Liquid biopsy using circulating tumor (ctDNA) detection and profiling is a valuable tool for clinicians in monitoring hepatocellular carcinoma (HCC), particularly in monitoring progression, researchers wrote in a recent review.

Details of the review, led by co–first authors Xueying Lyu and Yu-Man Tsui, both of the department of pathology and State Key Laboratory of Liver Research at the University of Hong Kong, were published in Cellular and Molecular Gastroenterology and Hepatology.

Because there are few treatment options for advanced-stage liver cancer, scientists are searching for noninvasive ways to detect liver cancer before is progresses. Liver resection is the primary treatment for HCC, but the recurrence rate is high. Early detection increases the ability to identify relevant molecular-targeted drugs and helps predict patient response.

There is growing interest in noninvasive circulating cell-free DNA (cfDNA) as well as in ctDNA – both are part of promising strategies to test circulating DNA in the bloodstream. Together with other circulating biomarkers, they are called liquid biopsy.

HCC can be detected noninvasively by detecting plasma ctDNA released from dying cancer cells. Detection depends on determining whether the circulating tumor DNA has the same molecular alterations as its tumor source. cfDNA contains genomic DNA from different tumor clones or tumors from different sites within a patient to help real-time monitoring of tumor progression.

Barriers to widespread clinical use of liquid biopsy include lack of standardization of the collection process. Procedures differ across health systems on how much blood should be collected, which tubes should be used for collection and how samples should be stored and shipped. The study authors suggested that “specialized tubes can be used for blood sample collection to reduce the chance of white blood cell rupture and genomic DNA contamination from the damaged white blood cells.”
 

Further research is needed

The study findings indicated that some aspects of liquid biopsy with cfDNA/ctDNA still need further exploration. For example, the effects of tumor vascularization, tumor aggressiveness, metabolic activity, and cell death mechanism on the dynamics of ctDNA in the bloodstream need to be identified.

It’s not yet clear how cfDNA is released into the bloodstream. Actively released cfDNA from the tumor may convey a different message from cfDNA released passively from dying cells upon treatment. The first represents treatment-resistant cells/subclones while the second represents treatment-responsive cells/subclones. Moreover, it is difficult to detect ctDNA mutation in early stage cancers that have lower tumor burden.

The investigators wrote: “The contributions of cfDNA from apoptosis, necrosis, autophagic cell death, and active release at different time points during disease progression, treatment response, and resistance appearance are poorly understood and will affect interpretation of the clinical observation in cfDNA assays.” A lower limit of detection needs to be determined and a standard curve set so that researchers can quantify the allelic frequencies of the mutants in cfDNA and avoid false-negative detection.

They urged establishing external quality assurance to verify laboratory performance, the proficiency in the cfDNA diagnostic test, and interpretation of results to identify errors in sampling, procedures, and decision making. Legal liability and cost effectiveness of using plasma cfDNA in treatment decisions also need to be considered.

The researchers wrote that, to better understand how ctDNA/cfDNA can be used to complement precision medicine in liver cancer, large multicenter cohorts and long-term follow-up are needed to compare ctDNA-guided decision-making against standard treatment without guidance from ctDNA profiling.

The authors disclosed having no conflicts of interest.

Liquid biopsy using circulating tumor (ctDNA) detection and profiling is a valuable tool for clinicians in monitoring hepatocellular carcinoma (HCC), particularly in monitoring progression, researchers wrote in a recent review.

Details of the review, led by co–first authors Xueying Lyu and Yu-Man Tsui, both of the department of pathology and State Key Laboratory of Liver Research at the University of Hong Kong, were published in Cellular and Molecular Gastroenterology and Hepatology.

Because there are few treatment options for advanced-stage liver cancer, scientists are searching for noninvasive ways to detect liver cancer before is progresses. Liver resection is the primary treatment for HCC, but the recurrence rate is high. Early detection increases the ability to identify relevant molecular-targeted drugs and helps predict patient response.

There is growing interest in noninvasive circulating cell-free DNA (cfDNA) as well as in ctDNA – both are part of promising strategies to test circulating DNA in the bloodstream. Together with other circulating biomarkers, they are called liquid biopsy.

HCC can be detected noninvasively by detecting plasma ctDNA released from dying cancer cells. Detection depends on determining whether the circulating tumor DNA has the same molecular alterations as its tumor source. cfDNA contains genomic DNA from different tumor clones or tumors from different sites within a patient to help real-time monitoring of tumor progression.

Barriers to widespread clinical use of liquid biopsy include lack of standardization of the collection process. Procedures differ across health systems on how much blood should be collected, which tubes should be used for collection and how samples should be stored and shipped. The study authors suggested that “specialized tubes can be used for blood sample collection to reduce the chance of white blood cell rupture and genomic DNA contamination from the damaged white blood cells.”
 

Further research is needed

The study findings indicated that some aspects of liquid biopsy with cfDNA/ctDNA still need further exploration. For example, the effects of tumor vascularization, tumor aggressiveness, metabolic activity, and cell death mechanism on the dynamics of ctDNA in the bloodstream need to be identified.

It’s not yet clear how cfDNA is released into the bloodstream. Actively released cfDNA from the tumor may convey a different message from cfDNA released passively from dying cells upon treatment. The first represents treatment-resistant cells/subclones while the second represents treatment-responsive cells/subclones. Moreover, it is difficult to detect ctDNA mutation in early stage cancers that have lower tumor burden.

The investigators wrote: “The contributions of cfDNA from apoptosis, necrosis, autophagic cell death, and active release at different time points during disease progression, treatment response, and resistance appearance are poorly understood and will affect interpretation of the clinical observation in cfDNA assays.” A lower limit of detection needs to be determined and a standard curve set so that researchers can quantify the allelic frequencies of the mutants in cfDNA and avoid false-negative detection.

They urged establishing external quality assurance to verify laboratory performance, the proficiency in the cfDNA diagnostic test, and interpretation of results to identify errors in sampling, procedures, and decision making. Legal liability and cost effectiveness of using plasma cfDNA in treatment decisions also need to be considered.

The researchers wrote that, to better understand how ctDNA/cfDNA can be used to complement precision medicine in liver cancer, large multicenter cohorts and long-term follow-up are needed to compare ctDNA-guided decision-making against standard treatment without guidance from ctDNA profiling.

The authors disclosed having no conflicts of interest.

Liquid biopsy using circulating tumor (ctDNA) detection and profiling is a valuable tool for clinicians in monitoring hepatocellular carcinoma (HCC), particularly in monitoring progression, researchers wrote in a recent review.

Details of the review, led by co–first authors Xueying Lyu and Yu-Man Tsui, both of the department of pathology and State Key Laboratory of Liver Research at the University of Hong Kong, were published in Cellular and Molecular Gastroenterology and Hepatology.

Because there are few treatment options for advanced-stage liver cancer, scientists are searching for noninvasive ways to detect liver cancer before is progresses. Liver resection is the primary treatment for HCC, but the recurrence rate is high. Early detection increases the ability to identify relevant molecular-targeted drugs and helps predict patient response.

There is growing interest in noninvasive circulating cell-free DNA (cfDNA) as well as in ctDNA – both are part of promising strategies to test circulating DNA in the bloodstream. Together with other circulating biomarkers, they are called liquid biopsy.

HCC can be detected noninvasively by detecting plasma ctDNA released from dying cancer cells. Detection depends on determining whether the circulating tumor DNA has the same molecular alterations as its tumor source. cfDNA contains genomic DNA from different tumor clones or tumors from different sites within a patient to help real-time monitoring of tumor progression.

Barriers to widespread clinical use of liquid biopsy include lack of standardization of the collection process. Procedures differ across health systems on how much blood should be collected, which tubes should be used for collection and how samples should be stored and shipped. The study authors suggested that “specialized tubes can be used for blood sample collection to reduce the chance of white blood cell rupture and genomic DNA contamination from the damaged white blood cells.”
 

Further research is needed

The study findings indicated that some aspects of liquid biopsy with cfDNA/ctDNA still need further exploration. For example, the effects of tumor vascularization, tumor aggressiveness, metabolic activity, and cell death mechanism on the dynamics of ctDNA in the bloodstream need to be identified.

It’s not yet clear how cfDNA is released into the bloodstream. Actively released cfDNA from the tumor may convey a different message from cfDNA released passively from dying cells upon treatment. The first represents treatment-resistant cells/subclones while the second represents treatment-responsive cells/subclones. Moreover, it is difficult to detect ctDNA mutation in early stage cancers that have lower tumor burden.

The investigators wrote: “The contributions of cfDNA from apoptosis, necrosis, autophagic cell death, and active release at different time points during disease progression, treatment response, and resistance appearance are poorly understood and will affect interpretation of the clinical observation in cfDNA assays.” A lower limit of detection needs to be determined and a standard curve set so that researchers can quantify the allelic frequencies of the mutants in cfDNA and avoid false-negative detection.

They urged establishing external quality assurance to verify laboratory performance, the proficiency in the cfDNA diagnostic test, and interpretation of results to identify errors in sampling, procedures, and decision making. Legal liability and cost effectiveness of using plasma cfDNA in treatment decisions also need to be considered.

The researchers wrote that, to better understand how ctDNA/cfDNA can be used to complement precision medicine in liver cancer, large multicenter cohorts and long-term follow-up are needed to compare ctDNA-guided decision-making against standard treatment without guidance from ctDNA profiling.

The authors disclosed having no conflicts of interest.

Using the 2021 Kidney Disease: Improving Global Outcomes (KDIGO) guideline target of systolic blood pressure (BP) < 120 mm Hg, 66% of adults with chronic kidney disease (CKD) would be eligible for BP lowering, according to a study from Korea.

This represents an added > 10% of patients compared with two earlier guidelines, and these patients have a high risk of cardiovascular disease (CVD), Hyeok-Hee Lee, MD, Yonsei University College of Medicine, Seoul, South Korea, and colleagues reported.

London_England/Thinkstock

The study was published online  in the Journal of the American College of Cardiology.

“New candidates for BP-lowering treatment per the 2021 KDIGO guideline account for a substantial proportion of the total CKD population and bear significantly high CVD risk,” the researchers concluded.

“Undoubtedly, a multipronged approach will be required to address the swelling number of people needing more intense treatment, especially against a background of falling rates of BP control in the general community,” Alexander G. Logan, MD, of Mount Sinai Hospital, Toronto, and the University of Toronto, wrote in an accompanying editorial.

“Let’s not forget hypertension is the number one killer today,” Valentin Fuster, MD, of Icahn School of Medicine at Mount Sinai, New York, who is editor-in-chief of the Journal of the American College of Cardiology, stressed in a podcast that accompanied the article.

“Only 50% of individuals know of their blood pressure, and from this, less than half are properly treated,” he said.

“Today the details of knowing blood pressure levels appear to dominate over the huge ignorance of not knowing about blood pressure at all. Let’s think more and more about this reality,” he urged.
 

Three guidelines, two study objectives

The researchers compared three guidelines:

• The 2021 KDIGO guidelines, with a target systolic BP of < 120 mm Hg (largely based on the SPRINT trial).
• The 2012 KDIGO guidelines, with a target BP of ≤ 130/80 mm Hg for patients with albuminuria and ≤ 140/90 mm Hg for patients without albuminuria.
• The 2017 American College of Cardiology/American Heart Association (ACC/AHA) BP guideline target of < 130/80 mm Hg.

The study had two objectives:

• To examine the proportions of concordance and discordance between the three guidelines among adults with CKD based on cross-sectional data from the Korea National Health and Nutrition Examination Survey (KNHANES).
• To evaluate the association of each concordance/discordance group with cardiovascular outcomes of patients in the Korean National Health Insurance Service (NHIS) database.

For the first objective, the researchers identified 1,939 adults with CKD from the 2011-2014 survey cycles of KNHANES. Patients were a median age of 59 and 51% were men.

Comparison of the KDIGO 2021 versus 2012 BP targets showed that 50% of patients had BP above both targets; 16% had BP above the KDIGO 2021 target only; 4% had BP above the KDIGO 2012 target only; and 30% had BP control within both targets.

Comparison of the KDIGO 2021 versus 2017 ACC/AHA BP targets showed that 55% of patients had BP above both targets; 11% had BP above the KDIGO 2021 target only; 5% had BP above the 2017 ACC/AHA target only; and 29% had BP control within both targets.

For the second objective, using the NHIS database, researchers identified 412,167 adults with CKD who had routine health examinations during 2009 and 2010. The patients were a median age of 65 and 44% were men.

During a median follow-up of 10 years, the patients had 37,912 incident CVD events, defined as the first hospitalization for myocardial infarction, stroke, or heart failure, or death from CVD.

The adjusted risk of a composite CVD event was higher in patients with BP above the 2021 KDIGO target only (HR, 1.28) or above both the 2012 and 2021 KDIGO targets (HR, 1.52), compared to patients who had BP within both targets.

The adjusted risk of a composite CVD event was also higher in patients with BP above the 2021 KDIGO target only (HR, 1.18) or above both the 2021 KDIGO target and the 2017 ACC/AHA target (HR, 1.41), compared with patients who had BP within both targets.
 

Editorialist highlights three study aspects

Dr. Fuster noted three main points made by Dr. Logan.

First, the KDIGO 2021 guideline is based on office blood pressure, measured according to the procedure used in the 2017 ACC/AHA guideline. However, the SPRINT ambulatory BP ancillary study found that daytime ambulatory systolic BP was 6.8 mm Hg higher in the < 120 mm Hg group than clinic systolic BP that was measured with an automated BP device, mostly without study personnel.

Second, Dr. Logan noted that “not surprisingly, the investigators showed that the weighted proportion of adults with CKD eligible for BP lowering was highest (66.1%) according to 2021 KDIGO guideline,” compared with the two earlier guidelines.

The findings by Dr. Lee and colleagues align with those of a study that used data from the 2015-2018 U.S. NHANES to estimate the proportion of U.S. adults with CKD eligible for BP lowering according to the 2021 KDIGO guidelines, Dr. Logan added. The study found that 69% of U.S. adults (roughly 24.5 million) should correct their BP.

Third, the study in Korea showed a small percentage of patients (3%-5% of the total) had elevated diastolic BP but controlled systolic BP (< 120 mm Hg) with no increased risk of CVD compared to a reference group of patients with well-controlled BP.

“There is a paucity of evidence examining the relationship between diastolic hypertension and outcomes independently from systolic BP level in CKD patients,” Dr. Logan wrote. Similarly, Dr. Lee and colleagues identified this as an area for further research.

This work was supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea. The authors and editorialist have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Using the 2021 Kidney Disease: Improving Global Outcomes (KDIGO) guideline target of systolic blood pressure (BP) < 120 mm Hg, 66% of adults with chronic kidney disease (CKD) would be eligible for BP lowering, according to a study from Korea.

This represents an added > 10% of patients compared with two earlier guidelines, and these patients have a high risk of cardiovascular disease (CVD), Hyeok-Hee Lee, MD, Yonsei University College of Medicine, Seoul, South Korea, and colleagues reported.

London_England/Thinkstock

The study was published online  in the Journal of the American College of Cardiology.

“New candidates for BP-lowering treatment per the 2021 KDIGO guideline account for a substantial proportion of the total CKD population and bear significantly high CVD risk,” the researchers concluded.

“Undoubtedly, a multipronged approach will be required to address the swelling number of people needing more intense treatment, especially against a background of falling rates of BP control in the general community,” Alexander G. Logan, MD, of Mount Sinai Hospital, Toronto, and the University of Toronto, wrote in an accompanying editorial.

“Let’s not forget hypertension is the number one killer today,” Valentin Fuster, MD, of Icahn School of Medicine at Mount Sinai, New York, who is editor-in-chief of the Journal of the American College of Cardiology, stressed in a podcast that accompanied the article.

“Only 50% of individuals know of their blood pressure, and from this, less than half are properly treated,” he said.

“Today the details of knowing blood pressure levels appear to dominate over the huge ignorance of not knowing about blood pressure at all. Let’s think more and more about this reality,” he urged.
 

Three guidelines, two study objectives

The researchers compared three guidelines:

• The 2021 KDIGO guidelines, with a target systolic BP of < 120 mm Hg (largely based on the SPRINT trial).
• The 2012 KDIGO guidelines, with a target BP of ≤ 130/80 mm Hg for patients with albuminuria and ≤ 140/90 mm Hg for patients without albuminuria.
• The 2017 American College of Cardiology/American Heart Association (ACC/AHA) BP guideline target of < 130/80 mm Hg.

The study had two objectives:

• To examine the proportions of concordance and discordance between the three guidelines among adults with CKD based on cross-sectional data from the Korea National Health and Nutrition Examination Survey (KNHANES).
• To evaluate the association of each concordance/discordance group with cardiovascular outcomes of patients in the Korean National Health Insurance Service (NHIS) database.

For the first objective, the researchers identified 1,939 adults with CKD from the 2011-2014 survey cycles of KNHANES. Patients were a median age of 59 and 51% were men.

Comparison of the KDIGO 2021 versus 2012 BP targets showed that 50% of patients had BP above both targets; 16% had BP above the KDIGO 2021 target only; 4% had BP above the KDIGO 2012 target only; and 30% had BP control within both targets.

Comparison of the KDIGO 2021 versus 2017 ACC/AHA BP targets showed that 55% of patients had BP above both targets; 11% had BP above the KDIGO 2021 target only; 5% had BP above the 2017 ACC/AHA target only; and 29% had BP control within both targets.

For the second objective, using the NHIS database, researchers identified 412,167 adults with CKD who had routine health examinations during 2009 and 2010. The patients were a median age of 65 and 44% were men.

During a median follow-up of 10 years, the patients had 37,912 incident CVD events, defined as the first hospitalization for myocardial infarction, stroke, or heart failure, or death from CVD.

The adjusted risk of a composite CVD event was higher in patients with BP above the 2021 KDIGO target only (HR, 1.28) or above both the 2012 and 2021 KDIGO targets (HR, 1.52), compared to patients who had BP within both targets.

The adjusted risk of a composite CVD event was also higher in patients with BP above the 2021 KDIGO target only (HR, 1.18) or above both the 2021 KDIGO target and the 2017 ACC/AHA target (HR, 1.41), compared with patients who had BP within both targets.
 

Editorialist highlights three study aspects

Dr. Fuster noted three main points made by Dr. Logan.

First, the KDIGO 2021 guideline is based on office blood pressure, measured according to the procedure used in the 2017 ACC/AHA guideline. However, the SPRINT ambulatory BP ancillary study found that daytime ambulatory systolic BP was 6.8 mm Hg higher in the < 120 mm Hg group than clinic systolic BP that was measured with an automated BP device, mostly without study personnel.

Second, Dr. Logan noted that “not surprisingly, the investigators showed that the weighted proportion of adults with CKD eligible for BP lowering was highest (66.1%) according to 2021 KDIGO guideline,” compared with the two earlier guidelines.

The findings by Dr. Lee and colleagues align with those of a study that used data from the 2015-2018 U.S. NHANES to estimate the proportion of U.S. adults with CKD eligible for BP lowering according to the 2021 KDIGO guidelines, Dr. Logan added. The study found that 69% of U.S. adults (roughly 24.5 million) should correct their BP.

Third, the study in Korea showed a small percentage of patients (3%-5% of the total) had elevated diastolic BP but controlled systolic BP (< 120 mm Hg) with no increased risk of CVD compared to a reference group of patients with well-controlled BP.

“There is a paucity of evidence examining the relationship between diastolic hypertension and outcomes independently from systolic BP level in CKD patients,” Dr. Logan wrote. Similarly, Dr. Lee and colleagues identified this as an area for further research.

This work was supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea. The authors and editorialist have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Using the 2021 Kidney Disease: Improving Global Outcomes (KDIGO) guideline target of systolic blood pressure (BP) < 120 mm Hg, 66% of adults with chronic kidney disease (CKD) would be eligible for BP lowering, according to a study from Korea.

This represents an added > 10% of patients compared with two earlier guidelines, and these patients have a high risk of cardiovascular disease (CVD), Hyeok-Hee Lee, MD, Yonsei University College of Medicine, Seoul, South Korea, and colleagues reported.

London_England/Thinkstock

The study was published online  in the Journal of the American College of Cardiology.

“New candidates for BP-lowering treatment per the 2021 KDIGO guideline account for a substantial proportion of the total CKD population and bear significantly high CVD risk,” the researchers concluded.

“Undoubtedly, a multipronged approach will be required to address the swelling number of people needing more intense treatment, especially against a background of falling rates of BP control in the general community,” Alexander G. Logan, MD, of Mount Sinai Hospital, Toronto, and the University of Toronto, wrote in an accompanying editorial.

“Let’s not forget hypertension is the number one killer today,” Valentin Fuster, MD, of Icahn School of Medicine at Mount Sinai, New York, who is editor-in-chief of the Journal of the American College of Cardiology, stressed in a podcast that accompanied the article.

“Only 50% of individuals know of their blood pressure, and from this, less than half are properly treated,” he said.

“Today the details of knowing blood pressure levels appear to dominate over the huge ignorance of not knowing about blood pressure at all. Let’s think more and more about this reality,” he urged.
 

Three guidelines, two study objectives

The researchers compared three guidelines:

• The 2021 KDIGO guidelines, with a target systolic BP of < 120 mm Hg (largely based on the SPRINT trial).
• The 2012 KDIGO guidelines, with a target BP of ≤ 130/80 mm Hg for patients with albuminuria and ≤ 140/90 mm Hg for patients without albuminuria.
• The 2017 American College of Cardiology/American Heart Association (ACC/AHA) BP guideline target of < 130/80 mm Hg.

The study had two objectives:

• To examine the proportions of concordance and discordance between the three guidelines among adults with CKD based on cross-sectional data from the Korea National Health and Nutrition Examination Survey (KNHANES).
• To evaluate the association of each concordance/discordance group with cardiovascular outcomes of patients in the Korean National Health Insurance Service (NHIS) database.

For the first objective, the researchers identified 1,939 adults with CKD from the 2011-2014 survey cycles of KNHANES. Patients were a median age of 59 and 51% were men.

Comparison of the KDIGO 2021 versus 2012 BP targets showed that 50% of patients had BP above both targets; 16% had BP above the KDIGO 2021 target only; 4% had BP above the KDIGO 2012 target only; and 30% had BP control within both targets.

Comparison of the KDIGO 2021 versus 2017 ACC/AHA BP targets showed that 55% of patients had BP above both targets; 11% had BP above the KDIGO 2021 target only; 5% had BP above the 2017 ACC/AHA target only; and 29% had BP control within both targets.

For the second objective, using the NHIS database, researchers identified 412,167 adults with CKD who had routine health examinations during 2009 and 2010. The patients were a median age of 65 and 44% were men.

During a median follow-up of 10 years, the patients had 37,912 incident CVD events, defined as the first hospitalization for myocardial infarction, stroke, or heart failure, or death from CVD.

The adjusted risk of a composite CVD event was higher in patients with BP above the 2021 KDIGO target only (HR, 1.28) or above both the 2012 and 2021 KDIGO targets (HR, 1.52), compared to patients who had BP within both targets.

The adjusted risk of a composite CVD event was also higher in patients with BP above the 2021 KDIGO target only (HR, 1.18) or above both the 2021 KDIGO target and the 2017 ACC/AHA target (HR, 1.41), compared with patients who had BP within both targets.
 

Editorialist highlights three study aspects

Dr. Fuster noted three main points made by Dr. Logan.

First, the KDIGO 2021 guideline is based on office blood pressure, measured according to the procedure used in the 2017 ACC/AHA guideline. However, the SPRINT ambulatory BP ancillary study found that daytime ambulatory systolic BP was 6.8 mm Hg higher in the < 120 mm Hg group than clinic systolic BP that was measured with an automated BP device, mostly without study personnel.

Second, Dr. Logan noted that “not surprisingly, the investigators showed that the weighted proportion of adults with CKD eligible for BP lowering was highest (66.1%) according to 2021 KDIGO guideline,” compared with the two earlier guidelines.

The findings by Dr. Lee and colleagues align with those of a study that used data from the 2015-2018 U.S. NHANES to estimate the proportion of U.S. adults with CKD eligible for BP lowering according to the 2021 KDIGO guidelines, Dr. Logan added. The study found that 69% of U.S. adults (roughly 24.5 million) should correct their BP.

Third, the study in Korea showed a small percentage of patients (3%-5% of the total) had elevated diastolic BP but controlled systolic BP (< 120 mm Hg) with no increased risk of CVD compared to a reference group of patients with well-controlled BP.

“There is a paucity of evidence examining the relationship between diastolic hypertension and outcomes independently from systolic BP level in CKD patients,” Dr. Logan wrote. Similarly, Dr. Lee and colleagues identified this as an area for further research.

This work was supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea. The authors and editorialist have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Two new cancer drugs have been recommended for approval in the European Union (EU): capmatinib (Tabrecta, Novartis) for the treatment of advanced non–small cell lung cancer (NSCLC) with certain mutations, and conditional approval of mosunetuzumab (Lunsumio, Roche) for relapsed or refractory follicular lymphoma.

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the two products at its April meeting.
 

New drug for certain lung cancer patients

Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and is indicated for the treatment of patients with advanced NSCLC harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping. Patients must have already been treated with immunotherapy and/or platinum-based chemotherapy.

The product is approved in the United States, and the Food and Drug Administration noted that it is the first approved treatment for NSCLC with MET exon 14-skipping mutations.

The FDA granted the drug an accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, which included a cohort of previously treated and treatment-naive patients. The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months.

The most common side effects were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
 

Conditional approval for lymphoma

Mosunetuzumab is an investigational bispecific antibody targeting CD20 and CD3, and redirects T cells to engage and eliminate malignant B cells.

The CHMP recommended a conditional approval for this drug for use as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma  who have received at least two prior systemic therapies.

Mosunetuzumab was reviewed under EMA’s accelerated access program, which usually takes 150 evaluation days as opposed to 210, and it was designated as an orphan medicine during its development.

The EMA stated that the benefits of this product are the high proportion of patients with a complete response and the durability of the treatment response.

As previously reported by this news organization, results from a phase 2 expansion study showed that when used as monotherapy, it induced high response rates and long-duration responses in patients with heavily pretreated, relapsed, or refractory follicular lymphoma.

At a median follow-up of 18.3 months, 54 of 90 patients (60%) had a complete response, and 18 (20%) had a partial response after treatment with mosunetuzumab.

The most common reported side effects were cytokine release syndrome, neutropenia, pyrexia (fever), hypophosphatemia, and headache.

Mosunetuzumab is awaiting FDA approval in the United States.

A conditional marketing authorization from CHMP is granted to products that meet an unmet medical need, and when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorization holder is expected to provide comprehensive clinical data at a later stage.

Detailed recommendations for the use of both products will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

A version of this article first appeared on Medscape.com.

Two new cancer drugs have been recommended for approval in the European Union (EU): capmatinib (Tabrecta, Novartis) for the treatment of advanced non–small cell lung cancer (NSCLC) with certain mutations, and conditional approval of mosunetuzumab (Lunsumio, Roche) for relapsed or refractory follicular lymphoma.

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the two products at its April meeting.
 

New drug for certain lung cancer patients

Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and is indicated for the treatment of patients with advanced NSCLC harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping. Patients must have already been treated with immunotherapy and/or platinum-based chemotherapy.

The product is approved in the United States, and the Food and Drug Administration noted that it is the first approved treatment for NSCLC with MET exon 14-skipping mutations.

The FDA granted the drug an accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, which included a cohort of previously treated and treatment-naive patients. The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months.

The most common side effects were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
 

Conditional approval for lymphoma

Mosunetuzumab is an investigational bispecific antibody targeting CD20 and CD3, and redirects T cells to engage and eliminate malignant B cells.

The CHMP recommended a conditional approval for this drug for use as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma  who have received at least two prior systemic therapies.

Mosunetuzumab was reviewed under EMA’s accelerated access program, which usually takes 150 evaluation days as opposed to 210, and it was designated as an orphan medicine during its development.

The EMA stated that the benefits of this product are the high proportion of patients with a complete response and the durability of the treatment response.

As previously reported by this news organization, results from a phase 2 expansion study showed that when used as monotherapy, it induced high response rates and long-duration responses in patients with heavily pretreated, relapsed, or refractory follicular lymphoma.

At a median follow-up of 18.3 months, 54 of 90 patients (60%) had a complete response, and 18 (20%) had a partial response after treatment with mosunetuzumab.

The most common reported side effects were cytokine release syndrome, neutropenia, pyrexia (fever), hypophosphatemia, and headache.

Mosunetuzumab is awaiting FDA approval in the United States.

A conditional marketing authorization from CHMP is granted to products that meet an unmet medical need, and when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorization holder is expected to provide comprehensive clinical data at a later stage.

Detailed recommendations for the use of both products will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

A version of this article first appeared on Medscape.com.

Two new cancer drugs have been recommended for approval in the European Union (EU): capmatinib (Tabrecta, Novartis) for the treatment of advanced non–small cell lung cancer (NSCLC) with certain mutations, and conditional approval of mosunetuzumab (Lunsumio, Roche) for relapsed or refractory follicular lymphoma.

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the two products at its April meeting.
 

New drug for certain lung cancer patients

Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and is indicated for the treatment of patients with advanced NSCLC harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping. Patients must have already been treated with immunotherapy and/or platinum-based chemotherapy.

The product is approved in the United States, and the Food and Drug Administration noted that it is the first approved treatment for NSCLC with MET exon 14-skipping mutations.

The FDA granted the drug an accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, which included a cohort of previously treated and treatment-naive patients. The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months.

The most common side effects were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
 

Conditional approval for lymphoma

Mosunetuzumab is an investigational bispecific antibody targeting CD20 and CD3, and redirects T cells to engage and eliminate malignant B cells.

The CHMP recommended a conditional approval for this drug for use as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma  who have received at least two prior systemic therapies.

Mosunetuzumab was reviewed under EMA’s accelerated access program, which usually takes 150 evaluation days as opposed to 210, and it was designated as an orphan medicine during its development.

The EMA stated that the benefits of this product are the high proportion of patients with a complete response and the durability of the treatment response.

As previously reported by this news organization, results from a phase 2 expansion study showed that when used as monotherapy, it induced high response rates and long-duration responses in patients with heavily pretreated, relapsed, or refractory follicular lymphoma.

At a median follow-up of 18.3 months, 54 of 90 patients (60%) had a complete response, and 18 (20%) had a partial response after treatment with mosunetuzumab.

The most common reported side effects were cytokine release syndrome, neutropenia, pyrexia (fever), hypophosphatemia, and headache.

Mosunetuzumab is awaiting FDA approval in the United States.

A conditional marketing authorization from CHMP is granted to products that meet an unmet medical need, and when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorization holder is expected to provide comprehensive clinical data at a later stage.

Detailed recommendations for the use of both products will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

A version of this article first appeared on Medscape.com.

Bacteria and viruses are the leading causes of community-acquired meningitis. Bacterial meningitis is associated with high morbidity and mortality, and prompt treatment with appropriate antibiotics is essential to optimize outcomes. Early diagnosis is therefore crucial for selecting patients who need antibiotics. On the other hand, the course of viral meningitis is generally benign, and there is usually no specific antimicrobial treatment required. Distinguishing between viral and bacterial causes of meningitis can be challenging; therefore, many patients receive empiric antibiotic treatment.

Etiology

Medscape

Among the etiologic agents of viral meningitis, the nonpolio enteroviruses (Echovirus 30, 11, 9, 6, 7, 18, 16, 71, 25; Coxsackie B2, A9, B1, B3, B4) are the most common, responsible for more than 85% of cases. Other viruses potentially responsible for meningitis include the herpes simplex virus (HSV), primarily type 2, and flavivirus (such as the Dengue virus).

Clinical presentation

The clinical presentation of bacterial meningitis is more severe than that of viral meningitis. The classic clinical triad of bacterial meningitis consists of fever, neck stiffness, and altered mental status. Only 41% of cases present with these three symptoms, however. Other clinical characteristics include severe headaches, decreased level of consciousness, nausea, vomiting, seizures, focal neurologic signs, and skin rash.

Viral meningitis is usually not associated with a decreased level of consciousness or significant decline in overall health status. The most frequently reported symptoms are unusual headaches, fever, nausea, vomiting, sensitivity to light, and neck stiffness. Patients may also present with skin changes and lymphadenopathy, and, depending on etiology, genital ulcers.
 

Diagnosis

The diagnosis of bacterial meningitis is based on clinical symptoms, blood panels (blood count, inflammation markers, cultures), and cerebrospinal fluid (CSF) cultures. Gram staining and latex agglutination may lead to false-negative results, and cultures may take a few days to provide a definitive result. Therefore, empiric antibiotic treatment is often started until the etiology can be determined.

A spinal tap must always be performed, preferably after a scan is taken, to rule out the risk of herniation. After CSF samples have been collected, they must undergo complete analysis, including cytological, biochemical, and microbiological evaluation, using conventional and molecular testing methods, when available.

Cytological and biochemical analyses of CSF may be helpful, as findings may indicate a higher probability of either bacterial or viral etiology.

CSF samples collected from patients with acute bacterial meningitis present characteristic neutrophilic pleocytosis (cell count usually ranging from hundreds to a few thousand, with >80% polymorphonuclear cells). In some cases of L. monocytogenes meningitis (from 25% to 30%), a lymphocytic predominance may occur. Normally, glucose is low (CSF glucose-to-blood-glucose ratio of ≤0.4 or <40 mg/dL), protein is very high (>200 mg/dL), and the CSF lactate level is high (≥31.53 mg/dL).

In viral meningitis, the white blood cell count is generally 10-300 cells/mm³. Although glucose levels are normal in most cases, they may be below normal limits in lymphocytic choriomeningitis virus (LCMV), HSV, mumps virus, and poliovirus meningitis. Protein levels tend to be slightly elevated, but they may still be within the reference range. 

A recent study investigated which of the cytological or biochemical markers best correlate with the definite etiologic diagnosis. This study, in which CSF samples were collected and analyzed from 2013 to 2017, considered cases of bacterial or viral meningitis confirmed via microbiological evaluation or polymerase chain reaction (PCR). CSF lactate was the best single CSF parameter, and CSF lactate above 30 mg/dL virtually excludes the possibility of a viral etiology. 
 

Etiologic determination

Despite the major contribution of globally analyzing CSF and secondary parameters, particularly CSF lactate, the precise etiologic definition is of great importance in cases of acute meningitis. Such precise definition is not simple, as identification of the causative microorganism is often difficult. Moreover, there are limits to conventional microbiological methods. Bacterioscopy is poorly sensitive, and although bacterial cultures are more sensitive, they can delay diagnosis because of the time it takes for the bacteria to grow in culture media.

Targeted molecular detection methods are usually more sensitive than conventional microbiological methods. Panel-based molecular tests identify multiple pathogens in a single test. In 2015, the U.S. Food and Drug Administration authorized the first commercial multiplex detection system for infectious causes of community-acquired meningitis and encephalitis. This test, the BioFire FilmArray system, detects 14 bacterial, viral, and fungal pathogens in a turnaround time of about 1 hour, including S. pneumoniae, N. meningitidis, H. influenzae, S. agalactiae (i.e., group B Streptococcus), E. coli (serotype K1), L. monocytogenes, HSV-1, HSV-2, varicella-zoster virus (VZV), cytomegalovirus (CMV), human herpesvirus 6 (HHV-6), human parechovirus (HPeV), and Cryptococcus neoformans/gattii.

A meta-analysis of eight precise diagnostic studies evaluating the BioFire FilmArray system showed a high sensitivity of 90% (95% confidence interval, 86%-93%) and specificity of 97% (95% CI, 94%-99%). The FilmArray ME panel can halve the time to microbiological result, allowing for earlier discontinuation of antimicrobial agents and hospital discharge in cases of viral meningitis. 
 

Conclusion

Acute community-acquired meningitis is usually the result of viral or bacterial infections. Given the low specificity of clinical symptoms and, very often, of the general laboratory panel findings, many patients are empirically treated with antibiotics. High-sensitivity and -specificity molecular techniques allow for rapid identification of the bacterial etiology (which requires antibiotic therapy) or the viral etiology of meningitis. The latter can be managed only with symptom-specific medications and does not usually require extended hospitalization. Therefore, these new techniques can improve the quality of care for these patients with viral meningitis.

A version of this article first appeared on Medscape.com.

Bacteria and viruses are the leading causes of community-acquired meningitis. Bacterial meningitis is associated with high morbidity and mortality, and prompt treatment with appropriate antibiotics is essential to optimize outcomes. Early diagnosis is therefore crucial for selecting patients who need antibiotics. On the other hand, the course of viral meningitis is generally benign, and there is usually no specific antimicrobial treatment required. Distinguishing between viral and bacterial causes of meningitis can be challenging; therefore, many patients receive empiric antibiotic treatment.

Etiology

Medscape

Among the etiologic agents of viral meningitis, the nonpolio enteroviruses (Echovirus 30, 11, 9, 6, 7, 18, 16, 71, 25; Coxsackie B2, A9, B1, B3, B4) are the most common, responsible for more than 85% of cases. Other viruses potentially responsible for meningitis include the herpes simplex virus (HSV), primarily type 2, and flavivirus (such as the Dengue virus).

Clinical presentation

The clinical presentation of bacterial meningitis is more severe than that of viral meningitis. The classic clinical triad of bacterial meningitis consists of fever, neck stiffness, and altered mental status. Only 41% of cases present with these three symptoms, however. Other clinical characteristics include severe headaches, decreased level of consciousness, nausea, vomiting, seizures, focal neurologic signs, and skin rash.

Viral meningitis is usually not associated with a decreased level of consciousness or significant decline in overall health status. The most frequently reported symptoms are unusual headaches, fever, nausea, vomiting, sensitivity to light, and neck stiffness. Patients may also present with skin changes and lymphadenopathy, and, depending on etiology, genital ulcers.
 

Diagnosis

The diagnosis of bacterial meningitis is based on clinical symptoms, blood panels (blood count, inflammation markers, cultures), and cerebrospinal fluid (CSF) cultures. Gram staining and latex agglutination may lead to false-negative results, and cultures may take a few days to provide a definitive result. Therefore, empiric antibiotic treatment is often started until the etiology can be determined.

A spinal tap must always be performed, preferably after a scan is taken, to rule out the risk of herniation. After CSF samples have been collected, they must undergo complete analysis, including cytological, biochemical, and microbiological evaluation, using conventional and molecular testing methods, when available.

Cytological and biochemical analyses of CSF may be helpful, as findings may indicate a higher probability of either bacterial or viral etiology.

CSF samples collected from patients with acute bacterial meningitis present characteristic neutrophilic pleocytosis (cell count usually ranging from hundreds to a few thousand, with >80% polymorphonuclear cells). In some cases of L. monocytogenes meningitis (from 25% to 30%), a lymphocytic predominance may occur. Normally, glucose is low (CSF glucose-to-blood-glucose ratio of ≤0.4 or <40 mg/dL), protein is very high (>200 mg/dL), and the CSF lactate level is high (≥31.53 mg/dL).

In viral meningitis, the white blood cell count is generally 10-300 cells/mm³. Although glucose levels are normal in most cases, they may be below normal limits in lymphocytic choriomeningitis virus (LCMV), HSV, mumps virus, and poliovirus meningitis. Protein levels tend to be slightly elevated, but they may still be within the reference range. 

A recent study investigated which of the cytological or biochemical markers best correlate with the definite etiologic diagnosis. This study, in which CSF samples were collected and analyzed from 2013 to 2017, considered cases of bacterial or viral meningitis confirmed via microbiological evaluation or polymerase chain reaction (PCR). CSF lactate was the best single CSF parameter, and CSF lactate above 30 mg/dL virtually excludes the possibility of a viral etiology. 
 

Etiologic determination

Despite the major contribution of globally analyzing CSF and secondary parameters, particularly CSF lactate, the precise etiologic definition is of great importance in cases of acute meningitis. Such precise definition is not simple, as identification of the causative microorganism is often difficult. Moreover, there are limits to conventional microbiological methods. Bacterioscopy is poorly sensitive, and although bacterial cultures are more sensitive, they can delay diagnosis because of the time it takes for the bacteria to grow in culture media.

Targeted molecular detection methods are usually more sensitive than conventional microbiological methods. Panel-based molecular tests identify multiple pathogens in a single test. In 2015, the U.S. Food and Drug Administration authorized the first commercial multiplex detection system for infectious causes of community-acquired meningitis and encephalitis. This test, the BioFire FilmArray system, detects 14 bacterial, viral, and fungal pathogens in a turnaround time of about 1 hour, including S. pneumoniae, N. meningitidis, H. influenzae, S. agalactiae (i.e., group B Streptococcus), E. coli (serotype K1), L. monocytogenes, HSV-1, HSV-2, varicella-zoster virus (VZV), cytomegalovirus (CMV), human herpesvirus 6 (HHV-6), human parechovirus (HPeV), and Cryptococcus neoformans/gattii.

A meta-analysis of eight precise diagnostic studies evaluating the BioFire FilmArray system showed a high sensitivity of 90% (95% confidence interval, 86%-93%) and specificity of 97% (95% CI, 94%-99%). The FilmArray ME panel can halve the time to microbiological result, allowing for earlier discontinuation of antimicrobial agents and hospital discharge in cases of viral meningitis. 
 

Conclusion

Acute community-acquired meningitis is usually the result of viral or bacterial infections. Given the low specificity of clinical symptoms and, very often, of the general laboratory panel findings, many patients are empirically treated with antibiotics. High-sensitivity and -specificity molecular techniques allow for rapid identification of the bacterial etiology (which requires antibiotic therapy) or the viral etiology of meningitis. The latter can be managed only with symptom-specific medications and does not usually require extended hospitalization. Therefore, these new techniques can improve the quality of care for these patients with viral meningitis.

A version of this article first appeared on Medscape.com.

Bacteria and viruses are the leading causes of community-acquired meningitis. Bacterial meningitis is associated with high morbidity and mortality, and prompt treatment with appropriate antibiotics is essential to optimize outcomes. Early diagnosis is therefore crucial for selecting patients who need antibiotics. On the other hand, the course of viral meningitis is generally benign, and there is usually no specific antimicrobial treatment required. Distinguishing between viral and bacterial causes of meningitis can be challenging; therefore, many patients receive empiric antibiotic treatment.

Etiology

Medscape

Among the etiologic agents of viral meningitis, the nonpolio enteroviruses (Echovirus 30, 11, 9, 6, 7, 18, 16, 71, 25; Coxsackie B2, A9, B1, B3, B4) are the most common, responsible for more than 85% of cases. Other viruses potentially responsible for meningitis include the herpes simplex virus (HSV), primarily type 2, and flavivirus (such as the Dengue virus).

Clinical presentation

The clinical presentation of bacterial meningitis is more severe than that of viral meningitis. The classic clinical triad of bacterial meningitis consists of fever, neck stiffness, and altered mental status. Only 41% of cases present with these three symptoms, however. Other clinical characteristics include severe headaches, decreased level of consciousness, nausea, vomiting, seizures, focal neurologic signs, and skin rash.

Viral meningitis is usually not associated with a decreased level of consciousness or significant decline in overall health status. The most frequently reported symptoms are unusual headaches, fever, nausea, vomiting, sensitivity to light, and neck stiffness. Patients may also present with skin changes and lymphadenopathy, and, depending on etiology, genital ulcers.
 

Diagnosis

The diagnosis of bacterial meningitis is based on clinical symptoms, blood panels (blood count, inflammation markers, cultures), and cerebrospinal fluid (CSF) cultures. Gram staining and latex agglutination may lead to false-negative results, and cultures may take a few days to provide a definitive result. Therefore, empiric antibiotic treatment is often started until the etiology can be determined.

A spinal tap must always be performed, preferably after a scan is taken, to rule out the risk of herniation. After CSF samples have been collected, they must undergo complete analysis, including cytological, biochemical, and microbiological evaluation, using conventional and molecular testing methods, when available.

Cytological and biochemical analyses of CSF may be helpful, as findings may indicate a higher probability of either bacterial or viral etiology.

CSF samples collected from patients with acute bacterial meningitis present characteristic neutrophilic pleocytosis (cell count usually ranging from hundreds to a few thousand, with >80% polymorphonuclear cells). In some cases of L. monocytogenes meningitis (from 25% to 30%), a lymphocytic predominance may occur. Normally, glucose is low (CSF glucose-to-blood-glucose ratio of ≤0.4 or <40 mg/dL), protein is very high (>200 mg/dL), and the CSF lactate level is high (≥31.53 mg/dL).

In viral meningitis, the white blood cell count is generally 10-300 cells/mm³. Although glucose levels are normal in most cases, they may be below normal limits in lymphocytic choriomeningitis virus (LCMV), HSV, mumps virus, and poliovirus meningitis. Protein levels tend to be slightly elevated, but they may still be within the reference range. 

A recent study investigated which of the cytological or biochemical markers best correlate with the definite etiologic diagnosis. This study, in which CSF samples were collected and analyzed from 2013 to 2017, considered cases of bacterial or viral meningitis confirmed via microbiological evaluation or polymerase chain reaction (PCR). CSF lactate was the best single CSF parameter, and CSF lactate above 30 mg/dL virtually excludes the possibility of a viral etiology. 
 

Etiologic determination

Despite the major contribution of globally analyzing CSF and secondary parameters, particularly CSF lactate, the precise etiologic definition is of great importance in cases of acute meningitis. Such precise definition is not simple, as identification of the causative microorganism is often difficult. Moreover, there are limits to conventional microbiological methods. Bacterioscopy is poorly sensitive, and although bacterial cultures are more sensitive, they can delay diagnosis because of the time it takes for the bacteria to grow in culture media.

Targeted molecular detection methods are usually more sensitive than conventional microbiological methods. Panel-based molecular tests identify multiple pathogens in a single test. In 2015, the U.S. Food and Drug Administration authorized the first commercial multiplex detection system for infectious causes of community-acquired meningitis and encephalitis. This test, the BioFire FilmArray system, detects 14 bacterial, viral, and fungal pathogens in a turnaround time of about 1 hour, including S. pneumoniae, N. meningitidis, H. influenzae, S. agalactiae (i.e., group B Streptococcus), E. coli (serotype K1), L. monocytogenes, HSV-1, HSV-2, varicella-zoster virus (VZV), cytomegalovirus (CMV), human herpesvirus 6 (HHV-6), human parechovirus (HPeV), and Cryptococcus neoformans/gattii.

A meta-analysis of eight precise diagnostic studies evaluating the BioFire FilmArray system showed a high sensitivity of 90% (95% confidence interval, 86%-93%) and specificity of 97% (95% CI, 94%-99%). The FilmArray ME panel can halve the time to microbiological result, allowing for earlier discontinuation of antimicrobial agents and hospital discharge in cases of viral meningitis. 
 

Conclusion

Acute community-acquired meningitis is usually the result of viral or bacterial infections. Given the low specificity of clinical symptoms and, very often, of the general laboratory panel findings, many patients are empirically treated with antibiotics. High-sensitivity and -specificity molecular techniques allow for rapid identification of the bacterial etiology (which requires antibiotic therapy) or the viral etiology of meningitis. The latter can be managed only with symptom-specific medications and does not usually require extended hospitalization. Therefore, these new techniques can improve the quality of care for these patients with viral meningitis.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

A version of this article first appeared on Medscape.com.

Contrary to popular belief, no association appeared between the number of intensive care unit beds and COVID-19 deaths, based on a review of data from all 50 states between March 1, 2020, and June 30, 2021.

One of the reasons for poor patient outcomes in the early months of the COVID-19 pandemic was the presumed scarcity of ICU beds, Omar Haider, MD, of Houston Methodist Hospital, and colleagues said. “We hypothesized that the states having a lower number of ICU beds had more COVID-related deaths when compared to the states that had a higher number of ICU beds,” they wrote in an abstract presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

According to the researchers, the total number of ICU beds in the United States is approximately 85,000. Hawaii has the highest number of beds per 10,000 persons, and the District of Columbia has the lowest (6.0 vs. 1.6).

The researchers collected data on ICU bed totals from the Kaiser Family Foundation. Statistics on COVID-19 deaths were obtained from The New York Times database, which provided real-time information collected from the Department of Health & Human Services, the Centers for Disease Control and Prevention, and the Census Bureau.

The researchers used the Pearson Correlation Coefficient to compare ICU beds and COVID deaths per 10,000 persons in each state. The R value was 0.29, which indicates no inverse correlation. “Our value of R2, the coefficient of determination, was 0.0858,” they added. They confirmed the results using the Spearman’s Rho, which yielded an rs of 0.3, also a sign of no inverse correlation. No correlation was found between low numbers of ICU beds and high numbers of COVID-19 deaths for any states.

The study findings were limited by several factors, including the lack of standardized reporting timelines across states, differences in state-based vaccination rates, the emergence of the Delta variant during the study period, and time-lag in contemporaneous database updates, the researchers noted.

However, the results suggest that physical ICU beds do not play a role in determining the number of COVID-related deaths. Instead, “other constraints such as less staffing, lack of medical supplies (ventilators and [personal protective equipment]) should be evaluated for potential implications on poor patients’ outcomes,” they concluded.
 

Pandemic challenges can inform future plans

“As the health care system emerges from the effects of the pandemic, it is important to understand the factors that contributed to adverse outcomes to better prepare for future challenges and improve the delivery of care,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview. 

“The findings are not surprising considering what is known about the multitude of factors that determine outcomes for our patients from medical comorbidities, and social determinants of health to upstream structural factors such as systemic inequities and generational trauma,” said Dr. Pal, who was not involved with the study. “Thus, a simple correlation of the number of ICU beds to COVID-19 outcomes is not likely to capture the interplay of all these factors.”

The challenges of the pandemic offer insights to inform future planning, said Dr. Pal.

“In my opinion, a key factor to understand and address would be employee wellness for health care workers,” he said. “The problem of burnout leading to health care workers leaving the workforce has exacerbated the already acute shortages in personnel in recent years.

“In the long term, it may be prudent to reconsider the approach to health by increasing support for preventative and primary care, addressing social factors such as education, nutrition, and housing, to mitigate preventable aspects of diseases.”

Further research is needed to examine the multitude of factors associated with the pandemic, and their interplay, said Dr. Pal. The goals of such research “would be needed to develop a deeper understanding of the factors that contributed to mortality in COVID-19 and the disparities with this across different subpopulations.”

The study received no outside funding. The researchers and Dr. Pal disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Contrary to popular belief, no association appeared between the number of intensive care unit beds and COVID-19 deaths, based on a review of data from all 50 states between March 1, 2020, and June 30, 2021.

One of the reasons for poor patient outcomes in the early months of the COVID-19 pandemic was the presumed scarcity of ICU beds, Omar Haider, MD, of Houston Methodist Hospital, and colleagues said. “We hypothesized that the states having a lower number of ICU beds had more COVID-related deaths when compared to the states that had a higher number of ICU beds,” they wrote in an abstract presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

According to the researchers, the total number of ICU beds in the United States is approximately 85,000. Hawaii has the highest number of beds per 10,000 persons, and the District of Columbia has the lowest (6.0 vs. 1.6).

The researchers collected data on ICU bed totals from the Kaiser Family Foundation. Statistics on COVID-19 deaths were obtained from The New York Times database, which provided real-time information collected from the Department of Health & Human Services, the Centers for Disease Control and Prevention, and the Census Bureau.

The researchers used the Pearson Correlation Coefficient to compare ICU beds and COVID deaths per 10,000 persons in each state. The R value was 0.29, which indicates no inverse correlation. “Our value of R2, the coefficient of determination, was 0.0858,” they added. They confirmed the results using the Spearman’s Rho, which yielded an rs of 0.3, also a sign of no inverse correlation. No correlation was found between low numbers of ICU beds and high numbers of COVID-19 deaths for any states.

The study findings were limited by several factors, including the lack of standardized reporting timelines across states, differences in state-based vaccination rates, the emergence of the Delta variant during the study period, and time-lag in contemporaneous database updates, the researchers noted.

However, the results suggest that physical ICU beds do not play a role in determining the number of COVID-related deaths. Instead, “other constraints such as less staffing, lack of medical supplies (ventilators and [personal protective equipment]) should be evaluated for potential implications on poor patients’ outcomes,” they concluded.
 

Pandemic challenges can inform future plans

“As the health care system emerges from the effects of the pandemic, it is important to understand the factors that contributed to adverse outcomes to better prepare for future challenges and improve the delivery of care,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview. 

“The findings are not surprising considering what is known about the multitude of factors that determine outcomes for our patients from medical comorbidities, and social determinants of health to upstream structural factors such as systemic inequities and generational trauma,” said Dr. Pal, who was not involved with the study. “Thus, a simple correlation of the number of ICU beds to COVID-19 outcomes is not likely to capture the interplay of all these factors.”

The challenges of the pandemic offer insights to inform future planning, said Dr. Pal.

“In my opinion, a key factor to understand and address would be employee wellness for health care workers,” he said. “The problem of burnout leading to health care workers leaving the workforce has exacerbated the already acute shortages in personnel in recent years.

“In the long term, it may be prudent to reconsider the approach to health by increasing support for preventative and primary care, addressing social factors such as education, nutrition, and housing, to mitigate preventable aspects of diseases.”

Further research is needed to examine the multitude of factors associated with the pandemic, and their interplay, said Dr. Pal. The goals of such research “would be needed to develop a deeper understanding of the factors that contributed to mortality in COVID-19 and the disparities with this across different subpopulations.”

The study received no outside funding. The researchers and Dr. Pal disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Contrary to popular belief, no association appeared between the number of intensive care unit beds and COVID-19 deaths, based on a review of data from all 50 states between March 1, 2020, and June 30, 2021.

One of the reasons for poor patient outcomes in the early months of the COVID-19 pandemic was the presumed scarcity of ICU beds, Omar Haider, MD, of Houston Methodist Hospital, and colleagues said. “We hypothesized that the states having a lower number of ICU beds had more COVID-related deaths when compared to the states that had a higher number of ICU beds,” they wrote in an abstract presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

According to the researchers, the total number of ICU beds in the United States is approximately 85,000. Hawaii has the highest number of beds per 10,000 persons, and the District of Columbia has the lowest (6.0 vs. 1.6).

The researchers collected data on ICU bed totals from the Kaiser Family Foundation. Statistics on COVID-19 deaths were obtained from The New York Times database, which provided real-time information collected from the Department of Health & Human Services, the Centers for Disease Control and Prevention, and the Census Bureau.

The researchers used the Pearson Correlation Coefficient to compare ICU beds and COVID deaths per 10,000 persons in each state. The R value was 0.29, which indicates no inverse correlation. “Our value of R2, the coefficient of determination, was 0.0858,” they added. They confirmed the results using the Spearman’s Rho, which yielded an rs of 0.3, also a sign of no inverse correlation. No correlation was found between low numbers of ICU beds and high numbers of COVID-19 deaths for any states.

The study findings were limited by several factors, including the lack of standardized reporting timelines across states, differences in state-based vaccination rates, the emergence of the Delta variant during the study period, and time-lag in contemporaneous database updates, the researchers noted.

However, the results suggest that physical ICU beds do not play a role in determining the number of COVID-related deaths. Instead, “other constraints such as less staffing, lack of medical supplies (ventilators and [personal protective equipment]) should be evaluated for potential implications on poor patients’ outcomes,” they concluded.
 

Pandemic challenges can inform future plans

“As the health care system emerges from the effects of the pandemic, it is important to understand the factors that contributed to adverse outcomes to better prepare for future challenges and improve the delivery of care,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview. 

“The findings are not surprising considering what is known about the multitude of factors that determine outcomes for our patients from medical comorbidities, and social determinants of health to upstream structural factors such as systemic inequities and generational trauma,” said Dr. Pal, who was not involved with the study. “Thus, a simple correlation of the number of ICU beds to COVID-19 outcomes is not likely to capture the interplay of all these factors.”

The challenges of the pandemic offer insights to inform future planning, said Dr. Pal.

“In my opinion, a key factor to understand and address would be employee wellness for health care workers,” he said. “The problem of burnout leading to health care workers leaving the workforce has exacerbated the already acute shortages in personnel in recent years.

“In the long term, it may be prudent to reconsider the approach to health by increasing support for preventative and primary care, addressing social factors such as education, nutrition, and housing, to mitigate preventable aspects of diseases.”

Further research is needed to examine the multitude of factors associated with the pandemic, and their interplay, said Dr. Pal. The goals of such research “would be needed to develop a deeper understanding of the factors that contributed to mortality in COVID-19 and the disparities with this across different subpopulations.”

The study received no outside funding. The researchers and Dr. Pal disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A novel virtual reality (VR) intervention significantly reduces agoraphobia in patients with psychosis, new research suggests.

The cognitive-behavioral therapy–based treatment was particularly effective for patients with the highest level of avoidance of everyday situations.

Courtesy University of Oxford

“Virtual reality is an inherently therapeutic medium which could be extremely useful in mental health services,” study investigator Daniel Freeman, PhD, DClinPsy, professor of clinical psychology, University of Oxford (England), told this news organization.  “This intervention is coming; the question really is when.”

The study was published online  in The Lancet Psychiatry.
 

Real-world feel

Immersive VR involves interactive three-dimensional computer-generated environments that produce the sensation of being in the real world.

For patients with psychosis, dealing with the real world can be an anxious experience, particularly if they have verbal or auditory hallucinations.

Some may develop agoraphobia and start to avoid places or situations. A virtual environment allows patients to practice dealing with situations that make them anxious or uncomfortable and to learn to reengage in everyday situations.

The study included 346 patients diagnosed with schizophrenia or a related disorder. The mean age of the patients was 37.2 years (67% were men, 85% were White). Most were single and unemployed. All were receiving treatment for psychosis and had difficulty going out because of anxiety.

The researchers randomly assigned 174 participants to an automated VR cognitive therapy intervention (gameChange) plus usual care and 172 to usual care alone. Trial assessors were blinded to group allocation.

The gameChange intervention was delivered in six sessions that were conducted over a 6-week period. Each session involved 30 minutes of VR.

A session begins when participants enter the virtual therapist’s office. They are met by a coach who guides them through the therapy. They can choose from among six VR social situations. These include a cafe, a general practice waiting room, a pub, a bus, opening the front door of their home onto the street, or entering a small local shop.

Each scenario has five levels of difficulty that are based on the number and proximity of people in the social situation and the degree of social interaction. Users can work their way through these various levels.

The virtual sessions took place in patients’ homes in about 50% of cases; the remainder were conducted in the clinic. A mental health worker was in the room during the therapy.

Between virtual sessions, participants were encouraged to apply what they learned in the real world, for example, by spending time in a pub.

Usual care typically included regular visits from a community mental health worker and occasional outpatient appointments with a psychiatrist.
 

Widely applicable?

The primary outcome was the eight-item Oxford Agoraphobic Avoidance Scale (O-AS) questionnaire. This scale assesses distress and avoidance related to performing increasingly difficult everyday tasks.

The researchers assessed patients at baseline, at the conclusion of the 6-week treatment, and at 26 weeks.

Compared with the group that received usual care alone, the VR therapy group demonstrated a significant reduction in both agoraphobic avoidance (O-AS adjusted mean difference, -0.47; 95% confidence interval [CI], –0.88 to –0.06; Cohen’s d, –0.18; P = .026) and distress (–4.33; 95% CI, –7.78 to –0.87; Cohen’s d, –0.26; P = .014) at 6 weeks.

This translates to being able to do about 1.5 more activities on the O-AS, such as going to a shopping center alone, said Dr. Freeman.

Further analyses showed that VR therapy was especially effective for patients with severe agoraphobia. On average, these patients could complete two more O-AS activities at 26 weeks, said Dr. Freeman.

The authors believe the intervention worked by reducing defense behaviors, such as avoiding eye contact and fearful thoughts.

There was no significant difference in occurrence of adverse events between the study groups. These events, which were mild, transient, and did not affect the outcome, included side effects such as claustrophobia when using headsets.

The intervention would likely work for patients with agoraphobia who do not have psychosis, said Dr. Freeman. “Agoraphobia is often the final common pathway in lots of mental health conditions.”

Automated VR not only addresses the problem of patients being too afraid to leave home for in-person treatment but may also help address the shortage of trained mental health care providers.

The intervention is available at pilot implementation sites in the United Kingdom and a few sites in the United States, he said.
 

‘Cool, interesting’

Commenting on the research, Arash Javanbakht, MD, associate professor (clinical scholar), Wayne State University, Detroit, described the study as “cool and interesting.”

However, he said, the findings were not surprising, because exposure therapy has proved effective in treating phobias. Because of the significant lack of access to exposure therapy providers, “the more mechanized, the more automated therapies that can be easily used, the better,” he said.

He noted the VR therapy did not require a high level of training; the study used peer support staff who sat next to those using the technology.

He also liked the fact that the intervention “focused on things that in reality impair a person’s life,” for example, not being able to go to the grocery store.

However, he wondered why the investigators studied VR for patients with psychosis and agoraphobia and not for those with just agoraphobia.

In addition, he noted that the treatment’s efficacy was partly due to having someone next to the participants offering support, which the control group didn’t have.

Dr. Javanbakht has researched augmented therapy (AR) for delivering exposure therapy. This technology, which mixes virtually created objects with reality and allows users to move around their real environment, is newer and more advanced than VR but is more complicated, he said.

He explained that AR is more appropriate for delivering exposure therapy in certain situations.

“The basis of exposure therapy is ‘extinction learning’ – exposing a person to a fear cue over and over again until the fear response is extinguished,” and extinction learning is “context dependent,” said Dr. Javanbakht.

“VR is good when you need to create the whole context and environment, and AR is good when you need to focus on specific objects or cues in the environment,” for example, spiders or snakes, he said.

The study was funded by the National Institute of Health Research. Dr. Freeman is a founder and a non-executive director of Oxford VR, which will commercialize the therapy. He holds equity in and receives personal payments from Oxford VR; holds a contract for his university team to advise Oxford VR on treatment development; and reports grants from the National Institute for Health Research, the Medical Research Council, and the International Foundation. Dr. Javanbakht has a patent for an AR exposure therapy.

A version of this article first appeared on Medscape.com.

A novel virtual reality (VR) intervention significantly reduces agoraphobia in patients with psychosis, new research suggests.

The cognitive-behavioral therapy–based treatment was particularly effective for patients with the highest level of avoidance of everyday situations.

Courtesy University of Oxford

“Virtual reality is an inherently therapeutic medium which could be extremely useful in mental health services,” study investigator Daniel Freeman, PhD, DClinPsy, professor of clinical psychology, University of Oxford (England), told this news organization.  “This intervention is coming; the question really is when.”

The study was published online  in The Lancet Psychiatry.
 

Real-world feel

Immersive VR involves interactive three-dimensional computer-generated environments that produce the sensation of being in the real world.

For patients with psychosis, dealing with the real world can be an anxious experience, particularly if they have verbal or auditory hallucinations.

Some may develop agoraphobia and start to avoid places or situations. A virtual environment allows patients to practice dealing with situations that make them anxious or uncomfortable and to learn to reengage in everyday situations.

The study included 346 patients diagnosed with schizophrenia or a related disorder. The mean age of the patients was 37.2 years (67% were men, 85% were White). Most were single and unemployed. All were receiving treatment for psychosis and had difficulty going out because of anxiety.

The researchers randomly assigned 174 participants to an automated VR cognitive therapy intervention (gameChange) plus usual care and 172 to usual care alone. Trial assessors were blinded to group allocation.

The gameChange intervention was delivered in six sessions that were conducted over a 6-week period. Each session involved 30 minutes of VR.

A session begins when participants enter the virtual therapist’s office. They are met by a coach who guides them through the therapy. They can choose from among six VR social situations. These include a cafe, a general practice waiting room, a pub, a bus, opening the front door of their home onto the street, or entering a small local shop.

Each scenario has five levels of difficulty that are based on the number and proximity of people in the social situation and the degree of social interaction. Users can work their way through these various levels.

The virtual sessions took place in patients’ homes in about 50% of cases; the remainder were conducted in the clinic. A mental health worker was in the room during the therapy.

Between virtual sessions, participants were encouraged to apply what they learned in the real world, for example, by spending time in a pub.

Usual care typically included regular visits from a community mental health worker and occasional outpatient appointments with a psychiatrist.
 

Widely applicable?

The primary outcome was the eight-item Oxford Agoraphobic Avoidance Scale (O-AS) questionnaire. This scale assesses distress and avoidance related to performing increasingly difficult everyday tasks.

The researchers assessed patients at baseline, at the conclusion of the 6-week treatment, and at 26 weeks.

Compared with the group that received usual care alone, the VR therapy group demonstrated a significant reduction in both agoraphobic avoidance (O-AS adjusted mean difference, -0.47; 95% confidence interval [CI], –0.88 to –0.06; Cohen’s d, –0.18; P = .026) and distress (–4.33; 95% CI, –7.78 to –0.87; Cohen’s d, –0.26; P = .014) at 6 weeks.

This translates to being able to do about 1.5 more activities on the O-AS, such as going to a shopping center alone, said Dr. Freeman.

Further analyses showed that VR therapy was especially effective for patients with severe agoraphobia. On average, these patients could complete two more O-AS activities at 26 weeks, said Dr. Freeman.

The authors believe the intervention worked by reducing defense behaviors, such as avoiding eye contact and fearful thoughts.

There was no significant difference in occurrence of adverse events between the study groups. These events, which were mild, transient, and did not affect the outcome, included side effects such as claustrophobia when using headsets.

The intervention would likely work for patients with agoraphobia who do not have psychosis, said Dr. Freeman. “Agoraphobia is often the final common pathway in lots of mental health conditions.”

Automated VR not only addresses the problem of patients being too afraid to leave home for in-person treatment but may also help address the shortage of trained mental health care providers.

The intervention is available at pilot implementation sites in the United Kingdom and a few sites in the United States, he said.
 

‘Cool, interesting’

Commenting on the research, Arash Javanbakht, MD, associate professor (clinical scholar), Wayne State University, Detroit, described the study as “cool and interesting.”

However, he said, the findings were not surprising, because exposure therapy has proved effective in treating phobias. Because of the significant lack of access to exposure therapy providers, “the more mechanized, the more automated therapies that can be easily used, the better,” he said.

He noted the VR therapy did not require a high level of training; the study used peer support staff who sat next to those using the technology.

He also liked the fact that the intervention “focused on things that in reality impair a person’s life,” for example, not being able to go to the grocery store.

However, he wondered why the investigators studied VR for patients with psychosis and agoraphobia and not for those with just agoraphobia.

In addition, he noted that the treatment’s efficacy was partly due to having someone next to the participants offering support, which the control group didn’t have.

Dr. Javanbakht has researched augmented therapy (AR) for delivering exposure therapy. This technology, which mixes virtually created objects with reality and allows users to move around their real environment, is newer and more advanced than VR but is more complicated, he said.

He explained that AR is more appropriate for delivering exposure therapy in certain situations.

“The basis of exposure therapy is ‘extinction learning’ – exposing a person to a fear cue over and over again until the fear response is extinguished,” and extinction learning is “context dependent,” said Dr. Javanbakht.

“VR is good when you need to create the whole context and environment, and AR is good when you need to focus on specific objects or cues in the environment,” for example, spiders or snakes, he said.

The study was funded by the National Institute of Health Research. Dr. Freeman is a founder and a non-executive director of Oxford VR, which will commercialize the therapy. He holds equity in and receives personal payments from Oxford VR; holds a contract for his university team to advise Oxford VR on treatment development; and reports grants from the National Institute for Health Research, the Medical Research Council, and the International Foundation. Dr. Javanbakht has a patent for an AR exposure therapy.

A version of this article first appeared on Medscape.com.

A novel virtual reality (VR) intervention significantly reduces agoraphobia in patients with psychosis, new research suggests.

The cognitive-behavioral therapy–based treatment was particularly effective for patients with the highest level of avoidance of everyday situations.

Courtesy University of Oxford

“Virtual reality is an inherently therapeutic medium which could be extremely useful in mental health services,” study investigator Daniel Freeman, PhD, DClinPsy, professor of clinical psychology, University of Oxford (England), told this news organization.  “This intervention is coming; the question really is when.”

The study was published online  in The Lancet Psychiatry.
 

Real-world feel

Immersive VR involves interactive three-dimensional computer-generated environments that produce the sensation of being in the real world.

For patients with psychosis, dealing with the real world can be an anxious experience, particularly if they have verbal or auditory hallucinations.

Some may develop agoraphobia and start to avoid places or situations. A virtual environment allows patients to practice dealing with situations that make them anxious or uncomfortable and to learn to reengage in everyday situations.

The study included 346 patients diagnosed with schizophrenia or a related disorder. The mean age of the patients was 37.2 years (67% were men, 85% were White). Most were single and unemployed. All were receiving treatment for psychosis and had difficulty going out because of anxiety.

The researchers randomly assigned 174 participants to an automated VR cognitive therapy intervention (gameChange) plus usual care and 172 to usual care alone. Trial assessors were blinded to group allocation.

The gameChange intervention was delivered in six sessions that were conducted over a 6-week period. Each session involved 30 minutes of VR.

A session begins when participants enter the virtual therapist’s office. They are met by a coach who guides them through the therapy. They can choose from among six VR social situations. These include a cafe, a general practice waiting room, a pub, a bus, opening the front door of their home onto the street, or entering a small local shop.

Each scenario has five levels of difficulty that are based on the number and proximity of people in the social situation and the degree of social interaction. Users can work their way through these various levels.

The virtual sessions took place in patients’ homes in about 50% of cases; the remainder were conducted in the clinic. A mental health worker was in the room during the therapy.

Between virtual sessions, participants were encouraged to apply what they learned in the real world, for example, by spending time in a pub.

Usual care typically included regular visits from a community mental health worker and occasional outpatient appointments with a psychiatrist.
 

Widely applicable?

The primary outcome was the eight-item Oxford Agoraphobic Avoidance Scale (O-AS) questionnaire. This scale assesses distress and avoidance related to performing increasingly difficult everyday tasks.

The researchers assessed patients at baseline, at the conclusion of the 6-week treatment, and at 26 weeks.

Compared with the group that received usual care alone, the VR therapy group demonstrated a significant reduction in both agoraphobic avoidance (O-AS adjusted mean difference, -0.47; 95% confidence interval [CI], –0.88 to –0.06; Cohen’s d, –0.18; P = .026) and distress (–4.33; 95% CI, –7.78 to –0.87; Cohen’s d, –0.26; P = .014) at 6 weeks.

This translates to being able to do about 1.5 more activities on the O-AS, such as going to a shopping center alone, said Dr. Freeman.

Further analyses showed that VR therapy was especially effective for patients with severe agoraphobia. On average, these patients could complete two more O-AS activities at 26 weeks, said Dr. Freeman.

The authors believe the intervention worked by reducing defense behaviors, such as avoiding eye contact and fearful thoughts.

There was no significant difference in occurrence of adverse events between the study groups. These events, which were mild, transient, and did not affect the outcome, included side effects such as claustrophobia when using headsets.

The intervention would likely work for patients with agoraphobia who do not have psychosis, said Dr. Freeman. “Agoraphobia is often the final common pathway in lots of mental health conditions.”

Automated VR not only addresses the problem of patients being too afraid to leave home for in-person treatment but may also help address the shortage of trained mental health care providers.

The intervention is available at pilot implementation sites in the United Kingdom and a few sites in the United States, he said.
 

‘Cool, interesting’

Commenting on the research, Arash Javanbakht, MD, associate professor (clinical scholar), Wayne State University, Detroit, described the study as “cool and interesting.”

However, he said, the findings were not surprising, because exposure therapy has proved effective in treating phobias. Because of the significant lack of access to exposure therapy providers, “the more mechanized, the more automated therapies that can be easily used, the better,” he said.

He noted the VR therapy did not require a high level of training; the study used peer support staff who sat next to those using the technology.

He also liked the fact that the intervention “focused on things that in reality impair a person’s life,” for example, not being able to go to the grocery store.

However, he wondered why the investigators studied VR for patients with psychosis and agoraphobia and not for those with just agoraphobia.

In addition, he noted that the treatment’s efficacy was partly due to having someone next to the participants offering support, which the control group didn’t have.

Dr. Javanbakht has researched augmented therapy (AR) for delivering exposure therapy. This technology, which mixes virtually created objects with reality and allows users to move around their real environment, is newer and more advanced than VR but is more complicated, he said.

He explained that AR is more appropriate for delivering exposure therapy in certain situations.

“The basis of exposure therapy is ‘extinction learning’ – exposing a person to a fear cue over and over again until the fear response is extinguished,” and extinction learning is “context dependent,” said Dr. Javanbakht.

“VR is good when you need to create the whole context and environment, and AR is good when you need to focus on specific objects or cues in the environment,” for example, spiders or snakes, he said.

The study was funded by the National Institute of Health Research. Dr. Freeman is a founder and a non-executive director of Oxford VR, which will commercialize the therapy. He holds equity in and receives personal payments from Oxford VR; holds a contract for his university team to advise Oxford VR on treatment development; and reports grants from the National Institute for Health Research, the Medical Research Council, and the International Foundation. Dr. Javanbakht has a patent for an AR exposure therapy.

A version of this article first appeared on Medscape.com.

Antidepressant use is not associated with significant improvement in health-related quality of life (HRQoL) in patients with depression, new research suggests.

Researchers who conducted the study admit this finding was unexpected, and outside experts say no firm conclusions can be drawn from the research.

“Of course we were surprised by the results,” first author Omar Almohammed, PharmD, PhD, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, told this news organization.

“We were expecting to see some positive impact with the use of antidepressant medications on the HRQoL measures when we compared these patients to patients that did not use antidepressant medications,” Dr. Almohammed said.

The study was published online  in PLOS ONE.
 

Controversial impact on quality of life

Depression is known to harm HRQoL. Despite evidence that antidepressants improve depressed mood, their effect on patients’ overall well-being and HRQoL remains controversial.

The researchers examined the effect of antidepressants on HRQoL in adults with depression using 11 years of data from the U.S. Medical Expenditures Panel Survey (MEPS), a large longitudinal survey that tracks health service use in the United States. HRQoL was measured using the 12-item Short Form Health Survey (SF-12).

On average, about 17.5 million adults were diagnosed with depression each year during the study period (2005-2016). More than half (57.6%) of these patients were treated with antidepressants.

Patients with depression had an average age of 48.3 years. Women made up more than two-thirds of the total sample (68%), and more women than men received antidepressants (61% vs. 52%).

Compared with no antidepressant use, antidepressant use was associated with some improvement on the mental, but not physical, component of the SF-12, the researchers report.

However, difference-in-differences (D-I-D) univariate analysis showed no significant difference between adults using and not using antidepressants in the SF-12 physical (-0.35 vs. -0.34; P = .9,595) or mental component (1.28 vs. 1.13; P = .6,405).

“The multivariate D-I-D analyses ensured the robustness of these results,” the researchers note.

The change in HRQoL observed in patients using antidepressants was not significantly different from that seen among peers not using these drugs, the researchers report.

“We are not saying that antidepressant medications are not helpful at all; HRQoL is only one of many measures intended to assess health outcomes,” Dr. Almohammed told this news organization.

“Based on our research design and data, we can only say that patients who used antidepressant medications did not experience better change in terms of HRQoL compared to patients who did not use antidepressant medications,” he said.

“These patients may have had some improvement on other clinical outcome measures, but that clinical improvement did not have a significant positive impact on HRQoL,” he noted.

“We still recommend that patients continue using their antidepressant medications, but they may want to ask their doctors to provide them with other nonpharmacologic interventions as this may have additional impact on their HRQoL,” Dr. Almohammed said.

Further research is needed to address a “gap in knowledge” about the impact of nondrug interventions – alone or in combination with antidepressant medications – on patients’ HRQoL, Dr. Almohammed added.
 

Experts weigh in

Several experts weighed in on the study in a statement from the British nonprofit Science Media Center.

Gemma Lewis, PhD, with University College London (UCL), noted that “clinical trials with experimental designs have found that antidepressants improve mental health-related quality of life.”

University College London

Bruce Jancin/MDedge News

A version of this article first appeared on Medscape.com.

Antidepressant use is not associated with significant improvement in health-related quality of life (HRQoL) in patients with depression, new research suggests.

Researchers who conducted the study admit this finding was unexpected, and outside experts say no firm conclusions can be drawn from the research.

“Of course we were surprised by the results,” first author Omar Almohammed, PharmD, PhD, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, told this news organization.

“We were expecting to see some positive impact with the use of antidepressant medications on the HRQoL measures when we compared these patients to patients that did not use antidepressant medications,” Dr. Almohammed said.

The study was published online  in PLOS ONE.
 

Controversial impact on quality of life

Depression is known to harm HRQoL. Despite evidence that antidepressants improve depressed mood, their effect on patients’ overall well-being and HRQoL remains controversial.

The researchers examined the effect of antidepressants on HRQoL in adults with depression using 11 years of data from the U.S. Medical Expenditures Panel Survey (MEPS), a large longitudinal survey that tracks health service use in the United States. HRQoL was measured using the 12-item Short Form Health Survey (SF-12).

On average, about 17.5 million adults were diagnosed with depression each year during the study period (2005-2016). More than half (57.6%) of these patients were treated with antidepressants.

Patients with depression had an average age of 48.3 years. Women made up more than two-thirds of the total sample (68%), and more women than men received antidepressants (61% vs. 52%).

Compared with no antidepressant use, antidepressant use was associated with some improvement on the mental, but not physical, component of the SF-12, the researchers report.

However, difference-in-differences (D-I-D) univariate analysis showed no significant difference between adults using and not using antidepressants in the SF-12 physical (-0.35 vs. -0.34; P = .9,595) or mental component (1.28 vs. 1.13; P = .6,405).

“The multivariate D-I-D analyses ensured the robustness of these results,” the researchers note.

The change in HRQoL observed in patients using antidepressants was not significantly different from that seen among peers not using these drugs, the researchers report.

“We are not saying that antidepressant medications are not helpful at all; HRQoL is only one of many measures intended to assess health outcomes,” Dr. Almohammed told this news organization.

“Based on our research design and data, we can only say that patients who used antidepressant medications did not experience better change in terms of HRQoL compared to patients who did not use antidepressant medications,” he said.

“These patients may have had some improvement on other clinical outcome measures, but that clinical improvement did not have a significant positive impact on HRQoL,” he noted.

“We still recommend that patients continue using their antidepressant medications, but they may want to ask their doctors to provide them with other nonpharmacologic interventions as this may have additional impact on their HRQoL,” Dr. Almohammed said.

Further research is needed to address a “gap in knowledge” about the impact of nondrug interventions – alone or in combination with antidepressant medications – on patients’ HRQoL, Dr. Almohammed added.
 

Experts weigh in

Several experts weighed in on the study in a statement from the British nonprofit Science Media Center.

Gemma Lewis, PhD, with University College London (UCL), noted that “clinical trials with experimental designs have found that antidepressants improve mental health-related quality of life.”

University College London

Bruce Jancin/MDedge News

A version of this article first appeared on Medscape.com.

Antidepressant use is not associated with significant improvement in health-related quality of life (HRQoL) in patients with depression, new research suggests.

Researchers who conducted the study admit this finding was unexpected, and outside experts say no firm conclusions can be drawn from the research.

“Of course we were surprised by the results,” first author Omar Almohammed, PharmD, PhD, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, told this news organization.

“We were expecting to see some positive impact with the use of antidepressant medications on the HRQoL measures when we compared these patients to patients that did not use antidepressant medications,” Dr. Almohammed said.

The study was published online  in PLOS ONE.
 

Controversial impact on quality of life

Depression is known to harm HRQoL. Despite evidence that antidepressants improve depressed mood, their effect on patients’ overall well-being and HRQoL remains controversial.

The researchers examined the effect of antidepressants on HRQoL in adults with depression using 11 years of data from the U.S. Medical Expenditures Panel Survey (MEPS), a large longitudinal survey that tracks health service use in the United States. HRQoL was measured using the 12-item Short Form Health Survey (SF-12).

On average, about 17.5 million adults were diagnosed with depression each year during the study period (2005-2016). More than half (57.6%) of these patients were treated with antidepressants.

Patients with depression had an average age of 48.3 years. Women made up more than two-thirds of the total sample (68%), and more women than men received antidepressants (61% vs. 52%).

Compared with no antidepressant use, antidepressant use was associated with some improvement on the mental, but not physical, component of the SF-12, the researchers report.

However, difference-in-differences (D-I-D) univariate analysis showed no significant difference between adults using and not using antidepressants in the SF-12 physical (-0.35 vs. -0.34; P = .9,595) or mental component (1.28 vs. 1.13; P = .6,405).

“The multivariate D-I-D analyses ensured the robustness of these results,” the researchers note.

The change in HRQoL observed in patients using antidepressants was not significantly different from that seen among peers not using these drugs, the researchers report.

“We are not saying that antidepressant medications are not helpful at all; HRQoL is only one of many measures intended to assess health outcomes,” Dr. Almohammed told this news organization.

“Based on our research design and data, we can only say that patients who used antidepressant medications did not experience better change in terms of HRQoL compared to patients who did not use antidepressant medications,” he said.

“These patients may have had some improvement on other clinical outcome measures, but that clinical improvement did not have a significant positive impact on HRQoL,” he noted.

“We still recommend that patients continue using their antidepressant medications, but they may want to ask their doctors to provide them with other nonpharmacologic interventions as this may have additional impact on their HRQoL,” Dr. Almohammed said.

Further research is needed to address a “gap in knowledge” about the impact of nondrug interventions – alone or in combination with antidepressant medications – on patients’ HRQoL, Dr. Almohammed added.
 

Experts weigh in

Several experts weighed in on the study in a statement from the British nonprofit Science Media Center.

Gemma Lewis, PhD, with University College London (UCL), noted that “clinical trials with experimental designs have found that antidepressants improve mental health-related quality of life.”

University College London

Bruce Jancin/MDedge News

A version of this article first appeared on Medscape.com.

This article was originally published in Italian on Univadis .

The arrival of Ukrainian refugees in Western Europe, and especially the arrival of women and children coming from the cities most affected by the attacks, has made local medical services the first point of contact for the diagnosis and care of the psychological effects of war.

Many studies demonstrate the high prevalence of posttraumatic stress disorder (PTSD), depression, and anxiety among refugees. For example, a study from 2019 on refugee mental health offers a disturbing epidemiologic insight: Ten percent of refugees escaping conflict in Nepal showed signs of PTSD, 27.5% suffered from depression, and 22.9% suffered from anxiety. The rate of depression surpasses 90% in all studies carried out on survivors of torture.
 

Official guidelines

Posttraumatic stress is a form of mental disorder that manifests after experiencing highly traumatic events. Defined and studied in the United States, especially in veterans of the Vietnam War, and subsequently reviewed in relation to more recent conflicts, PTSD may appear in people of all ages. It also can occur in family members, witnesses, and aid workers involved in traumatic events. PTSD may come from repeated exposure to episodes of violence and degradation.

Because PTSD is a complex mental disorder derived from multiple factors, both personal and environmental, a diagnosis is never straightforward. It is generally indicated as “a condition of acute stress which manifests after exposure to a traumatic event.”

Among the most common symptoms of war-related trauma, according to experts, are the onset of flashbacks of troublesome memories, intrusive trauma-related thoughts, panic attacks, insomnia and night terrors, and social avoidance. In children, elements of regression can be observed, such as a need to sleep next to their parents.

Research performed directly on different areas of the brain has demonstrated that people affected by PTSD produce abnormal levels of hormones that are involved in responding to stress and fear. The area of the brain responsible for this response is the amygdala, which activates during moments of fear and produces natural pain-relieving molecules. In people with PTSD, the production of these molecules can carry on long after the event is over, causing a change in emotional state. Furthermore, levels of neurotransmitters that reach the hippocampus are also altered, which influences memory and learning capability. These same alterations concerning neurotransmitter levels are the basis for sudden flashbacks.

People with PTSD are subject to a change in blood flow to the brain and structural changes to brain tissue.
 

Social factors

“A factor that worsens the mental condition of Ukrainian refugees is the speed in which they have passed from a normal life, similar to that of many other Western countries, to a state of war, death, and injury,” writes Arash Javanbakht, MD, associate professor of psychiatry at Wayne State University in Detroit, and an expert in PTSD in war refugees.

Courtesy Shantanu Madaboosi

“Furthermore, they are experiencing an awful feeling of injustice, as the democracy and freedom that they have fought so hard to have has been put at risk, and they don’t feel sufficiently supported by their allies.”

As of this writing, the World Health Organization has estimated that there are 3.6 million Ukrainian refugees. This population already has experienced war and its psychological consequences. A study from 2019 assessed the prevalence of PTSD (27%) and depression (21%) among the 1.5 million Ukrainians who had to leave their homes after the first Russian invasion in 2014 and the rebellion of predominantly Russian regions.

Children are particularly at risk of developing PTSD, as seen from studies conducted on Syrian refugees. They have a roughly 70% chance of developing separation anxiety, a condition that many workers and volunteers have experienced firsthand recently. Some children do not accept being separated from their parents even to allow them to go to the bathroom or wash themselves, which also aggravates stress levels among adults. Infant trauma increases the risk of developing physical or mental disorders during adulthood, including depression, chronic pain, heart disorders, and diabetes.

War-related trauma entails transmissible epigenetic alterations, as shown by studies on the transmissibility of trauma on a biological level.
 

Diagnosis and treatment

People with PTSD have difficulty controlling their emotions, resulting in irritability, sudden rage or emotional confusion, depression and anxiety, and insomnia. They also are determined to avoid any actions that remind them of the traumatic event. Another common symptom is a sense of shame, as a result of having survived or not having been able to save others.

Physical symptoms include chest pain, dizziness, gastrointestinal problems, migraine, and a weakened immune system. A diagnosis of PTSD can be made when, in accordance with the National Institute of Mental Health (NIMH), the patient presents with the characteristic symptoms for more than a month after the event that caused the symptoms occurred.

The NIMH highlights that a diagnosis cannot always be made in a systematic way. In many cases, patients with PTSD are treated for the physical symptoms only, without any consideration for the overall picture.

The American Psychiatric Association (APA) has created a detailed list of PTSD symptoms. According to the APA, these symptoms usually appear within 3 months of the trauma, even if stress may appear later. Symptoms are arranged into the following three well-defined categories:

• Intrusive memories. People with PTSD suffer from sudden, vivid memories that are accompanied by painful emotions and a feeling of reliving the trauma. At times, this experience is so strong that the person involved feels as though the traumatic event is repeating itself.
• Avoidance and numbing. The individual seeks to avoid contact with anyone or anything that brings back memories of the trauma. Initially, the person experiences an emotional state of disinterest and detachment, reducing the capacity for emotional interaction and resulting in participation only in simple, routine activities. A lack of emotional processing causes an accumulation of anxiety and tension, which can become a chronic condition, leading to depression. At the same time, people frequently experience a sense of shame.
• Hyperarousal and hypervigilance. People behave as if they are constantly threatened. They react in a sudden, violent way, are unable to concentrate, and have problems with their memory. At times, they use alcohol or other drugs to alleviate pain. People with PTSD may lose control of their lives and therefore be at risk for suicidal behavior.

Why do some people pass unscathed through traumatic situations, whereas others carry the scars forever? There is a correlation with the severity of the trauma, but also with biological and genetic factors, as well as with previous experiences that contribute to increasing an individual’s resilience. Another key element is the rapid and effective treatment of symptoms, which also relates to personal and financial security.

It is not a coincidence that the first guidelines that clinicians follow when treating a traumatized patient aren’t strictly medical. It is necessary to guarantee the financial security of a refugee, but also the security of the few valuable items they have with them (such as keepsakes and pets). Clinicians are advised to facilitate contact with any of the patient’s family members located elsewhere whenever possible. It is appropriate to use relaxation techniques that are compatible with the patient’s cultural approach. Clinicians also check for the most common conditions in the refugee’s population of origin. It is advisable constantly to check for trauma-related symptoms and to listen to the patient’s story. Caregivers should be allowed to stay close to their children and should be provided sufficient information, but not an overwhelming amount.

There isn’t a consensus on how to treat people with PTSD. The possibility that PTSD can be resolved even without specific treatments has not been excluded, if the affected person is cared for and helped within a family and community setting, and if the person’s personal condition allows for this. However, in general, some form of treatment is beneficial before symptoms become chronic.

Pharmacologic and psychological treatment may be implemented. For the latter, the NIMH and the APA suggest that good results can be obtained from cognitive behavioral therapy, where the patient learns to manage his or her anxiety and depression and amend dangerous behaviors, such as the dismissal of his or her own emotions. According to these organizations, group therapy and other forms of psychotherapy have provided good results. The indicated duration of treatment is generally 6-12 weeks, even if this duration strongly depends on the individual’s condition, with subsequent periodic follow-ups. The involvement of the patient’s family and community is important.

The National Center for PTSD in Washington (run by the U.S. Department of Veterans Affairs) has highlighted the importance of a detailed case-by-case assessment to put in place a precise therapy plan. If patients should continue to find themselves in a state of crisis, for example during a war or in cases of domestic violence, working toward removing the cause of stress is first necessary before beginning treatment.

An important aspect is making the victim aware of the disorder. Treatment should therefore begin after the patient and family have been informed about the possibility of PTSD and the way in which it develops. Recognizing the symptoms over the following weeks and working quickly to manage and treat them significantly affects treatment success.

A version of this article first appeared on Medscape.com.

This article was originally published in Italian on Univadis .

The arrival of Ukrainian refugees in Western Europe, and especially the arrival of women and children coming from the cities most affected by the attacks, has made local medical services the first point of contact for the diagnosis and care of the psychological effects of war.

Many studies demonstrate the high prevalence of posttraumatic stress disorder (PTSD), depression, and anxiety among refugees. For example, a study from 2019 on refugee mental health offers a disturbing epidemiologic insight: Ten percent of refugees escaping conflict in Nepal showed signs of PTSD, 27.5% suffered from depression, and 22.9% suffered from anxiety. The rate of depression surpasses 90% in all studies carried out on survivors of torture.
 

Official guidelines

Posttraumatic stress is a form of mental disorder that manifests after experiencing highly traumatic events. Defined and studied in the United States, especially in veterans of the Vietnam War, and subsequently reviewed in relation to more recent conflicts, PTSD may appear in people of all ages. It also can occur in family members, witnesses, and aid workers involved in traumatic events. PTSD may come from repeated exposure to episodes of violence and degradation.

Because PTSD is a complex mental disorder derived from multiple factors, both personal and environmental, a diagnosis is never straightforward. It is generally indicated as “a condition of acute stress which manifests after exposure to a traumatic event.”

Among the most common symptoms of war-related trauma, according to experts, are the onset of flashbacks of troublesome memories, intrusive trauma-related thoughts, panic attacks, insomnia and night terrors, and social avoidance. In children, elements of regression can be observed, such as a need to sleep next to their parents.

Research performed directly on different areas of the brain has demonstrated that people affected by PTSD produce abnormal levels of hormones that are involved in responding to stress and fear. The area of the brain responsible for this response is the amygdala, which activates during moments of fear and produces natural pain-relieving molecules. In people with PTSD, the production of these molecules can carry on long after the event is over, causing a change in emotional state. Furthermore, levels of neurotransmitters that reach the hippocampus are also altered, which influences memory and learning capability. These same alterations concerning neurotransmitter levels are the basis for sudden flashbacks.

People with PTSD are subject to a change in blood flow to the brain and structural changes to brain tissue.
 

Social factors

“A factor that worsens the mental condition of Ukrainian refugees is the speed in which they have passed from a normal life, similar to that of many other Western countries, to a state of war, death, and injury,” writes Arash Javanbakht, MD, associate professor of psychiatry at Wayne State University in Detroit, and an expert in PTSD in war refugees.

Courtesy Shantanu Madaboosi

“Furthermore, they are experiencing an awful feeling of injustice, as the democracy and freedom that they have fought so hard to have has been put at risk, and they don’t feel sufficiently supported by their allies.”

As of this writing, the World Health Organization has estimated that there are 3.6 million Ukrainian refugees. This population already has experienced war and its psychological consequences. A study from 2019 assessed the prevalence of PTSD (27%) and depression (21%) among the 1.5 million Ukrainians who had to leave their homes after the first Russian invasion in 2014 and the rebellion of predominantly Russian regions.

Children are particularly at risk of developing PTSD, as seen from studies conducted on Syrian refugees. They have a roughly 70% chance of developing separation anxiety, a condition that many workers and volunteers have experienced firsthand recently. Some children do not accept being separated from their parents even to allow them to go to the bathroom or wash themselves, which also aggravates stress levels among adults. Infant trauma increases the risk of developing physical or mental disorders during adulthood, including depression, chronic pain, heart disorders, and diabetes.

War-related trauma entails transmissible epigenetic alterations, as shown by studies on the transmissibility of trauma on a biological level.
 

Diagnosis and treatment

People with PTSD have difficulty controlling their emotions, resulting in irritability, sudden rage or emotional confusion, depression and anxiety, and insomnia. They also are determined to avoid any actions that remind them of the traumatic event. Another common symptom is a sense of shame, as a result of having survived or not having been able to save others.

Physical symptoms include chest pain, dizziness, gastrointestinal problems, migraine, and a weakened immune system. A diagnosis of PTSD can be made when, in accordance with the National Institute of Mental Health (NIMH), the patient presents with the characteristic symptoms for more than a month after the event that caused the symptoms occurred.

The NIMH highlights that a diagnosis cannot always be made in a systematic way. In many cases, patients with PTSD are treated for the physical symptoms only, without any consideration for the overall picture.

The American Psychiatric Association (APA) has created a detailed list of PTSD symptoms. According to the APA, these symptoms usually appear within 3 months of the trauma, even if stress may appear later. Symptoms are arranged into the following three well-defined categories:

• Intrusive memories. People with PTSD suffer from sudden, vivid memories that are accompanied by painful emotions and a feeling of reliving the trauma. At times, this experience is so strong that the person involved feels as though the traumatic event is repeating itself.
• Avoidance and numbing. The individual seeks to avoid contact with anyone or anything that brings back memories of the trauma. Initially, the person experiences an emotional state of disinterest and detachment, reducing the capacity for emotional interaction and resulting in participation only in simple, routine activities. A lack of emotional processing causes an accumulation of anxiety and tension, which can become a chronic condition, leading to depression. At the same time, people frequently experience a sense of shame.
• Hyperarousal and hypervigilance. People behave as if they are constantly threatened. They react in a sudden, violent way, are unable to concentrate, and have problems with their memory. At times, they use alcohol or other drugs to alleviate pain. People with PTSD may lose control of their lives and therefore be at risk for suicidal behavior.

Why do some people pass unscathed through traumatic situations, whereas others carry the scars forever? There is a correlation with the severity of the trauma, but also with biological and genetic factors, as well as with previous experiences that contribute to increasing an individual’s resilience. Another key element is the rapid and effective treatment of symptoms, which also relates to personal and financial security.

It is not a coincidence that the first guidelines that clinicians follow when treating a traumatized patient aren’t strictly medical. It is necessary to guarantee the financial security of a refugee, but also the security of the few valuable items they have with them (such as keepsakes and pets). Clinicians are advised to facilitate contact with any of the patient’s family members located elsewhere whenever possible. It is appropriate to use relaxation techniques that are compatible with the patient’s cultural approach. Clinicians also check for the most common conditions in the refugee’s population of origin. It is advisable constantly to check for trauma-related symptoms and to listen to the patient’s story. Caregivers should be allowed to stay close to their children and should be provided sufficient information, but not an overwhelming amount.

There isn’t a consensus on how to treat people with PTSD. The possibility that PTSD can be resolved even without specific treatments has not been excluded, if the affected person is cared for and helped within a family and community setting, and if the person’s personal condition allows for this. However, in general, some form of treatment is beneficial before symptoms become chronic.

Pharmacologic and psychological treatment may be implemented. For the latter, the NIMH and the APA suggest that good results can be obtained from cognitive behavioral therapy, where the patient learns to manage his or her anxiety and depression and amend dangerous behaviors, such as the dismissal of his or her own emotions. According to these organizations, group therapy and other forms of psychotherapy have provided good results. The indicated duration of treatment is generally 6-12 weeks, even if this duration strongly depends on the individual’s condition, with subsequent periodic follow-ups. The involvement of the patient’s family and community is important.

The National Center for PTSD in Washington (run by the U.S. Department of Veterans Affairs) has highlighted the importance of a detailed case-by-case assessment to put in place a precise therapy plan. If patients should continue to find themselves in a state of crisis, for example during a war or in cases of domestic violence, working toward removing the cause of stress is first necessary before beginning treatment.

An important aspect is making the victim aware of the disorder. Treatment should therefore begin after the patient and family have been informed about the possibility of PTSD and the way in which it develops. Recognizing the symptoms over the following weeks and working quickly to manage and treat them significantly affects treatment success.

A version of this article first appeared on Medscape.com.

This article was originally published in Italian on Univadis .

The arrival of Ukrainian refugees in Western Europe, and especially the arrival of women and children coming from the cities most affected by the attacks, has made local medical services the first point of contact for the diagnosis and care of the psychological effects of war.

Many studies demonstrate the high prevalence of posttraumatic stress disorder (PTSD), depression, and anxiety among refugees. For example, a study from 2019 on refugee mental health offers a disturbing epidemiologic insight: Ten percent of refugees escaping conflict in Nepal showed signs of PTSD, 27.5% suffered from depression, and 22.9% suffered from anxiety. The rate of depression surpasses 90% in all studies carried out on survivors of torture.
 

Official guidelines

Posttraumatic stress is a form of mental disorder that manifests after experiencing highly traumatic events. Defined and studied in the United States, especially in veterans of the Vietnam War, and subsequently reviewed in relation to more recent conflicts, PTSD may appear in people of all ages. It also can occur in family members, witnesses, and aid workers involved in traumatic events. PTSD may come from repeated exposure to episodes of violence and degradation.

Because PTSD is a complex mental disorder derived from multiple factors, both personal and environmental, a diagnosis is never straightforward. It is generally indicated as “a condition of acute stress which manifests after exposure to a traumatic event.”

Among the most common symptoms of war-related trauma, according to experts, are the onset of flashbacks of troublesome memories, intrusive trauma-related thoughts, panic attacks, insomnia and night terrors, and social avoidance. In children, elements of regression can be observed, such as a need to sleep next to their parents.

Research performed directly on different areas of the brain has demonstrated that people affected by PTSD produce abnormal levels of hormones that are involved in responding to stress and fear. The area of the brain responsible for this response is the amygdala, which activates during moments of fear and produces natural pain-relieving molecules. In people with PTSD, the production of these molecules can carry on long after the event is over, causing a change in emotional state. Furthermore, levels of neurotransmitters that reach the hippocampus are also altered, which influences memory and learning capability. These same alterations concerning neurotransmitter levels are the basis for sudden flashbacks.

People with PTSD are subject to a change in blood flow to the brain and structural changes to brain tissue.
 

Social factors

“A factor that worsens the mental condition of Ukrainian refugees is the speed in which they have passed from a normal life, similar to that of many other Western countries, to a state of war, death, and injury,” writes Arash Javanbakht, MD, associate professor of psychiatry at Wayne State University in Detroit, and an expert in PTSD in war refugees.

Courtesy Shantanu Madaboosi

“Furthermore, they are experiencing an awful feeling of injustice, as the democracy and freedom that they have fought so hard to have has been put at risk, and they don’t feel sufficiently supported by their allies.”

As of this writing, the World Health Organization has estimated that there are 3.6 million Ukrainian refugees. This population already has experienced war and its psychological consequences. A study from 2019 assessed the prevalence of PTSD (27%) and depression (21%) among the 1.5 million Ukrainians who had to leave their homes after the first Russian invasion in 2014 and the rebellion of predominantly Russian regions.

Children are particularly at risk of developing PTSD, as seen from studies conducted on Syrian refugees. They have a roughly 70% chance of developing separation anxiety, a condition that many workers and volunteers have experienced firsthand recently. Some children do not accept being separated from their parents even to allow them to go to the bathroom or wash themselves, which also aggravates stress levels among adults. Infant trauma increases the risk of developing physical or mental disorders during adulthood, including depression, chronic pain, heart disorders, and diabetes.

War-related trauma entails transmissible epigenetic alterations, as shown by studies on the transmissibility of trauma on a biological level.
 

Diagnosis and treatment

People with PTSD have difficulty controlling their emotions, resulting in irritability, sudden rage or emotional confusion, depression and anxiety, and insomnia. They also are determined to avoid any actions that remind them of the traumatic event. Another common symptom is a sense of shame, as a result of having survived or not having been able to save others.

Physical symptoms include chest pain, dizziness, gastrointestinal problems, migraine, and a weakened immune system. A diagnosis of PTSD can be made when, in accordance with the National Institute of Mental Health (NIMH), the patient presents with the characteristic symptoms for more than a month after the event that caused the symptoms occurred.

The NIMH highlights that a diagnosis cannot always be made in a systematic way. In many cases, patients with PTSD are treated for the physical symptoms only, without any consideration for the overall picture.

The American Psychiatric Association (APA) has created a detailed list of PTSD symptoms. According to the APA, these symptoms usually appear within 3 months of the trauma, even if stress may appear later. Symptoms are arranged into the following three well-defined categories:

• Intrusive memories. People with PTSD suffer from sudden, vivid memories that are accompanied by painful emotions and a feeling of reliving the trauma. At times, this experience is so strong that the person involved feels as though the traumatic event is repeating itself.
• Avoidance and numbing. The individual seeks to avoid contact with anyone or anything that brings back memories of the trauma. Initially, the person experiences an emotional state of disinterest and detachment, reducing the capacity for emotional interaction and resulting in participation only in simple, routine activities. A lack of emotional processing causes an accumulation of anxiety and tension, which can become a chronic condition, leading to depression. At the same time, people frequently experience a sense of shame.
• Hyperarousal and hypervigilance. People behave as if they are constantly threatened. They react in a sudden, violent way, are unable to concentrate, and have problems with their memory. At times, they use alcohol or other drugs to alleviate pain. People with PTSD may lose control of their lives and therefore be at risk for suicidal behavior.

Why do some people pass unscathed through traumatic situations, whereas others carry the scars forever? There is a correlation with the severity of the trauma, but also with biological and genetic factors, as well as with previous experiences that contribute to increasing an individual’s resilience. Another key element is the rapid and effective treatment of symptoms, which also relates to personal and financial security.

It is not a coincidence that the first guidelines that clinicians follow when treating a traumatized patient aren’t strictly medical. It is necessary to guarantee the financial security of a refugee, but also the security of the few valuable items they have with them (such as keepsakes and pets). Clinicians are advised to facilitate contact with any of the patient’s family members located elsewhere whenever possible. It is appropriate to use relaxation techniques that are compatible with the patient’s cultural approach. Clinicians also check for the most common conditions in the refugee’s population of origin. It is advisable constantly to check for trauma-related symptoms and to listen to the patient’s story. Caregivers should be allowed to stay close to their children and should be provided sufficient information, but not an overwhelming amount.

There isn’t a consensus on how to treat people with PTSD. The possibility that PTSD can be resolved even without specific treatments has not been excluded, if the affected person is cared for and helped within a family and community setting, and if the person’s personal condition allows for this. However, in general, some form of treatment is beneficial before symptoms become chronic.

Pharmacologic and psychological treatment may be implemented. For the latter, the NIMH and the APA suggest that good results can be obtained from cognitive behavioral therapy, where the patient learns to manage his or her anxiety and depression and amend dangerous behaviors, such as the dismissal of his or her own emotions. According to these organizations, group therapy and other forms of psychotherapy have provided good results. The indicated duration of treatment is generally 6-12 weeks, even if this duration strongly depends on the individual’s condition, with subsequent periodic follow-ups. The involvement of the patient’s family and community is important.

The National Center for PTSD in Washington (run by the U.S. Department of Veterans Affairs) has highlighted the importance of a detailed case-by-case assessment to put in place a precise therapy plan. If patients should continue to find themselves in a state of crisis, for example during a war or in cases of domestic violence, working toward removing the cause of stress is first necessary before beginning treatment.

An important aspect is making the victim aware of the disorder. Treatment should therefore begin after the patient and family have been informed about the possibility of PTSD and the way in which it develops. Recognizing the symptoms over the following weeks and working quickly to manage and treat them significantly affects treatment success.

A version of this article first appeared on Medscape.com.

New cases of COVID-19 in U.S. children went up for a second consecutive week, but the pace of increase slowed considerably, based on a report from the American Academy of Pediatrics and the Children’s Hospital Association.

New pediatric cases were up by 11.8% for the week of April 15-21, with a total of just over 37,000 reported. The previous week’s count – about 33,000 new COVID cases for April 8-14 – was almost 30% higher than the week before and marked the first rise in incidence after 11 straight weeks of declines, the AAP and CHA said in their weekly COVID-19 report, which is based on data from state and territorial health departments.

The cumulative number of child COVID-19 cases since the start of the pandemic is now over 12.9 million, with children representing 19.0% of cases among all ages. The Centers for Disease Control and Prevention, which uses a different age range for children (0-17 years) than many states, reports corresponding figures of 12.4 million and 17.6%, along with 1,501 deaths.

ED visits show a similar rising trend over recent weeks, as the 7-day average of ED visits with confirmed COVID has crept up from 0.5% in late March/early April to 0.8% on April 22 for children aged 0-11 years, from 0.3% for 0.5% for those aged 12-15, and from 0.3% to 0.6% for 16- and 17-year-olds, based on CDC data.

The daily rate for new admissions for children with confirmed COVID has also moved up slightly, rising from 0.13 per 100,000 population as late as April 13 to 0.15 per 100,000 on April 23. For the number of actual admissions, the latest 7-day (April 17-23) average was 107 in children aged 0-17, compared with 102 for the week of April 10-16, the CDC reported.

Uptake of the COVID vaccine, however, continued to slide since spiking in January. Initial vaccinations for the latest available week (April 14-20) were down to 48,000 from 59,000 the week before in children aged 5-11 years and 35,000 (vs. 47,000) for those aged 12-17. The weekly highs hit 500,000 and 331,000, respectively, during the Omicron surge, the AAP reported based on CDC data.

Among children aged 5-11, the CDC said that 35.0% had received at least one dose of COVID vaccine as of April 25 and that 28.3% are fully vaccinated, with corresponding figures of 68.8% and 58.8% for 12- to 17-year-olds on April 25.

Among the states, the highest vaccination rates generally are found in New England and the lowest in the Southeast. In Alabama, just 15% of children aged 5-11 have received an initial dose of the vaccine, compared with 66% in Vermont, while Wyoming is the lowest (41%) for children aged 12-17 and Massachusetts is the highest (96%), the AAP said in a separate report.

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New cases of COVID-19 in U.S. children went up for a second consecutive week, but the pace of increase slowed considerably, based on a report from the American Academy of Pediatrics and the Children’s Hospital Association.

New pediatric cases were up by 11.8% for the week of April 15-21, with a total of just over 37,000 reported. The previous week’s count – about 33,000 new COVID cases for April 8-14 – was almost 30% higher than the week before and marked the first rise in incidence after 11 straight weeks of declines, the AAP and CHA said in their weekly COVID-19 report, which is based on data from state and territorial health departments.

The cumulative number of child COVID-19 cases since the start of the pandemic is now over 12.9 million, with children representing 19.0% of cases among all ages. The Centers for Disease Control and Prevention, which uses a different age range for children (0-17 years) than many states, reports corresponding figures of 12.4 million and 17.6%, along with 1,501 deaths.

ED visits show a similar rising trend over recent weeks, as the 7-day average of ED visits with confirmed COVID has crept up from 0.5% in late March/early April to 0.8% on April 22 for children aged 0-11 years, from 0.3% for 0.5% for those aged 12-15, and from 0.3% to 0.6% for 16- and 17-year-olds, based on CDC data.

The daily rate for new admissions for children with confirmed COVID has also moved up slightly, rising from 0.13 per 100,000 population as late as April 13 to 0.15 per 100,000 on April 23. For the number of actual admissions, the latest 7-day (April 17-23) average was 107 in children aged 0-17, compared with 102 for the week of April 10-16, the CDC reported.

Uptake of the COVID vaccine, however, continued to slide since spiking in January. Initial vaccinations for the latest available week (April 14-20) were down to 48,000 from 59,000 the week before in children aged 5-11 years and 35,000 (vs. 47,000) for those aged 12-17. The weekly highs hit 500,000 and 331,000, respectively, during the Omicron surge, the AAP reported based on CDC data.

Among children aged 5-11, the CDC said that 35.0% had received at least one dose of COVID vaccine as of April 25 and that 28.3% are fully vaccinated, with corresponding figures of 68.8% and 58.8% for 12- to 17-year-olds on April 25.

Among the states, the highest vaccination rates generally are found in New England and the lowest in the Southeast. In Alabama, just 15% of children aged 5-11 have received an initial dose of the vaccine, compared with 66% in Vermont, while Wyoming is the lowest (41%) for children aged 12-17 and Massachusetts is the highest (96%), the AAP said in a separate report.

[email protected]

New cases of COVID-19 in U.S. children went up for a second consecutive week, but the pace of increase slowed considerably, based on a report from the American Academy of Pediatrics and the Children’s Hospital Association.

New pediatric cases were up by 11.8% for the week of April 15-21, with a total of just over 37,000 reported. The previous week’s count – about 33,000 new COVID cases for April 8-14 – was almost 30% higher than the week before and marked the first rise in incidence after 11 straight weeks of declines, the AAP and CHA said in their weekly COVID-19 report, which is based on data from state and territorial health departments.

The cumulative number of child COVID-19 cases since the start of the pandemic is now over 12.9 million, with children representing 19.0% of cases among all ages. The Centers for Disease Control and Prevention, which uses a different age range for children (0-17 years) than many states, reports corresponding figures of 12.4 million and 17.6%, along with 1,501 deaths.

ED visits show a similar rising trend over recent weeks, as the 7-day average of ED visits with confirmed COVID has crept up from 0.5% in late March/early April to 0.8% on April 22 for children aged 0-11 years, from 0.3% for 0.5% for those aged 12-15, and from 0.3% to 0.6% for 16- and 17-year-olds, based on CDC data.

The daily rate for new admissions for children with confirmed COVID has also moved up slightly, rising from 0.13 per 100,000 population as late as April 13 to 0.15 per 100,000 on April 23. For the number of actual admissions, the latest 7-day (April 17-23) average was 107 in children aged 0-17, compared with 102 for the week of April 10-16, the CDC reported.

Uptake of the COVID vaccine, however, continued to slide since spiking in January. Initial vaccinations for the latest available week (April 14-20) were down to 48,000 from 59,000 the week before in children aged 5-11 years and 35,000 (vs. 47,000) for those aged 12-17. The weekly highs hit 500,000 and 331,000, respectively, during the Omicron surge, the AAP reported based on CDC data.

Among children aged 5-11, the CDC said that 35.0% had received at least one dose of COVID vaccine as of April 25 and that 28.3% are fully vaccinated, with corresponding figures of 68.8% and 58.8% for 12- to 17-year-olds on April 25.

Among the states, the highest vaccination rates generally are found in New England and the lowest in the Southeast. In Alabama, just 15% of children aged 5-11 have received an initial dose of the vaccine, compared with 66% in Vermont, while Wyoming is the lowest (41%) for children aged 12-17 and Massachusetts is the highest (96%), the AAP said in a separate report.

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