MDedge Rheumatology

Electro-acupuncture resulted in significant improvement in pain and function, compared with sham acupuncture, in a randomized trial of more than 400 adults with knee OA.

The socioeconomic burden of knee OA (KOA) remains high, and will likely increase with the aging population and rising rates of obesity, wrote first author Jian-Feng Tu, MD, PhD, of Beijing University of Chinese Medicine and colleagues. “Since no disease-modifying pharmaceutical agents have been approved, current KOA treatments are mainly symptomatic,” and identifying new therapies in addition to pharmacological agents or surgery is a research priority, they added. The research on acupuncture as a treatment for KOA has increased, but remains controversial as researchers attempt to determine the number of sessions needed for effectiveness.

In a study published in Arthritis & Rheumatology, the researchers recruited 480 adults aged 45-75 years with confirmed KOA who reported knee pain for longer than 6 months. Participants were randomized to three groups: electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA). Each group received three treatment sessions per week. In all groups, electrodes were attached to selected acupuncture needles, but the current was turned on only in the EA treatment group.

The primary outcome was the response rate after 8 weeks of treatment, defined as patients who achieved the minimal clinically important improvement (MCII) on both the Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index function subscale.

Overall, response rates at 8 weeks were 60.3%, 58.6%, and 47.3% for the EA, MA, and SA groups, respectively.

Between-group differences were statistically significant for EA versus SA (13%, P = .0234) but not for MA versus SA (11.3%, P = .0507) at 8 weeks; however, both EA and MA groups showed significantly higher response rates, compared with the SA group at 16 and 26 weeks. “Although a clinically meaningful response rate for KOA is not available in the literature, the difference of 11.3%, which indicates the number needed to treat of 9, is acceptable in clinical practices,” the researchers noted.

Adverse events occurred in 11.5% of the EA group, 14.2% of the MA group, and 10.8% of the SA group, and included subcutaneous hematoma, post-needling pain, and pantalgia. All adverse events related to acupuncture resolved within a week and none were serious, the researchers wrote.

The study findings were limited by several factors, including the potential burden on patients of three sessions per week, the limited study population of patients with radiologic grades of II or III only, the use of self-reports, and the lack of blinding for outcome assessors, the researchers noted.

However, the results show persistent effects in reducing pain and improving function with EA or MA, compared with SA, the researchers wrote. The findings were strengthened by “adequate dosage of acupuncture, the use of the primary outcome at an individual level, and the rigorous methodology.” The use of the MCII in the primary outcome “can provide patients and policy makers with more straightforward information to decide whether a treatment should be used.”

Optimal dosing questions remain

Current options for managing KOA are limited by factors that include low efficacy and unwanted side effects, while joint replacements increase the burden on health care systems, wrote David J. Hunter, MBBS, PhD, of the University of Sydney, and Richard E. Harris, PhD, of the University of Michigan, Ann Arbor, in an accompanying editorial. “In this context, development of new treatments or identification of efficacy of existing therapies to address the huge unmet need of pain are strongly desired.” Acupuncture continues to gain popularity in North and South America, but its efficacy for pain and KOA remain controversial.

The question of dose is challenging when assessing acupuncture because the optimal dose and how to classify it remains unknown. “In this study, the authors used three treatments a week, which is more frequent than typical studies done in the West and potentially may not be feasible in some health care settings. A recent systematic review suggests that treatment frequency matters and a dose of three sessions per week may be superior to less frequent treatment,” they emphasized. Acupuncture is generally considered to be safe, but many health systems do not reimburse for it. Patients may have large out-of-pocket expenses because of the number of visits required, which may be a barrier to further implementation in practice.

“Acupuncture is already widely practiced and readily available in many countries and health care systems,” the editorialists said. However, “more research is needed in the areas of dose-response relationships, effects of blinding the acupuncturist, feasibility of three times weekly regimens, and clarifying the mechanism of effect, particularly given the persistence of benefit.”

The study was funded by Beijing Municipal Science & Technology Commission and Beijing Municipal Administration of Hospitals. The researchers had no financial conflicts to disclose. Dr. Hunter disclosed support from a National Health and Medical Research Council Investigator Grant and providing consulting advice for Merck Serono, TLC Bio, Tissuegene, Lilly, and Pfizer.

SOURCE: Tu J-F et al. Arthritis Rheumatol. 2020 Nov 10. doi: 10.1002/art.41584.

Electro-acupuncture resulted in significant improvement in pain and function, compared with sham acupuncture, in a randomized trial of more than 400 adults with knee OA.

The socioeconomic burden of knee OA (KOA) remains high, and will likely increase with the aging population and rising rates of obesity, wrote first author Jian-Feng Tu, MD, PhD, of Beijing University of Chinese Medicine and colleagues. “Since no disease-modifying pharmaceutical agents have been approved, current KOA treatments are mainly symptomatic,” and identifying new therapies in addition to pharmacological agents or surgery is a research priority, they added. The research on acupuncture as a treatment for KOA has increased, but remains controversial as researchers attempt to determine the number of sessions needed for effectiveness.

In a study published in Arthritis & Rheumatology, the researchers recruited 480 adults aged 45-75 years with confirmed KOA who reported knee pain for longer than 6 months. Participants were randomized to three groups: electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA). Each group received three treatment sessions per week. In all groups, electrodes were attached to selected acupuncture needles, but the current was turned on only in the EA treatment group.

The primary outcome was the response rate after 8 weeks of treatment, defined as patients who achieved the minimal clinically important improvement (MCII) on both the Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index function subscale.

Overall, response rates at 8 weeks were 60.3%, 58.6%, and 47.3% for the EA, MA, and SA groups, respectively.

Between-group differences were statistically significant for EA versus SA (13%, P = .0234) but not for MA versus SA (11.3%, P = .0507) at 8 weeks; however, both EA and MA groups showed significantly higher response rates, compared with the SA group at 16 and 26 weeks. “Although a clinically meaningful response rate for KOA is not available in the literature, the difference of 11.3%, which indicates the number needed to treat of 9, is acceptable in clinical practices,” the researchers noted.

Adverse events occurred in 11.5% of the EA group, 14.2% of the MA group, and 10.8% of the SA group, and included subcutaneous hematoma, post-needling pain, and pantalgia. All adverse events related to acupuncture resolved within a week and none were serious, the researchers wrote.

The study findings were limited by several factors, including the potential burden on patients of three sessions per week, the limited study population of patients with radiologic grades of II or III only, the use of self-reports, and the lack of blinding for outcome assessors, the researchers noted.

However, the results show persistent effects in reducing pain and improving function with EA or MA, compared with SA, the researchers wrote. The findings were strengthened by “adequate dosage of acupuncture, the use of the primary outcome at an individual level, and the rigorous methodology.” The use of the MCII in the primary outcome “can provide patients and policy makers with more straightforward information to decide whether a treatment should be used.”

Optimal dosing questions remain

Current options for managing KOA are limited by factors that include low efficacy and unwanted side effects, while joint replacements increase the burden on health care systems, wrote David J. Hunter, MBBS, PhD, of the University of Sydney, and Richard E. Harris, PhD, of the University of Michigan, Ann Arbor, in an accompanying editorial. “In this context, development of new treatments or identification of efficacy of existing therapies to address the huge unmet need of pain are strongly desired.” Acupuncture continues to gain popularity in North and South America, but its efficacy for pain and KOA remain controversial.

The question of dose is challenging when assessing acupuncture because the optimal dose and how to classify it remains unknown. “In this study, the authors used three treatments a week, which is more frequent than typical studies done in the West and potentially may not be feasible in some health care settings. A recent systematic review suggests that treatment frequency matters and a dose of three sessions per week may be superior to less frequent treatment,” they emphasized. Acupuncture is generally considered to be safe, but many health systems do not reimburse for it. Patients may have large out-of-pocket expenses because of the number of visits required, which may be a barrier to further implementation in practice.

“Acupuncture is already widely practiced and readily available in many countries and health care systems,” the editorialists said. However, “more research is needed in the areas of dose-response relationships, effects of blinding the acupuncturist, feasibility of three times weekly regimens, and clarifying the mechanism of effect, particularly given the persistence of benefit.”

The study was funded by Beijing Municipal Science & Technology Commission and Beijing Municipal Administration of Hospitals. The researchers had no financial conflicts to disclose. Dr. Hunter disclosed support from a National Health and Medical Research Council Investigator Grant and providing consulting advice for Merck Serono, TLC Bio, Tissuegene, Lilly, and Pfizer.

SOURCE: Tu J-F et al. Arthritis Rheumatol. 2020 Nov 10. doi: 10.1002/art.41584.

Electro-acupuncture resulted in significant improvement in pain and function, compared with sham acupuncture, in a randomized trial of more than 400 adults with knee OA.

The socioeconomic burden of knee OA (KOA) remains high, and will likely increase with the aging population and rising rates of obesity, wrote first author Jian-Feng Tu, MD, PhD, of Beijing University of Chinese Medicine and colleagues. “Since no disease-modifying pharmaceutical agents have been approved, current KOA treatments are mainly symptomatic,” and identifying new therapies in addition to pharmacological agents or surgery is a research priority, they added. The research on acupuncture as a treatment for KOA has increased, but remains controversial as researchers attempt to determine the number of sessions needed for effectiveness.

In a study published in Arthritis & Rheumatology, the researchers recruited 480 adults aged 45-75 years with confirmed KOA who reported knee pain for longer than 6 months. Participants were randomized to three groups: electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA). Each group received three treatment sessions per week. In all groups, electrodes were attached to selected acupuncture needles, but the current was turned on only in the EA treatment group.

The primary outcome was the response rate after 8 weeks of treatment, defined as patients who achieved the minimal clinically important improvement (MCII) on both the Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index function subscale.

Overall, response rates at 8 weeks were 60.3%, 58.6%, and 47.3% for the EA, MA, and SA groups, respectively.

Between-group differences were statistically significant for EA versus SA (13%, P = .0234) but not for MA versus SA (11.3%, P = .0507) at 8 weeks; however, both EA and MA groups showed significantly higher response rates, compared with the SA group at 16 and 26 weeks. “Although a clinically meaningful response rate for KOA is not available in the literature, the difference of 11.3%, which indicates the number needed to treat of 9, is acceptable in clinical practices,” the researchers noted.

Adverse events occurred in 11.5% of the EA group, 14.2% of the MA group, and 10.8% of the SA group, and included subcutaneous hematoma, post-needling pain, and pantalgia. All adverse events related to acupuncture resolved within a week and none were serious, the researchers wrote.

The study findings were limited by several factors, including the potential burden on patients of three sessions per week, the limited study population of patients with radiologic grades of II or III only, the use of self-reports, and the lack of blinding for outcome assessors, the researchers noted.

However, the results show persistent effects in reducing pain and improving function with EA or MA, compared with SA, the researchers wrote. The findings were strengthened by “adequate dosage of acupuncture, the use of the primary outcome at an individual level, and the rigorous methodology.” The use of the MCII in the primary outcome “can provide patients and policy makers with more straightforward information to decide whether a treatment should be used.”

Optimal dosing questions remain

Current options for managing KOA are limited by factors that include low efficacy and unwanted side effects, while joint replacements increase the burden on health care systems, wrote David J. Hunter, MBBS, PhD, of the University of Sydney, and Richard E. Harris, PhD, of the University of Michigan, Ann Arbor, in an accompanying editorial. “In this context, development of new treatments or identification of efficacy of existing therapies to address the huge unmet need of pain are strongly desired.” Acupuncture continues to gain popularity in North and South America, but its efficacy for pain and KOA remain controversial.

The question of dose is challenging when assessing acupuncture because the optimal dose and how to classify it remains unknown. “In this study, the authors used three treatments a week, which is more frequent than typical studies done in the West and potentially may not be feasible in some health care settings. A recent systematic review suggests that treatment frequency matters and a dose of three sessions per week may be superior to less frequent treatment,” they emphasized. Acupuncture is generally considered to be safe, but many health systems do not reimburse for it. Patients may have large out-of-pocket expenses because of the number of visits required, which may be a barrier to further implementation in practice.

“Acupuncture is already widely practiced and readily available in many countries and health care systems,” the editorialists said. However, “more research is needed in the areas of dose-response relationships, effects of blinding the acupuncturist, feasibility of three times weekly regimens, and clarifying the mechanism of effect, particularly given the persistence of benefit.”

The study was funded by Beijing Municipal Science & Technology Commission and Beijing Municipal Administration of Hospitals. The researchers had no financial conflicts to disclose. Dr. Hunter disclosed support from a National Health and Medical Research Council Investigator Grant and providing consulting advice for Merck Serono, TLC Bio, Tissuegene, Lilly, and Pfizer.

SOURCE: Tu J-F et al. Arthritis Rheumatol. 2020 Nov 10. doi: 10.1002/art.41584.

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

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

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

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

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

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

Low-dose chest CT for lung cancer screening provides the opportunity to simultaneously screen patients for osteoporosis, detecting notably higher rates of osteoporosis in men than the traditional tool of DXA, research published in the Journal of Bone and Mineral Research shows.

“Our large-scale, multicenter study of bone density measured from routine low-dose CT scans demonstrated the great potential of using low-dose CT for the opportunistic screening of osteoporosis as an alternative to standard DXA scans,” said senior author Wei Tian, MD, of the Chinese Academy of Engineering and Peking University, in a press statement from the journal.

“Our study revealed the unexpectedly high prevalence of osteoporosis in men, which may impact on the management strategy of men in the future,” Dr. Tian added.

Josephine Therkildsen, MD, of Herning Hospital, Denmark, who has conducted similar research using cardiac CT scans, said the findings add important new insights into the issue of opportunistic screening.

“The results are highly interesting, as they show that low-dose CT-based opportunistic screening could identify a substantial number of patients with low lumbar bone mineral density (BMD) with the future potential to diagnose osteoporosis and initiate relevant treatment before a fracture occurs,” she told this news organization.

Perry J. Pickhardt, MD, chief of gastrointestinal imaging at the University of Wisconsin School of Medicine and Public Health in Madison, agrees. He said in an interview that CT scans of the chest and abdomen, commonly performed for a variety of clinical indications and widespread in most developed countries, can in fact be essential for the detection of a multitude of other concerns – yet are underused for those other purposes.

Use of CT in this way “would likely be very cost effective and clinically efficacious,” he said, adding: “We are seeing greatly increased interest in leveraging this extra information that is contained within every CT scan.” And, “Importantly, artificial intelligence advances now allow for automated approaches, which should allow for expanded use.”
 

Lung cancer CT scans shed light on osteoporosis prevalence

In the study, led by Xiaoguang Cheng, MD, PhD, of the department of radiology, Beijing Jishuitan Hospital, China, researchers examined lung cancer CT screening data from the prospective China Biobank Project to determine the prevalence of osteoporosis in China.

This included the thoracic low-dose CT scans of 69,095 adults, including 40,733 men and 28,362 women, taken between 2018 and 2019.

To screen for osteoporosis, they used quantitative CT software to evaluate lumbar spine (L1-L2) trabecular volume BMD (vBMD) and diagnostic criteria from the American College of Radiology. Using the vBMD measures from the CT imaging, they found the prevalence of osteoporosis among those over 50 years of age in the Chinese population to be 29% for women (49 million) and 13.5% for men (22.8 million).

Interestingly, the osteoporosis prevalence rate among women was comparable to estimates in the population derived from DXA (29.1%); however, the rate in men was twice that estimated from DXA scans (6.5%).

Decreases in trabecular vBMD with age were observed in both genders. However, declines were steeper among women, who had higher peak trabecular vBMD (185.4 mg/cm³), compared with men (176.6 mg/cm³) at age 30-34 years, but significantly lower measures (62.4 mg/cm³) than men (92.1 mg/cm³) at age 80 years.

The prevalence of osteoporosis in women increased from 2.8% at age 50-54 years to 79.8% at age 85 or older, while in men, the prevalence was 3.2% at age 50-54 years and 44.1% at age 85 or older.

“This is the first study to establish Chinese reference data for vBMD using opportunistic screening from low-dose chest CT in a large population cohort,” the authors write.

“The opportunistic screening of osteoporosis using low-dose CT is clinically feasible and requires no additional exposure to ionizing radiation.”

In addition, no additional equipment or patient time was required, suggesting that “this approach has potential for opportunistic screening for osteoporosis.”

They note, however, that further cohort studies are needed to assess clinical utility of this method.
 

CT ‘likely a more accurate measure’ of volumetric BMD

Dr. Pickhardt said the differences in osteoporosis prevalence observed between DXA and CT-derived measures in men likely reflect the greater accuracy of CT.

“DXA is a planar technique with a number of drawbacks,” he said in an interview. “CT provides a more direct volumetric measure and is likely a more accurate method for BMD assessment.”

He speculated that the greater differences between DXA versus CT seen in men than women “may relate to sex differences in cortical bone of vertebral bodies, which cannot be separated from the underlying trabecular bone with DXA (whereas CT directly measures the inner trabecular bone).” 

The authors note that, although areal BMD (aBMD) derived from DXA is required for osteoporosis diagnosis according to World Health Organization criteria, “trabecular vBMD derived from CT can be also used for diagnosis based on thresholds published by the American College of Radiology of 120 mg/cm³ and 80 mg/cm³ to define osteopenia and osteoporosis, respectively, thresholds that were subsequently confirmed for the Chinese population.”

Furthermore, vBMD has been shown in some studies to be more strongly related to fracture risk, compared with DXA aBMD measures.

Importantly, in another recent study involving 9,223 adults, Dr. Pickhardt and colleagues reported that bone and muscle biomarkers derived from CT were comparable to the Fracture Risk Assessment Tool score for the presymptomatic prediction of future osteoporotic fractures.

Dr. Pickhardt is an advisor to Bracco Imaging and Zebra Medical Vision. Dr. Therkildsen has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Low-dose chest CT for lung cancer screening provides the opportunity to simultaneously screen patients for osteoporosis, detecting notably higher rates of osteoporosis in men than the traditional tool of DXA, research published in the Journal of Bone and Mineral Research shows.

“Our large-scale, multicenter study of bone density measured from routine low-dose CT scans demonstrated the great potential of using low-dose CT for the opportunistic screening of osteoporosis as an alternative to standard DXA scans,” said senior author Wei Tian, MD, of the Chinese Academy of Engineering and Peking University, in a press statement from the journal.

“Our study revealed the unexpectedly high prevalence of osteoporosis in men, which may impact on the management strategy of men in the future,” Dr. Tian added.

Josephine Therkildsen, MD, of Herning Hospital, Denmark, who has conducted similar research using cardiac CT scans, said the findings add important new insights into the issue of opportunistic screening.

“The results are highly interesting, as they show that low-dose CT-based opportunistic screening could identify a substantial number of patients with low lumbar bone mineral density (BMD) with the future potential to diagnose osteoporosis and initiate relevant treatment before a fracture occurs,” she told this news organization.

Perry J. Pickhardt, MD, chief of gastrointestinal imaging at the University of Wisconsin School of Medicine and Public Health in Madison, agrees. He said in an interview that CT scans of the chest and abdomen, commonly performed for a variety of clinical indications and widespread in most developed countries, can in fact be essential for the detection of a multitude of other concerns – yet are underused for those other purposes.

Use of CT in this way “would likely be very cost effective and clinically efficacious,” he said, adding: “We are seeing greatly increased interest in leveraging this extra information that is contained within every CT scan.” And, “Importantly, artificial intelligence advances now allow for automated approaches, which should allow for expanded use.”
 

Lung cancer CT scans shed light on osteoporosis prevalence

In the study, led by Xiaoguang Cheng, MD, PhD, of the department of radiology, Beijing Jishuitan Hospital, China, researchers examined lung cancer CT screening data from the prospective China Biobank Project to determine the prevalence of osteoporosis in China.

This included the thoracic low-dose CT scans of 69,095 adults, including 40,733 men and 28,362 women, taken between 2018 and 2019.

To screen for osteoporosis, they used quantitative CT software to evaluate lumbar spine (L1-L2) trabecular volume BMD (vBMD) and diagnostic criteria from the American College of Radiology. Using the vBMD measures from the CT imaging, they found the prevalence of osteoporosis among those over 50 years of age in the Chinese population to be 29% for women (49 million) and 13.5% for men (22.8 million).

Interestingly, the osteoporosis prevalence rate among women was comparable to estimates in the population derived from DXA (29.1%); however, the rate in men was twice that estimated from DXA scans (6.5%).

Decreases in trabecular vBMD with age were observed in both genders. However, declines were steeper among women, who had higher peak trabecular vBMD (185.4 mg/cm³), compared with men (176.6 mg/cm³) at age 30-34 years, but significantly lower measures (62.4 mg/cm³) than men (92.1 mg/cm³) at age 80 years.

The prevalence of osteoporosis in women increased from 2.8% at age 50-54 years to 79.8% at age 85 or older, while in men, the prevalence was 3.2% at age 50-54 years and 44.1% at age 85 or older.

“This is the first study to establish Chinese reference data for vBMD using opportunistic screening from low-dose chest CT in a large population cohort,” the authors write.

“The opportunistic screening of osteoporosis using low-dose CT is clinically feasible and requires no additional exposure to ionizing radiation.”

In addition, no additional equipment or patient time was required, suggesting that “this approach has potential for opportunistic screening for osteoporosis.”

They note, however, that further cohort studies are needed to assess clinical utility of this method.
 

CT ‘likely a more accurate measure’ of volumetric BMD

Dr. Pickhardt said the differences in osteoporosis prevalence observed between DXA and CT-derived measures in men likely reflect the greater accuracy of CT.

“DXA is a planar technique with a number of drawbacks,” he said in an interview. “CT provides a more direct volumetric measure and is likely a more accurate method for BMD assessment.”

He speculated that the greater differences between DXA versus CT seen in men than women “may relate to sex differences in cortical bone of vertebral bodies, which cannot be separated from the underlying trabecular bone with DXA (whereas CT directly measures the inner trabecular bone).” 

The authors note that, although areal BMD (aBMD) derived from DXA is required for osteoporosis diagnosis according to World Health Organization criteria, “trabecular vBMD derived from CT can be also used for diagnosis based on thresholds published by the American College of Radiology of 120 mg/cm³ and 80 mg/cm³ to define osteopenia and osteoporosis, respectively, thresholds that were subsequently confirmed for the Chinese population.”

Furthermore, vBMD has been shown in some studies to be more strongly related to fracture risk, compared with DXA aBMD measures.

Importantly, in another recent study involving 9,223 adults, Dr. Pickhardt and colleagues reported that bone and muscle biomarkers derived from CT were comparable to the Fracture Risk Assessment Tool score for the presymptomatic prediction of future osteoporotic fractures.

Dr. Pickhardt is an advisor to Bracco Imaging and Zebra Medical Vision. Dr. Therkildsen has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Low-dose chest CT for lung cancer screening provides the opportunity to simultaneously screen patients for osteoporosis, detecting notably higher rates of osteoporosis in men than the traditional tool of DXA, research published in the Journal of Bone and Mineral Research shows.

“Our large-scale, multicenter study of bone density measured from routine low-dose CT scans demonstrated the great potential of using low-dose CT for the opportunistic screening of osteoporosis as an alternative to standard DXA scans,” said senior author Wei Tian, MD, of the Chinese Academy of Engineering and Peking University, in a press statement from the journal.

“Our study revealed the unexpectedly high prevalence of osteoporosis in men, which may impact on the management strategy of men in the future,” Dr. Tian added.

Josephine Therkildsen, MD, of Herning Hospital, Denmark, who has conducted similar research using cardiac CT scans, said the findings add important new insights into the issue of opportunistic screening.

“The results are highly interesting, as they show that low-dose CT-based opportunistic screening could identify a substantial number of patients with low lumbar bone mineral density (BMD) with the future potential to diagnose osteoporosis and initiate relevant treatment before a fracture occurs,” she told this news organization.

Perry J. Pickhardt, MD, chief of gastrointestinal imaging at the University of Wisconsin School of Medicine and Public Health in Madison, agrees. He said in an interview that CT scans of the chest and abdomen, commonly performed for a variety of clinical indications and widespread in most developed countries, can in fact be essential for the detection of a multitude of other concerns – yet are underused for those other purposes.

Use of CT in this way “would likely be very cost effective and clinically efficacious,” he said, adding: “We are seeing greatly increased interest in leveraging this extra information that is contained within every CT scan.” And, “Importantly, artificial intelligence advances now allow for automated approaches, which should allow for expanded use.”
 

Lung cancer CT scans shed light on osteoporosis prevalence

In the study, led by Xiaoguang Cheng, MD, PhD, of the department of radiology, Beijing Jishuitan Hospital, China, researchers examined lung cancer CT screening data from the prospective China Biobank Project to determine the prevalence of osteoporosis in China.

This included the thoracic low-dose CT scans of 69,095 adults, including 40,733 men and 28,362 women, taken between 2018 and 2019.

To screen for osteoporosis, they used quantitative CT software to evaluate lumbar spine (L1-L2) trabecular volume BMD (vBMD) and diagnostic criteria from the American College of Radiology. Using the vBMD measures from the CT imaging, they found the prevalence of osteoporosis among those over 50 years of age in the Chinese population to be 29% for women (49 million) and 13.5% for men (22.8 million).

Interestingly, the osteoporosis prevalence rate among women was comparable to estimates in the population derived from DXA (29.1%); however, the rate in men was twice that estimated from DXA scans (6.5%).

Decreases in trabecular vBMD with age were observed in both genders. However, declines were steeper among women, who had higher peak trabecular vBMD (185.4 mg/cm³), compared with men (176.6 mg/cm³) at age 30-34 years, but significantly lower measures (62.4 mg/cm³) than men (92.1 mg/cm³) at age 80 years.

The prevalence of osteoporosis in women increased from 2.8% at age 50-54 years to 79.8% at age 85 or older, while in men, the prevalence was 3.2% at age 50-54 years and 44.1% at age 85 or older.

“This is the first study to establish Chinese reference data for vBMD using opportunistic screening from low-dose chest CT in a large population cohort,” the authors write.

“The opportunistic screening of osteoporosis using low-dose CT is clinically feasible and requires no additional exposure to ionizing radiation.”

In addition, no additional equipment or patient time was required, suggesting that “this approach has potential for opportunistic screening for osteoporosis.”

They note, however, that further cohort studies are needed to assess clinical utility of this method.
 

CT ‘likely a more accurate measure’ of volumetric BMD

Dr. Pickhardt said the differences in osteoporosis prevalence observed between DXA and CT-derived measures in men likely reflect the greater accuracy of CT.

“DXA is a planar technique with a number of drawbacks,” he said in an interview. “CT provides a more direct volumetric measure and is likely a more accurate method for BMD assessment.”

He speculated that the greater differences between DXA versus CT seen in men than women “may relate to sex differences in cortical bone of vertebral bodies, which cannot be separated from the underlying trabecular bone with DXA (whereas CT directly measures the inner trabecular bone).” 

The authors note that, although areal BMD (aBMD) derived from DXA is required for osteoporosis diagnosis according to World Health Organization criteria, “trabecular vBMD derived from CT can be also used for diagnosis based on thresholds published by the American College of Radiology of 120 mg/cm³ and 80 mg/cm³ to define osteopenia and osteoporosis, respectively, thresholds that were subsequently confirmed for the Chinese population.”

Furthermore, vBMD has been shown in some studies to be more strongly related to fracture risk, compared with DXA aBMD measures.

Importantly, in another recent study involving 9,223 adults, Dr. Pickhardt and colleagues reported that bone and muscle biomarkers derived from CT were comparable to the Fracture Risk Assessment Tool score for the presymptomatic prediction of future osteoporotic fractures.

Dr. Pickhardt is an advisor to Bracco Imaging and Zebra Medical Vision. Dr. Therkildsen has reported no relevant financial relationships.

This article first appeared on Medscape.com.

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

I am a retired advanced practice psychiatric nurse who has lived and worked on “both sides of the door.” This wording is paraphrased from psychologist and therapist Lauren Slater, PhD, who wrote about a time she went to McLean Hospital in Belmont, Massachusetts, as a therapist after staying there as a patient years earlier: “And now I am standing on the other—the wrong, I mean the right side of the door and I ring the buzzer.”¹ Here I tell my story of the physical and emotional effects of my mental illness and treatment.

Onset of bipolar disorder. My bipolar illness started with a bout of depression in 1963 at age 13, which resulted in a low-key summer of often staying inside. I received no medication, and no one sent me for evaluation. In the fall, I went back to school and finished the year without incident. I continued as a quiet, shy kid through high school in the late 1960s. In my senior year, I decided to take an overload of difficult courses and run on the varsity cross-country team. The amount and intensity of these activities were too much. This resulted in my first manic episode, which started during a weekend visit to a college I hoped to attend. I became excitable, grandiose, and had delusions. A day later, I returned home, and my parents had me admitted to a psychiatric hospital, where I remained for 3 months.

At first, my diagnosis was unclear, and initially no one considered what at the time was called manic depression. At that point, I was unaware of my extensive family psychiatric history. My pharmacologic treatment consisted of chlorpromazine, trifluoperazine, and procyclidine. I returned home just before Christmas and barely finished my senior year of high school. A good college accepted me. But during the orientation, I was asked to leave because I experienced a second manic episode. After 4 more psychiatric hospitalizations, I finally stabilized.

During one of my hospitalizations, I had the good fortune to be interviewed by Dr. Thomas Detre. During this interview, I talked expansively about Don Quixote, Aldonza, and Sancho Panza. Dr. Detre diagnosed me with manic depression, and suggested that I see Dr. Christiaan van der Velde, who was researching lithium carbonate.² In 1970, I was hospitalized at Norwich State Hospital in Preston, Connecticut and was started on lithium, even though it had not yet been FDA-approved. I responded well to lithium monotherapy.

An extensive family history. Having bipolar disorder was not something I would discuss with others because I felt ashamed. I commonly hid my medication during college, especially from my roommates or other friends. By then, I had learned a little about my family’s psychiatric history, but I knew few specifics. Over time, I became aware of a dense familial cluster of affective illness going back several generations. My maternal grandmother was hospitalized for depression in 1921 after her husband suddenly died during her fourth pregnancy. She became bereft and suicidal because she had no one to support her 4 children. During my grandmother’s hospitalization, her sister and sister’s husband took care of her children. My grandmother remained hospitalized until she died in 1943. At that time, no medications were available to treat her illness. Over the next 2 generations, 2 of her 4 children and 6 of her 12 grandchildren (including me) developed bipolar disorder.

A career and family. In 1970, I started to work as a nursing assistant, then as a nursing technician for 1.5 years in a specialty hospital in New England. In 1973, I began nursing school at a junior college. I received my RN in 1975, a BS in nursing in 1979, and an MS in psychiatric nursing in 1982. I worked steadily as a psychiatric nurse in both inpatient and outpatient settings from 1975 until I retired in 2019.

In the early 1980s, I married my first wife and had 2 wonderful children. During our courtship in 1981 and 1982, I became hypomanic, which perhaps made me more outgoing and sociable. In 1985, after my father required open heart surgery, I had a manic episode that lasted 1 week. Over the next 20 years, although I was not happy with my marriage, I remained euthymic and productive at work. My marriage ended in 2012.

Continue to: By the end of 2012...

By the end of 2012, I had been taking lithium continuously for 42 years. My laboratory tests showed peak lithium levels between 0.6 and 1.2 mmol/L. I remained otherwise healthy, as demonstrated by annual physical exams and laboratory test results. In 2015, I developed an increase in my blood pressure and my primary care physician (PCP) prescribed oral lisinopril, initially 10 mg/d, and later 10 mg twice daily. My blood pressure improved and ranged from 120/74 to 130/82 mm Hg.

Hyperparathyroidism. By 2016, my psychiatrist, PCP, and nephrologist all urged me to consider parathyroid surgery.^3-5 Hypercalcemia and hyperparathyroidism caused the most worry. Laboratory tests indicated calcium 11.2 mg/dL, parathyroid hormone (PTH) 88 pg/mL, estimated glomerular filtration rate (eGFR) 59 mL/min, and thyroid-stimulating hormone (TSH) 0.78 mIU/L. Electrocardiographysometimes showed a slight QT elongation. A right bundle branch block, which was first noted in 2015, continued. Due to my elevated calcium levels, I eliminated most calcium from my diet. My psychiatrist began to speak more strongly of parathyroid surgery. I then consulted a senior endocrinologist and a senior nephrologist, who each recommended parathyroid surgery.

I remarried in July 2016, and we moved to a different area of the country. My second wife became a stabilizing force for me. My new PCP, however, found elevated high-density lipoproteins during a routine physical examination, and started me on simvastatin, 10 mg/d. My calcium and PTH levels continued to be elevated. My PCP, nephrologist, therapist, and wife urged me to proceed with the parathyroidectomy. After a short period of watchful waiting and a second consultation with a nephrologist, I agreed to schedule a subtotal parathyroidectomy.

Surgery. In spring 2017, I began preparation for parathyroidectomy. At the time, my lithium carbonate dose was 600 mg/d, alternating with 900 mg/d. My peak level of lithium was 0.6 mmol/L. Lisinopril is synergistic, which allowed me to take a smaller effective dose of lithium.

My parathyroid surgery occurred on June 28, 2017 at Norman Parathyroid Center in Tampa, Florida.⁶ The surgeon recorded my parathyroid glands as 136, 602, and 348 units using a measure developed at Norman Parathyroid Center. No reading was given for my fourth parathyroid gland, which they did not remove. Following the surgery, I resumed my previous functions, including employment as a visiting nurse. I initially took calcium supplements after surgery, and my lithium dose was reduced to 300 mg orally, twice daily, which I have continued. I have remained euthymic. On August 3, 2017 my laboratory workup showed an eGFR of 64 mL/min, calcium 10.0 mg/dL, and PTH 17 pg/mL. Vitamin D25 OH 33, glucose, BUN/Cr, electrolytes, complete blood count, and albumin were all within normal limits. Repeat bloodwork on September 19, 2017 showed Ca⁺⁺ 10.1 mg/dL and PTH 18 pg/mL. Nine months after the surgery, I showed an incredibly positive physical and mental response, which has continued to this day.

Continue to: Clinical implications

Clinical implications. This is a single case study. However, it is important for clinicians treating patients with lithium carbonate to regularly order laboratory testing, including for lithium levels, PTH, and calcium, to detect early signs of complications from treatment, including hyperparathyroidism and hypercalcemia.⁷ These levels could be obtained every 6 months. If a patient’s PTH levels are >70 pg/mL and calcium levels are >11.0 mg/dL, it would be prudent to refer him/her for further medical evaluation. Additionally, it would be helpful to counsel the patient about considering alternative medication and adjunct mental health treatment. At some future point, it could be useful for the clinician and his/her patient to explore the idea of parathyroid surgery.

In addition to chronic lithium use, other causes of hyperparathyroidism include an adenoma on a gland, hyperplasia of ≥2 parathyroid glands, a malignant tumor, severe calcium deficiency, severe vitamin D deficiency, chronic renal failure, and (rarely) an inherited gene that causes hyperparathyroidism.

How I’m doing today. Currently, I am euthymic and in a happy marriage. My laboratory workup in May 2020 included glucose 107 mg/dL, Ca⁺⁺ 9.5 mg/dL, eGFR 61 mL/min, PTH 32 pg/mL, lithium 0.3 mmol/L (300 mg twice daily), and TSH 1.79 mIU/L. A comprehensive metabolic panel, complete blood count, and lipid panel were all within normal limits.

I am fortunate to continue having excellent care provided by my PCP, nephrologist, urologist, and psychiatric APRN. Together with these wonderful professionals, I have been able to maintain my physical and mental health.

Acknowledgment: I gratefully acknowledge the help and skills of Robin Scharak and Gary Blake for providing some of the editing on this article.

Bill Greenberg MS, RN, APRN
Delray Beach, Florida

I am a retired advanced practice psychiatric nurse who has lived and worked on “both sides of the door.” This wording is paraphrased from psychologist and therapist Lauren Slater, PhD, who wrote about a time she went to McLean Hospital in Belmont, Massachusetts, as a therapist after staying there as a patient years earlier: “And now I am standing on the other—the wrong, I mean the right side of the door and I ring the buzzer.”¹ Here I tell my story of the physical and emotional effects of my mental illness and treatment.

Onset of bipolar disorder. My bipolar illness started with a bout of depression in 1963 at age 13, which resulted in a low-key summer of often staying inside. I received no medication, and no one sent me for evaluation. In the fall, I went back to school and finished the year without incident. I continued as a quiet, shy kid through high school in the late 1960s. In my senior year, I decided to take an overload of difficult courses and run on the varsity cross-country team. The amount and intensity of these activities were too much. This resulted in my first manic episode, which started during a weekend visit to a college I hoped to attend. I became excitable, grandiose, and had delusions. A day later, I returned home, and my parents had me admitted to a psychiatric hospital, where I remained for 3 months.

At first, my diagnosis was unclear, and initially no one considered what at the time was called manic depression. At that point, I was unaware of my extensive family psychiatric history. My pharmacologic treatment consisted of chlorpromazine, trifluoperazine, and procyclidine. I returned home just before Christmas and barely finished my senior year of high school. A good college accepted me. But during the orientation, I was asked to leave because I experienced a second manic episode. After 4 more psychiatric hospitalizations, I finally stabilized.

During one of my hospitalizations, I had the good fortune to be interviewed by Dr. Thomas Detre. During this interview, I talked expansively about Don Quixote, Aldonza, and Sancho Panza. Dr. Detre diagnosed me with manic depression, and suggested that I see Dr. Christiaan van der Velde, who was researching lithium carbonate.² In 1970, I was hospitalized at Norwich State Hospital in Preston, Connecticut and was started on lithium, even though it had not yet been FDA-approved. I responded well to lithium monotherapy.

An extensive family history. Having bipolar disorder was not something I would discuss with others because I felt ashamed. I commonly hid my medication during college, especially from my roommates or other friends. By then, I had learned a little about my family’s psychiatric history, but I knew few specifics. Over time, I became aware of a dense familial cluster of affective illness going back several generations. My maternal grandmother was hospitalized for depression in 1921 after her husband suddenly died during her fourth pregnancy. She became bereft and suicidal because she had no one to support her 4 children. During my grandmother’s hospitalization, her sister and sister’s husband took care of her children. My grandmother remained hospitalized until she died in 1943. At that time, no medications were available to treat her illness. Over the next 2 generations, 2 of her 4 children and 6 of her 12 grandchildren (including me) developed bipolar disorder.

A career and family. In 1970, I started to work as a nursing assistant, then as a nursing technician for 1.5 years in a specialty hospital in New England. In 1973, I began nursing school at a junior college. I received my RN in 1975, a BS in nursing in 1979, and an MS in psychiatric nursing in 1982. I worked steadily as a psychiatric nurse in both inpatient and outpatient settings from 1975 until I retired in 2019.

In the early 1980s, I married my first wife and had 2 wonderful children. During our courtship in 1981 and 1982, I became hypomanic, which perhaps made me more outgoing and sociable. In 1985, after my father required open heart surgery, I had a manic episode that lasted 1 week. Over the next 20 years, although I was not happy with my marriage, I remained euthymic and productive at work. My marriage ended in 2012.

Continue to: By the end of 2012...

By the end of 2012, I had been taking lithium continuously for 42 years. My laboratory tests showed peak lithium levels between 0.6 and 1.2 mmol/L. I remained otherwise healthy, as demonstrated by annual physical exams and laboratory test results. In 2015, I developed an increase in my blood pressure and my primary care physician (PCP) prescribed oral lisinopril, initially 10 mg/d, and later 10 mg twice daily. My blood pressure improved and ranged from 120/74 to 130/82 mm Hg.

Hyperparathyroidism. By 2016, my psychiatrist, PCP, and nephrologist all urged me to consider parathyroid surgery.^3-5 Hypercalcemia and hyperparathyroidism caused the most worry. Laboratory tests indicated calcium 11.2 mg/dL, parathyroid hormone (PTH) 88 pg/mL, estimated glomerular filtration rate (eGFR) 59 mL/min, and thyroid-stimulating hormone (TSH) 0.78 mIU/L. Electrocardiographysometimes showed a slight QT elongation. A right bundle branch block, which was first noted in 2015, continued. Due to my elevated calcium levels, I eliminated most calcium from my diet. My psychiatrist began to speak more strongly of parathyroid surgery. I then consulted a senior endocrinologist and a senior nephrologist, who each recommended parathyroid surgery.

I remarried in July 2016, and we moved to a different area of the country. My second wife became a stabilizing force for me. My new PCP, however, found elevated high-density lipoproteins during a routine physical examination, and started me on simvastatin, 10 mg/d. My calcium and PTH levels continued to be elevated. My PCP, nephrologist, therapist, and wife urged me to proceed with the parathyroidectomy. After a short period of watchful waiting and a second consultation with a nephrologist, I agreed to schedule a subtotal parathyroidectomy.

Surgery. In spring 2017, I began preparation for parathyroidectomy. At the time, my lithium carbonate dose was 600 mg/d, alternating with 900 mg/d. My peak level of lithium was 0.6 mmol/L. Lisinopril is synergistic, which allowed me to take a smaller effective dose of lithium.

My parathyroid surgery occurred on June 28, 2017 at Norman Parathyroid Center in Tampa, Florida.⁶ The surgeon recorded my parathyroid glands as 136, 602, and 348 units using a measure developed at Norman Parathyroid Center. No reading was given for my fourth parathyroid gland, which they did not remove. Following the surgery, I resumed my previous functions, including employment as a visiting nurse. I initially took calcium supplements after surgery, and my lithium dose was reduced to 300 mg orally, twice daily, which I have continued. I have remained euthymic. On August 3, 2017 my laboratory workup showed an eGFR of 64 mL/min, calcium 10.0 mg/dL, and PTH 17 pg/mL. Vitamin D25 OH 33, glucose, BUN/Cr, electrolytes, complete blood count, and albumin were all within normal limits. Repeat bloodwork on September 19, 2017 showed Ca⁺⁺ 10.1 mg/dL and PTH 18 pg/mL. Nine months after the surgery, I showed an incredibly positive physical and mental response, which has continued to this day.

Continue to: Clinical implications

Clinical implications. This is a single case study. However, it is important for clinicians treating patients with lithium carbonate to regularly order laboratory testing, including for lithium levels, PTH, and calcium, to detect early signs of complications from treatment, including hyperparathyroidism and hypercalcemia.⁷ These levels could be obtained every 6 months. If a patient’s PTH levels are >70 pg/mL and calcium levels are >11.0 mg/dL, it would be prudent to refer him/her for further medical evaluation. Additionally, it would be helpful to counsel the patient about considering alternative medication and adjunct mental health treatment. At some future point, it could be useful for the clinician and his/her patient to explore the idea of parathyroid surgery.

In addition to chronic lithium use, other causes of hyperparathyroidism include an adenoma on a gland, hyperplasia of ≥2 parathyroid glands, a malignant tumor, severe calcium deficiency, severe vitamin D deficiency, chronic renal failure, and (rarely) an inherited gene that causes hyperparathyroidism.

How I’m doing today. Currently, I am euthymic and in a happy marriage. My laboratory workup in May 2020 included glucose 107 mg/dL, Ca⁺⁺ 9.5 mg/dL, eGFR 61 mL/min, PTH 32 pg/mL, lithium 0.3 mmol/L (300 mg twice daily), and TSH 1.79 mIU/L. A comprehensive metabolic panel, complete blood count, and lipid panel were all within normal limits.

I am fortunate to continue having excellent care provided by my PCP, nephrologist, urologist, and psychiatric APRN. Together with these wonderful professionals, I have been able to maintain my physical and mental health.

Acknowledgment: I gratefully acknowledge the help and skills of Robin Scharak and Gary Blake for providing some of the editing on this article.

Bill Greenberg MS, RN, APRN
Delray Beach, Florida

I am a retired advanced practice psychiatric nurse who has lived and worked on “both sides of the door.” This wording is paraphrased from psychologist and therapist Lauren Slater, PhD, who wrote about a time she went to McLean Hospital in Belmont, Massachusetts, as a therapist after staying there as a patient years earlier: “And now I am standing on the other—the wrong, I mean the right side of the door and I ring the buzzer.”¹ Here I tell my story of the physical and emotional effects of my mental illness and treatment.

Onset of bipolar disorder. My bipolar illness started with a bout of depression in 1963 at age 13, which resulted in a low-key summer of often staying inside. I received no medication, and no one sent me for evaluation. In the fall, I went back to school and finished the year without incident. I continued as a quiet, shy kid through high school in the late 1960s. In my senior year, I decided to take an overload of difficult courses and run on the varsity cross-country team. The amount and intensity of these activities were too much. This resulted in my first manic episode, which started during a weekend visit to a college I hoped to attend. I became excitable, grandiose, and had delusions. A day later, I returned home, and my parents had me admitted to a psychiatric hospital, where I remained for 3 months.

At first, my diagnosis was unclear, and initially no one considered what at the time was called manic depression. At that point, I was unaware of my extensive family psychiatric history. My pharmacologic treatment consisted of chlorpromazine, trifluoperazine, and procyclidine. I returned home just before Christmas and barely finished my senior year of high school. A good college accepted me. But during the orientation, I was asked to leave because I experienced a second manic episode. After 4 more psychiatric hospitalizations, I finally stabilized.

During one of my hospitalizations, I had the good fortune to be interviewed by Dr. Thomas Detre. During this interview, I talked expansively about Don Quixote, Aldonza, and Sancho Panza. Dr. Detre diagnosed me with manic depression, and suggested that I see Dr. Christiaan van der Velde, who was researching lithium carbonate.² In 1970, I was hospitalized at Norwich State Hospital in Preston, Connecticut and was started on lithium, even though it had not yet been FDA-approved. I responded well to lithium monotherapy.

An extensive family history. Having bipolar disorder was not something I would discuss with others because I felt ashamed. I commonly hid my medication during college, especially from my roommates or other friends. By then, I had learned a little about my family’s psychiatric history, but I knew few specifics. Over time, I became aware of a dense familial cluster of affective illness going back several generations. My maternal grandmother was hospitalized for depression in 1921 after her husband suddenly died during her fourth pregnancy. She became bereft and suicidal because she had no one to support her 4 children. During my grandmother’s hospitalization, her sister and sister’s husband took care of her children. My grandmother remained hospitalized until she died in 1943. At that time, no medications were available to treat her illness. Over the next 2 generations, 2 of her 4 children and 6 of her 12 grandchildren (including me) developed bipolar disorder.

A career and family. In 1970, I started to work as a nursing assistant, then as a nursing technician for 1.5 years in a specialty hospital in New England. In 1973, I began nursing school at a junior college. I received my RN in 1975, a BS in nursing in 1979, and an MS in psychiatric nursing in 1982. I worked steadily as a psychiatric nurse in both inpatient and outpatient settings from 1975 until I retired in 2019.

In the early 1980s, I married my first wife and had 2 wonderful children. During our courtship in 1981 and 1982, I became hypomanic, which perhaps made me more outgoing and sociable. In 1985, after my father required open heart surgery, I had a manic episode that lasted 1 week. Over the next 20 years, although I was not happy with my marriage, I remained euthymic and productive at work. My marriage ended in 2012.

Continue to: By the end of 2012...

By the end of 2012, I had been taking lithium continuously for 42 years. My laboratory tests showed peak lithium levels between 0.6 and 1.2 mmol/L. I remained otherwise healthy, as demonstrated by annual physical exams and laboratory test results. In 2015, I developed an increase in my blood pressure and my primary care physician (PCP) prescribed oral lisinopril, initially 10 mg/d, and later 10 mg twice daily. My blood pressure improved and ranged from 120/74 to 130/82 mm Hg.

Hyperparathyroidism. By 2016, my psychiatrist, PCP, and nephrologist all urged me to consider parathyroid surgery.^3-5 Hypercalcemia and hyperparathyroidism caused the most worry. Laboratory tests indicated calcium 11.2 mg/dL, parathyroid hormone (PTH) 88 pg/mL, estimated glomerular filtration rate (eGFR) 59 mL/min, and thyroid-stimulating hormone (TSH) 0.78 mIU/L. Electrocardiographysometimes showed a slight QT elongation. A right bundle branch block, which was first noted in 2015, continued. Due to my elevated calcium levels, I eliminated most calcium from my diet. My psychiatrist began to speak more strongly of parathyroid surgery. I then consulted a senior endocrinologist and a senior nephrologist, who each recommended parathyroid surgery.

I remarried in July 2016, and we moved to a different area of the country. My second wife became a stabilizing force for me. My new PCP, however, found elevated high-density lipoproteins during a routine physical examination, and started me on simvastatin, 10 mg/d. My calcium and PTH levels continued to be elevated. My PCP, nephrologist, therapist, and wife urged me to proceed with the parathyroidectomy. After a short period of watchful waiting and a second consultation with a nephrologist, I agreed to schedule a subtotal parathyroidectomy.

Surgery. In spring 2017, I began preparation for parathyroidectomy. At the time, my lithium carbonate dose was 600 mg/d, alternating with 900 mg/d. My peak level of lithium was 0.6 mmol/L. Lisinopril is synergistic, which allowed me to take a smaller effective dose of lithium.

My parathyroid surgery occurred on June 28, 2017 at Norman Parathyroid Center in Tampa, Florida.⁶ The surgeon recorded my parathyroid glands as 136, 602, and 348 units using a measure developed at Norman Parathyroid Center. No reading was given for my fourth parathyroid gland, which they did not remove. Following the surgery, I resumed my previous functions, including employment as a visiting nurse. I initially took calcium supplements after surgery, and my lithium dose was reduced to 300 mg orally, twice daily, which I have continued. I have remained euthymic. On August 3, 2017 my laboratory workup showed an eGFR of 64 mL/min, calcium 10.0 mg/dL, and PTH 17 pg/mL. Vitamin D25 OH 33, glucose, BUN/Cr, electrolytes, complete blood count, and albumin were all within normal limits. Repeat bloodwork on September 19, 2017 showed Ca⁺⁺ 10.1 mg/dL and PTH 18 pg/mL. Nine months after the surgery, I showed an incredibly positive physical and mental response, which has continued to this day.

Continue to: Clinical implications

Clinical implications. This is a single case study. However, it is important for clinicians treating patients with lithium carbonate to regularly order laboratory testing, including for lithium levels, PTH, and calcium, to detect early signs of complications from treatment, including hyperparathyroidism and hypercalcemia.⁷ These levels could be obtained every 6 months. If a patient’s PTH levels are >70 pg/mL and calcium levels are >11.0 mg/dL, it would be prudent to refer him/her for further medical evaluation. Additionally, it would be helpful to counsel the patient about considering alternative medication and adjunct mental health treatment. At some future point, it could be useful for the clinician and his/her patient to explore the idea of parathyroid surgery.

In addition to chronic lithium use, other causes of hyperparathyroidism include an adenoma on a gland, hyperplasia of ≥2 parathyroid glands, a malignant tumor, severe calcium deficiency, severe vitamin D deficiency, chronic renal failure, and (rarely) an inherited gene that causes hyperparathyroidism.

How I’m doing today. Currently, I am euthymic and in a happy marriage. My laboratory workup in May 2020 included glucose 107 mg/dL, Ca⁺⁺ 9.5 mg/dL, eGFR 61 mL/min, PTH 32 pg/mL, lithium 0.3 mmol/L (300 mg twice daily), and TSH 1.79 mIU/L. A comprehensive metabolic panel, complete blood count, and lipid panel were all within normal limits.

I am fortunate to continue having excellent care provided by my PCP, nephrologist, urologist, and psychiatric APRN. Together with these wonderful professionals, I have been able to maintain my physical and mental health.

Acknowledgment: I gratefully acknowledge the help and skills of Robin Scharak and Gary Blake for providing some of the editing on this article.

Bill Greenberg MS, RN, APRN
Delray Beach, Florida

It’s high time to say farewell to the traditional categorization of psoriasis severity into mild, moderate, or severe disease, according to the International Psoriasis Council.

The mild/moderate/severe categorization is vague and defined differently by different organizations and in different countries. It often underestimates disease severity because it ignores psoriasis involvement in particularly tough-to-treat special areas, including the scalp, palms, soles, face, nails, and genitalia, Bruce E. Strober, MD, PhD, asserted at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year. He chaired an IPC project in which prominent psoriasis experts in 32 countries employed a Delphi consensus approach aimed at achieving agreement on a more practical recategorization of psoriasis severity for use in both daily clinical practice and enrolling appropriate participants in clinical trials. What emerged was a simplified dichotomous categorization system.

“What we came up with is a very sensible approach to defining whether patients should get either topical or systemic therapy. In fact, there are only two groups of patients in psoriasis: those who should get topicals alone, and those who should get systemic therapy. It’s topicals or systemics,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., who also works in private practice in Cromwell, Conn.

Under the IPC classification, psoriasis patients are candidates for systemic therapy if they meet at least one of three criteria: body surface area of involvement greater than 10%, disease involving the previously mentioned special areas, or failure of topical therapy.

“This approach is about practically treating patients who are in need,” Dr. Strober said. “If patients meet just one of these three criteria they can move on to our current toolbox of systemic therapies, be they older systemic treatments, apremilast, phototherapy, or 1 of the 11 biologics currently approved for the treatment of psoriasis. The key point is that for patients with moderate to severe psoriasis – or should I say, systemic therapy–appropriate psoriasis – treatment should be based on individual patient characteristics. We don’t work on a stepwise approach. If a patient walks in with more than 10% body surface area involved, don’t make them fail topicals; you can go right to systemics.”

European dermatologists often use the Psoriasis Area and Severity Index (PASI) score to characterize disease severity and monitor response to therapy. In contrast, American dermatologists generally find PASI too complex and time-consuming for use in clinical practice, relying instead on the amount of body surface area involved with psoriasis. Neither of these measures incorporates disease involvement in special areas, which when present ought to automatically place a patient in the systemic therapy–appropriate category, according to Dr. Strober.

“I find this [IPC recategorization] a very practical approach. I hope you write this down and use this in your own practice,” Dr. Strober said.

The full IPC report was published in the Journal of the American Academy of Dermatology.

The IPC psoriasis severity reclassification project was unfunded. Dr. Strober reported receiving institutional research funding from and serving as a paid consultant to more than two dozen pharmaceutical companies.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

It’s high time to say farewell to the traditional categorization of psoriasis severity into mild, moderate, or severe disease, according to the International Psoriasis Council.

The mild/moderate/severe categorization is vague and defined differently by different organizations and in different countries. It often underestimates disease severity because it ignores psoriasis involvement in particularly tough-to-treat special areas, including the scalp, palms, soles, face, nails, and genitalia, Bruce E. Strober, MD, PhD, asserted at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year. He chaired an IPC project in which prominent psoriasis experts in 32 countries employed a Delphi consensus approach aimed at achieving agreement on a more practical recategorization of psoriasis severity for use in both daily clinical practice and enrolling appropriate participants in clinical trials. What emerged was a simplified dichotomous categorization system.

“What we came up with is a very sensible approach to defining whether patients should get either topical or systemic therapy. In fact, there are only two groups of patients in psoriasis: those who should get topicals alone, and those who should get systemic therapy. It’s topicals or systemics,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., who also works in private practice in Cromwell, Conn.

Under the IPC classification, psoriasis patients are candidates for systemic therapy if they meet at least one of three criteria: body surface area of involvement greater than 10%, disease involving the previously mentioned special areas, or failure of topical therapy.

“This approach is about practically treating patients who are in need,” Dr. Strober said. “If patients meet just one of these three criteria they can move on to our current toolbox of systemic therapies, be they older systemic treatments, apremilast, phototherapy, or 1 of the 11 biologics currently approved for the treatment of psoriasis. The key point is that for patients with moderate to severe psoriasis – or should I say, systemic therapy–appropriate psoriasis – treatment should be based on individual patient characteristics. We don’t work on a stepwise approach. If a patient walks in with more than 10% body surface area involved, don’t make them fail topicals; you can go right to systemics.”

European dermatologists often use the Psoriasis Area and Severity Index (PASI) score to characterize disease severity and monitor response to therapy. In contrast, American dermatologists generally find PASI too complex and time-consuming for use in clinical practice, relying instead on the amount of body surface area involved with psoriasis. Neither of these measures incorporates disease involvement in special areas, which when present ought to automatically place a patient in the systemic therapy–appropriate category, according to Dr. Strober.

“I find this [IPC recategorization] a very practical approach. I hope you write this down and use this in your own practice,” Dr. Strober said.

The full IPC report was published in the Journal of the American Academy of Dermatology.

The IPC psoriasis severity reclassification project was unfunded. Dr. Strober reported receiving institutional research funding from and serving as a paid consultant to more than two dozen pharmaceutical companies.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

It’s high time to say farewell to the traditional categorization of psoriasis severity into mild, moderate, or severe disease, according to the International Psoriasis Council.

The mild/moderate/severe categorization is vague and defined differently by different organizations and in different countries. It often underestimates disease severity because it ignores psoriasis involvement in particularly tough-to-treat special areas, including the scalp, palms, soles, face, nails, and genitalia, Bruce E. Strober, MD, PhD, asserted at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year. He chaired an IPC project in which prominent psoriasis experts in 32 countries employed a Delphi consensus approach aimed at achieving agreement on a more practical recategorization of psoriasis severity for use in both daily clinical practice and enrolling appropriate participants in clinical trials. What emerged was a simplified dichotomous categorization system.

“What we came up with is a very sensible approach to defining whether patients should get either topical or systemic therapy. In fact, there are only two groups of patients in psoriasis: those who should get topicals alone, and those who should get systemic therapy. It’s topicals or systemics,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., who also works in private practice in Cromwell, Conn.

Under the IPC classification, psoriasis patients are candidates for systemic therapy if they meet at least one of three criteria: body surface area of involvement greater than 10%, disease involving the previously mentioned special areas, or failure of topical therapy.

“This approach is about practically treating patients who are in need,” Dr. Strober said. “If patients meet just one of these three criteria they can move on to our current toolbox of systemic therapies, be they older systemic treatments, apremilast, phototherapy, or 1 of the 11 biologics currently approved for the treatment of psoriasis. The key point is that for patients with moderate to severe psoriasis – or should I say, systemic therapy–appropriate psoriasis – treatment should be based on individual patient characteristics. We don’t work on a stepwise approach. If a patient walks in with more than 10% body surface area involved, don’t make them fail topicals; you can go right to systemics.”

European dermatologists often use the Psoriasis Area and Severity Index (PASI) score to characterize disease severity and monitor response to therapy. In contrast, American dermatologists generally find PASI too complex and time-consuming for use in clinical practice, relying instead on the amount of body surface area involved with psoriasis. Neither of these measures incorporates disease involvement in special areas, which when present ought to automatically place a patient in the systemic therapy–appropriate category, according to Dr. Strober.

“I find this [IPC recategorization] a very practical approach. I hope you write this down and use this in your own practice,” Dr. Strober said.

The full IPC report was published in the Journal of the American Academy of Dermatology.

The IPC psoriasis severity reclassification project was unfunded. Dr. Strober reported receiving institutional research funding from and serving as a paid consultant to more than two dozen pharmaceutical companies.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

For mid-career oncologist Tanya Wildes, MD, the pandemic was the last straw. In late September, she tweeted: “I have done the academically unfathomable: I am resigning my faculty position without another job lined up.”

She wasn’t burned out, she insisted. She loved her patients and her research. But she was also “100% confident” in her decision and “also 100% sad. This did not have to happen,” she lamented, asking not to disclose her workplace for fear of retribution.

Being a woman in medicine “is a hard life to start with,” Dr. Wildes said in an interview. “We all have that tenuous balance going on and the pandemic made everything just a little bit harder.”

She describes her prepandemic work-life balance as a “Jenga tower, with everything only just in place.” But she realized that the balance had tipped, when after a difficult clinic she felt emotionally wrung out. Her 11-year-old son had asked her to help him fly his model airplane. “I told him, ‘Honey, I can’t do it because if it crashes or gets stuck in a tree ... you’re going to be devastated and I have nothing left for you.’ “

This was a eureka moment, as “I realized, this is not who I want to be,” she said, holding back tears. “Seventy years from now my son is going to tell his grandchildren about the pandemic and I don’t want his memory of his mom to be that she couldn’t be there for him because she was too spent.”

When Dr. Wildes shared her story on Twitter, other female oncologists and physicians responded that they too have felt they’re under increased pressure this year, with the extra stress of the pandemic leading others to quit as well.

The trend of doctors leaving medicine has been noticeable. A July survey from the Physicians Foundation found that roughly 16,000 medical practices had already closed during the pandemic, with another 8,000 predicted to close within the next year.

“Similar patterns” were evident in another analysis by the Larry A. Green Center and the Primary Care Collaborative, as reported in The New York Times. In that survey, nearly one-fifth of primary care clinicians said “someone in their practice plans to retire early or has already retired because of COVID-19,” and 15% say “someone has left or plans to leave the practice.” About half said their mental exhaustion was at an all-time high, the survey found.

“COVID-19 is a burden, and that added burden has tipped people over the edge of many things,” said Monica Bertagnolli, MD, chief of the division of surgical oncology at Brigham and Women’s Hospital, Boston, and former president of the American Society of Clinical Oncology.

“It has illustrated that we do have a lot of people who are working kind of on the edge of not being able to handle everything,” she said.

While many in medicine are struggling, the pandemic seems to be pushing more women to leave, highlighting longtime gender disparities and increased caregiving burdens. And their absence may be felt for years to come.

Firm numbers are hard to come by, said Julie Silver, MD, associate professor, associate chair, and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston, and an expert in gender equity in medicine. But she sees some troubling trends.

“There are many indications that women are leaving medicine in disproportionately high numbers,” Dr. Silver said in an interview. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

A survey of 1,809 women conducted in mid-April with the Physician Moms Facebook Group and accepted for online publication by the American Journal of Psychiatry found that 41% scored over the cutoff points for moderate or severe anxiety, with 46% meeting these criteria among front-line workers.

“It’s really important for society to recognize the extraordinary impact this pandemic is having on physician mothers, as there will be profound ripple effects on the ability of this key segment of the health care workforce to serve others if we do not address this problem urgently,” co-senior author Reshma Jagsi, MD, DPhil, a radiation oncologist at the University of Michigan, Ann Arbor, said in an interview.

Women weighed in on Twitter, in response to Dr. Silver’s tweet to #WomenInMedicine: “If you are thinking of leaving #medicine & need a reason to stay: we value you & need you.”

In reply, Emmy Betz, MD, MPH, associate professor of emergency medicine at the University of Colorado at Denver, Aurora, said via Twitter, “I’ve had lots of conversations with women considering leaving medicine.”

“I have thought about leaving many times. I love what I do, but medicine can be an unkind world at times,” responded Valerie Fitzhugh MD, associate professor and pathologist at New Jersey Medical School, Newark.

“Too late. Left at the end of July and it was the best decision ever,” wrote Michelle Gordon, DO, who was previously a board-certified general surgeon at Northern Westchester Surgical Associates in Putnam Valley, N.Y.


 

Prepandemic disparities accentuated

The pandemic “has merely accentuated – or made more apparent – some of the longstanding issues and struggles of women in oncology, women in medicine, women in academia,” said Sarah Holstein, MD, PhD, another mid-career oncologist and associate professor at the University of Nebraska Medical Center, Omaha.

“There are disparities in first-author/last-author publications, disparities in being asked to give speaking engagements, disparities in leadership,” Dr. Holstein said in an interview. “And then ... put on top of that the various surges with the pandemic where you are being asked to do clinical responsibilities you don’t normally do, perhaps some things you haven’t done since your training 10 or 20 years ago.”

This is backed up with data: There is already a “robust” body of prepandemic literature demonstrating pay gaps for female physicians and scientists, noted Dr. Silver, who founded the Her Time Is Now campaign for gender equity in medicine and runs a women’s leadership course at Harvard.

In addition, female physicians are more likely to be involved in “nonpromotable” work, group projects and educator roles that are often underappreciated and undercompensated, she said.

Writing recently in a blog post for the BMJ, Dr. Silver and colleagues predict that as a result of the pandemic, female physicians will “face disadvantages from unconscious bias in decisions about whose pay should be cut, whose operating schedules should take priority when resources are limited, and whose contributions merit retention ... The ground that women lose now will likely have a profound effect for many years to come, perhaps putting them at a disadvantage for the rest of their careers.”

There is already evidence of reduced publishing by female scientists during the pandemic, something that “could undermine the careers of an entire generation of women scholars,” noted Caitlyn Collins, PhD, assistant professor of sociology at Washington University in St. Louis.

“Science needs to address the culture of overwork,” Dr. Collins said in an interview. “Parents and other caregivers deserve support. The stress and ‘overwhelm’ they feel is not inevitable. A more fair, just, and humane approach to combining work and family is possible – what we need is the political will to pass better policies and a massive shift in our cultural understandings about how work should fit into family life, not the other way around.”

Lack of support for “vulnerable scientists,” particularly “junior scientists who are parents, women, or minorities” could lead to “severe attrition in cancer research in the coming years,” Cullen Taniguchi, MD, PhD, a radiation oncologist and associate professor at the University of Texas MD Anderson Cancer Center, Houston, and colleagues, warned in a recent letter to the journal Cancer Cell.

“The biggest worries of attrition will come from young faculty who started just before or after the pandemic,” Dr. Taniguchi said in an interview. “The first year in an academic setting is incredibly challenging but also important for establishing research efforts and building networks of colleagues to collaborate with. While completely necessary, the restrictions put in place during the pandemic made doing these things even more difficult.”
 

Another stressor: Caregiving at home

Another reason female physicians may be marginalized during the pandemic is that they are more often the primary caregivers at home.

“Anyone who is a caregiver, be it to kids, parents, or spouses, can relate to the challenges brought [on] by the pandemic,” said Ishwaria Subbiah, MD, a palliative care physician and medical oncologist at MD Anderson.

“Most of us work toward meeting our responsibilities by engaging a network of support, whether it’s home care workers, center-based or at-home child care, schools, or activities outside of school. The pandemic led to a level of disruption that brought most (if not all) of those responsibilities onto the caregivers themselves,” she said in an interview.

As the mother of an adult son with severe epilepsy, Dr. Bertagnolli has certainly experienced the challenges of parenting during the pandemic. “Our son is now 24 but he is handicapped, and lives with us. The care issues we have to deal with as professionals have been enormously magnified by COVID,” she said.

But she cautions against making gender distinctions when it comes to caregiving. “Has it fallen on the women? Well, this kind of stuff generally falls on the women, but I am certain it has fallen on an awful lot of men as well, because I think the world is changing that way, so it’s fallen on all of us.”

There is no question that female oncologists are bearing the brunt, both at work and at home, contended Dr. Taniguchi. “Absolutely. I have seen this first-hand,” he said.

“If it was difficult for women, underrepresented minorities, and junior faculty to find a voice in the room prepandemic, I think it can be harder in the times of virtual meetings when it is difficult to engage audiences,” he said. 

Dr. Holstein said she is lucky to be well-supported at her institution, with both a female chief of hematology/oncology and a female chair of internal medicine, but still, she worries about the long-term consequences of the pandemic on the gender landscape of medicine.

“If you’re having to put aside research projects because you have extra responsibilities – again because women just tend to have a lot of other things going on – that might not be a big deal for 3 months, 6 months, but this is going to be a year or 2 years before ‘normal’ comes back,” she says. “One to two years of underpublishing or not getting the grants could be career killers for women in academic oncology.”
 

Cancer COVID-19 combo

As Dr. Wildes completed her final weeks of seeing cancer patients, she received an outpouring of support, which she says convinced her of the shared experience of all doctors, and especially female doctors, during the pandemic. But even more specifically, she feels that she has tapped into the unique burden shouldered by oncologists during this time.

“It’s intimidating being an oncologist; we are literally giving people poison for a living. Then throw into it a pandemic where early in March we had so little data. I was helping my patients make decisions about their cancer care based on a case series of four patients in China. The burden of those conversations is something I never want to have to live through again,” she said.

“Oncology is a particularly intense subspecialty within medicine,” agreed Dr. Subbiah. “The people we care for have received a life-altering and potentially life-limiting diagnosis. Coupled with that, the COVID-19 pandemic has brought an unprecedented cloud of uncertainty ... Whether the patients can see it overtly or not, oncologists carry the weight of this worry with them for not just one but all of their patients.”

Dr. Wildes said she plans to return to academic medicine and clinical care “in time,” but for now, the gap that she and others like her leave is troubling to those who have stayed on.

“We need these women in medicine,” said Dr. Holstein. “We have data suggesting that women take more time with their patients than men, that patient outcomes are better if they have a female physician. But also for the generations coming up, we need the mid-career and senior women to be in place to mentor and guide and make sure we continue to increase women in leadership.”

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

For mid-career oncologist Tanya Wildes, MD, the pandemic was the last straw. In late September, she tweeted: “I have done the academically unfathomable: I am resigning my faculty position without another job lined up.”

She wasn’t burned out, she insisted. She loved her patients and her research. But she was also “100% confident” in her decision and “also 100% sad. This did not have to happen,” she lamented, asking not to disclose her workplace for fear of retribution.

Being a woman in medicine “is a hard life to start with,” Dr. Wildes said in an interview. “We all have that tenuous balance going on and the pandemic made everything just a little bit harder.”

She describes her prepandemic work-life balance as a “Jenga tower, with everything only just in place.” But she realized that the balance had tipped, when after a difficult clinic she felt emotionally wrung out. Her 11-year-old son had asked her to help him fly his model airplane. “I told him, ‘Honey, I can’t do it because if it crashes or gets stuck in a tree ... you’re going to be devastated and I have nothing left for you.’ “

This was a eureka moment, as “I realized, this is not who I want to be,” she said, holding back tears. “Seventy years from now my son is going to tell his grandchildren about the pandemic and I don’t want his memory of his mom to be that she couldn’t be there for him because she was too spent.”

When Dr. Wildes shared her story on Twitter, other female oncologists and physicians responded that they too have felt they’re under increased pressure this year, with the extra stress of the pandemic leading others to quit as well.

The trend of doctors leaving medicine has been noticeable. A July survey from the Physicians Foundation found that roughly 16,000 medical practices had already closed during the pandemic, with another 8,000 predicted to close within the next year.

“Similar patterns” were evident in another analysis by the Larry A. Green Center and the Primary Care Collaborative, as reported in The New York Times. In that survey, nearly one-fifth of primary care clinicians said “someone in their practice plans to retire early or has already retired because of COVID-19,” and 15% say “someone has left or plans to leave the practice.” About half said their mental exhaustion was at an all-time high, the survey found.

“COVID-19 is a burden, and that added burden has tipped people over the edge of many things,” said Monica Bertagnolli, MD, chief of the division of surgical oncology at Brigham and Women’s Hospital, Boston, and former president of the American Society of Clinical Oncology.

“It has illustrated that we do have a lot of people who are working kind of on the edge of not being able to handle everything,” she said.

While many in medicine are struggling, the pandemic seems to be pushing more women to leave, highlighting longtime gender disparities and increased caregiving burdens. And their absence may be felt for years to come.

Firm numbers are hard to come by, said Julie Silver, MD, associate professor, associate chair, and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston, and an expert in gender equity in medicine. But she sees some troubling trends.

“There are many indications that women are leaving medicine in disproportionately high numbers,” Dr. Silver said in an interview. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

A survey of 1,809 women conducted in mid-April with the Physician Moms Facebook Group and accepted for online publication by the American Journal of Psychiatry found that 41% scored over the cutoff points for moderate or severe anxiety, with 46% meeting these criteria among front-line workers.

“It’s really important for society to recognize the extraordinary impact this pandemic is having on physician mothers, as there will be profound ripple effects on the ability of this key segment of the health care workforce to serve others if we do not address this problem urgently,” co-senior author Reshma Jagsi, MD, DPhil, a radiation oncologist at the University of Michigan, Ann Arbor, said in an interview.

Women weighed in on Twitter, in response to Dr. Silver’s tweet to #WomenInMedicine: “If you are thinking of leaving #medicine & need a reason to stay: we value you & need you.”

In reply, Emmy Betz, MD, MPH, associate professor of emergency medicine at the University of Colorado at Denver, Aurora, said via Twitter, “I’ve had lots of conversations with women considering leaving medicine.”

“I have thought about leaving many times. I love what I do, but medicine can be an unkind world at times,” responded Valerie Fitzhugh MD, associate professor and pathologist at New Jersey Medical School, Newark.

“Too late. Left at the end of July and it was the best decision ever,” wrote Michelle Gordon, DO, who was previously a board-certified general surgeon at Northern Westchester Surgical Associates in Putnam Valley, N.Y.


 

Prepandemic disparities accentuated

The pandemic “has merely accentuated – or made more apparent – some of the longstanding issues and struggles of women in oncology, women in medicine, women in academia,” said Sarah Holstein, MD, PhD, another mid-career oncologist and associate professor at the University of Nebraska Medical Center, Omaha.

“There are disparities in first-author/last-author publications, disparities in being asked to give speaking engagements, disparities in leadership,” Dr. Holstein said in an interview. “And then ... put on top of that the various surges with the pandemic where you are being asked to do clinical responsibilities you don’t normally do, perhaps some things you haven’t done since your training 10 or 20 years ago.”

This is backed up with data: There is already a “robust” body of prepandemic literature demonstrating pay gaps for female physicians and scientists, noted Dr. Silver, who founded the Her Time Is Now campaign for gender equity in medicine and runs a women’s leadership course at Harvard.

In addition, female physicians are more likely to be involved in “nonpromotable” work, group projects and educator roles that are often underappreciated and undercompensated, she said.

Writing recently in a blog post for the BMJ, Dr. Silver and colleagues predict that as a result of the pandemic, female physicians will “face disadvantages from unconscious bias in decisions about whose pay should be cut, whose operating schedules should take priority when resources are limited, and whose contributions merit retention ... The ground that women lose now will likely have a profound effect for many years to come, perhaps putting them at a disadvantage for the rest of their careers.”

There is already evidence of reduced publishing by female scientists during the pandemic, something that “could undermine the careers of an entire generation of women scholars,” noted Caitlyn Collins, PhD, assistant professor of sociology at Washington University in St. Louis.

“Science needs to address the culture of overwork,” Dr. Collins said in an interview. “Parents and other caregivers deserve support. The stress and ‘overwhelm’ they feel is not inevitable. A more fair, just, and humane approach to combining work and family is possible – what we need is the political will to pass better policies and a massive shift in our cultural understandings about how work should fit into family life, not the other way around.”

Lack of support for “vulnerable scientists,” particularly “junior scientists who are parents, women, or minorities” could lead to “severe attrition in cancer research in the coming years,” Cullen Taniguchi, MD, PhD, a radiation oncologist and associate professor at the University of Texas MD Anderson Cancer Center, Houston, and colleagues, warned in a recent letter to the journal Cancer Cell.

“The biggest worries of attrition will come from young faculty who started just before or after the pandemic,” Dr. Taniguchi said in an interview. “The first year in an academic setting is incredibly challenging but also important for establishing research efforts and building networks of colleagues to collaborate with. While completely necessary, the restrictions put in place during the pandemic made doing these things even more difficult.”
 

Another stressor: Caregiving at home

Another reason female physicians may be marginalized during the pandemic is that they are more often the primary caregivers at home.

“Anyone who is a caregiver, be it to kids, parents, or spouses, can relate to the challenges brought [on] by the pandemic,” said Ishwaria Subbiah, MD, a palliative care physician and medical oncologist at MD Anderson.

“Most of us work toward meeting our responsibilities by engaging a network of support, whether it’s home care workers, center-based or at-home child care, schools, or activities outside of school. The pandemic led to a level of disruption that brought most (if not all) of those responsibilities onto the caregivers themselves,” she said in an interview.

As the mother of an adult son with severe epilepsy, Dr. Bertagnolli has certainly experienced the challenges of parenting during the pandemic. “Our son is now 24 but he is handicapped, and lives with us. The care issues we have to deal with as professionals have been enormously magnified by COVID,” she said.

But she cautions against making gender distinctions when it comes to caregiving. “Has it fallen on the women? Well, this kind of stuff generally falls on the women, but I am certain it has fallen on an awful lot of men as well, because I think the world is changing that way, so it’s fallen on all of us.”

There is no question that female oncologists are bearing the brunt, both at work and at home, contended Dr. Taniguchi. “Absolutely. I have seen this first-hand,” he said.

“If it was difficult for women, underrepresented minorities, and junior faculty to find a voice in the room prepandemic, I think it can be harder in the times of virtual meetings when it is difficult to engage audiences,” he said. 

Dr. Holstein said she is lucky to be well-supported at her institution, with both a female chief of hematology/oncology and a female chair of internal medicine, but still, she worries about the long-term consequences of the pandemic on the gender landscape of medicine.

“If you’re having to put aside research projects because you have extra responsibilities – again because women just tend to have a lot of other things going on – that might not be a big deal for 3 months, 6 months, but this is going to be a year or 2 years before ‘normal’ comes back,” she says. “One to two years of underpublishing or not getting the grants could be career killers for women in academic oncology.”
 

Cancer COVID-19 combo

As Dr. Wildes completed her final weeks of seeing cancer patients, she received an outpouring of support, which she says convinced her of the shared experience of all doctors, and especially female doctors, during the pandemic. But even more specifically, she feels that she has tapped into the unique burden shouldered by oncologists during this time.

“It’s intimidating being an oncologist; we are literally giving people poison for a living. Then throw into it a pandemic where early in March we had so little data. I was helping my patients make decisions about their cancer care based on a case series of four patients in China. The burden of those conversations is something I never want to have to live through again,” she said.

“Oncology is a particularly intense subspecialty within medicine,” agreed Dr. Subbiah. “The people we care for have received a life-altering and potentially life-limiting diagnosis. Coupled with that, the COVID-19 pandemic has brought an unprecedented cloud of uncertainty ... Whether the patients can see it overtly or not, oncologists carry the weight of this worry with them for not just one but all of their patients.”

Dr. Wildes said she plans to return to academic medicine and clinical care “in time,” but for now, the gap that she and others like her leave is troubling to those who have stayed on.

“We need these women in medicine,” said Dr. Holstein. “We have data suggesting that women take more time with their patients than men, that patient outcomes are better if they have a female physician. But also for the generations coming up, we need the mid-career and senior women to be in place to mentor and guide and make sure we continue to increase women in leadership.”

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

For mid-career oncologist Tanya Wildes, MD, the pandemic was the last straw. In late September, she tweeted: “I have done the academically unfathomable: I am resigning my faculty position without another job lined up.”

She wasn’t burned out, she insisted. She loved her patients and her research. But she was also “100% confident” in her decision and “also 100% sad. This did not have to happen,” she lamented, asking not to disclose her workplace for fear of retribution.

Being a woman in medicine “is a hard life to start with,” Dr. Wildes said in an interview. “We all have that tenuous balance going on and the pandemic made everything just a little bit harder.”

She describes her prepandemic work-life balance as a “Jenga tower, with everything only just in place.” But she realized that the balance had tipped, when after a difficult clinic she felt emotionally wrung out. Her 11-year-old son had asked her to help him fly his model airplane. “I told him, ‘Honey, I can’t do it because if it crashes or gets stuck in a tree ... you’re going to be devastated and I have nothing left for you.’ “

This was a eureka moment, as “I realized, this is not who I want to be,” she said, holding back tears. “Seventy years from now my son is going to tell his grandchildren about the pandemic and I don’t want his memory of his mom to be that she couldn’t be there for him because she was too spent.”

When Dr. Wildes shared her story on Twitter, other female oncologists and physicians responded that they too have felt they’re under increased pressure this year, with the extra stress of the pandemic leading others to quit as well.

The trend of doctors leaving medicine has been noticeable. A July survey from the Physicians Foundation found that roughly 16,000 medical practices had already closed during the pandemic, with another 8,000 predicted to close within the next year.

“Similar patterns” were evident in another analysis by the Larry A. Green Center and the Primary Care Collaborative, as reported in The New York Times. In that survey, nearly one-fifth of primary care clinicians said “someone in their practice plans to retire early or has already retired because of COVID-19,” and 15% say “someone has left or plans to leave the practice.” About half said their mental exhaustion was at an all-time high, the survey found.

“COVID-19 is a burden, and that added burden has tipped people over the edge of many things,” said Monica Bertagnolli, MD, chief of the division of surgical oncology at Brigham and Women’s Hospital, Boston, and former president of the American Society of Clinical Oncology.

“It has illustrated that we do have a lot of people who are working kind of on the edge of not being able to handle everything,” she said.

While many in medicine are struggling, the pandemic seems to be pushing more women to leave, highlighting longtime gender disparities and increased caregiving burdens. And their absence may be felt for years to come.

Firm numbers are hard to come by, said Julie Silver, MD, associate professor, associate chair, and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston, and an expert in gender equity in medicine. But she sees some troubling trends.

“There are many indications that women are leaving medicine in disproportionately high numbers,” Dr. Silver said in an interview. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

A survey of 1,809 women conducted in mid-April with the Physician Moms Facebook Group and accepted for online publication by the American Journal of Psychiatry found that 41% scored over the cutoff points for moderate or severe anxiety, with 46% meeting these criteria among front-line workers.

“It’s really important for society to recognize the extraordinary impact this pandemic is having on physician mothers, as there will be profound ripple effects on the ability of this key segment of the health care workforce to serve others if we do not address this problem urgently,” co-senior author Reshma Jagsi, MD, DPhil, a radiation oncologist at the University of Michigan, Ann Arbor, said in an interview.

Women weighed in on Twitter, in response to Dr. Silver’s tweet to #WomenInMedicine: “If you are thinking of leaving #medicine & need a reason to stay: we value you & need you.”

In reply, Emmy Betz, MD, MPH, associate professor of emergency medicine at the University of Colorado at Denver, Aurora, said via Twitter, “I’ve had lots of conversations with women considering leaving medicine.”

“I have thought about leaving many times. I love what I do, but medicine can be an unkind world at times,” responded Valerie Fitzhugh MD, associate professor and pathologist at New Jersey Medical School, Newark.

“Too late. Left at the end of July and it was the best decision ever,” wrote Michelle Gordon, DO, who was previously a board-certified general surgeon at Northern Westchester Surgical Associates in Putnam Valley, N.Y.


 

Prepandemic disparities accentuated

The pandemic “has merely accentuated – or made more apparent – some of the longstanding issues and struggles of women in oncology, women in medicine, women in academia,” said Sarah Holstein, MD, PhD, another mid-career oncologist and associate professor at the University of Nebraska Medical Center, Omaha.

“There are disparities in first-author/last-author publications, disparities in being asked to give speaking engagements, disparities in leadership,” Dr. Holstein said in an interview. “And then ... put on top of that the various surges with the pandemic where you are being asked to do clinical responsibilities you don’t normally do, perhaps some things you haven’t done since your training 10 or 20 years ago.”

This is backed up with data: There is already a “robust” body of prepandemic literature demonstrating pay gaps for female physicians and scientists, noted Dr. Silver, who founded the Her Time Is Now campaign for gender equity in medicine and runs a women’s leadership course at Harvard.

In addition, female physicians are more likely to be involved in “nonpromotable” work, group projects and educator roles that are often underappreciated and undercompensated, she said.

Writing recently in a blog post for the BMJ, Dr. Silver and colleagues predict that as a result of the pandemic, female physicians will “face disadvantages from unconscious bias in decisions about whose pay should be cut, whose operating schedules should take priority when resources are limited, and whose contributions merit retention ... The ground that women lose now will likely have a profound effect for many years to come, perhaps putting them at a disadvantage for the rest of their careers.”

There is already evidence of reduced publishing by female scientists during the pandemic, something that “could undermine the careers of an entire generation of women scholars,” noted Caitlyn Collins, PhD, assistant professor of sociology at Washington University in St. Louis.

“Science needs to address the culture of overwork,” Dr. Collins said in an interview. “Parents and other caregivers deserve support. The stress and ‘overwhelm’ they feel is not inevitable. A more fair, just, and humane approach to combining work and family is possible – what we need is the political will to pass better policies and a massive shift in our cultural understandings about how work should fit into family life, not the other way around.”

Lack of support for “vulnerable scientists,” particularly “junior scientists who are parents, women, or minorities” could lead to “severe attrition in cancer research in the coming years,” Cullen Taniguchi, MD, PhD, a radiation oncologist and associate professor at the University of Texas MD Anderson Cancer Center, Houston, and colleagues, warned in a recent letter to the journal Cancer Cell.

“The biggest worries of attrition will come from young faculty who started just before or after the pandemic,” Dr. Taniguchi said in an interview. “The first year in an academic setting is incredibly challenging but also important for establishing research efforts and building networks of colleagues to collaborate with. While completely necessary, the restrictions put in place during the pandemic made doing these things even more difficult.”
 

Another stressor: Caregiving at home

Another reason female physicians may be marginalized during the pandemic is that they are more often the primary caregivers at home.

“Anyone who is a caregiver, be it to kids, parents, or spouses, can relate to the challenges brought [on] by the pandemic,” said Ishwaria Subbiah, MD, a palliative care physician and medical oncologist at MD Anderson.

“Most of us work toward meeting our responsibilities by engaging a network of support, whether it’s home care workers, center-based or at-home child care, schools, or activities outside of school. The pandemic led to a level of disruption that brought most (if not all) of those responsibilities onto the caregivers themselves,” she said in an interview.

As the mother of an adult son with severe epilepsy, Dr. Bertagnolli has certainly experienced the challenges of parenting during the pandemic. “Our son is now 24 but he is handicapped, and lives with us. The care issues we have to deal with as professionals have been enormously magnified by COVID,” she said.

But she cautions against making gender distinctions when it comes to caregiving. “Has it fallen on the women? Well, this kind of stuff generally falls on the women, but I am certain it has fallen on an awful lot of men as well, because I think the world is changing that way, so it’s fallen on all of us.”

There is no question that female oncologists are bearing the brunt, both at work and at home, contended Dr. Taniguchi. “Absolutely. I have seen this first-hand,” he said.

“If it was difficult for women, underrepresented minorities, and junior faculty to find a voice in the room prepandemic, I think it can be harder in the times of virtual meetings when it is difficult to engage audiences,” he said. 

Dr. Holstein said she is lucky to be well-supported at her institution, with both a female chief of hematology/oncology and a female chair of internal medicine, but still, she worries about the long-term consequences of the pandemic on the gender landscape of medicine.

“If you’re having to put aside research projects because you have extra responsibilities – again because women just tend to have a lot of other things going on – that might not be a big deal for 3 months, 6 months, but this is going to be a year or 2 years before ‘normal’ comes back,” she says. “One to two years of underpublishing or not getting the grants could be career killers for women in academic oncology.”
 

Cancer COVID-19 combo

As Dr. Wildes completed her final weeks of seeing cancer patients, she received an outpouring of support, which she says convinced her of the shared experience of all doctors, and especially female doctors, during the pandemic. But even more specifically, she feels that she has tapped into the unique burden shouldered by oncologists during this time.

“It’s intimidating being an oncologist; we are literally giving people poison for a living. Then throw into it a pandemic where early in March we had so little data. I was helping my patients make decisions about their cancer care based on a case series of four patients in China. The burden of those conversations is something I never want to have to live through again,” she said.

“Oncology is a particularly intense subspecialty within medicine,” agreed Dr. Subbiah. “The people we care for have received a life-altering and potentially life-limiting diagnosis. Coupled with that, the COVID-19 pandemic has brought an unprecedented cloud of uncertainty ... Whether the patients can see it overtly or not, oncologists carry the weight of this worry with them for not just one but all of their patients.”

Dr. Wildes said she plans to return to academic medicine and clinical care “in time,” but for now, the gap that she and others like her leave is troubling to those who have stayed on.

“We need these women in medicine,” said Dr. Holstein. “We have data suggesting that women take more time with their patients than men, that patient outcomes are better if they have a female physician. But also for the generations coming up, we need the mid-career and senior women to be in place to mentor and guide and make sure we continue to increase women in leadership.”

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

Dr Stanley Cohen, of the University of Texas, Southwestern Medical School in Dallas, reviews key abstracts on the management of patients with rheumatoid arthritis (RA) that were presented at this year's American College of Rheumatology (ACR) annual meeting, held virtually because of COVID-19.

Dr Cohen highlights the updated ACR pharmacologic recommendations for the treatment of RA, including the need to maximize methotrexate therapy as well as the avoidance of glucocorticoids and their associated long-term toxicity.

Dr Cohen discusses two abstracts addressing the use of the recombinant zoster vaccine (RZV) in patients with RA, including research from Sweden comparing immunologic response in patients taking JAK inhibitors with that of patients not on disease-modifying therapy. He also reports on a safety study from the Cleveland Clinic which followed patients after they received RZV and measured their rate of flares over 3 months.

Additionally, he discusses recent trial data on the incidence of and risk for venous thromboembolism events in patients with RA enrolled in the upadacitinib phase 3 clinical trial program.

--

Stanley B. Cohen, MD, Clinical Professor, Department of Internal Medicine, Rheumatic Diseases Division, UT Southwestern Medical School; Director, Division of Rheumatology, Texas Health Resources, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships:
Received research grant from: Amgen; AbbVie; Genentech; Gilead; Pfizer; Roche.
 

Dr Stanley Cohen, of the University of Texas, Southwestern Medical School in Dallas, reviews key abstracts on the management of patients with rheumatoid arthritis (RA) that were presented at this year's American College of Rheumatology (ACR) annual meeting, held virtually because of COVID-19.

Dr Cohen highlights the updated ACR pharmacologic recommendations for the treatment of RA, including the need to maximize methotrexate therapy as well as the avoidance of glucocorticoids and their associated long-term toxicity.

Dr Cohen discusses two abstracts addressing the use of the recombinant zoster vaccine (RZV) in patients with RA, including research from Sweden comparing immunologic response in patients taking JAK inhibitors with that of patients not on disease-modifying therapy. He also reports on a safety study from the Cleveland Clinic which followed patients after they received RZV and measured their rate of flares over 3 months.

Additionally, he discusses recent trial data on the incidence of and risk for venous thromboembolism events in patients with RA enrolled in the upadacitinib phase 3 clinical trial program.

--

Stanley B. Cohen, MD, Clinical Professor, Department of Internal Medicine, Rheumatic Diseases Division, UT Southwestern Medical School; Director, Division of Rheumatology, Texas Health Resources, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships:
Received research grant from: Amgen; AbbVie; Genentech; Gilead; Pfizer; Roche.
 

Dr Stanley Cohen, of the University of Texas, Southwestern Medical School in Dallas, reviews key abstracts on the management of patients with rheumatoid arthritis (RA) that were presented at this year's American College of Rheumatology (ACR) annual meeting, held virtually because of COVID-19.

Dr Cohen highlights the updated ACR pharmacologic recommendations for the treatment of RA, including the need to maximize methotrexate therapy as well as the avoidance of glucocorticoids and their associated long-term toxicity.

Dr Cohen discusses two abstracts addressing the use of the recombinant zoster vaccine (RZV) in patients with RA, including research from Sweden comparing immunologic response in patients taking JAK inhibitors with that of patients not on disease-modifying therapy. He also reports on a safety study from the Cleveland Clinic which followed patients after they received RZV and measured their rate of flares over 3 months.

Additionally, he discusses recent trial data on the incidence of and risk for venous thromboembolism events in patients with RA enrolled in the upadacitinib phase 3 clinical trial program.

--

Stanley B. Cohen, MD, Clinical Professor, Department of Internal Medicine, Rheumatic Diseases Division, UT Southwestern Medical School; Director, Division of Rheumatology, Texas Health Resources, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships:
Received research grant from: Amgen; AbbVie; Genentech; Gilead; Pfizer; Roche.
 

Delayed health care brought on by the pandemic is taking its toll on patients, a survey of primary care doctors shows. 

More than half (56%) of responding clinicians reported seeing a decline in patient health because of delayed or inaccessible care amid the pandemic, according to the results of the latest survey by the Larry A. Green Center and the Primary Care Collaborative. The survey was conducted in mid-October and the results were published online Nov. 17.  

In addition, 37% of respondents said their patients with chronic conditions showed “noticeably worse health resulting from the pandemic.” And a resounding 85% said patient mental health had worsened. 

“I think it’s worse than we thought,” said Rebecca Etz, PhD, codirector of the Larry Green Center. “It’s the outcome of not sufficiently sending resources to primary care either before or during the pandemic.” According to Dr. Etz, survey respondents noted substantial increases in patient weight gain as well as weight loss, anxiety and depression, sleep issues, domestic abuse, and poor oral and eye health, among others.

One clinician from Pennsylvania wrote: “Patients are becoming sicker during the pandemic. I’m seeing more uncontrolled [diabetes]and new [patients with diabetes]. They prefer telehealth yet [have] no access to glucose monitoring or a blood pressure cuff. I am concerned about patients’ isolation and mental health. People are delaying care.”

Now, with COVID numbers peaking across much of the country, many clinicians are trying to close the gap in care with telehealth – something they’re more prepared to do now than they were in March. Over two-thirds of practices are using telehealth for visits to keep up with patients who have stable chronic conditions, according to the survey.

Over 60% of physicians report using telehealth for mental health visits. But a much smaller number – only 16% of respondents – said their practice had added staff to help manage the rising number of behavioral and mental health cases. About one-third (35%) of practices say they’re not financially able to take on new staff.

“We’ve been looking for more ways for patients to do self-support. A big part of chronic disease is health behaviors,” Alex Krist, MD, MPH, a family doctor in Fairfax, Va., and chairperson of the U.S. Preventive Services Task Force, said in an interview. And unfortunately, on top of limited access to basic care, healthy habits that are essential to managing many chronic conditions have become more difficult and less consistent during the pandemic. 

The survey – the 22nd iteration in a series of surveys the Green Center and the Primary Care Collaborative have conducted – received 580 respondents from 47 states and Guam. Over two-thirds of respondents were primary care physicians (MDs and DOs). Over half were owners, partners, or employees of a private practice, 66% of which were family medicine practices. And one fifth of respondents provided care in a rural area.

Funding and support for primary care has been wildly insufficient, Dr. Etz said in an interview. If that doesn’t change, patient health, clinic staffing, and public health strategies amid the pandemic will continue to suffer.

“When you think of the COVID vaccine, who do you think is going to be sending that out?” Dr. Etz asked. “If we don’t bolster primary care now how are they going to handle that.”
 

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

Delayed health care brought on by the pandemic is taking its toll on patients, a survey of primary care doctors shows. 

More than half (56%) of responding clinicians reported seeing a decline in patient health because of delayed or inaccessible care amid the pandemic, according to the results of the latest survey by the Larry A. Green Center and the Primary Care Collaborative. The survey was conducted in mid-October and the results were published online Nov. 17.  

In addition, 37% of respondents said their patients with chronic conditions showed “noticeably worse health resulting from the pandemic.” And a resounding 85% said patient mental health had worsened. 

“I think it’s worse than we thought,” said Rebecca Etz, PhD, codirector of the Larry Green Center. “It’s the outcome of not sufficiently sending resources to primary care either before or during the pandemic.” According to Dr. Etz, survey respondents noted substantial increases in patient weight gain as well as weight loss, anxiety and depression, sleep issues, domestic abuse, and poor oral and eye health, among others.

One clinician from Pennsylvania wrote: “Patients are becoming sicker during the pandemic. I’m seeing more uncontrolled [diabetes]and new [patients with diabetes]. They prefer telehealth yet [have] no access to glucose monitoring or a blood pressure cuff. I am concerned about patients’ isolation and mental health. People are delaying care.”

Now, with COVID numbers peaking across much of the country, many clinicians are trying to close the gap in care with telehealth – something they’re more prepared to do now than they were in March. Over two-thirds of practices are using telehealth for visits to keep up with patients who have stable chronic conditions, according to the survey.

Over 60% of physicians report using telehealth for mental health visits. But a much smaller number – only 16% of respondents – said their practice had added staff to help manage the rising number of behavioral and mental health cases. About one-third (35%) of practices say they’re not financially able to take on new staff.

“We’ve been looking for more ways for patients to do self-support. A big part of chronic disease is health behaviors,” Alex Krist, MD, MPH, a family doctor in Fairfax, Va., and chairperson of the U.S. Preventive Services Task Force, said in an interview. And unfortunately, on top of limited access to basic care, healthy habits that are essential to managing many chronic conditions have become more difficult and less consistent during the pandemic. 

The survey – the 22nd iteration in a series of surveys the Green Center and the Primary Care Collaborative have conducted – received 580 respondents from 47 states and Guam. Over two-thirds of respondents were primary care physicians (MDs and DOs). Over half were owners, partners, or employees of a private practice, 66% of which were family medicine practices. And one fifth of respondents provided care in a rural area.

Funding and support for primary care has been wildly insufficient, Dr. Etz said in an interview. If that doesn’t change, patient health, clinic staffing, and public health strategies amid the pandemic will continue to suffer.

“When you think of the COVID vaccine, who do you think is going to be sending that out?” Dr. Etz asked. “If we don’t bolster primary care now how are they going to handle that.”
 

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

Delayed health care brought on by the pandemic is taking its toll on patients, a survey of primary care doctors shows. 

More than half (56%) of responding clinicians reported seeing a decline in patient health because of delayed or inaccessible care amid the pandemic, according to the results of the latest survey by the Larry A. Green Center and the Primary Care Collaborative. The survey was conducted in mid-October and the results were published online Nov. 17.  

In addition, 37% of respondents said their patients with chronic conditions showed “noticeably worse health resulting from the pandemic.” And a resounding 85% said patient mental health had worsened. 

“I think it’s worse than we thought,” said Rebecca Etz, PhD, codirector of the Larry Green Center. “It’s the outcome of not sufficiently sending resources to primary care either before or during the pandemic.” According to Dr. Etz, survey respondents noted substantial increases in patient weight gain as well as weight loss, anxiety and depression, sleep issues, domestic abuse, and poor oral and eye health, among others.

One clinician from Pennsylvania wrote: “Patients are becoming sicker during the pandemic. I’m seeing more uncontrolled [diabetes]and new [patients with diabetes]. They prefer telehealth yet [have] no access to glucose monitoring or a blood pressure cuff. I am concerned about patients’ isolation and mental health. People are delaying care.”

Now, with COVID numbers peaking across much of the country, many clinicians are trying to close the gap in care with telehealth – something they’re more prepared to do now than they were in March. Over two-thirds of practices are using telehealth for visits to keep up with patients who have stable chronic conditions, according to the survey.

Over 60% of physicians report using telehealth for mental health visits. But a much smaller number – only 16% of respondents – said their practice had added staff to help manage the rising number of behavioral and mental health cases. About one-third (35%) of practices say they’re not financially able to take on new staff.

“We’ve been looking for more ways for patients to do self-support. A big part of chronic disease is health behaviors,” Alex Krist, MD, MPH, a family doctor in Fairfax, Va., and chairperson of the U.S. Preventive Services Task Force, said in an interview. And unfortunately, on top of limited access to basic care, healthy habits that are essential to managing many chronic conditions have become more difficult and less consistent during the pandemic. 

The survey – the 22nd iteration in a series of surveys the Green Center and the Primary Care Collaborative have conducted – received 580 respondents from 47 states and Guam. Over two-thirds of respondents were primary care physicians (MDs and DOs). Over half were owners, partners, or employees of a private practice, 66% of which were family medicine practices. And one fifth of respondents provided care in a rural area.

Funding and support for primary care has been wildly insufficient, Dr. Etz said in an interview. If that doesn’t change, patient health, clinic staffing, and public health strategies amid the pandemic will continue to suffer.

“When you think of the COVID vaccine, who do you think is going to be sending that out?” Dr. Etz asked. “If we don’t bolster primary care now how are they going to handle that.”
 

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

The Moderna COVID-19 vaccine in development was 94.1% effective in the final analysis of its 30,000-participant phase 3 study. Bolstered by the new findings, the company plans to file for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) today, according to a company release.

A total of 11 people in the mRNA-1273 vaccinated group later tested positive for COVID-19, compared with 185 participants given two placebo injections, resulting in a point estimate of 94.1% efficacy. This finding aligns with the 94.5% efficacy in interim trial results announced on November 16, as reported by Medscape Medical News.

Furthermore, Moderna announced that the vaccine prevented serious cases of infection. All 30 severe infections occurred among those people randomly assigned to placebo.

The FDA plans to review the Moderna vaccine safety and efficacy data at the next Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for December 17. If and when approved, healthcare providers can use the new 91301 CPT code specific to mRNA-1273 vaccination.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and, importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, MBA, MEng, chief executive officer of Moderna, in the news release. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”

Vaccine efficacy remained consistent across different groups analyzed by age, race/ethnicity, and gender. The 196 COVID-19 cases in the trial included 33 adults older than 65 years and 42 people from diverse communities, including 29 Hispanic or Latinx, six Black or African Americans, four Asian Americans, and three multiracial participants, the company reported.
 

No serious vaccine-related safety issues

The mRNA-1273 vaccine was generally well tolerated and no serious safety concerns with the vaccine have been identified to date, the company reported. 

Injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site were the most common solicited adverse events in a prior analysis. The company noted that these solicited adverse reactions increased in frequency and severity after the second vaccine dose. A continuous review of safety data is ongoing.

One COVID-19-related death in the study occurred in the placebo group.
 

Ready to start shipping

Moderna expects to have approximately 20 million doses of mRNA-1273 available in the United States by the end of this year. The company reports that it’s on track to manufacture 500 million to 1 billion doses globally in 2021.

The company also is seeking approval from nations and organizations worldwide, including a conditional approval from the European Medicines Agency (EMA). The  study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

Moderna will be the second company to file an EUA with the FDA for a COVID vaccine, after Pfizer requested one for its mRNA vaccine earlier this month.

This article first appeared on Medscape.com.

The Moderna COVID-19 vaccine in development was 94.1% effective in the final analysis of its 30,000-participant phase 3 study. Bolstered by the new findings, the company plans to file for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) today, according to a company release.

A total of 11 people in the mRNA-1273 vaccinated group later tested positive for COVID-19, compared with 185 participants given two placebo injections, resulting in a point estimate of 94.1% efficacy. This finding aligns with the 94.5% efficacy in interim trial results announced on November 16, as reported by Medscape Medical News.

Furthermore, Moderna announced that the vaccine prevented serious cases of infection. All 30 severe infections occurred among those people randomly assigned to placebo.

The FDA plans to review the Moderna vaccine safety and efficacy data at the next Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for December 17. If and when approved, healthcare providers can use the new 91301 CPT code specific to mRNA-1273 vaccination.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and, importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, MBA, MEng, chief executive officer of Moderna, in the news release. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”

Vaccine efficacy remained consistent across different groups analyzed by age, race/ethnicity, and gender. The 196 COVID-19 cases in the trial included 33 adults older than 65 years and 42 people from diverse communities, including 29 Hispanic or Latinx, six Black or African Americans, four Asian Americans, and three multiracial participants, the company reported.
 

No serious vaccine-related safety issues

The mRNA-1273 vaccine was generally well tolerated and no serious safety concerns with the vaccine have been identified to date, the company reported. 

Injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site were the most common solicited adverse events in a prior analysis. The company noted that these solicited adverse reactions increased in frequency and severity after the second vaccine dose. A continuous review of safety data is ongoing.

One COVID-19-related death in the study occurred in the placebo group.
 

Ready to start shipping

Moderna expects to have approximately 20 million doses of mRNA-1273 available in the United States by the end of this year. The company reports that it’s on track to manufacture 500 million to 1 billion doses globally in 2021.

The company also is seeking approval from nations and organizations worldwide, including a conditional approval from the European Medicines Agency (EMA). The  study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

Moderna will be the second company to file an EUA with the FDA for a COVID vaccine, after Pfizer requested one for its mRNA vaccine earlier this month.

This article first appeared on Medscape.com.

The Moderna COVID-19 vaccine in development was 94.1% effective in the final analysis of its 30,000-participant phase 3 study. Bolstered by the new findings, the company plans to file for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) today, according to a company release.

A total of 11 people in the mRNA-1273 vaccinated group later tested positive for COVID-19, compared with 185 participants given two placebo injections, resulting in a point estimate of 94.1% efficacy. This finding aligns with the 94.5% efficacy in interim trial results announced on November 16, as reported by Medscape Medical News.

Furthermore, Moderna announced that the vaccine prevented serious cases of infection. All 30 severe infections occurred among those people randomly assigned to placebo.

The FDA plans to review the Moderna vaccine safety and efficacy data at the next Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for December 17. If and when approved, healthcare providers can use the new 91301 CPT code specific to mRNA-1273 vaccination.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and, importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, MBA, MEng, chief executive officer of Moderna, in the news release. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”

Vaccine efficacy remained consistent across different groups analyzed by age, race/ethnicity, and gender. The 196 COVID-19 cases in the trial included 33 adults older than 65 years and 42 people from diverse communities, including 29 Hispanic or Latinx, six Black or African Americans, four Asian Americans, and three multiracial participants, the company reported.
 

No serious vaccine-related safety issues

The mRNA-1273 vaccine was generally well tolerated and no serious safety concerns with the vaccine have been identified to date, the company reported. 

Injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site were the most common solicited adverse events in a prior analysis. The company noted that these solicited adverse reactions increased in frequency and severity after the second vaccine dose. A continuous review of safety data is ongoing.

One COVID-19-related death in the study occurred in the placebo group.
 

Ready to start shipping

Moderna expects to have approximately 20 million doses of mRNA-1273 available in the United States by the end of this year. The company reports that it’s on track to manufacture 500 million to 1 billion doses globally in 2021.

The company also is seeking approval from nations and organizations worldwide, including a conditional approval from the European Medicines Agency (EMA). The  study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

Moderna will be the second company to file an EUA with the FDA for a COVID vaccine, after Pfizer requested one for its mRNA vaccine earlier this month.

This article first appeared on Medscape.com.