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Cancer Data Trends 2022
Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.
In this issue:
- Exposure-Related Cancers
- Cancer in Women
- Genitourinary Cancers
- Gastrointestinal Cancers
- Telehealth in Oncology
- Precision Oncology
- Palliative and Hospice Care
- Alcohol and Cancer
- Lung Cancer
- Oropharyngeal Cancer
- Hematologic Cancers
Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:
Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.
Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.
In this issue:
- Exposure-Related Cancers
- Cancer in Women
- Genitourinary Cancers
- Gastrointestinal Cancers
- Telehealth in Oncology
- Precision Oncology
- Palliative and Hospice Care
- Alcohol and Cancer
- Lung Cancer
- Oropharyngeal Cancer
- Hematologic Cancers
Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:
Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.
Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.
In this issue:
- Exposure-Related Cancers
- Cancer in Women
- Genitourinary Cancers
- Gastrointestinal Cancers
- Telehealth in Oncology
- Precision Oncology
- Palliative and Hospice Care
- Alcohol and Cancer
- Lung Cancer
- Oropharyngeal Cancer
- Hematologic Cancers
Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:
Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.
Cellulitis care costly from misdiagnosis, needless hospitalizations
BOSTON – The cost of care for the more than 14 million cases of cellulitis that occur each year in the United States is in the billions of dollars, but there are multiple opportunities, many involving dermatologists, to dramatically reduce these costs, according to an outline of strategies presented at the American Academy of Dermatology 2022 annual meeting in Boston.
“Cellulitis is misdiagnosed about one-third of the time, and that cost is very high,” reported Jennifer L. Adams, MD, assistant professor of dermatology, University of Nebraska, Omaha. She sees opportunities for dermatological consults to help weed through the many cellulitis mimickers, such as venous insufficiency or psoriasiform drug reactions, to prevent unnecessary admissions and ineffective therapy.
“There is a huge need for diagnostic accuracy as a means to deliver more cost-effective care,” Dr. Adams said.
Solving misdiagnosis is only part of the story. Costs of care are also ramped up by unnecessary hospitalizations. According to Dr. Adams, published criteria to triage emergency room patients with cellulitis to outpatient care are not always followed. In one review, 14% of admitted patients had met the criteria for outpatient treatment.
Cellulitis is a common skin infection that causes redness, swelling, and pain in the infected area, most often on the legs and feet.
Unnecessary hospitalizations for misdiagnosed cellulitis, which is associated with an average 4-day hospital stay, “range from $200 million to $500 million in avoidable direct healthcare costs,” Dr. Adams said.
Even for justifiable hospitalizations, there are still opportunities for cost savings. In one study, blood cultures were ordered in 73% of patients even though only 2% produced a finding relevant to care. According to Dr. Adams, most cellulitis cases are caused by the “usual suspects” – group A beta-hemolytic streptococcus, Streptococcus pneumoniae, and Staphylococcus aureus. The exceptions stand out by clinical criteria, such as known neutropenia, history of an animal bite, signs of Systemic Inflammatory Response Syndrome (SIRS), or a purulent appearance.
“Blood cultures are not cost-effective in uncomplicated cellulitis,” Dr. Adams said. She said there are numerous published algorithms to guide clinicians on decision-making in the management of soft tissue infections, including cellulitis, including a much-cited algorithm first published more than 15 years ago and updated in 2014.
Similarly, labs and imaging are commonly ordered with no strong likelihood that they will change management, she said. These types of decisions are also covered in published algorithms.
Strategies to prevent rehospitalization are another area where there is a large opportunity to reduce health care resources consumed by cellulitis. The rehospitalization rate at 30 days is approximately 10%, but many patients have recurrent episodes over years, according to Dr. Adams. The risk factors and the preventative measures have been well described.
“Scrupulous clinical care can reduce recurrence, and it is cost-effective,” said Dr. Adams, referring to control of edema, control of underlying conditions associated with increased risk, such as diabetes, and managing dry skin and erosions with topical agents or even moisturizers. Compression socks are a simple but effective tool, she added.
For patients with repeat episodes of cellulitis over years, Dr. Adams referred to a double-blind trial that associated a twice-daily dose of 250 mg penicillin with a 45% reduction in the risk of cellulitis recurrence over 1 year. At approximately $10 a month for this treatment, she said it is very cost-effective, although she acknowledged that recurrence rates of cellulitis climb back up when the penicillin is stopped.
“I think of this as a bridge while you work on addressing the venous insufficiency or other risk factors for cellulitis,” Dr. Adams said.
For reducing the costs of cellulitis, there is evidence that dermatologists can play a role. Dr. Adams cited a study that evaluated the impact of a dermatologist consultation for suspected cellulitis in the emergency room or within 24 hours of admission. Of 34 patients already prescribed antibiotics for presumed cellulitis, discontinuation was recommended in 82%. Of 39 admissions, pseudocellulitis was identified in 51%.
Extrapolating these data to national rates of cellulitis, there was an estimated savings of up to $200 million annually without any apparent increased risk of adverse outcomes, according to Dr. Adams.
When contacted about his experience, the senior investigator of that study, Arash Mostaghimi, MD, director of the Inpatient Dermatology Consult Service, Brigham and Women’s Hospital, Boston, largely agreed with the premise of Adam’s analysis. In particular, he said, avoiding misdiagnosis of cellulitis offers a major opportunity to lower costs while possibly improving care.
True of national practice and at the local level, “misdiagnosis of noninfectious inflammatory reactions such as cellulitis has substantial cost impacts,” Dr. Mostaghimi said in an interview. Based on evidence, the savings are derived directly from “unnecessary antibiotic exposure as well as inappropriate hospitalization.”
Following publication of his study, he became involved in addressing this issue at his institution.
“At Brigham and Women’s, we collaborated with colleagues in infectious disease and in the emergency department to create cellulitis protocols that identify patients at risk for misdiagnosis and facilitate early dermatology consultation for diagnostic confirmation,” he said.
Although there are algorithms to achieve this goal, he indicated that the expertise of dermatologists can quickly and efficiently differentiate inflammatory skin reactions and expedite appropriate care.
Dr. Adams and Dr. Mostaghimi have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – The cost of care for the more than 14 million cases of cellulitis that occur each year in the United States is in the billions of dollars, but there are multiple opportunities, many involving dermatologists, to dramatically reduce these costs, according to an outline of strategies presented at the American Academy of Dermatology 2022 annual meeting in Boston.
“Cellulitis is misdiagnosed about one-third of the time, and that cost is very high,” reported Jennifer L. Adams, MD, assistant professor of dermatology, University of Nebraska, Omaha. She sees opportunities for dermatological consults to help weed through the many cellulitis mimickers, such as venous insufficiency or psoriasiform drug reactions, to prevent unnecessary admissions and ineffective therapy.
“There is a huge need for diagnostic accuracy as a means to deliver more cost-effective care,” Dr. Adams said.
Solving misdiagnosis is only part of the story. Costs of care are also ramped up by unnecessary hospitalizations. According to Dr. Adams, published criteria to triage emergency room patients with cellulitis to outpatient care are not always followed. In one review, 14% of admitted patients had met the criteria for outpatient treatment.
Cellulitis is a common skin infection that causes redness, swelling, and pain in the infected area, most often on the legs and feet.
Unnecessary hospitalizations for misdiagnosed cellulitis, which is associated with an average 4-day hospital stay, “range from $200 million to $500 million in avoidable direct healthcare costs,” Dr. Adams said.
Even for justifiable hospitalizations, there are still opportunities for cost savings. In one study, blood cultures were ordered in 73% of patients even though only 2% produced a finding relevant to care. According to Dr. Adams, most cellulitis cases are caused by the “usual suspects” – group A beta-hemolytic streptococcus, Streptococcus pneumoniae, and Staphylococcus aureus. The exceptions stand out by clinical criteria, such as known neutropenia, history of an animal bite, signs of Systemic Inflammatory Response Syndrome (SIRS), or a purulent appearance.
“Blood cultures are not cost-effective in uncomplicated cellulitis,” Dr. Adams said. She said there are numerous published algorithms to guide clinicians on decision-making in the management of soft tissue infections, including cellulitis, including a much-cited algorithm first published more than 15 years ago and updated in 2014.
Similarly, labs and imaging are commonly ordered with no strong likelihood that they will change management, she said. These types of decisions are also covered in published algorithms.
Strategies to prevent rehospitalization are another area where there is a large opportunity to reduce health care resources consumed by cellulitis. The rehospitalization rate at 30 days is approximately 10%, but many patients have recurrent episodes over years, according to Dr. Adams. The risk factors and the preventative measures have been well described.
“Scrupulous clinical care can reduce recurrence, and it is cost-effective,” said Dr. Adams, referring to control of edema, control of underlying conditions associated with increased risk, such as diabetes, and managing dry skin and erosions with topical agents or even moisturizers. Compression socks are a simple but effective tool, she added.
For patients with repeat episodes of cellulitis over years, Dr. Adams referred to a double-blind trial that associated a twice-daily dose of 250 mg penicillin with a 45% reduction in the risk of cellulitis recurrence over 1 year. At approximately $10 a month for this treatment, she said it is very cost-effective, although she acknowledged that recurrence rates of cellulitis climb back up when the penicillin is stopped.
“I think of this as a bridge while you work on addressing the venous insufficiency or other risk factors for cellulitis,” Dr. Adams said.
For reducing the costs of cellulitis, there is evidence that dermatologists can play a role. Dr. Adams cited a study that evaluated the impact of a dermatologist consultation for suspected cellulitis in the emergency room or within 24 hours of admission. Of 34 patients already prescribed antibiotics for presumed cellulitis, discontinuation was recommended in 82%. Of 39 admissions, pseudocellulitis was identified in 51%.
Extrapolating these data to national rates of cellulitis, there was an estimated savings of up to $200 million annually without any apparent increased risk of adverse outcomes, according to Dr. Adams.
When contacted about his experience, the senior investigator of that study, Arash Mostaghimi, MD, director of the Inpatient Dermatology Consult Service, Brigham and Women’s Hospital, Boston, largely agreed with the premise of Adam’s analysis. In particular, he said, avoiding misdiagnosis of cellulitis offers a major opportunity to lower costs while possibly improving care.
True of national practice and at the local level, “misdiagnosis of noninfectious inflammatory reactions such as cellulitis has substantial cost impacts,” Dr. Mostaghimi said in an interview. Based on evidence, the savings are derived directly from “unnecessary antibiotic exposure as well as inappropriate hospitalization.”
Following publication of his study, he became involved in addressing this issue at his institution.
“At Brigham and Women’s, we collaborated with colleagues in infectious disease and in the emergency department to create cellulitis protocols that identify patients at risk for misdiagnosis and facilitate early dermatology consultation for diagnostic confirmation,” he said.
Although there are algorithms to achieve this goal, he indicated that the expertise of dermatologists can quickly and efficiently differentiate inflammatory skin reactions and expedite appropriate care.
Dr. Adams and Dr. Mostaghimi have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – The cost of care for the more than 14 million cases of cellulitis that occur each year in the United States is in the billions of dollars, but there are multiple opportunities, many involving dermatologists, to dramatically reduce these costs, according to an outline of strategies presented at the American Academy of Dermatology 2022 annual meeting in Boston.
“Cellulitis is misdiagnosed about one-third of the time, and that cost is very high,” reported Jennifer L. Adams, MD, assistant professor of dermatology, University of Nebraska, Omaha. She sees opportunities for dermatological consults to help weed through the many cellulitis mimickers, such as venous insufficiency or psoriasiform drug reactions, to prevent unnecessary admissions and ineffective therapy.
“There is a huge need for diagnostic accuracy as a means to deliver more cost-effective care,” Dr. Adams said.
Solving misdiagnosis is only part of the story. Costs of care are also ramped up by unnecessary hospitalizations. According to Dr. Adams, published criteria to triage emergency room patients with cellulitis to outpatient care are not always followed. In one review, 14% of admitted patients had met the criteria for outpatient treatment.
Cellulitis is a common skin infection that causes redness, swelling, and pain in the infected area, most often on the legs and feet.
Unnecessary hospitalizations for misdiagnosed cellulitis, which is associated with an average 4-day hospital stay, “range from $200 million to $500 million in avoidable direct healthcare costs,” Dr. Adams said.
Even for justifiable hospitalizations, there are still opportunities for cost savings. In one study, blood cultures were ordered in 73% of patients even though only 2% produced a finding relevant to care. According to Dr. Adams, most cellulitis cases are caused by the “usual suspects” – group A beta-hemolytic streptococcus, Streptococcus pneumoniae, and Staphylococcus aureus. The exceptions stand out by clinical criteria, such as known neutropenia, history of an animal bite, signs of Systemic Inflammatory Response Syndrome (SIRS), or a purulent appearance.
“Blood cultures are not cost-effective in uncomplicated cellulitis,” Dr. Adams said. She said there are numerous published algorithms to guide clinicians on decision-making in the management of soft tissue infections, including cellulitis, including a much-cited algorithm first published more than 15 years ago and updated in 2014.
Similarly, labs and imaging are commonly ordered with no strong likelihood that they will change management, she said. These types of decisions are also covered in published algorithms.
Strategies to prevent rehospitalization are another area where there is a large opportunity to reduce health care resources consumed by cellulitis. The rehospitalization rate at 30 days is approximately 10%, but many patients have recurrent episodes over years, according to Dr. Adams. The risk factors and the preventative measures have been well described.
“Scrupulous clinical care can reduce recurrence, and it is cost-effective,” said Dr. Adams, referring to control of edema, control of underlying conditions associated with increased risk, such as diabetes, and managing dry skin and erosions with topical agents or even moisturizers. Compression socks are a simple but effective tool, she added.
For patients with repeat episodes of cellulitis over years, Dr. Adams referred to a double-blind trial that associated a twice-daily dose of 250 mg penicillin with a 45% reduction in the risk of cellulitis recurrence over 1 year. At approximately $10 a month for this treatment, she said it is very cost-effective, although she acknowledged that recurrence rates of cellulitis climb back up when the penicillin is stopped.
“I think of this as a bridge while you work on addressing the venous insufficiency or other risk factors for cellulitis,” Dr. Adams said.
For reducing the costs of cellulitis, there is evidence that dermatologists can play a role. Dr. Adams cited a study that evaluated the impact of a dermatologist consultation for suspected cellulitis in the emergency room or within 24 hours of admission. Of 34 patients already prescribed antibiotics for presumed cellulitis, discontinuation was recommended in 82%. Of 39 admissions, pseudocellulitis was identified in 51%.
Extrapolating these data to national rates of cellulitis, there was an estimated savings of up to $200 million annually without any apparent increased risk of adverse outcomes, according to Dr. Adams.
When contacted about his experience, the senior investigator of that study, Arash Mostaghimi, MD, director of the Inpatient Dermatology Consult Service, Brigham and Women’s Hospital, Boston, largely agreed with the premise of Adam’s analysis. In particular, he said, avoiding misdiagnosis of cellulitis offers a major opportunity to lower costs while possibly improving care.
True of national practice and at the local level, “misdiagnosis of noninfectious inflammatory reactions such as cellulitis has substantial cost impacts,” Dr. Mostaghimi said in an interview. Based on evidence, the savings are derived directly from “unnecessary antibiotic exposure as well as inappropriate hospitalization.”
Following publication of his study, he became involved in addressing this issue at his institution.
“At Brigham and Women’s, we collaborated with colleagues in infectious disease and in the emergency department to create cellulitis protocols that identify patients at risk for misdiagnosis and facilitate early dermatology consultation for diagnostic confirmation,” he said.
Although there are algorithms to achieve this goal, he indicated that the expertise of dermatologists can quickly and efficiently differentiate inflammatory skin reactions and expedite appropriate care.
Dr. Adams and Dr. Mostaghimi have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AAD 2022
Global registry tracks COVID-19 outcomes in atopic dermatitis patients
BOSTON – , results from a global registry demonstrated.
Moreover, combination systemic treatment, especially those that included systemic corticosteroids, was associated with the highest risk of COVID-19–related hospitalization.
“Patients with inflammatory skin diseases such as AD may be at higher risk of COVID-19,” Annelie H. Musters, MD, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. “Another factor to consider is that AD patients are often treated with systemic immunomodulatory therapy, including systemic corticosteroids and nonsteroidal immunosuppressants such as methotrexate, cyclosporin, biologics, and Janus kinase inhibitors. Different mechanisms of action and levels of immunosuppression may impart variable risks of serious infections.”
On the other hand, some degree of immunomodulation may have beneficial effects on the course of COVID-19 in AD patients, said Dr. Musters, of the department of dermatology at Academic Medical Center, University of Amsterdam. Targeting of specific immune pathways could reduce the development of a hyperinflammatory state in severe COVID-19. Dual blockade of interleukin (IL)-4 and IL-13 with dupilumab may have a protective effect in the context of COVID-19 infection, because expression of Th2 cytokines, including IL-4 and IL-13, may be increased during COVID-19.
“At the start of the pandemic, many of us were faced with important questions, like do systemic immunomodulatory treatments influence outcomes of COVID-19 in patients with AD?” she said. “Do patients on dupilumab or other novel systemics fare better than those on conventional systemic treatment?”
To answer these questions, she and her colleagues launched a web-based registry in April 2020 to investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments. For the registry, known as Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD), clinicians in 27 countries used a web-based form to enter anonymized data after patients had fully recovered from COVID-19. Eligibility criteria included having proven or highly suspected COVID-19, and there were no restrictions on age nor the type of AD treatment they were receiving.
Dr. Musters reported results from 442 patients who were recruited between April 2, 2020, and Oct. 31, 2021. Their mean age was 35.6 years, their median body mass index was 23.7 kg/m2, and there was an even sex distribution. Most patients were White and were recruited from Italy. Of the 442 patients, 216 (48.8%) received dupilumab monotherapy, 131 (29.6%) received topical treatments, and 14 (3.16%) received combination systemic treatments, including systemic corticosteroids. About 12% presented to the emergency department and 6% were hospitalized. Of those hospitalized, 2% required intensive care and/or ventilation, and no deaths have occurred in the registry to date.
By treatment group, hospitalization rates were highest among those on combination treatments (35.7%), followed by systemic corticosteroids (14.3%), topical treatments only (9.9%), other conventional systemics (3.6%), methotrexate (3.3%), and dupilumab (2.3%).
To further explore the differences between hospitalization rates in treatment groups, the researchers performed a multivariable logistic regression analysis, adjusted for age, sex, ethnicity, and comorbidity score. Compared with those who received dupilumab, the adjusted odds ratios (ORs) for hospitalization were highest among those who received topical treatments (OR, 4.95), followed by those who received systemic corticosteroids (OR, 2.81), and those who received other conventional systemic treatments (OR, 2.36).
Dr. Musters and colleagues also found that compared with patients on nonsteroidal immunosuppressive therapy, patients on combination systemic therapy had a significantly higher odds of hospitalization, specifically an OR of 45.75 for those on combination treatment including corticosteroids, an OR of 37.57 for those on combination treatment not including steroids, and an OR of 1.87 for those on systemic corticosteroids as monotherapy.
“Overall, the risk of COVID-19 complications appears to be low in patients with AD, even when treated with systemic immunomodulatory agents,” Dr. Musters concluded. “Dupilumab monotherapy was associated with lower odds of hospitalizations compared with other therapies. Moreover, combination systemic treatment, especially combinations including systemic corticosteroids, was associated with the highest risk of severe COVID-19.”
She added that other population-based study designs are more suitable to answer other important questions, such as whether the overall risk of COVID-19 in patients with AD is higher or lower compared to healthy controls.
Amy S. Paller, MD, professor and chair of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, characterized the results as reassuring. In this patient population, “we expected that dupilumab would not cause any problems,” she said. “We wouldn’t necessarily expect it to [confer] a benefit, but I think it’s because the patients who need a systemic medication are going on something that’s very targeted (dupilumab) rather than something that has a broader immunosuppressing function. It was interesting but not surprising that those on systemic steroids had more of a problem. Get them on something that’s very targeted if you can and don’t suppress the immune systems that might be handling COVID-19.”
Dr. Musters reported having no disclosures. Dr. Paller disclosed that she is consultant to and/or an investigator for many pharmaceutical companies.
BOSTON – , results from a global registry demonstrated.
Moreover, combination systemic treatment, especially those that included systemic corticosteroids, was associated with the highest risk of COVID-19–related hospitalization.
“Patients with inflammatory skin diseases such as AD may be at higher risk of COVID-19,” Annelie H. Musters, MD, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. “Another factor to consider is that AD patients are often treated with systemic immunomodulatory therapy, including systemic corticosteroids and nonsteroidal immunosuppressants such as methotrexate, cyclosporin, biologics, and Janus kinase inhibitors. Different mechanisms of action and levels of immunosuppression may impart variable risks of serious infections.”
On the other hand, some degree of immunomodulation may have beneficial effects on the course of COVID-19 in AD patients, said Dr. Musters, of the department of dermatology at Academic Medical Center, University of Amsterdam. Targeting of specific immune pathways could reduce the development of a hyperinflammatory state in severe COVID-19. Dual blockade of interleukin (IL)-4 and IL-13 with dupilumab may have a protective effect in the context of COVID-19 infection, because expression of Th2 cytokines, including IL-4 and IL-13, may be increased during COVID-19.
“At the start of the pandemic, many of us were faced with important questions, like do systemic immunomodulatory treatments influence outcomes of COVID-19 in patients with AD?” she said. “Do patients on dupilumab or other novel systemics fare better than those on conventional systemic treatment?”
To answer these questions, she and her colleagues launched a web-based registry in April 2020 to investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments. For the registry, known as Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD), clinicians in 27 countries used a web-based form to enter anonymized data after patients had fully recovered from COVID-19. Eligibility criteria included having proven or highly suspected COVID-19, and there were no restrictions on age nor the type of AD treatment they were receiving.
Dr. Musters reported results from 442 patients who were recruited between April 2, 2020, and Oct. 31, 2021. Their mean age was 35.6 years, their median body mass index was 23.7 kg/m2, and there was an even sex distribution. Most patients were White and were recruited from Italy. Of the 442 patients, 216 (48.8%) received dupilumab monotherapy, 131 (29.6%) received topical treatments, and 14 (3.16%) received combination systemic treatments, including systemic corticosteroids. About 12% presented to the emergency department and 6% were hospitalized. Of those hospitalized, 2% required intensive care and/or ventilation, and no deaths have occurred in the registry to date.
By treatment group, hospitalization rates were highest among those on combination treatments (35.7%), followed by systemic corticosteroids (14.3%), topical treatments only (9.9%), other conventional systemics (3.6%), methotrexate (3.3%), and dupilumab (2.3%).
To further explore the differences between hospitalization rates in treatment groups, the researchers performed a multivariable logistic regression analysis, adjusted for age, sex, ethnicity, and comorbidity score. Compared with those who received dupilumab, the adjusted odds ratios (ORs) for hospitalization were highest among those who received topical treatments (OR, 4.95), followed by those who received systemic corticosteroids (OR, 2.81), and those who received other conventional systemic treatments (OR, 2.36).
Dr. Musters and colleagues also found that compared with patients on nonsteroidal immunosuppressive therapy, patients on combination systemic therapy had a significantly higher odds of hospitalization, specifically an OR of 45.75 for those on combination treatment including corticosteroids, an OR of 37.57 for those on combination treatment not including steroids, and an OR of 1.87 for those on systemic corticosteroids as monotherapy.
“Overall, the risk of COVID-19 complications appears to be low in patients with AD, even when treated with systemic immunomodulatory agents,” Dr. Musters concluded. “Dupilumab monotherapy was associated with lower odds of hospitalizations compared with other therapies. Moreover, combination systemic treatment, especially combinations including systemic corticosteroids, was associated with the highest risk of severe COVID-19.”
She added that other population-based study designs are more suitable to answer other important questions, such as whether the overall risk of COVID-19 in patients with AD is higher or lower compared to healthy controls.
Amy S. Paller, MD, professor and chair of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, characterized the results as reassuring. In this patient population, “we expected that dupilumab would not cause any problems,” she said. “We wouldn’t necessarily expect it to [confer] a benefit, but I think it’s because the patients who need a systemic medication are going on something that’s very targeted (dupilumab) rather than something that has a broader immunosuppressing function. It was interesting but not surprising that those on systemic steroids had more of a problem. Get them on something that’s very targeted if you can and don’t suppress the immune systems that might be handling COVID-19.”
Dr. Musters reported having no disclosures. Dr. Paller disclosed that she is consultant to and/or an investigator for many pharmaceutical companies.
BOSTON – , results from a global registry demonstrated.
Moreover, combination systemic treatment, especially those that included systemic corticosteroids, was associated with the highest risk of COVID-19–related hospitalization.
“Patients with inflammatory skin diseases such as AD may be at higher risk of COVID-19,” Annelie H. Musters, MD, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. “Another factor to consider is that AD patients are often treated with systemic immunomodulatory therapy, including systemic corticosteroids and nonsteroidal immunosuppressants such as methotrexate, cyclosporin, biologics, and Janus kinase inhibitors. Different mechanisms of action and levels of immunosuppression may impart variable risks of serious infections.”
On the other hand, some degree of immunomodulation may have beneficial effects on the course of COVID-19 in AD patients, said Dr. Musters, of the department of dermatology at Academic Medical Center, University of Amsterdam. Targeting of specific immune pathways could reduce the development of a hyperinflammatory state in severe COVID-19. Dual blockade of interleukin (IL)-4 and IL-13 with dupilumab may have a protective effect in the context of COVID-19 infection, because expression of Th2 cytokines, including IL-4 and IL-13, may be increased during COVID-19.
“At the start of the pandemic, many of us were faced with important questions, like do systemic immunomodulatory treatments influence outcomes of COVID-19 in patients with AD?” she said. “Do patients on dupilumab or other novel systemics fare better than those on conventional systemic treatment?”
To answer these questions, she and her colleagues launched a web-based registry in April 2020 to investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments. For the registry, known as Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD), clinicians in 27 countries used a web-based form to enter anonymized data after patients had fully recovered from COVID-19. Eligibility criteria included having proven or highly suspected COVID-19, and there were no restrictions on age nor the type of AD treatment they were receiving.
Dr. Musters reported results from 442 patients who were recruited between April 2, 2020, and Oct. 31, 2021. Their mean age was 35.6 years, their median body mass index was 23.7 kg/m2, and there was an even sex distribution. Most patients were White and were recruited from Italy. Of the 442 patients, 216 (48.8%) received dupilumab monotherapy, 131 (29.6%) received topical treatments, and 14 (3.16%) received combination systemic treatments, including systemic corticosteroids. About 12% presented to the emergency department and 6% were hospitalized. Of those hospitalized, 2% required intensive care and/or ventilation, and no deaths have occurred in the registry to date.
By treatment group, hospitalization rates were highest among those on combination treatments (35.7%), followed by systemic corticosteroids (14.3%), topical treatments only (9.9%), other conventional systemics (3.6%), methotrexate (3.3%), and dupilumab (2.3%).
To further explore the differences between hospitalization rates in treatment groups, the researchers performed a multivariable logistic regression analysis, adjusted for age, sex, ethnicity, and comorbidity score. Compared with those who received dupilumab, the adjusted odds ratios (ORs) for hospitalization were highest among those who received topical treatments (OR, 4.95), followed by those who received systemic corticosteroids (OR, 2.81), and those who received other conventional systemic treatments (OR, 2.36).
Dr. Musters and colleagues also found that compared with patients on nonsteroidal immunosuppressive therapy, patients on combination systemic therapy had a significantly higher odds of hospitalization, specifically an OR of 45.75 for those on combination treatment including corticosteroids, an OR of 37.57 for those on combination treatment not including steroids, and an OR of 1.87 for those on systemic corticosteroids as monotherapy.
“Overall, the risk of COVID-19 complications appears to be low in patients with AD, even when treated with systemic immunomodulatory agents,” Dr. Musters concluded. “Dupilumab monotherapy was associated with lower odds of hospitalizations compared with other therapies. Moreover, combination systemic treatment, especially combinations including systemic corticosteroids, was associated with the highest risk of severe COVID-19.”
She added that other population-based study designs are more suitable to answer other important questions, such as whether the overall risk of COVID-19 in patients with AD is higher or lower compared to healthy controls.
Amy S. Paller, MD, professor and chair of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, characterized the results as reassuring. In this patient population, “we expected that dupilumab would not cause any problems,” she said. “We wouldn’t necessarily expect it to [confer] a benefit, but I think it’s because the patients who need a systemic medication are going on something that’s very targeted (dupilumab) rather than something that has a broader immunosuppressing function. It was interesting but not surprising that those on systemic steroids had more of a problem. Get them on something that’s very targeted if you can and don’t suppress the immune systems that might be handling COVID-19.”
Dr. Musters reported having no disclosures. Dr. Paller disclosed that she is consultant to and/or an investigator for many pharmaceutical companies.
AT AAD 22
FDA okays semaglutide higher dose, 2 mg/week, for type 2 diabetes
The U.S. Food and Drug Administration has approved a higher 2-mg dose of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) for adults with type 2 diabetes, giving a higher-dose alternative to the previous maximum 1-mg dose of semaglutide, administered by subcutaneous injection once weekly.
Semaglutide is currently available as 0.5-mg and 1-mg doses.
Results from the pivotal SUSTAIN FORTE study of the 2-mg dose (which, like lower-dose semaglutide for type 2 diabetes, comes in a single-use pen injector) showed that when compared head-to-head with a 1-mg/week dose in a 40-week study with 961 randomized patients, the 2-mg regimen led to a significant average incremental reduction in A1c levels of 0.23 percentage points. The 2-mg dose also produced a significant incremental increase in weight loss, with patients losing 0.93 kg more on the higher dose.
The 2-mg dose gives patients with type 2 diabetes and clinicians an “additional option” when a bigger “shift” in blood glucose is needed, said Juan Pablo Frias, MD, National Research Institute, Los Angeles, California, who was lead investigator for SUSTAIN FORTE, in a written statement.
As well as reducing glucose levels, semaglutide has been shown to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known cardiovascular disease.
Semaglutide was approved as a 2.4-mg injectable dose, as Wegovy, in 2021 for weight loss in patients with overweight or obesity.
SUSTAIN FORTE and other trials of semaglutide were sponsored by Novo Nordisk. SURPASS-2 and other trials of tirzepatide were sponsored by Lilly. Dr. Frias was lead investigator for both SUSTAIN FORTE and SURPASS-2, as well as an investigator for other trials sponsored by Lilly, Novo Nordisk, and other companies.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a higher 2-mg dose of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) for adults with type 2 diabetes, giving a higher-dose alternative to the previous maximum 1-mg dose of semaglutide, administered by subcutaneous injection once weekly.
Semaglutide is currently available as 0.5-mg and 1-mg doses.
Results from the pivotal SUSTAIN FORTE study of the 2-mg dose (which, like lower-dose semaglutide for type 2 diabetes, comes in a single-use pen injector) showed that when compared head-to-head with a 1-mg/week dose in a 40-week study with 961 randomized patients, the 2-mg regimen led to a significant average incremental reduction in A1c levels of 0.23 percentage points. The 2-mg dose also produced a significant incremental increase in weight loss, with patients losing 0.93 kg more on the higher dose.
The 2-mg dose gives patients with type 2 diabetes and clinicians an “additional option” when a bigger “shift” in blood glucose is needed, said Juan Pablo Frias, MD, National Research Institute, Los Angeles, California, who was lead investigator for SUSTAIN FORTE, in a written statement.
As well as reducing glucose levels, semaglutide has been shown to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known cardiovascular disease.
Semaglutide was approved as a 2.4-mg injectable dose, as Wegovy, in 2021 for weight loss in patients with overweight or obesity.
SUSTAIN FORTE and other trials of semaglutide were sponsored by Novo Nordisk. SURPASS-2 and other trials of tirzepatide were sponsored by Lilly. Dr. Frias was lead investigator for both SUSTAIN FORTE and SURPASS-2, as well as an investigator for other trials sponsored by Lilly, Novo Nordisk, and other companies.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a higher 2-mg dose of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) for adults with type 2 diabetes, giving a higher-dose alternative to the previous maximum 1-mg dose of semaglutide, administered by subcutaneous injection once weekly.
Semaglutide is currently available as 0.5-mg and 1-mg doses.
Results from the pivotal SUSTAIN FORTE study of the 2-mg dose (which, like lower-dose semaglutide for type 2 diabetes, comes in a single-use pen injector) showed that when compared head-to-head with a 1-mg/week dose in a 40-week study with 961 randomized patients, the 2-mg regimen led to a significant average incremental reduction in A1c levels of 0.23 percentage points. The 2-mg dose also produced a significant incremental increase in weight loss, with patients losing 0.93 kg more on the higher dose.
The 2-mg dose gives patients with type 2 diabetes and clinicians an “additional option” when a bigger “shift” in blood glucose is needed, said Juan Pablo Frias, MD, National Research Institute, Los Angeles, California, who was lead investigator for SUSTAIN FORTE, in a written statement.
As well as reducing glucose levels, semaglutide has been shown to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known cardiovascular disease.
Semaglutide was approved as a 2.4-mg injectable dose, as Wegovy, in 2021 for weight loss in patients with overweight or obesity.
SUSTAIN FORTE and other trials of semaglutide were sponsored by Novo Nordisk. SURPASS-2 and other trials of tirzepatide were sponsored by Lilly. Dr. Frias was lead investigator for both SUSTAIN FORTE and SURPASS-2, as well as an investigator for other trials sponsored by Lilly, Novo Nordisk, and other companies.
A version of this article first appeared on Medscape.com.
Senate approves bill to ban crib bumpers
The Senate on Mar. 23 approved a bill to ban the sale of padded crib bumpers, which have been deemed risky by public health experts.
The Safe Cribs Act, introduced by Sen. Rob Portman (R-Ohio) and Sen. Tammy Duckworth (D-Ill.), would prohibit making and distributing bumpers – soft pads made to protect babies from hard sides of cribs – which have been found to increase suffocation risk.
The bill will now head to the House of Representatives.
According to data from the Consumer Product Safety Commission, 107 babies died in cribs with bumpers between 1990 and 2016, and 282 nonfatal incidents with bumpers were reported, including near-misses for strangulation and suffocation.
The American Academy of Pediatrics recommends keeping babies’ cribs free of any objects, including bumpers.
Despite this, bumpers are still widely sold by retailers.
“The fact that these deadly products can still be found on shelves across the country is extremely confusing to new parents who don’t believe stores would be selling them if they were truly dangerous to babies,” Sen. Duckworth said in a statement.
A 2020 survey released by Johns Hopkins University found that many parents were unaware of the dangers posed by crib bumpers and assumed they would be removed from stores if found unsafe.
Maryland banned the sale of bumpers in 2013, followed by Ohio in 2017. Chicago became the first city to ban them in 2011.
A version of this article first appeared on WebMD.com.
The Senate on Mar. 23 approved a bill to ban the sale of padded crib bumpers, which have been deemed risky by public health experts.
The Safe Cribs Act, introduced by Sen. Rob Portman (R-Ohio) and Sen. Tammy Duckworth (D-Ill.), would prohibit making and distributing bumpers – soft pads made to protect babies from hard sides of cribs – which have been found to increase suffocation risk.
The bill will now head to the House of Representatives.
According to data from the Consumer Product Safety Commission, 107 babies died in cribs with bumpers between 1990 and 2016, and 282 nonfatal incidents with bumpers were reported, including near-misses for strangulation and suffocation.
The American Academy of Pediatrics recommends keeping babies’ cribs free of any objects, including bumpers.
Despite this, bumpers are still widely sold by retailers.
“The fact that these deadly products can still be found on shelves across the country is extremely confusing to new parents who don’t believe stores would be selling them if they were truly dangerous to babies,” Sen. Duckworth said in a statement.
A 2020 survey released by Johns Hopkins University found that many parents were unaware of the dangers posed by crib bumpers and assumed they would be removed from stores if found unsafe.
Maryland banned the sale of bumpers in 2013, followed by Ohio in 2017. Chicago became the first city to ban them in 2011.
A version of this article first appeared on WebMD.com.
The Senate on Mar. 23 approved a bill to ban the sale of padded crib bumpers, which have been deemed risky by public health experts.
The Safe Cribs Act, introduced by Sen. Rob Portman (R-Ohio) and Sen. Tammy Duckworth (D-Ill.), would prohibit making and distributing bumpers – soft pads made to protect babies from hard sides of cribs – which have been found to increase suffocation risk.
The bill will now head to the House of Representatives.
According to data from the Consumer Product Safety Commission, 107 babies died in cribs with bumpers between 1990 and 2016, and 282 nonfatal incidents with bumpers were reported, including near-misses for strangulation and suffocation.
The American Academy of Pediatrics recommends keeping babies’ cribs free of any objects, including bumpers.
Despite this, bumpers are still widely sold by retailers.
“The fact that these deadly products can still be found on shelves across the country is extremely confusing to new parents who don’t believe stores would be selling them if they were truly dangerous to babies,” Sen. Duckworth said in a statement.
A 2020 survey released by Johns Hopkins University found that many parents were unaware of the dangers posed by crib bumpers and assumed they would be removed from stores if found unsafe.
Maryland banned the sale of bumpers in 2013, followed by Ohio in 2017. Chicago became the first city to ban them in 2011.
A version of this article first appeared on WebMD.com.
Cancer of the appendix on the rise in younger patients with appendicitis
Younger patients with appendicitis appear to be increasingly likely to have cancer of the appendix, a new study suggests.
While acute appendicitis can often be managed with antibiotics instead of surgery, patients who do not have surgery need to be closely followed to avoid missed diagnoses, the authors write.
“The most important finding is that between 2004 and 2017, relative to right-sided colon cancer, the number of appendiceal cancer cases increased,” said Mustafa Raoof, MD, who was not involved in the study. He is a surgical oncologist and an assistant professor of surgical oncology at City of Hope Comprehensive Cancer Center, Duarte, Calif. “Approximately one-fourth of these were carcinoid tumors, and this category saw the greatest increase, particularly in individuals under 50 years of age.”
“There is a push to treat acute appendicitis with only antibiotics to avoid surgery,” Dr. Raoof told this news organization by email. “One underappreciated downside of this strategy is that an appendiceal cancer can be missed if the appendix is not removed.”
As reported in Journal of the American College of Surgeons, lead study author Michelle C. Salazar, MD, MHS, a general surgery resident at Yale School of Medicine in New Haven, Conn., and her colleagues conducted a retrospective analysis of the National Cancer Database (NCDB). The NCDB contains hospital registry data of around 70% of new cancer diagnoses in the United States.
The researchers extracted data on patients aged 18 years and older who were diagnosed with right-sided colon cancer between 2004 and 2017 and who underwent appendectomy. The authors also identified all patients with appendiceal cancer. They divided that group into patients with carcinoid tumors and those with other types of appendiceal cancer. They also investigated trends by age group.
Of 387,867 patients with right-sided colon cancer, 19,570 (5%) had appendiceal cancer, and 5,628 of those patients (29%) had carcinoid tumor. The odds of appendiceal cancer, compared with other right-sided colon cancers, rose over the years studied (odds ratio, 2.56; 95% confidence interval, 2.35-2.79).
This increase in odds occurred in all age groups but was steepest among patients between 40 and 49 years of age, among whom it increased from 10% in 2004 (95% CI, 9-12) to 18% in 2017 (95% CI, 16-20; P < .001).
Odds of appendiceal carcinoid, compared with other appendiceal cancers, also rose during this period (OR, 1.70; 95% CI, 1.40-2.07). The sharpest increase occurred in the likelihood of carcinoid in patients younger than 40, from 24% in 2004 (95% CI, 15-34) to 45% in 2017 (95% CI, 37-53; P < .001).
“The findings in this study are yet another reason to temper excitement about nonoperative management of acute appendicitis in adults,” Richard S. Hoehn, MD, a surgical oncologist at University Hospitals Seidman Cancer Center, Cleveland, said. “The study is important because it reveals a potential risk of deferring appendectomy in adult patients with appendiceal pathology.”
“As our pathologic examinations of appendiceal cancers improve, we are gaining better understanding of these tumors and how to best manage these patients,” Dr. Hoehn, who also was not involved in the study, added in an email. “The findings should make surgeons more suspicious of malignant causes of acute appendicitis in adults, especially those under 40. Colonoscopy and appendectomy are necessary in adult patients with appendicitis.”
Gregory Botta, MD, PhD, a medical oncologist and associate professor of medicine at the University of California San Diego Health, mentioned limitations of the study in an email. They include the NCDB’s omission of around 30% of cases nationally and the study’s omission of patients diagnosed with primary appendiceal tumor, as well as patients who underwent total colectomies and those who did not have surgery.
“Appendiceal tumors are not normally seen during colonoscopies; screening colonoscopies are not recommended to younger patients under 40, and there is less surgical management for appendicitis,” explained Dr. Botta, who also was not involved in the study. “Thus, the cause of the increasing incidence is not due to increased detection on surveillance.
“Gastrointestinal oncologists are seeing an increase in colon cancer in younger patients and a parallel increase in appendix tumors. While carcinoid tumors are usually found localized and [are] therefore curable postsurgical resection, adenocarcinoma or mucinous subtypes tend to be more diffuse, metastatic, and noncurable,” he added. “Although the increase in colon cancer is being found in our younger population, the authors hint at causes not captured by the NCDB, including environmental exposures or each patient’s diet.”
“There is no good answer as to why there is an increase in carcinoids,” Dr. Salazar said in a press release. “It could be due to environmental reasons, or it could be due to better diagnostics technology.”
The researchers and independent experts share concerns that, because surgery provides the only definitive diagnosis of appendiceal cancer, among patients managed nonsurgically, there may be a delay in cancer diagnosis.
“I would counsel patients based on age,” Dr. Salazar added. “If you’re older, you are at less risk for appendiceal cancer and greater risk for complications from surgery. Younger, healthy patients are more likely to be able to tolerate an operation and may want to rule out cancer by undergoing the operation. The characteristics of appendicitis should be considered in the decision.”
Funding information was not provided. The authors, Dr. Raoof, Dr. Hoehn, and Dr. Botta have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Younger patients with appendicitis appear to be increasingly likely to have cancer of the appendix, a new study suggests.
While acute appendicitis can often be managed with antibiotics instead of surgery, patients who do not have surgery need to be closely followed to avoid missed diagnoses, the authors write.
“The most important finding is that between 2004 and 2017, relative to right-sided colon cancer, the number of appendiceal cancer cases increased,” said Mustafa Raoof, MD, who was not involved in the study. He is a surgical oncologist and an assistant professor of surgical oncology at City of Hope Comprehensive Cancer Center, Duarte, Calif. “Approximately one-fourth of these were carcinoid tumors, and this category saw the greatest increase, particularly in individuals under 50 years of age.”
“There is a push to treat acute appendicitis with only antibiotics to avoid surgery,” Dr. Raoof told this news organization by email. “One underappreciated downside of this strategy is that an appendiceal cancer can be missed if the appendix is not removed.”
As reported in Journal of the American College of Surgeons, lead study author Michelle C. Salazar, MD, MHS, a general surgery resident at Yale School of Medicine in New Haven, Conn., and her colleagues conducted a retrospective analysis of the National Cancer Database (NCDB). The NCDB contains hospital registry data of around 70% of new cancer diagnoses in the United States.
The researchers extracted data on patients aged 18 years and older who were diagnosed with right-sided colon cancer between 2004 and 2017 and who underwent appendectomy. The authors also identified all patients with appendiceal cancer. They divided that group into patients with carcinoid tumors and those with other types of appendiceal cancer. They also investigated trends by age group.
Of 387,867 patients with right-sided colon cancer, 19,570 (5%) had appendiceal cancer, and 5,628 of those patients (29%) had carcinoid tumor. The odds of appendiceal cancer, compared with other right-sided colon cancers, rose over the years studied (odds ratio, 2.56; 95% confidence interval, 2.35-2.79).
This increase in odds occurred in all age groups but was steepest among patients between 40 and 49 years of age, among whom it increased from 10% in 2004 (95% CI, 9-12) to 18% in 2017 (95% CI, 16-20; P < .001).
Odds of appendiceal carcinoid, compared with other appendiceal cancers, also rose during this period (OR, 1.70; 95% CI, 1.40-2.07). The sharpest increase occurred in the likelihood of carcinoid in patients younger than 40, from 24% in 2004 (95% CI, 15-34) to 45% in 2017 (95% CI, 37-53; P < .001).
“The findings in this study are yet another reason to temper excitement about nonoperative management of acute appendicitis in adults,” Richard S. Hoehn, MD, a surgical oncologist at University Hospitals Seidman Cancer Center, Cleveland, said. “The study is important because it reveals a potential risk of deferring appendectomy in adult patients with appendiceal pathology.”
“As our pathologic examinations of appendiceal cancers improve, we are gaining better understanding of these tumors and how to best manage these patients,” Dr. Hoehn, who also was not involved in the study, added in an email. “The findings should make surgeons more suspicious of malignant causes of acute appendicitis in adults, especially those under 40. Colonoscopy and appendectomy are necessary in adult patients with appendicitis.”
Gregory Botta, MD, PhD, a medical oncologist and associate professor of medicine at the University of California San Diego Health, mentioned limitations of the study in an email. They include the NCDB’s omission of around 30% of cases nationally and the study’s omission of patients diagnosed with primary appendiceal tumor, as well as patients who underwent total colectomies and those who did not have surgery.
“Appendiceal tumors are not normally seen during colonoscopies; screening colonoscopies are not recommended to younger patients under 40, and there is less surgical management for appendicitis,” explained Dr. Botta, who also was not involved in the study. “Thus, the cause of the increasing incidence is not due to increased detection on surveillance.
“Gastrointestinal oncologists are seeing an increase in colon cancer in younger patients and a parallel increase in appendix tumors. While carcinoid tumors are usually found localized and [are] therefore curable postsurgical resection, adenocarcinoma or mucinous subtypes tend to be more diffuse, metastatic, and noncurable,” he added. “Although the increase in colon cancer is being found in our younger population, the authors hint at causes not captured by the NCDB, including environmental exposures or each patient’s diet.”
“There is no good answer as to why there is an increase in carcinoids,” Dr. Salazar said in a press release. “It could be due to environmental reasons, or it could be due to better diagnostics technology.”
The researchers and independent experts share concerns that, because surgery provides the only definitive diagnosis of appendiceal cancer, among patients managed nonsurgically, there may be a delay in cancer diagnosis.
“I would counsel patients based on age,” Dr. Salazar added. “If you’re older, you are at less risk for appendiceal cancer and greater risk for complications from surgery. Younger, healthy patients are more likely to be able to tolerate an operation and may want to rule out cancer by undergoing the operation. The characteristics of appendicitis should be considered in the decision.”
Funding information was not provided. The authors, Dr. Raoof, Dr. Hoehn, and Dr. Botta have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Younger patients with appendicitis appear to be increasingly likely to have cancer of the appendix, a new study suggests.
While acute appendicitis can often be managed with antibiotics instead of surgery, patients who do not have surgery need to be closely followed to avoid missed diagnoses, the authors write.
“The most important finding is that between 2004 and 2017, relative to right-sided colon cancer, the number of appendiceal cancer cases increased,” said Mustafa Raoof, MD, who was not involved in the study. He is a surgical oncologist and an assistant professor of surgical oncology at City of Hope Comprehensive Cancer Center, Duarte, Calif. “Approximately one-fourth of these were carcinoid tumors, and this category saw the greatest increase, particularly in individuals under 50 years of age.”
“There is a push to treat acute appendicitis with only antibiotics to avoid surgery,” Dr. Raoof told this news organization by email. “One underappreciated downside of this strategy is that an appendiceal cancer can be missed if the appendix is not removed.”
As reported in Journal of the American College of Surgeons, lead study author Michelle C. Salazar, MD, MHS, a general surgery resident at Yale School of Medicine in New Haven, Conn., and her colleagues conducted a retrospective analysis of the National Cancer Database (NCDB). The NCDB contains hospital registry data of around 70% of new cancer diagnoses in the United States.
The researchers extracted data on patients aged 18 years and older who were diagnosed with right-sided colon cancer between 2004 and 2017 and who underwent appendectomy. The authors also identified all patients with appendiceal cancer. They divided that group into patients with carcinoid tumors and those with other types of appendiceal cancer. They also investigated trends by age group.
Of 387,867 patients with right-sided colon cancer, 19,570 (5%) had appendiceal cancer, and 5,628 of those patients (29%) had carcinoid tumor. The odds of appendiceal cancer, compared with other right-sided colon cancers, rose over the years studied (odds ratio, 2.56; 95% confidence interval, 2.35-2.79).
This increase in odds occurred in all age groups but was steepest among patients between 40 and 49 years of age, among whom it increased from 10% in 2004 (95% CI, 9-12) to 18% in 2017 (95% CI, 16-20; P < .001).
Odds of appendiceal carcinoid, compared with other appendiceal cancers, also rose during this period (OR, 1.70; 95% CI, 1.40-2.07). The sharpest increase occurred in the likelihood of carcinoid in patients younger than 40, from 24% in 2004 (95% CI, 15-34) to 45% in 2017 (95% CI, 37-53; P < .001).
“The findings in this study are yet another reason to temper excitement about nonoperative management of acute appendicitis in adults,” Richard S. Hoehn, MD, a surgical oncologist at University Hospitals Seidman Cancer Center, Cleveland, said. “The study is important because it reveals a potential risk of deferring appendectomy in adult patients with appendiceal pathology.”
“As our pathologic examinations of appendiceal cancers improve, we are gaining better understanding of these tumors and how to best manage these patients,” Dr. Hoehn, who also was not involved in the study, added in an email. “The findings should make surgeons more suspicious of malignant causes of acute appendicitis in adults, especially those under 40. Colonoscopy and appendectomy are necessary in adult patients with appendicitis.”
Gregory Botta, MD, PhD, a medical oncologist and associate professor of medicine at the University of California San Diego Health, mentioned limitations of the study in an email. They include the NCDB’s omission of around 30% of cases nationally and the study’s omission of patients diagnosed with primary appendiceal tumor, as well as patients who underwent total colectomies and those who did not have surgery.
“Appendiceal tumors are not normally seen during colonoscopies; screening colonoscopies are not recommended to younger patients under 40, and there is less surgical management for appendicitis,” explained Dr. Botta, who also was not involved in the study. “Thus, the cause of the increasing incidence is not due to increased detection on surveillance.
“Gastrointestinal oncologists are seeing an increase in colon cancer in younger patients and a parallel increase in appendix tumors. While carcinoid tumors are usually found localized and [are] therefore curable postsurgical resection, adenocarcinoma or mucinous subtypes tend to be more diffuse, metastatic, and noncurable,” he added. “Although the increase in colon cancer is being found in our younger population, the authors hint at causes not captured by the NCDB, including environmental exposures or each patient’s diet.”
“There is no good answer as to why there is an increase in carcinoids,” Dr. Salazar said in a press release. “It could be due to environmental reasons, or it could be due to better diagnostics technology.”
The researchers and independent experts share concerns that, because surgery provides the only definitive diagnosis of appendiceal cancer, among patients managed nonsurgically, there may be a delay in cancer diagnosis.
“I would counsel patients based on age,” Dr. Salazar added. “If you’re older, you are at less risk for appendiceal cancer and greater risk for complications from surgery. Younger, healthy patients are more likely to be able to tolerate an operation and may want to rule out cancer by undergoing the operation. The characteristics of appendicitis should be considered in the decision.”
Funding information was not provided. The authors, Dr. Raoof, Dr. Hoehn, and Dr. Botta have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Neonatal hypoglycemia doesn’t affect childhood academics
Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.
Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.
In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.
The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.
Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).
No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.
However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).
The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.
The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.
However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.
In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.
The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.
The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.
At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.
No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.
The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.
The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.
The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.
The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
Findings fuel further exploration
Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.
“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.
The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.
The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.
“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.
Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.
Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.
The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.
The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.
Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.
Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.
In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.
The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.
Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).
No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.
However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).
The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.
The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.
However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.
In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.
The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.
The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.
At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.
No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.
The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.
The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.
The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.
The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
Findings fuel further exploration
Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.
“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.
The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.
The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.
“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.
Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.
Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.
The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.
The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.
Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.
Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.
In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.
The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.
Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).
No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.
However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).
The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.
The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.
However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.
In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.
The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.
The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.
At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.
No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.
The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.
The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.
The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.
The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
Findings fuel further exploration
Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.
“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.
The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.
The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.
“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.
Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.
Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.
The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.
The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.
FROM JAMA
Is aspirin the best way to prevent blood clots after THA/TKA?
CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.
Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.
The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.
Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.
The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.
The researchers found that rates of VTE were higher among patients discharged to facilities.
Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).
However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.
Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).
“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.
“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.
Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.
He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”
Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.
“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.
“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.
Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.
The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.
Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.
Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.
The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.
Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.
The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.
The researchers found that rates of VTE were higher among patients discharged to facilities.
Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).
However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.
Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).
“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.
“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.
Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.
He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”
Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.
“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.
“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.
Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.
The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.
Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.
Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.
The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.
Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.
The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.
The researchers found that rates of VTE were higher among patients discharged to facilities.
Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).
However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.
Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).
“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.
“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.
Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.
He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”
Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.
“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.
“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.
Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.
The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.
Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AAOS 2022
Children and COVID: The long goodbye continues
COVID-19 continues to be a diminishing issue for U.S. children, as the number of new cases declined for the ninth consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
the AAP and CHA said in their weekly COVID report. The most recently infected children brought the total number of COVID-19 cases to just over 12.8 million since the pandemic began.
Other measures of COVID occurrence in children, such as hospital admissions and emergency department visits, also followed recent downward trends, although the sizes of the declines are beginning to decrease. Admissions dropped by 13.3% during the week ending March 26, but that followed declines of 25%, 20%, 26.5% and 24.4% for the 4 previous weeks, data from the Centers for Disease Control and Prevention show.
The slowdown in ED visits started a couple of weeks earlier, but the decline is still ongoing. As of March 25, ED visits with a confirmed COVID diagnosis represented just 0.4% of all visits for children aged 0-11 years, down from 1.1% on Feb. 25 and a peak of 14.3% on Jan. 15. For children aged 12-15, the latest figure is just 0.2%, compared with 0.5% on Feb. 25 and a peak of 14.3% on Jan. 9, the CDC reported on its COVID Data Tracker.
Although he was speaking of the nation as a whole and not specifically of children, Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, recently told the Washington Post that, “unless something changes dramatically,” another major surge isn’t on the horizon.
That sentiment, however, was not entirely shared by Moderna’s chief medical officer, Paul Burton, MD, PhD. In an interview with WebMD, he said that another COVID wave is inevitable and that it’s too soon to dismantle the vaccine infrastructure: “We’ve come so far. We’ve put so much into this to now take our foot off the gas. I think it would be a mistake for public health worldwide.”
Disparities during the Omicron surge
As the country puts Omicron in its rear view mirror, a quick look back at the CDC data shows some differences in how children were affected. At the surge’s peak in early to mid-January, Hispanic children were the most likely to get COVID-19, with incidence highest in the older groups. (See graph.)
At their peak week of Jan. 2-8, Hispanic children aged 16-17 years had a COVID rate of 1,568 cases per 100,000 population, versus 790 per 100,000 for White children, whose peak occurred a week later, from Jan. 9 to 15. Hispanic children aged 5-11 (1,098 per 100,000) and 12-15 (1,269 per 100,000) also had the highest recorded rates of the largest racial/ethnic groups, while Black children had the highest one-week rate, 625 per 100,000, among the 0- to 4-year-olds, according to the CDC.
COVID-19 continues to be a diminishing issue for U.S. children, as the number of new cases declined for the ninth consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
the AAP and CHA said in their weekly COVID report. The most recently infected children brought the total number of COVID-19 cases to just over 12.8 million since the pandemic began.
Other measures of COVID occurrence in children, such as hospital admissions and emergency department visits, also followed recent downward trends, although the sizes of the declines are beginning to decrease. Admissions dropped by 13.3% during the week ending March 26, but that followed declines of 25%, 20%, 26.5% and 24.4% for the 4 previous weeks, data from the Centers for Disease Control and Prevention show.
The slowdown in ED visits started a couple of weeks earlier, but the decline is still ongoing. As of March 25, ED visits with a confirmed COVID diagnosis represented just 0.4% of all visits for children aged 0-11 years, down from 1.1% on Feb. 25 and a peak of 14.3% on Jan. 15. For children aged 12-15, the latest figure is just 0.2%, compared with 0.5% on Feb. 25 and a peak of 14.3% on Jan. 9, the CDC reported on its COVID Data Tracker.
Although he was speaking of the nation as a whole and not specifically of children, Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, recently told the Washington Post that, “unless something changes dramatically,” another major surge isn’t on the horizon.
That sentiment, however, was not entirely shared by Moderna’s chief medical officer, Paul Burton, MD, PhD. In an interview with WebMD, he said that another COVID wave is inevitable and that it’s too soon to dismantle the vaccine infrastructure: “We’ve come so far. We’ve put so much into this to now take our foot off the gas. I think it would be a mistake for public health worldwide.”
Disparities during the Omicron surge
As the country puts Omicron in its rear view mirror, a quick look back at the CDC data shows some differences in how children were affected. At the surge’s peak in early to mid-January, Hispanic children were the most likely to get COVID-19, with incidence highest in the older groups. (See graph.)
At their peak week of Jan. 2-8, Hispanic children aged 16-17 years had a COVID rate of 1,568 cases per 100,000 population, versus 790 per 100,000 for White children, whose peak occurred a week later, from Jan. 9 to 15. Hispanic children aged 5-11 (1,098 per 100,000) and 12-15 (1,269 per 100,000) also had the highest recorded rates of the largest racial/ethnic groups, while Black children had the highest one-week rate, 625 per 100,000, among the 0- to 4-year-olds, according to the CDC.
COVID-19 continues to be a diminishing issue for U.S. children, as the number of new cases declined for the ninth consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
the AAP and CHA said in their weekly COVID report. The most recently infected children brought the total number of COVID-19 cases to just over 12.8 million since the pandemic began.
Other measures of COVID occurrence in children, such as hospital admissions and emergency department visits, also followed recent downward trends, although the sizes of the declines are beginning to decrease. Admissions dropped by 13.3% during the week ending March 26, but that followed declines of 25%, 20%, 26.5% and 24.4% for the 4 previous weeks, data from the Centers for Disease Control and Prevention show.
The slowdown in ED visits started a couple of weeks earlier, but the decline is still ongoing. As of March 25, ED visits with a confirmed COVID diagnosis represented just 0.4% of all visits for children aged 0-11 years, down from 1.1% on Feb. 25 and a peak of 14.3% on Jan. 15. For children aged 12-15, the latest figure is just 0.2%, compared with 0.5% on Feb. 25 and a peak of 14.3% on Jan. 9, the CDC reported on its COVID Data Tracker.
Although he was speaking of the nation as a whole and not specifically of children, Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, recently told the Washington Post that, “unless something changes dramatically,” another major surge isn’t on the horizon.
That sentiment, however, was not entirely shared by Moderna’s chief medical officer, Paul Burton, MD, PhD. In an interview with WebMD, he said that another COVID wave is inevitable and that it’s too soon to dismantle the vaccine infrastructure: “We’ve come so far. We’ve put so much into this to now take our foot off the gas. I think it would be a mistake for public health worldwide.”
Disparities during the Omicron surge
As the country puts Omicron in its rear view mirror, a quick look back at the CDC data shows some differences in how children were affected. At the surge’s peak in early to mid-January, Hispanic children were the most likely to get COVID-19, with incidence highest in the older groups. (See graph.)
At their peak week of Jan. 2-8, Hispanic children aged 16-17 years had a COVID rate of 1,568 cases per 100,000 population, versus 790 per 100,000 for White children, whose peak occurred a week later, from Jan. 9 to 15. Hispanic children aged 5-11 (1,098 per 100,000) and 12-15 (1,269 per 100,000) also had the highest recorded rates of the largest racial/ethnic groups, while Black children had the highest one-week rate, 625 per 100,000, among the 0- to 4-year-olds, according to the CDC.
What a sleep expert thinks of sleep trackers
The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.
This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.
The interview has been edited for length and clarity.
Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?
Dr. Baron: There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.
Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?
A: Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.
They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.
Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
Q: Are the wrist-worn devices better for sleep tracking?
A: They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.
Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?
A: You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.
Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?
A: No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.
There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.
Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.
Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”
A: In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.
You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?
A: I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.
There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.
Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?
A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.
We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?
A: As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.
I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?
I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.
A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.
When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.
A: Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.
Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
Q: Is there such a thing as an ideal hypnogram or does it vary by individual?
A: I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.
One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.
The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?
A: There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.
Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?
A: If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.
If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
Q: Is there anything else you want to mention?
A: I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.
As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.
Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.
The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.
This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.
The interview has been edited for length and clarity.
Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?
Dr. Baron: There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.
Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?
A: Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.
They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.
Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
Q: Are the wrist-worn devices better for sleep tracking?
A: They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.
Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?
A: You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.
Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?
A: No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.
There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.
Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.
Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”
A: In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.
You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?
A: I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.
There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.
Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?
A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.
We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?
A: As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.
I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?
I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.
A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.
When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.
A: Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.
Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
Q: Is there such a thing as an ideal hypnogram or does it vary by individual?
A: I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.
One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.
The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?
A: There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.
Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?
A: If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.
If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
Q: Is there anything else you want to mention?
A: I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.
As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.
Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.
The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.
This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.
The interview has been edited for length and clarity.
Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?
Dr. Baron: There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.
Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?
A: Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.
They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.
Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
Q: Are the wrist-worn devices better for sleep tracking?
A: They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.
Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?
A: You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.
Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?
A: No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.
There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.
Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.
Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”
A: In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.
You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?
A: I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.
There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.
Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?
A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.
We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?
A: As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.
I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?
I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.
A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.
When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.
A: Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.
Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
Q: Is there such a thing as an ideal hypnogram or does it vary by individual?
A: I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.
One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.
The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?
A: There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.
Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?
A: If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.
If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
Q: Is there anything else you want to mention?
A: I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.
As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.
Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.