Business of Medicine

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

In the October 2022 issue of JAMA Neurology was a research article and accompanying editorial on the ATN (amyloid/tau/neurodegeneration) framework for diagnosing and treating Alzheimer’s disease.

There are valid concerns with any system centered on early dementia diagnosis. If the new generation of Alzheimer’s treatments can reverse pathology before the symptoms are apparent, it certainly makes sense to treat people as early as possible. In a terrible disease with only partially effective treatments now, this is encouraging news.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

In the October 2022 issue of JAMA Neurology was a research article and accompanying editorial on the ATN (amyloid/tau/neurodegeneration) framework for diagnosing and treating Alzheimer’s disease.

There are valid concerns with any system centered on early dementia diagnosis. If the new generation of Alzheimer’s treatments can reverse pathology before the symptoms are apparent, it certainly makes sense to treat people as early as possible. In a terrible disease with only partially effective treatments now, this is encouraging news.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

In the October 2022 issue of JAMA Neurology was a research article and accompanying editorial on the ATN (amyloid/tau/neurodegeneration) framework for diagnosing and treating Alzheimer’s disease.

There are valid concerns with any system centered on early dementia diagnosis. If the new generation of Alzheimer’s treatments can reverse pathology before the symptoms are apparent, it certainly makes sense to treat people as early as possible. In a terrible disease with only partially effective treatments now, this is encouraging news.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

More women gave birth at home in America last year, continuing a pandemic trend and reaching the highest level in decades, according to figures released by the CDC.

The report said that almost 52,000 births occurred at home in 2021, out of 4 million total births in the country. This was an increase of 12% from 2020. The figure rose by 22% in 2020, when the COVID-19 pandemic hit, over 2019.

There were several possible reasons for the increase in home births. Infection rates and hospitalizations were high. Vaccinations were not available or were not widely used, and many people avoided going to hospitals or the doctor, said Elizabeth Gregory, the report’s lead author.

Also, some women didn’t have health insurance, lived far from a medical facility, or could not get to a hospital fast enough. About 25% of home births are not planned, the Associated Press reported.

Increases in home births occurred across all races, but home births were less common among Hispanics.

The AP reported that home births are riskier than hospital births, according to the American College of Obstetricians and Gynecologists. The organization advises against home births for women carrying multiple babies or who have previously had a cesarean section.

“Hospitals and accredited birth centers are the safest places to give birth, because although serious complications associated with labor and delivery are rare, they can be catastrophic,” said Jeffrey Ecker, M.D., chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

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

More women gave birth at home in America last year, continuing a pandemic trend and reaching the highest level in decades, according to figures released by the CDC.

The report said that almost 52,000 births occurred at home in 2021, out of 4 million total births in the country. This was an increase of 12% from 2020. The figure rose by 22% in 2020, when the COVID-19 pandemic hit, over 2019.

There were several possible reasons for the increase in home births. Infection rates and hospitalizations were high. Vaccinations were not available or were not widely used, and many people avoided going to hospitals or the doctor, said Elizabeth Gregory, the report’s lead author.

Also, some women didn’t have health insurance, lived far from a medical facility, or could not get to a hospital fast enough. About 25% of home births are not planned, the Associated Press reported.

Increases in home births occurred across all races, but home births were less common among Hispanics.

The AP reported that home births are riskier than hospital births, according to the American College of Obstetricians and Gynecologists. The organization advises against home births for women carrying multiple babies or who have previously had a cesarean section.

“Hospitals and accredited birth centers are the safest places to give birth, because although serious complications associated with labor and delivery are rare, they can be catastrophic,” said Jeffrey Ecker, M.D., chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

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

More women gave birth at home in America last year, continuing a pandemic trend and reaching the highest level in decades, according to figures released by the CDC.

The report said that almost 52,000 births occurred at home in 2021, out of 4 million total births in the country. This was an increase of 12% from 2020. The figure rose by 22% in 2020, when the COVID-19 pandemic hit, over 2019.

There were several possible reasons for the increase in home births. Infection rates and hospitalizations were high. Vaccinations were not available or were not widely used, and many people avoided going to hospitals or the doctor, said Elizabeth Gregory, the report’s lead author.

Also, some women didn’t have health insurance, lived far from a medical facility, or could not get to a hospital fast enough. About 25% of home births are not planned, the Associated Press reported.

Increases in home births occurred across all races, but home births were less common among Hispanics.

The AP reported that home births are riskier than hospital births, according to the American College of Obstetricians and Gynecologists. The organization advises against home births for women carrying multiple babies or who have previously had a cesarean section.

“Hospitals and accredited birth centers are the safest places to give birth, because although serious complications associated with labor and delivery are rare, they can be catastrophic,” said Jeffrey Ecker, M.D., chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

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

On one of the first days of medical school, Adaira Landry, MD, applied her favorite dark shade of lipstick and headed to her orientation. She was eager to learn about program expectations and connect with fellow aspiring physicians. But when Dr. Landry got there, one of her brand-new peers turned to her and asked, “Why do you wear your lipstick like an angry Black woman?”

“Imagine hearing that,” Dr. Landry, now an emergency medical physician in Boston, says. “It was so hurtful.”

So, what is a “standard-issue doctor” expected to look like? Physicians manage their appearances in myriad ways: through clothes, accessories, hair style, makeup; through a social media presence or lack thereof; in the rhythms and nuances of their interactions with patients and colleagues. These things add up to a professional “persona” – the Latin word for “mask,” or the face on display for the world to see.

Professional personae exist across various industries, but some standards for professionalism in medicine reflect a particularly narrow view of what a physician can or should be. While the health care field itself is diversifying, its guidelines for professionalism appear slower to change, often excluding or frowning upon expressions of individual personality or identity.

“Medicine is run primarily by men. It’s an objective truth,” Dr. Landry says. “Currently and historically, the standard of professionalism, especially in the physical sense, was set by them. As we increase diversity and welcome people bringing their authentic self to work, the prior definitions of professionalism are obviously in need of change.”
 

Split social media personalities

In August 2020, the Journal of Vascular Surgery published a study on the “prevalence of unprofessional social media content among young vascular surgeons.” The content that was deemed “unprofessional” included opinions on political issues like abortion and gun control. Photos of physicians holding alcoholic drinks or wearing “inappropriate/offensive attire,” including underwear, “provocative Halloween costumes,” and “bikinis/swimwear” were also censured. Six men and one woman worked on the study, and three of the male researchers took on the task of seeking out the “unprofessional” photos on social media. The resulting paper was reviewed by an all-male editorial board.

The study sparked immediate backlash and prompted hundreds of health care professionals to post photos of themselves in bathing suits with the hashtag “#medbikini.” The journal then retracted the study and issued an apology on Twitter, recognizing “errors in the design of the study with regards to conscious and unconscious bias.”

The researchers’ original definition of professionalism suggests that physicians should manage their personae even outside of work hours. “I think medicine in general is a very conservative and hierarchical field of study and of work, to say the least,” says Sarah Fraser, MD, a family medicine physician in Nova Scotia, Canada. “There’s this view that we have to have completely separate personal and professional lives, like church and state.”

The #medbikini controversy inspired Dr. Fraser to write an op-ed for the British Medical Journal blog about the flaws of requiring physicians to keep their personal and professional selves separate. The piece referenced Robert Louis Stevenson’s 1886 Gothic novella “The Strange Case of Dr. Jekyll and Mr. Hyde,” in which the respected scientist Dr. Jekyll creates an alter ego so he can express his evil urges without experiencing guilt, punishment, or loss of livelihood. Dr. Fraser likened this story to the pressure physicians feel to shrink or split themselves to squeeze into a narrow definition of professionalism.

But Dr. Landry points out that some elements of expression seen as unprofessional cannot be entirely separated from a physician’s fundamental identity. “For Black women, our daily behaviors and forms of expression that are deemed ‘unprofessional’ are much more subtle than being able to wear a bikini on social media,” she says. “The way we wear our hair, the tone of our voice, the color of our lipstick, the way we wear scrub caps are parts of us that are called into question.”
 

Keeping up appearances

The stereotype of what a doctor should look like starts to shape physicians’ professional personae in medical school. When Jennifer Caputo-Seidler, MD, started medical school in 2008, the dress code requirements for male students were simple: pants, a button-down shirt, a tie. But then there were the rules for women: Hair should be tied back. Minimal makeup. No flashy jewelry. Nothing without sleeves. Neutral colors. High necklines. Low hemlines. “The message I got was that we need to dress like the men in order to be taken seriously and to be seen as professional,” says Dr. Caputo-Seidler, now an assistant professor of medicine at the University of South Florida, Tampa, “and so that’s what I did.”

A 2018 analysis of 78 “draw-a-scientist” studies found that children have overwhelmingly associated scientific fields with men for the last 50 years. Overall, children drew 73% of scientists as men. The drawings grew more gender diverse over time, but even as more women entered scientific fields, both boys and girls continued to draw significantly more male than female scientists.

Not everyone at Dr. Caputo-Seidler’s medical school adhered to the environment’s gendered expectations. One resident she worked with often wore voluminous hairstyles, lipstick, and high heels. Dr. Caputo-Seidler overheard her peers as they gossiped behind the resident’s back, ridiculing the way she looked.

“She was good at her job,” Dr. Caputo-Seidler says. “She knew her patients. She had things down. She was, by all measures, very competent. But when people saw her dressing outside the norm and being forward with her femininity, there was definitely a lot of chatter about it.”

While expectations for a conservative appearance may disproportionately affect women, and particularly women of color, they also affect men who deviate from the norm. “As an LGBTQ+ person working as a ‘professional,’ I have countless stories and moments where I had my professionalism questioned,” Blair Peters, MD, a plastic surgeon and assistant professor at Oregon Health & Science University, Portland, wrote on Twitter. “Why is it ‘unprofessional’ to have colored hair? Why is it ‘unprofessional’ to have a visible tattoo? Why is it ‘unprofessional’ to wear bright colors and patterns?”

Dr. Fraser remembers a fellow medical student who had full-sleeve tattoos on both of his arms. A preceptor made a comment about it to Dr. Fraser, and then instructed the student to cover up his tattoos. “I think that there are scenarios when having tattoos or having different-colored hair or expressing your individual personality could help you even better bond with your patients,” Dr. Fraser says, “especially if you’re, for example, working with youth.”
 

Unmasking health care

Beyond the facets of dress codes and social media posts, the issue of professional personae speaks to the deeper issue of inclusion in medicine. As the field grows increasingly diverse, health care institutions and those they serve may need to expand their definitions of professionalism to include more truthful expressions of who contemporary health care professionals are as people.

Dr. Fraser suggests that the benefits of physicians embracing self-expression – rather than assimilating to an outdated model of professionalism – extend beyond the individual.

“Whether it comes to what you choose to wear to the clinic on a day-to-day basis, or what you choose to share on a social media account, as long as it’s not harming others, then I think that it’s a positive thing to be able to be yourself and express yourself,” she says. “I feel like doctors are expected to have a different personality when we’re at the clinic, and usually it’s more conservative or objective or aloof. But I think that by being open about who we are, we’ll actually help build a trusting relationship with both patients and society.”

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

On one of the first days of medical school, Adaira Landry, MD, applied her favorite dark shade of lipstick and headed to her orientation. She was eager to learn about program expectations and connect with fellow aspiring physicians. But when Dr. Landry got there, one of her brand-new peers turned to her and asked, “Why do you wear your lipstick like an angry Black woman?”

“Imagine hearing that,” Dr. Landry, now an emergency medical physician in Boston, says. “It was so hurtful.”

So, what is a “standard-issue doctor” expected to look like? Physicians manage their appearances in myriad ways: through clothes, accessories, hair style, makeup; through a social media presence or lack thereof; in the rhythms and nuances of their interactions with patients and colleagues. These things add up to a professional “persona” – the Latin word for “mask,” or the face on display for the world to see.

Professional personae exist across various industries, but some standards for professionalism in medicine reflect a particularly narrow view of what a physician can or should be. While the health care field itself is diversifying, its guidelines for professionalism appear slower to change, often excluding or frowning upon expressions of individual personality or identity.

“Medicine is run primarily by men. It’s an objective truth,” Dr. Landry says. “Currently and historically, the standard of professionalism, especially in the physical sense, was set by them. As we increase diversity and welcome people bringing their authentic self to work, the prior definitions of professionalism are obviously in need of change.”
 

Split social media personalities

In August 2020, the Journal of Vascular Surgery published a study on the “prevalence of unprofessional social media content among young vascular surgeons.” The content that was deemed “unprofessional” included opinions on political issues like abortion and gun control. Photos of physicians holding alcoholic drinks or wearing “inappropriate/offensive attire,” including underwear, “provocative Halloween costumes,” and “bikinis/swimwear” were also censured. Six men and one woman worked on the study, and three of the male researchers took on the task of seeking out the “unprofessional” photos on social media. The resulting paper was reviewed by an all-male editorial board.

The study sparked immediate backlash and prompted hundreds of health care professionals to post photos of themselves in bathing suits with the hashtag “#medbikini.” The journal then retracted the study and issued an apology on Twitter, recognizing “errors in the design of the study with regards to conscious and unconscious bias.”

The researchers’ original definition of professionalism suggests that physicians should manage their personae even outside of work hours. “I think medicine in general is a very conservative and hierarchical field of study and of work, to say the least,” says Sarah Fraser, MD, a family medicine physician in Nova Scotia, Canada. “There’s this view that we have to have completely separate personal and professional lives, like church and state.”

The #medbikini controversy inspired Dr. Fraser to write an op-ed for the British Medical Journal blog about the flaws of requiring physicians to keep their personal and professional selves separate. The piece referenced Robert Louis Stevenson’s 1886 Gothic novella “The Strange Case of Dr. Jekyll and Mr. Hyde,” in which the respected scientist Dr. Jekyll creates an alter ego so he can express his evil urges without experiencing guilt, punishment, or loss of livelihood. Dr. Fraser likened this story to the pressure physicians feel to shrink or split themselves to squeeze into a narrow definition of professionalism.

But Dr. Landry points out that some elements of expression seen as unprofessional cannot be entirely separated from a physician’s fundamental identity. “For Black women, our daily behaviors and forms of expression that are deemed ‘unprofessional’ are much more subtle than being able to wear a bikini on social media,” she says. “The way we wear our hair, the tone of our voice, the color of our lipstick, the way we wear scrub caps are parts of us that are called into question.”
 

Keeping up appearances

The stereotype of what a doctor should look like starts to shape physicians’ professional personae in medical school. When Jennifer Caputo-Seidler, MD, started medical school in 2008, the dress code requirements for male students were simple: pants, a button-down shirt, a tie. But then there were the rules for women: Hair should be tied back. Minimal makeup. No flashy jewelry. Nothing without sleeves. Neutral colors. High necklines. Low hemlines. “The message I got was that we need to dress like the men in order to be taken seriously and to be seen as professional,” says Dr. Caputo-Seidler, now an assistant professor of medicine at the University of South Florida, Tampa, “and so that’s what I did.”

A 2018 analysis of 78 “draw-a-scientist” studies found that children have overwhelmingly associated scientific fields with men for the last 50 years. Overall, children drew 73% of scientists as men. The drawings grew more gender diverse over time, but even as more women entered scientific fields, both boys and girls continued to draw significantly more male than female scientists.

Not everyone at Dr. Caputo-Seidler’s medical school adhered to the environment’s gendered expectations. One resident she worked with often wore voluminous hairstyles, lipstick, and high heels. Dr. Caputo-Seidler overheard her peers as they gossiped behind the resident’s back, ridiculing the way she looked.

“She was good at her job,” Dr. Caputo-Seidler says. “She knew her patients. She had things down. She was, by all measures, very competent. But when people saw her dressing outside the norm and being forward with her femininity, there was definitely a lot of chatter about it.”

While expectations for a conservative appearance may disproportionately affect women, and particularly women of color, they also affect men who deviate from the norm. “As an LGBTQ+ person working as a ‘professional,’ I have countless stories and moments where I had my professionalism questioned,” Blair Peters, MD, a plastic surgeon and assistant professor at Oregon Health & Science University, Portland, wrote on Twitter. “Why is it ‘unprofessional’ to have colored hair? Why is it ‘unprofessional’ to have a visible tattoo? Why is it ‘unprofessional’ to wear bright colors and patterns?”

Dr. Fraser remembers a fellow medical student who had full-sleeve tattoos on both of his arms. A preceptor made a comment about it to Dr. Fraser, and then instructed the student to cover up his tattoos. “I think that there are scenarios when having tattoos or having different-colored hair or expressing your individual personality could help you even better bond with your patients,” Dr. Fraser says, “especially if you’re, for example, working with youth.”
 

Unmasking health care

Beyond the facets of dress codes and social media posts, the issue of professional personae speaks to the deeper issue of inclusion in medicine. As the field grows increasingly diverse, health care institutions and those they serve may need to expand their definitions of professionalism to include more truthful expressions of who contemporary health care professionals are as people.

Dr. Fraser suggests that the benefits of physicians embracing self-expression – rather than assimilating to an outdated model of professionalism – extend beyond the individual.

“Whether it comes to what you choose to wear to the clinic on a day-to-day basis, or what you choose to share on a social media account, as long as it’s not harming others, then I think that it’s a positive thing to be able to be yourself and express yourself,” she says. “I feel like doctors are expected to have a different personality when we’re at the clinic, and usually it’s more conservative or objective or aloof. But I think that by being open about who we are, we’ll actually help build a trusting relationship with both patients and society.”

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

On one of the first days of medical school, Adaira Landry, MD, applied her favorite dark shade of lipstick and headed to her orientation. She was eager to learn about program expectations and connect with fellow aspiring physicians. But when Dr. Landry got there, one of her brand-new peers turned to her and asked, “Why do you wear your lipstick like an angry Black woman?”

“Imagine hearing that,” Dr. Landry, now an emergency medical physician in Boston, says. “It was so hurtful.”

So, what is a “standard-issue doctor” expected to look like? Physicians manage their appearances in myriad ways: through clothes, accessories, hair style, makeup; through a social media presence or lack thereof; in the rhythms and nuances of their interactions with patients and colleagues. These things add up to a professional “persona” – the Latin word for “mask,” or the face on display for the world to see.

Professional personae exist across various industries, but some standards for professionalism in medicine reflect a particularly narrow view of what a physician can or should be. While the health care field itself is diversifying, its guidelines for professionalism appear slower to change, often excluding or frowning upon expressions of individual personality or identity.

“Medicine is run primarily by men. It’s an objective truth,” Dr. Landry says. “Currently and historically, the standard of professionalism, especially in the physical sense, was set by them. As we increase diversity and welcome people bringing their authentic self to work, the prior definitions of professionalism are obviously in need of change.”
 

Split social media personalities

In August 2020, the Journal of Vascular Surgery published a study on the “prevalence of unprofessional social media content among young vascular surgeons.” The content that was deemed “unprofessional” included opinions on political issues like abortion and gun control. Photos of physicians holding alcoholic drinks or wearing “inappropriate/offensive attire,” including underwear, “provocative Halloween costumes,” and “bikinis/swimwear” were also censured. Six men and one woman worked on the study, and three of the male researchers took on the task of seeking out the “unprofessional” photos on social media. The resulting paper was reviewed by an all-male editorial board.

The study sparked immediate backlash and prompted hundreds of health care professionals to post photos of themselves in bathing suits with the hashtag “#medbikini.” The journal then retracted the study and issued an apology on Twitter, recognizing “errors in the design of the study with regards to conscious and unconscious bias.”

The researchers’ original definition of professionalism suggests that physicians should manage their personae even outside of work hours. “I think medicine in general is a very conservative and hierarchical field of study and of work, to say the least,” says Sarah Fraser, MD, a family medicine physician in Nova Scotia, Canada. “There’s this view that we have to have completely separate personal and professional lives, like church and state.”

The #medbikini controversy inspired Dr. Fraser to write an op-ed for the British Medical Journal blog about the flaws of requiring physicians to keep their personal and professional selves separate. The piece referenced Robert Louis Stevenson’s 1886 Gothic novella “The Strange Case of Dr. Jekyll and Mr. Hyde,” in which the respected scientist Dr. Jekyll creates an alter ego so he can express his evil urges without experiencing guilt, punishment, or loss of livelihood. Dr. Fraser likened this story to the pressure physicians feel to shrink or split themselves to squeeze into a narrow definition of professionalism.

But Dr. Landry points out that some elements of expression seen as unprofessional cannot be entirely separated from a physician’s fundamental identity. “For Black women, our daily behaviors and forms of expression that are deemed ‘unprofessional’ are much more subtle than being able to wear a bikini on social media,” she says. “The way we wear our hair, the tone of our voice, the color of our lipstick, the way we wear scrub caps are parts of us that are called into question.”
 

Keeping up appearances

The stereotype of what a doctor should look like starts to shape physicians’ professional personae in medical school. When Jennifer Caputo-Seidler, MD, started medical school in 2008, the dress code requirements for male students were simple: pants, a button-down shirt, a tie. But then there were the rules for women: Hair should be tied back. Minimal makeup. No flashy jewelry. Nothing without sleeves. Neutral colors. High necklines. Low hemlines. “The message I got was that we need to dress like the men in order to be taken seriously and to be seen as professional,” says Dr. Caputo-Seidler, now an assistant professor of medicine at the University of South Florida, Tampa, “and so that’s what I did.”

A 2018 analysis of 78 “draw-a-scientist” studies found that children have overwhelmingly associated scientific fields with men for the last 50 years. Overall, children drew 73% of scientists as men. The drawings grew more gender diverse over time, but even as more women entered scientific fields, both boys and girls continued to draw significantly more male than female scientists.

Not everyone at Dr. Caputo-Seidler’s medical school adhered to the environment’s gendered expectations. One resident she worked with often wore voluminous hairstyles, lipstick, and high heels. Dr. Caputo-Seidler overheard her peers as they gossiped behind the resident’s back, ridiculing the way she looked.

“She was good at her job,” Dr. Caputo-Seidler says. “She knew her patients. She had things down. She was, by all measures, very competent. But when people saw her dressing outside the norm and being forward with her femininity, there was definitely a lot of chatter about it.”

While expectations for a conservative appearance may disproportionately affect women, and particularly women of color, they also affect men who deviate from the norm. “As an LGBTQ+ person working as a ‘professional,’ I have countless stories and moments where I had my professionalism questioned,” Blair Peters, MD, a plastic surgeon and assistant professor at Oregon Health & Science University, Portland, wrote on Twitter. “Why is it ‘unprofessional’ to have colored hair? Why is it ‘unprofessional’ to have a visible tattoo? Why is it ‘unprofessional’ to wear bright colors and patterns?”

Dr. Fraser remembers a fellow medical student who had full-sleeve tattoos on both of his arms. A preceptor made a comment about it to Dr. Fraser, and then instructed the student to cover up his tattoos. “I think that there are scenarios when having tattoos or having different-colored hair or expressing your individual personality could help you even better bond with your patients,” Dr. Fraser says, “especially if you’re, for example, working with youth.”
 

Unmasking health care

Beyond the facets of dress codes and social media posts, the issue of professional personae speaks to the deeper issue of inclusion in medicine. As the field grows increasingly diverse, health care institutions and those they serve may need to expand their definitions of professionalism to include more truthful expressions of who contemporary health care professionals are as people.

Dr. Fraser suggests that the benefits of physicians embracing self-expression – rather than assimilating to an outdated model of professionalism – extend beyond the individual.

“Whether it comes to what you choose to wear to the clinic on a day-to-day basis, or what you choose to share on a social media account, as long as it’s not harming others, then I think that it’s a positive thing to be able to be yourself and express yourself,” she says. “I feel like doctors are expected to have a different personality when we’re at the clinic, and usually it’s more conservative or objective or aloof. But I think that by being open about who we are, we’ll actually help build a trusting relationship with both patients and society.”

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

Reminder messages sent through electronic health records (EHRs) to patient portals increased rates of scheduling and completion of well-child visits for those overdue for well care, as well as vaccination rates, according to data published today in JAMA Network Open.

Anne E. Berset, BA, with general and community pediatrics at Cincinnati Children’s Hospital, led a randomized clinical trial conducted at three academic primary care practices from July 30 to Oct. 4, 2021.

The practices serve a mostly non-Hispanic Black, low-income population and provide more than 60,000 visits a year to 30,000 patients.

The study population included 945 patients, 62.4% of them non-Hispanic Black and 807 (85.4%) covered by public insurance.
 

Standard message and tailored message compared

The study population was randomized to get either a standard reminder message, a tailored message, or no message (control group).

The standard messages referenced the patient’s first name and reminded parents their child was due for a well-child visit, and asked them to schedule it using the portal or by calling the number provided.

The tailored message added the date of the last well-child check-up “to address distortions of time perception experienced during the pandemic,” the authors write.

The primary outcome was whether the well-child visit was completed within 8 weeks. Other outcomes included whether a well-child visit was scheduled within 2 weeks of the first reminder message and whether the patient received a COVID-19 vaccine within 8 weeks of the reminder.
 

Reminders outperform control group

There was a significant increase in scheduling and completion of appointments after parents received the standard and tailored messages compared with controls.

The results with the COVID reminders were particularly striking. While only 3.7% of the eligible patients got a vaccine when they got no message, 17.3% got the vaccine in that time frame when they got the standard message. Interestingly, only 2.7% received the shot after the tailored message.

J. Howard Smart, MD, with Sharp HealthCare in San Diego, told this publication he was not surprised that a patient portal reminder would increase the rate of scheduling overdue well-child visits. “Parents may indeed have lost track of when their children need to have check-ups” during the pandemic, he said.

Reminders without tailored information more effective

He said he was surprised, just as the investigators were, that the reminders without the tailored information seemed to be more effective for some outcomes.

The authors explained that a focus group found “that families with patient portal accounts prefer straightforward, brief, and user-friendly messages.”

That may help explain why the standard message outperformed the tailored message, the authors write.

“Families may have been distracted by the additional information related to the child’s age and date of last WCC [well-child check-up] in the tailored message,” they write.

Dr. Smart said, “Their discussion of why this might be the case sounds reasonable. Simple, short messages may be better received.”

“Evidence like this should stimulate portal software vendors to make this kind of outgoing messaging easy to set up for providers,” he said.

Simple measure, large effect

Tim Joos, MD, a pediatrician in Seattle, told this publication he “was impressed by how such a simple measure increased rates of well-child care completion.”

Minority and low-income patients have traditionally had more access challenges to completing health care visits and vaccinations on schedule, he noted, so he was glad to see positive results from the intervention in this study population.

The authors note that research on portal messages have largely looked at use in non-Hispanic Whites and the privately insured.

Dr. Joos said the intervention also offers convenience in that once patients get into the portal, they can schedule an appointment there without having to wait on the phone or leave a message.

Funding/support was received from the Center for Clinical and Translational Science and Training at the University of Cincinnati, which is funded by the National Institutes of Health. William B. Brinkman, MD, MEd, MSc, one of the study authors, holds common stock in Pfizer, Merck, Abbott Laboratories, Viatris, and Johnson & Johnson outside the submitted work. No other author disclosures were reported. Dr. Smart and Dr. Joos declared no relevant financial relationships.

Reminder messages sent through electronic health records (EHRs) to patient portals increased rates of scheduling and completion of well-child visits for those overdue for well care, as well as vaccination rates, according to data published today in JAMA Network Open.

Anne E. Berset, BA, with general and community pediatrics at Cincinnati Children’s Hospital, led a randomized clinical trial conducted at three academic primary care practices from July 30 to Oct. 4, 2021.

The practices serve a mostly non-Hispanic Black, low-income population and provide more than 60,000 visits a year to 30,000 patients.

The study population included 945 patients, 62.4% of them non-Hispanic Black and 807 (85.4%) covered by public insurance.
 

Standard message and tailored message compared

The study population was randomized to get either a standard reminder message, a tailored message, or no message (control group).

The standard messages referenced the patient’s first name and reminded parents their child was due for a well-child visit, and asked them to schedule it using the portal or by calling the number provided.

The tailored message added the date of the last well-child check-up “to address distortions of time perception experienced during the pandemic,” the authors write.

The primary outcome was whether the well-child visit was completed within 8 weeks. Other outcomes included whether a well-child visit was scheduled within 2 weeks of the first reminder message and whether the patient received a COVID-19 vaccine within 8 weeks of the reminder.
 

Reminders outperform control group

There was a significant increase in scheduling and completion of appointments after parents received the standard and tailored messages compared with controls.

The results with the COVID reminders were particularly striking. While only 3.7% of the eligible patients got a vaccine when they got no message, 17.3% got the vaccine in that time frame when they got the standard message. Interestingly, only 2.7% received the shot after the tailored message.

J. Howard Smart, MD, with Sharp HealthCare in San Diego, told this publication he was not surprised that a patient portal reminder would increase the rate of scheduling overdue well-child visits. “Parents may indeed have lost track of when their children need to have check-ups” during the pandemic, he said.

Reminders without tailored information more effective

He said he was surprised, just as the investigators were, that the reminders without the tailored information seemed to be more effective for some outcomes.

The authors explained that a focus group found “that families with patient portal accounts prefer straightforward, brief, and user-friendly messages.”

That may help explain why the standard message outperformed the tailored message, the authors write.

“Families may have been distracted by the additional information related to the child’s age and date of last WCC [well-child check-up] in the tailored message,” they write.

Dr. Smart said, “Their discussion of why this might be the case sounds reasonable. Simple, short messages may be better received.”

“Evidence like this should stimulate portal software vendors to make this kind of outgoing messaging easy to set up for providers,” he said.

Simple measure, large effect

Tim Joos, MD, a pediatrician in Seattle, told this publication he “was impressed by how such a simple measure increased rates of well-child care completion.”

Minority and low-income patients have traditionally had more access challenges to completing health care visits and vaccinations on schedule, he noted, so he was glad to see positive results from the intervention in this study population.

The authors note that research on portal messages have largely looked at use in non-Hispanic Whites and the privately insured.

Dr. Joos said the intervention also offers convenience in that once patients get into the portal, they can schedule an appointment there without having to wait on the phone or leave a message.

Funding/support was received from the Center for Clinical and Translational Science and Training at the University of Cincinnati, which is funded by the National Institutes of Health. William B. Brinkman, MD, MEd, MSc, one of the study authors, holds common stock in Pfizer, Merck, Abbott Laboratories, Viatris, and Johnson & Johnson outside the submitted work. No other author disclosures were reported. Dr. Smart and Dr. Joos declared no relevant financial relationships.

Reminder messages sent through electronic health records (EHRs) to patient portals increased rates of scheduling and completion of well-child visits for those overdue for well care, as well as vaccination rates, according to data published today in JAMA Network Open.

Anne E. Berset, BA, with general and community pediatrics at Cincinnati Children’s Hospital, led a randomized clinical trial conducted at three academic primary care practices from July 30 to Oct. 4, 2021.

The practices serve a mostly non-Hispanic Black, low-income population and provide more than 60,000 visits a year to 30,000 patients.

The study population included 945 patients, 62.4% of them non-Hispanic Black and 807 (85.4%) covered by public insurance.
 

Standard message and tailored message compared

The study population was randomized to get either a standard reminder message, a tailored message, or no message (control group).

The standard messages referenced the patient’s first name and reminded parents their child was due for a well-child visit, and asked them to schedule it using the portal or by calling the number provided.

The tailored message added the date of the last well-child check-up “to address distortions of time perception experienced during the pandemic,” the authors write.

The primary outcome was whether the well-child visit was completed within 8 weeks. Other outcomes included whether a well-child visit was scheduled within 2 weeks of the first reminder message and whether the patient received a COVID-19 vaccine within 8 weeks of the reminder.
 

Reminders outperform control group

There was a significant increase in scheduling and completion of appointments after parents received the standard and tailored messages compared with controls.

The results with the COVID reminders were particularly striking. While only 3.7% of the eligible patients got a vaccine when they got no message, 17.3% got the vaccine in that time frame when they got the standard message. Interestingly, only 2.7% received the shot after the tailored message.

J. Howard Smart, MD, with Sharp HealthCare in San Diego, told this publication he was not surprised that a patient portal reminder would increase the rate of scheduling overdue well-child visits. “Parents may indeed have lost track of when their children need to have check-ups” during the pandemic, he said.

Reminders without tailored information more effective

He said he was surprised, just as the investigators were, that the reminders without the tailored information seemed to be more effective for some outcomes.

The authors explained that a focus group found “that families with patient portal accounts prefer straightforward, brief, and user-friendly messages.”

That may help explain why the standard message outperformed the tailored message, the authors write.

“Families may have been distracted by the additional information related to the child’s age and date of last WCC [well-child check-up] in the tailored message,” they write.

Dr. Smart said, “Their discussion of why this might be the case sounds reasonable. Simple, short messages may be better received.”

“Evidence like this should stimulate portal software vendors to make this kind of outgoing messaging easy to set up for providers,” he said.

Simple measure, large effect

Tim Joos, MD, a pediatrician in Seattle, told this publication he “was impressed by how such a simple measure increased rates of well-child care completion.”

Minority and low-income patients have traditionally had more access challenges to completing health care visits and vaccinations on schedule, he noted, so he was glad to see positive results from the intervention in this study population.

The authors note that research on portal messages have largely looked at use in non-Hispanic Whites and the privately insured.

Dr. Joos said the intervention also offers convenience in that once patients get into the portal, they can schedule an appointment there without having to wait on the phone or leave a message.

Funding/support was received from the Center for Clinical and Translational Science and Training at the University of Cincinnati, which is funded by the National Institutes of Health. William B. Brinkman, MD, MEd, MSc, one of the study authors, holds common stock in Pfizer, Merck, Abbott Laboratories, Viatris, and Johnson & Johnson outside the submitted work. No other author disclosures were reported. Dr. Smart and Dr. Joos declared no relevant financial relationships.

Farshad Fani Marvasti, MD, MPH, is part of a growing movement to fundamentally shift medical education to include training on how to cook healthy meals.

The way he sees it, the stakes couldn’t be higher. He believes doctors need to see food as medicine to be able to stem the tide of chronic disease.

About 6 in 10 adults in the United States live with chronic diseases, according to the Centers for Disease Control and Prevention, costing $4.1 trillion in annual health care costs. Adult obesity rates are rising, as are obesity-related conditions such as heart disease, stroke, type 2 diabetes, and certain types of cancer.

To turn the tide, Dr. Marvasti created a culinary medicine program in 2020 in collaboration with the University of Arizona Cooperative Extension and local chefs.

Dr. Marvasti, who is board certified in family medicine, graduated from the University of Arizona, Phoenix, where he serves as the director of the medical school’s Culinary Medicine Program.

The program offers an elective course for third- and fourth-year medical students, which introduces the evidence-based field of culinary medicine. Dr Marvasti’s goal is for the course to teach students how to use this science and the joy of cooking to improve long-term health outcomes for their patients.

As part of Dr. Marvasti’s program, students learn cooking fundamentals through chef demonstrations and hands-on practice – to teach students how food can be used to prevent and treat many chronic diseases.

One of the dishes students learn to make includes a quinoa salad made with cucumber, onion, bell peppers, corn, cherry tomatoes, beans, garlic, olive oil, and lemon juice. Another recipe includes a healthier take on dessert: Dark chocolate mousse made with three large, ripe avocados, dark chocolate powder, three tablespoons of agave or maple, coconut cream, nondairy milk, salt, and vanilla. Dr. Marvasti and his team are set to build out the existing program to develop additional resources for medically underserved and rural communities in Arizona, according to a statement from the university. These plans will be funded by a $750,000 grant from Novo Nordisk.

“We’re going to develop an open education curriculum to share, so it’s open access to everyone,” said Dr. Marvasti, who is also director of Public Health, Prevention and Health Promotion and an associate professor at the university. “It can be adaptable at the undergraduate, graduate, and postgraduate level.”

Dr. Marvasti and his colleagues at the University of Arizona aren’t alone. In fact, culinary medicine programs are sprouting some serious legs.
 

Culinary medicine programs catch on

Jaclyn Albin, MD, CCMS, an associate professor in the departments of internal medicine and pediatrics at UT Southwestern Medical Center, Dallas, conducted a scoping review of the literature on culinary medicine programs for medical students.* Her purpose was to learn how the programs were structured and how they assessed student knowledge and attitudes regarding nutrition counseling for patients.

Dr. Albin and her colleagues performed an initial literature search between June 1 and Aug. 1, 2020, of papers published between Jan. 1, 2012, and Aug. 1, 2020 – excluding some newer programs such as the one at the University of Arizona. The results of their research were published in Academic Medicine.

Ultimately, the authors identified and examined 34 programs offering medical student–focused culinary medicine courses.

Program instructors typically included a team of physicians, dietitians, chefs, and other professionals, the study found.

Most program participants exclusively taught medical students, though the training years of participants varied among programs, and they included first-, second-, third-, and fourth-year students. Some programs allowed students from outside their respective medical school to participate in the trainings.

As for the formats of the program, most included cohorts of 10-20 students attending multiple 2- to 3-hour sessions over the course of several months. The University of Alabama at Birmingham offers one of the longest courses, which spans 4-5 months, according to the paper. In contrast, the University of Rochester (N.Y.) program offers only a 1-day lab divided into four sessions, with each session lasting about 2 hours.

The culinary medicine programs’ course sessions tended to include a 10- to 30-minute didactic session involving videos, research articles, culinary theories, and other lectures, a 60- to 90-minute hands-on cooking session, and a 30-minute discussion around nutrition, culture, and patient care.

Most programs used pre- and post-program surveys to evaluate outcomes, though results varied between programs, according to the study. While each program evaluation had different metrics, the surveys generally revealed students felt more confident discussing dietary interventions with patients and in their own cooking skills following completion.
 

Course correction

Most of those programs are unfunded or minimally funded, Dr. Albin said.

Her own program, which is immensely popular with medical students, is one she teaches on a volunteer basis.

“I do this for free, in the evenings, because I believe in it,” she said.

Medical school education real estate is limited, so convincing medical schools to add something to the curriculum is difficult, Dr. Albin noted.

But it’s worth it, she said, because nutrition is the underpinning of so many diseases.

“Food is the top risk factor for early death in the U.S.,” Dr. Albin said. “I like to say that five times in a row. People have not digested it.”

During her culinary medicine courses, she also asks her medical students: “Who is comfortable in the kitchen?” Some sheepishly raise their hands, she said. Some don’t. Many don’t know anything about cooking.

Then she teaches students about healthy food and how to make it. As part of her program, medical students are given a pantry starter kit with olive oil and a variety of spices to take home and use.

Some recipes Dr. Albin teaches includes mango chili shrimp salad with lime vinaigrette, eggplant sliders, yellow vegetable curry, and strawberry banana chia pudding.

“If you figure out how to do it for your own busy, everyday life, you are now empowered to tell someone else about it,” she said.
 

A dietitian’s involvement

Milette Siler, RD, LD, CCMS, works with Dr. Albin to educate medical students and patients about food as medicine. A significant chunk of her job involves teaching future doctors what dietitians do.

When the class starts, many students don’t know two of the five basic things dietitians do, Ms. Siler said. By the end of the class, all students know what a dietitian does.

That’s important as students go on to become doctors.

“For us to remove barriers to care, we have to acknowledge most patients’ entry into health care is their physician,” she said. “The dietitian is often a referral. Doctors need to know enough to do no harm.”

Clinicians are often siloed, she said, and the key to better serving patients is partnership, transparency, and relationships. “I think everybody is at a point where everyone is saying what we’re doing isn’t working,” she said. “The American public deserves better, physicians deserve better, and clinicians deserve better.”
 

Popular with students

While the old guard has been slow to embrace the shift, her students have helped drive the growth of the culinary medicine field, Dr. Albin said.

“They are not settling for the inadequacy that somehow the rest of us did,” she continued. “I’m so hopeful for the future of the health system. We have a generation of people who will not stand for neglecting the most vital elements.”

Courtesy Farshad Fani Marvasti, MD, MPH

Lyndon Bui, a second-year medical student at the University of Arizona, Phoenix, is an example of one of these people.

As a member of a culinary medicine interest group on campus, he said, he has learned a lot about the importance of diet for long-term health. This has given him confidence to talk about food and nutrition.

His group does cooking demos at the Phoenix Farmers Market using food from various local vendors. They usually make a salad from local greens and cook seasonal veggies in a stir fry, he said.

They’ve previously made salad with microgreens – young seedlings of edible vegetables and herbs – and pomegranate seeds with a honey mustard vinaigrette, eggplant or cucumber, and hummus on pita bread, as well as almond butter and honey sandwiches, according to the university.

The group also talks with people in the community, answers questions, and learns about community needs.

Mr. Bui’s participation in this group has helped him cultivate a passion for community outreach that he wants to incorporate into his career.

“I feel like I have the knowledge to provide better advice to patients,” he said. “Knowing all these things about food, I feel more comfortable talking about it and more inclined to refer to a dietitian when maybe I wouldn’t have before.”
 

Family physician applauds culinary medicine programs

When Angie Neison, MD, CCMS, went to medical school, she was surprised there wasn’t more education on nutrition.

In fact, on average, physicians receive less than 20 hours of nutrition education, according to the University of Arizona.

Now 15 years into her career as a family physician, Dr. Neison says nutrition is a huge part of her practice. She spends time working to bust myths about nutrition for her patients – including that healthy food is boring and bland, that making it is time consuming, and that healthy food is expensive. She also spends time teaching aspects of culinary medicine to her colleagues – many of whom are well into their careers – so they can better serve their patients.

It’s worth it to spend time learning about nutrition, she said, whether that’s as a medical student in a culinary medicine program or a practicing physician taking additional courses.

Nutrition education in medical school hasn’t been a priority, she said, maybe because there is so much to learn, or maybe because there is no money to be made in prevention.

“If doctors learn it, they are able to better guide patients,” she said.

Correction, 11/29/22: An earlier version of this article misstated Dr. Albin's institution.
 

Farshad Fani Marvasti, MD, MPH, is part of a growing movement to fundamentally shift medical education to include training on how to cook healthy meals.

The way he sees it, the stakes couldn’t be higher. He believes doctors need to see food as medicine to be able to stem the tide of chronic disease.

About 6 in 10 adults in the United States live with chronic diseases, according to the Centers for Disease Control and Prevention, costing $4.1 trillion in annual health care costs. Adult obesity rates are rising, as are obesity-related conditions such as heart disease, stroke, type 2 diabetes, and certain types of cancer.

To turn the tide, Dr. Marvasti created a culinary medicine program in 2020 in collaboration with the University of Arizona Cooperative Extension and local chefs.

Dr. Marvasti, who is board certified in family medicine, graduated from the University of Arizona, Phoenix, where he serves as the director of the medical school’s Culinary Medicine Program.

The program offers an elective course for third- and fourth-year medical students, which introduces the evidence-based field of culinary medicine. Dr Marvasti’s goal is for the course to teach students how to use this science and the joy of cooking to improve long-term health outcomes for their patients.

As part of Dr. Marvasti’s program, students learn cooking fundamentals through chef demonstrations and hands-on practice – to teach students how food can be used to prevent and treat many chronic diseases.

One of the dishes students learn to make includes a quinoa salad made with cucumber, onion, bell peppers, corn, cherry tomatoes, beans, garlic, olive oil, and lemon juice. Another recipe includes a healthier take on dessert: Dark chocolate mousse made with three large, ripe avocados, dark chocolate powder, three tablespoons of agave or maple, coconut cream, nondairy milk, salt, and vanilla. Dr. Marvasti and his team are set to build out the existing program to develop additional resources for medically underserved and rural communities in Arizona, according to a statement from the university. These plans will be funded by a $750,000 grant from Novo Nordisk.

“We’re going to develop an open education curriculum to share, so it’s open access to everyone,” said Dr. Marvasti, who is also director of Public Health, Prevention and Health Promotion and an associate professor at the university. “It can be adaptable at the undergraduate, graduate, and postgraduate level.”

Dr. Marvasti and his colleagues at the University of Arizona aren’t alone. In fact, culinary medicine programs are sprouting some serious legs.
 

Culinary medicine programs catch on

Jaclyn Albin, MD, CCMS, an associate professor in the departments of internal medicine and pediatrics at UT Southwestern Medical Center, Dallas, conducted a scoping review of the literature on culinary medicine programs for medical students.* Her purpose was to learn how the programs were structured and how they assessed student knowledge and attitudes regarding nutrition counseling for patients.

Dr. Albin and her colleagues performed an initial literature search between June 1 and Aug. 1, 2020, of papers published between Jan. 1, 2012, and Aug. 1, 2020 – excluding some newer programs such as the one at the University of Arizona. The results of their research were published in Academic Medicine.

Ultimately, the authors identified and examined 34 programs offering medical student–focused culinary medicine courses.

Program instructors typically included a team of physicians, dietitians, chefs, and other professionals, the study found.

Most program participants exclusively taught medical students, though the training years of participants varied among programs, and they included first-, second-, third-, and fourth-year students. Some programs allowed students from outside their respective medical school to participate in the trainings.

As for the formats of the program, most included cohorts of 10-20 students attending multiple 2- to 3-hour sessions over the course of several months. The University of Alabama at Birmingham offers one of the longest courses, which spans 4-5 months, according to the paper. In contrast, the University of Rochester (N.Y.) program offers only a 1-day lab divided into four sessions, with each session lasting about 2 hours.

The culinary medicine programs’ course sessions tended to include a 10- to 30-minute didactic session involving videos, research articles, culinary theories, and other lectures, a 60- to 90-minute hands-on cooking session, and a 30-minute discussion around nutrition, culture, and patient care.

Most programs used pre- and post-program surveys to evaluate outcomes, though results varied between programs, according to the study. While each program evaluation had different metrics, the surveys generally revealed students felt more confident discussing dietary interventions with patients and in their own cooking skills following completion.
 

Course correction

Most of those programs are unfunded or minimally funded, Dr. Albin said.

Her own program, which is immensely popular with medical students, is one she teaches on a volunteer basis.

“I do this for free, in the evenings, because I believe in it,” she said.

Medical school education real estate is limited, so convincing medical schools to add something to the curriculum is difficult, Dr. Albin noted.

But it’s worth it, she said, because nutrition is the underpinning of so many diseases.

“Food is the top risk factor for early death in the U.S.,” Dr. Albin said. “I like to say that five times in a row. People have not digested it.”

During her culinary medicine courses, she also asks her medical students: “Who is comfortable in the kitchen?” Some sheepishly raise their hands, she said. Some don’t. Many don’t know anything about cooking.

Then she teaches students about healthy food and how to make it. As part of her program, medical students are given a pantry starter kit with olive oil and a variety of spices to take home and use.

Some recipes Dr. Albin teaches includes mango chili shrimp salad with lime vinaigrette, eggplant sliders, yellow vegetable curry, and strawberry banana chia pudding.

“If you figure out how to do it for your own busy, everyday life, you are now empowered to tell someone else about it,” she said.
 

A dietitian’s involvement

Milette Siler, RD, LD, CCMS, works with Dr. Albin to educate medical students and patients about food as medicine. A significant chunk of her job involves teaching future doctors what dietitians do.

When the class starts, many students don’t know two of the five basic things dietitians do, Ms. Siler said. By the end of the class, all students know what a dietitian does.

That’s important as students go on to become doctors.

“For us to remove barriers to care, we have to acknowledge most patients’ entry into health care is their physician,” she said. “The dietitian is often a referral. Doctors need to know enough to do no harm.”

Clinicians are often siloed, she said, and the key to better serving patients is partnership, transparency, and relationships. “I think everybody is at a point where everyone is saying what we’re doing isn’t working,” she said. “The American public deserves better, physicians deserve better, and clinicians deserve better.”
 

Popular with students

While the old guard has been slow to embrace the shift, her students have helped drive the growth of the culinary medicine field, Dr. Albin said.

“They are not settling for the inadequacy that somehow the rest of us did,” she continued. “I’m so hopeful for the future of the health system. We have a generation of people who will not stand for neglecting the most vital elements.”

Courtesy Farshad Fani Marvasti, MD, MPH

Lyndon Bui, a second-year medical student at the University of Arizona, Phoenix, is an example of one of these people.

As a member of a culinary medicine interest group on campus, he said, he has learned a lot about the importance of diet for long-term health. This has given him confidence to talk about food and nutrition.

His group does cooking demos at the Phoenix Farmers Market using food from various local vendors. They usually make a salad from local greens and cook seasonal veggies in a stir fry, he said.

They’ve previously made salad with microgreens – young seedlings of edible vegetables and herbs – and pomegranate seeds with a honey mustard vinaigrette, eggplant or cucumber, and hummus on pita bread, as well as almond butter and honey sandwiches, according to the university.

The group also talks with people in the community, answers questions, and learns about community needs.

Mr. Bui’s participation in this group has helped him cultivate a passion for community outreach that he wants to incorporate into his career.

“I feel like I have the knowledge to provide better advice to patients,” he said. “Knowing all these things about food, I feel more comfortable talking about it and more inclined to refer to a dietitian when maybe I wouldn’t have before.”
 

Family physician applauds culinary medicine programs

When Angie Neison, MD, CCMS, went to medical school, she was surprised there wasn’t more education on nutrition.

In fact, on average, physicians receive less than 20 hours of nutrition education, according to the University of Arizona.

Now 15 years into her career as a family physician, Dr. Neison says nutrition is a huge part of her practice. She spends time working to bust myths about nutrition for her patients – including that healthy food is boring and bland, that making it is time consuming, and that healthy food is expensive. She also spends time teaching aspects of culinary medicine to her colleagues – many of whom are well into their careers – so they can better serve their patients.

It’s worth it to spend time learning about nutrition, she said, whether that’s as a medical student in a culinary medicine program or a practicing physician taking additional courses.

Nutrition education in medical school hasn’t been a priority, she said, maybe because there is so much to learn, or maybe because there is no money to be made in prevention.

“If doctors learn it, they are able to better guide patients,” she said.

Correction, 11/29/22: An earlier version of this article misstated Dr. Albin's institution.
 

Farshad Fani Marvasti, MD, MPH, is part of a growing movement to fundamentally shift medical education to include training on how to cook healthy meals.

The way he sees it, the stakes couldn’t be higher. He believes doctors need to see food as medicine to be able to stem the tide of chronic disease.

About 6 in 10 adults in the United States live with chronic diseases, according to the Centers for Disease Control and Prevention, costing $4.1 trillion in annual health care costs. Adult obesity rates are rising, as are obesity-related conditions such as heart disease, stroke, type 2 diabetes, and certain types of cancer.

To turn the tide, Dr. Marvasti created a culinary medicine program in 2020 in collaboration with the University of Arizona Cooperative Extension and local chefs.

Dr. Marvasti, who is board certified in family medicine, graduated from the University of Arizona, Phoenix, where he serves as the director of the medical school’s Culinary Medicine Program.

The program offers an elective course for third- and fourth-year medical students, which introduces the evidence-based field of culinary medicine. Dr Marvasti’s goal is for the course to teach students how to use this science and the joy of cooking to improve long-term health outcomes for their patients.

As part of Dr. Marvasti’s program, students learn cooking fundamentals through chef demonstrations and hands-on practice – to teach students how food can be used to prevent and treat many chronic diseases.

One of the dishes students learn to make includes a quinoa salad made with cucumber, onion, bell peppers, corn, cherry tomatoes, beans, garlic, olive oil, and lemon juice. Another recipe includes a healthier take on dessert: Dark chocolate mousse made with three large, ripe avocados, dark chocolate powder, three tablespoons of agave or maple, coconut cream, nondairy milk, salt, and vanilla. Dr. Marvasti and his team are set to build out the existing program to develop additional resources for medically underserved and rural communities in Arizona, according to a statement from the university. These plans will be funded by a $750,000 grant from Novo Nordisk.

“We’re going to develop an open education curriculum to share, so it’s open access to everyone,” said Dr. Marvasti, who is also director of Public Health, Prevention and Health Promotion and an associate professor at the university. “It can be adaptable at the undergraduate, graduate, and postgraduate level.”

Dr. Marvasti and his colleagues at the University of Arizona aren’t alone. In fact, culinary medicine programs are sprouting some serious legs.
 

Culinary medicine programs catch on

Jaclyn Albin, MD, CCMS, an associate professor in the departments of internal medicine and pediatrics at UT Southwestern Medical Center, Dallas, conducted a scoping review of the literature on culinary medicine programs for medical students.* Her purpose was to learn how the programs were structured and how they assessed student knowledge and attitudes regarding nutrition counseling for patients.

Dr. Albin and her colleagues performed an initial literature search between June 1 and Aug. 1, 2020, of papers published between Jan. 1, 2012, and Aug. 1, 2020 – excluding some newer programs such as the one at the University of Arizona. The results of their research were published in Academic Medicine.

Ultimately, the authors identified and examined 34 programs offering medical student–focused culinary medicine courses.

Program instructors typically included a team of physicians, dietitians, chefs, and other professionals, the study found.

Most program participants exclusively taught medical students, though the training years of participants varied among programs, and they included first-, second-, third-, and fourth-year students. Some programs allowed students from outside their respective medical school to participate in the trainings.

As for the formats of the program, most included cohorts of 10-20 students attending multiple 2- to 3-hour sessions over the course of several months. The University of Alabama at Birmingham offers one of the longest courses, which spans 4-5 months, according to the paper. In contrast, the University of Rochester (N.Y.) program offers only a 1-day lab divided into four sessions, with each session lasting about 2 hours.

The culinary medicine programs’ course sessions tended to include a 10- to 30-minute didactic session involving videos, research articles, culinary theories, and other lectures, a 60- to 90-minute hands-on cooking session, and a 30-minute discussion around nutrition, culture, and patient care.

Most programs used pre- and post-program surveys to evaluate outcomes, though results varied between programs, according to the study. While each program evaluation had different metrics, the surveys generally revealed students felt more confident discussing dietary interventions with patients and in their own cooking skills following completion.
 

Course correction

Most of those programs are unfunded or minimally funded, Dr. Albin said.

Her own program, which is immensely popular with medical students, is one she teaches on a volunteer basis.

“I do this for free, in the evenings, because I believe in it,” she said.

Medical school education real estate is limited, so convincing medical schools to add something to the curriculum is difficult, Dr. Albin noted.

But it’s worth it, she said, because nutrition is the underpinning of so many diseases.

“Food is the top risk factor for early death in the U.S.,” Dr. Albin said. “I like to say that five times in a row. People have not digested it.”

During her culinary medicine courses, she also asks her medical students: “Who is comfortable in the kitchen?” Some sheepishly raise their hands, she said. Some don’t. Many don’t know anything about cooking.

Then she teaches students about healthy food and how to make it. As part of her program, medical students are given a pantry starter kit with olive oil and a variety of spices to take home and use.

Some recipes Dr. Albin teaches includes mango chili shrimp salad with lime vinaigrette, eggplant sliders, yellow vegetable curry, and strawberry banana chia pudding.

“If you figure out how to do it for your own busy, everyday life, you are now empowered to tell someone else about it,” she said.
 

A dietitian’s involvement

Milette Siler, RD, LD, CCMS, works with Dr. Albin to educate medical students and patients about food as medicine. A significant chunk of her job involves teaching future doctors what dietitians do.

When the class starts, many students don’t know two of the five basic things dietitians do, Ms. Siler said. By the end of the class, all students know what a dietitian does.

That’s important as students go on to become doctors.

“For us to remove barriers to care, we have to acknowledge most patients’ entry into health care is their physician,” she said. “The dietitian is often a referral. Doctors need to know enough to do no harm.”

Clinicians are often siloed, she said, and the key to better serving patients is partnership, transparency, and relationships. “I think everybody is at a point where everyone is saying what we’re doing isn’t working,” she said. “The American public deserves better, physicians deserve better, and clinicians deserve better.”
 

Popular with students

While the old guard has been slow to embrace the shift, her students have helped drive the growth of the culinary medicine field, Dr. Albin said.

“They are not settling for the inadequacy that somehow the rest of us did,” she continued. “I’m so hopeful for the future of the health system. We have a generation of people who will not stand for neglecting the most vital elements.”

Courtesy Farshad Fani Marvasti, MD, MPH

Lyndon Bui, a second-year medical student at the University of Arizona, Phoenix, is an example of one of these people.

As a member of a culinary medicine interest group on campus, he said, he has learned a lot about the importance of diet for long-term health. This has given him confidence to talk about food and nutrition.

His group does cooking demos at the Phoenix Farmers Market using food from various local vendors. They usually make a salad from local greens and cook seasonal veggies in a stir fry, he said.

They’ve previously made salad with microgreens – young seedlings of edible vegetables and herbs – and pomegranate seeds with a honey mustard vinaigrette, eggplant or cucumber, and hummus on pita bread, as well as almond butter and honey sandwiches, according to the university.

The group also talks with people in the community, answers questions, and learns about community needs.

Mr. Bui’s participation in this group has helped him cultivate a passion for community outreach that he wants to incorporate into his career.

“I feel like I have the knowledge to provide better advice to patients,” he said. “Knowing all these things about food, I feel more comfortable talking about it and more inclined to refer to a dietitian when maybe I wouldn’t have before.”
 

Family physician applauds culinary medicine programs

When Angie Neison, MD, CCMS, went to medical school, she was surprised there wasn’t more education on nutrition.

In fact, on average, physicians receive less than 20 hours of nutrition education, according to the University of Arizona.

Now 15 years into her career as a family physician, Dr. Neison says nutrition is a huge part of her practice. She spends time working to bust myths about nutrition for her patients – including that healthy food is boring and bland, that making it is time consuming, and that healthy food is expensive. She also spends time teaching aspects of culinary medicine to her colleagues – many of whom are well into their careers – so they can better serve their patients.

It’s worth it to spend time learning about nutrition, she said, whether that’s as a medical student in a culinary medicine program or a practicing physician taking additional courses.

Nutrition education in medical school hasn’t been a priority, she said, maybe because there is so much to learn, or maybe because there is no money to be made in prevention.

“If doctors learn it, they are able to better guide patients,” she said.

Correction, 11/29/22: An earlier version of this article misstated Dr. Albin's institution.
 

From Milwaukee County Behavioral Health Services, Milwaukee, WI.

Abstract

Objectives: The goal of this study was to determine whether a single-item quality of life (QOL) measure could serve as a useful population health–level metric within the Quadruple Aim framework in a publicly funded behavioral health system.

Design: This was a retrospective, cross-sectional study that examined the correlation between the single-item QOL measure and several other key measures of the social determinants of health and a composite measure of acute service utilization for all patients receiving mental health and substance use services in a community behavioral health system.

Methods: Data were collected for 4488 patients who had at least 1 assessment between October 1, 2020, and September 30, 2021. Data on social determinants of health were obtained through patient self-report; acute service use data were obtained from electronic health records.

Results: Statistical analyses revealed results in the expected direction for all relationships tested. Patients with higher QOL were more likely to report “Good” or better self-rated physical health, be employed, have a private residence, and report recent positive social interactions, and were less likely to have received acute services in the previous 90 days.

Conclusion: A single-item QOL measure shows promise as a general, minimally burdensome whole-system metric that can function as a target for population health management efforts in a large behavioral health system. Future research should explore whether this QOL measure is sensitive to change over time and examine its temporal relationship with other key outcome metrics.

Keywords: Quadruple Aim, single-item measures, social determinants of health, acute service utilization metrics.

The Triple Aim for health care—improving the individual experience of care, increasing the health of populations, and reducing the costs of care—was first proposed in 2008.¹ More recently, some have advocated for an expanded focus to include a fourth aim: the quality of staff work life.² Since this seminal paper was published, many health care systems have endeavored to adopt and implement the Quadruple Aim^3,4; however, the concepts representing each of the aims are not universally defined,³ nor are the measures needed to populate the Quadruple Aim always available within the health system in question.⁵

Although several assessment models and frameworks that provide guidance to stakeholders have been developed,^6,7 it is ultimately up to organizations themselves to determine which measures they should deploy to best represent the different quadrants of the Quadruple Aim.⁶ Evidence suggests, however, that quality measurement, and the administrative time required to conduct it, can be both financially and emotionally burdensome to providers and health systems.^8-10 Thus, it is incumbent on organizations to select a set of measures that are not only meaningful but as parsimonious as possible.^6,11,12

Quality of life (QOL) is a potential candidate to assess the aim of population health. Brief health-related QOL questions have long been used in epidemiological surveys, such as the Behavioral Risk Factor Surveillance System survey.¹³ Such questions are also a key component of community health frameworks, such as the County Health Rankings developed by the University of Wisconsin Population Health Institute.¹⁴ Furthermore, Humana recently revealed that increasing the number of physical and mental health “Healthy Days” (which are among the Centers for Disease Control and Prevention’s Health-Related Quality of Life questions¹⁵) among the members enrolled in their insurance plan would become a major goal for the organization.^16,17 Many of these measures, while brief, focus on QOL as a function of health, often as a self-rated construct (from “Poor” to “Excellent”) or in the form of days of poor physical or mental health in the past 30 days,¹⁵ rather than evaluating QOL itself; however, several authors have pointed out that health status and QOL are related but distinct concepts.^18,19

Brief single-item assessments focused specifically on QOL have been developed and implemented within nonclinical²⁰ and clinical populations, including individuals with cancer,²¹ adults with disabilities,²² individuals with cystic fibrosis,²³ and children with epilepsy.²⁴ Despite the long history of QOL assessment in behavioral health treatment,²⁵ single-item measures have not been widely implemented in this population.

Milwaukee County Behavioral Health Services (BHS), a publicly funded, county-based behavioral health care system in Milwaukee, Wisconsin, provides inpatient and ambulatory treatment, psychiatric emergency care, withdrawal management, care management, crisis services, and other support services to individuals in Milwaukee County. In 2018 the community services arm of BHS began implementing a single QOL question from the World Health Organization’s WHOQOL-BREF²⁶: On a 5-point rating scale of “Very Poor” to “Very Good,” “How would you rate your overall quality of life right now?” Previous research by Atroszko and colleagues,²⁰ which used a similar approach with the same item from the WHOQOL-BREF, reported correlations in the expected direction of the single-item QOL measure with perceived stress, depression, anxiety, loneliness, and daily hours of sleep. This study’s sample, however, comprised opportunistically recruited college students, not a clinical population. Further, the researchers did not examine the relationship of QOL with acute service utilization or other measures of the social determinants of health, such as housing, employment, or social connectedness.

The following study was designed to extend these results by focusing on a clinical population—individuals with mental health or substance use issues—being served in a large, publicly funded behavioral health system in Milwaukee, Wisconsin. The objective of this study was to determine whether a single-item QOL measure could be used as a brief, parsimonious measure of overall population health by examining its relationship with other key outcome measures for patients receiving services from BHS. This study was reviewed and approved by BHS’s Institutional Review Board.

Methods

All patients engaged in nonacute community services are offered a standardized assessment that includes, among other measures, items related to QOL, housing status, employment status, self-rated physical health, and social connectedness. This assessment is administered at intake, discharge, and every 6 months while patients are enrolled in services. Patients who received at least 1 assessment between October 1, 2020, and September 30, 2021, were included in the analyses. Patients receiving crisis, inpatient, or withdrawal management services alone (ie, did not receive any other community-based services) were not offered the standard assessment and thus were not included in the analyses. If patients had more than 1 assessment during this time period, QOL data from the last assessment were used. Data on housing (private residence status, defined as adults living alone or with others without supervision in a house or apartment), employment status, self-rated physical health, and social connectedness (measured by asking people whether they have had positive interactions with family or friends in the past 30 days) were extracted from the same timepoint as well.

Also included in the analyses were rates of acute service utilization, in which any patient with at least 1 visit to BHS’s psychiatric emergency department, withdrawal management facility, or psychiatric inpatient facility in the 90 days prior to the date of the assessment received a code of “Yes,” and any patient who did not receive any of these services received a code of “No.” Chi-square analyses were conducted to determine the relationship between QOL rankings (“Very Poor,” “Poor,” “Neither Good nor Poor,” “Good,” and “Very Good”) and housing, employment, self-rated physical health, social connectedness, and 90-day acute service use. All acute service utilization data were obtained from BHS’s electronic health records system. All data used in the study were stored on a secure, password-protected server. All analyses were conducted with SPSS software (SPSS 28; IBM).

Results

Data were available for 4488 patients who received an assessment between October 1, 2020, and September 30, 2021 (total numbers per item vary because some items had missing data; see supplementary eTables 1-3 for sample size per item). Demographics of the patient sample are listed in Table 1; the demographics of the patients who were missing data for specific outcomes are presented in eTables 1-3.

Statistical analyses revealed results in the expected direction for all relationships tested (Table 2). As patients’ self-reported QOL improved, so did the likelihood of higher rates of self-reported “Good” or better physical health, which was 576% higher among individuals who reported “Very Good” QOL relative to those who reported “Very Poor” QOL. Similarly, when compared with individuals with “Very Poor” QOL, individuals who reported “Very Good” QOL were 21.91% more likely to report having a private residence, 126.7% more likely to report being employed, and 29.17% more likely to report having had positive social interactions with family and friends in the past 30 days. There was an inverse relationship between QOL and the likelihood that a patient had received at least 1 admission for an acute service in the previous 90 days, such that patients who reported “Very Good” QOL were 86.34% less likely to have had an admission compared to patients with “Very Poor” QOL (2.8% vs 20.5%, respectively). The relationships among the criterion variables used in this study are presented in Table 3.

Discussion

The results of this preliminary analysis suggest that self-rated QOL is related to key health, social determinants of health, and acute service utilization metrics. These data are important for several reasons. First, because QOL is a diagnostically agnostic measure, it is a cross-cutting measure to use with clinically diverse populations receiving an array of different services. Second, at 1 item, the QOL measure is extremely brief and therefore minimally onerous to implement for both patients and administratively overburdened providers. Third, its correlation with other key metrics suggests that it can function as a broad population health measure for health care organizations because individuals with higher QOL will also likely have better outcomes in other key areas. This suggests that it has the potential to broadly represent the overall status of a population of patients, thus functioning as a type of “whole system” measure, which the Institute for Healthcare Improvement describes as “a small set of measures that reflect a health system’s overall performance on core dimensions of quality guided by the Triple Aim.”⁷ These whole system measures can help focus an organization’s strategic initiatives and efforts on the issues that matter most to the patients and community it serves.

The relationship of QOL to acute service utilization deserves special mention. As an administrative measure, utilization is not susceptible to the same response bias as the other self-reported variables. Furthermore, acute services are costly to health systems, and hospital readmissions are associated with payment reductions in the Centers for Medicare and Medicaid Services (CMS) Hospital Readmissions Reduction Program for hospitals that fail to meet certain performance targets.²⁷ Thus, because of its alignment with federal mandates, improved QOL (and potentially concomitant decreases in acute service use) may have significant financial implications for health systems as well.

This study was limited by several factors. First, it was focused on a population receiving publicly funded behavioral health services with strict eligibility requirements, one of which stipulated that individuals must be at 200% or less of the Federal Poverty Level; therefore, the results might not be applicable to health systems with a more clinically or socioeconomically diverse patient population. Second, because these data are cross-sectional, it was not possible to determine whether QOL improved over time or whether changes in QOL covaried longitudinally with the other metrics under observation. For example, if patients’ QOL improved from the first to last assessment, did their employment or residential status improve as well, or were these patients more likely to be employed at their first assessment? Furthermore, if there was covariance, did changes in employment, housing status, and so on precede changes in QOL or vice versa? Multiple longitudinal observations would help to address these questions and will be the focus of future analyses.

Conclusion

This preliminary study suggests that a single-item QOL measure may be a valuable population health–level metric for health systems. It requires little administrative effort on the part of either the clinician or patient. It is also agnostic with regard to clinical issue or treatment approach and can therefore admit of a range of diagnoses or patient-specific, idiosyncratic recovery goals. It is correlated with other key health, social determinants of health, and acute service utilization indicators and can therefore serve as a “whole system” measure because of its ability to broadly represent improvements in an entire population. Furthermore, QOL is patient-centered in that data are obtained through patient self-report, which is a high priority for CMS and other health care organizations.²⁸ In summary, a single-item QOL measure holds promise for health care organizations looking to implement the Quadruple Aim and assess the health of the populations they serve in a manner that is simple, efficient, and patient-centered.

Acknowledgments: The author thanks Jennifer Wittwer for her thoughtful comments on the initial draft of this manuscript and Gary Kraft for his help extracting the data used in the analyses.

Corresponding author: Walter Matthew Drymalski, PhD; [email protected]

Disclosures: None reported.

From Milwaukee County Behavioral Health Services, Milwaukee, WI.

Abstract

Objectives: The goal of this study was to determine whether a single-item quality of life (QOL) measure could serve as a useful population health–level metric within the Quadruple Aim framework in a publicly funded behavioral health system.

Design: This was a retrospective, cross-sectional study that examined the correlation between the single-item QOL measure and several other key measures of the social determinants of health and a composite measure of acute service utilization for all patients receiving mental health and substance use services in a community behavioral health system.

Methods: Data were collected for 4488 patients who had at least 1 assessment between October 1, 2020, and September 30, 2021. Data on social determinants of health were obtained through patient self-report; acute service use data were obtained from electronic health records.

Results: Statistical analyses revealed results in the expected direction for all relationships tested. Patients with higher QOL were more likely to report “Good” or better self-rated physical health, be employed, have a private residence, and report recent positive social interactions, and were less likely to have received acute services in the previous 90 days.

Conclusion: A single-item QOL measure shows promise as a general, minimally burdensome whole-system metric that can function as a target for population health management efforts in a large behavioral health system. Future research should explore whether this QOL measure is sensitive to change over time and examine its temporal relationship with other key outcome metrics.

Keywords: Quadruple Aim, single-item measures, social determinants of health, acute service utilization metrics.

The Triple Aim for health care—improving the individual experience of care, increasing the health of populations, and reducing the costs of care—was first proposed in 2008.¹ More recently, some have advocated for an expanded focus to include a fourth aim: the quality of staff work life.² Since this seminal paper was published, many health care systems have endeavored to adopt and implement the Quadruple Aim^3,4; however, the concepts representing each of the aims are not universally defined,³ nor are the measures needed to populate the Quadruple Aim always available within the health system in question.⁵

Although several assessment models and frameworks that provide guidance to stakeholders have been developed,^6,7 it is ultimately up to organizations themselves to determine which measures they should deploy to best represent the different quadrants of the Quadruple Aim.⁶ Evidence suggests, however, that quality measurement, and the administrative time required to conduct it, can be both financially and emotionally burdensome to providers and health systems.^8-10 Thus, it is incumbent on organizations to select a set of measures that are not only meaningful but as parsimonious as possible.^6,11,12

Quality of life (QOL) is a potential candidate to assess the aim of population health. Brief health-related QOL questions have long been used in epidemiological surveys, such as the Behavioral Risk Factor Surveillance System survey.¹³ Such questions are also a key component of community health frameworks, such as the County Health Rankings developed by the University of Wisconsin Population Health Institute.¹⁴ Furthermore, Humana recently revealed that increasing the number of physical and mental health “Healthy Days” (which are among the Centers for Disease Control and Prevention’s Health-Related Quality of Life questions¹⁵) among the members enrolled in their insurance plan would become a major goal for the organization.^16,17 Many of these measures, while brief, focus on QOL as a function of health, often as a self-rated construct (from “Poor” to “Excellent”) or in the form of days of poor physical or mental health in the past 30 days,¹⁵ rather than evaluating QOL itself; however, several authors have pointed out that health status and QOL are related but distinct concepts.^18,19

Brief single-item assessments focused specifically on QOL have been developed and implemented within nonclinical²⁰ and clinical populations, including individuals with cancer,²¹ adults with disabilities,²² individuals with cystic fibrosis,²³ and children with epilepsy.²⁴ Despite the long history of QOL assessment in behavioral health treatment,²⁵ single-item measures have not been widely implemented in this population.

Milwaukee County Behavioral Health Services (BHS), a publicly funded, county-based behavioral health care system in Milwaukee, Wisconsin, provides inpatient and ambulatory treatment, psychiatric emergency care, withdrawal management, care management, crisis services, and other support services to individuals in Milwaukee County. In 2018 the community services arm of BHS began implementing a single QOL question from the World Health Organization’s WHOQOL-BREF²⁶: On a 5-point rating scale of “Very Poor” to “Very Good,” “How would you rate your overall quality of life right now?” Previous research by Atroszko and colleagues,²⁰ which used a similar approach with the same item from the WHOQOL-BREF, reported correlations in the expected direction of the single-item QOL measure with perceived stress, depression, anxiety, loneliness, and daily hours of sleep. This study’s sample, however, comprised opportunistically recruited college students, not a clinical population. Further, the researchers did not examine the relationship of QOL with acute service utilization or other measures of the social determinants of health, such as housing, employment, or social connectedness.

The following study was designed to extend these results by focusing on a clinical population—individuals with mental health or substance use issues—being served in a large, publicly funded behavioral health system in Milwaukee, Wisconsin. The objective of this study was to determine whether a single-item QOL measure could be used as a brief, parsimonious measure of overall population health by examining its relationship with other key outcome measures for patients receiving services from BHS. This study was reviewed and approved by BHS’s Institutional Review Board.

Methods

All patients engaged in nonacute community services are offered a standardized assessment that includes, among other measures, items related to QOL, housing status, employment status, self-rated physical health, and social connectedness. This assessment is administered at intake, discharge, and every 6 months while patients are enrolled in services. Patients who received at least 1 assessment between October 1, 2020, and September 30, 2021, were included in the analyses. Patients receiving crisis, inpatient, or withdrawal management services alone (ie, did not receive any other community-based services) were not offered the standard assessment and thus were not included in the analyses. If patients had more than 1 assessment during this time period, QOL data from the last assessment were used. Data on housing (private residence status, defined as adults living alone or with others without supervision in a house or apartment), employment status, self-rated physical health, and social connectedness (measured by asking people whether they have had positive interactions with family or friends in the past 30 days) were extracted from the same timepoint as well.

Also included in the analyses were rates of acute service utilization, in which any patient with at least 1 visit to BHS’s psychiatric emergency department, withdrawal management facility, or psychiatric inpatient facility in the 90 days prior to the date of the assessment received a code of “Yes,” and any patient who did not receive any of these services received a code of “No.” Chi-square analyses were conducted to determine the relationship between QOL rankings (“Very Poor,” “Poor,” “Neither Good nor Poor,” “Good,” and “Very Good”) and housing, employment, self-rated physical health, social connectedness, and 90-day acute service use. All acute service utilization data were obtained from BHS’s electronic health records system. All data used in the study were stored on a secure, password-protected server. All analyses were conducted with SPSS software (SPSS 28; IBM).

Results

Data were available for 4488 patients who received an assessment between October 1, 2020, and September 30, 2021 (total numbers per item vary because some items had missing data; see supplementary eTables 1-3 for sample size per item). Demographics of the patient sample are listed in Table 1; the demographics of the patients who were missing data for specific outcomes are presented in eTables 1-3.

Statistical analyses revealed results in the expected direction for all relationships tested (Table 2). As patients’ self-reported QOL improved, so did the likelihood of higher rates of self-reported “Good” or better physical health, which was 576% higher among individuals who reported “Very Good” QOL relative to those who reported “Very Poor” QOL. Similarly, when compared with individuals with “Very Poor” QOL, individuals who reported “Very Good” QOL were 21.91% more likely to report having a private residence, 126.7% more likely to report being employed, and 29.17% more likely to report having had positive social interactions with family and friends in the past 30 days. There was an inverse relationship between QOL and the likelihood that a patient had received at least 1 admission for an acute service in the previous 90 days, such that patients who reported “Very Good” QOL were 86.34% less likely to have had an admission compared to patients with “Very Poor” QOL (2.8% vs 20.5%, respectively). The relationships among the criterion variables used in this study are presented in Table 3.

Discussion

The results of this preliminary analysis suggest that self-rated QOL is related to key health, social determinants of health, and acute service utilization metrics. These data are important for several reasons. First, because QOL is a diagnostically agnostic measure, it is a cross-cutting measure to use with clinically diverse populations receiving an array of different services. Second, at 1 item, the QOL measure is extremely brief and therefore minimally onerous to implement for both patients and administratively overburdened providers. Third, its correlation with other key metrics suggests that it can function as a broad population health measure for health care organizations because individuals with higher QOL will also likely have better outcomes in other key areas. This suggests that it has the potential to broadly represent the overall status of a population of patients, thus functioning as a type of “whole system” measure, which the Institute for Healthcare Improvement describes as “a small set of measures that reflect a health system’s overall performance on core dimensions of quality guided by the Triple Aim.”⁷ These whole system measures can help focus an organization’s strategic initiatives and efforts on the issues that matter most to the patients and community it serves.

The relationship of QOL to acute service utilization deserves special mention. As an administrative measure, utilization is not susceptible to the same response bias as the other self-reported variables. Furthermore, acute services are costly to health systems, and hospital readmissions are associated with payment reductions in the Centers for Medicare and Medicaid Services (CMS) Hospital Readmissions Reduction Program for hospitals that fail to meet certain performance targets.²⁷ Thus, because of its alignment with federal mandates, improved QOL (and potentially concomitant decreases in acute service use) may have significant financial implications for health systems as well.

This study was limited by several factors. First, it was focused on a population receiving publicly funded behavioral health services with strict eligibility requirements, one of which stipulated that individuals must be at 200% or less of the Federal Poverty Level; therefore, the results might not be applicable to health systems with a more clinically or socioeconomically diverse patient population. Second, because these data are cross-sectional, it was not possible to determine whether QOL improved over time or whether changes in QOL covaried longitudinally with the other metrics under observation. For example, if patients’ QOL improved from the first to last assessment, did their employment or residential status improve as well, or were these patients more likely to be employed at their first assessment? Furthermore, if there was covariance, did changes in employment, housing status, and so on precede changes in QOL or vice versa? Multiple longitudinal observations would help to address these questions and will be the focus of future analyses.

Conclusion

This preliminary study suggests that a single-item QOL measure may be a valuable population health–level metric for health systems. It requires little administrative effort on the part of either the clinician or patient. It is also agnostic with regard to clinical issue or treatment approach and can therefore admit of a range of diagnoses or patient-specific, idiosyncratic recovery goals. It is correlated with other key health, social determinants of health, and acute service utilization indicators and can therefore serve as a “whole system” measure because of its ability to broadly represent improvements in an entire population. Furthermore, QOL is patient-centered in that data are obtained through patient self-report, which is a high priority for CMS and other health care organizations.²⁸ In summary, a single-item QOL measure holds promise for health care organizations looking to implement the Quadruple Aim and assess the health of the populations they serve in a manner that is simple, efficient, and patient-centered.

Acknowledgments: The author thanks Jennifer Wittwer for her thoughtful comments on the initial draft of this manuscript and Gary Kraft for his help extracting the data used in the analyses.

Corresponding author: Walter Matthew Drymalski, PhD; [email protected]

Disclosures: None reported.

From Milwaukee County Behavioral Health Services, Milwaukee, WI.

Abstract

Objectives: The goal of this study was to determine whether a single-item quality of life (QOL) measure could serve as a useful population health–level metric within the Quadruple Aim framework in a publicly funded behavioral health system.

Design: This was a retrospective, cross-sectional study that examined the correlation between the single-item QOL measure and several other key measures of the social determinants of health and a composite measure of acute service utilization for all patients receiving mental health and substance use services in a community behavioral health system.

Methods: Data were collected for 4488 patients who had at least 1 assessment between October 1, 2020, and September 30, 2021. Data on social determinants of health were obtained through patient self-report; acute service use data were obtained from electronic health records.

Results: Statistical analyses revealed results in the expected direction for all relationships tested. Patients with higher QOL were more likely to report “Good” or better self-rated physical health, be employed, have a private residence, and report recent positive social interactions, and were less likely to have received acute services in the previous 90 days.

Conclusion: A single-item QOL measure shows promise as a general, minimally burdensome whole-system metric that can function as a target for population health management efforts in a large behavioral health system. Future research should explore whether this QOL measure is sensitive to change over time and examine its temporal relationship with other key outcome metrics.

Keywords: Quadruple Aim, single-item measures, social determinants of health, acute service utilization metrics.

The Triple Aim for health care—improving the individual experience of care, increasing the health of populations, and reducing the costs of care—was first proposed in 2008.¹ More recently, some have advocated for an expanded focus to include a fourth aim: the quality of staff work life.² Since this seminal paper was published, many health care systems have endeavored to adopt and implement the Quadruple Aim^3,4; however, the concepts representing each of the aims are not universally defined,³ nor are the measures needed to populate the Quadruple Aim always available within the health system in question.⁵

Although several assessment models and frameworks that provide guidance to stakeholders have been developed,^6,7 it is ultimately up to organizations themselves to determine which measures they should deploy to best represent the different quadrants of the Quadruple Aim.⁶ Evidence suggests, however, that quality measurement, and the administrative time required to conduct it, can be both financially and emotionally burdensome to providers and health systems.^8-10 Thus, it is incumbent on organizations to select a set of measures that are not only meaningful but as parsimonious as possible.^6,11,12

Quality of life (QOL) is a potential candidate to assess the aim of population health. Brief health-related QOL questions have long been used in epidemiological surveys, such as the Behavioral Risk Factor Surveillance System survey.¹³ Such questions are also a key component of community health frameworks, such as the County Health Rankings developed by the University of Wisconsin Population Health Institute.¹⁴ Furthermore, Humana recently revealed that increasing the number of physical and mental health “Healthy Days” (which are among the Centers for Disease Control and Prevention’s Health-Related Quality of Life questions¹⁵) among the members enrolled in their insurance plan would become a major goal for the organization.^16,17 Many of these measures, while brief, focus on QOL as a function of health, often as a self-rated construct (from “Poor” to “Excellent”) or in the form of days of poor physical or mental health in the past 30 days,¹⁵ rather than evaluating QOL itself; however, several authors have pointed out that health status and QOL are related but distinct concepts.^18,19

Brief single-item assessments focused specifically on QOL have been developed and implemented within nonclinical²⁰ and clinical populations, including individuals with cancer,²¹ adults with disabilities,²² individuals with cystic fibrosis,²³ and children with epilepsy.²⁴ Despite the long history of QOL assessment in behavioral health treatment,²⁵ single-item measures have not been widely implemented in this population.

Milwaukee County Behavioral Health Services (BHS), a publicly funded, county-based behavioral health care system in Milwaukee, Wisconsin, provides inpatient and ambulatory treatment, psychiatric emergency care, withdrawal management, care management, crisis services, and other support services to individuals in Milwaukee County. In 2018 the community services arm of BHS began implementing a single QOL question from the World Health Organization’s WHOQOL-BREF²⁶: On a 5-point rating scale of “Very Poor” to “Very Good,” “How would you rate your overall quality of life right now?” Previous research by Atroszko and colleagues,²⁰ which used a similar approach with the same item from the WHOQOL-BREF, reported correlations in the expected direction of the single-item QOL measure with perceived stress, depression, anxiety, loneliness, and daily hours of sleep. This study’s sample, however, comprised opportunistically recruited college students, not a clinical population. Further, the researchers did not examine the relationship of QOL with acute service utilization or other measures of the social determinants of health, such as housing, employment, or social connectedness.

The following study was designed to extend these results by focusing on a clinical population—individuals with mental health or substance use issues—being served in a large, publicly funded behavioral health system in Milwaukee, Wisconsin. The objective of this study was to determine whether a single-item QOL measure could be used as a brief, parsimonious measure of overall population health by examining its relationship with other key outcome measures for patients receiving services from BHS. This study was reviewed and approved by BHS’s Institutional Review Board.

Methods

All patients engaged in nonacute community services are offered a standardized assessment that includes, among other measures, items related to QOL, housing status, employment status, self-rated physical health, and social connectedness. This assessment is administered at intake, discharge, and every 6 months while patients are enrolled in services. Patients who received at least 1 assessment between October 1, 2020, and September 30, 2021, were included in the analyses. Patients receiving crisis, inpatient, or withdrawal management services alone (ie, did not receive any other community-based services) were not offered the standard assessment and thus were not included in the analyses. If patients had more than 1 assessment during this time period, QOL data from the last assessment were used. Data on housing (private residence status, defined as adults living alone or with others without supervision in a house or apartment), employment status, self-rated physical health, and social connectedness (measured by asking people whether they have had positive interactions with family or friends in the past 30 days) were extracted from the same timepoint as well.

Also included in the analyses were rates of acute service utilization, in which any patient with at least 1 visit to BHS’s psychiatric emergency department, withdrawal management facility, or psychiatric inpatient facility in the 90 days prior to the date of the assessment received a code of “Yes,” and any patient who did not receive any of these services received a code of “No.” Chi-square analyses were conducted to determine the relationship between QOL rankings (“Very Poor,” “Poor,” “Neither Good nor Poor,” “Good,” and “Very Good”) and housing, employment, self-rated physical health, social connectedness, and 90-day acute service use. All acute service utilization data were obtained from BHS’s electronic health records system. All data used in the study were stored on a secure, password-protected server. All analyses were conducted with SPSS software (SPSS 28; IBM).

Results

Data were available for 4488 patients who received an assessment between October 1, 2020, and September 30, 2021 (total numbers per item vary because some items had missing data; see supplementary eTables 1-3 for sample size per item). Demographics of the patient sample are listed in Table 1; the demographics of the patients who were missing data for specific outcomes are presented in eTables 1-3.

Statistical analyses revealed results in the expected direction for all relationships tested (Table 2). As patients’ self-reported QOL improved, so did the likelihood of higher rates of self-reported “Good” or better physical health, which was 576% higher among individuals who reported “Very Good” QOL relative to those who reported “Very Poor” QOL. Similarly, when compared with individuals with “Very Poor” QOL, individuals who reported “Very Good” QOL were 21.91% more likely to report having a private residence, 126.7% more likely to report being employed, and 29.17% more likely to report having had positive social interactions with family and friends in the past 30 days. There was an inverse relationship between QOL and the likelihood that a patient had received at least 1 admission for an acute service in the previous 90 days, such that patients who reported “Very Good” QOL were 86.34% less likely to have had an admission compared to patients with “Very Poor” QOL (2.8% vs 20.5%, respectively). The relationships among the criterion variables used in this study are presented in Table 3.

Discussion

The results of this preliminary analysis suggest that self-rated QOL is related to key health, social determinants of health, and acute service utilization metrics. These data are important for several reasons. First, because QOL is a diagnostically agnostic measure, it is a cross-cutting measure to use with clinically diverse populations receiving an array of different services. Second, at 1 item, the QOL measure is extremely brief and therefore minimally onerous to implement for both patients and administratively overburdened providers. Third, its correlation with other key metrics suggests that it can function as a broad population health measure for health care organizations because individuals with higher QOL will also likely have better outcomes in other key areas. This suggests that it has the potential to broadly represent the overall status of a population of patients, thus functioning as a type of “whole system” measure, which the Institute for Healthcare Improvement describes as “a small set of measures that reflect a health system’s overall performance on core dimensions of quality guided by the Triple Aim.”⁷ These whole system measures can help focus an organization’s strategic initiatives and efforts on the issues that matter most to the patients and community it serves.

The relationship of QOL to acute service utilization deserves special mention. As an administrative measure, utilization is not susceptible to the same response bias as the other self-reported variables. Furthermore, acute services are costly to health systems, and hospital readmissions are associated with payment reductions in the Centers for Medicare and Medicaid Services (CMS) Hospital Readmissions Reduction Program for hospitals that fail to meet certain performance targets.²⁷ Thus, because of its alignment with federal mandates, improved QOL (and potentially concomitant decreases in acute service use) may have significant financial implications for health systems as well.

This study was limited by several factors. First, it was focused on a population receiving publicly funded behavioral health services with strict eligibility requirements, one of which stipulated that individuals must be at 200% or less of the Federal Poverty Level; therefore, the results might not be applicable to health systems with a more clinically or socioeconomically diverse patient population. Second, because these data are cross-sectional, it was not possible to determine whether QOL improved over time or whether changes in QOL covaried longitudinally with the other metrics under observation. For example, if patients’ QOL improved from the first to last assessment, did their employment or residential status improve as well, or were these patients more likely to be employed at their first assessment? Furthermore, if there was covariance, did changes in employment, housing status, and so on precede changes in QOL or vice versa? Multiple longitudinal observations would help to address these questions and will be the focus of future analyses.

Conclusion

This preliminary study suggests that a single-item QOL measure may be a valuable population health–level metric for health systems. It requires little administrative effort on the part of either the clinician or patient. It is also agnostic with regard to clinical issue or treatment approach and can therefore admit of a range of diagnoses or patient-specific, idiosyncratic recovery goals. It is correlated with other key health, social determinants of health, and acute service utilization indicators and can therefore serve as a “whole system” measure because of its ability to broadly represent improvements in an entire population. Furthermore, QOL is patient-centered in that data are obtained through patient self-report, which is a high priority for CMS and other health care organizations.²⁸ In summary, a single-item QOL measure holds promise for health care organizations looking to implement the Quadruple Aim and assess the health of the populations they serve in a manner that is simple, efficient, and patient-centered.

Acknowledgments: The author thanks Jennifer Wittwer for her thoughtful comments on the initial draft of this manuscript and Gary Kraft for his help extracting the data used in the analyses.

Corresponding author: Walter Matthew Drymalski, PhD; [email protected]

Disclosures: None reported.

From the Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, TN (Stefan W. Koester, Puja Jagasia, and Drs. Liles, Dambrino IV, Feldman, and Chambless), and the Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN (Drs. Mathews and Tiwari).

ABSTRACT

Background: The COVID-19 pandemic has had broad effects on surgical care, including operating room (OR) staffing, personal protective equipment (PPE) utilization, and newly implemented anti-infective measures. Our aim was to assess neurosurgery OR efficiency before the COVID-19 pandemic, during peak COVID-19, and during current times.

Methods: Institutional perioperative databases at a single, high-volume neurosurgical center were queried for operations performed from December 2019 until October 2021. March 12, 2020, the day that the state of Tennessee declared a state of emergency, was chosen as the onset of the COVID-19 pandemic. The 90-day periods before and after this day were used to define the pre-COVID-19, peak-COVID-19, and post-peak restrictions time periods for comparative analysis. Outcomes included delay in first-start and OR turnover time between neurosurgical cases. Preset threshold times were used in analyses to adjust for normal leniency in OR scheduling (15 minutes for first start and 90 minutes for turnover). Univariate analysis used Wilcoxon rank-sum test for continuous outcomes, while chi-square test and Fisher’s exact test were used for categorical comparisons. Significance was defined as P < .05.

Results: First-start time was analyzed in 426 pre-COVID-19, 357 peak-restrictions, and 2304 post-peak-restrictions cases. The unadjusted mean delay length was found to be significantly different between the time periods, but the magnitude of increase in minutes was immaterial (mean [SD] minutes, 6 [18] vs 10 [21] vs 8 [20], respectively; P = .004). The adjusted average delay length and proportion of cases delayed beyond the 15-minute threshold were not significantly different. The proportion of cases that started early, as well as significantly early past a 15-minute threshold, have not been impacted. There was no significant change in turnover time during peak restrictions relative to the pre-COVID-19 period (88 [100] minutes vs 85 [95] minutes), and turnover time has since remained unchanged (83 [87] minutes).

Conclusion: Our center was able to maintain OR efficiency before, during, and after peak restrictions even while instituting advanced infection-control strategies. While there were significant changes, delays were relatively small in magnitude.

Keywords: operating room timing, hospital efficiency, socioeconomics, pandemic.

The COVID-19 pandemic has led to major changes in patient care both from a surgical perspective and in regard to inpatient hospital course. Safety protocols nationwide have been implemented to protect both patients and providers. Some elements of surgical care have drastically changed, including operating room (OR) staffing, personal protective equipment (PPE) utilization, and increased sterilization measures. Furloughs, layoffs, and reassignments due to the focus on nonelective and COVID-19–related cases challenged OR staffing and efficiency. Operating room staff with COVID-19 exposures or COVID-19 infections also caused last-minute changes in staffing. All of these scenarios can cause issues due to actual understaffing or due to staff members being pushed into highly specialized areas, such as neurosurgery, in which they have very little experience. A further obstacle to OR efficiency included policy changes involving PPE utilization, sterilization measures, and supply chain shortages of necessary resources such as PPE.

Neurosurgery in particular has been susceptible to COVID-19–related system-wide changes given operator proximity to the patient’s respiratory passages, frequency of emergent cases, and varying anesthetic needs, as well as the high level of specialization needed to perform neurosurgical care. Previous studies have shown a change in the makeup of neurosurgical patients seeking care, as well as in the acuity of neurological consult of these patients.¹ A study in orthopedic surgery by Andreata et al demonstrated worsened OR efficiency, with significantly increased first-start and turnover times.² In the COVID-19 era, OR quality and safety are crucially important to both patients and providers. Providing this safe and effective care in an efficient manner is important for optimal neurosurgical management in the long term.³ Moreover, the financial burden of implementing new protocols and standards can be compounded by additional financial losses due to reduced OR efficiency.

Methods

To analyze the effect of COVID-19 on neurosurgical OR efficiency, institutional perioperative databases at a single high-volume center were queried for operations performed from December 2019 until October 2021. March 12, 2020, was chosen as the onset of COVID-19 for analytic purposes, as this was the date when the state of Tennessee declared a state of emergency. The 90-day periods before and after this date were used for comparative analysis for pre-COVID-19, peak COVID-19, and post-peak-restrictions time periods. The peak COVID-19 period was defined as the 90-day period following the initial onset of COVID-19 and the surge of cases. For comparison purposes, post-peak COVID-19 was defined as the months following the first peak until October 2021 (approximately 17 months). COVID-19 burden was determined using a COVID-19 single-institution census of confirmed cases by polymerase chain reaction (PCR) for which the average number of cases of COVID-19 during a given month was determined. This number is a scaled trend, and a true number of COVID-19 cases in our hospital was not reported.

Neurosurgical and neuroendovascular cases were included in the analysis. Outcomes included delay in first-start and OR turnover time between neurosurgical cases, defined as the time from the patient leaving the room until the next patient entered the room. Preset threshold times were used in analyses to adjust for normal leniency in OR scheduling (15 minutes for first start and 90 minutes for turnover, which is a standard for our single-institution perioperative center). Statistical analyses, including data aggregation, were performed using R, version 4.0.1 (R Foundation for Statistical Computing). Patients’ demographic and clinical characteristics were analyzed using an independent 2-sample t-test for interval variables and a chi-square test for categorical variables. Significance was defined as P < .05.

Results

First-Start Time

First-start time was analyzed in 426 pre-COVID-19, 357 peak-COVID-19, and 2304 post-peak-COVID-19 cases. The unadjusted mean delay length was significantly different between the time periods, but the magnitude of increase in minutes was immaterial (mean [SD] minutes, 6 [18] vs 10 [21] vs 8 [20], respectively; P = .004) (Table 1).

The adjusted average delay length and proportion of cases delayed beyond the 15-minute threshold were not significantly different, but they have been slightly higher since the onset of COVID-19. The proportion of cases that have started early, as well as significantly early past a 15-minute threshold, have also trended down since the onset of the COVID-19 pandemic, but this difference was again not significant. The temporal relationship of first-start delay, both unadjusted and adjusted, from December 2019 to October 2021 is shown in Figure 1. The trend of increasing delay is loosely associated with the COVID-19 burden experienced by our hospital. The start of COVID-19 as well as both COVID-19 peaks have been associated with increased delays in our hospital.

Turnover Time

Turnover time was assessed in 437 pre-COVID-19, 278 peak-restrictions, and 2411 post-peak-restrictions cases. Turnover time during peak restrictions was not significantly different from pre-COVID-19 (88 [100] vs 85 [95]) and has since remained relatively unchanged (83 [87], P = .78). A similar trend held for comparisons of proportion of cases with turnover time past 90 minutes and average times past the 90-minute threshold (Table 2). The temporal relationship between COVID-19 burden and turnover time, both unadjusted and adjusted, from December 2019 to October 2021 is shown in Figure 2. Both figures demonstrate a slight initial increase in turnover time delay at the start of COVID-19, which stabilized with little variation thereafter.

We analyzed the OR efficiency metrics of first-start and turnover time during the 90-day period before COVID-19 (pre-COVID-19), the 90 days following Tennessee declaring a state of emergency (peak COVID-19), and the time following this period (post-COVID-19) for all neurosurgical and neuroendovascular cases at Vanderbilt University Medical Center (VUMC). We found a significant difference in unadjusted mean delay length in first-start time between the time periods, but the magnitude of increase in minutes was immaterial (mean [SD] minutes for pre-COVID-19, peak-COVID-19, and post-COVID-19: 6 [18] vs 10 [21] vs 8 [20], respectively; P = .004). No significant increase in turnover time between cases was found between these 3 time periods. Based on metrics from first-start delay and turnover time, our center was able to maintain OR efficiency before, during, and after peak COVID-19.

After the Centers for Disease Control and Prevention released guidelines recommending deferring elective procedures to conserve beds and PPE, VUMC made the decision to suspend all elective surgical procedures from March 18 to April 24, 2020. Prior research conducted during the COVID-19 pandemic has demonstrated more than 400 types of surgical procedures with negatively impacted outcomes when compared to surgical outcomes from the same time frame in 2018 and 2019.⁴ For more than 20 of these types of procedures, there was a significant association between procedure delay and adverse patient outcomes.⁴ Testing protocols for patients prior to surgery varied throughout the pandemic based on vaccination status and type of procedure. Before vaccines became widely available, all patients were required to obtain a PCR SARS-CoV-2 test within 48 to 72 hours of the scheduled procedure. If the patient’s procedure was urgent and testing was not feasible, the patient was treated as a SARS-CoV-2–positive patient, which required all health care workers involved in the case to wear gowns, gloves, surgical masks, and eye protection. Testing patients preoperatively likely helped to maintain OR efficiency since not all patients received test results prior to the scheduled procedure, leading to cancellations of cases and therefore more staff available for fewer cases.

After vaccines became widely available to the public, testing requirements for patients preoperatively were relaxed, and only patients who were not fully vaccinated or severely immunocompromised were required to test prior to procedures. However, approximately 40% of the population in Tennessee was fully vaccinated in 2021, which reflects the patient population of VUMC.⁵ This means that many patients who received care at VUMC were still tested prior to procedures.

Adopting adequate safety protocols was found to be key for OR efficiency during the COVID-19 pandemic since performing surgery increased the risk of infection for each health care worker in the OR.⁶ VUMC protocols identified procedures that required enhanced safety measures to prevent infection of health care workers and avoid staffing shortages, which would decrease OR efficiency. Protocols mandated that only anesthesia team members were allowed to be in the OR during intubation and extubation of patients, which could be one factor leading to increased delays and decreased efficiency for some institutions. Methods for neurosurgeons to decrease risk of infection in the OR include postponing all nonurgent cases, reappraising the necessity for general anesthesia and endotracheal intubation, considering alternative surgical approaches that avoid the respiratory tract, and limiting the use of aerosol-generating instruments.^7,8 VUMC’s success in implementing these protocols likely explains why our center was able to maintain OR efficiency throughout the COVID-19 pandemic.

A study conducted by Andreata et al showed a significantly increased mean first-case delay and a nonsignificant increased turnover time in orthopedic surgeries in Northern Italy when comparing surgeries performed during the COVID-19 pandemic to those performed prior to COVID-19.² Other studies have indicated a similar trend in decreased OR efficiency during COVID-19 in other areas around the world.^9,10 These findings are not consistent with our own findings for neurosurgical and neuroendovascular surgeries at VUMC, and any change at our institution was relatively immaterial. Factors that threatened to change OR efficiency—but did not result in meaningful changes in our institutional experience—include delays due to pending COVID-19 test results, safety procedures such as PPE donning, and planning difficulties to ensure the existence of teams with non-overlapping providers in the case of a surgeon being infected.^2,11-13

Globally, many surgery centers halted all elective surgeries during the initial COVID-19 spike to prevent a PPE shortage and mitigate risk of infection of patients and health care workers.^8,12,14 However, there is no centralized definition of which neurosurgical procedures are elective, so that decision was made on a surgeon or center level, which could lead to variability in efficiency trends.¹⁴ One study on neurosurgical procedures during COVID-19 found a 30% decline in all cases and a 23% decline in emergent procedures, showing that the decrease in volume was not only due to cancellation of elective procedures.¹⁵ This decrease in elective and emergent surgeries created a backlog of surgeries as well as a loss in health care revenue, and caused many patients to go without adequate health care.¹⁰ Looking forward, it is imperative that surgical centers study trends in OR efficiency from COVID-19 and learn how to better maintain OR efficiency during future pandemic conditions to prevent a backlog of cases, loss of health care revenue, and decreased health care access.

Limitations

Our data are from a single center and therefore may not be representative of experiences of other hospitals due to different populations and different impacts from COVID-19. However, given our center’s high volume and diverse patient population, we believe our analysis highlights important trends in neurosurgery practice. Notably, data for patient and OR timing are digitally generated and are entered manually by nurses in the electronic medical record, making it prone to errors and variability. This is in our experience, and if any error is present, we believe it is minimal.

Conclusion

The COVID-19 pandemic has had far-reaching effects on health care worldwide, including neurosurgical care. OR efficiency across the United States generally worsened given the stresses of supply chain issues, staffing shortages, and cancellations. At our institution, we were able to maintain OR efficiency during the known COVID-19 peaks until October 2021. Continually functional neurosurgical ORs are important in preventing delays in care and maintaining a steady revenue in order for hospitals and other health care entities to remain solvent. Further study of OR efficiency is needed for health care systems to prepare for future pandemics and other resource-straining events in order to provide optimal patient care.

Corresponding author: Campbell Liles, MD, Vanderbilt University Medical Center, Department of Neurological Surgery, 1161 21st Ave. South, T4224 Medical Center North, Nashville, TN 37232-2380; [email protected]

Disclosures: None reported.

From the Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, TN (Stefan W. Koester, Puja Jagasia, and Drs. Liles, Dambrino IV, Feldman, and Chambless), and the Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN (Drs. Mathews and Tiwari).

ABSTRACT

Background: The COVID-19 pandemic has had broad effects on surgical care, including operating room (OR) staffing, personal protective equipment (PPE) utilization, and newly implemented anti-infective measures. Our aim was to assess neurosurgery OR efficiency before the COVID-19 pandemic, during peak COVID-19, and during current times.

Methods: Institutional perioperative databases at a single, high-volume neurosurgical center were queried for operations performed from December 2019 until October 2021. March 12, 2020, the day that the state of Tennessee declared a state of emergency, was chosen as the onset of the COVID-19 pandemic. The 90-day periods before and after this day were used to define the pre-COVID-19, peak-COVID-19, and post-peak restrictions time periods for comparative analysis. Outcomes included delay in first-start and OR turnover time between neurosurgical cases. Preset threshold times were used in analyses to adjust for normal leniency in OR scheduling (15 minutes for first start and 90 minutes for turnover). Univariate analysis used Wilcoxon rank-sum test for continuous outcomes, while chi-square test and Fisher’s exact test were used for categorical comparisons. Significance was defined as P < .05.

Results: First-start time was analyzed in 426 pre-COVID-19, 357 peak-restrictions, and 2304 post-peak-restrictions cases. The unadjusted mean delay length was found to be significantly different between the time periods, but the magnitude of increase in minutes was immaterial (mean [SD] minutes, 6 [18] vs 10 [21] vs 8 [20], respectively; P = .004). The adjusted average delay length and proportion of cases delayed beyond the 15-minute threshold were not significantly different. The proportion of cases that started early, as well as significantly early past a 15-minute threshold, have not been impacted. There was no significant change in turnover time during peak restrictions relative to the pre-COVID-19 period (88 [100] minutes vs 85 [95] minutes), and turnover time has since remained unchanged (83 [87] minutes).

Conclusion: Our center was able to maintain OR efficiency before, during, and after peak restrictions even while instituting advanced infection-control strategies. While there were significant changes, delays were relatively small in magnitude.

Keywords: operating room timing, hospital efficiency, socioeconomics, pandemic.

The COVID-19 pandemic has led to major changes in patient care both from a surgical perspective and in regard to inpatient hospital course. Safety protocols nationwide have been implemented to protect both patients and providers. Some elements of surgical care have drastically changed, including operating room (OR) staffing, personal protective equipment (PPE) utilization, and increased sterilization measures. Furloughs, layoffs, and reassignments due to the focus on nonelective and COVID-19–related cases challenged OR staffing and efficiency. Operating room staff with COVID-19 exposures or COVID-19 infections also caused last-minute changes in staffing. All of these scenarios can cause issues due to actual understaffing or due to staff members being pushed into highly specialized areas, such as neurosurgery, in which they have very little experience. A further obstacle to OR efficiency included policy changes involving PPE utilization, sterilization measures, and supply chain shortages of necessary resources such as PPE.

Neurosurgery in particular has been susceptible to COVID-19–related system-wide changes given operator proximity to the patient’s respiratory passages, frequency of emergent cases, and varying anesthetic needs, as well as the high level of specialization needed to perform neurosurgical care. Previous studies have shown a change in the makeup of neurosurgical patients seeking care, as well as in the acuity of neurological consult of these patients.¹ A study in orthopedic surgery by Andreata et al demonstrated worsened OR efficiency, with significantly increased first-start and turnover times.² In the COVID-19 era, OR quality and safety are crucially important to both patients and providers. Providing this safe and effective care in an efficient manner is important for optimal neurosurgical management in the long term.³ Moreover, the financial burden of implementing new protocols and standards can be compounded by additional financial losses due to reduced OR efficiency.

Methods

To analyze the effect of COVID-19 on neurosurgical OR efficiency, institutional perioperative databases at a single high-volume center were queried for operations performed from December 2019 until October 2021. March 12, 2020, was chosen as the onset of COVID-19 for analytic purposes, as this was the date when the state of Tennessee declared a state of emergency. The 90-day periods before and after this date were used for comparative analysis for pre-COVID-19, peak COVID-19, and post-peak-restrictions time periods. The peak COVID-19 period was defined as the 90-day period following the initial onset of COVID-19 and the surge of cases. For comparison purposes, post-peak COVID-19 was defined as the months following the first peak until October 2021 (approximately 17 months). COVID-19 burden was determined using a COVID-19 single-institution census of confirmed cases by polymerase chain reaction (PCR) for which the average number of cases of COVID-19 during a given month was determined. This number is a scaled trend, and a true number of COVID-19 cases in our hospital was not reported.

Neurosurgical and neuroendovascular cases were included in the analysis. Outcomes included delay in first-start and OR turnover time between neurosurgical cases, defined as the time from the patient leaving the room until the next patient entered the room. Preset threshold times were used in analyses to adjust for normal leniency in OR scheduling (15 minutes for first start and 90 minutes for turnover, which is a standard for our single-institution perioperative center). Statistical analyses, including data aggregation, were performed using R, version 4.0.1 (R Foundation for Statistical Computing). Patients’ demographic and clinical characteristics were analyzed using an independent 2-sample t-test for interval variables and a chi-square test for categorical variables. Significance was defined as P < .05.

Results

First-Start Time

First-start time was analyzed in 426 pre-COVID-19, 357 peak-COVID-19, and 2304 post-peak-COVID-19 cases. The unadjusted mean delay length was significantly different between the time periods, but the magnitude of increase in minutes was immaterial (mean [SD] minutes, 6 [18] vs 10 [21] vs 8 [20], respectively; P = .004) (Table 1).

The adjusted average delay length and proportion of cases delayed beyond the 15-minute threshold were not significantly different, but they have been slightly higher since the onset of COVID-19. The proportion of cases that have started early, as well as significantly early past a 15-minute threshold, have also trended down since the onset of the COVID-19 pandemic, but this difference was again not significant. The temporal relationship of first-start delay, both unadjusted and adjusted, from December 2019 to October 2021 is shown in Figure 1. The trend of increasing delay is loosely associated with the COVID-19 burden experienced by our hospital. The start of COVID-19 as well as both COVID-19 peaks have been associated with increased delays in our hospital.

Turnover Time

Turnover time was assessed in 437 pre-COVID-19, 278 peak-restrictions, and 2411 post-peak-restrictions cases. Turnover time during peak restrictions was not significantly different from pre-COVID-19 (88 [100] vs 85 [95]) and has since remained relatively unchanged (83 [87], P = .78). A similar trend held for comparisons of proportion of cases with turnover time past 90 minutes and average times past the 90-minute threshold (Table 2). The temporal relationship between COVID-19 burden and turnover time, both unadjusted and adjusted, from December 2019 to October 2021 is shown in Figure 2. Both figures demonstrate a slight initial increase in turnover time delay at the start of COVID-19, which stabilized with little variation thereafter.

We analyzed the OR efficiency metrics of first-start and turnover time during the 90-day period before COVID-19 (pre-COVID-19), the 90 days following Tennessee declaring a state of emergency (peak COVID-19), and the time following this period (post-COVID-19) for all neurosurgical and neuroendovascular cases at Vanderbilt University Medical Center (VUMC). We found a significant difference in unadjusted mean delay length in first-start time between the time periods, but the magnitude of increase in minutes was immaterial (mean [SD] minutes for pre-COVID-19, peak-COVID-19, and post-COVID-19: 6 [18] vs 10 [21] vs 8 [20], respectively; P = .004). No significant increase in turnover time between cases was found between these 3 time periods. Based on metrics from first-start delay and turnover time, our center was able to maintain OR efficiency before, during, and after peak COVID-19.

After the Centers for Disease Control and Prevention released guidelines recommending deferring elective procedures to conserve beds and PPE, VUMC made the decision to suspend all elective surgical procedures from March 18 to April 24, 2020. Prior research conducted during the COVID-19 pandemic has demonstrated more than 400 types of surgical procedures with negatively impacted outcomes when compared to surgical outcomes from the same time frame in 2018 and 2019.⁴ For more than 20 of these types of procedures, there was a significant association between procedure delay and adverse patient outcomes.⁴ Testing protocols for patients prior to surgery varied throughout the pandemic based on vaccination status and type of procedure. Before vaccines became widely available, all patients were required to obtain a PCR SARS-CoV-2 test within 48 to 72 hours of the scheduled procedure. If the patient’s procedure was urgent and testing was not feasible, the patient was treated as a SARS-CoV-2–positive patient, which required all health care workers involved in the case to wear gowns, gloves, surgical masks, and eye protection. Testing patients preoperatively likely helped to maintain OR efficiency since not all patients received test results prior to the scheduled procedure, leading to cancellations of cases and therefore more staff available for fewer cases.

After vaccines became widely available to the public, testing requirements for patients preoperatively were relaxed, and only patients who were not fully vaccinated or severely immunocompromised were required to test prior to procedures. However, approximately 40% of the population in Tennessee was fully vaccinated in 2021, which reflects the patient population of VUMC.⁵ This means that many patients who received care at VUMC were still tested prior to procedures.

Adopting adequate safety protocols was found to be key for OR efficiency during the COVID-19 pandemic since performing surgery increased the risk of infection for each health care worker in the OR.⁶ VUMC protocols identified procedures that required enhanced safety measures to prevent infection of health care workers and avoid staffing shortages, which would decrease OR efficiency. Protocols mandated that only anesthesia team members were allowed to be in the OR during intubation and extubation of patients, which could be one factor leading to increased delays and decreased efficiency for some institutions. Methods for neurosurgeons to decrease risk of infection in the OR include postponing all nonurgent cases, reappraising the necessity for general anesthesia and endotracheal intubation, considering alternative surgical approaches that avoid the respiratory tract, and limiting the use of aerosol-generating instruments.^7,8 VUMC’s success in implementing these protocols likely explains why our center was able to maintain OR efficiency throughout the COVID-19 pandemic.

A study conducted by Andreata et al showed a significantly increased mean first-case delay and a nonsignificant increased turnover time in orthopedic surgeries in Northern Italy when comparing surgeries performed during the COVID-19 pandemic to those performed prior to COVID-19.² Other studies have indicated a similar trend in decreased OR efficiency during COVID-19 in other areas around the world.^9,10 These findings are not consistent with our own findings for neurosurgical and neuroendovascular surgeries at VUMC, and any change at our institution was relatively immaterial. Factors that threatened to change OR efficiency—but did not result in meaningful changes in our institutional experience—include delays due to pending COVID-19 test results, safety procedures such as PPE donning, and planning difficulties to ensure the existence of teams with non-overlapping providers in the case of a surgeon being infected.^2,11-13

Globally, many surgery centers halted all elective surgeries during the initial COVID-19 spike to prevent a PPE shortage and mitigate risk of infection of patients and health care workers.^8,12,14 However, there is no centralized definition of which neurosurgical procedures are elective, so that decision was made on a surgeon or center level, which could lead to variability in efficiency trends.¹⁴ One study on neurosurgical procedures during COVID-19 found a 30% decline in all cases and a 23% decline in emergent procedures, showing that the decrease in volume was not only due to cancellation of elective procedures.¹⁵ This decrease in elective and emergent surgeries created a backlog of surgeries as well as a loss in health care revenue, and caused many patients to go without adequate health care.¹⁰ Looking forward, it is imperative that surgical centers study trends in OR efficiency from COVID-19 and learn how to better maintain OR efficiency during future pandemic conditions to prevent a backlog of cases, loss of health care revenue, and decreased health care access.

Limitations

Our data are from a single center and therefore may not be representative of experiences of other hospitals due to different populations and different impacts from COVID-19. However, given our center’s high volume and diverse patient population, we believe our analysis highlights important trends in neurosurgery practice. Notably, data for patient and OR timing are digitally generated and are entered manually by nurses in the electronic medical record, making it prone to errors and variability. This is in our experience, and if any error is present, we believe it is minimal.

Conclusion

The COVID-19 pandemic has had far-reaching effects on health care worldwide, including neurosurgical care. OR efficiency across the United States generally worsened given the stresses of supply chain issues, staffing shortages, and cancellations. At our institution, we were able to maintain OR efficiency during the known COVID-19 peaks until October 2021. Continually functional neurosurgical ORs are important in preventing delays in care and maintaining a steady revenue in order for hospitals and other health care entities to remain solvent. Further study of OR efficiency is needed for health care systems to prepare for future pandemics and other resource-straining events in order to provide optimal patient care.

Corresponding author: Campbell Liles, MD, Vanderbilt University Medical Center, Department of Neurological Surgery, 1161 21st Ave. South, T4224 Medical Center North, Nashville, TN 37232-2380; [email protected]

Disclosures: None reported.

From the Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, TN (Stefan W. Koester, Puja Jagasia, and Drs. Liles, Dambrino IV, Feldman, and Chambless), and the Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN (Drs. Mathews and Tiwari).

ABSTRACT

Background: The COVID-19 pandemic has had broad effects on surgical care, including operating room (OR) staffing, personal protective equipment (PPE) utilization, and newly implemented anti-infective measures. Our aim was to assess neurosurgery OR efficiency before the COVID-19 pandemic, during peak COVID-19, and during current times.

Methods: Institutional perioperative databases at a single, high-volume neurosurgical center were queried for operations performed from December 2019 until October 2021. March 12, 2020, the day that the state of Tennessee declared a state of emergency, was chosen as the onset of the COVID-19 pandemic. The 90-day periods before and after this day were used to define the pre-COVID-19, peak-COVID-19, and post-peak restrictions time periods for comparative analysis. Outcomes included delay in first-start and OR turnover time between neurosurgical cases. Preset threshold times were used in analyses to adjust for normal leniency in OR scheduling (15 minutes for first start and 90 minutes for turnover). Univariate analysis used Wilcoxon rank-sum test for continuous outcomes, while chi-square test and Fisher’s exact test were used for categorical comparisons. Significance was defined as P < .05.

Results: First-start time was analyzed in 426 pre-COVID-19, 357 peak-restrictions, and 2304 post-peak-restrictions cases. The unadjusted mean delay length was found to be significantly different between the time periods, but the magnitude of increase in minutes was immaterial (mean [SD] minutes, 6 [18] vs 10 [21] vs 8 [20], respectively; P = .004). The adjusted average delay length and proportion of cases delayed beyond the 15-minute threshold were not significantly different. The proportion of cases that started early, as well as significantly early past a 15-minute threshold, have not been impacted. There was no significant change in turnover time during peak restrictions relative to the pre-COVID-19 period (88 [100] minutes vs 85 [95] minutes), and turnover time has since remained unchanged (83 [87] minutes).

Conclusion: Our center was able to maintain OR efficiency before, during, and after peak restrictions even while instituting advanced infection-control strategies. While there were significant changes, delays were relatively small in magnitude.

Keywords: operating room timing, hospital efficiency, socioeconomics, pandemic.

The COVID-19 pandemic has led to major changes in patient care both from a surgical perspective and in regard to inpatient hospital course. Safety protocols nationwide have been implemented to protect both patients and providers. Some elements of surgical care have drastically changed, including operating room (OR) staffing, personal protective equipment (PPE) utilization, and increased sterilization measures. Furloughs, layoffs, and reassignments due to the focus on nonelective and COVID-19–related cases challenged OR staffing and efficiency. Operating room staff with COVID-19 exposures or COVID-19 infections also caused last-minute changes in staffing. All of these scenarios can cause issues due to actual understaffing or due to staff members being pushed into highly specialized areas, such as neurosurgery, in which they have very little experience. A further obstacle to OR efficiency included policy changes involving PPE utilization, sterilization measures, and supply chain shortages of necessary resources such as PPE.

Neurosurgery in particular has been susceptible to COVID-19–related system-wide changes given operator proximity to the patient’s respiratory passages, frequency of emergent cases, and varying anesthetic needs, as well as the high level of specialization needed to perform neurosurgical care. Previous studies have shown a change in the makeup of neurosurgical patients seeking care, as well as in the acuity of neurological consult of these patients.¹ A study in orthopedic surgery by Andreata et al demonstrated worsened OR efficiency, with significantly increased first-start and turnover times.² In the COVID-19 era, OR quality and safety are crucially important to both patients and providers. Providing this safe and effective care in an efficient manner is important for optimal neurosurgical management in the long term.³ Moreover, the financial burden of implementing new protocols and standards can be compounded by additional financial losses due to reduced OR efficiency.

Methods

To analyze the effect of COVID-19 on neurosurgical OR efficiency, institutional perioperative databases at a single high-volume center were queried for operations performed from December 2019 until October 2021. March 12, 2020, was chosen as the onset of COVID-19 for analytic purposes, as this was the date when the state of Tennessee declared a state of emergency. The 90-day periods before and after this date were used for comparative analysis for pre-COVID-19, peak COVID-19, and post-peak-restrictions time periods. The peak COVID-19 period was defined as the 90-day period following the initial onset of COVID-19 and the surge of cases. For comparison purposes, post-peak COVID-19 was defined as the months following the first peak until October 2021 (approximately 17 months). COVID-19 burden was determined using a COVID-19 single-institution census of confirmed cases by polymerase chain reaction (PCR) for which the average number of cases of COVID-19 during a given month was determined. This number is a scaled trend, and a true number of COVID-19 cases in our hospital was not reported.

Neurosurgical and neuroendovascular cases were included in the analysis. Outcomes included delay in first-start and OR turnover time between neurosurgical cases, defined as the time from the patient leaving the room until the next patient entered the room. Preset threshold times were used in analyses to adjust for normal leniency in OR scheduling (15 minutes for first start and 90 minutes for turnover, which is a standard for our single-institution perioperative center). Statistical analyses, including data aggregation, were performed using R, version 4.0.1 (R Foundation for Statistical Computing). Patients’ demographic and clinical characteristics were analyzed using an independent 2-sample t-test for interval variables and a chi-square test for categorical variables. Significance was defined as P < .05.

Results

First-Start Time

First-start time was analyzed in 426 pre-COVID-19, 357 peak-COVID-19, and 2304 post-peak-COVID-19 cases. The unadjusted mean delay length was significantly different between the time periods, but the magnitude of increase in minutes was immaterial (mean [SD] minutes, 6 [18] vs 10 [21] vs 8 [20], respectively; P = .004) (Table 1).

The adjusted average delay length and proportion of cases delayed beyond the 15-minute threshold were not significantly different, but they have been slightly higher since the onset of COVID-19. The proportion of cases that have started early, as well as significantly early past a 15-minute threshold, have also trended down since the onset of the COVID-19 pandemic, but this difference was again not significant. The temporal relationship of first-start delay, both unadjusted and adjusted, from December 2019 to October 2021 is shown in Figure 1. The trend of increasing delay is loosely associated with the COVID-19 burden experienced by our hospital. The start of COVID-19 as well as both COVID-19 peaks have been associated with increased delays in our hospital.

Turnover Time

Turnover time was assessed in 437 pre-COVID-19, 278 peak-restrictions, and 2411 post-peak-restrictions cases. Turnover time during peak restrictions was not significantly different from pre-COVID-19 (88 [100] vs 85 [95]) and has since remained relatively unchanged (83 [87], P = .78). A similar trend held for comparisons of proportion of cases with turnover time past 90 minutes and average times past the 90-minute threshold (Table 2). The temporal relationship between COVID-19 burden and turnover time, both unadjusted and adjusted, from December 2019 to October 2021 is shown in Figure 2. Both figures demonstrate a slight initial increase in turnover time delay at the start of COVID-19, which stabilized with little variation thereafter.

We analyzed the OR efficiency metrics of first-start and turnover time during the 90-day period before COVID-19 (pre-COVID-19), the 90 days following Tennessee declaring a state of emergency (peak COVID-19), and the time following this period (post-COVID-19) for all neurosurgical and neuroendovascular cases at Vanderbilt University Medical Center (VUMC). We found a significant difference in unadjusted mean delay length in first-start time between the time periods, but the magnitude of increase in minutes was immaterial (mean [SD] minutes for pre-COVID-19, peak-COVID-19, and post-COVID-19: 6 [18] vs 10 [21] vs 8 [20], respectively; P = .004). No significant increase in turnover time between cases was found between these 3 time periods. Based on metrics from first-start delay and turnover time, our center was able to maintain OR efficiency before, during, and after peak COVID-19.

After the Centers for Disease Control and Prevention released guidelines recommending deferring elective procedures to conserve beds and PPE, VUMC made the decision to suspend all elective surgical procedures from March 18 to April 24, 2020. Prior research conducted during the COVID-19 pandemic has demonstrated more than 400 types of surgical procedures with negatively impacted outcomes when compared to surgical outcomes from the same time frame in 2018 and 2019.⁴ For more than 20 of these types of procedures, there was a significant association between procedure delay and adverse patient outcomes.⁴ Testing protocols for patients prior to surgery varied throughout the pandemic based on vaccination status and type of procedure. Before vaccines became widely available, all patients were required to obtain a PCR SARS-CoV-2 test within 48 to 72 hours of the scheduled procedure. If the patient’s procedure was urgent and testing was not feasible, the patient was treated as a SARS-CoV-2–positive patient, which required all health care workers involved in the case to wear gowns, gloves, surgical masks, and eye protection. Testing patients preoperatively likely helped to maintain OR efficiency since not all patients received test results prior to the scheduled procedure, leading to cancellations of cases and therefore more staff available for fewer cases.

After vaccines became widely available to the public, testing requirements for patients preoperatively were relaxed, and only patients who were not fully vaccinated or severely immunocompromised were required to test prior to procedures. However, approximately 40% of the population in Tennessee was fully vaccinated in 2021, which reflects the patient population of VUMC.⁵ This means that many patients who received care at VUMC were still tested prior to procedures.

Adopting adequate safety protocols was found to be key for OR efficiency during the COVID-19 pandemic since performing surgery increased the risk of infection for each health care worker in the OR.⁶ VUMC protocols identified procedures that required enhanced safety measures to prevent infection of health care workers and avoid staffing shortages, which would decrease OR efficiency. Protocols mandated that only anesthesia team members were allowed to be in the OR during intubation and extubation of patients, which could be one factor leading to increased delays and decreased efficiency for some institutions. Methods for neurosurgeons to decrease risk of infection in the OR include postponing all nonurgent cases, reappraising the necessity for general anesthesia and endotracheal intubation, considering alternative surgical approaches that avoid the respiratory tract, and limiting the use of aerosol-generating instruments.^7,8 VUMC’s success in implementing these protocols likely explains why our center was able to maintain OR efficiency throughout the COVID-19 pandemic.

A study conducted by Andreata et al showed a significantly increased mean first-case delay and a nonsignificant increased turnover time in orthopedic surgeries in Northern Italy when comparing surgeries performed during the COVID-19 pandemic to those performed prior to COVID-19.² Other studies have indicated a similar trend in decreased OR efficiency during COVID-19 in other areas around the world.^9,10 These findings are not consistent with our own findings for neurosurgical and neuroendovascular surgeries at VUMC, and any change at our institution was relatively immaterial. Factors that threatened to change OR efficiency—but did not result in meaningful changes in our institutional experience—include delays due to pending COVID-19 test results, safety procedures such as PPE donning, and planning difficulties to ensure the existence of teams with non-overlapping providers in the case of a surgeon being infected.^2,11-13

Globally, many surgery centers halted all elective surgeries during the initial COVID-19 spike to prevent a PPE shortage and mitigate risk of infection of patients and health care workers.^8,12,14 However, there is no centralized definition of which neurosurgical procedures are elective, so that decision was made on a surgeon or center level, which could lead to variability in efficiency trends.¹⁴ One study on neurosurgical procedures during COVID-19 found a 30% decline in all cases and a 23% decline in emergent procedures, showing that the decrease in volume was not only due to cancellation of elective procedures.¹⁵ This decrease in elective and emergent surgeries created a backlog of surgeries as well as a loss in health care revenue, and caused many patients to go without adequate health care.¹⁰ Looking forward, it is imperative that surgical centers study trends in OR efficiency from COVID-19 and learn how to better maintain OR efficiency during future pandemic conditions to prevent a backlog of cases, loss of health care revenue, and decreased health care access.

Limitations

Our data are from a single center and therefore may not be representative of experiences of other hospitals due to different populations and different impacts from COVID-19. However, given our center’s high volume and diverse patient population, we believe our analysis highlights important trends in neurosurgery practice. Notably, data for patient and OR timing are digitally generated and are entered manually by nurses in the electronic medical record, making it prone to errors and variability. This is in our experience, and if any error is present, we believe it is minimal.

Conclusion

The COVID-19 pandemic has had far-reaching effects on health care worldwide, including neurosurgical care. OR efficiency across the United States generally worsened given the stresses of supply chain issues, staffing shortages, and cancellations. At our institution, we were able to maintain OR efficiency during the known COVID-19 peaks until October 2021. Continually functional neurosurgical ORs are important in preventing delays in care and maintaining a steady revenue in order for hospitals and other health care entities to remain solvent. Further study of OR efficiency is needed for health care systems to prepare for future pandemics and other resource-straining events in order to provide optimal patient care.

Corresponding author: Campbell Liles, MD, Vanderbilt University Medical Center, Department of Neurological Surgery, 1161 21st Ave. South, T4224 Medical Center North, Nashville, TN 37232-2380; [email protected]

Disclosures: None reported.

Study 1 Overview (STICHES Investigators)

Objective: To assess the survival benefit of coronary-artery bypass grafting (CABG) added to guideline-directed medical therapy, compared to optimal medical therapy (OMT) alone, in patients with coronary artery disease, heart failure, and severe left ventricular dysfunction. Design: Multicenter, randomized, prospective study with extended follow-up (median duration of 9.8 years).

Setting and participants: A total of 1212 patients with left ventricular ejection fraction (LVEF) of 35% or less and coronary artery disease were randomized to medical therapy plus CABG or OMT alone at 127 clinical sites in 26 countries.

Main outcome measures: The primary endpoint was death from any cause. Main secondary endpoints were death from cardiovascular causes and a composite outcome of death from any cause or hospitalization for cardiovascular causes.

Main results: There were 359 primary outcome all-cause deaths (58.9%) in the CABG group and 398 (66.1%) in the medical therapy group (hazard ratio [HR], 0.84; 95% CI, 0.73-0.97; P = .02). Death from cardiovascular causes was reported in 247 patients (40.5%) in the CABG group and 297 patients (49.3%) in the medical therapy group (HR, 0.79; 95% CI, 0.66-0.93; P < .01). The composite outcome of death from any cause or hospitalization for cardiovascular causes occurred in 467 patients (76.6%) in the CABG group and 467 patients (87.0%) in the medical therapy group (HR, 0.72; 95% CI, 0.64-0.82; P < .01).

Conclusion: Over a median follow-up of 9.8 years in patients with ischemic cardiomyopathy with severely reduced ejection fraction, the rates of death from any cause, death from cardiovascular causes, and the composite of death from any cause or hospitalization for cardiovascular causes were significantly lower in patients undergoing CABG than in patients receiving medical therapy alone.

Study 2 Overview (REVIVED BCIS Trial Group)

Objective: To assess whether percutaneous coronary intervention (PCI) can improve survival and left ventricular function in patients with severe left ventricular systolic dysfunction as compared to OMT alone.

Design: Multicenter, randomized, prospective study.

Setting and participants: A total of 700 patients with LVEF <35% with severe coronary artery disease amendable to PCI and demonstrable myocardial viability were randomly assigned to either PCI plus optimal medical therapy (PCI group) or OMT alone (OMT group).

Main outcome measures: The primary outcome was death from any cause or hospitalization for heart failure. The main secondary outcomes were LVEF at 6 and 12 months and quality of life (QOL) scores.

Main results: Over a median follow-up of 41 months, the primary outcome was reported in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the OMT group (HR, 0.99; 95% CI, 0.78-1.27; P = .96). The LVEF was similar in the 2 groups at 6 months (mean difference, –1.6 percentage points; 95% CI, –3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, –1.7 to 3.4). QOL scores at 6 and 12 months favored the PCI group, but the difference had diminished at 24 months.

Conclusion: In patients with severe ischemic cardiomyopathy, revascularization by PCI in addition to OMT did not result in a lower incidence of death from any cause or hospitalization from heart failure.

Commentary

Coronary artery disease is the most common cause of heart failure with reduced ejection fraction and an important cause of mortality.¹ Patients with ischemic cardiomyopathy with reduced ejection fraction are often considered for revascularization in addition to OMT and device therapies. Although there have been multiple retrospective studies and registries suggesting that cardiac outcomes and LVEF improve with revascularization, the number of large-scale prospective studies that assessed this clinical question and randomized patients to revascularization plus OMT compared to OMT alone has been limited.

In the Surgical Treatment for Ischemic Heart Failure (STICH) study,^2,3 eligible patients had coronary artery disease amendable to CABG and a LVEF of 35% or less. Patients (N = 1212) were randomly assigned to CABG plus OMT or OMT alone between July 2002 and May 2007. The original study, with a median follow-up of 5 years, did not show survival benefit, but the investigators reported that the primary outcome of death from any cause was significantly lower in the CABG group compared to OMT alone when follow-up of the same study population was extended to 9.8 years (58.9% vs 66.1%, P = .02). The findings from this study led to a class I guideline recommendation of CABG over medical therapy in patients with multivessel disease and low ejection fraction.⁴

Since the STICH trial was designed, there have been significant improvements in devices and techniques used for PCI, and the procedure is now widely performed in patients with multivessel disease.⁵ The advantages of PCI over CABG include shorter recovery times and lower risk of immediate complications. In this context, the recently reported Revascularization for Ischemic Ventricular Dysfunction (REVIVED) study assessed clinical outcomes in patients with severe coronary artery disease and reduced ejection fraction by randomizing patients to either PCI with OMT or OMT alone.⁶ At a median follow-up of 3.5 years, the investigators found no difference in the primary outcome of death from any cause or hospitalization for heart failure (37.2% vs 38.0%; 95% CI, 0.78-1.28; P = .96). Moreover, the degree of LVEF improvement, assessed by follow-up echocardiogram read by the core lab, showed no difference in the degree of LVEF improvement between groups at 6 and 12 months. Finally, although results of the QOL assessment using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated, patient-reported, heart-failure-specific QOL scale, favored the PCI group at 6 and 12 months of follow-up, the difference had diminished at 24 months.

The main strength of the REVIVED study was that it targeted a patient population with severe coronary artery disease, including left main disease and severely reduced ejection fraction, that historically have been excluded from large-scale randomized controlled studies evaluating PCI with OMT compared to OMT alone.⁷ However, there are several points to consider when interpreting the results of this study. First, further details of the PCI procedures are necessary. The REVIVED study recommended revascularization of all territories with viable myocardium; the anatomical revascularization index utilizing the British Cardiovascular Intervention Society (BCIS) Jeopardy Score was 71%. It is important to note that this jeopardy score was operator-reported and the core-lab adjudicated anatomical revascularization rate may be lower. Although viability testing primarily utilizing cardiac magnetic resonance imaging was performed in most patients, correlation between the revascularization territory and the viable segments has yet to be reported. Moreover, procedural details such as use of intravascular ultrasound and physiological testing, known to improve clinical outcome, need to be reported.^8,9

Second, there is a high prevalence of ischemic cardiomyopathy, and it is important to note that the patients included in this study were highly selected from daily clinical practice, as evidenced by the prolonged enrollment period (8 years). Individuals were largely stable patients with less complex coronary anatomy as evidenced by the median interval from angiography to randomization of 80 days. Taking into consideration the degree of left ventricular dysfunction for patients included in the trial, only 14% of the patients had left main disease and half of the patients only had 2-vessel disease. The severity of the left main disease also needs to be clarified as it is likely that patients the operator determined to be critical were not enrolled in the study. Furthermore, the standard of care based on the STICH trial is to refer patients with severe multivessel coronary artery disease to CABG, making it more likely that patients with more severe and complex disease were not included in this trial. It is also important to note that this study enrolled patients with stable ischemic heart disease, and the data do not apply to patients presenting with acute coronary syndrome.

Third, although the primary outcome was similar between the groups, the secondary outcome of unplanned revascularization was lower in the PCI group. In addition, the rate of acute myocardial infarction (MI) was similar between the 2 groups, but the rate of spontaneous MI was lower in the PCI group compared to the OMT group (5.2% vs 9.3%) as 40% of MI cases in the PCI group were periprocedural MIs. The correlation between periprocedural MI and long-term outcomes has been modest compared to spontaneous MI. Moreover, with the longer follow-up, the number of spontaneous MI cases is expected to rise while the number of periprocedural MI cases is not. Extending the follow-up period is also important, as the STICH extension trial showed a statistically significant difference at 10-year follow up despite negative results at the time of the original publication.

Fourth, the REVIVED trial randomized a significantly lower number of patients compared to the STICH trial, and the authors reported fewer primary-outcome events than the estimated number needed to achieve the power to assess the primary hypothesis. In addition, significant improvements in medical treatment for heart failure with reduced ejection fraction since the STICH trial make comparison of PCI vs CABG in this patient population unfeasible.

Finally, although severe angina was not an exclusion criterion, two-thirds of the patients enrolled had no angina, and only 2% of the patients had baseline severe angina. This is important to consider when interpreting the results of the patient-reported health status as previous studies have shown that patients with worse angina at baseline derive the largest improvement in their QOL,^10,11 and symptom improvement is the main indication for PCI in patients with stable ischemic heart disease.

Applications for Clinical Practice and System Implementation

In patients with severe left ventricular systolic dysfunction and multivessel stable ischemic heart disease who are well compensated and have little or no angina at baseline, OMT alone as an initial strategy may be considered against the addition of PCI after careful risk and benefit discussion. Further details about revascularization and extended follow-up data from the REVIVED trial are necessary.

Practice Points

• Patients with ischemic cardiomyopathy with reduced ejection fraction have been an understudied population in previous studies.
• Further studies are necessary to understand the benefits of revascularization and the role of viability testing in this population.

– Taishi Hirai MD, and Ziad Sayed Ahmad, MD
University of Missouri, Columbia, MO

Study 1 Overview (STICHES Investigators)

Objective: To assess the survival benefit of coronary-artery bypass grafting (CABG) added to guideline-directed medical therapy, compared to optimal medical therapy (OMT) alone, in patients with coronary artery disease, heart failure, and severe left ventricular dysfunction. Design: Multicenter, randomized, prospective study with extended follow-up (median duration of 9.8 years).

Setting and participants: A total of 1212 patients with left ventricular ejection fraction (LVEF) of 35% or less and coronary artery disease were randomized to medical therapy plus CABG or OMT alone at 127 clinical sites in 26 countries.

Main outcome measures: The primary endpoint was death from any cause. Main secondary endpoints were death from cardiovascular causes and a composite outcome of death from any cause or hospitalization for cardiovascular causes.

Main results: There were 359 primary outcome all-cause deaths (58.9%) in the CABG group and 398 (66.1%) in the medical therapy group (hazard ratio [HR], 0.84; 95% CI, 0.73-0.97; P = .02). Death from cardiovascular causes was reported in 247 patients (40.5%) in the CABG group and 297 patients (49.3%) in the medical therapy group (HR, 0.79; 95% CI, 0.66-0.93; P < .01). The composite outcome of death from any cause or hospitalization for cardiovascular causes occurred in 467 patients (76.6%) in the CABG group and 467 patients (87.0%) in the medical therapy group (HR, 0.72; 95% CI, 0.64-0.82; P < .01).

Conclusion: Over a median follow-up of 9.8 years in patients with ischemic cardiomyopathy with severely reduced ejection fraction, the rates of death from any cause, death from cardiovascular causes, and the composite of death from any cause or hospitalization for cardiovascular causes were significantly lower in patients undergoing CABG than in patients receiving medical therapy alone.

Study 2 Overview (REVIVED BCIS Trial Group)

Objective: To assess whether percutaneous coronary intervention (PCI) can improve survival and left ventricular function in patients with severe left ventricular systolic dysfunction as compared to OMT alone.

Design: Multicenter, randomized, prospective study.

Setting and participants: A total of 700 patients with LVEF <35% with severe coronary artery disease amendable to PCI and demonstrable myocardial viability were randomly assigned to either PCI plus optimal medical therapy (PCI group) or OMT alone (OMT group).

Main outcome measures: The primary outcome was death from any cause or hospitalization for heart failure. The main secondary outcomes were LVEF at 6 and 12 months and quality of life (QOL) scores.

Main results: Over a median follow-up of 41 months, the primary outcome was reported in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the OMT group (HR, 0.99; 95% CI, 0.78-1.27; P = .96). The LVEF was similar in the 2 groups at 6 months (mean difference, –1.6 percentage points; 95% CI, –3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, –1.7 to 3.4). QOL scores at 6 and 12 months favored the PCI group, but the difference had diminished at 24 months.

Conclusion: In patients with severe ischemic cardiomyopathy, revascularization by PCI in addition to OMT did not result in a lower incidence of death from any cause or hospitalization from heart failure.

Commentary

Coronary artery disease is the most common cause of heart failure with reduced ejection fraction and an important cause of mortality.¹ Patients with ischemic cardiomyopathy with reduced ejection fraction are often considered for revascularization in addition to OMT and device therapies. Although there have been multiple retrospective studies and registries suggesting that cardiac outcomes and LVEF improve with revascularization, the number of large-scale prospective studies that assessed this clinical question and randomized patients to revascularization plus OMT compared to OMT alone has been limited.

In the Surgical Treatment for Ischemic Heart Failure (STICH) study,^2,3 eligible patients had coronary artery disease amendable to CABG and a LVEF of 35% or less. Patients (N = 1212) were randomly assigned to CABG plus OMT or OMT alone between July 2002 and May 2007. The original study, with a median follow-up of 5 years, did not show survival benefit, but the investigators reported that the primary outcome of death from any cause was significantly lower in the CABG group compared to OMT alone when follow-up of the same study population was extended to 9.8 years (58.9% vs 66.1%, P = .02). The findings from this study led to a class I guideline recommendation of CABG over medical therapy in patients with multivessel disease and low ejection fraction.⁴

Since the STICH trial was designed, there have been significant improvements in devices and techniques used for PCI, and the procedure is now widely performed in patients with multivessel disease.⁵ The advantages of PCI over CABG include shorter recovery times and lower risk of immediate complications. In this context, the recently reported Revascularization for Ischemic Ventricular Dysfunction (REVIVED) study assessed clinical outcomes in patients with severe coronary artery disease and reduced ejection fraction by randomizing patients to either PCI with OMT or OMT alone.⁶ At a median follow-up of 3.5 years, the investigators found no difference in the primary outcome of death from any cause or hospitalization for heart failure (37.2% vs 38.0%; 95% CI, 0.78-1.28; P = .96). Moreover, the degree of LVEF improvement, assessed by follow-up echocardiogram read by the core lab, showed no difference in the degree of LVEF improvement between groups at 6 and 12 months. Finally, although results of the QOL assessment using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated, patient-reported, heart-failure-specific QOL scale, favored the PCI group at 6 and 12 months of follow-up, the difference had diminished at 24 months.

The main strength of the REVIVED study was that it targeted a patient population with severe coronary artery disease, including left main disease and severely reduced ejection fraction, that historically have been excluded from large-scale randomized controlled studies evaluating PCI with OMT compared to OMT alone.⁷ However, there are several points to consider when interpreting the results of this study. First, further details of the PCI procedures are necessary. The REVIVED study recommended revascularization of all territories with viable myocardium; the anatomical revascularization index utilizing the British Cardiovascular Intervention Society (BCIS) Jeopardy Score was 71%. It is important to note that this jeopardy score was operator-reported and the core-lab adjudicated anatomical revascularization rate may be lower. Although viability testing primarily utilizing cardiac magnetic resonance imaging was performed in most patients, correlation between the revascularization territory and the viable segments has yet to be reported. Moreover, procedural details such as use of intravascular ultrasound and physiological testing, known to improve clinical outcome, need to be reported.^8,9

Second, there is a high prevalence of ischemic cardiomyopathy, and it is important to note that the patients included in this study were highly selected from daily clinical practice, as evidenced by the prolonged enrollment period (8 years). Individuals were largely stable patients with less complex coronary anatomy as evidenced by the median interval from angiography to randomization of 80 days. Taking into consideration the degree of left ventricular dysfunction for patients included in the trial, only 14% of the patients had left main disease and half of the patients only had 2-vessel disease. The severity of the left main disease also needs to be clarified as it is likely that patients the operator determined to be critical were not enrolled in the study. Furthermore, the standard of care based on the STICH trial is to refer patients with severe multivessel coronary artery disease to CABG, making it more likely that patients with more severe and complex disease were not included in this trial. It is also important to note that this study enrolled patients with stable ischemic heart disease, and the data do not apply to patients presenting with acute coronary syndrome.

Third, although the primary outcome was similar between the groups, the secondary outcome of unplanned revascularization was lower in the PCI group. In addition, the rate of acute myocardial infarction (MI) was similar between the 2 groups, but the rate of spontaneous MI was lower in the PCI group compared to the OMT group (5.2% vs 9.3%) as 40% of MI cases in the PCI group were periprocedural MIs. The correlation between periprocedural MI and long-term outcomes has been modest compared to spontaneous MI. Moreover, with the longer follow-up, the number of spontaneous MI cases is expected to rise while the number of periprocedural MI cases is not. Extending the follow-up period is also important, as the STICH extension trial showed a statistically significant difference at 10-year follow up despite negative results at the time of the original publication.

Fourth, the REVIVED trial randomized a significantly lower number of patients compared to the STICH trial, and the authors reported fewer primary-outcome events than the estimated number needed to achieve the power to assess the primary hypothesis. In addition, significant improvements in medical treatment for heart failure with reduced ejection fraction since the STICH trial make comparison of PCI vs CABG in this patient population unfeasible.

Finally, although severe angina was not an exclusion criterion, two-thirds of the patients enrolled had no angina, and only 2% of the patients had baseline severe angina. This is important to consider when interpreting the results of the patient-reported health status as previous studies have shown that patients with worse angina at baseline derive the largest improvement in their QOL,^10,11 and symptom improvement is the main indication for PCI in patients with stable ischemic heart disease.

Applications for Clinical Practice and System Implementation

In patients with severe left ventricular systolic dysfunction and multivessel stable ischemic heart disease who are well compensated and have little or no angina at baseline, OMT alone as an initial strategy may be considered against the addition of PCI after careful risk and benefit discussion. Further details about revascularization and extended follow-up data from the REVIVED trial are necessary.

Practice Points

• Patients with ischemic cardiomyopathy with reduced ejection fraction have been an understudied population in previous studies.
• Further studies are necessary to understand the benefits of revascularization and the role of viability testing in this population.

– Taishi Hirai MD, and Ziad Sayed Ahmad, MD
University of Missouri, Columbia, MO

Study 1 Overview (STICHES Investigators)

Objective: To assess the survival benefit of coronary-artery bypass grafting (CABG) added to guideline-directed medical therapy, compared to optimal medical therapy (OMT) alone, in patients with coronary artery disease, heart failure, and severe left ventricular dysfunction. Design: Multicenter, randomized, prospective study with extended follow-up (median duration of 9.8 years).

Setting and participants: A total of 1212 patients with left ventricular ejection fraction (LVEF) of 35% or less and coronary artery disease were randomized to medical therapy plus CABG or OMT alone at 127 clinical sites in 26 countries.

Main outcome measures: The primary endpoint was death from any cause. Main secondary endpoints were death from cardiovascular causes and a composite outcome of death from any cause or hospitalization for cardiovascular causes.

Main results: There were 359 primary outcome all-cause deaths (58.9%) in the CABG group and 398 (66.1%) in the medical therapy group (hazard ratio [HR], 0.84; 95% CI, 0.73-0.97; P = .02). Death from cardiovascular causes was reported in 247 patients (40.5%) in the CABG group and 297 patients (49.3%) in the medical therapy group (HR, 0.79; 95% CI, 0.66-0.93; P < .01). The composite outcome of death from any cause or hospitalization for cardiovascular causes occurred in 467 patients (76.6%) in the CABG group and 467 patients (87.0%) in the medical therapy group (HR, 0.72; 95% CI, 0.64-0.82; P < .01).

Conclusion: Over a median follow-up of 9.8 years in patients with ischemic cardiomyopathy with severely reduced ejection fraction, the rates of death from any cause, death from cardiovascular causes, and the composite of death from any cause or hospitalization for cardiovascular causes were significantly lower in patients undergoing CABG than in patients receiving medical therapy alone.

Study 2 Overview (REVIVED BCIS Trial Group)

Objective: To assess whether percutaneous coronary intervention (PCI) can improve survival and left ventricular function in patients with severe left ventricular systolic dysfunction as compared to OMT alone.

Design: Multicenter, randomized, prospective study.

Setting and participants: A total of 700 patients with LVEF <35% with severe coronary artery disease amendable to PCI and demonstrable myocardial viability were randomly assigned to either PCI plus optimal medical therapy (PCI group) or OMT alone (OMT group).

Main outcome measures: The primary outcome was death from any cause or hospitalization for heart failure. The main secondary outcomes were LVEF at 6 and 12 months and quality of life (QOL) scores.

Main results: Over a median follow-up of 41 months, the primary outcome was reported in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the OMT group (HR, 0.99; 95% CI, 0.78-1.27; P = .96). The LVEF was similar in the 2 groups at 6 months (mean difference, –1.6 percentage points; 95% CI, –3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, –1.7 to 3.4). QOL scores at 6 and 12 months favored the PCI group, but the difference had diminished at 24 months.

Conclusion: In patients with severe ischemic cardiomyopathy, revascularization by PCI in addition to OMT did not result in a lower incidence of death from any cause or hospitalization from heart failure.

Commentary

Coronary artery disease is the most common cause of heart failure with reduced ejection fraction and an important cause of mortality.¹ Patients with ischemic cardiomyopathy with reduced ejection fraction are often considered for revascularization in addition to OMT and device therapies. Although there have been multiple retrospective studies and registries suggesting that cardiac outcomes and LVEF improve with revascularization, the number of large-scale prospective studies that assessed this clinical question and randomized patients to revascularization plus OMT compared to OMT alone has been limited.

In the Surgical Treatment for Ischemic Heart Failure (STICH) study,^2,3 eligible patients had coronary artery disease amendable to CABG and a LVEF of 35% or less. Patients (N = 1212) were randomly assigned to CABG plus OMT or OMT alone between July 2002 and May 2007. The original study, with a median follow-up of 5 years, did not show survival benefit, but the investigators reported that the primary outcome of death from any cause was significantly lower in the CABG group compared to OMT alone when follow-up of the same study population was extended to 9.8 years (58.9% vs 66.1%, P = .02). The findings from this study led to a class I guideline recommendation of CABG over medical therapy in patients with multivessel disease and low ejection fraction.⁴

Since the STICH trial was designed, there have been significant improvements in devices and techniques used for PCI, and the procedure is now widely performed in patients with multivessel disease.⁵ The advantages of PCI over CABG include shorter recovery times and lower risk of immediate complications. In this context, the recently reported Revascularization for Ischemic Ventricular Dysfunction (REVIVED) study assessed clinical outcomes in patients with severe coronary artery disease and reduced ejection fraction by randomizing patients to either PCI with OMT or OMT alone.⁶ At a median follow-up of 3.5 years, the investigators found no difference in the primary outcome of death from any cause or hospitalization for heart failure (37.2% vs 38.0%; 95% CI, 0.78-1.28; P = .96). Moreover, the degree of LVEF improvement, assessed by follow-up echocardiogram read by the core lab, showed no difference in the degree of LVEF improvement between groups at 6 and 12 months. Finally, although results of the QOL assessment using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated, patient-reported, heart-failure-specific QOL scale, favored the PCI group at 6 and 12 months of follow-up, the difference had diminished at 24 months.

The main strength of the REVIVED study was that it targeted a patient population with severe coronary artery disease, including left main disease and severely reduced ejection fraction, that historically have been excluded from large-scale randomized controlled studies evaluating PCI with OMT compared to OMT alone.⁷ However, there are several points to consider when interpreting the results of this study. First, further details of the PCI procedures are necessary. The REVIVED study recommended revascularization of all territories with viable myocardium; the anatomical revascularization index utilizing the British Cardiovascular Intervention Society (BCIS) Jeopardy Score was 71%. It is important to note that this jeopardy score was operator-reported and the core-lab adjudicated anatomical revascularization rate may be lower. Although viability testing primarily utilizing cardiac magnetic resonance imaging was performed in most patients, correlation between the revascularization territory and the viable segments has yet to be reported. Moreover, procedural details such as use of intravascular ultrasound and physiological testing, known to improve clinical outcome, need to be reported.^8,9

Second, there is a high prevalence of ischemic cardiomyopathy, and it is important to note that the patients included in this study were highly selected from daily clinical practice, as evidenced by the prolonged enrollment period (8 years). Individuals were largely stable patients with less complex coronary anatomy as evidenced by the median interval from angiography to randomization of 80 days. Taking into consideration the degree of left ventricular dysfunction for patients included in the trial, only 14% of the patients had left main disease and half of the patients only had 2-vessel disease. The severity of the left main disease also needs to be clarified as it is likely that patients the operator determined to be critical were not enrolled in the study. Furthermore, the standard of care based on the STICH trial is to refer patients with severe multivessel coronary artery disease to CABG, making it more likely that patients with more severe and complex disease were not included in this trial. It is also important to note that this study enrolled patients with stable ischemic heart disease, and the data do not apply to patients presenting with acute coronary syndrome.

Third, although the primary outcome was similar between the groups, the secondary outcome of unplanned revascularization was lower in the PCI group. In addition, the rate of acute myocardial infarction (MI) was similar between the 2 groups, but the rate of spontaneous MI was lower in the PCI group compared to the OMT group (5.2% vs 9.3%) as 40% of MI cases in the PCI group were periprocedural MIs. The correlation between periprocedural MI and long-term outcomes has been modest compared to spontaneous MI. Moreover, with the longer follow-up, the number of spontaneous MI cases is expected to rise while the number of periprocedural MI cases is not. Extending the follow-up period is also important, as the STICH extension trial showed a statistically significant difference at 10-year follow up despite negative results at the time of the original publication.

Fourth, the REVIVED trial randomized a significantly lower number of patients compared to the STICH trial, and the authors reported fewer primary-outcome events than the estimated number needed to achieve the power to assess the primary hypothesis. In addition, significant improvements in medical treatment for heart failure with reduced ejection fraction since the STICH trial make comparison of PCI vs CABG in this patient population unfeasible.

Finally, although severe angina was not an exclusion criterion, two-thirds of the patients enrolled had no angina, and only 2% of the patients had baseline severe angina. This is important to consider when interpreting the results of the patient-reported health status as previous studies have shown that patients with worse angina at baseline derive the largest improvement in their QOL,^10,11 and symptom improvement is the main indication for PCI in patients with stable ischemic heart disease.

Applications for Clinical Practice and System Implementation

In patients with severe left ventricular systolic dysfunction and multivessel stable ischemic heart disease who are well compensated and have little or no angina at baseline, OMT alone as an initial strategy may be considered against the addition of PCI after careful risk and benefit discussion. Further details about revascularization and extended follow-up data from the REVIVED trial are necessary.

Practice Points

• Patients with ischemic cardiomyopathy with reduced ejection fraction have been an understudied population in previous studies.
• Further studies are necessary to understand the benefits of revascularization and the role of viability testing in this population.

– Taishi Hirai MD, and Ziad Sayed Ahmad, MD
University of Missouri, Columbia, MO