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New study supports safety of COVID-19 boosters during pregnancy
Doctors and health professionals continue to recommend COVID-19 vaccine boosters or third doses for adolescents and adults more than 5 months after their initial vaccinations with the Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 primary vaccine series or more than 2 months after receiving the Janssen JNJ-78436735 vaccine, Alisa Kachikis, MD, of the University of Washington, Seattle, and colleagues wrote in JAMA Network Open.
Although multiple studies have shown that the COVID-19 primary series is safe and well tolerated in pregnant and lactating women, information on the safety and tolerability of boosters are lacking, the researchers noted.
“COVID-19 will be with us for a while, and it is important to continue to provide data on COVID-19 vaccines in these groups, particularly because there still are many questions about the vaccine, and because pregnant individuals have been, understandably, more hesitant to receive COVID-19 vaccines,” Dr. Kachikis said in an interview. “The findings of this study that COVID-19 booster doses are well tolerated among pregnant and lactating individuals are especially pertinent with the new COVID-19 boosters available this fall.”
In the new study, the researchers reviewed data from 17,014 participants who were part of an ongoing online prospective study of COVID-19 vaccines in pregnant and lactating individuals. Data were collected between October 2021 and April 2022 through an online survey.
The study population included 2,009 participants (11.8%) who were pregnant at the time of their booster or third dose, 10,279 (60.4%) who were lactating, and 4,726 (27.8%) who were neither pregnant nor lactating. The mean age of the participants was 33.3 years; 92.1% self-identified as White, 94.5% self-identified as non-Hispanic, and 99.7% self-identified as female.
The receipt of a booster was similar across trimesters; 26.4%, 36.5%, and 37.1% of participants received boosters or third doses in the first, second, and third trimester, respectively. The primary outcome was self-reported vaccine reactions within 24 hours of the dose.
Overall, 82.8% of the respondents reported a reaction at the site of the injection, such as redness, pain, or swelling, and 67.9% reported at least one systemic symptom, such as aches and pains, headache, chills, or fever. The most frequently reported symptoms across all groups were injection-site pain (82.2%) and fatigue (54.4%).
The pregnant women were significantly more likely than nonpregnant or nonlactating individuals to report any local reaction at the injection site (adjusted odds ratio, 1.2; P = .01), but less likely to report any systemic reaction (aOR, 0.7; P < .001).
The majority (97.6%) of the pregnant respondents and 96.0% of those lactating reported no obstetric or lactation concerns after vaccination.
Overall, a majority of the respondents reported that recommendations from public health authorities were helpful in their decision to receive a COVID-19 booster or third dose (90.0% of pregnant respondents, 89.9% of lactating respondents, and 88.1% of those neither pregnant nor lactating).
Although vaccine uptake in the current study population was high (91.1% overall and 95.0% of those pregnant), “the importance of the health care professional’s recommendation is pertinent given the ongoing increased vaccine hesitancy among pregnant individuals in the context of the COVID-19 vaccine,” the researchers emphasized.
The study findings were limited by several factors including the reliance on self-reports and a convenience sample composed mainly of health care workers because of their vaccine eligibility at the time the study started, which limits generalizability, the researchers noted. Analyses on the pregnancy outcomes of those who were pregnant when vaccinated are in progress.
The results were strengthened by the large study population that included participants from all 50 states and several territories, and ability to compare results between pregnant and lactating individuals with those who were neither pregnant nor lactating, but were of childbearing age, they said.
The results support the safety of COVID-19 boosters for pregnant and breastfeeding individuals, and these data are important to inform discussions between patients and clinicians to boost vaccine uptake and acceptance in this population, they concluded.
“Our earlier data analysis showed that pregnant and lactating individuals did very well with the initial COVID-19 vaccine series, so it was not very surprising that they also did well with COVID-19 booster or third doses,” Dr. Kachikis said in an interview.
There are two takeaway messages for clinicians, she said: “First, pregnant and lactating individuals tolerated the COVID-19 booster well. The second is that clinicians are very important when it comes to vaccine acceptance.”
“In our study, we found that, while pregnant participants were more likely to report that they were hesitant to receive the booster, they also were more likely to have discussed the COVID-19 booster with their health care provider, and to have received a recommendation to receive the booster. So, spending a little bit of extra time with patients discussing COVID-19 boosters and recommending them can make a significant difference,” she said.
The message of the study is highly reassuring for pregnant and lactating individuals, Dr. Kachikis added. “Most of the participants reported that they had fewer symptoms with the COVID-19 booster compared to the primary vaccine series, which is good news, especially since a new COVID-19 booster is being recommended for the fall.”
Reassuring findings for doctors and patients
The current study is especially timely, as updated COVID-19 boosters have now been recommended for most individuals by the Centers for Disease Control and Prevention, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
The findings support previous studies on the tolerability of COVID-19 vaccinations in pregnant and lactating persons, said Dr. Badell, who was not involved in the study.
The reassuring message for clinicians is that COVID-19 booster vaccinations are similarly well tolerated in pregnancy and lactation as they are in nonpregnant individuals, said Dr. Badell. “Given the risks of COVID infections in pregnancy and neonates, reassuring data on the tolerability and safety of vaccination in this population is very important.” Also, the researchers found that all three cohorts reported that recommendations from public or medical health authorities helped them make a decision about vaccination; “thus the more data to support these recommendations, the better,” she emphasized.
If you are pregnant or breastfeeding, the message from the study is that COVID-19 booster vaccinations are similarly well tolerated by those who are pregnant or breastfeeding and those who are not, said Dr. Badell.
“This study provides additional support for the strong recommendation to encourage not only COVID-19 vaccination in pregnancy and lactation, but booster vaccinations specifically,” and pregnant and breastfeeding individuals should not be excluded from the new CDC recommendations for COVID-19 boosters, she said.
Future research suggestions
Next steps for research include evaluating the obstetrical and neonatal outcomes in pregnancy and lactation following COVID- 19 boosters, Dr. Badell added.
Dr. Kachikis suggested studies try to answer the remaining questions about COVID-19 vaccines and the immunity of pregnant and lactating persons, particularly since they were excluded from the early clinical trials in 2020.
The study was supported by the National Institute of Allergy and Infectious Diseases, a Women’s Reproductive Health Research Award, and the National Center for Advancing Translational Sciences of the National Institutes of Health. \Dr. Kachikis disclosed serving as a research consultant for Pfizer and GlaxoSmithKline and as an unpaid consultant for GlaxoSmithKline unrelated to the current study, as well as grant support from Merck and Pfizer unrelated to the current study. Dr. Badell had no financial conflicts to disclose.
Doctors and health professionals continue to recommend COVID-19 vaccine boosters or third doses for adolescents and adults more than 5 months after their initial vaccinations with the Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 primary vaccine series or more than 2 months after receiving the Janssen JNJ-78436735 vaccine, Alisa Kachikis, MD, of the University of Washington, Seattle, and colleagues wrote in JAMA Network Open.
Although multiple studies have shown that the COVID-19 primary series is safe and well tolerated in pregnant and lactating women, information on the safety and tolerability of boosters are lacking, the researchers noted.
“COVID-19 will be with us for a while, and it is important to continue to provide data on COVID-19 vaccines in these groups, particularly because there still are many questions about the vaccine, and because pregnant individuals have been, understandably, more hesitant to receive COVID-19 vaccines,” Dr. Kachikis said in an interview. “The findings of this study that COVID-19 booster doses are well tolerated among pregnant and lactating individuals are especially pertinent with the new COVID-19 boosters available this fall.”
In the new study, the researchers reviewed data from 17,014 participants who were part of an ongoing online prospective study of COVID-19 vaccines in pregnant and lactating individuals. Data were collected between October 2021 and April 2022 through an online survey.
The study population included 2,009 participants (11.8%) who were pregnant at the time of their booster or third dose, 10,279 (60.4%) who were lactating, and 4,726 (27.8%) who were neither pregnant nor lactating. The mean age of the participants was 33.3 years; 92.1% self-identified as White, 94.5% self-identified as non-Hispanic, and 99.7% self-identified as female.
The receipt of a booster was similar across trimesters; 26.4%, 36.5%, and 37.1% of participants received boosters or third doses in the first, second, and third trimester, respectively. The primary outcome was self-reported vaccine reactions within 24 hours of the dose.
Overall, 82.8% of the respondents reported a reaction at the site of the injection, such as redness, pain, or swelling, and 67.9% reported at least one systemic symptom, such as aches and pains, headache, chills, or fever. The most frequently reported symptoms across all groups were injection-site pain (82.2%) and fatigue (54.4%).
The pregnant women were significantly more likely than nonpregnant or nonlactating individuals to report any local reaction at the injection site (adjusted odds ratio, 1.2; P = .01), but less likely to report any systemic reaction (aOR, 0.7; P < .001).
The majority (97.6%) of the pregnant respondents and 96.0% of those lactating reported no obstetric or lactation concerns after vaccination.
Overall, a majority of the respondents reported that recommendations from public health authorities were helpful in their decision to receive a COVID-19 booster or third dose (90.0% of pregnant respondents, 89.9% of lactating respondents, and 88.1% of those neither pregnant nor lactating).
Although vaccine uptake in the current study population was high (91.1% overall and 95.0% of those pregnant), “the importance of the health care professional’s recommendation is pertinent given the ongoing increased vaccine hesitancy among pregnant individuals in the context of the COVID-19 vaccine,” the researchers emphasized.
The study findings were limited by several factors including the reliance on self-reports and a convenience sample composed mainly of health care workers because of their vaccine eligibility at the time the study started, which limits generalizability, the researchers noted. Analyses on the pregnancy outcomes of those who were pregnant when vaccinated are in progress.
The results were strengthened by the large study population that included participants from all 50 states and several territories, and ability to compare results between pregnant and lactating individuals with those who were neither pregnant nor lactating, but were of childbearing age, they said.
The results support the safety of COVID-19 boosters for pregnant and breastfeeding individuals, and these data are important to inform discussions between patients and clinicians to boost vaccine uptake and acceptance in this population, they concluded.
“Our earlier data analysis showed that pregnant and lactating individuals did very well with the initial COVID-19 vaccine series, so it was not very surprising that they also did well with COVID-19 booster or third doses,” Dr. Kachikis said in an interview.
There are two takeaway messages for clinicians, she said: “First, pregnant and lactating individuals tolerated the COVID-19 booster well. The second is that clinicians are very important when it comes to vaccine acceptance.”
“In our study, we found that, while pregnant participants were more likely to report that they were hesitant to receive the booster, they also were more likely to have discussed the COVID-19 booster with their health care provider, and to have received a recommendation to receive the booster. So, spending a little bit of extra time with patients discussing COVID-19 boosters and recommending them can make a significant difference,” she said.
The message of the study is highly reassuring for pregnant and lactating individuals, Dr. Kachikis added. “Most of the participants reported that they had fewer symptoms with the COVID-19 booster compared to the primary vaccine series, which is good news, especially since a new COVID-19 booster is being recommended for the fall.”
Reassuring findings for doctors and patients
The current study is especially timely, as updated COVID-19 boosters have now been recommended for most individuals by the Centers for Disease Control and Prevention, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
The findings support previous studies on the tolerability of COVID-19 vaccinations in pregnant and lactating persons, said Dr. Badell, who was not involved in the study.
The reassuring message for clinicians is that COVID-19 booster vaccinations are similarly well tolerated in pregnancy and lactation as they are in nonpregnant individuals, said Dr. Badell. “Given the risks of COVID infections in pregnancy and neonates, reassuring data on the tolerability and safety of vaccination in this population is very important.” Also, the researchers found that all three cohorts reported that recommendations from public or medical health authorities helped them make a decision about vaccination; “thus the more data to support these recommendations, the better,” she emphasized.
If you are pregnant or breastfeeding, the message from the study is that COVID-19 booster vaccinations are similarly well tolerated by those who are pregnant or breastfeeding and those who are not, said Dr. Badell.
“This study provides additional support for the strong recommendation to encourage not only COVID-19 vaccination in pregnancy and lactation, but booster vaccinations specifically,” and pregnant and breastfeeding individuals should not be excluded from the new CDC recommendations for COVID-19 boosters, she said.
Future research suggestions
Next steps for research include evaluating the obstetrical and neonatal outcomes in pregnancy and lactation following COVID- 19 boosters, Dr. Badell added.
Dr. Kachikis suggested studies try to answer the remaining questions about COVID-19 vaccines and the immunity of pregnant and lactating persons, particularly since they were excluded from the early clinical trials in 2020.
The study was supported by the National Institute of Allergy and Infectious Diseases, a Women’s Reproductive Health Research Award, and the National Center for Advancing Translational Sciences of the National Institutes of Health. \Dr. Kachikis disclosed serving as a research consultant for Pfizer and GlaxoSmithKline and as an unpaid consultant for GlaxoSmithKline unrelated to the current study, as well as grant support from Merck and Pfizer unrelated to the current study. Dr. Badell had no financial conflicts to disclose.
Doctors and health professionals continue to recommend COVID-19 vaccine boosters or third doses for adolescents and adults more than 5 months after their initial vaccinations with the Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 primary vaccine series or more than 2 months after receiving the Janssen JNJ-78436735 vaccine, Alisa Kachikis, MD, of the University of Washington, Seattle, and colleagues wrote in JAMA Network Open.
Although multiple studies have shown that the COVID-19 primary series is safe and well tolerated in pregnant and lactating women, information on the safety and tolerability of boosters are lacking, the researchers noted.
“COVID-19 will be with us for a while, and it is important to continue to provide data on COVID-19 vaccines in these groups, particularly because there still are many questions about the vaccine, and because pregnant individuals have been, understandably, more hesitant to receive COVID-19 vaccines,” Dr. Kachikis said in an interview. “The findings of this study that COVID-19 booster doses are well tolerated among pregnant and lactating individuals are especially pertinent with the new COVID-19 boosters available this fall.”
In the new study, the researchers reviewed data from 17,014 participants who were part of an ongoing online prospective study of COVID-19 vaccines in pregnant and lactating individuals. Data were collected between October 2021 and April 2022 through an online survey.
The study population included 2,009 participants (11.8%) who were pregnant at the time of their booster or third dose, 10,279 (60.4%) who were lactating, and 4,726 (27.8%) who were neither pregnant nor lactating. The mean age of the participants was 33.3 years; 92.1% self-identified as White, 94.5% self-identified as non-Hispanic, and 99.7% self-identified as female.
The receipt of a booster was similar across trimesters; 26.4%, 36.5%, and 37.1% of participants received boosters or third doses in the first, second, and third trimester, respectively. The primary outcome was self-reported vaccine reactions within 24 hours of the dose.
Overall, 82.8% of the respondents reported a reaction at the site of the injection, such as redness, pain, or swelling, and 67.9% reported at least one systemic symptom, such as aches and pains, headache, chills, or fever. The most frequently reported symptoms across all groups were injection-site pain (82.2%) and fatigue (54.4%).
The pregnant women were significantly more likely than nonpregnant or nonlactating individuals to report any local reaction at the injection site (adjusted odds ratio, 1.2; P = .01), but less likely to report any systemic reaction (aOR, 0.7; P < .001).
The majority (97.6%) of the pregnant respondents and 96.0% of those lactating reported no obstetric or lactation concerns after vaccination.
Overall, a majority of the respondents reported that recommendations from public health authorities were helpful in their decision to receive a COVID-19 booster or third dose (90.0% of pregnant respondents, 89.9% of lactating respondents, and 88.1% of those neither pregnant nor lactating).
Although vaccine uptake in the current study population was high (91.1% overall and 95.0% of those pregnant), “the importance of the health care professional’s recommendation is pertinent given the ongoing increased vaccine hesitancy among pregnant individuals in the context of the COVID-19 vaccine,” the researchers emphasized.
The study findings were limited by several factors including the reliance on self-reports and a convenience sample composed mainly of health care workers because of their vaccine eligibility at the time the study started, which limits generalizability, the researchers noted. Analyses on the pregnancy outcomes of those who were pregnant when vaccinated are in progress.
The results were strengthened by the large study population that included participants from all 50 states and several territories, and ability to compare results between pregnant and lactating individuals with those who were neither pregnant nor lactating, but were of childbearing age, they said.
The results support the safety of COVID-19 boosters for pregnant and breastfeeding individuals, and these data are important to inform discussions between patients and clinicians to boost vaccine uptake and acceptance in this population, they concluded.
“Our earlier data analysis showed that pregnant and lactating individuals did very well with the initial COVID-19 vaccine series, so it was not very surprising that they also did well with COVID-19 booster or third doses,” Dr. Kachikis said in an interview.
There are two takeaway messages for clinicians, she said: “First, pregnant and lactating individuals tolerated the COVID-19 booster well. The second is that clinicians are very important when it comes to vaccine acceptance.”
“In our study, we found that, while pregnant participants were more likely to report that they were hesitant to receive the booster, they also were more likely to have discussed the COVID-19 booster with their health care provider, and to have received a recommendation to receive the booster. So, spending a little bit of extra time with patients discussing COVID-19 boosters and recommending them can make a significant difference,” she said.
The message of the study is highly reassuring for pregnant and lactating individuals, Dr. Kachikis added. “Most of the participants reported that they had fewer symptoms with the COVID-19 booster compared to the primary vaccine series, which is good news, especially since a new COVID-19 booster is being recommended for the fall.”
Reassuring findings for doctors and patients
The current study is especially timely, as updated COVID-19 boosters have now been recommended for most individuals by the Centers for Disease Control and Prevention, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
The findings support previous studies on the tolerability of COVID-19 vaccinations in pregnant and lactating persons, said Dr. Badell, who was not involved in the study.
The reassuring message for clinicians is that COVID-19 booster vaccinations are similarly well tolerated in pregnancy and lactation as they are in nonpregnant individuals, said Dr. Badell. “Given the risks of COVID infections in pregnancy and neonates, reassuring data on the tolerability and safety of vaccination in this population is very important.” Also, the researchers found that all three cohorts reported that recommendations from public or medical health authorities helped them make a decision about vaccination; “thus the more data to support these recommendations, the better,” she emphasized.
If you are pregnant or breastfeeding, the message from the study is that COVID-19 booster vaccinations are similarly well tolerated by those who are pregnant or breastfeeding and those who are not, said Dr. Badell.
“This study provides additional support for the strong recommendation to encourage not only COVID-19 vaccination in pregnancy and lactation, but booster vaccinations specifically,” and pregnant and breastfeeding individuals should not be excluded from the new CDC recommendations for COVID-19 boosters, she said.
Future research suggestions
Next steps for research include evaluating the obstetrical and neonatal outcomes in pregnancy and lactation following COVID- 19 boosters, Dr. Badell added.
Dr. Kachikis suggested studies try to answer the remaining questions about COVID-19 vaccines and the immunity of pregnant and lactating persons, particularly since they were excluded from the early clinical trials in 2020.
The study was supported by the National Institute of Allergy and Infectious Diseases, a Women’s Reproductive Health Research Award, and the National Center for Advancing Translational Sciences of the National Institutes of Health. \Dr. Kachikis disclosed serving as a research consultant for Pfizer and GlaxoSmithKline and as an unpaid consultant for GlaxoSmithKline unrelated to the current study, as well as grant support from Merck and Pfizer unrelated to the current study. Dr. Badell had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Dolutegravir in pregnant patients with HIV showed more viral suppression at delivery vs. other treatments
“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.
In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.
The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.
The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.
The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.
“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.
Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.
A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.
“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.
“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.
The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.
However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
Findings fill a key research gap
The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.
Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.
The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.
The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”
Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.
The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.
The researchers and Dr. Badell had no financial conflicts to disclose.
“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.
In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.
The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.
The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.
The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.
“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.
Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.
A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.
“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.
“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.
The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.
However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
Findings fill a key research gap
The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.
Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.
The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.
The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”
Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.
The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.
The researchers and Dr. Badell had no financial conflicts to disclose.
“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.
In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.
The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.
The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.
The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.
“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.
Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.
A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.
“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.
“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.
The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.
However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
Findings fill a key research gap
The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.
Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.
The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.
The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”
Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.
The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.
The researchers and Dr. Badell had no financial conflicts to disclose.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Borderline personality disorder raises relapse risk for MDD patients after ECT
ECT has demonstrated effectiveness for treatment of unipolar and bipolar major depression, but relapses within 6 months are frequent, and potential factors affecting relapse have not been well studied, wrote Matthieu Hein, MD, PhD, of Erasme Hospital, Université Libre de Bruxelles, and colleagues.
Borderline personality disorder (BPD) is a common comorbidity among individuals with major depressive disorder, and previous research suggests a possible negative effect of BPD on ECT response in MDD patients, they wrote.
In a study published in Psychiatry Research, the researchers recruited 68 females and 41 males aged 18 years and older with diagnosed MDD who had partial or complete response to ECT after receiving treatment at a single center. Approximately two-thirds of the patients were aged 50 years and older, and 22 met criteria for BPD. The ECT consisted of three sessions per week; the total number of sessions ranged from 6 to 18.
The primary outcome was relapse at 6 months after ECT treatment. Relapse was defined as a score of 16 or higher on the Hamilton Depression Rating Scale in combination with a mean absolute increase of at least 10 points from the psychiatric interview at the end of the ECT.
Relapse rates at 6 months were 37.6% for the study population overall, but significantly higher for those with BPD, compared with those without BPD (72.7% vs. 28.7%; P < .001).
In a multivariate analysis, adjusting for age, gender, and mood stabilizer use after ECT, relapse was approximately four times more likely among individuals with BPD, compared with those without (hazard ratio, 4.14). No significant association appeared between increased relapse and other comorbid personality disorders, anxiety disorders, alcohol or substance use disorders, or hospitalization during the ECT treatment period.
Potential reasons for the increased relapse risk among individuals with MDD and BPD include the younger age of the individuals with BPD, which has been shown to increase MDD relapse risk; the direct negative impact of BPD on mental functioning; and the documented tendency to poor treatment adherence, the researchers wrote in their discussion.
“Given these different elements, it seems important to screen more systematically for BPD in major depressed individuals treated with ECT in order to allow the implementation of more effective prevention strategies for relapse within 6 months in this particular subpopulation,” they emphasized.
“The demonstration of this higher risk of relapse within 6 months associated with BPD in major depressed individuals treated with ECT could open new therapeutic perspectives to allow better maintenance of euthymia in this particular subpopulation,” they added.
The study findings were limited by several factors including the retrospective design and the focus on only BPD, which may not generalize to other personality disorders, the researchers noted.
However, the results support data from previous studies and highlight the need for more systematic BPD screening in MDD patients to prevent relapse after ECT, they said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
ECT has demonstrated effectiveness for treatment of unipolar and bipolar major depression, but relapses within 6 months are frequent, and potential factors affecting relapse have not been well studied, wrote Matthieu Hein, MD, PhD, of Erasme Hospital, Université Libre de Bruxelles, and colleagues.
Borderline personality disorder (BPD) is a common comorbidity among individuals with major depressive disorder, and previous research suggests a possible negative effect of BPD on ECT response in MDD patients, they wrote.
In a study published in Psychiatry Research, the researchers recruited 68 females and 41 males aged 18 years and older with diagnosed MDD who had partial or complete response to ECT after receiving treatment at a single center. Approximately two-thirds of the patients were aged 50 years and older, and 22 met criteria for BPD. The ECT consisted of three sessions per week; the total number of sessions ranged from 6 to 18.
The primary outcome was relapse at 6 months after ECT treatment. Relapse was defined as a score of 16 or higher on the Hamilton Depression Rating Scale in combination with a mean absolute increase of at least 10 points from the psychiatric interview at the end of the ECT.
Relapse rates at 6 months were 37.6% for the study population overall, but significantly higher for those with BPD, compared with those without BPD (72.7% vs. 28.7%; P < .001).
In a multivariate analysis, adjusting for age, gender, and mood stabilizer use after ECT, relapse was approximately four times more likely among individuals with BPD, compared with those without (hazard ratio, 4.14). No significant association appeared between increased relapse and other comorbid personality disorders, anxiety disorders, alcohol or substance use disorders, or hospitalization during the ECT treatment period.
Potential reasons for the increased relapse risk among individuals with MDD and BPD include the younger age of the individuals with BPD, which has been shown to increase MDD relapse risk; the direct negative impact of BPD on mental functioning; and the documented tendency to poor treatment adherence, the researchers wrote in their discussion.
“Given these different elements, it seems important to screen more systematically for BPD in major depressed individuals treated with ECT in order to allow the implementation of more effective prevention strategies for relapse within 6 months in this particular subpopulation,” they emphasized.
“The demonstration of this higher risk of relapse within 6 months associated with BPD in major depressed individuals treated with ECT could open new therapeutic perspectives to allow better maintenance of euthymia in this particular subpopulation,” they added.
The study findings were limited by several factors including the retrospective design and the focus on only BPD, which may not generalize to other personality disorders, the researchers noted.
However, the results support data from previous studies and highlight the need for more systematic BPD screening in MDD patients to prevent relapse after ECT, they said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
ECT has demonstrated effectiveness for treatment of unipolar and bipolar major depression, but relapses within 6 months are frequent, and potential factors affecting relapse have not been well studied, wrote Matthieu Hein, MD, PhD, of Erasme Hospital, Université Libre de Bruxelles, and colleagues.
Borderline personality disorder (BPD) is a common comorbidity among individuals with major depressive disorder, and previous research suggests a possible negative effect of BPD on ECT response in MDD patients, they wrote.
In a study published in Psychiatry Research, the researchers recruited 68 females and 41 males aged 18 years and older with diagnosed MDD who had partial or complete response to ECT after receiving treatment at a single center. Approximately two-thirds of the patients were aged 50 years and older, and 22 met criteria for BPD. The ECT consisted of three sessions per week; the total number of sessions ranged from 6 to 18.
The primary outcome was relapse at 6 months after ECT treatment. Relapse was defined as a score of 16 or higher on the Hamilton Depression Rating Scale in combination with a mean absolute increase of at least 10 points from the psychiatric interview at the end of the ECT.
Relapse rates at 6 months were 37.6% for the study population overall, but significantly higher for those with BPD, compared with those without BPD (72.7% vs. 28.7%; P < .001).
In a multivariate analysis, adjusting for age, gender, and mood stabilizer use after ECT, relapse was approximately four times more likely among individuals with BPD, compared with those without (hazard ratio, 4.14). No significant association appeared between increased relapse and other comorbid personality disorders, anxiety disorders, alcohol or substance use disorders, or hospitalization during the ECT treatment period.
Potential reasons for the increased relapse risk among individuals with MDD and BPD include the younger age of the individuals with BPD, which has been shown to increase MDD relapse risk; the direct negative impact of BPD on mental functioning; and the documented tendency to poor treatment adherence, the researchers wrote in their discussion.
“Given these different elements, it seems important to screen more systematically for BPD in major depressed individuals treated with ECT in order to allow the implementation of more effective prevention strategies for relapse within 6 months in this particular subpopulation,” they emphasized.
“The demonstration of this higher risk of relapse within 6 months associated with BPD in major depressed individuals treated with ECT could open new therapeutic perspectives to allow better maintenance of euthymia in this particular subpopulation,” they added.
The study findings were limited by several factors including the retrospective design and the focus on only BPD, which may not generalize to other personality disorders, the researchers noted.
However, the results support data from previous studies and highlight the need for more systematic BPD screening in MDD patients to prevent relapse after ECT, they said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM PSYCHIATRY RESEARCH
Sclerostin predicts exacerbations in COPD patients
Lower levels of serum sclerostin (SOST) were significantly associated with increased risk of lung exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD), based on data from 139 individuals.
COPD exacerbations contribute to poorer prognosis and diminished quality of life, but many potential triggers of these exacerbations, including serum biomarkers, have not been well studied, wrote Carlos A. Amado, MD, of Hospital Universitario Marqués de Valdecilla, Santander, Spain, and colleagues.
These biomarkers include sclerostin, which is associated with bone metabolism and may play a role in “muscle-bone crosstalk,” thereby impacting lung function, they said.
In a study published in Pulmonology, the researchers recruited 139 adult outpatients with stable COPD and normal kidney function who were treated at a single center. The patients were followed for 12 months after study enrollment and a baseline assessment of serum SOST, bone metabolism parameters, body composition, clinical characteristics, and lung function. The mean age of the participants was 65.8 years, and 71% were men. Notably, 41.7% of the participants were current smokers. Body composition was assessed using fat-free mass index (FFMI), and lung function was assessed using forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC).
A total of 55 patients had SOST levels of 20 pmol/L at baseline, and 84 had SOST levels greater than 20 pmol/L. In a multivariate analysis, only age and FFMI were positively correlated with SOST levels (beta = 0.264 and beta = 1.241, respectively).
Patients in the lower tertile of SOST levels had a significantly higher risk of moderate COPD exacerbation (hazard ratio, 2.015; P = .017) and hospital admission related to COPD (HR, 5.142; P = .015), compared with the other patients. Also in a multivariate analysis, low levels of SOST were independently associated with FFMI (odds ratio, 1.936; P = .004) but not with any of the other variables.
the researchers wrote in their discussion. However, “we found that SOST and FFMI were positively associated in patients with COPD; therefore, lower levels of circulating SOST might reflect sarcopenia,” they noted. Low levels of muscle mass are associated with COPD exacerbations, they added.
The study findings were limited by several factors, including the use of patients from only one center and the high prevalence of hypovitaminosis D in the study population. The study also was not designed to show causality, the researchers said.
However, the results were strengthened by their specific design and overall well-selected population, as well as the evaluation of bone metabolism, they said.
The study offers the first evidence of an association between SOST and clinical outcomes in COPD “and may have a role as a biomarker to evaluate the risk of exacerbation and hospitalization in COPD,” but more research is needed in other populations to fully evaluate the therapeutic aspects of the study findings, the researchers concluded.
The study was supported by the Instituto de Investigación Sanitaria of Cantabria. The researchers disclosed no financial conflicts.
A version of this article first appeared on Medscape.com.
Lower levels of serum sclerostin (SOST) were significantly associated with increased risk of lung exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD), based on data from 139 individuals.
COPD exacerbations contribute to poorer prognosis and diminished quality of life, but many potential triggers of these exacerbations, including serum biomarkers, have not been well studied, wrote Carlos A. Amado, MD, of Hospital Universitario Marqués de Valdecilla, Santander, Spain, and colleagues.
These biomarkers include sclerostin, which is associated with bone metabolism and may play a role in “muscle-bone crosstalk,” thereby impacting lung function, they said.
In a study published in Pulmonology, the researchers recruited 139 adult outpatients with stable COPD and normal kidney function who were treated at a single center. The patients were followed for 12 months after study enrollment and a baseline assessment of serum SOST, bone metabolism parameters, body composition, clinical characteristics, and lung function. The mean age of the participants was 65.8 years, and 71% were men. Notably, 41.7% of the participants were current smokers. Body composition was assessed using fat-free mass index (FFMI), and lung function was assessed using forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC).
A total of 55 patients had SOST levels of 20 pmol/L at baseline, and 84 had SOST levels greater than 20 pmol/L. In a multivariate analysis, only age and FFMI were positively correlated with SOST levels (beta = 0.264 and beta = 1.241, respectively).
Patients in the lower tertile of SOST levels had a significantly higher risk of moderate COPD exacerbation (hazard ratio, 2.015; P = .017) and hospital admission related to COPD (HR, 5.142; P = .015), compared with the other patients. Also in a multivariate analysis, low levels of SOST were independently associated with FFMI (odds ratio, 1.936; P = .004) but not with any of the other variables.
the researchers wrote in their discussion. However, “we found that SOST and FFMI were positively associated in patients with COPD; therefore, lower levels of circulating SOST might reflect sarcopenia,” they noted. Low levels of muscle mass are associated with COPD exacerbations, they added.
The study findings were limited by several factors, including the use of patients from only one center and the high prevalence of hypovitaminosis D in the study population. The study also was not designed to show causality, the researchers said.
However, the results were strengthened by their specific design and overall well-selected population, as well as the evaluation of bone metabolism, they said.
The study offers the first evidence of an association between SOST and clinical outcomes in COPD “and may have a role as a biomarker to evaluate the risk of exacerbation and hospitalization in COPD,” but more research is needed in other populations to fully evaluate the therapeutic aspects of the study findings, the researchers concluded.
The study was supported by the Instituto de Investigación Sanitaria of Cantabria. The researchers disclosed no financial conflicts.
A version of this article first appeared on Medscape.com.
Lower levels of serum sclerostin (SOST) were significantly associated with increased risk of lung exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD), based on data from 139 individuals.
COPD exacerbations contribute to poorer prognosis and diminished quality of life, but many potential triggers of these exacerbations, including serum biomarkers, have not been well studied, wrote Carlos A. Amado, MD, of Hospital Universitario Marqués de Valdecilla, Santander, Spain, and colleagues.
These biomarkers include sclerostin, which is associated with bone metabolism and may play a role in “muscle-bone crosstalk,” thereby impacting lung function, they said.
In a study published in Pulmonology, the researchers recruited 139 adult outpatients with stable COPD and normal kidney function who were treated at a single center. The patients were followed for 12 months after study enrollment and a baseline assessment of serum SOST, bone metabolism parameters, body composition, clinical characteristics, and lung function. The mean age of the participants was 65.8 years, and 71% were men. Notably, 41.7% of the participants were current smokers. Body composition was assessed using fat-free mass index (FFMI), and lung function was assessed using forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC).
A total of 55 patients had SOST levels of 20 pmol/L at baseline, and 84 had SOST levels greater than 20 pmol/L. In a multivariate analysis, only age and FFMI were positively correlated with SOST levels (beta = 0.264 and beta = 1.241, respectively).
Patients in the lower tertile of SOST levels had a significantly higher risk of moderate COPD exacerbation (hazard ratio, 2.015; P = .017) and hospital admission related to COPD (HR, 5.142; P = .015), compared with the other patients. Also in a multivariate analysis, low levels of SOST were independently associated with FFMI (odds ratio, 1.936; P = .004) but not with any of the other variables.
the researchers wrote in their discussion. However, “we found that SOST and FFMI were positively associated in patients with COPD; therefore, lower levels of circulating SOST might reflect sarcopenia,” they noted. Low levels of muscle mass are associated with COPD exacerbations, they added.
The study findings were limited by several factors, including the use of patients from only one center and the high prevalence of hypovitaminosis D in the study population. The study also was not designed to show causality, the researchers said.
However, the results were strengthened by their specific design and overall well-selected population, as well as the evaluation of bone metabolism, they said.
The study offers the first evidence of an association between SOST and clinical outcomes in COPD “and may have a role as a biomarker to evaluate the risk of exacerbation and hospitalization in COPD,” but more research is needed in other populations to fully evaluate the therapeutic aspects of the study findings, the researchers concluded.
The study was supported by the Instituto de Investigación Sanitaria of Cantabria. The researchers disclosed no financial conflicts.
A version of this article first appeared on Medscape.com.
Body contouring tops list of cosmetic procedures with adverse event reports
of data from the Manufacturer and User Facility Device Experience (MAUDE).
The number of noninvasive body-contouring procedures performed in the United States increased by fivefold from 2011 to 2019, attributed in part to a combination of improved technology and new medical devices, as well as a “cosmetically savvy consumer base heavily influenced by social media,” wrote Young Lim, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston, and coauthors.
However, premarket evaluations of many new medical devices fail to capture rare or delayed onset complications, and consumers and providers may not be fully aware of potential adverse events, they said. The MAUDE database was created by the Food and Drug Administration in 1991 to collect information on device-related deaths, serious injuries, or malfunctions based on reports from manufacturers, patients, and health care providers.
The researchers used the MAUDE database to identify and highlight adverse events associated with noninvasive body contouring technology in order to improve patient safety and satisfaction.
In their report, published in Lasers in Surgery and Medicine, they analyzed 723 medical device reports (MDRs) reported between 2015 and 2021: 660 for noninvasive body contouring, 55 for cellulite treatments, and 8 for muscle stimulation.
“Notably, of the 723 total MDRs between 2015 and 2021, 515 (71.2%) were reported in 2021, with the next highest reported being 64 in 2019 (8.8%),” the researchers wrote.
Overall, paradoxical hyperplasia (PAH) accounted for the majority of adverse reactions in the noninvasive body-contouring category (73.2%). In PAH, patients develop additional adipose tissue in areas treated with cryolipolysis. In this study, all reports of PAH as well as all 47 reported cases of abdominal hernias were attributed to the CoolSculpting device.
For cellulite treatments, the most common MDRs – 11 of 55 – were scars and keloids (20%). The Cellfina subcision technique accounted for 47% (26 of 55) of the MDRs in this category, including 9 of the scar and keloid cases.
Only eight of the MDRs analyzed were in the muscle stimulation category; of these, burns were the most common adverse event and accounted for three of the reports. The other reported AEs were two cases of pain and one report each of electrical shock, urticaria, and arrhythmia.
Patients are increasingly opting for noninvasive cosmetic procedures, but adverse events may be underreported despite the existence of databases such as MAUDE, the researchers wrote in their discussion.
“PAH, first reported in 2014 as an adverse sequelae of cryolipolysis, remains without known pathophysiology, though it proportionately affects men more than women,” they noted. The incidence of PAH varies widely, and the current treatment of choice is power-assisted liposuction, they said, although surgical abdominoplasty may be needed in severe cases.
The findings were limited by several factors including the reliance of the quality of submissions, the selection biases of the MAUDE database, and the potential for underreporting, the researchers noted.
However, “by cataloging the AEs of the growing noninvasive cosmetics market, the MAUDE can educate providers and inform patients to maximize safety and efficacy,” they said.
The size of the database and volume of reports provides a picture that likely reflects overall trends occurring in clinical practice, but in order to be effective, such databases require diligence on the part of manufacturers and clinicians to provide accurate, up-to-date information, the researchers concluded.
More procedures mean more complications
“As the market for minimally and noninvasive cosmetic procedures continues to expand, clinicians will likely encounter a greater number of patients with complications from these procedures,” said Jacqueline Watchmaker, MD, a general and cosmetic dermatologist in Scottsdale, Ariz., in an interview.
“Now more than ever, it is important for providers to understand potential side effects of procedures so that they can adequately counsel patients and optimize patient safety,” and therefore the current study is important at this time, she commented.
Dr. Watchmaker, who was not involved in the study, said that, overall, she was not surprised by the findings. “The adverse events analyzed from the Manufacturer and User Facility Device Experience parallel what is seen in clinical practice,” she said. “I did find it slightly surprising that an overwhelming majority of the medical device reports (515 of 723) were from 2021.” As the authors discuss, the reasons for this increase may include such factors as more flexible pandemic work schedules, pandemic weight gain, and the rise in MedSpas in recent years, she added.
“Some patients mistakenly think that ‘noninvasive’ or ‘minimally invasive’ procedures are risk free,” said Dr. Watchmaker. “However, as this review clearly demonstrates, complications can and do occur with these procedures. It is our job as clinicians to educate our patients on potential adverse events prior to treatment,” she emphasized. Also, she added, it is important for clinicians to report all adverse events to the MAUDE database so the true risks of noninvasive procedures can be more accurately assessed.
As for additional research, “It would be interesting to repeat the same study but to look at other minimally and noninvasive cosmetic devices such as radiofrequency and ultrasound devices,” Dr. Watchmaker noted.
The study received no outside funding. Dr. Lim and his coauthors, Adam Wulkan, MD, of the Lahey Clinic, Burlington, Mass., and Mathew Avram, MD, JD, of Massachusetts General Hospital, had no financial conflicts to disclose. Dr. Watchmaker had no financial conflicts to disclose.
Medical device–related adverse events can be reported to the FDA’s MAUDE database here .
of data from the Manufacturer and User Facility Device Experience (MAUDE).
The number of noninvasive body-contouring procedures performed in the United States increased by fivefold from 2011 to 2019, attributed in part to a combination of improved technology and new medical devices, as well as a “cosmetically savvy consumer base heavily influenced by social media,” wrote Young Lim, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston, and coauthors.
However, premarket evaluations of many new medical devices fail to capture rare or delayed onset complications, and consumers and providers may not be fully aware of potential adverse events, they said. The MAUDE database was created by the Food and Drug Administration in 1991 to collect information on device-related deaths, serious injuries, or malfunctions based on reports from manufacturers, patients, and health care providers.
The researchers used the MAUDE database to identify and highlight adverse events associated with noninvasive body contouring technology in order to improve patient safety and satisfaction.
In their report, published in Lasers in Surgery and Medicine, they analyzed 723 medical device reports (MDRs) reported between 2015 and 2021: 660 for noninvasive body contouring, 55 for cellulite treatments, and 8 for muscle stimulation.
“Notably, of the 723 total MDRs between 2015 and 2021, 515 (71.2%) were reported in 2021, with the next highest reported being 64 in 2019 (8.8%),” the researchers wrote.
Overall, paradoxical hyperplasia (PAH) accounted for the majority of adverse reactions in the noninvasive body-contouring category (73.2%). In PAH, patients develop additional adipose tissue in areas treated with cryolipolysis. In this study, all reports of PAH as well as all 47 reported cases of abdominal hernias were attributed to the CoolSculpting device.
For cellulite treatments, the most common MDRs – 11 of 55 – were scars and keloids (20%). The Cellfina subcision technique accounted for 47% (26 of 55) of the MDRs in this category, including 9 of the scar and keloid cases.
Only eight of the MDRs analyzed were in the muscle stimulation category; of these, burns were the most common adverse event and accounted for three of the reports. The other reported AEs were two cases of pain and one report each of electrical shock, urticaria, and arrhythmia.
Patients are increasingly opting for noninvasive cosmetic procedures, but adverse events may be underreported despite the existence of databases such as MAUDE, the researchers wrote in their discussion.
“PAH, first reported in 2014 as an adverse sequelae of cryolipolysis, remains without known pathophysiology, though it proportionately affects men more than women,” they noted. The incidence of PAH varies widely, and the current treatment of choice is power-assisted liposuction, they said, although surgical abdominoplasty may be needed in severe cases.
The findings were limited by several factors including the reliance of the quality of submissions, the selection biases of the MAUDE database, and the potential for underreporting, the researchers noted.
However, “by cataloging the AEs of the growing noninvasive cosmetics market, the MAUDE can educate providers and inform patients to maximize safety and efficacy,” they said.
The size of the database and volume of reports provides a picture that likely reflects overall trends occurring in clinical practice, but in order to be effective, such databases require diligence on the part of manufacturers and clinicians to provide accurate, up-to-date information, the researchers concluded.
More procedures mean more complications
“As the market for minimally and noninvasive cosmetic procedures continues to expand, clinicians will likely encounter a greater number of patients with complications from these procedures,” said Jacqueline Watchmaker, MD, a general and cosmetic dermatologist in Scottsdale, Ariz., in an interview.
“Now more than ever, it is important for providers to understand potential side effects of procedures so that they can adequately counsel patients and optimize patient safety,” and therefore the current study is important at this time, she commented.
Dr. Watchmaker, who was not involved in the study, said that, overall, she was not surprised by the findings. “The adverse events analyzed from the Manufacturer and User Facility Device Experience parallel what is seen in clinical practice,” she said. “I did find it slightly surprising that an overwhelming majority of the medical device reports (515 of 723) were from 2021.” As the authors discuss, the reasons for this increase may include such factors as more flexible pandemic work schedules, pandemic weight gain, and the rise in MedSpas in recent years, she added.
“Some patients mistakenly think that ‘noninvasive’ or ‘minimally invasive’ procedures are risk free,” said Dr. Watchmaker. “However, as this review clearly demonstrates, complications can and do occur with these procedures. It is our job as clinicians to educate our patients on potential adverse events prior to treatment,” she emphasized. Also, she added, it is important for clinicians to report all adverse events to the MAUDE database so the true risks of noninvasive procedures can be more accurately assessed.
As for additional research, “It would be interesting to repeat the same study but to look at other minimally and noninvasive cosmetic devices such as radiofrequency and ultrasound devices,” Dr. Watchmaker noted.
The study received no outside funding. Dr. Lim and his coauthors, Adam Wulkan, MD, of the Lahey Clinic, Burlington, Mass., and Mathew Avram, MD, JD, of Massachusetts General Hospital, had no financial conflicts to disclose. Dr. Watchmaker had no financial conflicts to disclose.
Medical device–related adverse events can be reported to the FDA’s MAUDE database here .
of data from the Manufacturer and User Facility Device Experience (MAUDE).
The number of noninvasive body-contouring procedures performed in the United States increased by fivefold from 2011 to 2019, attributed in part to a combination of improved technology and new medical devices, as well as a “cosmetically savvy consumer base heavily influenced by social media,” wrote Young Lim, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston, and coauthors.
However, premarket evaluations of many new medical devices fail to capture rare or delayed onset complications, and consumers and providers may not be fully aware of potential adverse events, they said. The MAUDE database was created by the Food and Drug Administration in 1991 to collect information on device-related deaths, serious injuries, or malfunctions based on reports from manufacturers, patients, and health care providers.
The researchers used the MAUDE database to identify and highlight adverse events associated with noninvasive body contouring technology in order to improve patient safety and satisfaction.
In their report, published in Lasers in Surgery and Medicine, they analyzed 723 medical device reports (MDRs) reported between 2015 and 2021: 660 for noninvasive body contouring, 55 for cellulite treatments, and 8 for muscle stimulation.
“Notably, of the 723 total MDRs between 2015 and 2021, 515 (71.2%) were reported in 2021, with the next highest reported being 64 in 2019 (8.8%),” the researchers wrote.
Overall, paradoxical hyperplasia (PAH) accounted for the majority of adverse reactions in the noninvasive body-contouring category (73.2%). In PAH, patients develop additional adipose tissue in areas treated with cryolipolysis. In this study, all reports of PAH as well as all 47 reported cases of abdominal hernias were attributed to the CoolSculpting device.
For cellulite treatments, the most common MDRs – 11 of 55 – were scars and keloids (20%). The Cellfina subcision technique accounted for 47% (26 of 55) of the MDRs in this category, including 9 of the scar and keloid cases.
Only eight of the MDRs analyzed were in the muscle stimulation category; of these, burns were the most common adverse event and accounted for three of the reports. The other reported AEs were two cases of pain and one report each of electrical shock, urticaria, and arrhythmia.
Patients are increasingly opting for noninvasive cosmetic procedures, but adverse events may be underreported despite the existence of databases such as MAUDE, the researchers wrote in their discussion.
“PAH, first reported in 2014 as an adverse sequelae of cryolipolysis, remains without known pathophysiology, though it proportionately affects men more than women,” they noted. The incidence of PAH varies widely, and the current treatment of choice is power-assisted liposuction, they said, although surgical abdominoplasty may be needed in severe cases.
The findings were limited by several factors including the reliance of the quality of submissions, the selection biases of the MAUDE database, and the potential for underreporting, the researchers noted.
However, “by cataloging the AEs of the growing noninvasive cosmetics market, the MAUDE can educate providers and inform patients to maximize safety and efficacy,” they said.
The size of the database and volume of reports provides a picture that likely reflects overall trends occurring in clinical practice, but in order to be effective, such databases require diligence on the part of manufacturers and clinicians to provide accurate, up-to-date information, the researchers concluded.
More procedures mean more complications
“As the market for minimally and noninvasive cosmetic procedures continues to expand, clinicians will likely encounter a greater number of patients with complications from these procedures,” said Jacqueline Watchmaker, MD, a general and cosmetic dermatologist in Scottsdale, Ariz., in an interview.
“Now more than ever, it is important for providers to understand potential side effects of procedures so that they can adequately counsel patients and optimize patient safety,” and therefore the current study is important at this time, she commented.
Dr. Watchmaker, who was not involved in the study, said that, overall, she was not surprised by the findings. “The adverse events analyzed from the Manufacturer and User Facility Device Experience parallel what is seen in clinical practice,” she said. “I did find it slightly surprising that an overwhelming majority of the medical device reports (515 of 723) were from 2021.” As the authors discuss, the reasons for this increase may include such factors as more flexible pandemic work schedules, pandemic weight gain, and the rise in MedSpas in recent years, she added.
“Some patients mistakenly think that ‘noninvasive’ or ‘minimally invasive’ procedures are risk free,” said Dr. Watchmaker. “However, as this review clearly demonstrates, complications can and do occur with these procedures. It is our job as clinicians to educate our patients on potential adverse events prior to treatment,” she emphasized. Also, she added, it is important for clinicians to report all adverse events to the MAUDE database so the true risks of noninvasive procedures can be more accurately assessed.
As for additional research, “It would be interesting to repeat the same study but to look at other minimally and noninvasive cosmetic devices such as radiofrequency and ultrasound devices,” Dr. Watchmaker noted.
The study received no outside funding. Dr. Lim and his coauthors, Adam Wulkan, MD, of the Lahey Clinic, Burlington, Mass., and Mathew Avram, MD, JD, of Massachusetts General Hospital, had no financial conflicts to disclose. Dr. Watchmaker had no financial conflicts to disclose.
Medical device–related adverse events can be reported to the FDA’s MAUDE database here .
FROM LASERS IN SURGERY AND MEDICINE
Well-child visits rise, but disparities remain
Adherence to well-child visits in the United States increased overall over a 10-year period, but a gap of up to 20% persisted between the highest and lowest adherence groups, reflecting disparities by race and ethnicity, poverty level, geography, and insurance status.
Well-child visits are recommended to provide children with preventive health and development services, ensure immunizations, and allow parents to discuss health concerns, wrote Salam Abdus, PhD, and Thomas M. Selden, PhD, of the Agency for Healthcare Research and Quality, Rockville, Md.
“We know from prior studies that as of 2008, well-child visits were trending upward, but often fell short of recommendations among key socioeconomic groups,” they wrote.
To examine recent trends in well-child visits, the researchers conducted a cross-sectional study of data from the Medical Expenditure Panel Survey (MEPS) on children aged 0 to 18 years. The findings were published in JAMA Pediatrics.
The study population included 19,018 children in 2006 and 2007 and 17,533 children in 2016 and 2017.
Adherence was defined as the ratio of reported well-child visits divided by the recommended number of visits in a calendar year.
Overall, the mean adherence increased from 47.9% in 2006-2007 to 62.3% in 2016-2017.
However, significant gaps persisted across race and ethnicity. Notably, adherence in the Hispanic population increased by nearly 22% between the study dates, compared to a 15.3% increase among White non-Hispanic children. However, Hispanic children still trailed White children overall in 2016-2017 (58% vs. 67.8%).
The smallest increase in adherence occurred among Black non-Hispanic children (5.6%) which further widened the gap between Black and White non-Hispanic children in 2016-2017 (52.5% vs. 67.8%).
Adherence rates increased similarly for children with public and private insurance (15.5% and 13.9%, respectively), but the adherence rates for uninsured children remained stable. Adherence in 2016-2017 for children with private, public, and no insurance were 66.3%, 58.7%, and 31.1%.
Also, despite overall increases in adherence across regions, a gap of more than 20% separated the region with the highest adherence (Northeast) from the lowest (West) in both the 2006-2007 and 2016-2017 periods (69.3% vs. 38.4%, and 79.3% vs. 55.2%, respectively).
The findings show an increase in well-child visits that spanned a time period of increased recommendations, economic changes, and the impact of the Affordable Care Act, but unaddressed disparities remain, the researchers noted.
Reducing disparities and improving adherence, “will require the combined efforts of researchers, policymakers, and clinicians to improve our understanding of adherence, to implement policies improving access to care, and to increase health care professional engagement with disadvantaged communities,” they concluded.
Overall increases are encouraging, but barriers need attention
“Demographic data are critical to determine which groups of children need the most support for recommended well child care,” Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. In the current study, “it was encouraging to see how either public or private insurance significantly increased the percentage of children receiving well child care,” she said.
The level of increased adherence to AAP-recommended guidelines for well-child visits was surprising, said Dr. Boulter. The overall increase is likely attributable in part to the increased coverage for well-child visits in the wake of the Affordable Care Act, as the study authors mention, she said.
“The gains experienced by Hispanic families were especially encouraging,” she added.
However, ongoing barriers to well-child care include “lack of adequate provider numbers and mix, transportation difficulties for patients, and lack of child care and time away from work for parents so they can complete the recommended well child visit schedule,” Dr. Boulter noted. “Provider schedules and locations of care should be improved so families would have easier access. Also, social media should have more positive well-child messages to counteract the negative messaging.”
More research is needed to examine the impact of COVID-19 on well-child visits, Dr. Boulter emphasized. “Most likely, the percentages in all groups will have changed since COVID-19 has impacted office practices,” she said. “Anxiety about COVID-19 transmissibility in the pediatric office decreased routine office visits, and skepticism about vaccines, including vaccine refusal, has significantly changed the percentage of children who have received the AAP recommended vaccines,” she explained. Ideally, the study authors will review the MEPS data again to examine changes since the COVID-19 pandemic began, she told this news organization.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Adherence to well-child visits in the United States increased overall over a 10-year period, but a gap of up to 20% persisted between the highest and lowest adherence groups, reflecting disparities by race and ethnicity, poverty level, geography, and insurance status.
Well-child visits are recommended to provide children with preventive health and development services, ensure immunizations, and allow parents to discuss health concerns, wrote Salam Abdus, PhD, and Thomas M. Selden, PhD, of the Agency for Healthcare Research and Quality, Rockville, Md.
“We know from prior studies that as of 2008, well-child visits were trending upward, but often fell short of recommendations among key socioeconomic groups,” they wrote.
To examine recent trends in well-child visits, the researchers conducted a cross-sectional study of data from the Medical Expenditure Panel Survey (MEPS) on children aged 0 to 18 years. The findings were published in JAMA Pediatrics.
The study population included 19,018 children in 2006 and 2007 and 17,533 children in 2016 and 2017.
Adherence was defined as the ratio of reported well-child visits divided by the recommended number of visits in a calendar year.
Overall, the mean adherence increased from 47.9% in 2006-2007 to 62.3% in 2016-2017.
However, significant gaps persisted across race and ethnicity. Notably, adherence in the Hispanic population increased by nearly 22% between the study dates, compared to a 15.3% increase among White non-Hispanic children. However, Hispanic children still trailed White children overall in 2016-2017 (58% vs. 67.8%).
The smallest increase in adherence occurred among Black non-Hispanic children (5.6%) which further widened the gap between Black and White non-Hispanic children in 2016-2017 (52.5% vs. 67.8%).
Adherence rates increased similarly for children with public and private insurance (15.5% and 13.9%, respectively), but the adherence rates for uninsured children remained stable. Adherence in 2016-2017 for children with private, public, and no insurance were 66.3%, 58.7%, and 31.1%.
Also, despite overall increases in adherence across regions, a gap of more than 20% separated the region with the highest adherence (Northeast) from the lowest (West) in both the 2006-2007 and 2016-2017 periods (69.3% vs. 38.4%, and 79.3% vs. 55.2%, respectively).
The findings show an increase in well-child visits that spanned a time period of increased recommendations, economic changes, and the impact of the Affordable Care Act, but unaddressed disparities remain, the researchers noted.
Reducing disparities and improving adherence, “will require the combined efforts of researchers, policymakers, and clinicians to improve our understanding of adherence, to implement policies improving access to care, and to increase health care professional engagement with disadvantaged communities,” they concluded.
Overall increases are encouraging, but barriers need attention
“Demographic data are critical to determine which groups of children need the most support for recommended well child care,” Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. In the current study, “it was encouraging to see how either public or private insurance significantly increased the percentage of children receiving well child care,” she said.
The level of increased adherence to AAP-recommended guidelines for well-child visits was surprising, said Dr. Boulter. The overall increase is likely attributable in part to the increased coverage for well-child visits in the wake of the Affordable Care Act, as the study authors mention, she said.
“The gains experienced by Hispanic families were especially encouraging,” she added.
However, ongoing barriers to well-child care include “lack of adequate provider numbers and mix, transportation difficulties for patients, and lack of child care and time away from work for parents so they can complete the recommended well child visit schedule,” Dr. Boulter noted. “Provider schedules and locations of care should be improved so families would have easier access. Also, social media should have more positive well-child messages to counteract the negative messaging.”
More research is needed to examine the impact of COVID-19 on well-child visits, Dr. Boulter emphasized. “Most likely, the percentages in all groups will have changed since COVID-19 has impacted office practices,” she said. “Anxiety about COVID-19 transmissibility in the pediatric office decreased routine office visits, and skepticism about vaccines, including vaccine refusal, has significantly changed the percentage of children who have received the AAP recommended vaccines,” she explained. Ideally, the study authors will review the MEPS data again to examine changes since the COVID-19 pandemic began, she told this news organization.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Adherence to well-child visits in the United States increased overall over a 10-year period, but a gap of up to 20% persisted between the highest and lowest adherence groups, reflecting disparities by race and ethnicity, poverty level, geography, and insurance status.
Well-child visits are recommended to provide children with preventive health and development services, ensure immunizations, and allow parents to discuss health concerns, wrote Salam Abdus, PhD, and Thomas M. Selden, PhD, of the Agency for Healthcare Research and Quality, Rockville, Md.
“We know from prior studies that as of 2008, well-child visits were trending upward, but often fell short of recommendations among key socioeconomic groups,” they wrote.
To examine recent trends in well-child visits, the researchers conducted a cross-sectional study of data from the Medical Expenditure Panel Survey (MEPS) on children aged 0 to 18 years. The findings were published in JAMA Pediatrics.
The study population included 19,018 children in 2006 and 2007 and 17,533 children in 2016 and 2017.
Adherence was defined as the ratio of reported well-child visits divided by the recommended number of visits in a calendar year.
Overall, the mean adherence increased from 47.9% in 2006-2007 to 62.3% in 2016-2017.
However, significant gaps persisted across race and ethnicity. Notably, adherence in the Hispanic population increased by nearly 22% between the study dates, compared to a 15.3% increase among White non-Hispanic children. However, Hispanic children still trailed White children overall in 2016-2017 (58% vs. 67.8%).
The smallest increase in adherence occurred among Black non-Hispanic children (5.6%) which further widened the gap between Black and White non-Hispanic children in 2016-2017 (52.5% vs. 67.8%).
Adherence rates increased similarly for children with public and private insurance (15.5% and 13.9%, respectively), but the adherence rates for uninsured children remained stable. Adherence in 2016-2017 for children with private, public, and no insurance were 66.3%, 58.7%, and 31.1%.
Also, despite overall increases in adherence across regions, a gap of more than 20% separated the region with the highest adherence (Northeast) from the lowest (West) in both the 2006-2007 and 2016-2017 periods (69.3% vs. 38.4%, and 79.3% vs. 55.2%, respectively).
The findings show an increase in well-child visits that spanned a time period of increased recommendations, economic changes, and the impact of the Affordable Care Act, but unaddressed disparities remain, the researchers noted.
Reducing disparities and improving adherence, “will require the combined efforts of researchers, policymakers, and clinicians to improve our understanding of adherence, to implement policies improving access to care, and to increase health care professional engagement with disadvantaged communities,” they concluded.
Overall increases are encouraging, but barriers need attention
“Demographic data are critical to determine which groups of children need the most support for recommended well child care,” Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. In the current study, “it was encouraging to see how either public or private insurance significantly increased the percentage of children receiving well child care,” she said.
The level of increased adherence to AAP-recommended guidelines for well-child visits was surprising, said Dr. Boulter. The overall increase is likely attributable in part to the increased coverage for well-child visits in the wake of the Affordable Care Act, as the study authors mention, she said.
“The gains experienced by Hispanic families were especially encouraging,” she added.
However, ongoing barriers to well-child care include “lack of adequate provider numbers and mix, transportation difficulties for patients, and lack of child care and time away from work for parents so they can complete the recommended well child visit schedule,” Dr. Boulter noted. “Provider schedules and locations of care should be improved so families would have easier access. Also, social media should have more positive well-child messages to counteract the negative messaging.”
More research is needed to examine the impact of COVID-19 on well-child visits, Dr. Boulter emphasized. “Most likely, the percentages in all groups will have changed since COVID-19 has impacted office practices,” she said. “Anxiety about COVID-19 transmissibility in the pediatric office decreased routine office visits, and skepticism about vaccines, including vaccine refusal, has significantly changed the percentage of children who have received the AAP recommended vaccines,” she explained. Ideally, the study authors will review the MEPS data again to examine changes since the COVID-19 pandemic began, she told this news organization.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM JAMA PEDIATRICS
Metformin fails as early COVID-19 treatment but shows potential
Neither metformin, ivermectin, or fluvoxamine had any impact on reducing disease severity, hospitalization, or death from COVID-19, according to results from more than 1,000 overweight or obese adult patients in the COVID-OUT randomized trial.
However, metformin showed some potential in a secondary analysis.
Early treatment to prevent severe disease remains a goal in managing the ongoing COVID-19 pandemic, and biophysical modeling suggested that metformin, ivermectin, and fluvoxamine may serve as antivirals to help reduce severe disease in COVID-19 patients, Carolyn T. Bramante, MD, of the University of Minnesota, Minneapolis, and colleagues wrote.
“We started enrolling patients at the end of December 2020,” Dr. Bramante said in an interview. “At that time, even though vaccine data were coming out, we thought it was important to test early outpatient treatment with widely available safe medications with no interactions, because the virus would evolve and vaccine availability may be limited.”
In a study published in the New England Journal of Medicine, the researchers used a two-by-three factorial design to test the ability of metformin, ivermectin, and fluvoxamine to prevent severe COVID-19 infection in nonhospitalized adults aged 30-85 years. A total of 1,431 patients at six U.S. sites were enrolled within 3 days of a confirmed infection and less than 7 days after the start of symptoms, then randomized to one of six groups: metformin plus fluvoxamine; metformin plus ivermectin; metformin plus placebo; placebo plus fluvoxamine; placebo plus ivermectin; and placebo plus placebo.
A total of 1,323 patients were included in the primary analysis. The median age of the patients was 46 years, 56% were female (of whom 6% were pregnant), and all individuals met criteria for overweight or obesity. About half (52%) of the patients had been vaccinated against COVID-19.
The primary endpoint was a composite of hypoxemia, ED visit, hospitalization, or death. The analyses were adjusted for COVID-19 vaccination and other trial medications. Overall, the adjusted odds ratios of any primary event, compared with placebo, was 0.84 for metformin (P = .19), 1.05 for ivermectin (P = .78), and 0.94 for fluvoxamine (P = .75).
The researchers also conducted a prespecified secondary analysis of components of the primary endpoint. In this analysis, the aORs for an ED visit, hospitalization, or death was 0.58 for metformin, 1.39 for ivermectin, and 1.17 for fluvoxamine. The aORs for hospitalization or death were 0.47, 0.73, and 1.11 for metformin, ivermectin, and fluvoxamine, respectively. No medication-related serious adverse events were reported with any of the drugs during the study period.
The possible benefit for prevention of severe COVID-19 with metformin was a prespecified secondary endpoint, and therefore not definitive until more research has been completed, the researchers said. Metformin has demonstrated anti-inflammatory actions in previous studies, and has shown protective effects against COVID-19 lung injury in animal studies.
Previous observational studies also have shown an association between metformin use and less severe COVID-19 in patients already taking metformin. “The proposed mechanisms of action against COVID-19 for metformin include anti-inflammatory and antiviral activity and the prevention of hyperglycemia during acute illness,” they added.
The study findings were limited by several factors including the population age range and focus on overweight and obese patients, which may limit generalizability, the researchers noted. Other limitations include the disproportionately small percentage of Black and Latino patients and the potential lack of accuracy in identifying hypoxemia via home oxygen monitors.
However, the results demonstrate that none of the three repurposed drugs – metformin, ivermectin, and fluvoxamine – prevented primary events or reduced symptom severity in COVID-19, compared with placebos, the researchers concluded.
“Metformin had several streams of evidence supporting its use: in vitro, in silico [computer modeled], observational, and in tissue. We were not surprised to see that it reduced emergency department visits, hospitalization, and death,” Dr. Bramante said in an interview.
The take-home message for clinicians is to continue to look to guideline committees for direction on COVID-19 treatments, but to continue to consider metformin along with other treatments, she said.
“All research should be replicated, whether the primary outcome is positive or negative,” Dr. Bramante emphasized. “In this case, when our positive outcome was negative and secondary outcome was positive, a confirmatory trial for metformin is particularly important.”
Ineffective drugs are inefficient use of resources
“The results of the COVID-OUT trial provide persuasive additional data that increase the confidence and degree of certainty that fluvoxamine and ivermectin are not effective in preventing progression to severe disease,” wrote Salim S. Abdool Karim, MB, and Nikita Devnarain, PhD, of the Centre for the AIDS Programme of Research in South Africa, Durban, in an accompanying editorial.
At the start of the study, in 2020, data on the use of the three drugs to prevent severe COVID-19 were “either unavailable or equivocal,” they said. Since then, accumulating data support the current study findings of the nonefficacy of ivermectin and fluvoxamine, and the World Health Organization has advised against their use for COVID-19, although the WHO has not provided guidance for the use of metformin.
The authors called on clinicians to stop using ivermectin and fluvoxamine to treat COVID-19 patients.
“With respect to clinical decisions about COVID-19 treatment, some drug choices, especially those that have negative [World Health Organization] recommendations, are clearly wrong,” they wrote. “In keeping with evidence-based medical practice, patients with COVID-19 must be treated with efficacious medications; they deserve nothing less.”
The study was supported by the Parsemus Foundation, Rainwater Charitable Foundation, Fast Grants, and UnitedHealth Group Foundation. The fluvoxamine placebo tablets were donated by Apotex Pharmaceuticals. The ivermectin placebo and active tablets were donated by Edenbridge Pharmaceuticals. Lead author Dr. Bramante was supported the National Center for Advancing Translational Sciences and the National Institute of Diabetes and Digestive and Kidney Diseases. The researchers had no financial conflicts to disclose. Dr. Abdool Karim serves as a member of the World Health Organization Science Council. Dr. Devnarain had no financial conflicts to disclose.
Neither metformin, ivermectin, or fluvoxamine had any impact on reducing disease severity, hospitalization, or death from COVID-19, according to results from more than 1,000 overweight or obese adult patients in the COVID-OUT randomized trial.
However, metformin showed some potential in a secondary analysis.
Early treatment to prevent severe disease remains a goal in managing the ongoing COVID-19 pandemic, and biophysical modeling suggested that metformin, ivermectin, and fluvoxamine may serve as antivirals to help reduce severe disease in COVID-19 patients, Carolyn T. Bramante, MD, of the University of Minnesota, Minneapolis, and colleagues wrote.
“We started enrolling patients at the end of December 2020,” Dr. Bramante said in an interview. “At that time, even though vaccine data were coming out, we thought it was important to test early outpatient treatment with widely available safe medications with no interactions, because the virus would evolve and vaccine availability may be limited.”
In a study published in the New England Journal of Medicine, the researchers used a two-by-three factorial design to test the ability of metformin, ivermectin, and fluvoxamine to prevent severe COVID-19 infection in nonhospitalized adults aged 30-85 years. A total of 1,431 patients at six U.S. sites were enrolled within 3 days of a confirmed infection and less than 7 days after the start of symptoms, then randomized to one of six groups: metformin plus fluvoxamine; metformin plus ivermectin; metformin plus placebo; placebo plus fluvoxamine; placebo plus ivermectin; and placebo plus placebo.
A total of 1,323 patients were included in the primary analysis. The median age of the patients was 46 years, 56% were female (of whom 6% were pregnant), and all individuals met criteria for overweight or obesity. About half (52%) of the patients had been vaccinated against COVID-19.
The primary endpoint was a composite of hypoxemia, ED visit, hospitalization, or death. The analyses were adjusted for COVID-19 vaccination and other trial medications. Overall, the adjusted odds ratios of any primary event, compared with placebo, was 0.84 for metformin (P = .19), 1.05 for ivermectin (P = .78), and 0.94 for fluvoxamine (P = .75).
The researchers also conducted a prespecified secondary analysis of components of the primary endpoint. In this analysis, the aORs for an ED visit, hospitalization, or death was 0.58 for metformin, 1.39 for ivermectin, and 1.17 for fluvoxamine. The aORs for hospitalization or death were 0.47, 0.73, and 1.11 for metformin, ivermectin, and fluvoxamine, respectively. No medication-related serious adverse events were reported with any of the drugs during the study period.
The possible benefit for prevention of severe COVID-19 with metformin was a prespecified secondary endpoint, and therefore not definitive until more research has been completed, the researchers said. Metformin has demonstrated anti-inflammatory actions in previous studies, and has shown protective effects against COVID-19 lung injury in animal studies.
Previous observational studies also have shown an association between metformin use and less severe COVID-19 in patients already taking metformin. “The proposed mechanisms of action against COVID-19 for metformin include anti-inflammatory and antiviral activity and the prevention of hyperglycemia during acute illness,” they added.
The study findings were limited by several factors including the population age range and focus on overweight and obese patients, which may limit generalizability, the researchers noted. Other limitations include the disproportionately small percentage of Black and Latino patients and the potential lack of accuracy in identifying hypoxemia via home oxygen monitors.
However, the results demonstrate that none of the three repurposed drugs – metformin, ivermectin, and fluvoxamine – prevented primary events or reduced symptom severity in COVID-19, compared with placebos, the researchers concluded.
“Metformin had several streams of evidence supporting its use: in vitro, in silico [computer modeled], observational, and in tissue. We were not surprised to see that it reduced emergency department visits, hospitalization, and death,” Dr. Bramante said in an interview.
The take-home message for clinicians is to continue to look to guideline committees for direction on COVID-19 treatments, but to continue to consider metformin along with other treatments, she said.
“All research should be replicated, whether the primary outcome is positive or negative,” Dr. Bramante emphasized. “In this case, when our positive outcome was negative and secondary outcome was positive, a confirmatory trial for metformin is particularly important.”
Ineffective drugs are inefficient use of resources
“The results of the COVID-OUT trial provide persuasive additional data that increase the confidence and degree of certainty that fluvoxamine and ivermectin are not effective in preventing progression to severe disease,” wrote Salim S. Abdool Karim, MB, and Nikita Devnarain, PhD, of the Centre for the AIDS Programme of Research in South Africa, Durban, in an accompanying editorial.
At the start of the study, in 2020, data on the use of the three drugs to prevent severe COVID-19 were “either unavailable or equivocal,” they said. Since then, accumulating data support the current study findings of the nonefficacy of ivermectin and fluvoxamine, and the World Health Organization has advised against their use for COVID-19, although the WHO has not provided guidance for the use of metformin.
The authors called on clinicians to stop using ivermectin and fluvoxamine to treat COVID-19 patients.
“With respect to clinical decisions about COVID-19 treatment, some drug choices, especially those that have negative [World Health Organization] recommendations, are clearly wrong,” they wrote. “In keeping with evidence-based medical practice, patients with COVID-19 must be treated with efficacious medications; they deserve nothing less.”
The study was supported by the Parsemus Foundation, Rainwater Charitable Foundation, Fast Grants, and UnitedHealth Group Foundation. The fluvoxamine placebo tablets were donated by Apotex Pharmaceuticals. The ivermectin placebo and active tablets were donated by Edenbridge Pharmaceuticals. Lead author Dr. Bramante was supported the National Center for Advancing Translational Sciences and the National Institute of Diabetes and Digestive and Kidney Diseases. The researchers had no financial conflicts to disclose. Dr. Abdool Karim serves as a member of the World Health Organization Science Council. Dr. Devnarain had no financial conflicts to disclose.
Neither metformin, ivermectin, or fluvoxamine had any impact on reducing disease severity, hospitalization, or death from COVID-19, according to results from more than 1,000 overweight or obese adult patients in the COVID-OUT randomized trial.
However, metformin showed some potential in a secondary analysis.
Early treatment to prevent severe disease remains a goal in managing the ongoing COVID-19 pandemic, and biophysical modeling suggested that metformin, ivermectin, and fluvoxamine may serve as antivirals to help reduce severe disease in COVID-19 patients, Carolyn T. Bramante, MD, of the University of Minnesota, Minneapolis, and colleagues wrote.
“We started enrolling patients at the end of December 2020,” Dr. Bramante said in an interview. “At that time, even though vaccine data were coming out, we thought it was important to test early outpatient treatment with widely available safe medications with no interactions, because the virus would evolve and vaccine availability may be limited.”
In a study published in the New England Journal of Medicine, the researchers used a two-by-three factorial design to test the ability of metformin, ivermectin, and fluvoxamine to prevent severe COVID-19 infection in nonhospitalized adults aged 30-85 years. A total of 1,431 patients at six U.S. sites were enrolled within 3 days of a confirmed infection and less than 7 days after the start of symptoms, then randomized to one of six groups: metformin plus fluvoxamine; metformin plus ivermectin; metformin plus placebo; placebo plus fluvoxamine; placebo plus ivermectin; and placebo plus placebo.
A total of 1,323 patients were included in the primary analysis. The median age of the patients was 46 years, 56% were female (of whom 6% were pregnant), and all individuals met criteria for overweight or obesity. About half (52%) of the patients had been vaccinated against COVID-19.
The primary endpoint was a composite of hypoxemia, ED visit, hospitalization, or death. The analyses were adjusted for COVID-19 vaccination and other trial medications. Overall, the adjusted odds ratios of any primary event, compared with placebo, was 0.84 for metformin (P = .19), 1.05 for ivermectin (P = .78), and 0.94 for fluvoxamine (P = .75).
The researchers also conducted a prespecified secondary analysis of components of the primary endpoint. In this analysis, the aORs for an ED visit, hospitalization, or death was 0.58 for metformin, 1.39 for ivermectin, and 1.17 for fluvoxamine. The aORs for hospitalization or death were 0.47, 0.73, and 1.11 for metformin, ivermectin, and fluvoxamine, respectively. No medication-related serious adverse events were reported with any of the drugs during the study period.
The possible benefit for prevention of severe COVID-19 with metformin was a prespecified secondary endpoint, and therefore not definitive until more research has been completed, the researchers said. Metformin has demonstrated anti-inflammatory actions in previous studies, and has shown protective effects against COVID-19 lung injury in animal studies.
Previous observational studies also have shown an association between metformin use and less severe COVID-19 in patients already taking metformin. “The proposed mechanisms of action against COVID-19 for metformin include anti-inflammatory and antiviral activity and the prevention of hyperglycemia during acute illness,” they added.
The study findings were limited by several factors including the population age range and focus on overweight and obese patients, which may limit generalizability, the researchers noted. Other limitations include the disproportionately small percentage of Black and Latino patients and the potential lack of accuracy in identifying hypoxemia via home oxygen monitors.
However, the results demonstrate that none of the three repurposed drugs – metformin, ivermectin, and fluvoxamine – prevented primary events or reduced symptom severity in COVID-19, compared with placebos, the researchers concluded.
“Metformin had several streams of evidence supporting its use: in vitro, in silico [computer modeled], observational, and in tissue. We were not surprised to see that it reduced emergency department visits, hospitalization, and death,” Dr. Bramante said in an interview.
The take-home message for clinicians is to continue to look to guideline committees for direction on COVID-19 treatments, but to continue to consider metformin along with other treatments, she said.
“All research should be replicated, whether the primary outcome is positive or negative,” Dr. Bramante emphasized. “In this case, when our positive outcome was negative and secondary outcome was positive, a confirmatory trial for metformin is particularly important.”
Ineffective drugs are inefficient use of resources
“The results of the COVID-OUT trial provide persuasive additional data that increase the confidence and degree of certainty that fluvoxamine and ivermectin are not effective in preventing progression to severe disease,” wrote Salim S. Abdool Karim, MB, and Nikita Devnarain, PhD, of the Centre for the AIDS Programme of Research in South Africa, Durban, in an accompanying editorial.
At the start of the study, in 2020, data on the use of the three drugs to prevent severe COVID-19 were “either unavailable or equivocal,” they said. Since then, accumulating data support the current study findings of the nonefficacy of ivermectin and fluvoxamine, and the World Health Organization has advised against their use for COVID-19, although the WHO has not provided guidance for the use of metformin.
The authors called on clinicians to stop using ivermectin and fluvoxamine to treat COVID-19 patients.
“With respect to clinical decisions about COVID-19 treatment, some drug choices, especially those that have negative [World Health Organization] recommendations, are clearly wrong,” they wrote. “In keeping with evidence-based medical practice, patients with COVID-19 must be treated with efficacious medications; they deserve nothing less.”
The study was supported by the Parsemus Foundation, Rainwater Charitable Foundation, Fast Grants, and UnitedHealth Group Foundation. The fluvoxamine placebo tablets were donated by Apotex Pharmaceuticals. The ivermectin placebo and active tablets were donated by Edenbridge Pharmaceuticals. Lead author Dr. Bramante was supported the National Center for Advancing Translational Sciences and the National Institute of Diabetes and Digestive and Kidney Diseases. The researchers had no financial conflicts to disclose. Dr. Abdool Karim serves as a member of the World Health Organization Science Council. Dr. Devnarain had no financial conflicts to disclose.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
One hour of walking per week may boost longevity for octogenarians
Adults aged 85 years and older who logged an hour or more of walking each week had a 40% reduced risk of all-cause mortality compared with less active peers, according to data from more than 7,000 individuals.
“Aging is accompanied by reduced physical activity and increased sedentary behavior, and reduced physical activity is associated with decreased life expectancy,” Moo-Nyun Jin, MD, of Inje University Sanggye Paik Hospital, Seoul, South Korea, said in an interview.
Reduced physical activity was especially likely in the elderly during the COVID-19 pandemic, he added.
“Promoting walking may be a simple way to help older adults avoid inactivity and encourage an active lifestyle for all-cause and cardiovascular mortality risk reduction,” Dr. Jin said.
Although walking is generally an easy form of exercise for the older adult population, the specific benefit of walking on reducing mortality has not been well studied, according to Dr. Jin and colleagues.
For adults of any age, current guidelines recommend at least 150 minutes per week of moderate activity or 75 minutes per week of vigorous activity, but the amount of physical activity tends to decline with age, and activity recommendations are more difficult to meet, the authors wrote in a press release accompanying their study.
In the study, to be presented at the European Society of Cardiology Congress on Aug. 28 (Abstract 85643), the researchers reviewed data from 7,047 adults aged 85 years and older who participated in the Korean National Health Screening Program. The average age of the study population was 87 years, and 68% were women. Participants completed questionnaires about the amount of time spent in leisure time activities each week, including walking at a slow pace, moderate activity (such as cycling or brisk walking), and vigorous activity (such as running).
Those who walked at a slow pace for at least 1 hour per week had a 40% reduced risk of all-cause mortality and a 39% reduced risk of cardiovascular mortality, compared with inactive participants.
The proportions of participants who reported walking, moderate activity, and vigorous intensity physical activity were 42.5%, 14.7%, and 11.0%, respectively. Roughly one-third (33%) of those who reported slow walking each week also reported moderate or vigorous physical activity.
However, walking for 1 hour per week significantly reduced the risk for all-cause mortality and cardiovascular mortality among individuals who reported walking only, without other moderate or vigorous physical activity (hazard ratio, 0.50 and 0.46, respectively).
“Walking was linked with a lower likelihood of dying in older adults, regardless of whether or not they did any moderate to vigorous intensity physical activity,” Dr. Jin told this news organization. “Our study indicates that walking even just 1 hour every week is advantageous to those aged 85 years and older compared to being inactive.”
The hour of walking need not be in long bouts, 10 minutes each day will do, Dr. Jin added.
The participants were divided into five groups based on reported amount of weekly walking. More than half (57.5%) reported no slow walking, 8.5% walked less than 1 hour per week, 12.0% walked 1-2 hours, 8.7% walked 2-3 hours, and 13.3% walked more than 3 hours.
Although the study was limited by the reliance on self-reports, the results were strengthened by the large sample size and support the value of easy walking for adults aged 85 years and older compared to being inactive.
“Walking may present an opportunity for promoting physical activity among the elderly population, offering a simple way to avoid inactivity and increase physical activity,” said Dr. Jin. However, more research is needed to evaluate the association between mortality and walking by objective measurement of walking levels, using a device such as a smart watch, he noted.
Results are preliminary
“This is an observational study, not an experiment, so it means causality cannot be presumed,” said Maria Fiatarone Singh, MD, a geriatrician with a focus on exercise physiology at the University of Sydney, in an interview. “In other words, it is possible that diseases resulting in mortality prevented people from walking rather than the other way around,” she noted. The only published experimental study on exercise and mortality in older adults was conducted by Dr. Fiatarone Singh and colleagues in Norway. In that study, published in the British Medical Journal in 2020, high-intensity training programs were associated with reduced all-cause mortality compared with inactive controls and individuals who engaged in moderate intensity exercise.
The current study “would have needed to control for many factors related to mortality, such as cardiovascular disease, hypertension, diabetes, malnutrition, and dementia to see what residual benefit might be related to walking,” Dr. Fiatarone Singh said.
“Although walking seems easy and safe, in fact people who are frail, sarcopenic, osteoporotic, or have fallen are recommended to do resistance and balance training rather than walking, and add walking later when they are able to do it safely,” she emphasized.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Fiatarone Singh had no financial conflicts to disclose.
Adults aged 85 years and older who logged an hour or more of walking each week had a 40% reduced risk of all-cause mortality compared with less active peers, according to data from more than 7,000 individuals.
“Aging is accompanied by reduced physical activity and increased sedentary behavior, and reduced physical activity is associated with decreased life expectancy,” Moo-Nyun Jin, MD, of Inje University Sanggye Paik Hospital, Seoul, South Korea, said in an interview.
Reduced physical activity was especially likely in the elderly during the COVID-19 pandemic, he added.
“Promoting walking may be a simple way to help older adults avoid inactivity and encourage an active lifestyle for all-cause and cardiovascular mortality risk reduction,” Dr. Jin said.
Although walking is generally an easy form of exercise for the older adult population, the specific benefit of walking on reducing mortality has not been well studied, according to Dr. Jin and colleagues.
For adults of any age, current guidelines recommend at least 150 minutes per week of moderate activity or 75 minutes per week of vigorous activity, but the amount of physical activity tends to decline with age, and activity recommendations are more difficult to meet, the authors wrote in a press release accompanying their study.
In the study, to be presented at the European Society of Cardiology Congress on Aug. 28 (Abstract 85643), the researchers reviewed data from 7,047 adults aged 85 years and older who participated in the Korean National Health Screening Program. The average age of the study population was 87 years, and 68% were women. Participants completed questionnaires about the amount of time spent in leisure time activities each week, including walking at a slow pace, moderate activity (such as cycling or brisk walking), and vigorous activity (such as running).
Those who walked at a slow pace for at least 1 hour per week had a 40% reduced risk of all-cause mortality and a 39% reduced risk of cardiovascular mortality, compared with inactive participants.
The proportions of participants who reported walking, moderate activity, and vigorous intensity physical activity were 42.5%, 14.7%, and 11.0%, respectively. Roughly one-third (33%) of those who reported slow walking each week also reported moderate or vigorous physical activity.
However, walking for 1 hour per week significantly reduced the risk for all-cause mortality and cardiovascular mortality among individuals who reported walking only, without other moderate or vigorous physical activity (hazard ratio, 0.50 and 0.46, respectively).
“Walking was linked with a lower likelihood of dying in older adults, regardless of whether or not they did any moderate to vigorous intensity physical activity,” Dr. Jin told this news organization. “Our study indicates that walking even just 1 hour every week is advantageous to those aged 85 years and older compared to being inactive.”
The hour of walking need not be in long bouts, 10 minutes each day will do, Dr. Jin added.
The participants were divided into five groups based on reported amount of weekly walking. More than half (57.5%) reported no slow walking, 8.5% walked less than 1 hour per week, 12.0% walked 1-2 hours, 8.7% walked 2-3 hours, and 13.3% walked more than 3 hours.
Although the study was limited by the reliance on self-reports, the results were strengthened by the large sample size and support the value of easy walking for adults aged 85 years and older compared to being inactive.
“Walking may present an opportunity for promoting physical activity among the elderly population, offering a simple way to avoid inactivity and increase physical activity,” said Dr. Jin. However, more research is needed to evaluate the association between mortality and walking by objective measurement of walking levels, using a device such as a smart watch, he noted.
Results are preliminary
“This is an observational study, not an experiment, so it means causality cannot be presumed,” said Maria Fiatarone Singh, MD, a geriatrician with a focus on exercise physiology at the University of Sydney, in an interview. “In other words, it is possible that diseases resulting in mortality prevented people from walking rather than the other way around,” she noted. The only published experimental study on exercise and mortality in older adults was conducted by Dr. Fiatarone Singh and colleagues in Norway. In that study, published in the British Medical Journal in 2020, high-intensity training programs were associated with reduced all-cause mortality compared with inactive controls and individuals who engaged in moderate intensity exercise.
The current study “would have needed to control for many factors related to mortality, such as cardiovascular disease, hypertension, diabetes, malnutrition, and dementia to see what residual benefit might be related to walking,” Dr. Fiatarone Singh said.
“Although walking seems easy and safe, in fact people who are frail, sarcopenic, osteoporotic, or have fallen are recommended to do resistance and balance training rather than walking, and add walking later when they are able to do it safely,” she emphasized.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Fiatarone Singh had no financial conflicts to disclose.
Adults aged 85 years and older who logged an hour or more of walking each week had a 40% reduced risk of all-cause mortality compared with less active peers, according to data from more than 7,000 individuals.
“Aging is accompanied by reduced physical activity and increased sedentary behavior, and reduced physical activity is associated with decreased life expectancy,” Moo-Nyun Jin, MD, of Inje University Sanggye Paik Hospital, Seoul, South Korea, said in an interview.
Reduced physical activity was especially likely in the elderly during the COVID-19 pandemic, he added.
“Promoting walking may be a simple way to help older adults avoid inactivity and encourage an active lifestyle for all-cause and cardiovascular mortality risk reduction,” Dr. Jin said.
Although walking is generally an easy form of exercise for the older adult population, the specific benefit of walking on reducing mortality has not been well studied, according to Dr. Jin and colleagues.
For adults of any age, current guidelines recommend at least 150 minutes per week of moderate activity or 75 minutes per week of vigorous activity, but the amount of physical activity tends to decline with age, and activity recommendations are more difficult to meet, the authors wrote in a press release accompanying their study.
In the study, to be presented at the European Society of Cardiology Congress on Aug. 28 (Abstract 85643), the researchers reviewed data from 7,047 adults aged 85 years and older who participated in the Korean National Health Screening Program. The average age of the study population was 87 years, and 68% were women. Participants completed questionnaires about the amount of time spent in leisure time activities each week, including walking at a slow pace, moderate activity (such as cycling or brisk walking), and vigorous activity (such as running).
Those who walked at a slow pace for at least 1 hour per week had a 40% reduced risk of all-cause mortality and a 39% reduced risk of cardiovascular mortality, compared with inactive participants.
The proportions of participants who reported walking, moderate activity, and vigorous intensity physical activity were 42.5%, 14.7%, and 11.0%, respectively. Roughly one-third (33%) of those who reported slow walking each week also reported moderate or vigorous physical activity.
However, walking for 1 hour per week significantly reduced the risk for all-cause mortality and cardiovascular mortality among individuals who reported walking only, without other moderate or vigorous physical activity (hazard ratio, 0.50 and 0.46, respectively).
“Walking was linked with a lower likelihood of dying in older adults, regardless of whether or not they did any moderate to vigorous intensity physical activity,” Dr. Jin told this news organization. “Our study indicates that walking even just 1 hour every week is advantageous to those aged 85 years and older compared to being inactive.”
The hour of walking need not be in long bouts, 10 minutes each day will do, Dr. Jin added.
The participants were divided into five groups based on reported amount of weekly walking. More than half (57.5%) reported no slow walking, 8.5% walked less than 1 hour per week, 12.0% walked 1-2 hours, 8.7% walked 2-3 hours, and 13.3% walked more than 3 hours.
Although the study was limited by the reliance on self-reports, the results were strengthened by the large sample size and support the value of easy walking for adults aged 85 years and older compared to being inactive.
“Walking may present an opportunity for promoting physical activity among the elderly population, offering a simple way to avoid inactivity and increase physical activity,” said Dr. Jin. However, more research is needed to evaluate the association between mortality and walking by objective measurement of walking levels, using a device such as a smart watch, he noted.
Results are preliminary
“This is an observational study, not an experiment, so it means causality cannot be presumed,” said Maria Fiatarone Singh, MD, a geriatrician with a focus on exercise physiology at the University of Sydney, in an interview. “In other words, it is possible that diseases resulting in mortality prevented people from walking rather than the other way around,” she noted. The only published experimental study on exercise and mortality in older adults was conducted by Dr. Fiatarone Singh and colleagues in Norway. In that study, published in the British Medical Journal in 2020, high-intensity training programs were associated with reduced all-cause mortality compared with inactive controls and individuals who engaged in moderate intensity exercise.
The current study “would have needed to control for many factors related to mortality, such as cardiovascular disease, hypertension, diabetes, malnutrition, and dementia to see what residual benefit might be related to walking,” Dr. Fiatarone Singh said.
“Although walking seems easy and safe, in fact people who are frail, sarcopenic, osteoporotic, or have fallen are recommended to do resistance and balance training rather than walking, and add walking later when they are able to do it safely,” she emphasized.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Fiatarone Singh had no financial conflicts to disclose.
FROM ESC CONGRESS 2022
Screen COPD patients for peripheral neuropathy
Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.
of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.
PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.
“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.
In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.
Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.
“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.
Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).
Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.
Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.
“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.
The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.
The study received no outside funding. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.
of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.
PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.
“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.
In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.
Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.
“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.
Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).
Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.
Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.
“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.
The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.
The study received no outside funding. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.
of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.
PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.
“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.
In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.
Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.
“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.
Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).
Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.
Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.
“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.
The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.
The study received no outside funding. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Brief Psychiatric Rating Scale succeeds as transdiagnostic measure
“Current DSM and ICD diagnoses do not depict psychopathology accurately, therefore their validity in research and utility in clinical practice is questioned,” wrote Andreas B. Hofmann, PhD, of the University of Zürich and colleagues.
The BPRS was developed to assess changes in psychopathology across a range of severe psychiatric disorders, but its potential to assess symptoms in nonpsychotic disorders has not been explored, the researchers said.
In a study published in Psychiatry Research, the investigators analyzed data from 600 adult psychiatric inpatients divided equally into six diagnostic categories: alcohol use disorder, major depressive disorder, anxiety disorders, bipolar disorder, schizophrenia, and personality disorders. The mean age of the patients was 41.5 years and 45.5% were women. The demographic characteristics were similar across most groups, although patients with a personality disorder were significantly more likely than other patients to be younger and female.
Patients were assessed using the BPRS based on their main diagnosis. The mini-ICF-APP, another validated measure for assessing psychiatric disorders, served as a comparator, and both were compared to the Clinical Global Impression Scale (CGI).
Overall, the BPRS and mini-ICF-APP showed moderate correlation and good agreement, the researchers said. The Pearson correlation coefficient for the BPRS and mini-ICF-APP scales was 0.53 and the concordance correlation coefficient was 0.52. The mean sum scores for the BPRS, the mini-ICF-APP, and the CGI were 45.4 (standard deviation, 14.4), 19.93 (SD, 8.21), and 5.55 (SD, 0.84), respectively, which indicated “markedly ill” to “severely ill” patients, the researchers said.
The researchers were able to detect three clusters of symptoms corresponding to externalizing, internalizing, and thought disturbance domains using the BPRS, and four clusters using the mini-ICF-APP.
The symptoms using BPRS and the functionality domains using the mini-ICF-APP “showed a close interplay,” the researchers noted.
“The symptoms and functional domains we found to be central within the network structure are among the first targets of any psychiatric or psychotherapeutic intervention, namely the building of a common language and understanding as well as the establishment of confidence in relationships and a trustworthy therapeutic alliance,” they wrote in their discussion.
The study findings were limited by several factors including the collection of data from routine practice rather than clinical trials, the focus on only the main diagnosis without comorbidities, and the inclusion only of patients requiring hospitalization, the researchers noted.
However, the results were strengthened by the large sample size, and demonstrate the validity of the BPRS as a measurement tool across a range of psychiatric diagnoses, they said.
“Since the BPRS is a widely known and readily available psychometric scale, our results support its use as a transdiagnostic measurement instrument of psychopathology,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
“Current DSM and ICD diagnoses do not depict psychopathology accurately, therefore their validity in research and utility in clinical practice is questioned,” wrote Andreas B. Hofmann, PhD, of the University of Zürich and colleagues.
The BPRS was developed to assess changes in psychopathology across a range of severe psychiatric disorders, but its potential to assess symptoms in nonpsychotic disorders has not been explored, the researchers said.
In a study published in Psychiatry Research, the investigators analyzed data from 600 adult psychiatric inpatients divided equally into six diagnostic categories: alcohol use disorder, major depressive disorder, anxiety disorders, bipolar disorder, schizophrenia, and personality disorders. The mean age of the patients was 41.5 years and 45.5% were women. The demographic characteristics were similar across most groups, although patients with a personality disorder were significantly more likely than other patients to be younger and female.
Patients were assessed using the BPRS based on their main diagnosis. The mini-ICF-APP, another validated measure for assessing psychiatric disorders, served as a comparator, and both were compared to the Clinical Global Impression Scale (CGI).
Overall, the BPRS and mini-ICF-APP showed moderate correlation and good agreement, the researchers said. The Pearson correlation coefficient for the BPRS and mini-ICF-APP scales was 0.53 and the concordance correlation coefficient was 0.52. The mean sum scores for the BPRS, the mini-ICF-APP, and the CGI were 45.4 (standard deviation, 14.4), 19.93 (SD, 8.21), and 5.55 (SD, 0.84), respectively, which indicated “markedly ill” to “severely ill” patients, the researchers said.
The researchers were able to detect three clusters of symptoms corresponding to externalizing, internalizing, and thought disturbance domains using the BPRS, and four clusters using the mini-ICF-APP.
The symptoms using BPRS and the functionality domains using the mini-ICF-APP “showed a close interplay,” the researchers noted.
“The symptoms and functional domains we found to be central within the network structure are among the first targets of any psychiatric or psychotherapeutic intervention, namely the building of a common language and understanding as well as the establishment of confidence in relationships and a trustworthy therapeutic alliance,” they wrote in their discussion.
The study findings were limited by several factors including the collection of data from routine practice rather than clinical trials, the focus on only the main diagnosis without comorbidities, and the inclusion only of patients requiring hospitalization, the researchers noted.
However, the results were strengthened by the large sample size, and demonstrate the validity of the BPRS as a measurement tool across a range of psychiatric diagnoses, they said.
“Since the BPRS is a widely known and readily available psychometric scale, our results support its use as a transdiagnostic measurement instrument of psychopathology,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
“Current DSM and ICD diagnoses do not depict psychopathology accurately, therefore their validity in research and utility in clinical practice is questioned,” wrote Andreas B. Hofmann, PhD, of the University of Zürich and colleagues.
The BPRS was developed to assess changes in psychopathology across a range of severe psychiatric disorders, but its potential to assess symptoms in nonpsychotic disorders has not been explored, the researchers said.
In a study published in Psychiatry Research, the investigators analyzed data from 600 adult psychiatric inpatients divided equally into six diagnostic categories: alcohol use disorder, major depressive disorder, anxiety disorders, bipolar disorder, schizophrenia, and personality disorders. The mean age of the patients was 41.5 years and 45.5% were women. The demographic characteristics were similar across most groups, although patients with a personality disorder were significantly more likely than other patients to be younger and female.
Patients were assessed using the BPRS based on their main diagnosis. The mini-ICF-APP, another validated measure for assessing psychiatric disorders, served as a comparator, and both were compared to the Clinical Global Impression Scale (CGI).
Overall, the BPRS and mini-ICF-APP showed moderate correlation and good agreement, the researchers said. The Pearson correlation coefficient for the BPRS and mini-ICF-APP scales was 0.53 and the concordance correlation coefficient was 0.52. The mean sum scores for the BPRS, the mini-ICF-APP, and the CGI were 45.4 (standard deviation, 14.4), 19.93 (SD, 8.21), and 5.55 (SD, 0.84), respectively, which indicated “markedly ill” to “severely ill” patients, the researchers said.
The researchers were able to detect three clusters of symptoms corresponding to externalizing, internalizing, and thought disturbance domains using the BPRS, and four clusters using the mini-ICF-APP.
The symptoms using BPRS and the functionality domains using the mini-ICF-APP “showed a close interplay,” the researchers noted.
“The symptoms and functional domains we found to be central within the network structure are among the first targets of any psychiatric or psychotherapeutic intervention, namely the building of a common language and understanding as well as the establishment of confidence in relationships and a trustworthy therapeutic alliance,” they wrote in their discussion.
The study findings were limited by several factors including the collection of data from routine practice rather than clinical trials, the focus on only the main diagnosis without comorbidities, and the inclusion only of patients requiring hospitalization, the researchers noted.
However, the results were strengthened by the large sample size, and demonstrate the validity of the BPRS as a measurement tool across a range of psychiatric diagnoses, they said.
“Since the BPRS is a widely known and readily available psychometric scale, our results support its use as a transdiagnostic measurement instrument of psychopathology,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM PSYCHIATRY RESEARCH