CASE Pregnant woman with symptoms of genital infection

A 23-year-old primigravid woman at 15 weeks and 2 days’ gestation reported having a 2-week history of increased urinary frequency and vaginal discharge. She said she experienced similar symptoms 6 weeks previously that resolved within a week. The patient has had 3 sexual partners in the past year. Her current partner was experiencing a yellow urethral discharge and dysuria. On the patient’s speculum examination, the clinician noted a yellow-green discharge emanating from the cervix as well as cervical motion tenderness.

What is the most likely diagnosis, and how would you treat this patient?
 

The culprit was chlamydia

Chlamydia trachomatis is an obligate intracellular bacterium that does not stain with Gram staining. A rigid cell wall encloses its intracellular component. C trachomatis infection begins when the chlamydial elementary body enters a susceptible host cell.

Once ingested, the organism’s surface antigens (major outer membrane protein and lipopolysaccharide antigens) provide intracellular sanctuary for the bacterium by inhibiting phagolysosomal fusion. Subsequently, the elementary body morphs into a reticular body, which replicates through adenosine triphosphate (ATP)–dependent binary fission. After approximately 48 hours of replication, the organism again morphs into an elementary body and is released to infect additional cells and acquire new ATP stores for further replication.

Chlamydia can be transmitted horizontally during oral, vaginal, or anal intercourse or vertically to the infant during vaginal delivery.

The US’s most common notifiable disease

According to the Centers for Disease Control and Prevention (CDC), the incidence of chlamydia infection in the United States increased considerably in recent years: from 976,455 cases in 2005 to 1,758,668 cases in 2018.¹ In 2018, rates of chlamydia infection in women were nearly double the rates in men, with an incidence of 688.2 versus 377.5 per 100,000 cases, and a prevalence of 1,150,672 versus 612,020.¹

Young adults have a higher frequency of chlamydia infection than any other age group. From 2017 to 2018, reported cases in women aged 15–19 years increased by 1.3%, to 3,306.8 per 100,000; in women aged 20–24 years, cases increased by 0.8%, to 4,064.6 per 100,000. In young men in the same age ranges, reported cases increased by 3.7%, to 959.0 cases per 100,000, and by 3.3%, to 1,784.5 per 100,000 cases, respectively.¹

Both the incidence and prevalence of chlamydia infection are higher in African Americans than in whites, while Asians have the lowest rates.¹ The prevalence of infection also is increased with incarceration, lower socioeconomic status, and residence in the southern United States.

The prevalence of chlamydia infection in pregnant women is approximately 2% to 3%, but it may be as high as 30% in high-risk populations, such as women who are unmarried, have multiple sex partners, are coinfected with another sexually transmitted disease (STD), have partners with nongonococcal urethritis, have mucopurulent discharge, have acute urethral syndrome, and have late or no prenatal care.² Since chlamydia infection often is asymptomatic and some infections resolve spontaneously, the true prevalence of infection probably is underreported.

Continue to: Chlamydia infection can cause serious clinical manifestations...

Chlamydia infection can cause serious clinical manifestations

The 15 serotypes of C trachomatis are grouped into 3 categories according to clinical manifestations:

• Serotypes A, B, Ba, and C cause endemic trachoma, characterized by bilateral irritation of the eyelids that progresses to eyelid thickening and scarring, eventually leading to corneal abrasion and blindness.
• Serotypes D–K manifest as conjunctivitis and pneumonia in newborns, proctitis in men (especially in men who have sex with men), and genitourinary infections in women. Reactive arthritis and inclusion conjunctivitis also can occur with D–K serotypes.
• Serotypes L1–L3 cause lymphogranuloma venereum.

About 70% of women with chlamydia infection are asymptomatic. Those who have symptoms often present with endocervicitis or acute urethral syndrome (acute urethritis). Manifestations of these 2 conditions include a frothy yellow-green vaginal and/or urethral discharge, dysuria, and frequency. Women who engage in rectal intercourse also may notice a purulent discharge from the anus. Untreated, C trachomatis organisms may ascend the reproductive tract, causing both endometritis and pelvic inflammatory disease (PID).

While a single episode of PID increases tubal infertility risk by 10%, a second episode increases the risk by 40%.³ Over time, recurrent and/or chronic PID causes scarring and adhesion formation, which may result in chronic pelvic pain. In addition, chronic infection is the single most important risk factor for ectopic pregnancy. Finally, chlamydia infection is a risk factor for Fitz-Hugh-Cutis syndrome (perihepatitis). In this condition, organisms ascend from the site of pelvic infection along the pericolic gutter to ultimately infect the liver capsule.

Specific complications in pregnancy

Chlamydia infection in pregnant women is associated with preterm delivery and preterm premature rupture of membranes. Infants born to mothers with untreated chlamydia infection are at risk for pneumonia, conjunctivitis, and even perinatal death.² Acquisition of infection occurs at the time of delivery rather than in the antepartum period.

The significant morbidity associated with chlamydia infection underscores the importance of regular screening, especially in pregnant women. The current United States Preventive Service Task Force guidelines recommend annual screening of all sexually active women who are 24 years of age or younger, as well as of older, high-risk women.

The CDC recommends routine screening of all pregnant women for chlamydia at the first prenatal visit. Repeat screening is recommended in the third trimester for all pregnant women younger than 25 years, those at increased risk, and those infected within the past 3 to 6 months or during the first trimester. Those who test positive should be retested 3 weeks after completion of treatment.¹

Chlamydia screening strategies

Historically, a chlamydia diagnosis was made by isolating the organisms in tissue culture. In the 1990s, however, that extremely time-consuming and resource-intensive procedure was replaced by nucleic acid amplification testing (NAAT).

NAAT methodology. NAAT is the gold standard for diagnosing C trachomatis infection; this methodology utilizes various assays, including polymerase chain reaction, ligase chain reaction, and transcription-mediated amplification.

Continue to: Compared with previous culture and antigen detection techniques...

Compared with previous culture and antigen detection techniques, NAAT’s advantages include excellent sensitivity and specificity (>90% and ≥99%, respectively), enabling detection of a low inoculum of organisms in a sample obtained by noninvasive methods, such as first-void urine collection or vaginal swab.^2,4,5 Furthermore, NAAT does not impose any specific storage regulations on collected specimens, is cost effective, and can jointly test for Neisseria gonorrhoeae, which commonly co-infects with C trachomatis.⁶

Screening in pregnancy. In 2012, Blatt and colleagues examined testing patterns in nearly 1.3 million obstetric patients and found that only 59% (761,315) of women were tested for chlamydia at least once in pregnancy.⁷ Only 1 in 3 women were tested during the first prenatal visit, as CDC guidelines recommend. Testing rates declined with increasing age. Of women screened, 3.5% tested positive for chlamydia.⁷ Of these, 3 of 4 were retested at least once, with almost 20% having at least 1 subsequent positive result.⁷

Of note, in a study of women who reported receptive anal intercourse (n = 2,818), 292 women tested positive for chlamydia; 10.4% tested positive in genital-only sites, 58.6% in genital and rectal sites, and 20.5% at the rectal site only.⁸

It is alarming that only 59% of pregnant women are screened for chlamydia given the significant perinatal complications associated with this infection. Barriers to screening pregnant women may include clinician discomfort in discussing STDs and patient refusal of screening. Furthermore, clinicians should routinely ask women about receptive anal sex. Women who report this risk factor should be tested for chlamydia in both the endocervix and rectum.

Retesting and follow-up. After the initial diagnosis of chlamydia, a test of cure 3 weeks after treatment is an important aspect of care. Thus, identifying and overcoming barriers to retesting is important. Clinicians should educate patients about the importance of follow-up. Also consider incorporating the use of home-based, self-obtained vaginal swabs for retesting. Results from 2 randomized trials showed that eliminating a patient’s transportation barriers and providing a home-based alternative to a follow-up visit significantly increased rescreening rates by 33% in STD clinic patients and by 59.2% in family planning clinic patients.⁹

Reinfection risk. The rate of venereal chlamydia transmission in heterosexual partners is 70%. Since sexually active chlamydia-positive patients are at risk for reinfection by their partner after treatment completion, clinicians should refer the sex partners for evaluation. If the sex partners are reluctant to have testing, it is reasonable to provide empiric antibiotic treatment to decrease the risk of re-infection in the patient.⁷ Before doing so, however, make certain that state law permits this practice, and be sure to document the prescribed treatment in the patient’s record.

Continue to: Treatment options...

Treatment options

Prompt treatment of C trachomatis infection is essential to decrease the risk of disease sequelae. Nonpregnant adults can be treated with oral doxycycline 100 mg twice daily for 7 days.

In a head-to-head study performed in a controlled environment that ensured treatment adherence, 97% efficacy was achieved with one oral dose of azithromycin (1 g) compared with 100% efficacy with doxycycline.¹⁰ However, in the real-world setting, imperfect adherence to the multi-day doxycycline regimen is associated with treatment failures. Thus, a single dose of azithromycin is preferable for patients with questionable compliance.¹¹

In obstetric patients, azithromycin and amoxicillin are preferred as first-line agents for treatment of C trachomatis due to their improved safety profile in this demographic. Amoxicillin 500 mg orally 3 times daily for 7 days has 95% efficacy.²

Women allergic to these agents may be treated with an alternative regimen of erythromycin base, 500 mg orally 4 times daily for 7 days, or erythromycin ethylsuccinate, 800 mg orally 4 times daily for 7 days. Erythromycin should be reserved for second-line therapy because of its lower efficacy (64%) and frequent gastrointestinal adverse effects.² Doxycycline is contraindicated in pregnancy because of possible teratogenic effects on the teeth and bone of the fetus.

CASE Pregnant woman with symptoms of genital infection

A 23-year-old primigravid woman at 15 weeks and 2 days’ gestation reported having a 2-week history of increased urinary frequency and vaginal discharge. She said she experienced similar symptoms 6 weeks previously that resolved within a week. The patient has had 3 sexual partners in the past year. Her current partner was experiencing a yellow urethral discharge and dysuria. On the patient’s speculum examination, the clinician noted a yellow-green discharge emanating from the cervix as well as cervical motion tenderness.

What is the most likely diagnosis, and how would you treat this patient?
 

The culprit was chlamydia

Chlamydia trachomatis is an obligate intracellular bacterium that does not stain with Gram staining. A rigid cell wall encloses its intracellular component. C trachomatis infection begins when the chlamydial elementary body enters a susceptible host cell.

Once ingested, the organism’s surface antigens (major outer membrane protein and lipopolysaccharide antigens) provide intracellular sanctuary for the bacterium by inhibiting phagolysosomal fusion. Subsequently, the elementary body morphs into a reticular body, which replicates through adenosine triphosphate (ATP)–dependent binary fission. After approximately 48 hours of replication, the organism again morphs into an elementary body and is released to infect additional cells and acquire new ATP stores for further replication.

Chlamydia can be transmitted horizontally during oral, vaginal, or anal intercourse or vertically to the infant during vaginal delivery.

The US’s most common notifiable disease

According to the Centers for Disease Control and Prevention (CDC), the incidence of chlamydia infection in the United States increased considerably in recent years: from 976,455 cases in 2005 to 1,758,668 cases in 2018.¹ In 2018, rates of chlamydia infection in women were nearly double the rates in men, with an incidence of 688.2 versus 377.5 per 100,000 cases, and a prevalence of 1,150,672 versus 612,020.¹

Young adults have a higher frequency of chlamydia infection than any other age group. From 2017 to 2018, reported cases in women aged 15–19 years increased by 1.3%, to 3,306.8 per 100,000; in women aged 20–24 years, cases increased by 0.8%, to 4,064.6 per 100,000. In young men in the same age ranges, reported cases increased by 3.7%, to 959.0 cases per 100,000, and by 3.3%, to 1,784.5 per 100,000 cases, respectively.¹

Both the incidence and prevalence of chlamydia infection are higher in African Americans than in whites, while Asians have the lowest rates.¹ The prevalence of infection also is increased with incarceration, lower socioeconomic status, and residence in the southern United States.

The prevalence of chlamydia infection in pregnant women is approximately 2% to 3%, but it may be as high as 30% in high-risk populations, such as women who are unmarried, have multiple sex partners, are coinfected with another sexually transmitted disease (STD), have partners with nongonococcal urethritis, have mucopurulent discharge, have acute urethral syndrome, and have late or no prenatal care.² Since chlamydia infection often is asymptomatic and some infections resolve spontaneously, the true prevalence of infection probably is underreported.

Continue to: Chlamydia infection can cause serious clinical manifestations...

Chlamydia infection can cause serious clinical manifestations

The 15 serotypes of C trachomatis are grouped into 3 categories according to clinical manifestations:

• Serotypes A, B, Ba, and C cause endemic trachoma, characterized by bilateral irritation of the eyelids that progresses to eyelid thickening and scarring, eventually leading to corneal abrasion and blindness.
• Serotypes D–K manifest as conjunctivitis and pneumonia in newborns, proctitis in men (especially in men who have sex with men), and genitourinary infections in women. Reactive arthritis and inclusion conjunctivitis also can occur with D–K serotypes.
• Serotypes L1–L3 cause lymphogranuloma venereum.

About 70% of women with chlamydia infection are asymptomatic. Those who have symptoms often present with endocervicitis or acute urethral syndrome (acute urethritis). Manifestations of these 2 conditions include a frothy yellow-green vaginal and/or urethral discharge, dysuria, and frequency. Women who engage in rectal intercourse also may notice a purulent discharge from the anus. Untreated, C trachomatis organisms may ascend the reproductive tract, causing both endometritis and pelvic inflammatory disease (PID).

While a single episode of PID increases tubal infertility risk by 10%, a second episode increases the risk by 40%.³ Over time, recurrent and/or chronic PID causes scarring and adhesion formation, which may result in chronic pelvic pain. In addition, chronic infection is the single most important risk factor for ectopic pregnancy. Finally, chlamydia infection is a risk factor for Fitz-Hugh-Cutis syndrome (perihepatitis). In this condition, organisms ascend from the site of pelvic infection along the pericolic gutter to ultimately infect the liver capsule.

Specific complications in pregnancy

Chlamydia infection in pregnant women is associated with preterm delivery and preterm premature rupture of membranes. Infants born to mothers with untreated chlamydia infection are at risk for pneumonia, conjunctivitis, and even perinatal death.² Acquisition of infection occurs at the time of delivery rather than in the antepartum period.

The significant morbidity associated with chlamydia infection underscores the importance of regular screening, especially in pregnant women. The current United States Preventive Service Task Force guidelines recommend annual screening of all sexually active women who are 24 years of age or younger, as well as of older, high-risk women.

The CDC recommends routine screening of all pregnant women for chlamydia at the first prenatal visit. Repeat screening is recommended in the third trimester for all pregnant women younger than 25 years, those at increased risk, and those infected within the past 3 to 6 months or during the first trimester. Those who test positive should be retested 3 weeks after completion of treatment.¹

Chlamydia screening strategies

Historically, a chlamydia diagnosis was made by isolating the organisms in tissue culture. In the 1990s, however, that extremely time-consuming and resource-intensive procedure was replaced by nucleic acid amplification testing (NAAT).

NAAT methodology. NAAT is the gold standard for diagnosing C trachomatis infection; this methodology utilizes various assays, including polymerase chain reaction, ligase chain reaction, and transcription-mediated amplification.

Continue to: Compared with previous culture and antigen detection techniques...

Compared with previous culture and antigen detection techniques, NAAT’s advantages include excellent sensitivity and specificity (>90% and ≥99%, respectively), enabling detection of a low inoculum of organisms in a sample obtained by noninvasive methods, such as first-void urine collection or vaginal swab.^2,4,5 Furthermore, NAAT does not impose any specific storage regulations on collected specimens, is cost effective, and can jointly test for Neisseria gonorrhoeae, which commonly co-infects with C trachomatis.⁶

Screening in pregnancy. In 2012, Blatt and colleagues examined testing patterns in nearly 1.3 million obstetric patients and found that only 59% (761,315) of women were tested for chlamydia at least once in pregnancy.⁷ Only 1 in 3 women were tested during the first prenatal visit, as CDC guidelines recommend. Testing rates declined with increasing age. Of women screened, 3.5% tested positive for chlamydia.⁷ Of these, 3 of 4 were retested at least once, with almost 20% having at least 1 subsequent positive result.⁷

Of note, in a study of women who reported receptive anal intercourse (n = 2,818), 292 women tested positive for chlamydia; 10.4% tested positive in genital-only sites, 58.6% in genital and rectal sites, and 20.5% at the rectal site only.⁸

It is alarming that only 59% of pregnant women are screened for chlamydia given the significant perinatal complications associated with this infection. Barriers to screening pregnant women may include clinician discomfort in discussing STDs and patient refusal of screening. Furthermore, clinicians should routinely ask women about receptive anal sex. Women who report this risk factor should be tested for chlamydia in both the endocervix and rectum.

Retesting and follow-up. After the initial diagnosis of chlamydia, a test of cure 3 weeks after treatment is an important aspect of care. Thus, identifying and overcoming barriers to retesting is important. Clinicians should educate patients about the importance of follow-up. Also consider incorporating the use of home-based, self-obtained vaginal swabs for retesting. Results from 2 randomized trials showed that eliminating a patient’s transportation barriers and providing a home-based alternative to a follow-up visit significantly increased rescreening rates by 33% in STD clinic patients and by 59.2% in family planning clinic patients.⁹

Reinfection risk. The rate of venereal chlamydia transmission in heterosexual partners is 70%. Since sexually active chlamydia-positive patients are at risk for reinfection by their partner after treatment completion, clinicians should refer the sex partners for evaluation. If the sex partners are reluctant to have testing, it is reasonable to provide empiric antibiotic treatment to decrease the risk of re-infection in the patient.⁷ Before doing so, however, make certain that state law permits this practice, and be sure to document the prescribed treatment in the patient’s record.

Continue to: Treatment options...

Treatment options

Prompt treatment of C trachomatis infection is essential to decrease the risk of disease sequelae. Nonpregnant adults can be treated with oral doxycycline 100 mg twice daily for 7 days.

In a head-to-head study performed in a controlled environment that ensured treatment adherence, 97% efficacy was achieved with one oral dose of azithromycin (1 g) compared with 100% efficacy with doxycycline.¹⁰ However, in the real-world setting, imperfect adherence to the multi-day doxycycline regimen is associated with treatment failures. Thus, a single dose of azithromycin is preferable for patients with questionable compliance.¹¹

In obstetric patients, azithromycin and amoxicillin are preferred as first-line agents for treatment of C trachomatis due to their improved safety profile in this demographic. Amoxicillin 500 mg orally 3 times daily for 7 days has 95% efficacy.²

Women allergic to these agents may be treated with an alternative regimen of erythromycin base, 500 mg orally 4 times daily for 7 days, or erythromycin ethylsuccinate, 800 mg orally 4 times daily for 7 days. Erythromycin should be reserved for second-line therapy because of its lower efficacy (64%) and frequent gastrointestinal adverse effects.² Doxycycline is contraindicated in pregnancy because of possible teratogenic effects on the teeth and bone of the fetus.

CASE Pregnant woman with symptoms of genital infection

A 23-year-old primigravid woman at 15 weeks and 2 days’ gestation reported having a 2-week history of increased urinary frequency and vaginal discharge. She said she experienced similar symptoms 6 weeks previously that resolved within a week. The patient has had 3 sexual partners in the past year. Her current partner was experiencing a yellow urethral discharge and dysuria. On the patient’s speculum examination, the clinician noted a yellow-green discharge emanating from the cervix as well as cervical motion tenderness.

What is the most likely diagnosis, and how would you treat this patient?
 

The culprit was chlamydia

Chlamydia trachomatis is an obligate intracellular bacterium that does not stain with Gram staining. A rigid cell wall encloses its intracellular component. C trachomatis infection begins when the chlamydial elementary body enters a susceptible host cell.

Once ingested, the organism’s surface antigens (major outer membrane protein and lipopolysaccharide antigens) provide intracellular sanctuary for the bacterium by inhibiting phagolysosomal fusion. Subsequently, the elementary body morphs into a reticular body, which replicates through adenosine triphosphate (ATP)–dependent binary fission. After approximately 48 hours of replication, the organism again morphs into an elementary body and is released to infect additional cells and acquire new ATP stores for further replication.

Chlamydia can be transmitted horizontally during oral, vaginal, or anal intercourse or vertically to the infant during vaginal delivery.

The US’s most common notifiable disease

According to the Centers for Disease Control and Prevention (CDC), the incidence of chlamydia infection in the United States increased considerably in recent years: from 976,455 cases in 2005 to 1,758,668 cases in 2018.¹ In 2018, rates of chlamydia infection in women were nearly double the rates in men, with an incidence of 688.2 versus 377.5 per 100,000 cases, and a prevalence of 1,150,672 versus 612,020.¹

Young adults have a higher frequency of chlamydia infection than any other age group. From 2017 to 2018, reported cases in women aged 15–19 years increased by 1.3%, to 3,306.8 per 100,000; in women aged 20–24 years, cases increased by 0.8%, to 4,064.6 per 100,000. In young men in the same age ranges, reported cases increased by 3.7%, to 959.0 cases per 100,000, and by 3.3%, to 1,784.5 per 100,000 cases, respectively.¹

Both the incidence and prevalence of chlamydia infection are higher in African Americans than in whites, while Asians have the lowest rates.¹ The prevalence of infection also is increased with incarceration, lower socioeconomic status, and residence in the southern United States.

The prevalence of chlamydia infection in pregnant women is approximately 2% to 3%, but it may be as high as 30% in high-risk populations, such as women who are unmarried, have multiple sex partners, are coinfected with another sexually transmitted disease (STD), have partners with nongonococcal urethritis, have mucopurulent discharge, have acute urethral syndrome, and have late or no prenatal care.² Since chlamydia infection often is asymptomatic and some infections resolve spontaneously, the true prevalence of infection probably is underreported.

Continue to: Chlamydia infection can cause serious clinical manifestations...

Chlamydia infection can cause serious clinical manifestations

The 15 serotypes of C trachomatis are grouped into 3 categories according to clinical manifestations:

• Serotypes A, B, Ba, and C cause endemic trachoma, characterized by bilateral irritation of the eyelids that progresses to eyelid thickening and scarring, eventually leading to corneal abrasion and blindness.
• Serotypes D–K manifest as conjunctivitis and pneumonia in newborns, proctitis in men (especially in men who have sex with men), and genitourinary infections in women. Reactive arthritis and inclusion conjunctivitis also can occur with D–K serotypes.
• Serotypes L1–L3 cause lymphogranuloma venereum.

About 70% of women with chlamydia infection are asymptomatic. Those who have symptoms often present with endocervicitis or acute urethral syndrome (acute urethritis). Manifestations of these 2 conditions include a frothy yellow-green vaginal and/or urethral discharge, dysuria, and frequency. Women who engage in rectal intercourse also may notice a purulent discharge from the anus. Untreated, C trachomatis organisms may ascend the reproductive tract, causing both endometritis and pelvic inflammatory disease (PID).

While a single episode of PID increases tubal infertility risk by 10%, a second episode increases the risk by 40%.³ Over time, recurrent and/or chronic PID causes scarring and adhesion formation, which may result in chronic pelvic pain. In addition, chronic infection is the single most important risk factor for ectopic pregnancy. Finally, chlamydia infection is a risk factor for Fitz-Hugh-Cutis syndrome (perihepatitis). In this condition, organisms ascend from the site of pelvic infection along the pericolic gutter to ultimately infect the liver capsule.

Specific complications in pregnancy

Chlamydia infection in pregnant women is associated with preterm delivery and preterm premature rupture of membranes. Infants born to mothers with untreated chlamydia infection are at risk for pneumonia, conjunctivitis, and even perinatal death.² Acquisition of infection occurs at the time of delivery rather than in the antepartum period.

The significant morbidity associated with chlamydia infection underscores the importance of regular screening, especially in pregnant women. The current United States Preventive Service Task Force guidelines recommend annual screening of all sexually active women who are 24 years of age or younger, as well as of older, high-risk women.

The CDC recommends routine screening of all pregnant women for chlamydia at the first prenatal visit. Repeat screening is recommended in the third trimester for all pregnant women younger than 25 years, those at increased risk, and those infected within the past 3 to 6 months or during the first trimester. Those who test positive should be retested 3 weeks after completion of treatment.¹

Chlamydia screening strategies

Historically, a chlamydia diagnosis was made by isolating the organisms in tissue culture. In the 1990s, however, that extremely time-consuming and resource-intensive procedure was replaced by nucleic acid amplification testing (NAAT).

NAAT methodology. NAAT is the gold standard for diagnosing C trachomatis infection; this methodology utilizes various assays, including polymerase chain reaction, ligase chain reaction, and transcription-mediated amplification.

Continue to: Compared with previous culture and antigen detection techniques...

Compared with previous culture and antigen detection techniques, NAAT’s advantages include excellent sensitivity and specificity (>90% and ≥99%, respectively), enabling detection of a low inoculum of organisms in a sample obtained by noninvasive methods, such as first-void urine collection or vaginal swab.^2,4,5 Furthermore, NAAT does not impose any specific storage regulations on collected specimens, is cost effective, and can jointly test for Neisseria gonorrhoeae, which commonly co-infects with C trachomatis.⁶

Screening in pregnancy. In 2012, Blatt and colleagues examined testing patterns in nearly 1.3 million obstetric patients and found that only 59% (761,315) of women were tested for chlamydia at least once in pregnancy.⁷ Only 1 in 3 women were tested during the first prenatal visit, as CDC guidelines recommend. Testing rates declined with increasing age. Of women screened, 3.5% tested positive for chlamydia.⁷ Of these, 3 of 4 were retested at least once, with almost 20% having at least 1 subsequent positive result.⁷

Of note, in a study of women who reported receptive anal intercourse (n = 2,818), 292 women tested positive for chlamydia; 10.4% tested positive in genital-only sites, 58.6% in genital and rectal sites, and 20.5% at the rectal site only.⁸

It is alarming that only 59% of pregnant women are screened for chlamydia given the significant perinatal complications associated with this infection. Barriers to screening pregnant women may include clinician discomfort in discussing STDs and patient refusal of screening. Furthermore, clinicians should routinely ask women about receptive anal sex. Women who report this risk factor should be tested for chlamydia in both the endocervix and rectum.

Retesting and follow-up. After the initial diagnosis of chlamydia, a test of cure 3 weeks after treatment is an important aspect of care. Thus, identifying and overcoming barriers to retesting is important. Clinicians should educate patients about the importance of follow-up. Also consider incorporating the use of home-based, self-obtained vaginal swabs for retesting. Results from 2 randomized trials showed that eliminating a patient’s transportation barriers and providing a home-based alternative to a follow-up visit significantly increased rescreening rates by 33% in STD clinic patients and by 59.2% in family planning clinic patients.⁹

Reinfection risk. The rate of venereal chlamydia transmission in heterosexual partners is 70%. Since sexually active chlamydia-positive patients are at risk for reinfection by their partner after treatment completion, clinicians should refer the sex partners for evaluation. If the sex partners are reluctant to have testing, it is reasonable to provide empiric antibiotic treatment to decrease the risk of re-infection in the patient.⁷ Before doing so, however, make certain that state law permits this practice, and be sure to document the prescribed treatment in the patient’s record.

Continue to: Treatment options...

Treatment options

Prompt treatment of C trachomatis infection is essential to decrease the risk of disease sequelae. Nonpregnant adults can be treated with oral doxycycline 100 mg twice daily for 7 days.

In a head-to-head study performed in a controlled environment that ensured treatment adherence, 97% efficacy was achieved with one oral dose of azithromycin (1 g) compared with 100% efficacy with doxycycline.¹⁰ However, in the real-world setting, imperfect adherence to the multi-day doxycycline regimen is associated with treatment failures. Thus, a single dose of azithromycin is preferable for patients with questionable compliance.¹¹

In obstetric patients, azithromycin and amoxicillin are preferred as first-line agents for treatment of C trachomatis due to their improved safety profile in this demographic. Amoxicillin 500 mg orally 3 times daily for 7 days has 95% efficacy.²

Women allergic to these agents may be treated with an alternative regimen of erythromycin base, 500 mg orally 4 times daily for 7 days, or erythromycin ethylsuccinate, 800 mg orally 4 times daily for 7 days. Erythromycin should be reserved for second-line therapy because of its lower efficacy (64%) and frequent gastrointestinal adverse effects.² Doxycycline is contraindicated in pregnancy because of possible teratogenic effects on the teeth and bone of the fetus.

Reference

1. US Preventive Services Task Force. Final recommendation statement: cognitive impairment in older adults: screening. www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/cognitive-impairment-in-older-adults-screening. Published February 2020. Accessed March 19, 2020.

Reference

1. US Preventive Services Task Force. Final recommendation statement: cognitive impairment in older adults: screening. www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/cognitive-impairment-in-older-adults-screening. Published February 2020. Accessed March 19, 2020.

Reference

1. US Preventive Services Task Force. Final recommendation statement: cognitive impairment in older adults: screening. www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/cognitive-impairment-in-older-adults-screening. Published February 2020. Accessed March 19, 2020.

For much of the past 50 years, many of the drugs used in dermatology have been adopted – and often adapted – from other specialties and used for dermatologic conditions.

“Almost every drug was more or less a hand-me-down” developed first for cancer or other diseases and found later, often serendipitously, to be useful for the skin, said William Eaglstein, MD, thinking back to the 1970s and recalling steroids, tetracyclines, methotrexate, and 5-flourouracil. “The perception always was that skin diseases weren’t serious, that the market was small.”

Much has changed. Knowledge about the pathophysiology of dermatologic diseases has exponentially increased, largely because of basic and translational research by dermatologist investigators, and “more and more companies are recognizing the importance of our diseases and the ability to get a return on investment,” said Dr. Eaglstein, past professor and chair of the departments of dermatology at the University of Miami and the University of Pittsburgh, who worked in industry after his academic career.

Psoriasis was a game changer, he and other dermatologists said in interviews. The tumor necrosis factor (TNF)–alpha blockers were first used for other indications, but their marked follow-on success in psoriasis “offered proof of concept clinically – showing that by targeting immune pathways in the skin we could achieve a clinical effect – and proof of concept commercially” that dermatology drugs are worth pursuing by pharmaceutical companies, said William Ju, MD, a cofounder and president of Advancing Innovation in Dermatology, a nonprofit organization that brings together stakeholders to develop novel dermatologic drugs and products.

This resulted in the approval of subsequent biologics, such as ustekinumab (Stelara) which inhibits the signaling of interleukin (IL)–12/IL-23, for psoriasis as their initial indication. Then, biologics targeting IL-17 followed this dermatology-first approach. “Researchers have continued further dissecting out the immunopathological pathways, and antibody drugs targeting IL-23p19 have been approved for psoriasis as the lead indication,” said Dr. Ju, a dermatologist who has worked in industry.

Seth Orlow, MD, PhD, who chairs the department of dermatology at NYU Langone Health, remembers the 1970s through the 1990s as the “era of topicals” developed for dermatologic conditions – topical antifungals, topical corticosteroids, and topical retinoids. The next decade was characterized by formulation tweaks and few novel treatments for dermatology, said Dr. Orlow, who is also professor of pediatric dermatology and director of the program in cutaneous biology at New York University.

Now, given the succession of psoriasis discoveries in the last decade, “large companies are interested in dermatology,” he said in an interview. “There’s an explosion of interest in atopic dermatitis. … and companies are dipping their toes in the water for alopecia areata and vitiligo. That’s amazing.”

Rare diseases like epidermolysis bullosa, ichthyosis, and basal cell nevus syndrome are getting attention as well, boosted by the Orphan Drug Act of 1983, in addition to increased research on disease pathways and growing appreciation of skin diseases. “There’s a lot under development, from small molecules to biologics to gene-based therapies,” Dr. Orlow commented.


 

The new frontier of atopic dermatitis

The approval in 2017 of dupilumab (Dupixent), a monoclonal antibody that inhibits the signaling of both IL-4 and IL-13) for moderate-severe atopic dermatitis (AD) in adults illustrates the new standing of dermatologic diseases in the field of drug development and commercialization. “Atopic dermatitis had always been the forgotten chronic disease in dermatology. … We’ve had no good treatments,” said Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland. “Dupilumab coming to the forefront [as a dermatology-first indication] has changed the entire perspective of the field. … Everyone is now trying to find the next best drug.”

As with psoriasis, a targeted therapy for AD was made possible by the development in the 1990s of monoclonal antibody technology and the ensuing ability to create biologics that target specific molecules in the body – as well as bedside-to-bench research that homed in on the involvement of particular cytokines.

But there also is a “new understanding of the burden of the disease,” Dr. Simpson observed. In the last 5 years, he said, research funded by the National Eczema Association documented that AD “not only causes inflammation of the skin … but that it affects people at school and in the workplace, that people have multiple mental health comorbidities and skin infections, and that the disease profoundly affects the entire patient in ways that weren’t really recognized or appreciated.”

Having evolved in the footsteps of psoriasis, AD is at a higher starting point in terms of the safety and efficacy of its first biologic, sources said. On the other hand, AD is a much more complex and heterogeneous disease, and researchers are trying to determine which immune pathways and cytokines are most important – and in which populations.

“We’re at the beginning. We’re trying to figure out how to get 80% of patients clear or almost clear [as we can now with psoriasis biologics] rather than almost 40% [as in the dupilumab pivotal trials],” said Dr. Simpson, former cochair of the National Eczema Association’s scientific committee. Public data from ongoing phase 2 and 3 trials of other Th2 cytokine inhibitors suggest that 25%-45% of enrolled patients achieve high levels of clearance, he noted.

Emma Guttman-Yassky, MD, PhD, Sol and Clara Kest Professor and vice-chair for research in the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said that AD’s heterogeneity involves “many factors, like ethnicity, age … and whether they have an atopic background such as asthma.”

Bruce Jancin/MDedge News

Her research is showing, for instance, that AD in Asian and black patients is different than AD in European-American patients, and that the presence of comorbidities may well have treatment implications. She has also shown that children may have a different phenotype than adults, with greater activation of the Th17 axis that typifies psoriasis.

“For certain patients, we may need to target more than one pathway, or target a different pathway than the Th2 pathway. And treatment may be different in the setting of comorbidities,” said Dr. Guttman-Yassky, who is also director of the laboratory of inflammatory skin diseases at Mount Sinai. “We may think of one treatment – dupilumab, for example – for someone who has asthma and AD. But for patients who don’t have asthma and are Asian, for instance, or for children, we may need additional agents.”

Her research over the years on AD has taught her the importance of human studies over mouse model studies; it was in humans, she noted, that she and other investigators demonstrated “without doubt” that AD is an immune disease and not simply a barrier disease. The Th2 cytokine pathway appears to play the predominant role in AD, though “there still is a strong Th1 component,” she said.

“We’re in a better position to figure this out today [than in the past 20 or even 10 years],” said Dr. Guttman-Yassky, who recalls being told years ago that AD was a “dead end,” that it “would kill [her] career.” Given the evolution of science and the recognition of comorbidities and seriousness of dermatologic diseases, “the stars are aligned to get more [therapies] to these patients.”

Janus kinase (JAK) inhibitors are among these therapies. Three JAK inhibitors are in or have recently completed phase 3 studies for AD; two are currently approved for rheumatoid arthritis, and the other has been designed specifically for AD, Dr. Simpson pointed out. The drugs are oral small molecule drugs that block the JAK signaling pathways for certain proinflammatory cytokines.

“The JAK inhibitors are a real exciting story for dermatology,” he said. “Theoretically, by blocking more cytokines than biologics do, there could be some safety issues – that’s why we’re awaiting big phase 3 study results so we can figure out the risk-benefit balance and guide our patients as to which drug is best.”

Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center in Portland – a stand-alone dermatology clinical trial center founded in 1998 – likes to envision the evolution of drugs for dermatologic conditions as a funnel, with the most broad-acting drugs at the wide top of the funnel and the most targeted drugs at the bottom tip.

JAK inhibitors, he said, sit near the middle – more targeted and safer than cyclosporine and methotrexate, for instance, but not as targeted as the biologics now available for psoriasis and being developed for AD. “The oral medications that have been developed for psoriasis and those coming for AD are not quite as targeted to the disease,” he noted. “JAK inhibitors have great efficacy – it’s more a question of safety and being able to treat without causing collateral damage.”

Dr. Blauvelt expects the armamentarium of new drugs approved for AD to go from one (dupilumab) to seven within the next 2 years. This will include three new biologics and three new oral JAK inhibitors, he predicts. As the specialty sorts through and integrates these new drugs into practice, dermatologists will increasingly personalize treatment and will face the “nonscientific” challenge of the cost of new therapies and patient access to them, he noted.

In the meantime, said Dr. Simpson, recent drug discoveries have driven more non–pharmaceutical-funded translational research aimed at understanding the underlying biology of AD. The National Institutes of Health, for instance, “is interested in dupilumab and its impact on the skin barrier and skin defense mechanisms,” he said. “We’ll learn a lot more [in coming years].”
 

Spillover to other diseases

JAK inhibitors – some in oral and some in topical form – are showing efficacy in ongoing research for alopecia areata (AA) and vitiligo as well, Dr. Blauvelt said.

“We’re understanding more about the pathophysiology of these diseases, which historically have been tough diseases for dermatologists to treat,” he said. “The successes in alopecia areata and vitiligo are incredibly exciting actually – it’s very exciting to see hair and pigment coming back. And as we learn more, we should be able to develop [additional] drugs that are more disease targeted than the JAK inhibitors.”

Already, some of the biologics used to treat psoriasis have been studied in patients with hidradenitis suppurativa (HS), a disease in which painful lumps and sometimes tunnels form under the skin, with some success; adalimumab (Humira), a TNF-inhibitor, is now FDA approved for the treatment of moderate-severe HS, and studies are ongoing of IL-17 and IL-23 blockers for the disease.

“The pathophysiology [of HS] is very complex; it’s not nearly as straightforward as psoriasis, and there haven’t been any major breakthroughs yet,” Dr. Blauvelt said. “But the drugs seem to be working better than historical alternatives.”

Regarding AA, Dr. Guttman-Yassky, who is participating in a study of dupilumab for AA, recently found in a retrospective cross-sectional study that patients with the condition are more likely to have atopic comorbidities – asthma, allergic rhinitis, and AD, for instance. “The more comorbid conditions, the greater the risk of developing alopecia areata,” she said. “That could point to a potential pathogenic role of the Th2 axis in the disorder [challenging the traditional view of AA as a singularly Th1-centered disease.] The future will tell.”
 

Action on rare skin diseases

Both large and small companies have moved into the orphan drug space, investing in research and pursuing orphan drug indications for dermatologic conditions, because “it’s clear now in the marketplace that companies can develop effective drugs for rare disorders and be quite successful,” Dr. Orlow said.

According to a recent analysis, as a result of incentives for rare disease drug development contained in the Orphan Drug Act, 72 indications have been approved for rare skin disease, skin-related cancers, and hereditary disorders with prominent dermatologic manifestations since the law was passed in 1983 (J. Am. Acad. Dermatol. 2019;81[3]:867-77).

Epidermolysis bullosa (EB) is a good example, he and other sources said, of commercial interests merging with growing knowledge of disease pathogenesis as well as the tools needed to develop new treatments.

Research by dermatology scientists and others over the past 40 years, Dr. Ju explained, shed light on the molecular basis underlying the structure and function of the junction between the epidermis and dermis, including the pivotal role that type VII collagen plays in the normal adhesion of these two layers. Researchers then learned that, in EB, the family of genetic diseases characterized by skin fragility, “dystrophic types are caused by mutations in the gene encoding type VII collagen,” he said.

“Just as the advent of monoclonal antibodies allowed us to start attacking psoriasis and atopic dermatitis in unprecedented ways, the advent of gene therapy allows us to potentially address the fundamental molecular genetic defect of various types of EB,” Dr. Ju said.

While gene therapy is “still in its infancy,” companies have begun using the tools to address EB. One gene therapy in the pipeline – in phase 3 clinical trial testing – involves grafting back into patients with recessive dystrophic EB their skin cells that have been genetically modified to produce a correct (nonmutated) type VII collagen, he said.

Basal cell nevus syndrome, or Gorlin syndrome, a rare disease in which patients develop a multitude of basal cell carcinoma tumors, is another example of a “dermatology first” approach, Dr. Ju said. Research identified a genetic mutation that causes the hedgehog signaling pathway to be inappropriately activated in the disease, and a drug, vismodegib, was developed to inhibit this pathway. The drug was initially approved for patients with metastatic basal cell cancer and types of advanced basal cell cancer, and is now being tested in cancers affecting other organs, he said.

Basal cell cancer “is a huge market, but it was really unrecognized in the past,” Dr. Eaglstein said. “Seeing drugs come to market for basal cell cancer – this wouldn’t have happened [decades ago].”

Dr. Ju has worked in the pharmaceutical industry; all other sources in this story have worked with pharmaceutical manufacturers of treatments that are being developed or have been approved to treat dermatologic diseases mentioned in this story. In addition to Dr. Ju, Dr. Eaglstein and Dr. Orlow are cofounders of the Advancing Innovation in Dermatology group; Dr. Orlow is a member of the program committee for the organization’s dermatology summit conference.

 

For much of the past 50 years, many of the drugs used in dermatology have been adopted – and often adapted – from other specialties and used for dermatologic conditions.

“Almost every drug was more or less a hand-me-down” developed first for cancer or other diseases and found later, often serendipitously, to be useful for the skin, said William Eaglstein, MD, thinking back to the 1970s and recalling steroids, tetracyclines, methotrexate, and 5-flourouracil. “The perception always was that skin diseases weren’t serious, that the market was small.”

Much has changed. Knowledge about the pathophysiology of dermatologic diseases has exponentially increased, largely because of basic and translational research by dermatologist investigators, and “more and more companies are recognizing the importance of our diseases and the ability to get a return on investment,” said Dr. Eaglstein, past professor and chair of the departments of dermatology at the University of Miami and the University of Pittsburgh, who worked in industry after his academic career.

Psoriasis was a game changer, he and other dermatologists said in interviews. The tumor necrosis factor (TNF)–alpha blockers were first used for other indications, but their marked follow-on success in psoriasis “offered proof of concept clinically – showing that by targeting immune pathways in the skin we could achieve a clinical effect – and proof of concept commercially” that dermatology drugs are worth pursuing by pharmaceutical companies, said William Ju, MD, a cofounder and president of Advancing Innovation in Dermatology, a nonprofit organization that brings together stakeholders to develop novel dermatologic drugs and products.

This resulted in the approval of subsequent biologics, such as ustekinumab (Stelara) which inhibits the signaling of interleukin (IL)–12/IL-23, for psoriasis as their initial indication. Then, biologics targeting IL-17 followed this dermatology-first approach. “Researchers have continued further dissecting out the immunopathological pathways, and antibody drugs targeting IL-23p19 have been approved for psoriasis as the lead indication,” said Dr. Ju, a dermatologist who has worked in industry.

Seth Orlow, MD, PhD, who chairs the department of dermatology at NYU Langone Health, remembers the 1970s through the 1990s as the “era of topicals” developed for dermatologic conditions – topical antifungals, topical corticosteroids, and topical retinoids. The next decade was characterized by formulation tweaks and few novel treatments for dermatology, said Dr. Orlow, who is also professor of pediatric dermatology and director of the program in cutaneous biology at New York University.

Now, given the succession of psoriasis discoveries in the last decade, “large companies are interested in dermatology,” he said in an interview. “There’s an explosion of interest in atopic dermatitis. … and companies are dipping their toes in the water for alopecia areata and vitiligo. That’s amazing.”

Rare diseases like epidermolysis bullosa, ichthyosis, and basal cell nevus syndrome are getting attention as well, boosted by the Orphan Drug Act of 1983, in addition to increased research on disease pathways and growing appreciation of skin diseases. “There’s a lot under development, from small molecules to biologics to gene-based therapies,” Dr. Orlow commented.


 

The new frontier of atopic dermatitis

The approval in 2017 of dupilumab (Dupixent), a monoclonal antibody that inhibits the signaling of both IL-4 and IL-13) for moderate-severe atopic dermatitis (AD) in adults illustrates the new standing of dermatologic diseases in the field of drug development and commercialization. “Atopic dermatitis had always been the forgotten chronic disease in dermatology. … We’ve had no good treatments,” said Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland. “Dupilumab coming to the forefront [as a dermatology-first indication] has changed the entire perspective of the field. … Everyone is now trying to find the next best drug.”

As with psoriasis, a targeted therapy for AD was made possible by the development in the 1990s of monoclonal antibody technology and the ensuing ability to create biologics that target specific molecules in the body – as well as bedside-to-bench research that homed in on the involvement of particular cytokines.

But there also is a “new understanding of the burden of the disease,” Dr. Simpson observed. In the last 5 years, he said, research funded by the National Eczema Association documented that AD “not only causes inflammation of the skin … but that it affects people at school and in the workplace, that people have multiple mental health comorbidities and skin infections, and that the disease profoundly affects the entire patient in ways that weren’t really recognized or appreciated.”

Having evolved in the footsteps of psoriasis, AD is at a higher starting point in terms of the safety and efficacy of its first biologic, sources said. On the other hand, AD is a much more complex and heterogeneous disease, and researchers are trying to determine which immune pathways and cytokines are most important – and in which populations.

“We’re at the beginning. We’re trying to figure out how to get 80% of patients clear or almost clear [as we can now with psoriasis biologics] rather than almost 40% [as in the dupilumab pivotal trials],” said Dr. Simpson, former cochair of the National Eczema Association’s scientific committee. Public data from ongoing phase 2 and 3 trials of other Th2 cytokine inhibitors suggest that 25%-45% of enrolled patients achieve high levels of clearance, he noted.

Emma Guttman-Yassky, MD, PhD, Sol and Clara Kest Professor and vice-chair for research in the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said that AD’s heterogeneity involves “many factors, like ethnicity, age … and whether they have an atopic background such as asthma.”

Bruce Jancin/MDedge News

Her research is showing, for instance, that AD in Asian and black patients is different than AD in European-American patients, and that the presence of comorbidities may well have treatment implications. She has also shown that children may have a different phenotype than adults, with greater activation of the Th17 axis that typifies psoriasis.

“For certain patients, we may need to target more than one pathway, or target a different pathway than the Th2 pathway. And treatment may be different in the setting of comorbidities,” said Dr. Guttman-Yassky, who is also director of the laboratory of inflammatory skin diseases at Mount Sinai. “We may think of one treatment – dupilumab, for example – for someone who has asthma and AD. But for patients who don’t have asthma and are Asian, for instance, or for children, we may need additional agents.”

Her research over the years on AD has taught her the importance of human studies over mouse model studies; it was in humans, she noted, that she and other investigators demonstrated “without doubt” that AD is an immune disease and not simply a barrier disease. The Th2 cytokine pathway appears to play the predominant role in AD, though “there still is a strong Th1 component,” she said.

“We’re in a better position to figure this out today [than in the past 20 or even 10 years],” said Dr. Guttman-Yassky, who recalls being told years ago that AD was a “dead end,” that it “would kill [her] career.” Given the evolution of science and the recognition of comorbidities and seriousness of dermatologic diseases, “the stars are aligned to get more [therapies] to these patients.”

Janus kinase (JAK) inhibitors are among these therapies. Three JAK inhibitors are in or have recently completed phase 3 studies for AD; two are currently approved for rheumatoid arthritis, and the other has been designed specifically for AD, Dr. Simpson pointed out. The drugs are oral small molecule drugs that block the JAK signaling pathways for certain proinflammatory cytokines.

“The JAK inhibitors are a real exciting story for dermatology,” he said. “Theoretically, by blocking more cytokines than biologics do, there could be some safety issues – that’s why we’re awaiting big phase 3 study results so we can figure out the risk-benefit balance and guide our patients as to which drug is best.”

Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center in Portland – a stand-alone dermatology clinical trial center founded in 1998 – likes to envision the evolution of drugs for dermatologic conditions as a funnel, with the most broad-acting drugs at the wide top of the funnel and the most targeted drugs at the bottom tip.

JAK inhibitors, he said, sit near the middle – more targeted and safer than cyclosporine and methotrexate, for instance, but not as targeted as the biologics now available for psoriasis and being developed for AD. “The oral medications that have been developed for psoriasis and those coming for AD are not quite as targeted to the disease,” he noted. “JAK inhibitors have great efficacy – it’s more a question of safety and being able to treat without causing collateral damage.”

Dr. Blauvelt expects the armamentarium of new drugs approved for AD to go from one (dupilumab) to seven within the next 2 years. This will include three new biologics and three new oral JAK inhibitors, he predicts. As the specialty sorts through and integrates these new drugs into practice, dermatologists will increasingly personalize treatment and will face the “nonscientific” challenge of the cost of new therapies and patient access to them, he noted.

In the meantime, said Dr. Simpson, recent drug discoveries have driven more non–pharmaceutical-funded translational research aimed at understanding the underlying biology of AD. The National Institutes of Health, for instance, “is interested in dupilumab and its impact on the skin barrier and skin defense mechanisms,” he said. “We’ll learn a lot more [in coming years].”
 

Spillover to other diseases

JAK inhibitors – some in oral and some in topical form – are showing efficacy in ongoing research for alopecia areata (AA) and vitiligo as well, Dr. Blauvelt said.

“We’re understanding more about the pathophysiology of these diseases, which historically have been tough diseases for dermatologists to treat,” he said. “The successes in alopecia areata and vitiligo are incredibly exciting actually – it’s very exciting to see hair and pigment coming back. And as we learn more, we should be able to develop [additional] drugs that are more disease targeted than the JAK inhibitors.”

Already, some of the biologics used to treat psoriasis have been studied in patients with hidradenitis suppurativa (HS), a disease in which painful lumps and sometimes tunnels form under the skin, with some success; adalimumab (Humira), a TNF-inhibitor, is now FDA approved for the treatment of moderate-severe HS, and studies are ongoing of IL-17 and IL-23 blockers for the disease.

“The pathophysiology [of HS] is very complex; it’s not nearly as straightforward as psoriasis, and there haven’t been any major breakthroughs yet,” Dr. Blauvelt said. “But the drugs seem to be working better than historical alternatives.”

Regarding AA, Dr. Guttman-Yassky, who is participating in a study of dupilumab for AA, recently found in a retrospective cross-sectional study that patients with the condition are more likely to have atopic comorbidities – asthma, allergic rhinitis, and AD, for instance. “The more comorbid conditions, the greater the risk of developing alopecia areata,” she said. “That could point to a potential pathogenic role of the Th2 axis in the disorder [challenging the traditional view of AA as a singularly Th1-centered disease.] The future will tell.”
 

Action on rare skin diseases

Both large and small companies have moved into the orphan drug space, investing in research and pursuing orphan drug indications for dermatologic conditions, because “it’s clear now in the marketplace that companies can develop effective drugs for rare disorders and be quite successful,” Dr. Orlow said.

According to a recent analysis, as a result of incentives for rare disease drug development contained in the Orphan Drug Act, 72 indications have been approved for rare skin disease, skin-related cancers, and hereditary disorders with prominent dermatologic manifestations since the law was passed in 1983 (J. Am. Acad. Dermatol. 2019;81[3]:867-77).

Epidermolysis bullosa (EB) is a good example, he and other sources said, of commercial interests merging with growing knowledge of disease pathogenesis as well as the tools needed to develop new treatments.

Research by dermatology scientists and others over the past 40 years, Dr. Ju explained, shed light on the molecular basis underlying the structure and function of the junction between the epidermis and dermis, including the pivotal role that type VII collagen plays in the normal adhesion of these two layers. Researchers then learned that, in EB, the family of genetic diseases characterized by skin fragility, “dystrophic types are caused by mutations in the gene encoding type VII collagen,” he said.

“Just as the advent of monoclonal antibodies allowed us to start attacking psoriasis and atopic dermatitis in unprecedented ways, the advent of gene therapy allows us to potentially address the fundamental molecular genetic defect of various types of EB,” Dr. Ju said.

While gene therapy is “still in its infancy,” companies have begun using the tools to address EB. One gene therapy in the pipeline – in phase 3 clinical trial testing – involves grafting back into patients with recessive dystrophic EB their skin cells that have been genetically modified to produce a correct (nonmutated) type VII collagen, he said.

Basal cell nevus syndrome, or Gorlin syndrome, a rare disease in which patients develop a multitude of basal cell carcinoma tumors, is another example of a “dermatology first” approach, Dr. Ju said. Research identified a genetic mutation that causes the hedgehog signaling pathway to be inappropriately activated in the disease, and a drug, vismodegib, was developed to inhibit this pathway. The drug was initially approved for patients with metastatic basal cell cancer and types of advanced basal cell cancer, and is now being tested in cancers affecting other organs, he said.

Basal cell cancer “is a huge market, but it was really unrecognized in the past,” Dr. Eaglstein said. “Seeing drugs come to market for basal cell cancer – this wouldn’t have happened [decades ago].”

Dr. Ju has worked in the pharmaceutical industry; all other sources in this story have worked with pharmaceutical manufacturers of treatments that are being developed or have been approved to treat dermatologic diseases mentioned in this story. In addition to Dr. Ju, Dr. Eaglstein and Dr. Orlow are cofounders of the Advancing Innovation in Dermatology group; Dr. Orlow is a member of the program committee for the organization’s dermatology summit conference.

 

For much of the past 50 years, many of the drugs used in dermatology have been adopted – and often adapted – from other specialties and used for dermatologic conditions.

“Almost every drug was more or less a hand-me-down” developed first for cancer or other diseases and found later, often serendipitously, to be useful for the skin, said William Eaglstein, MD, thinking back to the 1970s and recalling steroids, tetracyclines, methotrexate, and 5-flourouracil. “The perception always was that skin diseases weren’t serious, that the market was small.”

Much has changed. Knowledge about the pathophysiology of dermatologic diseases has exponentially increased, largely because of basic and translational research by dermatologist investigators, and “more and more companies are recognizing the importance of our diseases and the ability to get a return on investment,” said Dr. Eaglstein, past professor and chair of the departments of dermatology at the University of Miami and the University of Pittsburgh, who worked in industry after his academic career.

Psoriasis was a game changer, he and other dermatologists said in interviews. The tumor necrosis factor (TNF)–alpha blockers were first used for other indications, but their marked follow-on success in psoriasis “offered proof of concept clinically – showing that by targeting immune pathways in the skin we could achieve a clinical effect – and proof of concept commercially” that dermatology drugs are worth pursuing by pharmaceutical companies, said William Ju, MD, a cofounder and president of Advancing Innovation in Dermatology, a nonprofit organization that brings together stakeholders to develop novel dermatologic drugs and products.

This resulted in the approval of subsequent biologics, such as ustekinumab (Stelara) which inhibits the signaling of interleukin (IL)–12/IL-23, for psoriasis as their initial indication. Then, biologics targeting IL-17 followed this dermatology-first approach. “Researchers have continued further dissecting out the immunopathological pathways, and antibody drugs targeting IL-23p19 have been approved for psoriasis as the lead indication,” said Dr. Ju, a dermatologist who has worked in industry.

Seth Orlow, MD, PhD, who chairs the department of dermatology at NYU Langone Health, remembers the 1970s through the 1990s as the “era of topicals” developed for dermatologic conditions – topical antifungals, topical corticosteroids, and topical retinoids. The next decade was characterized by formulation tweaks and few novel treatments for dermatology, said Dr. Orlow, who is also professor of pediatric dermatology and director of the program in cutaneous biology at New York University.

Now, given the succession of psoriasis discoveries in the last decade, “large companies are interested in dermatology,” he said in an interview. “There’s an explosion of interest in atopic dermatitis. … and companies are dipping their toes in the water for alopecia areata and vitiligo. That’s amazing.”

Rare diseases like epidermolysis bullosa, ichthyosis, and basal cell nevus syndrome are getting attention as well, boosted by the Orphan Drug Act of 1983, in addition to increased research on disease pathways and growing appreciation of skin diseases. “There’s a lot under development, from small molecules to biologics to gene-based therapies,” Dr. Orlow commented.


 

The new frontier of atopic dermatitis

The approval in 2017 of dupilumab (Dupixent), a monoclonal antibody that inhibits the signaling of both IL-4 and IL-13) for moderate-severe atopic dermatitis (AD) in adults illustrates the new standing of dermatologic diseases in the field of drug development and commercialization. “Atopic dermatitis had always been the forgotten chronic disease in dermatology. … We’ve had no good treatments,” said Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland. “Dupilumab coming to the forefront [as a dermatology-first indication] has changed the entire perspective of the field. … Everyone is now trying to find the next best drug.”

As with psoriasis, a targeted therapy for AD was made possible by the development in the 1990s of monoclonal antibody technology and the ensuing ability to create biologics that target specific molecules in the body – as well as bedside-to-bench research that homed in on the involvement of particular cytokines.

But there also is a “new understanding of the burden of the disease,” Dr. Simpson observed. In the last 5 years, he said, research funded by the National Eczema Association documented that AD “not only causes inflammation of the skin … but that it affects people at school and in the workplace, that people have multiple mental health comorbidities and skin infections, and that the disease profoundly affects the entire patient in ways that weren’t really recognized or appreciated.”

Having evolved in the footsteps of psoriasis, AD is at a higher starting point in terms of the safety and efficacy of its first biologic, sources said. On the other hand, AD is a much more complex and heterogeneous disease, and researchers are trying to determine which immune pathways and cytokines are most important – and in which populations.

“We’re at the beginning. We’re trying to figure out how to get 80% of patients clear or almost clear [as we can now with psoriasis biologics] rather than almost 40% [as in the dupilumab pivotal trials],” said Dr. Simpson, former cochair of the National Eczema Association’s scientific committee. Public data from ongoing phase 2 and 3 trials of other Th2 cytokine inhibitors suggest that 25%-45% of enrolled patients achieve high levels of clearance, he noted.

Emma Guttman-Yassky, MD, PhD, Sol and Clara Kest Professor and vice-chair for research in the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said that AD’s heterogeneity involves “many factors, like ethnicity, age … and whether they have an atopic background such as asthma.”

Bruce Jancin/MDedge News

Her research is showing, for instance, that AD in Asian and black patients is different than AD in European-American patients, and that the presence of comorbidities may well have treatment implications. She has also shown that children may have a different phenotype than adults, with greater activation of the Th17 axis that typifies psoriasis.

“For certain patients, we may need to target more than one pathway, or target a different pathway than the Th2 pathway. And treatment may be different in the setting of comorbidities,” said Dr. Guttman-Yassky, who is also director of the laboratory of inflammatory skin diseases at Mount Sinai. “We may think of one treatment – dupilumab, for example – for someone who has asthma and AD. But for patients who don’t have asthma and are Asian, for instance, or for children, we may need additional agents.”

Her research over the years on AD has taught her the importance of human studies over mouse model studies; it was in humans, she noted, that she and other investigators demonstrated “without doubt” that AD is an immune disease and not simply a barrier disease. The Th2 cytokine pathway appears to play the predominant role in AD, though “there still is a strong Th1 component,” she said.

“We’re in a better position to figure this out today [than in the past 20 or even 10 years],” said Dr. Guttman-Yassky, who recalls being told years ago that AD was a “dead end,” that it “would kill [her] career.” Given the evolution of science and the recognition of comorbidities and seriousness of dermatologic diseases, “the stars are aligned to get more [therapies] to these patients.”

Janus kinase (JAK) inhibitors are among these therapies. Three JAK inhibitors are in or have recently completed phase 3 studies for AD; two are currently approved for rheumatoid arthritis, and the other has been designed specifically for AD, Dr. Simpson pointed out. The drugs are oral small molecule drugs that block the JAK signaling pathways for certain proinflammatory cytokines.

“The JAK inhibitors are a real exciting story for dermatology,” he said. “Theoretically, by blocking more cytokines than biologics do, there could be some safety issues – that’s why we’re awaiting big phase 3 study results so we can figure out the risk-benefit balance and guide our patients as to which drug is best.”

Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center in Portland – a stand-alone dermatology clinical trial center founded in 1998 – likes to envision the evolution of drugs for dermatologic conditions as a funnel, with the most broad-acting drugs at the wide top of the funnel and the most targeted drugs at the bottom tip.

JAK inhibitors, he said, sit near the middle – more targeted and safer than cyclosporine and methotrexate, for instance, but not as targeted as the biologics now available for psoriasis and being developed for AD. “The oral medications that have been developed for psoriasis and those coming for AD are not quite as targeted to the disease,” he noted. “JAK inhibitors have great efficacy – it’s more a question of safety and being able to treat without causing collateral damage.”

Dr. Blauvelt expects the armamentarium of new drugs approved for AD to go from one (dupilumab) to seven within the next 2 years. This will include three new biologics and three new oral JAK inhibitors, he predicts. As the specialty sorts through and integrates these new drugs into practice, dermatologists will increasingly personalize treatment and will face the “nonscientific” challenge of the cost of new therapies and patient access to them, he noted.

In the meantime, said Dr. Simpson, recent drug discoveries have driven more non–pharmaceutical-funded translational research aimed at understanding the underlying biology of AD. The National Institutes of Health, for instance, “is interested in dupilumab and its impact on the skin barrier and skin defense mechanisms,” he said. “We’ll learn a lot more [in coming years].”
 

Spillover to other diseases

JAK inhibitors – some in oral and some in topical form – are showing efficacy in ongoing research for alopecia areata (AA) and vitiligo as well, Dr. Blauvelt said.

“We’re understanding more about the pathophysiology of these diseases, which historically have been tough diseases for dermatologists to treat,” he said. “The successes in alopecia areata and vitiligo are incredibly exciting actually – it’s very exciting to see hair and pigment coming back. And as we learn more, we should be able to develop [additional] drugs that are more disease targeted than the JAK inhibitors.”

Already, some of the biologics used to treat psoriasis have been studied in patients with hidradenitis suppurativa (HS), a disease in which painful lumps and sometimes tunnels form under the skin, with some success; adalimumab (Humira), a TNF-inhibitor, is now FDA approved for the treatment of moderate-severe HS, and studies are ongoing of IL-17 and IL-23 blockers for the disease.

“The pathophysiology [of HS] is very complex; it’s not nearly as straightforward as psoriasis, and there haven’t been any major breakthroughs yet,” Dr. Blauvelt said. “But the drugs seem to be working better than historical alternatives.”

Regarding AA, Dr. Guttman-Yassky, who is participating in a study of dupilumab for AA, recently found in a retrospective cross-sectional study that patients with the condition are more likely to have atopic comorbidities – asthma, allergic rhinitis, and AD, for instance. “The more comorbid conditions, the greater the risk of developing alopecia areata,” she said. “That could point to a potential pathogenic role of the Th2 axis in the disorder [challenging the traditional view of AA as a singularly Th1-centered disease.] The future will tell.”
 

Action on rare skin diseases

Both large and small companies have moved into the orphan drug space, investing in research and pursuing orphan drug indications for dermatologic conditions, because “it’s clear now in the marketplace that companies can develop effective drugs for rare disorders and be quite successful,” Dr. Orlow said.

According to a recent analysis, as a result of incentives for rare disease drug development contained in the Orphan Drug Act, 72 indications have been approved for rare skin disease, skin-related cancers, and hereditary disorders with prominent dermatologic manifestations since the law was passed in 1983 (J. Am. Acad. Dermatol. 2019;81[3]:867-77).

Epidermolysis bullosa (EB) is a good example, he and other sources said, of commercial interests merging with growing knowledge of disease pathogenesis as well as the tools needed to develop new treatments.

Research by dermatology scientists and others over the past 40 years, Dr. Ju explained, shed light on the molecular basis underlying the structure and function of the junction between the epidermis and dermis, including the pivotal role that type VII collagen plays in the normal adhesion of these two layers. Researchers then learned that, in EB, the family of genetic diseases characterized by skin fragility, “dystrophic types are caused by mutations in the gene encoding type VII collagen,” he said.

“Just as the advent of monoclonal antibodies allowed us to start attacking psoriasis and atopic dermatitis in unprecedented ways, the advent of gene therapy allows us to potentially address the fundamental molecular genetic defect of various types of EB,” Dr. Ju said.

While gene therapy is “still in its infancy,” companies have begun using the tools to address EB. One gene therapy in the pipeline – in phase 3 clinical trial testing – involves grafting back into patients with recessive dystrophic EB their skin cells that have been genetically modified to produce a correct (nonmutated) type VII collagen, he said.

Basal cell nevus syndrome, or Gorlin syndrome, a rare disease in which patients develop a multitude of basal cell carcinoma tumors, is another example of a “dermatology first” approach, Dr. Ju said. Research identified a genetic mutation that causes the hedgehog signaling pathway to be inappropriately activated in the disease, and a drug, vismodegib, was developed to inhibit this pathway. The drug was initially approved for patients with metastatic basal cell cancer and types of advanced basal cell cancer, and is now being tested in cancers affecting other organs, he said.

Basal cell cancer “is a huge market, but it was really unrecognized in the past,” Dr. Eaglstein said. “Seeing drugs come to market for basal cell cancer – this wouldn’t have happened [decades ago].”

Dr. Ju has worked in the pharmaceutical industry; all other sources in this story have worked with pharmaceutical manufacturers of treatments that are being developed or have been approved to treat dermatologic diseases mentioned in this story. In addition to Dr. Ju, Dr. Eaglstein and Dr. Orlow are cofounders of the Advancing Innovation in Dermatology group; Dr. Orlow is a member of the program committee for the organization’s dermatology summit conference.

 

Patients with COVID-19 may be at risk for liver injury, but mechanisms of damage remain unclear, according to investigators.

Proposed mechanisms include direct virus-induced effects, immune-induced damage due to excessive inflammatory responses, and drug-induced injury, reported lead author Ling Xu of Huazhong University of Science and Technology, Wuhan, China, and colleagues.

“From a clinical perspective, in addition to actively dealing with the primary disease caused by coronavirus infection, attention should also be paid to monitor the occurrence of liver injury, and to the application of drugs which may induce liver damage,” the investigators wrote in Liver International. “Patients with liver damage are advised to be treated with drugs that could both protect liver functions and inhibit inflammatory responses, such as ammonium glycyrrhizinate, which may, in turn, accelerate the process of disease recovery.”

The review of liver injury associated with major pathogenic coronaviruses included severe acute respiratory syndrome coronavirus (SARS-CoV), the Middle East respiratory syndrome coronavirus (MERS-CoV), and the newly emergent SARS-CoV-2, which causes COVID-19.

In cases of COVID-19, reported incidence of liver injury ranges from 15% to 53%, based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST), along with slightly elevated bilirubin levels. In severe cases, albumin decreases have also been documented.

Liver injury appears to be significantly more common among those with severe infection. In one cohort of 82 patients who died from COVID-19, the incidence of liver injury was 78%, while another study of 36 nonsurvivors reported a rate of 58%.

According to the investigators, both bile duct epithelial cells and liver cells express angiotensin converting enzyme II (ACE2), which is an entry receptor for SARS-CoV-2; however, expression of ACE2 in bile duct cells is “much higher” than in liver cells, and comparable with alveolar type 2 cells in the lungs.

“Bile duct epithelial cells are known to play important roles in liver regeneration and immune response,” the investigators noted.

Beyond direct- and immune-induced effects of COVID-19, postmortem findings suggest that drug-induced liver injury may also be a possibility, with a number of theoretical culprits, including antibiotics, steroids, and antivirals. Although the investigators emphasized that data are insufficient to pinpoint an exact agent, they highlighted a recent preprint study, which reported a significantly higher rate of lopinavir/ritonavir administration among patients with abnormal liver function, compared with those who had normal liver function (56.1% vs. 25%; P = .009).

“Drug-induced liver injury during the treatment of coronavirus infection should not be ignored and needs to be carefully investigated,” the investigators concluded.

Fundamental Research Funds for the Central Universities supported the work. The investigators reported no conflicts of interest.

SOURCE: Xu L et al. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435.

Patients with COVID-19 may be at risk for liver injury, but mechanisms of damage remain unclear, according to investigators.

Proposed mechanisms include direct virus-induced effects, immune-induced damage due to excessive inflammatory responses, and drug-induced injury, reported lead author Ling Xu of Huazhong University of Science and Technology, Wuhan, China, and colleagues.

“From a clinical perspective, in addition to actively dealing with the primary disease caused by coronavirus infection, attention should also be paid to monitor the occurrence of liver injury, and to the application of drugs which may induce liver damage,” the investigators wrote in Liver International. “Patients with liver damage are advised to be treated with drugs that could both protect liver functions and inhibit inflammatory responses, such as ammonium glycyrrhizinate, which may, in turn, accelerate the process of disease recovery.”

The review of liver injury associated with major pathogenic coronaviruses included severe acute respiratory syndrome coronavirus (SARS-CoV), the Middle East respiratory syndrome coronavirus (MERS-CoV), and the newly emergent SARS-CoV-2, which causes COVID-19.

In cases of COVID-19, reported incidence of liver injury ranges from 15% to 53%, based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST), along with slightly elevated bilirubin levels. In severe cases, albumin decreases have also been documented.

Liver injury appears to be significantly more common among those with severe infection. In one cohort of 82 patients who died from COVID-19, the incidence of liver injury was 78%, while another study of 36 nonsurvivors reported a rate of 58%.

According to the investigators, both bile duct epithelial cells and liver cells express angiotensin converting enzyme II (ACE2), which is an entry receptor for SARS-CoV-2; however, expression of ACE2 in bile duct cells is “much higher” than in liver cells, and comparable with alveolar type 2 cells in the lungs.

“Bile duct epithelial cells are known to play important roles in liver regeneration and immune response,” the investigators noted.

Beyond direct- and immune-induced effects of COVID-19, postmortem findings suggest that drug-induced liver injury may also be a possibility, with a number of theoretical culprits, including antibiotics, steroids, and antivirals. Although the investigators emphasized that data are insufficient to pinpoint an exact agent, they highlighted a recent preprint study, which reported a significantly higher rate of lopinavir/ritonavir administration among patients with abnormal liver function, compared with those who had normal liver function (56.1% vs. 25%; P = .009).

“Drug-induced liver injury during the treatment of coronavirus infection should not be ignored and needs to be carefully investigated,” the investigators concluded.

Fundamental Research Funds for the Central Universities supported the work. The investigators reported no conflicts of interest.

SOURCE: Xu L et al. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435.

Patients with COVID-19 may be at risk for liver injury, but mechanisms of damage remain unclear, according to investigators.

Proposed mechanisms include direct virus-induced effects, immune-induced damage due to excessive inflammatory responses, and drug-induced injury, reported lead author Ling Xu of Huazhong University of Science and Technology, Wuhan, China, and colleagues.

“From a clinical perspective, in addition to actively dealing with the primary disease caused by coronavirus infection, attention should also be paid to monitor the occurrence of liver injury, and to the application of drugs which may induce liver damage,” the investigators wrote in Liver International. “Patients with liver damage are advised to be treated with drugs that could both protect liver functions and inhibit inflammatory responses, such as ammonium glycyrrhizinate, which may, in turn, accelerate the process of disease recovery.”

The review of liver injury associated with major pathogenic coronaviruses included severe acute respiratory syndrome coronavirus (SARS-CoV), the Middle East respiratory syndrome coronavirus (MERS-CoV), and the newly emergent SARS-CoV-2, which causes COVID-19.

In cases of COVID-19, reported incidence of liver injury ranges from 15% to 53%, based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST), along with slightly elevated bilirubin levels. In severe cases, albumin decreases have also been documented.

Liver injury appears to be significantly more common among those with severe infection. In one cohort of 82 patients who died from COVID-19, the incidence of liver injury was 78%, while another study of 36 nonsurvivors reported a rate of 58%.

According to the investigators, both bile duct epithelial cells and liver cells express angiotensin converting enzyme II (ACE2), which is an entry receptor for SARS-CoV-2; however, expression of ACE2 in bile duct cells is “much higher” than in liver cells, and comparable with alveolar type 2 cells in the lungs.

“Bile duct epithelial cells are known to play important roles in liver regeneration and immune response,” the investigators noted.

Beyond direct- and immune-induced effects of COVID-19, postmortem findings suggest that drug-induced liver injury may also be a possibility, with a number of theoretical culprits, including antibiotics, steroids, and antivirals. Although the investigators emphasized that data are insufficient to pinpoint an exact agent, they highlighted a recent preprint study, which reported a significantly higher rate of lopinavir/ritonavir administration among patients with abnormal liver function, compared with those who had normal liver function (56.1% vs. 25%; P = .009).

“Drug-induced liver injury during the treatment of coronavirus infection should not be ignored and needs to be carefully investigated,” the investigators concluded.

Fundamental Research Funds for the Central Universities supported the work. The investigators reported no conflicts of interest.

SOURCE: Xu L et al. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435.

So you think you can pandemic?

Courtesy NIAID-RML

What’s that? You say you’ve got an idea for the next great pandemic? Well, if your pandemic is going to beat coronavirus/COVID-19, it’s going to have to top this:

Sex: Porn star Lola Taylor (real name, Iyubov Bushueva) is currently in COVID-related isolation in Moscow and has offered to “have sex with the first scientist who finds a cure for coronavirus,” the Daily Star reported.

Sensible terrorists: “Islamic State has adopted a safety-first approach to the coronavirus pandemic and advised its members not to travel to Europe,” Politico reported. The terrorist group’s latest newsletter recommends that followers “stay away from the land of the epidemic” for the time being.

Drugs: Michigan is doing its part to keep the cannabis flowing. The state is temporarily lifting its ban against curbside pickup at marijuana stores as a way to limit exposure to coronavirus. “There has been an increase of customers who are stockpiling both medical and recreational cannabis, and sales are definitely up, just like other essentials,” Michigan Cannabis Industry Association Director Robin Schneider told mLive.com.

Sewage gridlock: Please don’t feed the fatbergs. That’s the message from the United Kingdom’s largest water and sewage authority. Thames Water is warning customers that flushing paper towels and wet wipes will add to the nonbiodegradable sewage blobs known as fatbergs, the Guardian reported. Thames Water’s position: “The only things that should be flushed are the 3 P’s: poo, pee and (toilet) paper,” the Guardian said.

Airship hospitals: China built two hospitals in response to the coronavirus epidemic, but can either of them fly? No. Science writer Bill Gourgey suggests that it’s time to revisit an idea proposed 100 years ago during a tuberculosis epidemic. Airships equipped as hospitals “could offer all of the resources – staff and equipment – to extract, quarantine, and treat patients. And a fleet could deliver at scale,” he wrote on OneZero.

The Governator: His royal Arnold-ness, along with this his pony Whiskey and donkey Lulu, has taken to Twitter to try to convince folks to stay inside and eat carrots together. Happily, Mr. Schwarzenegger did not go all Terminator when Whiskey tried to bite Lulu, instead offering a gentle, “You’ve got to get along.”

If your pandemic doesn’t have all of this, then you’re just not trying hard enough.
 

Earthworm Surprise

motorolka/iStock/Getty Images Plus

If you watched the Rugrats as a kid – or if your kids did, nonmillennials – you may remember how Phil and Lil used to eat bugs and worms whenever they played outside. We used to think it was gross, but now we think it may be time to follow their lead.

A Latvian scientist has unearthed (sorry) ways to make bread, muffins, lollipops, and so on using earthworms, claiming that earthworms are full of protein. Next time your children are crying for candy or sweets, why not hand them an earthworm lollipop to appease them? You’ll be making sure they’re getting their daily dose of protein!

The scientist, Ilga Gedrovica of the Latvian University of Life Science and Technologies, reported that earthworms not only contain just as much protein as meat, but they are also cheaper to produce. She also explained that, when dried, earthworms contain about three times more protein than meat.

Research is now underway to determine the safety of eating earthworms, fried or otherwise.

Just think: In a post–COVID-19 future, instead of a steak dinner, we could be making earthworm casseroles! Which, of course, kids won’t eat. Not because of the earthworms, of course. But because, ewwww, casseroles.
 

It’s ... Monty Python’s Flying Study!

Michael Blann/DigitalVision

It’s one of life’s most haunting questions, asked by one of our best philosophers: What is the velocity of an unladen swallow?

Sadly, Nathaniel Dominy and Erin Butler of Dartmouth University did not tackle this conundrum, but they did address another issue raised by Monty Python: Just how silly are the walks displayed by the Ministry of Silly Walks?

As you might expect, the minister himself is a masterclass of inefficiency, moving with 6.7 times more variability than someone walking in a nonhumorous fashion. Mr. Pudey, the man applying for the government grant to develop his own silly walk, is noticeably more efficient, merely displaying a rate of variability 3.3 times that of a normal walk. However, the researchers agreed with the minister that Mr. Pudey was well deserving of a government grant.

While we feel answering that question alone was worth a study, the researchers did have a larger point to make: comparing the bureaucratic inefficiency of the Ministry of Silly Walks to today’s peer-review process within the health field, particularly when researchers seek funding.

Grants take months to be approved and often involve researchers flying back and forth. A streamlined process could save huge amounts of both time and money, they noted.

The LOTME team would like to salute these two researchers for their excellent choice of metaphor, and hope they use Monty Python to make further points about health care. The swallow problem is just begging to be made into a metaphor.

So you think you can pandemic?

Courtesy NIAID-RML

What’s that? You say you’ve got an idea for the next great pandemic? Well, if your pandemic is going to beat coronavirus/COVID-19, it’s going to have to top this:

Sex: Porn star Lola Taylor (real name, Iyubov Bushueva) is currently in COVID-related isolation in Moscow and has offered to “have sex with the first scientist who finds a cure for coronavirus,” the Daily Star reported.

Sensible terrorists: “Islamic State has adopted a safety-first approach to the coronavirus pandemic and advised its members not to travel to Europe,” Politico reported. The terrorist group’s latest newsletter recommends that followers “stay away from the land of the epidemic” for the time being.

Drugs: Michigan is doing its part to keep the cannabis flowing. The state is temporarily lifting its ban against curbside pickup at marijuana stores as a way to limit exposure to coronavirus. “There has been an increase of customers who are stockpiling both medical and recreational cannabis, and sales are definitely up, just like other essentials,” Michigan Cannabis Industry Association Director Robin Schneider told mLive.com.

Sewage gridlock: Please don’t feed the fatbergs. That’s the message from the United Kingdom’s largest water and sewage authority. Thames Water is warning customers that flushing paper towels and wet wipes will add to the nonbiodegradable sewage blobs known as fatbergs, the Guardian reported. Thames Water’s position: “The only things that should be flushed are the 3 P’s: poo, pee and (toilet) paper,” the Guardian said.

Airship hospitals: China built two hospitals in response to the coronavirus epidemic, but can either of them fly? No. Science writer Bill Gourgey suggests that it’s time to revisit an idea proposed 100 years ago during a tuberculosis epidemic. Airships equipped as hospitals “could offer all of the resources – staff and equipment – to extract, quarantine, and treat patients. And a fleet could deliver at scale,” he wrote on OneZero.

The Governator: His royal Arnold-ness, along with this his pony Whiskey and donkey Lulu, has taken to Twitter to try to convince folks to stay inside and eat carrots together. Happily, Mr. Schwarzenegger did not go all Terminator when Whiskey tried to bite Lulu, instead offering a gentle, “You’ve got to get along.”

If your pandemic doesn’t have all of this, then you’re just not trying hard enough.
 

Earthworm Surprise

motorolka/iStock/Getty Images Plus

If you watched the Rugrats as a kid – or if your kids did, nonmillennials – you may remember how Phil and Lil used to eat bugs and worms whenever they played outside. We used to think it was gross, but now we think it may be time to follow their lead.

A Latvian scientist has unearthed (sorry) ways to make bread, muffins, lollipops, and so on using earthworms, claiming that earthworms are full of protein. Next time your children are crying for candy or sweets, why not hand them an earthworm lollipop to appease them? You’ll be making sure they’re getting their daily dose of protein!

The scientist, Ilga Gedrovica of the Latvian University of Life Science and Technologies, reported that earthworms not only contain just as much protein as meat, but they are also cheaper to produce. She also explained that, when dried, earthworms contain about three times more protein than meat.

Research is now underway to determine the safety of eating earthworms, fried or otherwise.

Just think: In a post–COVID-19 future, instead of a steak dinner, we could be making earthworm casseroles! Which, of course, kids won’t eat. Not because of the earthworms, of course. But because, ewwww, casseroles.
 

It’s ... Monty Python’s Flying Study!

Michael Blann/DigitalVision

It’s one of life’s most haunting questions, asked by one of our best philosophers: What is the velocity of an unladen swallow?

Sadly, Nathaniel Dominy and Erin Butler of Dartmouth University did not tackle this conundrum, but they did address another issue raised by Monty Python: Just how silly are the walks displayed by the Ministry of Silly Walks?

As you might expect, the minister himself is a masterclass of inefficiency, moving with 6.7 times more variability than someone walking in a nonhumorous fashion. Mr. Pudey, the man applying for the government grant to develop his own silly walk, is noticeably more efficient, merely displaying a rate of variability 3.3 times that of a normal walk. However, the researchers agreed with the minister that Mr. Pudey was well deserving of a government grant.

While we feel answering that question alone was worth a study, the researchers did have a larger point to make: comparing the bureaucratic inefficiency of the Ministry of Silly Walks to today’s peer-review process within the health field, particularly when researchers seek funding.

Grants take months to be approved and often involve researchers flying back and forth. A streamlined process could save huge amounts of both time and money, they noted.

The LOTME team would like to salute these two researchers for their excellent choice of metaphor, and hope they use Monty Python to make further points about health care. The swallow problem is just begging to be made into a metaphor.

So you think you can pandemic?

Courtesy NIAID-RML

What’s that? You say you’ve got an idea for the next great pandemic? Well, if your pandemic is going to beat coronavirus/COVID-19, it’s going to have to top this:

Sex: Porn star Lola Taylor (real name, Iyubov Bushueva) is currently in COVID-related isolation in Moscow and has offered to “have sex with the first scientist who finds a cure for coronavirus,” the Daily Star reported.

Sensible terrorists: “Islamic State has adopted a safety-first approach to the coronavirus pandemic and advised its members not to travel to Europe,” Politico reported. The terrorist group’s latest newsletter recommends that followers “stay away from the land of the epidemic” for the time being.

Drugs: Michigan is doing its part to keep the cannabis flowing. The state is temporarily lifting its ban against curbside pickup at marijuana stores as a way to limit exposure to coronavirus. “There has been an increase of customers who are stockpiling both medical and recreational cannabis, and sales are definitely up, just like other essentials,” Michigan Cannabis Industry Association Director Robin Schneider told mLive.com.

Sewage gridlock: Please don’t feed the fatbergs. That’s the message from the United Kingdom’s largest water and sewage authority. Thames Water is warning customers that flushing paper towels and wet wipes will add to the nonbiodegradable sewage blobs known as fatbergs, the Guardian reported. Thames Water’s position: “The only things that should be flushed are the 3 P’s: poo, pee and (toilet) paper,” the Guardian said.

Airship hospitals: China built two hospitals in response to the coronavirus epidemic, but can either of them fly? No. Science writer Bill Gourgey suggests that it’s time to revisit an idea proposed 100 years ago during a tuberculosis epidemic. Airships equipped as hospitals “could offer all of the resources – staff and equipment – to extract, quarantine, and treat patients. And a fleet could deliver at scale,” he wrote on OneZero.

The Governator: His royal Arnold-ness, along with this his pony Whiskey and donkey Lulu, has taken to Twitter to try to convince folks to stay inside and eat carrots together. Happily, Mr. Schwarzenegger did not go all Terminator when Whiskey tried to bite Lulu, instead offering a gentle, “You’ve got to get along.”

If your pandemic doesn’t have all of this, then you’re just not trying hard enough.
 

Earthworm Surprise

motorolka/iStock/Getty Images Plus

If you watched the Rugrats as a kid – or if your kids did, nonmillennials – you may remember how Phil and Lil used to eat bugs and worms whenever they played outside. We used to think it was gross, but now we think it may be time to follow their lead.

A Latvian scientist has unearthed (sorry) ways to make bread, muffins, lollipops, and so on using earthworms, claiming that earthworms are full of protein. Next time your children are crying for candy or sweets, why not hand them an earthworm lollipop to appease them? You’ll be making sure they’re getting their daily dose of protein!

The scientist, Ilga Gedrovica of the Latvian University of Life Science and Technologies, reported that earthworms not only contain just as much protein as meat, but they are also cheaper to produce. She also explained that, when dried, earthworms contain about three times more protein than meat.

Research is now underway to determine the safety of eating earthworms, fried or otherwise.

Just think: In a post–COVID-19 future, instead of a steak dinner, we could be making earthworm casseroles! Which, of course, kids won’t eat. Not because of the earthworms, of course. But because, ewwww, casseroles.
 

It’s ... Monty Python’s Flying Study!

Michael Blann/DigitalVision

It’s one of life’s most haunting questions, asked by one of our best philosophers: What is the velocity of an unladen swallow?

Sadly, Nathaniel Dominy and Erin Butler of Dartmouth University did not tackle this conundrum, but they did address another issue raised by Monty Python: Just how silly are the walks displayed by the Ministry of Silly Walks?

As you might expect, the minister himself is a masterclass of inefficiency, moving with 6.7 times more variability than someone walking in a nonhumorous fashion. Mr. Pudey, the man applying for the government grant to develop his own silly walk, is noticeably more efficient, merely displaying a rate of variability 3.3 times that of a normal walk. However, the researchers agreed with the minister that Mr. Pudey was well deserving of a government grant.

While we feel answering that question alone was worth a study, the researchers did have a larger point to make: comparing the bureaucratic inefficiency of the Ministry of Silly Walks to today’s peer-review process within the health field, particularly when researchers seek funding.

Grants take months to be approved and often involve researchers flying back and forth. A streamlined process could save huge amounts of both time and money, they noted.

The LOTME team would like to salute these two researchers for their excellent choice of metaphor, and hope they use Monty Python to make further points about health care. The swallow problem is just begging to be made into a metaphor.

Combination apatinib and vinorelbine “may have potential” for treating patients with wild-type, advanced non–small cell lung cancer (NSCLC) who failed at least two prior lines of chemotherapy, according to researchers.

In a phase 2 trial, apatinib plus vinorelbine produced an overall response rate of 36.7% and a disease control rate of 76.7%. Nearly half of patients required dose reductions, and 17% discontinued treatment due to adverse events.

Xiangyu Zhang, MD, of Hunan Cancer Hospital in Changsha, China, and colleagues conducted this trial (NCT03652857) and detailed the results in JAMA Network Open.

The researchers noted that there is no standard treatment strategy for patients who have advanced NSCLC without actionable mutations and have failed two or more lines of chemotherapy. So the team tested apatinib plus vinorelbine in 30 such patients.

The patients’ median age was 63 years (range, 34-78 years), 60% were men, and 90% had stage IV disease. They had received a median of 2 (range, 2-5) prior lines of chemotherapy.

In this study, patients received apatinib at 500 mg once daily and vinorelbine at 60 mg/m² once weekly. The dose of apatinib could be interrupted or reduced to manage adverse events. Patients could receive 250 mg or 500 mg on alternate days or 250 mg once daily. Patients were treated until they progressed, withdrew, or had unacceptable adverse events.
 

Results

Patients were treated for a median of 4 months (range, 1-22 months), and the median follow-up was 11 months (range, 4.5-14.1 months). Most patients (n = 25) continued treatment until they progressed, 17 were able to remain on the 500-mg dose of apatinib, 13 received the 250-mg dose of apatinib, and 5 patients discontinued treatment due to adverse events.

The overall response rate was 36.7%, and the disease control rate, defined as the proportion of patients with complete response, partial response, and stable disease, was 76.7%. There were no complete responses, 11 partial responses, 12 patients with stable disease, and 7 patients who progressed. Rates of response, disease control, and progression were similar whether patients received the 500-mg dose of apatinib or the 250-mg dose.

The median progression-free survival was 4.5 months, and the median overall survival was 10 months.

Hand-foot syndrome was the most common adverse event, with grade 1-2 hand-foot syndrome occurring in 13 patients (43%), grade 3 occurring in 5 patients (17%), and grade 4 occurring in 1 patient (3%).

The adverse events that led to treatment discontinuation were grade 3 weakness (n = 1), pleural effusion (n = 1), fungal infection (n = 1), and grade 3 hand-foot syndrome (n = 2). There were no fatal adverse events.

“[The] combination of apatinib and oral vinorelbine has promising efficacy and manageable toxic effects as a third-line or subsequent-line treatment in patients with driver variation-negative advanced NCSLC,” the researchers concluded. “Further evaluation of this combination in phase 3 trials is warranted.”

The current study was funded by grants from the National Natural Science Foundation of China and the Hunan Natural Science Foundation. The researchers disclosed no conflicts of interest.

[email protected]

SOURCE: Zhang X et al. JAMA Netw Open. 2020;3(3):e201226. doi: 10.1001/jamanetworkopen.2020.12.

Combination apatinib and vinorelbine “may have potential” for treating patients with wild-type, advanced non–small cell lung cancer (NSCLC) who failed at least two prior lines of chemotherapy, according to researchers.

In a phase 2 trial, apatinib plus vinorelbine produced an overall response rate of 36.7% and a disease control rate of 76.7%. Nearly half of patients required dose reductions, and 17% discontinued treatment due to adverse events.

Xiangyu Zhang, MD, of Hunan Cancer Hospital in Changsha, China, and colleagues conducted this trial (NCT03652857) and detailed the results in JAMA Network Open.

The researchers noted that there is no standard treatment strategy for patients who have advanced NSCLC without actionable mutations and have failed two or more lines of chemotherapy. So the team tested apatinib plus vinorelbine in 30 such patients.

The patients’ median age was 63 years (range, 34-78 years), 60% were men, and 90% had stage IV disease. They had received a median of 2 (range, 2-5) prior lines of chemotherapy.

In this study, patients received apatinib at 500 mg once daily and vinorelbine at 60 mg/m² once weekly. The dose of apatinib could be interrupted or reduced to manage adverse events. Patients could receive 250 mg or 500 mg on alternate days or 250 mg once daily. Patients were treated until they progressed, withdrew, or had unacceptable adverse events.
 

Results

Patients were treated for a median of 4 months (range, 1-22 months), and the median follow-up was 11 months (range, 4.5-14.1 months). Most patients (n = 25) continued treatment until they progressed, 17 were able to remain on the 500-mg dose of apatinib, 13 received the 250-mg dose of apatinib, and 5 patients discontinued treatment due to adverse events.

The overall response rate was 36.7%, and the disease control rate, defined as the proportion of patients with complete response, partial response, and stable disease, was 76.7%. There were no complete responses, 11 partial responses, 12 patients with stable disease, and 7 patients who progressed. Rates of response, disease control, and progression were similar whether patients received the 500-mg dose of apatinib or the 250-mg dose.

The median progression-free survival was 4.5 months, and the median overall survival was 10 months.

Hand-foot syndrome was the most common adverse event, with grade 1-2 hand-foot syndrome occurring in 13 patients (43%), grade 3 occurring in 5 patients (17%), and grade 4 occurring in 1 patient (3%).

The adverse events that led to treatment discontinuation were grade 3 weakness (n = 1), pleural effusion (n = 1), fungal infection (n = 1), and grade 3 hand-foot syndrome (n = 2). There were no fatal adverse events.

“[The] combination of apatinib and oral vinorelbine has promising efficacy and manageable toxic effects as a third-line or subsequent-line treatment in patients with driver variation-negative advanced NCSLC,” the researchers concluded. “Further evaluation of this combination in phase 3 trials is warranted.”

The current study was funded by grants from the National Natural Science Foundation of China and the Hunan Natural Science Foundation. The researchers disclosed no conflicts of interest.

[email protected]

SOURCE: Zhang X et al. JAMA Netw Open. 2020;3(3):e201226. doi: 10.1001/jamanetworkopen.2020.12.

Combination apatinib and vinorelbine “may have potential” for treating patients with wild-type, advanced non–small cell lung cancer (NSCLC) who failed at least two prior lines of chemotherapy, according to researchers.

In a phase 2 trial, apatinib plus vinorelbine produced an overall response rate of 36.7% and a disease control rate of 76.7%. Nearly half of patients required dose reductions, and 17% discontinued treatment due to adverse events.

Xiangyu Zhang, MD, of Hunan Cancer Hospital in Changsha, China, and colleagues conducted this trial (NCT03652857) and detailed the results in JAMA Network Open.

The researchers noted that there is no standard treatment strategy for patients who have advanced NSCLC without actionable mutations and have failed two or more lines of chemotherapy. So the team tested apatinib plus vinorelbine in 30 such patients.

The patients’ median age was 63 years (range, 34-78 years), 60% were men, and 90% had stage IV disease. They had received a median of 2 (range, 2-5) prior lines of chemotherapy.

In this study, patients received apatinib at 500 mg once daily and vinorelbine at 60 mg/m² once weekly. The dose of apatinib could be interrupted or reduced to manage adverse events. Patients could receive 250 mg or 500 mg on alternate days or 250 mg once daily. Patients were treated until they progressed, withdrew, or had unacceptable adverse events.
 

Results

Patients were treated for a median of 4 months (range, 1-22 months), and the median follow-up was 11 months (range, 4.5-14.1 months). Most patients (n = 25) continued treatment until they progressed, 17 were able to remain on the 500-mg dose of apatinib, 13 received the 250-mg dose of apatinib, and 5 patients discontinued treatment due to adverse events.

The overall response rate was 36.7%, and the disease control rate, defined as the proportion of patients with complete response, partial response, and stable disease, was 76.7%. There were no complete responses, 11 partial responses, 12 patients with stable disease, and 7 patients who progressed. Rates of response, disease control, and progression were similar whether patients received the 500-mg dose of apatinib or the 250-mg dose.

The median progression-free survival was 4.5 months, and the median overall survival was 10 months.

Hand-foot syndrome was the most common adverse event, with grade 1-2 hand-foot syndrome occurring in 13 patients (43%), grade 3 occurring in 5 patients (17%), and grade 4 occurring in 1 patient (3%).

The adverse events that led to treatment discontinuation were grade 3 weakness (n = 1), pleural effusion (n = 1), fungal infection (n = 1), and grade 3 hand-foot syndrome (n = 2). There were no fatal adverse events.

“[The] combination of apatinib and oral vinorelbine has promising efficacy and manageable toxic effects as a third-line or subsequent-line treatment in patients with driver variation-negative advanced NCSLC,” the researchers concluded. “Further evaluation of this combination in phase 3 trials is warranted.”

The current study was funded by grants from the National Natural Science Foundation of China and the Hunan Natural Science Foundation. The researchers disclosed no conflicts of interest.

[email protected]

SOURCE: Zhang X et al. JAMA Netw Open. 2020;3(3):e201226. doi: 10.1001/jamanetworkopen.2020.12.

As gastroenterologists and gastrointestinal researchers, we work with an increasingly diverse patient population amid known disparities in health care delivery and health outcomes. The American Gastroenterological Association values diversity and inclusion, and part of its strategic plan is to increase and diversify its membership and leaders. The AGA Diversity Committee supports this strategic goal by fostering and promoting involvement, advancement, and recognition of underrepresented diverse constituencies. This is accomplished through policy recommendations and programs, providing resources to AGA members for addressing barriers to access and utilization of health care services among diverse patient populations with attention to linguistic, racial, cultural, religious, sexual orientation, gender identity, disability, age, and economic diversity.

There are eight clinician and investigator members, including the chair as well as one trainee member on the AGA Diversity Committee. Four members are appointed at-large and three members are appointed from the AGA Institute Committees and the AGA Institute Council. The committee has set out to achieve mission-driven goals with several initiatives that align with its intention to cultivate a diverse, inclusive, and engaged membership, armed with the necessary tools to provide the highest quality care and perform the most effective research that will benefit our patient population.

The communications task force highlights programs and topics that support the committee’s missions. Members of the committee coauthored a paper on colorectal disparities published in GI & Hepatology News in May 2018.¹ In addition to presenting the disparities in colorectal screening, it provided ways to close this gap. A more recent publication in AGA Perspectives focused on unconscious bias as a prelude to the committee’s workshop at Digestive Disease Week^® (DDW) 2019.² An important initiative has been promoting Black History Month in February and Pride Month in June by posting cases or displaying prominent trailblazers on the AGA Community. In the upcoming months, profiles of several committee members will be featured in eDigest, GI & Hepatology News, and on AGA’s social media platforms.

DDW programming sponsored by the Diversity Committee is an important way to engage our members. At DDW 2019, the committee sponsored a clinical symposium title “Beyond Starbucks: Mitigating Bias Through Awareness.” This session was inspired by the 2018 incidence hallmarked by the inappropriate arrest of two African American men at a Philadelphia Starbucks. This event led to a nationwide educational breakout for all employees aimed at providing unconscious bias training. The Diversity Committee drew inspiration from these events, holding a symposium with set goals of defining unconscious bias and identifying areas within health care where unconscious bias can influence patient care. The committee invited Allyson Dylan Robinson, a portfolio lead from the Association of American Medical Colleges–endorsed Cook Ross Firm, who is nationally recognized as a leader in unconscious bias training. The assembly began with an introductory lecture followed by breakout sessions where small groups reviewed selected patient cases to determine the influence of unconscious bias in clinical scenarios. It was a well-attended symposium and was complementary to the wide array of didactic lectures offered at DDW. Bringing to light significant issues and barriers to health care is one key aspect of the mission set forth by the Diversity Committee.

The AGA Diversity Committee e-poster tour at DDW 2019 promoted the research led by scientist and physician members of underrepresented groups in medicine and/or research focused on gastrointestinal diseases in underrepresented populations. Several high-quality abstracts were reviewed and four were selected for the e-poster tour. Each scientist presented their research in front of an enthusiastic audience of DDW attendees, followed by a question and answer session. Gonzalo Parodi, BS (Cedars-Sinai Medical Center, Los Angeles), presented an elegant study showing that the antibiotic changes to intestinal microbiome were sex specific in mice. Alexis Rivera, MD (University of Puerto Rico, San Juan), found no association between inflammatory bowel disease (IBD) serologic markers and risk of surgery in patients with IBD in Puerto Rico. Maria Gonzalez-Pons, PhD (University of Puerto Rico Comprehensive Cancer Center, San Juan), presented the first study looking at the mutational landscape of early-onset colorectal cancer tumors in Puerto Rican Hispanics, as a first step toward personalizing early screening in this population. Finally, Sushrut Jangi, MD (Brigham and Women’s Hospital, Boston), presented the first longitudinal study describing the unique demographic and phenotypic characteristics of IBD in South Asians living in the United States, showing that smoking was less relevant as a risk factor, and that Crohn’s presented with a more aggressive penetrating phenotype in this population. At the conclusion of the e-poster tour, attendees and presenters had the opportunity to exchange future research ideas or follow-up and network.

The upcoming DDW 2020 AGA Diversity Committee–sponsored symposium entitled “GI Health Disparities and Creating Affirming Environments for the LGBT+ Community: The Gastroenterologist, Patient, Researcher and Educator Perspectives” will provide attendees with the opportunity to learn not only about challenges faced by the LGBTQ+ community as patients, learners, and scientists, but how we as educators, researchers, clinicians, and leaders can strategically address these challenges and intentionally create inclusive spaces in an effort to reduce health care disparities and inequities in both clinical and academic environments.

A current initiative is the creation of an archive of notable underrepresented gastroenterologists and GI scientists. The database will serve as a resource for conference organizers and committee members to identify junior speakers and mentors from diverse minority, ethnic, and racial backgrounds. This will be a platform for divisional chairs, program directors, and mentors to recommend and promote upcoming stars in their designated fields. Once the website and cloud database have been built, the diversity committee will reach out to divisional chairs, program directors, committee members, and leaders in the field to recommend physicians and scientists to include in this database. We will then reach out to nominees with an invitation and link to complete their profile in the database. We believe that this will be an opportunity for young physicians and scientists and a resource to promote diversity in medicine and science.

While we share many common experiences as ethnic minorities, the gastroenterologists comprising the AGA Diversity Committee come from various cultural backgrounds, ethnicities, and clinical practice settings. Yet rather than creating contention, our differences are the strength of this committee. Our diverse backgrounds lead to a plethora of innovative ideas and perspectives in group discussions, resulting in very robust and productive meetings. In recognizing that a diverse group can render novel solutions to many topics and issues, one of our goals is to increase membership of underrepresented groups in the AGA, as well as participation in AGA committees. This entails direct outreach to gastroenterologists in these groups and acquainting them with the ways active participation in the numerous AGA committees will support the issues affecting their profession and patients.

The process of serving on an AGA committee is simple. Interested members can nominate themselves or be nominated by another AGA member and fill out a short application. The list of AGA committees, responsibilities, open positions, and application can be found at https://www.gastro.org/aga-leadership/committees. We believe committee participation is personally and professionally rewarding, and serving on the Diversity Committee is particularly gratifying, as we can address pertinent issues that may otherwise be neglected.

Dr. Badurdeen is assistant professor at Johns Hopkins Medicine, Columbia, Md; Dr. Charabaty Pishvaian is associate professor, clinical director of the GI division, and director of the IBD Center at Sibley Memorial Hospital, Washington; Dr. Malespin is assistant professor at the University of South Florida, Tampa, and transplant hepatologist, Tampa General Hospital; Dr. Oduyebo is a gastroenterologist for Mid-Atlantic Permanente Medical Group, Shady Grove, Md; Dr. Quezada is associate professor and assistant dean for academic and multicultural affairs, University of Maryland, Baltimore County; and Dr. Stephen is a gastroenterologist at Annadel Medical Group, Santa Rosa, Calif.
 

References

1. Oduyebo I et al. Underserved populations and colorectal cancer screening: Patient perceptions of barriers to care and effective interventions. GI & Hepatology News. May 2018.

2. Munroe CA et al. The AGA Diversity Committee: Opening up a conversation about unconscious bias in GI practice. AGA Perspectives. July 2019.

As gastroenterologists and gastrointestinal researchers, we work with an increasingly diverse patient population amid known disparities in health care delivery and health outcomes. The American Gastroenterological Association values diversity and inclusion, and part of its strategic plan is to increase and diversify its membership and leaders. The AGA Diversity Committee supports this strategic goal by fostering and promoting involvement, advancement, and recognition of underrepresented diverse constituencies. This is accomplished through policy recommendations and programs, providing resources to AGA members for addressing barriers to access and utilization of health care services among diverse patient populations with attention to linguistic, racial, cultural, religious, sexual orientation, gender identity, disability, age, and economic diversity.

There are eight clinician and investigator members, including the chair as well as one trainee member on the AGA Diversity Committee. Four members are appointed at-large and three members are appointed from the AGA Institute Committees and the AGA Institute Council. The committee has set out to achieve mission-driven goals with several initiatives that align with its intention to cultivate a diverse, inclusive, and engaged membership, armed with the necessary tools to provide the highest quality care and perform the most effective research that will benefit our patient population.

The communications task force highlights programs and topics that support the committee’s missions. Members of the committee coauthored a paper on colorectal disparities published in GI & Hepatology News in May 2018.¹ In addition to presenting the disparities in colorectal screening, it provided ways to close this gap. A more recent publication in AGA Perspectives focused on unconscious bias as a prelude to the committee’s workshop at Digestive Disease Week^® (DDW) 2019.² An important initiative has been promoting Black History Month in February and Pride Month in June by posting cases or displaying prominent trailblazers on the AGA Community. In the upcoming months, profiles of several committee members will be featured in eDigest, GI & Hepatology News, and on AGA’s social media platforms.

DDW programming sponsored by the Diversity Committee is an important way to engage our members. At DDW 2019, the committee sponsored a clinical symposium title “Beyond Starbucks: Mitigating Bias Through Awareness.” This session was inspired by the 2018 incidence hallmarked by the inappropriate arrest of two African American men at a Philadelphia Starbucks. This event led to a nationwide educational breakout for all employees aimed at providing unconscious bias training. The Diversity Committee drew inspiration from these events, holding a symposium with set goals of defining unconscious bias and identifying areas within health care where unconscious bias can influence patient care. The committee invited Allyson Dylan Robinson, a portfolio lead from the Association of American Medical Colleges–endorsed Cook Ross Firm, who is nationally recognized as a leader in unconscious bias training. The assembly began with an introductory lecture followed by breakout sessions where small groups reviewed selected patient cases to determine the influence of unconscious bias in clinical scenarios. It was a well-attended symposium and was complementary to the wide array of didactic lectures offered at DDW. Bringing to light significant issues and barriers to health care is one key aspect of the mission set forth by the Diversity Committee.

The AGA Diversity Committee e-poster tour at DDW 2019 promoted the research led by scientist and physician members of underrepresented groups in medicine and/or research focused on gastrointestinal diseases in underrepresented populations. Several high-quality abstracts were reviewed and four were selected for the e-poster tour. Each scientist presented their research in front of an enthusiastic audience of DDW attendees, followed by a question and answer session. Gonzalo Parodi, BS (Cedars-Sinai Medical Center, Los Angeles), presented an elegant study showing that the antibiotic changes to intestinal microbiome were sex specific in mice. Alexis Rivera, MD (University of Puerto Rico, San Juan), found no association between inflammatory bowel disease (IBD) serologic markers and risk of surgery in patients with IBD in Puerto Rico. Maria Gonzalez-Pons, PhD (University of Puerto Rico Comprehensive Cancer Center, San Juan), presented the first study looking at the mutational landscape of early-onset colorectal cancer tumors in Puerto Rican Hispanics, as a first step toward personalizing early screening in this population. Finally, Sushrut Jangi, MD (Brigham and Women’s Hospital, Boston), presented the first longitudinal study describing the unique demographic and phenotypic characteristics of IBD in South Asians living in the United States, showing that smoking was less relevant as a risk factor, and that Crohn’s presented with a more aggressive penetrating phenotype in this population. At the conclusion of the e-poster tour, attendees and presenters had the opportunity to exchange future research ideas or follow-up and network.

The upcoming DDW 2020 AGA Diversity Committee–sponsored symposium entitled “GI Health Disparities and Creating Affirming Environments for the LGBT+ Community: The Gastroenterologist, Patient, Researcher and Educator Perspectives” will provide attendees with the opportunity to learn not only about challenges faced by the LGBTQ+ community as patients, learners, and scientists, but how we as educators, researchers, clinicians, and leaders can strategically address these challenges and intentionally create inclusive spaces in an effort to reduce health care disparities and inequities in both clinical and academic environments.

A current initiative is the creation of an archive of notable underrepresented gastroenterologists and GI scientists. The database will serve as a resource for conference organizers and committee members to identify junior speakers and mentors from diverse minority, ethnic, and racial backgrounds. This will be a platform for divisional chairs, program directors, and mentors to recommend and promote upcoming stars in their designated fields. Once the website and cloud database have been built, the diversity committee will reach out to divisional chairs, program directors, committee members, and leaders in the field to recommend physicians and scientists to include in this database. We will then reach out to nominees with an invitation and link to complete their profile in the database. We believe that this will be an opportunity for young physicians and scientists and a resource to promote diversity in medicine and science.

While we share many common experiences as ethnic minorities, the gastroenterologists comprising the AGA Diversity Committee come from various cultural backgrounds, ethnicities, and clinical practice settings. Yet rather than creating contention, our differences are the strength of this committee. Our diverse backgrounds lead to a plethora of innovative ideas and perspectives in group discussions, resulting in very robust and productive meetings. In recognizing that a diverse group can render novel solutions to many topics and issues, one of our goals is to increase membership of underrepresented groups in the AGA, as well as participation in AGA committees. This entails direct outreach to gastroenterologists in these groups and acquainting them with the ways active participation in the numerous AGA committees will support the issues affecting their profession and patients.

The process of serving on an AGA committee is simple. Interested members can nominate themselves or be nominated by another AGA member and fill out a short application. The list of AGA committees, responsibilities, open positions, and application can be found at https://www.gastro.org/aga-leadership/committees. We believe committee participation is personally and professionally rewarding, and serving on the Diversity Committee is particularly gratifying, as we can address pertinent issues that may otherwise be neglected.

Dr. Badurdeen is assistant professor at Johns Hopkins Medicine, Columbia, Md; Dr. Charabaty Pishvaian is associate professor, clinical director of the GI division, and director of the IBD Center at Sibley Memorial Hospital, Washington; Dr. Malespin is assistant professor at the University of South Florida, Tampa, and transplant hepatologist, Tampa General Hospital; Dr. Oduyebo is a gastroenterologist for Mid-Atlantic Permanente Medical Group, Shady Grove, Md; Dr. Quezada is associate professor and assistant dean for academic and multicultural affairs, University of Maryland, Baltimore County; and Dr. Stephen is a gastroenterologist at Annadel Medical Group, Santa Rosa, Calif.
 

References

1. Oduyebo I et al. Underserved populations and colorectal cancer screening: Patient perceptions of barriers to care and effective interventions. GI & Hepatology News. May 2018.

2. Munroe CA et al. The AGA Diversity Committee: Opening up a conversation about unconscious bias in GI practice. AGA Perspectives. July 2019.

As gastroenterologists and gastrointestinal researchers, we work with an increasingly diverse patient population amid known disparities in health care delivery and health outcomes. The American Gastroenterological Association values diversity and inclusion, and part of its strategic plan is to increase and diversify its membership and leaders. The AGA Diversity Committee supports this strategic goal by fostering and promoting involvement, advancement, and recognition of underrepresented diverse constituencies. This is accomplished through policy recommendations and programs, providing resources to AGA members for addressing barriers to access and utilization of health care services among diverse patient populations with attention to linguistic, racial, cultural, religious, sexual orientation, gender identity, disability, age, and economic diversity.

There are eight clinician and investigator members, including the chair as well as one trainee member on the AGA Diversity Committee. Four members are appointed at-large and three members are appointed from the AGA Institute Committees and the AGA Institute Council. The committee has set out to achieve mission-driven goals with several initiatives that align with its intention to cultivate a diverse, inclusive, and engaged membership, armed with the necessary tools to provide the highest quality care and perform the most effective research that will benefit our patient population.

The communications task force highlights programs and topics that support the committee’s missions. Members of the committee coauthored a paper on colorectal disparities published in GI & Hepatology News in May 2018.¹ In addition to presenting the disparities in colorectal screening, it provided ways to close this gap. A more recent publication in AGA Perspectives focused on unconscious bias as a prelude to the committee’s workshop at Digestive Disease Week^® (DDW) 2019.² An important initiative has been promoting Black History Month in February and Pride Month in June by posting cases or displaying prominent trailblazers on the AGA Community. In the upcoming months, profiles of several committee members will be featured in eDigest, GI & Hepatology News, and on AGA’s social media platforms.

DDW programming sponsored by the Diversity Committee is an important way to engage our members. At DDW 2019, the committee sponsored a clinical symposium title “Beyond Starbucks: Mitigating Bias Through Awareness.” This session was inspired by the 2018 incidence hallmarked by the inappropriate arrest of two African American men at a Philadelphia Starbucks. This event led to a nationwide educational breakout for all employees aimed at providing unconscious bias training. The Diversity Committee drew inspiration from these events, holding a symposium with set goals of defining unconscious bias and identifying areas within health care where unconscious bias can influence patient care. The committee invited Allyson Dylan Robinson, a portfolio lead from the Association of American Medical Colleges–endorsed Cook Ross Firm, who is nationally recognized as a leader in unconscious bias training. The assembly began with an introductory lecture followed by breakout sessions where small groups reviewed selected patient cases to determine the influence of unconscious bias in clinical scenarios. It was a well-attended symposium and was complementary to the wide array of didactic lectures offered at DDW. Bringing to light significant issues and barriers to health care is one key aspect of the mission set forth by the Diversity Committee.

The AGA Diversity Committee e-poster tour at DDW 2019 promoted the research led by scientist and physician members of underrepresented groups in medicine and/or research focused on gastrointestinal diseases in underrepresented populations. Several high-quality abstracts were reviewed and four were selected for the e-poster tour. Each scientist presented their research in front of an enthusiastic audience of DDW attendees, followed by a question and answer session. Gonzalo Parodi, BS (Cedars-Sinai Medical Center, Los Angeles), presented an elegant study showing that the antibiotic changes to intestinal microbiome were sex specific in mice. Alexis Rivera, MD (University of Puerto Rico, San Juan), found no association between inflammatory bowel disease (IBD) serologic markers and risk of surgery in patients with IBD in Puerto Rico. Maria Gonzalez-Pons, PhD (University of Puerto Rico Comprehensive Cancer Center, San Juan), presented the first study looking at the mutational landscape of early-onset colorectal cancer tumors in Puerto Rican Hispanics, as a first step toward personalizing early screening in this population. Finally, Sushrut Jangi, MD (Brigham and Women’s Hospital, Boston), presented the first longitudinal study describing the unique demographic and phenotypic characteristics of IBD in South Asians living in the United States, showing that smoking was less relevant as a risk factor, and that Crohn’s presented with a more aggressive penetrating phenotype in this population. At the conclusion of the e-poster tour, attendees and presenters had the opportunity to exchange future research ideas or follow-up and network.

The upcoming DDW 2020 AGA Diversity Committee–sponsored symposium entitled “GI Health Disparities and Creating Affirming Environments for the LGBT+ Community: The Gastroenterologist, Patient, Researcher and Educator Perspectives” will provide attendees with the opportunity to learn not only about challenges faced by the LGBTQ+ community as patients, learners, and scientists, but how we as educators, researchers, clinicians, and leaders can strategically address these challenges and intentionally create inclusive spaces in an effort to reduce health care disparities and inequities in both clinical and academic environments.

A current initiative is the creation of an archive of notable underrepresented gastroenterologists and GI scientists. The database will serve as a resource for conference organizers and committee members to identify junior speakers and mentors from diverse minority, ethnic, and racial backgrounds. This will be a platform for divisional chairs, program directors, and mentors to recommend and promote upcoming stars in their designated fields. Once the website and cloud database have been built, the diversity committee will reach out to divisional chairs, program directors, committee members, and leaders in the field to recommend physicians and scientists to include in this database. We will then reach out to nominees with an invitation and link to complete their profile in the database. We believe that this will be an opportunity for young physicians and scientists and a resource to promote diversity in medicine and science.

While we share many common experiences as ethnic minorities, the gastroenterologists comprising the AGA Diversity Committee come from various cultural backgrounds, ethnicities, and clinical practice settings. Yet rather than creating contention, our differences are the strength of this committee. Our diverse backgrounds lead to a plethora of innovative ideas and perspectives in group discussions, resulting in very robust and productive meetings. In recognizing that a diverse group can render novel solutions to many topics and issues, one of our goals is to increase membership of underrepresented groups in the AGA, as well as participation in AGA committees. This entails direct outreach to gastroenterologists in these groups and acquainting them with the ways active participation in the numerous AGA committees will support the issues affecting their profession and patients.

The process of serving on an AGA committee is simple. Interested members can nominate themselves or be nominated by another AGA member and fill out a short application. The list of AGA committees, responsibilities, open positions, and application can be found at https://www.gastro.org/aga-leadership/committees. We believe committee participation is personally and professionally rewarding, and serving on the Diversity Committee is particularly gratifying, as we can address pertinent issues that may otherwise be neglected.

Dr. Badurdeen is assistant professor at Johns Hopkins Medicine, Columbia, Md; Dr. Charabaty Pishvaian is associate professor, clinical director of the GI division, and director of the IBD Center at Sibley Memorial Hospital, Washington; Dr. Malespin is assistant professor at the University of South Florida, Tampa, and transplant hepatologist, Tampa General Hospital; Dr. Oduyebo is a gastroenterologist for Mid-Atlantic Permanente Medical Group, Shady Grove, Md; Dr. Quezada is associate professor and assistant dean for academic and multicultural affairs, University of Maryland, Baltimore County; and Dr. Stephen is a gastroenterologist at Annadel Medical Group, Santa Rosa, Calif.
 

References

1. Oduyebo I et al. Underserved populations and colorectal cancer screening: Patient perceptions of barriers to care and effective interventions. GI & Hepatology News. May 2018.

2. Munroe CA et al. The AGA Diversity Committee: Opening up a conversation about unconscious bias in GI practice. AGA Perspectives. July 2019.

PHOENIX, ARIZ. – Cardiovascular disease risk factors differ significantly between three black ethnic subgroups in the United States, compared with whites, results from a large, long-term cross-sectional study show.

Doug Brunk/MDedge News

“Race alone does not account for health disparities in CVD risk factors,” lead author Diana Baptiste, DNP, RN, CNE, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “We must consider the environmental, psychosocial, and social factors that may play a larger role in CVD risk among these populations.”

Dr. Baptiste, of the Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care in Baltimore, noted that blacks bear a disproportionately greater burden of CVD than that of any other racial group. “Blacks living in the U.S. are not monolithic and include different ethnic subgroups: African Americans, Afro-Caribbeans, defined as black persons who are born in the Caribbean islands, and African immigrants, defined as black persons who are born in Africa,” she said. “It is unclear how Afro-Caribbeans and African immigrants compare to African Americans and whites with regard to CVD risk factors.”

To examine trends in CVD risk factors among the three black ethnic subgroups compared with whites, she and her colleagues performed a cross-sectional analysis of 452,997 adults who participated in the 2010-2018 National Health Interview Survey (NHIS). Of these, 82% were white and 18% were black. Among blacks, 89% were African Americans, 6% were Afro-Caribbeans, and 5% were African immigrants. Outcomes of interest were four self-reported CVD risk factors: hypertension, diabetes, overweight/obesity, and smoking. The researchers used generalized linear models with Poisson distribution to calculate predictive probabilities of CVD risk factors, adjusted for age and sex.

Dr. Baptiste reported that African immigrants represented the youngest subgroup, with an average age of 41 years, compared with an average age of 50 among whites. They were also less likely to have health insurance (76%), compared with Afro-Caribbeans (81%), African Americans (83%), and whites (91%; P < .001). Disparities were observed in the proportion of individuals living below the poverty level. This was led by African Americans (24%), followed by African immigrants (22%), Afro-Caribbeans (18%), and whites (9%).

African immigrants were most likely to be college educated (36%), compared with whites (32%), Afro-Caribbeans (23%), and African Americans (17%; P =.001). In addition, only 33% of African Americans were married, compared with more than 50% of participants in the other ethnic groups.

African Americans had the highest prevalence of hypertension over the time period (from 44% in 2010 to 42% in 2018), while African immigrants had the lowest (from 19% to 17%). African Americans also had the highest prevalence of diabetes over the time period (from 14% to 15%), while African immigrants had the lowest (from 9% to 7%). The prevalence of overweight and obesity was highest among African Americans (from 74% to 76%), while African immigrants had the lowest (63% to 60%). Finally, smoking prevalence was highest in whites and African Americans compared with African immigrants and Afro-Caribbeans, but the prevalence decreased significantly between 2010 and 2018 (P for trend < .001).

In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, said that the study’s findings underscore the importance of heterogeneity when counseling patients about CVD risk factors. “Everybody comes from a different cultural background,” said Dr. Brown, a cardiologist and physician scientist at Mayo Clinic, Rochester, Minn. “Cultural backgrounds have an impact on when people eat, how they eat, who they eat with, when they exercise, and whether obesity is valued or not. It’s important to recognize that those cultural underpinnings can contribute to heterogeneity. Other factors – whether they are psychosocial or socioeconomic or environmental – also contribute.”

Strengths of the study, Dr. Baptiste said, included the use of a large, nationally representative dataset. Limitations included its cross-sectional design and the National Health Interview Survey’s reliance on self-reported data. “There were also small sample sizes for African immigrants and Afro-Caribbeans,” she said.

The study was supported by Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care. Dr. Baptiste reported having no financial disclosures.

The meeting was sponsored by the American Heart Association.

[email protected]

SOURCE: Baptiste D et al. EPI/Lifestyle 2020, Session 4, Abstract 8.

PHOENIX, ARIZ. – Cardiovascular disease risk factors differ significantly between three black ethnic subgroups in the United States, compared with whites, results from a large, long-term cross-sectional study show.

Doug Brunk/MDedge News

“Race alone does not account for health disparities in CVD risk factors,” lead author Diana Baptiste, DNP, RN, CNE, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “We must consider the environmental, psychosocial, and social factors that may play a larger role in CVD risk among these populations.”

Dr. Baptiste, of the Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care in Baltimore, noted that blacks bear a disproportionately greater burden of CVD than that of any other racial group. “Blacks living in the U.S. are not monolithic and include different ethnic subgroups: African Americans, Afro-Caribbeans, defined as black persons who are born in the Caribbean islands, and African immigrants, defined as black persons who are born in Africa,” she said. “It is unclear how Afro-Caribbeans and African immigrants compare to African Americans and whites with regard to CVD risk factors.”

To examine trends in CVD risk factors among the three black ethnic subgroups compared with whites, she and her colleagues performed a cross-sectional analysis of 452,997 adults who participated in the 2010-2018 National Health Interview Survey (NHIS). Of these, 82% were white and 18% were black. Among blacks, 89% were African Americans, 6% were Afro-Caribbeans, and 5% were African immigrants. Outcomes of interest were four self-reported CVD risk factors: hypertension, diabetes, overweight/obesity, and smoking. The researchers used generalized linear models with Poisson distribution to calculate predictive probabilities of CVD risk factors, adjusted for age and sex.

Dr. Baptiste reported that African immigrants represented the youngest subgroup, with an average age of 41 years, compared with an average age of 50 among whites. They were also less likely to have health insurance (76%), compared with Afro-Caribbeans (81%), African Americans (83%), and whites (91%; P < .001). Disparities were observed in the proportion of individuals living below the poverty level. This was led by African Americans (24%), followed by African immigrants (22%), Afro-Caribbeans (18%), and whites (9%).

African immigrants were most likely to be college educated (36%), compared with whites (32%), Afro-Caribbeans (23%), and African Americans (17%; P =.001). In addition, only 33% of African Americans were married, compared with more than 50% of participants in the other ethnic groups.

African Americans had the highest prevalence of hypertension over the time period (from 44% in 2010 to 42% in 2018), while African immigrants had the lowest (from 19% to 17%). African Americans also had the highest prevalence of diabetes over the time period (from 14% to 15%), while African immigrants had the lowest (from 9% to 7%). The prevalence of overweight and obesity was highest among African Americans (from 74% to 76%), while African immigrants had the lowest (63% to 60%). Finally, smoking prevalence was highest in whites and African Americans compared with African immigrants and Afro-Caribbeans, but the prevalence decreased significantly between 2010 and 2018 (P for trend < .001).

In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, said that the study’s findings underscore the importance of heterogeneity when counseling patients about CVD risk factors. “Everybody comes from a different cultural background,” said Dr. Brown, a cardiologist and physician scientist at Mayo Clinic, Rochester, Minn. “Cultural backgrounds have an impact on when people eat, how they eat, who they eat with, when they exercise, and whether obesity is valued or not. It’s important to recognize that those cultural underpinnings can contribute to heterogeneity. Other factors – whether they are psychosocial or socioeconomic or environmental – also contribute.”

Strengths of the study, Dr. Baptiste said, included the use of a large, nationally representative dataset. Limitations included its cross-sectional design and the National Health Interview Survey’s reliance on self-reported data. “There were also small sample sizes for African immigrants and Afro-Caribbeans,” she said.

The study was supported by Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care. Dr. Baptiste reported having no financial disclosures.

The meeting was sponsored by the American Heart Association.

[email protected]

SOURCE: Baptiste D et al. EPI/Lifestyle 2020, Session 4, Abstract 8.

PHOENIX, ARIZ. – Cardiovascular disease risk factors differ significantly between three black ethnic subgroups in the United States, compared with whites, results from a large, long-term cross-sectional study show.

Doug Brunk/MDedge News

“Race alone does not account for health disparities in CVD risk factors,” lead author Diana Baptiste, DNP, RN, CNE, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “We must consider the environmental, psychosocial, and social factors that may play a larger role in CVD risk among these populations.”

Dr. Baptiste, of the Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care in Baltimore, noted that blacks bear a disproportionately greater burden of CVD than that of any other racial group. “Blacks living in the U.S. are not monolithic and include different ethnic subgroups: African Americans, Afro-Caribbeans, defined as black persons who are born in the Caribbean islands, and African immigrants, defined as black persons who are born in Africa,” she said. “It is unclear how Afro-Caribbeans and African immigrants compare to African Americans and whites with regard to CVD risk factors.”

To examine trends in CVD risk factors among the three black ethnic subgroups compared with whites, she and her colleagues performed a cross-sectional analysis of 452,997 adults who participated in the 2010-2018 National Health Interview Survey (NHIS). Of these, 82% were white and 18% were black. Among blacks, 89% were African Americans, 6% were Afro-Caribbeans, and 5% were African immigrants. Outcomes of interest were four self-reported CVD risk factors: hypertension, diabetes, overweight/obesity, and smoking. The researchers used generalized linear models with Poisson distribution to calculate predictive probabilities of CVD risk factors, adjusted for age and sex.

Dr. Baptiste reported that African immigrants represented the youngest subgroup, with an average age of 41 years, compared with an average age of 50 among whites. They were also less likely to have health insurance (76%), compared with Afro-Caribbeans (81%), African Americans (83%), and whites (91%; P < .001). Disparities were observed in the proportion of individuals living below the poverty level. This was led by African Americans (24%), followed by African immigrants (22%), Afro-Caribbeans (18%), and whites (9%).

African immigrants were most likely to be college educated (36%), compared with whites (32%), Afro-Caribbeans (23%), and African Americans (17%; P =.001). In addition, only 33% of African Americans were married, compared with more than 50% of participants in the other ethnic groups.

African Americans had the highest prevalence of hypertension over the time period (from 44% in 2010 to 42% in 2018), while African immigrants had the lowest (from 19% to 17%). African Americans also had the highest prevalence of diabetes over the time period (from 14% to 15%), while African immigrants had the lowest (from 9% to 7%). The prevalence of overweight and obesity was highest among African Americans (from 74% to 76%), while African immigrants had the lowest (63% to 60%). Finally, smoking prevalence was highest in whites and African Americans compared with African immigrants and Afro-Caribbeans, but the prevalence decreased significantly between 2010 and 2018 (P for trend < .001).

In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, said that the study’s findings underscore the importance of heterogeneity when counseling patients about CVD risk factors. “Everybody comes from a different cultural background,” said Dr. Brown, a cardiologist and physician scientist at Mayo Clinic, Rochester, Minn. “Cultural backgrounds have an impact on when people eat, how they eat, who they eat with, when they exercise, and whether obesity is valued or not. It’s important to recognize that those cultural underpinnings can contribute to heterogeneity. Other factors – whether they are psychosocial or socioeconomic or environmental – also contribute.”

Strengths of the study, Dr. Baptiste said, included the use of a large, nationally representative dataset. Limitations included its cross-sectional design and the National Health Interview Survey’s reliance on self-reported data. “There were also small sample sizes for African immigrants and Afro-Caribbeans,” she said.

The study was supported by Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care. Dr. Baptiste reported having no financial disclosures.

The meeting was sponsored by the American Heart Association.

[email protected]

SOURCE: Baptiste D et al. EPI/Lifestyle 2020, Session 4, Abstract 8.

As I gear up to welcome and onboard new hires to our hospitalist group, I could not help but reflect on my first day as a hospitalist. Fresh out of residency, my orientation was a day and a half long.

The medical director gave me a brief overview of the program. The program administrator handed me a thick folder of policies followed by a quick tour of the hospital and an afternoon training for the computerized order entry system (that was a time before EHRs). The next morning, I was given my full panel of patients, my new lab coat, and sent off into the battlefield.

I can vividly remember feeling anxious, a bit confused, and quite overwhelmed as I went through my day. The days turned into a week and the next. I kept wondering if I was doing everything right. It took me a month to feel a little more comfortable. It all turned out fine. Since nobody told me otherwise, I assumed it did.

Quite a bit has changed since then in hospital medicine. Hospital medicine groups, nowadays, have to tackle the changing landscape of payment reform, take on responsibility for an increasing range of hospital quality metrics and juggle a swath of subspecialty comanagement agreements. Hospital medicine providers function from the inpatient to the post-acute care arena, all while continuing to demonstrate their value to the hospital administration. Simultaneously, they have to ensure their providers are engaged and functioning at their optimal level while battling the ever-increasing threat of burnout.

Thus, for new hires, all the above aspects of my orientation have become critical but alas terribly insufficient. Well into its third decade, the hospital medicine job market continues to boom but remains a revolving door. Hospital medicine groups continue to grow in size and integrate across hospitals in a given health system. The vast majority of the new hires tend to be fresh out of residency. The first year remains the most vulnerable period for a new hospitalist. Hospital medicine groups must design and implement a robust onboarding program for their new hires. It goes beyond welcoming and orientation of new hires to full integration and assimilation in order to transform them into highly efficient and productive team members. Effective onboarding is table stakes for a successful and thriving hospital medicine group.
 

The content

An effective onboarding program should focus on three key dimensions: the organizational, the technical, and the social.¹

1. The organizational or administrative aspect: The most common aspect of onboarding is providing new hires with information on the group’s policies and procedures: what to do and how to do it. Equally essential is giving them the tools and contacts that will help them understand and navigate their first few months. Information on how to contact consultants, signing on and off shifts, and so on can be easily conveyed through documents. However, having peers and the critical administrative staff communicate other aspects such as a detailed tour of the hospital, scheduling, and vacation policies is far more effective. It provides an excellent opportunity to introduce new hires to the key personnel in the group and vice versa as new hires get familiar with the unofficial workplace language. Breaking down all this information into meaningful, absorbable boluses, spread over time, is key to avoiding information overload. Allowing new hires to assimilate and adapt to the group norms requires follow-up and reinforcement. Group leaders should plan to meet with them at predetermined intervals, such as at 30, 60, 90 days, to engage them in conversations about the group’s values, performance measurements, rewards, and the opportunities for growth that exist within the group and institution.

2. The technical or the clinical aspect: The majority of physicians and advanced providers hired to a hospital medicine group have come immediately from training. Transition into the autonomous role of an attending, or a semi-autonomous role for advanced providers, with a larger patient panel can be quite unnerving and stressful. It can be disorientating even for experienced providers transitioning into a new health system. A well-structured onboarding can allow providers to deploy their training and experience at your organization effectively. Many onboarding programs have a clinical ramp-up period. The providers begin with a limited patient panel and gradually acclimatize into a full patient load. Many programs pair a senior hospitalist with the new hire during this period – a ‘buddy.’ Buddies are available to help new hires navigate the health system and familiarize them with the stakeholders. They help new hires by providing context to understand their new role and how they can contribute to the group’s success. In many instances, buddies help outline the unspoken rules of the group.

3. The social aspect – enculturation and networking: This is probably the most important of the three elements. It is quite common for new hires to feel like a stranger in a new land. A well-designed onboarding program provides new hires the space to forge relationships with each other and existing members of the hospital medicine team. Groups can do this in myriad ways – an informal welcome social, a meet and greet breakfast or lunch, in-person orientation when designing the administrative onboarding, and assignment of buddies or mentors during their clinical ramp-up period. It is all about providing a space to establish and nurture lasting relationships between the new hires and the group. When done well, this helps transform a group into a community. It also lays the groundwork to avoid stress and loneliness, some of the culprits that lead to physician burnout. It is through these interpersonal connections that new hires adapt to a hospital medicine group’s prevailing culture.

The personnel

Effective onboarding should be more than mere orientation. Group leaders should make an active attempt at understanding the core values and needs of the group. A good onboarding process assists new hires to internalize and accept the norms of the group. This process is not just a result of what comes from top management but also what they see and hear from the rank and file providers in the group. Hence it is critical to have the right people who understand and embody these values at the planning table. It is equally essential that necessary time and resources are devoted to building a program that meets the needs of the group. The practice management committee at SHM interviewed five different programs across a spectrum of settings. All of them had a designated onboarding program leader with a planning committee that included the administrative staff and senior frontline hospitalists.

The costs

According to one estimate, the cost of physician turnover is $400,000-$600,000 per provider.² Given such staggering costs, it is not difficult to justify the financial resources required to structure an effective onboarding program. Activities such as a detailed facility tour, a welcome breakfast, and a peer buddy system cost virtually nothing. They go a long way in building comradery, make new hires feel like they are part of a team, and reduce burnout and turnover. Costs of an onboarding program are typically related to wages during shadowing and clinical ramp-up. However, all the programs we interviewed acknowledged that the costs associated with onboarding, in the broader context, were small and necessary.

The bottom line

An effective onboarding program that is well planned, well structured, and well executed is inherently valuable. It sends a positive signal to new hires, reassuring them that they made a great decision by joining the group. It also reminds the existing providers why they want to be a part of the group and its culture.

It is not about what is said or done during the onboarding process or how long it lasts. It need not be overly complicated. It is how the process makes everyone feel about the group. At the end of the day, like in all aspects of life, that is what ultimately matters.

The SHM Practice Management Committee has created a document that outlines the guiding principles for effective onboarding with attached case studies. Visit the SHM website for more information: https://www.hospitalmedicine.org.
 

Dr. Irani is a hospitalist affiliated with Baystate Health in Springfield, Mass. He would like to thank Joshua Lapps, Luke Heisenger, and all the members of the SHM Practice Management Committee for their assistance and input in drafting the guiding principles of onboarding and the case studies that have heavily inspired the above article.

References

1. Carucci R. To Retain New Hires, Spend More Time Onboarding Them. Harvard Busines Review. Dec 3, 2018. https://hbr.org/2018/12/to-retain-new-hires-spend-more-time-onboarding-them

2. Franz D. The staggering costs of physician turnover. Today’s Hospitalist. August 2016. https://www.todayshospitalist.com/staggering-costs-physician-turnover/

As I gear up to welcome and onboard new hires to our hospitalist group, I could not help but reflect on my first day as a hospitalist. Fresh out of residency, my orientation was a day and a half long.

The medical director gave me a brief overview of the program. The program administrator handed me a thick folder of policies followed by a quick tour of the hospital and an afternoon training for the computerized order entry system (that was a time before EHRs). The next morning, I was given my full panel of patients, my new lab coat, and sent off into the battlefield.

I can vividly remember feeling anxious, a bit confused, and quite overwhelmed as I went through my day. The days turned into a week and the next. I kept wondering if I was doing everything right. It took me a month to feel a little more comfortable. It all turned out fine. Since nobody told me otherwise, I assumed it did.

Quite a bit has changed since then in hospital medicine. Hospital medicine groups, nowadays, have to tackle the changing landscape of payment reform, take on responsibility for an increasing range of hospital quality metrics and juggle a swath of subspecialty comanagement agreements. Hospital medicine providers function from the inpatient to the post-acute care arena, all while continuing to demonstrate their value to the hospital administration. Simultaneously, they have to ensure their providers are engaged and functioning at their optimal level while battling the ever-increasing threat of burnout.

Thus, for new hires, all the above aspects of my orientation have become critical but alas terribly insufficient. Well into its third decade, the hospital medicine job market continues to boom but remains a revolving door. Hospital medicine groups continue to grow in size and integrate across hospitals in a given health system. The vast majority of the new hires tend to be fresh out of residency. The first year remains the most vulnerable period for a new hospitalist. Hospital medicine groups must design and implement a robust onboarding program for their new hires. It goes beyond welcoming and orientation of new hires to full integration and assimilation in order to transform them into highly efficient and productive team members. Effective onboarding is table stakes for a successful and thriving hospital medicine group.
 

The content

An effective onboarding program should focus on three key dimensions: the organizational, the technical, and the social.¹

1. The organizational or administrative aspect: The most common aspect of onboarding is providing new hires with information on the group’s policies and procedures: what to do and how to do it. Equally essential is giving them the tools and contacts that will help them understand and navigate their first few months. Information on how to contact consultants, signing on and off shifts, and so on can be easily conveyed through documents. However, having peers and the critical administrative staff communicate other aspects such as a detailed tour of the hospital, scheduling, and vacation policies is far more effective. It provides an excellent opportunity to introduce new hires to the key personnel in the group and vice versa as new hires get familiar with the unofficial workplace language. Breaking down all this information into meaningful, absorbable boluses, spread over time, is key to avoiding information overload. Allowing new hires to assimilate and adapt to the group norms requires follow-up and reinforcement. Group leaders should plan to meet with them at predetermined intervals, such as at 30, 60, 90 days, to engage them in conversations about the group’s values, performance measurements, rewards, and the opportunities for growth that exist within the group and institution.

2. The technical or the clinical aspect: The majority of physicians and advanced providers hired to a hospital medicine group have come immediately from training. Transition into the autonomous role of an attending, or a semi-autonomous role for advanced providers, with a larger patient panel can be quite unnerving and stressful. It can be disorientating even for experienced providers transitioning into a new health system. A well-structured onboarding can allow providers to deploy their training and experience at your organization effectively. Many onboarding programs have a clinical ramp-up period. The providers begin with a limited patient panel and gradually acclimatize into a full patient load. Many programs pair a senior hospitalist with the new hire during this period – a ‘buddy.’ Buddies are available to help new hires navigate the health system and familiarize them with the stakeholders. They help new hires by providing context to understand their new role and how they can contribute to the group’s success. In many instances, buddies help outline the unspoken rules of the group.

3. The social aspect – enculturation and networking: This is probably the most important of the three elements. It is quite common for new hires to feel like a stranger in a new land. A well-designed onboarding program provides new hires the space to forge relationships with each other and existing members of the hospital medicine team. Groups can do this in myriad ways – an informal welcome social, a meet and greet breakfast or lunch, in-person orientation when designing the administrative onboarding, and assignment of buddies or mentors during their clinical ramp-up period. It is all about providing a space to establish and nurture lasting relationships between the new hires and the group. When done well, this helps transform a group into a community. It also lays the groundwork to avoid stress and loneliness, some of the culprits that lead to physician burnout. It is through these interpersonal connections that new hires adapt to a hospital medicine group’s prevailing culture.

The personnel

Effective onboarding should be more than mere orientation. Group leaders should make an active attempt at understanding the core values and needs of the group. A good onboarding process assists new hires to internalize and accept the norms of the group. This process is not just a result of what comes from top management but also what they see and hear from the rank and file providers in the group. Hence it is critical to have the right people who understand and embody these values at the planning table. It is equally essential that necessary time and resources are devoted to building a program that meets the needs of the group. The practice management committee at SHM interviewed five different programs across a spectrum of settings. All of them had a designated onboarding program leader with a planning committee that included the administrative staff and senior frontline hospitalists.

The costs

According to one estimate, the cost of physician turnover is $400,000-$600,000 per provider.² Given such staggering costs, it is not difficult to justify the financial resources required to structure an effective onboarding program. Activities such as a detailed facility tour, a welcome breakfast, and a peer buddy system cost virtually nothing. They go a long way in building comradery, make new hires feel like they are part of a team, and reduce burnout and turnover. Costs of an onboarding program are typically related to wages during shadowing and clinical ramp-up. However, all the programs we interviewed acknowledged that the costs associated with onboarding, in the broader context, were small and necessary.

The bottom line

An effective onboarding program that is well planned, well structured, and well executed is inherently valuable. It sends a positive signal to new hires, reassuring them that they made a great decision by joining the group. It also reminds the existing providers why they want to be a part of the group and its culture.

It is not about what is said or done during the onboarding process or how long it lasts. It need not be overly complicated. It is how the process makes everyone feel about the group. At the end of the day, like in all aspects of life, that is what ultimately matters.

The SHM Practice Management Committee has created a document that outlines the guiding principles for effective onboarding with attached case studies. Visit the SHM website for more information: https://www.hospitalmedicine.org.
 

Dr. Irani is a hospitalist affiliated with Baystate Health in Springfield, Mass. He would like to thank Joshua Lapps, Luke Heisenger, and all the members of the SHM Practice Management Committee for their assistance and input in drafting the guiding principles of onboarding and the case studies that have heavily inspired the above article.

References

1. Carucci R. To Retain New Hires, Spend More Time Onboarding Them. Harvard Busines Review. Dec 3, 2018. https://hbr.org/2018/12/to-retain-new-hires-spend-more-time-onboarding-them

2. Franz D. The staggering costs of physician turnover. Today’s Hospitalist. August 2016. https://www.todayshospitalist.com/staggering-costs-physician-turnover/

As I gear up to welcome and onboard new hires to our hospitalist group, I could not help but reflect on my first day as a hospitalist. Fresh out of residency, my orientation was a day and a half long.

The medical director gave me a brief overview of the program. The program administrator handed me a thick folder of policies followed by a quick tour of the hospital and an afternoon training for the computerized order entry system (that was a time before EHRs). The next morning, I was given my full panel of patients, my new lab coat, and sent off into the battlefield.

I can vividly remember feeling anxious, a bit confused, and quite overwhelmed as I went through my day. The days turned into a week and the next. I kept wondering if I was doing everything right. It took me a month to feel a little more comfortable. It all turned out fine. Since nobody told me otherwise, I assumed it did.

Quite a bit has changed since then in hospital medicine. Hospital medicine groups, nowadays, have to tackle the changing landscape of payment reform, take on responsibility for an increasing range of hospital quality metrics and juggle a swath of subspecialty comanagement agreements. Hospital medicine providers function from the inpatient to the post-acute care arena, all while continuing to demonstrate their value to the hospital administration. Simultaneously, they have to ensure their providers are engaged and functioning at their optimal level while battling the ever-increasing threat of burnout.

Thus, for new hires, all the above aspects of my orientation have become critical but alas terribly insufficient. Well into its third decade, the hospital medicine job market continues to boom but remains a revolving door. Hospital medicine groups continue to grow in size and integrate across hospitals in a given health system. The vast majority of the new hires tend to be fresh out of residency. The first year remains the most vulnerable period for a new hospitalist. Hospital medicine groups must design and implement a robust onboarding program for their new hires. It goes beyond welcoming and orientation of new hires to full integration and assimilation in order to transform them into highly efficient and productive team members. Effective onboarding is table stakes for a successful and thriving hospital medicine group.
 

The content

An effective onboarding program should focus on three key dimensions: the organizational, the technical, and the social.¹

1. The organizational or administrative aspect: The most common aspect of onboarding is providing new hires with information on the group’s policies and procedures: what to do and how to do it. Equally essential is giving them the tools and contacts that will help them understand and navigate their first few months. Information on how to contact consultants, signing on and off shifts, and so on can be easily conveyed through documents. However, having peers and the critical administrative staff communicate other aspects such as a detailed tour of the hospital, scheduling, and vacation policies is far more effective. It provides an excellent opportunity to introduce new hires to the key personnel in the group and vice versa as new hires get familiar with the unofficial workplace language. Breaking down all this information into meaningful, absorbable boluses, spread over time, is key to avoiding information overload. Allowing new hires to assimilate and adapt to the group norms requires follow-up and reinforcement. Group leaders should plan to meet with them at predetermined intervals, such as at 30, 60, 90 days, to engage them in conversations about the group’s values, performance measurements, rewards, and the opportunities for growth that exist within the group and institution.

2. The technical or the clinical aspect: The majority of physicians and advanced providers hired to a hospital medicine group have come immediately from training. Transition into the autonomous role of an attending, or a semi-autonomous role for advanced providers, with a larger patient panel can be quite unnerving and stressful. It can be disorientating even for experienced providers transitioning into a new health system. A well-structured onboarding can allow providers to deploy their training and experience at your organization effectively. Many onboarding programs have a clinical ramp-up period. The providers begin with a limited patient panel and gradually acclimatize into a full patient load. Many programs pair a senior hospitalist with the new hire during this period – a ‘buddy.’ Buddies are available to help new hires navigate the health system and familiarize them with the stakeholders. They help new hires by providing context to understand their new role and how they can contribute to the group’s success. In many instances, buddies help outline the unspoken rules of the group.

3. The social aspect – enculturation and networking: This is probably the most important of the three elements. It is quite common for new hires to feel like a stranger in a new land. A well-designed onboarding program provides new hires the space to forge relationships with each other and existing members of the hospital medicine team. Groups can do this in myriad ways – an informal welcome social, a meet and greet breakfast or lunch, in-person orientation when designing the administrative onboarding, and assignment of buddies or mentors during their clinical ramp-up period. It is all about providing a space to establish and nurture lasting relationships between the new hires and the group. When done well, this helps transform a group into a community. It also lays the groundwork to avoid stress and loneliness, some of the culprits that lead to physician burnout. It is through these interpersonal connections that new hires adapt to a hospital medicine group’s prevailing culture.

The personnel

Effective onboarding should be more than mere orientation. Group leaders should make an active attempt at understanding the core values and needs of the group. A good onboarding process assists new hires to internalize and accept the norms of the group. This process is not just a result of what comes from top management but also what they see and hear from the rank and file providers in the group. Hence it is critical to have the right people who understand and embody these values at the planning table. It is equally essential that necessary time and resources are devoted to building a program that meets the needs of the group. The practice management committee at SHM interviewed five different programs across a spectrum of settings. All of them had a designated onboarding program leader with a planning committee that included the administrative staff and senior frontline hospitalists.

The costs

According to one estimate, the cost of physician turnover is $400,000-$600,000 per provider.² Given such staggering costs, it is not difficult to justify the financial resources required to structure an effective onboarding program. Activities such as a detailed facility tour, a welcome breakfast, and a peer buddy system cost virtually nothing. They go a long way in building comradery, make new hires feel like they are part of a team, and reduce burnout and turnover. Costs of an onboarding program are typically related to wages during shadowing and clinical ramp-up. However, all the programs we interviewed acknowledged that the costs associated with onboarding, in the broader context, were small and necessary.

The bottom line

An effective onboarding program that is well planned, well structured, and well executed is inherently valuable. It sends a positive signal to new hires, reassuring them that they made a great decision by joining the group. It also reminds the existing providers why they want to be a part of the group and its culture.

It is not about what is said or done during the onboarding process or how long it lasts. It need not be overly complicated. It is how the process makes everyone feel about the group. At the end of the day, like in all aspects of life, that is what ultimately matters.

The SHM Practice Management Committee has created a document that outlines the guiding principles for effective onboarding with attached case studies. Visit the SHM website for more information: https://www.hospitalmedicine.org.
 

Dr. Irani is a hospitalist affiliated with Baystate Health in Springfield, Mass. He would like to thank Joshua Lapps, Luke Heisenger, and all the members of the SHM Practice Management Committee for their assistance and input in drafting the guiding principles of onboarding and the case studies that have heavily inspired the above article.

References

1. Carucci R. To Retain New Hires, Spend More Time Onboarding Them. Harvard Busines Review. Dec 3, 2018. https://hbr.org/2018/12/to-retain-new-hires-spend-more-time-onboarding-them

2. Franz D. The staggering costs of physician turnover. Today’s Hospitalist. August 2016. https://www.todayshospitalist.com/staggering-costs-physician-turnover/

In a JAMA Live Stream interview, Anthony S. Fauci, MD, a key member of the White House Coronavirus Task Force, urged resolve, rather than panic, as the coronavirus pandemic takes hold in the United States.

Dr. Fauci got into the details of what is known, what is unknown, what is being done in laboratories, and what clinical elements are still not understood about this disease.

The next several weeks, he said, are likely to tell the tale of whether our health care system is up to the challenge of care for the most ill among those who will be affected by COVID-19.

“It shouldn’t panic or frighten us, but we have to know we’re dealing with a very serious problem that we have to address, and we have to deal with it in a very bold way,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Speaking in an interview with JAMA Editor in Chief Howard Bauchner, MD, Dr. Fauci said the situation favors action over fear. “Let’s apply that energy to doing the things that we know can mitigate this.”

He added that he heard the message loud and clear from health care leaders in Italy and France during a World Health Organization coronavirus call earlier in the day. Officials in those countries, he said, were “almost pleading with the rest of the world to please take this very seriously, because it happens all of a sudden – very abruptly. ... The best time to mitigate is before that happens, because if you wait until after it happens you’re playing catch-up.”

Dr. Bauchner, noting that strict social distancing has been underway in many parts of the United States for several days, posited that, by early April, “We’ll really have a sense if we can manage in terms of serious illness.” Seattle, New York, Boston, and the San Francisco Bay Area may experience demand that outstrips ICU capacity at that point, but the rest of the country, he said, “is doing relatively well.”
 

Stress test on the health care system

Dr. Fauci agreed with this statement and added: “We’re going to know – for better or worse – whether we have enough of what it takes to be able to practice the kind of medicine that we optimally would want to practice.

In the matter of a week or 2 ... I think we’ll get a feel for whether or not we really have enough of the supplies that it takes.”

The well-publicized regional shortages in personal protective equipment (PPE) are forcing tough choices in some areas. As expedited – and even drive-through – testing begins, some of the demand for testing-related PPE may abate, especially if protocols include self-administration of nasal swabs, he noted.

Dr. Fauci added that the strategic national stockpile of medical supplies and equipment has not yet been tapped, “but you need to backfill that as quickly as you can once you start drawing from the strategic national stockpile.”
 

Returning to work after COVID-19 infection

Regarding the thorny question of when health care workers should be permitted to return to work after coronavirus infection, “it’s an evolving story,” said Dr. Fauci. Current guidance advises that health care providers stay away from work until two negative tests after resolution of fever and improvement of respiratory symptoms, or 3 fever-free days.

“We are approaching a point where you’re going to get enough people who are getting infected that we aren’t going to be able to do that,” he said. Depending on the stress to the health care system in a given locality, he said that facilities are going to have to “decide with good judgment” when health care workers go back on the job after coronavirus infection.

Asked how soon an individual would reliably test positive for COVID-19 after exposure, Dr. Fauci said, “We don’t know the answer to that. ... We can surmise it ...” He noted that it’s a median of about 5 days with a range of 2 to 14 days, before an infected individual becomes symptomatic. “I can say it’s not going to happen immediately,” he added, noting that he wouldn’t expect to see a positive test until about 2 days after exposure at the earliest. “When you get to the point where you are symptomatic, you’re almost certainly going to be positive then. ... This is just an extrapolation,” rather than conclusions drawn from solid data, he emphasized.
 

Higher risk reported in cardiac patients

Dr. Bauchner, who was relaying questions sent in from physicians during the live-streamed interview, asked about a newly issued joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America, which on March 17 affirmed that individuals on ACE inhibitors and angiotensin receptor blockers (ARBs) continue that therapy if they should become ill with COVID-19. The European Society of Cardiology issued a similar recommendation a few days prior.

Despite these societies’ statements, Dr. Fauci pointed to population-level data in Italy as suggesting that the case isn’t yet closed. “We really need to get data, and we need to get data fast. There’s a mechanistic rationale for the concern. It’s there, and it’s firm,” he said. The theoretical concern is that ACE inhibitors can upregulate expression of the ACE-2 protein on cell membranes, which is the entry point for SARS-Cov-2 to enter cells.

He added that he remains concerned about the number of coronavirus fatalities of patients in Italy who had hypertension as their only, or primary, underlying health problem.“That to me was a bit of a red flag,” he said. “Patients with hypertension almost certainly had a physician, and the physician almost certainly treated that person with medication. Why should someone who has hypertension that was well controlled have a much greater chance of dying?” he asked, noting that “I look at a person with well-controlled hypertension as a relatively healthy person. I don’t know what the answer is, but somebody has to look very carefully,” ideally by means of a natural history study that identifies medications used by those who died from coronavirus.
 

Potential therapies

Regarding potential therapies for COVID-19, Dr. Fauci acknowledged the social media buzz and flurry of medical letters and case reports about the use of hydroxychloroquine (Plaquenil) to treat active infection. He said that he and other researchers are “in active discussion” about how best to study the efficacy and safety of hydroxychloroquine, but he also acknowledged that many treating clinicians will use hydroxychloroquine empirically in the absence of other treatments with proven efficacy.

Clinical trials underway in China for antiviral medication are facing some enrollment challenges currently “because people want to get the drug,” said Dr. Fauci. “They don’t want to be in the trial; they just want to get the drug.” Though each of two trials has targeted approximately 500 participants as the number needed for sufficient statistical power, Dr. Fauci urged Chinese data safety monitoring boards to “take a close look” at the data already accrued for the several hundred patients who have already enrolled for the studies “to see if there’s any hint of efficacy.”

[email protected]

In a JAMA Live Stream interview, Anthony S. Fauci, MD, a key member of the White House Coronavirus Task Force, urged resolve, rather than panic, as the coronavirus pandemic takes hold in the United States.

Dr. Fauci got into the details of what is known, what is unknown, what is being done in laboratories, and what clinical elements are still not understood about this disease.

The next several weeks, he said, are likely to tell the tale of whether our health care system is up to the challenge of care for the most ill among those who will be affected by COVID-19.

“It shouldn’t panic or frighten us, but we have to know we’re dealing with a very serious problem that we have to address, and we have to deal with it in a very bold way,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Speaking in an interview with JAMA Editor in Chief Howard Bauchner, MD, Dr. Fauci said the situation favors action over fear. “Let’s apply that energy to doing the things that we know can mitigate this.”

He added that he heard the message loud and clear from health care leaders in Italy and France during a World Health Organization coronavirus call earlier in the day. Officials in those countries, he said, were “almost pleading with the rest of the world to please take this very seriously, because it happens all of a sudden – very abruptly. ... The best time to mitigate is before that happens, because if you wait until after it happens you’re playing catch-up.”

Dr. Bauchner, noting that strict social distancing has been underway in many parts of the United States for several days, posited that, by early April, “We’ll really have a sense if we can manage in terms of serious illness.” Seattle, New York, Boston, and the San Francisco Bay Area may experience demand that outstrips ICU capacity at that point, but the rest of the country, he said, “is doing relatively well.”
 

Stress test on the health care system

Dr. Fauci agreed with this statement and added: “We’re going to know – for better or worse – whether we have enough of what it takes to be able to practice the kind of medicine that we optimally would want to practice.

In the matter of a week or 2 ... I think we’ll get a feel for whether or not we really have enough of the supplies that it takes.”

The well-publicized regional shortages in personal protective equipment (PPE) are forcing tough choices in some areas. As expedited – and even drive-through – testing begins, some of the demand for testing-related PPE may abate, especially if protocols include self-administration of nasal swabs, he noted.

Dr. Fauci added that the strategic national stockpile of medical supplies and equipment has not yet been tapped, “but you need to backfill that as quickly as you can once you start drawing from the strategic national stockpile.”
 

Returning to work after COVID-19 infection

Regarding the thorny question of when health care workers should be permitted to return to work after coronavirus infection, “it’s an evolving story,” said Dr. Fauci. Current guidance advises that health care providers stay away from work until two negative tests after resolution of fever and improvement of respiratory symptoms, or 3 fever-free days.

“We are approaching a point where you’re going to get enough people who are getting infected that we aren’t going to be able to do that,” he said. Depending on the stress to the health care system in a given locality, he said that facilities are going to have to “decide with good judgment” when health care workers go back on the job after coronavirus infection.

Asked how soon an individual would reliably test positive for COVID-19 after exposure, Dr. Fauci said, “We don’t know the answer to that. ... We can surmise it ...” He noted that it’s a median of about 5 days with a range of 2 to 14 days, before an infected individual becomes symptomatic. “I can say it’s not going to happen immediately,” he added, noting that he wouldn’t expect to see a positive test until about 2 days after exposure at the earliest. “When you get to the point where you are symptomatic, you’re almost certainly going to be positive then. ... This is just an extrapolation,” rather than conclusions drawn from solid data, he emphasized.
 

Higher risk reported in cardiac patients

Dr. Bauchner, who was relaying questions sent in from physicians during the live-streamed interview, asked about a newly issued joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America, which on March 17 affirmed that individuals on ACE inhibitors and angiotensin receptor blockers (ARBs) continue that therapy if they should become ill with COVID-19. The European Society of Cardiology issued a similar recommendation a few days prior.

Despite these societies’ statements, Dr. Fauci pointed to population-level data in Italy as suggesting that the case isn’t yet closed. “We really need to get data, and we need to get data fast. There’s a mechanistic rationale for the concern. It’s there, and it’s firm,” he said. The theoretical concern is that ACE inhibitors can upregulate expression of the ACE-2 protein on cell membranes, which is the entry point for SARS-Cov-2 to enter cells.

He added that he remains concerned about the number of coronavirus fatalities of patients in Italy who had hypertension as their only, or primary, underlying health problem.“That to me was a bit of a red flag,” he said. “Patients with hypertension almost certainly had a physician, and the physician almost certainly treated that person with medication. Why should someone who has hypertension that was well controlled have a much greater chance of dying?” he asked, noting that “I look at a person with well-controlled hypertension as a relatively healthy person. I don’t know what the answer is, but somebody has to look very carefully,” ideally by means of a natural history study that identifies medications used by those who died from coronavirus.
 

Potential therapies

Regarding potential therapies for COVID-19, Dr. Fauci acknowledged the social media buzz and flurry of medical letters and case reports about the use of hydroxychloroquine (Plaquenil) to treat active infection. He said that he and other researchers are “in active discussion” about how best to study the efficacy and safety of hydroxychloroquine, but he also acknowledged that many treating clinicians will use hydroxychloroquine empirically in the absence of other treatments with proven efficacy.

Clinical trials underway in China for antiviral medication are facing some enrollment challenges currently “because people want to get the drug,” said Dr. Fauci. “They don’t want to be in the trial; they just want to get the drug.” Though each of two trials has targeted approximately 500 participants as the number needed for sufficient statistical power, Dr. Fauci urged Chinese data safety monitoring boards to “take a close look” at the data already accrued for the several hundred patients who have already enrolled for the studies “to see if there’s any hint of efficacy.”

[email protected]

In a JAMA Live Stream interview, Anthony S. Fauci, MD, a key member of the White House Coronavirus Task Force, urged resolve, rather than panic, as the coronavirus pandemic takes hold in the United States.

Dr. Fauci got into the details of what is known, what is unknown, what is being done in laboratories, and what clinical elements are still not understood about this disease.

The next several weeks, he said, are likely to tell the tale of whether our health care system is up to the challenge of care for the most ill among those who will be affected by COVID-19.

“It shouldn’t panic or frighten us, but we have to know we’re dealing with a very serious problem that we have to address, and we have to deal with it in a very bold way,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Speaking in an interview with JAMA Editor in Chief Howard Bauchner, MD, Dr. Fauci said the situation favors action over fear. “Let’s apply that energy to doing the things that we know can mitigate this.”

He added that he heard the message loud and clear from health care leaders in Italy and France during a World Health Organization coronavirus call earlier in the day. Officials in those countries, he said, were “almost pleading with the rest of the world to please take this very seriously, because it happens all of a sudden – very abruptly. ... The best time to mitigate is before that happens, because if you wait until after it happens you’re playing catch-up.”

Dr. Bauchner, noting that strict social distancing has been underway in many parts of the United States for several days, posited that, by early April, “We’ll really have a sense if we can manage in terms of serious illness.” Seattle, New York, Boston, and the San Francisco Bay Area may experience demand that outstrips ICU capacity at that point, but the rest of the country, he said, “is doing relatively well.”
 

Stress test on the health care system

Dr. Fauci agreed with this statement and added: “We’re going to know – for better or worse – whether we have enough of what it takes to be able to practice the kind of medicine that we optimally would want to practice.

In the matter of a week or 2 ... I think we’ll get a feel for whether or not we really have enough of the supplies that it takes.”

The well-publicized regional shortages in personal protective equipment (PPE) are forcing tough choices in some areas. As expedited – and even drive-through – testing begins, some of the demand for testing-related PPE may abate, especially if protocols include self-administration of nasal swabs, he noted.

Dr. Fauci added that the strategic national stockpile of medical supplies and equipment has not yet been tapped, “but you need to backfill that as quickly as you can once you start drawing from the strategic national stockpile.”
 

Returning to work after COVID-19 infection

Regarding the thorny question of when health care workers should be permitted to return to work after coronavirus infection, “it’s an evolving story,” said Dr. Fauci. Current guidance advises that health care providers stay away from work until two negative tests after resolution of fever and improvement of respiratory symptoms, or 3 fever-free days.

“We are approaching a point where you’re going to get enough people who are getting infected that we aren’t going to be able to do that,” he said. Depending on the stress to the health care system in a given locality, he said that facilities are going to have to “decide with good judgment” when health care workers go back on the job after coronavirus infection.

Asked how soon an individual would reliably test positive for COVID-19 after exposure, Dr. Fauci said, “We don’t know the answer to that. ... We can surmise it ...” He noted that it’s a median of about 5 days with a range of 2 to 14 days, before an infected individual becomes symptomatic. “I can say it’s not going to happen immediately,” he added, noting that he wouldn’t expect to see a positive test until about 2 days after exposure at the earliest. “When you get to the point where you are symptomatic, you’re almost certainly going to be positive then. ... This is just an extrapolation,” rather than conclusions drawn from solid data, he emphasized.
 

Higher risk reported in cardiac patients

Dr. Bauchner, who was relaying questions sent in from physicians during the live-streamed interview, asked about a newly issued joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America, which on March 17 affirmed that individuals on ACE inhibitors and angiotensin receptor blockers (ARBs) continue that therapy if they should become ill with COVID-19. The European Society of Cardiology issued a similar recommendation a few days prior.

Despite these societies’ statements, Dr. Fauci pointed to population-level data in Italy as suggesting that the case isn’t yet closed. “We really need to get data, and we need to get data fast. There’s a mechanistic rationale for the concern. It’s there, and it’s firm,” he said. The theoretical concern is that ACE inhibitors can upregulate expression of the ACE-2 protein on cell membranes, which is the entry point for SARS-Cov-2 to enter cells.

He added that he remains concerned about the number of coronavirus fatalities of patients in Italy who had hypertension as their only, or primary, underlying health problem.“That to me was a bit of a red flag,” he said. “Patients with hypertension almost certainly had a physician, and the physician almost certainly treated that person with medication. Why should someone who has hypertension that was well controlled have a much greater chance of dying?” he asked, noting that “I look at a person with well-controlled hypertension as a relatively healthy person. I don’t know what the answer is, but somebody has to look very carefully,” ideally by means of a natural history study that identifies medications used by those who died from coronavirus.
 

Potential therapies

Regarding potential therapies for COVID-19, Dr. Fauci acknowledged the social media buzz and flurry of medical letters and case reports about the use of hydroxychloroquine (Plaquenil) to treat active infection. He said that he and other researchers are “in active discussion” about how best to study the efficacy and safety of hydroxychloroquine, but he also acknowledged that many treating clinicians will use hydroxychloroquine empirically in the absence of other treatments with proven efficacy.

Clinical trials underway in China for antiviral medication are facing some enrollment challenges currently “because people want to get the drug,” said Dr. Fauci. “They don’t want to be in the trial; they just want to get the drug.” Though each of two trials has targeted approximately 500 participants as the number needed for sufficient statistical power, Dr. Fauci urged Chinese data safety monitoring boards to “take a close look” at the data already accrued for the several hundred patients who have already enrolled for the studies “to see if there’s any hint of efficacy.”

[email protected]