Infectious Diseases

Sexually transmitted infection rates have not increased as dramatically in older women as they have in women in their teens and 20s, but rates of chlamydia and gonorrhea in women over age 35 have seen a steady incline over the past decade, and syphilis rates have climbed steeply, according to data from the Centers for Disease Control and Prevention.

That makes the STI treatment guidelines released by the CDC in July even timelier for practitioners of menopause medicine, according to Michael S. Policar, MD, MPH, a professor emeritus of ob.gyn. and reproductive sciences at the University of California, San Francisco.

Dr. Policar discussed what clinicians need to know about STIs in midlife women at the hybrid annual meeting of the North American Menopause Society. Even the nomenclature change in the guidelines from “sexually transmitted diseases” to “sexually transmitted infections” is important “because they want to acknowledge the fact that a lot of the sexually transmitted infections that we’re treating are asymptomatic, are colonizations, and are not yet diseases,” Dr. Policar said. “We’re trying to be much more expansive in thinking about finding these infections before they actually start causing morbidity in the form of a disease.”
 

Sexual history

The primary guidelines update for taking sexual history is the recommendation to ask patients about their intentions regarding pregnancy. The “5 Ps” of sexual history are now Partners, Practices, Protection from STIs, Past history of STIs, and Pregnancy intention.

“There should be a sixth P that has to do with pleasure questions,” Policar added. “We ask all the time for patients that we see in the context of perimenopausal and menopausal services, ‘Are you satisfied with your sexual relationship with your partner?’ Hopefully that will make it into the CDC guidelines as the sixth P at some point, but for now, that’s aspirational.”

In asking about partners, instead of asking patients whether they have sex with men, women, or both, clinicians should ask first if the patient is having sex of any kind – oral, vaginal, or anal – with anyone. From there, providers should ask how many sex partners the patient has had, the gender(s) of the partners, and whether they or their partners have other sex partners, using more gender-inclusive language.

When asking about practices, in addition to asking about the type of sexual contact patients have had, additional questions include whether the patient met their partners online or through apps, whether they or any of their partners use drugs, and whether the patient has exchanged sex for any needs, such as money, housing, or drugs. The additional questions can identify those at higher risk for STIs.

After reviewing the CDC’s list of risk factors for gonorrhea and chlamydia screening, Dr. Policar shared the screening list from the California Department of Public Health, which he finds more helpful:

• History of gonorrhea, chlamydia, or pelvic inflammatory disease (PID) in the past 2 years.
• More than 1 sexual partner in the past year.
• New sexual partner within 90 days.
• Reason to believe that a sex partner has had other partners in the past year.
• Exchanging sex for drugs or money within the past year.
• Other factors identified locally, including prevalence of infection in the community.

STI screening guidelines

For those with a positive gonorrhea/chlamydia (GC/CT) screen, a nucleic acid amplification test (NAAT) vaginal swab is the preferred specimen source, and self-collection is fine for women of any age, Dr. Policar said. In addition, cis-women who received anal intercourse in the preceding year should consider undergoing a rectal GC/CT NAAT, and those who performed oral sex should consider a pharyngeal GC/CT NAAT, based on shared clinical decision-making. A rectal swab requires an insertion of 3-4 cm and a 360-degree twirl of the wrist, not the swab, to ensure you get a sample from the entire circumference. Pharyngeal samples require swabbing both tonsillar pillars while taking care for those who may gag.

For contact testing – asymptomatic people who have had a high-risk sexual exposure – providers should test for gonorrhea, chlamydia, HIV, and syphilis but not for herpes, high-risk HPV, hepatitis B, hepatitis C, or bacterial vaginosis. “Maybe we’ll do a screen for trichomoniasis, and maybe we’ll offer herpes type 2 serology or antibody screening,” Dr. Policar said. Providers should also ask patients requesting contact testing if they have been vaccinated for hepatitis B. If not, “the conversation should be how can we get you vaccinated for hepatitis B,” Dr. Policar said.

HIV screening only needs to occur once between the ages of 15 and 65 for low-risk people and then once annually (or more often if necessary) for those who have a sex partner with HIV, use injectable drugs, engage in commercial sex work, have a new sex partner with unknown HIV status, received care at an STD or TB clinic, or were in a correctional facility or homeless shelter.

Those at increased risk for syphilis include men who have sex with men, men under age 29, and anyone living with HIV or who has a history of incarceration or a history of commercial sex work. In addition, African Americans have the greatest risk for syphilis of racial/ethnic groups, followed by Hispanics. Most adults only require hepatitis C screening with anti-hep C antibody testing once in their lifetime. Periodic hepatitis C screening should occur for people who inject drugs. If the screening is positive, providers should conduct an RNA polymerase chain reaction (PCR) test to determine whether a chronic infection is present.

Trichomoniasis screening should occur annually in women living with HIV or in correctional facilities. Others to consider screening include people with new or multiple sex partners, a history of STIs, inconsistent condom use, a history of sex work, and intravenous drug use. Dr. Policar also noted that several new assays, including NAAT, PCR, and a rapid test, are available for trichomoniasis.
 

STI treatment guidelines

For women with mucoprurulent cervicitis, the cause could be chlamydia, gonorrhea, herpes, trichomonas, mycoplasma, or even progesterone from pregnancy or contraception, Dr. Policar said. The new preferred treatment is 100 mg of doxycycline. The alternative, albeit less preferred, treatment is 1 g azithromycin.

The preferred treatment for chlamydia is now 100 mg oral doxycycline twice daily, or doxycycline 200 mg delayed-release once daily, for 7 days. Alternative regimens include 1 g oral azithromycin in a single dose or 500 mg oral levofloxacin once daily for 7 days. The switch to recommending doxycycline over azithromycin is based on recent evidence showing that doxycycline has a slightly higher efficacy for urogenital chlamydia and a substantially higher efficacy for rectal chlamydia. In addition, an increasing proportion of gonorrheal infections have shown resistance to azithromycin, particularly beginning in 2014.

Preferred treatment of new, uncomplicated gonorrhea infections of the cervix, urethra, rectum, and pharynx is one 500-mg dose of ceftriaxone for those weighing under 150 kg and 1 g for those weighing 150 kg or more. If ceftriaxone is unavailable, the new alternative recommended treatment for gonorrhea is 800 mg cefixime. For pharyngeal gonorrhea only, the CDC recommends a test-of-cure 7-14 days after treatment.

For gonorrheal infections, the CDC also recommends treatment with doxycycline if chlamydia has not been excluded, but the agency no longer recommends dual therapy with azithromycin unless it’s used in place of doxycycline for those who are pregnant, have an allergy, or may not be compliant with a 7-day doxycycline regimen.

The preferred treatment for bacterial vaginosis has not changed. The new recommended regimen for trichomoniasis is 500 mg oral metronidazole for 7 days, with the alternative being a single 2-g dose of tinidazole. Male partners should receive 2 g oral metronidazole. The CDC also notes that patients taking metronidazole no longer need to abstain from alcohol during treatment.

”Another area where the guidelines changed is in their description of expedited partner therapy, which means that, when we find an index case who has gonorrhea or chlamydia, we always have a discussion with her about getting her partners treated,” Dr. Policar said. “The CDC was quite clear that the responsibility for discussing partner treatment rests with us as the diagnosing provider” since city and county health departments don’t have the time or resources for contact tracing these STIs.

The two main ways to treat partners are to have the patient bring their partner(s) to the appointment with them or to do patient-delivered partner therapy. Ideally, clinicians who dispense their own medications can give the patient enough drugs to give her partner(s) a complete dose as well. Otherwise, providers can prescribe extra doses in the index patients’ name or write prescriptions in the partner’s name.

“In every state of the union now, it is legal for you to to prescribe antibiotics for partners sight unseen, Dr. Policar said.

Margaret Sullivan, MD, an ob.gyn. from rural western North Carolina, noted during the Q&A that an obstacle to partner therapy at her practice has been cost, particularly since many of the men don’t have insurance.

“I have not heard before of prescribing the extra doses for partners under the patient’s name,” Dr. Sullivan said. “I’ve thought about doing it, but [was worried about] it potentially being fraudulent if that patient has Medicaid and we’re prescribing extra doses under her name, so how do you work around that?”

Dr. Policar acknowledged that barrier and recommended that patients use the website/app Goodrx.com to find discounts for out-of-pocket generic medications. He also noted the occasional obstacle of pharmacists balking at filling a double or triple dose.

“What we’ve been suggesting in that circumstance is to literally copy that part of the CDC guidelines, which explains expedited partner therapy or patient-delivered partner therapy and send that off to the pharmacist so they can see that it’s a national recommendation of the CDC,” Dr. Policar said.

Claudia Rodriguez, MD, an ob.gyn. who works at Sherman Hospital in Elgin, Ill., asked about the CDC recommendations for HPV vaccination in older women. Although the CDC permits women over age 26 to receive the HPV vaccine, the agency does not “make a solid recommendation to have this done, which oftentimes makes a big difference in whether or not health insurance will actually pay for vaccination in that circumstance,” Dr. Policar said.

Patients are welcome to request the vaccine after shared decision-making, but “we should never present this as something which is routine,” he said. For women in their 50s, for example, “there’s virtually no data about any additional degree of protection that you would get” from HPV vaccination, Dr. Policar said in response to a similar question from Tara Allmen, MD, an ob.gyn. in New York City. “If you ask me for my personal clinical opinion about it, I would say it’s not going to be worth it,” he said.

Dr Policar had no disclosures. Disclosures were unavailable for attendees who spoke.

Sexually transmitted infection rates have not increased as dramatically in older women as they have in women in their teens and 20s, but rates of chlamydia and gonorrhea in women over age 35 have seen a steady incline over the past decade, and syphilis rates have climbed steeply, according to data from the Centers for Disease Control and Prevention.

That makes the STI treatment guidelines released by the CDC in July even timelier for practitioners of menopause medicine, according to Michael S. Policar, MD, MPH, a professor emeritus of ob.gyn. and reproductive sciences at the University of California, San Francisco.

Dr. Policar discussed what clinicians need to know about STIs in midlife women at the hybrid annual meeting of the North American Menopause Society. Even the nomenclature change in the guidelines from “sexually transmitted diseases” to “sexually transmitted infections” is important “because they want to acknowledge the fact that a lot of the sexually transmitted infections that we’re treating are asymptomatic, are colonizations, and are not yet diseases,” Dr. Policar said. “We’re trying to be much more expansive in thinking about finding these infections before they actually start causing morbidity in the form of a disease.”
 

Sexual history

The primary guidelines update for taking sexual history is the recommendation to ask patients about their intentions regarding pregnancy. The “5 Ps” of sexual history are now Partners, Practices, Protection from STIs, Past history of STIs, and Pregnancy intention.

“There should be a sixth P that has to do with pleasure questions,” Policar added. “We ask all the time for patients that we see in the context of perimenopausal and menopausal services, ‘Are you satisfied with your sexual relationship with your partner?’ Hopefully that will make it into the CDC guidelines as the sixth P at some point, but for now, that’s aspirational.”

In asking about partners, instead of asking patients whether they have sex with men, women, or both, clinicians should ask first if the patient is having sex of any kind – oral, vaginal, or anal – with anyone. From there, providers should ask how many sex partners the patient has had, the gender(s) of the partners, and whether they or their partners have other sex partners, using more gender-inclusive language.

When asking about practices, in addition to asking about the type of sexual contact patients have had, additional questions include whether the patient met their partners online or through apps, whether they or any of their partners use drugs, and whether the patient has exchanged sex for any needs, such as money, housing, or drugs. The additional questions can identify those at higher risk for STIs.

After reviewing the CDC’s list of risk factors for gonorrhea and chlamydia screening, Dr. Policar shared the screening list from the California Department of Public Health, which he finds more helpful:

• History of gonorrhea, chlamydia, or pelvic inflammatory disease (PID) in the past 2 years.
• More than 1 sexual partner in the past year.
• New sexual partner within 90 days.
• Reason to believe that a sex partner has had other partners in the past year.
• Exchanging sex for drugs or money within the past year.
• Other factors identified locally, including prevalence of infection in the community.

STI screening guidelines

For those with a positive gonorrhea/chlamydia (GC/CT) screen, a nucleic acid amplification test (NAAT) vaginal swab is the preferred specimen source, and self-collection is fine for women of any age, Dr. Policar said. In addition, cis-women who received anal intercourse in the preceding year should consider undergoing a rectal GC/CT NAAT, and those who performed oral sex should consider a pharyngeal GC/CT NAAT, based on shared clinical decision-making. A rectal swab requires an insertion of 3-4 cm and a 360-degree twirl of the wrist, not the swab, to ensure you get a sample from the entire circumference. Pharyngeal samples require swabbing both tonsillar pillars while taking care for those who may gag.

For contact testing – asymptomatic people who have had a high-risk sexual exposure – providers should test for gonorrhea, chlamydia, HIV, and syphilis but not for herpes, high-risk HPV, hepatitis B, hepatitis C, or bacterial vaginosis. “Maybe we’ll do a screen for trichomoniasis, and maybe we’ll offer herpes type 2 serology or antibody screening,” Dr. Policar said. Providers should also ask patients requesting contact testing if they have been vaccinated for hepatitis B. If not, “the conversation should be how can we get you vaccinated for hepatitis B,” Dr. Policar said.

HIV screening only needs to occur once between the ages of 15 and 65 for low-risk people and then once annually (or more often if necessary) for those who have a sex partner with HIV, use injectable drugs, engage in commercial sex work, have a new sex partner with unknown HIV status, received care at an STD or TB clinic, or were in a correctional facility or homeless shelter.

Those at increased risk for syphilis include men who have sex with men, men under age 29, and anyone living with HIV or who has a history of incarceration or a history of commercial sex work. In addition, African Americans have the greatest risk for syphilis of racial/ethnic groups, followed by Hispanics. Most adults only require hepatitis C screening with anti-hep C antibody testing once in their lifetime. Periodic hepatitis C screening should occur for people who inject drugs. If the screening is positive, providers should conduct an RNA polymerase chain reaction (PCR) test to determine whether a chronic infection is present.

Trichomoniasis screening should occur annually in women living with HIV or in correctional facilities. Others to consider screening include people with new or multiple sex partners, a history of STIs, inconsistent condom use, a history of sex work, and intravenous drug use. Dr. Policar also noted that several new assays, including NAAT, PCR, and a rapid test, are available for trichomoniasis.
 

STI treatment guidelines

For women with mucoprurulent cervicitis, the cause could be chlamydia, gonorrhea, herpes, trichomonas, mycoplasma, or even progesterone from pregnancy or contraception, Dr. Policar said. The new preferred treatment is 100 mg of doxycycline. The alternative, albeit less preferred, treatment is 1 g azithromycin.

The preferred treatment for chlamydia is now 100 mg oral doxycycline twice daily, or doxycycline 200 mg delayed-release once daily, for 7 days. Alternative regimens include 1 g oral azithromycin in a single dose or 500 mg oral levofloxacin once daily for 7 days. The switch to recommending doxycycline over azithromycin is based on recent evidence showing that doxycycline has a slightly higher efficacy for urogenital chlamydia and a substantially higher efficacy for rectal chlamydia. In addition, an increasing proportion of gonorrheal infections have shown resistance to azithromycin, particularly beginning in 2014.

Preferred treatment of new, uncomplicated gonorrhea infections of the cervix, urethra, rectum, and pharynx is one 500-mg dose of ceftriaxone for those weighing under 150 kg and 1 g for those weighing 150 kg or more. If ceftriaxone is unavailable, the new alternative recommended treatment for gonorrhea is 800 mg cefixime. For pharyngeal gonorrhea only, the CDC recommends a test-of-cure 7-14 days after treatment.

For gonorrheal infections, the CDC also recommends treatment with doxycycline if chlamydia has not been excluded, but the agency no longer recommends dual therapy with azithromycin unless it’s used in place of doxycycline for those who are pregnant, have an allergy, or may not be compliant with a 7-day doxycycline regimen.

The preferred treatment for bacterial vaginosis has not changed. The new recommended regimen for trichomoniasis is 500 mg oral metronidazole for 7 days, with the alternative being a single 2-g dose of tinidazole. Male partners should receive 2 g oral metronidazole. The CDC also notes that patients taking metronidazole no longer need to abstain from alcohol during treatment.

”Another area where the guidelines changed is in their description of expedited partner therapy, which means that, when we find an index case who has gonorrhea or chlamydia, we always have a discussion with her about getting her partners treated,” Dr. Policar said. “The CDC was quite clear that the responsibility for discussing partner treatment rests with us as the diagnosing provider” since city and county health departments don’t have the time or resources for contact tracing these STIs.

The two main ways to treat partners are to have the patient bring their partner(s) to the appointment with them or to do patient-delivered partner therapy. Ideally, clinicians who dispense their own medications can give the patient enough drugs to give her partner(s) a complete dose as well. Otherwise, providers can prescribe extra doses in the index patients’ name or write prescriptions in the partner’s name.

“In every state of the union now, it is legal for you to to prescribe antibiotics for partners sight unseen, Dr. Policar said.

Margaret Sullivan, MD, an ob.gyn. from rural western North Carolina, noted during the Q&A that an obstacle to partner therapy at her practice has been cost, particularly since many of the men don’t have insurance.

“I have not heard before of prescribing the extra doses for partners under the patient’s name,” Dr. Sullivan said. “I’ve thought about doing it, but [was worried about] it potentially being fraudulent if that patient has Medicaid and we’re prescribing extra doses under her name, so how do you work around that?”

Dr. Policar acknowledged that barrier and recommended that patients use the website/app Goodrx.com to find discounts for out-of-pocket generic medications. He also noted the occasional obstacle of pharmacists balking at filling a double or triple dose.

“What we’ve been suggesting in that circumstance is to literally copy that part of the CDC guidelines, which explains expedited partner therapy or patient-delivered partner therapy and send that off to the pharmacist so they can see that it’s a national recommendation of the CDC,” Dr. Policar said.

Claudia Rodriguez, MD, an ob.gyn. who works at Sherman Hospital in Elgin, Ill., asked about the CDC recommendations for HPV vaccination in older women. Although the CDC permits women over age 26 to receive the HPV vaccine, the agency does not “make a solid recommendation to have this done, which oftentimes makes a big difference in whether or not health insurance will actually pay for vaccination in that circumstance,” Dr. Policar said.

Patients are welcome to request the vaccine after shared decision-making, but “we should never present this as something which is routine,” he said. For women in their 50s, for example, “there’s virtually no data about any additional degree of protection that you would get” from HPV vaccination, Dr. Policar said in response to a similar question from Tara Allmen, MD, an ob.gyn. in New York City. “If you ask me for my personal clinical opinion about it, I would say it’s not going to be worth it,” he said.

Dr Policar had no disclosures. Disclosures were unavailable for attendees who spoke.

Sexually transmitted infection rates have not increased as dramatically in older women as they have in women in their teens and 20s, but rates of chlamydia and gonorrhea in women over age 35 have seen a steady incline over the past decade, and syphilis rates have climbed steeply, according to data from the Centers for Disease Control and Prevention.

That makes the STI treatment guidelines released by the CDC in July even timelier for practitioners of menopause medicine, according to Michael S. Policar, MD, MPH, a professor emeritus of ob.gyn. and reproductive sciences at the University of California, San Francisco.

Dr. Policar discussed what clinicians need to know about STIs in midlife women at the hybrid annual meeting of the North American Menopause Society. Even the nomenclature change in the guidelines from “sexually transmitted diseases” to “sexually transmitted infections” is important “because they want to acknowledge the fact that a lot of the sexually transmitted infections that we’re treating are asymptomatic, are colonizations, and are not yet diseases,” Dr. Policar said. “We’re trying to be much more expansive in thinking about finding these infections before they actually start causing morbidity in the form of a disease.”
 

Sexual history

The primary guidelines update for taking sexual history is the recommendation to ask patients about their intentions regarding pregnancy. The “5 Ps” of sexual history are now Partners, Practices, Protection from STIs, Past history of STIs, and Pregnancy intention.

“There should be a sixth P that has to do with pleasure questions,” Policar added. “We ask all the time for patients that we see in the context of perimenopausal and menopausal services, ‘Are you satisfied with your sexual relationship with your partner?’ Hopefully that will make it into the CDC guidelines as the sixth P at some point, but for now, that’s aspirational.”

In asking about partners, instead of asking patients whether they have sex with men, women, or both, clinicians should ask first if the patient is having sex of any kind – oral, vaginal, or anal – with anyone. From there, providers should ask how many sex partners the patient has had, the gender(s) of the partners, and whether they or their partners have other sex partners, using more gender-inclusive language.

When asking about practices, in addition to asking about the type of sexual contact patients have had, additional questions include whether the patient met their partners online or through apps, whether they or any of their partners use drugs, and whether the patient has exchanged sex for any needs, such as money, housing, or drugs. The additional questions can identify those at higher risk for STIs.

After reviewing the CDC’s list of risk factors for gonorrhea and chlamydia screening, Dr. Policar shared the screening list from the California Department of Public Health, which he finds more helpful:

• History of gonorrhea, chlamydia, or pelvic inflammatory disease (PID) in the past 2 years.
• More than 1 sexual partner in the past year.
• New sexual partner within 90 days.
• Reason to believe that a sex partner has had other partners in the past year.
• Exchanging sex for drugs or money within the past year.
• Other factors identified locally, including prevalence of infection in the community.

STI screening guidelines

For those with a positive gonorrhea/chlamydia (GC/CT) screen, a nucleic acid amplification test (NAAT) vaginal swab is the preferred specimen source, and self-collection is fine for women of any age, Dr. Policar said. In addition, cis-women who received anal intercourse in the preceding year should consider undergoing a rectal GC/CT NAAT, and those who performed oral sex should consider a pharyngeal GC/CT NAAT, based on shared clinical decision-making. A rectal swab requires an insertion of 3-4 cm and a 360-degree twirl of the wrist, not the swab, to ensure you get a sample from the entire circumference. Pharyngeal samples require swabbing both tonsillar pillars while taking care for those who may gag.

For contact testing – asymptomatic people who have had a high-risk sexual exposure – providers should test for gonorrhea, chlamydia, HIV, and syphilis but not for herpes, high-risk HPV, hepatitis B, hepatitis C, or bacterial vaginosis. “Maybe we’ll do a screen for trichomoniasis, and maybe we’ll offer herpes type 2 serology or antibody screening,” Dr. Policar said. Providers should also ask patients requesting contact testing if they have been vaccinated for hepatitis B. If not, “the conversation should be how can we get you vaccinated for hepatitis B,” Dr. Policar said.

HIV screening only needs to occur once between the ages of 15 and 65 for low-risk people and then once annually (or more often if necessary) for those who have a sex partner with HIV, use injectable drugs, engage in commercial sex work, have a new sex partner with unknown HIV status, received care at an STD or TB clinic, or were in a correctional facility or homeless shelter.

Those at increased risk for syphilis include men who have sex with men, men under age 29, and anyone living with HIV or who has a history of incarceration or a history of commercial sex work. In addition, African Americans have the greatest risk for syphilis of racial/ethnic groups, followed by Hispanics. Most adults only require hepatitis C screening with anti-hep C antibody testing once in their lifetime. Periodic hepatitis C screening should occur for people who inject drugs. If the screening is positive, providers should conduct an RNA polymerase chain reaction (PCR) test to determine whether a chronic infection is present.

Trichomoniasis screening should occur annually in women living with HIV or in correctional facilities. Others to consider screening include people with new or multiple sex partners, a history of STIs, inconsistent condom use, a history of sex work, and intravenous drug use. Dr. Policar also noted that several new assays, including NAAT, PCR, and a rapid test, are available for trichomoniasis.
 

STI treatment guidelines

For women with mucoprurulent cervicitis, the cause could be chlamydia, gonorrhea, herpes, trichomonas, mycoplasma, or even progesterone from pregnancy or contraception, Dr. Policar said. The new preferred treatment is 100 mg of doxycycline. The alternative, albeit less preferred, treatment is 1 g azithromycin.

The preferred treatment for chlamydia is now 100 mg oral doxycycline twice daily, or doxycycline 200 mg delayed-release once daily, for 7 days. Alternative regimens include 1 g oral azithromycin in a single dose or 500 mg oral levofloxacin once daily for 7 days. The switch to recommending doxycycline over azithromycin is based on recent evidence showing that doxycycline has a slightly higher efficacy for urogenital chlamydia and a substantially higher efficacy for rectal chlamydia. In addition, an increasing proportion of gonorrheal infections have shown resistance to azithromycin, particularly beginning in 2014.

Preferred treatment of new, uncomplicated gonorrhea infections of the cervix, urethra, rectum, and pharynx is one 500-mg dose of ceftriaxone for those weighing under 150 kg and 1 g for those weighing 150 kg or more. If ceftriaxone is unavailable, the new alternative recommended treatment for gonorrhea is 800 mg cefixime. For pharyngeal gonorrhea only, the CDC recommends a test-of-cure 7-14 days after treatment.

For gonorrheal infections, the CDC also recommends treatment with doxycycline if chlamydia has not been excluded, but the agency no longer recommends dual therapy with azithromycin unless it’s used in place of doxycycline for those who are pregnant, have an allergy, or may not be compliant with a 7-day doxycycline regimen.

The preferred treatment for bacterial vaginosis has not changed. The new recommended regimen for trichomoniasis is 500 mg oral metronidazole for 7 days, with the alternative being a single 2-g dose of tinidazole. Male partners should receive 2 g oral metronidazole. The CDC also notes that patients taking metronidazole no longer need to abstain from alcohol during treatment.

”Another area where the guidelines changed is in their description of expedited partner therapy, which means that, when we find an index case who has gonorrhea or chlamydia, we always have a discussion with her about getting her partners treated,” Dr. Policar said. “The CDC was quite clear that the responsibility for discussing partner treatment rests with us as the diagnosing provider” since city and county health departments don’t have the time or resources for contact tracing these STIs.

The two main ways to treat partners are to have the patient bring their partner(s) to the appointment with them or to do patient-delivered partner therapy. Ideally, clinicians who dispense their own medications can give the patient enough drugs to give her partner(s) a complete dose as well. Otherwise, providers can prescribe extra doses in the index patients’ name or write prescriptions in the partner’s name.

“In every state of the union now, it is legal for you to to prescribe antibiotics for partners sight unseen, Dr. Policar said.

Margaret Sullivan, MD, an ob.gyn. from rural western North Carolina, noted during the Q&A that an obstacle to partner therapy at her practice has been cost, particularly since many of the men don’t have insurance.

“I have not heard before of prescribing the extra doses for partners under the patient’s name,” Dr. Sullivan said. “I’ve thought about doing it, but [was worried about] it potentially being fraudulent if that patient has Medicaid and we’re prescribing extra doses under her name, so how do you work around that?”

Dr. Policar acknowledged that barrier and recommended that patients use the website/app Goodrx.com to find discounts for out-of-pocket generic medications. He also noted the occasional obstacle of pharmacists balking at filling a double or triple dose.

“What we’ve been suggesting in that circumstance is to literally copy that part of the CDC guidelines, which explains expedited partner therapy or patient-delivered partner therapy and send that off to the pharmacist so they can see that it’s a national recommendation of the CDC,” Dr. Policar said.

Claudia Rodriguez, MD, an ob.gyn. who works at Sherman Hospital in Elgin, Ill., asked about the CDC recommendations for HPV vaccination in older women. Although the CDC permits women over age 26 to receive the HPV vaccine, the agency does not “make a solid recommendation to have this done, which oftentimes makes a big difference in whether or not health insurance will actually pay for vaccination in that circumstance,” Dr. Policar said.

Patients are welcome to request the vaccine after shared decision-making, but “we should never present this as something which is routine,” he said. For women in their 50s, for example, “there’s virtually no data about any additional degree of protection that you would get” from HPV vaccination, Dr. Policar said in response to a similar question from Tara Allmen, MD, an ob.gyn. in New York City. “If you ask me for my personal clinical opinion about it, I would say it’s not going to be worth it,” he said.

Dr Policar had no disclosures. Disclosures were unavailable for attendees who spoke.

Phaeohyphomycosis are caused by dematiaceous (pigmented) mycoses that produce dark colored hyphae due to melanin deposition in their cell walls. There are more than 100 species of dematiaceous fungi that can cause phaeohyphomycosis, including Alternaria, Exophiala, Phialophora, Wangiella, Bipolaris, Curvularia, and Exserohilum.^1,2 The causative fungi are found in plants and soil, so they are commonly seen after activities such as gardening or walking barefoot. Trauma, such as a splinter, typically incites the infection. Infections can present with superficial, cutaneous and subcutaneous involvement.

Donna Bilu Martin, MD

Sporotrichosis, also called Rose gardener’s disease, is a mycosis caused by Sporothrix schenckii. A typical presentation is when a gardener gets pricked by a rose thorn. Classically, a pustule will develop at the site of inoculation, with additional lesions forming along the path of lymphatic drainage (called a “sporotrichoid” pattern) weeks later. Atypical mycobacterial infections, mainly Mycobacterium marinum, may also present in this way. Histopathology and tissue cultures help to differentiate the two.

An incision and drainage with pathology was performed in the office. Upon opening the nodule, a large wood splinter was extracted. Both the foreign body and a punch biopsy of skin were sent in for examination. Pathology revealed polarizable foreign material in association with suppurative inflammation and dematiaceous fungi. PAS (Periodic-acid Schiff) and GMS (Grocott methenamine silver) stain highlighted fungal forms. Cultures were negative.

Local disease may be treated with excision alone. Oral antifungals, such as itraconazole, fluconazole, or ketoconazole may be used, although may require long treatment courses for months. Amphotericin B and flucytosine may be required in systemic cases. Almost all cases of disseminated disease occur in immunocompromised patients. Our patient’s hand resolved after removal of the causative thorn.

This case and these photos were submitted by Dr. Bilu Martin.
 

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. Kradin R. Diagnostic Pathology of Infectious Disease, 1st edition (Saunders, Feb. 2, 2010).

2. Bolognia J et al. Dermatology (St. Louis: Mosby/Elsevier, 2008).

Phaeohyphomycosis are caused by dematiaceous (pigmented) mycoses that produce dark colored hyphae due to melanin deposition in their cell walls. There are more than 100 species of dematiaceous fungi that can cause phaeohyphomycosis, including Alternaria, Exophiala, Phialophora, Wangiella, Bipolaris, Curvularia, and Exserohilum.^1,2 The causative fungi are found in plants and soil, so they are commonly seen after activities such as gardening or walking barefoot. Trauma, such as a splinter, typically incites the infection. Infections can present with superficial, cutaneous and subcutaneous involvement.

Donna Bilu Martin, MD

Sporotrichosis, also called Rose gardener’s disease, is a mycosis caused by Sporothrix schenckii. A typical presentation is when a gardener gets pricked by a rose thorn. Classically, a pustule will develop at the site of inoculation, with additional lesions forming along the path of lymphatic drainage (called a “sporotrichoid” pattern) weeks later. Atypical mycobacterial infections, mainly Mycobacterium marinum, may also present in this way. Histopathology and tissue cultures help to differentiate the two.

An incision and drainage with pathology was performed in the office. Upon opening the nodule, a large wood splinter was extracted. Both the foreign body and a punch biopsy of skin were sent in for examination. Pathology revealed polarizable foreign material in association with suppurative inflammation and dematiaceous fungi. PAS (Periodic-acid Schiff) and GMS (Grocott methenamine silver) stain highlighted fungal forms. Cultures were negative.

Local disease may be treated with excision alone. Oral antifungals, such as itraconazole, fluconazole, or ketoconazole may be used, although may require long treatment courses for months. Amphotericin B and flucytosine may be required in systemic cases. Almost all cases of disseminated disease occur in immunocompromised patients. Our patient’s hand resolved after removal of the causative thorn.

This case and these photos were submitted by Dr. Bilu Martin.
 

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. Kradin R. Diagnostic Pathology of Infectious Disease, 1st edition (Saunders, Feb. 2, 2010).

2. Bolognia J et al. Dermatology (St. Louis: Mosby/Elsevier, 2008).

Phaeohyphomycosis are caused by dematiaceous (pigmented) mycoses that produce dark colored hyphae due to melanin deposition in their cell walls. There are more than 100 species of dematiaceous fungi that can cause phaeohyphomycosis, including Alternaria, Exophiala, Phialophora, Wangiella, Bipolaris, Curvularia, and Exserohilum.^1,2 The causative fungi are found in plants and soil, so they are commonly seen after activities such as gardening or walking barefoot. Trauma, such as a splinter, typically incites the infection. Infections can present with superficial, cutaneous and subcutaneous involvement.

Donna Bilu Martin, MD

Sporotrichosis, also called Rose gardener’s disease, is a mycosis caused by Sporothrix schenckii. A typical presentation is when a gardener gets pricked by a rose thorn. Classically, a pustule will develop at the site of inoculation, with additional lesions forming along the path of lymphatic drainage (called a “sporotrichoid” pattern) weeks later. Atypical mycobacterial infections, mainly Mycobacterium marinum, may also present in this way. Histopathology and tissue cultures help to differentiate the two.

An incision and drainage with pathology was performed in the office. Upon opening the nodule, a large wood splinter was extracted. Both the foreign body and a punch biopsy of skin were sent in for examination. Pathology revealed polarizable foreign material in association with suppurative inflammation and dematiaceous fungi. PAS (Periodic-acid Schiff) and GMS (Grocott methenamine silver) stain highlighted fungal forms. Cultures were negative.

Local disease may be treated with excision alone. Oral antifungals, such as itraconazole, fluconazole, or ketoconazole may be used, although may require long treatment courses for months. Amphotericin B and flucytosine may be required in systemic cases. Almost all cases of disseminated disease occur in immunocompromised patients. Our patient’s hand resolved after removal of the causative thorn.

This case and these photos were submitted by Dr. Bilu Martin.
 

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. Kradin R. Diagnostic Pathology of Infectious Disease, 1st edition (Saunders, Feb. 2, 2010).

2. Bolognia J et al. Dermatology (St. Louis: Mosby/Elsevier, 2008).

From Northwell Health, Lake Success, NY.

Objective: Northwell Health, New York’s largest health care organization, rapidly adopted technology solutions to support patient and family communication during the COVID-19 pandemic.

Methods: This case series outlines the pragmatic, interdisciplinary approach Northwell underwent to rapidly implement patient virtual visitation processes during the peak of the initial crisis.

Results: Implementation of large-scale virtual visitation required leadership, technology, and dedicated, empathetic frontline professionals. Patient and family feedback uncovered varied feelings and perspectives, from confusion to gratitude.

Conclusion: Subsequent efforts to obtain direct patient and family perspectives and insights helped Northwell identify areas of strength and ongoing performance improvement.

Keywords: virtual visitation; COVID-19; technology; communication; patient experience.

The power of human connection has become increasingly apparent throughout the COVID-19 pandemic and subsequent recovery phases. Due to the need for social distancing, people worldwide have turned to virtual means of communication, staying in touch with family, friends, and colleagues via digital technology platforms. On March 18, 2020, the New York State Department of Health (NYSDOH) issued a health advisory, suspending all hospital visitation.¹ As a result, hospitals rapidly transformed existing in-person visitation practices to meet large-scale virtual programming needs.

Family members often take on various roles—such as advocate, emotional support person, and postdischarge caregiver—for an ill or injured loved one.² The Institute for Patient- and Family-Centered Care, a nonprofit organization founded in 1992, has been leading a cultural transformation where families are valued as care partners, as opposed to “visitors.”³ Although widely adopted and well-received in specialized units, such as neonatal intensive care units,⁴ virtual visitation had not been widely implemented across adult care settings. The NYSDOH guidance therefore required organizational leadership, innovation, flexibility, and systems ingenuity to meet the evolving needs of patients, families, and health care professionals. An overarching goal was ensuring patients and families were afforded opportunities to stay connected throughout hospitalization.

Reflecting the impact of COVID-19 surges, hospital environments became increasingly depersonalized, with health care providers wearing extensive personal protective equipment (PPE) and taking remarkable measures to socially distance and minimize exposure. Patients’ room doors were kept primarily closed, while codes and alerts blared in the halls overhead. The lack of families and visitors became increasingly obvious, aiding feelings of isolation and confinement. With fear of nosocomial transmission, impactful modalities (such as sitting at the bedside) and empathetic, therapeutic touch were no longer taking place.

With those scenarios—common to so many health care systems during the pandemic—as a backdrop, comes our experience. Northwell Health is the largest health care system in New York State, geographically spread throughout New York City’s 5 boroughs, Westchester County, and Long Island. With 23 hospitals, approximately 820 medical practices, and over 72 000 employees, Northwell has cared for more than 100 000 COVID-positive patients to date. This case series outlines a pragmatic approach to implementing virtual visitation during the initial peak and obtaining patient and family perspectives to help inform performance improvement and future programming.

Methods

Implementing virtual visitation

Through swift and focused multidisciplinary collaboration, numerous Northwell teams came together to implement large-scale virtual visitation across the organization during the first wave of the COVID crisis. The initial priority involved securing devices that could support patient-family communication. Prior to COVID, each facility had only a handful of tablets that were used primarily during leadership rounding, so once visitation was restricted, we needed a large quantity of devices within a matter of days. Through diligent work from System Procurement and internal Foundation, Northwell was able to acquire nearly 900 devices, including iPads, PadInMotion tablets, and Samsung tablets.

Typically, the benefits of using wireless tablets within a health care setting include long battery life, powerful data processing, advanced operating systems, large screens, and easy end-user navigation.⁴ During COVID-19 and its associated isolation precautions, tablets offered a lifeline for effective and socially distant communication. With new devices in hand, the system Office of the Chief Information Officer (OCIO) and site-based Information Technology (IT) teams were engaged. They worked tirelessly to streamline connectivity, download necessary apps, test devices on approved WiFi networks, and troubleshoot issues. Once set up, devices were strategically deployed across all Northwell hospitals and post-acute rehabilitation facilities.

Frontline teams quickly realized that a model similar to mobile proning teams, who focus solely on turning and positioning COVID patients to promote optimal respiratory ventilation,⁵ was needed to support virtual visitation. During the initial COVID wave, elective surgeries were not permissible, as per the NYSDOH. As a result, large numbers of clinical and nonclinical ambulatory surgery employees were redeployed throughout the organization, with many assigned and dedicated to facilitating newly created virtual visitation processes. These employees were primarily responsible for creating unit-based schedules, coordinating logistics, navigating devices on behalf of patients, being present during video calls, and sanitizing the devices between uses. Finally, if necessary, virtual interpretation services were used to overcome language barriers between staff and patients.

What began as an ad hoc function quickly became a valued and meaningful role. Utilizing triage mentality, virtual visitation was first offered during unit-based rounding protocols to those patients with the highest acuity and need to connect with family. We had no formal script; instead, unit-based leaders and frontline team members had open dialogues with patients and families to gauge their interest in virtual visitation. That included patients with an active end-of-life care plan, critically ill patients within intensive care units, and those soon to be intubated or recently extubated. Utilization also occurred within specialty areas such as labor and delivery, pediatrics, inpatient psychiatry, medical units, and long-term rehab facilities. Frontline teams appreciated the supplementary support so they could prioritize ongoing physical assessments and medical interventions. Donned in PPE, virtual visitation team members often served as physical extensions of the patient’s loved ones—holding their hand, offering prayers, and, at times, bearing witness to a last breath. In reflecting on that time, this role required absolute professionalism, empathy, and compassion.

In summer 2020, although demand for virtual visitation was still at an all-time high when ambulatory surgery was reinstated, redeployed staff returned to their responsibilities. To fill this void without interruption to patients and their families, site leaders quickly pivoted and refined processes and protocols utilizing Patient & Customer Experience and Hospitality department team members. Throughout spring 2021, the NYSDOH offered guidance to open in-person visitation, and the institution’s Clinical Advisory Group has been taking a pragmatic approach to doing that in a measured and safe manner across care settings.

Listening to the ‘voice’ of patients and families

Our institution’s mission is grounded in providing “quality service and patient-centered care.” Honoring those tenets, during the initial COVID wave, the system “Voice of the Customer End User Device Workgroup” was created with system and site-based interdisciplinary representation. Despite challenging and unprecedented times, conscious attention and effort was undertaken to assess the use and impact of virtual devices. One of the major work streams was to capture and examine patient and family thoughts, feedback, and the overall experience as it relates to virtual visitation.

The system Office of Patient & Customer Experience (OPCE), led by Sven Gierlinger, SVP Chief Experience Officer, reached out to our colleagues at Press Ganey to add a custom question to patient experience surveys. Beginning on December 1, 2020, discharged inpatients were asked to rate the “Degree to which you were able to stay connected with your family/caregiver during your stay.” Potential answers include the Likert scale responses of Always, Usually, Sometimes, and Never, with “Always” representing the Top Box score. The OPCE team believes these quantitative insights are important to track and trend, particularly since in-person and virtual visitation remain in constant flux.

In an effort to obtain additional, focused, qualitative feedback, OPCE partnered with our institution’s Digital Patient Experience (dPX) colleagues. The approach consisted of voluntary, semistructured, interview-type conversations with patients and family members who engaged in virtual visitation multiple times while the patient was hospitalized. OPCE contacted site-based Patient Experience leads, also known as Culture Leaders, at 3 hospitals, asking them to identify potential participants. This convenience sample excluded instances where the patient passed away during and/or immediately following hospitalization.

The OPCE team phoned potential interview candidates to make a personalized connection, explain the purpose of the interviews, and schedule them, if interested. For consistency, the same Digital Customer Experience Researcher on the dPX team facilitated all sessions, which were 30-minute, semiscripted interviews conducted virtually via Microsoft Teams. The tone was intentionally conversational so that patients and family members would feel comfortable delving into themes that were most impactful during their experience. After some initial ice breakers, such as “What were some of your feelings about being a patient/having a loved one in the hospital during the early days of the COVID-19 pandemic?” we moved on to some more pragmatic, implementation questions and rating scales. These included questions such as “How did you first learn about the option for virtual visitation? Was it something you inquired about or did someone offer it to you? How was it explained to you?” Patients were also asked, on a scale of 1 (easy) to 5 (difficult), to rate their experience with the technology aspect when connecting with their loved ones. They also provided verbal consent to be recorded and were given a $15 gift card upon completion of the interview.

Transcriptions were generated by uploading the interview recordings to a platform called UserTesting. In addition to these transcriptions, this platform also allowed for a keyword mapping tool that organized high-level themes and adjectives into groupings along a sentiment axis from negative to neutral to positive. Transcripts were then read carefully and annotated by the Digital Customer Experience Researcher, which allowed for strengthening of some of the automated themes as well as the emergence of new, more nuanced themes. These themes were organized into those that we could address with design and/or procedure updates (actionable insights), those that came up most frequently overall (frequency), and those that came up across our 3 interview sessions (commonality).

This feedback, along with the responses to the new Press Ganey question, was presented to the system Voice of the Customer End User Device Workgroup. The results led to robust discussion and brainstorming regarding how to improve the process to be more patient-centered. Findings were also shared with our hospital-based Culture Leaders. As many of their local strategic plans focused on patient-family communication, this information was helpful to them in considering plans for expansion and/or sustaining virtual visitation efforts. The process map in the Figure outlines key milestones within this feedback loop.

Outcomes

During the height of the initial COVID-19 crisis, virtual visitation was a new and ever-evolving process. Amidst the chaos, mechanisms to capture the quantity and quality of virtual visits were not in place. Based on informal observation, a majority of patients utilized personal devices to connect with loved ones, and staff even offered their own cellular devices to facilitate timely patient-family communication. The technology primarily used included FaceTime, Zoom, and EZCall, as there was much public awareness and comfort with those platforms.

In the first quarter of 2021, our institution overall performed at a Top Box score of 60.2 for our ability to assist patients with staying connected to their family/caregiver during their inpatient visit. With more than 6700 returned surveys during that time period, our hospitals earned Top Box scores ranging between 48.0 and 75.3. At this time, obtaining a national benchmark ranking is not possible, because the question regarding connectedness is unique to Northwell inpatient settings. As other health care organizations adopt this customized question, further peer-to-peer measurements can be established.

Regarding virtual interviews, 25 patients were initially contacted to determine their interest in participating. Of that sample, 17 patients were engaged over the phone, representing a reach rate of 68%. Overall, 10 interviews were scheduled; 7 patients did not show up, resulting in 3 completed interviews. During follow-up, “no-show” participants either gave no response or stated they had a conflict at their originally scheduled time but were not interested in rescheduling due to personal circumstances. Through such conversations, ongoing health complications were found to be a reoccurring barrier to participation.

Each of the participating patients had experienced being placed on a ventilator. They described their hospitalization as a time of “confusion and despair” in the first days after extubation. After we reviewed interview recordings, a reoccurring theme across all interviews was the feeling of gratitude. Patients expressed deep and heartfelt appreciation for being given the opportunity to connect as a family. One patient described virtual visitation sessions as her “only tether to reality when nothing else made sense.”

Interestingly enough, none of the participants knew that virtual visitation was an option and/or thought to inquire about it before a hospital staff member offered to set up a session. Patients recounted how they were weak and physically unable to connect to the sessions without significant assistance. They reported examples of not having the physical strength to hold up the tablet or needing a staff member to facilitate the conversation because the patient could not speak loudly enough and/or they were having difficulty hearing over background medical equipment noises. Participants also described times when a nurse or social worker would stand and hold the tablet for 20 to 30 minutes at a time, further describing mixed feelings of gratitude, guilt for “taking up their time,” and a desire for more privacy to have those precious conversations.

Discussion

Our institution encountered various barriers when establishing, implementing, and sustaining virtual visitation. The acquisition and bulk purchasing of devices, so that each hospital unit and department had adequate par levels during a high-demand time frame, was an initial challenge. Ensuring appropriate safeguards, software programming, and access to WiFi required ingenuity from IT teams. Leaders sought to advocate for the importance of prioritizing virtual visitation alongside clinical interventions. For team members, education was needed to build awareness, learn how to navigate technology, and troubleshoot, in real-time, issues such as poor connectivity. However, despite these organizational struggles, the hospital’s frontline professionals fully recognized and understood the humanistic value of connecting ill patients with their loved ones. Harnessing their teamwork, empathy, and innovative spirits, they forged through such difficulties to create meaningful interactions.

Although virtual visitation occurred prior to the COVID-19 pandemic, particularly in subspecialty areas such as neonatal intensive care units,⁶ it was not commonplace in most adult inpatient care settings. However, now that virtual means to communication are widely accepted and preferred, our hospital anticipates these offerings will become a broad patient expectation and, therefore, part of standard hospital care and operations. Health care leaders and interdisciplinary teams must therefore prioritize virtual visitation protocols, efforts, and future programming. It is no longer an exception to the rule, but rather a critical approach when ensuring quality communication between patients, families, and care teams.

We strive to continually improve by including user feedback as part of an interactive design process. For a broader, more permanent installation of virtual visitation, health care organizations must proactively promote this capability as a valued option. Considering health literacy and comfort with technology, functionality, and logistics must be carefully explained to patients and their families. This may require additional staff training so that they are knowledgeable, comfortable with, and able to troubleshoot questions/concerns in real time. There needs to be an adequate number of mobile devices available at a unit or departmental level to meet short-term and long-term demands. Additionally, now that we have emerged from our initial crisis-based mentality, it is time to consider alternatives to alleviate the need for staff assistance, such as mounts to hold devices and enabling voice controls.

Conclusion

As an organization grounded in the spirit of innovation, Northwell has been able to quickly pivot, adopting virtual visitation to address emerging and complex communication needs. Taking a best practice established during a crisis period and engraining it into sustainable organizational culture and operations requires visionary leadership, strong teamwork, and an unbridled commitment to patient and family centeredness. Despite unprecedented challenges, our commitment to listening to the “voice” of patients and families never wavered. Using their insights and feedback as critical components to the decision-making process, there is much work ahead within the realm of virtual visitation.

Acknowledgements: The authors would like to acknowledge the Northwell Health providers, frontline health care professionals, and team members who worked tirelessly to care for its community during initial COVID-19 waves and every day thereafter. Heartfelt gratitude to Northwell’s senior leaders for the visionary leadership; the OCIO and hospital-based IT teams for their swift collaboration; and dedicated Culture Leaders, Patient Experience team members, and redeployed staff for their unbridled passion for caring for patients and families. Special thanks to Agnes Barden, DNP, RN, CPXP, Joseph Narvaez, MBA, and Natalie Bashkin, MBA, from the system Office of Patient & Customer Experience, and Carolyne Burgess, MPH, from the Digital Patient Experience teams, for their participation, leadership, and syngeristic partnerships.

Corresponding Author: Nicole Giammarinaro, MSN, RN, CPXP, Director, Patient & Customer Experience, Northwell Health, 2000 Marcus Ave, Lake Success, NY 11042; [email protected].

Financial disclosures: Sven Gierlinger serves on the Speakers Bureau for Northwell Health and as an Executive Board Member for The Beryl Institute.

From Northwell Health, Lake Success, NY.

Objective: Northwell Health, New York’s largest health care organization, rapidly adopted technology solutions to support patient and family communication during the COVID-19 pandemic.

Methods: This case series outlines the pragmatic, interdisciplinary approach Northwell underwent to rapidly implement patient virtual visitation processes during the peak of the initial crisis.

Results: Implementation of large-scale virtual visitation required leadership, technology, and dedicated, empathetic frontline professionals. Patient and family feedback uncovered varied feelings and perspectives, from confusion to gratitude.

Conclusion: Subsequent efforts to obtain direct patient and family perspectives and insights helped Northwell identify areas of strength and ongoing performance improvement.

Keywords: virtual visitation; COVID-19; technology; communication; patient experience.

The power of human connection has become increasingly apparent throughout the COVID-19 pandemic and subsequent recovery phases. Due to the need for social distancing, people worldwide have turned to virtual means of communication, staying in touch with family, friends, and colleagues via digital technology platforms. On March 18, 2020, the New York State Department of Health (NYSDOH) issued a health advisory, suspending all hospital visitation.¹ As a result, hospitals rapidly transformed existing in-person visitation practices to meet large-scale virtual programming needs.

Family members often take on various roles—such as advocate, emotional support person, and postdischarge caregiver—for an ill or injured loved one.² The Institute for Patient- and Family-Centered Care, a nonprofit organization founded in 1992, has been leading a cultural transformation where families are valued as care partners, as opposed to “visitors.”³ Although widely adopted and well-received in specialized units, such as neonatal intensive care units,⁴ virtual visitation had not been widely implemented across adult care settings. The NYSDOH guidance therefore required organizational leadership, innovation, flexibility, and systems ingenuity to meet the evolving needs of patients, families, and health care professionals. An overarching goal was ensuring patients and families were afforded opportunities to stay connected throughout hospitalization.

Reflecting the impact of COVID-19 surges, hospital environments became increasingly depersonalized, with health care providers wearing extensive personal protective equipment (PPE) and taking remarkable measures to socially distance and minimize exposure. Patients’ room doors were kept primarily closed, while codes and alerts blared in the halls overhead. The lack of families and visitors became increasingly obvious, aiding feelings of isolation and confinement. With fear of nosocomial transmission, impactful modalities (such as sitting at the bedside) and empathetic, therapeutic touch were no longer taking place.

With those scenarios—common to so many health care systems during the pandemic—as a backdrop, comes our experience. Northwell Health is the largest health care system in New York State, geographically spread throughout New York City’s 5 boroughs, Westchester County, and Long Island. With 23 hospitals, approximately 820 medical practices, and over 72 000 employees, Northwell has cared for more than 100 000 COVID-positive patients to date. This case series outlines a pragmatic approach to implementing virtual visitation during the initial peak and obtaining patient and family perspectives to help inform performance improvement and future programming.

Methods

Implementing virtual visitation

Through swift and focused multidisciplinary collaboration, numerous Northwell teams came together to implement large-scale virtual visitation across the organization during the first wave of the COVID crisis. The initial priority involved securing devices that could support patient-family communication. Prior to COVID, each facility had only a handful of tablets that were used primarily during leadership rounding, so once visitation was restricted, we needed a large quantity of devices within a matter of days. Through diligent work from System Procurement and internal Foundation, Northwell was able to acquire nearly 900 devices, including iPads, PadInMotion tablets, and Samsung tablets.

Typically, the benefits of using wireless tablets within a health care setting include long battery life, powerful data processing, advanced operating systems, large screens, and easy end-user navigation.⁴ During COVID-19 and its associated isolation precautions, tablets offered a lifeline for effective and socially distant communication. With new devices in hand, the system Office of the Chief Information Officer (OCIO) and site-based Information Technology (IT) teams were engaged. They worked tirelessly to streamline connectivity, download necessary apps, test devices on approved WiFi networks, and troubleshoot issues. Once set up, devices were strategically deployed across all Northwell hospitals and post-acute rehabilitation facilities.

Frontline teams quickly realized that a model similar to mobile proning teams, who focus solely on turning and positioning COVID patients to promote optimal respiratory ventilation,⁵ was needed to support virtual visitation. During the initial COVID wave, elective surgeries were not permissible, as per the NYSDOH. As a result, large numbers of clinical and nonclinical ambulatory surgery employees were redeployed throughout the organization, with many assigned and dedicated to facilitating newly created virtual visitation processes. These employees were primarily responsible for creating unit-based schedules, coordinating logistics, navigating devices on behalf of patients, being present during video calls, and sanitizing the devices between uses. Finally, if necessary, virtual interpretation services were used to overcome language barriers between staff and patients.

What began as an ad hoc function quickly became a valued and meaningful role. Utilizing triage mentality, virtual visitation was first offered during unit-based rounding protocols to those patients with the highest acuity and need to connect with family. We had no formal script; instead, unit-based leaders and frontline team members had open dialogues with patients and families to gauge their interest in virtual visitation. That included patients with an active end-of-life care plan, critically ill patients within intensive care units, and those soon to be intubated or recently extubated. Utilization also occurred within specialty areas such as labor and delivery, pediatrics, inpatient psychiatry, medical units, and long-term rehab facilities. Frontline teams appreciated the supplementary support so they could prioritize ongoing physical assessments and medical interventions. Donned in PPE, virtual visitation team members often served as physical extensions of the patient’s loved ones—holding their hand, offering prayers, and, at times, bearing witness to a last breath. In reflecting on that time, this role required absolute professionalism, empathy, and compassion.

In summer 2020, although demand for virtual visitation was still at an all-time high when ambulatory surgery was reinstated, redeployed staff returned to their responsibilities. To fill this void without interruption to patients and their families, site leaders quickly pivoted and refined processes and protocols utilizing Patient & Customer Experience and Hospitality department team members. Throughout spring 2021, the NYSDOH offered guidance to open in-person visitation, and the institution’s Clinical Advisory Group has been taking a pragmatic approach to doing that in a measured and safe manner across care settings.

Listening to the ‘voice’ of patients and families

Our institution’s mission is grounded in providing “quality service and patient-centered care.” Honoring those tenets, during the initial COVID wave, the system “Voice of the Customer End User Device Workgroup” was created with system and site-based interdisciplinary representation. Despite challenging and unprecedented times, conscious attention and effort was undertaken to assess the use and impact of virtual devices. One of the major work streams was to capture and examine patient and family thoughts, feedback, and the overall experience as it relates to virtual visitation.

The system Office of Patient & Customer Experience (OPCE), led by Sven Gierlinger, SVP Chief Experience Officer, reached out to our colleagues at Press Ganey to add a custom question to patient experience surveys. Beginning on December 1, 2020, discharged inpatients were asked to rate the “Degree to which you were able to stay connected with your family/caregiver during your stay.” Potential answers include the Likert scale responses of Always, Usually, Sometimes, and Never, with “Always” representing the Top Box score. The OPCE team believes these quantitative insights are important to track and trend, particularly since in-person and virtual visitation remain in constant flux.

In an effort to obtain additional, focused, qualitative feedback, OPCE partnered with our institution’s Digital Patient Experience (dPX) colleagues. The approach consisted of voluntary, semistructured, interview-type conversations with patients and family members who engaged in virtual visitation multiple times while the patient was hospitalized. OPCE contacted site-based Patient Experience leads, also known as Culture Leaders, at 3 hospitals, asking them to identify potential participants. This convenience sample excluded instances where the patient passed away during and/or immediately following hospitalization.

The OPCE team phoned potential interview candidates to make a personalized connection, explain the purpose of the interviews, and schedule them, if interested. For consistency, the same Digital Customer Experience Researcher on the dPX team facilitated all sessions, which were 30-minute, semiscripted interviews conducted virtually via Microsoft Teams. The tone was intentionally conversational so that patients and family members would feel comfortable delving into themes that were most impactful during their experience. After some initial ice breakers, such as “What were some of your feelings about being a patient/having a loved one in the hospital during the early days of the COVID-19 pandemic?” we moved on to some more pragmatic, implementation questions and rating scales. These included questions such as “How did you first learn about the option for virtual visitation? Was it something you inquired about or did someone offer it to you? How was it explained to you?” Patients were also asked, on a scale of 1 (easy) to 5 (difficult), to rate their experience with the technology aspect when connecting with their loved ones. They also provided verbal consent to be recorded and were given a $15 gift card upon completion of the interview.

Transcriptions were generated by uploading the interview recordings to a platform called UserTesting. In addition to these transcriptions, this platform also allowed for a keyword mapping tool that organized high-level themes and adjectives into groupings along a sentiment axis from negative to neutral to positive. Transcripts were then read carefully and annotated by the Digital Customer Experience Researcher, which allowed for strengthening of some of the automated themes as well as the emergence of new, more nuanced themes. These themes were organized into those that we could address with design and/or procedure updates (actionable insights), those that came up most frequently overall (frequency), and those that came up across our 3 interview sessions (commonality).

This feedback, along with the responses to the new Press Ganey question, was presented to the system Voice of the Customer End User Device Workgroup. The results led to robust discussion and brainstorming regarding how to improve the process to be more patient-centered. Findings were also shared with our hospital-based Culture Leaders. As many of their local strategic plans focused on patient-family communication, this information was helpful to them in considering plans for expansion and/or sustaining virtual visitation efforts. The process map in the Figure outlines key milestones within this feedback loop.

Outcomes

During the height of the initial COVID-19 crisis, virtual visitation was a new and ever-evolving process. Amidst the chaos, mechanisms to capture the quantity and quality of virtual visits were not in place. Based on informal observation, a majority of patients utilized personal devices to connect with loved ones, and staff even offered their own cellular devices to facilitate timely patient-family communication. The technology primarily used included FaceTime, Zoom, and EZCall, as there was much public awareness and comfort with those platforms.

In the first quarter of 2021, our institution overall performed at a Top Box score of 60.2 for our ability to assist patients with staying connected to their family/caregiver during their inpatient visit. With more than 6700 returned surveys during that time period, our hospitals earned Top Box scores ranging between 48.0 and 75.3. At this time, obtaining a national benchmark ranking is not possible, because the question regarding connectedness is unique to Northwell inpatient settings. As other health care organizations adopt this customized question, further peer-to-peer measurements can be established.

Regarding virtual interviews, 25 patients were initially contacted to determine their interest in participating. Of that sample, 17 patients were engaged over the phone, representing a reach rate of 68%. Overall, 10 interviews were scheduled; 7 patients did not show up, resulting in 3 completed interviews. During follow-up, “no-show” participants either gave no response or stated they had a conflict at their originally scheduled time but were not interested in rescheduling due to personal circumstances. Through such conversations, ongoing health complications were found to be a reoccurring barrier to participation.

Each of the participating patients had experienced being placed on a ventilator. They described their hospitalization as a time of “confusion and despair” in the first days after extubation. After we reviewed interview recordings, a reoccurring theme across all interviews was the feeling of gratitude. Patients expressed deep and heartfelt appreciation for being given the opportunity to connect as a family. One patient described virtual visitation sessions as her “only tether to reality when nothing else made sense.”

Interestingly enough, none of the participants knew that virtual visitation was an option and/or thought to inquire about it before a hospital staff member offered to set up a session. Patients recounted how they were weak and physically unable to connect to the sessions without significant assistance. They reported examples of not having the physical strength to hold up the tablet or needing a staff member to facilitate the conversation because the patient could not speak loudly enough and/or they were having difficulty hearing over background medical equipment noises. Participants also described times when a nurse or social worker would stand and hold the tablet for 20 to 30 minutes at a time, further describing mixed feelings of gratitude, guilt for “taking up their time,” and a desire for more privacy to have those precious conversations.

Discussion

Our institution encountered various barriers when establishing, implementing, and sustaining virtual visitation. The acquisition and bulk purchasing of devices, so that each hospital unit and department had adequate par levels during a high-demand time frame, was an initial challenge. Ensuring appropriate safeguards, software programming, and access to WiFi required ingenuity from IT teams. Leaders sought to advocate for the importance of prioritizing virtual visitation alongside clinical interventions. For team members, education was needed to build awareness, learn how to navigate technology, and troubleshoot, in real-time, issues such as poor connectivity. However, despite these organizational struggles, the hospital’s frontline professionals fully recognized and understood the humanistic value of connecting ill patients with their loved ones. Harnessing their teamwork, empathy, and innovative spirits, they forged through such difficulties to create meaningful interactions.

Although virtual visitation occurred prior to the COVID-19 pandemic, particularly in subspecialty areas such as neonatal intensive care units,⁶ it was not commonplace in most adult inpatient care settings. However, now that virtual means to communication are widely accepted and preferred, our hospital anticipates these offerings will become a broad patient expectation and, therefore, part of standard hospital care and operations. Health care leaders and interdisciplinary teams must therefore prioritize virtual visitation protocols, efforts, and future programming. It is no longer an exception to the rule, but rather a critical approach when ensuring quality communication between patients, families, and care teams.

We strive to continually improve by including user feedback as part of an interactive design process. For a broader, more permanent installation of virtual visitation, health care organizations must proactively promote this capability as a valued option. Considering health literacy and comfort with technology, functionality, and logistics must be carefully explained to patients and their families. This may require additional staff training so that they are knowledgeable, comfortable with, and able to troubleshoot questions/concerns in real time. There needs to be an adequate number of mobile devices available at a unit or departmental level to meet short-term and long-term demands. Additionally, now that we have emerged from our initial crisis-based mentality, it is time to consider alternatives to alleviate the need for staff assistance, such as mounts to hold devices and enabling voice controls.

Conclusion

As an organization grounded in the spirit of innovation, Northwell has been able to quickly pivot, adopting virtual visitation to address emerging and complex communication needs. Taking a best practice established during a crisis period and engraining it into sustainable organizational culture and operations requires visionary leadership, strong teamwork, and an unbridled commitment to patient and family centeredness. Despite unprecedented challenges, our commitment to listening to the “voice” of patients and families never wavered. Using their insights and feedback as critical components to the decision-making process, there is much work ahead within the realm of virtual visitation.

Acknowledgements: The authors would like to acknowledge the Northwell Health providers, frontline health care professionals, and team members who worked tirelessly to care for its community during initial COVID-19 waves and every day thereafter. Heartfelt gratitude to Northwell’s senior leaders for the visionary leadership; the OCIO and hospital-based IT teams for their swift collaboration; and dedicated Culture Leaders, Patient Experience team members, and redeployed staff for their unbridled passion for caring for patients and families. Special thanks to Agnes Barden, DNP, RN, CPXP, Joseph Narvaez, MBA, and Natalie Bashkin, MBA, from the system Office of Patient & Customer Experience, and Carolyne Burgess, MPH, from the Digital Patient Experience teams, for their participation, leadership, and syngeristic partnerships.

Corresponding Author: Nicole Giammarinaro, MSN, RN, CPXP, Director, Patient & Customer Experience, Northwell Health, 2000 Marcus Ave, Lake Success, NY 11042; [email protected].

Financial disclosures: Sven Gierlinger serves on the Speakers Bureau for Northwell Health and as an Executive Board Member for The Beryl Institute.

From Northwell Health, Lake Success, NY.

Objective: Northwell Health, New York’s largest health care organization, rapidly adopted technology solutions to support patient and family communication during the COVID-19 pandemic.

Methods: This case series outlines the pragmatic, interdisciplinary approach Northwell underwent to rapidly implement patient virtual visitation processes during the peak of the initial crisis.

Results: Implementation of large-scale virtual visitation required leadership, technology, and dedicated, empathetic frontline professionals. Patient and family feedback uncovered varied feelings and perspectives, from confusion to gratitude.

Conclusion: Subsequent efforts to obtain direct patient and family perspectives and insights helped Northwell identify areas of strength and ongoing performance improvement.

Keywords: virtual visitation; COVID-19; technology; communication; patient experience.

The power of human connection has become increasingly apparent throughout the COVID-19 pandemic and subsequent recovery phases. Due to the need for social distancing, people worldwide have turned to virtual means of communication, staying in touch with family, friends, and colleagues via digital technology platforms. On March 18, 2020, the New York State Department of Health (NYSDOH) issued a health advisory, suspending all hospital visitation.¹ As a result, hospitals rapidly transformed existing in-person visitation practices to meet large-scale virtual programming needs.

Family members often take on various roles—such as advocate, emotional support person, and postdischarge caregiver—for an ill or injured loved one.² The Institute for Patient- and Family-Centered Care, a nonprofit organization founded in 1992, has been leading a cultural transformation where families are valued as care partners, as opposed to “visitors.”³ Although widely adopted and well-received in specialized units, such as neonatal intensive care units,⁴ virtual visitation had not been widely implemented across adult care settings. The NYSDOH guidance therefore required organizational leadership, innovation, flexibility, and systems ingenuity to meet the evolving needs of patients, families, and health care professionals. An overarching goal was ensuring patients and families were afforded opportunities to stay connected throughout hospitalization.

Reflecting the impact of COVID-19 surges, hospital environments became increasingly depersonalized, with health care providers wearing extensive personal protective equipment (PPE) and taking remarkable measures to socially distance and minimize exposure. Patients’ room doors were kept primarily closed, while codes and alerts blared in the halls overhead. The lack of families and visitors became increasingly obvious, aiding feelings of isolation and confinement. With fear of nosocomial transmission, impactful modalities (such as sitting at the bedside) and empathetic, therapeutic touch were no longer taking place.

With those scenarios—common to so many health care systems during the pandemic—as a backdrop, comes our experience. Northwell Health is the largest health care system in New York State, geographically spread throughout New York City’s 5 boroughs, Westchester County, and Long Island. With 23 hospitals, approximately 820 medical practices, and over 72 000 employees, Northwell has cared for more than 100 000 COVID-positive patients to date. This case series outlines a pragmatic approach to implementing virtual visitation during the initial peak and obtaining patient and family perspectives to help inform performance improvement and future programming.

Methods

Implementing virtual visitation

Through swift and focused multidisciplinary collaboration, numerous Northwell teams came together to implement large-scale virtual visitation across the organization during the first wave of the COVID crisis. The initial priority involved securing devices that could support patient-family communication. Prior to COVID, each facility had only a handful of tablets that were used primarily during leadership rounding, so once visitation was restricted, we needed a large quantity of devices within a matter of days. Through diligent work from System Procurement and internal Foundation, Northwell was able to acquire nearly 900 devices, including iPads, PadInMotion tablets, and Samsung tablets.

Typically, the benefits of using wireless tablets within a health care setting include long battery life, powerful data processing, advanced operating systems, large screens, and easy end-user navigation.⁴ During COVID-19 and its associated isolation precautions, tablets offered a lifeline for effective and socially distant communication. With new devices in hand, the system Office of the Chief Information Officer (OCIO) and site-based Information Technology (IT) teams were engaged. They worked tirelessly to streamline connectivity, download necessary apps, test devices on approved WiFi networks, and troubleshoot issues. Once set up, devices were strategically deployed across all Northwell hospitals and post-acute rehabilitation facilities.

Frontline teams quickly realized that a model similar to mobile proning teams, who focus solely on turning and positioning COVID patients to promote optimal respiratory ventilation,⁵ was needed to support virtual visitation. During the initial COVID wave, elective surgeries were not permissible, as per the NYSDOH. As a result, large numbers of clinical and nonclinical ambulatory surgery employees were redeployed throughout the organization, with many assigned and dedicated to facilitating newly created virtual visitation processes. These employees were primarily responsible for creating unit-based schedules, coordinating logistics, navigating devices on behalf of patients, being present during video calls, and sanitizing the devices between uses. Finally, if necessary, virtual interpretation services were used to overcome language barriers between staff and patients.

What began as an ad hoc function quickly became a valued and meaningful role. Utilizing triage mentality, virtual visitation was first offered during unit-based rounding protocols to those patients with the highest acuity and need to connect with family. We had no formal script; instead, unit-based leaders and frontline team members had open dialogues with patients and families to gauge their interest in virtual visitation. That included patients with an active end-of-life care plan, critically ill patients within intensive care units, and those soon to be intubated or recently extubated. Utilization also occurred within specialty areas such as labor and delivery, pediatrics, inpatient psychiatry, medical units, and long-term rehab facilities. Frontline teams appreciated the supplementary support so they could prioritize ongoing physical assessments and medical interventions. Donned in PPE, virtual visitation team members often served as physical extensions of the patient’s loved ones—holding their hand, offering prayers, and, at times, bearing witness to a last breath. In reflecting on that time, this role required absolute professionalism, empathy, and compassion.

In summer 2020, although demand for virtual visitation was still at an all-time high when ambulatory surgery was reinstated, redeployed staff returned to their responsibilities. To fill this void without interruption to patients and their families, site leaders quickly pivoted and refined processes and protocols utilizing Patient & Customer Experience and Hospitality department team members. Throughout spring 2021, the NYSDOH offered guidance to open in-person visitation, and the institution’s Clinical Advisory Group has been taking a pragmatic approach to doing that in a measured and safe manner across care settings.

Listening to the ‘voice’ of patients and families

Our institution’s mission is grounded in providing “quality service and patient-centered care.” Honoring those tenets, during the initial COVID wave, the system “Voice of the Customer End User Device Workgroup” was created with system and site-based interdisciplinary representation. Despite challenging and unprecedented times, conscious attention and effort was undertaken to assess the use and impact of virtual devices. One of the major work streams was to capture and examine patient and family thoughts, feedback, and the overall experience as it relates to virtual visitation.

The system Office of Patient & Customer Experience (OPCE), led by Sven Gierlinger, SVP Chief Experience Officer, reached out to our colleagues at Press Ganey to add a custom question to patient experience surveys. Beginning on December 1, 2020, discharged inpatients were asked to rate the “Degree to which you were able to stay connected with your family/caregiver during your stay.” Potential answers include the Likert scale responses of Always, Usually, Sometimes, and Never, with “Always” representing the Top Box score. The OPCE team believes these quantitative insights are important to track and trend, particularly since in-person and virtual visitation remain in constant flux.

In an effort to obtain additional, focused, qualitative feedback, OPCE partnered with our institution’s Digital Patient Experience (dPX) colleagues. The approach consisted of voluntary, semistructured, interview-type conversations with patients and family members who engaged in virtual visitation multiple times while the patient was hospitalized. OPCE contacted site-based Patient Experience leads, also known as Culture Leaders, at 3 hospitals, asking them to identify potential participants. This convenience sample excluded instances where the patient passed away during and/or immediately following hospitalization.

The OPCE team phoned potential interview candidates to make a personalized connection, explain the purpose of the interviews, and schedule them, if interested. For consistency, the same Digital Customer Experience Researcher on the dPX team facilitated all sessions, which were 30-minute, semiscripted interviews conducted virtually via Microsoft Teams. The tone was intentionally conversational so that patients and family members would feel comfortable delving into themes that were most impactful during their experience. After some initial ice breakers, such as “What were some of your feelings about being a patient/having a loved one in the hospital during the early days of the COVID-19 pandemic?” we moved on to some more pragmatic, implementation questions and rating scales. These included questions such as “How did you first learn about the option for virtual visitation? Was it something you inquired about or did someone offer it to you? How was it explained to you?” Patients were also asked, on a scale of 1 (easy) to 5 (difficult), to rate their experience with the technology aspect when connecting with their loved ones. They also provided verbal consent to be recorded and were given a $15 gift card upon completion of the interview.

Transcriptions were generated by uploading the interview recordings to a platform called UserTesting. In addition to these transcriptions, this platform also allowed for a keyword mapping tool that organized high-level themes and adjectives into groupings along a sentiment axis from negative to neutral to positive. Transcripts were then read carefully and annotated by the Digital Customer Experience Researcher, which allowed for strengthening of some of the automated themes as well as the emergence of new, more nuanced themes. These themes were organized into those that we could address with design and/or procedure updates (actionable insights), those that came up most frequently overall (frequency), and those that came up across our 3 interview sessions (commonality).

This feedback, along with the responses to the new Press Ganey question, was presented to the system Voice of the Customer End User Device Workgroup. The results led to robust discussion and brainstorming regarding how to improve the process to be more patient-centered. Findings were also shared with our hospital-based Culture Leaders. As many of their local strategic plans focused on patient-family communication, this information was helpful to them in considering plans for expansion and/or sustaining virtual visitation efforts. The process map in the Figure outlines key milestones within this feedback loop.

Outcomes

During the height of the initial COVID-19 crisis, virtual visitation was a new and ever-evolving process. Amidst the chaos, mechanisms to capture the quantity and quality of virtual visits were not in place. Based on informal observation, a majority of patients utilized personal devices to connect with loved ones, and staff even offered their own cellular devices to facilitate timely patient-family communication. The technology primarily used included FaceTime, Zoom, and EZCall, as there was much public awareness and comfort with those platforms.

In the first quarter of 2021, our institution overall performed at a Top Box score of 60.2 for our ability to assist patients with staying connected to their family/caregiver during their inpatient visit. With more than 6700 returned surveys during that time period, our hospitals earned Top Box scores ranging between 48.0 and 75.3. At this time, obtaining a national benchmark ranking is not possible, because the question regarding connectedness is unique to Northwell inpatient settings. As other health care organizations adopt this customized question, further peer-to-peer measurements can be established.

Regarding virtual interviews, 25 patients were initially contacted to determine their interest in participating. Of that sample, 17 patients were engaged over the phone, representing a reach rate of 68%. Overall, 10 interviews were scheduled; 7 patients did not show up, resulting in 3 completed interviews. During follow-up, “no-show” participants either gave no response or stated they had a conflict at their originally scheduled time but were not interested in rescheduling due to personal circumstances. Through such conversations, ongoing health complications were found to be a reoccurring barrier to participation.

Each of the participating patients had experienced being placed on a ventilator. They described their hospitalization as a time of “confusion and despair” in the first days after extubation. After we reviewed interview recordings, a reoccurring theme across all interviews was the feeling of gratitude. Patients expressed deep and heartfelt appreciation for being given the opportunity to connect as a family. One patient described virtual visitation sessions as her “only tether to reality when nothing else made sense.”

Interestingly enough, none of the participants knew that virtual visitation was an option and/or thought to inquire about it before a hospital staff member offered to set up a session. Patients recounted how they were weak and physically unable to connect to the sessions without significant assistance. They reported examples of not having the physical strength to hold up the tablet or needing a staff member to facilitate the conversation because the patient could not speak loudly enough and/or they were having difficulty hearing over background medical equipment noises. Participants also described times when a nurse or social worker would stand and hold the tablet for 20 to 30 minutes at a time, further describing mixed feelings of gratitude, guilt for “taking up their time,” and a desire for more privacy to have those precious conversations.

Discussion

Our institution encountered various barriers when establishing, implementing, and sustaining virtual visitation. The acquisition and bulk purchasing of devices, so that each hospital unit and department had adequate par levels during a high-demand time frame, was an initial challenge. Ensuring appropriate safeguards, software programming, and access to WiFi required ingenuity from IT teams. Leaders sought to advocate for the importance of prioritizing virtual visitation alongside clinical interventions. For team members, education was needed to build awareness, learn how to navigate technology, and troubleshoot, in real-time, issues such as poor connectivity. However, despite these organizational struggles, the hospital’s frontline professionals fully recognized and understood the humanistic value of connecting ill patients with their loved ones. Harnessing their teamwork, empathy, and innovative spirits, they forged through such difficulties to create meaningful interactions.

Although virtual visitation occurred prior to the COVID-19 pandemic, particularly in subspecialty areas such as neonatal intensive care units,⁶ it was not commonplace in most adult inpatient care settings. However, now that virtual means to communication are widely accepted and preferred, our hospital anticipates these offerings will become a broad patient expectation and, therefore, part of standard hospital care and operations. Health care leaders and interdisciplinary teams must therefore prioritize virtual visitation protocols, efforts, and future programming. It is no longer an exception to the rule, but rather a critical approach when ensuring quality communication between patients, families, and care teams.

We strive to continually improve by including user feedback as part of an interactive design process. For a broader, more permanent installation of virtual visitation, health care organizations must proactively promote this capability as a valued option. Considering health literacy and comfort with technology, functionality, and logistics must be carefully explained to patients and their families. This may require additional staff training so that they are knowledgeable, comfortable with, and able to troubleshoot questions/concerns in real time. There needs to be an adequate number of mobile devices available at a unit or departmental level to meet short-term and long-term demands. Additionally, now that we have emerged from our initial crisis-based mentality, it is time to consider alternatives to alleviate the need for staff assistance, such as mounts to hold devices and enabling voice controls.

Conclusion

As an organization grounded in the spirit of innovation, Northwell has been able to quickly pivot, adopting virtual visitation to address emerging and complex communication needs. Taking a best practice established during a crisis period and engraining it into sustainable organizational culture and operations requires visionary leadership, strong teamwork, and an unbridled commitment to patient and family centeredness. Despite unprecedented challenges, our commitment to listening to the “voice” of patients and families never wavered. Using their insights and feedback as critical components to the decision-making process, there is much work ahead within the realm of virtual visitation.

Acknowledgements: The authors would like to acknowledge the Northwell Health providers, frontline health care professionals, and team members who worked tirelessly to care for its community during initial COVID-19 waves and every day thereafter. Heartfelt gratitude to Northwell’s senior leaders for the visionary leadership; the OCIO and hospital-based IT teams for their swift collaboration; and dedicated Culture Leaders, Patient Experience team members, and redeployed staff for their unbridled passion for caring for patients and families. Special thanks to Agnes Barden, DNP, RN, CPXP, Joseph Narvaez, MBA, and Natalie Bashkin, MBA, from the system Office of Patient & Customer Experience, and Carolyne Burgess, MPH, from the Digital Patient Experience teams, for their participation, leadership, and syngeristic partnerships.

Corresponding Author: Nicole Giammarinaro, MSN, RN, CPXP, Director, Patient & Customer Experience, Northwell Health, 2000 Marcus Ave, Lake Success, NY 11042; [email protected].

Financial disclosures: Sven Gierlinger serves on the Speakers Bureau for Northwell Health and as an Executive Board Member for The Beryl Institute.

From Health Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates (Dr. Virji and Aisha Al Hamiz), Public Health, Abu Dhabi Public Health Center, Abu Dhabi, United Arab Emirates (Drs. Al Hajeri, Al Shehhi, Al Memari, and Ahlam Al Maskari), College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates, Department of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates (Dr. Alhajri), Public Health Research Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates, Oxford University Hospitals NHS Foundation Trust, Oxford, England, and the MRC Epidemiology Unit, University of Cambridge, Cambridge, England (Dr. Ali).

Objective: The pandemic has forced closures of primary schools, resulting in loss of learning time on a global scale. In addition to face coverings, social distancing, and hand hygiene, an efficient testing method is important to mitigate the spread of COVID-19 in schools. We evaluated the feasibility of a saliva-based SARS-CoV-2 polymerase chain reaction testing program among 18 primary schools in the Emirate of Abu Dhabi, United Arab Emirates. Qualitative results show that children 4 to 5 years old had difficulty producing an adequate saliva specimen compared to those 6 to 12 years old.

Methods: A short training video on saliva collection beforehand helps demystify the process for students and parents alike. Informed consent was challenging yet should be done beforehand by school health nurses or other medical professionals to reassure parents and maximize participation.

Results: Telephone interviews with school administrators resulted in an 83% response rate. Overall, 93% of school administrators had a positive experience with saliva testing and felt the program improved the safety of their schools. The ongoing use of saliva testing for SARS-CoV-2 was supported by 73% of respondents.

Conclusion: On-campus saliva testing is a feasible option for primary schools to screen for COVID-19 in their student population to help keep their campuses safe and open for learning.

Keywords: COVID-19; saliva testing; mitigation; primary school.

The COVID-19 pandemic is a leading cause of morbidity and mortality worldwide and continues to exhaust health care resources on a large scale.¹ Efficient testing is critical to identify cases early and to help mitigate the deleterious effects of the pandemic.² Saliva polymerase chain reaction (PCR) nucleic acid amplification testing (NAAT) is more comfortable than nasopharyngeal (NP) NAAT and has been validated as a test for SARS-CoV-2.¹ Although children are less susceptible to severe disease, primary schools are considered a vector for transmission and community spread.³ Efficient and scalable methods of routine testing are needed globally to help keep schools open. Saliva testing has proven a useful resource for this population.^4,5

Abu Dhabi is the largest Emirate in the United Arab Emirates (UAE), with an estimated population of 2.5 million.⁶ The first case of COVID-19 was discovered in the UAE on January 29, 2020.⁷ The UAE has been recognized worldwide for its robust pandemic response. Along with the coordinated and swift application of public health measures, the country has one of the highest COVID-19 testing rates per capita and one of the highest vaccination rates worldwide.^8,9 The Abu Dhabi Public Health Center (ADPHC) works alongside the Ministry of Education (MOE) to establish testing, quarantine, and general safety guidelines for primary schools. In December 2020, the ADPHC partnered with a local, accredited diagnostic laboratory to test the feasibility of a saliva-based screening program for COVID-19 directly on school campuses for 18 primary schools in the Emirate.

Saliva-based PCR testing for COVID-19 was approved for use in schools in the UAE on January 24, 2021.¹⁰ As part of a greater mitigation strategy to reduce both school-based transmission and, hence, community spread, the ADPHC focused its on-site testing program on children aged 4 to 12 years. The program required collaboration among medical professionals, school administrators and teachers, students, and parents. Our study evaluates the feasibility of implementing a saliva-based COVID-19 screening program directly on primary school campuses involving children as young as 4 years of age.

Methods

The ADPHC, in collaboration with G42 Biogenix Labs, conducted a saliva SARS-CoV-2 NAAT testing program in 18 primary schools in the Emirate. Schools were selected based on outbreak prevalence at the time and focused on “hot spot” areas. The school on-site saliva testing program included children aged 4 to 12 years old in a “bubble” attendance model during the school day. This model involved children being assigned to groups or “pods.” This allowed us to limit a potential outbreak to a single pod, as opposed to risk exposing the entire school, should a single student test positive. The well-established SalivaDirect protocol developed at Yale University was used for testing and included an RNA extraction-free, RT-qPCR method for SARS-CoV-2 detection.¹¹

We conducted a qualitative study involving telephone interviews of school administrators to evaluate their experience with the ADPHC testing program at their schools. In addition, we interviewed the G42 Biogenix Lab providers to understand the logistics that supported on-campus collection of saliva specimens for this age group. We also gathered the attitudes of school children before and after testing. This study was reviewed and approved by the Abu Dhabi Health Research and Technology Committee and the Institutional Review Board (IRB), New York University Abu Dhabi (NYUAD).

Sample and recruitment

The original sample collection of saliva specimens was performed by the ADPHC in collaboration with G42 Biogenix Lab providers on school campuses between December 6 and December 10, 2020. During this time, schools operated in a hybrid teaching model, where learning took place both online and in person. Infection control measures were deployed based on ADPHC standards and guidelines. Nurses utilized appropriate patient protective equipment, frequent hand hygiene, and social distancing during the collection process. Inclusion criteria included asymptomatic students aged 4 to 12 years attending in-person classes on campus. Students with respiratory symptoms who were asked to stay home or those not attending in-person classes were excluded.

Data with regard to school children’s attitudes before and after testing were compiled through an online survey sent randomly to participants postintervention. Data from school administrators were collected through video and telephone interviews between April 14 and April 29, 2021. We first interviewed G42 Biogenix Lab providers to obtain previously acquired qualitative and quantitative data, which were collected during the intervention itself. After obtaining this information, we designed a questionnaire and proceeded with a structured interview process for school officials.

We interviewed school principals and administrators to collect their overall experiences with the saliva testing program. Before starting each interview, we established the interviewees preferred language, either English or Arabic. We then introduced the meeting attendees and provided study details, aims, and objectives, and described collaborating entities. We obtained verbal informed consent from a script approved by the NYUAD IRB and then proceeded with the interview, which included 4 questions. The first 3 questions were answered on a 5-point Likert scale model that consisted of 5 answer options: 5 being completely agree, 4 agree, 3 somewhat agree, 2 somewhat disagree, and 1 completely disagree. The fourth question invited open-ended feedback and comments on the following statements:

1. I believe the COVID-19 saliva testing program improved the safety for my school campus.
2. Our community had an overall positive experience with the COVID saliva testing.
3. We would like to continue a saliva-based COVID testing program on our school campus.
4. Please provide any additional comments you feel important about the program.

During the interview, we transcribed the answers as the interviewee was answering. We then translated those in Arabic into English and collected the data in 1 Excel spreadsheet. School interviewees and school names were de-identified in the collection and storage process.

Results

A total of 2011 saliva samples were collected from 18 different primary school campuses. Samples were sent the same day to G42 Biogenix Labs in Abu Dhabi for COVID PCR testing. A team consisting of 5 doctors providing general oversight, along with 2 to 6 nurses per site, were able to manage the collection process for all 18 school campuses. Samples were collected between 8 am and 2 pm and required variation among sites depending on factors such as staff availability and class schedules. Additional scheduling challenges included compliance with public safety mandates involving the maintenance of defined “safety bubbles” that forbid certain personnel from moving between floors, and the avoidance of mixing students from different classes.

Sample stations were set up in either the school auditorium or gymnasium to ensure appropriate crowd control and ventilation. Teachers and other school staff, including public safety, were able to manage lines and the shuttling of students back and forth from classes to testing stations, which allowed medical staff to focus on sample collection.

Informed consent was obtained by prior electronic communication to parents from school staff, asking them to agree to allow their child to participate in the testing program. Informed consent was identified as a challenge: Getting parents to understand that saliva testing was more comfortable than NP testing, and that the results were only being used to help keep the school safe, took time. School staff are used to obtaining consent from parents for field trips, but this was clearly more challenging for them.

The saliva collection process per child took more time than expected. Children fasted for 45 minutes before saliva collection. We used an active drool technique, which required children to pool saliva in their mouth then express it into a collection tube. Adults can generally do this on command, but we found it took 10 to 12 minutes per child. Saliva production was cued by asking the children to think about food, and by showing them pictures and TV commercials depicting food. Children 4 to 5 years old had more difficulty with the process despite active cueing, while those 6 to 12 years old had an easier time with the process. We collected data on a cohort of 80 children regarding their attitudes pre (Figure 1) and post collection (Figure 2). Children felt happier, less nervous, and less scared after collection than before collection. This trend reassured us that future collections would be easier for students.

A total of 15 of 18 school principals completed the telephone interview, yielding a response rate of 83%. Overall, 93% of the school principals agreed or completely agreed that the COVID-19 saliva testing program improved school safety; 93% agreed or completely agreed that they had an overall positive experience with the program; and 73% supported the ongoing use of saliva testing in their schools (Table 1). Administrators’ open-ended comments on their experience were positive overall (Table 2).

Discussion

By March 2020, many kindergarten to grade 12 public and private schools suspended in-person classes due to the pandemic and turned to online learning platforms. The negative impact of school closures on academic achievement is projected to be significant.^7,12,13 Ensuring schools can stay open and run operations safely will require routine SARS-CoV-2 testing. Our study investigated the feasibility of routine saliva testing on children aged 4 to 12 years on their school campuses. The ADPHC school on-site saliva testing program involved bringing lab providers onto 18 primary school campuses and required cooperation among parents, students, school administrators, and health care professionals.

Children younger than 6 years had difficulty producing an adequate saliva specimen, whereas those 6 to 12 years did so with relative ease when cued by thoughts or pictures of food while waiting in line for collection. Schools considering on-site testing programs should consider the age range of 6 to 12 years as a viable age range for saliva screening. Children should fast for a minimum of 45 minutes prior to saliva collection and should be cued by thoughts of food, food pictures, or food commercials. Setting up a sampling station close to the cafeteria where students can smell meal preparation may also help.^14,15 Sampling before breakfast or lunch, when children are potentially at their hungriest, should also be considered.

The greatest challenge was obtaining informed consent from parents who were not yet familiar with the reliability of saliva testing as a tool for SARS-CoV-2 screening or with the saliva collection process as a whole. Informed consent was initially done electronically, lacking direct human interaction to answer parents’ questions. Parents who refused had a follow-up call from the school nurse to further explain the logistics and rationale for saliva screening. Having medical professionals directly answer parents’ questions was helpful. Parents were reassured that the process was painless, confidential, and only to be used for school safety purposes. Despite school administrators being experienced in obtaining consent from parents for field trips, obtaining informed consent for a medical testing procedure is more complicated, and parents aren’t accustomed to providing such consent in a school environment. Schools considering on-site testing should ensure that their school nurse or other health care providers are on the front line obtaining informed consent and allaying parents’ fears.

School staff were able to effectively provide crowd control for testing, and children felt at ease being in a familiar environment. Teachers and public safety officers are well-equipped at managing the shuttling of students to class, to lunch, to physical education, and, finally, to dismissal. They were equally equipped at handling the logistics of students to and from testing, including minimizing crowds and helping students feel at ease during the process. This effective collaboration allowed the lab personnel to focus on sample collection and storage, while school staff managed all other aspects of the children’s safety and care.

Conclusion

Overall, school administrators had a positive experience with the testing program, felt the program improved the safety of their schools, and supported the ongoing use of saliva testing for SARS-CoV-2 on their school campuses. Children aged 6 years and older were able to provide adequate saliva samples, and children felt happier and less nervous after the process, indicating repeatability. Our findings highlight the feasibility of an integrated on-site saliva testing model for primary school campuses. Further research is needed to determine the scalability of such a model and whether the added compliance and safety of on-site testing compensates for the potential loss of learning time that testing during school hours would require.

Corresponding author: Ayaz Virji, MD, New York University Abu Dhabi, PO Box 129188, Abu Dhabi, United Arab Emirates; [email protected].

Financial disclosures: None.

From Health Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates (Dr. Virji and Aisha Al Hamiz), Public Health, Abu Dhabi Public Health Center, Abu Dhabi, United Arab Emirates (Drs. Al Hajeri, Al Shehhi, Al Memari, and Ahlam Al Maskari), College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates, Department of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates (Dr. Alhajri), Public Health Research Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates, Oxford University Hospitals NHS Foundation Trust, Oxford, England, and the MRC Epidemiology Unit, University of Cambridge, Cambridge, England (Dr. Ali).

Objective: The pandemic has forced closures of primary schools, resulting in loss of learning time on a global scale. In addition to face coverings, social distancing, and hand hygiene, an efficient testing method is important to mitigate the spread of COVID-19 in schools. We evaluated the feasibility of a saliva-based SARS-CoV-2 polymerase chain reaction testing program among 18 primary schools in the Emirate of Abu Dhabi, United Arab Emirates. Qualitative results show that children 4 to 5 years old had difficulty producing an adequate saliva specimen compared to those 6 to 12 years old.

Methods: A short training video on saliva collection beforehand helps demystify the process for students and parents alike. Informed consent was challenging yet should be done beforehand by school health nurses or other medical professionals to reassure parents and maximize participation.

Results: Telephone interviews with school administrators resulted in an 83% response rate. Overall, 93% of school administrators had a positive experience with saliva testing and felt the program improved the safety of their schools. The ongoing use of saliva testing for SARS-CoV-2 was supported by 73% of respondents.

Conclusion: On-campus saliva testing is a feasible option for primary schools to screen for COVID-19 in their student population to help keep their campuses safe and open for learning.

Keywords: COVID-19; saliva testing; mitigation; primary school.

The COVID-19 pandemic is a leading cause of morbidity and mortality worldwide and continues to exhaust health care resources on a large scale.¹ Efficient testing is critical to identify cases early and to help mitigate the deleterious effects of the pandemic.² Saliva polymerase chain reaction (PCR) nucleic acid amplification testing (NAAT) is more comfortable than nasopharyngeal (NP) NAAT and has been validated as a test for SARS-CoV-2.¹ Although children are less susceptible to severe disease, primary schools are considered a vector for transmission and community spread.³ Efficient and scalable methods of routine testing are needed globally to help keep schools open. Saliva testing has proven a useful resource for this population.^4,5

Abu Dhabi is the largest Emirate in the United Arab Emirates (UAE), with an estimated population of 2.5 million.⁶ The first case of COVID-19 was discovered in the UAE on January 29, 2020.⁷ The UAE has been recognized worldwide for its robust pandemic response. Along with the coordinated and swift application of public health measures, the country has one of the highest COVID-19 testing rates per capita and one of the highest vaccination rates worldwide.^8,9 The Abu Dhabi Public Health Center (ADPHC) works alongside the Ministry of Education (MOE) to establish testing, quarantine, and general safety guidelines for primary schools. In December 2020, the ADPHC partnered with a local, accredited diagnostic laboratory to test the feasibility of a saliva-based screening program for COVID-19 directly on school campuses for 18 primary schools in the Emirate.

Saliva-based PCR testing for COVID-19 was approved for use in schools in the UAE on January 24, 2021.¹⁰ As part of a greater mitigation strategy to reduce both school-based transmission and, hence, community spread, the ADPHC focused its on-site testing program on children aged 4 to 12 years. The program required collaboration among medical professionals, school administrators and teachers, students, and parents. Our study evaluates the feasibility of implementing a saliva-based COVID-19 screening program directly on primary school campuses involving children as young as 4 years of age.

Methods

The ADPHC, in collaboration with G42 Biogenix Labs, conducted a saliva SARS-CoV-2 NAAT testing program in 18 primary schools in the Emirate. Schools were selected based on outbreak prevalence at the time and focused on “hot spot” areas. The school on-site saliva testing program included children aged 4 to 12 years old in a “bubble” attendance model during the school day. This model involved children being assigned to groups or “pods.” This allowed us to limit a potential outbreak to a single pod, as opposed to risk exposing the entire school, should a single student test positive. The well-established SalivaDirect protocol developed at Yale University was used for testing and included an RNA extraction-free, RT-qPCR method for SARS-CoV-2 detection.¹¹

We conducted a qualitative study involving telephone interviews of school administrators to evaluate their experience with the ADPHC testing program at their schools. In addition, we interviewed the G42 Biogenix Lab providers to understand the logistics that supported on-campus collection of saliva specimens for this age group. We also gathered the attitudes of school children before and after testing. This study was reviewed and approved by the Abu Dhabi Health Research and Technology Committee and the Institutional Review Board (IRB), New York University Abu Dhabi (NYUAD).

Sample and recruitment

The original sample collection of saliva specimens was performed by the ADPHC in collaboration with G42 Biogenix Lab providers on school campuses between December 6 and December 10, 2020. During this time, schools operated in a hybrid teaching model, where learning took place both online and in person. Infection control measures were deployed based on ADPHC standards and guidelines. Nurses utilized appropriate patient protective equipment, frequent hand hygiene, and social distancing during the collection process. Inclusion criteria included asymptomatic students aged 4 to 12 years attending in-person classes on campus. Students with respiratory symptoms who were asked to stay home or those not attending in-person classes were excluded.

Data with regard to school children’s attitudes before and after testing were compiled through an online survey sent randomly to participants postintervention. Data from school administrators were collected through video and telephone interviews between April 14 and April 29, 2021. We first interviewed G42 Biogenix Lab providers to obtain previously acquired qualitative and quantitative data, which were collected during the intervention itself. After obtaining this information, we designed a questionnaire and proceeded with a structured interview process for school officials.

We interviewed school principals and administrators to collect their overall experiences with the saliva testing program. Before starting each interview, we established the interviewees preferred language, either English or Arabic. We then introduced the meeting attendees and provided study details, aims, and objectives, and described collaborating entities. We obtained verbal informed consent from a script approved by the NYUAD IRB and then proceeded with the interview, which included 4 questions. The first 3 questions were answered on a 5-point Likert scale model that consisted of 5 answer options: 5 being completely agree, 4 agree, 3 somewhat agree, 2 somewhat disagree, and 1 completely disagree. The fourth question invited open-ended feedback and comments on the following statements:

1. I believe the COVID-19 saliva testing program improved the safety for my school campus.
2. Our community had an overall positive experience with the COVID saliva testing.
3. We would like to continue a saliva-based COVID testing program on our school campus.
4. Please provide any additional comments you feel important about the program.

During the interview, we transcribed the answers as the interviewee was answering. We then translated those in Arabic into English and collected the data in 1 Excel spreadsheet. School interviewees and school names were de-identified in the collection and storage process.

Results

A total of 2011 saliva samples were collected from 18 different primary school campuses. Samples were sent the same day to G42 Biogenix Labs in Abu Dhabi for COVID PCR testing. A team consisting of 5 doctors providing general oversight, along with 2 to 6 nurses per site, were able to manage the collection process for all 18 school campuses. Samples were collected between 8 am and 2 pm and required variation among sites depending on factors such as staff availability and class schedules. Additional scheduling challenges included compliance with public safety mandates involving the maintenance of defined “safety bubbles” that forbid certain personnel from moving between floors, and the avoidance of mixing students from different classes.

Sample stations were set up in either the school auditorium or gymnasium to ensure appropriate crowd control and ventilation. Teachers and other school staff, including public safety, were able to manage lines and the shuttling of students back and forth from classes to testing stations, which allowed medical staff to focus on sample collection.

Informed consent was obtained by prior electronic communication to parents from school staff, asking them to agree to allow their child to participate in the testing program. Informed consent was identified as a challenge: Getting parents to understand that saliva testing was more comfortable than NP testing, and that the results were only being used to help keep the school safe, took time. School staff are used to obtaining consent from parents for field trips, but this was clearly more challenging for them.

The saliva collection process per child took more time than expected. Children fasted for 45 minutes before saliva collection. We used an active drool technique, which required children to pool saliva in their mouth then express it into a collection tube. Adults can generally do this on command, but we found it took 10 to 12 minutes per child. Saliva production was cued by asking the children to think about food, and by showing them pictures and TV commercials depicting food. Children 4 to 5 years old had more difficulty with the process despite active cueing, while those 6 to 12 years old had an easier time with the process. We collected data on a cohort of 80 children regarding their attitudes pre (Figure 1) and post collection (Figure 2). Children felt happier, less nervous, and less scared after collection than before collection. This trend reassured us that future collections would be easier for students.

A total of 15 of 18 school principals completed the telephone interview, yielding a response rate of 83%. Overall, 93% of the school principals agreed or completely agreed that the COVID-19 saliva testing program improved school safety; 93% agreed or completely agreed that they had an overall positive experience with the program; and 73% supported the ongoing use of saliva testing in their schools (Table 1). Administrators’ open-ended comments on their experience were positive overall (Table 2).

Discussion

By March 2020, many kindergarten to grade 12 public and private schools suspended in-person classes due to the pandemic and turned to online learning platforms. The negative impact of school closures on academic achievement is projected to be significant.^7,12,13 Ensuring schools can stay open and run operations safely will require routine SARS-CoV-2 testing. Our study investigated the feasibility of routine saliva testing on children aged 4 to 12 years on their school campuses. The ADPHC school on-site saliva testing program involved bringing lab providers onto 18 primary school campuses and required cooperation among parents, students, school administrators, and health care professionals.

Children younger than 6 years had difficulty producing an adequate saliva specimen, whereas those 6 to 12 years did so with relative ease when cued by thoughts or pictures of food while waiting in line for collection. Schools considering on-site testing programs should consider the age range of 6 to 12 years as a viable age range for saliva screening. Children should fast for a minimum of 45 minutes prior to saliva collection and should be cued by thoughts of food, food pictures, or food commercials. Setting up a sampling station close to the cafeteria where students can smell meal preparation may also help.^14,15 Sampling before breakfast or lunch, when children are potentially at their hungriest, should also be considered.

The greatest challenge was obtaining informed consent from parents who were not yet familiar with the reliability of saliva testing as a tool for SARS-CoV-2 screening or with the saliva collection process as a whole. Informed consent was initially done electronically, lacking direct human interaction to answer parents’ questions. Parents who refused had a follow-up call from the school nurse to further explain the logistics and rationale for saliva screening. Having medical professionals directly answer parents’ questions was helpful. Parents were reassured that the process was painless, confidential, and only to be used for school safety purposes. Despite school administrators being experienced in obtaining consent from parents for field trips, obtaining informed consent for a medical testing procedure is more complicated, and parents aren’t accustomed to providing such consent in a school environment. Schools considering on-site testing should ensure that their school nurse or other health care providers are on the front line obtaining informed consent and allaying parents’ fears.

School staff were able to effectively provide crowd control for testing, and children felt at ease being in a familiar environment. Teachers and public safety officers are well-equipped at managing the shuttling of students to class, to lunch, to physical education, and, finally, to dismissal. They were equally equipped at handling the logistics of students to and from testing, including minimizing crowds and helping students feel at ease during the process. This effective collaboration allowed the lab personnel to focus on sample collection and storage, while school staff managed all other aspects of the children’s safety and care.

Conclusion

Overall, school administrators had a positive experience with the testing program, felt the program improved the safety of their schools, and supported the ongoing use of saliva testing for SARS-CoV-2 on their school campuses. Children aged 6 years and older were able to provide adequate saliva samples, and children felt happier and less nervous after the process, indicating repeatability. Our findings highlight the feasibility of an integrated on-site saliva testing model for primary school campuses. Further research is needed to determine the scalability of such a model and whether the added compliance and safety of on-site testing compensates for the potential loss of learning time that testing during school hours would require.

Corresponding author: Ayaz Virji, MD, New York University Abu Dhabi, PO Box 129188, Abu Dhabi, United Arab Emirates; [email protected].

Financial disclosures: None.

From Health Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates (Dr. Virji and Aisha Al Hamiz), Public Health, Abu Dhabi Public Health Center, Abu Dhabi, United Arab Emirates (Drs. Al Hajeri, Al Shehhi, Al Memari, and Ahlam Al Maskari), College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates, Department of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates (Dr. Alhajri), Public Health Research Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates, Oxford University Hospitals NHS Foundation Trust, Oxford, England, and the MRC Epidemiology Unit, University of Cambridge, Cambridge, England (Dr. Ali).

Objective: The pandemic has forced closures of primary schools, resulting in loss of learning time on a global scale. In addition to face coverings, social distancing, and hand hygiene, an efficient testing method is important to mitigate the spread of COVID-19 in schools. We evaluated the feasibility of a saliva-based SARS-CoV-2 polymerase chain reaction testing program among 18 primary schools in the Emirate of Abu Dhabi, United Arab Emirates. Qualitative results show that children 4 to 5 years old had difficulty producing an adequate saliva specimen compared to those 6 to 12 years old.

Methods: A short training video on saliva collection beforehand helps demystify the process for students and parents alike. Informed consent was challenging yet should be done beforehand by school health nurses or other medical professionals to reassure parents and maximize participation.

Results: Telephone interviews with school administrators resulted in an 83% response rate. Overall, 93% of school administrators had a positive experience with saliva testing and felt the program improved the safety of their schools. The ongoing use of saliva testing for SARS-CoV-2 was supported by 73% of respondents.

Conclusion: On-campus saliva testing is a feasible option for primary schools to screen for COVID-19 in their student population to help keep their campuses safe and open for learning.

Keywords: COVID-19; saliva testing; mitigation; primary school.

The COVID-19 pandemic is a leading cause of morbidity and mortality worldwide and continues to exhaust health care resources on a large scale.¹ Efficient testing is critical to identify cases early and to help mitigate the deleterious effects of the pandemic.² Saliva polymerase chain reaction (PCR) nucleic acid amplification testing (NAAT) is more comfortable than nasopharyngeal (NP) NAAT and has been validated as a test for SARS-CoV-2.¹ Although children are less susceptible to severe disease, primary schools are considered a vector for transmission and community spread.³ Efficient and scalable methods of routine testing are needed globally to help keep schools open. Saliva testing has proven a useful resource for this population.^4,5

Abu Dhabi is the largest Emirate in the United Arab Emirates (UAE), with an estimated population of 2.5 million.⁶ The first case of COVID-19 was discovered in the UAE on January 29, 2020.⁷ The UAE has been recognized worldwide for its robust pandemic response. Along with the coordinated and swift application of public health measures, the country has one of the highest COVID-19 testing rates per capita and one of the highest vaccination rates worldwide.^8,9 The Abu Dhabi Public Health Center (ADPHC) works alongside the Ministry of Education (MOE) to establish testing, quarantine, and general safety guidelines for primary schools. In December 2020, the ADPHC partnered with a local, accredited diagnostic laboratory to test the feasibility of a saliva-based screening program for COVID-19 directly on school campuses for 18 primary schools in the Emirate.

Saliva-based PCR testing for COVID-19 was approved for use in schools in the UAE on January 24, 2021.¹⁰ As part of a greater mitigation strategy to reduce both school-based transmission and, hence, community spread, the ADPHC focused its on-site testing program on children aged 4 to 12 years. The program required collaboration among medical professionals, school administrators and teachers, students, and parents. Our study evaluates the feasibility of implementing a saliva-based COVID-19 screening program directly on primary school campuses involving children as young as 4 years of age.

Methods

The ADPHC, in collaboration with G42 Biogenix Labs, conducted a saliva SARS-CoV-2 NAAT testing program in 18 primary schools in the Emirate. Schools were selected based on outbreak prevalence at the time and focused on “hot spot” areas. The school on-site saliva testing program included children aged 4 to 12 years old in a “bubble” attendance model during the school day. This model involved children being assigned to groups or “pods.” This allowed us to limit a potential outbreak to a single pod, as opposed to risk exposing the entire school, should a single student test positive. The well-established SalivaDirect protocol developed at Yale University was used for testing and included an RNA extraction-free, RT-qPCR method for SARS-CoV-2 detection.¹¹

We conducted a qualitative study involving telephone interviews of school administrators to evaluate their experience with the ADPHC testing program at their schools. In addition, we interviewed the G42 Biogenix Lab providers to understand the logistics that supported on-campus collection of saliva specimens for this age group. We also gathered the attitudes of school children before and after testing. This study was reviewed and approved by the Abu Dhabi Health Research and Technology Committee and the Institutional Review Board (IRB), New York University Abu Dhabi (NYUAD).

Sample and recruitment

The original sample collection of saliva specimens was performed by the ADPHC in collaboration with G42 Biogenix Lab providers on school campuses between December 6 and December 10, 2020. During this time, schools operated in a hybrid teaching model, where learning took place both online and in person. Infection control measures were deployed based on ADPHC standards and guidelines. Nurses utilized appropriate patient protective equipment, frequent hand hygiene, and social distancing during the collection process. Inclusion criteria included asymptomatic students aged 4 to 12 years attending in-person classes on campus. Students with respiratory symptoms who were asked to stay home or those not attending in-person classes were excluded.

Data with regard to school children’s attitudes before and after testing were compiled through an online survey sent randomly to participants postintervention. Data from school administrators were collected through video and telephone interviews between April 14 and April 29, 2021. We first interviewed G42 Biogenix Lab providers to obtain previously acquired qualitative and quantitative data, which were collected during the intervention itself. After obtaining this information, we designed a questionnaire and proceeded with a structured interview process for school officials.

We interviewed school principals and administrators to collect their overall experiences with the saliva testing program. Before starting each interview, we established the interviewees preferred language, either English or Arabic. We then introduced the meeting attendees and provided study details, aims, and objectives, and described collaborating entities. We obtained verbal informed consent from a script approved by the NYUAD IRB and then proceeded with the interview, which included 4 questions. The first 3 questions were answered on a 5-point Likert scale model that consisted of 5 answer options: 5 being completely agree, 4 agree, 3 somewhat agree, 2 somewhat disagree, and 1 completely disagree. The fourth question invited open-ended feedback and comments on the following statements:

1. I believe the COVID-19 saliva testing program improved the safety for my school campus.
2. Our community had an overall positive experience with the COVID saliva testing.
3. We would like to continue a saliva-based COVID testing program on our school campus.
4. Please provide any additional comments you feel important about the program.

During the interview, we transcribed the answers as the interviewee was answering. We then translated those in Arabic into English and collected the data in 1 Excel spreadsheet. School interviewees and school names were de-identified in the collection and storage process.

Results

A total of 2011 saliva samples were collected from 18 different primary school campuses. Samples were sent the same day to G42 Biogenix Labs in Abu Dhabi for COVID PCR testing. A team consisting of 5 doctors providing general oversight, along with 2 to 6 nurses per site, were able to manage the collection process for all 18 school campuses. Samples were collected between 8 am and 2 pm and required variation among sites depending on factors such as staff availability and class schedules. Additional scheduling challenges included compliance with public safety mandates involving the maintenance of defined “safety bubbles” that forbid certain personnel from moving between floors, and the avoidance of mixing students from different classes.

Sample stations were set up in either the school auditorium or gymnasium to ensure appropriate crowd control and ventilation. Teachers and other school staff, including public safety, were able to manage lines and the shuttling of students back and forth from classes to testing stations, which allowed medical staff to focus on sample collection.

Informed consent was obtained by prior electronic communication to parents from school staff, asking them to agree to allow their child to participate in the testing program. Informed consent was identified as a challenge: Getting parents to understand that saliva testing was more comfortable than NP testing, and that the results were only being used to help keep the school safe, took time. School staff are used to obtaining consent from parents for field trips, but this was clearly more challenging for them.

The saliva collection process per child took more time than expected. Children fasted for 45 minutes before saliva collection. We used an active drool technique, which required children to pool saliva in their mouth then express it into a collection tube. Adults can generally do this on command, but we found it took 10 to 12 minutes per child. Saliva production was cued by asking the children to think about food, and by showing them pictures and TV commercials depicting food. Children 4 to 5 years old had more difficulty with the process despite active cueing, while those 6 to 12 years old had an easier time with the process. We collected data on a cohort of 80 children regarding their attitudes pre (Figure 1) and post collection (Figure 2). Children felt happier, less nervous, and less scared after collection than before collection. This trend reassured us that future collections would be easier for students.

A total of 15 of 18 school principals completed the telephone interview, yielding a response rate of 83%. Overall, 93% of the school principals agreed or completely agreed that the COVID-19 saliva testing program improved school safety; 93% agreed or completely agreed that they had an overall positive experience with the program; and 73% supported the ongoing use of saliva testing in their schools (Table 1). Administrators’ open-ended comments on their experience were positive overall (Table 2).

Discussion

By March 2020, many kindergarten to grade 12 public and private schools suspended in-person classes due to the pandemic and turned to online learning platforms. The negative impact of school closures on academic achievement is projected to be significant.^7,12,13 Ensuring schools can stay open and run operations safely will require routine SARS-CoV-2 testing. Our study investigated the feasibility of routine saliva testing on children aged 4 to 12 years on their school campuses. The ADPHC school on-site saliva testing program involved bringing lab providers onto 18 primary school campuses and required cooperation among parents, students, school administrators, and health care professionals.

Children younger than 6 years had difficulty producing an adequate saliva specimen, whereas those 6 to 12 years did so with relative ease when cued by thoughts or pictures of food while waiting in line for collection. Schools considering on-site testing programs should consider the age range of 6 to 12 years as a viable age range for saliva screening. Children should fast for a minimum of 45 minutes prior to saliva collection and should be cued by thoughts of food, food pictures, or food commercials. Setting up a sampling station close to the cafeteria where students can smell meal preparation may also help.^14,15 Sampling before breakfast or lunch, when children are potentially at their hungriest, should also be considered.

The greatest challenge was obtaining informed consent from parents who were not yet familiar with the reliability of saliva testing as a tool for SARS-CoV-2 screening or with the saliva collection process as a whole. Informed consent was initially done electronically, lacking direct human interaction to answer parents’ questions. Parents who refused had a follow-up call from the school nurse to further explain the logistics and rationale for saliva screening. Having medical professionals directly answer parents’ questions was helpful. Parents were reassured that the process was painless, confidential, and only to be used for school safety purposes. Despite school administrators being experienced in obtaining consent from parents for field trips, obtaining informed consent for a medical testing procedure is more complicated, and parents aren’t accustomed to providing such consent in a school environment. Schools considering on-site testing should ensure that their school nurse or other health care providers are on the front line obtaining informed consent and allaying parents’ fears.

School staff were able to effectively provide crowd control for testing, and children felt at ease being in a familiar environment. Teachers and public safety officers are well-equipped at managing the shuttling of students to class, to lunch, to physical education, and, finally, to dismissal. They were equally equipped at handling the logistics of students to and from testing, including minimizing crowds and helping students feel at ease during the process. This effective collaboration allowed the lab personnel to focus on sample collection and storage, while school staff managed all other aspects of the children’s safety and care.

Conclusion

Overall, school administrators had a positive experience with the testing program, felt the program improved the safety of their schools, and supported the ongoing use of saliva testing for SARS-CoV-2 on their school campuses. Children aged 6 years and older were able to provide adequate saliva samples, and children felt happier and less nervous after the process, indicating repeatability. Our findings highlight the feasibility of an integrated on-site saliva testing model for primary school campuses. Further research is needed to determine the scalability of such a model and whether the added compliance and safety of on-site testing compensates for the potential loss of learning time that testing during school hours would require.

Corresponding author: Ayaz Virji, MD, New York University Abu Dhabi, PO Box 129188, Abu Dhabi, United Arab Emirates; [email protected].

Financial disclosures: None.

While sick at home with a 26-day symptomatic course of COVID-19 in March 2020, I watched the surge unfold in my state and the hospital where I work as an inpatient adult medicine physician. Although the preponderance of my professional life is dedicated to leading teams in implementing delivery system transformation, the hat I wore in that moment involved living through and keeping up with the changes around me. Once I recovered and returned to the arena as a COVID doctor, I adapted to and made changes during constant shifts in how we provided care.

Looking back on those months during the worst of the COVID-19 hospital surge in my region, I reflect on the factors that helped me, as a frontline and shift-work clinician, adapt to and make those changes. In reflecting on the elements that were meaningful to me during the crisis, I recognize a set of change-enabling factors that have broad relevance for those of us who work to improve outcomes for patients and populations.

Confidence engendered by liberating data

In the early days of the surge, there was much uncertainty, and unfortunately, some seriously imperfect messaging. Trust was broken or badly bruised for many frontline clinicians. I share this painful phase not to criticize, but rather reflect on what mattered to me during that crisis of confidence. It was data. Raw, unadjusted, best-available data. Produced and pushed out. Available, trended over time, telling the story of where we are, now. Counts of tests, beds, and ventilators. The consistent, transparent availability of relevant and straightforward data provided an active antidote to a sense of uncertainty during a crisis of confidence.

Personal practice change stimulated by relevance and urgency

For half a decade, I have been encouraging interdisciplinary inpatient teams to identify and actively engage the family and/or care partner as a member of the care team. Despite even the American Association of Retired Persons mobilizing an impressive regulatory approach in 32 states to require that family and/or care partners are included as such, the practice change efforts continued on a slow and steady path. Why? We just didn’t believe it was of urgent, relevant, mission-critical importance to our daily practice to do so. That all changed in March 2020.

Without needing to be told, educated, or incentivized, my first night as a COVID doctor found me calling every single patient’s family upon admission, regardless of what time it was. It was critical to review the diagnosis, transparently discuss the uncertainty regarding the upcoming hours and days, review the potential contingencies, and ask, right there and then, whether intubation is consistent with goals of care. It was that urgent and relevant. Without exception, families were grateful for the effort and candor.

The significance of this practice—undoubtedly adopted by every inpatient provider who has worked a COVID surge—is rooted in decades of academic deliberation on which is the “right” doctor to have these discussions. None of that mattered. Historical opinions changed due to what was urgent and relevant given the situation at hand and the job we had to do. Imagine, for example, what we could do and how we could change if we now consider it urgent and relevant to identify and mobilize enhanced services and supports to patients who experience inequities because we believe it to be mission-critical to the job we show up to do every day.

Change fostered by a creative problem-solving ecosystem

Embracing personal practice change was made easier and implicitly affirmed by the creative problem solving that occurred everywhere. Tents, drive-throughs, and even college field houses were now settings of care. Primary care physicians, cardiologists, and gastrointestinal (GI) and postanesthesia care nurses staffed the COVID floors. Rolling stands held iPads so staff could communicate with patients without entering the room. This creative ecosystem fostered individual practice change. No debates were needed to recognize that standard processes were inadequate. No single role or service of any discipline was singularly asked to change to meet the needs of the moment. Because of this ecosystem of creative, active change, there was a much greater flexibility among individuals, role types, departments, and disciplines to change. This is particularly poignant to me in light of the work I lead to improve care for patients who experience systemic inequities in our health care system. When we ask a single role type or discipline to change, it can be met with resistance; far more success is achieved when we engage an interdisciplinary and interdepartmental approach to change. When surrounded by others making change, it makes us more willing to change, too.

It is so often invoked that health care is a team sport. In practicality, while we may aspire to work as a team, health care delivery is still all too often comprised of a set of individual actors with individualized responsibilities trying to communicate the best they can with each other.

What I experienced during the surge at my hospital was the very best version of teamwork I have ever been a part of in health care: empathetic, mutually interdependent strangers coming together during daily changes in staffing, processes, and resources. I will never forget nights walking into the pediatric floor or day surgery recovery area—now repurposed as a COVID unit—to entirely new faces comprised of GI suite nurses, outpatient doctors, and moonlighting intensivists.

We were all new to each other, all new to working in this setting, and all new to whatever the newest changes of the day brought. I will never forget how we greeted each other and introduced ourselves. We asked each other where we were “from,” and held a genuine appreciation to each other for being there. Imagine how this impacted how we worked together. Looking back on those night shifts, I remember us as a truly interdependent team. I will endeavor to bring that sense of mutual regard and interdependency into my work to foster effective interdisciplinary and cross-continuum teamwork.

Takeaways

As a student and practitioner of delivery system transformation, I am often in conversations about imperfect data, incomplete evidence, and role-specific and organizational resistance to change. As an acute care provider during the COVID-19 hospital surge in my region, the experiences I had as a participant in the COVID-related delivery system change will stay with me as I lead value-based delivery system change. What worked in an infectious disease crisis holds great relevance to our pressing, urgent, relevant work to create a more person-centered, equitable, and value-based delivery system.

I am confident that if those of us seeking to improve outcomes use visible and accessible data to engender confidence, clearly link practice change to the relevant and urgent issue at hand, promote broadly visible creative problem solving to foster an ecosystem of change, and cultivate empathy and mutual interdependence to promote the teamwork we aspire to have, that we will foster meaningful progress in our efforts to improve care for patients and populations.

Corresponding author: Amy Boutwell, MD, MPP, President, Collaborative Healthcare Strategies, Lexington, MA; [email protected].

Financial disclosures: None.

While sick at home with a 26-day symptomatic course of COVID-19 in March 2020, I watched the surge unfold in my state and the hospital where I work as an inpatient adult medicine physician. Although the preponderance of my professional life is dedicated to leading teams in implementing delivery system transformation, the hat I wore in that moment involved living through and keeping up with the changes around me. Once I recovered and returned to the arena as a COVID doctor, I adapted to and made changes during constant shifts in how we provided care.

Looking back on those months during the worst of the COVID-19 hospital surge in my region, I reflect on the factors that helped me, as a frontline and shift-work clinician, adapt to and make those changes. In reflecting on the elements that were meaningful to me during the crisis, I recognize a set of change-enabling factors that have broad relevance for those of us who work to improve outcomes for patients and populations.

Confidence engendered by liberating data

In the early days of the surge, there was much uncertainty, and unfortunately, some seriously imperfect messaging. Trust was broken or badly bruised for many frontline clinicians. I share this painful phase not to criticize, but rather reflect on what mattered to me during that crisis of confidence. It was data. Raw, unadjusted, best-available data. Produced and pushed out. Available, trended over time, telling the story of where we are, now. Counts of tests, beds, and ventilators. The consistent, transparent availability of relevant and straightforward data provided an active antidote to a sense of uncertainty during a crisis of confidence.

Personal practice change stimulated by relevance and urgency

For half a decade, I have been encouraging interdisciplinary inpatient teams to identify and actively engage the family and/or care partner as a member of the care team. Despite even the American Association of Retired Persons mobilizing an impressive regulatory approach in 32 states to require that family and/or care partners are included as such, the practice change efforts continued on a slow and steady path. Why? We just didn’t believe it was of urgent, relevant, mission-critical importance to our daily practice to do so. That all changed in March 2020.

Without needing to be told, educated, or incentivized, my first night as a COVID doctor found me calling every single patient’s family upon admission, regardless of what time it was. It was critical to review the diagnosis, transparently discuss the uncertainty regarding the upcoming hours and days, review the potential contingencies, and ask, right there and then, whether intubation is consistent with goals of care. It was that urgent and relevant. Without exception, families were grateful for the effort and candor.

The significance of this practice—undoubtedly adopted by every inpatient provider who has worked a COVID surge—is rooted in decades of academic deliberation on which is the “right” doctor to have these discussions. None of that mattered. Historical opinions changed due to what was urgent and relevant given the situation at hand and the job we had to do. Imagine, for example, what we could do and how we could change if we now consider it urgent and relevant to identify and mobilize enhanced services and supports to patients who experience inequities because we believe it to be mission-critical to the job we show up to do every day.

Change fostered by a creative problem-solving ecosystem

Embracing personal practice change was made easier and implicitly affirmed by the creative problem solving that occurred everywhere. Tents, drive-throughs, and even college field houses were now settings of care. Primary care physicians, cardiologists, and gastrointestinal (GI) and postanesthesia care nurses staffed the COVID floors. Rolling stands held iPads so staff could communicate with patients without entering the room. This creative ecosystem fostered individual practice change. No debates were needed to recognize that standard processes were inadequate. No single role or service of any discipline was singularly asked to change to meet the needs of the moment. Because of this ecosystem of creative, active change, there was a much greater flexibility among individuals, role types, departments, and disciplines to change. This is particularly poignant to me in light of the work I lead to improve care for patients who experience systemic inequities in our health care system. When we ask a single role type or discipline to change, it can be met with resistance; far more success is achieved when we engage an interdisciplinary and interdepartmental approach to change. When surrounded by others making change, it makes us more willing to change, too.

It is so often invoked that health care is a team sport. In practicality, while we may aspire to work as a team, health care delivery is still all too often comprised of a set of individual actors with individualized responsibilities trying to communicate the best they can with each other.

What I experienced during the surge at my hospital was the very best version of teamwork I have ever been a part of in health care: empathetic, mutually interdependent strangers coming together during daily changes in staffing, processes, and resources. I will never forget nights walking into the pediatric floor or day surgery recovery area—now repurposed as a COVID unit—to entirely new faces comprised of GI suite nurses, outpatient doctors, and moonlighting intensivists.

We were all new to each other, all new to working in this setting, and all new to whatever the newest changes of the day brought. I will never forget how we greeted each other and introduced ourselves. We asked each other where we were “from,” and held a genuine appreciation to each other for being there. Imagine how this impacted how we worked together. Looking back on those night shifts, I remember us as a truly interdependent team. I will endeavor to bring that sense of mutual regard and interdependency into my work to foster effective interdisciplinary and cross-continuum teamwork.

Takeaways

As a student and practitioner of delivery system transformation, I am often in conversations about imperfect data, incomplete evidence, and role-specific and organizational resistance to change. As an acute care provider during the COVID-19 hospital surge in my region, the experiences I had as a participant in the COVID-related delivery system change will stay with me as I lead value-based delivery system change. What worked in an infectious disease crisis holds great relevance to our pressing, urgent, relevant work to create a more person-centered, equitable, and value-based delivery system.

I am confident that if those of us seeking to improve outcomes use visible and accessible data to engender confidence, clearly link practice change to the relevant and urgent issue at hand, promote broadly visible creative problem solving to foster an ecosystem of change, and cultivate empathy and mutual interdependence to promote the teamwork we aspire to have, that we will foster meaningful progress in our efforts to improve care for patients and populations.

Corresponding author: Amy Boutwell, MD, MPP, President, Collaborative Healthcare Strategies, Lexington, MA; [email protected].

Financial disclosures: None.

While sick at home with a 26-day symptomatic course of COVID-19 in March 2020, I watched the surge unfold in my state and the hospital where I work as an inpatient adult medicine physician. Although the preponderance of my professional life is dedicated to leading teams in implementing delivery system transformation, the hat I wore in that moment involved living through and keeping up with the changes around me. Once I recovered and returned to the arena as a COVID doctor, I adapted to and made changes during constant shifts in how we provided care.

Looking back on those months during the worst of the COVID-19 hospital surge in my region, I reflect on the factors that helped me, as a frontline and shift-work clinician, adapt to and make those changes. In reflecting on the elements that were meaningful to me during the crisis, I recognize a set of change-enabling factors that have broad relevance for those of us who work to improve outcomes for patients and populations.

Confidence engendered by liberating data

In the early days of the surge, there was much uncertainty, and unfortunately, some seriously imperfect messaging. Trust was broken or badly bruised for many frontline clinicians. I share this painful phase not to criticize, but rather reflect on what mattered to me during that crisis of confidence. It was data. Raw, unadjusted, best-available data. Produced and pushed out. Available, trended over time, telling the story of where we are, now. Counts of tests, beds, and ventilators. The consistent, transparent availability of relevant and straightforward data provided an active antidote to a sense of uncertainty during a crisis of confidence.

Personal practice change stimulated by relevance and urgency

For half a decade, I have been encouraging interdisciplinary inpatient teams to identify and actively engage the family and/or care partner as a member of the care team. Despite even the American Association of Retired Persons mobilizing an impressive regulatory approach in 32 states to require that family and/or care partners are included as such, the practice change efforts continued on a slow and steady path. Why? We just didn’t believe it was of urgent, relevant, mission-critical importance to our daily practice to do so. That all changed in March 2020.

Without needing to be told, educated, or incentivized, my first night as a COVID doctor found me calling every single patient’s family upon admission, regardless of what time it was. It was critical to review the diagnosis, transparently discuss the uncertainty regarding the upcoming hours and days, review the potential contingencies, and ask, right there and then, whether intubation is consistent with goals of care. It was that urgent and relevant. Without exception, families were grateful for the effort and candor.

The significance of this practice—undoubtedly adopted by every inpatient provider who has worked a COVID surge—is rooted in decades of academic deliberation on which is the “right” doctor to have these discussions. None of that mattered. Historical opinions changed due to what was urgent and relevant given the situation at hand and the job we had to do. Imagine, for example, what we could do and how we could change if we now consider it urgent and relevant to identify and mobilize enhanced services and supports to patients who experience inequities because we believe it to be mission-critical to the job we show up to do every day.

Change fostered by a creative problem-solving ecosystem

Embracing personal practice change was made easier and implicitly affirmed by the creative problem solving that occurred everywhere. Tents, drive-throughs, and even college field houses were now settings of care. Primary care physicians, cardiologists, and gastrointestinal (GI) and postanesthesia care nurses staffed the COVID floors. Rolling stands held iPads so staff could communicate with patients without entering the room. This creative ecosystem fostered individual practice change. No debates were needed to recognize that standard processes were inadequate. No single role or service of any discipline was singularly asked to change to meet the needs of the moment. Because of this ecosystem of creative, active change, there was a much greater flexibility among individuals, role types, departments, and disciplines to change. This is particularly poignant to me in light of the work I lead to improve care for patients who experience systemic inequities in our health care system. When we ask a single role type or discipline to change, it can be met with resistance; far more success is achieved when we engage an interdisciplinary and interdepartmental approach to change. When surrounded by others making change, it makes us more willing to change, too.

It is so often invoked that health care is a team sport. In practicality, while we may aspire to work as a team, health care delivery is still all too often comprised of a set of individual actors with individualized responsibilities trying to communicate the best they can with each other.

What I experienced during the surge at my hospital was the very best version of teamwork I have ever been a part of in health care: empathetic, mutually interdependent strangers coming together during daily changes in staffing, processes, and resources. I will never forget nights walking into the pediatric floor or day surgery recovery area—now repurposed as a COVID unit—to entirely new faces comprised of GI suite nurses, outpatient doctors, and moonlighting intensivists.

We were all new to each other, all new to working in this setting, and all new to whatever the newest changes of the day brought. I will never forget how we greeted each other and introduced ourselves. We asked each other where we were “from,” and held a genuine appreciation to each other for being there. Imagine how this impacted how we worked together. Looking back on those night shifts, I remember us as a truly interdependent team. I will endeavor to bring that sense of mutual regard and interdependency into my work to foster effective interdisciplinary and cross-continuum teamwork.

Takeaways

As a student and practitioner of delivery system transformation, I am often in conversations about imperfect data, incomplete evidence, and role-specific and organizational resistance to change. As an acute care provider during the COVID-19 hospital surge in my region, the experiences I had as a participant in the COVID-related delivery system change will stay with me as I lead value-based delivery system change. What worked in an infectious disease crisis holds great relevance to our pressing, urgent, relevant work to create a more person-centered, equitable, and value-based delivery system.

I am confident that if those of us seeking to improve outcomes use visible and accessible data to engender confidence, clearly link practice change to the relevant and urgent issue at hand, promote broadly visible creative problem solving to foster an ecosystem of change, and cultivate empathy and mutual interdependence to promote the teamwork we aspire to have, that we will foster meaningful progress in our efforts to improve care for patients and populations.

Corresponding author: Amy Boutwell, MD, MPP, President, Collaborative Healthcare Strategies, Lexington, MA; [email protected].

Financial disclosures: None.

George Froehle, PA, a primary care clinician at CentraCare in rural St. Cloud, Minn., has been prescribing the HIV prevention pill tenofovir disoproxil fumarate plus emtricitabine since it was marketed by the brand name Truvada and the Food and Drug Administration approved it in 2012. But recently, he’s been having conversations with patients about the new HIV prevention pill, tenofovir alafenamide plus emtricitabine (TAF/FTC, Descovy) as well.

“They may have a friend who has heard that Descovy is newer and safer,” Mr. Froehle said. But that’s not necessarily the case, at least according to lab values. A recent study in the journal Open Forum Infectious Diseases suggests that only between 1 in 10 and 1 in 3 switches to the new formulation of HIV pre-exposure prophylaxis (PrEP) are indicated by lab work – and that nearly half of people receiving a prescription for the new version had lab results actually contraindicating the switch.

This, combined with the lower cost of generic Truvada and the steep cost of Descovy, led study coauthor and HIV PrEP prescriber Douglas Krakower, MD, and colleagues to suggest that the generic version should be standard of care for all people on PrEP unless otherwise indicated.

This just “makes good sense,” Dr. Krakower, assistant professor of medicine at Harvard Medical School, Boston, told this news organization.

“It’s important to ultimately allow for patients and providers to have access to all of the PrEP options so they can choose the best option for each person,” he said. “But our data suggest that strategies to optimize the cost-effectiveness of PrEP prescribing, such as formulary interventions and education for patients and providers, could be beneficial – as long as there is an easy mechanism for patients and providers to override restrictions when there are clinical indications.”

Current PrEP guidelines from the Centers for Disease Control and Prevention don’t list a first-line or second-line treatment for PrEP. But recent guidance issued to insurance companies by the Biden administration specifically grants insurers permission to employ stepped formularies and cost sharing.

“Since the branded version of PrEP is not specified in the [U.S. Preventive Services Task Force] recommendation, plans and issuers may cover a generic version of PrEP without cost sharing and impose cost sharing on an equivalent branded version,” the rule, issued July 19, states. “However, plans and insurers must accommodate any individual for whom a particular PrEP medication [generic or brand name] would be medically inappropriate, as determined by the individual’s health care provider, by having a mechanism for waiving the otherwise applicable cost-sharing for the brand or nonpreferred brand version.”

Both drugs have been found to be 99% effective in stopping HIV acquisition in people at risk for it. Descovy is approved specifically for gay and bisexual men, transgender women, and anyone having anal sex. Ongoing studies are looking at the effectiveness of Descovy in people having vaginal sex. Generic Truvada has been approved for all people.
 

The biomarkers of switching

To be clear, both medicines are exceedingly safe, said lead author and epidemiologist Julia Marcus, PhD, MPH, associate professor at Harvard Medical School. Side effects have been mild and include nausea and diarrhea in the first month. What lab work tells clinicians is the potential for physiologic changes, but those changes don’t necessarily translate to clinical events.

“When I say harmful, I mean potentially harmful,” she said in an interview. “It’s really based on these incremental changes that maybe, in the long run, could be harmful.”

But she added that there are two types of damage from medicines: “There’s potential physiological damage, but there’s also potential financial damage.” While generic Truvada has a list price as low as $30 a bottle, Descovy has a list price of up to $2,000 a month. And the push for PrEP is growing. Recently, the head of the division of HIV/AIDS at the National Institute of Allergy and Infectious Diseases urged providers to get all their “HIV-negative, at-risk patients on PrEP tomorrow,” in light of the latest HIV vaccine failure.

So Dr. Marcus and team looked at data from the 2892 people who started taking PrEP in the year before the FDA approved Descovy in October 2019. Participants accessed PrEP through Fenway Health, a Boston-area health clinic serving a largely gay, lesbian, bisexual, transgender, and otherwise queer population, and the largest PrEP prescriber in New England. They then tracked which participants switched to Descovy and correlated the switches to lab work and CDC guidance for PrEP.

What they found was that just 11.9% of participants, or 343 people, switched to the newer formulation. That’s lower than the 27.2% who switched in nationally available data, which were released at a recent HIV conference. But when Dr. Krakower and colleagues looked at whether their PrEP prescriptions were appropriate based on the patients’ lab work, the findings were mixed.

On the one hand, they showed that 24 of those 343 people who switched to Descovy had creatinine clearance levels or bone mineral density measurements low enough to make the switch a good option. But that’s just 7% of all people who switched. They then ran a secondary model, in which they broadened the criteria for a switch from strictly those lab values to conditions that might indicate borderline kidney function, which could eventually lead to kidney damage. These included diagnoses of hypertension or diabetes, or borderline creatinine levels between 60 and 70 mL/minute.

“Even when we defined clinical indications as generously as we could, we still saw that only a minority had clinical indications for switching,” said “Most of the switching to TAF/FTC was potentially unnecessary, and some of it may have been harmful for people who had cardiovascular risk factors.”

That’s because although Descovy doesn’t affect renal and bone mineral markers, it does affect cholesterol levels and weight. Aftermarket and FDA data revealed a small but noticeable increase in statin use among people taking the new brand-name PrEP pill. When Marcus and colleagues looked for those biomarkers – total cholesterol greater than200, BMI of 30 or more, LDL cholesterol of more than 160 or HDL cholesterol of less than 40 – 14% of switches fit the criteria for contraindications for Descovy. That’s 10 times the rate of potential harm in switching as there was for those who stayed on the generic Truvada and would have been better served on Descovy. That came in at just 1.4%.

“There may be many reasons why patients or providers might choose to switch that we couldn’t document in our study,” she said. For instance, the newer formulation, Descovy, is a significantly smaller pill than the generic is. Or the perception of novelty might drive some switches.

“But I think we need qualitative work to understand how these decisions are being made,” she said in an interview. “It will be important to follow these patients to see what happens in terms of clinical outcomes.”

For his part, Mr. Froehle found the study intriguing. It reflects his own thinking around the value of the newer formulation. He also prescribes for people living with HIV. For them, the benefit of the new formulation of tenofovir present in Descovy has clear clinical relevance. After all, people living with HIV can be on their drug regimens for decades.

But people on PrEP aren’t likely to be on the pills as long, and so the real benefit of the newer, more expensive formulation is less clear. And he added that he’s already getting “pushback” from some insurance companies on the name-brand version, with companies asking for proof via lab values that a person has a history of kidney impairment or bone mineral density loss.

“It doesn’t happen a ton,” he said. “But it’s starting to happen, and normally it kind of builds from there.”

So when a patient comes in and asks specifically for Descovy, he usually will talk to them about it.

“If it’s what the patient wants and insurance covers it and it’s not unsafe for them to be on it, there might not be a reason to not prescribe Descovy,” said Mr. Froehle, who served as a sub-principal investigator for the DISCOVER clinical trial that showed the new PrEP was as effective as Truvada. “But now with Truvada being generic, we will talk about Truvada as being something we start up front because it may have a lower cost and it’s cheaper to the system. Then we can always switch to Descovy as needed.”

This study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Marcus reported receiving fees from Kaiser Permanente Northern California on a research grant from Gilead Sciences. Dr. Krakower reported having conducted research that was funded by Gilead Sciences and Merck, as well as honoraria for medical education content and presentations for Medscape Medical News, MED-IQ, and DKBMed and royalties from work conducted by UpToDate. Mr. Froehle reported receiving fees from Gilead Sciences in connection with a Gilead advisory board.

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

George Froehle, PA, a primary care clinician at CentraCare in rural St. Cloud, Minn., has been prescribing the HIV prevention pill tenofovir disoproxil fumarate plus emtricitabine since it was marketed by the brand name Truvada and the Food and Drug Administration approved it in 2012. But recently, he’s been having conversations with patients about the new HIV prevention pill, tenofovir alafenamide plus emtricitabine (TAF/FTC, Descovy) as well.

“They may have a friend who has heard that Descovy is newer and safer,” Mr. Froehle said. But that’s not necessarily the case, at least according to lab values. A recent study in the journal Open Forum Infectious Diseases suggests that only between 1 in 10 and 1 in 3 switches to the new formulation of HIV pre-exposure prophylaxis (PrEP) are indicated by lab work – and that nearly half of people receiving a prescription for the new version had lab results actually contraindicating the switch.

This, combined with the lower cost of generic Truvada and the steep cost of Descovy, led study coauthor and HIV PrEP prescriber Douglas Krakower, MD, and colleagues to suggest that the generic version should be standard of care for all people on PrEP unless otherwise indicated.

This just “makes good sense,” Dr. Krakower, assistant professor of medicine at Harvard Medical School, Boston, told this news organization.

“It’s important to ultimately allow for patients and providers to have access to all of the PrEP options so they can choose the best option for each person,” he said. “But our data suggest that strategies to optimize the cost-effectiveness of PrEP prescribing, such as formulary interventions and education for patients and providers, could be beneficial – as long as there is an easy mechanism for patients and providers to override restrictions when there are clinical indications.”

Current PrEP guidelines from the Centers for Disease Control and Prevention don’t list a first-line or second-line treatment for PrEP. But recent guidance issued to insurance companies by the Biden administration specifically grants insurers permission to employ stepped formularies and cost sharing.

“Since the branded version of PrEP is not specified in the [U.S. Preventive Services Task Force] recommendation, plans and issuers may cover a generic version of PrEP without cost sharing and impose cost sharing on an equivalent branded version,” the rule, issued July 19, states. “However, plans and insurers must accommodate any individual for whom a particular PrEP medication [generic or brand name] would be medically inappropriate, as determined by the individual’s health care provider, by having a mechanism for waiving the otherwise applicable cost-sharing for the brand or nonpreferred brand version.”

Both drugs have been found to be 99% effective in stopping HIV acquisition in people at risk for it. Descovy is approved specifically for gay and bisexual men, transgender women, and anyone having anal sex. Ongoing studies are looking at the effectiveness of Descovy in people having vaginal sex. Generic Truvada has been approved for all people.
 

The biomarkers of switching

To be clear, both medicines are exceedingly safe, said lead author and epidemiologist Julia Marcus, PhD, MPH, associate professor at Harvard Medical School. Side effects have been mild and include nausea and diarrhea in the first month. What lab work tells clinicians is the potential for physiologic changes, but those changes don’t necessarily translate to clinical events.

“When I say harmful, I mean potentially harmful,” she said in an interview. “It’s really based on these incremental changes that maybe, in the long run, could be harmful.”

But she added that there are two types of damage from medicines: “There’s potential physiological damage, but there’s also potential financial damage.” While generic Truvada has a list price as low as $30 a bottle, Descovy has a list price of up to $2,000 a month. And the push for PrEP is growing. Recently, the head of the division of HIV/AIDS at the National Institute of Allergy and Infectious Diseases urged providers to get all their “HIV-negative, at-risk patients on PrEP tomorrow,” in light of the latest HIV vaccine failure.

So Dr. Marcus and team looked at data from the 2892 people who started taking PrEP in the year before the FDA approved Descovy in October 2019. Participants accessed PrEP through Fenway Health, a Boston-area health clinic serving a largely gay, lesbian, bisexual, transgender, and otherwise queer population, and the largest PrEP prescriber in New England. They then tracked which participants switched to Descovy and correlated the switches to lab work and CDC guidance for PrEP.

What they found was that just 11.9% of participants, or 343 people, switched to the newer formulation. That’s lower than the 27.2% who switched in nationally available data, which were released at a recent HIV conference. But when Dr. Krakower and colleagues looked at whether their PrEP prescriptions were appropriate based on the patients’ lab work, the findings were mixed.

On the one hand, they showed that 24 of those 343 people who switched to Descovy had creatinine clearance levels or bone mineral density measurements low enough to make the switch a good option. But that’s just 7% of all people who switched. They then ran a secondary model, in which they broadened the criteria for a switch from strictly those lab values to conditions that might indicate borderline kidney function, which could eventually lead to kidney damage. These included diagnoses of hypertension or diabetes, or borderline creatinine levels between 60 and 70 mL/minute.

“Even when we defined clinical indications as generously as we could, we still saw that only a minority had clinical indications for switching,” said “Most of the switching to TAF/FTC was potentially unnecessary, and some of it may have been harmful for people who had cardiovascular risk factors.”

That’s because although Descovy doesn’t affect renal and bone mineral markers, it does affect cholesterol levels and weight. Aftermarket and FDA data revealed a small but noticeable increase in statin use among people taking the new brand-name PrEP pill. When Marcus and colleagues looked for those biomarkers – total cholesterol greater than200, BMI of 30 or more, LDL cholesterol of more than 160 or HDL cholesterol of less than 40 – 14% of switches fit the criteria for contraindications for Descovy. That’s 10 times the rate of potential harm in switching as there was for those who stayed on the generic Truvada and would have been better served on Descovy. That came in at just 1.4%.

“There may be many reasons why patients or providers might choose to switch that we couldn’t document in our study,” she said. For instance, the newer formulation, Descovy, is a significantly smaller pill than the generic is. Or the perception of novelty might drive some switches.

“But I think we need qualitative work to understand how these decisions are being made,” she said in an interview. “It will be important to follow these patients to see what happens in terms of clinical outcomes.”

For his part, Mr. Froehle found the study intriguing. It reflects his own thinking around the value of the newer formulation. He also prescribes for people living with HIV. For them, the benefit of the new formulation of tenofovir present in Descovy has clear clinical relevance. After all, people living with HIV can be on their drug regimens for decades.

But people on PrEP aren’t likely to be on the pills as long, and so the real benefit of the newer, more expensive formulation is less clear. And he added that he’s already getting “pushback” from some insurance companies on the name-brand version, with companies asking for proof via lab values that a person has a history of kidney impairment or bone mineral density loss.

“It doesn’t happen a ton,” he said. “But it’s starting to happen, and normally it kind of builds from there.”

So when a patient comes in and asks specifically for Descovy, he usually will talk to them about it.

“If it’s what the patient wants and insurance covers it and it’s not unsafe for them to be on it, there might not be a reason to not prescribe Descovy,” said Mr. Froehle, who served as a sub-principal investigator for the DISCOVER clinical trial that showed the new PrEP was as effective as Truvada. “But now with Truvada being generic, we will talk about Truvada as being something we start up front because it may have a lower cost and it’s cheaper to the system. Then we can always switch to Descovy as needed.”

This study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Marcus reported receiving fees from Kaiser Permanente Northern California on a research grant from Gilead Sciences. Dr. Krakower reported having conducted research that was funded by Gilead Sciences and Merck, as well as honoraria for medical education content and presentations for Medscape Medical News, MED-IQ, and DKBMed and royalties from work conducted by UpToDate. Mr. Froehle reported receiving fees from Gilead Sciences in connection with a Gilead advisory board.

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

George Froehle, PA, a primary care clinician at CentraCare in rural St. Cloud, Minn., has been prescribing the HIV prevention pill tenofovir disoproxil fumarate plus emtricitabine since it was marketed by the brand name Truvada and the Food and Drug Administration approved it in 2012. But recently, he’s been having conversations with patients about the new HIV prevention pill, tenofovir alafenamide plus emtricitabine (TAF/FTC, Descovy) as well.

“They may have a friend who has heard that Descovy is newer and safer,” Mr. Froehle said. But that’s not necessarily the case, at least according to lab values. A recent study in the journal Open Forum Infectious Diseases suggests that only between 1 in 10 and 1 in 3 switches to the new formulation of HIV pre-exposure prophylaxis (PrEP) are indicated by lab work – and that nearly half of people receiving a prescription for the new version had lab results actually contraindicating the switch.

This, combined with the lower cost of generic Truvada and the steep cost of Descovy, led study coauthor and HIV PrEP prescriber Douglas Krakower, MD, and colleagues to suggest that the generic version should be standard of care for all people on PrEP unless otherwise indicated.

This just “makes good sense,” Dr. Krakower, assistant professor of medicine at Harvard Medical School, Boston, told this news organization.

“It’s important to ultimately allow for patients and providers to have access to all of the PrEP options so they can choose the best option for each person,” he said. “But our data suggest that strategies to optimize the cost-effectiveness of PrEP prescribing, such as formulary interventions and education for patients and providers, could be beneficial – as long as there is an easy mechanism for patients and providers to override restrictions when there are clinical indications.”

Current PrEP guidelines from the Centers for Disease Control and Prevention don’t list a first-line or second-line treatment for PrEP. But recent guidance issued to insurance companies by the Biden administration specifically grants insurers permission to employ stepped formularies and cost sharing.

“Since the branded version of PrEP is not specified in the [U.S. Preventive Services Task Force] recommendation, plans and issuers may cover a generic version of PrEP without cost sharing and impose cost sharing on an equivalent branded version,” the rule, issued July 19, states. “However, plans and insurers must accommodate any individual for whom a particular PrEP medication [generic or brand name] would be medically inappropriate, as determined by the individual’s health care provider, by having a mechanism for waiving the otherwise applicable cost-sharing for the brand or nonpreferred brand version.”

Both drugs have been found to be 99% effective in stopping HIV acquisition in people at risk for it. Descovy is approved specifically for gay and bisexual men, transgender women, and anyone having anal sex. Ongoing studies are looking at the effectiveness of Descovy in people having vaginal sex. Generic Truvada has been approved for all people.
 

The biomarkers of switching

To be clear, both medicines are exceedingly safe, said lead author and epidemiologist Julia Marcus, PhD, MPH, associate professor at Harvard Medical School. Side effects have been mild and include nausea and diarrhea in the first month. What lab work tells clinicians is the potential for physiologic changes, but those changes don’t necessarily translate to clinical events.

“When I say harmful, I mean potentially harmful,” she said in an interview. “It’s really based on these incremental changes that maybe, in the long run, could be harmful.”

But she added that there are two types of damage from medicines: “There’s potential physiological damage, but there’s also potential financial damage.” While generic Truvada has a list price as low as $30 a bottle, Descovy has a list price of up to $2,000 a month. And the push for PrEP is growing. Recently, the head of the division of HIV/AIDS at the National Institute of Allergy and Infectious Diseases urged providers to get all their “HIV-negative, at-risk patients on PrEP tomorrow,” in light of the latest HIV vaccine failure.

So Dr. Marcus and team looked at data from the 2892 people who started taking PrEP in the year before the FDA approved Descovy in October 2019. Participants accessed PrEP through Fenway Health, a Boston-area health clinic serving a largely gay, lesbian, bisexual, transgender, and otherwise queer population, and the largest PrEP prescriber in New England. They then tracked which participants switched to Descovy and correlated the switches to lab work and CDC guidance for PrEP.

What they found was that just 11.9% of participants, or 343 people, switched to the newer formulation. That’s lower than the 27.2% who switched in nationally available data, which were released at a recent HIV conference. But when Dr. Krakower and colleagues looked at whether their PrEP prescriptions were appropriate based on the patients’ lab work, the findings were mixed.

On the one hand, they showed that 24 of those 343 people who switched to Descovy had creatinine clearance levels or bone mineral density measurements low enough to make the switch a good option. But that’s just 7% of all people who switched. They then ran a secondary model, in which they broadened the criteria for a switch from strictly those lab values to conditions that might indicate borderline kidney function, which could eventually lead to kidney damage. These included diagnoses of hypertension or diabetes, or borderline creatinine levels between 60 and 70 mL/minute.

“Even when we defined clinical indications as generously as we could, we still saw that only a minority had clinical indications for switching,” said “Most of the switching to TAF/FTC was potentially unnecessary, and some of it may have been harmful for people who had cardiovascular risk factors.”

That’s because although Descovy doesn’t affect renal and bone mineral markers, it does affect cholesterol levels and weight. Aftermarket and FDA data revealed a small but noticeable increase in statin use among people taking the new brand-name PrEP pill. When Marcus and colleagues looked for those biomarkers – total cholesterol greater than200, BMI of 30 or more, LDL cholesterol of more than 160 or HDL cholesterol of less than 40 – 14% of switches fit the criteria for contraindications for Descovy. That’s 10 times the rate of potential harm in switching as there was for those who stayed on the generic Truvada and would have been better served on Descovy. That came in at just 1.4%.

“There may be many reasons why patients or providers might choose to switch that we couldn’t document in our study,” she said. For instance, the newer formulation, Descovy, is a significantly smaller pill than the generic is. Or the perception of novelty might drive some switches.

“But I think we need qualitative work to understand how these decisions are being made,” she said in an interview. “It will be important to follow these patients to see what happens in terms of clinical outcomes.”

For his part, Mr. Froehle found the study intriguing. It reflects his own thinking around the value of the newer formulation. He also prescribes for people living with HIV. For them, the benefit of the new formulation of tenofovir present in Descovy has clear clinical relevance. After all, people living with HIV can be on their drug regimens for decades.

But people on PrEP aren’t likely to be on the pills as long, and so the real benefit of the newer, more expensive formulation is less clear. And he added that he’s already getting “pushback” from some insurance companies on the name-brand version, with companies asking for proof via lab values that a person has a history of kidney impairment or bone mineral density loss.

“It doesn’t happen a ton,” he said. “But it’s starting to happen, and normally it kind of builds from there.”

So when a patient comes in and asks specifically for Descovy, he usually will talk to them about it.

“If it’s what the patient wants and insurance covers it and it’s not unsafe for them to be on it, there might not be a reason to not prescribe Descovy,” said Mr. Froehle, who served as a sub-principal investigator for the DISCOVER clinical trial that showed the new PrEP was as effective as Truvada. “But now with Truvada being generic, we will talk about Truvada as being something we start up front because it may have a lower cost and it’s cheaper to the system. Then we can always switch to Descovy as needed.”

This study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Marcus reported receiving fees from Kaiser Permanente Northern California on a research grant from Gilead Sciences. Dr. Krakower reported having conducted research that was funded by Gilead Sciences and Merck, as well as honoraria for medical education content and presentations for Medscape Medical News, MED-IQ, and DKBMed and royalties from work conducted by UpToDate. Mr. Froehle reported receiving fees from Gilead Sciences in connection with a Gilead advisory board.

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

Two new cases of a mysterious virus have been reported by the Alaska Department of Health and Social Services. Both people were diagnosed after receiving urgent care in a Fairbanks-area clinic. One was a child with a sore on the left elbow, along with fever and swollen lymph nodes. And the other was an unrelated middle-aged woman with a pox mark on her leg, swollen lymph nodes, and joint pain. In both cases, symptoms improved within 3 weeks.

This isn’t the first time the so-called Alaskapox virus has been detected in the region. In 2015, a woman living near Fairbanks turned up at her doctor’s office with a single reddened pox-like mark on her upper arm and a feeling of fatigue.

Sampling of the pox mark showed that it was caused by a previously unidentified virus of the same family as smallpox and cowpox.

Five years later, another woman showed up with similar signs and symptoms, and her pox also proved to be the result of what public health experts started calling the Alaskapox virus.

In both cases, the women recovered completely.
 

Smallpox-like illness

Public health sleuths figured out that in three of the four cases, the patients lived in a home with a cat or cats, and one of these cats was known to hunt small animals.

Experts already knew that cats mingling in cow pastures and sickened by cattle virus had helped cowpox make the leap from bovines to humans. And just as in the case of cowpox, they suspected that cats might again be spreading this new virus to people, too.

All four of the infected people lived in sparsely populated areas amid forests. Officials laid animal traps where some of the affected people lived and identified the virus in several species of small wild animals.

The animals that turned up most often with Alaskapox were small mouse-like voles. The rodents with rounded muzzles are known for burrowing in the region. And scientists suspect the Alaskapox virus makes its way from these wild animals to humans through their pet cats or possibly by direct exposure outdoors.

None of the four people identified so far with Alaskapox knew each other or interacted, so officials also suspect that there are more cases going unrecognized, possibly because the symptoms are mild or nonexistent.

There are no documented cases of person-to-person transmission of Alaskapox, according to public health officials monitoring the small number of cases. But other pox viruses can spread by direct contact with skin lesions, so clinicians are recommending that people cover wounds with bandages. Three of the people with Alaskapox mistook their lesions at first for a bite from a spider or insect.

A version of this article first appeared on WebMD.com.

Two new cases of a mysterious virus have been reported by the Alaska Department of Health and Social Services. Both people were diagnosed after receiving urgent care in a Fairbanks-area clinic. One was a child with a sore on the left elbow, along with fever and swollen lymph nodes. And the other was an unrelated middle-aged woman with a pox mark on her leg, swollen lymph nodes, and joint pain. In both cases, symptoms improved within 3 weeks.

This isn’t the first time the so-called Alaskapox virus has been detected in the region. In 2015, a woman living near Fairbanks turned up at her doctor’s office with a single reddened pox-like mark on her upper arm and a feeling of fatigue.

Sampling of the pox mark showed that it was caused by a previously unidentified virus of the same family as smallpox and cowpox.

Five years later, another woman showed up with similar signs and symptoms, and her pox also proved to be the result of what public health experts started calling the Alaskapox virus.

In both cases, the women recovered completely.
 

Smallpox-like illness

Public health sleuths figured out that in three of the four cases, the patients lived in a home with a cat or cats, and one of these cats was known to hunt small animals.

Experts already knew that cats mingling in cow pastures and sickened by cattle virus had helped cowpox make the leap from bovines to humans. And just as in the case of cowpox, they suspected that cats might again be spreading this new virus to people, too.

All four of the infected people lived in sparsely populated areas amid forests. Officials laid animal traps where some of the affected people lived and identified the virus in several species of small wild animals.

The animals that turned up most often with Alaskapox were small mouse-like voles. The rodents with rounded muzzles are known for burrowing in the region. And scientists suspect the Alaskapox virus makes its way from these wild animals to humans through their pet cats or possibly by direct exposure outdoors.

None of the four people identified so far with Alaskapox knew each other or interacted, so officials also suspect that there are more cases going unrecognized, possibly because the symptoms are mild or nonexistent.

There are no documented cases of person-to-person transmission of Alaskapox, according to public health officials monitoring the small number of cases. But other pox viruses can spread by direct contact with skin lesions, so clinicians are recommending that people cover wounds with bandages. Three of the people with Alaskapox mistook their lesions at first for a bite from a spider or insect.

A version of this article first appeared on WebMD.com.

Two new cases of a mysterious virus have been reported by the Alaska Department of Health and Social Services. Both people were diagnosed after receiving urgent care in a Fairbanks-area clinic. One was a child with a sore on the left elbow, along with fever and swollen lymph nodes. And the other was an unrelated middle-aged woman with a pox mark on her leg, swollen lymph nodes, and joint pain. In both cases, symptoms improved within 3 weeks.

This isn’t the first time the so-called Alaskapox virus has been detected in the region. In 2015, a woman living near Fairbanks turned up at her doctor’s office with a single reddened pox-like mark on her upper arm and a feeling of fatigue.

Sampling of the pox mark showed that it was caused by a previously unidentified virus of the same family as smallpox and cowpox.

Five years later, another woman showed up with similar signs and symptoms, and her pox also proved to be the result of what public health experts started calling the Alaskapox virus.

In both cases, the women recovered completely.
 

Smallpox-like illness

Public health sleuths figured out that in three of the four cases, the patients lived in a home with a cat or cats, and one of these cats was known to hunt small animals.

Experts already knew that cats mingling in cow pastures and sickened by cattle virus had helped cowpox make the leap from bovines to humans. And just as in the case of cowpox, they suspected that cats might again be spreading this new virus to people, too.

All four of the infected people lived in sparsely populated areas amid forests. Officials laid animal traps where some of the affected people lived and identified the virus in several species of small wild animals.

The animals that turned up most often with Alaskapox were small mouse-like voles. The rodents with rounded muzzles are known for burrowing in the region. And scientists suspect the Alaskapox virus makes its way from these wild animals to humans through their pet cats or possibly by direct exposure outdoors.

None of the four people identified so far with Alaskapox knew each other or interacted, so officials also suspect that there are more cases going unrecognized, possibly because the symptoms are mild or nonexistent.

There are no documented cases of person-to-person transmission of Alaskapox, according to public health officials monitoring the small number of cases. But other pox viruses can spread by direct contact with skin lesions, so clinicians are recommending that people cover wounds with bandages. Three of the people with Alaskapox mistook their lesions at first for a bite from a spider or insect.

A version of this article first appeared on WebMD.com.

My co-authors and I appreciate the excellent comments regarding our Photo Rounds column, “Foot rash and joint pain,” and would like to provide some additional detail.

After our patient’s 27-day hospital stay, he was admitted to a rehabilitation center for continued inpatient physical therapy for 14 days due to weakness and deconditioning. Following his discharge from the rehabilitation center, the patient was still confined to a wheelchair. He was prescribed an oral prednisone taper (as mentioned in our article) and celecoxib 200 mg bid and referred for outpatient physical therapy. At a follow-up appointment with the rheumatologist, he received adalimumab 80 mg followed by 40 mg every other week, which led to improvement in his range of motion and pain. Two months after outpatient physical therapy, the patient was lost to follow-up.

We agree with Dr. Hahn et al that many of these patients with chlamydia-associated ReA become “long-haulers.” In medicine—especially when rare diseases are considered—we must often make decisions without perfect science. The studies referenced by Dr. Hahn et al suggest that combinations of doxycycline and rifampin or azithromycin and rifampin may treat not only chlamydial infection, but ReA and associated cutaneous disease, as well.^1,2 While these studies are small in size, larger studies may never be funded. We agree that combination therapy should be considered in this population of patients.

Hannah R. Badon, MD
Ross L. Pearlman, MD
Robert T. Brodell, MD
Jackson, MS

My co-authors and I appreciate the excellent comments regarding our Photo Rounds column, “Foot rash and joint pain,” and would like to provide some additional detail.

After our patient’s 27-day hospital stay, he was admitted to a rehabilitation center for continued inpatient physical therapy for 14 days due to weakness and deconditioning. Following his discharge from the rehabilitation center, the patient was still confined to a wheelchair. He was prescribed an oral prednisone taper (as mentioned in our article) and celecoxib 200 mg bid and referred for outpatient physical therapy. At a follow-up appointment with the rheumatologist, he received adalimumab 80 mg followed by 40 mg every other week, which led to improvement in his range of motion and pain. Two months after outpatient physical therapy, the patient was lost to follow-up.

We agree with Dr. Hahn et al that many of these patients with chlamydia-associated ReA become “long-haulers.” In medicine—especially when rare diseases are considered—we must often make decisions without perfect science. The studies referenced by Dr. Hahn et al suggest that combinations of doxycycline and rifampin or azithromycin and rifampin may treat not only chlamydial infection, but ReA and associated cutaneous disease, as well.^1,2 While these studies are small in size, larger studies may never be funded. We agree that combination therapy should be considered in this population of patients.

Hannah R. Badon, MD
Ross L. Pearlman, MD
Robert T. Brodell, MD
Jackson, MS

My co-authors and I appreciate the excellent comments regarding our Photo Rounds column, “Foot rash and joint pain,” and would like to provide some additional detail.

After our patient’s 27-day hospital stay, he was admitted to a rehabilitation center for continued inpatient physical therapy for 14 days due to weakness and deconditioning. Following his discharge from the rehabilitation center, the patient was still confined to a wheelchair. He was prescribed an oral prednisone taper (as mentioned in our article) and celecoxib 200 mg bid and referred for outpatient physical therapy. At a follow-up appointment with the rheumatologist, he received adalimumab 80 mg followed by 40 mg every other week, which led to improvement in his range of motion and pain. Two months after outpatient physical therapy, the patient was lost to follow-up.

We agree with Dr. Hahn et al that many of these patients with chlamydia-associated ReA become “long-haulers.” In medicine—especially when rare diseases are considered—we must often make decisions without perfect science. The studies referenced by Dr. Hahn et al suggest that combinations of doxycycline and rifampin or azithromycin and rifampin may treat not only chlamydial infection, but ReA and associated cutaneous disease, as well.^1,2 While these studies are small in size, larger studies may never be funded. We agree that combination therapy should be considered in this population of patients.

Hannah R. Badon, MD
Ross L. Pearlman, MD
Robert T. Brodell, MD
Jackson, MS

In medicine—especially when rare diseases are considered—we must often make decisions without perfect science.

In the June Photo Rounds column, “Foot rash and joint pain” (J Fam Pract. 2021;70:249-251), Badon et al presented a case of ­chlamydia-associated reactive arthritis (ReA), formerly called Reiter syndrome, in a 21-year-old man following Chlamydia trachomatis urethritis. We would like to point out that, contrary to the conventional definition of ReA, in which the causative pathogen can’t be cultured from the affected joints,¹ chlamydia-associated ReA is associated with evidence of chronic joint infection that, while not cultivable, can be confirmed by real-time polymerase chain reaction testing of metabolically active pathogens in synovial tissue and/or fluid.²

C trachomatis and C pneumoniae are the most frequent causative pathogens to elicit ReA.³ Short-course antibiotics and anti-­inflammatory treatments can palliate ReA, but these treatments often do not provide a cure.³ Two controlled clinical trials demonstrated that chlamydia-associated ReA can be treated successfully with longer-term combination antibiotic therapy.^4,5 ReA is usually diagnosed in the acute stage (first 6 months) and can become chronic in 30% of cases.⁶ It would be interesting to know the long-term treatment and outcome data for the case patient.

David L. Hahn, MD, MS
Alan P. Hudson, PhD
Charles Stratton, MD
Wilmore Webley, PhD
Judith Whittum-Hudson, PhD

In medicine—especially when rare diseases are considered—we must often make decisions without perfect science.

In the June Photo Rounds column, “Foot rash and joint pain” (J Fam Pract. 2021;70:249-251), Badon et al presented a case of ­chlamydia-associated reactive arthritis (ReA), formerly called Reiter syndrome, in a 21-year-old man following Chlamydia trachomatis urethritis. We would like to point out that, contrary to the conventional definition of ReA, in which the causative pathogen can’t be cultured from the affected joints,¹ chlamydia-associated ReA is associated with evidence of chronic joint infection that, while not cultivable, can be confirmed by real-time polymerase chain reaction testing of metabolically active pathogens in synovial tissue and/or fluid.²

C trachomatis and C pneumoniae are the most frequent causative pathogens to elicit ReA.³ Short-course antibiotics and anti-­inflammatory treatments can palliate ReA, but these treatments often do not provide a cure.³ Two controlled clinical trials demonstrated that chlamydia-associated ReA can be treated successfully with longer-term combination antibiotic therapy.^4,5 ReA is usually diagnosed in the acute stage (first 6 months) and can become chronic in 30% of cases.⁶ It would be interesting to know the long-term treatment and outcome data for the case patient.

David L. Hahn, MD, MS
Alan P. Hudson, PhD
Charles Stratton, MD
Wilmore Webley, PhD
Judith Whittum-Hudson, PhD

In medicine—especially when rare diseases are considered—we must often make decisions without perfect science.

In the June Photo Rounds column, “Foot rash and joint pain” (J Fam Pract. 2021;70:249-251), Badon et al presented a case of ­chlamydia-associated reactive arthritis (ReA), formerly called Reiter syndrome, in a 21-year-old man following Chlamydia trachomatis urethritis. We would like to point out that, contrary to the conventional definition of ReA, in which the causative pathogen can’t be cultured from the affected joints,¹ chlamydia-associated ReA is associated with evidence of chronic joint infection that, while not cultivable, can be confirmed by real-time polymerase chain reaction testing of metabolically active pathogens in synovial tissue and/or fluid.²

C trachomatis and C pneumoniae are the most frequent causative pathogens to elicit ReA.³ Short-course antibiotics and anti-­inflammatory treatments can palliate ReA, but these treatments often do not provide a cure.³ Two controlled clinical trials demonstrated that chlamydia-associated ReA can be treated successfully with longer-term combination antibiotic therapy.^4,5 ReA is usually diagnosed in the acute stage (first 6 months) and can become chronic in 30% of cases.⁶ It would be interesting to know the long-term treatment and outcome data for the case patient.

David L. Hahn, MD, MS
Alan P. Hudson, PhD
Charles Stratton, MD
Wilmore Webley, PhD
Judith Whittum-Hudson, PhD

Cobra the dog has been hard at work at the Miami International Airport, sniffing masks proffered by American Airlines employees making their way through a security checkpoint. If she identifies a specific scent, she’ll let her handler know simply by sitting down. When this good girl sits, that means Cobra has detected an olfactory signal of the coronavirus, the virus that causes COVID-19.

Cobra, a Belgian Malinois, is one of two canines – her partner is One Betta, a Dutch shepherd – working this checkpoint at Miami International. They are part of a pilot program with the Global Forensic and Justice Center at Florida International University, using the detection dogs as a quick screen for people who have COVID-19.

Their detection rate is high, at more than 98%, and the program has been such a success that it’s being extended for another month at the airport.

If these two dogs continue to accurately detect COVID-19, they and other canines with similar training could be deployed to other places with lots of people coming and going at once, including other airports or even schools. In fact, COVID-sniffing dogs are in use in some university classrooms already.

But building up a big brigade of live animals as disease detectors involves some thorny issues, including where the animals retire once their careers are complete.

“When COVID first arose, we said let’s see if we can train these two dogs on either the virus or the odor of COVID-19,” says Kenneth Furton, PhD, a professor of chemistry and biochemistry, provost, and executive vice president at Florida International University.

His team had completed a study with what he calls “medical detector dogs,” animals that might be able to detect the odor of someone having a seizure. That led them to see how well the animals could detect other kinds of disorders.

Training a dog to sniff out specific odors starts with getting them to understand the task in general. Dr. Furton says that the animals first are trained to grasp that their job is to detect one odor among many. Once the dogs grasp that, they can be trained on just about any specific odor.

In fact, in addition to detecting seizures, dogs reportedly have been able to identify diabetes and even some cancers, such as ovarian cancer.

Dr. Furton says he’s not aware of any previous use of dogs to screen for infectious disease. That may simply be because nothing recently has struck with the global ferocity of COVID, driving humans to turn to their best friends for help.

Cobra and One Betta got their start learning to identify the presence of laurel wilt, a fungus that attacks avocado trees and kills them, costing Florida growers millions. With that expertise under their collars, the two dogs need only a few weeks to get good at detecting other smells assigned to them.
 

Training the dogs, safely

To train Cobra and One Betta on COVID-19 odors, Dr. Furton’s team first acquired mask samples from people hospitalized with COVID and people who did not have the disease. In battling the viruses, people produce certain chemicals that they exhale every time they breathe. When Dr. Furton and his colleagues compared the exhaled components trapped in the masks, they found differences between masks from people with COVID and those without.

Having confirmed that exhalations can be COVID-specific, the research team trained four dogs – Cobra, One Betta, Hubble, and Max – to detect masks from people with COVID among an assortment of mask choices. Before this step, though, the researchers made sure that any trace of active virus was destroyed by ultraviolet light so that the dogs would not be infected.

Each time the dogs accurately selected a mask from a COVID patient, their reward was access to a favorite toy: A red ball to chew on. Although all four dogs performed very well, yes, they did, Cobra and One Betta showed the most accuracy, outperforming their training colleagues. From their training scores, Cobra ranked first, with 99.45% accuracy. Despite her name, says Dr. Furton, One Betta was “not one better,” coming in second at 98.1%, which is still quite high.

Both dogs are good at their airport screening duties. If one of them sits after sniffing a mask at the checkpoint, the next step is for the mask owner to be tested.

From Aug. 23 to Sept. 8, the two canines screened 1,093 people during 8 working days, alerting on only one case, according to Greg Chin, communications director for the Miami-Dade Aviation Department. That person had tested positive for COVID 2 weeks earlier and was returning to work after quarantine, and their rapid test after the dog alerted was negative.

Dr. Furton says that there are some reports of dogs also alerting before tests can show a positive result, suggesting the dogs’ odor detection can be more precise. They hope to expand their study to see how tight the window of dog-based detection is.

For now, the detector dogs are doing so well that the program has been extended for 30 more days, Mr. Chin says.

As promising as this seems, using dogs for screening carries some logistical and ethical tangles. Training a canine army to deploy for high-volume detection points means that once the work is done, a whole lot of dogs will need a safe place to retire. In addition, the initial training takes several months, says Dr. Furton, whereas if a device were developed for screening, manufacturing could likely be ramped up quickly to meet demand.

The dogs might not need to retire right away, though.

“We envision that they could be redeployed to another type of detection for another infectious disease” if the need arises, Dr. Furton says. But in the end, when working with dogs, he says, there is “a moral connection that you don’t have to deal with using instruments.”

Although the pilot screening at Miami International is the first airport test, the dogs have also done this work in other venues, including at a state emergency operations center in Florida and in some university classrooms, says Dr. Furton.

A version of this article first appeared on WebMD.com.

Cobra the dog has been hard at work at the Miami International Airport, sniffing masks proffered by American Airlines employees making their way through a security checkpoint. If she identifies a specific scent, she’ll let her handler know simply by sitting down. When this good girl sits, that means Cobra has detected an olfactory signal of the coronavirus, the virus that causes COVID-19.

Cobra, a Belgian Malinois, is one of two canines – her partner is One Betta, a Dutch shepherd – working this checkpoint at Miami International. They are part of a pilot program with the Global Forensic and Justice Center at Florida International University, using the detection dogs as a quick screen for people who have COVID-19.

Their detection rate is high, at more than 98%, and the program has been such a success that it’s being extended for another month at the airport.

If these two dogs continue to accurately detect COVID-19, they and other canines with similar training could be deployed to other places with lots of people coming and going at once, including other airports or even schools. In fact, COVID-sniffing dogs are in use in some university classrooms already.

But building up a big brigade of live animals as disease detectors involves some thorny issues, including where the animals retire once their careers are complete.

“When COVID first arose, we said let’s see if we can train these two dogs on either the virus or the odor of COVID-19,” says Kenneth Furton, PhD, a professor of chemistry and biochemistry, provost, and executive vice president at Florida International University.

His team had completed a study with what he calls “medical detector dogs,” animals that might be able to detect the odor of someone having a seizure. That led them to see how well the animals could detect other kinds of disorders.

Training a dog to sniff out specific odors starts with getting them to understand the task in general. Dr. Furton says that the animals first are trained to grasp that their job is to detect one odor among many. Once the dogs grasp that, they can be trained on just about any specific odor.

In fact, in addition to detecting seizures, dogs reportedly have been able to identify diabetes and even some cancers, such as ovarian cancer.

Dr. Furton says he’s not aware of any previous use of dogs to screen for infectious disease. That may simply be because nothing recently has struck with the global ferocity of COVID, driving humans to turn to their best friends for help.

Cobra and One Betta got their start learning to identify the presence of laurel wilt, a fungus that attacks avocado trees and kills them, costing Florida growers millions. With that expertise under their collars, the two dogs need only a few weeks to get good at detecting other smells assigned to them.
 

Training the dogs, safely

To train Cobra and One Betta on COVID-19 odors, Dr. Furton’s team first acquired mask samples from people hospitalized with COVID and people who did not have the disease. In battling the viruses, people produce certain chemicals that they exhale every time they breathe. When Dr. Furton and his colleagues compared the exhaled components trapped in the masks, they found differences between masks from people with COVID and those without.

Having confirmed that exhalations can be COVID-specific, the research team trained four dogs – Cobra, One Betta, Hubble, and Max – to detect masks from people with COVID among an assortment of mask choices. Before this step, though, the researchers made sure that any trace of active virus was destroyed by ultraviolet light so that the dogs would not be infected.

Each time the dogs accurately selected a mask from a COVID patient, their reward was access to a favorite toy: A red ball to chew on. Although all four dogs performed very well, yes, they did, Cobra and One Betta showed the most accuracy, outperforming their training colleagues. From their training scores, Cobra ranked first, with 99.45% accuracy. Despite her name, says Dr. Furton, One Betta was “not one better,” coming in second at 98.1%, which is still quite high.

Both dogs are good at their airport screening duties. If one of them sits after sniffing a mask at the checkpoint, the next step is for the mask owner to be tested.

From Aug. 23 to Sept. 8, the two canines screened 1,093 people during 8 working days, alerting on only one case, according to Greg Chin, communications director for the Miami-Dade Aviation Department. That person had tested positive for COVID 2 weeks earlier and was returning to work after quarantine, and their rapid test after the dog alerted was negative.

Dr. Furton says that there are some reports of dogs also alerting before tests can show a positive result, suggesting the dogs’ odor detection can be more precise. They hope to expand their study to see how tight the window of dog-based detection is.

For now, the detector dogs are doing so well that the program has been extended for 30 more days, Mr. Chin says.

As promising as this seems, using dogs for screening carries some logistical and ethical tangles. Training a canine army to deploy for high-volume detection points means that once the work is done, a whole lot of dogs will need a safe place to retire. In addition, the initial training takes several months, says Dr. Furton, whereas if a device were developed for screening, manufacturing could likely be ramped up quickly to meet demand.

The dogs might not need to retire right away, though.

“We envision that they could be redeployed to another type of detection for another infectious disease” if the need arises, Dr. Furton says. But in the end, when working with dogs, he says, there is “a moral connection that you don’t have to deal with using instruments.”

Although the pilot screening at Miami International is the first airport test, the dogs have also done this work in other venues, including at a state emergency operations center in Florida and in some university classrooms, says Dr. Furton.

A version of this article first appeared on WebMD.com.

Cobra the dog has been hard at work at the Miami International Airport, sniffing masks proffered by American Airlines employees making their way through a security checkpoint. If she identifies a specific scent, she’ll let her handler know simply by sitting down. When this good girl sits, that means Cobra has detected an olfactory signal of the coronavirus, the virus that causes COVID-19.

Cobra, a Belgian Malinois, is one of two canines – her partner is One Betta, a Dutch shepherd – working this checkpoint at Miami International. They are part of a pilot program with the Global Forensic and Justice Center at Florida International University, using the detection dogs as a quick screen for people who have COVID-19.

Their detection rate is high, at more than 98%, and the program has been such a success that it’s being extended for another month at the airport.

If these two dogs continue to accurately detect COVID-19, they and other canines with similar training could be deployed to other places with lots of people coming and going at once, including other airports or even schools. In fact, COVID-sniffing dogs are in use in some university classrooms already.

But building up a big brigade of live animals as disease detectors involves some thorny issues, including where the animals retire once their careers are complete.

“When COVID first arose, we said let’s see if we can train these two dogs on either the virus or the odor of COVID-19,” says Kenneth Furton, PhD, a professor of chemistry and biochemistry, provost, and executive vice president at Florida International University.

His team had completed a study with what he calls “medical detector dogs,” animals that might be able to detect the odor of someone having a seizure. That led them to see how well the animals could detect other kinds of disorders.

Training a dog to sniff out specific odors starts with getting them to understand the task in general. Dr. Furton says that the animals first are trained to grasp that their job is to detect one odor among many. Once the dogs grasp that, they can be trained on just about any specific odor.

In fact, in addition to detecting seizures, dogs reportedly have been able to identify diabetes and even some cancers, such as ovarian cancer.

Dr. Furton says he’s not aware of any previous use of dogs to screen for infectious disease. That may simply be because nothing recently has struck with the global ferocity of COVID, driving humans to turn to their best friends for help.

Cobra and One Betta got their start learning to identify the presence of laurel wilt, a fungus that attacks avocado trees and kills them, costing Florida growers millions. With that expertise under their collars, the two dogs need only a few weeks to get good at detecting other smells assigned to them.
 

Training the dogs, safely

To train Cobra and One Betta on COVID-19 odors, Dr. Furton’s team first acquired mask samples from people hospitalized with COVID and people who did not have the disease. In battling the viruses, people produce certain chemicals that they exhale every time they breathe. When Dr. Furton and his colleagues compared the exhaled components trapped in the masks, they found differences between masks from people with COVID and those without.

Having confirmed that exhalations can be COVID-specific, the research team trained four dogs – Cobra, One Betta, Hubble, and Max – to detect masks from people with COVID among an assortment of mask choices. Before this step, though, the researchers made sure that any trace of active virus was destroyed by ultraviolet light so that the dogs would not be infected.

Each time the dogs accurately selected a mask from a COVID patient, their reward was access to a favorite toy: A red ball to chew on. Although all four dogs performed very well, yes, they did, Cobra and One Betta showed the most accuracy, outperforming their training colleagues. From their training scores, Cobra ranked first, with 99.45% accuracy. Despite her name, says Dr. Furton, One Betta was “not one better,” coming in second at 98.1%, which is still quite high.

Both dogs are good at their airport screening duties. If one of them sits after sniffing a mask at the checkpoint, the next step is for the mask owner to be tested.

From Aug. 23 to Sept. 8, the two canines screened 1,093 people during 8 working days, alerting on only one case, according to Greg Chin, communications director for the Miami-Dade Aviation Department. That person had tested positive for COVID 2 weeks earlier and was returning to work after quarantine, and their rapid test after the dog alerted was negative.

Dr. Furton says that there are some reports of dogs also alerting before tests can show a positive result, suggesting the dogs’ odor detection can be more precise. They hope to expand their study to see how tight the window of dog-based detection is.

For now, the detector dogs are doing so well that the program has been extended for 30 more days, Mr. Chin says.

As promising as this seems, using dogs for screening carries some logistical and ethical tangles. Training a canine army to deploy for high-volume detection points means that once the work is done, a whole lot of dogs will need a safe place to retire. In addition, the initial training takes several months, says Dr. Furton, whereas if a device were developed for screening, manufacturing could likely be ramped up quickly to meet demand.

The dogs might not need to retire right away, though.

“We envision that they could be redeployed to another type of detection for another infectious disease” if the need arises, Dr. Furton says. But in the end, when working with dogs, he says, there is “a moral connection that you don’t have to deal with using instruments.”

Although the pilot screening at Miami International is the first airport test, the dogs have also done this work in other venues, including at a state emergency operations center in Florida and in some university classrooms, says Dr. Furton.

A version of this article first appeared on WebMD.com.