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VTE prophylaxis overused in low-risk hospitalized patients
A majority of hospitalized patients at low risk for venous thromboembolism were unnecessarily treated with medication, based on data from more than 400 individuals.
Prevention of venous thromboembolism (VTE) is important, and current guidelines from the American College of Chest Physicians suggest that patients with high or moderate risk for VTE be treated with mechanical prophylaxis, and that pharmacological prophylaxis is not recommended for patients at high risk for bleeding, said Hui Chong Lau, MD, in a presentation at the annual meeting of the American College of Chest Physicians (CHEST).
However, the nature of VTE prophylaxis using a risk assessment score has not been explored, said Dr. Lau, a third-year resident in internal medicine at Crozer-Chester Medical Center, Upland, Penn.
Low-molecular-weight heparin (LWMH) and intermittent pneumatic compression are often used to reduce VTE risk during hospitalization, but for patients with low VTE risk, prophylaxis is not necessarily recommended, he said. In fact, overuse of chemical prophylaxis in low-risk patients can increase bleeding risk and contribute to patient discomfort in the form of additional needle sticks while hospitalized, Dr. Lau said in the presentation.
“We wanted to see how well physicians in the hospital used a risk assessment model to stratify patients,” and how well the patients were assigned to the correct prophylaxis, he explained.
Dr. Lau and colleagues reviewed data from 469 adult patients hospitalized at a single medical center who were hospitalized between January 2021 and June 2021. The researchers retrospectively performed risk assessment using the Padua prediction score. A score of less than 4 was considered low risk for VTE, and a score of 4 or higher was considered high risk.
In the study population, 180 patients were identified as low risk and 289 were considered high risk.
Based on the Padua score, 95% of the patients at high risk were on the correct prophylaxis, Dr. Lau said.
A total of 193 high-risk patients were on heparin. However, many of these patients had good kidney function, and could have been treated with enoxaparin instead; “this would have spared them two needle sticks per day,” Dr. Lau noted.
Of the 180 low-risk patients, 168 (93.3%) were on chemical prophylaxis, and should have been on mechanical prophylaxis, he said. Only 10 patients (5%) who were considered low risk were placed on mechanical prophylaxis.
Overall, 3.6% of all patients who received chemical VTE prophylaxis developed bleeding.
The results were limited by the retrospective design and use of data from a single center. However, the findings emphasize the need for better attention to VTE risk when considering prophylaxis, said Dr. Lau. “We have to have risk assessment every day,” during a hospital stay, and adjust treatment accordingly, he said.
he concluded.
Additional research is needed to better understand the potential consequences of overusing chemical VTE, including not only bleeding risk, but also financial costs and patient discomfort, he said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
A majority of hospitalized patients at low risk for venous thromboembolism were unnecessarily treated with medication, based on data from more than 400 individuals.
Prevention of venous thromboembolism (VTE) is important, and current guidelines from the American College of Chest Physicians suggest that patients with high or moderate risk for VTE be treated with mechanical prophylaxis, and that pharmacological prophylaxis is not recommended for patients at high risk for bleeding, said Hui Chong Lau, MD, in a presentation at the annual meeting of the American College of Chest Physicians (CHEST).
However, the nature of VTE prophylaxis using a risk assessment score has not been explored, said Dr. Lau, a third-year resident in internal medicine at Crozer-Chester Medical Center, Upland, Penn.
Low-molecular-weight heparin (LWMH) and intermittent pneumatic compression are often used to reduce VTE risk during hospitalization, but for patients with low VTE risk, prophylaxis is not necessarily recommended, he said. In fact, overuse of chemical prophylaxis in low-risk patients can increase bleeding risk and contribute to patient discomfort in the form of additional needle sticks while hospitalized, Dr. Lau said in the presentation.
“We wanted to see how well physicians in the hospital used a risk assessment model to stratify patients,” and how well the patients were assigned to the correct prophylaxis, he explained.
Dr. Lau and colleagues reviewed data from 469 adult patients hospitalized at a single medical center who were hospitalized between January 2021 and June 2021. The researchers retrospectively performed risk assessment using the Padua prediction score. A score of less than 4 was considered low risk for VTE, and a score of 4 or higher was considered high risk.
In the study population, 180 patients were identified as low risk and 289 were considered high risk.
Based on the Padua score, 95% of the patients at high risk were on the correct prophylaxis, Dr. Lau said.
A total of 193 high-risk patients were on heparin. However, many of these patients had good kidney function, and could have been treated with enoxaparin instead; “this would have spared them two needle sticks per day,” Dr. Lau noted.
Of the 180 low-risk patients, 168 (93.3%) were on chemical prophylaxis, and should have been on mechanical prophylaxis, he said. Only 10 patients (5%) who were considered low risk were placed on mechanical prophylaxis.
Overall, 3.6% of all patients who received chemical VTE prophylaxis developed bleeding.
The results were limited by the retrospective design and use of data from a single center. However, the findings emphasize the need for better attention to VTE risk when considering prophylaxis, said Dr. Lau. “We have to have risk assessment every day,” during a hospital stay, and adjust treatment accordingly, he said.
he concluded.
Additional research is needed to better understand the potential consequences of overusing chemical VTE, including not only bleeding risk, but also financial costs and patient discomfort, he said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
A majority of hospitalized patients at low risk for venous thromboembolism were unnecessarily treated with medication, based on data from more than 400 individuals.
Prevention of venous thromboembolism (VTE) is important, and current guidelines from the American College of Chest Physicians suggest that patients with high or moderate risk for VTE be treated with mechanical prophylaxis, and that pharmacological prophylaxis is not recommended for patients at high risk for bleeding, said Hui Chong Lau, MD, in a presentation at the annual meeting of the American College of Chest Physicians (CHEST).
However, the nature of VTE prophylaxis using a risk assessment score has not been explored, said Dr. Lau, a third-year resident in internal medicine at Crozer-Chester Medical Center, Upland, Penn.
Low-molecular-weight heparin (LWMH) and intermittent pneumatic compression are often used to reduce VTE risk during hospitalization, but for patients with low VTE risk, prophylaxis is not necessarily recommended, he said. In fact, overuse of chemical prophylaxis in low-risk patients can increase bleeding risk and contribute to patient discomfort in the form of additional needle sticks while hospitalized, Dr. Lau said in the presentation.
“We wanted to see how well physicians in the hospital used a risk assessment model to stratify patients,” and how well the patients were assigned to the correct prophylaxis, he explained.
Dr. Lau and colleagues reviewed data from 469 adult patients hospitalized at a single medical center who were hospitalized between January 2021 and June 2021. The researchers retrospectively performed risk assessment using the Padua prediction score. A score of less than 4 was considered low risk for VTE, and a score of 4 or higher was considered high risk.
In the study population, 180 patients were identified as low risk and 289 were considered high risk.
Based on the Padua score, 95% of the patients at high risk were on the correct prophylaxis, Dr. Lau said.
A total of 193 high-risk patients were on heparin. However, many of these patients had good kidney function, and could have been treated with enoxaparin instead; “this would have spared them two needle sticks per day,” Dr. Lau noted.
Of the 180 low-risk patients, 168 (93.3%) were on chemical prophylaxis, and should have been on mechanical prophylaxis, he said. Only 10 patients (5%) who were considered low risk were placed on mechanical prophylaxis.
Overall, 3.6% of all patients who received chemical VTE prophylaxis developed bleeding.
The results were limited by the retrospective design and use of data from a single center. However, the findings emphasize the need for better attention to VTE risk when considering prophylaxis, said Dr. Lau. “We have to have risk assessment every day,” during a hospital stay, and adjust treatment accordingly, he said.
he concluded.
Additional research is needed to better understand the potential consequences of overusing chemical VTE, including not only bleeding risk, but also financial costs and patient discomfort, he said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM CHEST 2022
Hospitalizations for VAP rose prior to pandemic
Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.
VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.
To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.
Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.
The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.
A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.
The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.
The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.
The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.
The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.
The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.
The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.
VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.
To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.
Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.
The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.
A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.
The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.
The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.
The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.
The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.
The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.
The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.
VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.
To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.
Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.
The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.
A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.
The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.
The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.
The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.
The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.
The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.
The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM CHEST 2022
Teens with diagnosed and undiagnosed ADHD report similar quality of life
The results align with findings from other studies suggesting lower quality of life (QOL) in teens with ADHD, but the current study is the first known to focus on the association between ADHD diagnosis itself vs. ADHD symptoms, and QOL, the researchers wrote. The findings show that at least some of the reduced QOL is associated with the diagnosis itself, they explained.
The researchers directly compared 393 teens with a childhood ADHD diagnosis to 393 matched teens with no ADHD diagnosis but who had hyperactive/inattentive behaviors.
The researchers reviewed self-reports from individuals who were enrolled in a population-based prospective study in Australia. The primary outcome was quality of life at age 14-15, which was measured with Child Health Utility 9D (CHU9D), a validated quality of life measure.
Study results
Overall, teens with and without an ADHD diagnosis reported similar levels of overall quality of life; the mean difference in the primary outcome CHU9D score was –0.03 (P = .10). Teens with and without an ADHD diagnosis also showed similar scores on measures of general health, happiness, and peer trust, the researchers noted.
The researchers also reviewed eight other prespecified, self-reported measures: academic self-concept, global health, negative social behaviors, overall happiness, peer trust, psychological sense of school membership, self-efficacy, and self-harm.
Teens diagnosed with ADHD in childhood were more than twice as likely to report self-harm (odds ratio 2.53, P less than .001) and displayed significantly more negative social behaviors (mean difference 1.56, P = .002), compared with teens without an ADHD diagnosis.
Teens diagnosed with ADHD in childhood also scored significantly worse on measures of sense of school membership (mean difference −2.58, P less than .001), academic self-concept (mean difference, −0.14; P = .02), and self-efficacy (mean difference −0.20; P = .007), compared to teens without an ADHD diagnosis.
The average age at ADHD diagnosis was 10 years, and 72% of the ADHD-diagnosed group were boys. No significant differences were noted for levels of hyperactive/inattentive behaviors and between girls and boys, but girls overall and children with the highest levels of hyperactive and inattentive behaviors reported generally worse outcomes, regardless of ADHD diagnosis, the researchers noted.
Don’t rush to diagnosis
Although rates of ADHD diagnosis in children continue to rise, the prevalence of hyperactivity and inattentive behaviors appears stable, which suggests a problem with diagnosis, senior author Alexandra Barratt, MBBS, MPH, PhD, professor of public health at the University of Sydney, Australia, said in an interview.
“Our hypothesis was that children who had been diagnosed, and we assume treated for, ADHD would have better outcomes, compared to children matched for hyperactivity/inattention behaviors who were left undiagnosed and untreated, but we were surprised to find that, at best, outcomes were unchanged, and for some outcomes, worse,” Dr. Barratt said.
“Our study provides evidence that diagnosing ADHD may lead, inadvertently, to long-term harms, particularly for children with mild or borderline hyperactivity and inattention behaviors,” she emphasized.
“We can’t say from this study what to do instead, but previously one of our team has looked at stepped diagnosis as an alternative option for children with mild or borderline hyperactivity and inattention behaviors,” she said.
The stepped diagnosis includes such actions as gathering behavior data from multiple sources, and conducting a period of watchful waiting without presumption of a diagnosis or active treatment.
Given the findings of the new study, “I would ask that health professionals considering a child who may have ADHD be aware that there is an evidence gap around the long-term impact of an ADHD diagnosis on children, and to proceed cautiously,” Dr. Barratt said. As for additional research, independent, high-quality, randomized controlled trials of ADHD diagnosis in children with mild or borderline hyperactivity/inattention behaviors are urgently needed, with long-term, patient-centered outcomes including quality of life she noted.
ADHD screening needs improvement
The incidence and prevalence of ADHD is on the rise, but much of the perceived increase in ADHD may be due to overdiagnosis, “and a lack of robust thorough psychological testing as standard of care for diagnosis,” Peter Loper, MD, a pediatrician and psychiatrist at the University of South Carolina, Columbia, said in an interview.
The current study “reinforces the necessity of consistent screening for comorbid mental health problems, and specifically for thoughts of self-harm, in those children who are diagnosed with ADHD,” he said.
Expressing his lack of astonishment about the study findings, Dr. Loper said: “Previous data indicates that while following initial diagnosis of a medical or mental health problem, patients may experience a sense of relief; however, this is followed shortly thereafter by feelings of insufficiency or anxiety related to their specific diagnosis.”
“As it stands now, ADHD is often diagnosed in children and adolescents using basic screening questionnaires,” said Dr. Loper. “The findings of this study may bolster calls for more robust and thorough psychological testing for supporting the diagnosis of ADHD,” he said.
Individuals diagnosed with ADHD can sometimes have difficulty with social skills and relating to others, said Dr. Loper. “They may be more prone to internalize their poor school performance as due to being ‘stupid’ or ‘dumb,’ ” he said. Children and teens with ADHD should, whenever possible, be involved in extracurricular activities that support the development of social skills, he said. Parents’ praise of the process/effort, rather than focusing only on outcomes such as grades, is very important for the esteem of children and teens with ADHD, he added.
The study limitations included the use of observational data vs. data from randomized trials, and the potential for confounding factors in propensity scoring, the researchers wrote. Additional limitations include the size of the sample, which may have been too small to detect additional differences between diagnosed teens and matched controls, they noted.
“As the study authors appropriately cite, a large, randomized trial would be very helpful in supporting additional understanding of this issue,” Dr. Loper added.
The study was supported by the National Health and Medical Research Council The researchers and Dr. Loper had no financial conflicts to disclose.
The results align with findings from other studies suggesting lower quality of life (QOL) in teens with ADHD, but the current study is the first known to focus on the association between ADHD diagnosis itself vs. ADHD symptoms, and QOL, the researchers wrote. The findings show that at least some of the reduced QOL is associated with the diagnosis itself, they explained.
The researchers directly compared 393 teens with a childhood ADHD diagnosis to 393 matched teens with no ADHD diagnosis but who had hyperactive/inattentive behaviors.
The researchers reviewed self-reports from individuals who were enrolled in a population-based prospective study in Australia. The primary outcome was quality of life at age 14-15, which was measured with Child Health Utility 9D (CHU9D), a validated quality of life measure.
Study results
Overall, teens with and without an ADHD diagnosis reported similar levels of overall quality of life; the mean difference in the primary outcome CHU9D score was –0.03 (P = .10). Teens with and without an ADHD diagnosis also showed similar scores on measures of general health, happiness, and peer trust, the researchers noted.
The researchers also reviewed eight other prespecified, self-reported measures: academic self-concept, global health, negative social behaviors, overall happiness, peer trust, psychological sense of school membership, self-efficacy, and self-harm.
Teens diagnosed with ADHD in childhood were more than twice as likely to report self-harm (odds ratio 2.53, P less than .001) and displayed significantly more negative social behaviors (mean difference 1.56, P = .002), compared with teens without an ADHD diagnosis.
Teens diagnosed with ADHD in childhood also scored significantly worse on measures of sense of school membership (mean difference −2.58, P less than .001), academic self-concept (mean difference, −0.14; P = .02), and self-efficacy (mean difference −0.20; P = .007), compared to teens without an ADHD diagnosis.
The average age at ADHD diagnosis was 10 years, and 72% of the ADHD-diagnosed group were boys. No significant differences were noted for levels of hyperactive/inattentive behaviors and between girls and boys, but girls overall and children with the highest levels of hyperactive and inattentive behaviors reported generally worse outcomes, regardless of ADHD diagnosis, the researchers noted.
Don’t rush to diagnosis
Although rates of ADHD diagnosis in children continue to rise, the prevalence of hyperactivity and inattentive behaviors appears stable, which suggests a problem with diagnosis, senior author Alexandra Barratt, MBBS, MPH, PhD, professor of public health at the University of Sydney, Australia, said in an interview.
“Our hypothesis was that children who had been diagnosed, and we assume treated for, ADHD would have better outcomes, compared to children matched for hyperactivity/inattention behaviors who were left undiagnosed and untreated, but we were surprised to find that, at best, outcomes were unchanged, and for some outcomes, worse,” Dr. Barratt said.
“Our study provides evidence that diagnosing ADHD may lead, inadvertently, to long-term harms, particularly for children with mild or borderline hyperactivity and inattention behaviors,” she emphasized.
“We can’t say from this study what to do instead, but previously one of our team has looked at stepped diagnosis as an alternative option for children with mild or borderline hyperactivity and inattention behaviors,” she said.
The stepped diagnosis includes such actions as gathering behavior data from multiple sources, and conducting a period of watchful waiting without presumption of a diagnosis or active treatment.
Given the findings of the new study, “I would ask that health professionals considering a child who may have ADHD be aware that there is an evidence gap around the long-term impact of an ADHD diagnosis on children, and to proceed cautiously,” Dr. Barratt said. As for additional research, independent, high-quality, randomized controlled trials of ADHD diagnosis in children with mild or borderline hyperactivity/inattention behaviors are urgently needed, with long-term, patient-centered outcomes including quality of life she noted.
ADHD screening needs improvement
The incidence and prevalence of ADHD is on the rise, but much of the perceived increase in ADHD may be due to overdiagnosis, “and a lack of robust thorough psychological testing as standard of care for diagnosis,” Peter Loper, MD, a pediatrician and psychiatrist at the University of South Carolina, Columbia, said in an interview.
The current study “reinforces the necessity of consistent screening for comorbid mental health problems, and specifically for thoughts of self-harm, in those children who are diagnosed with ADHD,” he said.
Expressing his lack of astonishment about the study findings, Dr. Loper said: “Previous data indicates that while following initial diagnosis of a medical or mental health problem, patients may experience a sense of relief; however, this is followed shortly thereafter by feelings of insufficiency or anxiety related to their specific diagnosis.”
“As it stands now, ADHD is often diagnosed in children and adolescents using basic screening questionnaires,” said Dr. Loper. “The findings of this study may bolster calls for more robust and thorough psychological testing for supporting the diagnosis of ADHD,” he said.
Individuals diagnosed with ADHD can sometimes have difficulty with social skills and relating to others, said Dr. Loper. “They may be more prone to internalize their poor school performance as due to being ‘stupid’ or ‘dumb,’ ” he said. Children and teens with ADHD should, whenever possible, be involved in extracurricular activities that support the development of social skills, he said. Parents’ praise of the process/effort, rather than focusing only on outcomes such as grades, is very important for the esteem of children and teens with ADHD, he added.
The study limitations included the use of observational data vs. data from randomized trials, and the potential for confounding factors in propensity scoring, the researchers wrote. Additional limitations include the size of the sample, which may have been too small to detect additional differences between diagnosed teens and matched controls, they noted.
“As the study authors appropriately cite, a large, randomized trial would be very helpful in supporting additional understanding of this issue,” Dr. Loper added.
The study was supported by the National Health and Medical Research Council The researchers and Dr. Loper had no financial conflicts to disclose.
The results align with findings from other studies suggesting lower quality of life (QOL) in teens with ADHD, but the current study is the first known to focus on the association between ADHD diagnosis itself vs. ADHD symptoms, and QOL, the researchers wrote. The findings show that at least some of the reduced QOL is associated with the diagnosis itself, they explained.
The researchers directly compared 393 teens with a childhood ADHD diagnosis to 393 matched teens with no ADHD diagnosis but who had hyperactive/inattentive behaviors.
The researchers reviewed self-reports from individuals who were enrolled in a population-based prospective study in Australia. The primary outcome was quality of life at age 14-15, which was measured with Child Health Utility 9D (CHU9D), a validated quality of life measure.
Study results
Overall, teens with and without an ADHD diagnosis reported similar levels of overall quality of life; the mean difference in the primary outcome CHU9D score was –0.03 (P = .10). Teens with and without an ADHD diagnosis also showed similar scores on measures of general health, happiness, and peer trust, the researchers noted.
The researchers also reviewed eight other prespecified, self-reported measures: academic self-concept, global health, negative social behaviors, overall happiness, peer trust, psychological sense of school membership, self-efficacy, and self-harm.
Teens diagnosed with ADHD in childhood were more than twice as likely to report self-harm (odds ratio 2.53, P less than .001) and displayed significantly more negative social behaviors (mean difference 1.56, P = .002), compared with teens without an ADHD diagnosis.
Teens diagnosed with ADHD in childhood also scored significantly worse on measures of sense of school membership (mean difference −2.58, P less than .001), academic self-concept (mean difference, −0.14; P = .02), and self-efficacy (mean difference −0.20; P = .007), compared to teens without an ADHD diagnosis.
The average age at ADHD diagnosis was 10 years, and 72% of the ADHD-diagnosed group were boys. No significant differences were noted for levels of hyperactive/inattentive behaviors and between girls and boys, but girls overall and children with the highest levels of hyperactive and inattentive behaviors reported generally worse outcomes, regardless of ADHD diagnosis, the researchers noted.
Don’t rush to diagnosis
Although rates of ADHD diagnosis in children continue to rise, the prevalence of hyperactivity and inattentive behaviors appears stable, which suggests a problem with diagnosis, senior author Alexandra Barratt, MBBS, MPH, PhD, professor of public health at the University of Sydney, Australia, said in an interview.
“Our hypothesis was that children who had been diagnosed, and we assume treated for, ADHD would have better outcomes, compared to children matched for hyperactivity/inattention behaviors who were left undiagnosed and untreated, but we were surprised to find that, at best, outcomes were unchanged, and for some outcomes, worse,” Dr. Barratt said.
“Our study provides evidence that diagnosing ADHD may lead, inadvertently, to long-term harms, particularly for children with mild or borderline hyperactivity and inattention behaviors,” she emphasized.
“We can’t say from this study what to do instead, but previously one of our team has looked at stepped diagnosis as an alternative option for children with mild or borderline hyperactivity and inattention behaviors,” she said.
The stepped diagnosis includes such actions as gathering behavior data from multiple sources, and conducting a period of watchful waiting without presumption of a diagnosis or active treatment.
Given the findings of the new study, “I would ask that health professionals considering a child who may have ADHD be aware that there is an evidence gap around the long-term impact of an ADHD diagnosis on children, and to proceed cautiously,” Dr. Barratt said. As for additional research, independent, high-quality, randomized controlled trials of ADHD diagnosis in children with mild or borderline hyperactivity/inattention behaviors are urgently needed, with long-term, patient-centered outcomes including quality of life she noted.
ADHD screening needs improvement
The incidence and prevalence of ADHD is on the rise, but much of the perceived increase in ADHD may be due to overdiagnosis, “and a lack of robust thorough psychological testing as standard of care for diagnosis,” Peter Loper, MD, a pediatrician and psychiatrist at the University of South Carolina, Columbia, said in an interview.
The current study “reinforces the necessity of consistent screening for comorbid mental health problems, and specifically for thoughts of self-harm, in those children who are diagnosed with ADHD,” he said.
Expressing his lack of astonishment about the study findings, Dr. Loper said: “Previous data indicates that while following initial diagnosis of a medical or mental health problem, patients may experience a sense of relief; however, this is followed shortly thereafter by feelings of insufficiency or anxiety related to their specific diagnosis.”
“As it stands now, ADHD is often diagnosed in children and adolescents using basic screening questionnaires,” said Dr. Loper. “The findings of this study may bolster calls for more robust and thorough psychological testing for supporting the diagnosis of ADHD,” he said.
Individuals diagnosed with ADHD can sometimes have difficulty with social skills and relating to others, said Dr. Loper. “They may be more prone to internalize their poor school performance as due to being ‘stupid’ or ‘dumb,’ ” he said. Children and teens with ADHD should, whenever possible, be involved in extracurricular activities that support the development of social skills, he said. Parents’ praise of the process/effort, rather than focusing only on outcomes such as grades, is very important for the esteem of children and teens with ADHD, he added.
The study limitations included the use of observational data vs. data from randomized trials, and the potential for confounding factors in propensity scoring, the researchers wrote. Additional limitations include the size of the sample, which may have been too small to detect additional differences between diagnosed teens and matched controls, they noted.
“As the study authors appropriately cite, a large, randomized trial would be very helpful in supporting additional understanding of this issue,” Dr. Loper added.
The study was supported by the National Health and Medical Research Council The researchers and Dr. Loper had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Sepsis predictor tool falls short in emergency setting
Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.
“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.
The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.
In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.
To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.
The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).
A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).
Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.
“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.
The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that he said.
“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”
The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.
“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.
The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.
In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.
To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.
The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).
A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).
Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.
“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.
The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that he said.
“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”
The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.
“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.
The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.
In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.
To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.
The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).
A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).
Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.
“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.
The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that he said.
“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”
The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CHEST 2022
Hard-rock mining and other mining work raise RA risk
Workers in the hard rock and other mining industries were significantly more likely to develop rheumatoid arthritis than were controls in the general population, based on data from nearly 2,000 individuals.
Although respirable silica exposure has been consistently linked to rheumatoid arthritis (RA) in a variety of occupations including foundry work, construction, and stone crushing and drilling, the association between RA risk and hard rock mining has not been investigated, lead author Paul D. Blanc, MD, of the University of California, San Francisco, and colleagues wrote in a study published in JAMA Network Open.
“Many clinical rheumatologists and most generalists are unaware that what a person does for a living can be a risk factor for rheumatoid arthritis,” Dr. Blanc said in an interview. “This study makes an important contribution to showing that work exposures can more than double the risk of RA,” he said.
“We were surprised by the widespread nature of the work-related risk within and beyond the mining sector,” Dr. Blanc noted. Given the range of potential occupational exposures, his take-home message to rheumatologists is to ask each and every patient about their work history.
The researchers conducted random telephone surveys of 1,988 men aged 50 years and older living in the Four Corners region of the United States (Colorado, New Mexico, and Utah) in counties selected for high levels of pneumoconiosis mortality. The surveys were conducted between Jan. 12, 2021, and May 4, 2021. The mean age of the study population was 68.6 years, and 82.6% were non-Hispanic White. Approximately half reported being former or current smokers.
RA was defined as having a clinician diagnosis, and was further defined by treatment with corticosteroids or disease-modifying antirheumatic drugs (DMARDs).
A total of 262 respondents (13.1%) reported work in surface mining or ore processing, with no underground exposure; 118 respondents (5.9%) reported work in underground hard rock mining; and 62 (3.1%) reported work in underground mining of other type, primarily coal mining.
Overall, after adjusting for age, smoking, and nonmining silica exposure, any mining work was associated with a three- to fourfold increased risk of RA for individuals with a RA diagnosis who were treated with corticosteroids and those treated with DMARDs (odds ratios, 4.12 and 3.30, respectively).
The risk was approximately nine times and six times higher for individuals with a history of underground soft rock mining (mainly coal, no hard rock mining), with odds ratios of 9.74 and 6.42, for those with RA treated with corticosteroids and DMARDs, respectively.
The odds of RA were higher with coal and other underground fossil hydrocarbon mining, compared with underground hard rock mining, the researchers wrote in their discussion. Reasons for this difference could include the longer employment duration for underground coal mining, but also the possibility that “in coal mining, silica inhalation may not be the sole cause, but rather that carbonaceous materials may also be involved etiologically in RA risk in that occupation,” they wrote. No association was found between increased risk of RA and current or former smoking, they noted, in contrast to the researchers’ previous studies of Appalachian coal miners.
The study findings were limited by several factors including the potential for recall bias and misclassified exposure and diagnoses, the researchers noted. Other limitations include the focus on individuals aged 50 years and older in a limited geographic region of the United States and the relatively short time of employment in mining, they said.
However, the results support previous studies showing an increased RA risk with respirable silica exposure, and suggest that clinicians consider mining among other work exposures that could increase the risk for developing RA, the researchers concluded.
Looking ahead, Dr. Blanc said that additional research is needed to tease out disease progression and severity in the face of past occupational exposures.
The study was supported by the Alpha Foundation and the Russell/Engleman Rheumatology Research Center through grants to the researchers. The researchers had no other financial conflicts to disclose.
Workers in the hard rock and other mining industries were significantly more likely to develop rheumatoid arthritis than were controls in the general population, based on data from nearly 2,000 individuals.
Although respirable silica exposure has been consistently linked to rheumatoid arthritis (RA) in a variety of occupations including foundry work, construction, and stone crushing and drilling, the association between RA risk and hard rock mining has not been investigated, lead author Paul D. Blanc, MD, of the University of California, San Francisco, and colleagues wrote in a study published in JAMA Network Open.
“Many clinical rheumatologists and most generalists are unaware that what a person does for a living can be a risk factor for rheumatoid arthritis,” Dr. Blanc said in an interview. “This study makes an important contribution to showing that work exposures can more than double the risk of RA,” he said.
“We were surprised by the widespread nature of the work-related risk within and beyond the mining sector,” Dr. Blanc noted. Given the range of potential occupational exposures, his take-home message to rheumatologists is to ask each and every patient about their work history.
The researchers conducted random telephone surveys of 1,988 men aged 50 years and older living in the Four Corners region of the United States (Colorado, New Mexico, and Utah) in counties selected for high levels of pneumoconiosis mortality. The surveys were conducted between Jan. 12, 2021, and May 4, 2021. The mean age of the study population was 68.6 years, and 82.6% were non-Hispanic White. Approximately half reported being former or current smokers.
RA was defined as having a clinician diagnosis, and was further defined by treatment with corticosteroids or disease-modifying antirheumatic drugs (DMARDs).
A total of 262 respondents (13.1%) reported work in surface mining or ore processing, with no underground exposure; 118 respondents (5.9%) reported work in underground hard rock mining; and 62 (3.1%) reported work in underground mining of other type, primarily coal mining.
Overall, after adjusting for age, smoking, and nonmining silica exposure, any mining work was associated with a three- to fourfold increased risk of RA for individuals with a RA diagnosis who were treated with corticosteroids and those treated with DMARDs (odds ratios, 4.12 and 3.30, respectively).
The risk was approximately nine times and six times higher for individuals with a history of underground soft rock mining (mainly coal, no hard rock mining), with odds ratios of 9.74 and 6.42, for those with RA treated with corticosteroids and DMARDs, respectively.
The odds of RA were higher with coal and other underground fossil hydrocarbon mining, compared with underground hard rock mining, the researchers wrote in their discussion. Reasons for this difference could include the longer employment duration for underground coal mining, but also the possibility that “in coal mining, silica inhalation may not be the sole cause, but rather that carbonaceous materials may also be involved etiologically in RA risk in that occupation,” they wrote. No association was found between increased risk of RA and current or former smoking, they noted, in contrast to the researchers’ previous studies of Appalachian coal miners.
The study findings were limited by several factors including the potential for recall bias and misclassified exposure and diagnoses, the researchers noted. Other limitations include the focus on individuals aged 50 years and older in a limited geographic region of the United States and the relatively short time of employment in mining, they said.
However, the results support previous studies showing an increased RA risk with respirable silica exposure, and suggest that clinicians consider mining among other work exposures that could increase the risk for developing RA, the researchers concluded.
Looking ahead, Dr. Blanc said that additional research is needed to tease out disease progression and severity in the face of past occupational exposures.
The study was supported by the Alpha Foundation and the Russell/Engleman Rheumatology Research Center through grants to the researchers. The researchers had no other financial conflicts to disclose.
Workers in the hard rock and other mining industries were significantly more likely to develop rheumatoid arthritis than were controls in the general population, based on data from nearly 2,000 individuals.
Although respirable silica exposure has been consistently linked to rheumatoid arthritis (RA) in a variety of occupations including foundry work, construction, and stone crushing and drilling, the association between RA risk and hard rock mining has not been investigated, lead author Paul D. Blanc, MD, of the University of California, San Francisco, and colleagues wrote in a study published in JAMA Network Open.
“Many clinical rheumatologists and most generalists are unaware that what a person does for a living can be a risk factor for rheumatoid arthritis,” Dr. Blanc said in an interview. “This study makes an important contribution to showing that work exposures can more than double the risk of RA,” he said.
“We were surprised by the widespread nature of the work-related risk within and beyond the mining sector,” Dr. Blanc noted. Given the range of potential occupational exposures, his take-home message to rheumatologists is to ask each and every patient about their work history.
The researchers conducted random telephone surveys of 1,988 men aged 50 years and older living in the Four Corners region of the United States (Colorado, New Mexico, and Utah) in counties selected for high levels of pneumoconiosis mortality. The surveys were conducted between Jan. 12, 2021, and May 4, 2021. The mean age of the study population was 68.6 years, and 82.6% were non-Hispanic White. Approximately half reported being former or current smokers.
RA was defined as having a clinician diagnosis, and was further defined by treatment with corticosteroids or disease-modifying antirheumatic drugs (DMARDs).
A total of 262 respondents (13.1%) reported work in surface mining or ore processing, with no underground exposure; 118 respondents (5.9%) reported work in underground hard rock mining; and 62 (3.1%) reported work in underground mining of other type, primarily coal mining.
Overall, after adjusting for age, smoking, and nonmining silica exposure, any mining work was associated with a three- to fourfold increased risk of RA for individuals with a RA diagnosis who were treated with corticosteroids and those treated with DMARDs (odds ratios, 4.12 and 3.30, respectively).
The risk was approximately nine times and six times higher for individuals with a history of underground soft rock mining (mainly coal, no hard rock mining), with odds ratios of 9.74 and 6.42, for those with RA treated with corticosteroids and DMARDs, respectively.
The odds of RA were higher with coal and other underground fossil hydrocarbon mining, compared with underground hard rock mining, the researchers wrote in their discussion. Reasons for this difference could include the longer employment duration for underground coal mining, but also the possibility that “in coal mining, silica inhalation may not be the sole cause, but rather that carbonaceous materials may also be involved etiologically in RA risk in that occupation,” they wrote. No association was found between increased risk of RA and current or former smoking, they noted, in contrast to the researchers’ previous studies of Appalachian coal miners.
The study findings were limited by several factors including the potential for recall bias and misclassified exposure and diagnoses, the researchers noted. Other limitations include the focus on individuals aged 50 years and older in a limited geographic region of the United States and the relatively short time of employment in mining, they said.
However, the results support previous studies showing an increased RA risk with respirable silica exposure, and suggest that clinicians consider mining among other work exposures that could increase the risk for developing RA, the researchers concluded.
Looking ahead, Dr. Blanc said that additional research is needed to tease out disease progression and severity in the face of past occupational exposures.
The study was supported by the Alpha Foundation and the Russell/Engleman Rheumatology Research Center through grants to the researchers. The researchers had no other financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Home-based transcranial stimulation succeeds for MDD
Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.
Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.
“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.
The researchers proposed that tDCS could be provided at home under real-time remote supervision.
In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.
The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.
Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.
The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.
All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”
The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”
However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.
The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.
Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.
“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.
The researchers proposed that tDCS could be provided at home under real-time remote supervision.
In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.
The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.
Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.
The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.
All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”
The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”
However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.
The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.
Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.
“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.
The researchers proposed that tDCS could be provided at home under real-time remote supervision.
In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.
The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.
Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.
The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.
All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”
The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”
However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.
The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF PSYCHIATRIC RESEARCH
Novel head-up CPR position raises odds of survival of out-of-hospital heart attacks
Individuals who experience out-of-hospital cardiac arrest (OHCA) with nonshockable presentations have a better chance of survival when first responders use a novel CPR approach that includes gradual head-up positioning combined with basic but effective circulation-enhancing adjuncts, as shown from data from more than 2,000 patients.
In a study presented at the annual meeting of the American College of Emergency Physicians, Paul Pepe, MD, medical director for Dallas County Emergency Medical Services, reviewed data from five EMS systems that had adopted the new approach. Data were collected prospectively over the past 2 years from a national registry of patients who had received what Dr. Pepe called a “neuroprotective CPR bundle” (NP-CPR).
The study compared 380 NP-CPR case patients to 1,852 control patients who had received conventional CPR. Control data came from high-performance EMS systems that had participated in well-monitored, published OHCA trials funded by the National Institutes of Health. The primary outcome that was used for comparison was successful survival to hospital discharge with neurologically intact status (SURV-NI).
Traditional CPR supine chest compression techniques, if performed early and properly, can be lifesaving, but they are suboptimal, Dr. Pepe said. “Current techniques create pressure waves that run up the arterial side, but they also create back-pressure on the venous side, increasing intracranial pressure (ICP), thus compromising optimal cerebral blood flow,” he told this news organization.
For that reason, a modified physiologic approach to CPR was designed. It involves an airway adjunct called an impedance threshold device (ITD) and active compression-decompression (ACD) with a device “resembling a toilet plunger,” Dr. Pepe said.
The devices draw more blood out of the brain and into the thorax in a complementary fashion. The combination of these two adjuncts had dramatically improved SURV-NI by 50% in a clinical trial, Dr. Pepe said.
The new technology uses automated gradual head-up/torso-up positioning (AHUP) after first “priming the pump” with ITD-ACD–enhanced circulation. It was found to markedly augment that effect even further. In the laboratory setting, this synergistic NP-CPR bundle has been shown to help normalize cerebral perfusion pressure, further promoting neuro-intact survival. Normalization of end-tidal CO2 is routinely observed, according to Dr. Pepe.
In contrast to patients who present with ventricular fibrillation (shockable cases), patients with nonshockable presentations always have had grim prognoses, Dr. Pepe said. Until now, lifesaving advances had not been found, despite the fact that nonshockable presentations (asystole or electrical activity with no pulse) constitute approximately 80% of OHCA cases, or about 250,000 to 300,00 cases a year in the United States, he said.
In the study, approximately 60% of both the NP-CPR patients and control patients had asystole (flatline) presentations. The NP-CPR group had a significant threefold improvement in SURV-NI, compared with patients treated with conventional CPR in the high-functioning systems (odds ratio, 3.09). In a propensity-scored analysis matching all variables known to affect outcome, the OR increased to nearly fourfold higher (OR, 3.87; 95% confidence interval, 1.27-11.78), Dr. Pepe said.
The researchers also found that the time from receipt of a 911 call to initiation of AHUP was associated with progressively higher chances of survival. The median time for application was 11 minutes; when the elapsed time was less than 11 minutes, the SURV-NI was nearly 11-fold higher for NP-CPR patients than for control patients (OR, 10.59), with survival chances of 6% versus 0.5%. ORs were even higher when the time to treatment was less than 16 minutes (OR, 13.58), with survival rates of 5% versus 0.4%.
The findings not only demonstrate proof of concept in these most futile cases but also that implementation is feasible for the majority of patients, considering that the median time to the start of any CPR by a first responder was 8 minutes for both NP-CPR patients and control patients, “let alone 11 minutes for the AHUP initiation,” Dr. Pepe said. “This finally gives some hope for these nonshockable cases,” he emphasized.
“All of these devices have now been cleared by the Food and Drug Administration and should be adopted by all first-in responders,” said Dr. Pepe. “But they should be implemented as a bundle and in the proper sequence and as soon as feasible.”
Training and implementation efforts continue to expand, and more lives can be saved as more firefighters and first-in response teams acquire equipment and training, which can cut the time to response, he said.
The registry will continue to monitor outcomes with NP-CPR – the term was suggested by a patient who survived through this new approach – and Dr. Pepe and colleagues expect the statistics to improve further with wider adoption and faster implementation with the fastest responders.
A recent study by Dr. Pepe’s team, published in Resuscitation, showed the effectiveness of the neuroprotective bundle in improving survival for OHCA patients overall. The current study confirmed its impact on neuro-intact survival for the subgroup of patients with nonshockable cases.
One other take-home message is that head-up CPR cannot yet be performed by lay bystanders. “Also, do not implement this unless you are going to do it right,” Dr. Pepe emphasized in an interview.
Advanced CPR Solutions provided some materials and research funding for an independent data collector. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
Individuals who experience out-of-hospital cardiac arrest (OHCA) with nonshockable presentations have a better chance of survival when first responders use a novel CPR approach that includes gradual head-up positioning combined with basic but effective circulation-enhancing adjuncts, as shown from data from more than 2,000 patients.
In a study presented at the annual meeting of the American College of Emergency Physicians, Paul Pepe, MD, medical director for Dallas County Emergency Medical Services, reviewed data from five EMS systems that had adopted the new approach. Data were collected prospectively over the past 2 years from a national registry of patients who had received what Dr. Pepe called a “neuroprotective CPR bundle” (NP-CPR).
The study compared 380 NP-CPR case patients to 1,852 control patients who had received conventional CPR. Control data came from high-performance EMS systems that had participated in well-monitored, published OHCA trials funded by the National Institutes of Health. The primary outcome that was used for comparison was successful survival to hospital discharge with neurologically intact status (SURV-NI).
Traditional CPR supine chest compression techniques, if performed early and properly, can be lifesaving, but they are suboptimal, Dr. Pepe said. “Current techniques create pressure waves that run up the arterial side, but they also create back-pressure on the venous side, increasing intracranial pressure (ICP), thus compromising optimal cerebral blood flow,” he told this news organization.
For that reason, a modified physiologic approach to CPR was designed. It involves an airway adjunct called an impedance threshold device (ITD) and active compression-decompression (ACD) with a device “resembling a toilet plunger,” Dr. Pepe said.
The devices draw more blood out of the brain and into the thorax in a complementary fashion. The combination of these two adjuncts had dramatically improved SURV-NI by 50% in a clinical trial, Dr. Pepe said.
The new technology uses automated gradual head-up/torso-up positioning (AHUP) after first “priming the pump” with ITD-ACD–enhanced circulation. It was found to markedly augment that effect even further. In the laboratory setting, this synergistic NP-CPR bundle has been shown to help normalize cerebral perfusion pressure, further promoting neuro-intact survival. Normalization of end-tidal CO2 is routinely observed, according to Dr. Pepe.
In contrast to patients who present with ventricular fibrillation (shockable cases), patients with nonshockable presentations always have had grim prognoses, Dr. Pepe said. Until now, lifesaving advances had not been found, despite the fact that nonshockable presentations (asystole or electrical activity with no pulse) constitute approximately 80% of OHCA cases, or about 250,000 to 300,00 cases a year in the United States, he said.
In the study, approximately 60% of both the NP-CPR patients and control patients had asystole (flatline) presentations. The NP-CPR group had a significant threefold improvement in SURV-NI, compared with patients treated with conventional CPR in the high-functioning systems (odds ratio, 3.09). In a propensity-scored analysis matching all variables known to affect outcome, the OR increased to nearly fourfold higher (OR, 3.87; 95% confidence interval, 1.27-11.78), Dr. Pepe said.
The researchers also found that the time from receipt of a 911 call to initiation of AHUP was associated with progressively higher chances of survival. The median time for application was 11 minutes; when the elapsed time was less than 11 minutes, the SURV-NI was nearly 11-fold higher for NP-CPR patients than for control patients (OR, 10.59), with survival chances of 6% versus 0.5%. ORs were even higher when the time to treatment was less than 16 minutes (OR, 13.58), with survival rates of 5% versus 0.4%.
The findings not only demonstrate proof of concept in these most futile cases but also that implementation is feasible for the majority of patients, considering that the median time to the start of any CPR by a first responder was 8 minutes for both NP-CPR patients and control patients, “let alone 11 minutes for the AHUP initiation,” Dr. Pepe said. “This finally gives some hope for these nonshockable cases,” he emphasized.
“All of these devices have now been cleared by the Food and Drug Administration and should be adopted by all first-in responders,” said Dr. Pepe. “But they should be implemented as a bundle and in the proper sequence and as soon as feasible.”
Training and implementation efforts continue to expand, and more lives can be saved as more firefighters and first-in response teams acquire equipment and training, which can cut the time to response, he said.
The registry will continue to monitor outcomes with NP-CPR – the term was suggested by a patient who survived through this new approach – and Dr. Pepe and colleagues expect the statistics to improve further with wider adoption and faster implementation with the fastest responders.
A recent study by Dr. Pepe’s team, published in Resuscitation, showed the effectiveness of the neuroprotective bundle in improving survival for OHCA patients overall. The current study confirmed its impact on neuro-intact survival for the subgroup of patients with nonshockable cases.
One other take-home message is that head-up CPR cannot yet be performed by lay bystanders. “Also, do not implement this unless you are going to do it right,” Dr. Pepe emphasized in an interview.
Advanced CPR Solutions provided some materials and research funding for an independent data collector. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
Individuals who experience out-of-hospital cardiac arrest (OHCA) with nonshockable presentations have a better chance of survival when first responders use a novel CPR approach that includes gradual head-up positioning combined with basic but effective circulation-enhancing adjuncts, as shown from data from more than 2,000 patients.
In a study presented at the annual meeting of the American College of Emergency Physicians, Paul Pepe, MD, medical director for Dallas County Emergency Medical Services, reviewed data from five EMS systems that had adopted the new approach. Data were collected prospectively over the past 2 years from a national registry of patients who had received what Dr. Pepe called a “neuroprotective CPR bundle” (NP-CPR).
The study compared 380 NP-CPR case patients to 1,852 control patients who had received conventional CPR. Control data came from high-performance EMS systems that had participated in well-monitored, published OHCA trials funded by the National Institutes of Health. The primary outcome that was used for comparison was successful survival to hospital discharge with neurologically intact status (SURV-NI).
Traditional CPR supine chest compression techniques, if performed early and properly, can be lifesaving, but they are suboptimal, Dr. Pepe said. “Current techniques create pressure waves that run up the arterial side, but they also create back-pressure on the venous side, increasing intracranial pressure (ICP), thus compromising optimal cerebral blood flow,” he told this news organization.
For that reason, a modified physiologic approach to CPR was designed. It involves an airway adjunct called an impedance threshold device (ITD) and active compression-decompression (ACD) with a device “resembling a toilet plunger,” Dr. Pepe said.
The devices draw more blood out of the brain and into the thorax in a complementary fashion. The combination of these two adjuncts had dramatically improved SURV-NI by 50% in a clinical trial, Dr. Pepe said.
The new technology uses automated gradual head-up/torso-up positioning (AHUP) after first “priming the pump” with ITD-ACD–enhanced circulation. It was found to markedly augment that effect even further. In the laboratory setting, this synergistic NP-CPR bundle has been shown to help normalize cerebral perfusion pressure, further promoting neuro-intact survival. Normalization of end-tidal CO2 is routinely observed, according to Dr. Pepe.
In contrast to patients who present with ventricular fibrillation (shockable cases), patients with nonshockable presentations always have had grim prognoses, Dr. Pepe said. Until now, lifesaving advances had not been found, despite the fact that nonshockable presentations (asystole or electrical activity with no pulse) constitute approximately 80% of OHCA cases, or about 250,000 to 300,00 cases a year in the United States, he said.
In the study, approximately 60% of both the NP-CPR patients and control patients had asystole (flatline) presentations. The NP-CPR group had a significant threefold improvement in SURV-NI, compared with patients treated with conventional CPR in the high-functioning systems (odds ratio, 3.09). In a propensity-scored analysis matching all variables known to affect outcome, the OR increased to nearly fourfold higher (OR, 3.87; 95% confidence interval, 1.27-11.78), Dr. Pepe said.
The researchers also found that the time from receipt of a 911 call to initiation of AHUP was associated with progressively higher chances of survival. The median time for application was 11 minutes; when the elapsed time was less than 11 minutes, the SURV-NI was nearly 11-fold higher for NP-CPR patients than for control patients (OR, 10.59), with survival chances of 6% versus 0.5%. ORs were even higher when the time to treatment was less than 16 minutes (OR, 13.58), with survival rates of 5% versus 0.4%.
The findings not only demonstrate proof of concept in these most futile cases but also that implementation is feasible for the majority of patients, considering that the median time to the start of any CPR by a first responder was 8 minutes for both NP-CPR patients and control patients, “let alone 11 minutes for the AHUP initiation,” Dr. Pepe said. “This finally gives some hope for these nonshockable cases,” he emphasized.
“All of these devices have now been cleared by the Food and Drug Administration and should be adopted by all first-in responders,” said Dr. Pepe. “But they should be implemented as a bundle and in the proper sequence and as soon as feasible.”
Training and implementation efforts continue to expand, and more lives can be saved as more firefighters and first-in response teams acquire equipment and training, which can cut the time to response, he said.
The registry will continue to monitor outcomes with NP-CPR – the term was suggested by a patient who survived through this new approach – and Dr. Pepe and colleagues expect the statistics to improve further with wider adoption and faster implementation with the fastest responders.
A recent study by Dr. Pepe’s team, published in Resuscitation, showed the effectiveness of the neuroprotective bundle in improving survival for OHCA patients overall. The current study confirmed its impact on neuro-intact survival for the subgroup of patients with nonshockable cases.
One other take-home message is that head-up CPR cannot yet be performed by lay bystanders. “Also, do not implement this unless you are going to do it right,” Dr. Pepe emphasized in an interview.
Advanced CPR Solutions provided some materials and research funding for an independent data collector. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
FROM ACEP 2022
Vaccination tied to lower mortality in ventilated patients with COVID-19
Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.
In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.
The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.
Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).
In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.
“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.
Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.
The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.
The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.
The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.
In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.
The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.
Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).
In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.
“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.
Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.
The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.
The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.
The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.
In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.
The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.
Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).
In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.
“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.
Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.
The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.
The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.
The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
E-health program improves perinatal depression
Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.
Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.
An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.
In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.
The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.
After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).
A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.
Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.
The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.
However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.
“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
Expanding e-health options may improve outcomes and reduce disparities
Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.
“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.
In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.
“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”
More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”
The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.
Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.
Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.
An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.
In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.
The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.
After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).
A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.
Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.
The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.
However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.
“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
Expanding e-health options may improve outcomes and reduce disparities
Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.
“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.
In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.
“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”
More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”
The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.
Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.
Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.
An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.
In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.
The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.
After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).
A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.
Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.
The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.
However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.
“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
Expanding e-health options may improve outcomes and reduce disparities
Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.
“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.
In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.
“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”
More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”
The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.
FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY
Sigmoidoscopy screening cuts CRC mortality, incidence
Although endoscopic screening provides an opportunity for early identification and removal of premalignant polyps, data quantifying the long-term effects of sigmoidoscopy screening are lacking, corresponding author Frederik E. Juul, MD, said in an interview.
“Sigmoidoscopy screening have been shown to reduce colorectal cancer incidence and mortality, but it was unknown how long-lasting the effects were, and whether the effect differed by sex or age,” Dr. Juul said.
“For the first time, we were able to pool data from all four randomized sigmoidoscopy screening trials and include data from recent updates from two of the trials (U.S. and Italy), which means that we were able to answer these questions better than ever before,” he said.
In the pooled analysis, published in Annals of Internal Medicine, researchers from Norway, the United States, Italy, and the United Kingdom reviewed data from four studies with at least 15 years of follow-up. The analysis included 137,493 individuals randomized to at least one sigmoidoscopy screening and 137,459 randomized to usual care.
The primary outcomes were the incidence and mortality of CRC after sigmoidoscopy screening, compared with usual care, in adults with average CRC risk aged 55-64 years. Secondary outcomes included CRC incidence and mortality based on distal versus proximal colon, sex, and older versus younger age group (55-59 years vs. 60-64 years at study enrollment).
After 15 years’ follow-up, the pooled cumulative incidence of CRC was 1.84 cases per 100 persons in the screening group versus 2.35 cases per 100 persons in the usual-care group, representing a 21% reduction in incidence among those who were screened.
The pooled cumulative CRC mortality was 0.51 deaths per 100 persons in the screening group versus 0.65 deaths per 100 persons in the usual-care group, representing a 20% reduction in CRC mortality for those who were screened, the researchers noted. The all-cause mortality was reduced by 2% in the screening group compared with usual care; the pooled cumulative all-cause mortality was 14.3 deaths per 100 persons in the screening group versus 14.6 deaths per 100 persons in the usual-care group.
In terms of secondary outcomes, the significant reductions in CRC incidence and mortality were confined to the distal colon, with no significant differences observed in the proximal colon, the researchers noted. The reasons for this difference are unclear. Previous studies of three of the four trials showed a small reduction in CRC in the proximal colon, but may be related to the longer follow-up in the analysis of four trials.
The incidence of CRC varied by gender, with an incidence reduction of 25% for men versus 16% for women. The reasons for the gender difference are yet to be undetermined, but may include differences in the quality of bowel preparation, the greater technical challenge of screening women, and the higher incidence and proportion of proximal colon cancer versus distal colon cancer in women, the researchers noted.
“The long-term benefit of one single procedure was probably what surprised us the most,” Dr. Juul said in an interview. “Not only were the cumulative incidence and mortality lower in screened individuals 15 years after the procedure, but the yearly incidence was consistently lower in screened individuals compared to usual care, even at the end of the follow-up period.
“Although a previous study in Norway had indicated a sex difference in effect, we were surprised to see this in a pooled analysis across trials in four different countries,” he added.
Data may drive screening guidelines
The main finding of the study is that sigmoidoscopy screening with investigation of the distal colon provides at least 15 years of protection against colorectal cancer; “this may have an impact on how often average-risk individuals needs to be screened,” Dr. Juul said in an interview.
As for additional research, ongoing studies are examining primary colonoscopy screening, including a study recently published in the New England Journal of Medicine, Dr. Juul said.“Our study investigating sigmoidoscopy screening has a longer follow-up and it will be interesting to see if primary colonoscopy screening is equally or more effective as sigmoidoscopy at 15-years follow-up.”
More research is needed on direct comparisons of different colorectal cancer screening methods such as sigmoidoscopy and colonoscopy, said Dr. Juul. In addition, “The optimal surveillance interval in individuals identified at screening to be low- or high-risk of developing colorectal cancer are unknown,” he said.
“Our research group is involved in trials [the EPoS trials] looking into this question, but there are still years until we have the final results,” he added.
The findings were limited by several factors including the variation in methodology among the four trials and the lower number of individuals referred for colonoscopy in the U.K. and Italian trials, lack of analysis of potential confounding variables, and less granular data from the U.K. trial because of privacy regulations, the researchers wrote.
However, the findings were strengthened by the large study population, long-term follow-up, and detailed data, and they indicate a “significant and sustained” effect of screening sigmoidoscopy for the long-term reduction of CRC incidence and mortality, the authors concluded.
Findings can inform shared decision-making
“Colon cancer is the third-leading cause of death in the United States in men and women, and the second-leading cause of cancer deaths if we were to combine both genders,” Noel Deep, MD, said in an interview. “Sigmoidoscopy is more acceptable as a screening tool compared to a colonoscopy because of the lower risk of bowel injury, fewer side effects and less of a bowel prep, and also less need for sedation. This current study confirms prior data, including the 2012 PLCO trial, that it [sigmoidoscopy] reduces the incidence and mortality from colorectal cancer.”
The study findings were not surprising, given the prior knowledge and evidence of the benefits of sigmoidoscopy, Dr. Deep said, who was not involved in the study. However, “the fact that a single sigmoidoscopy led to decreased incidence and decreased mortality at 15 years was surprising to me, as current models suggest increasing incidence of proximal colon adenomas and cancers, which did not seem to be the case in this study.”
The current study can help primary care physicians and advance practice clinicians in patient counseling by supporting sigmoidoscopy as an option for patients who are unwilling to commit to a full colonoscopy, Dr. Deep said. However, “the patients should be advised that abnormal findings on the sigmoidoscopy would necessitate them being referred for a colonoscopy, and also the limitations of a sigmoidoscopy in detecting polyps or cancers in the cecum, ascending colon, transverse colon and descending colon.”
Looking ahead, “I would like to see research into the appropriate age for colorectal cancer screening using sigmoidoscopy and any benefit in offering this option at an earlier age,” Dr. Deep said. He also expressed a wish to know more about the reasons for the decreased benefit of screening sigmoidoscopy in women, and the reasons for the observed difference in all-cause mortality between genders.
“I would also like to see what the results of screening colonoscopies in a general population would reveal, and if it would reveal similar benefits, and also if there would be a gender difference or age-based difference in outcomes,” he said.
The study was supported by the Health Fund of South-East Norway. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.
Although endoscopic screening provides an opportunity for early identification and removal of premalignant polyps, data quantifying the long-term effects of sigmoidoscopy screening are lacking, corresponding author Frederik E. Juul, MD, said in an interview.
“Sigmoidoscopy screening have been shown to reduce colorectal cancer incidence and mortality, but it was unknown how long-lasting the effects were, and whether the effect differed by sex or age,” Dr. Juul said.
“For the first time, we were able to pool data from all four randomized sigmoidoscopy screening trials and include data from recent updates from two of the trials (U.S. and Italy), which means that we were able to answer these questions better than ever before,” he said.
In the pooled analysis, published in Annals of Internal Medicine, researchers from Norway, the United States, Italy, and the United Kingdom reviewed data from four studies with at least 15 years of follow-up. The analysis included 137,493 individuals randomized to at least one sigmoidoscopy screening and 137,459 randomized to usual care.
The primary outcomes were the incidence and mortality of CRC after sigmoidoscopy screening, compared with usual care, in adults with average CRC risk aged 55-64 years. Secondary outcomes included CRC incidence and mortality based on distal versus proximal colon, sex, and older versus younger age group (55-59 years vs. 60-64 years at study enrollment).
After 15 years’ follow-up, the pooled cumulative incidence of CRC was 1.84 cases per 100 persons in the screening group versus 2.35 cases per 100 persons in the usual-care group, representing a 21% reduction in incidence among those who were screened.
The pooled cumulative CRC mortality was 0.51 deaths per 100 persons in the screening group versus 0.65 deaths per 100 persons in the usual-care group, representing a 20% reduction in CRC mortality for those who were screened, the researchers noted. The all-cause mortality was reduced by 2% in the screening group compared with usual care; the pooled cumulative all-cause mortality was 14.3 deaths per 100 persons in the screening group versus 14.6 deaths per 100 persons in the usual-care group.
In terms of secondary outcomes, the significant reductions in CRC incidence and mortality were confined to the distal colon, with no significant differences observed in the proximal colon, the researchers noted. The reasons for this difference are unclear. Previous studies of three of the four trials showed a small reduction in CRC in the proximal colon, but may be related to the longer follow-up in the analysis of four trials.
The incidence of CRC varied by gender, with an incidence reduction of 25% for men versus 16% for women. The reasons for the gender difference are yet to be undetermined, but may include differences in the quality of bowel preparation, the greater technical challenge of screening women, and the higher incidence and proportion of proximal colon cancer versus distal colon cancer in women, the researchers noted.
“The long-term benefit of one single procedure was probably what surprised us the most,” Dr. Juul said in an interview. “Not only were the cumulative incidence and mortality lower in screened individuals 15 years after the procedure, but the yearly incidence was consistently lower in screened individuals compared to usual care, even at the end of the follow-up period.
“Although a previous study in Norway had indicated a sex difference in effect, we were surprised to see this in a pooled analysis across trials in four different countries,” he added.
Data may drive screening guidelines
The main finding of the study is that sigmoidoscopy screening with investigation of the distal colon provides at least 15 years of protection against colorectal cancer; “this may have an impact on how often average-risk individuals needs to be screened,” Dr. Juul said in an interview.
As for additional research, ongoing studies are examining primary colonoscopy screening, including a study recently published in the New England Journal of Medicine, Dr. Juul said.“Our study investigating sigmoidoscopy screening has a longer follow-up and it will be interesting to see if primary colonoscopy screening is equally or more effective as sigmoidoscopy at 15-years follow-up.”
More research is needed on direct comparisons of different colorectal cancer screening methods such as sigmoidoscopy and colonoscopy, said Dr. Juul. In addition, “The optimal surveillance interval in individuals identified at screening to be low- or high-risk of developing colorectal cancer are unknown,” he said.
“Our research group is involved in trials [the EPoS trials] looking into this question, but there are still years until we have the final results,” he added.
The findings were limited by several factors including the variation in methodology among the four trials and the lower number of individuals referred for colonoscopy in the U.K. and Italian trials, lack of analysis of potential confounding variables, and less granular data from the U.K. trial because of privacy regulations, the researchers wrote.
However, the findings were strengthened by the large study population, long-term follow-up, and detailed data, and they indicate a “significant and sustained” effect of screening sigmoidoscopy for the long-term reduction of CRC incidence and mortality, the authors concluded.
Findings can inform shared decision-making
“Colon cancer is the third-leading cause of death in the United States in men and women, and the second-leading cause of cancer deaths if we were to combine both genders,” Noel Deep, MD, said in an interview. “Sigmoidoscopy is more acceptable as a screening tool compared to a colonoscopy because of the lower risk of bowel injury, fewer side effects and less of a bowel prep, and also less need for sedation. This current study confirms prior data, including the 2012 PLCO trial, that it [sigmoidoscopy] reduces the incidence and mortality from colorectal cancer.”
The study findings were not surprising, given the prior knowledge and evidence of the benefits of sigmoidoscopy, Dr. Deep said, who was not involved in the study. However, “the fact that a single sigmoidoscopy led to decreased incidence and decreased mortality at 15 years was surprising to me, as current models suggest increasing incidence of proximal colon adenomas and cancers, which did not seem to be the case in this study.”
The current study can help primary care physicians and advance practice clinicians in patient counseling by supporting sigmoidoscopy as an option for patients who are unwilling to commit to a full colonoscopy, Dr. Deep said. However, “the patients should be advised that abnormal findings on the sigmoidoscopy would necessitate them being referred for a colonoscopy, and also the limitations of a sigmoidoscopy in detecting polyps or cancers in the cecum, ascending colon, transverse colon and descending colon.”
Looking ahead, “I would like to see research into the appropriate age for colorectal cancer screening using sigmoidoscopy and any benefit in offering this option at an earlier age,” Dr. Deep said. He also expressed a wish to know more about the reasons for the decreased benefit of screening sigmoidoscopy in women, and the reasons for the observed difference in all-cause mortality between genders.
“I would also like to see what the results of screening colonoscopies in a general population would reveal, and if it would reveal similar benefits, and also if there would be a gender difference or age-based difference in outcomes,” he said.
The study was supported by the Health Fund of South-East Norway. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.
Although endoscopic screening provides an opportunity for early identification and removal of premalignant polyps, data quantifying the long-term effects of sigmoidoscopy screening are lacking, corresponding author Frederik E. Juul, MD, said in an interview.
“Sigmoidoscopy screening have been shown to reduce colorectal cancer incidence and mortality, but it was unknown how long-lasting the effects were, and whether the effect differed by sex or age,” Dr. Juul said.
“For the first time, we were able to pool data from all four randomized sigmoidoscopy screening trials and include data from recent updates from two of the trials (U.S. and Italy), which means that we were able to answer these questions better than ever before,” he said.
In the pooled analysis, published in Annals of Internal Medicine, researchers from Norway, the United States, Italy, and the United Kingdom reviewed data from four studies with at least 15 years of follow-up. The analysis included 137,493 individuals randomized to at least one sigmoidoscopy screening and 137,459 randomized to usual care.
The primary outcomes were the incidence and mortality of CRC after sigmoidoscopy screening, compared with usual care, in adults with average CRC risk aged 55-64 years. Secondary outcomes included CRC incidence and mortality based on distal versus proximal colon, sex, and older versus younger age group (55-59 years vs. 60-64 years at study enrollment).
After 15 years’ follow-up, the pooled cumulative incidence of CRC was 1.84 cases per 100 persons in the screening group versus 2.35 cases per 100 persons in the usual-care group, representing a 21% reduction in incidence among those who were screened.
The pooled cumulative CRC mortality was 0.51 deaths per 100 persons in the screening group versus 0.65 deaths per 100 persons in the usual-care group, representing a 20% reduction in CRC mortality for those who were screened, the researchers noted. The all-cause mortality was reduced by 2% in the screening group compared with usual care; the pooled cumulative all-cause mortality was 14.3 deaths per 100 persons in the screening group versus 14.6 deaths per 100 persons in the usual-care group.
In terms of secondary outcomes, the significant reductions in CRC incidence and mortality were confined to the distal colon, with no significant differences observed in the proximal colon, the researchers noted. The reasons for this difference are unclear. Previous studies of three of the four trials showed a small reduction in CRC in the proximal colon, but may be related to the longer follow-up in the analysis of four trials.
The incidence of CRC varied by gender, with an incidence reduction of 25% for men versus 16% for women. The reasons for the gender difference are yet to be undetermined, but may include differences in the quality of bowel preparation, the greater technical challenge of screening women, and the higher incidence and proportion of proximal colon cancer versus distal colon cancer in women, the researchers noted.
“The long-term benefit of one single procedure was probably what surprised us the most,” Dr. Juul said in an interview. “Not only were the cumulative incidence and mortality lower in screened individuals 15 years after the procedure, but the yearly incidence was consistently lower in screened individuals compared to usual care, even at the end of the follow-up period.
“Although a previous study in Norway had indicated a sex difference in effect, we were surprised to see this in a pooled analysis across trials in four different countries,” he added.
Data may drive screening guidelines
The main finding of the study is that sigmoidoscopy screening with investigation of the distal colon provides at least 15 years of protection against colorectal cancer; “this may have an impact on how often average-risk individuals needs to be screened,” Dr. Juul said in an interview.
As for additional research, ongoing studies are examining primary colonoscopy screening, including a study recently published in the New England Journal of Medicine, Dr. Juul said.“Our study investigating sigmoidoscopy screening has a longer follow-up and it will be interesting to see if primary colonoscopy screening is equally or more effective as sigmoidoscopy at 15-years follow-up.”
More research is needed on direct comparisons of different colorectal cancer screening methods such as sigmoidoscopy and colonoscopy, said Dr. Juul. In addition, “The optimal surveillance interval in individuals identified at screening to be low- or high-risk of developing colorectal cancer are unknown,” he said.
“Our research group is involved in trials [the EPoS trials] looking into this question, but there are still years until we have the final results,” he added.
The findings were limited by several factors including the variation in methodology among the four trials and the lower number of individuals referred for colonoscopy in the U.K. and Italian trials, lack of analysis of potential confounding variables, and less granular data from the U.K. trial because of privacy regulations, the researchers wrote.
However, the findings were strengthened by the large study population, long-term follow-up, and detailed data, and they indicate a “significant and sustained” effect of screening sigmoidoscopy for the long-term reduction of CRC incidence and mortality, the authors concluded.
Findings can inform shared decision-making
“Colon cancer is the third-leading cause of death in the United States in men and women, and the second-leading cause of cancer deaths if we were to combine both genders,” Noel Deep, MD, said in an interview. “Sigmoidoscopy is more acceptable as a screening tool compared to a colonoscopy because of the lower risk of bowel injury, fewer side effects and less of a bowel prep, and also less need for sedation. This current study confirms prior data, including the 2012 PLCO trial, that it [sigmoidoscopy] reduces the incidence and mortality from colorectal cancer.”
The study findings were not surprising, given the prior knowledge and evidence of the benefits of sigmoidoscopy, Dr. Deep said, who was not involved in the study. However, “the fact that a single sigmoidoscopy led to decreased incidence and decreased mortality at 15 years was surprising to me, as current models suggest increasing incidence of proximal colon adenomas and cancers, which did not seem to be the case in this study.”
The current study can help primary care physicians and advance practice clinicians in patient counseling by supporting sigmoidoscopy as an option for patients who are unwilling to commit to a full colonoscopy, Dr. Deep said. However, “the patients should be advised that abnormal findings on the sigmoidoscopy would necessitate them being referred for a colonoscopy, and also the limitations of a sigmoidoscopy in detecting polyps or cancers in the cecum, ascending colon, transverse colon and descending colon.”
Looking ahead, “I would like to see research into the appropriate age for colorectal cancer screening using sigmoidoscopy and any benefit in offering this option at an earlier age,” Dr. Deep said. He also expressed a wish to know more about the reasons for the decreased benefit of screening sigmoidoscopy in women, and the reasons for the observed difference in all-cause mortality between genders.
“I would also like to see what the results of screening colonoscopies in a general population would reveal, and if it would reveal similar benefits, and also if there would be a gender difference or age-based difference in outcomes,” he said.
The study was supported by the Health Fund of South-East Norway. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.
FROM ANNALS OF INTERNAL MEDICINE