Elevated pulmonary artery diastolic pressure is “perhaps the best predictor of bad outcomes in patients with heart failure, including hospitalization and death,” and new evidence clearly showed that the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin cuts this metric in patients by a clinically significant amount, Mikhail Kosiborod, MD, said at the virtual annual scientific meeting of the Heart Failure Society of America.

Doug Brunk/MDedge News

The evidence he collected from a total of 65 heart failure patients with either reduced or preserved ejection fraction is the first documentation from a randomized, controlled study to show a direct effect by a SGLT2 inhibitor on pulmonary artery (PA) pressures.

Other key findings were that the drop in PA diastolic pressure with empagliflozin treatment compared with placebo became discernible early (within the first 4 weeks on treatment), that the pressure-lowering effect steadily grew over time, and that it showed no link to the intensity of loop diuretic treatment, which held steady during 12 weeks on treatment and 13 weeks of overall monitoring.

The study’s primary endpoint was the change from baseline in PA diastolic pressure after 12 weeks on treatment. The 31 patients who completed the full 12-week course had an average drop in their PA diastolic pressure of about 1.5 mm Hg, compared with 28 patients who completed 12 weeks on placebo. Average PA diastolic pressure at baseline was about 21 mm Hg in both treatment arms, and on treatment this fell by more than 0.5 mm Hg among those who received empagliflozin and rose by close to 1 mm Hg among control patients.

“There appears to be a direct effect of empagliflozin on pulmonary artery pressure that’s not been previously demonstrated” by an SGLT2 inhibitor, Dr. Kosiborod said. “I think this is one mechanism of action” for this drug class. “If you control pulmonary artery filling pressures you can prevent hospitalizations and deaths.”
 

Small reductions matter

“Small pressure differences are particularly important for pulmonary hypertension,” commented Lynne W. Stevenson, MD, professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn., and the report’s designated discussant.

“In the Vanderbilt heart failure database, patients with a pulmonary artery mean pressure of 20-24 mm Hg had 30% higher mortality than patients with lower pressures,” Dr. Stevenson noted. “This has led to a new definition of pulmonary hypertension, a mean pulmonary artery pressure above at or above 20 mm Hg.”

In Dr. Kosiborod’s study, patients began with an average PA mean pressure of about 30 mm Hg, and empagliflozin treatment led to a reduction in this metric with about the same magnitude as its effect on PA diastolic pressure. Empagliflozin also produced a similar reduction in average PA systolic pressure.

Mitchel L. Zoler/MDedge News

A study built on ambulatory PA monitoring

The results “also provide more proof for the concept of ambulatory hemodynamic monitoring” in patients with heart failure to monitor their status, she added. The study enrolled only patients who had already received a CardioMEMS implant as part of their routine care. This device allows for frequent, noninvasive monitoring of PA pressures. Researchers collected PA pressure data from patients twice daily for the entire 13-week study.

The EMBRACE HF (Empagliflozin Impact on Hemodynamics in Patients With Heart Failure) study enrolled patients with established heart failure, a CardioMEMS implant, and New York Heart Association class II-IV symptoms at any of eight U.S. centers. Patients averaged about 65 years old, and slightly more than half had class III disease, which denotes marked limitation of physical activity.

Despite the brief treatment period, patients who received empagliflozin showed other evidence of benefit including a trend toward improved quality of life scores, reduced levels of two different forms of brain natriuretic peptide, and significant weight loss, compared with controls, that averaged 2.4 kg.

The mechanism by which empagliflozin and other drugs in its class might lower PA filling pressures is unclear, but Dr. Kosiborod stressed that the consistent level of loop diuretic use during the study seems to rule out a diuretic effect from the SGLT2 inhibitor as having a role. A pulmonary vasculature effect is “much more likely,” perhaps mediated through modified endothelial function and vasodilation, he suggested.

EMBRACE HF was funded by Boehringer Ingelheim, the company that markets empagliflozin (Jardiance) along with Eli Lilly. Dr. Kosiborod has received research support and honoraria from Boehringer Ingelheim, and he has received honoraria from several other companies. Dr. Stevenson had no disclosures.

mzoler@mdedge.com

Elevated pulmonary artery diastolic pressure is “perhaps the best predictor of bad outcomes in patients with heart failure, including hospitalization and death,” and new evidence clearly showed that the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin cuts this metric in patients by a clinically significant amount, Mikhail Kosiborod, MD, said at the virtual annual scientific meeting of the Heart Failure Society of America.

Doug Brunk/MDedge News

The evidence he collected from a total of 65 heart failure patients with either reduced or preserved ejection fraction is the first documentation from a randomized, controlled study to show a direct effect by a SGLT2 inhibitor on pulmonary artery (PA) pressures.

Other key findings were that the drop in PA diastolic pressure with empagliflozin treatment compared with placebo became discernible early (within the first 4 weeks on treatment), that the pressure-lowering effect steadily grew over time, and that it showed no link to the intensity of loop diuretic treatment, which held steady during 12 weeks on treatment and 13 weeks of overall monitoring.

The study’s primary endpoint was the change from baseline in PA diastolic pressure after 12 weeks on treatment. The 31 patients who completed the full 12-week course had an average drop in their PA diastolic pressure of about 1.5 mm Hg, compared with 28 patients who completed 12 weeks on placebo. Average PA diastolic pressure at baseline was about 21 mm Hg in both treatment arms, and on treatment this fell by more than 0.5 mm Hg among those who received empagliflozin and rose by close to 1 mm Hg among control patients.

“There appears to be a direct effect of empagliflozin on pulmonary artery pressure that’s not been previously demonstrated” by an SGLT2 inhibitor, Dr. Kosiborod said. “I think this is one mechanism of action” for this drug class. “If you control pulmonary artery filling pressures you can prevent hospitalizations and deaths.”
 

Small reductions matter

“Small pressure differences are particularly important for pulmonary hypertension,” commented Lynne W. Stevenson, MD, professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn., and the report’s designated discussant.

“In the Vanderbilt heart failure database, patients with a pulmonary artery mean pressure of 20-24 mm Hg had 30% higher mortality than patients with lower pressures,” Dr. Stevenson noted. “This has led to a new definition of pulmonary hypertension, a mean pulmonary artery pressure above at or above 20 mm Hg.”

In Dr. Kosiborod’s study, patients began with an average PA mean pressure of about 30 mm Hg, and empagliflozin treatment led to a reduction in this metric with about the same magnitude as its effect on PA diastolic pressure. Empagliflozin also produced a similar reduction in average PA systolic pressure.

Mitchel L. Zoler/MDedge News

A study built on ambulatory PA monitoring

The results “also provide more proof for the concept of ambulatory hemodynamic monitoring” in patients with heart failure to monitor their status, she added. The study enrolled only patients who had already received a CardioMEMS implant as part of their routine care. This device allows for frequent, noninvasive monitoring of PA pressures. Researchers collected PA pressure data from patients twice daily for the entire 13-week study.

The EMBRACE HF (Empagliflozin Impact on Hemodynamics in Patients With Heart Failure) study enrolled patients with established heart failure, a CardioMEMS implant, and New York Heart Association class II-IV symptoms at any of eight U.S. centers. Patients averaged about 65 years old, and slightly more than half had class III disease, which denotes marked limitation of physical activity.

Despite the brief treatment period, patients who received empagliflozin showed other evidence of benefit including a trend toward improved quality of life scores, reduced levels of two different forms of brain natriuretic peptide, and significant weight loss, compared with controls, that averaged 2.4 kg.

The mechanism by which empagliflozin and other drugs in its class might lower PA filling pressures is unclear, but Dr. Kosiborod stressed that the consistent level of loop diuretic use during the study seems to rule out a diuretic effect from the SGLT2 inhibitor as having a role. A pulmonary vasculature effect is “much more likely,” perhaps mediated through modified endothelial function and vasodilation, he suggested.

EMBRACE HF was funded by Boehringer Ingelheim, the company that markets empagliflozin (Jardiance) along with Eli Lilly. Dr. Kosiborod has received research support and honoraria from Boehringer Ingelheim, and he has received honoraria from several other companies. Dr. Stevenson had no disclosures.

mzoler@mdedge.com

Elevated pulmonary artery diastolic pressure is “perhaps the best predictor of bad outcomes in patients with heart failure, including hospitalization and death,” and new evidence clearly showed that the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin cuts this metric in patients by a clinically significant amount, Mikhail Kosiborod, MD, said at the virtual annual scientific meeting of the Heart Failure Society of America.

Doug Brunk/MDedge News

The evidence he collected from a total of 65 heart failure patients with either reduced or preserved ejection fraction is the first documentation from a randomized, controlled study to show a direct effect by a SGLT2 inhibitor on pulmonary artery (PA) pressures.

Other key findings were that the drop in PA diastolic pressure with empagliflozin treatment compared with placebo became discernible early (within the first 4 weeks on treatment), that the pressure-lowering effect steadily grew over time, and that it showed no link to the intensity of loop diuretic treatment, which held steady during 12 weeks on treatment and 13 weeks of overall monitoring.

The study’s primary endpoint was the change from baseline in PA diastolic pressure after 12 weeks on treatment. The 31 patients who completed the full 12-week course had an average drop in their PA diastolic pressure of about 1.5 mm Hg, compared with 28 patients who completed 12 weeks on placebo. Average PA diastolic pressure at baseline was about 21 mm Hg in both treatment arms, and on treatment this fell by more than 0.5 mm Hg among those who received empagliflozin and rose by close to 1 mm Hg among control patients.

“There appears to be a direct effect of empagliflozin on pulmonary artery pressure that’s not been previously demonstrated” by an SGLT2 inhibitor, Dr. Kosiborod said. “I think this is one mechanism of action” for this drug class. “If you control pulmonary artery filling pressures you can prevent hospitalizations and deaths.”
 

Small reductions matter

“Small pressure differences are particularly important for pulmonary hypertension,” commented Lynne W. Stevenson, MD, professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn., and the report’s designated discussant.

“In the Vanderbilt heart failure database, patients with a pulmonary artery mean pressure of 20-24 mm Hg had 30% higher mortality than patients with lower pressures,” Dr. Stevenson noted. “This has led to a new definition of pulmonary hypertension, a mean pulmonary artery pressure above at or above 20 mm Hg.”

In Dr. Kosiborod’s study, patients began with an average PA mean pressure of about 30 mm Hg, and empagliflozin treatment led to a reduction in this metric with about the same magnitude as its effect on PA diastolic pressure. Empagliflozin also produced a similar reduction in average PA systolic pressure.

Mitchel L. Zoler/MDedge News

A study built on ambulatory PA monitoring

The results “also provide more proof for the concept of ambulatory hemodynamic monitoring” in patients with heart failure to monitor their status, she added. The study enrolled only patients who had already received a CardioMEMS implant as part of their routine care. This device allows for frequent, noninvasive monitoring of PA pressures. Researchers collected PA pressure data from patients twice daily for the entire 13-week study.

The EMBRACE HF (Empagliflozin Impact on Hemodynamics in Patients With Heart Failure) study enrolled patients with established heart failure, a CardioMEMS implant, and New York Heart Association class II-IV symptoms at any of eight U.S. centers. Patients averaged about 65 years old, and slightly more than half had class III disease, which denotes marked limitation of physical activity.

Despite the brief treatment period, patients who received empagliflozin showed other evidence of benefit including a trend toward improved quality of life scores, reduced levels of two different forms of brain natriuretic peptide, and significant weight loss, compared with controls, that averaged 2.4 kg.

The mechanism by which empagliflozin and other drugs in its class might lower PA filling pressures is unclear, but Dr. Kosiborod stressed that the consistent level of loop diuretic use during the study seems to rule out a diuretic effect from the SGLT2 inhibitor as having a role. A pulmonary vasculature effect is “much more likely,” perhaps mediated through modified endothelial function and vasodilation, he suggested.

EMBRACE HF was funded by Boehringer Ingelheim, the company that markets empagliflozin (Jardiance) along with Eli Lilly. Dr. Kosiborod has received research support and honoraria from Boehringer Ingelheim, and he has received honoraria from several other companies. Dr. Stevenson had no disclosures.

mzoler@mdedge.com

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

The Diagnosis: Fusariosis 

A periodic acid-Schiff stain of the seropurulent drainage from a skin nodule revealed neutrophils and scarce branching hyaline hyphae. Skin and blood cultures grew a white cottony colony. Microscopic examination showed sickle-shaped macroconidia and septate hyaline hyphae with branching acute angles (Figure). Molecular analysis by polymerase chain reaction yielded Fusarium solani species complex. Histopathology as well as culture and molecular findings were consistent with a diagnosis of disseminated fusariosis. Amphotericin B was started with rapid clinical improvement. The patient was asymptomatic upon discharge with voriconazole 200 mg twice daily. 

Fusariosis is an emerging, opportunistic, and life-threatening mycosis. In immunocompetent patients it may cause onychomycosis and keratitis.¹ Invasive fusariosis predominantly is caused by the F solani species complex and affects immunocompromised patients, especially those with neutropenia or acute leukemia or hematopoietic stem cell transplant recipients.² 

Before invasion, the infection frequently may begin by affecting the nail apparatus as onychomycosis or paronychia of the skin. As in our case, trauma or manipulation of the nail favors dissemination.³ Skin manifestations include erythematous to violaceous papules, macules, and nodules with central necrosis or crust; some may exhibit target morphology. Other organs may be affected, including the sinuses, lungs, liver, spleen, and kidneys. A comprehensive clinical examination before hematopoietic cell transplant and during fever and neutropenia may opportunely identify these potential infective foci.^3,4 

The differential diagnosis of disseminated fusariosis includes bacterial infections, especially Staphylococcus aureus and Pseudomonas aeruginosa, and other invasive fungal infections, particularly aspergillosis, mucormycosis, and candidiasis.⁵ Symptom persistence after broad-spectrum antibiotic initiation should raise diagnostic suspicion of systemic mycosis or mycobacterial infection. Mucormycosis and candidiasis have histopathologic profiles that differ from fusariosis, presenting with broad ribbonlike hyphae with 90° angulation and pseudohyphae with budding yeast cells, respectively. Differentiation of disseminated fusariosis and aspergillosis in neutropenic patients is difficult. Hyphae cannot be differentiated from those of Aspergillus species on histology.⁶ Furthermore, serologic assays, such as galactomannan and (1,3)-β-D-glucan, cross-react with both genera. Clinically, Fusarium species exhibit metastatic skin lesions, cellulitis, and positive blood cultures due to adventitious sporulation more frequently than Aspergillus species. Patients with aspergillosis more commonly present with sinusitis, pneumonia, and pulmonary macronodules with the halo sign.⁶ Although nocardiosis presents with disseminated subcutaneous nodules with pulmonary affection in immunocompromised patients, its morphology is very different from fusariosis. Nocardia presents with a gram-positive bacillus with the microscopic appearance of branching filaments. Yeastlike microorganisms with morphology ranging from oval to sausagelike are found in talaromycosis, an uncommon fungal infection predominantly caused by Talaromyces marneffei. Fusarium species culture reveals white cottony colonies with characteristic hyaline, canoe-shaped or sickle-shaped (banana-shaped), multicellular macroconidia, and microconidia. Precise species identification requires molecular analyses such as polymerase chain reaction. 

Mortality is high, ranging from 50% to 70% of cases.⁵ Voriconazole or lipid-based amphotericin B are considered first-line treatments. Posaconazole may be employed as a second-line alternative. Surgical debridement of infected tissues and removal of colonized venous catheters is recommended. Secondary prophylaxis should be considered with agents such as voriconazole, posaconazole, or amphotericin B.⁵ Resolution of immunosuppression and neutropenia is an important factor to reduce the mortality rate. 

The Diagnosis: Fusariosis 

A periodic acid-Schiff stain of the seropurulent drainage from a skin nodule revealed neutrophils and scarce branching hyaline hyphae. Skin and blood cultures grew a white cottony colony. Microscopic examination showed sickle-shaped macroconidia and septate hyaline hyphae with branching acute angles (Figure). Molecular analysis by polymerase chain reaction yielded Fusarium solani species complex. Histopathology as well as culture and molecular findings were consistent with a diagnosis of disseminated fusariosis. Amphotericin B was started with rapid clinical improvement. The patient was asymptomatic upon discharge with voriconazole 200 mg twice daily. 

Fusariosis is an emerging, opportunistic, and life-threatening mycosis. In immunocompetent patients it may cause onychomycosis and keratitis.¹ Invasive fusariosis predominantly is caused by the F solani species complex and affects immunocompromised patients, especially those with neutropenia or acute leukemia or hematopoietic stem cell transplant recipients.² 

Before invasion, the infection frequently may begin by affecting the nail apparatus as onychomycosis or paronychia of the skin. As in our case, trauma or manipulation of the nail favors dissemination.³ Skin manifestations include erythematous to violaceous papules, macules, and nodules with central necrosis or crust; some may exhibit target morphology. Other organs may be affected, including the sinuses, lungs, liver, spleen, and kidneys. A comprehensive clinical examination before hematopoietic cell transplant and during fever and neutropenia may opportunely identify these potential infective foci.^3,4 

The differential diagnosis of disseminated fusariosis includes bacterial infections, especially Staphylococcus aureus and Pseudomonas aeruginosa, and other invasive fungal infections, particularly aspergillosis, mucormycosis, and candidiasis.⁵ Symptom persistence after broad-spectrum antibiotic initiation should raise diagnostic suspicion of systemic mycosis or mycobacterial infection. Mucormycosis and candidiasis have histopathologic profiles that differ from fusariosis, presenting with broad ribbonlike hyphae with 90° angulation and pseudohyphae with budding yeast cells, respectively. Differentiation of disseminated fusariosis and aspergillosis in neutropenic patients is difficult. Hyphae cannot be differentiated from those of Aspergillus species on histology.⁶ Furthermore, serologic assays, such as galactomannan and (1,3)-β-D-glucan, cross-react with both genera. Clinically, Fusarium species exhibit metastatic skin lesions, cellulitis, and positive blood cultures due to adventitious sporulation more frequently than Aspergillus species. Patients with aspergillosis more commonly present with sinusitis, pneumonia, and pulmonary macronodules with the halo sign.⁶ Although nocardiosis presents with disseminated subcutaneous nodules with pulmonary affection in immunocompromised patients, its morphology is very different from fusariosis. Nocardia presents with a gram-positive bacillus with the microscopic appearance of branching filaments. Yeastlike microorganisms with morphology ranging from oval to sausagelike are found in talaromycosis, an uncommon fungal infection predominantly caused by Talaromyces marneffei. Fusarium species culture reveals white cottony colonies with characteristic hyaline, canoe-shaped or sickle-shaped (banana-shaped), multicellular macroconidia, and microconidia. Precise species identification requires molecular analyses such as polymerase chain reaction. 

Mortality is high, ranging from 50% to 70% of cases.⁵ Voriconazole or lipid-based amphotericin B are considered first-line treatments. Posaconazole may be employed as a second-line alternative. Surgical debridement of infected tissues and removal of colonized venous catheters is recommended. Secondary prophylaxis should be considered with agents such as voriconazole, posaconazole, or amphotericin B.⁵ Resolution of immunosuppression and neutropenia is an important factor to reduce the mortality rate. 

The Diagnosis: Fusariosis 

A periodic acid-Schiff stain of the seropurulent drainage from a skin nodule revealed neutrophils and scarce branching hyaline hyphae. Skin and blood cultures grew a white cottony colony. Microscopic examination showed sickle-shaped macroconidia and septate hyaline hyphae with branching acute angles (Figure). Molecular analysis by polymerase chain reaction yielded Fusarium solani species complex. Histopathology as well as culture and molecular findings were consistent with a diagnosis of disseminated fusariosis. Amphotericin B was started with rapid clinical improvement. The patient was asymptomatic upon discharge with voriconazole 200 mg twice daily. 

Fusariosis is an emerging, opportunistic, and life-threatening mycosis. In immunocompetent patients it may cause onychomycosis and keratitis.¹ Invasive fusariosis predominantly is caused by the F solani species complex and affects immunocompromised patients, especially those with neutropenia or acute leukemia or hematopoietic stem cell transplant recipients.² 

Before invasion, the infection frequently may begin by affecting the nail apparatus as onychomycosis or paronychia of the skin. As in our case, trauma or manipulation of the nail favors dissemination.³ Skin manifestations include erythematous to violaceous papules, macules, and nodules with central necrosis or crust; some may exhibit target morphology. Other organs may be affected, including the sinuses, lungs, liver, spleen, and kidneys. A comprehensive clinical examination before hematopoietic cell transplant and during fever and neutropenia may opportunely identify these potential infective foci.^3,4 

The differential diagnosis of disseminated fusariosis includes bacterial infections, especially Staphylococcus aureus and Pseudomonas aeruginosa, and other invasive fungal infections, particularly aspergillosis, mucormycosis, and candidiasis.⁵ Symptom persistence after broad-spectrum antibiotic initiation should raise diagnostic suspicion of systemic mycosis or mycobacterial infection. Mucormycosis and candidiasis have histopathologic profiles that differ from fusariosis, presenting with broad ribbonlike hyphae with 90° angulation and pseudohyphae with budding yeast cells, respectively. Differentiation of disseminated fusariosis and aspergillosis in neutropenic patients is difficult. Hyphae cannot be differentiated from those of Aspergillus species on histology.⁶ Furthermore, serologic assays, such as galactomannan and (1,3)-β-D-glucan, cross-react with both genera. Clinically, Fusarium species exhibit metastatic skin lesions, cellulitis, and positive blood cultures due to adventitious sporulation more frequently than Aspergillus species. Patients with aspergillosis more commonly present with sinusitis, pneumonia, and pulmonary macronodules with the halo sign.⁶ Although nocardiosis presents with disseminated subcutaneous nodules with pulmonary affection in immunocompromised patients, its morphology is very different from fusariosis. Nocardia presents with a gram-positive bacillus with the microscopic appearance of branching filaments. Yeastlike microorganisms with morphology ranging from oval to sausagelike are found in talaromycosis, an uncommon fungal infection predominantly caused by Talaromyces marneffei. Fusarium species culture reveals white cottony colonies with characteristic hyaline, canoe-shaped or sickle-shaped (banana-shaped), multicellular macroconidia, and microconidia. Precise species identification requires molecular analyses such as polymerase chain reaction. 

Mortality is high, ranging from 50% to 70% of cases.⁵ Voriconazole or lipid-based amphotericin B are considered first-line treatments. Posaconazole may be employed as a second-line alternative. Surgical debridement of infected tissues and removal of colonized venous catheters is recommended. Secondary prophylaxis should be considered with agents such as voriconazole, posaconazole, or amphotericin B.⁵ Resolution of immunosuppression and neutropenia is an important factor to reduce the mortality rate. 

Gender-incongruent youth who present for gender-affirming medical care later in adolescence have higher rates of mental health problems than their younger counterparts, based on data from a review of 300 individuals.

Peerayot/Thinkstock.com

“Puberty is a vulnerable time for youth with gender dysphoria because distress may intensify with the development of secondary sex characteristics corresponding to the assigned rather than the experienced gender,” wrote Julia C. Sorbara, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, and colleagues.

Although gender-affirming medical care (GAMC) in the form of hormone blockers and/or gender-affirming hormones early in puberty can decrease in emotional and behavioral problems, many teens present later in puberty, and the relationship between pubertal stage at presentation for treatment and mental health has not been examined, they wrote.

In a study published in Pediatrics, the researchers reviewed data from youth with gender incongruence who were seen at a single center; 116 were younger than 15 years at presentation for GAMC and were defined as younger-presenting youth (YPY), and 184 patients aged 15 years and older were defined as older-presenting youth (OPY).

Overall, 78% of the youth reported at least one mental health problem at their initial visit. Significantly more OPY than YPY reported diagnosed depression (46% vs. 30%), self-harm (40% vs. 28%), suicidal thoughts (52% vs. 40%), suicide attempts (17% vs. 9%), and use of psychoactive medications (36% vs. 23%), all with P < .05.

In a multivariate analysis, patients in Tanner stages 4 and 5 were five times more likely to experience depressive disorders (odds ratio, 5.49) and four times as likely to experience depressive disorders (OR, 4.18) as those in earlier Tanner stages. Older age remained significantly associated with use of psychoactive medications (OR, 1.31), but not with anxiety or depression, the researchers wrote.

The YPY group were significantly younger at the age of recognizing gender incongruence, compared with the OPY group, with median ages at recognition of 5.8 years and 9 years, respectively, and younger patients came out about their gender identity at an average of 12 years, compared with 15 years for older patients.

The quantitative data are among the first to relate pubertal stage to mental health in gender-incongruent youth, “supporting clinical observations that pubertal development, menses, and erections are distressing to these youth and consistent with the beneficial role of pubertal suppression, even when used as monotherapy without gender-affirming hormones,” Dr. Sorbara and associates wrote.

The study findings were limited by several factors including the cross-sectional design and the collection of mental health data at only one time point and by the use of self-reports. However, the results suggest that “[gender-incongruent] youth who present to GAMC later in life are a particularly high-risk subset of a vulnerable population,” they noted. “Further study is required to better describe the mental health trajectories of transgender youth and determine if mental health status or age at initiation of GAMC is correlated with psychological well-being in adulthood.”
 

Don’t rush to puberty suppression in younger teens

To reduce the stress of puberty on gender-nonconforming youth, puberty suppression as “a reversible medical intervention” was introduced by Dutch clinicians in the early 2000s, Annelou L.C. de Vries, MD, PhD, of Amsterdam University Medical Center, wrote in an accompanying editorial.

“The aim of puberty suppression was to prevent the psychological suffering stemming from undesired physical changes when puberty starts and allowing the adolescent time to make plans regarding further transition or not,” Dr. de Vries said. “Following this rationale, younger age at the time of starting medical-affirming treatment (puberty suppression or hormones) would be expected to correlate with fewer psychological difficulties related to physical changes than older individuals,” which was confirmed in the current study.

However, clinicians should be cautious in offering puberty suppression at a younger age, in part because “despite the increased availability of gender-affirming medical interventions for younger ages in recent years, there has not been a proportional decline in older presenting youth with gender incongruence,” she said.

More data are needed on youth with postpuberty adolescent-onset transgender histories. The original Dutch studies on gender-affirming medical interventions note case histories describing “the complexities that may be associated with later-presenting transgender adolescents and describe that some eventually detransition,” Dr. de Vries explained.

Ultimately, prospective studies with longer follow-up data are needed to better inform clinicians in developing an individualized treatment plan for youth with gender incongruence, Dr. de Vries concluded.
 

Care barriers can include parents, access, insurance

The study authors describe the situation of gender-affirming medical care in teens perfectly, M. Brett Cooper, MD, of the University of Texas Southwestern Medical Center/Children’s Health Dallas, said in an interview.

Given a variety of factors that need further exploration, “many youth often don’t end up seeking gender-affirming medical care until puberty has progressed to near full maturity,” he said. “The findings from this study provide preliminary evidence to show that if we can identify these youth earlier in their gender journey, we might be able to impact adverse mental health outcomes in a positive way.”

Dr. Cooper said he was not surprised by the study findings. “They are similar to what I see in my clinic.

“Many of our patients often don’t present for medical care until around age 15 or older, similar to the findings of the study,” he added. “The majority of our patients have had a diagnosis of anxiety or depression at some point in their lifetime, including inpatient hospitalizations for their mental health.”

One of the most important barriers to care often can be parents or guardians, said Dr. Cooper. “Young people usually know their gender identity by about age 4-5 but parents may think that a gender-diverse identity could simply be a ‘phase.’ Other times, young people may hide their identity out of fear of a negative reaction from their parents. The distress around identity may become more pronounced once pubertal changes, such as breast and testicle development, begin to worsen their dysphoria.”

“Another barrier to care can be the inability to find a competent, gender-affirming provider,” Dr. Cooper said. “Most large United States cities have at least one gender-affirming clinic, but for those youth who grow up in smaller towns, it may be difficult to access these clinics. In addition, some clinics require a letter from a therapist stating that the young person is transgender before they can be seen for medical care. This creates an access barrier, as it may be difficult not just to find a therapist but one who has experience working with gender-diverse youth.”

Insurance coverage, including lack thereof, is yet another barrier to care for transgender youth, said Dr. Cooper. “While many insurance companies have begun to cover medications such as testosterone and estrogen for gender-affirming care, many still have exclusions on things like puberty blockers and surgical interventions.” These interventions can be lifesaving, but financially prohibitive for many families if not covered by insurance.

As for the value of early timing of gender-affirming care, Dr. Cooper agreed with the study findings that the earlier that a young person can get into medical care for their gender identity, the better chance there is to reduce the prevalence of serious mental health outcomes. “This also prevents the potential development of secondary sexual characteristics, decreasing the need for or amount of surgery in the future if desired,” he said.

“More research is needed to better understand the reasons why many youth don’t present to care until later in puberty. In addition, we need better research on interventions that are effective at reducing serious mental health events in transgender and gender diverse youth,” Dr. Cooper stated. “Another area that I would like to see researched is looking at the mental health of non-Caucasian youth. As the authors noted in their study, many clinics have a high percentage of patients presenting for care who identify as White or Caucasian, and we need to better understand why these other youth are not presenting for care.”

The study received no outside funding. Dr. Sorbara disclosed salary support from the Canadian Pediatric Endocrine Group fellowship program. Dr. de Vries had no financial conflicts to disclose. Dr. Cooper had no financial conflicts to disclose, and serves as a contributor to LGBTQ Youth Consult in Pediatric News.

SOURCES: Sorbara JC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2019-3600; de Vries ALC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2020-010611.

Gender-incongruent youth who present for gender-affirming medical care later in adolescence have higher rates of mental health problems than their younger counterparts, based on data from a review of 300 individuals.

Peerayot/Thinkstock.com

“Puberty is a vulnerable time for youth with gender dysphoria because distress may intensify with the development of secondary sex characteristics corresponding to the assigned rather than the experienced gender,” wrote Julia C. Sorbara, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, and colleagues.

Although gender-affirming medical care (GAMC) in the form of hormone blockers and/or gender-affirming hormones early in puberty can decrease in emotional and behavioral problems, many teens present later in puberty, and the relationship between pubertal stage at presentation for treatment and mental health has not been examined, they wrote.

In a study published in Pediatrics, the researchers reviewed data from youth with gender incongruence who were seen at a single center; 116 were younger than 15 years at presentation for GAMC and were defined as younger-presenting youth (YPY), and 184 patients aged 15 years and older were defined as older-presenting youth (OPY).

Overall, 78% of the youth reported at least one mental health problem at their initial visit. Significantly more OPY than YPY reported diagnosed depression (46% vs. 30%), self-harm (40% vs. 28%), suicidal thoughts (52% vs. 40%), suicide attempts (17% vs. 9%), and use of psychoactive medications (36% vs. 23%), all with P < .05.

In a multivariate analysis, patients in Tanner stages 4 and 5 were five times more likely to experience depressive disorders (odds ratio, 5.49) and four times as likely to experience depressive disorders (OR, 4.18) as those in earlier Tanner stages. Older age remained significantly associated with use of psychoactive medications (OR, 1.31), but not with anxiety or depression, the researchers wrote.

The YPY group were significantly younger at the age of recognizing gender incongruence, compared with the OPY group, with median ages at recognition of 5.8 years and 9 years, respectively, and younger patients came out about their gender identity at an average of 12 years, compared with 15 years for older patients.

The quantitative data are among the first to relate pubertal stage to mental health in gender-incongruent youth, “supporting clinical observations that pubertal development, menses, and erections are distressing to these youth and consistent with the beneficial role of pubertal suppression, even when used as monotherapy without gender-affirming hormones,” Dr. Sorbara and associates wrote.

The study findings were limited by several factors including the cross-sectional design and the collection of mental health data at only one time point and by the use of self-reports. However, the results suggest that “[gender-incongruent] youth who present to GAMC later in life are a particularly high-risk subset of a vulnerable population,” they noted. “Further study is required to better describe the mental health trajectories of transgender youth and determine if mental health status or age at initiation of GAMC is correlated with psychological well-being in adulthood.”
 

Don’t rush to puberty suppression in younger teens

To reduce the stress of puberty on gender-nonconforming youth, puberty suppression as “a reversible medical intervention” was introduced by Dutch clinicians in the early 2000s, Annelou L.C. de Vries, MD, PhD, of Amsterdam University Medical Center, wrote in an accompanying editorial.

“The aim of puberty suppression was to prevent the psychological suffering stemming from undesired physical changes when puberty starts and allowing the adolescent time to make plans regarding further transition or not,” Dr. de Vries said. “Following this rationale, younger age at the time of starting medical-affirming treatment (puberty suppression or hormones) would be expected to correlate with fewer psychological difficulties related to physical changes than older individuals,” which was confirmed in the current study.

However, clinicians should be cautious in offering puberty suppression at a younger age, in part because “despite the increased availability of gender-affirming medical interventions for younger ages in recent years, there has not been a proportional decline in older presenting youth with gender incongruence,” she said.

More data are needed on youth with postpuberty adolescent-onset transgender histories. The original Dutch studies on gender-affirming medical interventions note case histories describing “the complexities that may be associated with later-presenting transgender adolescents and describe that some eventually detransition,” Dr. de Vries explained.

Ultimately, prospective studies with longer follow-up data are needed to better inform clinicians in developing an individualized treatment plan for youth with gender incongruence, Dr. de Vries concluded.
 

Care barriers can include parents, access, insurance

The study authors describe the situation of gender-affirming medical care in teens perfectly, M. Brett Cooper, MD, of the University of Texas Southwestern Medical Center/Children’s Health Dallas, said in an interview.

Given a variety of factors that need further exploration, “many youth often don’t end up seeking gender-affirming medical care until puberty has progressed to near full maturity,” he said. “The findings from this study provide preliminary evidence to show that if we can identify these youth earlier in their gender journey, we might be able to impact adverse mental health outcomes in a positive way.”

Dr. Cooper said he was not surprised by the study findings. “They are similar to what I see in my clinic.

“Many of our patients often don’t present for medical care until around age 15 or older, similar to the findings of the study,” he added. “The majority of our patients have had a diagnosis of anxiety or depression at some point in their lifetime, including inpatient hospitalizations for their mental health.”

One of the most important barriers to care often can be parents or guardians, said Dr. Cooper. “Young people usually know their gender identity by about age 4-5 but parents may think that a gender-diverse identity could simply be a ‘phase.’ Other times, young people may hide their identity out of fear of a negative reaction from their parents. The distress around identity may become more pronounced once pubertal changes, such as breast and testicle development, begin to worsen their dysphoria.”

“Another barrier to care can be the inability to find a competent, gender-affirming provider,” Dr. Cooper said. “Most large United States cities have at least one gender-affirming clinic, but for those youth who grow up in smaller towns, it may be difficult to access these clinics. In addition, some clinics require a letter from a therapist stating that the young person is transgender before they can be seen for medical care. This creates an access barrier, as it may be difficult not just to find a therapist but one who has experience working with gender-diverse youth.”

Insurance coverage, including lack thereof, is yet another barrier to care for transgender youth, said Dr. Cooper. “While many insurance companies have begun to cover medications such as testosterone and estrogen for gender-affirming care, many still have exclusions on things like puberty blockers and surgical interventions.” These interventions can be lifesaving, but financially prohibitive for many families if not covered by insurance.

As for the value of early timing of gender-affirming care, Dr. Cooper agreed with the study findings that the earlier that a young person can get into medical care for their gender identity, the better chance there is to reduce the prevalence of serious mental health outcomes. “This also prevents the potential development of secondary sexual characteristics, decreasing the need for or amount of surgery in the future if desired,” he said.

“More research is needed to better understand the reasons why many youth don’t present to care until later in puberty. In addition, we need better research on interventions that are effective at reducing serious mental health events in transgender and gender diverse youth,” Dr. Cooper stated. “Another area that I would like to see researched is looking at the mental health of non-Caucasian youth. As the authors noted in their study, many clinics have a high percentage of patients presenting for care who identify as White or Caucasian, and we need to better understand why these other youth are not presenting for care.”

The study received no outside funding. Dr. Sorbara disclosed salary support from the Canadian Pediatric Endocrine Group fellowship program. Dr. de Vries had no financial conflicts to disclose. Dr. Cooper had no financial conflicts to disclose, and serves as a contributor to LGBTQ Youth Consult in Pediatric News.

SOURCES: Sorbara JC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2019-3600; de Vries ALC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2020-010611.

Gender-incongruent youth who present for gender-affirming medical care later in adolescence have higher rates of mental health problems than their younger counterparts, based on data from a review of 300 individuals.

Peerayot/Thinkstock.com

“Puberty is a vulnerable time for youth with gender dysphoria because distress may intensify with the development of secondary sex characteristics corresponding to the assigned rather than the experienced gender,” wrote Julia C. Sorbara, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, and colleagues.

Although gender-affirming medical care (GAMC) in the form of hormone blockers and/or gender-affirming hormones early in puberty can decrease in emotional and behavioral problems, many teens present later in puberty, and the relationship between pubertal stage at presentation for treatment and mental health has not been examined, they wrote.

In a study published in Pediatrics, the researchers reviewed data from youth with gender incongruence who were seen at a single center; 116 were younger than 15 years at presentation for GAMC and were defined as younger-presenting youth (YPY), and 184 patients aged 15 years and older were defined as older-presenting youth (OPY).

Overall, 78% of the youth reported at least one mental health problem at their initial visit. Significantly more OPY than YPY reported diagnosed depression (46% vs. 30%), self-harm (40% vs. 28%), suicidal thoughts (52% vs. 40%), suicide attempts (17% vs. 9%), and use of psychoactive medications (36% vs. 23%), all with P < .05.

In a multivariate analysis, patients in Tanner stages 4 and 5 were five times more likely to experience depressive disorders (odds ratio, 5.49) and four times as likely to experience depressive disorders (OR, 4.18) as those in earlier Tanner stages. Older age remained significantly associated with use of psychoactive medications (OR, 1.31), but not with anxiety or depression, the researchers wrote.

The YPY group were significantly younger at the age of recognizing gender incongruence, compared with the OPY group, with median ages at recognition of 5.8 years and 9 years, respectively, and younger patients came out about their gender identity at an average of 12 years, compared with 15 years for older patients.

The quantitative data are among the first to relate pubertal stage to mental health in gender-incongruent youth, “supporting clinical observations that pubertal development, menses, and erections are distressing to these youth and consistent with the beneficial role of pubertal suppression, even when used as monotherapy without gender-affirming hormones,” Dr. Sorbara and associates wrote.

The study findings were limited by several factors including the cross-sectional design and the collection of mental health data at only one time point and by the use of self-reports. However, the results suggest that “[gender-incongruent] youth who present to GAMC later in life are a particularly high-risk subset of a vulnerable population,” they noted. “Further study is required to better describe the mental health trajectories of transgender youth and determine if mental health status or age at initiation of GAMC is correlated with psychological well-being in adulthood.”
 

Don’t rush to puberty suppression in younger teens

To reduce the stress of puberty on gender-nonconforming youth, puberty suppression as “a reversible medical intervention” was introduced by Dutch clinicians in the early 2000s, Annelou L.C. de Vries, MD, PhD, of Amsterdam University Medical Center, wrote in an accompanying editorial.

“The aim of puberty suppression was to prevent the psychological suffering stemming from undesired physical changes when puberty starts and allowing the adolescent time to make plans regarding further transition or not,” Dr. de Vries said. “Following this rationale, younger age at the time of starting medical-affirming treatment (puberty suppression or hormones) would be expected to correlate with fewer psychological difficulties related to physical changes than older individuals,” which was confirmed in the current study.

However, clinicians should be cautious in offering puberty suppression at a younger age, in part because “despite the increased availability of gender-affirming medical interventions for younger ages in recent years, there has not been a proportional decline in older presenting youth with gender incongruence,” she said.

More data are needed on youth with postpuberty adolescent-onset transgender histories. The original Dutch studies on gender-affirming medical interventions note case histories describing “the complexities that may be associated with later-presenting transgender adolescents and describe that some eventually detransition,” Dr. de Vries explained.

Ultimately, prospective studies with longer follow-up data are needed to better inform clinicians in developing an individualized treatment plan for youth with gender incongruence, Dr. de Vries concluded.
 

Care barriers can include parents, access, insurance

The study authors describe the situation of gender-affirming medical care in teens perfectly, M. Brett Cooper, MD, of the University of Texas Southwestern Medical Center/Children’s Health Dallas, said in an interview.

Given a variety of factors that need further exploration, “many youth often don’t end up seeking gender-affirming medical care until puberty has progressed to near full maturity,” he said. “The findings from this study provide preliminary evidence to show that if we can identify these youth earlier in their gender journey, we might be able to impact adverse mental health outcomes in a positive way.”

Dr. Cooper said he was not surprised by the study findings. “They are similar to what I see in my clinic.

“Many of our patients often don’t present for medical care until around age 15 or older, similar to the findings of the study,” he added. “The majority of our patients have had a diagnosis of anxiety or depression at some point in their lifetime, including inpatient hospitalizations for their mental health.”

One of the most important barriers to care often can be parents or guardians, said Dr. Cooper. “Young people usually know their gender identity by about age 4-5 but parents may think that a gender-diverse identity could simply be a ‘phase.’ Other times, young people may hide their identity out of fear of a negative reaction from their parents. The distress around identity may become more pronounced once pubertal changes, such as breast and testicle development, begin to worsen their dysphoria.”

“Another barrier to care can be the inability to find a competent, gender-affirming provider,” Dr. Cooper said. “Most large United States cities have at least one gender-affirming clinic, but for those youth who grow up in smaller towns, it may be difficult to access these clinics. In addition, some clinics require a letter from a therapist stating that the young person is transgender before they can be seen for medical care. This creates an access barrier, as it may be difficult not just to find a therapist but one who has experience working with gender-diverse youth.”

Insurance coverage, including lack thereof, is yet another barrier to care for transgender youth, said Dr. Cooper. “While many insurance companies have begun to cover medications such as testosterone and estrogen for gender-affirming care, many still have exclusions on things like puberty blockers and surgical interventions.” These interventions can be lifesaving, but financially prohibitive for many families if not covered by insurance.

As for the value of early timing of gender-affirming care, Dr. Cooper agreed with the study findings that the earlier that a young person can get into medical care for their gender identity, the better chance there is to reduce the prevalence of serious mental health outcomes. “This also prevents the potential development of secondary sexual characteristics, decreasing the need for or amount of surgery in the future if desired,” he said.

“More research is needed to better understand the reasons why many youth don’t present to care until later in puberty. In addition, we need better research on interventions that are effective at reducing serious mental health events in transgender and gender diverse youth,” Dr. Cooper stated. “Another area that I would like to see researched is looking at the mental health of non-Caucasian youth. As the authors noted in their study, many clinics have a high percentage of patients presenting for care who identify as White or Caucasian, and we need to better understand why these other youth are not presenting for care.”

The study received no outside funding. Dr. Sorbara disclosed salary support from the Canadian Pediatric Endocrine Group fellowship program. Dr. de Vries had no financial conflicts to disclose. Dr. Cooper had no financial conflicts to disclose, and serves as a contributor to LGBTQ Youth Consult in Pediatric News.

SOURCES: Sorbara JC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2019-3600; de Vries ALC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2020-010611.

An 80-year-old woman with a history of hypertension, hyperlipidemia, psoriasis vulgaris with associated pruritus, and well-controlled type 2 diabetes mellitus presented with a slowly enlarging ulceration on her left leg of 1 year’s duration. She noted that this lesion healed less rapidly than previous stasis leg ulcerations, despite using the same treatment approach that included dressings, elevation, and diuretics to decrease pedal edema.

Physical examination revealed plaques with white micaceous scaling over her extensor surfaces and scalp, as well as guttate lesions on the trunk, typical of psoriasis vulgaris. A 5.8 × 7.2-cm malodorous ulceration was superimposed on a large psoriatic plaque on her left anterior lower leg (FIGURE 1). A 4-mm punch biopsy was obtained from the peripheral margin.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Histopathological examination revealed elongated strands of closely packed basaloid cells embedded in a dense fibrous stroma with overlying ulceration and crusting (FIGURE 2). Immunohistochemical staining with cytokeratin (CK) 5/6 decorated the cytoplasm of the tumor cells, which confirmed that the tumor was a keratinocyte cancer. CK 20 was negative, excluding the possibility of a Merkel cell carcinoma. Scout biopsies from 3 additional areas of ulceration confirmed that the entire ulceration was infiltrated by basal cell carcinoma (BCC).

IMAGE COURTESY OF ROBERT BRODELL, MD

A surprise hidden in a chronic ulcer

More than 6 million Americans have chronic ulcers and most occur on the legs.¹ The majority of these chronic ulcerations are etiologically related to venous stasis, arterial insufficiency, or neuropathy.²

Bacterial pyoderma, chronic infection caused by atypical acid-fast bacilli or deep fungal infection, pyoderma gangrenosum, cutaneous vasculitis, calciphylaxis, and venous ulceration were all considered to explain this patient’s nonhealing wound. A biopsy was required to fully assess these possibilities.

Don’t overlook the possibility of malignancy. In a cross-sectional, multicenter study by Senet et al,³ 144 patients with 154 total chronic leg ulcers were evaluated in tertiary care centers for malignancy, which was found to occur at a rate of 10.4%. Similarly, Ghasemi et al⁴ demonstrated a malignancy rate of 16.1% in 124 patients who underwent biopsy; the anterior shin was determined to be the most frequent location for malignancy. The most common skin cancer identified within the setting of chronic ulcers is squamous cell carcinoma.³ Although rare, there are reports of BCC identified in chronic wounds.^3-7

Morphological signs suggestive of malignancy in chronic ulcerations include hyperkeratosis, granulation tissue surrounded by a raised border, unusual pain or bleeding, and increased tissue friability. Our patient had none of these signs and symptoms. However, it is possible that she had a tumor that ulcerated and would not heal.

Continue to: Which came first?

Which came first? It’s difficult to know in this case whether a persistent BCC ulcerated, forming this lesion, or if scarring associated with a chronic ulceration led to the development of the BCC.⁶ Based on biopsies taken at an earlier date, Schnirring-Judge and Belpedio⁷ concluded that a chronic leg ulcer could, indeed, transform into a BCC; however, pre-existing BCC more commonly ulcerates and then does not heal.

Treatment options

While smaller, superficial BCCs can be treated with topical imiquimod, photodynamic therapy, or electrodesiccation and curettage, larger lesions should be treated with Mohs micrographic surgery and excisional surgery with grafting. Inoperable tumors may be treated with radiation therapy and vismodegib.

Our patient. Once the diagnosis of BCC was established, treatment options were discussed, including excision, local radiation therapy, and oral hedgehog inhibitor drug therapy.⁸ Our patient opted to undergo a wide local excision of the lesion followed by negative-pressure wound therapy, which led to complete healing.

CORRESPONDENCE
David Crasto, DO, William Carey University College of Osteopathic Medicine, 498 Tuscan Avenue, Hattiesburg, MS 39401; crastodave@gmail.com

An 80-year-old woman with a history of hypertension, hyperlipidemia, psoriasis vulgaris with associated pruritus, and well-controlled type 2 diabetes mellitus presented with a slowly enlarging ulceration on her left leg of 1 year’s duration. She noted that this lesion healed less rapidly than previous stasis leg ulcerations, despite using the same treatment approach that included dressings, elevation, and diuretics to decrease pedal edema.

Physical examination revealed plaques with white micaceous scaling over her extensor surfaces and scalp, as well as guttate lesions on the trunk, typical of psoriasis vulgaris. A 5.8 × 7.2-cm malodorous ulceration was superimposed on a large psoriatic plaque on her left anterior lower leg (FIGURE 1). A 4-mm punch biopsy was obtained from the peripheral margin.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Histopathological examination revealed elongated strands of closely packed basaloid cells embedded in a dense fibrous stroma with overlying ulceration and crusting (FIGURE 2). Immunohistochemical staining with cytokeratin (CK) 5/6 decorated the cytoplasm of the tumor cells, which confirmed that the tumor was a keratinocyte cancer. CK 20 was negative, excluding the possibility of a Merkel cell carcinoma. Scout biopsies from 3 additional areas of ulceration confirmed that the entire ulceration was infiltrated by basal cell carcinoma (BCC).

IMAGE COURTESY OF ROBERT BRODELL, MD

A surprise hidden in a chronic ulcer

More than 6 million Americans have chronic ulcers and most occur on the legs.¹ The majority of these chronic ulcerations are etiologically related to venous stasis, arterial insufficiency, or neuropathy.²

Bacterial pyoderma, chronic infection caused by atypical acid-fast bacilli or deep fungal infection, pyoderma gangrenosum, cutaneous vasculitis, calciphylaxis, and venous ulceration were all considered to explain this patient’s nonhealing wound. A biopsy was required to fully assess these possibilities.

Don’t overlook the possibility of malignancy. In a cross-sectional, multicenter study by Senet et al,³ 144 patients with 154 total chronic leg ulcers were evaluated in tertiary care centers for malignancy, which was found to occur at a rate of 10.4%. Similarly, Ghasemi et al⁴ demonstrated a malignancy rate of 16.1% in 124 patients who underwent biopsy; the anterior shin was determined to be the most frequent location for malignancy. The most common skin cancer identified within the setting of chronic ulcers is squamous cell carcinoma.³ Although rare, there are reports of BCC identified in chronic wounds.^3-7

Morphological signs suggestive of malignancy in chronic ulcerations include hyperkeratosis, granulation tissue surrounded by a raised border, unusual pain or bleeding, and increased tissue friability. Our patient had none of these signs and symptoms. However, it is possible that she had a tumor that ulcerated and would not heal.

Continue to: Which came first?

Which came first? It’s difficult to know in this case whether a persistent BCC ulcerated, forming this lesion, or if scarring associated with a chronic ulceration led to the development of the BCC.⁶ Based on biopsies taken at an earlier date, Schnirring-Judge and Belpedio⁷ concluded that a chronic leg ulcer could, indeed, transform into a BCC; however, pre-existing BCC more commonly ulcerates and then does not heal.

Treatment options

While smaller, superficial BCCs can be treated with topical imiquimod, photodynamic therapy, or electrodesiccation and curettage, larger lesions should be treated with Mohs micrographic surgery and excisional surgery with grafting. Inoperable tumors may be treated with radiation therapy and vismodegib.

Our patient. Once the diagnosis of BCC was established, treatment options were discussed, including excision, local radiation therapy, and oral hedgehog inhibitor drug therapy.⁸ Our patient opted to undergo a wide local excision of the lesion followed by negative-pressure wound therapy, which led to complete healing.

CORRESPONDENCE
David Crasto, DO, William Carey University College of Osteopathic Medicine, 498 Tuscan Avenue, Hattiesburg, MS 39401; crastodave@gmail.com

An 80-year-old woman with a history of hypertension, hyperlipidemia, psoriasis vulgaris with associated pruritus, and well-controlled type 2 diabetes mellitus presented with a slowly enlarging ulceration on her left leg of 1 year’s duration. She noted that this lesion healed less rapidly than previous stasis leg ulcerations, despite using the same treatment approach that included dressings, elevation, and diuretics to decrease pedal edema.

Physical examination revealed plaques with white micaceous scaling over her extensor surfaces and scalp, as well as guttate lesions on the trunk, typical of psoriasis vulgaris. A 5.8 × 7.2-cm malodorous ulceration was superimposed on a large psoriatic plaque on her left anterior lower leg (FIGURE 1). A 4-mm punch biopsy was obtained from the peripheral margin.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Histopathological examination revealed elongated strands of closely packed basaloid cells embedded in a dense fibrous stroma with overlying ulceration and crusting (FIGURE 2). Immunohistochemical staining with cytokeratin (CK) 5/6 decorated the cytoplasm of the tumor cells, which confirmed that the tumor was a keratinocyte cancer. CK 20 was negative, excluding the possibility of a Merkel cell carcinoma. Scout biopsies from 3 additional areas of ulceration confirmed that the entire ulceration was infiltrated by basal cell carcinoma (BCC).

IMAGE COURTESY OF ROBERT BRODELL, MD

A surprise hidden in a chronic ulcer

More than 6 million Americans have chronic ulcers and most occur on the legs.¹ The majority of these chronic ulcerations are etiologically related to venous stasis, arterial insufficiency, or neuropathy.²

Bacterial pyoderma, chronic infection caused by atypical acid-fast bacilli or deep fungal infection, pyoderma gangrenosum, cutaneous vasculitis, calciphylaxis, and venous ulceration were all considered to explain this patient’s nonhealing wound. A biopsy was required to fully assess these possibilities.

Don’t overlook the possibility of malignancy. In a cross-sectional, multicenter study by Senet et al,³ 144 patients with 154 total chronic leg ulcers were evaluated in tertiary care centers for malignancy, which was found to occur at a rate of 10.4%. Similarly, Ghasemi et al⁴ demonstrated a malignancy rate of 16.1% in 124 patients who underwent biopsy; the anterior shin was determined to be the most frequent location for malignancy. The most common skin cancer identified within the setting of chronic ulcers is squamous cell carcinoma.³ Although rare, there are reports of BCC identified in chronic wounds.^3-7

Morphological signs suggestive of malignancy in chronic ulcerations include hyperkeratosis, granulation tissue surrounded by a raised border, unusual pain or bleeding, and increased tissue friability. Our patient had none of these signs and symptoms. However, it is possible that she had a tumor that ulcerated and would not heal.

Continue to: Which came first?

Which came first? It’s difficult to know in this case whether a persistent BCC ulcerated, forming this lesion, or if scarring associated with a chronic ulceration led to the development of the BCC.⁶ Based on biopsies taken at an earlier date, Schnirring-Judge and Belpedio⁷ concluded that a chronic leg ulcer could, indeed, transform into a BCC; however, pre-existing BCC more commonly ulcerates and then does not heal.

Treatment options

While smaller, superficial BCCs can be treated with topical imiquimod, photodynamic therapy, or electrodesiccation and curettage, larger lesions should be treated with Mohs micrographic surgery and excisional surgery with grafting. Inoperable tumors may be treated with radiation therapy and vismodegib.

Our patient. Once the diagnosis of BCC was established, treatment options were discussed, including excision, local radiation therapy, and oral hedgehog inhibitor drug therapy.⁸ Our patient opted to undergo a wide local excision of the lesion followed by negative-pressure wound therapy, which led to complete healing.

CORRESPONDENCE
David Crasto, DO, William Carey University College of Osteopathic Medicine, 498 Tuscan Avenue, Hattiesburg, MS 39401; crastodave@gmail.com

Rates of human papillomavirus vaccination increased for both boys and girls in the United States over the past decade, but remain below target levels and vary widely across states based on data from a nested cohort study including more than 7 million children.

Dzurag/iStock/Getty Images

“Understanding regional and temporal variations in HPV vaccination coverage may help improve HPV vaccination uptake by informing public health policy,” Szu-Ta Chen, MD, of Harvard University, Boston, and colleagues wrote in Pediatrics.

To identify trends in one-dose and two-dose human papillomavirus (HPV) vaccination coverage, the researchers reviewed data from the MarketScan health care database between January 2003 and December 2017 that included 7,837,480 children and 19,843,737 person-years. The children were followed starting at age 9, when HPV vaccination could begin, and ending at one of the following: the first or second vaccination, insurance disenrollment, December 2017, or the end of the year in which they turned 17.

Overall, the proportion of 15-year-old girls and boys with at least a one-dose HPV vaccination increased from 38% and 5%, respectively, in 2011 to 57% and 51%, respectively, in 2017. The comparable proportions of girls and boys with at least a two-dose vaccination increased from 30% and 2%, respectively, in 2011 to 46% and 39%, respectively, in 2017.

Coverage lacks consistency across states

However, the vaccination coverage varied widely across states; two-dose HPV vaccination coverage ranged from 80% of girls in the District of Columbia to 15% of boys in Mississippi. In general, states with more HPV vaccine interventions had higher levels of vaccination, the researchers noted.

Legislation to improve vaccination education showed the strongest association with coverage; an 8.8% increase in coverage for girls and an 8.7% increase for boys. Pediatrician availability also was a factor associated with a 1.1% increase in coverage estimated for every pediatrician per 10,000 children.

Cumulative HPV vaccinations seen among children continuously enrolled in the study were similar to the primary analysis, the Dr. Chen and associates said. “After the initial HPV vaccination, 87% of girls and 82% of boys received a second dose by age 17 in the most recent cohorts.”

However, the HPV vaccination coverage remains below the Healthy People 2020 goal of 80% of children vaccinated by age 15 years, the researchers said. Barriers to vaccination may include a lack of routine clinical encounters in adolescents aged 11-17 years. HPV vaccination coverage was higher in urban populations, compared with rural, which may be related to a lack of providers in rural areas.

“Thus, measures beyond recommending routine vaccination at annual check-ups might be necessary to attain sufficient HPV vaccine coverage, and the optimal strategy may differ by state characteristics,” they wrote.

The study findings were limited by several factors including the use of data from only commercially-insured children and lack of data on vaccines received outside of insurance, the researchers noted.

However, the results were strengthened by the large, population-based sample, and support the need for increased efforts in HPV vaccination. “Most states will not achieve the Healthy People 2020 goal of 80% coverage with at least two HPV vaccine doses by 2020,” Dr. Chen and associates concluded.

Vaccination goals are possible with effort in the right places

The fact of below-target vaccination for HPV in the United States may be old news, but the current study offers new insights on HPV uptake, Amanda F. Dempsey, MD, PhD, of the University of Colorado at Denver, in Aurora, wrote in an accompanying editorial.

“A unique feature of this study is the ability of its researchers to study individuals over time, particularly at a national scope,” which yielded two key messages, she said.

The longitudinal examination of vaccination levels among birth cohorts showed that similar vaccination levels were achieved more quickly each year.

“For example, among the birth cohort from the year 2000, representing 17-year-olds at the time data were abstracted for the study, 40% vaccination coverage was achieved when this group was 14 years old. In contrast, among the birth cohort from the year 2005, representing 12-year-olds at the time of data abstraction, 40% vaccination coverage was reached at the age of 12,” Dr. Dempsey explained.

In addition, the study design allowed the researchers to model future vaccine coverage based on current trends, said Dr. Dempsey. “The authors estimate that, by the year 2022, the 2012 birth cohort will have reached 80% coverage for the first dose in the HPV vaccine series.”

Dr. Dempsey said she was surprised that the models did not support the hypothesis that school mandates for vaccination would increase coverage; however, there were few states in this category.

Although the findings were limited by the lack of data on uninsured children and those insured by Medicaid, the state-by-state results show that the achievement of national vaccination goals is possible, Dr. Dempsey said. In addition, the findings “warrant close consideration by policy makers and the medical community at large regarding vaccination policies and workforce,” she emphasized.The study received no outside funding. Dr. Chen had no financial conflicts to disclose. Several coauthors reported research grants to their institutions from pharmaceutical companies or being consultants to such companies. Dr. Dempsey disclosed serving on the advisory boards for Merck, Pfizer, and Sanofi Pasteur.

SOURCE: Chen S-T et al. Pediatrics. 2020 Sep 14. doi: 10.1542/peds.2019-3557.

Rates of human papillomavirus vaccination increased for both boys and girls in the United States over the past decade, but remain below target levels and vary widely across states based on data from a nested cohort study including more than 7 million children.

Dzurag/iStock/Getty Images

“Understanding regional and temporal variations in HPV vaccination coverage may help improve HPV vaccination uptake by informing public health policy,” Szu-Ta Chen, MD, of Harvard University, Boston, and colleagues wrote in Pediatrics.

To identify trends in one-dose and two-dose human papillomavirus (HPV) vaccination coverage, the researchers reviewed data from the MarketScan health care database between January 2003 and December 2017 that included 7,837,480 children and 19,843,737 person-years. The children were followed starting at age 9, when HPV vaccination could begin, and ending at one of the following: the first or second vaccination, insurance disenrollment, December 2017, or the end of the year in which they turned 17.

Overall, the proportion of 15-year-old girls and boys with at least a one-dose HPV vaccination increased from 38% and 5%, respectively, in 2011 to 57% and 51%, respectively, in 2017. The comparable proportions of girls and boys with at least a two-dose vaccination increased from 30% and 2%, respectively, in 2011 to 46% and 39%, respectively, in 2017.

Coverage lacks consistency across states

However, the vaccination coverage varied widely across states; two-dose HPV vaccination coverage ranged from 80% of girls in the District of Columbia to 15% of boys in Mississippi. In general, states with more HPV vaccine interventions had higher levels of vaccination, the researchers noted.

Legislation to improve vaccination education showed the strongest association with coverage; an 8.8% increase in coverage for girls and an 8.7% increase for boys. Pediatrician availability also was a factor associated with a 1.1% increase in coverage estimated for every pediatrician per 10,000 children.

Cumulative HPV vaccinations seen among children continuously enrolled in the study were similar to the primary analysis, the Dr. Chen and associates said. “After the initial HPV vaccination, 87% of girls and 82% of boys received a second dose by age 17 in the most recent cohorts.”

However, the HPV vaccination coverage remains below the Healthy People 2020 goal of 80% of children vaccinated by age 15 years, the researchers said. Barriers to vaccination may include a lack of routine clinical encounters in adolescents aged 11-17 years. HPV vaccination coverage was higher in urban populations, compared with rural, which may be related to a lack of providers in rural areas.

“Thus, measures beyond recommending routine vaccination at annual check-ups might be necessary to attain sufficient HPV vaccine coverage, and the optimal strategy may differ by state characteristics,” they wrote.

The study findings were limited by several factors including the use of data from only commercially-insured children and lack of data on vaccines received outside of insurance, the researchers noted.

However, the results were strengthened by the large, population-based sample, and support the need for increased efforts in HPV vaccination. “Most states will not achieve the Healthy People 2020 goal of 80% coverage with at least two HPV vaccine doses by 2020,” Dr. Chen and associates concluded.

Vaccination goals are possible with effort in the right places

The fact of below-target vaccination for HPV in the United States may be old news, but the current study offers new insights on HPV uptake, Amanda F. Dempsey, MD, PhD, of the University of Colorado at Denver, in Aurora, wrote in an accompanying editorial.

“A unique feature of this study is the ability of its researchers to study individuals over time, particularly at a national scope,” which yielded two key messages, she said.

The longitudinal examination of vaccination levels among birth cohorts showed that similar vaccination levels were achieved more quickly each year.

“For example, among the birth cohort from the year 2000, representing 17-year-olds at the time data were abstracted for the study, 40% vaccination coverage was achieved when this group was 14 years old. In contrast, among the birth cohort from the year 2005, representing 12-year-olds at the time of data abstraction, 40% vaccination coverage was reached at the age of 12,” Dr. Dempsey explained.

In addition, the study design allowed the researchers to model future vaccine coverage based on current trends, said Dr. Dempsey. “The authors estimate that, by the year 2022, the 2012 birth cohort will have reached 80% coverage for the first dose in the HPV vaccine series.”

Dr. Dempsey said she was surprised that the models did not support the hypothesis that school mandates for vaccination would increase coverage; however, there were few states in this category.

Although the findings were limited by the lack of data on uninsured children and those insured by Medicaid, the state-by-state results show that the achievement of national vaccination goals is possible, Dr. Dempsey said. In addition, the findings “warrant close consideration by policy makers and the medical community at large regarding vaccination policies and workforce,” she emphasized.The study received no outside funding. Dr. Chen had no financial conflicts to disclose. Several coauthors reported research grants to their institutions from pharmaceutical companies or being consultants to such companies. Dr. Dempsey disclosed serving on the advisory boards for Merck, Pfizer, and Sanofi Pasteur.

SOURCE: Chen S-T et al. Pediatrics. 2020 Sep 14. doi: 10.1542/peds.2019-3557.

Rates of human papillomavirus vaccination increased for both boys and girls in the United States over the past decade, but remain below target levels and vary widely across states based on data from a nested cohort study including more than 7 million children.

Dzurag/iStock/Getty Images

“Understanding regional and temporal variations in HPV vaccination coverage may help improve HPV vaccination uptake by informing public health policy,” Szu-Ta Chen, MD, of Harvard University, Boston, and colleagues wrote in Pediatrics.

To identify trends in one-dose and two-dose human papillomavirus (HPV) vaccination coverage, the researchers reviewed data from the MarketScan health care database between January 2003 and December 2017 that included 7,837,480 children and 19,843,737 person-years. The children were followed starting at age 9, when HPV vaccination could begin, and ending at one of the following: the first or second vaccination, insurance disenrollment, December 2017, or the end of the year in which they turned 17.

Overall, the proportion of 15-year-old girls and boys with at least a one-dose HPV vaccination increased from 38% and 5%, respectively, in 2011 to 57% and 51%, respectively, in 2017. The comparable proportions of girls and boys with at least a two-dose vaccination increased from 30% and 2%, respectively, in 2011 to 46% and 39%, respectively, in 2017.

Coverage lacks consistency across states

However, the vaccination coverage varied widely across states; two-dose HPV vaccination coverage ranged from 80% of girls in the District of Columbia to 15% of boys in Mississippi. In general, states with more HPV vaccine interventions had higher levels of vaccination, the researchers noted.

Legislation to improve vaccination education showed the strongest association with coverage; an 8.8% increase in coverage for girls and an 8.7% increase for boys. Pediatrician availability also was a factor associated with a 1.1% increase in coverage estimated for every pediatrician per 10,000 children.

Cumulative HPV vaccinations seen among children continuously enrolled in the study were similar to the primary analysis, the Dr. Chen and associates said. “After the initial HPV vaccination, 87% of girls and 82% of boys received a second dose by age 17 in the most recent cohorts.”

However, the HPV vaccination coverage remains below the Healthy People 2020 goal of 80% of children vaccinated by age 15 years, the researchers said. Barriers to vaccination may include a lack of routine clinical encounters in adolescents aged 11-17 years. HPV vaccination coverage was higher in urban populations, compared with rural, which may be related to a lack of providers in rural areas.

“Thus, measures beyond recommending routine vaccination at annual check-ups might be necessary to attain sufficient HPV vaccine coverage, and the optimal strategy may differ by state characteristics,” they wrote.

The study findings were limited by several factors including the use of data from only commercially-insured children and lack of data on vaccines received outside of insurance, the researchers noted.

However, the results were strengthened by the large, population-based sample, and support the need for increased efforts in HPV vaccination. “Most states will not achieve the Healthy People 2020 goal of 80% coverage with at least two HPV vaccine doses by 2020,” Dr. Chen and associates concluded.

Vaccination goals are possible with effort in the right places

The fact of below-target vaccination for HPV in the United States may be old news, but the current study offers new insights on HPV uptake, Amanda F. Dempsey, MD, PhD, of the University of Colorado at Denver, in Aurora, wrote in an accompanying editorial.

“A unique feature of this study is the ability of its researchers to study individuals over time, particularly at a national scope,” which yielded two key messages, she said.

The longitudinal examination of vaccination levels among birth cohorts showed that similar vaccination levels were achieved more quickly each year.

“For example, among the birth cohort from the year 2000, representing 17-year-olds at the time data were abstracted for the study, 40% vaccination coverage was achieved when this group was 14 years old. In contrast, among the birth cohort from the year 2005, representing 12-year-olds at the time of data abstraction, 40% vaccination coverage was reached at the age of 12,” Dr. Dempsey explained.

In addition, the study design allowed the researchers to model future vaccine coverage based on current trends, said Dr. Dempsey. “The authors estimate that, by the year 2022, the 2012 birth cohort will have reached 80% coverage for the first dose in the HPV vaccine series.”

Dr. Dempsey said she was surprised that the models did not support the hypothesis that school mandates for vaccination would increase coverage; however, there were few states in this category.

Although the findings were limited by the lack of data on uninsured children and those insured by Medicaid, the state-by-state results show that the achievement of national vaccination goals is possible, Dr. Dempsey said. In addition, the findings “warrant close consideration by policy makers and the medical community at large regarding vaccination policies and workforce,” she emphasized.The study received no outside funding. Dr. Chen had no financial conflicts to disclose. Several coauthors reported research grants to their institutions from pharmaceutical companies or being consultants to such companies. Dr. Dempsey disclosed serving on the advisory boards for Merck, Pfizer, and Sanofi Pasteur.

SOURCE: Chen S-T et al. Pediatrics. 2020 Sep 14. doi: 10.1542/peds.2019-3557.

THE CASE

A 28-year-old woman with an extensive psychiatric history—including generalized anxiety disorder, panic disorder, and recent postpartum depression—presented with a chief complaint of right leg weakness. She stated this weakness had begun 4 days earlier. It occurred episodically and was preceded by tingling and cramping sensations. Each episode lasted a couple of minutes and spontaneously resolved. Associated with it, she experienced slurred speech and altered mentation. There was no loss of consciousness and no pain. A panic attack usually followed, consisting of feelings of impending doom, rapid breathing, palpitations, and nausea.

She had 3 prior diagnostic evaluations for this same chief complaint, twice in an emergency department (ED) and once with her primary care physician. These evaluations included lab work and extensive head imaging, which demonstrated no acute intracranial pathology. At each previous presentation, the diagnosis was an exacerbation of her anxiety disorder, and she was treated with lorazepam.

At the current presentation, her vital signs were stable. Examination revealed a notably anxious patient. She repeatedly expressed concern that she might have a brain tumor or some other deadly disease, as she had a family history of brain cancer. Her physical exam was entirely normal, including normal strength, sensation, and reflexes in all extremities.

Further head imaging (computed tomography, CT angiography, and magnetic resonance imaging of the brain) failed to reveal an etiology of her symptoms. With no clear organic cause, her medical providers again suspected an anxiety or panic episode. She was given reassurance, and an outpatient neurology consult was arranged.

THE DIAGNOSIS

One week later, at her outpatient neurology appointment, an electroencephalogram (EEG) was performed. Following photic stimulation, the EEG showed multiple right- and left-hemisphere foci of cortical hyperexcitability including a subtle sharp component (see FIGURE). Immediately following the longest of these episodes, the patient expressed a sense of anxiety and an altered sensorium similar to her prior presentations.

The EEG findings, in addition to the postictal anxiety symptoms and clinical history, were all important components that led the treating neurologist to the diagnosis of localization-related (focal) epilepsy.¹ The patient was started on oxcarbazepine, a first-line anti-epileptic medication used in the treatment of focal epilepsy.² She is being followed by a neurologist regularly and after optimizing her anti-epileptic medication, is no longer having seizures.

DISCUSSION

The difficulty of this case stems from the atypical presentation of the patient’s seizures. The key step to the correct diagnosis was a neurological consultation and an ensuing EEG. However, the patient received a vast spectrum of care, including multiple work-ups, prior to a conclusive diagnosis—which highlights an important issue health care providers must address.

Continue to: The role of bias

The role of bias. From the patient’s initial visits to the ED to her hospital admission, there was a prominent affixation, known as the anchoring bias,³ by the clinicians providing her care: All were focused heavily on her psychiatric features. Conversely, the evaluation for patients with suspected psychiatric diagnoses should focus on successfully ruling out major organic etiology with a broad differential diagnosis. It is crucial for providers to take a step back and make a conscious attempt to avoid fixation on a particular diagnosis, especially when it is psychiatric in nature. This allows the provider to actively consider alternative explanations for a patient presentation and work through a more encompassing differential.

The distinguishing symptoms. There is a common association between comorbid mood disorders (eg, depression, anxiety) and epilepsy.⁴ Another clue is ictal anxiety or nervousness, which is commonly observed in patients with partial seizures (and occurred with our patient).

These ictal episodes can be difficult to identify within the context of an isolated psychiatric diagnosis.⁵ The distinction can be clarified by the presence of associated somatic symptoms, which in this case included unilateral cramping, paresthesia, and weakness. These symptoms should clue in a practitioner to the possibility of underlying neurologic pathology, which should prompt the ordering of either an EEG or, at minimum, a neurological consultation.

THE TAKEAWAY

This case report shows how anchoring bias can lead to a delay in diagnosis and treatment. Avoidance of this type of bias requires heightened cognitive awareness by medical providers. A more system-based approach is to have structured diagnostic assessments,⁶ such as conducting a thorough neurological exam for patients with somatic symptoms and exacerbating comorbid psychiatric conditions.

It may also help to review cases like this with colleagues from diverse disciplinary backgrounds, highlighting thought processes and sharing uncertainty.³ These processes may shed light on confounding diagnoses that might be playing a role in a patient’s presentation and ultimately aid in the decision-making process.

CORRESPONDENCE
Paimon Ameli, DO, Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92134; paimonm@gmail.com

THE CASE

A 28-year-old woman with an extensive psychiatric history—including generalized anxiety disorder, panic disorder, and recent postpartum depression—presented with a chief complaint of right leg weakness. She stated this weakness had begun 4 days earlier. It occurred episodically and was preceded by tingling and cramping sensations. Each episode lasted a couple of minutes and spontaneously resolved. Associated with it, she experienced slurred speech and altered mentation. There was no loss of consciousness and no pain. A panic attack usually followed, consisting of feelings of impending doom, rapid breathing, palpitations, and nausea.

She had 3 prior diagnostic evaluations for this same chief complaint, twice in an emergency department (ED) and once with her primary care physician. These evaluations included lab work and extensive head imaging, which demonstrated no acute intracranial pathology. At each previous presentation, the diagnosis was an exacerbation of her anxiety disorder, and she was treated with lorazepam.

At the current presentation, her vital signs were stable. Examination revealed a notably anxious patient. She repeatedly expressed concern that she might have a brain tumor or some other deadly disease, as she had a family history of brain cancer. Her physical exam was entirely normal, including normal strength, sensation, and reflexes in all extremities.

Further head imaging (computed tomography, CT angiography, and magnetic resonance imaging of the brain) failed to reveal an etiology of her symptoms. With no clear organic cause, her medical providers again suspected an anxiety or panic episode. She was given reassurance, and an outpatient neurology consult was arranged.

THE DIAGNOSIS

One week later, at her outpatient neurology appointment, an electroencephalogram (EEG) was performed. Following photic stimulation, the EEG showed multiple right- and left-hemisphere foci of cortical hyperexcitability including a subtle sharp component (see FIGURE). Immediately following the longest of these episodes, the patient expressed a sense of anxiety and an altered sensorium similar to her prior presentations.

The EEG findings, in addition to the postictal anxiety symptoms and clinical history, were all important components that led the treating neurologist to the diagnosis of localization-related (focal) epilepsy.¹ The patient was started on oxcarbazepine, a first-line anti-epileptic medication used in the treatment of focal epilepsy.² She is being followed by a neurologist regularly and after optimizing her anti-epileptic medication, is no longer having seizures.

DISCUSSION

The difficulty of this case stems from the atypical presentation of the patient’s seizures. The key step to the correct diagnosis was a neurological consultation and an ensuing EEG. However, the patient received a vast spectrum of care, including multiple work-ups, prior to a conclusive diagnosis—which highlights an important issue health care providers must address.

Continue to: The role of bias

The role of bias. From the patient’s initial visits to the ED to her hospital admission, there was a prominent affixation, known as the anchoring bias,³ by the clinicians providing her care: All were focused heavily on her psychiatric features. Conversely, the evaluation for patients with suspected psychiatric diagnoses should focus on successfully ruling out major organic etiology with a broad differential diagnosis. It is crucial for providers to take a step back and make a conscious attempt to avoid fixation on a particular diagnosis, especially when it is psychiatric in nature. This allows the provider to actively consider alternative explanations for a patient presentation and work through a more encompassing differential.

The distinguishing symptoms. There is a common association between comorbid mood disorders (eg, depression, anxiety) and epilepsy.⁴ Another clue is ictal anxiety or nervousness, which is commonly observed in patients with partial seizures (and occurred with our patient).

These ictal episodes can be difficult to identify within the context of an isolated psychiatric diagnosis.⁵ The distinction can be clarified by the presence of associated somatic symptoms, which in this case included unilateral cramping, paresthesia, and weakness. These symptoms should clue in a practitioner to the possibility of underlying neurologic pathology, which should prompt the ordering of either an EEG or, at minimum, a neurological consultation.

THE TAKEAWAY

This case report shows how anchoring bias can lead to a delay in diagnosis and treatment. Avoidance of this type of bias requires heightened cognitive awareness by medical providers. A more system-based approach is to have structured diagnostic assessments,⁶ such as conducting a thorough neurological exam for patients with somatic symptoms and exacerbating comorbid psychiatric conditions.

It may also help to review cases like this with colleagues from diverse disciplinary backgrounds, highlighting thought processes and sharing uncertainty.³ These processes may shed light on confounding diagnoses that might be playing a role in a patient’s presentation and ultimately aid in the decision-making process.

CORRESPONDENCE
Paimon Ameli, DO, Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92134; paimonm@gmail.com

THE CASE

A 28-year-old woman with an extensive psychiatric history—including generalized anxiety disorder, panic disorder, and recent postpartum depression—presented with a chief complaint of right leg weakness. She stated this weakness had begun 4 days earlier. It occurred episodically and was preceded by tingling and cramping sensations. Each episode lasted a couple of minutes and spontaneously resolved. Associated with it, she experienced slurred speech and altered mentation. There was no loss of consciousness and no pain. A panic attack usually followed, consisting of feelings of impending doom, rapid breathing, palpitations, and nausea.

She had 3 prior diagnostic evaluations for this same chief complaint, twice in an emergency department (ED) and once with her primary care physician. These evaluations included lab work and extensive head imaging, which demonstrated no acute intracranial pathology. At each previous presentation, the diagnosis was an exacerbation of her anxiety disorder, and she was treated with lorazepam.

At the current presentation, her vital signs were stable. Examination revealed a notably anxious patient. She repeatedly expressed concern that she might have a brain tumor or some other deadly disease, as she had a family history of brain cancer. Her physical exam was entirely normal, including normal strength, sensation, and reflexes in all extremities.

Further head imaging (computed tomography, CT angiography, and magnetic resonance imaging of the brain) failed to reveal an etiology of her symptoms. With no clear organic cause, her medical providers again suspected an anxiety or panic episode. She was given reassurance, and an outpatient neurology consult was arranged.

THE DIAGNOSIS

One week later, at her outpatient neurology appointment, an electroencephalogram (EEG) was performed. Following photic stimulation, the EEG showed multiple right- and left-hemisphere foci of cortical hyperexcitability including a subtle sharp component (see FIGURE). Immediately following the longest of these episodes, the patient expressed a sense of anxiety and an altered sensorium similar to her prior presentations.

The EEG findings, in addition to the postictal anxiety symptoms and clinical history, were all important components that led the treating neurologist to the diagnosis of localization-related (focal) epilepsy.¹ The patient was started on oxcarbazepine, a first-line anti-epileptic medication used in the treatment of focal epilepsy.² She is being followed by a neurologist regularly and after optimizing her anti-epileptic medication, is no longer having seizures.

DISCUSSION

The difficulty of this case stems from the atypical presentation of the patient’s seizures. The key step to the correct diagnosis was a neurological consultation and an ensuing EEG. However, the patient received a vast spectrum of care, including multiple work-ups, prior to a conclusive diagnosis—which highlights an important issue health care providers must address.

Continue to: The role of bias

The role of bias. From the patient’s initial visits to the ED to her hospital admission, there was a prominent affixation, known as the anchoring bias,³ by the clinicians providing her care: All were focused heavily on her psychiatric features. Conversely, the evaluation for patients with suspected psychiatric diagnoses should focus on successfully ruling out major organic etiology with a broad differential diagnosis. It is crucial for providers to take a step back and make a conscious attempt to avoid fixation on a particular diagnosis, especially when it is psychiatric in nature. This allows the provider to actively consider alternative explanations for a patient presentation and work through a more encompassing differential.

The distinguishing symptoms. There is a common association between comorbid mood disorders (eg, depression, anxiety) and epilepsy.⁴ Another clue is ictal anxiety or nervousness, which is commonly observed in patients with partial seizures (and occurred with our patient).

These ictal episodes can be difficult to identify within the context of an isolated psychiatric diagnosis.⁵ The distinction can be clarified by the presence of associated somatic symptoms, which in this case included unilateral cramping, paresthesia, and weakness. These symptoms should clue in a practitioner to the possibility of underlying neurologic pathology, which should prompt the ordering of either an EEG or, at minimum, a neurological consultation.

THE TAKEAWAY

This case report shows how anchoring bias can lead to a delay in diagnosis and treatment. Avoidance of this type of bias requires heightened cognitive awareness by medical providers. A more system-based approach is to have structured diagnostic assessments,⁶ such as conducting a thorough neurological exam for patients with somatic symptoms and exacerbating comorbid psychiatric conditions.

It may also help to review cases like this with colleagues from diverse disciplinary backgrounds, highlighting thought processes and sharing uncertainty.³ These processes may shed light on confounding diagnoses that might be playing a role in a patient’s presentation and ultimately aid in the decision-making process.

CORRESPONDENCE
Paimon Ameli, DO, Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92134; paimonm@gmail.com

Ultrapotent topical corticosteroids remain the core treatment for vulvar lichen sclerosus, although other therapies can be added, according to an expert speaking at the virtual conference on diseases of the vulva and vagina.

If needed, intralesional steroid injections or calcineurin inhibitors can be added to a topical corticosteroid regimen, Libby Edwards, MD, suggested at the meeting, hosted by the International Society for the Study of Vulvovaginal Disease. In addition, early reports indicate that newer interventions such as fractional CO₂ laser treatments may help patients with refractory disease.

Still, “there is no question, there is no argument: First-, second- and third-line treatment for lichen sclerosus is an ultrapotent or superpotent topical corticosteroid,” she said. Steroids include halobetasol, clobetasol, or betamethasone dipropionate in augmented vehicle ointment once or twice per day. Patients should continue this regimen until the skin texture is normal or the disease is controlled as well as possible, which usually takes several months, said Dr. Edwards, of Southeast Vulvar Clinic in Charlotte, N.C.

Patients then should continue treatment, but less frequently or with a lower potency steroid.

Although corticosteroids are not Food and Drug Administration–approved for the treatment of lichen sclerosus, double-blind, placebo-controlled trials support their use, Dr. Edwards said.

Getting patients to use topical corticosteroids as directed can be a challenge, however, and patient education is crucial.

After about 10 days, many patients start to feel better and stop the medication prematurely, which may lead to recurrence.

“That is such an important counseling point,” Aruna Venkatesan, MD, chief of dermatology and director of the genital dermatology clinic at Santa Clara Valley Medical Center in San Jose, Calif., said during a panel discussion. “Tell them, listen, I may not see you back for a couple months, and you may start feeling better sooner. But I want you to keep using this at this frequency so that when you come back we can make a good decision about whether you’re ready” for a lower potency regimen.

To encourage daily use, Hope K. Haefner, MD, asks patients whether they brush their teeth every night. “When they say yes, I tell them to put the steroid ointment by their toothpaste and use it after brushing,” Dr. Haefner, the Harold A. Furlong Professor of Women’s Health at Michigan Medicine in Ann Arbor, said during the discussion. “But don’t mix up the tubes.”

Once lichen sclerosus is controlled, options include decreasing the superpotent steroid to once, three times per week or changing to a midpotency steroid such as triamcinolone ointment every day, Dr. Edwards said.

Evidence suggests that controlling lichen sclerosus may prevent squamous cell carcinoma and scarring. In a study of more than 500 patients, about 70% complied with treatment instructions, whereas about 30% were considered partially compliant (JAMA Dermatol. 2015 Oct;151[10]:1061-7.). Patients who adhered to their therapy were less likely to have cancer or ongoing scarring during an average of 4.7 years of follow-up.
 

Beyond topical steroids

“Almost always, topical steroids are all you need,” said Dr. Edwards. “Before I go beyond that, I think of other issues that may be causing symptoms,” such as atrophic vagina, steroid dermatitis, or vulvodynia.

For patients with refractory lichen sclerosus, other treatments “can add more oomph to your topical steroid, but they are not better,” she said.

Intralesional corticosteroid injections are one option.

Another option is adding a calcineurin inhibitor such as tacrolimus or pimecrolimus, although these medications can burn with application and irritate. In addition, they carry warnings about rare cases of cancer associated with their use.

Dr. Edwards also uses methotrexate, which is supported by case reports and an open-label study. In a recently published study that included 21 patients with vulvar lichen sclerosus and 24 patients with extragenital lichen sclerosus, about half improved after receiving methotrexate (Dermatol Ther. 2020 Apr 29;e13473.).
 

What about lasers?

Fractional CO₂ laser treatments, which are pulsed to minimize damage from heat, have “a lot of providers very excited,” Dr. Edwards said. In one open-label study of 40 patients, most reported a decrease in symptoms. (J Low Genit Tract Dis. 2020 Apr;24[2]:225-8.)

“We’re awaiting blinded, controlled studies,” Dr. Edwards said. “We don’t have those available yet although they are in progress.”

Ten of Dr. Edwards’ patients who did not improve enough with medication have received laser treatments. One patient stopped laser therapy after one treatment. One did not improve. Two were completely cleared, and six had significant improvement.

If patients who improved stopped steroids against recommendations, lichen sclerosus recurred, Dr. Edwards said.

The ISSVD does not recommend laser for the routine treatment of lichen sclerosus because of a lack of adequate studies and long-term safety data and biologic implausibility, Dr. Edwards noted (J Low Genit Tract Dis. 2019 Apr;23[2]:151-60.) Laser treatments for lichen sclerosus should not be used outside of clinical trials or without special arrangements for clinical governance, consent, and audit, according to a consensus document from the society.

“I mostly agree with that,” Dr. Edwards said. “But I now think that this is a reasonable thing to use when other treatments have been exhausted.”

Dr. Edwards and Dr. Venkatesan had no conflicts of interest. Dr. Haefner is an author for UpToDate.

jremaly@mdedge.com

Ultrapotent topical corticosteroids remain the core treatment for vulvar lichen sclerosus, although other therapies can be added, according to an expert speaking at the virtual conference on diseases of the vulva and vagina.

If needed, intralesional steroid injections or calcineurin inhibitors can be added to a topical corticosteroid regimen, Libby Edwards, MD, suggested at the meeting, hosted by the International Society for the Study of Vulvovaginal Disease. In addition, early reports indicate that newer interventions such as fractional CO₂ laser treatments may help patients with refractory disease.

Still, “there is no question, there is no argument: First-, second- and third-line treatment for lichen sclerosus is an ultrapotent or superpotent topical corticosteroid,” she said. Steroids include halobetasol, clobetasol, or betamethasone dipropionate in augmented vehicle ointment once or twice per day. Patients should continue this regimen until the skin texture is normal or the disease is controlled as well as possible, which usually takes several months, said Dr. Edwards, of Southeast Vulvar Clinic in Charlotte, N.C.

Patients then should continue treatment, but less frequently or with a lower potency steroid.

Although corticosteroids are not Food and Drug Administration–approved for the treatment of lichen sclerosus, double-blind, placebo-controlled trials support their use, Dr. Edwards said.

Getting patients to use topical corticosteroids as directed can be a challenge, however, and patient education is crucial.

After about 10 days, many patients start to feel better and stop the medication prematurely, which may lead to recurrence.

“That is such an important counseling point,” Aruna Venkatesan, MD, chief of dermatology and director of the genital dermatology clinic at Santa Clara Valley Medical Center in San Jose, Calif., said during a panel discussion. “Tell them, listen, I may not see you back for a couple months, and you may start feeling better sooner. But I want you to keep using this at this frequency so that when you come back we can make a good decision about whether you’re ready” for a lower potency regimen.

To encourage daily use, Hope K. Haefner, MD, asks patients whether they brush their teeth every night. “When they say yes, I tell them to put the steroid ointment by their toothpaste and use it after brushing,” Dr. Haefner, the Harold A. Furlong Professor of Women’s Health at Michigan Medicine in Ann Arbor, said during the discussion. “But don’t mix up the tubes.”

Once lichen sclerosus is controlled, options include decreasing the superpotent steroid to once, three times per week or changing to a midpotency steroid such as triamcinolone ointment every day, Dr. Edwards said.

Evidence suggests that controlling lichen sclerosus may prevent squamous cell carcinoma and scarring. In a study of more than 500 patients, about 70% complied with treatment instructions, whereas about 30% were considered partially compliant (JAMA Dermatol. 2015 Oct;151[10]:1061-7.). Patients who adhered to their therapy were less likely to have cancer or ongoing scarring during an average of 4.7 years of follow-up.
 

Beyond topical steroids

“Almost always, topical steroids are all you need,” said Dr. Edwards. “Before I go beyond that, I think of other issues that may be causing symptoms,” such as atrophic vagina, steroid dermatitis, or vulvodynia.

For patients with refractory lichen sclerosus, other treatments “can add more oomph to your topical steroid, but they are not better,” she said.

Intralesional corticosteroid injections are one option.

Another option is adding a calcineurin inhibitor such as tacrolimus or pimecrolimus, although these medications can burn with application and irritate. In addition, they carry warnings about rare cases of cancer associated with their use.

Dr. Edwards also uses methotrexate, which is supported by case reports and an open-label study. In a recently published study that included 21 patients with vulvar lichen sclerosus and 24 patients with extragenital lichen sclerosus, about half improved after receiving methotrexate (Dermatol Ther. 2020 Apr 29;e13473.).
 

What about lasers?

Fractional CO₂ laser treatments, which are pulsed to minimize damage from heat, have “a lot of providers very excited,” Dr. Edwards said. In one open-label study of 40 patients, most reported a decrease in symptoms. (J Low Genit Tract Dis. 2020 Apr;24[2]:225-8.)

“We’re awaiting blinded, controlled studies,” Dr. Edwards said. “We don’t have those available yet although they are in progress.”

Ten of Dr. Edwards’ patients who did not improve enough with medication have received laser treatments. One patient stopped laser therapy after one treatment. One did not improve. Two were completely cleared, and six had significant improvement.

If patients who improved stopped steroids against recommendations, lichen sclerosus recurred, Dr. Edwards said.

The ISSVD does not recommend laser for the routine treatment of lichen sclerosus because of a lack of adequate studies and long-term safety data and biologic implausibility, Dr. Edwards noted (J Low Genit Tract Dis. 2019 Apr;23[2]:151-60.) Laser treatments for lichen sclerosus should not be used outside of clinical trials or without special arrangements for clinical governance, consent, and audit, according to a consensus document from the society.

“I mostly agree with that,” Dr. Edwards said. “But I now think that this is a reasonable thing to use when other treatments have been exhausted.”

Dr. Edwards and Dr. Venkatesan had no conflicts of interest. Dr. Haefner is an author for UpToDate.

jremaly@mdedge.com

Ultrapotent topical corticosteroids remain the core treatment for vulvar lichen sclerosus, although other therapies can be added, according to an expert speaking at the virtual conference on diseases of the vulva and vagina.

If needed, intralesional steroid injections or calcineurin inhibitors can be added to a topical corticosteroid regimen, Libby Edwards, MD, suggested at the meeting, hosted by the International Society for the Study of Vulvovaginal Disease. In addition, early reports indicate that newer interventions such as fractional CO₂ laser treatments may help patients with refractory disease.

Still, “there is no question, there is no argument: First-, second- and third-line treatment for lichen sclerosus is an ultrapotent or superpotent topical corticosteroid,” she said. Steroids include halobetasol, clobetasol, or betamethasone dipropionate in augmented vehicle ointment once or twice per day. Patients should continue this regimen until the skin texture is normal or the disease is controlled as well as possible, which usually takes several months, said Dr. Edwards, of Southeast Vulvar Clinic in Charlotte, N.C.

Patients then should continue treatment, but less frequently or with a lower potency steroid.

Although corticosteroids are not Food and Drug Administration–approved for the treatment of lichen sclerosus, double-blind, placebo-controlled trials support their use, Dr. Edwards said.

Getting patients to use topical corticosteroids as directed can be a challenge, however, and patient education is crucial.

After about 10 days, many patients start to feel better and stop the medication prematurely, which may lead to recurrence.

“That is such an important counseling point,” Aruna Venkatesan, MD, chief of dermatology and director of the genital dermatology clinic at Santa Clara Valley Medical Center in San Jose, Calif., said during a panel discussion. “Tell them, listen, I may not see you back for a couple months, and you may start feeling better sooner. But I want you to keep using this at this frequency so that when you come back we can make a good decision about whether you’re ready” for a lower potency regimen.

To encourage daily use, Hope K. Haefner, MD, asks patients whether they brush their teeth every night. “When they say yes, I tell them to put the steroid ointment by their toothpaste and use it after brushing,” Dr. Haefner, the Harold A. Furlong Professor of Women’s Health at Michigan Medicine in Ann Arbor, said during the discussion. “But don’t mix up the tubes.”

Once lichen sclerosus is controlled, options include decreasing the superpotent steroid to once, three times per week or changing to a midpotency steroid such as triamcinolone ointment every day, Dr. Edwards said.

Evidence suggests that controlling lichen sclerosus may prevent squamous cell carcinoma and scarring. In a study of more than 500 patients, about 70% complied with treatment instructions, whereas about 30% were considered partially compliant (JAMA Dermatol. 2015 Oct;151[10]:1061-7.). Patients who adhered to their therapy were less likely to have cancer or ongoing scarring during an average of 4.7 years of follow-up.
 

Beyond topical steroids

“Almost always, topical steroids are all you need,” said Dr. Edwards. “Before I go beyond that, I think of other issues that may be causing symptoms,” such as atrophic vagina, steroid dermatitis, or vulvodynia.

For patients with refractory lichen sclerosus, other treatments “can add more oomph to your topical steroid, but they are not better,” she said.

Intralesional corticosteroid injections are one option.

Another option is adding a calcineurin inhibitor such as tacrolimus or pimecrolimus, although these medications can burn with application and irritate. In addition, they carry warnings about rare cases of cancer associated with their use.

Dr. Edwards also uses methotrexate, which is supported by case reports and an open-label study. In a recently published study that included 21 patients with vulvar lichen sclerosus and 24 patients with extragenital lichen sclerosus, about half improved after receiving methotrexate (Dermatol Ther. 2020 Apr 29;e13473.).
 

What about lasers?

Fractional CO₂ laser treatments, which are pulsed to minimize damage from heat, have “a lot of providers very excited,” Dr. Edwards said. In one open-label study of 40 patients, most reported a decrease in symptoms. (J Low Genit Tract Dis. 2020 Apr;24[2]:225-8.)

“We’re awaiting blinded, controlled studies,” Dr. Edwards said. “We don’t have those available yet although they are in progress.”

Ten of Dr. Edwards’ patients who did not improve enough with medication have received laser treatments. One patient stopped laser therapy after one treatment. One did not improve. Two were completely cleared, and six had significant improvement.

If patients who improved stopped steroids against recommendations, lichen sclerosus recurred, Dr. Edwards said.

The ISSVD does not recommend laser for the routine treatment of lichen sclerosus because of a lack of adequate studies and long-term safety data and biologic implausibility, Dr. Edwards noted (J Low Genit Tract Dis. 2019 Apr;23[2]:151-60.) Laser treatments for lichen sclerosus should not be used outside of clinical trials or without special arrangements for clinical governance, consent, and audit, according to a consensus document from the society.

“I mostly agree with that,” Dr. Edwards said. “But I now think that this is a reasonable thing to use when other treatments have been exhausted.”

Dr. Edwards and Dr. Venkatesan had no conflicts of interest. Dr. Haefner is an author for UpToDate.

jremaly@mdedge.com

The 2020-2021 influenza season is shaping up to be challenging. Its likely concurrence with the ongoing severe acute respiratory syndrome-coronavirus 2 (­SARS-coV-2) pandemic (COVID-19) will pose diagnostic and therapeutic dilemmas and could overload the hospital system. But there could also be potential synergies in preventing morbidity and mortality from each disease.

A consistent pattern overthe past few influenza seasons

During the 2019-2020 flu season, there were an estimated 410,000 to 740,000 hospitalizations and 24,000 to 62,000 deaths attributed to influenza.¹ As seen in FIGURE 1, office visits for influenza-like illness (ILI) began to increase in late November and early December in each of the last 3 years (2017-2018, 2018-2019, ­2019-2020) and stayed elevated above baseline for about 4 months each season.¹

The effectiveness of influenza vaccine during the 2019-2020 season is being estimated using the US Flu Vaccine Effectiveness Network, which has close to 9000 enrollees. Overall, it appears the vaccine was 39% effective against medically attended influenza, with a higher effectiveness against influenza B (44%) than against A/H1N1 (31%). Effectiveness against influenza B was similar in all age groups, but effectiveness against A/H1N1 was highest for those ages 50 to 64 years (45%) and lowest for those ages 6 months through 8 years (22%), although 95% confidence intervals overlapped for all age groups (FIGURE 2). These preliminary effectiveness rates were presented at the summer meeting of the Advisory Committee on Immunization Practices (ACIP).¹

Influenza vaccine safety data for ­2019-2020 were based on the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, and on the Vaccine Safety Datalink (VSD) system, an active surveillance system involving close to 6 million doses administered at VSD sites. No safety concerns were identified for any of the different vaccine types. Both the VAERS and VSD surveillance systems have been described in more detail in a previous Practice Alert.²

Recommendations for 2020-2021

The composition of the influenza vaccines for this year’s flu season will be different for 3 of the 4 antigens: A/H1N1, A/H2N2 and B/Victoria.³ The antigens included in the influenza vaccines each year are decided on in the spring, based on surveillance of circulating strains around the world. The effectiveness of the vaccine each year largely depends on how well the strains included in the vaccine match those circulating in the United States during the influenza season.

The main immunization recommendation for preventing morbidity and mortality from influenza has not changed: All individuals ages 6 months and older without a contraindication should receive an influenza vaccine.⁴ The Centers for Disease Control and Prevention (CDC) recommends that patients receive the vaccine by the end of October.⁴ This includes the second dose for those children younger than 9 years who need 2 doses—ie, those who have received fewer than 2 doses of influenza vaccine prior to July 2020. Vaccination should continue through the end of the season for anyone who has not received a 2020-2021 influenza vaccine.

Two new influenza vaccine products are available for use in those ages 65 years and older: Fluzone high-dose quadrivalent and Fluad Quadrivalent (adjuvanted).⁴ Both of these products were available last year as trivalent options. Currently no specific vaccine product is listed as preferred by ACIP for those ages 65 and older.

Continue to: New vaccine contraindications

New vaccine contraindications. Four medical conditions have been added to the list of contraindications for quadrivalent live, attenuated influenza vaccine (LAIV4): cochlear implant, cerebrospinal fluid leak, asplenia (anatomic and functional), and sickle cell anemia.⁴ In addition, those who receive LAIV4 should not be prescribed an influenza antiviral until 2 weeks after receiving the vaccine. And the vaccine should not be administered for 48 hours after receipt of oseltamivir or zanamivir, 5 days after peramivir, and 17 days after baloxavir marboxil.⁴ This is to prevent possible antiviral inactivation of the live attenuated influenza viruses in the ­vaccine.

For those who have a history of severe allergic reaction to eggs, there are now 2 egg-free options: cell-culture-based inactivated vaccine (ccIIV4) and recombinant influenza vaccine (RIV4).^3,4 Urticaria alone is not considered a severe reaction. If neither of these egg-free options is available, a vaccine may still be administered in a medical setting supervised by a provider who is able to manage a severe allergic reaction (which rarely occurs).

All vaccine products available for the upcoming influenza season are listed and described on the CDC Web site, as is a summary of related recommendations.⁴ Particular attention should be paid to the dose of vaccine administered, as it differs by product for those ages 6 through 35 months of age and those ages 65 years and older.

Use of antiviral medications

Four antiviral medications are now available for treating influenza (3 neuraminidase inhibitors and 1 endonuclease inhibitor), and there are 2 agents for preventing influenza, both neuraminidase inhibitors (TABLE 1).⁵ The CDC recommends treating with antivirals as soon as possible if individuals with confirmed or suspected influenza require hospitalization; have severe, complicated, or progressive illness; or are at high risk for complications. Use antivirals based on clinical judgment if previously healthy individuals do not have severe complications and are not at increased risk for complications, and only if the medication can be started within 48 hours of symptom onset.

The CDC discourages widespread use of antivirals to prevent influenza, either pre- or postexposure, although it specifies certain situations in which usage would be acceptable (TABLE 2).⁵ There is some concern that widespread use could lead to the emergence of drug-resistant strains and that using postexposure dosing could lead to suboptimal treatment if influenza infection occurred before the start of prophylaxis. If postexposure antivirals are prescribed, they should be started within 48 hours of exposure and continued for 7 days after the last exposure.

Continue to: A potential perfect storm

While we have vaccines and antivirals to prevent influenza, and have effective antivirals for treatment, no prevention or treatment options exist for COVID-19, except, possibly, dexamethasone to reduce mortality among those seriously ill.⁶ The concurrence of influenza and COVID-19 will present unique challenges for the health care system.

Action steps. Keep abreast of the incidences of circulating SARS-coV-19 and influenza viruses in your community. The similar signs and symptoms of these 2 infectious agents will complicate diagnosis. Rapid, or point-of-care, tests for influenza are widely available, but their accuracy varies and not all tests detect both influenza A and B. The CDC lists approved point-of-care tests at www.cdc.gov/flu/professionals/diagnosis/table-ridt.html and advises on how to interpret these test results when influenza is and is not circulating in the community, at www.cdc.gov/flu/­professionals/diagnosis/clinician_­guidance_ridt.htm.

Clinical practice advice for both conditions should be implemented when any patient presents with ILI:⁷

• Most patients who are not seriously ill and have no conditions that place them at high risk for adverse outcomes can be treated symptomatically at home.
• Those with ILI should be tested for both influenza virus and SARS-CoV-2 if testing is available. It is possible to be co-infected.
• Sick patients should self-isolate at home for the duration of their symptoms.
• If others live in the house, the sick person should stay in a separate room and wear a mask. Everyone in the house should cover coughs and sneezes (if not wearing a mask), dispose of used tissues in a trash can (rather than leaving them on night stands and countertops), and wash hands frequently.
• All household members should be vaccinated against influenza. Those who are unvaccinated, and those at high risk who have been recently vaccinated, can consider influenza antiviral prophylaxis. If the sick family member is confirmed to have COVID-19, with no co-existing influenza, anti-influenza antiviral prophylaxis may be discontinued.
• Clinical infection control practices should be the same for anyone presenting with ILI.⁷ Enhanced clinic-based infection control practices to prevent spread of SARS-CoV-2 are listed in TABLE 3.⁸

Since there currently are no preventive medications proven to work for COVID-19, the main clinical decision physicians will have to make when a patient presents with ILI is whether to use antivirals to treat those who are at risk for complications based on the result of rapid, on-site influenza testing, or clinical presentation, or both. In this situation, knowledge of which viruses are circulating at high rates in the community could be valuable.

Milder season or perfect storm? The society-wide interventions that have been encouraged (although not mandated everywhere) to prevent community spread of ­SARS-CoV-2 should help prevent the community spread of influenza as well, and, if adhered to, may lead to a milder influenza season than would otherwise have occurred. However, given the uncertainties, the combination of influenza and coronavirus could present a perfect storm for the health care system and result in higher-than-normal morbidity and mortality from ILI and pneumonia overall.

Continue to: The possibility that one or more vaccines...

The possibility that one or more vaccines to prevent COVID-19 may be available in late 2020 or early 2021 offers hope. However, in current testing, the vaccine is not being given simultaneously with the influenza vaccine. If the potential for adverse interaction exists between the vaccines, it is important that influenza vaccine be given by mid- to late-October to avoid such an interaction if and when the new SARS-CoV-2 vaccine becomes available. Individuals who have symptoms of COVID-19 should not be vaccinated with influenza vaccine until they are considered noninfectious.

Encourage influenza vaccination. The COVID-19 pandemic may make it difficult to achieve desired community influenza vaccine levels because of decreased visits to medical facilities for preventive care, possible lower insurance coverage due to loss of employment, and a decrease in worksite mass vaccination programs. This makes it important for family physicians to encourage and offer influenza vaccines at their clinical sites.

Several evidence-based practices have been shown to improve vaccine uptake. Examples of such practices include patient reminder and recall systems that provide feedback to clinicians about rates of vaccination among patients, and establishing standing orders for vaccine administration that allow other health care providers to assess a patient’s immunization status and administer vaccinations according to a protocol.⁹ Finally, the CDC provides a video on how to recommend influenza vaccine to those who may be resistant (www.cdc.gov/vaccines/howirecommend/adult-vacc-videos.html).

The 2020-2021 influenza season is shaping up to be challenging. Its likely concurrence with the ongoing severe acute respiratory syndrome-coronavirus 2 (­SARS-coV-2) pandemic (COVID-19) will pose diagnostic and therapeutic dilemmas and could overload the hospital system. But there could also be potential synergies in preventing morbidity and mortality from each disease.

A consistent pattern overthe past few influenza seasons

During the 2019-2020 flu season, there were an estimated 410,000 to 740,000 hospitalizations and 24,000 to 62,000 deaths attributed to influenza.¹ As seen in FIGURE 1, office visits for influenza-like illness (ILI) began to increase in late November and early December in each of the last 3 years (2017-2018, 2018-2019, ­2019-2020) and stayed elevated above baseline for about 4 months each season.¹

The effectiveness of influenza vaccine during the 2019-2020 season is being estimated using the US Flu Vaccine Effectiveness Network, which has close to 9000 enrollees. Overall, it appears the vaccine was 39% effective against medically attended influenza, with a higher effectiveness against influenza B (44%) than against A/H1N1 (31%). Effectiveness against influenza B was similar in all age groups, but effectiveness against A/H1N1 was highest for those ages 50 to 64 years (45%) and lowest for those ages 6 months through 8 years (22%), although 95% confidence intervals overlapped for all age groups (FIGURE 2). These preliminary effectiveness rates were presented at the summer meeting of the Advisory Committee on Immunization Practices (ACIP).¹

Influenza vaccine safety data for ­2019-2020 were based on the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, and on the Vaccine Safety Datalink (VSD) system, an active surveillance system involving close to 6 million doses administered at VSD sites. No safety concerns were identified for any of the different vaccine types. Both the VAERS and VSD surveillance systems have been described in more detail in a previous Practice Alert.²

Recommendations for 2020-2021

The composition of the influenza vaccines for this year’s flu season will be different for 3 of the 4 antigens: A/H1N1, A/H2N2 and B/Victoria.³ The antigens included in the influenza vaccines each year are decided on in the spring, based on surveillance of circulating strains around the world. The effectiveness of the vaccine each year largely depends on how well the strains included in the vaccine match those circulating in the United States during the influenza season.

The main immunization recommendation for preventing morbidity and mortality from influenza has not changed: All individuals ages 6 months and older without a contraindication should receive an influenza vaccine.⁴ The Centers for Disease Control and Prevention (CDC) recommends that patients receive the vaccine by the end of October.⁴ This includes the second dose for those children younger than 9 years who need 2 doses—ie, those who have received fewer than 2 doses of influenza vaccine prior to July 2020. Vaccination should continue through the end of the season for anyone who has not received a 2020-2021 influenza vaccine.

Two new influenza vaccine products are available for use in those ages 65 years and older: Fluzone high-dose quadrivalent and Fluad Quadrivalent (adjuvanted).⁴ Both of these products were available last year as trivalent options. Currently no specific vaccine product is listed as preferred by ACIP for those ages 65 and older.

Continue to: New vaccine contraindications

New vaccine contraindications. Four medical conditions have been added to the list of contraindications for quadrivalent live, attenuated influenza vaccine (LAIV4): cochlear implant, cerebrospinal fluid leak, asplenia (anatomic and functional), and sickle cell anemia.⁴ In addition, those who receive LAIV4 should not be prescribed an influenza antiviral until 2 weeks after receiving the vaccine. And the vaccine should not be administered for 48 hours after receipt of oseltamivir or zanamivir, 5 days after peramivir, and 17 days after baloxavir marboxil.⁴ This is to prevent possible antiviral inactivation of the live attenuated influenza viruses in the ­vaccine.

For those who have a history of severe allergic reaction to eggs, there are now 2 egg-free options: cell-culture-based inactivated vaccine (ccIIV4) and recombinant influenza vaccine (RIV4).^3,4 Urticaria alone is not considered a severe reaction. If neither of these egg-free options is available, a vaccine may still be administered in a medical setting supervised by a provider who is able to manage a severe allergic reaction (which rarely occurs).

All vaccine products available for the upcoming influenza season are listed and described on the CDC Web site, as is a summary of related recommendations.⁴ Particular attention should be paid to the dose of vaccine administered, as it differs by product for those ages 6 through 35 months of age and those ages 65 years and older.

Use of antiviral medications

Four antiviral medications are now available for treating influenza (3 neuraminidase inhibitors and 1 endonuclease inhibitor), and there are 2 agents for preventing influenza, both neuraminidase inhibitors (TABLE 1).⁵ The CDC recommends treating with antivirals as soon as possible if individuals with confirmed or suspected influenza require hospitalization; have severe, complicated, or progressive illness; or are at high risk for complications. Use antivirals based on clinical judgment if previously healthy individuals do not have severe complications and are not at increased risk for complications, and only if the medication can be started within 48 hours of symptom onset.

The CDC discourages widespread use of antivirals to prevent influenza, either pre- or postexposure, although it specifies certain situations in which usage would be acceptable (TABLE 2).⁵ There is some concern that widespread use could lead to the emergence of drug-resistant strains and that using postexposure dosing could lead to suboptimal treatment if influenza infection occurred before the start of prophylaxis. If postexposure antivirals are prescribed, they should be started within 48 hours of exposure and continued for 7 days after the last exposure.

Continue to: A potential perfect storm

While we have vaccines and antivirals to prevent influenza, and have effective antivirals for treatment, no prevention or treatment options exist for COVID-19, except, possibly, dexamethasone to reduce mortality among those seriously ill.⁶ The concurrence of influenza and COVID-19 will present unique challenges for the health care system.

Action steps. Keep abreast of the incidences of circulating SARS-coV-19 and influenza viruses in your community. The similar signs and symptoms of these 2 infectious agents will complicate diagnosis. Rapid, or point-of-care, tests for influenza are widely available, but their accuracy varies and not all tests detect both influenza A and B. The CDC lists approved point-of-care tests at www.cdc.gov/flu/professionals/diagnosis/table-ridt.html and advises on how to interpret these test results when influenza is and is not circulating in the community, at www.cdc.gov/flu/­professionals/diagnosis/clinician_­guidance_ridt.htm.

Clinical practice advice for both conditions should be implemented when any patient presents with ILI:⁷

• Most patients who are not seriously ill and have no conditions that place them at high risk for adverse outcomes can be treated symptomatically at home.
• Those with ILI should be tested for both influenza virus and SARS-CoV-2 if testing is available. It is possible to be co-infected.
• Sick patients should self-isolate at home for the duration of their symptoms.
• If others live in the house, the sick person should stay in a separate room and wear a mask. Everyone in the house should cover coughs and sneezes (if not wearing a mask), dispose of used tissues in a trash can (rather than leaving them on night stands and countertops), and wash hands frequently.
• All household members should be vaccinated against influenza. Those who are unvaccinated, and those at high risk who have been recently vaccinated, can consider influenza antiviral prophylaxis. If the sick family member is confirmed to have COVID-19, with no co-existing influenza, anti-influenza antiviral prophylaxis may be discontinued.
• Clinical infection control practices should be the same for anyone presenting with ILI.⁷ Enhanced clinic-based infection control practices to prevent spread of SARS-CoV-2 are listed in TABLE 3.⁸

Since there currently are no preventive medications proven to work for COVID-19, the main clinical decision physicians will have to make when a patient presents with ILI is whether to use antivirals to treat those who are at risk for complications based on the result of rapid, on-site influenza testing, or clinical presentation, or both. In this situation, knowledge of which viruses are circulating at high rates in the community could be valuable.

Milder season or perfect storm? The society-wide interventions that have been encouraged (although not mandated everywhere) to prevent community spread of ­SARS-CoV-2 should help prevent the community spread of influenza as well, and, if adhered to, may lead to a milder influenza season than would otherwise have occurred. However, given the uncertainties, the combination of influenza and coronavirus could present a perfect storm for the health care system and result in higher-than-normal morbidity and mortality from ILI and pneumonia overall.

Continue to: The possibility that one or more vaccines...

The possibility that one or more vaccines to prevent COVID-19 may be available in late 2020 or early 2021 offers hope. However, in current testing, the vaccine is not being given simultaneously with the influenza vaccine. If the potential for adverse interaction exists between the vaccines, it is important that influenza vaccine be given by mid- to late-October to avoid such an interaction if and when the new SARS-CoV-2 vaccine becomes available. Individuals who have symptoms of COVID-19 should not be vaccinated with influenza vaccine until they are considered noninfectious.

Encourage influenza vaccination. The COVID-19 pandemic may make it difficult to achieve desired community influenza vaccine levels because of decreased visits to medical facilities for preventive care, possible lower insurance coverage due to loss of employment, and a decrease in worksite mass vaccination programs. This makes it important for family physicians to encourage and offer influenza vaccines at their clinical sites.

Several evidence-based practices have been shown to improve vaccine uptake. Examples of such practices include patient reminder and recall systems that provide feedback to clinicians about rates of vaccination among patients, and establishing standing orders for vaccine administration that allow other health care providers to assess a patient’s immunization status and administer vaccinations according to a protocol.⁹ Finally, the CDC provides a video on how to recommend influenza vaccine to those who may be resistant (www.cdc.gov/vaccines/howirecommend/adult-vacc-videos.html).

The 2020-2021 influenza season is shaping up to be challenging. Its likely concurrence with the ongoing severe acute respiratory syndrome-coronavirus 2 (­SARS-coV-2) pandemic (COVID-19) will pose diagnostic and therapeutic dilemmas and could overload the hospital system. But there could also be potential synergies in preventing morbidity and mortality from each disease.

A consistent pattern overthe past few influenza seasons

During the 2019-2020 flu season, there were an estimated 410,000 to 740,000 hospitalizations and 24,000 to 62,000 deaths attributed to influenza.¹ As seen in FIGURE 1, office visits for influenza-like illness (ILI) began to increase in late November and early December in each of the last 3 years (2017-2018, 2018-2019, ­2019-2020) and stayed elevated above baseline for about 4 months each season.¹

The effectiveness of influenza vaccine during the 2019-2020 season is being estimated using the US Flu Vaccine Effectiveness Network, which has close to 9000 enrollees. Overall, it appears the vaccine was 39% effective against medically attended influenza, with a higher effectiveness against influenza B (44%) than against A/H1N1 (31%). Effectiveness against influenza B was similar in all age groups, but effectiveness against A/H1N1 was highest for those ages 50 to 64 years (45%) and lowest for those ages 6 months through 8 years (22%), although 95% confidence intervals overlapped for all age groups (FIGURE 2). These preliminary effectiveness rates were presented at the summer meeting of the Advisory Committee on Immunization Practices (ACIP).¹

Influenza vaccine safety data for ­2019-2020 were based on the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, and on the Vaccine Safety Datalink (VSD) system, an active surveillance system involving close to 6 million doses administered at VSD sites. No safety concerns were identified for any of the different vaccine types. Both the VAERS and VSD surveillance systems have been described in more detail in a previous Practice Alert.²

Recommendations for 2020-2021

The composition of the influenza vaccines for this year’s flu season will be different for 3 of the 4 antigens: A/H1N1, A/H2N2 and B/Victoria.³ The antigens included in the influenza vaccines each year are decided on in the spring, based on surveillance of circulating strains around the world. The effectiveness of the vaccine each year largely depends on how well the strains included in the vaccine match those circulating in the United States during the influenza season.

The main immunization recommendation for preventing morbidity and mortality from influenza has not changed: All individuals ages 6 months and older without a contraindication should receive an influenza vaccine.⁴ The Centers for Disease Control and Prevention (CDC) recommends that patients receive the vaccine by the end of October.⁴ This includes the second dose for those children younger than 9 years who need 2 doses—ie, those who have received fewer than 2 doses of influenza vaccine prior to July 2020. Vaccination should continue through the end of the season for anyone who has not received a 2020-2021 influenza vaccine.

Two new influenza vaccine products are available for use in those ages 65 years and older: Fluzone high-dose quadrivalent and Fluad Quadrivalent (adjuvanted).⁴ Both of these products were available last year as trivalent options. Currently no specific vaccine product is listed as preferred by ACIP for those ages 65 and older.

Continue to: New vaccine contraindications

New vaccine contraindications. Four medical conditions have been added to the list of contraindications for quadrivalent live, attenuated influenza vaccine (LAIV4): cochlear implant, cerebrospinal fluid leak, asplenia (anatomic and functional), and sickle cell anemia.⁴ In addition, those who receive LAIV4 should not be prescribed an influenza antiviral until 2 weeks after receiving the vaccine. And the vaccine should not be administered for 48 hours after receipt of oseltamivir or zanamivir, 5 days after peramivir, and 17 days after baloxavir marboxil.⁴ This is to prevent possible antiviral inactivation of the live attenuated influenza viruses in the ­vaccine.

For those who have a history of severe allergic reaction to eggs, there are now 2 egg-free options: cell-culture-based inactivated vaccine (ccIIV4) and recombinant influenza vaccine (RIV4).^3,4 Urticaria alone is not considered a severe reaction. If neither of these egg-free options is available, a vaccine may still be administered in a medical setting supervised by a provider who is able to manage a severe allergic reaction (which rarely occurs).

All vaccine products available for the upcoming influenza season are listed and described on the CDC Web site, as is a summary of related recommendations.⁴ Particular attention should be paid to the dose of vaccine administered, as it differs by product for those ages 6 through 35 months of age and those ages 65 years and older.

Use of antiviral medications

Four antiviral medications are now available for treating influenza (3 neuraminidase inhibitors and 1 endonuclease inhibitor), and there are 2 agents for preventing influenza, both neuraminidase inhibitors (TABLE 1).⁵ The CDC recommends treating with antivirals as soon as possible if individuals with confirmed or suspected influenza require hospitalization; have severe, complicated, or progressive illness; or are at high risk for complications. Use antivirals based on clinical judgment if previously healthy individuals do not have severe complications and are not at increased risk for complications, and only if the medication can be started within 48 hours of symptom onset.

The CDC discourages widespread use of antivirals to prevent influenza, either pre- or postexposure, although it specifies certain situations in which usage would be acceptable (TABLE 2).⁵ There is some concern that widespread use could lead to the emergence of drug-resistant strains and that using postexposure dosing could lead to suboptimal treatment if influenza infection occurred before the start of prophylaxis. If postexposure antivirals are prescribed, they should be started within 48 hours of exposure and continued for 7 days after the last exposure.

Continue to: A potential perfect storm

While we have vaccines and antivirals to prevent influenza, and have effective antivirals for treatment, no prevention or treatment options exist for COVID-19, except, possibly, dexamethasone to reduce mortality among those seriously ill.⁶ The concurrence of influenza and COVID-19 will present unique challenges for the health care system.

Action steps. Keep abreast of the incidences of circulating SARS-coV-19 and influenza viruses in your community. The similar signs and symptoms of these 2 infectious agents will complicate diagnosis. Rapid, or point-of-care, tests for influenza are widely available, but their accuracy varies and not all tests detect both influenza A and B. The CDC lists approved point-of-care tests at www.cdc.gov/flu/professionals/diagnosis/table-ridt.html and advises on how to interpret these test results when influenza is and is not circulating in the community, at www.cdc.gov/flu/­professionals/diagnosis/clinician_­guidance_ridt.htm.

Clinical practice advice for both conditions should be implemented when any patient presents with ILI:⁷

• Most patients who are not seriously ill and have no conditions that place them at high risk for adverse outcomes can be treated symptomatically at home.
• Those with ILI should be tested for both influenza virus and SARS-CoV-2 if testing is available. It is possible to be co-infected.
• Sick patients should self-isolate at home for the duration of their symptoms.
• If others live in the house, the sick person should stay in a separate room and wear a mask. Everyone in the house should cover coughs and sneezes (if not wearing a mask), dispose of used tissues in a trash can (rather than leaving them on night stands and countertops), and wash hands frequently.
• All household members should be vaccinated against influenza. Those who are unvaccinated, and those at high risk who have been recently vaccinated, can consider influenza antiviral prophylaxis. If the sick family member is confirmed to have COVID-19, with no co-existing influenza, anti-influenza antiviral prophylaxis may be discontinued.
• Clinical infection control practices should be the same for anyone presenting with ILI.⁷ Enhanced clinic-based infection control practices to prevent spread of SARS-CoV-2 are listed in TABLE 3.⁸

Since there currently are no preventive medications proven to work for COVID-19, the main clinical decision physicians will have to make when a patient presents with ILI is whether to use antivirals to treat those who are at risk for complications based on the result of rapid, on-site influenza testing, or clinical presentation, or both. In this situation, knowledge of which viruses are circulating at high rates in the community could be valuable.

Milder season or perfect storm? The society-wide interventions that have been encouraged (although not mandated everywhere) to prevent community spread of ­SARS-CoV-2 should help prevent the community spread of influenza as well, and, if adhered to, may lead to a milder influenza season than would otherwise have occurred. However, given the uncertainties, the combination of influenza and coronavirus could present a perfect storm for the health care system and result in higher-than-normal morbidity and mortality from ILI and pneumonia overall.

Continue to: The possibility that one or more vaccines...

The possibility that one or more vaccines to prevent COVID-19 may be available in late 2020 or early 2021 offers hope. However, in current testing, the vaccine is not being given simultaneously with the influenza vaccine. If the potential for adverse interaction exists between the vaccines, it is important that influenza vaccine be given by mid- to late-October to avoid such an interaction if and when the new SARS-CoV-2 vaccine becomes available. Individuals who have symptoms of COVID-19 should not be vaccinated with influenza vaccine until they are considered noninfectious.

Encourage influenza vaccination. The COVID-19 pandemic may make it difficult to achieve desired community influenza vaccine levels because of decreased visits to medical facilities for preventive care, possible lower insurance coverage due to loss of employment, and a decrease in worksite mass vaccination programs. This makes it important for family physicians to encourage and offer influenza vaccines at their clinical sites.

Several evidence-based practices have been shown to improve vaccine uptake. Examples of such practices include patient reminder and recall systems that provide feedback to clinicians about rates of vaccination among patients, and establishing standing orders for vaccine administration that allow other health care providers to assess a patient’s immunization status and administer vaccinations according to a protocol.⁹ Finally, the CDC provides a video on how to recommend influenza vaccine to those who may be resistant (www.cdc.gov/vaccines/howirecommend/adult-vacc-videos.html).

When medical care is based on consistent, good-quality evidence, most physicians adopt it. However, not all care is well supported by the literature and may, in fact, be overused without offering benefit to patients. Choosing Wisely, at www.choosingwisely.org, is a health care initiative that highlights screening and testing recommendations from specialty societies in an effort to encourage patients and clinicians to talk about how to make high-value, effective health care decisions and avoid overuse. (See “Test and Tx overutilization: A bigger problem than you might think"^1-3).

Enabling physician and patient dialogue. The initiative began in 2010 when the American Board of Internal Medicine convened a panel of experts to identify low-value tests and therapies. Their list took the form of a “Top Five Things” that may not be high value in patient care, and it used language tailored to patients and physicians so that they could converse meaningfully. Physicians could use the evidence to make a clinical decision, and patients could feel empowered to ask informed questions about recommendations they received. The initiative has now expanded to include ways that health care systems can reduce low-value interventions.

Scope of participation. Since the first Choosing Wisely recommendations were published in 2013, more than 80 professional associations have contributed lists of their own. Professional societies participate voluntarily. The American Academy of Family Physicians (AAFP), Society of General Internal Medicine, and American Academy of Pediatrics (AAP) have contributed lists relevant to primary care. All Choosing Wisely recommendations can be searched or sorted by specialty organization. Recommendations are reviewed and revised regularly. If the evidence becomes conflicted or contradictory, recommendations are withdrawn.

Making meaningful improvements by Choosing Wisely

Several studies have shown that health care systems can implement Choosing Wisely recommendations to reduce overuse of unnecessary tests. A 2015 study examined the effect of applying a Choosing Wisely recommendation to reduce the use of continuous pulse oximetry in pediatric inpatients with asthma, wheezing, or bronchiolitis. The recommendation, from the Society of Hospital Medicine–Pediatric Hospital Medicine, advises against continuous pulse oximetry in children with acute respiratory illnesses unless the child is using supplemental oxygen.⁴ This study, done at the Cincinnati Children’s Hospital Medical Center, found that within 3 months of initiating a protocol on all general pediatrics floors, the average time on pulse oximetry after meeting clinical goals decreased from 10.7 hours to 3.1 hours. In addition, the percentage of patients who had their continuous pulse oximetry stopped within 2 hours of clinical stability (a goal time) increased from 25% to 46%.⁵

Patients are important drivers of health care utilization. A 2003 study showed that physicians are more likely to order referrals, tests, and prescriptions when patients ask for them, and that nearly 1 in 4 patients did so.⁶ A 2002 study found that physicians granted all but 3% of patient’s requests for orders or tests, and that fulfilling requests correlated with patient satisfaction in the specialty office studied (cardiology) but not in the primary care (internal medicine) office.⁷

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidencebased advice from a specialty society to its members and to patients about care that is often unnecessary.

From its inception, Choosing Wisely has considered patients as full partners in conversations about health care utilization. Choosing Wisely partners with Consumer Reports to create and disseminate plain-language summaries of recommendations. Community groups and physician organizations have also participated in implementation efforts. In 2018, Choosing Wisely secured a grant to expand outreach to diverse or underserved communities.

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidence-based advice from a specialty society to its members and to patients about care that is often unnecessary. The goal is to create a conversation and not to eliminate these services from ever being offered or used.

Continue to: Improve your practice with these 10 primary care recommendations

Improve your practice with these 10 primary care recommendations

 1 Avoid imaging studies in early acute low back pain without red flags.

Both the AAFP and the American Society of Anesthesiologists recommend against routine X-rays, magnetic resonance imaging, and computed tomography (CT) scans in the first 6 weeks of acute low back pain (LBP).^8,9 The American College of Emergency Physicians (ACEP) recommends against routine lumbar spine imaging for emergency department (ED) patients.¹⁰ In all cases, imaging is indicated if the patient has any signs or symptoms of neurologic deficits or other indications, such as signs of spinal infection or fracture. However, as ACEP notes, diagnostic imaging does not typically help identify the cause of acute LBP, and when it does, it does not reduce the time to symptom improvement.¹⁰

2 Prescribe oral contraceptives on the basis of a medical history and a blood pressure measurement. No routine pelvic exam or other physical exam is necessary.

This AAFP recommendation¹¹ is based on clinical practice guidelines from the American College of Obstetricians and Gynecologists (ACOG) and other research.¹² The ACOG practice guideline supports provision of hormonal contraception without a pelvic exam, cervical cancer (Pap) testing, urine pregnancy testing, or testing for sexually transmitted infections. ACOG guidelines also support over-the-counter provision of hormonal contraceptives, including combined oral contraceptives.¹²

3 Stop recommending daily self-glucose monitoring for patients with diabetes who are not using insulin.

Both the AAFP and the Society for General Internal Medicine recommend against daily blood sugar checks for people who do not use insulin.^13,14 A Cochrane review of 9 trials (3300 patients) found that after 6 months, hemoglobin A1C was reduced by 0.3% in people who checked their sugar daily compared with those who did not, but this difference was not significant after a year.¹⁵ Hypoglycemic episodes were more common in the “checking” group, and there were no differences in quality of life. A qualitative study found that blood sugar results had little impact on patients’ motivation to change behavior.¹⁶

4 Don’t screen for herpes simplex virus (HSV) infection in asymptomatic adults, even those who are pregnant.

This AAFP recommendation¹⁷ comes from a US Preventive Services Task Force (USPSTF) Grade D recommendation.18 Most people with positive HSV-2 serology have had an outbreak; even those who do not think they have had one will realize that they had the symptoms once they hear them described.18 With available tests, 1 in 2 positive results for HSV-2 among asymptomatic people will be a false-positive.¹⁸

A 2006 analysis of inpatient lab studies found that doctors ordered an average of 2.96 studies per patient per day, but only 29% of these tests contributed to management.

There is no known cure, intervention, or reduction in transmission for infected patients who do not have symptoms.¹⁸ Also, serologically detected HSV-2 does not reliably predict genital herpes; and HSV-1 has been found to cause an increasing percentage of genital infection cases.¹⁸

Continue to: 5 Don't screen for testicular cancer in asymptomatic individuals

5 Don’t screen for testicular cancer in asymptomatic individuals.

This AAFP recommendation¹⁹ also comes from a USPSTF Grade D recommendation.²⁰ A 2010 systematic review found no evidence to support screening of asymptomatic people with a physical exam or ultrasound. All available studies involved symptomatic patients.²⁰

 6 Stop recommending cough and cold medicines for children younger than 4 years.

The AAP recommends that clinicians discourage the use of any cough or cold medicine for children in this age-group.²¹ A 2008 study found that more than 7000 children annually presented to EDs for adverse events from cough and cold medicines.²² Previous studies found no benefit in reducing symptoms.²³ In children older than 12 months, a Cochrane review found that honey has a modest benefit for cough in single-night trials.²⁴

7 Avoid performing serum allergy panels.

The American Academy of Allergy, Asthma, and Immunology discourages the use of serum panel testing when patients present with allergy symptoms.²⁵ A patient can have a strong positive immunoglobulin E (IgE) serum result to an allergen and have no clinical allergic symptoms or can have a weak positive serum result and a strong clinical reaction. Targeted skin or serum IgE testing—for example, testing for cashew allergy in a patient known to have had a reaction after eating one—is reasonable.²⁶

8 Avoid routine electroencephalography (EEG), head CT, and carotid ultrasound as initial work-up for simple syncope in adults.

These recommendations, from the American Epilepsy Society,²⁷ ACEP,²⁸ American College of Physicians,²⁹ and American Academy of Neurology (AAN),³⁰ emphasize the low yield of routine work-ups for patients with simple syncope. The AAN notes that 40% of people will experience syncope during adulthood and most will not have carotid disease, which generally manifests with stroke-like symptoms rather than syncope. One study found that approximately 1 in 8 patients referred to an epilepsy clinic had neurocardiogenic syncope rather than epilepsy.³¹

EEGs have high false-negative and false-positive rates, and history-taking is a better tool with which to make a diagnosis. CT scans performed in the ED were found to contribute to the diagnosis of simple syncope in fewer than 2% of cases of syncope, compared with orthostatic blood pressure (25% of cases).³²

Continue to: 9 Wait to refer children with umbilical hernias to pediatric surgery until they are 4 to 5 years of age

The AAP Section on Surgery offers evidence that the risk-benefit analysis strongly favors waiting on intervention.³³ About 1 in 4 children will have an umbilical hernia, and about 85% of cases will resolve by age 5. The strangulation rate with umbilical hernias is very low, and although the risk of infection with surgery is likewise low, the risk of recurrence following surgery before the age of 4 is as high as 2.4%.³⁴ The AAP Section on Surgery recommends against strapping or restraining the hernia, as well.

10 Avoid using appetite stimulants, such as megesterol, and high-calorie nutritional supplements to treat anorexia and cachexia in older adults.

Instead, the American Geriatrics Society recommends that physicians encourage caregivers to serve appealing food, provide support with eating, and remove barriers to appetite and nutrition.³⁵ A Cochrane review showed that high-calorie supplements, such as Boost or Ensure, are associated with very modest weight gain—about 2% of weight—but are not associated with an increased life expectancy or improved quality of life.³⁶

Both the AAFP and the American Society of Anesthesiologists recommend against routine x-rays, MRIs, and CT scans during the first 6 weeks of acute low back pain.

Prescription appetite stimulants are associated with adverse effects and yield inconsistent benefits in older adults. Megesterol, for example, was associated with headache, gastrointestinal adverse effects, insomnia, weakness, and fatigue. Mirtazapine is associated with sedation and fatigue.³⁷

CORRESPONDENCE
Kathleen Rowland, MD, MS, Rush Copley Family Medicine Residency, Rush Medical College, 600 South Paulina, Kidston House Room 605, Chicago IL 60612; kathleen_rowland@rush.edu.

When medical care is based on consistent, good-quality evidence, most physicians adopt it. However, not all care is well supported by the literature and may, in fact, be overused without offering benefit to patients. Choosing Wisely, at www.choosingwisely.org, is a health care initiative that highlights screening and testing recommendations from specialty societies in an effort to encourage patients and clinicians to talk about how to make high-value, effective health care decisions and avoid overuse. (See “Test and Tx overutilization: A bigger problem than you might think"^1-3).

Enabling physician and patient dialogue. The initiative began in 2010 when the American Board of Internal Medicine convened a panel of experts to identify low-value tests and therapies. Their list took the form of a “Top Five Things” that may not be high value in patient care, and it used language tailored to patients and physicians so that they could converse meaningfully. Physicians could use the evidence to make a clinical decision, and patients could feel empowered to ask informed questions about recommendations they received. The initiative has now expanded to include ways that health care systems can reduce low-value interventions.

Scope of participation. Since the first Choosing Wisely recommendations were published in 2013, more than 80 professional associations have contributed lists of their own. Professional societies participate voluntarily. The American Academy of Family Physicians (AAFP), Society of General Internal Medicine, and American Academy of Pediatrics (AAP) have contributed lists relevant to primary care. All Choosing Wisely recommendations can be searched or sorted by specialty organization. Recommendations are reviewed and revised regularly. If the evidence becomes conflicted or contradictory, recommendations are withdrawn.

Making meaningful improvements by Choosing Wisely

Several studies have shown that health care systems can implement Choosing Wisely recommendations to reduce overuse of unnecessary tests. A 2015 study examined the effect of applying a Choosing Wisely recommendation to reduce the use of continuous pulse oximetry in pediatric inpatients with asthma, wheezing, or bronchiolitis. The recommendation, from the Society of Hospital Medicine–Pediatric Hospital Medicine, advises against continuous pulse oximetry in children with acute respiratory illnesses unless the child is using supplemental oxygen.⁴ This study, done at the Cincinnati Children’s Hospital Medical Center, found that within 3 months of initiating a protocol on all general pediatrics floors, the average time on pulse oximetry after meeting clinical goals decreased from 10.7 hours to 3.1 hours. In addition, the percentage of patients who had their continuous pulse oximetry stopped within 2 hours of clinical stability (a goal time) increased from 25% to 46%.⁵

Patients are important drivers of health care utilization. A 2003 study showed that physicians are more likely to order referrals, tests, and prescriptions when patients ask for them, and that nearly 1 in 4 patients did so.⁶ A 2002 study found that physicians granted all but 3% of patient’s requests for orders or tests, and that fulfilling requests correlated with patient satisfaction in the specialty office studied (cardiology) but not in the primary care (internal medicine) office.⁷

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidencebased advice from a specialty society to its members and to patients about care that is often unnecessary.

From its inception, Choosing Wisely has considered patients as full partners in conversations about health care utilization. Choosing Wisely partners with Consumer Reports to create and disseminate plain-language summaries of recommendations. Community groups and physician organizations have also participated in implementation efforts. In 2018, Choosing Wisely secured a grant to expand outreach to diverse or underserved communities.

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidence-based advice from a specialty society to its members and to patients about care that is often unnecessary. The goal is to create a conversation and not to eliminate these services from ever being offered or used.

Continue to: Improve your practice with these 10 primary care recommendations

Improve your practice with these 10 primary care recommendations

 1 Avoid imaging studies in early acute low back pain without red flags.

Both the AAFP and the American Society of Anesthesiologists recommend against routine X-rays, magnetic resonance imaging, and computed tomography (CT) scans in the first 6 weeks of acute low back pain (LBP).^8,9 The American College of Emergency Physicians (ACEP) recommends against routine lumbar spine imaging for emergency department (ED) patients.¹⁰ In all cases, imaging is indicated if the patient has any signs or symptoms of neurologic deficits or other indications, such as signs of spinal infection or fracture. However, as ACEP notes, diagnostic imaging does not typically help identify the cause of acute LBP, and when it does, it does not reduce the time to symptom improvement.¹⁰

2 Prescribe oral contraceptives on the basis of a medical history and a blood pressure measurement. No routine pelvic exam or other physical exam is necessary.

This AAFP recommendation¹¹ is based on clinical practice guidelines from the American College of Obstetricians and Gynecologists (ACOG) and other research.¹² The ACOG practice guideline supports provision of hormonal contraception without a pelvic exam, cervical cancer (Pap) testing, urine pregnancy testing, or testing for sexually transmitted infections. ACOG guidelines also support over-the-counter provision of hormonal contraceptives, including combined oral contraceptives.¹²

3 Stop recommending daily self-glucose monitoring for patients with diabetes who are not using insulin.

Both the AAFP and the Society for General Internal Medicine recommend against daily blood sugar checks for people who do not use insulin.^13,14 A Cochrane review of 9 trials (3300 patients) found that after 6 months, hemoglobin A1C was reduced by 0.3% in people who checked their sugar daily compared with those who did not, but this difference was not significant after a year.¹⁵ Hypoglycemic episodes were more common in the “checking” group, and there were no differences in quality of life. A qualitative study found that blood sugar results had little impact on patients’ motivation to change behavior.¹⁶

4 Don’t screen for herpes simplex virus (HSV) infection in asymptomatic adults, even those who are pregnant.

This AAFP recommendation¹⁷ comes from a US Preventive Services Task Force (USPSTF) Grade D recommendation.18 Most people with positive HSV-2 serology have had an outbreak; even those who do not think they have had one will realize that they had the symptoms once they hear them described.18 With available tests, 1 in 2 positive results for HSV-2 among asymptomatic people will be a false-positive.¹⁸

A 2006 analysis of inpatient lab studies found that doctors ordered an average of 2.96 studies per patient per day, but only 29% of these tests contributed to management.

There is no known cure, intervention, or reduction in transmission for infected patients who do not have symptoms.¹⁸ Also, serologically detected HSV-2 does not reliably predict genital herpes; and HSV-1 has been found to cause an increasing percentage of genital infection cases.¹⁸

Continue to: 5 Don't screen for testicular cancer in asymptomatic individuals

5 Don’t screen for testicular cancer in asymptomatic individuals.

This AAFP recommendation¹⁹ also comes from a USPSTF Grade D recommendation.²⁰ A 2010 systematic review found no evidence to support screening of asymptomatic people with a physical exam or ultrasound. All available studies involved symptomatic patients.²⁰

 6 Stop recommending cough and cold medicines for children younger than 4 years.

The AAP recommends that clinicians discourage the use of any cough or cold medicine for children in this age-group.²¹ A 2008 study found that more than 7000 children annually presented to EDs for adverse events from cough and cold medicines.²² Previous studies found no benefit in reducing symptoms.²³ In children older than 12 months, a Cochrane review found that honey has a modest benefit for cough in single-night trials.²⁴

7 Avoid performing serum allergy panels.

The American Academy of Allergy, Asthma, and Immunology discourages the use of serum panel testing when patients present with allergy symptoms.²⁵ A patient can have a strong positive immunoglobulin E (IgE) serum result to an allergen and have no clinical allergic symptoms or can have a weak positive serum result and a strong clinical reaction. Targeted skin or serum IgE testing—for example, testing for cashew allergy in a patient known to have had a reaction after eating one—is reasonable.²⁶

8 Avoid routine electroencephalography (EEG), head CT, and carotid ultrasound as initial work-up for simple syncope in adults.

These recommendations, from the American Epilepsy Society,²⁷ ACEP,²⁸ American College of Physicians,²⁹ and American Academy of Neurology (AAN),³⁰ emphasize the low yield of routine work-ups for patients with simple syncope. The AAN notes that 40% of people will experience syncope during adulthood and most will not have carotid disease, which generally manifests with stroke-like symptoms rather than syncope. One study found that approximately 1 in 8 patients referred to an epilepsy clinic had neurocardiogenic syncope rather than epilepsy.³¹

EEGs have high false-negative and false-positive rates, and history-taking is a better tool with which to make a diagnosis. CT scans performed in the ED were found to contribute to the diagnosis of simple syncope in fewer than 2% of cases of syncope, compared with orthostatic blood pressure (25% of cases).³²

Continue to: 9 Wait to refer children with umbilical hernias to pediatric surgery until they are 4 to 5 years of age

The AAP Section on Surgery offers evidence that the risk-benefit analysis strongly favors waiting on intervention.³³ About 1 in 4 children will have an umbilical hernia, and about 85% of cases will resolve by age 5. The strangulation rate with umbilical hernias is very low, and although the risk of infection with surgery is likewise low, the risk of recurrence following surgery before the age of 4 is as high as 2.4%.³⁴ The AAP Section on Surgery recommends against strapping or restraining the hernia, as well.

10 Avoid using appetite stimulants, such as megesterol, and high-calorie nutritional supplements to treat anorexia and cachexia in older adults.

Instead, the American Geriatrics Society recommends that physicians encourage caregivers to serve appealing food, provide support with eating, and remove barriers to appetite and nutrition.³⁵ A Cochrane review showed that high-calorie supplements, such as Boost or Ensure, are associated with very modest weight gain—about 2% of weight—but are not associated with an increased life expectancy or improved quality of life.³⁶

Both the AAFP and the American Society of Anesthesiologists recommend against routine x-rays, MRIs, and CT scans during the first 6 weeks of acute low back pain.

Prescription appetite stimulants are associated with adverse effects and yield inconsistent benefits in older adults. Megesterol, for example, was associated with headache, gastrointestinal adverse effects, insomnia, weakness, and fatigue. Mirtazapine is associated with sedation and fatigue.³⁷

CORRESPONDENCE
Kathleen Rowland, MD, MS, Rush Copley Family Medicine Residency, Rush Medical College, 600 South Paulina, Kidston House Room 605, Chicago IL 60612; kathleen_rowland@rush.edu.

When medical care is based on consistent, good-quality evidence, most physicians adopt it. However, not all care is well supported by the literature and may, in fact, be overused without offering benefit to patients. Choosing Wisely, at www.choosingwisely.org, is a health care initiative that highlights screening and testing recommendations from specialty societies in an effort to encourage patients and clinicians to talk about how to make high-value, effective health care decisions and avoid overuse. (See “Test and Tx overutilization: A bigger problem than you might think"^1-3).

Enabling physician and patient dialogue. The initiative began in 2010 when the American Board of Internal Medicine convened a panel of experts to identify low-value tests and therapies. Their list took the form of a “Top Five Things” that may not be high value in patient care, and it used language tailored to patients and physicians so that they could converse meaningfully. Physicians could use the evidence to make a clinical decision, and patients could feel empowered to ask informed questions about recommendations they received. The initiative has now expanded to include ways that health care systems can reduce low-value interventions.

Scope of participation. Since the first Choosing Wisely recommendations were published in 2013, more than 80 professional associations have contributed lists of their own. Professional societies participate voluntarily. The American Academy of Family Physicians (AAFP), Society of General Internal Medicine, and American Academy of Pediatrics (AAP) have contributed lists relevant to primary care. All Choosing Wisely recommendations can be searched or sorted by specialty organization. Recommendations are reviewed and revised regularly. If the evidence becomes conflicted or contradictory, recommendations are withdrawn.

Making meaningful improvements by Choosing Wisely

Several studies have shown that health care systems can implement Choosing Wisely recommendations to reduce overuse of unnecessary tests. A 2015 study examined the effect of applying a Choosing Wisely recommendation to reduce the use of continuous pulse oximetry in pediatric inpatients with asthma, wheezing, or bronchiolitis. The recommendation, from the Society of Hospital Medicine–Pediatric Hospital Medicine, advises against continuous pulse oximetry in children with acute respiratory illnesses unless the child is using supplemental oxygen.⁴ This study, done at the Cincinnati Children’s Hospital Medical Center, found that within 3 months of initiating a protocol on all general pediatrics floors, the average time on pulse oximetry after meeting clinical goals decreased from 10.7 hours to 3.1 hours. In addition, the percentage of patients who had their continuous pulse oximetry stopped within 2 hours of clinical stability (a goal time) increased from 25% to 46%.⁵

Patients are important drivers of health care utilization. A 2003 study showed that physicians are more likely to order referrals, tests, and prescriptions when patients ask for them, and that nearly 1 in 4 patients did so.⁶ A 2002 study found that physicians granted all but 3% of patient’s requests for orders or tests, and that fulfilling requests correlated with patient satisfaction in the specialty office studied (cardiology) but not in the primary care (internal medicine) office.⁷

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidencebased advice from a specialty society to its members and to patients about care that is often unnecessary.

From its inception, Choosing Wisely has considered patients as full partners in conversations about health care utilization. Choosing Wisely partners with Consumer Reports to create and disseminate plain-language summaries of recommendations. Community groups and physician organizations have also participated in implementation efforts. In 2018, Choosing Wisely secured a grant to expand outreach to diverse or underserved communities.

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidence-based advice from a specialty society to its members and to patients about care that is often unnecessary. The goal is to create a conversation and not to eliminate these services from ever being offered or used.

Continue to: Improve your practice with these 10 primary care recommendations

Improve your practice with these 10 primary care recommendations

 1 Avoid imaging studies in early acute low back pain without red flags.

Both the AAFP and the American Society of Anesthesiologists recommend against routine X-rays, magnetic resonance imaging, and computed tomography (CT) scans in the first 6 weeks of acute low back pain (LBP).^8,9 The American College of Emergency Physicians (ACEP) recommends against routine lumbar spine imaging for emergency department (ED) patients.¹⁰ In all cases, imaging is indicated if the patient has any signs or symptoms of neurologic deficits or other indications, such as signs of spinal infection or fracture. However, as ACEP notes, diagnostic imaging does not typically help identify the cause of acute LBP, and when it does, it does not reduce the time to symptom improvement.¹⁰

2 Prescribe oral contraceptives on the basis of a medical history and a blood pressure measurement. No routine pelvic exam or other physical exam is necessary.

This AAFP recommendation¹¹ is based on clinical practice guidelines from the American College of Obstetricians and Gynecologists (ACOG) and other research.¹² The ACOG practice guideline supports provision of hormonal contraception without a pelvic exam, cervical cancer (Pap) testing, urine pregnancy testing, or testing for sexually transmitted infections. ACOG guidelines also support over-the-counter provision of hormonal contraceptives, including combined oral contraceptives.¹²

3 Stop recommending daily self-glucose monitoring for patients with diabetes who are not using insulin.

Both the AAFP and the Society for General Internal Medicine recommend against daily blood sugar checks for people who do not use insulin.^13,14 A Cochrane review of 9 trials (3300 patients) found that after 6 months, hemoglobin A1C was reduced by 0.3% in people who checked their sugar daily compared with those who did not, but this difference was not significant after a year.¹⁵ Hypoglycemic episodes were more common in the “checking” group, and there were no differences in quality of life. A qualitative study found that blood sugar results had little impact on patients’ motivation to change behavior.¹⁶

4 Don’t screen for herpes simplex virus (HSV) infection in asymptomatic adults, even those who are pregnant.

This AAFP recommendation¹⁷ comes from a US Preventive Services Task Force (USPSTF) Grade D recommendation.18 Most people with positive HSV-2 serology have had an outbreak; even those who do not think they have had one will realize that they had the symptoms once they hear them described.18 With available tests, 1 in 2 positive results for HSV-2 among asymptomatic people will be a false-positive.¹⁸

A 2006 analysis of inpatient lab studies found that doctors ordered an average of 2.96 studies per patient per day, but only 29% of these tests contributed to management.

There is no known cure, intervention, or reduction in transmission for infected patients who do not have symptoms.¹⁸ Also, serologically detected HSV-2 does not reliably predict genital herpes; and HSV-1 has been found to cause an increasing percentage of genital infection cases.¹⁸

Continue to: 5 Don't screen for testicular cancer in asymptomatic individuals

5 Don’t screen for testicular cancer in asymptomatic individuals.

This AAFP recommendation¹⁹ also comes from a USPSTF Grade D recommendation.²⁰ A 2010 systematic review found no evidence to support screening of asymptomatic people with a physical exam or ultrasound. All available studies involved symptomatic patients.²⁰

 6 Stop recommending cough and cold medicines for children younger than 4 years.

The AAP recommends that clinicians discourage the use of any cough or cold medicine for children in this age-group.²¹ A 2008 study found that more than 7000 children annually presented to EDs for adverse events from cough and cold medicines.²² Previous studies found no benefit in reducing symptoms.²³ In children older than 12 months, a Cochrane review found that honey has a modest benefit for cough in single-night trials.²⁴

7 Avoid performing serum allergy panels.

The American Academy of Allergy, Asthma, and Immunology discourages the use of serum panel testing when patients present with allergy symptoms.²⁵ A patient can have a strong positive immunoglobulin E (IgE) serum result to an allergen and have no clinical allergic symptoms or can have a weak positive serum result and a strong clinical reaction. Targeted skin or serum IgE testing—for example, testing for cashew allergy in a patient known to have had a reaction after eating one—is reasonable.²⁶

8 Avoid routine electroencephalography (EEG), head CT, and carotid ultrasound as initial work-up for simple syncope in adults.

These recommendations, from the American Epilepsy Society,²⁷ ACEP,²⁸ American College of Physicians,²⁹ and American Academy of Neurology (AAN),³⁰ emphasize the low yield of routine work-ups for patients with simple syncope. The AAN notes that 40% of people will experience syncope during adulthood and most will not have carotid disease, which generally manifests with stroke-like symptoms rather than syncope. One study found that approximately 1 in 8 patients referred to an epilepsy clinic had neurocardiogenic syncope rather than epilepsy.³¹

EEGs have high false-negative and false-positive rates, and history-taking is a better tool with which to make a diagnosis. CT scans performed in the ED were found to contribute to the diagnosis of simple syncope in fewer than 2% of cases of syncope, compared with orthostatic blood pressure (25% of cases).³²

Continue to: 9 Wait to refer children with umbilical hernias to pediatric surgery until they are 4 to 5 years of age

The AAP Section on Surgery offers evidence that the risk-benefit analysis strongly favors waiting on intervention.³³ About 1 in 4 children will have an umbilical hernia, and about 85% of cases will resolve by age 5. The strangulation rate with umbilical hernias is very low, and although the risk of infection with surgery is likewise low, the risk of recurrence following surgery before the age of 4 is as high as 2.4%.³⁴ The AAP Section on Surgery recommends against strapping or restraining the hernia, as well.

10 Avoid using appetite stimulants, such as megesterol, and high-calorie nutritional supplements to treat anorexia and cachexia in older adults.

Instead, the American Geriatrics Society recommends that physicians encourage caregivers to serve appealing food, provide support with eating, and remove barriers to appetite and nutrition.³⁵ A Cochrane review showed that high-calorie supplements, such as Boost or Ensure, are associated with very modest weight gain—about 2% of weight—but are not associated with an increased life expectancy or improved quality of life.³⁶

Both the AAFP and the American Society of Anesthesiologists recommend against routine x-rays, MRIs, and CT scans during the first 6 weeks of acute low back pain.

Prescription appetite stimulants are associated with adverse effects and yield inconsistent benefits in older adults. Megesterol, for example, was associated with headache, gastrointestinal adverse effects, insomnia, weakness, and fatigue. Mirtazapine is associated with sedation and fatigue.³⁷

CORRESPONDENCE
Kathleen Rowland, MD, MS, Rush Copley Family Medicine Residency, Rush Medical College, 600 South Paulina, Kidston House Room 605, Chicago IL 60612; kathleen_rowland@rush.edu.