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COVID-19 has brought more complex, longer office visits
Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.
The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.
More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.
Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.
In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.
“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
‘We’re going to be playing catch-up’
Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”
The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.
“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.
Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”
She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”
At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
Long COVID could overwhelm existing health care capacity
Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.
As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.
“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
Anxiety, depression ‘have gone off the charts’
Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”
“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”
Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.
COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.
“That really affects my ability to care for them,” they said.
Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.
To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.
Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.
“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
Rethinking workflow
Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.
“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.
“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.
Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.
“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.
Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.
“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.
As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.
That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.
Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.
Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.
The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.
More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.
Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.
In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.
“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
‘We’re going to be playing catch-up’
Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”
The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.
“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.
Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”
She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”
At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
Long COVID could overwhelm existing health care capacity
Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.
As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.
“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
Anxiety, depression ‘have gone off the charts’
Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”
“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”
Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.
COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.
“That really affects my ability to care for them,” they said.
Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.
To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.
Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.
“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
Rethinking workflow
Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.
“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.
“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.
Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.
“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.
Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.
“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.
As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.
That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.
Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.
Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.
The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.
More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.
Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.
In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.
“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
‘We’re going to be playing catch-up’
Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”
The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.
“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.
Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”
She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”
At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
Long COVID could overwhelm existing health care capacity
Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.
As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.
“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
Anxiety, depression ‘have gone off the charts’
Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”
“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”
Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.
COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.
“That really affects my ability to care for them,” they said.
Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.
To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.
Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.
“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
Rethinking workflow
Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.
“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.
“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.
Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.
“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.
Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.
“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.
As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.
That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.
Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.
Small fiber neuropathy is rising in the U.S., but why is a mystery
The exact reason for the increase in isolated SFN “remains unclear,” said Christopher J. Klein, MD, of the Mayo Clinic in Rochester, Minn. However, “we noted during the study period the population has had increased BMI, which appears to be a risk factor for this disorder, with many (50%) developing either glucose impairment or frank diabetes during the study period even if not present at first small fiber neuropathy presentation, also with associated higher triglyceride levels,” he explained.
The study was published online October 27 in Neurology.
Significant upward trend
Investigators reviewed the records of all 94 adults diagnosed with pure SFN (no large fiber involvement) between 1998 and 2017 in Olmsted and adjacent counties in Minnesota – and compared them with 282 adults of similar age and gender who did not have neuropathy.
The incidence of SFN over the entire study period was 1.3 per 100,000 per year and the prevalence was 13.3 per 100,000.
There was a “significant upward trend” in SFN incidence over the study period that could not be attributed to the availability of intraepidermal nerve fiber density testing, the authors reported.
The median age of onset of SFN was 54 years and two-thirds were women (67%).
Diabetes, obesity, and hypertriglyceridemia were significantly more common in patients with SFN compared with matched controls. These metabolic risk factors are also associated with peripheral neuropathy regardless of fiber type.
Autonomic symptoms were common and generally mild, affecting 85% of patients with SFN, and included male erectile dysfunction, constipation, light-headedness and palpitations, urinary symptoms, diarrhea, dry eyes and mouth, sweat abnormalities, and gastroparesis.
Insomnia and use of opioid pain medication were more common in those with SFN than matched controls.
More than one-third (36%) of patients with SFN developed large fiber neuropathy an average of 5.3 years after developing SFN.
During an average follow-up of 6.1 years, adults with SFN were significantly more likely to suffer myocardial infarction (46% vs. 27%; odds ratio, 2.0; 95% CI, 1.8-4.9), congestive heart failure (27% vs. 12%; OR, 2.6; 95% CI, 1.4-4.8), peripheral vascular disease (22% vs. 6%; OR, 4.0; 95% CI, 1.9-8.1), stroke (24% vs. 10%; OR, 2.8; 95% CI, 1.5-5.3), diabetes (51% vs. 22%; OR, 4.6; 95% CI, 2.8-7.6) and rheumatologic disease (30% vs. 7%; OR, 5.3; 95% CI, 2.8-10.4).
For 70% of patients, no cause for SFN could be determined. Diabetes (15%) was the most common cause identified. Other less common causes included Sjögren syndrome, lupus, amyloidosis, and Fabry disease.
“It is important to quantitatively diagnose patients with SFN as many non-neurological musculoskeletal causes can mimic the disorder,” said Dr. Klein.
“If rates of progression are rapid, sinister causes such as out-of-control diabetes, hereditary [transthyretin] TTR amyloidosis, and Fabry disease can be responsible. For other patients, rates of progression are slow and generally do not lead to significant neurologic impairments,” he added.
“However,” he said, “internal medicine follow-up is important for all as this disorder associates with development with higher risk of cardiovascular disease, including commonly heart attacks.”
Of note, although mean age at death was not significantly different in patients with SFN than controls (70 vs. 73 years), there was a significantly higher number of deaths in patients with SFN (n = 18; 19%) than in matched controls (n = 35; 12%) from the time of symptom onset, the researchers reported.
Important research
This “important” study sheds light on the comorbidities and longitudinal consequences of SFN, wrote Brian Callaghan, MD, with the University of Michigan, Ann Arbor, and J. Robinson Singleton, MD, with the University of Utah, Salt Lake City, in an accompanying editorial in Neurology.
The study demonstrates clearly that SFN has “metabolic risk factors similar to those seen for sensory predominant peripheral neuropathies affecting a broader range of fiber types. As a result, therapies that address metabolic risk factors are likely to help prevent or treat both conditions,” they wrote.
Dr. Callaghan and Dr. Singleton added that a key strength of the study is the detailed follow-up that examines SFN progression over time. “The authors found that patients with SFN do not report high disability and that progression tends to be slow. Therefore, patients with SFN can be counseled that progression and disability are likely to be modest in most cases. However, when patients do progress quickly, uncommon etiologies should be sought,” the editorialists wrote.
The study was supported by the Mayo Clinic Foundation, Mayo Clinic Center for Individualized Medicine, and Mayo Clinic Center of MS and Autoimmune Neurology. Dr. Klein has received teaching honorarium from Ackea pharmaceuticals for lectures on hereditary transthyretin amyloidosis and Fabry disease, consulted for Pfizer regarding tafamidis (all compensation for consulting activities is paid directly to Mayo Clinic), and participated in the clinical trials for inotersen and patisiran but received no personal compensation for his participation. Dr. Callaghan consults for DynaMed, performs medical legal consultations, including consultations for the Vaccine Injury Compensation Program, and receives research support from the American Academy of Neurology. Dr. Singleton has consulted for Regenacy.
A version of this article first appeared on Medscape.com.
The exact reason for the increase in isolated SFN “remains unclear,” said Christopher J. Klein, MD, of the Mayo Clinic in Rochester, Minn. However, “we noted during the study period the population has had increased BMI, which appears to be a risk factor for this disorder, with many (50%) developing either glucose impairment or frank diabetes during the study period even if not present at first small fiber neuropathy presentation, also with associated higher triglyceride levels,” he explained.
The study was published online October 27 in Neurology.
Significant upward trend
Investigators reviewed the records of all 94 adults diagnosed with pure SFN (no large fiber involvement) between 1998 and 2017 in Olmsted and adjacent counties in Minnesota – and compared them with 282 adults of similar age and gender who did not have neuropathy.
The incidence of SFN over the entire study period was 1.3 per 100,000 per year and the prevalence was 13.3 per 100,000.
There was a “significant upward trend” in SFN incidence over the study period that could not be attributed to the availability of intraepidermal nerve fiber density testing, the authors reported.
The median age of onset of SFN was 54 years and two-thirds were women (67%).
Diabetes, obesity, and hypertriglyceridemia were significantly more common in patients with SFN compared with matched controls. These metabolic risk factors are also associated with peripheral neuropathy regardless of fiber type.
Autonomic symptoms were common and generally mild, affecting 85% of patients with SFN, and included male erectile dysfunction, constipation, light-headedness and palpitations, urinary symptoms, diarrhea, dry eyes and mouth, sweat abnormalities, and gastroparesis.
Insomnia and use of opioid pain medication were more common in those with SFN than matched controls.
More than one-third (36%) of patients with SFN developed large fiber neuropathy an average of 5.3 years after developing SFN.
During an average follow-up of 6.1 years, adults with SFN were significantly more likely to suffer myocardial infarction (46% vs. 27%; odds ratio, 2.0; 95% CI, 1.8-4.9), congestive heart failure (27% vs. 12%; OR, 2.6; 95% CI, 1.4-4.8), peripheral vascular disease (22% vs. 6%; OR, 4.0; 95% CI, 1.9-8.1), stroke (24% vs. 10%; OR, 2.8; 95% CI, 1.5-5.3), diabetes (51% vs. 22%; OR, 4.6; 95% CI, 2.8-7.6) and rheumatologic disease (30% vs. 7%; OR, 5.3; 95% CI, 2.8-10.4).
For 70% of patients, no cause for SFN could be determined. Diabetes (15%) was the most common cause identified. Other less common causes included Sjögren syndrome, lupus, amyloidosis, and Fabry disease.
“It is important to quantitatively diagnose patients with SFN as many non-neurological musculoskeletal causes can mimic the disorder,” said Dr. Klein.
“If rates of progression are rapid, sinister causes such as out-of-control diabetes, hereditary [transthyretin] TTR amyloidosis, and Fabry disease can be responsible. For other patients, rates of progression are slow and generally do not lead to significant neurologic impairments,” he added.
“However,” he said, “internal medicine follow-up is important for all as this disorder associates with development with higher risk of cardiovascular disease, including commonly heart attacks.”
Of note, although mean age at death was not significantly different in patients with SFN than controls (70 vs. 73 years), there was a significantly higher number of deaths in patients with SFN (n = 18; 19%) than in matched controls (n = 35; 12%) from the time of symptom onset, the researchers reported.
Important research
This “important” study sheds light on the comorbidities and longitudinal consequences of SFN, wrote Brian Callaghan, MD, with the University of Michigan, Ann Arbor, and J. Robinson Singleton, MD, with the University of Utah, Salt Lake City, in an accompanying editorial in Neurology.
The study demonstrates clearly that SFN has “metabolic risk factors similar to those seen for sensory predominant peripheral neuropathies affecting a broader range of fiber types. As a result, therapies that address metabolic risk factors are likely to help prevent or treat both conditions,” they wrote.
Dr. Callaghan and Dr. Singleton added that a key strength of the study is the detailed follow-up that examines SFN progression over time. “The authors found that patients with SFN do not report high disability and that progression tends to be slow. Therefore, patients with SFN can be counseled that progression and disability are likely to be modest in most cases. However, when patients do progress quickly, uncommon etiologies should be sought,” the editorialists wrote.
The study was supported by the Mayo Clinic Foundation, Mayo Clinic Center for Individualized Medicine, and Mayo Clinic Center of MS and Autoimmune Neurology. Dr. Klein has received teaching honorarium from Ackea pharmaceuticals for lectures on hereditary transthyretin amyloidosis and Fabry disease, consulted for Pfizer regarding tafamidis (all compensation for consulting activities is paid directly to Mayo Clinic), and participated in the clinical trials for inotersen and patisiran but received no personal compensation for his participation. Dr. Callaghan consults for DynaMed, performs medical legal consultations, including consultations for the Vaccine Injury Compensation Program, and receives research support from the American Academy of Neurology. Dr. Singleton has consulted for Regenacy.
A version of this article first appeared on Medscape.com.
The exact reason for the increase in isolated SFN “remains unclear,” said Christopher J. Klein, MD, of the Mayo Clinic in Rochester, Minn. However, “we noted during the study period the population has had increased BMI, which appears to be a risk factor for this disorder, with many (50%) developing either glucose impairment or frank diabetes during the study period even if not present at first small fiber neuropathy presentation, also with associated higher triglyceride levels,” he explained.
The study was published online October 27 in Neurology.
Significant upward trend
Investigators reviewed the records of all 94 adults diagnosed with pure SFN (no large fiber involvement) between 1998 and 2017 in Olmsted and adjacent counties in Minnesota – and compared them with 282 adults of similar age and gender who did not have neuropathy.
The incidence of SFN over the entire study period was 1.3 per 100,000 per year and the prevalence was 13.3 per 100,000.
There was a “significant upward trend” in SFN incidence over the study period that could not be attributed to the availability of intraepidermal nerve fiber density testing, the authors reported.
The median age of onset of SFN was 54 years and two-thirds were women (67%).
Diabetes, obesity, and hypertriglyceridemia were significantly more common in patients with SFN compared with matched controls. These metabolic risk factors are also associated with peripheral neuropathy regardless of fiber type.
Autonomic symptoms were common and generally mild, affecting 85% of patients with SFN, and included male erectile dysfunction, constipation, light-headedness and palpitations, urinary symptoms, diarrhea, dry eyes and mouth, sweat abnormalities, and gastroparesis.
Insomnia and use of opioid pain medication were more common in those with SFN than matched controls.
More than one-third (36%) of patients with SFN developed large fiber neuropathy an average of 5.3 years after developing SFN.
During an average follow-up of 6.1 years, adults with SFN were significantly more likely to suffer myocardial infarction (46% vs. 27%; odds ratio, 2.0; 95% CI, 1.8-4.9), congestive heart failure (27% vs. 12%; OR, 2.6; 95% CI, 1.4-4.8), peripheral vascular disease (22% vs. 6%; OR, 4.0; 95% CI, 1.9-8.1), stroke (24% vs. 10%; OR, 2.8; 95% CI, 1.5-5.3), diabetes (51% vs. 22%; OR, 4.6; 95% CI, 2.8-7.6) and rheumatologic disease (30% vs. 7%; OR, 5.3; 95% CI, 2.8-10.4).
For 70% of patients, no cause for SFN could be determined. Diabetes (15%) was the most common cause identified. Other less common causes included Sjögren syndrome, lupus, amyloidosis, and Fabry disease.
“It is important to quantitatively diagnose patients with SFN as many non-neurological musculoskeletal causes can mimic the disorder,” said Dr. Klein.
“If rates of progression are rapid, sinister causes such as out-of-control diabetes, hereditary [transthyretin] TTR amyloidosis, and Fabry disease can be responsible. For other patients, rates of progression are slow and generally do not lead to significant neurologic impairments,” he added.
“However,” he said, “internal medicine follow-up is important for all as this disorder associates with development with higher risk of cardiovascular disease, including commonly heart attacks.”
Of note, although mean age at death was not significantly different in patients with SFN than controls (70 vs. 73 years), there was a significantly higher number of deaths in patients with SFN (n = 18; 19%) than in matched controls (n = 35; 12%) from the time of symptom onset, the researchers reported.
Important research
This “important” study sheds light on the comorbidities and longitudinal consequences of SFN, wrote Brian Callaghan, MD, with the University of Michigan, Ann Arbor, and J. Robinson Singleton, MD, with the University of Utah, Salt Lake City, in an accompanying editorial in Neurology.
The study demonstrates clearly that SFN has “metabolic risk factors similar to those seen for sensory predominant peripheral neuropathies affecting a broader range of fiber types. As a result, therapies that address metabolic risk factors are likely to help prevent or treat both conditions,” they wrote.
Dr. Callaghan and Dr. Singleton added that a key strength of the study is the detailed follow-up that examines SFN progression over time. “The authors found that patients with SFN do not report high disability and that progression tends to be slow. Therefore, patients with SFN can be counseled that progression and disability are likely to be modest in most cases. However, when patients do progress quickly, uncommon etiologies should be sought,” the editorialists wrote.
The study was supported by the Mayo Clinic Foundation, Mayo Clinic Center for Individualized Medicine, and Mayo Clinic Center of MS and Autoimmune Neurology. Dr. Klein has received teaching honorarium from Ackea pharmaceuticals for lectures on hereditary transthyretin amyloidosis and Fabry disease, consulted for Pfizer regarding tafamidis (all compensation for consulting activities is paid directly to Mayo Clinic), and participated in the clinical trials for inotersen and patisiran but received no personal compensation for his participation. Dr. Callaghan consults for DynaMed, performs medical legal consultations, including consultations for the Vaccine Injury Compensation Program, and receives research support from the American Academy of Neurology. Dr. Singleton has consulted for Regenacy.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
Success of HPV vaccination: ‘Dramatic’ reduction in cervical cancer
Among young women who received the HPV vaccine when they were 12-13 years old (before their sexual debut), cervical cancer rates are 87% lower than among previous nonvaccinated generations.
“It’s been incredible to see the impact of HPV vaccination, and now we can prove it prevented hundreds of women from developing cancer in England,” senior author Peter Sasieni, MD, King’s College London, said in a statement. “To see the real-life impact of the vaccine has been truly rewarding.”
“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” Kate Soldan, MD, U.K. Health Security Agency, London, commented in a statement.
Vanessa Saliba, MD, a consultant epidemiologist for the U.K. Health Security Agency, agreed, saying that “these remarkable findings confirm that the HPV vaccine saves lives by dramatically reducing cervical cancer rates among women.
“This reminds us that vaccines are one of the most important tools we have to help us live longer, healthier lives,” she added.
The study was published online Nov. 3, 2021, in The Lancet.
Approached for comment on the new study, Maurice Markman, MD, president, Medicine and Science Cancer Treatment Centers of America, noted that the results of the English study are very similar to those of a Swedish study of the quadrivalent vaccine alone.
“You can put any superlatives you want in here, but these are stunningly positive results,” Dr. Markman said in an interview. He said that, as an oncologist who has been treating cervical cancer for 40 years, particularly patients with advanced cervical cancer, “I can tell you this is one of the most devastating diseases to women, and the ability to eliminate this cancer with something as simple as a vaccine is the goal of cancer therapy, and it’s been remarkably successful.
“I can only emphasize the critical importance of all parents to see that their children who are eligible for the vaccine receive it. This is a cancer prevention strategy that is unbelievably, remarkably effective and safe,” Dr. Markman added.
National vaccination program
The national HPV vaccination program in England began in 2008. Initially, the bivalent Cervarix vaccine against HPV 16 and 18 was used. HPV 16 and 18 are responsible for 70% to 80% of all cervical cancers in England, the researchers note in their article.
In 2012, the program switched to the quadrivalent HPV vaccine (Gardasil), which is effective against two additional HPV types, HPV 6 and 11. Those strains cause genital warts.
The prevention program originally recommended a three-dose regimen in which both HPV vaccines were used. Currently, two doses are given to girls younger than 15 years. In addition, a single dose of the HPV vaccine provides good protection against persistent infection. The efficacy rate of a single dose is similar to that of three doses, the authors comment.
Population-based registry
The new data come from a population-based cancer registry that shows the incidence of cervical cancer and noninvasive cervical carcinoma (CIN3) in England between January 2006 and June 2019.
The study included seven cohorts of women who were aged 20-64 years at the end of 2019. Three of these cohorts composed the vaccinated population.
The team reports that overall, from January 2006 to June 2019, there were 27,946 cases of cervical cancer and 318,058 cases of CIN3.
In the three vaccinated cohorts, there were around 450 fewer cases of cervical cancer and 17,200 fewer cases of CIN3 than would be expected in a nonvaccinated population.
The three vaccinated cohorts had been eligible to receive Cervarix when they were aged 12-13 years. A catch-up scheme aimed at 14- to 16-year-olds and 16- to 18-year-olds. Most of these persons were vaccinated through a school vaccination program.
The team analyzed the data for each of these cohorts.
Among the cohort eligible for vaccination at 12-13 years of age, 89% received at least one dose of the HPV vaccine; 85% received three shots and were fully vaccinated. Among these persons, the rate of cervical cancer was 87% lower than expected in a nonvaccinated population, and the rate of CIN3 was 97% lower than expected.
For the cohort that was eligible to be vaccinated between the ages of 14 and 16 years, the corresponding reductions were 62% for cervical cancer and 75% for CIN3.
For the cohort eligible for vaccination between the ages of 16 and 18 years (of whom 60% had received at least one dose and 45% were fully vaccinated), the corresponding reduction were 34% for cervical cancer and 39% for CIN3.
The authors acknowledge some limitations with the study, principally that cervical cancer is rare in young women, and these vaccinated populations are still young. The youngest would have been vaccinated at age 12 in 2008 and so would be only 23 years old in 2019, when the follow-up in this current study ended. The authors emphasize that because the vaccinated populations are still young, it is too early to assess the full impact of HPV vaccination on cervical cancer rates.
Editorial commentary
“The relative reductions in cervical cancer, expected as a result of the HPV vaccination program, support the anticipated vaccine effectiveness,” commented two authors of an accompanying editorial, Maggie Cruickshank, MD, University of Aberdeen (Scotland), and Mihaela Grigore, MD, University of Medicine and Pharmacy, Lasi, Romania.
“The scale of the HPV vaccination effect reported by this study should also stimulate vaccination programs in low-income and middle-income countries where the problem of cervical cancer is a far greater public health issue than in those with well established systems of vaccination and screening,” they comment.
“The most important issue, besides the availability of the vaccine ... is the education of the population to accept the vaccination because a high rate of immunization is a key element of success,” they emphasize. “Even in a wealthy country, such as England with free access to HPV immunization, uptake has not reached the 90% vaccination target of girls aged 15 years set by WHO [World Health Organization].”
The authors and editorialists disclosed no relevant financial relationships. Dr. Markman is a regular contributor to Medscape Oncology. He has received income of $250 or more from Genentech, AstraZeneca, Celgene, Clovis, and Amgen.
A version of this article first appeared on Medscape.com.
Among young women who received the HPV vaccine when they were 12-13 years old (before their sexual debut), cervical cancer rates are 87% lower than among previous nonvaccinated generations.
“It’s been incredible to see the impact of HPV vaccination, and now we can prove it prevented hundreds of women from developing cancer in England,” senior author Peter Sasieni, MD, King’s College London, said in a statement. “To see the real-life impact of the vaccine has been truly rewarding.”
“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” Kate Soldan, MD, U.K. Health Security Agency, London, commented in a statement.
Vanessa Saliba, MD, a consultant epidemiologist for the U.K. Health Security Agency, agreed, saying that “these remarkable findings confirm that the HPV vaccine saves lives by dramatically reducing cervical cancer rates among women.
“This reminds us that vaccines are one of the most important tools we have to help us live longer, healthier lives,” she added.
The study was published online Nov. 3, 2021, in The Lancet.
Approached for comment on the new study, Maurice Markman, MD, president, Medicine and Science Cancer Treatment Centers of America, noted that the results of the English study are very similar to those of a Swedish study of the quadrivalent vaccine alone.
“You can put any superlatives you want in here, but these are stunningly positive results,” Dr. Markman said in an interview. He said that, as an oncologist who has been treating cervical cancer for 40 years, particularly patients with advanced cervical cancer, “I can tell you this is one of the most devastating diseases to women, and the ability to eliminate this cancer with something as simple as a vaccine is the goal of cancer therapy, and it’s been remarkably successful.
“I can only emphasize the critical importance of all parents to see that their children who are eligible for the vaccine receive it. This is a cancer prevention strategy that is unbelievably, remarkably effective and safe,” Dr. Markman added.
National vaccination program
The national HPV vaccination program in England began in 2008. Initially, the bivalent Cervarix vaccine against HPV 16 and 18 was used. HPV 16 and 18 are responsible for 70% to 80% of all cervical cancers in England, the researchers note in their article.
In 2012, the program switched to the quadrivalent HPV vaccine (Gardasil), which is effective against two additional HPV types, HPV 6 and 11. Those strains cause genital warts.
The prevention program originally recommended a three-dose regimen in which both HPV vaccines were used. Currently, two doses are given to girls younger than 15 years. In addition, a single dose of the HPV vaccine provides good protection against persistent infection. The efficacy rate of a single dose is similar to that of three doses, the authors comment.
Population-based registry
The new data come from a population-based cancer registry that shows the incidence of cervical cancer and noninvasive cervical carcinoma (CIN3) in England between January 2006 and June 2019.
The study included seven cohorts of women who were aged 20-64 years at the end of 2019. Three of these cohorts composed the vaccinated population.
The team reports that overall, from January 2006 to June 2019, there were 27,946 cases of cervical cancer and 318,058 cases of CIN3.
In the three vaccinated cohorts, there were around 450 fewer cases of cervical cancer and 17,200 fewer cases of CIN3 than would be expected in a nonvaccinated population.
The three vaccinated cohorts had been eligible to receive Cervarix when they were aged 12-13 years. A catch-up scheme aimed at 14- to 16-year-olds and 16- to 18-year-olds. Most of these persons were vaccinated through a school vaccination program.
The team analyzed the data for each of these cohorts.
Among the cohort eligible for vaccination at 12-13 years of age, 89% received at least one dose of the HPV vaccine; 85% received three shots and were fully vaccinated. Among these persons, the rate of cervical cancer was 87% lower than expected in a nonvaccinated population, and the rate of CIN3 was 97% lower than expected.
For the cohort that was eligible to be vaccinated between the ages of 14 and 16 years, the corresponding reductions were 62% for cervical cancer and 75% for CIN3.
For the cohort eligible for vaccination between the ages of 16 and 18 years (of whom 60% had received at least one dose and 45% were fully vaccinated), the corresponding reduction were 34% for cervical cancer and 39% for CIN3.
The authors acknowledge some limitations with the study, principally that cervical cancer is rare in young women, and these vaccinated populations are still young. The youngest would have been vaccinated at age 12 in 2008 and so would be only 23 years old in 2019, when the follow-up in this current study ended. The authors emphasize that because the vaccinated populations are still young, it is too early to assess the full impact of HPV vaccination on cervical cancer rates.
Editorial commentary
“The relative reductions in cervical cancer, expected as a result of the HPV vaccination program, support the anticipated vaccine effectiveness,” commented two authors of an accompanying editorial, Maggie Cruickshank, MD, University of Aberdeen (Scotland), and Mihaela Grigore, MD, University of Medicine and Pharmacy, Lasi, Romania.
“The scale of the HPV vaccination effect reported by this study should also stimulate vaccination programs in low-income and middle-income countries where the problem of cervical cancer is a far greater public health issue than in those with well established systems of vaccination and screening,” they comment.
“The most important issue, besides the availability of the vaccine ... is the education of the population to accept the vaccination because a high rate of immunization is a key element of success,” they emphasize. “Even in a wealthy country, such as England with free access to HPV immunization, uptake has not reached the 90% vaccination target of girls aged 15 years set by WHO [World Health Organization].”
The authors and editorialists disclosed no relevant financial relationships. Dr. Markman is a regular contributor to Medscape Oncology. He has received income of $250 or more from Genentech, AstraZeneca, Celgene, Clovis, and Amgen.
A version of this article first appeared on Medscape.com.
Among young women who received the HPV vaccine when they were 12-13 years old (before their sexual debut), cervical cancer rates are 87% lower than among previous nonvaccinated generations.
“It’s been incredible to see the impact of HPV vaccination, and now we can prove it prevented hundreds of women from developing cancer in England,” senior author Peter Sasieni, MD, King’s College London, said in a statement. “To see the real-life impact of the vaccine has been truly rewarding.”
“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” Kate Soldan, MD, U.K. Health Security Agency, London, commented in a statement.
Vanessa Saliba, MD, a consultant epidemiologist for the U.K. Health Security Agency, agreed, saying that “these remarkable findings confirm that the HPV vaccine saves lives by dramatically reducing cervical cancer rates among women.
“This reminds us that vaccines are one of the most important tools we have to help us live longer, healthier lives,” she added.
The study was published online Nov. 3, 2021, in The Lancet.
Approached for comment on the new study, Maurice Markman, MD, president, Medicine and Science Cancer Treatment Centers of America, noted that the results of the English study are very similar to those of a Swedish study of the quadrivalent vaccine alone.
“You can put any superlatives you want in here, but these are stunningly positive results,” Dr. Markman said in an interview. He said that, as an oncologist who has been treating cervical cancer for 40 years, particularly patients with advanced cervical cancer, “I can tell you this is one of the most devastating diseases to women, and the ability to eliminate this cancer with something as simple as a vaccine is the goal of cancer therapy, and it’s been remarkably successful.
“I can only emphasize the critical importance of all parents to see that their children who are eligible for the vaccine receive it. This is a cancer prevention strategy that is unbelievably, remarkably effective and safe,” Dr. Markman added.
National vaccination program
The national HPV vaccination program in England began in 2008. Initially, the bivalent Cervarix vaccine against HPV 16 and 18 was used. HPV 16 and 18 are responsible for 70% to 80% of all cervical cancers in England, the researchers note in their article.
In 2012, the program switched to the quadrivalent HPV vaccine (Gardasil), which is effective against two additional HPV types, HPV 6 and 11. Those strains cause genital warts.
The prevention program originally recommended a three-dose regimen in which both HPV vaccines were used. Currently, two doses are given to girls younger than 15 years. In addition, a single dose of the HPV vaccine provides good protection against persistent infection. The efficacy rate of a single dose is similar to that of three doses, the authors comment.
Population-based registry
The new data come from a population-based cancer registry that shows the incidence of cervical cancer and noninvasive cervical carcinoma (CIN3) in England between January 2006 and June 2019.
The study included seven cohorts of women who were aged 20-64 years at the end of 2019. Three of these cohorts composed the vaccinated population.
The team reports that overall, from January 2006 to June 2019, there were 27,946 cases of cervical cancer and 318,058 cases of CIN3.
In the three vaccinated cohorts, there were around 450 fewer cases of cervical cancer and 17,200 fewer cases of CIN3 than would be expected in a nonvaccinated population.
The three vaccinated cohorts had been eligible to receive Cervarix when they were aged 12-13 years. A catch-up scheme aimed at 14- to 16-year-olds and 16- to 18-year-olds. Most of these persons were vaccinated through a school vaccination program.
The team analyzed the data for each of these cohorts.
Among the cohort eligible for vaccination at 12-13 years of age, 89% received at least one dose of the HPV vaccine; 85% received three shots and were fully vaccinated. Among these persons, the rate of cervical cancer was 87% lower than expected in a nonvaccinated population, and the rate of CIN3 was 97% lower than expected.
For the cohort that was eligible to be vaccinated between the ages of 14 and 16 years, the corresponding reductions were 62% for cervical cancer and 75% for CIN3.
For the cohort eligible for vaccination between the ages of 16 and 18 years (of whom 60% had received at least one dose and 45% were fully vaccinated), the corresponding reduction were 34% for cervical cancer and 39% for CIN3.
The authors acknowledge some limitations with the study, principally that cervical cancer is rare in young women, and these vaccinated populations are still young. The youngest would have been vaccinated at age 12 in 2008 and so would be only 23 years old in 2019, when the follow-up in this current study ended. The authors emphasize that because the vaccinated populations are still young, it is too early to assess the full impact of HPV vaccination on cervical cancer rates.
Editorial commentary
“The relative reductions in cervical cancer, expected as a result of the HPV vaccination program, support the anticipated vaccine effectiveness,” commented two authors of an accompanying editorial, Maggie Cruickshank, MD, University of Aberdeen (Scotland), and Mihaela Grigore, MD, University of Medicine and Pharmacy, Lasi, Romania.
“The scale of the HPV vaccination effect reported by this study should also stimulate vaccination programs in low-income and middle-income countries where the problem of cervical cancer is a far greater public health issue than in those with well established systems of vaccination and screening,” they comment.
“The most important issue, besides the availability of the vaccine ... is the education of the population to accept the vaccination because a high rate of immunization is a key element of success,” they emphasize. “Even in a wealthy country, such as England with free access to HPV immunization, uptake has not reached the 90% vaccination target of girls aged 15 years set by WHO [World Health Organization].”
The authors and editorialists disclosed no relevant financial relationships. Dr. Markman is a regular contributor to Medscape Oncology. He has received income of $250 or more from Genentech, AstraZeneca, Celgene, Clovis, and Amgen.
A version of this article first appeared on Medscape.com.
Q&A: Meeting the challenge of giving COVID vaccines to younger kids
This news organization spoke to several pediatric experts to get answers.
More than 6 million children and adolescents (up to age 18 years) in the United States have been infected with SARS-CoV-2. Children represent about 17% of all cases, and an estimated 0.1%-2% of infected children end up hospitalized, according to Oct. 28 data from the American Academy of Pediatrics.
Physicians and other health care practitioners are gearing up for what could be an influx of patients. “Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible,” Lee Savio Beers, MD, FAAP, president of the AAP, said in a statement.
In this Q&A, this news organization asked for additional advice from Sara “Sally” Goza, MD, a pediatrician in Fayetteville, Georgia, and immediate past president of the AAP; Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, both in Houston; and Danielle M. Zerr, MD, professor and chief of the division of pediatric infectious disease at the University of Washington, Seattle, and medical director of infection prevention at Seattle Children’s Hospital.
Q: How are smaller pediatric practices and solo practitioners going to handle the additional vaccinations?
Dr. Goza: It’s a scheduling challenge with this rollout and all the people who want it and want it right now. They’re going to want it this week.
I’ve actually had some children asking their moms: “When can I get it? When can I get it?” It’s been very interesting – they are chomping at the bit.
If I give the vaccine to a patient this week, in 3 weeks the second dose will be right around Thanksgiving. No one in my office is going to want to be here to give the shot on Thanksgiving, and no patient is going to want to come in on Thanksgiving weekend. So I’m trying to delay those parents – saying, let’s do it next week. That way we’re not messing up a holiday.
Children are going to need two doses, and they won’t be fully protected until 2 weeks after their second dose. So they won’t get full protection for Thanksgiving, but they will have full protection for Christmas.
I know there are a lot of pediatricians who have preordered the vaccine. I know in our office they sent us an email ... to let us know our vaccines are being shipped. So I think a lot of pediatricians are going to have the vaccine.
Q: How should pediatricians counsel parents who are fearful or hesitant?
Dr. Hotez: It’s important to emphasize the severity of the 2021 summer Delta epidemic in children. We need to get beyond this false narrative that COVID only produces a mild disease in children. It’s caused thousands of pediatric hospitalizations, not to mention long COVID.
Dr. Zerr: It is key to find out what concerns parents have and then focus on answering their specific questions. It is helpful to emphasize the safety and efficacy of the vaccine and to explain the rigorous processes that the vaccine went through to receive Food and Drug Administration approval.
Q: How should pediatricians counter any misinformation/disinformation out there about the COVID-19 vaccines?
Dr. Goza: The most important thing is not to discount what they are saying. Don’t say: “That’s crazy” or “That’s not true.” Don’t roll your eyes and say: “Really, you’re going to believe all that?”
Instead, have a conversation with them about why we think that is not true, or why we know that’s not true. We really have to have that relationship and ask: “Well, what are your concerns?” And then really counter (any misinformation) with facts, with science, and based on your experience.
Q: Do the data presented to the FDA and the CDC about the safety and effectiveness of the COVID-19 vaccine for 5- to 11-year-olds seem robust to you?
Dr. Zerr: Yes, and data collection will be ongoing.
Dr. Hotez: I’ve only seen what’s publicly available so far, and it seems to support moving forward with emergency use authorization. The only shortfall is the size, roughly 2,200 children, which would not be of sufficient size to detect a rare safety signal.
Q: Do previous controversies around pediatric vaccines (for example, the MMR vaccine and autism) give pediatricians some background and experience so they can address any pushback on the COVID-19 vaccines?
Dr. Goza: Pediatricians have been dealing with vaccine hesitancy for a while now, ever since the MMR and autism controversy started. Even before then, there were certain groups of people who didn’t want vaccines.
We’ve really worked hard at helping teach pediatricians how to deal with the misinformation, how to counter it, and how to help parents understand the vaccines are safe and effective – and that they save lives.
That (experience) will help us in some ways. Unfortunately, there is more misinformation out there – there is almost a concerted effort on misinformation. It’s big.
Pediatricians will do everything we can, but we need help countering it. We need the misinformation to quit getting spread on social media. We can talk one on one with patients and families, but if all they are hearing on social media is the misinformation, it’s really hard.
Q: Are pediatricians, especially solo practitioners or pediatricians at smaller practices, going to face challenges with multidose vials and not wasting vaccine product?
Dr. Goza: I’m at a small practice. We have 3.5 FTEs (full-time equivalents) of MDs and three FTEs of nurse practitioners. So we’re not that big – about six providers.
You know, it is a challenge. We’re not going to buy the super-duper freezer, and we’re not going to be able to store these vaccines for a long period of time.
So when we order, we need smaller amounts. For the 12- to 18-year-olds, [maximum storage] was 45 days. Now for the 5- to 11-year-olds, we’re going to be able to store the vaccine in the refrigerator for 10 weeks, which gives us more leeway there.
We try to do all of vaccinations on 1 day, so we know how many people are coming in, and we are not going to waste too many doses.
Our Department of Public Health in Georgia has said: “We want these vaccines in the arms of kids, and if you have to waste some doses, don’t worry about it.” But it’s a 10-dose vial. It’s going to be hard for me to open it up for one child. I just don’t like wasting anything like this.
Our main goal is to get this vaccine in to the arms of children whose parents want it.
Q: What are some additional sources of information for pediatricians?
Dr. Zerr: There are a lot of great resources on vaccine hesitancy from reputable sources, including these from the CDC and from the National Academies of Sciences, Engineering, and Medicine:
- Building Confidence With OVID-19 Vaccines
- How to Talk With Parents About COVID-19 Vaccination
- Strategies for Building Confidence in the COVID-19 Vaccines
- Communication Strategies for Building Confidence in COVID-19 Vaccines: Addressing Variants and Childhood Vaccinations
A version of this article first appeared on Medscape.com.
This news organization spoke to several pediatric experts to get answers.
More than 6 million children and adolescents (up to age 18 years) in the United States have been infected with SARS-CoV-2. Children represent about 17% of all cases, and an estimated 0.1%-2% of infected children end up hospitalized, according to Oct. 28 data from the American Academy of Pediatrics.
Physicians and other health care practitioners are gearing up for what could be an influx of patients. “Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible,” Lee Savio Beers, MD, FAAP, president of the AAP, said in a statement.
In this Q&A, this news organization asked for additional advice from Sara “Sally” Goza, MD, a pediatrician in Fayetteville, Georgia, and immediate past president of the AAP; Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, both in Houston; and Danielle M. Zerr, MD, professor and chief of the division of pediatric infectious disease at the University of Washington, Seattle, and medical director of infection prevention at Seattle Children’s Hospital.
Q: How are smaller pediatric practices and solo practitioners going to handle the additional vaccinations?
Dr. Goza: It’s a scheduling challenge with this rollout and all the people who want it and want it right now. They’re going to want it this week.
I’ve actually had some children asking their moms: “When can I get it? When can I get it?” It’s been very interesting – they are chomping at the bit.
If I give the vaccine to a patient this week, in 3 weeks the second dose will be right around Thanksgiving. No one in my office is going to want to be here to give the shot on Thanksgiving, and no patient is going to want to come in on Thanksgiving weekend. So I’m trying to delay those parents – saying, let’s do it next week. That way we’re not messing up a holiday.
Children are going to need two doses, and they won’t be fully protected until 2 weeks after their second dose. So they won’t get full protection for Thanksgiving, but they will have full protection for Christmas.
I know there are a lot of pediatricians who have preordered the vaccine. I know in our office they sent us an email ... to let us know our vaccines are being shipped. So I think a lot of pediatricians are going to have the vaccine.
Q: How should pediatricians counsel parents who are fearful or hesitant?
Dr. Hotez: It’s important to emphasize the severity of the 2021 summer Delta epidemic in children. We need to get beyond this false narrative that COVID only produces a mild disease in children. It’s caused thousands of pediatric hospitalizations, not to mention long COVID.
Dr. Zerr: It is key to find out what concerns parents have and then focus on answering their specific questions. It is helpful to emphasize the safety and efficacy of the vaccine and to explain the rigorous processes that the vaccine went through to receive Food and Drug Administration approval.
Q: How should pediatricians counter any misinformation/disinformation out there about the COVID-19 vaccines?
Dr. Goza: The most important thing is not to discount what they are saying. Don’t say: “That’s crazy” or “That’s not true.” Don’t roll your eyes and say: “Really, you’re going to believe all that?”
Instead, have a conversation with them about why we think that is not true, or why we know that’s not true. We really have to have that relationship and ask: “Well, what are your concerns?” And then really counter (any misinformation) with facts, with science, and based on your experience.
Q: Do the data presented to the FDA and the CDC about the safety and effectiveness of the COVID-19 vaccine for 5- to 11-year-olds seem robust to you?
Dr. Zerr: Yes, and data collection will be ongoing.
Dr. Hotez: I’ve only seen what’s publicly available so far, and it seems to support moving forward with emergency use authorization. The only shortfall is the size, roughly 2,200 children, which would not be of sufficient size to detect a rare safety signal.
Q: Do previous controversies around pediatric vaccines (for example, the MMR vaccine and autism) give pediatricians some background and experience so they can address any pushback on the COVID-19 vaccines?
Dr. Goza: Pediatricians have been dealing with vaccine hesitancy for a while now, ever since the MMR and autism controversy started. Even before then, there were certain groups of people who didn’t want vaccines.
We’ve really worked hard at helping teach pediatricians how to deal with the misinformation, how to counter it, and how to help parents understand the vaccines are safe and effective – and that they save lives.
That (experience) will help us in some ways. Unfortunately, there is more misinformation out there – there is almost a concerted effort on misinformation. It’s big.
Pediatricians will do everything we can, but we need help countering it. We need the misinformation to quit getting spread on social media. We can talk one on one with patients and families, but if all they are hearing on social media is the misinformation, it’s really hard.
Q: Are pediatricians, especially solo practitioners or pediatricians at smaller practices, going to face challenges with multidose vials and not wasting vaccine product?
Dr. Goza: I’m at a small practice. We have 3.5 FTEs (full-time equivalents) of MDs and three FTEs of nurse practitioners. So we’re not that big – about six providers.
You know, it is a challenge. We’re not going to buy the super-duper freezer, and we’re not going to be able to store these vaccines for a long period of time.
So when we order, we need smaller amounts. For the 12- to 18-year-olds, [maximum storage] was 45 days. Now for the 5- to 11-year-olds, we’re going to be able to store the vaccine in the refrigerator for 10 weeks, which gives us more leeway there.
We try to do all of vaccinations on 1 day, so we know how many people are coming in, and we are not going to waste too many doses.
Our Department of Public Health in Georgia has said: “We want these vaccines in the arms of kids, and if you have to waste some doses, don’t worry about it.” But it’s a 10-dose vial. It’s going to be hard for me to open it up for one child. I just don’t like wasting anything like this.
Our main goal is to get this vaccine in to the arms of children whose parents want it.
Q: What are some additional sources of information for pediatricians?
Dr. Zerr: There are a lot of great resources on vaccine hesitancy from reputable sources, including these from the CDC and from the National Academies of Sciences, Engineering, and Medicine:
- Building Confidence With OVID-19 Vaccines
- How to Talk With Parents About COVID-19 Vaccination
- Strategies for Building Confidence in the COVID-19 Vaccines
- Communication Strategies for Building Confidence in COVID-19 Vaccines: Addressing Variants and Childhood Vaccinations
A version of this article first appeared on Medscape.com.
This news organization spoke to several pediatric experts to get answers.
More than 6 million children and adolescents (up to age 18 years) in the United States have been infected with SARS-CoV-2. Children represent about 17% of all cases, and an estimated 0.1%-2% of infected children end up hospitalized, according to Oct. 28 data from the American Academy of Pediatrics.
Physicians and other health care practitioners are gearing up for what could be an influx of patients. “Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible,” Lee Savio Beers, MD, FAAP, president of the AAP, said in a statement.
In this Q&A, this news organization asked for additional advice from Sara “Sally” Goza, MD, a pediatrician in Fayetteville, Georgia, and immediate past president of the AAP; Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, both in Houston; and Danielle M. Zerr, MD, professor and chief of the division of pediatric infectious disease at the University of Washington, Seattle, and medical director of infection prevention at Seattle Children’s Hospital.
Q: How are smaller pediatric practices and solo practitioners going to handle the additional vaccinations?
Dr. Goza: It’s a scheduling challenge with this rollout and all the people who want it and want it right now. They’re going to want it this week.
I’ve actually had some children asking their moms: “When can I get it? When can I get it?” It’s been very interesting – they are chomping at the bit.
If I give the vaccine to a patient this week, in 3 weeks the second dose will be right around Thanksgiving. No one in my office is going to want to be here to give the shot on Thanksgiving, and no patient is going to want to come in on Thanksgiving weekend. So I’m trying to delay those parents – saying, let’s do it next week. That way we’re not messing up a holiday.
Children are going to need two doses, and they won’t be fully protected until 2 weeks after their second dose. So they won’t get full protection for Thanksgiving, but they will have full protection for Christmas.
I know there are a lot of pediatricians who have preordered the vaccine. I know in our office they sent us an email ... to let us know our vaccines are being shipped. So I think a lot of pediatricians are going to have the vaccine.
Q: How should pediatricians counsel parents who are fearful or hesitant?
Dr. Hotez: It’s important to emphasize the severity of the 2021 summer Delta epidemic in children. We need to get beyond this false narrative that COVID only produces a mild disease in children. It’s caused thousands of pediatric hospitalizations, not to mention long COVID.
Dr. Zerr: It is key to find out what concerns parents have and then focus on answering their specific questions. It is helpful to emphasize the safety and efficacy of the vaccine and to explain the rigorous processes that the vaccine went through to receive Food and Drug Administration approval.
Q: How should pediatricians counter any misinformation/disinformation out there about the COVID-19 vaccines?
Dr. Goza: The most important thing is not to discount what they are saying. Don’t say: “That’s crazy” or “That’s not true.” Don’t roll your eyes and say: “Really, you’re going to believe all that?”
Instead, have a conversation with them about why we think that is not true, or why we know that’s not true. We really have to have that relationship and ask: “Well, what are your concerns?” And then really counter (any misinformation) with facts, with science, and based on your experience.
Q: Do the data presented to the FDA and the CDC about the safety and effectiveness of the COVID-19 vaccine for 5- to 11-year-olds seem robust to you?
Dr. Zerr: Yes, and data collection will be ongoing.
Dr. Hotez: I’ve only seen what’s publicly available so far, and it seems to support moving forward with emergency use authorization. The only shortfall is the size, roughly 2,200 children, which would not be of sufficient size to detect a rare safety signal.
Q: Do previous controversies around pediatric vaccines (for example, the MMR vaccine and autism) give pediatricians some background and experience so they can address any pushback on the COVID-19 vaccines?
Dr. Goza: Pediatricians have been dealing with vaccine hesitancy for a while now, ever since the MMR and autism controversy started. Even before then, there were certain groups of people who didn’t want vaccines.
We’ve really worked hard at helping teach pediatricians how to deal with the misinformation, how to counter it, and how to help parents understand the vaccines are safe and effective – and that they save lives.
That (experience) will help us in some ways. Unfortunately, there is more misinformation out there – there is almost a concerted effort on misinformation. It’s big.
Pediatricians will do everything we can, but we need help countering it. We need the misinformation to quit getting spread on social media. We can talk one on one with patients and families, but if all they are hearing on social media is the misinformation, it’s really hard.
Q: Are pediatricians, especially solo practitioners or pediatricians at smaller practices, going to face challenges with multidose vials and not wasting vaccine product?
Dr. Goza: I’m at a small practice. We have 3.5 FTEs (full-time equivalents) of MDs and three FTEs of nurse practitioners. So we’re not that big – about six providers.
You know, it is a challenge. We’re not going to buy the super-duper freezer, and we’re not going to be able to store these vaccines for a long period of time.
So when we order, we need smaller amounts. For the 12- to 18-year-olds, [maximum storage] was 45 days. Now for the 5- to 11-year-olds, we’re going to be able to store the vaccine in the refrigerator for 10 weeks, which gives us more leeway there.
We try to do all of vaccinations on 1 day, so we know how many people are coming in, and we are not going to waste too many doses.
Our Department of Public Health in Georgia has said: “We want these vaccines in the arms of kids, and if you have to waste some doses, don’t worry about it.” But it’s a 10-dose vial. It’s going to be hard for me to open it up for one child. I just don’t like wasting anything like this.
Our main goal is to get this vaccine in to the arms of children whose parents want it.
Q: What are some additional sources of information for pediatricians?
Dr. Zerr: There are a lot of great resources on vaccine hesitancy from reputable sources, including these from the CDC and from the National Academies of Sciences, Engineering, and Medicine:
- Building Confidence With OVID-19 Vaccines
- How to Talk With Parents About COVID-19 Vaccination
- Strategies for Building Confidence in the COVID-19 Vaccines
- Communication Strategies for Building Confidence in COVID-19 Vaccines: Addressing Variants and Childhood Vaccinations
A version of this article first appeared on Medscape.com.
Influenza tied to long-term increased risk for Parkinson’s disease
Influenza infection is linked to a subsequent diagnosis of Parkinson’s disease (PD) more than 10 years later, resurfacing a long-held debate about whether infection increases the risk for movement disorders over the long term.
In a large case-control study, investigators found and by more than 70% for PD occurring more than 10 years after the flu.
“This study is not definitive by any means, but it certainly suggests there are potential long-term consequences from influenza,” study investigator Noelle M. Cocoros, DSc, research scientist at Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, said in an interview.
The study was published online Oct. 25 in JAMA Neurology.
Ongoing debate
The debate about whether influenza is associated with PD has been going on as far back as the 1918 influenza pandemic, when experts documented parkinsonism in affected individuals.
Using data from the Danish patient registry, researchers identified 10,271 subjects diagnosed with PD during a 17-year period (2000-2016). Of these, 38.7% were female, and the mean age was 71.4 years.
They matched these subjects for age and sex to 51,355 controls without PD. Compared with controls, slightly fewer individuals with PD had chronic obstructive pulmonary disease (COPD) or emphysema, but there was a similar distribution of cardiovascular disease and various other conditions.
Researchers collected data on influenza diagnoses from inpatient and outpatient hospital clinics from 1977 to 2016. They plotted these by month and year on a graph, calculated the median number of diagnoses per month, and identified peaks as those with more than threefold the median.
They categorized cases in groups related to the time between the infection and PD: More than 10 years, 10-15 years, and more than 15 years.
The time lapse accounts for a rather long “run-up” to PD, said Dr. Cocoros. There’s a sometimes decades-long preclinical phase before patients develop typical motor signs and a prodromal phase where they may present with nonmotor symptoms such as sleep disorders and constipation.
“We expected there would be at least 10 years between any infection and PD if there was an association present,” said Dr. Cocoros.
Investigators found an association between influenza exposure and PD diagnosis “that held up over time,” she said.
For more than 10 years before PD, the likelihood of a diagnosis for the infected compared with the unexposed was increased 73% (odds ratio [OR] 1.73; 95% confidence interval, 1.11-2.71; P = .02) after adjustment for cardiovascular disease, diabetes, chronic obstructive pulmonary disease, emphysema, lung cancer, Crohn’s disease, and ulcerative colitis.
The odds increased with more time from infection. For more than 15 years, the adjusted OR was 1.91 (95% CI, 1.14 - 3.19; P =.01).
However, for the 10- to 15-year time frame, the point estimate was reduced and the CI nonsignificant (OR, 1.33; 95% CI, 0.54-3.27; P = .53). This “is a little hard to interpret,” but could be a result of the small numbers, exposure misclassification, or because “the longer time interval is what’s meaningful,” said Dr. Cocoros.
Potential COVID-19–related PD surge?
In a sensitivity analysis, researchers looked at peak infection activity. “We wanted to increase the likelihood of these diagnoses representing actual infection,” Dr. Cocoros noted.
Here, the OR was still elevated at more than 10 years, but the CI was quite wide and included 1 (OR, 1.52; 95% CI, 0.80-2.89; P = .21). “So the association holds up, but the estimates are quite unstable,” said Dr. Cocoros.
Researchers examined associations with numerous other infection types, but did not see the same trend over time. Some infections – for example, gastrointestinal infections and septicemia – were associated with PD within 5 years, but most associations appeared to be null after more than 10 years.
“There seemed to be associations earlier between the infection and PD, which we interpret to suggest there’s actually not a meaningful association,” said Dr. Cocoros.
An exception might be urinary tract infections (UTIs), where after 10 years, the adjusted OR was 1.19 (95% CI, 1.01-1.40). Research suggests patients with PD often have UTIs and neurogenic bladder.
“It’s possible that UTIs could be an early symptom of PD rather than a causative factor,” said Dr. Cocoros.
It’s unclear how influenza might lead to PD but it could be that the virus gets into the central nervous system, resulting in neuroinflammation. Cytokines generated in response to the influenza infection might damage the brain.
“The infection could be a ‘primer’ or an initial ‘hit’ to the system, maybe setting people up for PD,” said Dr. Cocoros.
As for the current COVID-19 pandemic, some experts are concerned about a potential surge in PD cases in decades to come, and are calling for prospective monitoring of patients with this infection, said Dr. Cocoros.
However, she noted that infections don’t account for all PD cases and that genetic and environmental factors also influence risk.
Many individuals who contract influenza don’t seek medical care or get tested, so it’s possible the study counted those who had the infection as unexposed. Another potential study limitation was that small numbers for some infections, for example, Helicobacter pylori and hepatitis C, limited the ability to interpret results.
‘Exciting and important’ findings
Commenting on the research for this news organization, Aparna Wagle Shukla, MD, professor, Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, said the results amid the current pandemic are “exciting and important” and “have reinvigorated interest” in the role of infection in PD.
However, the study had some limitations, an important one being lack of accounting for confounding factors, including environmental factors, she said. Exposure to pesticides, living in a rural area, drinking well water, and having had a head injury may increase PD risk, whereas high intake of caffeine, nicotine, alcohol, and nonsteroidal anti-inflammatory drugs might lower the risk.
The researchers did not take into account exposure to multiple microbes or “infection burden,” said Dr. Wagle Shukla, who was not involved in the current study. In addition, as the data are from a single country with exposure to specific influenza strains, application of the findings elsewhere may be limited.
Dr. Wagle Shukla noted that a case-control design “isn’t ideal” from an epidemiological perspective. “Future studies should involve large cohorts followed longitudinally.”
The study was supported by grants from the Lundbeck Foundation and the Augustinus Foundation. Dr. Cocoros has disclosed no relevant financial relationships. Several coauthors have disclosed relationships with industry. The full list can be found with the original article.
A version of this article first appeared on Medscape.com.
Influenza infection is linked to a subsequent diagnosis of Parkinson’s disease (PD) more than 10 years later, resurfacing a long-held debate about whether infection increases the risk for movement disorders over the long term.
In a large case-control study, investigators found and by more than 70% for PD occurring more than 10 years after the flu.
“This study is not definitive by any means, but it certainly suggests there are potential long-term consequences from influenza,” study investigator Noelle M. Cocoros, DSc, research scientist at Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, said in an interview.
The study was published online Oct. 25 in JAMA Neurology.
Ongoing debate
The debate about whether influenza is associated with PD has been going on as far back as the 1918 influenza pandemic, when experts documented parkinsonism in affected individuals.
Using data from the Danish patient registry, researchers identified 10,271 subjects diagnosed with PD during a 17-year period (2000-2016). Of these, 38.7% were female, and the mean age was 71.4 years.
They matched these subjects for age and sex to 51,355 controls without PD. Compared with controls, slightly fewer individuals with PD had chronic obstructive pulmonary disease (COPD) or emphysema, but there was a similar distribution of cardiovascular disease and various other conditions.
Researchers collected data on influenza diagnoses from inpatient and outpatient hospital clinics from 1977 to 2016. They plotted these by month and year on a graph, calculated the median number of diagnoses per month, and identified peaks as those with more than threefold the median.
They categorized cases in groups related to the time between the infection and PD: More than 10 years, 10-15 years, and more than 15 years.
The time lapse accounts for a rather long “run-up” to PD, said Dr. Cocoros. There’s a sometimes decades-long preclinical phase before patients develop typical motor signs and a prodromal phase where they may present with nonmotor symptoms such as sleep disorders and constipation.
“We expected there would be at least 10 years between any infection and PD if there was an association present,” said Dr. Cocoros.
Investigators found an association between influenza exposure and PD diagnosis “that held up over time,” she said.
For more than 10 years before PD, the likelihood of a diagnosis for the infected compared with the unexposed was increased 73% (odds ratio [OR] 1.73; 95% confidence interval, 1.11-2.71; P = .02) after adjustment for cardiovascular disease, diabetes, chronic obstructive pulmonary disease, emphysema, lung cancer, Crohn’s disease, and ulcerative colitis.
The odds increased with more time from infection. For more than 15 years, the adjusted OR was 1.91 (95% CI, 1.14 - 3.19; P =.01).
However, for the 10- to 15-year time frame, the point estimate was reduced and the CI nonsignificant (OR, 1.33; 95% CI, 0.54-3.27; P = .53). This “is a little hard to interpret,” but could be a result of the small numbers, exposure misclassification, or because “the longer time interval is what’s meaningful,” said Dr. Cocoros.
Potential COVID-19–related PD surge?
In a sensitivity analysis, researchers looked at peak infection activity. “We wanted to increase the likelihood of these diagnoses representing actual infection,” Dr. Cocoros noted.
Here, the OR was still elevated at more than 10 years, but the CI was quite wide and included 1 (OR, 1.52; 95% CI, 0.80-2.89; P = .21). “So the association holds up, but the estimates are quite unstable,” said Dr. Cocoros.
Researchers examined associations with numerous other infection types, but did not see the same trend over time. Some infections – for example, gastrointestinal infections and septicemia – were associated with PD within 5 years, but most associations appeared to be null after more than 10 years.
“There seemed to be associations earlier between the infection and PD, which we interpret to suggest there’s actually not a meaningful association,” said Dr. Cocoros.
An exception might be urinary tract infections (UTIs), where after 10 years, the adjusted OR was 1.19 (95% CI, 1.01-1.40). Research suggests patients with PD often have UTIs and neurogenic bladder.
“It’s possible that UTIs could be an early symptom of PD rather than a causative factor,” said Dr. Cocoros.
It’s unclear how influenza might lead to PD but it could be that the virus gets into the central nervous system, resulting in neuroinflammation. Cytokines generated in response to the influenza infection might damage the brain.
“The infection could be a ‘primer’ or an initial ‘hit’ to the system, maybe setting people up for PD,” said Dr. Cocoros.
As for the current COVID-19 pandemic, some experts are concerned about a potential surge in PD cases in decades to come, and are calling for prospective monitoring of patients with this infection, said Dr. Cocoros.
However, she noted that infections don’t account for all PD cases and that genetic and environmental factors also influence risk.
Many individuals who contract influenza don’t seek medical care or get tested, so it’s possible the study counted those who had the infection as unexposed. Another potential study limitation was that small numbers for some infections, for example, Helicobacter pylori and hepatitis C, limited the ability to interpret results.
‘Exciting and important’ findings
Commenting on the research for this news organization, Aparna Wagle Shukla, MD, professor, Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, said the results amid the current pandemic are “exciting and important” and “have reinvigorated interest” in the role of infection in PD.
However, the study had some limitations, an important one being lack of accounting for confounding factors, including environmental factors, she said. Exposure to pesticides, living in a rural area, drinking well water, and having had a head injury may increase PD risk, whereas high intake of caffeine, nicotine, alcohol, and nonsteroidal anti-inflammatory drugs might lower the risk.
The researchers did not take into account exposure to multiple microbes or “infection burden,” said Dr. Wagle Shukla, who was not involved in the current study. In addition, as the data are from a single country with exposure to specific influenza strains, application of the findings elsewhere may be limited.
Dr. Wagle Shukla noted that a case-control design “isn’t ideal” from an epidemiological perspective. “Future studies should involve large cohorts followed longitudinally.”
The study was supported by grants from the Lundbeck Foundation and the Augustinus Foundation. Dr. Cocoros has disclosed no relevant financial relationships. Several coauthors have disclosed relationships with industry. The full list can be found with the original article.
A version of this article first appeared on Medscape.com.
Influenza infection is linked to a subsequent diagnosis of Parkinson’s disease (PD) more than 10 years later, resurfacing a long-held debate about whether infection increases the risk for movement disorders over the long term.
In a large case-control study, investigators found and by more than 70% for PD occurring more than 10 years after the flu.
“This study is not definitive by any means, but it certainly suggests there are potential long-term consequences from influenza,” study investigator Noelle M. Cocoros, DSc, research scientist at Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, said in an interview.
The study was published online Oct. 25 in JAMA Neurology.
Ongoing debate
The debate about whether influenza is associated with PD has been going on as far back as the 1918 influenza pandemic, when experts documented parkinsonism in affected individuals.
Using data from the Danish patient registry, researchers identified 10,271 subjects diagnosed with PD during a 17-year period (2000-2016). Of these, 38.7% were female, and the mean age was 71.4 years.
They matched these subjects for age and sex to 51,355 controls without PD. Compared with controls, slightly fewer individuals with PD had chronic obstructive pulmonary disease (COPD) or emphysema, but there was a similar distribution of cardiovascular disease and various other conditions.
Researchers collected data on influenza diagnoses from inpatient and outpatient hospital clinics from 1977 to 2016. They plotted these by month and year on a graph, calculated the median number of diagnoses per month, and identified peaks as those with more than threefold the median.
They categorized cases in groups related to the time between the infection and PD: More than 10 years, 10-15 years, and more than 15 years.
The time lapse accounts for a rather long “run-up” to PD, said Dr. Cocoros. There’s a sometimes decades-long preclinical phase before patients develop typical motor signs and a prodromal phase where they may present with nonmotor symptoms such as sleep disorders and constipation.
“We expected there would be at least 10 years between any infection and PD if there was an association present,” said Dr. Cocoros.
Investigators found an association between influenza exposure and PD diagnosis “that held up over time,” she said.
For more than 10 years before PD, the likelihood of a diagnosis for the infected compared with the unexposed was increased 73% (odds ratio [OR] 1.73; 95% confidence interval, 1.11-2.71; P = .02) after adjustment for cardiovascular disease, diabetes, chronic obstructive pulmonary disease, emphysema, lung cancer, Crohn’s disease, and ulcerative colitis.
The odds increased with more time from infection. For more than 15 years, the adjusted OR was 1.91 (95% CI, 1.14 - 3.19; P =.01).
However, for the 10- to 15-year time frame, the point estimate was reduced and the CI nonsignificant (OR, 1.33; 95% CI, 0.54-3.27; P = .53). This “is a little hard to interpret,” but could be a result of the small numbers, exposure misclassification, or because “the longer time interval is what’s meaningful,” said Dr. Cocoros.
Potential COVID-19–related PD surge?
In a sensitivity analysis, researchers looked at peak infection activity. “We wanted to increase the likelihood of these diagnoses representing actual infection,” Dr. Cocoros noted.
Here, the OR was still elevated at more than 10 years, but the CI was quite wide and included 1 (OR, 1.52; 95% CI, 0.80-2.89; P = .21). “So the association holds up, but the estimates are quite unstable,” said Dr. Cocoros.
Researchers examined associations with numerous other infection types, but did not see the same trend over time. Some infections – for example, gastrointestinal infections and septicemia – were associated with PD within 5 years, but most associations appeared to be null after more than 10 years.
“There seemed to be associations earlier between the infection and PD, which we interpret to suggest there’s actually not a meaningful association,” said Dr. Cocoros.
An exception might be urinary tract infections (UTIs), where after 10 years, the adjusted OR was 1.19 (95% CI, 1.01-1.40). Research suggests patients with PD often have UTIs and neurogenic bladder.
“It’s possible that UTIs could be an early symptom of PD rather than a causative factor,” said Dr. Cocoros.
It’s unclear how influenza might lead to PD but it could be that the virus gets into the central nervous system, resulting in neuroinflammation. Cytokines generated in response to the influenza infection might damage the brain.
“The infection could be a ‘primer’ or an initial ‘hit’ to the system, maybe setting people up for PD,” said Dr. Cocoros.
As for the current COVID-19 pandemic, some experts are concerned about a potential surge in PD cases in decades to come, and are calling for prospective monitoring of patients with this infection, said Dr. Cocoros.
However, she noted that infections don’t account for all PD cases and that genetic and environmental factors also influence risk.
Many individuals who contract influenza don’t seek medical care or get tested, so it’s possible the study counted those who had the infection as unexposed. Another potential study limitation was that small numbers for some infections, for example, Helicobacter pylori and hepatitis C, limited the ability to interpret results.
‘Exciting and important’ findings
Commenting on the research for this news organization, Aparna Wagle Shukla, MD, professor, Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, said the results amid the current pandemic are “exciting and important” and “have reinvigorated interest” in the role of infection in PD.
However, the study had some limitations, an important one being lack of accounting for confounding factors, including environmental factors, she said. Exposure to pesticides, living in a rural area, drinking well water, and having had a head injury may increase PD risk, whereas high intake of caffeine, nicotine, alcohol, and nonsteroidal anti-inflammatory drugs might lower the risk.
The researchers did not take into account exposure to multiple microbes or “infection burden,” said Dr. Wagle Shukla, who was not involved in the current study. In addition, as the data are from a single country with exposure to specific influenza strains, application of the findings elsewhere may be limited.
Dr. Wagle Shukla noted that a case-control design “isn’t ideal” from an epidemiological perspective. “Future studies should involve large cohorts followed longitudinally.”
The study was supported by grants from the Lundbeck Foundation and the Augustinus Foundation. Dr. Cocoros has disclosed no relevant financial relationships. Several coauthors have disclosed relationships with industry. The full list can be found with the original article.
A version of this article first appeared on Medscape.com.
Sleep time ‘sweet spot’ to slow cognitive decline identified?
In a longitudinal study, investigators found older adults who slept less than 4.5 hours or more than 6.5 hours a night reported significant cognitive decline over time, but cognitive scores for those with sleep duration in between that range remained stable.
“This really suggests that there’s this middle range, a ‘sweet spot,’ where your sleep is really optimal,” lead author Brendan Lucey, MD, MSCI, associate professor of neurology and director of the Washington University Sleep Medicine Center, St. Louis, said in an interview.
The study, published online Oct. 20, 2021, in the journal Brain, is part of a growing body of research that seeks to determine if sleep can be used as a marker of Alzheimer’s disease progression.
A complex relationship
Studies suggest a strong relationship between sleep patterns and Alzheimer’s disease, which affects nearly 6 million Americans. The challenge, Dr. Lucey said, is unwinding the complex links between sleep, AD, and cognitive function.
An earlier study by Dr. Lucey and colleagues found that poor sleep quality is associated with early signs of AD, and a report published in September found that elderly people who slept less than 6 hours a night had a greater burden of amyloid-beta, a hallmark sign of AD.
For this new study, researchers monitored sleep-wake activity over 4-6 nights in 100 participants who underwent annual cognitive assessments and clinical studies, including APOE genotyping, as part of a longitudinal study at the Knight Alzheimer Disease Research Center at Washington University.
Participants also provided cerebrospinal fluid (CSF) total tau and amyloid-beta 42 and wore a small EEG device on their forehead while they slept.
The majority of participants had a clinical dementia rating (CDR) score of 0, indicating no cognitive impairment. Twelve individuals had a CDR greater than 0, with most reporting mild cognitive impairment.
As expected, CSF analysis showed greater evidence of AD pathology in those with a baseline CDR greater than 0.
Changes in cognitive function were measured using a Preclinical Alzheimer Cognitive Composite (PACC) score, a composite of results from a neuropsychological testing battery that included the Free and Cued Selective Reminding Test, the Logical Memory Delayed Recall Test from the Wechsler Memory Scale–Revised, the Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale–Revised, and the Mini-Mental State Examination.
Researchers found an upside-down U-shaped relationship between PACC scores and sleep duration, with dramatic cognitive decline in those who slept less than 4.5 hours or more than 6.5 hours a night (P < .001 for both).
The U-shaped relationship was also found with measures of sleep phases, including time spent in rapid eye movement and in non-REM sleep (P < .001 for both).
The findings persisted even after controlling for confounders that can affect sleep and cognition, such as age, CSF total tau/amyloid-beta 42 ratio, apo E four-allele carrier status, years of education, and sex.
Understanding how sleep changes at different stages of AD could help researchers determine if sleep can be used as a marker of disease progression, Dr. Lucey said. That could lead to interventions to slow that process.
“We’re not at the point yet where we can say that we need to monitor someone’s sleep time and then do an intervention to see if it would improve their risk for cognitive decline,” said Dr. Lucey, who plans to repeat this sleep study with the same cohort to track changes in sleep patterns and cognitive function over time. “But that’s a question I’m very excited to try to answer.”
A component of cognitive health
Commenting on the findings for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, noted that the study adds to a body of evidence linking sleep and cognition, especially how sleep quality can optimize brain function.
“We’ve seen previous research that’s shown poor sleep contributes to dementia risk, as well as research showing sleep duration may play a role in cognition,” she said.
“We also need studies that look at sleep as an intervention for cognitive health,” Dr. Snyder said. “Sleep is an important aspect of our overall health. Clinicians should have conversations with their patients about sleep as part of standard discussions about their health habits and wellness.”
The study was funded by the National Institutes of Health, the American Sleep Medicine Foundation, the Roger and Paula Riney Fund, and the Daniel J. Brennan, MD Fund. Dr. Lucey consults for Merck and Eli Lilly. Dr. Snyder has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a longitudinal study, investigators found older adults who slept less than 4.5 hours or more than 6.5 hours a night reported significant cognitive decline over time, but cognitive scores for those with sleep duration in between that range remained stable.
“This really suggests that there’s this middle range, a ‘sweet spot,’ where your sleep is really optimal,” lead author Brendan Lucey, MD, MSCI, associate professor of neurology and director of the Washington University Sleep Medicine Center, St. Louis, said in an interview.
The study, published online Oct. 20, 2021, in the journal Brain, is part of a growing body of research that seeks to determine if sleep can be used as a marker of Alzheimer’s disease progression.
A complex relationship
Studies suggest a strong relationship between sleep patterns and Alzheimer’s disease, which affects nearly 6 million Americans. The challenge, Dr. Lucey said, is unwinding the complex links between sleep, AD, and cognitive function.
An earlier study by Dr. Lucey and colleagues found that poor sleep quality is associated with early signs of AD, and a report published in September found that elderly people who slept less than 6 hours a night had a greater burden of amyloid-beta, a hallmark sign of AD.
For this new study, researchers monitored sleep-wake activity over 4-6 nights in 100 participants who underwent annual cognitive assessments and clinical studies, including APOE genotyping, as part of a longitudinal study at the Knight Alzheimer Disease Research Center at Washington University.
Participants also provided cerebrospinal fluid (CSF) total tau and amyloid-beta 42 and wore a small EEG device on their forehead while they slept.
The majority of participants had a clinical dementia rating (CDR) score of 0, indicating no cognitive impairment. Twelve individuals had a CDR greater than 0, with most reporting mild cognitive impairment.
As expected, CSF analysis showed greater evidence of AD pathology in those with a baseline CDR greater than 0.
Changes in cognitive function were measured using a Preclinical Alzheimer Cognitive Composite (PACC) score, a composite of results from a neuropsychological testing battery that included the Free and Cued Selective Reminding Test, the Logical Memory Delayed Recall Test from the Wechsler Memory Scale–Revised, the Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale–Revised, and the Mini-Mental State Examination.
Researchers found an upside-down U-shaped relationship between PACC scores and sleep duration, with dramatic cognitive decline in those who slept less than 4.5 hours or more than 6.5 hours a night (P < .001 for both).
The U-shaped relationship was also found with measures of sleep phases, including time spent in rapid eye movement and in non-REM sleep (P < .001 for both).
The findings persisted even after controlling for confounders that can affect sleep and cognition, such as age, CSF total tau/amyloid-beta 42 ratio, apo E four-allele carrier status, years of education, and sex.
Understanding how sleep changes at different stages of AD could help researchers determine if sleep can be used as a marker of disease progression, Dr. Lucey said. That could lead to interventions to slow that process.
“We’re not at the point yet where we can say that we need to monitor someone’s sleep time and then do an intervention to see if it would improve their risk for cognitive decline,” said Dr. Lucey, who plans to repeat this sleep study with the same cohort to track changes in sleep patterns and cognitive function over time. “But that’s a question I’m very excited to try to answer.”
A component of cognitive health
Commenting on the findings for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, noted that the study adds to a body of evidence linking sleep and cognition, especially how sleep quality can optimize brain function.
“We’ve seen previous research that’s shown poor sleep contributes to dementia risk, as well as research showing sleep duration may play a role in cognition,” she said.
“We also need studies that look at sleep as an intervention for cognitive health,” Dr. Snyder said. “Sleep is an important aspect of our overall health. Clinicians should have conversations with their patients about sleep as part of standard discussions about their health habits and wellness.”
The study was funded by the National Institutes of Health, the American Sleep Medicine Foundation, the Roger and Paula Riney Fund, and the Daniel J. Brennan, MD Fund. Dr. Lucey consults for Merck and Eli Lilly. Dr. Snyder has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a longitudinal study, investigators found older adults who slept less than 4.5 hours or more than 6.5 hours a night reported significant cognitive decline over time, but cognitive scores for those with sleep duration in between that range remained stable.
“This really suggests that there’s this middle range, a ‘sweet spot,’ where your sleep is really optimal,” lead author Brendan Lucey, MD, MSCI, associate professor of neurology and director of the Washington University Sleep Medicine Center, St. Louis, said in an interview.
The study, published online Oct. 20, 2021, in the journal Brain, is part of a growing body of research that seeks to determine if sleep can be used as a marker of Alzheimer’s disease progression.
A complex relationship
Studies suggest a strong relationship between sleep patterns and Alzheimer’s disease, which affects nearly 6 million Americans. The challenge, Dr. Lucey said, is unwinding the complex links between sleep, AD, and cognitive function.
An earlier study by Dr. Lucey and colleagues found that poor sleep quality is associated with early signs of AD, and a report published in September found that elderly people who slept less than 6 hours a night had a greater burden of amyloid-beta, a hallmark sign of AD.
For this new study, researchers monitored sleep-wake activity over 4-6 nights in 100 participants who underwent annual cognitive assessments and clinical studies, including APOE genotyping, as part of a longitudinal study at the Knight Alzheimer Disease Research Center at Washington University.
Participants also provided cerebrospinal fluid (CSF) total tau and amyloid-beta 42 and wore a small EEG device on their forehead while they slept.
The majority of participants had a clinical dementia rating (CDR) score of 0, indicating no cognitive impairment. Twelve individuals had a CDR greater than 0, with most reporting mild cognitive impairment.
As expected, CSF analysis showed greater evidence of AD pathology in those with a baseline CDR greater than 0.
Changes in cognitive function were measured using a Preclinical Alzheimer Cognitive Composite (PACC) score, a composite of results from a neuropsychological testing battery that included the Free and Cued Selective Reminding Test, the Logical Memory Delayed Recall Test from the Wechsler Memory Scale–Revised, the Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale–Revised, and the Mini-Mental State Examination.
Researchers found an upside-down U-shaped relationship between PACC scores and sleep duration, with dramatic cognitive decline in those who slept less than 4.5 hours or more than 6.5 hours a night (P < .001 for both).
The U-shaped relationship was also found with measures of sleep phases, including time spent in rapid eye movement and in non-REM sleep (P < .001 for both).
The findings persisted even after controlling for confounders that can affect sleep and cognition, such as age, CSF total tau/amyloid-beta 42 ratio, apo E four-allele carrier status, years of education, and sex.
Understanding how sleep changes at different stages of AD could help researchers determine if sleep can be used as a marker of disease progression, Dr. Lucey said. That could lead to interventions to slow that process.
“We’re not at the point yet where we can say that we need to monitor someone’s sleep time and then do an intervention to see if it would improve their risk for cognitive decline,” said Dr. Lucey, who plans to repeat this sleep study with the same cohort to track changes in sleep patterns and cognitive function over time. “But that’s a question I’m very excited to try to answer.”
A component of cognitive health
Commenting on the findings for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, noted that the study adds to a body of evidence linking sleep and cognition, especially how sleep quality can optimize brain function.
“We’ve seen previous research that’s shown poor sleep contributes to dementia risk, as well as research showing sleep duration may play a role in cognition,” she said.
“We also need studies that look at sleep as an intervention for cognitive health,” Dr. Snyder said. “Sleep is an important aspect of our overall health. Clinicians should have conversations with their patients about sleep as part of standard discussions about their health habits and wellness.”
The study was funded by the National Institutes of Health, the American Sleep Medicine Foundation, the Roger and Paula Riney Fund, and the Daniel J. Brennan, MD Fund. Dr. Lucey consults for Merck and Eli Lilly. Dr. Snyder has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Managing simple febrile seizures without lumbar puncture safe: 15-year study
Most children with simple febrile seizures (SFSs) can be safely managed without lumbar puncture or other diagnostic tests without risking delayed diagnosis of bacterial meningitis, new data gathered from a 15-year span suggest.
Vidya R. Raghavan, MD, with the division of emergency medicine at Boston Children’s Hospital and Harvard Medical School, also in Boston, published their findings in Pediatrics.
In 2011, researchers published the American Academy of Pediatrics simple febrile seizure guideline, which recommends limiting lumbar puncture to non–low-risk patients. The guidelines also specified that neuroimaging and hematologic testing are not routinely recommended.
Dr. Raghavan and coauthors studied evaluation and management trends of the patients before and after the guidelines. They identified 142,121 children diagnosed with SFS who presented to 1 of 49 pediatric tertiary EDs and met other study criteria. Changes in management of SFS had started years before the guideline and positive effects continued after the guideline publication.
Researchers found a significant 95% decline in rates of lumbar puncture between 2005 and 2019 from 11.6% (95% confidence interval, 10.8%-12.4%) of children in 2005 to 0.6% (95% CI, 0.5%-0.8%; P < .001) in 2019. The most significant declines were among infants 6 months to 1 year.
“We found similar declines in rates of diagnostic laboratory and radiologic testing, intravenous antibiotic administration, hospitalization, and costs,” the authors wrote.
“Importantly,” they wrote, “the decrease in testing was not associated with a concurrent increase in delayed diagnoses of bacterial meningitis.”
The number of hospital admissions and total costs also dropped significantly over the 15-year span of the study. After adjusting for inflation, the authors wrote, costs dropped from an average $1,523 in 2005 to $605 (P < .001) in 2019.
Among first-time presentations for SFSs, 19.2% (95% CI, 18.3%-20.2%) resulted in admission in 2005. That rate dropped to 5.2% (95% CI, 4.8%-5.6%) in 2019 (P < .001), although the authors noted that trend largely plateaued after the guideline was published.
“Our findings are consistent with smaller studies published before 2011 in which researchers found declining rates of LP [lumbar puncture] in children presenting to the ED with their first SFS,” the authors wrote.
Mercedes Blackstone, MD, an emergency physician at the Children’s Hospital of Philadelphia, said in an interview that the paper offers reassurance for changed practice over the last decade.
She said there was substantial relief in pediatrics when the 2011 guidelines recognized formally that protocols were outdated, especially as bacterial meningitis had become increasingly rare with widespread use of pneumococcal and Haemophilus influenzae vaccines. Practitioners had already started to limit the spinal taps on their own.
“We were not really complying with the prior recommendation to do a spinal tap in all those children because it often felt like doing a pretty invasive procedure with a very low yield in what was often a very well child in front of you,” she said.
In 2007, the authors noted, a few years before the guidelines, rates of bacterial meningitis had decreased to 7 per 100,000 in children aged between 2 and 23 months and 0.56 per 100,000 in children aged between 2 and 10 years.
However, Dr. Blackstone said, there was still a worry among some practitioners that there could be missed cases of bacterial meningitis.
“It’s very helpful to see that in all those years, the guidelines have been very validated and there were really no missed cases,” said Dr. Blackstone, author of CHOP’s febrile seizures clinical pathway.
It was good to see the number of CT scans drop as well, she said. Dr. Raghavan’s team found they decreased from 10.6% to 1.6%; P < .001, over the study period.
“Earlier work had shown that there was still a fair amount of head CTs happening and that’s radiation to the young brain,” Dr. Blackstone noted. “This is great news.”
Dr. Blackstone said it was great to see so many children from so many children’s hospitals included in the study.
The paper confirmed that “we’ve reduced a lot of unnecessary testing, saved a lot of cost, and had no increased risk to the patients,” she said.
Dr. Blackstone pointed out that the authors include a limitation that many children are seen in nonpediatric centers in community adult ED and she said those settings tend to have more testing.
“Hopefully, these guidelines have penetrated into the whole community,” she said. “With this paper they should feel reassured that they can spare children some of these tests and procedures.”
Dr. Raghavan and Dr. Blackstone declared no relevant financial relationships.
Most children with simple febrile seizures (SFSs) can be safely managed without lumbar puncture or other diagnostic tests without risking delayed diagnosis of bacterial meningitis, new data gathered from a 15-year span suggest.
Vidya R. Raghavan, MD, with the division of emergency medicine at Boston Children’s Hospital and Harvard Medical School, also in Boston, published their findings in Pediatrics.
In 2011, researchers published the American Academy of Pediatrics simple febrile seizure guideline, which recommends limiting lumbar puncture to non–low-risk patients. The guidelines also specified that neuroimaging and hematologic testing are not routinely recommended.
Dr. Raghavan and coauthors studied evaluation and management trends of the patients before and after the guidelines. They identified 142,121 children diagnosed with SFS who presented to 1 of 49 pediatric tertiary EDs and met other study criteria. Changes in management of SFS had started years before the guideline and positive effects continued after the guideline publication.
Researchers found a significant 95% decline in rates of lumbar puncture between 2005 and 2019 from 11.6% (95% confidence interval, 10.8%-12.4%) of children in 2005 to 0.6% (95% CI, 0.5%-0.8%; P < .001) in 2019. The most significant declines were among infants 6 months to 1 year.
“We found similar declines in rates of diagnostic laboratory and radiologic testing, intravenous antibiotic administration, hospitalization, and costs,” the authors wrote.
“Importantly,” they wrote, “the decrease in testing was not associated with a concurrent increase in delayed diagnoses of bacterial meningitis.”
The number of hospital admissions and total costs also dropped significantly over the 15-year span of the study. After adjusting for inflation, the authors wrote, costs dropped from an average $1,523 in 2005 to $605 (P < .001) in 2019.
Among first-time presentations for SFSs, 19.2% (95% CI, 18.3%-20.2%) resulted in admission in 2005. That rate dropped to 5.2% (95% CI, 4.8%-5.6%) in 2019 (P < .001), although the authors noted that trend largely plateaued after the guideline was published.
“Our findings are consistent with smaller studies published before 2011 in which researchers found declining rates of LP [lumbar puncture] in children presenting to the ED with their first SFS,” the authors wrote.
Mercedes Blackstone, MD, an emergency physician at the Children’s Hospital of Philadelphia, said in an interview that the paper offers reassurance for changed practice over the last decade.
She said there was substantial relief in pediatrics when the 2011 guidelines recognized formally that protocols were outdated, especially as bacterial meningitis had become increasingly rare with widespread use of pneumococcal and Haemophilus influenzae vaccines. Practitioners had already started to limit the spinal taps on their own.
“We were not really complying with the prior recommendation to do a spinal tap in all those children because it often felt like doing a pretty invasive procedure with a very low yield in what was often a very well child in front of you,” she said.
In 2007, the authors noted, a few years before the guidelines, rates of bacterial meningitis had decreased to 7 per 100,000 in children aged between 2 and 23 months and 0.56 per 100,000 in children aged between 2 and 10 years.
However, Dr. Blackstone said, there was still a worry among some practitioners that there could be missed cases of bacterial meningitis.
“It’s very helpful to see that in all those years, the guidelines have been very validated and there were really no missed cases,” said Dr. Blackstone, author of CHOP’s febrile seizures clinical pathway.
It was good to see the number of CT scans drop as well, she said. Dr. Raghavan’s team found they decreased from 10.6% to 1.6%; P < .001, over the study period.
“Earlier work had shown that there was still a fair amount of head CTs happening and that’s radiation to the young brain,” Dr. Blackstone noted. “This is great news.”
Dr. Blackstone said it was great to see so many children from so many children’s hospitals included in the study.
The paper confirmed that “we’ve reduced a lot of unnecessary testing, saved a lot of cost, and had no increased risk to the patients,” she said.
Dr. Blackstone pointed out that the authors include a limitation that many children are seen in nonpediatric centers in community adult ED and she said those settings tend to have more testing.
“Hopefully, these guidelines have penetrated into the whole community,” she said. “With this paper they should feel reassured that they can spare children some of these tests and procedures.”
Dr. Raghavan and Dr. Blackstone declared no relevant financial relationships.
Most children with simple febrile seizures (SFSs) can be safely managed without lumbar puncture or other diagnostic tests without risking delayed diagnosis of bacterial meningitis, new data gathered from a 15-year span suggest.
Vidya R. Raghavan, MD, with the division of emergency medicine at Boston Children’s Hospital and Harvard Medical School, also in Boston, published their findings in Pediatrics.
In 2011, researchers published the American Academy of Pediatrics simple febrile seizure guideline, which recommends limiting lumbar puncture to non–low-risk patients. The guidelines also specified that neuroimaging and hematologic testing are not routinely recommended.
Dr. Raghavan and coauthors studied evaluation and management trends of the patients before and after the guidelines. They identified 142,121 children diagnosed with SFS who presented to 1 of 49 pediatric tertiary EDs and met other study criteria. Changes in management of SFS had started years before the guideline and positive effects continued after the guideline publication.
Researchers found a significant 95% decline in rates of lumbar puncture between 2005 and 2019 from 11.6% (95% confidence interval, 10.8%-12.4%) of children in 2005 to 0.6% (95% CI, 0.5%-0.8%; P < .001) in 2019. The most significant declines were among infants 6 months to 1 year.
“We found similar declines in rates of diagnostic laboratory and radiologic testing, intravenous antibiotic administration, hospitalization, and costs,” the authors wrote.
“Importantly,” they wrote, “the decrease in testing was not associated with a concurrent increase in delayed diagnoses of bacterial meningitis.”
The number of hospital admissions and total costs also dropped significantly over the 15-year span of the study. After adjusting for inflation, the authors wrote, costs dropped from an average $1,523 in 2005 to $605 (P < .001) in 2019.
Among first-time presentations for SFSs, 19.2% (95% CI, 18.3%-20.2%) resulted in admission in 2005. That rate dropped to 5.2% (95% CI, 4.8%-5.6%) in 2019 (P < .001), although the authors noted that trend largely plateaued after the guideline was published.
“Our findings are consistent with smaller studies published before 2011 in which researchers found declining rates of LP [lumbar puncture] in children presenting to the ED with their first SFS,” the authors wrote.
Mercedes Blackstone, MD, an emergency physician at the Children’s Hospital of Philadelphia, said in an interview that the paper offers reassurance for changed practice over the last decade.
She said there was substantial relief in pediatrics when the 2011 guidelines recognized formally that protocols were outdated, especially as bacterial meningitis had become increasingly rare with widespread use of pneumococcal and Haemophilus influenzae vaccines. Practitioners had already started to limit the spinal taps on their own.
“We were not really complying with the prior recommendation to do a spinal tap in all those children because it often felt like doing a pretty invasive procedure with a very low yield in what was often a very well child in front of you,” she said.
In 2007, the authors noted, a few years before the guidelines, rates of bacterial meningitis had decreased to 7 per 100,000 in children aged between 2 and 23 months and 0.56 per 100,000 in children aged between 2 and 10 years.
However, Dr. Blackstone said, there was still a worry among some practitioners that there could be missed cases of bacterial meningitis.
“It’s very helpful to see that in all those years, the guidelines have been very validated and there were really no missed cases,” said Dr. Blackstone, author of CHOP’s febrile seizures clinical pathway.
It was good to see the number of CT scans drop as well, she said. Dr. Raghavan’s team found they decreased from 10.6% to 1.6%; P < .001, over the study period.
“Earlier work had shown that there was still a fair amount of head CTs happening and that’s radiation to the young brain,” Dr. Blackstone noted. “This is great news.”
Dr. Blackstone said it was great to see so many children from so many children’s hospitals included in the study.
The paper confirmed that “we’ve reduced a lot of unnecessary testing, saved a lot of cost, and had no increased risk to the patients,” she said.
Dr. Blackstone pointed out that the authors include a limitation that many children are seen in nonpediatric centers in community adult ED and she said those settings tend to have more testing.
“Hopefully, these guidelines have penetrated into the whole community,” she said. “With this paper they should feel reassured that they can spare children some of these tests and procedures.”
Dr. Raghavan and Dr. Blackstone declared no relevant financial relationships.
FROM PEDIATRICS
MS fundraising during a pandemic
Fundraising walks for multiple sclerosis (MS) should be familiar to everyone nationwide. They serve to raise money for MS, bolster public awareness of the disease, and build a sense of community. But such in-person events took a big hit during the pandemic.
Recently, this news organization spoke with Kristin Gibbs, vice president of Walk MS for the National MS Society.
How has the National MS Society raised money before the pandemic?
We are a peer-to-peer fundraising event. That means our registered participants ask their family, friends and coworkers to support them by donating. More than 90% of our participants are friends-and-family teams, and nearly everyone who participates in Walk MS has a connection to MS. We do also have corporate and national teams that fundraise, as well as national and local sponsors that provide monetary support of Walk MS.
About how many Walk MS events were held nationally in an average prepandemic year?
Going back to 2019, we held almost 400 Walk MS events. Next year, the Society will host 234 events, with at least one in each state. The reduction in the number of events reflects a prepandemic strategy of focusing our limited resources in areas where we can have the biggest impact.
How has the pandemic impacted fundraising and community building/outreach?
Fewer people registered and participated in our virtual events in 2020 and 2021, and the pandemic made it challenging for participants to fundraise. While normally we might see more than 200,000 participants nationally, in 2021 we attracted 40,000. Our fundraising decreased from nearly $40 million in prepandemic years to around $20 million in 2021. Our experience is similar to that of most nonprofit peer-to-peer events. However, we were encouraged by the individuals who did support Walk MS during the pandemic, as their fundraising averages were higher than prepandemic campaigns.
What kinds of ‘virtual events’ were held during the pandemic lockdowns?
When it comes to building community, during the pandemic we innovatively utilized online gathering technology, especially Teams, to bring our Walk MS participants together. We held numerous meetings for Team Captains and conducted pre-event pep rallies online to help share information and generate excitement. We produced Facebook Live broadcasts and launched a cutting-edge online version of a Walk MS event called Walk MS On Demand. On Demand visitors could create a virtual bib, learn about the Society, watch inspirational videos, and secure information from national and local sponsors.
How is fundraising handled nationally and locally?
In 2022 we will have 234 Walk MS events spread across the country. We are anticipating 100,000 participants will register and our goal is to raise $24 million. Our fundraising will come from individuals, teams, and corporations who contribute at the local and national levels. We are hopeful the excitement surrounding safely being back in person will allow the Walk MS campaign to quickly regain its financial and community-building impact.
Has the pandemic impacted corporate contributions?
We were extremely lucky to maintain support of our national sponsors, and to engage a strong number of local partners. Because we offered the Walk MS On Demand online experience where sponsors could showcase their companies in innovative ways, even though we were virtual we could provide our important partners with a unique way to connect to our constituents. That made a tremendous difference. Also, our partners are strongly committed to the mission and knew their continued support during the pandemic was critical to our organization.
How is the money distributed? Who benefits and how?
Walk MS is the United States’ 7th-largest nonprofit walk series, and the 12th-largest nonprofit event overall. Our Walk MS funds help provide support, programming, and research for individuals diagnosed with MS. Over the history of Walk MS, participants and sponsors have generated more than $1 billion to support those who live with MS.
How can clinicians and health care practitioners get involved?
There are several exciting ways for clinicians and health care practitioners to get involved in Walk MS. Many health care practitioners and clinicians form their own Walk MS teams and fundraise for the event – sometimes inviting patients to join them. Being at Walk MS with your team is an experience like no other when it comes to engaging with the MS community. Several health care organizations also sponsor their local Walk MS event and are able to showcase their brand in front of an important target audience. Still others support Walk MS as volunteers and many clinicians and health care practitioners spread awareness by promoting Walk MS to their patients. You can find ideas for Walk MS engagement and sponsorship details at WalkMS.org.
How do individuals with MS benefit from Walk MS initiatives?
Over its 30-plus-year history, Walk MS has generated more than $1 billion to support the Society’s mission to cure MS while empowering people affected by MS to live their best lives. Funds raised at Walk MS fuel cutting-edge MS research, power advocacy, generate awareness, and provide access to resources that connect those affected by MS to the information and people they need to live their best lives.
Any future plans?
Walk MS historically has been the society’s largest gathering. We are excited in 2022 to return to in-person events after a nearly 2-year hiatus. Society-hosted events will occur at 234 locations across the United States. The Walk MS season spans from February to June and you can register at WalkMS.org. New this year – and a carry-over from our pandemic experience – we’re offering a Your Way option. No matter where you are located or how you want to commemorate Walk MS, you can participate in this virtual option and still receive fundraising support and exciting prizes.
Fundraising walks for multiple sclerosis (MS) should be familiar to everyone nationwide. They serve to raise money for MS, bolster public awareness of the disease, and build a sense of community. But such in-person events took a big hit during the pandemic.
Recently, this news organization spoke with Kristin Gibbs, vice president of Walk MS for the National MS Society.
How has the National MS Society raised money before the pandemic?
We are a peer-to-peer fundraising event. That means our registered participants ask their family, friends and coworkers to support them by donating. More than 90% of our participants are friends-and-family teams, and nearly everyone who participates in Walk MS has a connection to MS. We do also have corporate and national teams that fundraise, as well as national and local sponsors that provide monetary support of Walk MS.
About how many Walk MS events were held nationally in an average prepandemic year?
Going back to 2019, we held almost 400 Walk MS events. Next year, the Society will host 234 events, with at least one in each state. The reduction in the number of events reflects a prepandemic strategy of focusing our limited resources in areas where we can have the biggest impact.
How has the pandemic impacted fundraising and community building/outreach?
Fewer people registered and participated in our virtual events in 2020 and 2021, and the pandemic made it challenging for participants to fundraise. While normally we might see more than 200,000 participants nationally, in 2021 we attracted 40,000. Our fundraising decreased from nearly $40 million in prepandemic years to around $20 million in 2021. Our experience is similar to that of most nonprofit peer-to-peer events. However, we were encouraged by the individuals who did support Walk MS during the pandemic, as their fundraising averages were higher than prepandemic campaigns.
What kinds of ‘virtual events’ were held during the pandemic lockdowns?
When it comes to building community, during the pandemic we innovatively utilized online gathering technology, especially Teams, to bring our Walk MS participants together. We held numerous meetings for Team Captains and conducted pre-event pep rallies online to help share information and generate excitement. We produced Facebook Live broadcasts and launched a cutting-edge online version of a Walk MS event called Walk MS On Demand. On Demand visitors could create a virtual bib, learn about the Society, watch inspirational videos, and secure information from national and local sponsors.
How is fundraising handled nationally and locally?
In 2022 we will have 234 Walk MS events spread across the country. We are anticipating 100,000 participants will register and our goal is to raise $24 million. Our fundraising will come from individuals, teams, and corporations who contribute at the local and national levels. We are hopeful the excitement surrounding safely being back in person will allow the Walk MS campaign to quickly regain its financial and community-building impact.
Has the pandemic impacted corporate contributions?
We were extremely lucky to maintain support of our national sponsors, and to engage a strong number of local partners. Because we offered the Walk MS On Demand online experience where sponsors could showcase their companies in innovative ways, even though we were virtual we could provide our important partners with a unique way to connect to our constituents. That made a tremendous difference. Also, our partners are strongly committed to the mission and knew their continued support during the pandemic was critical to our organization.
How is the money distributed? Who benefits and how?
Walk MS is the United States’ 7th-largest nonprofit walk series, and the 12th-largest nonprofit event overall. Our Walk MS funds help provide support, programming, and research for individuals diagnosed with MS. Over the history of Walk MS, participants and sponsors have generated more than $1 billion to support those who live with MS.
How can clinicians and health care practitioners get involved?
There are several exciting ways for clinicians and health care practitioners to get involved in Walk MS. Many health care practitioners and clinicians form their own Walk MS teams and fundraise for the event – sometimes inviting patients to join them. Being at Walk MS with your team is an experience like no other when it comes to engaging with the MS community. Several health care organizations also sponsor their local Walk MS event and are able to showcase their brand in front of an important target audience. Still others support Walk MS as volunteers and many clinicians and health care practitioners spread awareness by promoting Walk MS to their patients. You can find ideas for Walk MS engagement and sponsorship details at WalkMS.org.
How do individuals with MS benefit from Walk MS initiatives?
Over its 30-plus-year history, Walk MS has generated more than $1 billion to support the Society’s mission to cure MS while empowering people affected by MS to live their best lives. Funds raised at Walk MS fuel cutting-edge MS research, power advocacy, generate awareness, and provide access to resources that connect those affected by MS to the information and people they need to live their best lives.
Any future plans?
Walk MS historically has been the society’s largest gathering. We are excited in 2022 to return to in-person events after a nearly 2-year hiatus. Society-hosted events will occur at 234 locations across the United States. The Walk MS season spans from February to June and you can register at WalkMS.org. New this year – and a carry-over from our pandemic experience – we’re offering a Your Way option. No matter where you are located or how you want to commemorate Walk MS, you can participate in this virtual option and still receive fundraising support and exciting prizes.
Fundraising walks for multiple sclerosis (MS) should be familiar to everyone nationwide. They serve to raise money for MS, bolster public awareness of the disease, and build a sense of community. But such in-person events took a big hit during the pandemic.
Recently, this news organization spoke with Kristin Gibbs, vice president of Walk MS for the National MS Society.
How has the National MS Society raised money before the pandemic?
We are a peer-to-peer fundraising event. That means our registered participants ask their family, friends and coworkers to support them by donating. More than 90% of our participants are friends-and-family teams, and nearly everyone who participates in Walk MS has a connection to MS. We do also have corporate and national teams that fundraise, as well as national and local sponsors that provide monetary support of Walk MS.
About how many Walk MS events were held nationally in an average prepandemic year?
Going back to 2019, we held almost 400 Walk MS events. Next year, the Society will host 234 events, with at least one in each state. The reduction in the number of events reflects a prepandemic strategy of focusing our limited resources in areas where we can have the biggest impact.
How has the pandemic impacted fundraising and community building/outreach?
Fewer people registered and participated in our virtual events in 2020 and 2021, and the pandemic made it challenging for participants to fundraise. While normally we might see more than 200,000 participants nationally, in 2021 we attracted 40,000. Our fundraising decreased from nearly $40 million in prepandemic years to around $20 million in 2021. Our experience is similar to that of most nonprofit peer-to-peer events. However, we were encouraged by the individuals who did support Walk MS during the pandemic, as their fundraising averages were higher than prepandemic campaigns.
What kinds of ‘virtual events’ were held during the pandemic lockdowns?
When it comes to building community, during the pandemic we innovatively utilized online gathering technology, especially Teams, to bring our Walk MS participants together. We held numerous meetings for Team Captains and conducted pre-event pep rallies online to help share information and generate excitement. We produced Facebook Live broadcasts and launched a cutting-edge online version of a Walk MS event called Walk MS On Demand. On Demand visitors could create a virtual bib, learn about the Society, watch inspirational videos, and secure information from national and local sponsors.
How is fundraising handled nationally and locally?
In 2022 we will have 234 Walk MS events spread across the country. We are anticipating 100,000 participants will register and our goal is to raise $24 million. Our fundraising will come from individuals, teams, and corporations who contribute at the local and national levels. We are hopeful the excitement surrounding safely being back in person will allow the Walk MS campaign to quickly regain its financial and community-building impact.
Has the pandemic impacted corporate contributions?
We were extremely lucky to maintain support of our national sponsors, and to engage a strong number of local partners. Because we offered the Walk MS On Demand online experience where sponsors could showcase their companies in innovative ways, even though we were virtual we could provide our important partners with a unique way to connect to our constituents. That made a tremendous difference. Also, our partners are strongly committed to the mission and knew their continued support during the pandemic was critical to our organization.
How is the money distributed? Who benefits and how?
Walk MS is the United States’ 7th-largest nonprofit walk series, and the 12th-largest nonprofit event overall. Our Walk MS funds help provide support, programming, and research for individuals diagnosed with MS. Over the history of Walk MS, participants and sponsors have generated more than $1 billion to support those who live with MS.
How can clinicians and health care practitioners get involved?
There are several exciting ways for clinicians and health care practitioners to get involved in Walk MS. Many health care practitioners and clinicians form their own Walk MS teams and fundraise for the event – sometimes inviting patients to join them. Being at Walk MS with your team is an experience like no other when it comes to engaging with the MS community. Several health care organizations also sponsor their local Walk MS event and are able to showcase their brand in front of an important target audience. Still others support Walk MS as volunteers and many clinicians and health care practitioners spread awareness by promoting Walk MS to their patients. You can find ideas for Walk MS engagement and sponsorship details at WalkMS.org.
How do individuals with MS benefit from Walk MS initiatives?
Over its 30-plus-year history, Walk MS has generated more than $1 billion to support the Society’s mission to cure MS while empowering people affected by MS to live their best lives. Funds raised at Walk MS fuel cutting-edge MS research, power advocacy, generate awareness, and provide access to resources that connect those affected by MS to the information and people they need to live their best lives.
Any future plans?
Walk MS historically has been the society’s largest gathering. We are excited in 2022 to return to in-person events after a nearly 2-year hiatus. Society-hosted events will occur at 234 locations across the United States. The Walk MS season spans from February to June and you can register at WalkMS.org. New this year – and a carry-over from our pandemic experience – we’re offering a Your Way option. No matter where you are located or how you want to commemorate Walk MS, you can participate in this virtual option and still receive fundraising support and exciting prizes.
Some diuretics tied to increased skin cancer risk
The findings were originally reported in two Danish case-control studies in which physicians reported a fourfold increased risk of squamous cell carcinoma, and a moderate increased risk of basal cell carcinoma and cutaneous malignant melanoma in patients who used hydrochlorothiazide long-term.
And, while the new study did not find an increased risk of basal cell carcinoma and cutaneous malignant melanoma among long-term users of hydrochlorothiazide, they suggest that bendroflumethiazide “may be a safer alternative for patients at increased risk of skin cancer.” The long-term use of indapamide was associated with a moderately increased risk of cutaneous malignant melanoma but did not alter the risk of either squamous cell or basal cell carcinoma
“Our results suggest that bendroflumethiazide may be a safer alternative to hydrochlorothiazide and indapamide, especially for patients at increased risk of skin cancer, but future studies are needed to rule out a causal association between bendroflumethiazide and cutaneous malignant melanoma,” wrote authors who were led by Christoph R. Meier, PhD, a professor in pharmacy with University Hospital Basel (Switzerland) and a contributor to the Boston Collaborative Drug Surveillance Program.
This study adds to existing evidence that there is a dose-dependent increased risk of squamous cell carcinoma in users of high cumulative doses of hydrochlorothiazide, compared with non–hydrochlorothiazide users.
The study, an observational cohort study, was published earlier this year. It is based on data from the U.K.-based Clinical Practice Research Datalink. It included 271,154 new users of thiazides and thiazidelike diuretics, the majority at 87.6% having been prescribed bendroflumethiazide, 5.8% indapamide, and 3.6% hydrochlorothiazide. Outcomes were compared to those observed in 275,263 users of calcium channel blockers.
“The three primary outcomes of interest were a first-time diagnosis of cutaneous malignant melanoma, basal cell carcinoma, or squamous cell carcinoma,” the authors wrote.
Incidence rates and incidence rate ratios were estimated for both short-term and long-term users of thiazidelike diuretics and calcium channel blockers, while a propensity score (PS) analysis was done in order to control for 23 baseline covariates. The mean follow-up after PS weighting was 3.9 years for indapamide users and 5.5 years for hydrochlorothiazide users. Overall, the incidence rate ratios of squamous cell carcinoma were not markedly increased for either short-term or long-term users of thiazidelike diuretics, the authors reported.
In contrast, the incidence rate ratios of squamous cell carcinoma for hydrochlorothiazide users were increased by 29% for short-term users at an IRR of 1.29 while they were increased by almost twofold for long-term hydrochlorothiazide users at an IRR of 1.95.
Long-term use of hydrochlorothiazide was again associated with a 64% increased risk of basal cell carcinoma, compared with users of a renin-angiotensin inhibitor at a weighted IRR of 1.64.
In contrast, weighted incident rate ratios for basal cell carcinoma for both short-term and long-term thiazide users were not significantly different and results were similar for patients who took hydrochlorothiazide, indapamide, or bendroflumethiazide.
Weighted overall incident rate ratios for cutaneous malignant melanoma were not significantly different for either short-term or long-term users of thiazidelike diuretics, compared with calcium channel blocker users.
However, there was a 43% increased risk of cutaneous malignant melanoma among long-term indapamide users at a weighted IRR of 1.43, compared with calcium channel blocker users, the authors reported.
“Given the biological plausibility and the severe clinical implications of cutaneous malignant melanoma, this finding should be considered carefully,” they cautioned.
Limitations to the study include the fact that the database analyzed does not have information on sun exposure, skin characteristics, or socioeconomic status which may affect the amount of sun exposure participants received.
The authors had no conflicts of interest to declare.
The findings were originally reported in two Danish case-control studies in which physicians reported a fourfold increased risk of squamous cell carcinoma, and a moderate increased risk of basal cell carcinoma and cutaneous malignant melanoma in patients who used hydrochlorothiazide long-term.
And, while the new study did not find an increased risk of basal cell carcinoma and cutaneous malignant melanoma among long-term users of hydrochlorothiazide, they suggest that bendroflumethiazide “may be a safer alternative for patients at increased risk of skin cancer.” The long-term use of indapamide was associated with a moderately increased risk of cutaneous malignant melanoma but did not alter the risk of either squamous cell or basal cell carcinoma
“Our results suggest that bendroflumethiazide may be a safer alternative to hydrochlorothiazide and indapamide, especially for patients at increased risk of skin cancer, but future studies are needed to rule out a causal association between bendroflumethiazide and cutaneous malignant melanoma,” wrote authors who were led by Christoph R. Meier, PhD, a professor in pharmacy with University Hospital Basel (Switzerland) and a contributor to the Boston Collaborative Drug Surveillance Program.
This study adds to existing evidence that there is a dose-dependent increased risk of squamous cell carcinoma in users of high cumulative doses of hydrochlorothiazide, compared with non–hydrochlorothiazide users.
The study, an observational cohort study, was published earlier this year. It is based on data from the U.K.-based Clinical Practice Research Datalink. It included 271,154 new users of thiazides and thiazidelike diuretics, the majority at 87.6% having been prescribed bendroflumethiazide, 5.8% indapamide, and 3.6% hydrochlorothiazide. Outcomes were compared to those observed in 275,263 users of calcium channel blockers.
“The three primary outcomes of interest were a first-time diagnosis of cutaneous malignant melanoma, basal cell carcinoma, or squamous cell carcinoma,” the authors wrote.
Incidence rates and incidence rate ratios were estimated for both short-term and long-term users of thiazidelike diuretics and calcium channel blockers, while a propensity score (PS) analysis was done in order to control for 23 baseline covariates. The mean follow-up after PS weighting was 3.9 years for indapamide users and 5.5 years for hydrochlorothiazide users. Overall, the incidence rate ratios of squamous cell carcinoma were not markedly increased for either short-term or long-term users of thiazidelike diuretics, the authors reported.
In contrast, the incidence rate ratios of squamous cell carcinoma for hydrochlorothiazide users were increased by 29% for short-term users at an IRR of 1.29 while they were increased by almost twofold for long-term hydrochlorothiazide users at an IRR of 1.95.
Long-term use of hydrochlorothiazide was again associated with a 64% increased risk of basal cell carcinoma, compared with users of a renin-angiotensin inhibitor at a weighted IRR of 1.64.
In contrast, weighted incident rate ratios for basal cell carcinoma for both short-term and long-term thiazide users were not significantly different and results were similar for patients who took hydrochlorothiazide, indapamide, or bendroflumethiazide.
Weighted overall incident rate ratios for cutaneous malignant melanoma were not significantly different for either short-term or long-term users of thiazidelike diuretics, compared with calcium channel blocker users.
However, there was a 43% increased risk of cutaneous malignant melanoma among long-term indapamide users at a weighted IRR of 1.43, compared with calcium channel blocker users, the authors reported.
“Given the biological plausibility and the severe clinical implications of cutaneous malignant melanoma, this finding should be considered carefully,” they cautioned.
Limitations to the study include the fact that the database analyzed does not have information on sun exposure, skin characteristics, or socioeconomic status which may affect the amount of sun exposure participants received.
The authors had no conflicts of interest to declare.
The findings were originally reported in two Danish case-control studies in which physicians reported a fourfold increased risk of squamous cell carcinoma, and a moderate increased risk of basal cell carcinoma and cutaneous malignant melanoma in patients who used hydrochlorothiazide long-term.
And, while the new study did not find an increased risk of basal cell carcinoma and cutaneous malignant melanoma among long-term users of hydrochlorothiazide, they suggest that bendroflumethiazide “may be a safer alternative for patients at increased risk of skin cancer.” The long-term use of indapamide was associated with a moderately increased risk of cutaneous malignant melanoma but did not alter the risk of either squamous cell or basal cell carcinoma
“Our results suggest that bendroflumethiazide may be a safer alternative to hydrochlorothiazide and indapamide, especially for patients at increased risk of skin cancer, but future studies are needed to rule out a causal association between bendroflumethiazide and cutaneous malignant melanoma,” wrote authors who were led by Christoph R. Meier, PhD, a professor in pharmacy with University Hospital Basel (Switzerland) and a contributor to the Boston Collaborative Drug Surveillance Program.
This study adds to existing evidence that there is a dose-dependent increased risk of squamous cell carcinoma in users of high cumulative doses of hydrochlorothiazide, compared with non–hydrochlorothiazide users.
The study, an observational cohort study, was published earlier this year. It is based on data from the U.K.-based Clinical Practice Research Datalink. It included 271,154 new users of thiazides and thiazidelike diuretics, the majority at 87.6% having been prescribed bendroflumethiazide, 5.8% indapamide, and 3.6% hydrochlorothiazide. Outcomes were compared to those observed in 275,263 users of calcium channel blockers.
“The three primary outcomes of interest were a first-time diagnosis of cutaneous malignant melanoma, basal cell carcinoma, or squamous cell carcinoma,” the authors wrote.
Incidence rates and incidence rate ratios were estimated for both short-term and long-term users of thiazidelike diuretics and calcium channel blockers, while a propensity score (PS) analysis was done in order to control for 23 baseline covariates. The mean follow-up after PS weighting was 3.9 years for indapamide users and 5.5 years for hydrochlorothiazide users. Overall, the incidence rate ratios of squamous cell carcinoma were not markedly increased for either short-term or long-term users of thiazidelike diuretics, the authors reported.
In contrast, the incidence rate ratios of squamous cell carcinoma for hydrochlorothiazide users were increased by 29% for short-term users at an IRR of 1.29 while they were increased by almost twofold for long-term hydrochlorothiazide users at an IRR of 1.95.
Long-term use of hydrochlorothiazide was again associated with a 64% increased risk of basal cell carcinoma, compared with users of a renin-angiotensin inhibitor at a weighted IRR of 1.64.
In contrast, weighted incident rate ratios for basal cell carcinoma for both short-term and long-term thiazide users were not significantly different and results were similar for patients who took hydrochlorothiazide, indapamide, or bendroflumethiazide.
Weighted overall incident rate ratios for cutaneous malignant melanoma were not significantly different for either short-term or long-term users of thiazidelike diuretics, compared with calcium channel blocker users.
However, there was a 43% increased risk of cutaneous malignant melanoma among long-term indapamide users at a weighted IRR of 1.43, compared with calcium channel blocker users, the authors reported.
“Given the biological plausibility and the severe clinical implications of cutaneous malignant melanoma, this finding should be considered carefully,” they cautioned.
Limitations to the study include the fact that the database analyzed does not have information on sun exposure, skin characteristics, or socioeconomic status which may affect the amount of sun exposure participants received.
The authors had no conflicts of interest to declare.
FROM BRITISH JOURNAL OF DERMATOLOGY
Unvaccinated pregnant women have more severe COVID
An increasing number of people who are unvaccinated and pregnant are being hospitalized for COVID-19, report investigators who saw hospital admissions double in a single year.
“With the surge, we had expected to begin treating patients who developed severe or critical illness again in pregnancy,” says Emily Adhikari, MD, from the University of Texas Southwestern Medical Center in Dallas. “But we did not expect the level of respiratory illness that we began to see in our patients. That was a surprise and an alarming finding that we felt was really important to get out there.”
The researchers followed more than 1,500 pregnant women diagnosed with COVID-19 who received care from Parkland Health and Hospital System in Dallas County, one of the nation’s busiest for deliveries. After the emergence of the Delta variant, the number of pregnant women hospitalized with COVID-19 more than doubled over the previous year.
And 82 pregnant women went on to develop severe or critical COVID, they report in their study, published online in the American Journal of Obstetrics and Gynecology. All but 1 of these patients were unvaccinated, 10 needed a ventilator, and two died.
The proportion of cases that were critical was about 5% in 2020. However, in April 2021, even though the number of total cases remained low, the number of severe illnesses started to rise. After the Delta variant became dominant, both the number and severity of cases increased, and after August 2021, more than 25% of pregnant people diagnosed with COVID-19 required hospitalization.
Hospitalizations Double
“We need to focus and really act urgently to recommend vaccination in pregnancy because that is the primary prevention tool that we have,” says Dr. Adhikari. “We do not have a proven cure for this illness, and that is important to know.”
These findings, which focus on a vulnerable population, are especially important given the elevated prevalence of COVID-19 in pregnant people of lower economic status, said Lissette Tanner, MD, MPH, from Emory University in Atlanta, who was not involved with the study.
“There are higher rates of hospitalization and death among Black, Hispanic, and Native American communities,” she reported. “It is essential to know how the virus is affecting those most affected and often most disadvantaged to deal with the pandemic.”
Vaccination rates are low in this population; just 19.2% of pregnant women receive at least one dose during pregnancy, according to the CDC. But pregnancy confers a higher risk for severe COVID-19 illness and for adverse outcomes, such as preterm birth and stillbirth.
Of the 665 people in the study cohort who were pregnant or had given birth when the vaccines were available, only 21.4% received at least one dose of a COVID-19 vaccine.
Given the increased risk for COVID-19 during pregnancy, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC recommend vaccination for people who are pregnant, breastfeeding, or trying to get pregnant.
According to ACOG, pregnant women who are fully vaccinated can follow the same guidelines as everyone else who is fully vaccinated; however, to prevent breakthrough infections, they might want to continue wearing a mask. ACOG also recommends that those not fully vaccinated follow physical-distancing guidelines and limit contact with people as much as possible to avoid infection.
A version of this article first appeared on WebMD.com.
An increasing number of people who are unvaccinated and pregnant are being hospitalized for COVID-19, report investigators who saw hospital admissions double in a single year.
“With the surge, we had expected to begin treating patients who developed severe or critical illness again in pregnancy,” says Emily Adhikari, MD, from the University of Texas Southwestern Medical Center in Dallas. “But we did not expect the level of respiratory illness that we began to see in our patients. That was a surprise and an alarming finding that we felt was really important to get out there.”
The researchers followed more than 1,500 pregnant women diagnosed with COVID-19 who received care from Parkland Health and Hospital System in Dallas County, one of the nation’s busiest for deliveries. After the emergence of the Delta variant, the number of pregnant women hospitalized with COVID-19 more than doubled over the previous year.
And 82 pregnant women went on to develop severe or critical COVID, they report in their study, published online in the American Journal of Obstetrics and Gynecology. All but 1 of these patients were unvaccinated, 10 needed a ventilator, and two died.
The proportion of cases that were critical was about 5% in 2020. However, in April 2021, even though the number of total cases remained low, the number of severe illnesses started to rise. After the Delta variant became dominant, both the number and severity of cases increased, and after August 2021, more than 25% of pregnant people diagnosed with COVID-19 required hospitalization.
Hospitalizations Double
“We need to focus and really act urgently to recommend vaccination in pregnancy because that is the primary prevention tool that we have,” says Dr. Adhikari. “We do not have a proven cure for this illness, and that is important to know.”
These findings, which focus on a vulnerable population, are especially important given the elevated prevalence of COVID-19 in pregnant people of lower economic status, said Lissette Tanner, MD, MPH, from Emory University in Atlanta, who was not involved with the study.
“There are higher rates of hospitalization and death among Black, Hispanic, and Native American communities,” she reported. “It is essential to know how the virus is affecting those most affected and often most disadvantaged to deal with the pandemic.”
Vaccination rates are low in this population; just 19.2% of pregnant women receive at least one dose during pregnancy, according to the CDC. But pregnancy confers a higher risk for severe COVID-19 illness and for adverse outcomes, such as preterm birth and stillbirth.
Of the 665 people in the study cohort who were pregnant or had given birth when the vaccines were available, only 21.4% received at least one dose of a COVID-19 vaccine.
Given the increased risk for COVID-19 during pregnancy, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC recommend vaccination for people who are pregnant, breastfeeding, or trying to get pregnant.
According to ACOG, pregnant women who are fully vaccinated can follow the same guidelines as everyone else who is fully vaccinated; however, to prevent breakthrough infections, they might want to continue wearing a mask. ACOG also recommends that those not fully vaccinated follow physical-distancing guidelines and limit contact with people as much as possible to avoid infection.
A version of this article first appeared on WebMD.com.
An increasing number of people who are unvaccinated and pregnant are being hospitalized for COVID-19, report investigators who saw hospital admissions double in a single year.
“With the surge, we had expected to begin treating patients who developed severe or critical illness again in pregnancy,” says Emily Adhikari, MD, from the University of Texas Southwestern Medical Center in Dallas. “But we did not expect the level of respiratory illness that we began to see in our patients. That was a surprise and an alarming finding that we felt was really important to get out there.”
The researchers followed more than 1,500 pregnant women diagnosed with COVID-19 who received care from Parkland Health and Hospital System in Dallas County, one of the nation’s busiest for deliveries. After the emergence of the Delta variant, the number of pregnant women hospitalized with COVID-19 more than doubled over the previous year.
And 82 pregnant women went on to develop severe or critical COVID, they report in their study, published online in the American Journal of Obstetrics and Gynecology. All but 1 of these patients were unvaccinated, 10 needed a ventilator, and two died.
The proportion of cases that were critical was about 5% in 2020. However, in April 2021, even though the number of total cases remained low, the number of severe illnesses started to rise. After the Delta variant became dominant, both the number and severity of cases increased, and after August 2021, more than 25% of pregnant people diagnosed with COVID-19 required hospitalization.
Hospitalizations Double
“We need to focus and really act urgently to recommend vaccination in pregnancy because that is the primary prevention tool that we have,” says Dr. Adhikari. “We do not have a proven cure for this illness, and that is important to know.”
These findings, which focus on a vulnerable population, are especially important given the elevated prevalence of COVID-19 in pregnant people of lower economic status, said Lissette Tanner, MD, MPH, from Emory University in Atlanta, who was not involved with the study.
“There are higher rates of hospitalization and death among Black, Hispanic, and Native American communities,” she reported. “It is essential to know how the virus is affecting those most affected and often most disadvantaged to deal with the pandemic.”
Vaccination rates are low in this population; just 19.2% of pregnant women receive at least one dose during pregnancy, according to the CDC. But pregnancy confers a higher risk for severe COVID-19 illness and for adverse outcomes, such as preterm birth and stillbirth.
Of the 665 people in the study cohort who were pregnant or had given birth when the vaccines were available, only 21.4% received at least one dose of a COVID-19 vaccine.
Given the increased risk for COVID-19 during pregnancy, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC recommend vaccination for people who are pregnant, breastfeeding, or trying to get pregnant.
According to ACOG, pregnant women who are fully vaccinated can follow the same guidelines as everyone else who is fully vaccinated; however, to prevent breakthrough infections, they might want to continue wearing a mask. ACOG also recommends that those not fully vaccinated follow physical-distancing guidelines and limit contact with people as much as possible to avoid infection.
A version of this article first appeared on WebMD.com.