The Center for Tobacco Products, part of the Food and Drug Administration, has issued a warning letter to JUUL Labs Inc. for illegal marketing of unauthorized modified-risk tobacco products, citing violation of the Federal Food, Drug, and Cosmetic Act.

According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.

As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”

In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”

In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”

The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.

[email protected]

The Center for Tobacco Products, part of the Food and Drug Administration, has issued a warning letter to JUUL Labs Inc. for illegal marketing of unauthorized modified-risk tobacco products, citing violation of the Federal Food, Drug, and Cosmetic Act.

According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.

As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”

In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”

In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”

The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.

[email protected]

The Center for Tobacco Products, part of the Food and Drug Administration, has issued a warning letter to JUUL Labs Inc. for illegal marketing of unauthorized modified-risk tobacco products, citing violation of the Federal Food, Drug, and Cosmetic Act.

According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.

As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”

In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”

In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”

The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.

[email protected]

Screening for colorectal cancer in patients with cystic fibrosis is cost effective, and should be started at a younger age and performed more often, new research suggests.

While colorectal cancer (CRC) screening traditionally begins at age 50 years in people at average risk for the disease, those at high risk usually begin undergoing colonoscopies at an earlier age. Patients with cystic fibrosis fall under the latter category, wrote Andrea Gini, of the department of public health at Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues, with an incidence of CRC up to 30 times higher than the general population, but their shorter lifespan has led to a “different trade-off between the benefits and harms of CRC screening.”

Between 2000 and 2015, the median predicted survival age for patients with cystic fibrosis increased from 33.3 years to 41.7 years; this increased survival has brought increased risk for other diseases, particularly in the GI tract, Mr. Gini and colleagues wrote in Gastroenterology. By using the Microsimulation Screening Analysis–Colon model – a joint project between Erasmus Medical Center and Memorial Sloan Kettering Cancer Center in New York – the investigators assessed the cost-effectiveness of CRC screening in patients with cystic fibrosis.

Three cohorts of 10 million patients each were simulated, with one cohort having undergone transplant, one cohort not having transplant, and one cohort of individuals without cystic fibrosis. The simulated patient age was 30 years in 2017. A total of 76 different colonoscopy-screening strategies were assessed, with each differing in screening interval (3, 5, or 10 years for colonoscopy), age to start screening (30, 35, 40, 45, or 50 years), and age to end screening (55, 60, 65, 70, or 75 years). The optimal screening strategy was determined based on a willingness-to-pay threshold of $100,000 per life-year gained, the investigators wrote.

In the absence of screening, the mortality rate for nontransplant cystic fibrosis patients was 19.1 per 1,000 people, and the rate for cystic fibrosis patients who had undergone transplant was 22.3 per 1,000 people. The standard screening strategy prevented more than 73% of CRC deaths in the general population, 66% of deaths in nontransplant cystic fibrosis patients, and 36% of deaths in cystic fibrosis patients with transplant; however, the model predicted that only 22% of individuals who received a transplant and 36% of those who did not would reach the age of 50 years.

According to the model, the optimal colonoscopy-screening strategy for nontransplant patients was one screen every 5 years, starting at 40 and screening until the age of 75. The incremental cost-effectiveness ratio (ICER) was $84,000 per life-year gained; CRC incidence was reduced by 52% and CRC mortality was reduced by 79%. For transplant patients, the best strategy was one screen every 3 years between the ages of 35 and 55, which reduced CRC mortality by 82% at an ICER of $71,000 per life-year gained.

In a separate analysis of fecal immunochemical testing, a less-demanding alternative to colonoscopy, the optimal screening strategy was an annual test between the age of 35 and 75 years for nontransplant cystic fibrosis patients, for an ICER of $47,000 per life-year gained and a CRC mortality reduction of 78%. The best strategy for transplant patients was once a year between the ages of 30 and 60, which reduced CRC mortality by 77% at an ICER of $86,000 per life-year gained. While fecal immunochemical testing may be more cost effective than colonoscopy, “specific evidence of its performance in the cystic fibrosis population is required before considering this screening modality,” the investigators noted.

“This study indicates that there is benefit to earlier CRC screening in the cystic fibrosis population and [that it] can be done at acceptable costs,” the investigators wrote. “The findings of this analysis support clinicians, researchers, and policy makers who aim to define a tailored CRC screening for individuals with cystic fibrosis in the United States.”

The study was funded by the Cystic Fibrosis Foundation, the Cancer Intervention and Surveillance Modeling Network consortium, and Memorial Sloan Kettering Cancer Center. The investigators reported no conflicts of interest.

[email protected]

SOURCE: Gini A et al. Gastroenterology. 2017 Dec 27. doi: 10.1053/j.gastro.2017.12.011.

Screening for colorectal cancer in patients with cystic fibrosis is cost effective, and should be started at a younger age and performed more often, new research suggests.

While colorectal cancer (CRC) screening traditionally begins at age 50 years in people at average risk for the disease, those at high risk usually begin undergoing colonoscopies at an earlier age. Patients with cystic fibrosis fall under the latter category, wrote Andrea Gini, of the department of public health at Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues, with an incidence of CRC up to 30 times higher than the general population, but their shorter lifespan has led to a “different trade-off between the benefits and harms of CRC screening.”

Between 2000 and 2015, the median predicted survival age for patients with cystic fibrosis increased from 33.3 years to 41.7 years; this increased survival has brought increased risk for other diseases, particularly in the GI tract, Mr. Gini and colleagues wrote in Gastroenterology. By using the Microsimulation Screening Analysis–Colon model – a joint project between Erasmus Medical Center and Memorial Sloan Kettering Cancer Center in New York – the investigators assessed the cost-effectiveness of CRC screening in patients with cystic fibrosis.

Three cohorts of 10 million patients each were simulated, with one cohort having undergone transplant, one cohort not having transplant, and one cohort of individuals without cystic fibrosis. The simulated patient age was 30 years in 2017. A total of 76 different colonoscopy-screening strategies were assessed, with each differing in screening interval (3, 5, or 10 years for colonoscopy), age to start screening (30, 35, 40, 45, or 50 years), and age to end screening (55, 60, 65, 70, or 75 years). The optimal screening strategy was determined based on a willingness-to-pay threshold of $100,000 per life-year gained, the investigators wrote.

In the absence of screening, the mortality rate for nontransplant cystic fibrosis patients was 19.1 per 1,000 people, and the rate for cystic fibrosis patients who had undergone transplant was 22.3 per 1,000 people. The standard screening strategy prevented more than 73% of CRC deaths in the general population, 66% of deaths in nontransplant cystic fibrosis patients, and 36% of deaths in cystic fibrosis patients with transplant; however, the model predicted that only 22% of individuals who received a transplant and 36% of those who did not would reach the age of 50 years.

According to the model, the optimal colonoscopy-screening strategy for nontransplant patients was one screen every 5 years, starting at 40 and screening until the age of 75. The incremental cost-effectiveness ratio (ICER) was $84,000 per life-year gained; CRC incidence was reduced by 52% and CRC mortality was reduced by 79%. For transplant patients, the best strategy was one screen every 3 years between the ages of 35 and 55, which reduced CRC mortality by 82% at an ICER of $71,000 per life-year gained.

In a separate analysis of fecal immunochemical testing, a less-demanding alternative to colonoscopy, the optimal screening strategy was an annual test between the age of 35 and 75 years for nontransplant cystic fibrosis patients, for an ICER of $47,000 per life-year gained and a CRC mortality reduction of 78%. The best strategy for transplant patients was once a year between the ages of 30 and 60, which reduced CRC mortality by 77% at an ICER of $86,000 per life-year gained. While fecal immunochemical testing may be more cost effective than colonoscopy, “specific evidence of its performance in the cystic fibrosis population is required before considering this screening modality,” the investigators noted.

“This study indicates that there is benefit to earlier CRC screening in the cystic fibrosis population and [that it] can be done at acceptable costs,” the investigators wrote. “The findings of this analysis support clinicians, researchers, and policy makers who aim to define a tailored CRC screening for individuals with cystic fibrosis in the United States.”

The study was funded by the Cystic Fibrosis Foundation, the Cancer Intervention and Surveillance Modeling Network consortium, and Memorial Sloan Kettering Cancer Center. The investigators reported no conflicts of interest.

[email protected]

SOURCE: Gini A et al. Gastroenterology. 2017 Dec 27. doi: 10.1053/j.gastro.2017.12.011.

Screening for colorectal cancer in patients with cystic fibrosis is cost effective, and should be started at a younger age and performed more often, new research suggests.

While colorectal cancer (CRC) screening traditionally begins at age 50 years in people at average risk for the disease, those at high risk usually begin undergoing colonoscopies at an earlier age. Patients with cystic fibrosis fall under the latter category, wrote Andrea Gini, of the department of public health at Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues, with an incidence of CRC up to 30 times higher than the general population, but their shorter lifespan has led to a “different trade-off between the benefits and harms of CRC screening.”

Between 2000 and 2015, the median predicted survival age for patients with cystic fibrosis increased from 33.3 years to 41.7 years; this increased survival has brought increased risk for other diseases, particularly in the GI tract, Mr. Gini and colleagues wrote in Gastroenterology. By using the Microsimulation Screening Analysis–Colon model – a joint project between Erasmus Medical Center and Memorial Sloan Kettering Cancer Center in New York – the investigators assessed the cost-effectiveness of CRC screening in patients with cystic fibrosis.

Three cohorts of 10 million patients each were simulated, with one cohort having undergone transplant, one cohort not having transplant, and one cohort of individuals without cystic fibrosis. The simulated patient age was 30 years in 2017. A total of 76 different colonoscopy-screening strategies were assessed, with each differing in screening interval (3, 5, or 10 years for colonoscopy), age to start screening (30, 35, 40, 45, or 50 years), and age to end screening (55, 60, 65, 70, or 75 years). The optimal screening strategy was determined based on a willingness-to-pay threshold of $100,000 per life-year gained, the investigators wrote.

In the absence of screening, the mortality rate for nontransplant cystic fibrosis patients was 19.1 per 1,000 people, and the rate for cystic fibrosis patients who had undergone transplant was 22.3 per 1,000 people. The standard screening strategy prevented more than 73% of CRC deaths in the general population, 66% of deaths in nontransplant cystic fibrosis patients, and 36% of deaths in cystic fibrosis patients with transplant; however, the model predicted that only 22% of individuals who received a transplant and 36% of those who did not would reach the age of 50 years.

According to the model, the optimal colonoscopy-screening strategy for nontransplant patients was one screen every 5 years, starting at 40 and screening until the age of 75. The incremental cost-effectiveness ratio (ICER) was $84,000 per life-year gained; CRC incidence was reduced by 52% and CRC mortality was reduced by 79%. For transplant patients, the best strategy was one screen every 3 years between the ages of 35 and 55, which reduced CRC mortality by 82% at an ICER of $71,000 per life-year gained.

In a separate analysis of fecal immunochemical testing, a less-demanding alternative to colonoscopy, the optimal screening strategy was an annual test between the age of 35 and 75 years for nontransplant cystic fibrosis patients, for an ICER of $47,000 per life-year gained and a CRC mortality reduction of 78%. The best strategy for transplant patients was once a year between the ages of 30 and 60, which reduced CRC mortality by 77% at an ICER of $86,000 per life-year gained. While fecal immunochemical testing may be more cost effective than colonoscopy, “specific evidence of its performance in the cystic fibrosis population is required before considering this screening modality,” the investigators noted.

“This study indicates that there is benefit to earlier CRC screening in the cystic fibrosis population and [that it] can be done at acceptable costs,” the investigators wrote. “The findings of this analysis support clinicians, researchers, and policy makers who aim to define a tailored CRC screening for individuals with cystic fibrosis in the United States.”

The study was funded by the Cystic Fibrosis Foundation, the Cancer Intervention and Surveillance Modeling Network consortium, and Memorial Sloan Kettering Cancer Center. The investigators reported no conflicts of interest.

[email protected]

SOURCE: Gini A et al. Gastroenterology. 2017 Dec 27. doi: 10.1053/j.gastro.2017.12.011.

CASE Patient has adverse effects from halted estrogen pills

JR twists her hands nervously as you step into the room. “They stopped my hormones,” she sighs as you pull up her lab results.

JR recently had been admitted to an inpatient cardiology unit for several days for a heart failure exacerbation. Her ankles are still swollen beneath her floral print skirt, but she is breathing much easier now. She is back at your primary care office, hoping to get clearance to restart her estrogen pills.

JR reports having mood swings and terrible nightmares while not taking her hormones, which she has been taking for more than 3 years. She hesitates before sharing, “One of the doctors kept asking me questions about my sex life that had nothing to do with my heart condition. I don’t want to go back there.”

Providing compassionate and comprehensive care to gender-nonconforming individuals is challenging for a multitude of reasons, from clinician ignorance to systemic discrimination. About 33% of transgender patients reported being harassed, denied care, or even being assaulted when seeking health care, while 23% reported avoiding going to the doctor altogether when sick or injured out of fear of discrimination.¹

Unfortunately, now, further increases to barriers to care may be put in place. In late May of this year, the Department of Health and Human Services (HHS) proposed new regulations that would reverse previous regulations granted through section 1557 of the Affordable Care Act (ACA)—the Health Care Rights Law—which affirmed the rights of gender nonbinary persons to medical care. Among the proposed changes is the elimination of protections against discrimination in health care based on gender identity.² The proposed regulation changes come on the heels of a federal court case, which seeks to declare that hospital systems may turn away patients based on gender identity.³

Unraveling rights afforded under the ACA

The Health Care Rights Law was passed under the ACA; it prohibits discrimination based on race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance. Multiple lower courts have supported that the rights of transgender individuals is included within these protections against discrimination on the basis of sex.⁴ These court rulings not only have ensured the ability of gender-diverse individuals to access care but also have enforced insurance coverage of therapies for gender dysphoria. It was only in 2014 that Medicaid began providing coverage for gender-affirming surgeries and eliminating language that such procedures were “experimental” or “cosmetic.” The 2016 passage of the ACA mandated that private insurance companies follow suit. Unfortunately, the recent proposed regulation changes to the Health Care Rights Law may spark a reversal from insurance companies as well. Such a setback would affect gender-diverse individuals’ hormone treatments as well as their ability to access a full spectrum of care within the health care system.

Continue to: ACOG urges nondiscriminatory practices...

ACOG urges nondiscriminatory practices

The proposed regulation changes to the Health Care Rights Law are from the Conscience and Religious Freedom Division of the HHS Office for Civil Rights, which was established in 2018 and has been advocating for the rights of health care providers to refuse to treat patients based on their own religious beliefs.⁵ We argue, however, that providing care to persons of varying backgrounds is not an assault on our individual liberties but rather a privilege as providers. As obstetrician-gynecologists, it may be easy to only consider cis-gendered women our responsibility. But our field also emphasizes individual empowerment above all else—we fight every day for our patients’ rights to contraception, fertility, pregnancy, parenthood, and sexual freedoms. Let us continue speaking up for the rights of all those who need gynecologic care, regardless of the pronouns they use.

“The American College of Obstetricians and Gynecologists urges health care providers to foster nondiscriminatory practices and policies to increase identification and to facilitate quality health care for transgender individuals, both in assisting with the transition if desired as well as providing long-term preventive health care.”⁶

We urge you to take action

• Reach out to your local representatives about protecting transgender health access
• Educate yourself on the unique needs of transgender individuals
• Read personal accounts
• Share your personal story
• Find referring providers near your practice

CASE Patient has adverse effects from halted estrogen pills

JR twists her hands nervously as you step into the room. “They stopped my hormones,” she sighs as you pull up her lab results.

JR recently had been admitted to an inpatient cardiology unit for several days for a heart failure exacerbation. Her ankles are still swollen beneath her floral print skirt, but she is breathing much easier now. She is back at your primary care office, hoping to get clearance to restart her estrogen pills.

JR reports having mood swings and terrible nightmares while not taking her hormones, which she has been taking for more than 3 years. She hesitates before sharing, “One of the doctors kept asking me questions about my sex life that had nothing to do with my heart condition. I don’t want to go back there.”

Providing compassionate and comprehensive care to gender-nonconforming individuals is challenging for a multitude of reasons, from clinician ignorance to systemic discrimination. About 33% of transgender patients reported being harassed, denied care, or even being assaulted when seeking health care, while 23% reported avoiding going to the doctor altogether when sick or injured out of fear of discrimination.¹

Unfortunately, now, further increases to barriers to care may be put in place. In late May of this year, the Department of Health and Human Services (HHS) proposed new regulations that would reverse previous regulations granted through section 1557 of the Affordable Care Act (ACA)—the Health Care Rights Law—which affirmed the rights of gender nonbinary persons to medical care. Among the proposed changes is the elimination of protections against discrimination in health care based on gender identity.² The proposed regulation changes come on the heels of a federal court case, which seeks to declare that hospital systems may turn away patients based on gender identity.³

Unraveling rights afforded under the ACA

The Health Care Rights Law was passed under the ACA; it prohibits discrimination based on race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance. Multiple lower courts have supported that the rights of transgender individuals is included within these protections against discrimination on the basis of sex.⁴ These court rulings not only have ensured the ability of gender-diverse individuals to access care but also have enforced insurance coverage of therapies for gender dysphoria. It was only in 2014 that Medicaid began providing coverage for gender-affirming surgeries and eliminating language that such procedures were “experimental” or “cosmetic.” The 2016 passage of the ACA mandated that private insurance companies follow suit. Unfortunately, the recent proposed regulation changes to the Health Care Rights Law may spark a reversal from insurance companies as well. Such a setback would affect gender-diverse individuals’ hormone treatments as well as their ability to access a full spectrum of care within the health care system.

Continue to: ACOG urges nondiscriminatory practices...

ACOG urges nondiscriminatory practices

The proposed regulation changes to the Health Care Rights Law are from the Conscience and Religious Freedom Division of the HHS Office for Civil Rights, which was established in 2018 and has been advocating for the rights of health care providers to refuse to treat patients based on their own religious beliefs.⁵ We argue, however, that providing care to persons of varying backgrounds is not an assault on our individual liberties but rather a privilege as providers. As obstetrician-gynecologists, it may be easy to only consider cis-gendered women our responsibility. But our field also emphasizes individual empowerment above all else—we fight every day for our patients’ rights to contraception, fertility, pregnancy, parenthood, and sexual freedoms. Let us continue speaking up for the rights of all those who need gynecologic care, regardless of the pronouns they use.

“The American College of Obstetricians and Gynecologists urges health care providers to foster nondiscriminatory practices and policies to increase identification and to facilitate quality health care for transgender individuals, both in assisting with the transition if desired as well as providing long-term preventive health care.”⁶

We urge you to take action

• Reach out to your local representatives about protecting transgender health access
• Educate yourself on the unique needs of transgender individuals
• Read personal accounts
• Share your personal story
• Find referring providers near your practice

CASE Patient has adverse effects from halted estrogen pills

JR twists her hands nervously as you step into the room. “They stopped my hormones,” she sighs as you pull up her lab results.

JR recently had been admitted to an inpatient cardiology unit for several days for a heart failure exacerbation. Her ankles are still swollen beneath her floral print skirt, but she is breathing much easier now. She is back at your primary care office, hoping to get clearance to restart her estrogen pills.

JR reports having mood swings and terrible nightmares while not taking her hormones, which she has been taking for more than 3 years. She hesitates before sharing, “One of the doctors kept asking me questions about my sex life that had nothing to do with my heart condition. I don’t want to go back there.”

Providing compassionate and comprehensive care to gender-nonconforming individuals is challenging for a multitude of reasons, from clinician ignorance to systemic discrimination. About 33% of transgender patients reported being harassed, denied care, or even being assaulted when seeking health care, while 23% reported avoiding going to the doctor altogether when sick or injured out of fear of discrimination.¹

Unfortunately, now, further increases to barriers to care may be put in place. In late May of this year, the Department of Health and Human Services (HHS) proposed new regulations that would reverse previous regulations granted through section 1557 of the Affordable Care Act (ACA)—the Health Care Rights Law—which affirmed the rights of gender nonbinary persons to medical care. Among the proposed changes is the elimination of protections against discrimination in health care based on gender identity.² The proposed regulation changes come on the heels of a federal court case, which seeks to declare that hospital systems may turn away patients based on gender identity.³

Unraveling rights afforded under the ACA

The Health Care Rights Law was passed under the ACA; it prohibits discrimination based on race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance. Multiple lower courts have supported that the rights of transgender individuals is included within these protections against discrimination on the basis of sex.⁴ These court rulings not only have ensured the ability of gender-diverse individuals to access care but also have enforced insurance coverage of therapies for gender dysphoria. It was only in 2014 that Medicaid began providing coverage for gender-affirming surgeries and eliminating language that such procedures were “experimental” or “cosmetic.” The 2016 passage of the ACA mandated that private insurance companies follow suit. Unfortunately, the recent proposed regulation changes to the Health Care Rights Law may spark a reversal from insurance companies as well. Such a setback would affect gender-diverse individuals’ hormone treatments as well as their ability to access a full spectrum of care within the health care system.

Continue to: ACOG urges nondiscriminatory practices...

ACOG urges nondiscriminatory practices

The proposed regulation changes to the Health Care Rights Law are from the Conscience and Religious Freedom Division of the HHS Office for Civil Rights, which was established in 2018 and has been advocating for the rights of health care providers to refuse to treat patients based on their own religious beliefs.⁵ We argue, however, that providing care to persons of varying backgrounds is not an assault on our individual liberties but rather a privilege as providers. As obstetrician-gynecologists, it may be easy to only consider cis-gendered women our responsibility. But our field also emphasizes individual empowerment above all else—we fight every day for our patients’ rights to contraception, fertility, pregnancy, parenthood, and sexual freedoms. Let us continue speaking up for the rights of all those who need gynecologic care, regardless of the pronouns they use.

“The American College of Obstetricians and Gynecologists urges health care providers to foster nondiscriminatory practices and policies to increase identification and to facilitate quality health care for transgender individuals, both in assisting with the transition if desired as well as providing long-term preventive health care.”⁶

We urge you to take action

• Reach out to your local representatives about protecting transgender health access
• Educate yourself on the unique needs of transgender individuals
• Read personal accounts
• Share your personal story
• Find referring providers near your practice

The SVS PSO is looking for a part-time Associate Medical Director. This person will be responsible for assisting the SVS PSO Medical Director and the SVS PSO staff, with guidance and over site in its clinical operations. The new associate director will be nominated by the SVS PSO Executive Committee and approved the SVS and the SVS Executive Board. He or she will serve a one-year term, with the opportunity to serve two additional one-year terms. There is a modest honorary associated with this position and the potential to advance into the role of SVS PSO Medical Director. Submit your application before Oct. 11 to be considered. Read the full job description here. Please email your completed resume to [email protected].

The SVS PSO is looking for a part-time Associate Medical Director. This person will be responsible for assisting the SVS PSO Medical Director and the SVS PSO staff, with guidance and over site in its clinical operations. The new associate director will be nominated by the SVS PSO Executive Committee and approved the SVS and the SVS Executive Board. He or she will serve a one-year term, with the opportunity to serve two additional one-year terms. There is a modest honorary associated with this position and the potential to advance into the role of SVS PSO Medical Director. Submit your application before Oct. 11 to be considered. Read the full job description here. Please email your completed resume to [email protected].

The SVS PSO is looking for a part-time Associate Medical Director. This person will be responsible for assisting the SVS PSO Medical Director and the SVS PSO staff, with guidance and over site in its clinical operations. The new associate director will be nominated by the SVS PSO Executive Committee and approved the SVS and the SVS Executive Board. He or she will serve a one-year term, with the opportunity to serve two additional one-year terms. There is a modest honorary associated with this position and the potential to advance into the role of SVS PSO Medical Director. Submit your application before Oct. 11 to be considered. Read the full job description here. Please email your completed resume to [email protected].

Background: The PARADIGM-HF trial demonstrated that patients with chronic HFrEF treated with an ARNI (sacubitril/valsartan) had significantly reduced cardiovascular mortality and hospitalizations when compared with enalapril. Patients with acute decompensated heart failure were excluded from this trial. The PIONEER-HF trial was designed to determine whether initiation of an ARNI in patients with acute decompensated heart failure is effective.

A limitation of this study is that 20% of patients in each group discontinued treatment by 8 weeks secondary to an adverse event. Additionally, a clinical measure such as cardiovascular mortality, all-cause mortality, or rehospitalization for heart failure was not included in the primary outcome.

Bottom line: In patients with acute decompensated HFrEF, ARNIs are more effective at reducing NT-proBNP levels than enalapril, while maintaining a similar safety profile. Further investigation to evaluate clinical outcomes needs to be completed.

Citation: Velazquez EJ et al. Angiotensin–neprilysin inhibition in acute decompensated heart failure. N Engl J Med. 2018 Nov 11. doi: 10.1056/NEJMoa1812851.

Dr. McIntyre is an associate physician in the division of hospital medicine at the University of California, San Diego.

Background: The PARADIGM-HF trial demonstrated that patients with chronic HFrEF treated with an ARNI (sacubitril/valsartan) had significantly reduced cardiovascular mortality and hospitalizations when compared with enalapril. Patients with acute decompensated heart failure were excluded from this trial. The PIONEER-HF trial was designed to determine whether initiation of an ARNI in patients with acute decompensated heart failure is effective.

A limitation of this study is that 20% of patients in each group discontinued treatment by 8 weeks secondary to an adverse event. Additionally, a clinical measure such as cardiovascular mortality, all-cause mortality, or rehospitalization for heart failure was not included in the primary outcome.

Bottom line: In patients with acute decompensated HFrEF, ARNIs are more effective at reducing NT-proBNP levels than enalapril, while maintaining a similar safety profile. Further investigation to evaluate clinical outcomes needs to be completed.

Citation: Velazquez EJ et al. Angiotensin–neprilysin inhibition in acute decompensated heart failure. N Engl J Med. 2018 Nov 11. doi: 10.1056/NEJMoa1812851.

Dr. McIntyre is an associate physician in the division of hospital medicine at the University of California, San Diego.

Background: The PARADIGM-HF trial demonstrated that patients with chronic HFrEF treated with an ARNI (sacubitril/valsartan) had significantly reduced cardiovascular mortality and hospitalizations when compared with enalapril. Patients with acute decompensated heart failure were excluded from this trial. The PIONEER-HF trial was designed to determine whether initiation of an ARNI in patients with acute decompensated heart failure is effective.

A limitation of this study is that 20% of patients in each group discontinued treatment by 8 weeks secondary to an adverse event. Additionally, a clinical measure such as cardiovascular mortality, all-cause mortality, or rehospitalization for heart failure was not included in the primary outcome.

Bottom line: In patients with acute decompensated HFrEF, ARNIs are more effective at reducing NT-proBNP levels than enalapril, while maintaining a similar safety profile. Further investigation to evaluate clinical outcomes needs to be completed.

Citation: Velazquez EJ et al. Angiotensin–neprilysin inhibition in acute decompensated heart failure. N Engl J Med. 2018 Nov 11. doi: 10.1056/NEJMoa1812851.

Dr. McIntyre is an associate physician in the division of hospital medicine at the University of California, San Diego.

If you are a young vascular surgeon from outside North America, consider applying for the International Scholars Program. Recipients of the award will receive a $5,000 stipend, spend two weeks in the U.S, visiting universities and clinics, and attend the 2020 VAM in Toronto. Scholars will work with a mentor to schedule various vascular program visits, including clinical, teaching and research programs. Apply before Sept. 16 to be considered. Learn more.

If you are a young vascular surgeon from outside North America, consider applying for the International Scholars Program. Recipients of the award will receive a $5,000 stipend, spend two weeks in the U.S, visiting universities and clinics, and attend the 2020 VAM in Toronto. Scholars will work with a mentor to schedule various vascular program visits, including clinical, teaching and research programs. Apply before Sept. 16 to be considered. Learn more.

If you are a young vascular surgeon from outside North America, consider applying for the International Scholars Program. Recipients of the award will receive a $5,000 stipend, spend two weeks in the U.S, visiting universities and clinics, and attend the 2020 VAM in Toronto. Scholars will work with a mentor to schedule various vascular program visits, including clinical, teaching and research programs. Apply before Sept. 16 to be considered. Learn more.

The SVS has officially announced its new Mentor Match program on its online community, SVSConnect. This program provides a simple way to match general surgery residents and medical students with vascular surgeons who will, ideally, help guide them on their career path. Our resident and student members have been awaiting a program like this, and it will only be successful if we have a large pool of Active SVS members enrolled as mentors. Mentees will be able to enroll soon, at which time the matching process will begin. Please look out for communication from us for when that occurs.  Questions? Reach out to [email protected].

The SVS has officially announced its new Mentor Match program on its online community, SVSConnect. This program provides a simple way to match general surgery residents and medical students with vascular surgeons who will, ideally, help guide them on their career path. Our resident and student members have been awaiting a program like this, and it will only be successful if we have a large pool of Active SVS members enrolled as mentors. Mentees will be able to enroll soon, at which time the matching process will begin. Please look out for communication from us for when that occurs.  Questions? Reach out to [email protected].

The SVS has officially announced its new Mentor Match program on its online community, SVSConnect. This program provides a simple way to match general surgery residents and medical students with vascular surgeons who will, ideally, help guide them on their career path. Our resident and student members have been awaiting a program like this, and it will only be successful if we have a large pool of Active SVS members enrolled as mentors. Mentees will be able to enroll soon, at which time the matching process will begin. Please look out for communication from us for when that occurs.  Questions? Reach out to [email protected].

Join us as we celebrate all vascular nurses September 8 to 14 during Vascular Nurses Week. Be sure to let your nurses know how much you value them and their important contributions to your vascular team. You may also encourage your vascular nurses to join the SVS as affiliate members. Membership benefits include discounted meeting registrations, scholarship opportunities, leadership opportunities and more. Read more about Affiliate membership for vascular nurses here.

Join us as we celebrate all vascular nurses September 8 to 14 during Vascular Nurses Week. Be sure to let your nurses know how much you value them and their important contributions to your vascular team. You may also encourage your vascular nurses to join the SVS as affiliate members. Membership benefits include discounted meeting registrations, scholarship opportunities, leadership opportunities and more. Read more about Affiliate membership for vascular nurses here.

Join us as we celebrate all vascular nurses September 8 to 14 during Vascular Nurses Week. Be sure to let your nurses know how much you value them and their important contributions to your vascular team. You may also encourage your vascular nurses to join the SVS as affiliate members. Membership benefits include discounted meeting registrations, scholarship opportunities, leadership opportunities and more. Read more about Affiliate membership for vascular nurses here.

Ms. M, a generally healthy 55-year-old woman, was diagnosed recently with severe vitamin D deficiency (serum 25-hydroxyvitamin D [25(OH)D] level of 8 ng/mL). She presents with her second episode of acute viral bronchitis in the past 6 months. She has no history of significant smoking or exposure or history of asthma and does not take respiratory medications. Standard treatment for her level of vitamin D deficiency is 50,000 IU/wk in bolus dosing—but is that your best option for the patient?

ARTIs include nonspecific upper respiratory illnesses, otitis media, sinusitis (~70% viral), pharyngitis, acute bronchitis (also ~70% viral), influenza, respiratory syncytial virus, and pneumonia.^1,2 In the United States, ARTIs strain the health care system and are the most common reason for ambulatory care visits, accounting for almost 120 million (about 10% of all) visits per year.³ In addition, ARTIs account for almost 50% of antibiotic prescriptions for adults and almost 75% of antibiotic prescriptions for children—many of which are unnecessary.^2,4

While patient and parent education, antibiotic stewardship programs, and demand management may reduce inappropriate antibiotic use and the overall burden of ARTIs on the health care system, prevention of infections is a powerful tool within the overall approach to managing ARTIs.

STUDY SUMMARY

Vitamin D is protective in smaller doses

This 2017 systematic review and meta-analysis of 25 trials (N = 10,933) evaluated vitamin D supplementation for the prevention of ARTIs in the primary care setting. Individual participant data were reevaluated to reduce risk for bias. The Cochrane risk-for-bias tool was used to address threats to validity.

The study included institutional review board–approved, randomized, double-blind, placebo-controlled trials of vitamin D₃ or D₂ supplementation of any duration and in any language. The incidence of ARTI was a prespecified efficacy outcome. Duration of the included randomized controlled trials (RCTs) ranged from 7 weeks to 1.5 years.

Outcomes. The primary outcome was an incidence of at least 1 ARTI. Secondary outcomes included incidence of upper and lower ARTIs; incidence of adverse reactions to vitamin D; incidence of emergency department visits or hospital admission or both for ARTI; use of antimicrobials for ARTI; absence from work or school due to ARTI; and mortality (ARTI-related and all-cause).

Findings. Daily or weekly vitamin D supplementation (in doses ranging from < 20 to ≥ 50 µg/d) reduced the risk for ARTI (adjusted odds ratio [AOR], 0.88; number needed to treat [NNT], 33). In subgroup ­an­alysis, daily or weekly vitamin D was protective (AOR, 0.81), but bolus dosing (≥ 30,000 IU) was not (AOR, 0.97).

In 2-step analysis, patients benefited if they had baseline circulating 25(OH)D concentrations < 10 ng/mL (AOR, 0.30; NNT, 4); had baseline circulating 25(OH)D levels of 10 to 28 ng/mL (AOR, 0.75; NNT, 15); were ages 1.1 to 15.9 (AOR, 0.59); were ages 16 to 65 (AOR, 0.79); or had a BMI < 25 (AOR, 0.82).

Higher D levels are a different story. Vitamin D supplementation in people with circulating levels of 25(OH)D ≥ 30 ng/mL did not appear to provide benefit (AOR, 0.96). Supplementation in this population did not influence any of the secondary outcomes, ­including risk for all-cause serious adverse events (AOR, 0.98).

WHAT’S NEW

A more accurate snapshot

Previous studies of vitamin D and respiratory tract infections were mostly observational in nature. Those that were RCTs used variable doses of vitamin D, had variable baseline 25(OH)D levels, and employed various methods to monitor ARTI symptoms/incidence.^5-8 This is the first systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials with supplementation using vitamin D₃ or D₂ that used individual participant-level data, which gives a more accurate estimate of outcomes when compared with traditional meta-analyses.

CAVEATS

Only the most deficient benefit?

Vitamin D supplementation was safe and protected against ARTIs overall, but the greatest effect was noted in those who were most severely vitamin D deficient (those with circulating 25(OH)D levels < 10 ng/mL [NNT, 4] and those with circulating 25(OH)D levels 10-28 ng/mL [NNT, 15]). There was no demonstrable effect once circulating 25(OH)D levels reached 30 ng/mL.

CHALLENGES TO IMPLEMENTATION

Breaking tradition

The study found that both daily and weekly doses of vitamin D were effective in reducing the incidence of ARTIs. However, the doses studied were much lower than those commonly used (10,000 to 50,000 IU bolus), which were ineffective in reducing ARTIs in this meta-analysis. Changing from bolus dosing may prove challenging, as it is an ingrained practice for many providers.

In addition, the authors of the study suggest that one way to provide this level of vitamin D is through food fortification. But this method is often complicated by emotional and/or political issues that could thwart implementation.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[4]:230-231).

Ms. M, a generally healthy 55-year-old woman, was diagnosed recently with severe vitamin D deficiency (serum 25-hydroxyvitamin D [25(OH)D] level of 8 ng/mL). She presents with her second episode of acute viral bronchitis in the past 6 months. She has no history of significant smoking or exposure or history of asthma and does not take respiratory medications. Standard treatment for her level of vitamin D deficiency is 50,000 IU/wk in bolus dosing—but is that your best option for the patient?

ARTIs include nonspecific upper respiratory illnesses, otitis media, sinusitis (~70% viral), pharyngitis, acute bronchitis (also ~70% viral), influenza, respiratory syncytial virus, and pneumonia.^1,2 In the United States, ARTIs strain the health care system and are the most common reason for ambulatory care visits, accounting for almost 120 million (about 10% of all) visits per year.³ In addition, ARTIs account for almost 50% of antibiotic prescriptions for adults and almost 75% of antibiotic prescriptions for children—many of which are unnecessary.^2,4

While patient and parent education, antibiotic stewardship programs, and demand management may reduce inappropriate antibiotic use and the overall burden of ARTIs on the health care system, prevention of infections is a powerful tool within the overall approach to managing ARTIs.

STUDY SUMMARY

Vitamin D is protective in smaller doses

This 2017 systematic review and meta-analysis of 25 trials (N = 10,933) evaluated vitamin D supplementation for the prevention of ARTIs in the primary care setting. Individual participant data were reevaluated to reduce risk for bias. The Cochrane risk-for-bias tool was used to address threats to validity.

The study included institutional review board–approved, randomized, double-blind, placebo-controlled trials of vitamin D₃ or D₂ supplementation of any duration and in any language. The incidence of ARTI was a prespecified efficacy outcome. Duration of the included randomized controlled trials (RCTs) ranged from 7 weeks to 1.5 years.

Outcomes. The primary outcome was an incidence of at least 1 ARTI. Secondary outcomes included incidence of upper and lower ARTIs; incidence of adverse reactions to vitamin D; incidence of emergency department visits or hospital admission or both for ARTI; use of antimicrobials for ARTI; absence from work or school due to ARTI; and mortality (ARTI-related and all-cause).

Findings. Daily or weekly vitamin D supplementation (in doses ranging from < 20 to ≥ 50 µg/d) reduced the risk for ARTI (adjusted odds ratio [AOR], 0.88; number needed to treat [NNT], 33). In subgroup ­an­alysis, daily or weekly vitamin D was protective (AOR, 0.81), but bolus dosing (≥ 30,000 IU) was not (AOR, 0.97).

In 2-step analysis, patients benefited if they had baseline circulating 25(OH)D concentrations < 10 ng/mL (AOR, 0.30; NNT, 4); had baseline circulating 25(OH)D levels of 10 to 28 ng/mL (AOR, 0.75; NNT, 15); were ages 1.1 to 15.9 (AOR, 0.59); were ages 16 to 65 (AOR, 0.79); or had a BMI < 25 (AOR, 0.82).

Higher D levels are a different story. Vitamin D supplementation in people with circulating levels of 25(OH)D ≥ 30 ng/mL did not appear to provide benefit (AOR, 0.96). Supplementation in this population did not influence any of the secondary outcomes, ­including risk for all-cause serious adverse events (AOR, 0.98).

WHAT’S NEW

A more accurate snapshot

Previous studies of vitamin D and respiratory tract infections were mostly observational in nature. Those that were RCTs used variable doses of vitamin D, had variable baseline 25(OH)D levels, and employed various methods to monitor ARTI symptoms/incidence.^5-8 This is the first systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials with supplementation using vitamin D₃ or D₂ that used individual participant-level data, which gives a more accurate estimate of outcomes when compared with traditional meta-analyses.

CAVEATS

Only the most deficient benefit?

Vitamin D supplementation was safe and protected against ARTIs overall, but the greatest effect was noted in those who were most severely vitamin D deficient (those with circulating 25(OH)D levels < 10 ng/mL [NNT, 4] and those with circulating 25(OH)D levels 10-28 ng/mL [NNT, 15]). There was no demonstrable effect once circulating 25(OH)D levels reached 30 ng/mL.

CHALLENGES TO IMPLEMENTATION

Breaking tradition

The study found that both daily and weekly doses of vitamin D were effective in reducing the incidence of ARTIs. However, the doses studied were much lower than those commonly used (10,000 to 50,000 IU bolus), which were ineffective in reducing ARTIs in this meta-analysis. Changing from bolus dosing may prove challenging, as it is an ingrained practice for many providers.

In addition, the authors of the study suggest that one way to provide this level of vitamin D is through food fortification. But this method is often complicated by emotional and/or political issues that could thwart implementation.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[4]:230-231).

Ms. M, a generally healthy 55-year-old woman, was diagnosed recently with severe vitamin D deficiency (serum 25-hydroxyvitamin D [25(OH)D] level of 8 ng/mL). She presents with her second episode of acute viral bronchitis in the past 6 months. She has no history of significant smoking or exposure or history of asthma and does not take respiratory medications. Standard treatment for her level of vitamin D deficiency is 50,000 IU/wk in bolus dosing—but is that your best option for the patient?

ARTIs include nonspecific upper respiratory illnesses, otitis media, sinusitis (~70% viral), pharyngitis, acute bronchitis (also ~70% viral), influenza, respiratory syncytial virus, and pneumonia.^1,2 In the United States, ARTIs strain the health care system and are the most common reason for ambulatory care visits, accounting for almost 120 million (about 10% of all) visits per year.³ In addition, ARTIs account for almost 50% of antibiotic prescriptions for adults and almost 75% of antibiotic prescriptions for children—many of which are unnecessary.^2,4

While patient and parent education, antibiotic stewardship programs, and demand management may reduce inappropriate antibiotic use and the overall burden of ARTIs on the health care system, prevention of infections is a powerful tool within the overall approach to managing ARTIs.

STUDY SUMMARY

Vitamin D is protective in smaller doses

This 2017 systematic review and meta-analysis of 25 trials (N = 10,933) evaluated vitamin D supplementation for the prevention of ARTIs in the primary care setting. Individual participant data were reevaluated to reduce risk for bias. The Cochrane risk-for-bias tool was used to address threats to validity.

The study included institutional review board–approved, randomized, double-blind, placebo-controlled trials of vitamin D₃ or D₂ supplementation of any duration and in any language. The incidence of ARTI was a prespecified efficacy outcome. Duration of the included randomized controlled trials (RCTs) ranged from 7 weeks to 1.5 years.

Outcomes. The primary outcome was an incidence of at least 1 ARTI. Secondary outcomes included incidence of upper and lower ARTIs; incidence of adverse reactions to vitamin D; incidence of emergency department visits or hospital admission or both for ARTI; use of antimicrobials for ARTI; absence from work or school due to ARTI; and mortality (ARTI-related and all-cause).

Findings. Daily or weekly vitamin D supplementation (in doses ranging from < 20 to ≥ 50 µg/d) reduced the risk for ARTI (adjusted odds ratio [AOR], 0.88; number needed to treat [NNT], 33). In subgroup ­an­alysis, daily or weekly vitamin D was protective (AOR, 0.81), but bolus dosing (≥ 30,000 IU) was not (AOR, 0.97).

In 2-step analysis, patients benefited if they had baseline circulating 25(OH)D concentrations < 10 ng/mL (AOR, 0.30; NNT, 4); had baseline circulating 25(OH)D levels of 10 to 28 ng/mL (AOR, 0.75; NNT, 15); were ages 1.1 to 15.9 (AOR, 0.59); were ages 16 to 65 (AOR, 0.79); or had a BMI < 25 (AOR, 0.82).

Higher D levels are a different story. Vitamin D supplementation in people with circulating levels of 25(OH)D ≥ 30 ng/mL did not appear to provide benefit (AOR, 0.96). Supplementation in this population did not influence any of the secondary outcomes, ­including risk for all-cause serious adverse events (AOR, 0.98).

WHAT’S NEW

A more accurate snapshot

Previous studies of vitamin D and respiratory tract infections were mostly observational in nature. Those that were RCTs used variable doses of vitamin D, had variable baseline 25(OH)D levels, and employed various methods to monitor ARTI symptoms/incidence.^5-8 This is the first systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials with supplementation using vitamin D₃ or D₂ that used individual participant-level data, which gives a more accurate estimate of outcomes when compared with traditional meta-analyses.

CAVEATS

Only the most deficient benefit?

Vitamin D supplementation was safe and protected against ARTIs overall, but the greatest effect was noted in those who were most severely vitamin D deficient (those with circulating 25(OH)D levels < 10 ng/mL [NNT, 4] and those with circulating 25(OH)D levels 10-28 ng/mL [NNT, 15]). There was no demonstrable effect once circulating 25(OH)D levels reached 30 ng/mL.

CHALLENGES TO IMPLEMENTATION

Breaking tradition

The study found that both daily and weekly doses of vitamin D were effective in reducing the incidence of ARTIs. However, the doses studied were much lower than those commonly used (10,000 to 50,000 IU bolus), which were ineffective in reducing ARTIs in this meta-analysis. Changing from bolus dosing may prove challenging, as it is an ingrained practice for many providers.

In addition, the authors of the study suggest that one way to provide this level of vitamin D is through food fortification. But this method is often complicated by emotional and/or political issues that could thwart implementation.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[4]:230-231).