User login
Osteoarthritis burden grows worldwide, Global Burden of Disease study finds
Prevalent cases of osteoarthritis increased significantly worldwide from 1990 to 2019, based on data from the Global Burden of Disease Study 2019.
OA remains a highly prevalent condition worldwide, with no nonsurgical interventions to prevent progression, wrote Huibin Long, MD, of Capital Medical University, Beijing, and colleagues.
Data from previous studies show that the prevalence of OA varies depending on the joints involved, with the knee being most frequently affected. However, site-specific data on OA trends and disease burden across regions or territories has not been well documented, they said.
In a study published in Arthritis & Rheumatology, the researchers analyzed data from the Global Burden of Disease Study, an ongoing project involving researchers in approximately 200 countries and territories to provide up-to-date information on the disease burdens of more than 350 types of diseases and injuries.
The Global Burden of Disease study for 2019 (GBD 2019) included data on age- and sex-specific incidence, prevalence, mortality, years of life lost, and disability-adjusted life-years for 369 diseases and injuries in 204 countries and territories. Countries were divided into five groups based on a composite sociodemographic index (SDI) of factors including fertility, income, and educational attainment; the SDI represents the quality and availability of health care, the researchers wrote.
OA was defined as radiologically confirmed Kellgren-Lawrence grade 2-4 and pain for at least 1 month during the past 12 months.
Overall, prevalent OA cases increased by 113.25% worldwide, from 247.51 million in 1990 to 527.81 million in 2019. China had the highest number of cases in 2019 (132.81 million), followed by India (62.36 million), and the United States (51.87 million). The percentage increases for these three countries from 1990 to 2019 were 156.58%, 165.75%, and 79.63%, respectively.
To further calculate trends in OA, the researchers used age-standardized prevalence rates (ASRs). The overall ASRs increased from 6,173.38 per 100,000 individuals in 1990 to 6,348.25 per 100,000 individuals in 2019, for an estimated annual percentage change of 0.12%. The ASR of OA varied substantially across countries in 2019, with the highest level observed in the United States (9,960.88 per 100,000) and the lowest in Timor-Leste (3,768.44 per 100,000). The prevalence of OA was higher in countries with higher SDI levels, such as the United States and the Republic of Korea, and increased life expectancy may play a role, they said.
OA prevalence increased with age; the prevalence of OA among adults peaked at 60-64 years in both 1990 and 2019. The absolute number of cases rose most sharply among individuals aged 95 years and older, increasing nearly fourfold during the 30-year period. The ASR of OA was also highest for people aged 95 years or older.
As for site-specific prevalence in 2019, OA of the knee was the most common site worldwide (60.6% of cases), followed by OA of the hand (23.7%), other joint sites (10.2%), and the hip (5.5%).
The ASR of OA increased for knee, hip, and other joints, with estimated annual percentage changes of 0.32%, 0.28%, and 0.18%, respectively, but decreased by 0.36% for the hand.
OA in large joints, such as the knee and hip, is often associated with higher disease burden, the researchers said. However, this held true for only knee OA because in this study, “globally as well as in most regions and countries, joints with the main disease burden were the knee, followed by the hand, [and] other joints except spine, while OA [of the] hip contributed the least,” they noted.
The study findings were limited by several factors including the adjustments from individual studies in the GBD and the exclusion of spinal symptoms, which might have contributed to an underestimation of disease burden, the researchers noted. Other limitations included the lack of assessment of the effect of health systems as part of the SDI, they said.
Overall, the results support a trend of increasing OA worldwide that is expected to continue in part because of the aging global population and the ongoing epidemic of obesity, the researchers said.
“Public awareness of the modifiable risk factors, and potential education programs of prevention of disease occurrence are essential to alleviate the enormous burden of OA,” they concluded.
The study was supported by the Beijing Postdoctoral Research Foundation and National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
Prevalent cases of osteoarthritis increased significantly worldwide from 1990 to 2019, based on data from the Global Burden of Disease Study 2019.
OA remains a highly prevalent condition worldwide, with no nonsurgical interventions to prevent progression, wrote Huibin Long, MD, of Capital Medical University, Beijing, and colleagues.
Data from previous studies show that the prevalence of OA varies depending on the joints involved, with the knee being most frequently affected. However, site-specific data on OA trends and disease burden across regions or territories has not been well documented, they said.
In a study published in Arthritis & Rheumatology, the researchers analyzed data from the Global Burden of Disease Study, an ongoing project involving researchers in approximately 200 countries and territories to provide up-to-date information on the disease burdens of more than 350 types of diseases and injuries.
The Global Burden of Disease study for 2019 (GBD 2019) included data on age- and sex-specific incidence, prevalence, mortality, years of life lost, and disability-adjusted life-years for 369 diseases and injuries in 204 countries and territories. Countries were divided into five groups based on a composite sociodemographic index (SDI) of factors including fertility, income, and educational attainment; the SDI represents the quality and availability of health care, the researchers wrote.
OA was defined as radiologically confirmed Kellgren-Lawrence grade 2-4 and pain for at least 1 month during the past 12 months.
Overall, prevalent OA cases increased by 113.25% worldwide, from 247.51 million in 1990 to 527.81 million in 2019. China had the highest number of cases in 2019 (132.81 million), followed by India (62.36 million), and the United States (51.87 million). The percentage increases for these three countries from 1990 to 2019 were 156.58%, 165.75%, and 79.63%, respectively.
To further calculate trends in OA, the researchers used age-standardized prevalence rates (ASRs). The overall ASRs increased from 6,173.38 per 100,000 individuals in 1990 to 6,348.25 per 100,000 individuals in 2019, for an estimated annual percentage change of 0.12%. The ASR of OA varied substantially across countries in 2019, with the highest level observed in the United States (9,960.88 per 100,000) and the lowest in Timor-Leste (3,768.44 per 100,000). The prevalence of OA was higher in countries with higher SDI levels, such as the United States and the Republic of Korea, and increased life expectancy may play a role, they said.
OA prevalence increased with age; the prevalence of OA among adults peaked at 60-64 years in both 1990 and 2019. The absolute number of cases rose most sharply among individuals aged 95 years and older, increasing nearly fourfold during the 30-year period. The ASR of OA was also highest for people aged 95 years or older.
As for site-specific prevalence in 2019, OA of the knee was the most common site worldwide (60.6% of cases), followed by OA of the hand (23.7%), other joint sites (10.2%), and the hip (5.5%).
The ASR of OA increased for knee, hip, and other joints, with estimated annual percentage changes of 0.32%, 0.28%, and 0.18%, respectively, but decreased by 0.36% for the hand.
OA in large joints, such as the knee and hip, is often associated with higher disease burden, the researchers said. However, this held true for only knee OA because in this study, “globally as well as in most regions and countries, joints with the main disease burden were the knee, followed by the hand, [and] other joints except spine, while OA [of the] hip contributed the least,” they noted.
The study findings were limited by several factors including the adjustments from individual studies in the GBD and the exclusion of spinal symptoms, which might have contributed to an underestimation of disease burden, the researchers noted. Other limitations included the lack of assessment of the effect of health systems as part of the SDI, they said.
Overall, the results support a trend of increasing OA worldwide that is expected to continue in part because of the aging global population and the ongoing epidemic of obesity, the researchers said.
“Public awareness of the modifiable risk factors, and potential education programs of prevention of disease occurrence are essential to alleviate the enormous burden of OA,” they concluded.
The study was supported by the Beijing Postdoctoral Research Foundation and National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
Prevalent cases of osteoarthritis increased significantly worldwide from 1990 to 2019, based on data from the Global Burden of Disease Study 2019.
OA remains a highly prevalent condition worldwide, with no nonsurgical interventions to prevent progression, wrote Huibin Long, MD, of Capital Medical University, Beijing, and colleagues.
Data from previous studies show that the prevalence of OA varies depending on the joints involved, with the knee being most frequently affected. However, site-specific data on OA trends and disease burden across regions or territories has not been well documented, they said.
In a study published in Arthritis & Rheumatology, the researchers analyzed data from the Global Burden of Disease Study, an ongoing project involving researchers in approximately 200 countries and territories to provide up-to-date information on the disease burdens of more than 350 types of diseases and injuries.
The Global Burden of Disease study for 2019 (GBD 2019) included data on age- and sex-specific incidence, prevalence, mortality, years of life lost, and disability-adjusted life-years for 369 diseases and injuries in 204 countries and territories. Countries were divided into five groups based on a composite sociodemographic index (SDI) of factors including fertility, income, and educational attainment; the SDI represents the quality and availability of health care, the researchers wrote.
OA was defined as radiologically confirmed Kellgren-Lawrence grade 2-4 and pain for at least 1 month during the past 12 months.
Overall, prevalent OA cases increased by 113.25% worldwide, from 247.51 million in 1990 to 527.81 million in 2019. China had the highest number of cases in 2019 (132.81 million), followed by India (62.36 million), and the United States (51.87 million). The percentage increases for these three countries from 1990 to 2019 were 156.58%, 165.75%, and 79.63%, respectively.
To further calculate trends in OA, the researchers used age-standardized prevalence rates (ASRs). The overall ASRs increased from 6,173.38 per 100,000 individuals in 1990 to 6,348.25 per 100,000 individuals in 2019, for an estimated annual percentage change of 0.12%. The ASR of OA varied substantially across countries in 2019, with the highest level observed in the United States (9,960.88 per 100,000) and the lowest in Timor-Leste (3,768.44 per 100,000). The prevalence of OA was higher in countries with higher SDI levels, such as the United States and the Republic of Korea, and increased life expectancy may play a role, they said.
OA prevalence increased with age; the prevalence of OA among adults peaked at 60-64 years in both 1990 and 2019. The absolute number of cases rose most sharply among individuals aged 95 years and older, increasing nearly fourfold during the 30-year period. The ASR of OA was also highest for people aged 95 years or older.
As for site-specific prevalence in 2019, OA of the knee was the most common site worldwide (60.6% of cases), followed by OA of the hand (23.7%), other joint sites (10.2%), and the hip (5.5%).
The ASR of OA increased for knee, hip, and other joints, with estimated annual percentage changes of 0.32%, 0.28%, and 0.18%, respectively, but decreased by 0.36% for the hand.
OA in large joints, such as the knee and hip, is often associated with higher disease burden, the researchers said. However, this held true for only knee OA because in this study, “globally as well as in most regions and countries, joints with the main disease burden were the knee, followed by the hand, [and] other joints except spine, while OA [of the] hip contributed the least,” they noted.
The study findings were limited by several factors including the adjustments from individual studies in the GBD and the exclusion of spinal symptoms, which might have contributed to an underestimation of disease burden, the researchers noted. Other limitations included the lack of assessment of the effect of health systems as part of the SDI, they said.
Overall, the results support a trend of increasing OA worldwide that is expected to continue in part because of the aging global population and the ongoing epidemic of obesity, the researchers said.
“Public awareness of the modifiable risk factors, and potential education programs of prevention of disease occurrence are essential to alleviate the enormous burden of OA,” they concluded.
The study was supported by the Beijing Postdoctoral Research Foundation and National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
FROM ARTHRITIS & RHEUMATOLOGY
Immediate postpartum IUD insertion increases expulsion risk
Expulsion of intrauterine devices was significantly more likely when the devices were inserted within the first 3 days after delivery compared with later insertions, based on data from more than 300,000 women.
Intrauterine devices are effective contraception, and current guidelines support immediate postpartum IUD insertion as a safe, effective, and convenient option, Mary Anne Armstrong, MA, of Kaiser Permanente Northern California, Oakland, and colleagues wrote. Although IUD expulsion rates are low overall, data from previous studies suggest that timing of insertion may affect expulsion rates, and that breastfeeding may play a role.
In the Association of Perforation and Expulsion of Intrauterine Devices (APEX-IUD) cohort study published in JAMA Network Open, the researchers reviewed data from the electronic health records at four sites; the study population included women aged 50 years and younger who underwent IUD insertion between 2001 and 2018.
The women were grouped by postpartum status and timing of IUD placement: 0-3 days, 4 days to 6 weeks, 6-14 weeks, 14-52 weeks, and nonpostpartum (defined as more than 52 weeks or no evidence of delivery).
The researchers also compared expulsion rates in postpartum women who were and were not breastfeeding at the time of IUD insertion based on clinical records, diagnostic codes, or questionnaires at well-baby visits.
The total study population included 326,658 women with a mean age of 32.0 years; 42% were non-Hispanic White, 17.2% were Hispanic other, 13.0% were Hispanic White, 11.9% were Asian or Pacific Islander, 8.7% were non-Hispanic Black, and 0.2% were Hispanic Black. Approximately 80% of the IUDs were levonorgestrel releasing.
A total of 8,943 expulsions were reported, for an overall expulsion rate of 13.94 per 1,000 person-years.
The adjusted hazard ratios for IUD expulsion were 5.34, 1.22, 1.06, and 1.43 for women with insertion times, respectively, of 0-3 days, 4 days to 6 or fewer weeks, 6-14 weeks, and 14-52 weeks. Women with nonpostpartum IUD insertion served as the referent.
The 5-year cumulative incidence of IUD expulsion was highest with placement between 0 and 3 days post partum and lowest with placement at 6-14 weeks postpartum (10.73% and 3.18%, respectively).
“Within the group with IUD insertions 0-3 days postpartum, the highest expulsion rates were discovered within 12 weeks of insertion, with the highest incidence rate occurring at week 6 (844 per 1,000 person-years), a time women are commonly seen post delivery,” the researchers noted.
In a subcohort of 94,817 women with known breastfeeding status, the 5-year cumulative incidence of expulsion was 3.49% for breastfeeding women and 4.57% for nonbreastfeeding women, with an adjusted HR of 0.71 for breastfeeding versus not breastfeeding.
“While women who accept immediate postpartum IUD placement report high satisfaction rates, information on women’s preferences and satisfaction associated with different timing of postpartum placement would also be helpful to understand the benefit-risk profile,” the researchers wrote in their discussion of the findings. “The fact that most expulsions in the immediate postpartum group occurred early presents an opportunity to mitigate risk of unrecognized expulsion and unintended pregnancy via counseling on signs of expulsion and follow-up examination.”
The study findings were limited by several factors including the potential misclassification of exposures and the primary outcome of expulsion, especially since some postpartum women may be lactating whether or not they are breastfeeding, the researchers noted. Other limitations included the combination of complete and partial expulsions, and the dating of IUD expulsion based on when it came to medical attention, which was not necessarily when it occurred. More data are needed on the potential association between lactational amenorrhea and lower expulsion risk among postpartum women who are breastfeeding.
However, the results were strengthened by the large and diverse study population, the use of linked mother-infant records to identify exposures, and the use electronic health records to identify outcomes, and the data can inform patient counseling for postpartum IUDs, the researchers concluded.
Study reflects findings from Europe
“The FDA mandated this study in response to a European study, EURAS-IUD1, a European prospective observational study that enrolled 61,448 participants between 2006 and 2012,” Ms. Armstrong said in an interview. In the European study “women breastfeeding at the time of device insertion or with the device inserted at 36 weeks’ postpartum or less had higher risk of uterine perforation. The FDA wanted to know if the risks were similar in the United States population”
The APEX-IUD study was designed to reflect current United States clinical practice. “The aims of APEX-IUD are to evaluate risk of IUD-related uterine perforation and device expulsion among women who are breastfeeding or within 12 months postpartum at insertion. The perforation outcome is addressed in a separate paper,” Ms. Armstrong noted.
“We were not surprised by the findings; they aligned with previous findings and confirm the overall safety of intrauterine devices,” said Ms. Armstrong. “Data from this study provides IUD expulsion risk estimates that can be used to inform clinical practice and preinsertion counseling. IUD insertions 0-3 days postpartum might decrease the risk of unintended pregnancy and provide more convenience and efficiency for new mothers. This has proven to be especially important during the pandemic. The higher risk of expulsion at 0-3 days post partum must be balanced with the low IUD-related uterine perforation risk to provide a comprehensive picture that aids in clinical decision-making.
“Potential barriers to postpartum IUD placement include lack of provision of education on the range of contraceptive options available during prenatal care and failure or inability of hospital inpatient units to stock the intrauterine devices for use when needed,” said Ms. Armstrong.
Looking ahead, “future research could evaluate risk factors for partial versus complete expulsions, the association of preinsertion counseling with recognition of potential expulsions and corresponding IUD failure rates, and whether ultrasound verification of IUD position in the uterus after insertion is associated with expulsion risk,” she said.
Identifying risk factors informs patient counseling
“The current study examines breastfeeding at time of IUD insertion as a risk factor for expulsion,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview. “There is biologic plausibility that breastfeeding may be a risk factor of IUD expulsion. Breastfeeding stimulates secretion of oxytocin, a hormone which plays a key role in the contraction of the uterus during labor and uterine involution postpartum. It also plays a key role in the contraction of milk ducts to allow for milk letdown. Because of its dual role some mothers may occasionally report uterine cramping with breastfeeding. Prior studies have suggested that breastfeeding may be associated with an increased risk of uterine perforation with postpartum IUD placement, but how breastfeeding may contribute to risk of IUD expulsion has not been studied extensively.”
The current data are consistent with previous studies suggesting the highest risk of IUD expulsion is with placement in the immediate postpartum period (0-3 days). “In a subcohort analysis by breastfeeding status, the risk of IUD expulsion was lower for women who were breastfeeding versus not breastfeeding;” however, “these findings may be due to amenorrhea that can also be seen with breastfeeding,” Dr. Krishna said. “Menstrual bleeding is an independent risk factor for IUD expulsion and not having menstrual bleeding while breastfeeding may lower risk of expulsion.
“Patients should be counseled on the benefits of immediate postpartum IUD placement, the risk of IUD expulsion, and alternative contraception options to be able to make an informed decision about the right contraception for them,” Dr. Krishna emphasized. “Clinicians can reassure patients that the uterine cramping they may feel while breastfeeding does not appear to increase the risk of IUD expulsion and that the amenorrhea that may result from breastfeeding also may lower the risk of IUD expulsion.”
The study was supported by Bayer through support to RTI Health Solutions, Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the Regenstrief Institute. Ms. Armstrong and several coauthors disclosed support from Bayer during the study. Dr. Krishna had no relevant disclosures.
Expulsion of intrauterine devices was significantly more likely when the devices were inserted within the first 3 days after delivery compared with later insertions, based on data from more than 300,000 women.
Intrauterine devices are effective contraception, and current guidelines support immediate postpartum IUD insertion as a safe, effective, and convenient option, Mary Anne Armstrong, MA, of Kaiser Permanente Northern California, Oakland, and colleagues wrote. Although IUD expulsion rates are low overall, data from previous studies suggest that timing of insertion may affect expulsion rates, and that breastfeeding may play a role.
In the Association of Perforation and Expulsion of Intrauterine Devices (APEX-IUD) cohort study published in JAMA Network Open, the researchers reviewed data from the electronic health records at four sites; the study population included women aged 50 years and younger who underwent IUD insertion between 2001 and 2018.
The women were grouped by postpartum status and timing of IUD placement: 0-3 days, 4 days to 6 weeks, 6-14 weeks, 14-52 weeks, and nonpostpartum (defined as more than 52 weeks or no evidence of delivery).
The researchers also compared expulsion rates in postpartum women who were and were not breastfeeding at the time of IUD insertion based on clinical records, diagnostic codes, or questionnaires at well-baby visits.
The total study population included 326,658 women with a mean age of 32.0 years; 42% were non-Hispanic White, 17.2% were Hispanic other, 13.0% were Hispanic White, 11.9% were Asian or Pacific Islander, 8.7% were non-Hispanic Black, and 0.2% were Hispanic Black. Approximately 80% of the IUDs were levonorgestrel releasing.
A total of 8,943 expulsions were reported, for an overall expulsion rate of 13.94 per 1,000 person-years.
The adjusted hazard ratios for IUD expulsion were 5.34, 1.22, 1.06, and 1.43 for women with insertion times, respectively, of 0-3 days, 4 days to 6 or fewer weeks, 6-14 weeks, and 14-52 weeks. Women with nonpostpartum IUD insertion served as the referent.
The 5-year cumulative incidence of IUD expulsion was highest with placement between 0 and 3 days post partum and lowest with placement at 6-14 weeks postpartum (10.73% and 3.18%, respectively).
“Within the group with IUD insertions 0-3 days postpartum, the highest expulsion rates were discovered within 12 weeks of insertion, with the highest incidence rate occurring at week 6 (844 per 1,000 person-years), a time women are commonly seen post delivery,” the researchers noted.
In a subcohort of 94,817 women with known breastfeeding status, the 5-year cumulative incidence of expulsion was 3.49% for breastfeeding women and 4.57% for nonbreastfeeding women, with an adjusted HR of 0.71 for breastfeeding versus not breastfeeding.
“While women who accept immediate postpartum IUD placement report high satisfaction rates, information on women’s preferences and satisfaction associated with different timing of postpartum placement would also be helpful to understand the benefit-risk profile,” the researchers wrote in their discussion of the findings. “The fact that most expulsions in the immediate postpartum group occurred early presents an opportunity to mitigate risk of unrecognized expulsion and unintended pregnancy via counseling on signs of expulsion and follow-up examination.”
The study findings were limited by several factors including the potential misclassification of exposures and the primary outcome of expulsion, especially since some postpartum women may be lactating whether or not they are breastfeeding, the researchers noted. Other limitations included the combination of complete and partial expulsions, and the dating of IUD expulsion based on when it came to medical attention, which was not necessarily when it occurred. More data are needed on the potential association between lactational amenorrhea and lower expulsion risk among postpartum women who are breastfeeding.
However, the results were strengthened by the large and diverse study population, the use of linked mother-infant records to identify exposures, and the use electronic health records to identify outcomes, and the data can inform patient counseling for postpartum IUDs, the researchers concluded.
Study reflects findings from Europe
“The FDA mandated this study in response to a European study, EURAS-IUD1, a European prospective observational study that enrolled 61,448 participants between 2006 and 2012,” Ms. Armstrong said in an interview. In the European study “women breastfeeding at the time of device insertion or with the device inserted at 36 weeks’ postpartum or less had higher risk of uterine perforation. The FDA wanted to know if the risks were similar in the United States population”
The APEX-IUD study was designed to reflect current United States clinical practice. “The aims of APEX-IUD are to evaluate risk of IUD-related uterine perforation and device expulsion among women who are breastfeeding or within 12 months postpartum at insertion. The perforation outcome is addressed in a separate paper,” Ms. Armstrong noted.
“We were not surprised by the findings; they aligned with previous findings and confirm the overall safety of intrauterine devices,” said Ms. Armstrong. “Data from this study provides IUD expulsion risk estimates that can be used to inform clinical practice and preinsertion counseling. IUD insertions 0-3 days postpartum might decrease the risk of unintended pregnancy and provide more convenience and efficiency for new mothers. This has proven to be especially important during the pandemic. The higher risk of expulsion at 0-3 days post partum must be balanced with the low IUD-related uterine perforation risk to provide a comprehensive picture that aids in clinical decision-making.
“Potential barriers to postpartum IUD placement include lack of provision of education on the range of contraceptive options available during prenatal care and failure or inability of hospital inpatient units to stock the intrauterine devices for use when needed,” said Ms. Armstrong.
Looking ahead, “future research could evaluate risk factors for partial versus complete expulsions, the association of preinsertion counseling with recognition of potential expulsions and corresponding IUD failure rates, and whether ultrasound verification of IUD position in the uterus after insertion is associated with expulsion risk,” she said.
Identifying risk factors informs patient counseling
“The current study examines breastfeeding at time of IUD insertion as a risk factor for expulsion,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview. “There is biologic plausibility that breastfeeding may be a risk factor of IUD expulsion. Breastfeeding stimulates secretion of oxytocin, a hormone which plays a key role in the contraction of the uterus during labor and uterine involution postpartum. It also plays a key role in the contraction of milk ducts to allow for milk letdown. Because of its dual role some mothers may occasionally report uterine cramping with breastfeeding. Prior studies have suggested that breastfeeding may be associated with an increased risk of uterine perforation with postpartum IUD placement, but how breastfeeding may contribute to risk of IUD expulsion has not been studied extensively.”
The current data are consistent with previous studies suggesting the highest risk of IUD expulsion is with placement in the immediate postpartum period (0-3 days). “In a subcohort analysis by breastfeeding status, the risk of IUD expulsion was lower for women who were breastfeeding versus not breastfeeding;” however, “these findings may be due to amenorrhea that can also be seen with breastfeeding,” Dr. Krishna said. “Menstrual bleeding is an independent risk factor for IUD expulsion and not having menstrual bleeding while breastfeeding may lower risk of expulsion.
“Patients should be counseled on the benefits of immediate postpartum IUD placement, the risk of IUD expulsion, and alternative contraception options to be able to make an informed decision about the right contraception for them,” Dr. Krishna emphasized. “Clinicians can reassure patients that the uterine cramping they may feel while breastfeeding does not appear to increase the risk of IUD expulsion and that the amenorrhea that may result from breastfeeding also may lower the risk of IUD expulsion.”
The study was supported by Bayer through support to RTI Health Solutions, Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the Regenstrief Institute. Ms. Armstrong and several coauthors disclosed support from Bayer during the study. Dr. Krishna had no relevant disclosures.
Expulsion of intrauterine devices was significantly more likely when the devices were inserted within the first 3 days after delivery compared with later insertions, based on data from more than 300,000 women.
Intrauterine devices are effective contraception, and current guidelines support immediate postpartum IUD insertion as a safe, effective, and convenient option, Mary Anne Armstrong, MA, of Kaiser Permanente Northern California, Oakland, and colleagues wrote. Although IUD expulsion rates are low overall, data from previous studies suggest that timing of insertion may affect expulsion rates, and that breastfeeding may play a role.
In the Association of Perforation and Expulsion of Intrauterine Devices (APEX-IUD) cohort study published in JAMA Network Open, the researchers reviewed data from the electronic health records at four sites; the study population included women aged 50 years and younger who underwent IUD insertion between 2001 and 2018.
The women were grouped by postpartum status and timing of IUD placement: 0-3 days, 4 days to 6 weeks, 6-14 weeks, 14-52 weeks, and nonpostpartum (defined as more than 52 weeks or no evidence of delivery).
The researchers also compared expulsion rates in postpartum women who were and were not breastfeeding at the time of IUD insertion based on clinical records, diagnostic codes, or questionnaires at well-baby visits.
The total study population included 326,658 women with a mean age of 32.0 years; 42% were non-Hispanic White, 17.2% were Hispanic other, 13.0% were Hispanic White, 11.9% were Asian or Pacific Islander, 8.7% were non-Hispanic Black, and 0.2% were Hispanic Black. Approximately 80% of the IUDs were levonorgestrel releasing.
A total of 8,943 expulsions were reported, for an overall expulsion rate of 13.94 per 1,000 person-years.
The adjusted hazard ratios for IUD expulsion were 5.34, 1.22, 1.06, and 1.43 for women with insertion times, respectively, of 0-3 days, 4 days to 6 or fewer weeks, 6-14 weeks, and 14-52 weeks. Women with nonpostpartum IUD insertion served as the referent.
The 5-year cumulative incidence of IUD expulsion was highest with placement between 0 and 3 days post partum and lowest with placement at 6-14 weeks postpartum (10.73% and 3.18%, respectively).
“Within the group with IUD insertions 0-3 days postpartum, the highest expulsion rates were discovered within 12 weeks of insertion, with the highest incidence rate occurring at week 6 (844 per 1,000 person-years), a time women are commonly seen post delivery,” the researchers noted.
In a subcohort of 94,817 women with known breastfeeding status, the 5-year cumulative incidence of expulsion was 3.49% for breastfeeding women and 4.57% for nonbreastfeeding women, with an adjusted HR of 0.71 for breastfeeding versus not breastfeeding.
“While women who accept immediate postpartum IUD placement report high satisfaction rates, information on women’s preferences and satisfaction associated with different timing of postpartum placement would also be helpful to understand the benefit-risk profile,” the researchers wrote in their discussion of the findings. “The fact that most expulsions in the immediate postpartum group occurred early presents an opportunity to mitigate risk of unrecognized expulsion and unintended pregnancy via counseling on signs of expulsion and follow-up examination.”
The study findings were limited by several factors including the potential misclassification of exposures and the primary outcome of expulsion, especially since some postpartum women may be lactating whether or not they are breastfeeding, the researchers noted. Other limitations included the combination of complete and partial expulsions, and the dating of IUD expulsion based on when it came to medical attention, which was not necessarily when it occurred. More data are needed on the potential association between lactational amenorrhea and lower expulsion risk among postpartum women who are breastfeeding.
However, the results were strengthened by the large and diverse study population, the use of linked mother-infant records to identify exposures, and the use electronic health records to identify outcomes, and the data can inform patient counseling for postpartum IUDs, the researchers concluded.
Study reflects findings from Europe
“The FDA mandated this study in response to a European study, EURAS-IUD1, a European prospective observational study that enrolled 61,448 participants between 2006 and 2012,” Ms. Armstrong said in an interview. In the European study “women breastfeeding at the time of device insertion or with the device inserted at 36 weeks’ postpartum or less had higher risk of uterine perforation. The FDA wanted to know if the risks were similar in the United States population”
The APEX-IUD study was designed to reflect current United States clinical practice. “The aims of APEX-IUD are to evaluate risk of IUD-related uterine perforation and device expulsion among women who are breastfeeding or within 12 months postpartum at insertion. The perforation outcome is addressed in a separate paper,” Ms. Armstrong noted.
“We were not surprised by the findings; they aligned with previous findings and confirm the overall safety of intrauterine devices,” said Ms. Armstrong. “Data from this study provides IUD expulsion risk estimates that can be used to inform clinical practice and preinsertion counseling. IUD insertions 0-3 days postpartum might decrease the risk of unintended pregnancy and provide more convenience and efficiency for new mothers. This has proven to be especially important during the pandemic. The higher risk of expulsion at 0-3 days post partum must be balanced with the low IUD-related uterine perforation risk to provide a comprehensive picture that aids in clinical decision-making.
“Potential barriers to postpartum IUD placement include lack of provision of education on the range of contraceptive options available during prenatal care and failure or inability of hospital inpatient units to stock the intrauterine devices for use when needed,” said Ms. Armstrong.
Looking ahead, “future research could evaluate risk factors for partial versus complete expulsions, the association of preinsertion counseling with recognition of potential expulsions and corresponding IUD failure rates, and whether ultrasound verification of IUD position in the uterus after insertion is associated with expulsion risk,” she said.
Identifying risk factors informs patient counseling
“The current study examines breastfeeding at time of IUD insertion as a risk factor for expulsion,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview. “There is biologic plausibility that breastfeeding may be a risk factor of IUD expulsion. Breastfeeding stimulates secretion of oxytocin, a hormone which plays a key role in the contraction of the uterus during labor and uterine involution postpartum. It also plays a key role in the contraction of milk ducts to allow for milk letdown. Because of its dual role some mothers may occasionally report uterine cramping with breastfeeding. Prior studies have suggested that breastfeeding may be associated with an increased risk of uterine perforation with postpartum IUD placement, but how breastfeeding may contribute to risk of IUD expulsion has not been studied extensively.”
The current data are consistent with previous studies suggesting the highest risk of IUD expulsion is with placement in the immediate postpartum period (0-3 days). “In a subcohort analysis by breastfeeding status, the risk of IUD expulsion was lower for women who were breastfeeding versus not breastfeeding;” however, “these findings may be due to amenorrhea that can also be seen with breastfeeding,” Dr. Krishna said. “Menstrual bleeding is an independent risk factor for IUD expulsion and not having menstrual bleeding while breastfeeding may lower risk of expulsion.
“Patients should be counseled on the benefits of immediate postpartum IUD placement, the risk of IUD expulsion, and alternative contraception options to be able to make an informed decision about the right contraception for them,” Dr. Krishna emphasized. “Clinicians can reassure patients that the uterine cramping they may feel while breastfeeding does not appear to increase the risk of IUD expulsion and that the amenorrhea that may result from breastfeeding also may lower the risk of IUD expulsion.”
The study was supported by Bayer through support to RTI Health Solutions, Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the Regenstrief Institute. Ms. Armstrong and several coauthors disclosed support from Bayer during the study. Dr. Krishna had no relevant disclosures.
FROM JAMA NETWORK OPEN
Phthalate exposure via maternal and cord blood affects infant outcomes
Exposure to phthalates through maternal blood and cord blood affected outcomes including head circumference and anogenital index for male and female infants, according to data from 65 mother-infant pairs.
Phthalates are recognized endocrine disruptors that have been associated with adverse birth outcomes, but the specific relationship between maternal phthalate exposure and birth outcomes has not been well studied, wrote Hsiao-Lin Hwa, MD, of National Taiwan University, Taipei, and colleagues.
Previous research suggests that trace exposure to hazardous chemicals during the fetal period “may cause fetal metabolic dysfunction and adversely change the morphology of body systems,” they said. In 2011, “the Taiwan Food and Drug Administration found that di‐2‐ethylhexyl phthalate (DEHP) and DiNP [di‐isononyl phthalate] had been illegally added as emulsifiers to replace palm oil in beverages and food,” they added. The researchers sought to examine the association between infant birth outcomes and phthalate exposure levels in the Taiwanese population after 2011. In a study published in Environmental Toxicology and Chemistry, the researchers recruited 65 pregnant women in Taiwan between 2016 and 2017. Birth length, birth weight, head circumference, anogenital distance (AGD), anoscrotal distance (ASD), and anofourchette distance (AFD) were measured for each newborn at the time of delivery. The average age of the women was 33.6 years, and the rate of low birth weight was 13.7%. The mean measures of birth length, birth weight, head circumference, and chest circumference were 47.6 cm, 3022 g, 32.9 cm, and 30.8 mm, respectively. The mean AFD and ASD were 14.2 mm and 22.3 mm, respectively.
The researchers tested for 12 phthalates in maternal blood and cord blood samples. Of these, the six most frequently detected phthalate metabolites were mono‐ethyl phthalate (MEP), mono‐isobutyl phthalate (MiBP), mono‐n‐butyl phthalate (MnBP), mono‐(2‐ethyl‐5‐oxohexyl)‐phthalate (MEOHP), mono‐(2‐ethyl‐5‐hydroxyhexyl) phthalate (MEHHP), and mono‐n‐octyl phthalate (MOP); these six were present in 80%–100% of the maternal blood samples.
Overall, the mean levels of MEP, MiBP, MnBP, and MEHP were relatively higher in both maternal and infant blood than other phthalates, the researchers noted. The mean concentrations of metabolites in maternal blood and infant cord blood were 0.03-2.27 ng/mL and 0.01-3.74 ng/mL, respectively.
Among male infants, levels of MMP, MiBP, and MEHP in maternal blood were inversely related to anogenital index (AGI), with P values for regression coefficients ranging from .011 to .033. In addition, the total concentration of MEHP, MEOHP, and MEHHP (designated as Σdi‐2‐ethylhexyl phthalate, ΣDEHP) was inversely related to AGI in males.
Among female infants, however, phthalates in cord blood, rather than maternal blood, were positively related to AGI, including MMP, MibP, MnBP, and MOP, with P values for regression coefficients ranging from .001 to .034.
Cord blood levels of MnBP, MEOHP, MEHP, and ΣDEHP were inversely associated with gestational age-adjusted head circumference in all infants, with beta coefficients of –0.15, –0.12, –0.01, and –0.01, respectively (P < .05 for all).
“The detection rates of MEHHP, MEOHP, and MEHP in the cord blood were lower than those in the maternal blood, particularly those of MEHHP and MEOHP, which were approximately 25% lower,” which may be caused by slow placental transfer, the researchers wrote in their discussion section. “The high detection rate of phthalate metabolites indicated that our subjects may continue to be exposed to these phthalates even after the 2011 Taiwan DEHP incident,” they noted.
The study findings were limited by several factors including the possibility for contamination of samples and other environmental confounders, the researchers noted. However, the results support the role of phthalates as endocrine disruptors, and the distinction in effects between males and females “may suggest that phthalate monoesters are potentially estrogenic and antiandrogenic chemicals,” they added.
“Further investigations involving multiple phthalate analyses during pregnancy and measurements throughout childhood are necessary to confirm our findings,” they concluded.
Direct clinical implications remain uncertain
“Phthalates are a group of chemicals that are used to make plastic more durable; they are found in multiple everyday materials, food products, and common household products,” Marissa Platner, MD, of Emory University, Atlanta, said in an interview. “It is known that we are exposed to phthalates on a routine basis but the long-term effects of this exposure are unclear,” she said.
The current study findings “were not entirely surprising given data from prior animal studies because they do imply that there is some placental transfer of the phthalate metabolites that can cause adverse effects on the developing fetus,” said Dr. Platner. “However, they also demonstrate that the placenta acts as a filter for certain larger molecules to protect the fetus,” she said.
“This study was based on a small sample size, therefore the clinical implications are not clear,” Dr. Platner noted. “However it may be worthwhile after further research to encourage our pregnant patients to try to decrease their exposure to phthalates,” she said.
Dr. Platner identified two areas for additional research to explore the role of phthalate exposure.
“The first would be to assess the level of maternal phthalate exposure throughout the pregnancy instead of just at one point in time, and the second would be to assess how the reproductive system differences at birth translate to long-term outcomes in children, such as early puberty in females or decreased fertility in males,” she said.
The study was funded by the Ministry of Science and Technology of Taiwan and the Far Eastern Memorial Hospital‐National Taiwan University Hospital. The researchers and Dr. Platner had no financial conflicts to disclose.
Exposure to phthalates through maternal blood and cord blood affected outcomes including head circumference and anogenital index for male and female infants, according to data from 65 mother-infant pairs.
Phthalates are recognized endocrine disruptors that have been associated with adverse birth outcomes, but the specific relationship between maternal phthalate exposure and birth outcomes has not been well studied, wrote Hsiao-Lin Hwa, MD, of National Taiwan University, Taipei, and colleagues.
Previous research suggests that trace exposure to hazardous chemicals during the fetal period “may cause fetal metabolic dysfunction and adversely change the morphology of body systems,” they said. In 2011, “the Taiwan Food and Drug Administration found that di‐2‐ethylhexyl phthalate (DEHP) and DiNP [di‐isononyl phthalate] had been illegally added as emulsifiers to replace palm oil in beverages and food,” they added. The researchers sought to examine the association between infant birth outcomes and phthalate exposure levels in the Taiwanese population after 2011. In a study published in Environmental Toxicology and Chemistry, the researchers recruited 65 pregnant women in Taiwan between 2016 and 2017. Birth length, birth weight, head circumference, anogenital distance (AGD), anoscrotal distance (ASD), and anofourchette distance (AFD) were measured for each newborn at the time of delivery. The average age of the women was 33.6 years, and the rate of low birth weight was 13.7%. The mean measures of birth length, birth weight, head circumference, and chest circumference were 47.6 cm, 3022 g, 32.9 cm, and 30.8 mm, respectively. The mean AFD and ASD were 14.2 mm and 22.3 mm, respectively.
The researchers tested for 12 phthalates in maternal blood and cord blood samples. Of these, the six most frequently detected phthalate metabolites were mono‐ethyl phthalate (MEP), mono‐isobutyl phthalate (MiBP), mono‐n‐butyl phthalate (MnBP), mono‐(2‐ethyl‐5‐oxohexyl)‐phthalate (MEOHP), mono‐(2‐ethyl‐5‐hydroxyhexyl) phthalate (MEHHP), and mono‐n‐octyl phthalate (MOP); these six were present in 80%–100% of the maternal blood samples.
Overall, the mean levels of MEP, MiBP, MnBP, and MEHP were relatively higher in both maternal and infant blood than other phthalates, the researchers noted. The mean concentrations of metabolites in maternal blood and infant cord blood were 0.03-2.27 ng/mL and 0.01-3.74 ng/mL, respectively.
Among male infants, levels of MMP, MiBP, and MEHP in maternal blood were inversely related to anogenital index (AGI), with P values for regression coefficients ranging from .011 to .033. In addition, the total concentration of MEHP, MEOHP, and MEHHP (designated as Σdi‐2‐ethylhexyl phthalate, ΣDEHP) was inversely related to AGI in males.
Among female infants, however, phthalates in cord blood, rather than maternal blood, were positively related to AGI, including MMP, MibP, MnBP, and MOP, with P values for regression coefficients ranging from .001 to .034.
Cord blood levels of MnBP, MEOHP, MEHP, and ΣDEHP were inversely associated with gestational age-adjusted head circumference in all infants, with beta coefficients of –0.15, –0.12, –0.01, and –0.01, respectively (P < .05 for all).
“The detection rates of MEHHP, MEOHP, and MEHP in the cord blood were lower than those in the maternal blood, particularly those of MEHHP and MEOHP, which were approximately 25% lower,” which may be caused by slow placental transfer, the researchers wrote in their discussion section. “The high detection rate of phthalate metabolites indicated that our subjects may continue to be exposed to these phthalates even after the 2011 Taiwan DEHP incident,” they noted.
The study findings were limited by several factors including the possibility for contamination of samples and other environmental confounders, the researchers noted. However, the results support the role of phthalates as endocrine disruptors, and the distinction in effects between males and females “may suggest that phthalate monoesters are potentially estrogenic and antiandrogenic chemicals,” they added.
“Further investigations involving multiple phthalate analyses during pregnancy and measurements throughout childhood are necessary to confirm our findings,” they concluded.
Direct clinical implications remain uncertain
“Phthalates are a group of chemicals that are used to make plastic more durable; they are found in multiple everyday materials, food products, and common household products,” Marissa Platner, MD, of Emory University, Atlanta, said in an interview. “It is known that we are exposed to phthalates on a routine basis but the long-term effects of this exposure are unclear,” she said.
The current study findings “were not entirely surprising given data from prior animal studies because they do imply that there is some placental transfer of the phthalate metabolites that can cause adverse effects on the developing fetus,” said Dr. Platner. “However, they also demonstrate that the placenta acts as a filter for certain larger molecules to protect the fetus,” she said.
“This study was based on a small sample size, therefore the clinical implications are not clear,” Dr. Platner noted. “However it may be worthwhile after further research to encourage our pregnant patients to try to decrease their exposure to phthalates,” she said.
Dr. Platner identified two areas for additional research to explore the role of phthalate exposure.
“The first would be to assess the level of maternal phthalate exposure throughout the pregnancy instead of just at one point in time, and the second would be to assess how the reproductive system differences at birth translate to long-term outcomes in children, such as early puberty in females or decreased fertility in males,” she said.
The study was funded by the Ministry of Science and Technology of Taiwan and the Far Eastern Memorial Hospital‐National Taiwan University Hospital. The researchers and Dr. Platner had no financial conflicts to disclose.
Exposure to phthalates through maternal blood and cord blood affected outcomes including head circumference and anogenital index for male and female infants, according to data from 65 mother-infant pairs.
Phthalates are recognized endocrine disruptors that have been associated with adverse birth outcomes, but the specific relationship between maternal phthalate exposure and birth outcomes has not been well studied, wrote Hsiao-Lin Hwa, MD, of National Taiwan University, Taipei, and colleagues.
Previous research suggests that trace exposure to hazardous chemicals during the fetal period “may cause fetal metabolic dysfunction and adversely change the morphology of body systems,” they said. In 2011, “the Taiwan Food and Drug Administration found that di‐2‐ethylhexyl phthalate (DEHP) and DiNP [di‐isononyl phthalate] had been illegally added as emulsifiers to replace palm oil in beverages and food,” they added. The researchers sought to examine the association between infant birth outcomes and phthalate exposure levels in the Taiwanese population after 2011. In a study published in Environmental Toxicology and Chemistry, the researchers recruited 65 pregnant women in Taiwan between 2016 and 2017. Birth length, birth weight, head circumference, anogenital distance (AGD), anoscrotal distance (ASD), and anofourchette distance (AFD) were measured for each newborn at the time of delivery. The average age of the women was 33.6 years, and the rate of low birth weight was 13.7%. The mean measures of birth length, birth weight, head circumference, and chest circumference were 47.6 cm, 3022 g, 32.9 cm, and 30.8 mm, respectively. The mean AFD and ASD were 14.2 mm and 22.3 mm, respectively.
The researchers tested for 12 phthalates in maternal blood and cord blood samples. Of these, the six most frequently detected phthalate metabolites were mono‐ethyl phthalate (MEP), mono‐isobutyl phthalate (MiBP), mono‐n‐butyl phthalate (MnBP), mono‐(2‐ethyl‐5‐oxohexyl)‐phthalate (MEOHP), mono‐(2‐ethyl‐5‐hydroxyhexyl) phthalate (MEHHP), and mono‐n‐octyl phthalate (MOP); these six were present in 80%–100% of the maternal blood samples.
Overall, the mean levels of MEP, MiBP, MnBP, and MEHP were relatively higher in both maternal and infant blood than other phthalates, the researchers noted. The mean concentrations of metabolites in maternal blood and infant cord blood were 0.03-2.27 ng/mL and 0.01-3.74 ng/mL, respectively.
Among male infants, levels of MMP, MiBP, and MEHP in maternal blood were inversely related to anogenital index (AGI), with P values for regression coefficients ranging from .011 to .033. In addition, the total concentration of MEHP, MEOHP, and MEHHP (designated as Σdi‐2‐ethylhexyl phthalate, ΣDEHP) was inversely related to AGI in males.
Among female infants, however, phthalates in cord blood, rather than maternal blood, were positively related to AGI, including MMP, MibP, MnBP, and MOP, with P values for regression coefficients ranging from .001 to .034.
Cord blood levels of MnBP, MEOHP, MEHP, and ΣDEHP were inversely associated with gestational age-adjusted head circumference in all infants, with beta coefficients of –0.15, –0.12, –0.01, and –0.01, respectively (P < .05 for all).
“The detection rates of MEHHP, MEOHP, and MEHP in the cord blood were lower than those in the maternal blood, particularly those of MEHHP and MEOHP, which were approximately 25% lower,” which may be caused by slow placental transfer, the researchers wrote in their discussion section. “The high detection rate of phthalate metabolites indicated that our subjects may continue to be exposed to these phthalates even after the 2011 Taiwan DEHP incident,” they noted.
The study findings were limited by several factors including the possibility for contamination of samples and other environmental confounders, the researchers noted. However, the results support the role of phthalates as endocrine disruptors, and the distinction in effects between males and females “may suggest that phthalate monoesters are potentially estrogenic and antiandrogenic chemicals,” they added.
“Further investigations involving multiple phthalate analyses during pregnancy and measurements throughout childhood are necessary to confirm our findings,” they concluded.
Direct clinical implications remain uncertain
“Phthalates are a group of chemicals that are used to make plastic more durable; they are found in multiple everyday materials, food products, and common household products,” Marissa Platner, MD, of Emory University, Atlanta, said in an interview. “It is known that we are exposed to phthalates on a routine basis but the long-term effects of this exposure are unclear,” she said.
The current study findings “were not entirely surprising given data from prior animal studies because they do imply that there is some placental transfer of the phthalate metabolites that can cause adverse effects on the developing fetus,” said Dr. Platner. “However, they also demonstrate that the placenta acts as a filter for certain larger molecules to protect the fetus,” she said.
“This study was based on a small sample size, therefore the clinical implications are not clear,” Dr. Platner noted. “However it may be worthwhile after further research to encourage our pregnant patients to try to decrease their exposure to phthalates,” she said.
Dr. Platner identified two areas for additional research to explore the role of phthalate exposure.
“The first would be to assess the level of maternal phthalate exposure throughout the pregnancy instead of just at one point in time, and the second would be to assess how the reproductive system differences at birth translate to long-term outcomes in children, such as early puberty in females or decreased fertility in males,” she said.
The study was funded by the Ministry of Science and Technology of Taiwan and the Far Eastern Memorial Hospital‐National Taiwan University Hospital. The researchers and Dr. Platner had no financial conflicts to disclose.
FROM ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY
Nasal microbiota show promise as polyp predictor
A study of the nasal microbiome helped researchers predict recurrent polyps in chronic rhinosinusitis patients with more than 90% accuracy, based on data from 85 individuals.
Chronic rhinosinusitis with nasal polyps (CRSwNP) has a significant impact on patient quality of life, but the underlying mechanism of the disease has not been well studied, and treatment options remain limited, wrote Yan Zhao, MD, of Capital Medical University, Beijing, and study coauthors.
Previous research has shown that nasal microbiome composition differs in patients with and without asthma, and some studies suggest that changes in microbiota could contribute to CRSwNP, the authors wrote. The researchers wondered if features of the nasal microbiome can predict the recurrence of nasal polyps after endoscopic sinus surgery and serve as a potential treatment target.
In a study in Allergy, the researchers examined nasal swab samples from 85 adults with CRSwNP who underwent endoscopic sinus surgery between August 2014 and March 2016 at a single center in China. The researchers performed bacterial analysis and gene sequencing on all samples.
The patients ranged in age from 18-73 years, with a mean age of 46 years, and included 64 men and 21 women. The primary outcome was recurrence of polyps. Of the total, 39 individuals had recurrence, and 46 did not.
When the researchers compared microbiota from swab samples of recurrent and nonrecurrent patients, they found differences in composition based on bacterial genus abundance. “Campylobacter, Bdellovibrio, and Aggregatibacter, among others, were more abundant in swabs from CRSwNP recurrence samples, whereas Actinobacillus, Gemella, and Moraxella were more abundant in non-recurrence samples,” they wrote.
The researchers then tested their theory that distinct nasal microbiota could be a predictive marker of risk for future nasal polyp recurrence. They used a training set of 48 samples and constructed models from nasal microbiota alone, clinical features alone, and both together.
The regression model identified Porphyromonas, Bacteroides, Moryella, Aggregatibacter, Butyrivibrio, Shewanella, Pseudoxanthomonas, Friedmanniella, Limnobacter, and Curvibacter as the most important taxa that distinguished recurrence from nonrecurrence in the specimens. When the model was validated, the area under the curve was 0.914, yielding a predictor of nasal polyp recurrence with 91.4% accuracy.
“It is highly likely that proteins, nucleic acids, and other small molecules produced by nasal microbiota are associated with the progression of CRSwNP,” the researchers noted in their discussion of the findings. “Further, the nasal microbiota could maintain a stable community environment through the secretion of various chemical compounds and/or inflammatory factors, thus playing a central role in the development of CRSwNP.”
The study findings were limited by several factors, including the analysis of nasal flora only at the genus level in the screening phase, the use only of bioinformatic analysis for recurrence prediction, and the inclusion only of subjects from a single center, the researchers noted. Future studies should combine predictors to increase accuracy and include deeper sequencing, they said. However, the results support data from previous studies and suggest a strategy to meet the need for predictors of recurrence in CRSwNP, they concluded.
“There is a critical need to understand the role of the upper airway microbiome in different phenotypes of CRS,” said Emily K. Cope, PhD, assistant director at the Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, in an interview. “This was one of the first studies to evaluate the predictive power of the microbiome in recurrence of a common CRS phenotype – CRS with nasal polyps,” she said. “Importantly, the researchers were able to predict recurrence of polyps prior to the disease manifestation,” she noted.
“Given the nascent state of current upper airway microbiome research, I was surprised that they were able to predict polyp recurrence prior to disease manifestation,” Dr. Cope said. “This is exciting, and I can imagine a future where we use microbiome data to understand risk for disease.”
What is the take-home message for clinicians? Although the immediate clinical implications are limited, Dr. Cope expressed enthusiasm for additional research. “At this point, there’s not a lot we can do without validation studies, but this study is promising. I hope we can understand the mechanism that an altered microbiome might drive (or be a result of) polyposis,” she said.
The study was supported by the National Natural Science Foundation of China, the program for the Changjiang scholars and innovative research team, the Beijing Bai-Qian-Wan talent project, the Public Welfare Development and Reform Pilot Project, the National Science and Technology Major Project, and the CAMS Innovation Fund for Medical Sciences. The researchers and Dr. Cope disclosed no financial conflicts.
A version of this article first appeared on Medscape.com.
A study of the nasal microbiome helped researchers predict recurrent polyps in chronic rhinosinusitis patients with more than 90% accuracy, based on data from 85 individuals.
Chronic rhinosinusitis with nasal polyps (CRSwNP) has a significant impact on patient quality of life, but the underlying mechanism of the disease has not been well studied, and treatment options remain limited, wrote Yan Zhao, MD, of Capital Medical University, Beijing, and study coauthors.
Previous research has shown that nasal microbiome composition differs in patients with and without asthma, and some studies suggest that changes in microbiota could contribute to CRSwNP, the authors wrote. The researchers wondered if features of the nasal microbiome can predict the recurrence of nasal polyps after endoscopic sinus surgery and serve as a potential treatment target.
In a study in Allergy, the researchers examined nasal swab samples from 85 adults with CRSwNP who underwent endoscopic sinus surgery between August 2014 and March 2016 at a single center in China. The researchers performed bacterial analysis and gene sequencing on all samples.
The patients ranged in age from 18-73 years, with a mean age of 46 years, and included 64 men and 21 women. The primary outcome was recurrence of polyps. Of the total, 39 individuals had recurrence, and 46 did not.
When the researchers compared microbiota from swab samples of recurrent and nonrecurrent patients, they found differences in composition based on bacterial genus abundance. “Campylobacter, Bdellovibrio, and Aggregatibacter, among others, were more abundant in swabs from CRSwNP recurrence samples, whereas Actinobacillus, Gemella, and Moraxella were more abundant in non-recurrence samples,” they wrote.
The researchers then tested their theory that distinct nasal microbiota could be a predictive marker of risk for future nasal polyp recurrence. They used a training set of 48 samples and constructed models from nasal microbiota alone, clinical features alone, and both together.
The regression model identified Porphyromonas, Bacteroides, Moryella, Aggregatibacter, Butyrivibrio, Shewanella, Pseudoxanthomonas, Friedmanniella, Limnobacter, and Curvibacter as the most important taxa that distinguished recurrence from nonrecurrence in the specimens. When the model was validated, the area under the curve was 0.914, yielding a predictor of nasal polyp recurrence with 91.4% accuracy.
“It is highly likely that proteins, nucleic acids, and other small molecules produced by nasal microbiota are associated with the progression of CRSwNP,” the researchers noted in their discussion of the findings. “Further, the nasal microbiota could maintain a stable community environment through the secretion of various chemical compounds and/or inflammatory factors, thus playing a central role in the development of CRSwNP.”
The study findings were limited by several factors, including the analysis of nasal flora only at the genus level in the screening phase, the use only of bioinformatic analysis for recurrence prediction, and the inclusion only of subjects from a single center, the researchers noted. Future studies should combine predictors to increase accuracy and include deeper sequencing, they said. However, the results support data from previous studies and suggest a strategy to meet the need for predictors of recurrence in CRSwNP, they concluded.
“There is a critical need to understand the role of the upper airway microbiome in different phenotypes of CRS,” said Emily K. Cope, PhD, assistant director at the Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, in an interview. “This was one of the first studies to evaluate the predictive power of the microbiome in recurrence of a common CRS phenotype – CRS with nasal polyps,” she said. “Importantly, the researchers were able to predict recurrence of polyps prior to the disease manifestation,” she noted.
“Given the nascent state of current upper airway microbiome research, I was surprised that they were able to predict polyp recurrence prior to disease manifestation,” Dr. Cope said. “This is exciting, and I can imagine a future where we use microbiome data to understand risk for disease.”
What is the take-home message for clinicians? Although the immediate clinical implications are limited, Dr. Cope expressed enthusiasm for additional research. “At this point, there’s not a lot we can do without validation studies, but this study is promising. I hope we can understand the mechanism that an altered microbiome might drive (or be a result of) polyposis,” she said.
The study was supported by the National Natural Science Foundation of China, the program for the Changjiang scholars and innovative research team, the Beijing Bai-Qian-Wan talent project, the Public Welfare Development and Reform Pilot Project, the National Science and Technology Major Project, and the CAMS Innovation Fund for Medical Sciences. The researchers and Dr. Cope disclosed no financial conflicts.
A version of this article first appeared on Medscape.com.
A study of the nasal microbiome helped researchers predict recurrent polyps in chronic rhinosinusitis patients with more than 90% accuracy, based on data from 85 individuals.
Chronic rhinosinusitis with nasal polyps (CRSwNP) has a significant impact on patient quality of life, but the underlying mechanism of the disease has not been well studied, and treatment options remain limited, wrote Yan Zhao, MD, of Capital Medical University, Beijing, and study coauthors.
Previous research has shown that nasal microbiome composition differs in patients with and without asthma, and some studies suggest that changes in microbiota could contribute to CRSwNP, the authors wrote. The researchers wondered if features of the nasal microbiome can predict the recurrence of nasal polyps after endoscopic sinus surgery and serve as a potential treatment target.
In a study in Allergy, the researchers examined nasal swab samples from 85 adults with CRSwNP who underwent endoscopic sinus surgery between August 2014 and March 2016 at a single center in China. The researchers performed bacterial analysis and gene sequencing on all samples.
The patients ranged in age from 18-73 years, with a mean age of 46 years, and included 64 men and 21 women. The primary outcome was recurrence of polyps. Of the total, 39 individuals had recurrence, and 46 did not.
When the researchers compared microbiota from swab samples of recurrent and nonrecurrent patients, they found differences in composition based on bacterial genus abundance. “Campylobacter, Bdellovibrio, and Aggregatibacter, among others, were more abundant in swabs from CRSwNP recurrence samples, whereas Actinobacillus, Gemella, and Moraxella were more abundant in non-recurrence samples,” they wrote.
The researchers then tested their theory that distinct nasal microbiota could be a predictive marker of risk for future nasal polyp recurrence. They used a training set of 48 samples and constructed models from nasal microbiota alone, clinical features alone, and both together.
The regression model identified Porphyromonas, Bacteroides, Moryella, Aggregatibacter, Butyrivibrio, Shewanella, Pseudoxanthomonas, Friedmanniella, Limnobacter, and Curvibacter as the most important taxa that distinguished recurrence from nonrecurrence in the specimens. When the model was validated, the area under the curve was 0.914, yielding a predictor of nasal polyp recurrence with 91.4% accuracy.
“It is highly likely that proteins, nucleic acids, and other small molecules produced by nasal microbiota are associated with the progression of CRSwNP,” the researchers noted in their discussion of the findings. “Further, the nasal microbiota could maintain a stable community environment through the secretion of various chemical compounds and/or inflammatory factors, thus playing a central role in the development of CRSwNP.”
The study findings were limited by several factors, including the analysis of nasal flora only at the genus level in the screening phase, the use only of bioinformatic analysis for recurrence prediction, and the inclusion only of subjects from a single center, the researchers noted. Future studies should combine predictors to increase accuracy and include deeper sequencing, they said. However, the results support data from previous studies and suggest a strategy to meet the need for predictors of recurrence in CRSwNP, they concluded.
“There is a critical need to understand the role of the upper airway microbiome in different phenotypes of CRS,” said Emily K. Cope, PhD, assistant director at the Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, in an interview. “This was one of the first studies to evaluate the predictive power of the microbiome in recurrence of a common CRS phenotype – CRS with nasal polyps,” she said. “Importantly, the researchers were able to predict recurrence of polyps prior to the disease manifestation,” she noted.
“Given the nascent state of current upper airway microbiome research, I was surprised that they were able to predict polyp recurrence prior to disease manifestation,” Dr. Cope said. “This is exciting, and I can imagine a future where we use microbiome data to understand risk for disease.”
What is the take-home message for clinicians? Although the immediate clinical implications are limited, Dr. Cope expressed enthusiasm for additional research. “At this point, there’s not a lot we can do without validation studies, but this study is promising. I hope we can understand the mechanism that an altered microbiome might drive (or be a result of) polyposis,” she said.
The study was supported by the National Natural Science Foundation of China, the program for the Changjiang scholars and innovative research team, the Beijing Bai-Qian-Wan talent project, the Public Welfare Development and Reform Pilot Project, the National Science and Technology Major Project, and the CAMS Innovation Fund for Medical Sciences. The researchers and Dr. Cope disclosed no financial conflicts.
A version of this article first appeared on Medscape.com.
Women with von Willebrand disease: Managing menstrual and postpartum bleeding
Women with von Willebrand disease (VWD) experience many obstetric and gynecologic challenges, including higher levels of von Willebrand factor (VWF) in pregnancy, Romina Brignardello-Petersen, PhD, of McMaster University, Hamilton, Ont., and colleagues wrote.
The American Society of Hematology, the International Society on Thrombosis and Haemostasis, the National Hemophilia Foundation, and the World Federation of Hemophilia convened a working group in 2017 to address updated guidelines on VWD with a focus on women, the researchers said.
In an article published in Blood Advances, the researchers described the evidence from three systematic reviews conducted to inform three recommendations for the guidelines: first-line management of heavy menstrual bleeding (HMB), treatment of women requiring or desiring neuraxial analgesia, and management of postpartum hemorrhage. The authors identified studies published through October 2019.
The first systematic review of first-line therapies for HMB included five case series, one retrospective cohort study, and one randomized controlled trial. In the randomized controlled trial of 232 patients, low-certainty evidence suggested less reduction of blood loss with desmopressin, compared with tranexamic acid (TxA), with no significant differences in side effects. Very-low-certainty evidence from an observational study also supported lower effectiveness of desmopressin versus hormonal therapy. Finally, the case series showed very-low-certainty evidence for the comparative effectiveness of hormonal therapy delivered via a levonorgestrel-releasing intrauterine system (LNG-IUS) and other therapies for HMB control.
The second systematic review compared VWF levels in women who received neuraxial anesthesia during labor.
The review included five case series that described outcomes of women with VWF levels greater than 0.50 IU/mL; however, the studies did not describe outcomes according to VWF levels and did not cite the proportion of women with VWF levels greater than 1.50 IU/mL. Consequently, the evidence for the effects of increasing VWF levels was very low certainty, the authors said. In a meta-analysis, the proportion of anesthesia complications in these women was 6% (very low certainty). The complications included hypotension, accidental dural puncture, inadequate analgesia, bloody tap with no further complications, and failed block requiring general anesthesia.
The third systemic review included two retrospective cohort studies on the use of TxA during the postpartum period. In these studies, the authors found very-low-certainty evidence that TxA reduced the risk of severe primary postpartum hemorrhage, primary postpartum hemorrhage, and secondary postpartum hemorrhage (risk ratios, 0.36, 0.25, and 0.42, respectively). The effects of TxA on blood transfusions, vaginal hematoma, blood loss, and thrombotic complications also showed very-low-certainty evidence.
The currently available evidence for treatment options in women with VWD remains very low certainty, the researchers wrote in their discussion. “Because hormonal therapy is effective in controlling HMB (based on data from women without bleeding disorders), we believe the most effective strategy to be hormonal therapy with a LNG-IUS or combined oral contraceptives, followed by TxA and desmopressin.”
The study findings were limited by several factors including scarce evidence, the risk of bias in the observational studies, and lack of comparisons/controls in the case series, the researchers noted. Notable literature gaps included data on outcomes including major bleeding and the need for surgery or additional treatments in the first review; mortality, major bleeding, spinal hematoma, transfusion, and thrombotic events in the second review; and mortality, major bleeding, and the need for other procedures in the third review.
However, the findings were strengthened by the use of broad eligibility criteria to include any studies with potential useful advice, including case series, if these were the only available options. In developing recommendations, “the guideline panel interpreted the evidence adding their experience and knowledge of indirect evidence,” the authors noted.
The current evidence, though mainly very low certainty, “is the best available to inform decisions about management. Clinicians seeking advice on how to manage their patients with VWD should refer to the practice guidelines and assess to what extent they are applicable to their patients,” the researchers concluded.
Meeting the need for evidence-based guidelines
The review is important at this time because current evidence-based guidelines are limited, said coauthor Veronica Flood, MD, a pediatric hematologist at the Medical College of Wisconsin, Milwaukee, and a VWD researcher.
“While we have some guidelines that address von Willebrand disease, these were primarily based on expert opinion and not necessarily based on the best available evidence,” said Dr. Flood.
“Given how many people have von Willebrand disease, it is important that we actually base our recommendations on the data,” she emphasized. The new guidelines also incorporate patient feedback, with the inclusion of multiple panelists who are individuals living with VWD. “The final recommendations looked at not only the evidence, but the cost effectiveness, feasibility, and patient values and preferences,” she added.
“I was surprised we did not have better evidence for some of these common issues for patients with VWD,” said Dr. Flood. “I think that speaks to the need to do more high-quality research in this area.”
From a clinical standpoint, “we now have evidence-based guidelines that support the use of prophylaxis in patients with VWD and significant bleeding, as well as recommendations for surgery and bleeding issues around menstruation,” said Dr. Flood. “I do think it is also important to recognize that many of these are conditional recommendations, meaning there is room for patient preferences in implementation, which is helpful since we know that some people will have different priorities.”
Dr. Flood noted that more research is needed in many aspects of VWD. “We definitely need to better understand best options for surgical treatment, and I consider that a high priority. We are also hoping, along with the National Hemophilia Foundation, to develop some patient decision aids to help with some of these issues.”
Coauthor Nathan T. Connell, MD, an adult hematologist at the Brigham and Women’s Hospital and Harvard Medical School, both in Boston, served as the vice chair for the guideline panel. Dr. Connell agreed with the importance of the reviews and the need for additional research. “I, too, was surprised to see the lack of robust data to answer many of the basic questions about how to manage people living with VWD. Regarding the systematic reviews, I was surprised to see the power of combining the limited data in this way to come up with an evidence base for the panels to review,” he added.
The study was supported by the ASH, ISTH, NHF, and the WFH 2020 Guidelines for Management of VWD. The researchers had no financial conflicts to disclose.
Women with von Willebrand disease (VWD) experience many obstetric and gynecologic challenges, including higher levels of von Willebrand factor (VWF) in pregnancy, Romina Brignardello-Petersen, PhD, of McMaster University, Hamilton, Ont., and colleagues wrote.
The American Society of Hematology, the International Society on Thrombosis and Haemostasis, the National Hemophilia Foundation, and the World Federation of Hemophilia convened a working group in 2017 to address updated guidelines on VWD with a focus on women, the researchers said.
In an article published in Blood Advances, the researchers described the evidence from three systematic reviews conducted to inform three recommendations for the guidelines: first-line management of heavy menstrual bleeding (HMB), treatment of women requiring or desiring neuraxial analgesia, and management of postpartum hemorrhage. The authors identified studies published through October 2019.
The first systematic review of first-line therapies for HMB included five case series, one retrospective cohort study, and one randomized controlled trial. In the randomized controlled trial of 232 patients, low-certainty evidence suggested less reduction of blood loss with desmopressin, compared with tranexamic acid (TxA), with no significant differences in side effects. Very-low-certainty evidence from an observational study also supported lower effectiveness of desmopressin versus hormonal therapy. Finally, the case series showed very-low-certainty evidence for the comparative effectiveness of hormonal therapy delivered via a levonorgestrel-releasing intrauterine system (LNG-IUS) and other therapies for HMB control.
The second systematic review compared VWF levels in women who received neuraxial anesthesia during labor.
The review included five case series that described outcomes of women with VWF levels greater than 0.50 IU/mL; however, the studies did not describe outcomes according to VWF levels and did not cite the proportion of women with VWF levels greater than 1.50 IU/mL. Consequently, the evidence for the effects of increasing VWF levels was very low certainty, the authors said. In a meta-analysis, the proportion of anesthesia complications in these women was 6% (very low certainty). The complications included hypotension, accidental dural puncture, inadequate analgesia, bloody tap with no further complications, and failed block requiring general anesthesia.
The third systemic review included two retrospective cohort studies on the use of TxA during the postpartum period. In these studies, the authors found very-low-certainty evidence that TxA reduced the risk of severe primary postpartum hemorrhage, primary postpartum hemorrhage, and secondary postpartum hemorrhage (risk ratios, 0.36, 0.25, and 0.42, respectively). The effects of TxA on blood transfusions, vaginal hematoma, blood loss, and thrombotic complications also showed very-low-certainty evidence.
The currently available evidence for treatment options in women with VWD remains very low certainty, the researchers wrote in their discussion. “Because hormonal therapy is effective in controlling HMB (based on data from women without bleeding disorders), we believe the most effective strategy to be hormonal therapy with a LNG-IUS or combined oral contraceptives, followed by TxA and desmopressin.”
The study findings were limited by several factors including scarce evidence, the risk of bias in the observational studies, and lack of comparisons/controls in the case series, the researchers noted. Notable literature gaps included data on outcomes including major bleeding and the need for surgery or additional treatments in the first review; mortality, major bleeding, spinal hematoma, transfusion, and thrombotic events in the second review; and mortality, major bleeding, and the need for other procedures in the third review.
However, the findings were strengthened by the use of broad eligibility criteria to include any studies with potential useful advice, including case series, if these were the only available options. In developing recommendations, “the guideline panel interpreted the evidence adding their experience and knowledge of indirect evidence,” the authors noted.
The current evidence, though mainly very low certainty, “is the best available to inform decisions about management. Clinicians seeking advice on how to manage their patients with VWD should refer to the practice guidelines and assess to what extent they are applicable to their patients,” the researchers concluded.
Meeting the need for evidence-based guidelines
The review is important at this time because current evidence-based guidelines are limited, said coauthor Veronica Flood, MD, a pediatric hematologist at the Medical College of Wisconsin, Milwaukee, and a VWD researcher.
“While we have some guidelines that address von Willebrand disease, these were primarily based on expert opinion and not necessarily based on the best available evidence,” said Dr. Flood.
“Given how many people have von Willebrand disease, it is important that we actually base our recommendations on the data,” she emphasized. The new guidelines also incorporate patient feedback, with the inclusion of multiple panelists who are individuals living with VWD. “The final recommendations looked at not only the evidence, but the cost effectiveness, feasibility, and patient values and preferences,” she added.
“I was surprised we did not have better evidence for some of these common issues for patients with VWD,” said Dr. Flood. “I think that speaks to the need to do more high-quality research in this area.”
From a clinical standpoint, “we now have evidence-based guidelines that support the use of prophylaxis in patients with VWD and significant bleeding, as well as recommendations for surgery and bleeding issues around menstruation,” said Dr. Flood. “I do think it is also important to recognize that many of these are conditional recommendations, meaning there is room for patient preferences in implementation, which is helpful since we know that some people will have different priorities.”
Dr. Flood noted that more research is needed in many aspects of VWD. “We definitely need to better understand best options for surgical treatment, and I consider that a high priority. We are also hoping, along with the National Hemophilia Foundation, to develop some patient decision aids to help with some of these issues.”
Coauthor Nathan T. Connell, MD, an adult hematologist at the Brigham and Women’s Hospital and Harvard Medical School, both in Boston, served as the vice chair for the guideline panel. Dr. Connell agreed with the importance of the reviews and the need for additional research. “I, too, was surprised to see the lack of robust data to answer many of the basic questions about how to manage people living with VWD. Regarding the systematic reviews, I was surprised to see the power of combining the limited data in this way to come up with an evidence base for the panels to review,” he added.
The study was supported by the ASH, ISTH, NHF, and the WFH 2020 Guidelines for Management of VWD. The researchers had no financial conflicts to disclose.
Women with von Willebrand disease (VWD) experience many obstetric and gynecologic challenges, including higher levels of von Willebrand factor (VWF) in pregnancy, Romina Brignardello-Petersen, PhD, of McMaster University, Hamilton, Ont., and colleagues wrote.
The American Society of Hematology, the International Society on Thrombosis and Haemostasis, the National Hemophilia Foundation, and the World Federation of Hemophilia convened a working group in 2017 to address updated guidelines on VWD with a focus on women, the researchers said.
In an article published in Blood Advances, the researchers described the evidence from three systematic reviews conducted to inform three recommendations for the guidelines: first-line management of heavy menstrual bleeding (HMB), treatment of women requiring or desiring neuraxial analgesia, and management of postpartum hemorrhage. The authors identified studies published through October 2019.
The first systematic review of first-line therapies for HMB included five case series, one retrospective cohort study, and one randomized controlled trial. In the randomized controlled trial of 232 patients, low-certainty evidence suggested less reduction of blood loss with desmopressin, compared with tranexamic acid (TxA), with no significant differences in side effects. Very-low-certainty evidence from an observational study also supported lower effectiveness of desmopressin versus hormonal therapy. Finally, the case series showed very-low-certainty evidence for the comparative effectiveness of hormonal therapy delivered via a levonorgestrel-releasing intrauterine system (LNG-IUS) and other therapies for HMB control.
The second systematic review compared VWF levels in women who received neuraxial anesthesia during labor.
The review included five case series that described outcomes of women with VWF levels greater than 0.50 IU/mL; however, the studies did not describe outcomes according to VWF levels and did not cite the proportion of women with VWF levels greater than 1.50 IU/mL. Consequently, the evidence for the effects of increasing VWF levels was very low certainty, the authors said. In a meta-analysis, the proportion of anesthesia complications in these women was 6% (very low certainty). The complications included hypotension, accidental dural puncture, inadequate analgesia, bloody tap with no further complications, and failed block requiring general anesthesia.
The third systemic review included two retrospective cohort studies on the use of TxA during the postpartum period. In these studies, the authors found very-low-certainty evidence that TxA reduced the risk of severe primary postpartum hemorrhage, primary postpartum hemorrhage, and secondary postpartum hemorrhage (risk ratios, 0.36, 0.25, and 0.42, respectively). The effects of TxA on blood transfusions, vaginal hematoma, blood loss, and thrombotic complications also showed very-low-certainty evidence.
The currently available evidence for treatment options in women with VWD remains very low certainty, the researchers wrote in their discussion. “Because hormonal therapy is effective in controlling HMB (based on data from women without bleeding disorders), we believe the most effective strategy to be hormonal therapy with a LNG-IUS or combined oral contraceptives, followed by TxA and desmopressin.”
The study findings were limited by several factors including scarce evidence, the risk of bias in the observational studies, and lack of comparisons/controls in the case series, the researchers noted. Notable literature gaps included data on outcomes including major bleeding and the need for surgery or additional treatments in the first review; mortality, major bleeding, spinal hematoma, transfusion, and thrombotic events in the second review; and mortality, major bleeding, and the need for other procedures in the third review.
However, the findings were strengthened by the use of broad eligibility criteria to include any studies with potential useful advice, including case series, if these were the only available options. In developing recommendations, “the guideline panel interpreted the evidence adding their experience and knowledge of indirect evidence,” the authors noted.
The current evidence, though mainly very low certainty, “is the best available to inform decisions about management. Clinicians seeking advice on how to manage their patients with VWD should refer to the practice guidelines and assess to what extent they are applicable to their patients,” the researchers concluded.
Meeting the need for evidence-based guidelines
The review is important at this time because current evidence-based guidelines are limited, said coauthor Veronica Flood, MD, a pediatric hematologist at the Medical College of Wisconsin, Milwaukee, and a VWD researcher.
“While we have some guidelines that address von Willebrand disease, these were primarily based on expert opinion and not necessarily based on the best available evidence,” said Dr. Flood.
“Given how many people have von Willebrand disease, it is important that we actually base our recommendations on the data,” she emphasized. The new guidelines also incorporate patient feedback, with the inclusion of multiple panelists who are individuals living with VWD. “The final recommendations looked at not only the evidence, but the cost effectiveness, feasibility, and patient values and preferences,” she added.
“I was surprised we did not have better evidence for some of these common issues for patients with VWD,” said Dr. Flood. “I think that speaks to the need to do more high-quality research in this area.”
From a clinical standpoint, “we now have evidence-based guidelines that support the use of prophylaxis in patients with VWD and significant bleeding, as well as recommendations for surgery and bleeding issues around menstruation,” said Dr. Flood. “I do think it is also important to recognize that many of these are conditional recommendations, meaning there is room for patient preferences in implementation, which is helpful since we know that some people will have different priorities.”
Dr. Flood noted that more research is needed in many aspects of VWD. “We definitely need to better understand best options for surgical treatment, and I consider that a high priority. We are also hoping, along with the National Hemophilia Foundation, to develop some patient decision aids to help with some of these issues.”
Coauthor Nathan T. Connell, MD, an adult hematologist at the Brigham and Women’s Hospital and Harvard Medical School, both in Boston, served as the vice chair for the guideline panel. Dr. Connell agreed with the importance of the reviews and the need for additional research. “I, too, was surprised to see the lack of robust data to answer many of the basic questions about how to manage people living with VWD. Regarding the systematic reviews, I was surprised to see the power of combining the limited data in this way to come up with an evidence base for the panels to review,” he added.
The study was supported by the ASH, ISTH, NHF, and the WFH 2020 Guidelines for Management of VWD. The researchers had no financial conflicts to disclose.
FROM BLOOD ADVANCES
New MIS-C guidance addresses diagnostic challenges, cardiac care
Updated guidance for health care providers on multisystem inflammatory syndrome in children (MIS-C) recognizes the evolving nature of the disease and offers strategies for pediatric rheumatologists, who also may be asked to recommend treatment for hyperinflammation in children with acute COVID-19.
Guidance is needed for many reasons, including the variable case definitions for MIS-C, the presence of MIS-C features in other infections and childhood rheumatic diseases, the extrapolation of treatment strategies from other conditions with similar presentations, and the issue of myocardial dysfunction, wrote Lauren A. Henderson, MD, MMSC, of Boston Children’s Hospital, and members of the American College of Rheumatology MIS-C and COVID-19–Related Hyperinflammation Task Force.
However, “modifications to treatment plans, particularly in patients with complex conditions, are highly disease, patient, geography, and time specific, and therefore must be individualized as part of a shared decision-making process,” the authors said. The updated guidance was published in Arthritis & Rheumatology.
Update needed in wake of Omicron
“We continue to see cases of MIS-C across the United States due to the spike in SARS-CoV-2 infections from the Omicron variant,” and therefore updated guidance is important at this time, Dr. Henderson told this news organization.
“MIS-C remains a serious complication of COVID-19 in children and the ACR wanted to continue to provide pediatricians with up-to-date recommendations for the management of MIS-C,” she said.
“Children began to present with MIS-C in April 2020. At that time, little was known about this entity. Most of the recommendations in the first version of the MIS-C guidance were based on expert opinion,” she explained. However, “over the last 2 years, pediatricians have worked very hard to conduct high-quality research studies to better understand MIS-C, so we now have more scientific evidence to guide our recommendations.
“In version three of the MIS-C guidance, there are new recommendations on treatment. Previously, it was unclear what medications should be used for first-line treatment in patients with MIS-C. Some children were given intravenous immunoglobulin while others were given IVIg and steroids together. Several new studies show that children with MIS-C who are treated with a combination of IVIg and steroids have better outcomes. Accordingly, the MIS-C guidance now recommends dual therapy with IVIg and steroids in children with MIS-C.”
Diagnostic evaluation
The guidance calls for maintaining a broad differential diagnosis of MIS-C, given that the condition remains rare, and that most children with COVID-19 present with mild symptoms and have excellent outcomes, the authors noted. The range of clinical features associated with MIS-C include fever, mucocutaneous findings, myocardial dysfunction, cardiac conduction abnormalities, shock, gastrointestinal symptoms, and lymphadenopathy.
Some patients also experience neurologic involvement in the form of severe headache, altered mental status, seizures, cranial nerve palsies, meningismus, cerebral edema, and ischemic or hemorrhagic stroke. Given the nonspecific nature of these symptoms, “it is imperative that a diagnostic evaluation for MIS-C include investigation for other possible causes, as deemed appropriate by the treating provider,” the authors emphasized. Other diagnostic considerations include the prevalence and chronology of COVID-19 in the community, which may change over time.
MIS-C and Kawasaki disease phenotypes
Earlier in the pandemic, when MIS-C first emerged, it was compared with Kawasaki disease (KD). “However, a closer examination of the literature shows that only about one-quarter to half of patients with a reported diagnosis of MIS-C meet the full diagnostic criteria for KD,” the authors wrote. Key features that separate MIS-C from KD include the greater incidence of KD among children in Japan and East Asia versus the higher incidence of MIS-C among non-Hispanic Black children. In addition, children with MIS-C have shown a wider age range, more prominent gastrointestinal and neurologic symptoms, and more frequent cardiac dysfunction, compared with those with KD.
Cardiac management
Close follow-up with cardiology is essential for children with MIS-C, according to the authors. The recommendations call for repeat echocardiograms for all children with MIS-C at a minimum of 7-14 days, then again at 4-6 weeks after the initial presentation. The authors also recommended additional echocardiograms for children with left ventricular dysfunction and cardiac aortic aneurysms.
MIS-C treatment
Current treatment recommendations emphasize that patients under investigation for MIS-C with life-threatening manifestations may need immunomodulatory therapy before a full diagnostic evaluation is complete, the authors said. However, patients without life-threatening manifestations should be evaluated before starting immunomodulatory treatment to avoid potentially harmful therapies for pediatric patients who don’t need them.
When MIS-C is refractory to initial immunomodulatory treatment, a second dose of IVIg is not recommended, but intensification therapy is advised with either high-dose (10-30 mg/kg per day) glucocorticoids, anakinra, or infliximab. However, there is little evidence available for selecting a specific agent for intensification therapy.
The task force also advises giving low-dose aspirin (3-5 mg/kg per day, up to 81 mg once daily) to all MIS-C patients without active bleeding or significant bleeding risk until normalization of the platelet count and confirmed normal coronary arteries at least 4 weeks after diagnosis.
COVID-19 and hyperinflammation
The task force also noted a distinction between MIS-C and severe COVID-19 in children. Although many children with MIS-C are previously healthy, most children who develop severe COVID-19 during an initial infection have complex conditions or comorbidities such as developmental delay or genetic anomaly, or chronic conditions such as congenital heart disease, type 1 diabetes, or asthma, the authors said. They recommend that “hospitalized children with COVID-19 requiring supplemental oxygen or respiratory support should be considered for immunomodulatory therapy in addition to supportive care and antiviral medications.”
The authors acknowledged the limitations and evolving nature of the recommendations, which will continue to change and do not replace clinical judgment for the management of individual patients. In the meantime, the ACR will support the task force in reviewing new evidence and providing revised versions of the current document.
Many questions about MIS-C remain, Dr. Henderson said in an interview. “It can be very hard to diagnose children with MIS-C because many of the symptoms are similar to those seen in other febrile illness of childhood. We need to identify better biomarkers to help us make the diagnosis of MIS-C. In addition, we need studies to provide information about what treatments should be used if children fail to respond to IVIg and steroids. Finally, it appears that vaccination [against SARS-CoV-2] protects against severe forms of MIS-C, and studies are needed to see how vaccination protects children from MIS-C.”
The development of the guidance was supported by the American College of Rheumatology. Dr. Henderson disclosed relationships with companies including Sobi, Pfizer, and Adaptive Biotechnologies (less than $10,000) and research support from the Childhood Arthritis and Rheumatology Research Alliance and research grant support from Bristol-Myers Squibb.
A version of this article first appeared on Medscape.com.
Updated guidance for health care providers on multisystem inflammatory syndrome in children (MIS-C) recognizes the evolving nature of the disease and offers strategies for pediatric rheumatologists, who also may be asked to recommend treatment for hyperinflammation in children with acute COVID-19.
Guidance is needed for many reasons, including the variable case definitions for MIS-C, the presence of MIS-C features in other infections and childhood rheumatic diseases, the extrapolation of treatment strategies from other conditions with similar presentations, and the issue of myocardial dysfunction, wrote Lauren A. Henderson, MD, MMSC, of Boston Children’s Hospital, and members of the American College of Rheumatology MIS-C and COVID-19–Related Hyperinflammation Task Force.
However, “modifications to treatment plans, particularly in patients with complex conditions, are highly disease, patient, geography, and time specific, and therefore must be individualized as part of a shared decision-making process,” the authors said. The updated guidance was published in Arthritis & Rheumatology.
Update needed in wake of Omicron
“We continue to see cases of MIS-C across the United States due to the spike in SARS-CoV-2 infections from the Omicron variant,” and therefore updated guidance is important at this time, Dr. Henderson told this news organization.
“MIS-C remains a serious complication of COVID-19 in children and the ACR wanted to continue to provide pediatricians with up-to-date recommendations for the management of MIS-C,” she said.
“Children began to present with MIS-C in April 2020. At that time, little was known about this entity. Most of the recommendations in the first version of the MIS-C guidance were based on expert opinion,” she explained. However, “over the last 2 years, pediatricians have worked very hard to conduct high-quality research studies to better understand MIS-C, so we now have more scientific evidence to guide our recommendations.
“In version three of the MIS-C guidance, there are new recommendations on treatment. Previously, it was unclear what medications should be used for first-line treatment in patients with MIS-C. Some children were given intravenous immunoglobulin while others were given IVIg and steroids together. Several new studies show that children with MIS-C who are treated with a combination of IVIg and steroids have better outcomes. Accordingly, the MIS-C guidance now recommends dual therapy with IVIg and steroids in children with MIS-C.”
Diagnostic evaluation
The guidance calls for maintaining a broad differential diagnosis of MIS-C, given that the condition remains rare, and that most children with COVID-19 present with mild symptoms and have excellent outcomes, the authors noted. The range of clinical features associated with MIS-C include fever, mucocutaneous findings, myocardial dysfunction, cardiac conduction abnormalities, shock, gastrointestinal symptoms, and lymphadenopathy.
Some patients also experience neurologic involvement in the form of severe headache, altered mental status, seizures, cranial nerve palsies, meningismus, cerebral edema, and ischemic or hemorrhagic stroke. Given the nonspecific nature of these symptoms, “it is imperative that a diagnostic evaluation for MIS-C include investigation for other possible causes, as deemed appropriate by the treating provider,” the authors emphasized. Other diagnostic considerations include the prevalence and chronology of COVID-19 in the community, which may change over time.
MIS-C and Kawasaki disease phenotypes
Earlier in the pandemic, when MIS-C first emerged, it was compared with Kawasaki disease (KD). “However, a closer examination of the literature shows that only about one-quarter to half of patients with a reported diagnosis of MIS-C meet the full diagnostic criteria for KD,” the authors wrote. Key features that separate MIS-C from KD include the greater incidence of KD among children in Japan and East Asia versus the higher incidence of MIS-C among non-Hispanic Black children. In addition, children with MIS-C have shown a wider age range, more prominent gastrointestinal and neurologic symptoms, and more frequent cardiac dysfunction, compared with those with KD.
Cardiac management
Close follow-up with cardiology is essential for children with MIS-C, according to the authors. The recommendations call for repeat echocardiograms for all children with MIS-C at a minimum of 7-14 days, then again at 4-6 weeks after the initial presentation. The authors also recommended additional echocardiograms for children with left ventricular dysfunction and cardiac aortic aneurysms.
MIS-C treatment
Current treatment recommendations emphasize that patients under investigation for MIS-C with life-threatening manifestations may need immunomodulatory therapy before a full diagnostic evaluation is complete, the authors said. However, patients without life-threatening manifestations should be evaluated before starting immunomodulatory treatment to avoid potentially harmful therapies for pediatric patients who don’t need them.
When MIS-C is refractory to initial immunomodulatory treatment, a second dose of IVIg is not recommended, but intensification therapy is advised with either high-dose (10-30 mg/kg per day) glucocorticoids, anakinra, or infliximab. However, there is little evidence available for selecting a specific agent for intensification therapy.
The task force also advises giving low-dose aspirin (3-5 mg/kg per day, up to 81 mg once daily) to all MIS-C patients without active bleeding or significant bleeding risk until normalization of the platelet count and confirmed normal coronary arteries at least 4 weeks after diagnosis.
COVID-19 and hyperinflammation
The task force also noted a distinction between MIS-C and severe COVID-19 in children. Although many children with MIS-C are previously healthy, most children who develop severe COVID-19 during an initial infection have complex conditions or comorbidities such as developmental delay or genetic anomaly, or chronic conditions such as congenital heart disease, type 1 diabetes, or asthma, the authors said. They recommend that “hospitalized children with COVID-19 requiring supplemental oxygen or respiratory support should be considered for immunomodulatory therapy in addition to supportive care and antiviral medications.”
The authors acknowledged the limitations and evolving nature of the recommendations, which will continue to change and do not replace clinical judgment for the management of individual patients. In the meantime, the ACR will support the task force in reviewing new evidence and providing revised versions of the current document.
Many questions about MIS-C remain, Dr. Henderson said in an interview. “It can be very hard to diagnose children with MIS-C because many of the symptoms are similar to those seen in other febrile illness of childhood. We need to identify better biomarkers to help us make the diagnosis of MIS-C. In addition, we need studies to provide information about what treatments should be used if children fail to respond to IVIg and steroids. Finally, it appears that vaccination [against SARS-CoV-2] protects against severe forms of MIS-C, and studies are needed to see how vaccination protects children from MIS-C.”
The development of the guidance was supported by the American College of Rheumatology. Dr. Henderson disclosed relationships with companies including Sobi, Pfizer, and Adaptive Biotechnologies (less than $10,000) and research support from the Childhood Arthritis and Rheumatology Research Alliance and research grant support from Bristol-Myers Squibb.
A version of this article first appeared on Medscape.com.
Updated guidance for health care providers on multisystem inflammatory syndrome in children (MIS-C) recognizes the evolving nature of the disease and offers strategies for pediatric rheumatologists, who also may be asked to recommend treatment for hyperinflammation in children with acute COVID-19.
Guidance is needed for many reasons, including the variable case definitions for MIS-C, the presence of MIS-C features in other infections and childhood rheumatic diseases, the extrapolation of treatment strategies from other conditions with similar presentations, and the issue of myocardial dysfunction, wrote Lauren A. Henderson, MD, MMSC, of Boston Children’s Hospital, and members of the American College of Rheumatology MIS-C and COVID-19–Related Hyperinflammation Task Force.
However, “modifications to treatment plans, particularly in patients with complex conditions, are highly disease, patient, geography, and time specific, and therefore must be individualized as part of a shared decision-making process,” the authors said. The updated guidance was published in Arthritis & Rheumatology.
Update needed in wake of Omicron
“We continue to see cases of MIS-C across the United States due to the spike in SARS-CoV-2 infections from the Omicron variant,” and therefore updated guidance is important at this time, Dr. Henderson told this news organization.
“MIS-C remains a serious complication of COVID-19 in children and the ACR wanted to continue to provide pediatricians with up-to-date recommendations for the management of MIS-C,” she said.
“Children began to present with MIS-C in April 2020. At that time, little was known about this entity. Most of the recommendations in the first version of the MIS-C guidance were based on expert opinion,” she explained. However, “over the last 2 years, pediatricians have worked very hard to conduct high-quality research studies to better understand MIS-C, so we now have more scientific evidence to guide our recommendations.
“In version three of the MIS-C guidance, there are new recommendations on treatment. Previously, it was unclear what medications should be used for first-line treatment in patients with MIS-C. Some children were given intravenous immunoglobulin while others were given IVIg and steroids together. Several new studies show that children with MIS-C who are treated with a combination of IVIg and steroids have better outcomes. Accordingly, the MIS-C guidance now recommends dual therapy with IVIg and steroids in children with MIS-C.”
Diagnostic evaluation
The guidance calls for maintaining a broad differential diagnosis of MIS-C, given that the condition remains rare, and that most children with COVID-19 present with mild symptoms and have excellent outcomes, the authors noted. The range of clinical features associated with MIS-C include fever, mucocutaneous findings, myocardial dysfunction, cardiac conduction abnormalities, shock, gastrointestinal symptoms, and lymphadenopathy.
Some patients also experience neurologic involvement in the form of severe headache, altered mental status, seizures, cranial nerve palsies, meningismus, cerebral edema, and ischemic or hemorrhagic stroke. Given the nonspecific nature of these symptoms, “it is imperative that a diagnostic evaluation for MIS-C include investigation for other possible causes, as deemed appropriate by the treating provider,” the authors emphasized. Other diagnostic considerations include the prevalence and chronology of COVID-19 in the community, which may change over time.
MIS-C and Kawasaki disease phenotypes
Earlier in the pandemic, when MIS-C first emerged, it was compared with Kawasaki disease (KD). “However, a closer examination of the literature shows that only about one-quarter to half of patients with a reported diagnosis of MIS-C meet the full diagnostic criteria for KD,” the authors wrote. Key features that separate MIS-C from KD include the greater incidence of KD among children in Japan and East Asia versus the higher incidence of MIS-C among non-Hispanic Black children. In addition, children with MIS-C have shown a wider age range, more prominent gastrointestinal and neurologic symptoms, and more frequent cardiac dysfunction, compared with those with KD.
Cardiac management
Close follow-up with cardiology is essential for children with MIS-C, according to the authors. The recommendations call for repeat echocardiograms for all children with MIS-C at a minimum of 7-14 days, then again at 4-6 weeks after the initial presentation. The authors also recommended additional echocardiograms for children with left ventricular dysfunction and cardiac aortic aneurysms.
MIS-C treatment
Current treatment recommendations emphasize that patients under investigation for MIS-C with life-threatening manifestations may need immunomodulatory therapy before a full diagnostic evaluation is complete, the authors said. However, patients without life-threatening manifestations should be evaluated before starting immunomodulatory treatment to avoid potentially harmful therapies for pediatric patients who don’t need them.
When MIS-C is refractory to initial immunomodulatory treatment, a second dose of IVIg is not recommended, but intensification therapy is advised with either high-dose (10-30 mg/kg per day) glucocorticoids, anakinra, or infliximab. However, there is little evidence available for selecting a specific agent for intensification therapy.
The task force also advises giving low-dose aspirin (3-5 mg/kg per day, up to 81 mg once daily) to all MIS-C patients without active bleeding or significant bleeding risk until normalization of the platelet count and confirmed normal coronary arteries at least 4 weeks after diagnosis.
COVID-19 and hyperinflammation
The task force also noted a distinction between MIS-C and severe COVID-19 in children. Although many children with MIS-C are previously healthy, most children who develop severe COVID-19 during an initial infection have complex conditions or comorbidities such as developmental delay or genetic anomaly, or chronic conditions such as congenital heart disease, type 1 diabetes, or asthma, the authors said. They recommend that “hospitalized children with COVID-19 requiring supplemental oxygen or respiratory support should be considered for immunomodulatory therapy in addition to supportive care and antiviral medications.”
The authors acknowledged the limitations and evolving nature of the recommendations, which will continue to change and do not replace clinical judgment for the management of individual patients. In the meantime, the ACR will support the task force in reviewing new evidence and providing revised versions of the current document.
Many questions about MIS-C remain, Dr. Henderson said in an interview. “It can be very hard to diagnose children with MIS-C because many of the symptoms are similar to those seen in other febrile illness of childhood. We need to identify better biomarkers to help us make the diagnosis of MIS-C. In addition, we need studies to provide information about what treatments should be used if children fail to respond to IVIg and steroids. Finally, it appears that vaccination [against SARS-CoV-2] protects against severe forms of MIS-C, and studies are needed to see how vaccination protects children from MIS-C.”
The development of the guidance was supported by the American College of Rheumatology. Dr. Henderson disclosed relationships with companies including Sobi, Pfizer, and Adaptive Biotechnologies (less than $10,000) and research support from the Childhood Arthritis and Rheumatology Research Alliance and research grant support from Bristol-Myers Squibb.
A version of this article first appeared on Medscape.com.
FROM ARTHRITIS AND RHEUMATOLOGY
Childhood-onset insomnia persists into adolescence and adulthood
Childhood-onset insomnia is a chronic problem in 43% of children, based on 15-year follow-up data from approximately 500 individuals.
Difficulty initiating or maintaining sleep (DIMS) is the most frequently reported insomnia symptom in children and teens, but longitudinal data on the trajectory of insomnia symptoms from childhood into adulthood are limited, Julio Fernandez-Mendoza, PhD, of Penn State University, Hershey, and colleagues wrote.
Previous studies have shown varying results, notably on the effect of objective short sleep duration (OSSD), they said. The extent to which the effect of OSSD on insomnia trajectories, and whether OSSD affects the development of insomnia in the transition to adulthood remains uncertain.
In a study published in Pediatrics, the researchers reviewed data from 502 children who enrolled at age 5-12 years between 2000 and 2005. The participants underwent laboratory polysomnography visits at baseline; 421 had a second laboratory visit between 2010 and 2013 (median age, 16 years), and 502 completed a structured self-reported survey between 2018 and 2021 at a median age of 24 years. At the first visit, 118 children met criteria for insomnia, defined as parent reports of often/moderate or very often/severe DIMS and/or use of over-the-counter or prescription sleep medications for DIMS. At the second visit, 120 children met the definition for insomnia.
Among children with insomnia symptoms at baseline, 53.7% had persistence of insomnia symptoms in adolescence and 61.9% had symptoms in young adulthood; 46.3% and 38.1% remitted at these times.
Among children with insomnia symptoms at adolescence, 57.5% and 42.5% had persistence and remittance, respectively, in young adulthood.
In children with insomnia at baseline, therefore, the most frequent developmental trajectory was persistence (43.3%) followed by remission (26.9% since childhood and 11.2% since adolescence) and a waxing and waning pattern (18.6%), the researchers said.
Among children with normal sleep at baseline, 69.7% retained normal sleep patterns in adolescence and 63.3% retained normal sleep in young adulthood; 30.3% and 36.7% developed insomnia in adolescence and young adulthood, respectively.
Overall, adult insomnia was reported by 22.0% and 20.8% of individuals with childhood and adolescent insomnia, respectively. In a multivariate analysis, the odds of adult insomnia were 2.6 times and 5.5 times higher among those with histories of short-sleeping in childhood and adolescence, respectively.
“The most common developmental trajectory for insomnia symptoms was that of persistence from childhood through young adulthood,” the researchers wrote in their discussion of the study.
“These 15-year longitudinal findings across three developmental stages indicate that insomnia symptoms should not be expected to developmentally remit in at least 40% of children and that adolescence is a critical developmental period for the adverse prognosis of the insomnia with short sleep duration phenotype,” they emphasized.
The study findings were limited by several factors including the collection of OSSD and other sleep data via a 1-night, 9-hour polysomnography, which might not be representative of habitual sleep at home, the researchers noted. Other limitations include the lack of polysomnography data to accompany the young adult survey and the inability to validate insomnia in young adults via strict diagnostic criteria.
However, the results reveal that the persistence of childhood insomnia is higher than suggested in previous studies, and that these children and adolescents, especially short sleepers, are at significantly increased risk of adult insomnia, the researchers concluded.
“Early sleep interventions are a priority, as clinicians should not expect insomnia symptoms to developmentally remit in a high proportion of children, although objective sleep measures may be indicated in adolescence to identify those with poorer long-term prognosis,” they said.
Pandemic prompts interest in sleep issues
The current study is important at this time because sleep disruptions in children and adolescents have increased over the course of the COVID-19 pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was especially surprised to see that adolescent insomnia will most likely not remit in young adulthood, as she had considered it a disorder of adolescence.
The study highlights the need for early intervention to manage insomnia in children. However, there are several barriers to such intervention. “Parents [of young children] are overwhelmed and just need sleep themselves, so they don’t always have the energy to work on good sleep habits in their children,” she said. Improving sleep habits in adolescents requires overcoming the barrier of the young patients’ attitudes. “For adolescents, they need to buy into the change.”
However, the take-home message for clinicians is that it is important to work to overcome these barriers and improve sleep in children and teens, because the longitudinal data suggest that the problem is “likely to persist and unlikely to remit,” for many, she said.
As for additional studies, “I would like to see more research done on neurologic and psychological causes of insomnia,” Dr. Kinsella said.
The study was supported in part by grants from the National Heart, Lung, and Blood Institute; National Institute of Mental Health; and the National Center for Advancing Translational Sciences of the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Childhood-onset insomnia is a chronic problem in 43% of children, based on 15-year follow-up data from approximately 500 individuals.
Difficulty initiating or maintaining sleep (DIMS) is the most frequently reported insomnia symptom in children and teens, but longitudinal data on the trajectory of insomnia symptoms from childhood into adulthood are limited, Julio Fernandez-Mendoza, PhD, of Penn State University, Hershey, and colleagues wrote.
Previous studies have shown varying results, notably on the effect of objective short sleep duration (OSSD), they said. The extent to which the effect of OSSD on insomnia trajectories, and whether OSSD affects the development of insomnia in the transition to adulthood remains uncertain.
In a study published in Pediatrics, the researchers reviewed data from 502 children who enrolled at age 5-12 years between 2000 and 2005. The participants underwent laboratory polysomnography visits at baseline; 421 had a second laboratory visit between 2010 and 2013 (median age, 16 years), and 502 completed a structured self-reported survey between 2018 and 2021 at a median age of 24 years. At the first visit, 118 children met criteria for insomnia, defined as parent reports of often/moderate or very often/severe DIMS and/or use of over-the-counter or prescription sleep medications for DIMS. At the second visit, 120 children met the definition for insomnia.
Among children with insomnia symptoms at baseline, 53.7% had persistence of insomnia symptoms in adolescence and 61.9% had symptoms in young adulthood; 46.3% and 38.1% remitted at these times.
Among children with insomnia symptoms at adolescence, 57.5% and 42.5% had persistence and remittance, respectively, in young adulthood.
In children with insomnia at baseline, therefore, the most frequent developmental trajectory was persistence (43.3%) followed by remission (26.9% since childhood and 11.2% since adolescence) and a waxing and waning pattern (18.6%), the researchers said.
Among children with normal sleep at baseline, 69.7% retained normal sleep patterns in adolescence and 63.3% retained normal sleep in young adulthood; 30.3% and 36.7% developed insomnia in adolescence and young adulthood, respectively.
Overall, adult insomnia was reported by 22.0% and 20.8% of individuals with childhood and adolescent insomnia, respectively. In a multivariate analysis, the odds of adult insomnia were 2.6 times and 5.5 times higher among those with histories of short-sleeping in childhood and adolescence, respectively.
“The most common developmental trajectory for insomnia symptoms was that of persistence from childhood through young adulthood,” the researchers wrote in their discussion of the study.
“These 15-year longitudinal findings across three developmental stages indicate that insomnia symptoms should not be expected to developmentally remit in at least 40% of children and that adolescence is a critical developmental period for the adverse prognosis of the insomnia with short sleep duration phenotype,” they emphasized.
The study findings were limited by several factors including the collection of OSSD and other sleep data via a 1-night, 9-hour polysomnography, which might not be representative of habitual sleep at home, the researchers noted. Other limitations include the lack of polysomnography data to accompany the young adult survey and the inability to validate insomnia in young adults via strict diagnostic criteria.
However, the results reveal that the persistence of childhood insomnia is higher than suggested in previous studies, and that these children and adolescents, especially short sleepers, are at significantly increased risk of adult insomnia, the researchers concluded.
“Early sleep interventions are a priority, as clinicians should not expect insomnia symptoms to developmentally remit in a high proportion of children, although objective sleep measures may be indicated in adolescence to identify those with poorer long-term prognosis,” they said.
Pandemic prompts interest in sleep issues
The current study is important at this time because sleep disruptions in children and adolescents have increased over the course of the COVID-19 pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was especially surprised to see that adolescent insomnia will most likely not remit in young adulthood, as she had considered it a disorder of adolescence.
The study highlights the need for early intervention to manage insomnia in children. However, there are several barriers to such intervention. “Parents [of young children] are overwhelmed and just need sleep themselves, so they don’t always have the energy to work on good sleep habits in their children,” she said. Improving sleep habits in adolescents requires overcoming the barrier of the young patients’ attitudes. “For adolescents, they need to buy into the change.”
However, the take-home message for clinicians is that it is important to work to overcome these barriers and improve sleep in children and teens, because the longitudinal data suggest that the problem is “likely to persist and unlikely to remit,” for many, she said.
As for additional studies, “I would like to see more research done on neurologic and psychological causes of insomnia,” Dr. Kinsella said.
The study was supported in part by grants from the National Heart, Lung, and Blood Institute; National Institute of Mental Health; and the National Center for Advancing Translational Sciences of the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Childhood-onset insomnia is a chronic problem in 43% of children, based on 15-year follow-up data from approximately 500 individuals.
Difficulty initiating or maintaining sleep (DIMS) is the most frequently reported insomnia symptom in children and teens, but longitudinal data on the trajectory of insomnia symptoms from childhood into adulthood are limited, Julio Fernandez-Mendoza, PhD, of Penn State University, Hershey, and colleagues wrote.
Previous studies have shown varying results, notably on the effect of objective short sleep duration (OSSD), they said. The extent to which the effect of OSSD on insomnia trajectories, and whether OSSD affects the development of insomnia in the transition to adulthood remains uncertain.
In a study published in Pediatrics, the researchers reviewed data from 502 children who enrolled at age 5-12 years between 2000 and 2005. The participants underwent laboratory polysomnography visits at baseline; 421 had a second laboratory visit between 2010 and 2013 (median age, 16 years), and 502 completed a structured self-reported survey between 2018 and 2021 at a median age of 24 years. At the first visit, 118 children met criteria for insomnia, defined as parent reports of often/moderate or very often/severe DIMS and/or use of over-the-counter or prescription sleep medications for DIMS. At the second visit, 120 children met the definition for insomnia.
Among children with insomnia symptoms at baseline, 53.7% had persistence of insomnia symptoms in adolescence and 61.9% had symptoms in young adulthood; 46.3% and 38.1% remitted at these times.
Among children with insomnia symptoms at adolescence, 57.5% and 42.5% had persistence and remittance, respectively, in young adulthood.
In children with insomnia at baseline, therefore, the most frequent developmental trajectory was persistence (43.3%) followed by remission (26.9% since childhood and 11.2% since adolescence) and a waxing and waning pattern (18.6%), the researchers said.
Among children with normal sleep at baseline, 69.7% retained normal sleep patterns in adolescence and 63.3% retained normal sleep in young adulthood; 30.3% and 36.7% developed insomnia in adolescence and young adulthood, respectively.
Overall, adult insomnia was reported by 22.0% and 20.8% of individuals with childhood and adolescent insomnia, respectively. In a multivariate analysis, the odds of adult insomnia were 2.6 times and 5.5 times higher among those with histories of short-sleeping in childhood and adolescence, respectively.
“The most common developmental trajectory for insomnia symptoms was that of persistence from childhood through young adulthood,” the researchers wrote in their discussion of the study.
“These 15-year longitudinal findings across three developmental stages indicate that insomnia symptoms should not be expected to developmentally remit in at least 40% of children and that adolescence is a critical developmental period for the adverse prognosis of the insomnia with short sleep duration phenotype,” they emphasized.
The study findings were limited by several factors including the collection of OSSD and other sleep data via a 1-night, 9-hour polysomnography, which might not be representative of habitual sleep at home, the researchers noted. Other limitations include the lack of polysomnography data to accompany the young adult survey and the inability to validate insomnia in young adults via strict diagnostic criteria.
However, the results reveal that the persistence of childhood insomnia is higher than suggested in previous studies, and that these children and adolescents, especially short sleepers, are at significantly increased risk of adult insomnia, the researchers concluded.
“Early sleep interventions are a priority, as clinicians should not expect insomnia symptoms to developmentally remit in a high proportion of children, although objective sleep measures may be indicated in adolescence to identify those with poorer long-term prognosis,” they said.
Pandemic prompts interest in sleep issues
The current study is important at this time because sleep disruptions in children and adolescents have increased over the course of the COVID-19 pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was especially surprised to see that adolescent insomnia will most likely not remit in young adulthood, as she had considered it a disorder of adolescence.
The study highlights the need for early intervention to manage insomnia in children. However, there are several barriers to such intervention. “Parents [of young children] are overwhelmed and just need sleep themselves, so they don’t always have the energy to work on good sleep habits in their children,” she said. Improving sleep habits in adolescents requires overcoming the barrier of the young patients’ attitudes. “For adolescents, they need to buy into the change.”
However, the take-home message for clinicians is that it is important to work to overcome these barriers and improve sleep in children and teens, because the longitudinal data suggest that the problem is “likely to persist and unlikely to remit,” for many, she said.
As for additional studies, “I would like to see more research done on neurologic and psychological causes of insomnia,” Dr. Kinsella said.
The study was supported in part by grants from the National Heart, Lung, and Blood Institute; National Institute of Mental Health; and the National Center for Advancing Translational Sciences of the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM PEDIATRICS
Imaging links insula and frontal cortex to anxiety in Parkinson’s disease
Anxiety occurs in approximately 31% of Parkinson’s disease patients, but the underlying mechanisms are not well understood, wrote Nacim Betrouni, MD, of the University of Lille, France, and colleagues. Previous research has shown associations between anxiety severity and increased activity in brain areas of emotion processing, based on MRI and positron emission tomography, but electroencephalography (EEG) has not been widely used, they said.
In a study published in Neurophysiologie Clinique , the researchers compared EEG spectral patterns and functional resting-state networks in Parkinson’s disease patients with and without anxiety disorders. They identified data from 33 PD patients who met criteria for anxiety, and 75 without anxiety. The average age of the patients was 65 years, and the average disease duration was 9.76 years in anxiety patients and 7.83 years in patients without anxiety.
Overall, findings on spectral analysis showed an association between anxiety and changes in the alpha activity in the right frontal cortex, the researchers said. They also found the relative power in the alpha1 frequency band in the right prefrontal cortex was lower in patients with anxiety than without; this finding was significantly associated with avoidance behavior on a subscale of the Parkinson’s Anxiety Scale (PAS_C, P = .035). A trend toward a significant association with episodic anxiety was noted (PAS_B, P = .06), but no significant associations were noted for persistent anxiety or the total scale score.
The imaging also showed an increased connectivity between the insula and the posterior cingulate cortex in several frequency bands in the anxiety patients, the researchers said. “The increased connectivity observed here may be a marker of the maintenance of avoidance behaviors that characterize anxiety in PD,” they noted.
The study findings were limited by several factors including the small and unbalanced proportion of the study population with anxiety, and the consideration of global anxiety only, without distinguishing anxiety subtypes, the researchers noted. Another limitation was the use only of static EEC patterns, without using dynamic patterns, they said.
The study is the first known to use EEG to explore the mechanisms of PD-related anxiety and “the reported results provide new insights, supporting findings of previous studies using other modalities, mainly rs-fMRI, and show that EEG could be a relevant technique to explore these disorders,” the researchers wrote.
However, more research is needed to confirm the findings in patients with a larger panel of anxiety disorders, they concluded.
The study was supported by the Michael J. Fox Foundation. The researchers had no financial conflicts to disclose.
Anxiety occurs in approximately 31% of Parkinson’s disease patients, but the underlying mechanisms are not well understood, wrote Nacim Betrouni, MD, of the University of Lille, France, and colleagues. Previous research has shown associations between anxiety severity and increased activity in brain areas of emotion processing, based on MRI and positron emission tomography, but electroencephalography (EEG) has not been widely used, they said.
In a study published in Neurophysiologie Clinique , the researchers compared EEG spectral patterns and functional resting-state networks in Parkinson’s disease patients with and without anxiety disorders. They identified data from 33 PD patients who met criteria for anxiety, and 75 without anxiety. The average age of the patients was 65 years, and the average disease duration was 9.76 years in anxiety patients and 7.83 years in patients without anxiety.
Overall, findings on spectral analysis showed an association between anxiety and changes in the alpha activity in the right frontal cortex, the researchers said. They also found the relative power in the alpha1 frequency band in the right prefrontal cortex was lower in patients with anxiety than without; this finding was significantly associated with avoidance behavior on a subscale of the Parkinson’s Anxiety Scale (PAS_C, P = .035). A trend toward a significant association with episodic anxiety was noted (PAS_B, P = .06), but no significant associations were noted for persistent anxiety or the total scale score.
The imaging also showed an increased connectivity between the insula and the posterior cingulate cortex in several frequency bands in the anxiety patients, the researchers said. “The increased connectivity observed here may be a marker of the maintenance of avoidance behaviors that characterize anxiety in PD,” they noted.
The study findings were limited by several factors including the small and unbalanced proportion of the study population with anxiety, and the consideration of global anxiety only, without distinguishing anxiety subtypes, the researchers noted. Another limitation was the use only of static EEC patterns, without using dynamic patterns, they said.
The study is the first known to use EEG to explore the mechanisms of PD-related anxiety and “the reported results provide new insights, supporting findings of previous studies using other modalities, mainly rs-fMRI, and show that EEG could be a relevant technique to explore these disorders,” the researchers wrote.
However, more research is needed to confirm the findings in patients with a larger panel of anxiety disorders, they concluded.
The study was supported by the Michael J. Fox Foundation. The researchers had no financial conflicts to disclose.
Anxiety occurs in approximately 31% of Parkinson’s disease patients, but the underlying mechanisms are not well understood, wrote Nacim Betrouni, MD, of the University of Lille, France, and colleagues. Previous research has shown associations between anxiety severity and increased activity in brain areas of emotion processing, based on MRI and positron emission tomography, but electroencephalography (EEG) has not been widely used, they said.
In a study published in Neurophysiologie Clinique , the researchers compared EEG spectral patterns and functional resting-state networks in Parkinson’s disease patients with and without anxiety disorders. They identified data from 33 PD patients who met criteria for anxiety, and 75 without anxiety. The average age of the patients was 65 years, and the average disease duration was 9.76 years in anxiety patients and 7.83 years in patients without anxiety.
Overall, findings on spectral analysis showed an association between anxiety and changes in the alpha activity in the right frontal cortex, the researchers said. They also found the relative power in the alpha1 frequency band in the right prefrontal cortex was lower in patients with anxiety than without; this finding was significantly associated with avoidance behavior on a subscale of the Parkinson’s Anxiety Scale (PAS_C, P = .035). A trend toward a significant association with episodic anxiety was noted (PAS_B, P = .06), but no significant associations were noted for persistent anxiety or the total scale score.
The imaging also showed an increased connectivity between the insula and the posterior cingulate cortex in several frequency bands in the anxiety patients, the researchers said. “The increased connectivity observed here may be a marker of the maintenance of avoidance behaviors that characterize anxiety in PD,” they noted.
The study findings were limited by several factors including the small and unbalanced proportion of the study population with anxiety, and the consideration of global anxiety only, without distinguishing anxiety subtypes, the researchers noted. Another limitation was the use only of static EEC patterns, without using dynamic patterns, they said.
The study is the first known to use EEG to explore the mechanisms of PD-related anxiety and “the reported results provide new insights, supporting findings of previous studies using other modalities, mainly rs-fMRI, and show that EEG could be a relevant technique to explore these disorders,” the researchers wrote.
However, more research is needed to confirm the findings in patients with a larger panel of anxiety disorders, they concluded.
The study was supported by the Michael J. Fox Foundation. The researchers had no financial conflicts to disclose.
FROM NEUROPHYSIOLOGIE CLINIQUE
Seizure phobia stands out in epilepsy patients
Anxiety and depression are known to affect quality of life in epilepsy patients, and previous studies have shown that anticipatory anxiety of epileptic seizures (AAS) was present in 53% of patients with focal epilepsy, wrote lead author Aviva Weiss of Psychiatric Hostels affiliated with Kidum Rehabilitation Projects, Jerusalem, and colleagues.
“Although recognized by the epilepsy and the psychiatric communities, seizure phobia as a distinct anxiety disorder among PWE is insufficiently described in the medical literature,” they said.
Seizure phobia has been defined as an anxiety disorder in which patients experience fear related to anticipation of seizures in certain situations.
In a study published in Seizure: European Journal of Epilepsy, the researchers recruited 69 PWE who were treated at an outpatient clinic. Data were collected from interviews, questionnaires, and medical records. The average age of the participants was 36.8 years, 41 were women, and 41 were married.
Overall, 19 individuals (27.5%) were diagnosed with seizure phobia. Compared with PWE without seizure phobia, the seizure phobia patients were significantly more likely to be women (84.2% vs. 44.2%; P = .005) and to have comorbid anxiety disorders (84.2% vs. 34.9%; P = .01). Individuals with seizure phobia also were significantly more likely than those without seizure phobia to have a past major depressive episode (63.2% vs. 20.9%; P = .003), and posttraumatic stress disorder (26.3% vs. 7%; P = .05).
Seizure phobia was significantly associated with comorbid psychogenic nonepileptic seizures (PNES) (36.8% vs. 11.6%; P = .034). PNES have been significantly associated with panic attacks, and “all patients with both panic attacks and comorbid PNES were diagnosed with seizure phobia,” the researchers noted. However, no significant association was found with epilepsy-related variables, they said.
A multivariate logistic regression model to predict seizure phobia showed that anxiety and a past MDE were significant predictors; the odds of seizure phobia were 10.45 times higher if a patient reported any anxiety disorder, and 6.85 times higher if the patient had a history of MDE.
The study findings were limited by several factors, including the use of semistructured interviews to diagnose seizure phobia, which are subject to interviewer bias, and by the small study population with a high proportion of comorbid PNES and epilepsy, the researchers noted. However, the results support seizure phobia as a distinct clinical entity worthy of management with education, psychosocial interventions, and potential medication changes, they said.
“Development of appropriate screening tools and implementation of effective treatment interventions is warranted for individual patients, combined with large-scale population-targeted psychoeducation, aimed to mitigate the risk of developing seizure phobia in PWE,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Anxiety and depression are known to affect quality of life in epilepsy patients, and previous studies have shown that anticipatory anxiety of epileptic seizures (AAS) was present in 53% of patients with focal epilepsy, wrote lead author Aviva Weiss of Psychiatric Hostels affiliated with Kidum Rehabilitation Projects, Jerusalem, and colleagues.
“Although recognized by the epilepsy and the psychiatric communities, seizure phobia as a distinct anxiety disorder among PWE is insufficiently described in the medical literature,” they said.
Seizure phobia has been defined as an anxiety disorder in which patients experience fear related to anticipation of seizures in certain situations.
In a study published in Seizure: European Journal of Epilepsy, the researchers recruited 69 PWE who were treated at an outpatient clinic. Data were collected from interviews, questionnaires, and medical records. The average age of the participants was 36.8 years, 41 were women, and 41 were married.
Overall, 19 individuals (27.5%) were diagnosed with seizure phobia. Compared with PWE without seizure phobia, the seizure phobia patients were significantly more likely to be women (84.2% vs. 44.2%; P = .005) and to have comorbid anxiety disorders (84.2% vs. 34.9%; P = .01). Individuals with seizure phobia also were significantly more likely than those without seizure phobia to have a past major depressive episode (63.2% vs. 20.9%; P = .003), and posttraumatic stress disorder (26.3% vs. 7%; P = .05).
Seizure phobia was significantly associated with comorbid psychogenic nonepileptic seizures (PNES) (36.8% vs. 11.6%; P = .034). PNES have been significantly associated with panic attacks, and “all patients with both panic attacks and comorbid PNES were diagnosed with seizure phobia,” the researchers noted. However, no significant association was found with epilepsy-related variables, they said.
A multivariate logistic regression model to predict seizure phobia showed that anxiety and a past MDE were significant predictors; the odds of seizure phobia were 10.45 times higher if a patient reported any anxiety disorder, and 6.85 times higher if the patient had a history of MDE.
The study findings were limited by several factors, including the use of semistructured interviews to diagnose seizure phobia, which are subject to interviewer bias, and by the small study population with a high proportion of comorbid PNES and epilepsy, the researchers noted. However, the results support seizure phobia as a distinct clinical entity worthy of management with education, psychosocial interventions, and potential medication changes, they said.
“Development of appropriate screening tools and implementation of effective treatment interventions is warranted for individual patients, combined with large-scale population-targeted psychoeducation, aimed to mitigate the risk of developing seizure phobia in PWE,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Anxiety and depression are known to affect quality of life in epilepsy patients, and previous studies have shown that anticipatory anxiety of epileptic seizures (AAS) was present in 53% of patients with focal epilepsy, wrote lead author Aviva Weiss of Psychiatric Hostels affiliated with Kidum Rehabilitation Projects, Jerusalem, and colleagues.
“Although recognized by the epilepsy and the psychiatric communities, seizure phobia as a distinct anxiety disorder among PWE is insufficiently described in the medical literature,” they said.
Seizure phobia has been defined as an anxiety disorder in which patients experience fear related to anticipation of seizures in certain situations.
In a study published in Seizure: European Journal of Epilepsy, the researchers recruited 69 PWE who were treated at an outpatient clinic. Data were collected from interviews, questionnaires, and medical records. The average age of the participants was 36.8 years, 41 were women, and 41 were married.
Overall, 19 individuals (27.5%) were diagnosed with seizure phobia. Compared with PWE without seizure phobia, the seizure phobia patients were significantly more likely to be women (84.2% vs. 44.2%; P = .005) and to have comorbid anxiety disorders (84.2% vs. 34.9%; P = .01). Individuals with seizure phobia also were significantly more likely than those without seizure phobia to have a past major depressive episode (63.2% vs. 20.9%; P = .003), and posttraumatic stress disorder (26.3% vs. 7%; P = .05).
Seizure phobia was significantly associated with comorbid psychogenic nonepileptic seizures (PNES) (36.8% vs. 11.6%; P = .034). PNES have been significantly associated with panic attacks, and “all patients with both panic attacks and comorbid PNES were diagnosed with seizure phobia,” the researchers noted. However, no significant association was found with epilepsy-related variables, they said.
A multivariate logistic regression model to predict seizure phobia showed that anxiety and a past MDE were significant predictors; the odds of seizure phobia were 10.45 times higher if a patient reported any anxiety disorder, and 6.85 times higher if the patient had a history of MDE.
The study findings were limited by several factors, including the use of semistructured interviews to diagnose seizure phobia, which are subject to interviewer bias, and by the small study population with a high proportion of comorbid PNES and epilepsy, the researchers noted. However, the results support seizure phobia as a distinct clinical entity worthy of management with education, psychosocial interventions, and potential medication changes, they said.
“Development of appropriate screening tools and implementation of effective treatment interventions is warranted for individual patients, combined with large-scale population-targeted psychoeducation, aimed to mitigate the risk of developing seizure phobia in PWE,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM SEIZURE: EUROPEAN JOURNAL OF EPILEPSY
Early-onset severe COPD: Similar physical symptoms, but higher depression rates
Younger and older patients with severe chronic obstructive pulmonary disease have similar pulmonary and physical health limitations, based on data from 1,058 adults.
Although chronic obstructive pulmonary disease (COPD) generally appears in older patients, the prevalence among adults aged 45-55 years was 6.5% in 2014-2015, wrote Rosanne J.H.C.G. Beijers, PhD, of Maastricht (the Netherlands) University Medical Center, and colleagues. However, data on the early-onset COPD phenotype are limited. In particular, the extent to which younger patients with early-onset severe COPD experienced the same physical and mental health problems as older patients with similar degree of airflow limitation has not been examined, they said.
In a study published in Clinical Nutrition, the researchers analyzed data from adults with COPD who were referred for pulmonary rehabilitation at a single center between July 2013 and August 2018. Severe disease was defined as FEV1< 50%, and early onset was defined as younger than 55 years. The mean age difference between older and younger patient groups was 15.8 years.
The study population included 79 individuals with early-onset severe disease, 54 with early-onset mild to moderate disease, 158 older adults with severe disease, and 103 older adults with mild to moderate disease. The researchers compared disease markers including body composition, physical performance, and mental health between the groups. A significantly greater proportion of the early-onset group were women, compared to the older group (64% vs. 44%).
In comparing early-onset and older patients with severe COPD, the researchers found that clinical characteristics were similar for body composition, skeletal muscle index, fat percentage, and bone mineral content, and for physical performance factors including the percent predicted maximal work capacity (Wmax), 6-minute walk test, and isokinetic strength. However, a higher prevalence of depression appeared in the early-onset severe-disease patients, compared with the older severe-disease patients (51.9% vs. 32.7%; P = .029).
Although the prevalence of depression was not based on a clinical diagnosis, this finding should prompt health care professionals to pay more attention to psychosocial and emotional well-being in early-onset severe COPD patients, the researchers noted.
In comparing early-onset severe-disease patients and early-onset patients with mild to moderate disease, patients with early-onset severe COPD had significantly lower exercise performance, based on a 6-minute walk test and percent predicted Wmax. However, body composition and isokinetic muscle strength were not significantly different between both early-onset groups.
The findings were limited by several factors including the relatively small number of early-onset patients and the lack of data on whether older patients were diagnosed with severe COPD at a younger age, and more research using age and lung function at the time of diagnosis is needed, the researchers noted. However, the results highlight the importance of early identification of patients at risk for early-onset severe COPD, they said. “Within these individuals at risk, special attention should also be paid to the development of extrapulmonary disease manifestations such as exercise limitations, impaired body composition, and psychological and emotional problems,” the researchers said. “Subsequently, intervention strategies need to be applied that not only focus on the regular advice of quitting smoking but also include decreasing the exposure to air pollutants and promoting a healthy lifestyle including physical activity and a healthy diet,” they added.
The study received no outside funding. Lead author Dr. Beijers had no financial conflicts to disclose.
Younger and older patients with severe chronic obstructive pulmonary disease have similar pulmonary and physical health limitations, based on data from 1,058 adults.
Although chronic obstructive pulmonary disease (COPD) generally appears in older patients, the prevalence among adults aged 45-55 years was 6.5% in 2014-2015, wrote Rosanne J.H.C.G. Beijers, PhD, of Maastricht (the Netherlands) University Medical Center, and colleagues. However, data on the early-onset COPD phenotype are limited. In particular, the extent to which younger patients with early-onset severe COPD experienced the same physical and mental health problems as older patients with similar degree of airflow limitation has not been examined, they said.
In a study published in Clinical Nutrition, the researchers analyzed data from adults with COPD who were referred for pulmonary rehabilitation at a single center between July 2013 and August 2018. Severe disease was defined as FEV1< 50%, and early onset was defined as younger than 55 years. The mean age difference between older and younger patient groups was 15.8 years.
The study population included 79 individuals with early-onset severe disease, 54 with early-onset mild to moderate disease, 158 older adults with severe disease, and 103 older adults with mild to moderate disease. The researchers compared disease markers including body composition, physical performance, and mental health between the groups. A significantly greater proportion of the early-onset group were women, compared to the older group (64% vs. 44%).
In comparing early-onset and older patients with severe COPD, the researchers found that clinical characteristics were similar for body composition, skeletal muscle index, fat percentage, and bone mineral content, and for physical performance factors including the percent predicted maximal work capacity (Wmax), 6-minute walk test, and isokinetic strength. However, a higher prevalence of depression appeared in the early-onset severe-disease patients, compared with the older severe-disease patients (51.9% vs. 32.7%; P = .029).
Although the prevalence of depression was not based on a clinical diagnosis, this finding should prompt health care professionals to pay more attention to psychosocial and emotional well-being in early-onset severe COPD patients, the researchers noted.
In comparing early-onset severe-disease patients and early-onset patients with mild to moderate disease, patients with early-onset severe COPD had significantly lower exercise performance, based on a 6-minute walk test and percent predicted Wmax. However, body composition and isokinetic muscle strength were not significantly different between both early-onset groups.
The findings were limited by several factors including the relatively small number of early-onset patients and the lack of data on whether older patients were diagnosed with severe COPD at a younger age, and more research using age and lung function at the time of diagnosis is needed, the researchers noted. However, the results highlight the importance of early identification of patients at risk for early-onset severe COPD, they said. “Within these individuals at risk, special attention should also be paid to the development of extrapulmonary disease manifestations such as exercise limitations, impaired body composition, and psychological and emotional problems,” the researchers said. “Subsequently, intervention strategies need to be applied that not only focus on the regular advice of quitting smoking but also include decreasing the exposure to air pollutants and promoting a healthy lifestyle including physical activity and a healthy diet,” they added.
The study received no outside funding. Lead author Dr. Beijers had no financial conflicts to disclose.
Younger and older patients with severe chronic obstructive pulmonary disease have similar pulmonary and physical health limitations, based on data from 1,058 adults.
Although chronic obstructive pulmonary disease (COPD) generally appears in older patients, the prevalence among adults aged 45-55 years was 6.5% in 2014-2015, wrote Rosanne J.H.C.G. Beijers, PhD, of Maastricht (the Netherlands) University Medical Center, and colleagues. However, data on the early-onset COPD phenotype are limited. In particular, the extent to which younger patients with early-onset severe COPD experienced the same physical and mental health problems as older patients with similar degree of airflow limitation has not been examined, they said.
In a study published in Clinical Nutrition, the researchers analyzed data from adults with COPD who were referred for pulmonary rehabilitation at a single center between July 2013 and August 2018. Severe disease was defined as FEV1< 50%, and early onset was defined as younger than 55 years. The mean age difference between older and younger patient groups was 15.8 years.
The study population included 79 individuals with early-onset severe disease, 54 with early-onset mild to moderate disease, 158 older adults with severe disease, and 103 older adults with mild to moderate disease. The researchers compared disease markers including body composition, physical performance, and mental health between the groups. A significantly greater proportion of the early-onset group were women, compared to the older group (64% vs. 44%).
In comparing early-onset and older patients with severe COPD, the researchers found that clinical characteristics were similar for body composition, skeletal muscle index, fat percentage, and bone mineral content, and for physical performance factors including the percent predicted maximal work capacity (Wmax), 6-minute walk test, and isokinetic strength. However, a higher prevalence of depression appeared in the early-onset severe-disease patients, compared with the older severe-disease patients (51.9% vs. 32.7%; P = .029).
Although the prevalence of depression was not based on a clinical diagnosis, this finding should prompt health care professionals to pay more attention to psychosocial and emotional well-being in early-onset severe COPD patients, the researchers noted.
In comparing early-onset severe-disease patients and early-onset patients with mild to moderate disease, patients with early-onset severe COPD had significantly lower exercise performance, based on a 6-minute walk test and percent predicted Wmax. However, body composition and isokinetic muscle strength were not significantly different between both early-onset groups.
The findings were limited by several factors including the relatively small number of early-onset patients and the lack of data on whether older patients were diagnosed with severe COPD at a younger age, and more research using age and lung function at the time of diagnosis is needed, the researchers noted. However, the results highlight the importance of early identification of patients at risk for early-onset severe COPD, they said. “Within these individuals at risk, special attention should also be paid to the development of extrapulmonary disease manifestations such as exercise limitations, impaired body composition, and psychological and emotional problems,” the researchers said. “Subsequently, intervention strategies need to be applied that not only focus on the regular advice of quitting smoking but also include decreasing the exposure to air pollutants and promoting a healthy lifestyle including physical activity and a healthy diet,” they added.
The study received no outside funding. Lead author Dr. Beijers had no financial conflicts to disclose.
FROM CLINICAL NUTRITION