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.

[email protected]

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.

[email protected]

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.

[email protected]

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; [email protected].

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; [email protected].

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; [email protected].

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Interventional chest and diagnostic procedures

Impact of COVID-19 pandemic in patients with non-advanced LC

The COVID-19 pandemic has challenged the way we screen for, diagnose, and treat lung cancer.1, 2 Knowing that these patients are at higher risk of respiratory failure, and that COVID-19 causes poor outcomes in cancer patients,^1,3,4 valid concerns regarding viral transmission to patients and health-care workers have hampered the expedited care this population needs.

In recent months, efforts to manage the pandemic have been herculean. With the goal of limiting transmission, expert panels have offered guidance including limiting access to medical facilities, decreasing aerosolizing procedures, and prioritizing curative treatments.^2,5 In general, lung cancer screening should be delayed, and patients with highly suspicious localized pulmonary lesions could receive empiric regimens, surgery, or stereotactic radiotherapy.^1,3-5

The conundrum occurs when diagnostic bronchoscopy is required for staging, acquiring tissue for targeted therapy, or a moderate-risk pulmonary nodule with indeterminate PET-CT and/or high-risk for CT-guided biopsy. Thoughtful balancing of risks and benefits depends on patient comorbidities, hospital resources – such preprocedural COVID screening, adequate protective personal equipment- and rate of local viral prevalence.^6,7 Delaying diagnosis and staging could lead to progression of cancer and preclude curative or adjuvant therapy for appropriate candidates. Furthermore, we should not dismiss the appalling psychological impact of delayed care on our patients.

While the pandemic continues and challenges arise in the care of patients with lung cancer, the value of a multidisciplinary input and individualized care cannot be overstated, with focus on providing the best care possible while both minimizing transmission and increasing the chances of acceptable outcomes.

Jose De Cardenas MD, FCCP – Steering Committee Member

Abdul Hamid Alraiyes MD, FCCP – Steering Committee Member

References

1. Mazzone PJ, et al. Chest. 2020;158(1):406-415. doi: 10.1016/j.chest.2020.04.020.

2. Banna G, et al. ESMO Open. 2020;5(2):e000765. doi: 10.1136/esmoopen-2020-000765.

3. Liang W, et al. Lancet Oncol. 2020;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6.

4. Singh AP, et al. JCO Oncol Pract. 2020 May 26;OP2000286. doi: 10.1200/OP.20.00286.

5. Dingemans AC, et al. J Thorac Oncol. 2020;15(7):1119-1136. doi: 10.1016/j.jtho.2020.05.001.

6. Wahidi MM, et al. J Bronchology Interv Pulmonol. 2020 Mar 18. doi: 10.1097/LBR.0000000000000681.

7. Pritchett MA, et al. J Thorac Dis. 2020;12(5):1781-1798. doi: 10.21037/jtd.2020.04.32.


 

Pediatric chest medicine

FDA strengthens the boxed warning for montelukast

Early this year the Food and Drug Administration (FDA) updated the boxed warning for montelukast (Singulair), related to the potential for serious mental health side effects, such as agitation, aggressive behavior, depression, hallucinations, and suicidal thoughts and actions. Since its approval in 1998, montelukast is part of the therapeutic approach for persistent asthma in children age 1 year and older, allergic rhinitis from 6 months and older, and exercises induced bronchospasm in children age 6 years and older. In 2018, around 2.3 million children younger than 17 years received a prescription for montelukast.

The FDA reviewed data from their Sentinel System comparing children receiving montelukast vs inhaled corticosteroids, and this study failed to demonstrate significant increased risk of hospitalized depressive disorders, outpatient depressive disorders, self-harm, or suicide. However, a focused evaluation by the FDA of suicides identified 82 cases of completed suicides associated with montelukast, and 19 of these cases were in children younger than 17 years of age.

Post-marketing case reports submitted to the FDA, published observational and animal studies were evaluated along with the Sentinel System study that led to the new recommendations.

Finally, on March 4, 2020, the FDA updated the Singulair®/montelukast black box warning, focusing on the importance of advising patients and caregivers about the potential for serious neuropsychiatric side effects and advice to immediately discontinue use if symptoms occurred. The warning contains a strong recommendation to reserve use of Singulair®/montelukast to patients with allergic rhinitis who have an inadequate response or intolerance to alternate therapies.

Endy Dominguez Silveyra, MD - Fellow-in-Training Member
 

References

1. FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis. FDA Drug Safety Communication, March 4, 2020.

2. Neuropsychiatric events following montelukast use: A propensity score matched analysis. Sentinel, Sept. 27, 2019.


 

Pulmonary physiology, function, and rehabilitation

The happy hypoxic

In early December 2019, the novel coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified. Over the ensuing months, SARS-CoV-2 would cause a wide range of pulmonary symptoms from cough and mild shortness of breath to acute respiratory distress syndrome (ARDS) with severe hypoxia that puzzled intensivists worldwide.

One such mystifying presentation was finding patients with critically low oxygen levels who did not appear to be short of breath. This concept was dubbed “happy or silent hypoxemia.” Novel mechanisms of the SARS-Co-V-2 virus on the respiratory system have been proposed to explain this paradox, but recent literature suggests that foundational pulmonary physiology concepts can explain most of these findings.¹

Breathing is centrally controlled by the respiratory center in the brain stem and is influenced mainly by dissolved carbon dioxide and pH.² Hypercapnia is, therefore, a powerful stimulus to breathe and increase minute ventilation. It can cause dyspnea if this demand is not met.³

Hypoxia, on the other hand, is less powerful and does not evoke dyspnea until the PaO₂ drops below 60 mm Hg.⁴ Hypercapnia potentiates this response: the higher the PaCO₂, the higher the hypoxic response. Patients with a PaCO₂ of 39 mm Hg or less may not experience dyspnea even when hypoxia is severe.¹

Other possible explanations for silent hypoxemia include the poor accuracy of the pulse oximeter for estimating oxygen saturation of less than 80%,¹ especially in the critically ill5 and the leftward shift of the oxygen dissociation curve due to fever, making the oxygen saturation lower for any given PaO₂.¹

In conclusion, the clinical management of COVID-19 pneumonia with a broad range of clinical features presents many unknowns, but it is reassuring to find an anchor in good old pulmonary physiology concepts.⁵

It is back to the basics for us all and that might be a good thing.

Oriade Adeoye, MD – Fellow-in-Training Member
 

References

1. Tobin MJ, et al. Am J Respir Crit Care Med. 2020;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.

2. Vaporidi K, et al. Am J Respir Crit Care Med. 2020;201(1):20-32. doi: 10.1164/rccm.201903-0596SO.

3. Dhont S, et al. Respir Res. 2020;21(1):198. doi:10.1186/s12931-020-01462-5.

4. Weil JV, et al. J Clin Invest. 1970;49(6):1061-1072. doi:10.1172/JCI106322.

5. Tobin MJ. Am J Respir Crit Care Med. 2020;201(11):1319-1320. doi:10.1164/rccm.202004-1076ED.


 

Pulmonary vascular disease

COVID-19 and pulmonary vasculature: an intriguing relationship

Hypoxemia is the cardinal symptom in patients with severe coronavirus disease-2019 (COVID-19). However, hypoxemia disproportionate to radiographic opacities has led to growing suspicion that involvement of pulmonary vasculature (PV), leading to shunt physiology, may be a driver of this marked hypoxemia.

The virus’s affinity for PV is explained by presence of angiotensin-converting enzyme 2 receptor, which serves as the functional receptor for SARS-CoV-2, on pulmonary endothelium (Provencher, et al. Pulm Circ. 2020 Jun 10;10[3]:2045894020933088. doi: 10.1177/2045894020933088).

This increased affinity predisposes PV to pathologic effects of SARS-CoV-2, noted in COVID-19 patients’ autopsies, which revealed pulmonary endothelial injury and abnormal vessel growth (intussusceptive angiogenesis). These changes, along with profound inflammatory response, further predispose the PV to thrombosis and microangiopathy in COVID-19 (Ackermann, et al. N Engl J Med. 2020 Jul 9;383[2]:120-128).

These autopsy results also explain the radiologic findings of PV in COVID-19. Dual energy CT scanning, used to evaluate lung perfusion in these patients, has demonstrated PV thickening, mosaicism, and pulmonary vessel dilation; the latter likely occurring due to aberrations in physiologic hypoxic pulmonary vasoconstriction (Lang, et al. Lancet. 2020 Apr 30;S1473-3099[20]30367).

Despite PV’s involvement, only few cases of COVID-19 have been reported in patients with pulmonary arterial hypertension (PAH) , leading to the hypothesis that pre-existing vascular changes may have a protective effect in PAH patients (Horn, et al. Pulm Circ. 2020;10(2):1-2).

The above discussion details the complex and multifaceted relationship between COVID-19 and PV which underscores the value of understanding this interaction further and may prove to be insightful for discovering potential therapeutic targets in COVID-19.

Humna Abid Memon, MD – Fellow-in-Training Member

Interventional chest and diagnostic procedures

Impact of COVID-19 pandemic in patients with non-advanced LC

The COVID-19 pandemic has challenged the way we screen for, diagnose, and treat lung cancer.1, 2 Knowing that these patients are at higher risk of respiratory failure, and that COVID-19 causes poor outcomes in cancer patients,^1,3,4 valid concerns regarding viral transmission to patients and health-care workers have hampered the expedited care this population needs.

In recent months, efforts to manage the pandemic have been herculean. With the goal of limiting transmission, expert panels have offered guidance including limiting access to medical facilities, decreasing aerosolizing procedures, and prioritizing curative treatments.^2,5 In general, lung cancer screening should be delayed, and patients with highly suspicious localized pulmonary lesions could receive empiric regimens, surgery, or stereotactic radiotherapy.^1,3-5

The conundrum occurs when diagnostic bronchoscopy is required for staging, acquiring tissue for targeted therapy, or a moderate-risk pulmonary nodule with indeterminate PET-CT and/or high-risk for CT-guided biopsy. Thoughtful balancing of risks and benefits depends on patient comorbidities, hospital resources – such preprocedural COVID screening, adequate protective personal equipment- and rate of local viral prevalence.^6,7 Delaying diagnosis and staging could lead to progression of cancer and preclude curative or adjuvant therapy for appropriate candidates. Furthermore, we should not dismiss the appalling psychological impact of delayed care on our patients.

While the pandemic continues and challenges arise in the care of patients with lung cancer, the value of a multidisciplinary input and individualized care cannot be overstated, with focus on providing the best care possible while both minimizing transmission and increasing the chances of acceptable outcomes.

Jose De Cardenas MD, FCCP – Steering Committee Member

Abdul Hamid Alraiyes MD, FCCP – Steering Committee Member

References

1. Mazzone PJ, et al. Chest. 2020;158(1):406-415. doi: 10.1016/j.chest.2020.04.020.

2. Banna G, et al. ESMO Open. 2020;5(2):e000765. doi: 10.1136/esmoopen-2020-000765.

3. Liang W, et al. Lancet Oncol. 2020;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6.

4. Singh AP, et al. JCO Oncol Pract. 2020 May 26;OP2000286. doi: 10.1200/OP.20.00286.

5. Dingemans AC, et al. J Thorac Oncol. 2020;15(7):1119-1136. doi: 10.1016/j.jtho.2020.05.001.

6. Wahidi MM, et al. J Bronchology Interv Pulmonol. 2020 Mar 18. doi: 10.1097/LBR.0000000000000681.

7. Pritchett MA, et al. J Thorac Dis. 2020;12(5):1781-1798. doi: 10.21037/jtd.2020.04.32.


 

Pediatric chest medicine

FDA strengthens the boxed warning for montelukast

Early this year the Food and Drug Administration (FDA) updated the boxed warning for montelukast (Singulair), related to the potential for serious mental health side effects, such as agitation, aggressive behavior, depression, hallucinations, and suicidal thoughts and actions. Since its approval in 1998, montelukast is part of the therapeutic approach for persistent asthma in children age 1 year and older, allergic rhinitis from 6 months and older, and exercises induced bronchospasm in children age 6 years and older. In 2018, around 2.3 million children younger than 17 years received a prescription for montelukast.

The FDA reviewed data from their Sentinel System comparing children receiving montelukast vs inhaled corticosteroids, and this study failed to demonstrate significant increased risk of hospitalized depressive disorders, outpatient depressive disorders, self-harm, or suicide. However, a focused evaluation by the FDA of suicides identified 82 cases of completed suicides associated with montelukast, and 19 of these cases were in children younger than 17 years of age.

Post-marketing case reports submitted to the FDA, published observational and animal studies were evaluated along with the Sentinel System study that led to the new recommendations.

Finally, on March 4, 2020, the FDA updated the Singulair®/montelukast black box warning, focusing on the importance of advising patients and caregivers about the potential for serious neuropsychiatric side effects and advice to immediately discontinue use if symptoms occurred. The warning contains a strong recommendation to reserve use of Singulair®/montelukast to patients with allergic rhinitis who have an inadequate response or intolerance to alternate therapies.

Endy Dominguez Silveyra, MD - Fellow-in-Training Member
 

References

1. FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis. FDA Drug Safety Communication, March 4, 2020.

2. Neuropsychiatric events following montelukast use: A propensity score matched analysis. Sentinel, Sept. 27, 2019.


 

Pulmonary physiology, function, and rehabilitation

The happy hypoxic

In early December 2019, the novel coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified. Over the ensuing months, SARS-CoV-2 would cause a wide range of pulmonary symptoms from cough and mild shortness of breath to acute respiratory distress syndrome (ARDS) with severe hypoxia that puzzled intensivists worldwide.

One such mystifying presentation was finding patients with critically low oxygen levels who did not appear to be short of breath. This concept was dubbed “happy or silent hypoxemia.” Novel mechanisms of the SARS-Co-V-2 virus on the respiratory system have been proposed to explain this paradox, but recent literature suggests that foundational pulmonary physiology concepts can explain most of these findings.¹

Breathing is centrally controlled by the respiratory center in the brain stem and is influenced mainly by dissolved carbon dioxide and pH.² Hypercapnia is, therefore, a powerful stimulus to breathe and increase minute ventilation. It can cause dyspnea if this demand is not met.³

Hypoxia, on the other hand, is less powerful and does not evoke dyspnea until the PaO₂ drops below 60 mm Hg.⁴ Hypercapnia potentiates this response: the higher the PaCO₂, the higher the hypoxic response. Patients with a PaCO₂ of 39 mm Hg or less may not experience dyspnea even when hypoxia is severe.¹

Other possible explanations for silent hypoxemia include the poor accuracy of the pulse oximeter for estimating oxygen saturation of less than 80%,¹ especially in the critically ill5 and the leftward shift of the oxygen dissociation curve due to fever, making the oxygen saturation lower for any given PaO₂.¹

In conclusion, the clinical management of COVID-19 pneumonia with a broad range of clinical features presents many unknowns, but it is reassuring to find an anchor in good old pulmonary physiology concepts.⁵

It is back to the basics for us all and that might be a good thing.

Oriade Adeoye, MD – Fellow-in-Training Member
 

References

1. Tobin MJ, et al. Am J Respir Crit Care Med. 2020;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.

2. Vaporidi K, et al. Am J Respir Crit Care Med. 2020;201(1):20-32. doi: 10.1164/rccm.201903-0596SO.

3. Dhont S, et al. Respir Res. 2020;21(1):198. doi:10.1186/s12931-020-01462-5.

4. Weil JV, et al. J Clin Invest. 1970;49(6):1061-1072. doi:10.1172/JCI106322.

5. Tobin MJ. Am J Respir Crit Care Med. 2020;201(11):1319-1320. doi:10.1164/rccm.202004-1076ED.


 

Pulmonary vascular disease

COVID-19 and pulmonary vasculature: an intriguing relationship

Hypoxemia is the cardinal symptom in patients with severe coronavirus disease-2019 (COVID-19). However, hypoxemia disproportionate to radiographic opacities has led to growing suspicion that involvement of pulmonary vasculature (PV), leading to shunt physiology, may be a driver of this marked hypoxemia.

The virus’s affinity for PV is explained by presence of angiotensin-converting enzyme 2 receptor, which serves as the functional receptor for SARS-CoV-2, on pulmonary endothelium (Provencher, et al. Pulm Circ. 2020 Jun 10;10[3]:2045894020933088. doi: 10.1177/2045894020933088).

This increased affinity predisposes PV to pathologic effects of SARS-CoV-2, noted in COVID-19 patients’ autopsies, which revealed pulmonary endothelial injury and abnormal vessel growth (intussusceptive angiogenesis). These changes, along with profound inflammatory response, further predispose the PV to thrombosis and microangiopathy in COVID-19 (Ackermann, et al. N Engl J Med. 2020 Jul 9;383[2]:120-128).

These autopsy results also explain the radiologic findings of PV in COVID-19. Dual energy CT scanning, used to evaluate lung perfusion in these patients, has demonstrated PV thickening, mosaicism, and pulmonary vessel dilation; the latter likely occurring due to aberrations in physiologic hypoxic pulmonary vasoconstriction (Lang, et al. Lancet. 2020 Apr 30;S1473-3099[20]30367).

Despite PV’s involvement, only few cases of COVID-19 have been reported in patients with pulmonary arterial hypertension (PAH) , leading to the hypothesis that pre-existing vascular changes may have a protective effect in PAH patients (Horn, et al. Pulm Circ. 2020;10(2):1-2).

The above discussion details the complex and multifaceted relationship between COVID-19 and PV which underscores the value of understanding this interaction further and may prove to be insightful for discovering potential therapeutic targets in COVID-19.

Humna Abid Memon, MD – Fellow-in-Training Member

Interventional chest and diagnostic procedures

Impact of COVID-19 pandemic in patients with non-advanced LC

The COVID-19 pandemic has challenged the way we screen for, diagnose, and treat lung cancer.1, 2 Knowing that these patients are at higher risk of respiratory failure, and that COVID-19 causes poor outcomes in cancer patients,^1,3,4 valid concerns regarding viral transmission to patients and health-care workers have hampered the expedited care this population needs.

In recent months, efforts to manage the pandemic have been herculean. With the goal of limiting transmission, expert panels have offered guidance including limiting access to medical facilities, decreasing aerosolizing procedures, and prioritizing curative treatments.^2,5 In general, lung cancer screening should be delayed, and patients with highly suspicious localized pulmonary lesions could receive empiric regimens, surgery, or stereotactic radiotherapy.^1,3-5

The conundrum occurs when diagnostic bronchoscopy is required for staging, acquiring tissue for targeted therapy, or a moderate-risk pulmonary nodule with indeterminate PET-CT and/or high-risk for CT-guided biopsy. Thoughtful balancing of risks and benefits depends on patient comorbidities, hospital resources – such preprocedural COVID screening, adequate protective personal equipment- and rate of local viral prevalence.^6,7 Delaying diagnosis and staging could lead to progression of cancer and preclude curative or adjuvant therapy for appropriate candidates. Furthermore, we should not dismiss the appalling psychological impact of delayed care on our patients.

While the pandemic continues and challenges arise in the care of patients with lung cancer, the value of a multidisciplinary input and individualized care cannot be overstated, with focus on providing the best care possible while both minimizing transmission and increasing the chances of acceptable outcomes.

Jose De Cardenas MD, FCCP – Steering Committee Member

Abdul Hamid Alraiyes MD, FCCP – Steering Committee Member

References

1. Mazzone PJ, et al. Chest. 2020;158(1):406-415. doi: 10.1016/j.chest.2020.04.020.

2. Banna G, et al. ESMO Open. 2020;5(2):e000765. doi: 10.1136/esmoopen-2020-000765.

3. Liang W, et al. Lancet Oncol. 2020;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6.

4. Singh AP, et al. JCO Oncol Pract. 2020 May 26;OP2000286. doi: 10.1200/OP.20.00286.

5. Dingemans AC, et al. J Thorac Oncol. 2020;15(7):1119-1136. doi: 10.1016/j.jtho.2020.05.001.

6. Wahidi MM, et al. J Bronchology Interv Pulmonol. 2020 Mar 18. doi: 10.1097/LBR.0000000000000681.

7. Pritchett MA, et al. J Thorac Dis. 2020;12(5):1781-1798. doi: 10.21037/jtd.2020.04.32.


 

Pediatric chest medicine

FDA strengthens the boxed warning for montelukast

Early this year the Food and Drug Administration (FDA) updated the boxed warning for montelukast (Singulair), related to the potential for serious mental health side effects, such as agitation, aggressive behavior, depression, hallucinations, and suicidal thoughts and actions. Since its approval in 1998, montelukast is part of the therapeutic approach for persistent asthma in children age 1 year and older, allergic rhinitis from 6 months and older, and exercises induced bronchospasm in children age 6 years and older. In 2018, around 2.3 million children younger than 17 years received a prescription for montelukast.

The FDA reviewed data from their Sentinel System comparing children receiving montelukast vs inhaled corticosteroids, and this study failed to demonstrate significant increased risk of hospitalized depressive disorders, outpatient depressive disorders, self-harm, or suicide. However, a focused evaluation by the FDA of suicides identified 82 cases of completed suicides associated with montelukast, and 19 of these cases were in children younger than 17 years of age.

Post-marketing case reports submitted to the FDA, published observational and animal studies were evaluated along with the Sentinel System study that led to the new recommendations.

Finally, on March 4, 2020, the FDA updated the Singulair®/montelukast black box warning, focusing on the importance of advising patients and caregivers about the potential for serious neuropsychiatric side effects and advice to immediately discontinue use if symptoms occurred. The warning contains a strong recommendation to reserve use of Singulair®/montelukast to patients with allergic rhinitis who have an inadequate response or intolerance to alternate therapies.

Endy Dominguez Silveyra, MD - Fellow-in-Training Member
 

References

1. FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis. FDA Drug Safety Communication, March 4, 2020.

2. Neuropsychiatric events following montelukast use: A propensity score matched analysis. Sentinel, Sept. 27, 2019.


 

Pulmonary physiology, function, and rehabilitation

The happy hypoxic

In early December 2019, the novel coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified. Over the ensuing months, SARS-CoV-2 would cause a wide range of pulmonary symptoms from cough and mild shortness of breath to acute respiratory distress syndrome (ARDS) with severe hypoxia that puzzled intensivists worldwide.

One such mystifying presentation was finding patients with critically low oxygen levels who did not appear to be short of breath. This concept was dubbed “happy or silent hypoxemia.” Novel mechanisms of the SARS-Co-V-2 virus on the respiratory system have been proposed to explain this paradox, but recent literature suggests that foundational pulmonary physiology concepts can explain most of these findings.¹

Breathing is centrally controlled by the respiratory center in the brain stem and is influenced mainly by dissolved carbon dioxide and pH.² Hypercapnia is, therefore, a powerful stimulus to breathe and increase minute ventilation. It can cause dyspnea if this demand is not met.³

Hypoxia, on the other hand, is less powerful and does not evoke dyspnea until the PaO₂ drops below 60 mm Hg.⁴ Hypercapnia potentiates this response: the higher the PaCO₂, the higher the hypoxic response. Patients with a PaCO₂ of 39 mm Hg or less may not experience dyspnea even when hypoxia is severe.¹

Other possible explanations for silent hypoxemia include the poor accuracy of the pulse oximeter for estimating oxygen saturation of less than 80%,¹ especially in the critically ill5 and the leftward shift of the oxygen dissociation curve due to fever, making the oxygen saturation lower for any given PaO₂.¹

In conclusion, the clinical management of COVID-19 pneumonia with a broad range of clinical features presents many unknowns, but it is reassuring to find an anchor in good old pulmonary physiology concepts.⁵

It is back to the basics for us all and that might be a good thing.

Oriade Adeoye, MD – Fellow-in-Training Member
 

References

1. Tobin MJ, et al. Am J Respir Crit Care Med. 2020;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.

2. Vaporidi K, et al. Am J Respir Crit Care Med. 2020;201(1):20-32. doi: 10.1164/rccm.201903-0596SO.

3. Dhont S, et al. Respir Res. 2020;21(1):198. doi:10.1186/s12931-020-01462-5.

4. Weil JV, et al. J Clin Invest. 1970;49(6):1061-1072. doi:10.1172/JCI106322.

5. Tobin MJ. Am J Respir Crit Care Med. 2020;201(11):1319-1320. doi:10.1164/rccm.202004-1076ED.


 

Pulmonary vascular disease

COVID-19 and pulmonary vasculature: an intriguing relationship

Hypoxemia is the cardinal symptom in patients with severe coronavirus disease-2019 (COVID-19). However, hypoxemia disproportionate to radiographic opacities has led to growing suspicion that involvement of pulmonary vasculature (PV), leading to shunt physiology, may be a driver of this marked hypoxemia.

The virus’s affinity for PV is explained by presence of angiotensin-converting enzyme 2 receptor, which serves as the functional receptor for SARS-CoV-2, on pulmonary endothelium (Provencher, et al. Pulm Circ. 2020 Jun 10;10[3]:2045894020933088. doi: 10.1177/2045894020933088).

This increased affinity predisposes PV to pathologic effects of SARS-CoV-2, noted in COVID-19 patients’ autopsies, which revealed pulmonary endothelial injury and abnormal vessel growth (intussusceptive angiogenesis). These changes, along with profound inflammatory response, further predispose the PV to thrombosis and microangiopathy in COVID-19 (Ackermann, et al. N Engl J Med. 2020 Jul 9;383[2]:120-128).

These autopsy results also explain the radiologic findings of PV in COVID-19. Dual energy CT scanning, used to evaluate lung perfusion in these patients, has demonstrated PV thickening, mosaicism, and pulmonary vessel dilation; the latter likely occurring due to aberrations in physiologic hypoxic pulmonary vasoconstriction (Lang, et al. Lancet. 2020 Apr 30;S1473-3099[20]30367).

Despite PV’s involvement, only few cases of COVID-19 have been reported in patients with pulmonary arterial hypertension (PAH) , leading to the hypothesis that pre-existing vascular changes may have a protective effect in PAH patients (Horn, et al. Pulm Circ. 2020;10(2):1-2).

The above discussion details the complex and multifaceted relationship between COVID-19 and PV which underscores the value of understanding this interaction further and may prove to be insightful for discovering potential therapeutic targets in COVID-19.

Humna Abid Memon, MD – Fellow-in-Training Member

The coronavirus disease 2019 (COVID-19) pandemic has changed the way we deliver healthcare for the foreseeable future. Not only have we had to rapidly learn how to evaluate, diagnose, and treat this new disease, we have also had to shift how we screen, triage, and care for other patients for both their safety and ours. As the virus is primarily spread via respiratory droplets, aerosol-generating procedures (AGP), such as bronchoscopy and tracheostomy, are high-risk for viral transmission. We have therefore had to reassess the risk/benefit ratio of performing these procedures – what is the risk to the patient by procedure postponement vs the risk to the health-care personnel (HCP) involved by moving ahead with the procedure? And, if proceeding, how should we protect ourselves? How do we screen patients to help us stratify risk? In order to answer these questions, we generally divide patients into three categories: the asymptomatic outpatient, the symptomatic patient, and the critically ill patient.

The asymptomatic outpatient

Early in the pandemic as cases began to spike in the US, many hospitals decided to postpone all elective procedures and surgeries. Guidelines quickly emerged stratifying bronchoscopic procedures into emergent, urgent, acute, subacute, and truly elective with recommendations on the subsequent timing of those procedures (Pritchett MA, et al. J Thorac Dis. 2020 May;12[5]:1781-1798). As we have obtained further data and our infrastructure has been bolstered, many physicians have begun performing more routine procedures. Preprocedural screening, both with symptom questionnaires and nasopharyngeal swabs, has been enacted as a measure to prevent inadvertent exposure to infected patients. While there are limited data regarding the reliability of this measure, emerging data have shown good concordance between nasopharyngeal SARS-CoV-2 polymerase chain reaction (PCR) swabs and bronchoalveolar lavage (BAL) samples in low-risk patients (Oberg, et al. Personal communication, Sept 2020). Emergency procedures, such as foreign body aspiration, critical airway obstruction, and massive hemoptysis, were generally performed without delay throughout the pandemic. More recently, emphasis has been placed on prioritizing procedures for acute clinical diagnoses, such as biopsies for concerning lung nodules or masses in potentially early-stage patients, in those where staging is needed and in those where disease progression is suspected. Subacute procedures, such as inspection bronchoscopy for cough, minor hemoptysis, or airway stent surveillance, have generally been reintroduced while elective procedures, such as bronchial thermoplasty and bronchoscopic lung volume reduction, are considered elective, and their frequency and timing is determined mostly by the number of new cases of COVID-19 in the local community.

For all procedures, general modifications have been made. High-efficiency particulate air (HEPA) filters should be placed on all ventilatory circuits. When equivalent, flexible bronchoscopy is preferred over rigid bronchoscopy due to the closed circuit. Enhanced personal protective equipment (PPE) for all procedures is recommended – this typically includes a gown, gloves, hair bonnet, N-95 mask, and a face shield. Strict adherence to the Centers for Disease Control and Prevention (CDC) guidelines for postprocedure cleaning and sterilization is strongly recommended. In some cases, single-use bronchoscopes are being preferentially used, though no strong recommendations exist for this.
 

The symptomatic COVID-19 patient

In patients who have been diagnosed with SARS-CoV-2, we generally recommend postponing all procedures other than for life-threatening indications. For outpatients, we generally wait for two negative nasopharyngeal swabs prior to performing any nonemergent procedure. In inpatients, similar recommendations exist. Potential inpatient indications for bronchoscopy include diagnostic evaluation for alternate or coinfections, and therapeutic aspiration of clinically significant secretions. These should be carefully considered and performed only if deemed absolutely necessary. If bronchoscopy is needed in a patient with suspected or confirmed COVID-19, at a minimum, gown, gloves, head cover, face shield, and an N-95 mask should be worn. A powered air purifying respirator (PAPR) can be used and may provide increased protection. Proper donning and doffing techniques should be reviewed prior to any procedure. Personnel involved in the case should be limited to the minimum required. The procedure should be performed by experienced operators and limited in length. Removal and reinsertion of the bronchoscope should be minimized.

The critically ill COVID-19 patient

While the majority of patients infected with SARS-CoV-2 will have only mild symptoms, we know that a subset of patients will develop respiratory failure. Of those, a small but significant number will require prolonged mechanical ventilation during their clinical course. Thus, the consideration for tracheostomy comes into play.

Multiple issues arise when discussing tracheostomy placement in the COVID-19 world. Should it be done at all? If yes, what is the best technique and who should do it? When and where should it be done? Importantly – how do we care for patients once it is in place to facilitate recovery and, hopefully, decannulation?

Tracheostomy tubes are used in the ICU for patients who require prolonged mechanical ventilation for many reasons – patient comfort, decreased need for sedation, and to facilitate transfer out of the ICU to less acute care areas. These reasons are just as important in patients afflicted with respiratory failure from COVID-19, if not more so. As the patient volumes surge, health-care systems can quickly become overwhelmed. The ability to safely move patients out of the ICU frees up those resources for others who are more acutely ill.

The optimal technique for tracheostomy placement largely depends on the technological and human capital of each institution. Emphasis should be placed on procedural experience, efficiency, safety, and minimizing risk to HCP. While mortality rates do not differ between the surgical and percutaneous techniques, the percutaneous approach has been shown to require less procedural time (Iftikhar IH, et al. Lung. 2019[Jun];197[3]:267-275), an important infection control advantage in COVID-19 patients. Additionally, percutaneous tracheostomies are typically performed at the bedside, which offers the immediate benefit of minimizing patient transfer. This decreases exposure to multiple HCP, as well as contamination of other health-care areas. If performing a bronchoscopic-guided percutaneous tracheostomy, apnea should be maintained from insertion of the guiding catheter to tracheostomy insertion in order to minimize aerosolization. A novel technique involving placing the bronchoscope beside the endotracheal tube instead of through it has also been described (Angel L, et al. Ann Thorac Surg. 2020[Sep];110[3]:1006–1011).

Timing of tracheostomy placement in COVID-19 patients has varied widely. Initially, concern for the safety of HCP performing these procedures led to recommendations of waiting at least 21 days of intubation or until COVID-19 testing became negative. However, more recently, multiple recommendations have been made for tracheostomy placement after day 10 of intubation (McGrath, et al. Lancet Respir Med. 2020[Jul];8[7]:717-725).

Finally, once a tracheostomy tube has been placed, the care does not stop there. As patients are transitioned to rehabilitation centers or skilled nursing facilities and are assessed for weaning, downsizing, and decannulation, care should be taken to avoid virus aerosolization during key high-risk steps. Modifications such as performing spontaneous breathing trials using pressure support (a closed circuit) rather than tracheostomy mask, bypassing speaking valve trials in favor of direct tracheostomy capping, and avoiding routine tracheostomy downsizing are examples of simple steps that can be taken to facilitate patient progress while minimizing HCP risk (Divo, et al. Respir Care. 2020[Aug]5;respcare.08157).
 

What’s ahead?

As we move forward, we will continue to balance caring for patients effectively and efficiently while minimizing risk to ourselves and others. Ultimately until a vaccine exists, we will have to focus on prevention of infection and spread; therefore, the core principles of hand hygiene, mask wearing, and social distancing have never been more important. We encourage continued study, scrutiny, and collaboration in order to optimize procedural techniques as more information becomes available.
 

Dr. Oberg is with the Section of Interventional Pulmonology, David Geffen School of Medicine at UCLA; Dr. Beattie is with the Section of Interventional Pulmonology, Memorial Sloan Kettering Cancer Center, New York; and Dr. Folch is with the Section of Interventional Pulmonology, Massachusetts General Hospital, Harvard Medical School.

The coronavirus disease 2019 (COVID-19) pandemic has changed the way we deliver healthcare for the foreseeable future. Not only have we had to rapidly learn how to evaluate, diagnose, and treat this new disease, we have also had to shift how we screen, triage, and care for other patients for both their safety and ours. As the virus is primarily spread via respiratory droplets, aerosol-generating procedures (AGP), such as bronchoscopy and tracheostomy, are high-risk for viral transmission. We have therefore had to reassess the risk/benefit ratio of performing these procedures – what is the risk to the patient by procedure postponement vs the risk to the health-care personnel (HCP) involved by moving ahead with the procedure? And, if proceeding, how should we protect ourselves? How do we screen patients to help us stratify risk? In order to answer these questions, we generally divide patients into three categories: the asymptomatic outpatient, the symptomatic patient, and the critically ill patient.

The asymptomatic outpatient

Early in the pandemic as cases began to spike in the US, many hospitals decided to postpone all elective procedures and surgeries. Guidelines quickly emerged stratifying bronchoscopic procedures into emergent, urgent, acute, subacute, and truly elective with recommendations on the subsequent timing of those procedures (Pritchett MA, et al. J Thorac Dis. 2020 May;12[5]:1781-1798). As we have obtained further data and our infrastructure has been bolstered, many physicians have begun performing more routine procedures. Preprocedural screening, both with symptom questionnaires and nasopharyngeal swabs, has been enacted as a measure to prevent inadvertent exposure to infected patients. While there are limited data regarding the reliability of this measure, emerging data have shown good concordance between nasopharyngeal SARS-CoV-2 polymerase chain reaction (PCR) swabs and bronchoalveolar lavage (BAL) samples in low-risk patients (Oberg, et al. Personal communication, Sept 2020). Emergency procedures, such as foreign body aspiration, critical airway obstruction, and massive hemoptysis, were generally performed without delay throughout the pandemic. More recently, emphasis has been placed on prioritizing procedures for acute clinical diagnoses, such as biopsies for concerning lung nodules or masses in potentially early-stage patients, in those where staging is needed and in those where disease progression is suspected. Subacute procedures, such as inspection bronchoscopy for cough, minor hemoptysis, or airway stent surveillance, have generally been reintroduced while elective procedures, such as bronchial thermoplasty and bronchoscopic lung volume reduction, are considered elective, and their frequency and timing is determined mostly by the number of new cases of COVID-19 in the local community.

For all procedures, general modifications have been made. High-efficiency particulate air (HEPA) filters should be placed on all ventilatory circuits. When equivalent, flexible bronchoscopy is preferred over rigid bronchoscopy due to the closed circuit. Enhanced personal protective equipment (PPE) for all procedures is recommended – this typically includes a gown, gloves, hair bonnet, N-95 mask, and a face shield. Strict adherence to the Centers for Disease Control and Prevention (CDC) guidelines for postprocedure cleaning and sterilization is strongly recommended. In some cases, single-use bronchoscopes are being preferentially used, though no strong recommendations exist for this.
 

The symptomatic COVID-19 patient

In patients who have been diagnosed with SARS-CoV-2, we generally recommend postponing all procedures other than for life-threatening indications. For outpatients, we generally wait for two negative nasopharyngeal swabs prior to performing any nonemergent procedure. In inpatients, similar recommendations exist. Potential inpatient indications for bronchoscopy include diagnostic evaluation for alternate or coinfections, and therapeutic aspiration of clinically significant secretions. These should be carefully considered and performed only if deemed absolutely necessary. If bronchoscopy is needed in a patient with suspected or confirmed COVID-19, at a minimum, gown, gloves, head cover, face shield, and an N-95 mask should be worn. A powered air purifying respirator (PAPR) can be used and may provide increased protection. Proper donning and doffing techniques should be reviewed prior to any procedure. Personnel involved in the case should be limited to the minimum required. The procedure should be performed by experienced operators and limited in length. Removal and reinsertion of the bronchoscope should be minimized.

The critically ill COVID-19 patient

While the majority of patients infected with SARS-CoV-2 will have only mild symptoms, we know that a subset of patients will develop respiratory failure. Of those, a small but significant number will require prolonged mechanical ventilation during their clinical course. Thus, the consideration for tracheostomy comes into play.

Multiple issues arise when discussing tracheostomy placement in the COVID-19 world. Should it be done at all? If yes, what is the best technique and who should do it? When and where should it be done? Importantly – how do we care for patients once it is in place to facilitate recovery and, hopefully, decannulation?

Tracheostomy tubes are used in the ICU for patients who require prolonged mechanical ventilation for many reasons – patient comfort, decreased need for sedation, and to facilitate transfer out of the ICU to less acute care areas. These reasons are just as important in patients afflicted with respiratory failure from COVID-19, if not more so. As the patient volumes surge, health-care systems can quickly become overwhelmed. The ability to safely move patients out of the ICU frees up those resources for others who are more acutely ill.

The optimal technique for tracheostomy placement largely depends on the technological and human capital of each institution. Emphasis should be placed on procedural experience, efficiency, safety, and minimizing risk to HCP. While mortality rates do not differ between the surgical and percutaneous techniques, the percutaneous approach has been shown to require less procedural time (Iftikhar IH, et al. Lung. 2019[Jun];197[3]:267-275), an important infection control advantage in COVID-19 patients. Additionally, percutaneous tracheostomies are typically performed at the bedside, which offers the immediate benefit of minimizing patient transfer. This decreases exposure to multiple HCP, as well as contamination of other health-care areas. If performing a bronchoscopic-guided percutaneous tracheostomy, apnea should be maintained from insertion of the guiding catheter to tracheostomy insertion in order to minimize aerosolization. A novel technique involving placing the bronchoscope beside the endotracheal tube instead of through it has also been described (Angel L, et al. Ann Thorac Surg. 2020[Sep];110[3]:1006–1011).

Timing of tracheostomy placement in COVID-19 patients has varied widely. Initially, concern for the safety of HCP performing these procedures led to recommendations of waiting at least 21 days of intubation or until COVID-19 testing became negative. However, more recently, multiple recommendations have been made for tracheostomy placement after day 10 of intubation (McGrath, et al. Lancet Respir Med. 2020[Jul];8[7]:717-725).

Finally, once a tracheostomy tube has been placed, the care does not stop there. As patients are transitioned to rehabilitation centers or skilled nursing facilities and are assessed for weaning, downsizing, and decannulation, care should be taken to avoid virus aerosolization during key high-risk steps. Modifications such as performing spontaneous breathing trials using pressure support (a closed circuit) rather than tracheostomy mask, bypassing speaking valve trials in favor of direct tracheostomy capping, and avoiding routine tracheostomy downsizing are examples of simple steps that can be taken to facilitate patient progress while minimizing HCP risk (Divo, et al. Respir Care. 2020[Aug]5;respcare.08157).
 

What’s ahead?

As we move forward, we will continue to balance caring for patients effectively and efficiently while minimizing risk to ourselves and others. Ultimately until a vaccine exists, we will have to focus on prevention of infection and spread; therefore, the core principles of hand hygiene, mask wearing, and social distancing have never been more important. We encourage continued study, scrutiny, and collaboration in order to optimize procedural techniques as more information becomes available.
 

Dr. Oberg is with the Section of Interventional Pulmonology, David Geffen School of Medicine at UCLA; Dr. Beattie is with the Section of Interventional Pulmonology, Memorial Sloan Kettering Cancer Center, New York; and Dr. Folch is with the Section of Interventional Pulmonology, Massachusetts General Hospital, Harvard Medical School.

The coronavirus disease 2019 (COVID-19) pandemic has changed the way we deliver healthcare for the foreseeable future. Not only have we had to rapidly learn how to evaluate, diagnose, and treat this new disease, we have also had to shift how we screen, triage, and care for other patients for both their safety and ours. As the virus is primarily spread via respiratory droplets, aerosol-generating procedures (AGP), such as bronchoscopy and tracheostomy, are high-risk for viral transmission. We have therefore had to reassess the risk/benefit ratio of performing these procedures – what is the risk to the patient by procedure postponement vs the risk to the health-care personnel (HCP) involved by moving ahead with the procedure? And, if proceeding, how should we protect ourselves? How do we screen patients to help us stratify risk? In order to answer these questions, we generally divide patients into three categories: the asymptomatic outpatient, the symptomatic patient, and the critically ill patient.

The asymptomatic outpatient

Early in the pandemic as cases began to spike in the US, many hospitals decided to postpone all elective procedures and surgeries. Guidelines quickly emerged stratifying bronchoscopic procedures into emergent, urgent, acute, subacute, and truly elective with recommendations on the subsequent timing of those procedures (Pritchett MA, et al. J Thorac Dis. 2020 May;12[5]:1781-1798). As we have obtained further data and our infrastructure has been bolstered, many physicians have begun performing more routine procedures. Preprocedural screening, both with symptom questionnaires and nasopharyngeal swabs, has been enacted as a measure to prevent inadvertent exposure to infected patients. While there are limited data regarding the reliability of this measure, emerging data have shown good concordance between nasopharyngeal SARS-CoV-2 polymerase chain reaction (PCR) swabs and bronchoalveolar lavage (BAL) samples in low-risk patients (Oberg, et al. Personal communication, Sept 2020). Emergency procedures, such as foreign body aspiration, critical airway obstruction, and massive hemoptysis, were generally performed without delay throughout the pandemic. More recently, emphasis has been placed on prioritizing procedures for acute clinical diagnoses, such as biopsies for concerning lung nodules or masses in potentially early-stage patients, in those where staging is needed and in those where disease progression is suspected. Subacute procedures, such as inspection bronchoscopy for cough, minor hemoptysis, or airway stent surveillance, have generally been reintroduced while elective procedures, such as bronchial thermoplasty and bronchoscopic lung volume reduction, are considered elective, and their frequency and timing is determined mostly by the number of new cases of COVID-19 in the local community.

For all procedures, general modifications have been made. High-efficiency particulate air (HEPA) filters should be placed on all ventilatory circuits. When equivalent, flexible bronchoscopy is preferred over rigid bronchoscopy due to the closed circuit. Enhanced personal protective equipment (PPE) for all procedures is recommended – this typically includes a gown, gloves, hair bonnet, N-95 mask, and a face shield. Strict adherence to the Centers for Disease Control and Prevention (CDC) guidelines for postprocedure cleaning and sterilization is strongly recommended. In some cases, single-use bronchoscopes are being preferentially used, though no strong recommendations exist for this.
 

The symptomatic COVID-19 patient

In patients who have been diagnosed with SARS-CoV-2, we generally recommend postponing all procedures other than for life-threatening indications. For outpatients, we generally wait for two negative nasopharyngeal swabs prior to performing any nonemergent procedure. In inpatients, similar recommendations exist. Potential inpatient indications for bronchoscopy include diagnostic evaluation for alternate or coinfections, and therapeutic aspiration of clinically significant secretions. These should be carefully considered and performed only if deemed absolutely necessary. If bronchoscopy is needed in a patient with suspected or confirmed COVID-19, at a minimum, gown, gloves, head cover, face shield, and an N-95 mask should be worn. A powered air purifying respirator (PAPR) can be used and may provide increased protection. Proper donning and doffing techniques should be reviewed prior to any procedure. Personnel involved in the case should be limited to the minimum required. The procedure should be performed by experienced operators and limited in length. Removal and reinsertion of the bronchoscope should be minimized.

The critically ill COVID-19 patient

While the majority of patients infected with SARS-CoV-2 will have only mild symptoms, we know that a subset of patients will develop respiratory failure. Of those, a small but significant number will require prolonged mechanical ventilation during their clinical course. Thus, the consideration for tracheostomy comes into play.

Multiple issues arise when discussing tracheostomy placement in the COVID-19 world. Should it be done at all? If yes, what is the best technique and who should do it? When and where should it be done? Importantly – how do we care for patients once it is in place to facilitate recovery and, hopefully, decannulation?

Tracheostomy tubes are used in the ICU for patients who require prolonged mechanical ventilation for many reasons – patient comfort, decreased need for sedation, and to facilitate transfer out of the ICU to less acute care areas. These reasons are just as important in patients afflicted with respiratory failure from COVID-19, if not more so. As the patient volumes surge, health-care systems can quickly become overwhelmed. The ability to safely move patients out of the ICU frees up those resources for others who are more acutely ill.

The optimal technique for tracheostomy placement largely depends on the technological and human capital of each institution. Emphasis should be placed on procedural experience, efficiency, safety, and minimizing risk to HCP. While mortality rates do not differ between the surgical and percutaneous techniques, the percutaneous approach has been shown to require less procedural time (Iftikhar IH, et al. Lung. 2019[Jun];197[3]:267-275), an important infection control advantage in COVID-19 patients. Additionally, percutaneous tracheostomies are typically performed at the bedside, which offers the immediate benefit of minimizing patient transfer. This decreases exposure to multiple HCP, as well as contamination of other health-care areas. If performing a bronchoscopic-guided percutaneous tracheostomy, apnea should be maintained from insertion of the guiding catheter to tracheostomy insertion in order to minimize aerosolization. A novel technique involving placing the bronchoscope beside the endotracheal tube instead of through it has also been described (Angel L, et al. Ann Thorac Surg. 2020[Sep];110[3]:1006–1011).

Timing of tracheostomy placement in COVID-19 patients has varied widely. Initially, concern for the safety of HCP performing these procedures led to recommendations of waiting at least 21 days of intubation or until COVID-19 testing became negative. However, more recently, multiple recommendations have been made for tracheostomy placement after day 10 of intubation (McGrath, et al. Lancet Respir Med. 2020[Jul];8[7]:717-725).

Finally, once a tracheostomy tube has been placed, the care does not stop there. As patients are transitioned to rehabilitation centers or skilled nursing facilities and are assessed for weaning, downsizing, and decannulation, care should be taken to avoid virus aerosolization during key high-risk steps. Modifications such as performing spontaneous breathing trials using pressure support (a closed circuit) rather than tracheostomy mask, bypassing speaking valve trials in favor of direct tracheostomy capping, and avoiding routine tracheostomy downsizing are examples of simple steps that can be taken to facilitate patient progress while minimizing HCP risk (Divo, et al. Respir Care. 2020[Aug]5;respcare.08157).
 

What’s ahead?

As we move forward, we will continue to balance caring for patients effectively and efficiently while minimizing risk to ourselves and others. Ultimately until a vaccine exists, we will have to focus on prevention of infection and spread; therefore, the core principles of hand hygiene, mask wearing, and social distancing have never been more important. We encourage continued study, scrutiny, and collaboration in order to optimize procedural techniques as more information becomes available.
 

Dr. Oberg is with the Section of Interventional Pulmonology, David Geffen School of Medicine at UCLA; Dr. Beattie is with the Section of Interventional Pulmonology, Memorial Sloan Kettering Cancer Center, New York; and Dr. Folch is with the Section of Interventional Pulmonology, Massachusetts General Hospital, Harvard Medical School.

CHEST’s premier event in pulmonary, critical care, and sleep medicine is just around the corner! Join us for CHEST Annual Meeting 2020, taking place October 18-21. We know it’s hard to plan out your schedule during an ever-changing pandemic, which is why this year’s meeting is being brought to you on a virtual platform. You’ll be able to access the meeting content from any device, in any location, at any time. It’s that convenient! Plus, you can join in immersive, interactive live sessions taught by expert faculty and followed by Q&As, or listen to prerecorded content at your own pace. Don’t worry if you’re unable to attend a session — all meeting content will be available to registrants until January 2021.

This year, you can expect:

• A keynote address by Anthony Fauci, MD, covering COVID-19.

• Over 88 live sessions, including panel and case-based discussions.

• Critically relevant sessions focusing on COVID-19 and cultural diversity.

• Original investigation presentations with new, unpublished science.

• Unique networking opportunities.

• Fun and interactive CHEST Games.

Register Today

Chestmeeting.chestnet.org

CHEST’s premier event in pulmonary, critical care, and sleep medicine is just around the corner! Join us for CHEST Annual Meeting 2020, taking place October 18-21. We know it’s hard to plan out your schedule during an ever-changing pandemic, which is why this year’s meeting is being brought to you on a virtual platform. You’ll be able to access the meeting content from any device, in any location, at any time. It’s that convenient! Plus, you can join in immersive, interactive live sessions taught by expert faculty and followed by Q&As, or listen to prerecorded content at your own pace. Don’t worry if you’re unable to attend a session — all meeting content will be available to registrants until January 2021.

This year, you can expect:

• A keynote address by Anthony Fauci, MD, covering COVID-19.

• Over 88 live sessions, including panel and case-based discussions.

• Critically relevant sessions focusing on COVID-19 and cultural diversity.

• Original investigation presentations with new, unpublished science.

• Unique networking opportunities.

• Fun and interactive CHEST Games.

Register Today

Chestmeeting.chestnet.org

CHEST’s premier event in pulmonary, critical care, and sleep medicine is just around the corner! Join us for CHEST Annual Meeting 2020, taking place October 18-21. We know it’s hard to plan out your schedule during an ever-changing pandemic, which is why this year’s meeting is being brought to you on a virtual platform. You’ll be able to access the meeting content from any device, in any location, at any time. It’s that convenient! Plus, you can join in immersive, interactive live sessions taught by expert faculty and followed by Q&As, or listen to prerecorded content at your own pace. Don’t worry if you’re unable to attend a session — all meeting content will be available to registrants until January 2021.

This year, you can expect:

• A keynote address by Anthony Fauci, MD, covering COVID-19.

• Over 88 live sessions, including panel and case-based discussions.

• Critically relevant sessions focusing on COVID-19 and cultural diversity.

• Original investigation presentations with new, unpublished science.

• Unique networking opportunities.

• Fun and interactive CHEST Games.

Register Today

Chestmeeting.chestnet.org

Individualizing risk prediction for positive COVID-19 testing: results from 11,672 patients. By Dr. Lara Jehi, et al.



Airway clearance techniques in bronchiectasis: Analysis from the United States Bronchiectasis and NTM research registry. By Dr. Ashwin Basavaraj, et al.



Emotional experiences and coping strategies of family members of critically ill patients. By Dr. Emily Harlan, et al.



Coronavirus disease and smoking: How and why we implemented a tobacco treatment campaign. By Dr. Adam Lang, et al.

Individualizing risk prediction for positive COVID-19 testing: results from 11,672 patients. By Dr. Lara Jehi, et al.



Airway clearance techniques in bronchiectasis: Analysis from the United States Bronchiectasis and NTM research registry. By Dr. Ashwin Basavaraj, et al.



Emotional experiences and coping strategies of family members of critically ill patients. By Dr. Emily Harlan, et al.



Coronavirus disease and smoking: How and why we implemented a tobacco treatment campaign. By Dr. Adam Lang, et al.

Individualizing risk prediction for positive COVID-19 testing: results from 11,672 patients. By Dr. Lara Jehi, et al.



Airway clearance techniques in bronchiectasis: Analysis from the United States Bronchiectasis and NTM research registry. By Dr. Ashwin Basavaraj, et al.



Emotional experiences and coping strategies of family members of critically ill patients. By Dr. Emily Harlan, et al.



Coronavirus disease and smoking: How and why we implemented a tobacco treatment campaign. By Dr. Adam Lang, et al.

Join the CHEST Foundation at one of its many virtual events designed around the three pillars of the organization—access, empowerment, and research—during CHEST 2020. Please check CHESTMeeting.chestnet.org for more details on each event.
 

Virtual Champion’s Circle Donor Lounge

The virtual donor lounge will act as the hub of a wheel – linking the spokes of Foundation programming and events to a central location for easy accessibility. Foundation staff and Board of Trustee members will staff the donor lounge throughout the meeting.
 

Women & Pulmonary Event – Sunday, October 18 at 11:00 AM – 12:30 PM CT

Connect with key thought leaders and participants to support the advancement of women in the fields of pulmonary, critical care, sleep medicine, and in leadership. The event includes a panel discussion on How to remain in control during a pandemic: family, career and mental wellness, followed by an intimate roundtable discussion moderated by the Women & Pulmonary council. RSVPs are necessary to attend this event.
 

CHEST Foundation Donor Reception– Sunday, October 18 7:30 PM CT

Join your colleagues and CHEST leadership for a night of fun and networking. Learn to play Texas Hold’em in a complimentary, casual poker tournament and join the high stakes tournament later this month!

Wine Night with CEO Bob Musacchio – Invite Only – Sunday, October 18 7:30 CST

Join CHEST’s CEO, Bob Musacchio for an interactive, exclusive wine night. The evening will include wine chosen from Bob’s personal favorites and kick off the CHEST 2020 annual meeting as we have never done before!
 

Young Professionals Reception – Monday, October 19, 2020 at 8:00 PM CT – Invite Only

Join your colleagues for a fun evening of trivia, prizes, and celebration! Let the Foundation show some appreciation for your commitment to chest medicine and come learn more about our work!

 

Join the CHEST Foundation at one of its many virtual events designed around the three pillars of the organization—access, empowerment, and research—during CHEST 2020. Please check CHESTMeeting.chestnet.org for more details on each event.
 

Virtual Champion’s Circle Donor Lounge

The virtual donor lounge will act as the hub of a wheel – linking the spokes of Foundation programming and events to a central location for easy accessibility. Foundation staff and Board of Trustee members will staff the donor lounge throughout the meeting.
 

Women & Pulmonary Event – Sunday, October 18 at 11:00 AM – 12:30 PM CT

Connect with key thought leaders and participants to support the advancement of women in the fields of pulmonary, critical care, sleep medicine, and in leadership. The event includes a panel discussion on How to remain in control during a pandemic: family, career and mental wellness, followed by an intimate roundtable discussion moderated by the Women & Pulmonary council. RSVPs are necessary to attend this event.
 

CHEST Foundation Donor Reception– Sunday, October 18 7:30 PM CT

Join your colleagues and CHEST leadership for a night of fun and networking. Learn to play Texas Hold’em in a complimentary, casual poker tournament and join the high stakes tournament later this month!

Wine Night with CEO Bob Musacchio – Invite Only – Sunday, October 18 7:30 CST

Join CHEST’s CEO, Bob Musacchio for an interactive, exclusive wine night. The evening will include wine chosen from Bob’s personal favorites and kick off the CHEST 2020 annual meeting as we have never done before!
 

Young Professionals Reception – Monday, October 19, 2020 at 8:00 PM CT – Invite Only

Join your colleagues for a fun evening of trivia, prizes, and celebration! Let the Foundation show some appreciation for your commitment to chest medicine and come learn more about our work!

 

Join the CHEST Foundation at one of its many virtual events designed around the three pillars of the organization—access, empowerment, and research—during CHEST 2020. Please check CHESTMeeting.chestnet.org for more details on each event.
 

Virtual Champion’s Circle Donor Lounge

The virtual donor lounge will act as the hub of a wheel – linking the spokes of Foundation programming and events to a central location for easy accessibility. Foundation staff and Board of Trustee members will staff the donor lounge throughout the meeting.
 

Women & Pulmonary Event – Sunday, October 18 at 11:00 AM – 12:30 PM CT

Connect with key thought leaders and participants to support the advancement of women in the fields of pulmonary, critical care, sleep medicine, and in leadership. The event includes a panel discussion on How to remain in control during a pandemic: family, career and mental wellness, followed by an intimate roundtable discussion moderated by the Women & Pulmonary council. RSVPs are necessary to attend this event.
 

CHEST Foundation Donor Reception– Sunday, October 18 7:30 PM CT

Join your colleagues and CHEST leadership for a night of fun and networking. Learn to play Texas Hold’em in a complimentary, casual poker tournament and join the high stakes tournament later this month!

Wine Night with CEO Bob Musacchio – Invite Only – Sunday, October 18 7:30 CST

Join CHEST’s CEO, Bob Musacchio for an interactive, exclusive wine night. The evening will include wine chosen from Bob’s personal favorites and kick off the CHEST 2020 annual meeting as we have never done before!
 

Young Professionals Reception – Monday, October 19, 2020 at 8:00 PM CT – Invite Only

Join your colleagues for a fun evening of trivia, prizes, and celebration! Let the Foundation show some appreciation for your commitment to chest medicine and come learn more about our work!

 

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.

“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.

An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.

The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.

According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”

This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.

Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.

SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.

“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.

An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.

The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.

According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”

This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.

Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.

SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.

“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.

An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.

The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.

According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”

This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.

Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.

SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.