factor for hypertension, but future studies should focus on racial and ethnic subgroups already at increased risk for both preterm delivery and hypertension, they added.

“Additional follow-up will be needed to examine these associations in older adulthood when hypertension increasingly and disproportionately affects women,” they concluded.

Data highlight the need for patient and provider education

“This study furthers our knowledge regarding long-term complications associated with the frequent pregnancy complication of preterm delivery,” Stephen S. Crane, MD, an ob.gyn. and maternal-fetal medicine specialist in private practice in Orlando, said in an interview. “Cardiovascular disease is the leading cause of death and often goes unrecognized in women. There are shared risk factors among women and men for developing CVD, the most common being hypertension. However, women have the unique risk factor of pregnancy and its attendant complications including preeclampsia, glucose intolerance, and preterm delivery. Hypertensive disorders in pregnancy often lead to indicated premature delivery, and are associated with development of chronic hypertension and subsequent CVD. However, prior data suggest that preterm delivery itself is a risk factor for developing chronic hypertension later in life.

“The current study, which evaluates one of the most complete population data sets with up to 43 years of follow-up, is the first to assess for familial determinants by cosibling analysis, and supports preterm delivery as an independent risk factor for the development of hypertension,” he said. The study results illustrate that this risk is longstanding, and that recurrent preterm birth further increases the risk of developing hypertension.

Dr. Crane said he was not surprised by the study findings, given that inflammatory processes have been linked to the development of hypertension and CVD. “Similarly, inflammatory processes have been implicated in the pathophysiology of preterm labor and inflammatory cytokines may also play a role in normal term labor. Therefore, it is not surprising that preterm delivery would be a marker for the risk of development of hypertension, as both may be responses to underlying inflammatory processes. Identification of these underlying inflammatory processes and methods for prevention will be critical if we are to decrease both the incidence of preterm birth and CVD.

“As prenatal care may be the only medical care women obtain, it is important to take this opportunity to educate patients regarding their long-term risks of developing hypertension and the need for long-term follow up. Interventions that may help reduce the risk for recurrent preterm birth and long-term risks for developing hypertension and CVD include weight loss, increased activity, and smoking cessation; the resources to achieve these goals need to be shared with patients,” he said.

“Knowledge deficits both on the part of the provider and patient may be a significant barrier to intervention that may be overcome with improved education,” said Dr. Crane. “Care providers need education regarding the long-term risks associated with a history of preterm delivery in order to better educate their patients regarding both prevention of recurrent preterm birth and the development of hypertension and CVD.” However, socioeconomic status, education level, and the inability to obtain further health care remain common barriers to intervention for many women.

“Additional research is needed to identify the causes of inflammatory processes leading to preterm delivery and risks for hypertension and CVD,” said Dr. Crane. “Only after the causes are identified can treatments be sought to successfully treat these conditions.”

The study was supported by the National Heart, Lung, and Blood Institute at the National Institutes of Health; the Swedish Research Council; the Swedish Heart-Lung Foundation; and an Avtal om Läkarutbildning och Forskning (Agreement on Medical Training and Research) (ALF) project grant from Region Skåne/Lund University. Neither the researchers nor Dr. Crane had any financial conflicts to disclose.

Women who had a preterm delivery were at least 1.6 times as likely to develop hypertension over the next decade as those who had full-term deliveries, based on data from a national cohort study of more than 2 million women.

Pregnancy complications such as preeclampsia and other hypertensive disorders of pregnancy have been associated with chronic hypertension as well as with preterm delivery, but the independent role of preterm delivery in chronic hypertension risk remains unclear, Casey Crump, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote. “A better understanding of the long-term hypertension risks associated with preterm delivery is needed to improve risk stratification, clinical monitoring, and CVD [cardiovascular disease] prevention in women.”

In a study published in JAMA Cardiology, the researchers reviewed data from 2,195,989 women with 4,308,286 singleton deliveries in Sweden from Jan. 1, 1973, to Dec. 31, 2015. Women with preexisting hypertension before their first pregnancy were excluded. Pregnancy duration was based on maternal reports of the last menstrual period for patients in the 1970s, and based on ultrasound estimates in the 1980s and beyond. Pregnancy duration was divided into six groups in terms of completed weeks of gestation: extremely preterm (22-27 weeks), moderately preterm (28-33 weeks), late preterm (34-36 weeks), early term (37-38 weeks), full term (39-41 weeks), and post term (≥42 weeks). Full-term delivery was used as the reference, and the three preterm groups were combined for summaries of preterm delivery (less than 37 weeks).

Overall, women who delivered at less than 37 weeks’ gestation had a 1.6-fold increased risk of hypertension (adjusted hazard ratio, 1.67) within the next 10 years, compared with women who delivered full term after controlling for preeclampsia, other hypertensive disorders of pregnancy, and maternal factors.

When further stratified by pregnancy duration, the aHRs for extremely preterm, moderately preterm, late preterm, and early term, compared with full-term deliveries were 2.23, 1.85, 1.55, and 1.26, respectively, in the first decade after delivery. Each additional week of pregnancy was associated with a mean 7% reduction in hypertension risk (a HR, 0.93).

The increased hypertension risk following preterm delivery (less than 37 weeks) persisted at 10-19 years, 20-29 years, and 30-43 years, with aHRs of 1.40, 1.20, and 1.12, respectively. Early-term delivery at 37-38 weeks also carried an increased risk of long-term hypertension compared with full-term delivery, with aHRs of 1.12 and 1.06 at 20-29 years and 30-43 years, respectively.

“Cosibling analyses suggested that these findings were only partially explained by familial (genetic and/or early-life environmental) factors that are shared determinants of both preterm delivery and hypertension,” the researchers noted. The findings suggest that preterm delivery itself may contribute to or affect the pathophysiology that leads to cardiovascular disease, they added, hypothesizing that endothelial dysfunction caused by preterm delivery may cause functional impairments in the microvasculature.

The study findings were limited by several factors including the lack of detailed records to verify hypertension and the use of data from a single country, the researchers noted. However, the results were strengthened by the large study population, the use of highly complete prenatal and birth records to minimize selection bias, and the long-term follow-up.

The results are consistent with those from previous studies, and support the recognition of preterm delivery as a lifetime risk factor for hypertension, but future studies should focus on racial and ethnic subgroups already at increased risk for both preterm delivery and hypertension, they added.

“Additional follow-up will be needed to examine these associations in older adulthood when hypertension increasingly and disproportionately affects women,” they concluded.

Data highlight the need for patient and provider education

“This study furthers our knowledge regarding long-term complications associated with the frequent pregnancy complication of preterm delivery,” Stephen S. Crane, MD, an ob.gyn. and maternal-fetal medicine specialist in private practice in Orlando, said in an interview. “Cardiovascular disease is the leading cause of death and often goes unrecognized in women. There are shared risk factors among women and men for developing CVD, the most common being hypertension. However, women have the unique risk factor of pregnancy and its attendant complications including preeclampsia, glucose intolerance, and preterm delivery. Hypertensive disorders in pregnancy often lead to indicated premature delivery, and are associated with development of chronic hypertension and subsequent CVD. However, prior data suggest that preterm delivery itself is a risk factor for developing chronic hypertension later in life.

“The current study, which evaluates one of the most complete population data sets with up to 43 years of follow-up, is the first to assess for familial determinants by cosibling analysis, and supports preterm delivery as an independent risk factor for the development of hypertension,” he said. The study results illustrate that this risk is longstanding, and that recurrent preterm birth further increases the risk of developing hypertension.

Dr. Crane said he was not surprised by the study findings, given that inflammatory processes have been linked to the development of hypertension and CVD. “Similarly, inflammatory processes have been implicated in the pathophysiology of preterm labor and inflammatory cytokines may also play a role in normal term labor. Therefore, it is not surprising that preterm delivery would be a marker for the risk of development of hypertension, as both may be responses to underlying inflammatory processes. Identification of these underlying inflammatory processes and methods for prevention will be critical if we are to decrease both the incidence of preterm birth and CVD.

“As prenatal care may be the only medical care women obtain, it is important to take this opportunity to educate patients regarding their long-term risks of developing hypertension and the need for long-term follow up. Interventions that may help reduce the risk for recurrent preterm birth and long-term risks for developing hypertension and CVD include weight loss, increased activity, and smoking cessation; the resources to achieve these goals need to be shared with patients,” he said.

“Knowledge deficits both on the part of the provider and patient may be a significant barrier to intervention that may be overcome with improved education,” said Dr. Crane. “Care providers need education regarding the long-term risks associated with a history of preterm delivery in order to better educate their patients regarding both prevention of recurrent preterm birth and the development of hypertension and CVD.” However, socioeconomic status, education level, and the inability to obtain further health care remain common barriers to intervention for many women.

“Additional research is needed to identify the causes of inflammatory processes leading to preterm delivery and risks for hypertension and CVD,” said Dr. Crane. “Only after the causes are identified can treatments be sought to successfully treat these conditions.”

The study was supported by the National Heart, Lung, and Blood Institute at the National Institutes of Health; the Swedish Research Council; the Swedish Heart-Lung Foundation; and an Avtal om Läkarutbildning och Forskning (Agreement on Medical Training and Research) (ALF) project grant from Region Skåne/Lund University. Neither the researchers nor Dr. Crane had any financial conflicts to disclose.

Approximately one-third of colonoscopies with inadequate bowel preparation were repeated within 1 year despite current guidelines, according to data from a new study of more than 260,000 procedures.

Eraxion/Thinkstock

Previous studies have shown that poor bowel prep, which occurs in approximately 25% of colonoscopies, can lead to lesion miss rates of as much as 42%-48%, Audrey H. Calderwood, MD, an associate professor of medicine at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues wrote. However, factors affecting recommendations for repeat colonoscopies following poor bowel prep have not been examined.

In the study, published in Gastrointestinal Endoscopy, the researchers conducted a cross-sectional retrospective analysis of 260,314 colonoscopies reported to the GI Quality Improvement Consortium (GIQuIC) from 2011 to 2018. The review included adults aged 50-75 years in whom bowel preparation was deemed inadequate. The GIQuIC database defines adequate bowel preparation as “sufficient to accurately detect polyps greater than 5 mm in size,” the researchers noted. The procedures in this study were performed at 672 sites by 4,001 endoscopists, and the primary outcome was a recommendation for a repeat colonoscopy within 1 year.

In 31.9% of the procedures, the recommended follow-up interval for repeat colonoscopy was within 1 year, and there were no significant differences according to indication for the procedures (32.3% of screening and 31.2% of surveillance). Of these, 54.9% of patients received a follow-up interval of 1 year and 24.7% a follow-up interval within 3 months. Only 2.4% were advised they required no follow-up procedure.

The researchers found that patients with more severe disease had a higher likelihood of receiving a recommendation for follow-up colonoscopy within 1 year – 84% with adenocarcinoma, 51.8% with advanced lesions, and 23.2% with one to two small adenomas.

In the multivariate analysis, there were specific patient factors significantly associated with 1-year follow-up recommendations. The researchers found patients aged 70-75 years were less likely than younger patients (adjusted odds ratio, 0.96; 95% confidence interval, 0.93-0.98) to receive a 1-year follow-up recommendation; men were more likely than women (aOR, 1.04; 95% CI, 1.02-1.06) to receive a 1-year follow-up recommendation; and patients with adenocarcinoma findings more likely to receive a 1-year follow-up recommendation compared to those with no adenocarcinoma (aOR, 10.43; 95% CI, 7.77-13.98). In addition, they found patients residing in the Northeast and those whose procedure was performed by an endoscopist with an adenoma detection rate of at least25% were more likely to receive recommendations for a repeat colonoscopy within 1 year.

“The recommendation for repeat screening or surveillance colonoscopy within 1 year when the index colonoscopy has an inadequate bowel preparation is currently a quality measure in gastroenterology,” the researchers noted. “Although our study period started in 2011, when we looked at the time period of 2014 to 2018, which is after publication of guidelines of when to repeat colonoscopy after inadequate bowel preparation, there were still low rates of guideline-concordant recommendations.”

These overall low rates, which are consistent with other studies, may be due uncertainty on the part of the endoscopist in determining inadequate bowel prep based on evolving guidelines, the researchers noted. However, the higher frequency of recommendations for repeat procedures within 1 year for patients with advanced disease suggests that endoscopists are taking pathology into account.

The study findings were limited by several factors, including the lack of standardized assessment of bowel prep quality, variation in descriptions of bowel cleanliness, and lack of information on the primary factor in follow-up recommendations. However, the results were strengthened by the large sample size, the inclusion of multiple sites and providers, and the low volume of timely repeat procedures, which has clinical implications in terms of missed lesions, “including potential interval CRC [colorectal cancer],” the researchers said.
 

Get the word out on describing preps and planning follow-ups

The current study is important because it highlights that, even when endoscopists have a reasonable understanding on how to set follow-up intervals for polyp follow-up, what to do with a patient who comes in poorly prepped is more of a problem, Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, said in an interview.

Dr Isaacs said she was not surprised by the study findings. “There are all gradations of inadequate preps that limit visualization in different ways, and there are many ways of recording this on procedure reports. The findings in the current study emphasize several points. The first is that the recommendation of following up an inadequate or poor prep in a year needs to be widely disseminated. The second is that there needs to be more education on standardization on how preps are described. In some poor preps, much of the colon can be seen, and clinicians can identify polyps 5-6 mm, so a 1-year follow-up may not be needed.” This type of research is challenging if the data are not standardized, she added. 

Dr. Isaacs agreed with the authors’ description of repeat colonoscopies after poor bowel prep as a quality improvement area given the variability in following current recommendations, which leads into next steps for research.

“Understanding reasons for the recommendations that endoscopists made for follow-up would be the next step in this type of research,” Dr Isaacs noted. “After that, studies on the impact of an educational intervention, followed by repeating the initial assessment.”

The study received no outside funding. The researchers had no financial conflicts to disclose; however, lead author Dr. Calderwood disclosed support from the National Cancer Institute, the Dartmouth-Hitchcock Cancer Research Fellows Program, the Dartmouth-Hitchcock Norris Cotton Cancer Center, and the Dartmouth Clinical and Translational Science Institute. Dr Isaacs had no financial conflicts to disclose but has previously served on the editorial board of GI & Hepatology News.

Approximately one-third of colonoscopies with inadequate bowel preparation were repeated within 1 year despite current guidelines, according to data from a new study of more than 260,000 procedures.

Eraxion/Thinkstock

Previous studies have shown that poor bowel prep, which occurs in approximately 25% of colonoscopies, can lead to lesion miss rates of as much as 42%-48%, Audrey H. Calderwood, MD, an associate professor of medicine at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues wrote. However, factors affecting recommendations for repeat colonoscopies following poor bowel prep have not been examined.

In the study, published in Gastrointestinal Endoscopy, the researchers conducted a cross-sectional retrospective analysis of 260,314 colonoscopies reported to the GI Quality Improvement Consortium (GIQuIC) from 2011 to 2018. The review included adults aged 50-75 years in whom bowel preparation was deemed inadequate. The GIQuIC database defines adequate bowel preparation as “sufficient to accurately detect polyps greater than 5 mm in size,” the researchers noted. The procedures in this study were performed at 672 sites by 4,001 endoscopists, and the primary outcome was a recommendation for a repeat colonoscopy within 1 year.

In 31.9% of the procedures, the recommended follow-up interval for repeat colonoscopy was within 1 year, and there were no significant differences according to indication for the procedures (32.3% of screening and 31.2% of surveillance). Of these, 54.9% of patients received a follow-up interval of 1 year and 24.7% a follow-up interval within 3 months. Only 2.4% were advised they required no follow-up procedure.

The researchers found that patients with more severe disease had a higher likelihood of receiving a recommendation for follow-up colonoscopy within 1 year – 84% with adenocarcinoma, 51.8% with advanced lesions, and 23.2% with one to two small adenomas.

In the multivariate analysis, there were specific patient factors significantly associated with 1-year follow-up recommendations. The researchers found patients aged 70-75 years were less likely than younger patients (adjusted odds ratio, 0.96; 95% confidence interval, 0.93-0.98) to receive a 1-year follow-up recommendation; men were more likely than women (aOR, 1.04; 95% CI, 1.02-1.06) to receive a 1-year follow-up recommendation; and patients with adenocarcinoma findings more likely to receive a 1-year follow-up recommendation compared to those with no adenocarcinoma (aOR, 10.43; 95% CI, 7.77-13.98). In addition, they found patients residing in the Northeast and those whose procedure was performed by an endoscopist with an adenoma detection rate of at least25% were more likely to receive recommendations for a repeat colonoscopy within 1 year.

“The recommendation for repeat screening or surveillance colonoscopy within 1 year when the index colonoscopy has an inadequate bowel preparation is currently a quality measure in gastroenterology,” the researchers noted. “Although our study period started in 2011, when we looked at the time period of 2014 to 2018, which is after publication of guidelines of when to repeat colonoscopy after inadequate bowel preparation, there were still low rates of guideline-concordant recommendations.”

These overall low rates, which are consistent with other studies, may be due uncertainty on the part of the endoscopist in determining inadequate bowel prep based on evolving guidelines, the researchers noted. However, the higher frequency of recommendations for repeat procedures within 1 year for patients with advanced disease suggests that endoscopists are taking pathology into account.

The study findings were limited by several factors, including the lack of standardized assessment of bowel prep quality, variation in descriptions of bowel cleanliness, and lack of information on the primary factor in follow-up recommendations. However, the results were strengthened by the large sample size, the inclusion of multiple sites and providers, and the low volume of timely repeat procedures, which has clinical implications in terms of missed lesions, “including potential interval CRC [colorectal cancer],” the researchers said.
 

Get the word out on describing preps and planning follow-ups

The current study is important because it highlights that, even when endoscopists have a reasonable understanding on how to set follow-up intervals for polyp follow-up, what to do with a patient who comes in poorly prepped is more of a problem, Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, said in an interview.

Dr Isaacs said she was not surprised by the study findings. “There are all gradations of inadequate preps that limit visualization in different ways, and there are many ways of recording this on procedure reports. The findings in the current study emphasize several points. The first is that the recommendation of following up an inadequate or poor prep in a year needs to be widely disseminated. The second is that there needs to be more education on standardization on how preps are described. In some poor preps, much of the colon can be seen, and clinicians can identify polyps 5-6 mm, so a 1-year follow-up may not be needed.” This type of research is challenging if the data are not standardized, she added. 

Dr. Isaacs agreed with the authors’ description of repeat colonoscopies after poor bowel prep as a quality improvement area given the variability in following current recommendations, which leads into next steps for research.

“Understanding reasons for the recommendations that endoscopists made for follow-up would be the next step in this type of research,” Dr Isaacs noted. “After that, studies on the impact of an educational intervention, followed by repeating the initial assessment.”

The study received no outside funding. The researchers had no financial conflicts to disclose; however, lead author Dr. Calderwood disclosed support from the National Cancer Institute, the Dartmouth-Hitchcock Cancer Research Fellows Program, the Dartmouth-Hitchcock Norris Cotton Cancer Center, and the Dartmouth Clinical and Translational Science Institute. Dr Isaacs had no financial conflicts to disclose but has previously served on the editorial board of GI & Hepatology News.

Approximately one-third of colonoscopies with inadequate bowel preparation were repeated within 1 year despite current guidelines, according to data from a new study of more than 260,000 procedures.

Eraxion/Thinkstock

Previous studies have shown that poor bowel prep, which occurs in approximately 25% of colonoscopies, can lead to lesion miss rates of as much as 42%-48%, Audrey H. Calderwood, MD, an associate professor of medicine at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues wrote. However, factors affecting recommendations for repeat colonoscopies following poor bowel prep have not been examined.

In the study, published in Gastrointestinal Endoscopy, the researchers conducted a cross-sectional retrospective analysis of 260,314 colonoscopies reported to the GI Quality Improvement Consortium (GIQuIC) from 2011 to 2018. The review included adults aged 50-75 years in whom bowel preparation was deemed inadequate. The GIQuIC database defines adequate bowel preparation as “sufficient to accurately detect polyps greater than 5 mm in size,” the researchers noted. The procedures in this study were performed at 672 sites by 4,001 endoscopists, and the primary outcome was a recommendation for a repeat colonoscopy within 1 year.

In 31.9% of the procedures, the recommended follow-up interval for repeat colonoscopy was within 1 year, and there were no significant differences according to indication for the procedures (32.3% of screening and 31.2% of surveillance). Of these, 54.9% of patients received a follow-up interval of 1 year and 24.7% a follow-up interval within 3 months. Only 2.4% were advised they required no follow-up procedure.

The researchers found that patients with more severe disease had a higher likelihood of receiving a recommendation for follow-up colonoscopy within 1 year – 84% with adenocarcinoma, 51.8% with advanced lesions, and 23.2% with one to two small adenomas.

In the multivariate analysis, there were specific patient factors significantly associated with 1-year follow-up recommendations. The researchers found patients aged 70-75 years were less likely than younger patients (adjusted odds ratio, 0.96; 95% confidence interval, 0.93-0.98) to receive a 1-year follow-up recommendation; men were more likely than women (aOR, 1.04; 95% CI, 1.02-1.06) to receive a 1-year follow-up recommendation; and patients with adenocarcinoma findings more likely to receive a 1-year follow-up recommendation compared to those with no adenocarcinoma (aOR, 10.43; 95% CI, 7.77-13.98). In addition, they found patients residing in the Northeast and those whose procedure was performed by an endoscopist with an adenoma detection rate of at least25% were more likely to receive recommendations for a repeat colonoscopy within 1 year.

“The recommendation for repeat screening or surveillance colonoscopy within 1 year when the index colonoscopy has an inadequate bowel preparation is currently a quality measure in gastroenterology,” the researchers noted. “Although our study period started in 2011, when we looked at the time period of 2014 to 2018, which is after publication of guidelines of when to repeat colonoscopy after inadequate bowel preparation, there were still low rates of guideline-concordant recommendations.”

These overall low rates, which are consistent with other studies, may be due uncertainty on the part of the endoscopist in determining inadequate bowel prep based on evolving guidelines, the researchers noted. However, the higher frequency of recommendations for repeat procedures within 1 year for patients with advanced disease suggests that endoscopists are taking pathology into account.

The study findings were limited by several factors, including the lack of standardized assessment of bowel prep quality, variation in descriptions of bowel cleanliness, and lack of information on the primary factor in follow-up recommendations. However, the results were strengthened by the large sample size, the inclusion of multiple sites and providers, and the low volume of timely repeat procedures, which has clinical implications in terms of missed lesions, “including potential interval CRC [colorectal cancer],” the researchers said.
 

Get the word out on describing preps and planning follow-ups

The current study is important because it highlights that, even when endoscopists have a reasonable understanding on how to set follow-up intervals for polyp follow-up, what to do with a patient who comes in poorly prepped is more of a problem, Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, said in an interview.

Dr Isaacs said she was not surprised by the study findings. “There are all gradations of inadequate preps that limit visualization in different ways, and there are many ways of recording this on procedure reports. The findings in the current study emphasize several points. The first is that the recommendation of following up an inadequate or poor prep in a year needs to be widely disseminated. The second is that there needs to be more education on standardization on how preps are described. In some poor preps, much of the colon can be seen, and clinicians can identify polyps 5-6 mm, so a 1-year follow-up may not be needed.” This type of research is challenging if the data are not standardized, she added. 

Dr. Isaacs agreed with the authors’ description of repeat colonoscopies after poor bowel prep as a quality improvement area given the variability in following current recommendations, which leads into next steps for research.

“Understanding reasons for the recommendations that endoscopists made for follow-up would be the next step in this type of research,” Dr Isaacs noted. “After that, studies on the impact of an educational intervention, followed by repeating the initial assessment.”

The study received no outside funding. The researchers had no financial conflicts to disclose; however, lead author Dr. Calderwood disclosed support from the National Cancer Institute, the Dartmouth-Hitchcock Cancer Research Fellows Program, the Dartmouth-Hitchcock Norris Cotton Cancer Center, and the Dartmouth Clinical and Translational Science Institute. Dr Isaacs had no financial conflicts to disclose but has previously served on the editorial board of GI & Hepatology News.

The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.

tupungato/Thinkstock

The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.

PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.

The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.

White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.

The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.

The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.

“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.

The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.

tupungato/Thinkstock

The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.

PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.

The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.

White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.

The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.

The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.

“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.

The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.

tupungato/Thinkstock

The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.

PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.

The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.

White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.

The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.

The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.

“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.

The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.

“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.

The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.

Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.

The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.

In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.

The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.

Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.

Full prescribing information for Flucelvax is available here.

The FDA approval letter is available here.pdnews@mdedge.com

The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.

“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.

The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.

Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.

The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.

In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.

The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.

Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.

Full prescribing information for Flucelvax is available here.

The FDA approval letter is available here.pdnews@mdedge.com

The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.

“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.

The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.

Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.

The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.

In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.

The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.

Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.

Full prescribing information for Flucelvax is available here.

The FDA approval letter is available here.pdnews@mdedge.com

Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.

Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.

“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.

In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.

Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.

Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.

Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.

“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.

The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.

Birth location should be an informed decision

The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.

“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.

“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.

“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.

Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
 

Patient selection is key to successful community birth

The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.

“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.

Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.

“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.

“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.

“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.

The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.

Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.

Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.

“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.

In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.

Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.

Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.

Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.

“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.

The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.

Birth location should be an informed decision

The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.

“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.

“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.

“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.

Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
 

Patient selection is key to successful community birth

The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.

“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.

Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.

“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.

“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.

“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.

The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.

Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.

Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.

“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.

In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.

Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.

Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.

Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.

“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.

The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.

Birth location should be an informed decision

The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.

“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.

“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.

“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.

Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
 

Patient selection is key to successful community birth

The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.

“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.

Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.

“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.

“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.

“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.

The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.

Patients with functional neurological disorders demonstrate higher levels of depression and alexithymia – in addition to signs of an avoidant attachment style – compared with those with other neurological disorders and healthy controls, investigators report.

The pathological mechanism of functional neurological disorders (FND) remains poorly understood, but current models include both psychological and environmental factors, Sofia Cuoco, PhD, and colleagues wrote in a study published in the Journal of Psychosomatic Research.

Previous studies have suggested a relationship between attachment styles (AS) and psychiatric symptoms in FND patients but most have been limited to the FND population, noted Dr. Cuoco, of the University of Salerno, Italy, and colleagues. In FND, “it is unclear to what extent psychiatric features are explained by AS per se or are part of the FND spectrum,” they said.

To conduct the study, the investigators recruited 46 patients with FND, 34 patients with neurological disorders (ND) and 30 healthy controls. Demographic characteristics, including age, education, and gender, were similar among the groups. Overall, depression and alexithymia were significantly more prevalent in the FND group, compared with the other groups. Anxiety was more common in the FND group, compared with healthy controls, but similar compared with the ND group. Patients in the FND group reported significantly lower quality of life, compared with those in the other groups.

In a multivariate analysis aimed at examining AS and psychiatric features, the researchers found that the Experiences in Close Relationships–Revised questionnaire avoidance, Beck Depression Inventory, Somatic Affective, and the 20-item Toronto Alexithymia Scale Difficulty Identifying Feelings scale (TAS-20 Difficulty Identifying Feelings) were significant predictors of FND and accounted for about half of the variance.

The researchers also compared FND to functional seizures, and found that the TAS-20 Difficulty Identifying Feelings scale, the Hamilton Anxiety Scale–Anxiety, and female gender were significant predictors of functional seizures.

The results were mainly in line with those from previous studies, the researchers said. However, “one of the novelties of this study is the inclusion of patients with other ND, whereby we demonstrated that FND patients were more depressed, anxious, and alexithymic than ND, which might suggest that these psychiatric features would not be merely reactive to physical symptoms,” they noted.

The study findings were limited by several factors, including the absence of systematic interviews for personality disorders or traits, monitoring psychotropic medications, and conducting formal psychiatric assessments, the researchers noted. Other limitations include the heterogenous study population and absence of data on symptom severity, history of trauma, or other factors that might contributed to FND, they said.

However, the results suggest that avoidant AS might play an important role in the occurrence of psychiatric features in FND patients and should be considered in managing these conditions. More research is needed to explore the impact of attachment on pathophysiology with more complex instruments, such as the Adult Attachment Interview, Dr. Cuoco and colleagues said.

The study received no outside funding, and the researchers disclosed no financial conflicts.

Patients with functional neurological disorders demonstrate higher levels of depression and alexithymia – in addition to signs of an avoidant attachment style – compared with those with other neurological disorders and healthy controls, investigators report.

The pathological mechanism of functional neurological disorders (FND) remains poorly understood, but current models include both psychological and environmental factors, Sofia Cuoco, PhD, and colleagues wrote in a study published in the Journal of Psychosomatic Research.

Previous studies have suggested a relationship between attachment styles (AS) and psychiatric symptoms in FND patients but most have been limited to the FND population, noted Dr. Cuoco, of the University of Salerno, Italy, and colleagues. In FND, “it is unclear to what extent psychiatric features are explained by AS per se or are part of the FND spectrum,” they said.

To conduct the study, the investigators recruited 46 patients with FND, 34 patients with neurological disorders (ND) and 30 healthy controls. Demographic characteristics, including age, education, and gender, were similar among the groups. Overall, depression and alexithymia were significantly more prevalent in the FND group, compared with the other groups. Anxiety was more common in the FND group, compared with healthy controls, but similar compared with the ND group. Patients in the FND group reported significantly lower quality of life, compared with those in the other groups.

In a multivariate analysis aimed at examining AS and psychiatric features, the researchers found that the Experiences in Close Relationships–Revised questionnaire avoidance, Beck Depression Inventory, Somatic Affective, and the 20-item Toronto Alexithymia Scale Difficulty Identifying Feelings scale (TAS-20 Difficulty Identifying Feelings) were significant predictors of FND and accounted for about half of the variance.

The researchers also compared FND to functional seizures, and found that the TAS-20 Difficulty Identifying Feelings scale, the Hamilton Anxiety Scale–Anxiety, and female gender were significant predictors of functional seizures.

The results were mainly in line with those from previous studies, the researchers said. However, “one of the novelties of this study is the inclusion of patients with other ND, whereby we demonstrated that FND patients were more depressed, anxious, and alexithymic than ND, which might suggest that these psychiatric features would not be merely reactive to physical symptoms,” they noted.

The study findings were limited by several factors, including the absence of systematic interviews for personality disorders or traits, monitoring psychotropic medications, and conducting formal psychiatric assessments, the researchers noted. Other limitations include the heterogenous study population and absence of data on symptom severity, history of trauma, or other factors that might contributed to FND, they said.

However, the results suggest that avoidant AS might play an important role in the occurrence of psychiatric features in FND patients and should be considered in managing these conditions. More research is needed to explore the impact of attachment on pathophysiology with more complex instruments, such as the Adult Attachment Interview, Dr. Cuoco and colleagues said.

The study received no outside funding, and the researchers disclosed no financial conflicts.

Patients with functional neurological disorders demonstrate higher levels of depression and alexithymia – in addition to signs of an avoidant attachment style – compared with those with other neurological disorders and healthy controls, investigators report.

The pathological mechanism of functional neurological disorders (FND) remains poorly understood, but current models include both psychological and environmental factors, Sofia Cuoco, PhD, and colleagues wrote in a study published in the Journal of Psychosomatic Research.

Previous studies have suggested a relationship between attachment styles (AS) and psychiatric symptoms in FND patients but most have been limited to the FND population, noted Dr. Cuoco, of the University of Salerno, Italy, and colleagues. In FND, “it is unclear to what extent psychiatric features are explained by AS per se or are part of the FND spectrum,” they said.

To conduct the study, the investigators recruited 46 patients with FND, 34 patients with neurological disorders (ND) and 30 healthy controls. Demographic characteristics, including age, education, and gender, were similar among the groups. Overall, depression and alexithymia were significantly more prevalent in the FND group, compared with the other groups. Anxiety was more common in the FND group, compared with healthy controls, but similar compared with the ND group. Patients in the FND group reported significantly lower quality of life, compared with those in the other groups.

In a multivariate analysis aimed at examining AS and psychiatric features, the researchers found that the Experiences in Close Relationships–Revised questionnaire avoidance, Beck Depression Inventory, Somatic Affective, and the 20-item Toronto Alexithymia Scale Difficulty Identifying Feelings scale (TAS-20 Difficulty Identifying Feelings) were significant predictors of FND and accounted for about half of the variance.

The researchers also compared FND to functional seizures, and found that the TAS-20 Difficulty Identifying Feelings scale, the Hamilton Anxiety Scale–Anxiety, and female gender were significant predictors of functional seizures.

The results were mainly in line with those from previous studies, the researchers said. However, “one of the novelties of this study is the inclusion of patients with other ND, whereby we demonstrated that FND patients were more depressed, anxious, and alexithymic than ND, which might suggest that these psychiatric features would not be merely reactive to physical symptoms,” they noted.

The study findings were limited by several factors, including the absence of systematic interviews for personality disorders or traits, monitoring psychotropic medications, and conducting formal psychiatric assessments, the researchers noted. Other limitations include the heterogenous study population and absence of data on symptom severity, history of trauma, or other factors that might contributed to FND, they said.

However, the results suggest that avoidant AS might play an important role in the occurrence of psychiatric features in FND patients and should be considered in managing these conditions. More research is needed to explore the impact of attachment on pathophysiology with more complex instruments, such as the Adult Attachment Interview, Dr. Cuoco and colleagues said.

The study received no outside funding, and the researchers disclosed no financial conflicts.

Homework adherence between behavior therapy sessions is a significant predictor of therapeutic improvement in patients with Tourette’s disorder (TD), a study of 119 youth and adults suggests.

The assigning of “homework” to be completed between sessions – often used in cognitive-behavioral therapy – has been shown to reinforce learning but has not been well studied in TD.

“Understanding the relationship between homework adherence and therapeutic improvement from behavior therapy for TD may offer new insights for enhancing tic severity reductions achieved during this evidence-based treatment,” wrote Joey Ka-Yee Essoe, PhD, of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, and colleagues.

To conduct the study, published in Behaviour Research and Therapy, the researchers recruited 70 youth and 49 adults with TD, ranging in age from 9 to 67 years, who underwent treatment at a single center. The average age was 21 years, and 80 participants were male. Treatment response was based on the Clinical Global Impressions of Improvement scale (CGI-I). Participants were assessed at baseline for tic severity and received eight sessions over 10 weeks. During those sessions, they were taught to perform a competing response to inhibit the expression of a tic when the tic or urge was detected.

Participants received homework at each weekly therapy session; most consisted of three to four practice sessions of about 30 minutes per week. Therapists reviewed the homework at the following session and adapted as needed to improve tic reduction skills.

After eight sessions of behavior therapy, overall greater homework adherence significantly predicted reduced tic severity and therapeutic improvement. However, early homework adherence predicted therapeutic improvement in youth, while late homework adherence predicted it in adults.

Overall, homework adherence significantly predicted tic reductions, compared with baseline (P = .037), based on the clinician-rated Yale Global Tic Severity Scale.

However, homework adherence dipped midway through treatment in youth and showed a linear decline in adults, the researchers noted.

Among youth, baseline predictors of early homework adherence included lower levels of hyperactivity/impulsivity and caregiver strain. Among adults, baseline predictors of early homework adherence included lower anger scores, less social disability, and greater work disability.

The study findings were limited by several factors, including the absence of complete data on baseline predictors of homework adherence, reliance on a single measure of tic severity and improvement, and reliance on therapists’ reports of homework adherence, the researchers noted.

Future research should include objective measures of homework adherence, such as time-stamped videos, and different strategies may be needed for youth vs. adults, they added.

“Strategies that optimize homework adherence may enhance the efficacy of behavioral therapy, lead to greater tic severity reductions, and higher treatment response rates,” Dr. Essoe and colleagues wrote.

The study was supported by the Tourette Association of America, the National Institute of Mental Health, the American Academy of Neurology, and the American Psychological Foundation.

Homework adherence between behavior therapy sessions is a significant predictor of therapeutic improvement in patients with Tourette’s disorder (TD), a study of 119 youth and adults suggests.

The assigning of “homework” to be completed between sessions – often used in cognitive-behavioral therapy – has been shown to reinforce learning but has not been well studied in TD.

“Understanding the relationship between homework adherence and therapeutic improvement from behavior therapy for TD may offer new insights for enhancing tic severity reductions achieved during this evidence-based treatment,” wrote Joey Ka-Yee Essoe, PhD, of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, and colleagues.

To conduct the study, published in Behaviour Research and Therapy, the researchers recruited 70 youth and 49 adults with TD, ranging in age from 9 to 67 years, who underwent treatment at a single center. The average age was 21 years, and 80 participants were male. Treatment response was based on the Clinical Global Impressions of Improvement scale (CGI-I). Participants were assessed at baseline for tic severity and received eight sessions over 10 weeks. During those sessions, they were taught to perform a competing response to inhibit the expression of a tic when the tic or urge was detected.

Participants received homework at each weekly therapy session; most consisted of three to four practice sessions of about 30 minutes per week. Therapists reviewed the homework at the following session and adapted as needed to improve tic reduction skills.

After eight sessions of behavior therapy, overall greater homework adherence significantly predicted reduced tic severity and therapeutic improvement. However, early homework adherence predicted therapeutic improvement in youth, while late homework adherence predicted it in adults.

Overall, homework adherence significantly predicted tic reductions, compared with baseline (P = .037), based on the clinician-rated Yale Global Tic Severity Scale.

However, homework adherence dipped midway through treatment in youth and showed a linear decline in adults, the researchers noted.

Among youth, baseline predictors of early homework adherence included lower levels of hyperactivity/impulsivity and caregiver strain. Among adults, baseline predictors of early homework adherence included lower anger scores, less social disability, and greater work disability.

The study findings were limited by several factors, including the absence of complete data on baseline predictors of homework adherence, reliance on a single measure of tic severity and improvement, and reliance on therapists’ reports of homework adherence, the researchers noted.

Future research should include objective measures of homework adherence, such as time-stamped videos, and different strategies may be needed for youth vs. adults, they added.

“Strategies that optimize homework adherence may enhance the efficacy of behavioral therapy, lead to greater tic severity reductions, and higher treatment response rates,” Dr. Essoe and colleagues wrote.

The study was supported by the Tourette Association of America, the National Institute of Mental Health, the American Academy of Neurology, and the American Psychological Foundation.

Homework adherence between behavior therapy sessions is a significant predictor of therapeutic improvement in patients with Tourette’s disorder (TD), a study of 119 youth and adults suggests.

The assigning of “homework” to be completed between sessions – often used in cognitive-behavioral therapy – has been shown to reinforce learning but has not been well studied in TD.

“Understanding the relationship between homework adherence and therapeutic improvement from behavior therapy for TD may offer new insights for enhancing tic severity reductions achieved during this evidence-based treatment,” wrote Joey Ka-Yee Essoe, PhD, of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, and colleagues.

To conduct the study, published in Behaviour Research and Therapy, the researchers recruited 70 youth and 49 adults with TD, ranging in age from 9 to 67 years, who underwent treatment at a single center. The average age was 21 years, and 80 participants were male. Treatment response was based on the Clinical Global Impressions of Improvement scale (CGI-I). Participants were assessed at baseline for tic severity and received eight sessions over 10 weeks. During those sessions, they were taught to perform a competing response to inhibit the expression of a tic when the tic or urge was detected.

Participants received homework at each weekly therapy session; most consisted of three to four practice sessions of about 30 minutes per week. Therapists reviewed the homework at the following session and adapted as needed to improve tic reduction skills.

After eight sessions of behavior therapy, overall greater homework adherence significantly predicted reduced tic severity and therapeutic improvement. However, early homework adherence predicted therapeutic improvement in youth, while late homework adherence predicted it in adults.

Overall, homework adherence significantly predicted tic reductions, compared with baseline (P = .037), based on the clinician-rated Yale Global Tic Severity Scale.

However, homework adherence dipped midway through treatment in youth and showed a linear decline in adults, the researchers noted.

Among youth, baseline predictors of early homework adherence included lower levels of hyperactivity/impulsivity and caregiver strain. Among adults, baseline predictors of early homework adherence included lower anger scores, less social disability, and greater work disability.

The study findings were limited by several factors, including the absence of complete data on baseline predictors of homework adherence, reliance on a single measure of tic severity and improvement, and reliance on therapists’ reports of homework adherence, the researchers noted.

Future research should include objective measures of homework adherence, such as time-stamped videos, and different strategies may be needed for youth vs. adults, they added.

“Strategies that optimize homework adherence may enhance the efficacy of behavioral therapy, lead to greater tic severity reductions, and higher treatment response rates,” Dr. Essoe and colleagues wrote.

The study was supported by the Tourette Association of America, the National Institute of Mental Health, the American Academy of Neurology, and the American Psychological Foundation.

The selective and reversible Janus kinase inhibitor upadacitinib (Rinvoq) significantly improved symptoms in adults with either ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA) when compared with placebo in a pair of studies from the phase 3 SELECT-AXIS 2 clinical trial, according to press releases issued Oct. 7 by manufacturer AbbVie.

Upadacitinib is currently approved in the European Union for patients with active AS, as well as patients with moderate to severe active rheumatoid arthritis and active psoriatic arthritis. Upadacitinib is approved by the Food and Drug Administration for adults with moderately to severely active RA, but is not currently approved for active AS or nr-axSpA.

In study 1, significantly more patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of 40% improvement in Assessment in Spondyloarthritis International Society (ASAS 40) response criteria at week 14, compared with placebo (45% vs. 18%) after 14 weeks (P < .0001).

The study of 420 patients with an inadequate response to biologic disease-modifying antirheumatic drug therapy gave half upadacitinib for 104 weeks and the other half placebo for 14 weeks, followed by upadacitinib for 90 weeks.

Patients treated with upadacitinib showed significant improvements in secondary endpoints of back pain, inflammation, physical function, and disease activity at week 14, compared with placebo.

Significantly more upadacitinib- than placebo-treated patients reached low disease activity on the AS Disease Activity Score (ASDAS) (44% vs. 10%). Upadacitinib also led to significantly greater improvements from baseline than did placebo on MRI Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Spine, Patient’s Assessment of Total Back Pain, and Bath AS Functional Index (BASFI) score (–2.26 vs. –1.09).

COVID-19 and headache were the most common adverse events that were seen with upadacitinib during the first 14 weeks of the study (occurring in 3% or more). No adverse events led to study discontinuation among patients taking upadacitinib, compared with 1.4% on placebo, and serious adverse events were reported in 2.8% taking upadacitinib and in 0.5% on placebo. Serious infections with upadacitinib included four cases of COVID-19 and one case of uveitis.

Study 2 in patients with nr-axSpA

Study 2, which included 313 adults with nr-axSpA, yielded results similar to those of study 1 on the primary endpoint of meeting ASAS40 response criteria at week 14 (45% with upadacitinib 15 mg once daily vs. 23% with placebo; P < .0001), as well as on a variety of secondary efficacy endpoints and safety data.

Significantly better responses were observed at week 14 with upadacitinib for rate of low disease activity according to ASDAS (42% vs. 18%), changes in MRI SPARCC Scores for SI joints (–2.49 vs. 0.57), Patient’s Assessment of Total Back Pain (-2.91 vs. -2.00), and physical function based on the BASFI (–2.61 vs. –1.47).

The most common adverse events at 14 weeks, occurring in at least 3% of patients taking upadacitinib, included headache, COVID-19, nasopharyngitis, and nausea. Adverse events leading to study discontinuation occurred in 2.6% with upadacitinib and 1.3% with placebo; serious adverse events occurred in 2.6% and 1.3%, respectively.

Serious infections included COVID-19-induced pneumonia and pyelonephritis in patients taking upadacitinib and one case of hemorrhagic fever with renal syndrome with placebo.

The full results of the SELECT-AXIS 2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal, according to AbbVie.

The selective and reversible Janus kinase inhibitor upadacitinib (Rinvoq) significantly improved symptoms in adults with either ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA) when compared with placebo in a pair of studies from the phase 3 SELECT-AXIS 2 clinical trial, according to press releases issued Oct. 7 by manufacturer AbbVie.

Upadacitinib is currently approved in the European Union for patients with active AS, as well as patients with moderate to severe active rheumatoid arthritis and active psoriatic arthritis. Upadacitinib is approved by the Food and Drug Administration for adults with moderately to severely active RA, but is not currently approved for active AS or nr-axSpA.

In study 1, significantly more patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of 40% improvement in Assessment in Spondyloarthritis International Society (ASAS 40) response criteria at week 14, compared with placebo (45% vs. 18%) after 14 weeks (P < .0001).

The study of 420 patients with an inadequate response to biologic disease-modifying antirheumatic drug therapy gave half upadacitinib for 104 weeks and the other half placebo for 14 weeks, followed by upadacitinib for 90 weeks.

Patients treated with upadacitinib showed significant improvements in secondary endpoints of back pain, inflammation, physical function, and disease activity at week 14, compared with placebo.

Significantly more upadacitinib- than placebo-treated patients reached low disease activity on the AS Disease Activity Score (ASDAS) (44% vs. 10%). Upadacitinib also led to significantly greater improvements from baseline than did placebo on MRI Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Spine, Patient’s Assessment of Total Back Pain, and Bath AS Functional Index (BASFI) score (–2.26 vs. –1.09).

COVID-19 and headache were the most common adverse events that were seen with upadacitinib during the first 14 weeks of the study (occurring in 3% or more). No adverse events led to study discontinuation among patients taking upadacitinib, compared with 1.4% on placebo, and serious adverse events were reported in 2.8% taking upadacitinib and in 0.5% on placebo. Serious infections with upadacitinib included four cases of COVID-19 and one case of uveitis.

Study 2 in patients with nr-axSpA

Study 2, which included 313 adults with nr-axSpA, yielded results similar to those of study 1 on the primary endpoint of meeting ASAS40 response criteria at week 14 (45% with upadacitinib 15 mg once daily vs. 23% with placebo; P < .0001), as well as on a variety of secondary efficacy endpoints and safety data.

Significantly better responses were observed at week 14 with upadacitinib for rate of low disease activity according to ASDAS (42% vs. 18%), changes in MRI SPARCC Scores for SI joints (–2.49 vs. 0.57), Patient’s Assessment of Total Back Pain (-2.91 vs. -2.00), and physical function based on the BASFI (–2.61 vs. –1.47).

The most common adverse events at 14 weeks, occurring in at least 3% of patients taking upadacitinib, included headache, COVID-19, nasopharyngitis, and nausea. Adverse events leading to study discontinuation occurred in 2.6% with upadacitinib and 1.3% with placebo; serious adverse events occurred in 2.6% and 1.3%, respectively.

Serious infections included COVID-19-induced pneumonia and pyelonephritis in patients taking upadacitinib and one case of hemorrhagic fever with renal syndrome with placebo.

The full results of the SELECT-AXIS 2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal, according to AbbVie.

The selective and reversible Janus kinase inhibitor upadacitinib (Rinvoq) significantly improved symptoms in adults with either ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA) when compared with placebo in a pair of studies from the phase 3 SELECT-AXIS 2 clinical trial, according to press releases issued Oct. 7 by manufacturer AbbVie.

Upadacitinib is currently approved in the European Union for patients with active AS, as well as patients with moderate to severe active rheumatoid arthritis and active psoriatic arthritis. Upadacitinib is approved by the Food and Drug Administration for adults with moderately to severely active RA, but is not currently approved for active AS or nr-axSpA.

In study 1, significantly more patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of 40% improvement in Assessment in Spondyloarthritis International Society (ASAS 40) response criteria at week 14, compared with placebo (45% vs. 18%) after 14 weeks (P < .0001).

The study of 420 patients with an inadequate response to biologic disease-modifying antirheumatic drug therapy gave half upadacitinib for 104 weeks and the other half placebo for 14 weeks, followed by upadacitinib for 90 weeks.

Patients treated with upadacitinib showed significant improvements in secondary endpoints of back pain, inflammation, physical function, and disease activity at week 14, compared with placebo.

Significantly more upadacitinib- than placebo-treated patients reached low disease activity on the AS Disease Activity Score (ASDAS) (44% vs. 10%). Upadacitinib also led to significantly greater improvements from baseline than did placebo on MRI Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Spine, Patient’s Assessment of Total Back Pain, and Bath AS Functional Index (BASFI) score (–2.26 vs. –1.09).

COVID-19 and headache were the most common adverse events that were seen with upadacitinib during the first 14 weeks of the study (occurring in 3% or more). No adverse events led to study discontinuation among patients taking upadacitinib, compared with 1.4% on placebo, and serious adverse events were reported in 2.8% taking upadacitinib and in 0.5% on placebo. Serious infections with upadacitinib included four cases of COVID-19 and one case of uveitis.

Study 2 in patients with nr-axSpA

Study 2, which included 313 adults with nr-axSpA, yielded results similar to those of study 1 on the primary endpoint of meeting ASAS40 response criteria at week 14 (45% with upadacitinib 15 mg once daily vs. 23% with placebo; P < .0001), as well as on a variety of secondary efficacy endpoints and safety data.

Significantly better responses were observed at week 14 with upadacitinib for rate of low disease activity according to ASDAS (42% vs. 18%), changes in MRI SPARCC Scores for SI joints (–2.49 vs. 0.57), Patient’s Assessment of Total Back Pain (-2.91 vs. -2.00), and physical function based on the BASFI (–2.61 vs. –1.47).

The most common adverse events at 14 weeks, occurring in at least 3% of patients taking upadacitinib, included headache, COVID-19, nasopharyngitis, and nausea. Adverse events leading to study discontinuation occurred in 2.6% with upadacitinib and 1.3% with placebo; serious adverse events occurred in 2.6% and 1.3%, respectively.

Serious infections included COVID-19-induced pneumonia and pyelonephritis in patients taking upadacitinib and one case of hemorrhagic fever with renal syndrome with placebo.

The full results of the SELECT-AXIS 2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal, according to AbbVie.