Against the backdrop of a near doubling in the incidence of congenital syphilis in the United States, the U.S. Preventive Services Task Force has reaffirmed its 2009 recommendation to screen all pregnant women for syphilis as early as possible in pregnancy.

The advice was the task force’s primary recommendation, based on a systematic review of seven studies and backed by the highest grade of evidence, in a statement published in JAMA. Untreated syphilis can be transmitted to the fetus at any time during pregnancy or birth, and congenital syphilis is associated with significant neonatal morbidity – including bone deformities and neurologic impairment – as well as stillbirth and neonatal death.

The prevalence of congenital syphilis was in decline from 2008 to 2012, but then increased by 87% from 2012 to 2016 – from 8.4 cases per 100,000 live births in 2012 to 15.7 cases in 2016. The increase coincided with rising national rates of syphilis among women of reproductive age – from 0.9 cases of primary and secondary syphilis infection per 100,000 women in 2012 to 1.9 cases in 2016.

Additionally, the task force recommended that pregnant women who had not received prenatal care be screened at delivery.

“Although nearly 70% of infants with congenital syphilis are born to mothers who received prenatal care, detection, and treatment of maternal syphilis often occurs too late to treat the fetus and prevent congenital syphilis,” wrote Susan J. Curry, PhD, from the University of Iowa, Iowa City, and her coauthors. “Recent data suggest that while screening rates for syphilis infection are generally high, the proportion of women screened earlier in pregnancy remains low (for example, 20% of women are screened only at the time of delivery).”

The review pointed to an observational study of the impact of the introduction of syphilis screening during pregnancy in China. That study of more than 2 million women showed that screening for syphilis in pregnancy increased from 89.8% of women in 2002 to 97.2% of women in 2012 and was associated with a decrease in the incidence of congenital syphilis from 109.3 cases to 9.4 cases per 100,000 live births.

The group found convincing evidence that screening reduced both the incidence of congenital syphilis and the risk of adverse outcomes related to maternal infection and that the potential harms of screening – such as false positives – were small.

The paper also referenced guidelines from the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists that high-risk women – such as those living in areas or communities with a higher prevalence of syphilis, women with HIV, or with a history of incarceration or sex work – should also be rescreened early in the third trimester and again at delivery. Similarly, women who are exposed to an infected partner also should be rescreened.

Further, the task force recommended screening for nonpregnant adolescents and adults at increased risk of syphilis infection.

In terms of treatment, the CDC currently recommends parenteral penicillin G benzathine as the treatment of choice for syphilis in pregnant women. However, the task force recommended clinicians consult the CDC website for updates.

The authors noted that no studies that met the inclusion criteria examined whether penicillin use during pregnancy was associated with any harm or looked at serious adverse events in women with a history of penicillin allergy.

“Because the review was primarily focused on screening, it did not address the efficacy of alternative antibiotic treatments [e.g., ceftriaxone] in pregnant women [with or without penicillin allergies],” the authors wrote.

The research was funded by the U.S. Department of Health and Human Services. No conflicts of interest were reported.

SOURCE: Curry S et al. JAMA. 2018;320:911-7.

Against the backdrop of a near doubling in the incidence of congenital syphilis in the United States, the U.S. Preventive Services Task Force has reaffirmed its 2009 recommendation to screen all pregnant women for syphilis as early as possible in pregnancy.

The advice was the task force’s primary recommendation, based on a systematic review of seven studies and backed by the highest grade of evidence, in a statement published in JAMA. Untreated syphilis can be transmitted to the fetus at any time during pregnancy or birth, and congenital syphilis is associated with significant neonatal morbidity – including bone deformities and neurologic impairment – as well as stillbirth and neonatal death.

The prevalence of congenital syphilis was in decline from 2008 to 2012, but then increased by 87% from 2012 to 2016 – from 8.4 cases per 100,000 live births in 2012 to 15.7 cases in 2016. The increase coincided with rising national rates of syphilis among women of reproductive age – from 0.9 cases of primary and secondary syphilis infection per 100,000 women in 2012 to 1.9 cases in 2016.

Additionally, the task force recommended that pregnant women who had not received prenatal care be screened at delivery.

“Although nearly 70% of infants with congenital syphilis are born to mothers who received prenatal care, detection, and treatment of maternal syphilis often occurs too late to treat the fetus and prevent congenital syphilis,” wrote Susan J. Curry, PhD, from the University of Iowa, Iowa City, and her coauthors. “Recent data suggest that while screening rates for syphilis infection are generally high, the proportion of women screened earlier in pregnancy remains low (for example, 20% of women are screened only at the time of delivery).”

The review pointed to an observational study of the impact of the introduction of syphilis screening during pregnancy in China. That study of more than 2 million women showed that screening for syphilis in pregnancy increased from 89.8% of women in 2002 to 97.2% of women in 2012 and was associated with a decrease in the incidence of congenital syphilis from 109.3 cases to 9.4 cases per 100,000 live births.

The group found convincing evidence that screening reduced both the incidence of congenital syphilis and the risk of adverse outcomes related to maternal infection and that the potential harms of screening – such as false positives – were small.

The paper also referenced guidelines from the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists that high-risk women – such as those living in areas or communities with a higher prevalence of syphilis, women with HIV, or with a history of incarceration or sex work – should also be rescreened early in the third trimester and again at delivery. Similarly, women who are exposed to an infected partner also should be rescreened.

Further, the task force recommended screening for nonpregnant adolescents and adults at increased risk of syphilis infection.

In terms of treatment, the CDC currently recommends parenteral penicillin G benzathine as the treatment of choice for syphilis in pregnant women. However, the task force recommended clinicians consult the CDC website for updates.

The authors noted that no studies that met the inclusion criteria examined whether penicillin use during pregnancy was associated with any harm or looked at serious adverse events in women with a history of penicillin allergy.

“Because the review was primarily focused on screening, it did not address the efficacy of alternative antibiotic treatments [e.g., ceftriaxone] in pregnant women [with or without penicillin allergies],” the authors wrote.

The research was funded by the U.S. Department of Health and Human Services. No conflicts of interest were reported.

SOURCE: Curry S et al. JAMA. 2018;320:911-7.

Against the backdrop of a near doubling in the incidence of congenital syphilis in the United States, the U.S. Preventive Services Task Force has reaffirmed its 2009 recommendation to screen all pregnant women for syphilis as early as possible in pregnancy.

The advice was the task force’s primary recommendation, based on a systematic review of seven studies and backed by the highest grade of evidence, in a statement published in JAMA. Untreated syphilis can be transmitted to the fetus at any time during pregnancy or birth, and congenital syphilis is associated with significant neonatal morbidity – including bone deformities and neurologic impairment – as well as stillbirth and neonatal death.

The prevalence of congenital syphilis was in decline from 2008 to 2012, but then increased by 87% from 2012 to 2016 – from 8.4 cases per 100,000 live births in 2012 to 15.7 cases in 2016. The increase coincided with rising national rates of syphilis among women of reproductive age – from 0.9 cases of primary and secondary syphilis infection per 100,000 women in 2012 to 1.9 cases in 2016.

Additionally, the task force recommended that pregnant women who had not received prenatal care be screened at delivery.

“Although nearly 70% of infants with congenital syphilis are born to mothers who received prenatal care, detection, and treatment of maternal syphilis often occurs too late to treat the fetus and prevent congenital syphilis,” wrote Susan J. Curry, PhD, from the University of Iowa, Iowa City, and her coauthors. “Recent data suggest that while screening rates for syphilis infection are generally high, the proportion of women screened earlier in pregnancy remains low (for example, 20% of women are screened only at the time of delivery).”

The review pointed to an observational study of the impact of the introduction of syphilis screening during pregnancy in China. That study of more than 2 million women showed that screening for syphilis in pregnancy increased from 89.8% of women in 2002 to 97.2% of women in 2012 and was associated with a decrease in the incidence of congenital syphilis from 109.3 cases to 9.4 cases per 100,000 live births.

The group found convincing evidence that screening reduced both the incidence of congenital syphilis and the risk of adverse outcomes related to maternal infection and that the potential harms of screening – such as false positives – were small.

The paper also referenced guidelines from the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists that high-risk women – such as those living in areas or communities with a higher prevalence of syphilis, women with HIV, or with a history of incarceration or sex work – should also be rescreened early in the third trimester and again at delivery. Similarly, women who are exposed to an infected partner also should be rescreened.

Further, the task force recommended screening for nonpregnant adolescents and adults at increased risk of syphilis infection.

In terms of treatment, the CDC currently recommends parenteral penicillin G benzathine as the treatment of choice for syphilis in pregnant women. However, the task force recommended clinicians consult the CDC website for updates.

The authors noted that no studies that met the inclusion criteria examined whether penicillin use during pregnancy was associated with any harm or looked at serious adverse events in women with a history of penicillin allergy.

“Because the review was primarily focused on screening, it did not address the efficacy of alternative antibiotic treatments [e.g., ceftriaxone] in pregnant women [with or without penicillin allergies],” the authors wrote.

The research was funded by the U.S. Department of Health and Human Services. No conflicts of interest were reported.

SOURCE: Curry S et al. JAMA. 2018;320:911-7.

Practicing in the field of obstetrics and gynecology affords us a special privilege: we are part of the most important and unforgettable events in our patients’ lives, both in sickness and in health. Along with the great joys we share comes profound responsibility and the recognition that we are only as effective as the team with whom we work. Although we live in a country that is home to some of the best health care systems in the world, the maternal mortality rates and disease burden among women in underserved communities belie this fact. A University of Washington study demonstrated a more than 20-year gap in life expectancy between wealthy and poor communities in the United States from 1980 to 2014.¹ Not surprisingly, access to medical care was a contributing factor.

Poverty only partly explains this disparity. Racial differences are at play as well. In 1992, a seminal study by Schoendorf and colleagues² demonstrated that the death rates of babies born to educated African American parents were higher due to lower birth weights. Concern recently has been amplified, and many lay publications have publicly raised the alarm.³ Several states have started investigating the causes, and the American College of Obstetrics and Gynecology, as well as other organizations, are studying possible solutions.

With nearly 50% of US births financed by Medicaid,⁵ there was great hope that the Patient Protection and Affordable Care Act and expansion of Medicaid would result in improved access and quality of health care for underserved patients; however, it has become apparent that coverage did not confer improved access to quality care, especially for medical specialties.

Urban and rural poor populations generally seek medical services from safety net clinics staffed by midlevel and physician primary care providers whose tight schedules, documentation demands, and low reimbursement rates are coupled with complex medical and socioeconomic patient populations. While these providers may be skilled in basic primary care, their patients often present with conditions outside their scope of practice. Our country’s growing physician shortage, along with patient location and personal logistics, adds to the challenges for patients and providers alike. And who among us is not asked several times a week, even by our well-insured patients, for a primary care or specialist physician recommendation? The barriers for seeking medical care in rural populations are even greater, as local hospitals and clinics are closing at an alarming rate.

Alumni at work

Communities of physicians across the country recognize both the access problem and the potential to create solutions. Organizations such as Project ECHO, launched in 2003 through the University of New Mexico, connect rural providers with university physicians to aid in treatment of hepatitis C and other illnesses.

As the date for implementation of the Patient Protection and Affordable Care Act approached, a group of medical school alumni leaders recognized that we could come together and offer our services to address growing health care disparities. Galvanized by the challenge, the Medical Alumni Volunteer Expert Network, or MAVEN Project, was, in our parlance, “born.”

While the concept of the MAVEN Project was germinating, we interviewed numerous colleagues for advice and input and were struck by their desire—especially among the newly retired—to continue to give back. Medicine is a calling, not just a job, and for many of us the joy of helping—the exhilaration of that first birth that sold us on our specialty—gives us meaning and purpose. Many physicians who had left full-time clinical medicine missed the collegiality of the “doctors’ lounge.” Throughout our careers, we are part of a cohort: our medical school class, our residency partners, our hospital staff—we all crave community. With 36% of US physicians older than age 55 and 240,000 retired doctors in the country, we realized a motivated, previously untapped workforce could be marshaled to form a community to serve the most vulnerable among us.⁵

At the same time, telemedicine had come into its own. Simple technology could enable us to see each other on smartphones and computers and even perform portions of a physical examination from afar.

We realized we could marry opportunity (the workforce), need (underserved populations across the country), and technology. The Harvard Medical School Center Primary Care supported a feasibility study, and the MAVEN Project began “seeing” patients in 2016.

A model of hope

The MAVEN Project matches physician volunteers with safety net clinics serving patients in need and provides malpractice insurance and a Health Information Portability and Accountability Act–compliant technology platform to facilitate remote communication. Our volunteers mentor and educate primary care providers in the field and offer both immediate and asynchronous advisory consults. Clinic providers can group cases for discussion, ask urgent questions, or receive advice and support for the day-to-day challenges facing clinicians today. Clinics choose educational topics, focusing on tools needed for patient care rather than esoteric mechanisms of disease. Patients receive best-in-class care conveniently and locally, and by making volunteering easy, we build partnerships that augment patient and provider satisfaction, support long-term capacity building, and improve service delivery.

Our volunteer physicians now represent more than 30 medical specialties and 25 medical schools, and we have completed more than 2,000 consultations to date. Our clinics are located in 6 states (California, Florida, Massachusetts, New York, South Dakota, and Washington), and thanks to our model, physician state of licensure is not an impediment to volunteering. Several colleagues in our specialty are providing advice in women’s health.

Driving innovative solutions

Elizabeth Kopin, MD, an ObGyn who practiced for 28 years in Worcester, Massachusetts, and volunteers for the MAVEN Project, eloquently described in correspondence with Project coordinators the spirit that embodies the pursuit of medicine and the organization’s mission. As Dr. Kopin stated, “The driving force behind my entering medicine was to help people in an essential and meaningful way. I was especially driven to participate in the care of women. I wanted to gain knowledge and skills to help women with health care throughout their lives.”

Dr. Kopin’s capacity to care for patients in the clinic and hospital was progressively reduced as her multiple sclerosis advanced. As a result, she retired from clinical practice, but her desire to participate and contribute to medicine with the passion with which she entered it remained.

Her father was an internist who started a charitable clinic in Georgia. Like her father, Dr. Kopin began her medical career in academic medicine. Her father felt that his last 15 years in medicine were the most meaningful of his career because of his work with underserved populations. Dr. Kopin is following in his footsteps. For her, “Looking for a telehealth vehicle helping communities in need gives me the opportunity to use my abilities in the best way possible.” Dr. Kopin also stated, “Helping the underserved was something I wanted to devote my time to and The MAVEN Project has given me that possibility.”

We like to think of ourselves as Match. com meets the Peace Corps, with the goal to reach underserved patients in all 50 states in both rural and urban communities. We ask for as little as 4 hours of your time per month, and all you need is a computer or smartphone and a medical license. We welcome volunteers in active or part-time practice, academics, and industry: your years of wisdom are invaluable.

The vast complexities of the US health care system are by no measure easy to address, but standing by and allowing a fractured system to rupture is not an option. Each of us has an expertise and an opportunity to make incremental steps to ensure that those who need health care do not slip through the cracks. Dr. Kopin and I are fortunate to have a skill to help others and, in the MAVEN Project, a robust, dedicated network of individuals who share our vision.

There are many who have and continue to inspire a guiding conscience to serve beyond oneself. George H.W. Bush said it best when explaining why he founded the Points of Light organization nearly 3 decades ago⁶:

I have pursued life itself over many years now and with varying degrees of happiness. Some of my happiness still comes from trying to be in my own small way a true “point of light.” I believe I was right when I said, as President, there can be no definition of a successful life that does not include service to others. So I do that now, and I gain happiness. I do not seek a Pulitzer Prize. I do not want press attention…. I have found happiness. I no longer pursue it, for it is mine.

Please join us on our mission!

How to join

We are actively seeking specialty and primary care physicians to provide advisory consultations, mentorship, and education via telehealth technology. We welcome physician volunteers who:

• are newly retired, semi-retired, in industry, or in clinical practice
• have a minimum of 2 years of clinical practice experience
• have been active in the medical community in the past 3 years
• have an active or volunteer US medical license (any state)
• are able to provide 3 professional references
• are willing to commit a minimum of 4 hours per month for 6 months.

Visit us online to complete our physician volunteer inquiry form (https://www.mavenproject.org/work-with-us/#wwu-volunteer-as-a-physician-lightblue).

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Practicing in the field of obstetrics and gynecology affords us a special privilege: we are part of the most important and unforgettable events in our patients’ lives, both in sickness and in health. Along with the great joys we share comes profound responsibility and the recognition that we are only as effective as the team with whom we work. Although we live in a country that is home to some of the best health care systems in the world, the maternal mortality rates and disease burden among women in underserved communities belie this fact. A University of Washington study demonstrated a more than 20-year gap in life expectancy between wealthy and poor communities in the United States from 1980 to 2014.¹ Not surprisingly, access to medical care was a contributing factor.

Poverty only partly explains this disparity. Racial differences are at play as well. In 1992, a seminal study by Schoendorf and colleagues² demonstrated that the death rates of babies born to educated African American parents were higher due to lower birth weights. Concern recently has been amplified, and many lay publications have publicly raised the alarm.³ Several states have started investigating the causes, and the American College of Obstetrics and Gynecology, as well as other organizations, are studying possible solutions.

With nearly 50% of US births financed by Medicaid,⁵ there was great hope that the Patient Protection and Affordable Care Act and expansion of Medicaid would result in improved access and quality of health care for underserved patients; however, it has become apparent that coverage did not confer improved access to quality care, especially for medical specialties.

Urban and rural poor populations generally seek medical services from safety net clinics staffed by midlevel and physician primary care providers whose tight schedules, documentation demands, and low reimbursement rates are coupled with complex medical and socioeconomic patient populations. While these providers may be skilled in basic primary care, their patients often present with conditions outside their scope of practice. Our country’s growing physician shortage, along with patient location and personal logistics, adds to the challenges for patients and providers alike. And who among us is not asked several times a week, even by our well-insured patients, for a primary care or specialist physician recommendation? The barriers for seeking medical care in rural populations are even greater, as local hospitals and clinics are closing at an alarming rate.

Alumni at work

Communities of physicians across the country recognize both the access problem and the potential to create solutions. Organizations such as Project ECHO, launched in 2003 through the University of New Mexico, connect rural providers with university physicians to aid in treatment of hepatitis C and other illnesses.

As the date for implementation of the Patient Protection and Affordable Care Act approached, a group of medical school alumni leaders recognized that we could come together and offer our services to address growing health care disparities. Galvanized by the challenge, the Medical Alumni Volunteer Expert Network, or MAVEN Project, was, in our parlance, “born.”

While the concept of the MAVEN Project was germinating, we interviewed numerous colleagues for advice and input and were struck by their desire—especially among the newly retired—to continue to give back. Medicine is a calling, not just a job, and for many of us the joy of helping—the exhilaration of that first birth that sold us on our specialty—gives us meaning and purpose. Many physicians who had left full-time clinical medicine missed the collegiality of the “doctors’ lounge.” Throughout our careers, we are part of a cohort: our medical school class, our residency partners, our hospital staff—we all crave community. With 36% of US physicians older than age 55 and 240,000 retired doctors in the country, we realized a motivated, previously untapped workforce could be marshaled to form a community to serve the most vulnerable among us.⁵

At the same time, telemedicine had come into its own. Simple technology could enable us to see each other on smartphones and computers and even perform portions of a physical examination from afar.

We realized we could marry opportunity (the workforce), need (underserved populations across the country), and technology. The Harvard Medical School Center Primary Care supported a feasibility study, and the MAVEN Project began “seeing” patients in 2016.

A model of hope

The MAVEN Project matches physician volunteers with safety net clinics serving patients in need and provides malpractice insurance and a Health Information Portability and Accountability Act–compliant technology platform to facilitate remote communication. Our volunteers mentor and educate primary care providers in the field and offer both immediate and asynchronous advisory consults. Clinic providers can group cases for discussion, ask urgent questions, or receive advice and support for the day-to-day challenges facing clinicians today. Clinics choose educational topics, focusing on tools needed for patient care rather than esoteric mechanisms of disease. Patients receive best-in-class care conveniently and locally, and by making volunteering easy, we build partnerships that augment patient and provider satisfaction, support long-term capacity building, and improve service delivery.

Our volunteer physicians now represent more than 30 medical specialties and 25 medical schools, and we have completed more than 2,000 consultations to date. Our clinics are located in 6 states (California, Florida, Massachusetts, New York, South Dakota, and Washington), and thanks to our model, physician state of licensure is not an impediment to volunteering. Several colleagues in our specialty are providing advice in women’s health.

Driving innovative solutions

Elizabeth Kopin, MD, an ObGyn who practiced for 28 years in Worcester, Massachusetts, and volunteers for the MAVEN Project, eloquently described in correspondence with Project coordinators the spirit that embodies the pursuit of medicine and the organization’s mission. As Dr. Kopin stated, “The driving force behind my entering medicine was to help people in an essential and meaningful way. I was especially driven to participate in the care of women. I wanted to gain knowledge and skills to help women with health care throughout their lives.”

Dr. Kopin’s capacity to care for patients in the clinic and hospital was progressively reduced as her multiple sclerosis advanced. As a result, she retired from clinical practice, but her desire to participate and contribute to medicine with the passion with which she entered it remained.

Her father was an internist who started a charitable clinic in Georgia. Like her father, Dr. Kopin began her medical career in academic medicine. Her father felt that his last 15 years in medicine were the most meaningful of his career because of his work with underserved populations. Dr. Kopin is following in his footsteps. For her, “Looking for a telehealth vehicle helping communities in need gives me the opportunity to use my abilities in the best way possible.” Dr. Kopin also stated, “Helping the underserved was something I wanted to devote my time to and The MAVEN Project has given me that possibility.”

We like to think of ourselves as Match. com meets the Peace Corps, with the goal to reach underserved patients in all 50 states in both rural and urban communities. We ask for as little as 4 hours of your time per month, and all you need is a computer or smartphone and a medical license. We welcome volunteers in active or part-time practice, academics, and industry: your years of wisdom are invaluable.

The vast complexities of the US health care system are by no measure easy to address, but standing by and allowing a fractured system to rupture is not an option. Each of us has an expertise and an opportunity to make incremental steps to ensure that those who need health care do not slip through the cracks. Dr. Kopin and I are fortunate to have a skill to help others and, in the MAVEN Project, a robust, dedicated network of individuals who share our vision.

There are many who have and continue to inspire a guiding conscience to serve beyond oneself. George H.W. Bush said it best when explaining why he founded the Points of Light organization nearly 3 decades ago⁶:

I have pursued life itself over many years now and with varying degrees of happiness. Some of my happiness still comes from trying to be in my own small way a true “point of light.” I believe I was right when I said, as President, there can be no definition of a successful life that does not include service to others. So I do that now, and I gain happiness. I do not seek a Pulitzer Prize. I do not want press attention…. I have found happiness. I no longer pursue it, for it is mine.

Please join us on our mission!

How to join

We are actively seeking specialty and primary care physicians to provide advisory consultations, mentorship, and education via telehealth technology. We welcome physician volunteers who:

• are newly retired, semi-retired, in industry, or in clinical practice
• have a minimum of 2 years of clinical practice experience
• have been active in the medical community in the past 3 years
• have an active or volunteer US medical license (any state)
• are able to provide 3 professional references
• are willing to commit a minimum of 4 hours per month for 6 months.

Visit us online to complete our physician volunteer inquiry form (https://www.mavenproject.org/work-with-us/#wwu-volunteer-as-a-physician-lightblue).

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Practicing in the field of obstetrics and gynecology affords us a special privilege: we are part of the most important and unforgettable events in our patients’ lives, both in sickness and in health. Along with the great joys we share comes profound responsibility and the recognition that we are only as effective as the team with whom we work. Although we live in a country that is home to some of the best health care systems in the world, the maternal mortality rates and disease burden among women in underserved communities belie this fact. A University of Washington study demonstrated a more than 20-year gap in life expectancy between wealthy and poor communities in the United States from 1980 to 2014.¹ Not surprisingly, access to medical care was a contributing factor.

Poverty only partly explains this disparity. Racial differences are at play as well. In 1992, a seminal study by Schoendorf and colleagues² demonstrated that the death rates of babies born to educated African American parents were higher due to lower birth weights. Concern recently has been amplified, and many lay publications have publicly raised the alarm.³ Several states have started investigating the causes, and the American College of Obstetrics and Gynecology, as well as other organizations, are studying possible solutions.

With nearly 50% of US births financed by Medicaid,⁵ there was great hope that the Patient Protection and Affordable Care Act and expansion of Medicaid would result in improved access and quality of health care for underserved patients; however, it has become apparent that coverage did not confer improved access to quality care, especially for medical specialties.

Urban and rural poor populations generally seek medical services from safety net clinics staffed by midlevel and physician primary care providers whose tight schedules, documentation demands, and low reimbursement rates are coupled with complex medical and socioeconomic patient populations. While these providers may be skilled in basic primary care, their patients often present with conditions outside their scope of practice. Our country’s growing physician shortage, along with patient location and personal logistics, adds to the challenges for patients and providers alike. And who among us is not asked several times a week, even by our well-insured patients, for a primary care or specialist physician recommendation? The barriers for seeking medical care in rural populations are even greater, as local hospitals and clinics are closing at an alarming rate.

Alumni at work

Communities of physicians across the country recognize both the access problem and the potential to create solutions. Organizations such as Project ECHO, launched in 2003 through the University of New Mexico, connect rural providers with university physicians to aid in treatment of hepatitis C and other illnesses.

As the date for implementation of the Patient Protection and Affordable Care Act approached, a group of medical school alumni leaders recognized that we could come together and offer our services to address growing health care disparities. Galvanized by the challenge, the Medical Alumni Volunteer Expert Network, or MAVEN Project, was, in our parlance, “born.”

While the concept of the MAVEN Project was germinating, we interviewed numerous colleagues for advice and input and were struck by their desire—especially among the newly retired—to continue to give back. Medicine is a calling, not just a job, and for many of us the joy of helping—the exhilaration of that first birth that sold us on our specialty—gives us meaning and purpose. Many physicians who had left full-time clinical medicine missed the collegiality of the “doctors’ lounge.” Throughout our careers, we are part of a cohort: our medical school class, our residency partners, our hospital staff—we all crave community. With 36% of US physicians older than age 55 and 240,000 retired doctors in the country, we realized a motivated, previously untapped workforce could be marshaled to form a community to serve the most vulnerable among us.⁵

At the same time, telemedicine had come into its own. Simple technology could enable us to see each other on smartphones and computers and even perform portions of a physical examination from afar.

We realized we could marry opportunity (the workforce), need (underserved populations across the country), and technology. The Harvard Medical School Center Primary Care supported a feasibility study, and the MAVEN Project began “seeing” patients in 2016.

A model of hope

The MAVEN Project matches physician volunteers with safety net clinics serving patients in need and provides malpractice insurance and a Health Information Portability and Accountability Act–compliant technology platform to facilitate remote communication. Our volunteers mentor and educate primary care providers in the field and offer both immediate and asynchronous advisory consults. Clinic providers can group cases for discussion, ask urgent questions, or receive advice and support for the day-to-day challenges facing clinicians today. Clinics choose educational topics, focusing on tools needed for patient care rather than esoteric mechanisms of disease. Patients receive best-in-class care conveniently and locally, and by making volunteering easy, we build partnerships that augment patient and provider satisfaction, support long-term capacity building, and improve service delivery.

Our volunteer physicians now represent more than 30 medical specialties and 25 medical schools, and we have completed more than 2,000 consultations to date. Our clinics are located in 6 states (California, Florida, Massachusetts, New York, South Dakota, and Washington), and thanks to our model, physician state of licensure is not an impediment to volunteering. Several colleagues in our specialty are providing advice in women’s health.

Driving innovative solutions

Elizabeth Kopin, MD, an ObGyn who practiced for 28 years in Worcester, Massachusetts, and volunteers for the MAVEN Project, eloquently described in correspondence with Project coordinators the spirit that embodies the pursuit of medicine and the organization’s mission. As Dr. Kopin stated, “The driving force behind my entering medicine was to help people in an essential and meaningful way. I was especially driven to participate in the care of women. I wanted to gain knowledge and skills to help women with health care throughout their lives.”

Dr. Kopin’s capacity to care for patients in the clinic and hospital was progressively reduced as her multiple sclerosis advanced. As a result, she retired from clinical practice, but her desire to participate and contribute to medicine with the passion with which she entered it remained.

Her father was an internist who started a charitable clinic in Georgia. Like her father, Dr. Kopin began her medical career in academic medicine. Her father felt that his last 15 years in medicine were the most meaningful of his career because of his work with underserved populations. Dr. Kopin is following in his footsteps. For her, “Looking for a telehealth vehicle helping communities in need gives me the opportunity to use my abilities in the best way possible.” Dr. Kopin also stated, “Helping the underserved was something I wanted to devote my time to and The MAVEN Project has given me that possibility.”

We like to think of ourselves as Match. com meets the Peace Corps, with the goal to reach underserved patients in all 50 states in both rural and urban communities. We ask for as little as 4 hours of your time per month, and all you need is a computer or smartphone and a medical license. We welcome volunteers in active or part-time practice, academics, and industry: your years of wisdom are invaluable.

The vast complexities of the US health care system are by no measure easy to address, but standing by and allowing a fractured system to rupture is not an option. Each of us has an expertise and an opportunity to make incremental steps to ensure that those who need health care do not slip through the cracks. Dr. Kopin and I are fortunate to have a skill to help others and, in the MAVEN Project, a robust, dedicated network of individuals who share our vision.

There are many who have and continue to inspire a guiding conscience to serve beyond oneself. George H.W. Bush said it best when explaining why he founded the Points of Light organization nearly 3 decades ago⁶:

I have pursued life itself over many years now and with varying degrees of happiness. Some of my happiness still comes from trying to be in my own small way a true “point of light.” I believe I was right when I said, as President, there can be no definition of a successful life that does not include service to others. So I do that now, and I gain happiness. I do not seek a Pulitzer Prize. I do not want press attention…. I have found happiness. I no longer pursue it, for it is mine.

Please join us on our mission!

How to join

We are actively seeking specialty and primary care physicians to provide advisory consultations, mentorship, and education via telehealth technology. We welcome physician volunteers who:

• are newly retired, semi-retired, in industry, or in clinical practice
• have a minimum of 2 years of clinical practice experience
• have been active in the medical community in the past 3 years
• have an active or volunteer US medical license (any state)
• are able to provide 3 professional references
• are willing to commit a minimum of 4 hours per month for 6 months.

Visit us online to complete our physician volunteer inquiry form (https://www.mavenproject.org/work-with-us/#wwu-volunteer-as-a-physician-lightblue).

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The European Commission has approved a new indication for daratumumab (Darzalex), according to the manufacturer.

The drug is now authorized for use in combination with bortezomib, melphalan, and prednisone (VMP) to treat adults with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant, according to a press release published on the Genmab website.

Daratumumab was previously approved by the European Commission (EC) for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone to treat adults with MM who have received at least one prior therapy.

In addition, daratumumab is approved by the EC as monotherapy for adults with relapsed and refractory MM whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who had disease progression on their last therapy.

The EC’s latest approval for daratumumab is based on results from the phase 3 ALCYONE trial. Results from this study were presented at the 2017 annual meeting of the American Society of Hematology and simultaneously published in the New England Journal of Medicine.

ALCYONE enrolled 706 patients with newly diagnosed MM who were not eligible for high-dose chemotherapy with autologous stem cell transplant. Patients were randomized to receive VMP or daratumumab plus VMP (D-VMP).

The overall response rates were 91% in the D-VMP arm and 74% in the VMP arm (P less than.0001), and rates of complete response were 43% and 24%, respectively. Rates of minimal residual disease negativity were 22% and 6%, respectively.

[email protected]

The European Commission has approved a new indication for daratumumab (Darzalex), according to the manufacturer.

The drug is now authorized for use in combination with bortezomib, melphalan, and prednisone (VMP) to treat adults with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant, according to a press release published on the Genmab website.

Daratumumab was previously approved by the European Commission (EC) for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone to treat adults with MM who have received at least one prior therapy.

In addition, daratumumab is approved by the EC as monotherapy for adults with relapsed and refractory MM whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who had disease progression on their last therapy.

The EC’s latest approval for daratumumab is based on results from the phase 3 ALCYONE trial. Results from this study were presented at the 2017 annual meeting of the American Society of Hematology and simultaneously published in the New England Journal of Medicine.

ALCYONE enrolled 706 patients with newly diagnosed MM who were not eligible for high-dose chemotherapy with autologous stem cell transplant. Patients were randomized to receive VMP or daratumumab plus VMP (D-VMP).

The overall response rates were 91% in the D-VMP arm and 74% in the VMP arm (P less than.0001), and rates of complete response were 43% and 24%, respectively. Rates of minimal residual disease negativity were 22% and 6%, respectively.

[email protected]

The European Commission has approved a new indication for daratumumab (Darzalex), according to the manufacturer.

The drug is now authorized for use in combination with bortezomib, melphalan, and prednisone (VMP) to treat adults with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant, according to a press release published on the Genmab website.

Daratumumab was previously approved by the European Commission (EC) for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone to treat adults with MM who have received at least one prior therapy.

In addition, daratumumab is approved by the EC as monotherapy for adults with relapsed and refractory MM whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who had disease progression on their last therapy.

The EC’s latest approval for daratumumab is based on results from the phase 3 ALCYONE trial. Results from this study were presented at the 2017 annual meeting of the American Society of Hematology and simultaneously published in the New England Journal of Medicine.

ALCYONE enrolled 706 patients with newly diagnosed MM who were not eligible for high-dose chemotherapy with autologous stem cell transplant. Patients were randomized to receive VMP or daratumumab plus VMP (D-VMP).

The overall response rates were 91% in the D-VMP arm and 74% in the VMP arm (P less than.0001), and rates of complete response were 43% and 24%, respectively. Rates of minimal residual disease negativity were 22% and 6%, respectively.

[email protected]

Approximately one-third of children seen for head trauma visits in EDs underwent CT scans over a 9-year period in the United States, despite quality improvement initiatives to reduce unnecessary scans, based on a data from a cross-sectional survey published in Pediatrics.

©Thinkstock.com

“Computed tomography (CT) is the reference standard to provide a rapid and definitive diagnosis of intracranial pathology but must be balanced against the risks of radiation-induced malignancy,” wrote Brett Burstein, MD, PhD, of Harvard T.H. Chan School of Public Health, Cambridge, Mass., and his colleagues.

The researchers reviewed data from National Hospital Ambulatory Care Medical Survey database of nationally representative ED visits by children younger than 18 years for head trauma from 2007 to 2015. The median age of the patients was 6 years; 61% were boys. Approximately 88% were seen in nonteaching or nonpediatric hospitals.

During the 9-year period, 32% of 3,054 children underwent head CT scans; the 3,054 represented an estimated 14.3 million children making pediatric ED visits for head trauma. No significant differences were noted from year to year after the researchers controlled for confounding patient and ED factors.

Overall, use of CT was associated with patient’s age 2 years and older (adjusted odds ratio 1.51), white race (aOR 1.43), highest level of triage (aOR 8.24), and treatment at a nonteaching or nonpediatric hospital (aOR 1.47 and 1.53, respectively).

No significant differences in CT use were observed when the researchers compared the periods before (2007-2009) and after (2010-2015) the introduction of the Pediatric Emergency Care Applied Research Network (PECARN) rules – a clinical prediction protocol to assess head injuries in children in an ED setting. The unadjusted proportion of children who underwent CTs during the before PECARN and after PECARN periods was 33% and 31%, respectively.

“The finding of no decrease in CT neuroimaging during the 9-year study period, and particularly after the publication of the PECARN rules in 2009, was counter to the a priori hypothesis of this study,” Dr. Burstein and his associates noted.

The findings were limited by several factors including the lack of data on the severity of the head injuries, data on repeat visits, and potential misclassification of hospitals, they said. However, the results highlight the need for targeted interventions to disseminate the latest clinical decisions into practice.

Dr. Burstein and his associates had no financial conflicts to disclose.

SOURCE: Burstein B al. Pediatrics. 2018 Sept 4. doi: 10.1542/peds.2018-0814.

Approximately one-third of children seen for head trauma visits in EDs underwent CT scans over a 9-year period in the United States, despite quality improvement initiatives to reduce unnecessary scans, based on a data from a cross-sectional survey published in Pediatrics.

©Thinkstock.com

“Computed tomography (CT) is the reference standard to provide a rapid and definitive diagnosis of intracranial pathology but must be balanced against the risks of radiation-induced malignancy,” wrote Brett Burstein, MD, PhD, of Harvard T.H. Chan School of Public Health, Cambridge, Mass., and his colleagues.

The researchers reviewed data from National Hospital Ambulatory Care Medical Survey database of nationally representative ED visits by children younger than 18 years for head trauma from 2007 to 2015. The median age of the patients was 6 years; 61% were boys. Approximately 88% were seen in nonteaching or nonpediatric hospitals.

During the 9-year period, 32% of 3,054 children underwent head CT scans; the 3,054 represented an estimated 14.3 million children making pediatric ED visits for head trauma. No significant differences were noted from year to year after the researchers controlled for confounding patient and ED factors.

Overall, use of CT was associated with patient’s age 2 years and older (adjusted odds ratio 1.51), white race (aOR 1.43), highest level of triage (aOR 8.24), and treatment at a nonteaching or nonpediatric hospital (aOR 1.47 and 1.53, respectively).

No significant differences in CT use were observed when the researchers compared the periods before (2007-2009) and after (2010-2015) the introduction of the Pediatric Emergency Care Applied Research Network (PECARN) rules – a clinical prediction protocol to assess head injuries in children in an ED setting. The unadjusted proportion of children who underwent CTs during the before PECARN and after PECARN periods was 33% and 31%, respectively.

“The finding of no decrease in CT neuroimaging during the 9-year study period, and particularly after the publication of the PECARN rules in 2009, was counter to the a priori hypothesis of this study,” Dr. Burstein and his associates noted.

The findings were limited by several factors including the lack of data on the severity of the head injuries, data on repeat visits, and potential misclassification of hospitals, they said. However, the results highlight the need for targeted interventions to disseminate the latest clinical decisions into practice.

Dr. Burstein and his associates had no financial conflicts to disclose.

SOURCE: Burstein B al. Pediatrics. 2018 Sept 4. doi: 10.1542/peds.2018-0814.

Approximately one-third of children seen for head trauma visits in EDs underwent CT scans over a 9-year period in the United States, despite quality improvement initiatives to reduce unnecessary scans, based on a data from a cross-sectional survey published in Pediatrics.

©Thinkstock.com

“Computed tomography (CT) is the reference standard to provide a rapid and definitive diagnosis of intracranial pathology but must be balanced against the risks of radiation-induced malignancy,” wrote Brett Burstein, MD, PhD, of Harvard T.H. Chan School of Public Health, Cambridge, Mass., and his colleagues.

The researchers reviewed data from National Hospital Ambulatory Care Medical Survey database of nationally representative ED visits by children younger than 18 years for head trauma from 2007 to 2015. The median age of the patients was 6 years; 61% were boys. Approximately 88% were seen in nonteaching or nonpediatric hospitals.

During the 9-year period, 32% of 3,054 children underwent head CT scans; the 3,054 represented an estimated 14.3 million children making pediatric ED visits for head trauma. No significant differences were noted from year to year after the researchers controlled for confounding patient and ED factors.

Overall, use of CT was associated with patient’s age 2 years and older (adjusted odds ratio 1.51), white race (aOR 1.43), highest level of triage (aOR 8.24), and treatment at a nonteaching or nonpediatric hospital (aOR 1.47 and 1.53, respectively).

No significant differences in CT use were observed when the researchers compared the periods before (2007-2009) and after (2010-2015) the introduction of the Pediatric Emergency Care Applied Research Network (PECARN) rules – a clinical prediction protocol to assess head injuries in children in an ED setting. The unadjusted proportion of children who underwent CTs during the before PECARN and after PECARN periods was 33% and 31%, respectively.

“The finding of no decrease in CT neuroimaging during the 9-year study period, and particularly after the publication of the PECARN rules in 2009, was counter to the a priori hypothesis of this study,” Dr. Burstein and his associates noted.

The findings were limited by several factors including the lack of data on the severity of the head injuries, data on repeat visits, and potential misclassification of hospitals, they said. However, the results highlight the need for targeted interventions to disseminate the latest clinical decisions into practice.

Dr. Burstein and his associates had no financial conflicts to disclose.

SOURCE: Burstein B al. Pediatrics. 2018 Sept 4. doi: 10.1542/peds.2018-0814.

Expression of programmed death-1 (PD1) mRNA may predict outcomes after anti-PD1 therapy across cancer types, according to investigators.

High levels of PD1 mRNA were significantly associated with response to anti-PD1 monotherapy, investigators found in an analysis of tumor samples from 117 patients with advanced cancers who had received either nivolumab or pembrolizumab.

Further validation of PD1 mRNA is warranted to help select patients who might benefit from an anti-PD1 treatment strategy, wrote investigator Aleix Prat, MD, PhD, of Hospital Clínic of Barcelona, and his coinvestigators.

“Identification of reproducible biomarkers that can be applied to predict benefit of anti-PD1 monotherapy might be of clinical value,” Dr. Prat and his coinvestigators note. The report is in Annals of Oncology.

Previous studies support use of PDL1 expression by immunohistochemistry as a biomarker for pembrolizumab in non–small-cell lung cancer; however, that biomarker has some technical limitations, and has not been predictive in other cancer types and with other anti-PD1 drugs including nivolumab, Dr. Prat and his coinvestigators said.

The 117 tumor samples evaluated for PD1 mRNA expression comprised 59 advanced melanomas, 32 non–small-cell lung cancers, 14 renal cell cancers, and 12 other tumors, according to the report. Sixty-two of the patients had been treated with pembrolizumab, and 55 received nivolumab.

About one-quarter of the samples (28.2%) were classified as “PD1-high” with a preestablished cutoff value developed by Dr. Prat and his coinvestigators.

The overall response rate was 51.5% for the patients who had PD1-high tumors, versus 23.8% for the remaining tumors (P less than .001). Those non-PD1-high tumors, when grouped as PD1-intermediate and PD1-low, had overall response rates of 26.6% and 15.0%, respectively.

Median progression-free survival was 8.17 months for PD1-high tumors and 3.18 months for the rest of the tumors (P = .011), the report shows. Similarly, overall survival was a median of 23.4 months for PD1-high tumors and 14.9 months for the rest (P = .330).

Dr. Prat and his colleagues detailed earlier investigations validating PD1 mRNA as a biomarker, including an analysis of PD1 and immune-related gene expression in 10,078 samples from 34 cancer types in The Cancer Genome Atlas.

In that analysis, PD1 was strongly correlated with a group of 30 genes that were “significantly enriched” in biological processes including CD8-T-cell activation, the investigators said.

Moreover, high levels of PD1 mRNA expression were strongly correlated with overall response rates reported in the literature for anti-PD1 monotherapy, they added.

They also reported results of an analysis they used to develop the PD1-high cutoff value. That analysis was based on PD1 mRNA expression in 773 tumor samples across 17 tumor types.

“Our results are consistent with the hypothesis that identification of a preexisting and stable adaptive immune response using PD1 mRNA expression predicts outcome across cancer-types following anti-PD1 monotherapy,” the researchers wrote.

The work was partially sponsored by Instituto de Salud Carlos III, Spanish Society of Medical Oncology, Banco Bilbao Vizcaya Argentaria Foundation, Pas a Pas, Save the Mama, and the Breast Cancer Research Foundation. Dr. Prat disclosed an advisory role with Nanostring Technologies.

SOURCE: Paré L et al. Ann Oncol. 2018 Aug 27. doi: 10.1093/annonc/mdy335.

Expression of programmed death-1 (PD1) mRNA may predict outcomes after anti-PD1 therapy across cancer types, according to investigators.

High levels of PD1 mRNA were significantly associated with response to anti-PD1 monotherapy, investigators found in an analysis of tumor samples from 117 patients with advanced cancers who had received either nivolumab or pembrolizumab.

Further validation of PD1 mRNA is warranted to help select patients who might benefit from an anti-PD1 treatment strategy, wrote investigator Aleix Prat, MD, PhD, of Hospital Clínic of Barcelona, and his coinvestigators.

“Identification of reproducible biomarkers that can be applied to predict benefit of anti-PD1 monotherapy might be of clinical value,” Dr. Prat and his coinvestigators note. The report is in Annals of Oncology.

Previous studies support use of PDL1 expression by immunohistochemistry as a biomarker for pembrolizumab in non–small-cell lung cancer; however, that biomarker has some technical limitations, and has not been predictive in other cancer types and with other anti-PD1 drugs including nivolumab, Dr. Prat and his coinvestigators said.

The 117 tumor samples evaluated for PD1 mRNA expression comprised 59 advanced melanomas, 32 non–small-cell lung cancers, 14 renal cell cancers, and 12 other tumors, according to the report. Sixty-two of the patients had been treated with pembrolizumab, and 55 received nivolumab.

About one-quarter of the samples (28.2%) were classified as “PD1-high” with a preestablished cutoff value developed by Dr. Prat and his coinvestigators.

The overall response rate was 51.5% for the patients who had PD1-high tumors, versus 23.8% for the remaining tumors (P less than .001). Those non-PD1-high tumors, when grouped as PD1-intermediate and PD1-low, had overall response rates of 26.6% and 15.0%, respectively.

Median progression-free survival was 8.17 months for PD1-high tumors and 3.18 months for the rest of the tumors (P = .011), the report shows. Similarly, overall survival was a median of 23.4 months for PD1-high tumors and 14.9 months for the rest (P = .330).

Dr. Prat and his colleagues detailed earlier investigations validating PD1 mRNA as a biomarker, including an analysis of PD1 and immune-related gene expression in 10,078 samples from 34 cancer types in The Cancer Genome Atlas.

In that analysis, PD1 was strongly correlated with a group of 30 genes that were “significantly enriched” in biological processes including CD8-T-cell activation, the investigators said.

Moreover, high levels of PD1 mRNA expression were strongly correlated with overall response rates reported in the literature for anti-PD1 monotherapy, they added.

They also reported results of an analysis they used to develop the PD1-high cutoff value. That analysis was based on PD1 mRNA expression in 773 tumor samples across 17 tumor types.

“Our results are consistent with the hypothesis that identification of a preexisting and stable adaptive immune response using PD1 mRNA expression predicts outcome across cancer-types following anti-PD1 monotherapy,” the researchers wrote.

The work was partially sponsored by Instituto de Salud Carlos III, Spanish Society of Medical Oncology, Banco Bilbao Vizcaya Argentaria Foundation, Pas a Pas, Save the Mama, and the Breast Cancer Research Foundation. Dr. Prat disclosed an advisory role with Nanostring Technologies.

SOURCE: Paré L et al. Ann Oncol. 2018 Aug 27. doi: 10.1093/annonc/mdy335.

Expression of programmed death-1 (PD1) mRNA may predict outcomes after anti-PD1 therapy across cancer types, according to investigators.

High levels of PD1 mRNA were significantly associated with response to anti-PD1 monotherapy, investigators found in an analysis of tumor samples from 117 patients with advanced cancers who had received either nivolumab or pembrolizumab.

Further validation of PD1 mRNA is warranted to help select patients who might benefit from an anti-PD1 treatment strategy, wrote investigator Aleix Prat, MD, PhD, of Hospital Clínic of Barcelona, and his coinvestigators.

“Identification of reproducible biomarkers that can be applied to predict benefit of anti-PD1 monotherapy might be of clinical value,” Dr. Prat and his coinvestigators note. The report is in Annals of Oncology.

Previous studies support use of PDL1 expression by immunohistochemistry as a biomarker for pembrolizumab in non–small-cell lung cancer; however, that biomarker has some technical limitations, and has not been predictive in other cancer types and with other anti-PD1 drugs including nivolumab, Dr. Prat and his coinvestigators said.

The 117 tumor samples evaluated for PD1 mRNA expression comprised 59 advanced melanomas, 32 non–small-cell lung cancers, 14 renal cell cancers, and 12 other tumors, according to the report. Sixty-two of the patients had been treated with pembrolizumab, and 55 received nivolumab.

About one-quarter of the samples (28.2%) were classified as “PD1-high” with a preestablished cutoff value developed by Dr. Prat and his coinvestigators.

The overall response rate was 51.5% for the patients who had PD1-high tumors, versus 23.8% for the remaining tumors (P less than .001). Those non-PD1-high tumors, when grouped as PD1-intermediate and PD1-low, had overall response rates of 26.6% and 15.0%, respectively.

Median progression-free survival was 8.17 months for PD1-high tumors and 3.18 months for the rest of the tumors (P = .011), the report shows. Similarly, overall survival was a median of 23.4 months for PD1-high tumors and 14.9 months for the rest (P = .330).

Dr. Prat and his colleagues detailed earlier investigations validating PD1 mRNA as a biomarker, including an analysis of PD1 and immune-related gene expression in 10,078 samples from 34 cancer types in The Cancer Genome Atlas.

In that analysis, PD1 was strongly correlated with a group of 30 genes that were “significantly enriched” in biological processes including CD8-T-cell activation, the investigators said.

Moreover, high levels of PD1 mRNA expression were strongly correlated with overall response rates reported in the literature for anti-PD1 monotherapy, they added.

They also reported results of an analysis they used to develop the PD1-high cutoff value. That analysis was based on PD1 mRNA expression in 773 tumor samples across 17 tumor types.

“Our results are consistent with the hypothesis that identification of a preexisting and stable adaptive immune response using PD1 mRNA expression predicts outcome across cancer-types following anti-PD1 monotherapy,” the researchers wrote.

The work was partially sponsored by Instituto de Salud Carlos III, Spanish Society of Medical Oncology, Banco Bilbao Vizcaya Argentaria Foundation, Pas a Pas, Save the Mama, and the Breast Cancer Research Foundation. Dr. Prat disclosed an advisory role with Nanostring Technologies.

SOURCE: Paré L et al. Ann Oncol. 2018 Aug 27. doi: 10.1093/annonc/mdy335.

Physician groups are expressing concerns regarding a new policy that will allow indication-based formulary design in the Medicare Part D prescription drug benefit.

Kenishirotie/Thinkstock

The Centers for Medicare & Medicaid Services announced the new policy in an Aug. 29 memo to Part D plan sponsors.

According to a fact sheet issued by CMS on the same day, indication-based formulary design “is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications.”

Current Part D policy requires plan sponsors to cover all Food and Drug Administration–approved indications for each drug that is on a plan formulary. Sponsors can begin to implement the new indication-based formulary design policy for plans issued in 2020.

The memo notes that if a Part D plan sponsor chooses to opt into this policy, “it must ensure that there is another therapeutically similar drug on formulary for the nonformulary indication. For example, if a tumor necrosis factor (TNF) blocker is FDA-approved for both Crohn’s disease and plaque psoriasis, but the Part D plan will include it on formulary for plaque psoriasis only, the plan must ensure that there is another TNF blocker on formulary that will be covered for Crohn’s disease.”

Beneficiaries can use the exceptions process to get coverage for a drug that has an indication not on the formulary.

“By allowing Medicare’s prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries,” CMS Administrator Seema Verma said in a statement.

However, physician groups see this more as something that could create access issues for patients.

The “proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy,” the American College of Rheumatology said in a statement. “Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. ... We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.”

The ACR called on CMS to clarify the exception process to make sure patients have access to their needed drugs.

The American Medical Association agreed.

“Under the plan, Medicare patients will face increased challenges as they navigate health plans to make sure that their needed drug is on their selected formulary, which can change based on what health conditions they have,” AMA President Barbara McAneny, MD, said in a statement. “While the CMS notice included a statement that plans had to include information addressing indication-based formularies in materials provided to prospective enrollees, that is not much help to patients who are not sophisticated in how formularies work.”

Dr. McAneny added that it will be even more difficult for physicians who are working with patients to get them on the best medicines covered by the patient’s formulary.

“Physicians already lack ready access to accurate formulary information – preferred/tier status, on/off formulary, PA [prior authorization] and step therapy requirements – at the point of care in their EHRs,” she said. “These transparency problems will expand by an order of magnitude by the complications this change introduces.”

She also noted that it could be difficult for patients who have multiple chronic conditions to find a drug plan that covers the range of their medications, although CMS said the move is expected to increase the number of drugs available on a given plan’s formulary.

[email protected]

Physician groups are expressing concerns regarding a new policy that will allow indication-based formulary design in the Medicare Part D prescription drug benefit.

Kenishirotie/Thinkstock

The Centers for Medicare & Medicaid Services announced the new policy in an Aug. 29 memo to Part D plan sponsors.

According to a fact sheet issued by CMS on the same day, indication-based formulary design “is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications.”

Current Part D policy requires plan sponsors to cover all Food and Drug Administration–approved indications for each drug that is on a plan formulary. Sponsors can begin to implement the new indication-based formulary design policy for plans issued in 2020.

The memo notes that if a Part D plan sponsor chooses to opt into this policy, “it must ensure that there is another therapeutically similar drug on formulary for the nonformulary indication. For example, if a tumor necrosis factor (TNF) blocker is FDA-approved for both Crohn’s disease and plaque psoriasis, but the Part D plan will include it on formulary for plaque psoriasis only, the plan must ensure that there is another TNF blocker on formulary that will be covered for Crohn’s disease.”

Beneficiaries can use the exceptions process to get coverage for a drug that has an indication not on the formulary.

“By allowing Medicare’s prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries,” CMS Administrator Seema Verma said in a statement.

However, physician groups see this more as something that could create access issues for patients.

The “proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy,” the American College of Rheumatology said in a statement. “Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. ... We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.”

The ACR called on CMS to clarify the exception process to make sure patients have access to their needed drugs.

The American Medical Association agreed.

“Under the plan, Medicare patients will face increased challenges as they navigate health plans to make sure that their needed drug is on their selected formulary, which can change based on what health conditions they have,” AMA President Barbara McAneny, MD, said in a statement. “While the CMS notice included a statement that plans had to include information addressing indication-based formularies in materials provided to prospective enrollees, that is not much help to patients who are not sophisticated in how formularies work.”

Dr. McAneny added that it will be even more difficult for physicians who are working with patients to get them on the best medicines covered by the patient’s formulary.

“Physicians already lack ready access to accurate formulary information – preferred/tier status, on/off formulary, PA [prior authorization] and step therapy requirements – at the point of care in their EHRs,” she said. “These transparency problems will expand by an order of magnitude by the complications this change introduces.”

She also noted that it could be difficult for patients who have multiple chronic conditions to find a drug plan that covers the range of their medications, although CMS said the move is expected to increase the number of drugs available on a given plan’s formulary.

[email protected]

Physician groups are expressing concerns regarding a new policy that will allow indication-based formulary design in the Medicare Part D prescription drug benefit.

Kenishirotie/Thinkstock

The Centers for Medicare & Medicaid Services announced the new policy in an Aug. 29 memo to Part D plan sponsors.

According to a fact sheet issued by CMS on the same day, indication-based formulary design “is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications.”

Current Part D policy requires plan sponsors to cover all Food and Drug Administration–approved indications for each drug that is on a plan formulary. Sponsors can begin to implement the new indication-based formulary design policy for plans issued in 2020.

The memo notes that if a Part D plan sponsor chooses to opt into this policy, “it must ensure that there is another therapeutically similar drug on formulary for the nonformulary indication. For example, if a tumor necrosis factor (TNF) blocker is FDA-approved for both Crohn’s disease and plaque psoriasis, but the Part D plan will include it on formulary for plaque psoriasis only, the plan must ensure that there is another TNF blocker on formulary that will be covered for Crohn’s disease.”

Beneficiaries can use the exceptions process to get coverage for a drug that has an indication not on the formulary.

“By allowing Medicare’s prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries,” CMS Administrator Seema Verma said in a statement.

However, physician groups see this more as something that could create access issues for patients.

The “proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy,” the American College of Rheumatology said in a statement. “Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. ... We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.”

The ACR called on CMS to clarify the exception process to make sure patients have access to their needed drugs.

The American Medical Association agreed.

“Under the plan, Medicare patients will face increased challenges as they navigate health plans to make sure that their needed drug is on their selected formulary, which can change based on what health conditions they have,” AMA President Barbara McAneny, MD, said in a statement. “While the CMS notice included a statement that plans had to include information addressing indication-based formularies in materials provided to prospective enrollees, that is not much help to patients who are not sophisticated in how formularies work.”

Dr. McAneny added that it will be even more difficult for physicians who are working with patients to get them on the best medicines covered by the patient’s formulary.

“Physicians already lack ready access to accurate formulary information – preferred/tier status, on/off formulary, PA [prior authorization] and step therapy requirements – at the point of care in their EHRs,” she said. “These transparency problems will expand by an order of magnitude by the complications this change introduces.”

She also noted that it could be difficult for patients who have multiple chronic conditions to find a drug plan that covers the range of their medications, although CMS said the move is expected to increase the number of drugs available on a given plan’s formulary.

[email protected]

The Food and Drug Administration has granted fast-track designation to CX-01 as a treatment for patients older than 60 years receiving induction therapy for newly diagnosed acute myeloid leukemia (AML).

CX-01 also has orphan drug designation from the FDA.

CX-01 is a polysaccharide derived from heparin thought to enhance chemotherapy by disrupting leukemia cell adhesion in bone marrow. Cantex Pharmaceuticals is conducting a randomized, phase 2b study to determine whether CX-01 can improve the efficacy of frontline chemotherapy in patients with AML.

This study builds upon results of a pilot study, which were published in Blood Advances (Blood Adv. 2018 Feb 27;2[4]:381-9). The pilot study enrolled 12 adults with newly diagnosed AML who received CX-01 as a continuous infusion for 7 days, along with standard induction chemotherapy (cytarabine and idarubicin).

The FDA’s fast-track development program is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

[email protected]

The Food and Drug Administration has granted fast-track designation to CX-01 as a treatment for patients older than 60 years receiving induction therapy for newly diagnosed acute myeloid leukemia (AML).

CX-01 also has orphan drug designation from the FDA.

CX-01 is a polysaccharide derived from heparin thought to enhance chemotherapy by disrupting leukemia cell adhesion in bone marrow. Cantex Pharmaceuticals is conducting a randomized, phase 2b study to determine whether CX-01 can improve the efficacy of frontline chemotherapy in patients with AML.

This study builds upon results of a pilot study, which were published in Blood Advances (Blood Adv. 2018 Feb 27;2[4]:381-9). The pilot study enrolled 12 adults with newly diagnosed AML who received CX-01 as a continuous infusion for 7 days, along with standard induction chemotherapy (cytarabine and idarubicin).

The FDA’s fast-track development program is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

[email protected]

The Food and Drug Administration has granted fast-track designation to CX-01 as a treatment for patients older than 60 years receiving induction therapy for newly diagnosed acute myeloid leukemia (AML).

CX-01 also has orphan drug designation from the FDA.

CX-01 is a polysaccharide derived from heparin thought to enhance chemotherapy by disrupting leukemia cell adhesion in bone marrow. Cantex Pharmaceuticals is conducting a randomized, phase 2b study to determine whether CX-01 can improve the efficacy of frontline chemotherapy in patients with AML.

This study builds upon results of a pilot study, which were published in Blood Advances (Blood Adv. 2018 Feb 27;2[4]:381-9). The pilot study enrolled 12 adults with newly diagnosed AML who received CX-01 as a continuous infusion for 7 days, along with standard induction chemotherapy (cytarabine and idarubicin).

The FDA’s fast-track development program is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

[email protected]

Once again, a study has shown that when it comes to managing patients with serious advanced malignancies – in this case, metastatic renal cell carcinoma – experience matters.

A review of data on 41,836 patients with metastatic renal cell carcinoma (mRCC) treated at 1,222 facilities (TFs) showed that across all cohorts, including patients with known liver and lung metastases who received systemic therapies, treatment-center volume was significantly associated with longer survival, reported Daniel M. Geynisman, MD of Fox Chase Cancer Center in Philadelphia, and his colleagues.

“These findings may help define the optimal treatment environment for the management of patients with mRCC. The improved survival outcomes at higher-volume TFs should also be a call to improve mRCC management at lower-volume facilities. Given the negative externalities of care regionalization, focus should shift toward policies that help equalize mRCC management at lower-volume TFs by expanding treatment options, clinical trial access, and specialized resource availability,” the researchers wrote. Their report is in European Urology.

The investigators noted that several studies have demonstrated that patients with localized RCC treated at high-volume centers had better postoperative outcomes and few complications following surgery for renal cancer, but whether treatment volume makes a difference for patients with metastatic disease was less clear.

To get a better understanding of the association between case volume and outcomes for patients with advanced RCC, the investigators searched the National Cancer Database for information on all U.S. patients with mRCC from 2004 through 2013 for whom survival data were available.

To confirm the association with volume, they created five cohorts with increasingly restrictive inclusion criteria, as follows:

• Cohort A: All patients with survival data (41,836 patients).
• Cohort B: Patients with mRCC who received active treatment of any kind (27,557).
• Cohort C: Patients treated with systemic therapy with or without primary surgery (19,138).
• Cohort D: Patients treated with systemic therapy at the reporting facility (12,000).
• Cohort E: Patients with known sites of metastases (4,933).

The investigators also conducted sensitivity analyses on subcohorts of patients who did not receive nephrectomies in cohorts C, D, and E.

They found in a multivariable analysis that increased volume, measured as cases per year, was associated with reduced overall mortality across all cohorts.

For example, in cohort A, the hazard ratio (HR) for overall mortality for TFs caring for a mean of 5 patients per year was 0.92, compared with 0.84 for centers with 10 cases per year, and 0.74 for TFs caring for a mean of 20 patients per year (P less than .001). Similarly, the respective HRs for patients in cohort E were 0.88, 0.79, and 0.72 (P less than .001).

The overall probability of mortality was also significantly lower in higher-volume centers for those patients in cohorts C, D, and E who did not undergo nephrectomy.

The investigators acknowledged that the study was limited by the retrospective nature of the database information, and by the absence of data on treatment regimens used at specific facilities, which may explain mechanisms of the effects they observed.

The investigators did not specify a study funding source. Dr. Geynisman reported having no conflicts of interest.

SOURCE: Joshi SS et al. Eur Urol. 2018 Sep;74[3]:387-93.

Once again, a study has shown that when it comes to managing patients with serious advanced malignancies – in this case, metastatic renal cell carcinoma – experience matters.

A review of data on 41,836 patients with metastatic renal cell carcinoma (mRCC) treated at 1,222 facilities (TFs) showed that across all cohorts, including patients with known liver and lung metastases who received systemic therapies, treatment-center volume was significantly associated with longer survival, reported Daniel M. Geynisman, MD of Fox Chase Cancer Center in Philadelphia, and his colleagues.

“These findings may help define the optimal treatment environment for the management of patients with mRCC. The improved survival outcomes at higher-volume TFs should also be a call to improve mRCC management at lower-volume facilities. Given the negative externalities of care regionalization, focus should shift toward policies that help equalize mRCC management at lower-volume TFs by expanding treatment options, clinical trial access, and specialized resource availability,” the researchers wrote. Their report is in European Urology.

The investigators noted that several studies have demonstrated that patients with localized RCC treated at high-volume centers had better postoperative outcomes and few complications following surgery for renal cancer, but whether treatment volume makes a difference for patients with metastatic disease was less clear.

To get a better understanding of the association between case volume and outcomes for patients with advanced RCC, the investigators searched the National Cancer Database for information on all U.S. patients with mRCC from 2004 through 2013 for whom survival data were available.

To confirm the association with volume, they created five cohorts with increasingly restrictive inclusion criteria, as follows:

• Cohort A: All patients with survival data (41,836 patients).
• Cohort B: Patients with mRCC who received active treatment of any kind (27,557).
• Cohort C: Patients treated with systemic therapy with or without primary surgery (19,138).
• Cohort D: Patients treated with systemic therapy at the reporting facility (12,000).
• Cohort E: Patients with known sites of metastases (4,933).

The investigators also conducted sensitivity analyses on subcohorts of patients who did not receive nephrectomies in cohorts C, D, and E.

They found in a multivariable analysis that increased volume, measured as cases per year, was associated with reduced overall mortality across all cohorts.

For example, in cohort A, the hazard ratio (HR) for overall mortality for TFs caring for a mean of 5 patients per year was 0.92, compared with 0.84 for centers with 10 cases per year, and 0.74 for TFs caring for a mean of 20 patients per year (P less than .001). Similarly, the respective HRs for patients in cohort E were 0.88, 0.79, and 0.72 (P less than .001).

The overall probability of mortality was also significantly lower in higher-volume centers for those patients in cohorts C, D, and E who did not undergo nephrectomy.

The investigators acknowledged that the study was limited by the retrospective nature of the database information, and by the absence of data on treatment regimens used at specific facilities, which may explain mechanisms of the effects they observed.

The investigators did not specify a study funding source. Dr. Geynisman reported having no conflicts of interest.

SOURCE: Joshi SS et al. Eur Urol. 2018 Sep;74[3]:387-93.

Once again, a study has shown that when it comes to managing patients with serious advanced malignancies – in this case, metastatic renal cell carcinoma – experience matters.

A review of data on 41,836 patients with metastatic renal cell carcinoma (mRCC) treated at 1,222 facilities (TFs) showed that across all cohorts, including patients with known liver and lung metastases who received systemic therapies, treatment-center volume was significantly associated with longer survival, reported Daniel M. Geynisman, MD of Fox Chase Cancer Center in Philadelphia, and his colleagues.

“These findings may help define the optimal treatment environment for the management of patients with mRCC. The improved survival outcomes at higher-volume TFs should also be a call to improve mRCC management at lower-volume facilities. Given the negative externalities of care regionalization, focus should shift toward policies that help equalize mRCC management at lower-volume TFs by expanding treatment options, clinical trial access, and specialized resource availability,” the researchers wrote. Their report is in European Urology.

The investigators noted that several studies have demonstrated that patients with localized RCC treated at high-volume centers had better postoperative outcomes and few complications following surgery for renal cancer, but whether treatment volume makes a difference for patients with metastatic disease was less clear.

To get a better understanding of the association between case volume and outcomes for patients with advanced RCC, the investigators searched the National Cancer Database for information on all U.S. patients with mRCC from 2004 through 2013 for whom survival data were available.

To confirm the association with volume, they created five cohorts with increasingly restrictive inclusion criteria, as follows:

• Cohort A: All patients with survival data (41,836 patients).
• Cohort B: Patients with mRCC who received active treatment of any kind (27,557).
• Cohort C: Patients treated with systemic therapy with or without primary surgery (19,138).
• Cohort D: Patients treated with systemic therapy at the reporting facility (12,000).
• Cohort E: Patients with known sites of metastases (4,933).

The investigators also conducted sensitivity analyses on subcohorts of patients who did not receive nephrectomies in cohorts C, D, and E.

They found in a multivariable analysis that increased volume, measured as cases per year, was associated with reduced overall mortality across all cohorts.

For example, in cohort A, the hazard ratio (HR) for overall mortality for TFs caring for a mean of 5 patients per year was 0.92, compared with 0.84 for centers with 10 cases per year, and 0.74 for TFs caring for a mean of 20 patients per year (P less than .001). Similarly, the respective HRs for patients in cohort E were 0.88, 0.79, and 0.72 (P less than .001).

The overall probability of mortality was also significantly lower in higher-volume centers for those patients in cohorts C, D, and E who did not undergo nephrectomy.

The investigators acknowledged that the study was limited by the retrospective nature of the database information, and by the absence of data on treatment regimens used at specific facilities, which may explain mechanisms of the effects they observed.

The investigators did not specify a study funding source. Dr. Geynisman reported having no conflicts of interest.

SOURCE: Joshi SS et al. Eur Urol. 2018 Sep;74[3]:387-93.

Obesity is a major health problem in the United States. The facts are well known:

• Its prevalence has almost tripled since the early 1960s¹
• More than 35% of US adults are obese (body mass index [BMI] ≥ 30 kg/m²)²
• It increases the risk of comorbid conditions including type 2 diabetes mellitus, heart disease, hypertension, obstructive sleep apnea, certain cancers, asthma, and osteoarthritis^3,4
• It decreases life expectancy⁵
• Medical costs are up to 6 times higher per patient.⁶

Moreover, obesity is often not appropriately managed, owing to a variety of factors. In this article, we describe use of shared medical appointments as a strategy to improve the efficiency and effectiveness of treating patients with obesity.

Big benefits from small changes in weight

As little as 3% to 5% weight loss is associated with significant clinical benefits, such as improved glycemic control, reduced blood pressure, and reduced cholesterol levels.^7,8 However, many patients are unable to reach this modest goal using current approaches to obesity management.

This failure is partially related to the complexity and chronic nature of obesity, which requires continued medical management from a multidisciplinary team. We believe this is an area of care that can be appropriately addressed through shared medical appointments.

CURRENT APPROACHES

Interventions for obesity have increased along with the prevalence of the disease. Hundreds of diets, exercise plans, natural products, and behavioral interventions are marketed, all claiming to be successful. More-intense treatment options include antiobesity medications, intra-abdominal weight loss devices, and bariatric surgery. Despite the availability of treatments, rates of obesity have not declined.

Counseling is important, but underused

Lifestyle modifications that encompass nutrition, physical activity, and behavioral interventions are the mainstay of obesity treatment.

Intensive interventions work better than less-intensive ones. In large clinical trials in overweight patients with diabetes, those who received intensive lifestyle interventions lost 3 to 5 kg more (3% to 8% of body weight) than those who received brief diet and nutrition counseling, as is often performed in a physician’s office.^9–12 The US Preventive Services Task Force recommends that patients whose BMI is 30 kg/m² or higher be offered intensive lifestyle intervention consisting of at least 12 sessions in 1 year.¹³

But fewer than half of primary care practitioners consistently provide specific guidance on diet, exercise, or weight control to patients with obesity, including those with a weight-related comorbidity.¹⁴ The rate has decreased since the 1990s despite the increase in obesity.¹⁵

One reason for the underuse is that many primary care practitioners do not have the training or time to deliver the recommended high-intensity obesity treatment.¹⁴ Plus, evidence does not clearly show a weight loss benefit from low-intensity interventions. Even when patients lose weight, most regain it, and only 20% are able to maintain their weight loss 1 year after treatment ends.¹⁶

Drugs and surgery also underused

Antiobesity medications and bariatric surgery are effective when added to lifestyle interventions, but they are also underused.

Bariatric surgery provides the greatest and most durable weight loss—15% to 30% of body weight—along with improvement in comorbidities such as type 2 diabetes, and its benefits are sustained for at least 10 years.¹⁷ However, fewer than 1% of eligible patients undergo bariatric surgery because of its limited availability, invasive nature, potential complications, limited insurance coverage, and high cost.¹⁷

The story is similar for antiobesity drugs. They are useful adjuncts to lifestyle interventions, providing an additional 3% to 7% weight loss,¹⁸ but fewer than 2% of eligible patients receive them.¹⁹ This may be attributed to their modest effectiveness, weight regain after discontinuation, potential adverse effects, and expense due to lack of insurance coverage.

ARE SHARED MEDICAL APPOINTMEMNTS AN ANSWER?

Although treatments have shown some effectiveness at producing weight loss, none has had a widespread impact on obesity. Lifestyle interventions, drugs, and bariatric surgery continue to be underused. Current treatment models are not providing patients with the intensive interventions needed.

Providers often find themselves offering repetitive advice to patients with obesity regarding nutrition and exercise, while simultaneously trying to manage obesity-related comorbidities, all in a 20-minute appointment. Too often, a patient returns home with prescriptions for hypertension or diabetes but no clear plan for weight management.

What can a shared medical appointment do?

A shared medical appointment is a group medical visit in which several patients with a similar clinical diagnosis, such as obesity, see a multidisciplinary team of healthcare providers. Typically, 5 to 10 patients have consultations with providers during a 60- to 90-minute appointment.²⁰

Part of the session is dedicated to education on the patients’ common medical condition with the goal of improving their self-management, but most of the time is spent addressing individual patient concerns.

Each patient takes a turn consulting with a provider, as in a traditional medical appointment, but in a group setting. This allows others in the group to observe and learn from their peers’ experiences. During this consultation, the patient’s concerns are addressed, medications are managed, necessary tests are ordered, and a treatment plan is made.

Patients can continue to receive follow-up care through shared medical appointments at predetermined times, instead of traditional individual medical appointments.

Shared medical appointments could improve patient access, clinical outcomes, and patient and provider satisfaction and decrease costs.^20,21 Since being introduced in the 1990s, their use has dramatically increased. For example, in the first 2 years of conducting shared medical appointments at Cleveland Clinic (2002–2004), there were just 385 shared medical appointments,²¹ but in 2017 there were approximately 12,300. They are used in a variety of medical and surgical specialties, and have been studied most for treating diabetes.^22–24

Increased face time and access

Individual patient follow-up visits typically last 15 to 20 minutes, limiting the provider to seeing a maximum of 6 patients in 90 minutes. In that same time in the setting of a shared appointment, a multidisciplinary team can see up to 10 patients, and the patients receive up to 90 minutes of time with multiple providers.

Additionally, shared medical appointments can improve patient access to timely appointments. In a busy bariatric surgery practice, implementing shared medical appointments reduced patients’ wait time for an appointment by more than half.²⁵ This is particularly important for patients with obesity, who usually require 12 to 26 appointments per year.

Improved patient outcomes

Use of shared medical appointments has improved clinical outcomes compared with traditional care. Patients with type 2 diabetes who attend shared medical appointments are more likely to reach target hemoglobin A_1c and blood pressure levels.^22­­−24 These benefits may be attributed to increased access to care, improved self-management skills, more frequent visits, peer support of the group, and the synergistic knowledge of multiple providers on the shared medical appointment team.

Although some trials reported patient retention rates of 75% to 90% in shared medical appointments, many trials did not report their rates. It is likely that some patients declined randomization to avoid shared medical appointments, which could have led to potential attrition and selection biases.²³

Increased patient and provider satisfaction

Both patients and providers report high satisfaction with shared medical appointments.^22,26 Although patients may initially hesitate to participate, their opinions significantly improve after attending 1 session.²⁶ From 85% to 90% of patients who attend a shared medical appointment schedule their next follow-up appointment as a shared appointment as well.^21,25

In comparative studies, patients who attended shared medical appointments had satisfaction rates equal to or higher than rates in patients who participated in usual care,²² noting better access to care and more sensitivity to their needs.²⁷ Providers report greater satisfaction from working more directly with a team of providers, clearing up a backlogged schedule, and adding variety to their practice.^21,24

Decreased costs

Data on the cost-effectiveness of shared medical appointments are mixed; however, some studies have shown that they are associated with a decrease in hospital admissions and emergency department visits.²² It seems reasonable to assume that, in an appropriate patient population, shared medical appointments can be cost-effective owing to increased provider productivity, but more research is needed to verify this.

CHALLENGES TO STARTING SHARED APPOINTMENTS FOR OBESITY

Despite their potential to provide comprehensive care to patients, shared medical appointments have limitations. These need to be addressed before implementing a shared medical appointment program.

Adequate resources and staff training

To be successful, a shared medical appointment program needs to have intensive physical and staffing resources. You need a space large enough to accommodate the group and access to the necessary equipment (eg, projector, whiteboard) for educational sessions. Larger or armless chairs may better accommodate patients with obesity. Facilitators need training in how to lead the group sessions, including time management and handling conflicts between patients. Schedulers and clinical intake staff need training in answering patient questions regarding these appointments.

Maintaining patient attendance

The benefits of provider efficiency rest on having an adequate number of patients attend the shared appointments.²¹ Patient cancellations and no-shows decrease both the efficiency and cost-effectiveness of this model, and they detract from the peer support and group learning that occurs in the group dynamic. To help minimize patient dropout, a discussion of patient expectations should take place prior to enrollment in shared medical appointments. This should include information on the concept of shared appointments, frequency and duration of appointments, and realistic weight loss goals.

Logistical challenges

A shared medical appointment requires a longer patient time slot and is usually less flexible than an individual appointment. Not all patients can take the time for a prescheduled 60- to 90-minute appointment. However, reduced waiting-room time and increased face time with a provider offset some of these challenges.

Recruiting patients

A shared medical appointment is a novel experience for some, and concerns about it may make it a challenge to recruit patients. Patients might worry that the presence of the group will compromise the patient-doctor relationship. Other concerns include potential irrelevance of other patients’ medical issues and reluctance to participate because of body image and the stigma of obesity.

One solution is to select patients from your existing practice so that the individual patient-provider relationship is established before introducing the concept of shared appointments. You will need to explain how shared appointments work, discuss their pros and cons, stress your expectations about attendance and confidentiality, and address any concerns of the patient. It is also important to emphasize that nearly all patients find shared medical appointments useful.

Once a group is established, it may be a challenge to keep a constant group membership to promote positive group dynamics. In practice, patients may drop out or be added, and facilitators need to be able to integrate new members into the group. It is important to emphasize to the group that obesity is chronic and that patients at all stages and levels of treatment can contribute to group learning.

Despite the advantages of shared medical appointments, some patients may not find them useful, even after attending several sessions. These patients should be offered individual follow-up visits. Also, shared appointments may not be suitable for patients who cannot speak English very well, are hearing-impaired, have significant cognitive impairment, or have acute medical issues.

Maintaining confidentiality of personal and health information in a shared medical appointment is an important concern for patients but can be appropriately managed. In a survey of patients attending pulmonary hypertension shared medical appointments, 24% had concerns about confidentiality before participating, but after a few sessions, this rate was cut in half.²⁸

Patients have reported initially withholding some information, but over time, they usually become more comfortable with the group and disclose more helpful information.²⁹ Strategies to ensure confidentiality include having patients sign a confidentiality agreement at each appointment, providing specific instruction on what characterizes confidentiality breaches, and allowing patients the opportunity to schedule individual appointments as needed.

Ensuring insurance coverage

A shared medical appointment should be billed as an individual medical appointment for level of care, rather than time spent with the provider. This ensures that insurance coverage and copayments are the same as for individual medical appointments.

Lack of insurance coverage is a major barrier to obesity treatment in general. The US Centers for Medicare and Medicaid Services reimburses intensive behavioral obesity treatment delivered by a primary care practitioner, but limits it to 1 year of treatment and requires patients to meet weight loss goals. Some individual and employer-based healthcare plans do not cover dietitian visits, weight management programs, or antiobesity prescriptions.

EVIDENCE OF EFFECTIVENESS IN OBESITY

Few studies have investigated the use of shared medical appointments in obesity treatment. In the pediatric population, these programs significantly decreased BMI and some other anthropometric measurements,^30–32 but they did not consistently involve a prescribing provider. This means they did not manage medications or comorbidities as would be expected in a shared medical appointment.

In adults, reported effects have been encouraging, although the studies are not particularly robust. In a 2-year observational study of a single physician conducting biweekly weight management shared medical appointments, participants lost 1% of their baseline weight, while those continuing with usual care gained 0.8%, a statistically significant difference.³³ However, participation rates were low, with patients attending an average of only 3 shared medical appointments during the study.

In a meta-analysis of 13 randomized controlled trials of shared medical appointments for patients with type 2 diabetes, only 3 studies reported weight outcomes.²³ These results indicated a trend toward weight loss among patients attending shared appointments, but they were not statistically significant.

Positive results also were reported by the Veterans Administration’s MOVE! (Managing Overweight/obesity for Veterans Everywhere) program.³⁴ Participants in shared medical appointments reported that they felt empowered to make positive lifestyle changes, gained knowledge about obesity, were held accountable by their peers, and appreciated the individualized care they received from the multidisciplinary healthcare teams.

A systematic review involving 336 participants in group-based obesity interventions found group treatment produced more robust weight loss than individual treatment.³⁵ However, shared medical appointments are different from weight loss groups in that they combine an educational session and a medical appointment in a peer-group setting, which requires a provider with prescribing privileges to be present. Thus, shared medical appointments can manage medications as well as weight-related comorbidities such as diabetes, hypertension, polycystic ovarian syndrome, and hyperlipidemia.

One more point is that continued attendance at shared medical appointments, even after successful weight loss, may help to maintain the weight loss, which has otherwise been found to be extremely challenging using traditional medical approaches.

WHO SHOULD BE ON THE TEAM?

Because obesity is multifactorial, it requires a comprehensive treatment approach that can be difficult to deliver given the limited time of an individual appointment. In a shared appointment, providers across multiple specialties can meet with patients at the same time to coordinate approaches to obesity treatment.

A multidisciplinary team for shared medical appointments for obesity needs a physician or a nurse practitioner—or ideally, both— who specializes in obesity to facilitate the session. Other key providers include a registered dietitian, an exercise physiologist, a behavioral health specialist, a sleep specialist, and a social worker to participate as needed in the educational component of the appointment or act as outside consultants.

WHAT ARE REALISTIC TARGETS?

• Nutrition
• Physical activity
• Appetite control
• Sleep
• Stress and mood disorders.

Nutrition

A calorie deficit of 500 to 750 calories per day is recommended for weight loss.^7,8 Although there is no consensus on the best nutritional content of a diet, adherence to a diet is a significant predictor of weight loss.³⁶ One reason diets fail to bring about weight loss is that patients tend to underestimate their caloric intake by almost 50%.³⁷ Thus, they may benefit from a structured and supervised diet plan.

A dietitian can help patients develop an individualized diet plan that will promote adherence, which includes specific information on food choices, portion sizes, and timing of meals.

Physical activity

At least 150 minutes of physical activity per week is recommended for weight loss, and 200 to 300 minutes per week is recommended for long-term weight maintenance.^7,8

An exercise physiologist can help patients design a personalized exercise plan to help achieve these goals. This plan should take into account the patient’s cardiac status, activity level, degree of mobility, and lifestyle.

Most patients are not able to achieve the recommended physical activity goals initially, and activity levels need to be gradually increased over a period of weeks to months. Patients who were previously inactive or have evidence of cardiovascular, renal, or metabolic disease may require a cardiopulmonary assessment, including an electrocardiogram and cardiac stress test, before starting an exercise program.

It is very difficult for patients to lose weight without appetite control. Weight loss that results from diet and exercise is often accompanied by a change in weight-regulating hormones (eg, leptin, ghrelin, peptide YY, and cholecystokinin) that promote weight regain.³⁸ Thus, multiple compensatory mechanisms promote weight regain through increases in appetite and decreases in energy expenditure, resisting weight loss efforts.

Antiobesity drugs can help mitigate these adaptive weight-promoting responses through several mechanisms. They are indicated for use with lifestyle interventions for patients with a BMI of at least 30 mg/kg² or a BMI of at least 27 kg/m² with an obesity-related comorbidity.

These drugs promote an additional 3% to 7% weight loss when added to lifestyle interventions.¹⁸ But their effects are limited without appropriate lifestyle interventions.

Sleep

Adequate sleep is an often-overlooked component of obesity treatment. Inadequate sleep is associated with weight gain and an appetite-inducing hormone profile.³⁹ Just 2 days of sleep deprivation in healthy normal-weight adult men was associated with a 70% increase in the ghrelin-to-leptin ratio, which showed a linear relationship with self-reported increased hunger.³⁹ Sleep disorders, especially obstructive sleep apnea, are common in patients with obesity but are often underdiagnosed and undertreated.⁴⁰

Healthy sleep habits and sleep quality should be addressed in shared medical appointments for obesity, as patients may be unaware of the impact that sleep may be having on their obesity treatment. The STOP-BANG questionnaire (­snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference, and male sex) is a simple and reliable tool to screen for obstructive sleep apnea.⁴¹ Patients with symptoms of a sleep disorder should be referred to a sleep specialist for diagnosis and management.

Stress management and mood disorders

Stress and psychiatric disorders are underappreciated contributors to obesity. All patients receiving obesity treatment need to be screened for mood disorders and suicidal ideation.⁸

Chronic stress promotes weight gain through activation of the hypothalamic-pituitary-adrenocortical axis, whereby increased cortisol levels enhance appetite and accumulation of visceral fat.⁴² In addition, obesity is associated with a 25% increased risk of mood disorders, although the mechanism and direction of this association are unclear.⁴³ Weight gain as a side effect of antidepressant or other psychiatric medications is another important consideration.

Management of stress and psychiatric disorders through goal-setting, self-monitoring, and patient education is vital to help patients fully participate in lifestyle changes and maximize weight loss. Patients participating in shared medical appointments usually benefit from consultations with psychiatrists or psychologists to manage psychiatric comorbidities and assist with adherence to behavior modification. 


IN FAVOR OF SHARED MEDICAL APPOINTMENTS FOR OBESITY

Shared medical appointments can be an effective method of addressing the challenges of treating patients with obesity, using a multidisciplinary approach that combines nutrition, physical activity, appetite suppression, sleep improvement, and stress management. In addition, shared appointments allow practitioners to treat the primary problem of excess weight, rather than just its comorbidities, recognizing that obesity is a chronic disease that requires long-term, individualized treatment. Satisfaction rates are high for both patients and providers. Overall, education is essential to implementing and maintaining a successful shared medical appointment program.

Obesity is a major health problem in the United States. The facts are well known:

• Its prevalence has almost tripled since the early 1960s¹
• More than 35% of US adults are obese (body mass index [BMI] ≥ 30 kg/m²)²
• It increases the risk of comorbid conditions including type 2 diabetes mellitus, heart disease, hypertension, obstructive sleep apnea, certain cancers, asthma, and osteoarthritis^3,4
• It decreases life expectancy⁵
• Medical costs are up to 6 times higher per patient.⁶

Moreover, obesity is often not appropriately managed, owing to a variety of factors. In this article, we describe use of shared medical appointments as a strategy to improve the efficiency and effectiveness of treating patients with obesity.

Big benefits from small changes in weight

As little as 3% to 5% weight loss is associated with significant clinical benefits, such as improved glycemic control, reduced blood pressure, and reduced cholesterol levels.^7,8 However, many patients are unable to reach this modest goal using current approaches to obesity management.

This failure is partially related to the complexity and chronic nature of obesity, which requires continued medical management from a multidisciplinary team. We believe this is an area of care that can be appropriately addressed through shared medical appointments.

CURRENT APPROACHES

Interventions for obesity have increased along with the prevalence of the disease. Hundreds of diets, exercise plans, natural products, and behavioral interventions are marketed, all claiming to be successful. More-intense treatment options include antiobesity medications, intra-abdominal weight loss devices, and bariatric surgery. Despite the availability of treatments, rates of obesity have not declined.

Counseling is important, but underused

Lifestyle modifications that encompass nutrition, physical activity, and behavioral interventions are the mainstay of obesity treatment.

Intensive interventions work better than less-intensive ones. In large clinical trials in overweight patients with diabetes, those who received intensive lifestyle interventions lost 3 to 5 kg more (3% to 8% of body weight) than those who received brief diet and nutrition counseling, as is often performed in a physician’s office.^9–12 The US Preventive Services Task Force recommends that patients whose BMI is 30 kg/m² or higher be offered intensive lifestyle intervention consisting of at least 12 sessions in 1 year.¹³

But fewer than half of primary care practitioners consistently provide specific guidance on diet, exercise, or weight control to patients with obesity, including those with a weight-related comorbidity.¹⁴ The rate has decreased since the 1990s despite the increase in obesity.¹⁵

One reason for the underuse is that many primary care practitioners do not have the training or time to deliver the recommended high-intensity obesity treatment.¹⁴ Plus, evidence does not clearly show a weight loss benefit from low-intensity interventions. Even when patients lose weight, most regain it, and only 20% are able to maintain their weight loss 1 year after treatment ends.¹⁶

Drugs and surgery also underused

Antiobesity medications and bariatric surgery are effective when added to lifestyle interventions, but they are also underused.

Bariatric surgery provides the greatest and most durable weight loss—15% to 30% of body weight—along with improvement in comorbidities such as type 2 diabetes, and its benefits are sustained for at least 10 years.¹⁷ However, fewer than 1% of eligible patients undergo bariatric surgery because of its limited availability, invasive nature, potential complications, limited insurance coverage, and high cost.¹⁷

The story is similar for antiobesity drugs. They are useful adjuncts to lifestyle interventions, providing an additional 3% to 7% weight loss,¹⁸ but fewer than 2% of eligible patients receive them.¹⁹ This may be attributed to their modest effectiveness, weight regain after discontinuation, potential adverse effects, and expense due to lack of insurance coverage.

ARE SHARED MEDICAL APPOINTMEMNTS AN ANSWER?

Although treatments have shown some effectiveness at producing weight loss, none has had a widespread impact on obesity. Lifestyle interventions, drugs, and bariatric surgery continue to be underused. Current treatment models are not providing patients with the intensive interventions needed.

Providers often find themselves offering repetitive advice to patients with obesity regarding nutrition and exercise, while simultaneously trying to manage obesity-related comorbidities, all in a 20-minute appointment. Too often, a patient returns home with prescriptions for hypertension or diabetes but no clear plan for weight management.

What can a shared medical appointment do?

A shared medical appointment is a group medical visit in which several patients with a similar clinical diagnosis, such as obesity, see a multidisciplinary team of healthcare providers. Typically, 5 to 10 patients have consultations with providers during a 60- to 90-minute appointment.²⁰

Part of the session is dedicated to education on the patients’ common medical condition with the goal of improving their self-management, but most of the time is spent addressing individual patient concerns.

Each patient takes a turn consulting with a provider, as in a traditional medical appointment, but in a group setting. This allows others in the group to observe and learn from their peers’ experiences. During this consultation, the patient’s concerns are addressed, medications are managed, necessary tests are ordered, and a treatment plan is made.

Patients can continue to receive follow-up care through shared medical appointments at predetermined times, instead of traditional individual medical appointments.

Shared medical appointments could improve patient access, clinical outcomes, and patient and provider satisfaction and decrease costs.^20,21 Since being introduced in the 1990s, their use has dramatically increased. For example, in the first 2 years of conducting shared medical appointments at Cleveland Clinic (2002–2004), there were just 385 shared medical appointments,²¹ but in 2017 there were approximately 12,300. They are used in a variety of medical and surgical specialties, and have been studied most for treating diabetes.^22–24

Increased face time and access

Individual patient follow-up visits typically last 15 to 20 minutes, limiting the provider to seeing a maximum of 6 patients in 90 minutes. In that same time in the setting of a shared appointment, a multidisciplinary team can see up to 10 patients, and the patients receive up to 90 minutes of time with multiple providers.

Additionally, shared medical appointments can improve patient access to timely appointments. In a busy bariatric surgery practice, implementing shared medical appointments reduced patients’ wait time for an appointment by more than half.²⁵ This is particularly important for patients with obesity, who usually require 12 to 26 appointments per year.

Improved patient outcomes

Use of shared medical appointments has improved clinical outcomes compared with traditional care. Patients with type 2 diabetes who attend shared medical appointments are more likely to reach target hemoglobin A_1c and blood pressure levels.^22­­−24 These benefits may be attributed to increased access to care, improved self-management skills, more frequent visits, peer support of the group, and the synergistic knowledge of multiple providers on the shared medical appointment team.

Although some trials reported patient retention rates of 75% to 90% in shared medical appointments, many trials did not report their rates. It is likely that some patients declined randomization to avoid shared medical appointments, which could have led to potential attrition and selection biases.²³

Increased patient and provider satisfaction

Both patients and providers report high satisfaction with shared medical appointments.^22,26 Although patients may initially hesitate to participate, their opinions significantly improve after attending 1 session.²⁶ From 85% to 90% of patients who attend a shared medical appointment schedule their next follow-up appointment as a shared appointment as well.^21,25

In comparative studies, patients who attended shared medical appointments had satisfaction rates equal to or higher than rates in patients who participated in usual care,²² noting better access to care and more sensitivity to their needs.²⁷ Providers report greater satisfaction from working more directly with a team of providers, clearing up a backlogged schedule, and adding variety to their practice.^21,24

Decreased costs

Data on the cost-effectiveness of shared medical appointments are mixed; however, some studies have shown that they are associated with a decrease in hospital admissions and emergency department visits.²² It seems reasonable to assume that, in an appropriate patient population, shared medical appointments can be cost-effective owing to increased provider productivity, but more research is needed to verify this.

CHALLENGES TO STARTING SHARED APPOINTMENTS FOR OBESITY

Despite their potential to provide comprehensive care to patients, shared medical appointments have limitations. These need to be addressed before implementing a shared medical appointment program.

Adequate resources and staff training

To be successful, a shared medical appointment program needs to have intensive physical and staffing resources. You need a space large enough to accommodate the group and access to the necessary equipment (eg, projector, whiteboard) for educational sessions. Larger or armless chairs may better accommodate patients with obesity. Facilitators need training in how to lead the group sessions, including time management and handling conflicts between patients. Schedulers and clinical intake staff need training in answering patient questions regarding these appointments.

Maintaining patient attendance

The benefits of provider efficiency rest on having an adequate number of patients attend the shared appointments.²¹ Patient cancellations and no-shows decrease both the efficiency and cost-effectiveness of this model, and they detract from the peer support and group learning that occurs in the group dynamic. To help minimize patient dropout, a discussion of patient expectations should take place prior to enrollment in shared medical appointments. This should include information on the concept of shared appointments, frequency and duration of appointments, and realistic weight loss goals.

Logistical challenges

A shared medical appointment requires a longer patient time slot and is usually less flexible than an individual appointment. Not all patients can take the time for a prescheduled 60- to 90-minute appointment. However, reduced waiting-room time and increased face time with a provider offset some of these challenges.

Recruiting patients

A shared medical appointment is a novel experience for some, and concerns about it may make it a challenge to recruit patients. Patients might worry that the presence of the group will compromise the patient-doctor relationship. Other concerns include potential irrelevance of other patients’ medical issues and reluctance to participate because of body image and the stigma of obesity.

One solution is to select patients from your existing practice so that the individual patient-provider relationship is established before introducing the concept of shared appointments. You will need to explain how shared appointments work, discuss their pros and cons, stress your expectations about attendance and confidentiality, and address any concerns of the patient. It is also important to emphasize that nearly all patients find shared medical appointments useful.

Once a group is established, it may be a challenge to keep a constant group membership to promote positive group dynamics. In practice, patients may drop out or be added, and facilitators need to be able to integrate new members into the group. It is important to emphasize to the group that obesity is chronic and that patients at all stages and levels of treatment can contribute to group learning.

Despite the advantages of shared medical appointments, some patients may not find them useful, even after attending several sessions. These patients should be offered individual follow-up visits. Also, shared appointments may not be suitable for patients who cannot speak English very well, are hearing-impaired, have significant cognitive impairment, or have acute medical issues.

Maintaining confidentiality of personal and health information in a shared medical appointment is an important concern for patients but can be appropriately managed. In a survey of patients attending pulmonary hypertension shared medical appointments, 24% had concerns about confidentiality before participating, but after a few sessions, this rate was cut in half.²⁸

Patients have reported initially withholding some information, but over time, they usually become more comfortable with the group and disclose more helpful information.²⁹ Strategies to ensure confidentiality include having patients sign a confidentiality agreement at each appointment, providing specific instruction on what characterizes confidentiality breaches, and allowing patients the opportunity to schedule individual appointments as needed.

Ensuring insurance coverage

A shared medical appointment should be billed as an individual medical appointment for level of care, rather than time spent with the provider. This ensures that insurance coverage and copayments are the same as for individual medical appointments.

Lack of insurance coverage is a major barrier to obesity treatment in general. The US Centers for Medicare and Medicaid Services reimburses intensive behavioral obesity treatment delivered by a primary care practitioner, but limits it to 1 year of treatment and requires patients to meet weight loss goals. Some individual and employer-based healthcare plans do not cover dietitian visits, weight management programs, or antiobesity prescriptions.

EVIDENCE OF EFFECTIVENESS IN OBESITY

Few studies have investigated the use of shared medical appointments in obesity treatment. In the pediatric population, these programs significantly decreased BMI and some other anthropometric measurements,^30–32 but they did not consistently involve a prescribing provider. This means they did not manage medications or comorbidities as would be expected in a shared medical appointment.

In adults, reported effects have been encouraging, although the studies are not particularly robust. In a 2-year observational study of a single physician conducting biweekly weight management shared medical appointments, participants lost 1% of their baseline weight, while those continuing with usual care gained 0.8%, a statistically significant difference.³³ However, participation rates were low, with patients attending an average of only 3 shared medical appointments during the study.

In a meta-analysis of 13 randomized controlled trials of shared medical appointments for patients with type 2 diabetes, only 3 studies reported weight outcomes.²³ These results indicated a trend toward weight loss among patients attending shared appointments, but they were not statistically significant.

Positive results also were reported by the Veterans Administration’s MOVE! (Managing Overweight/obesity for Veterans Everywhere) program.³⁴ Participants in shared medical appointments reported that they felt empowered to make positive lifestyle changes, gained knowledge about obesity, were held accountable by their peers, and appreciated the individualized care they received from the multidisciplinary healthcare teams.

A systematic review involving 336 participants in group-based obesity interventions found group treatment produced more robust weight loss than individual treatment.³⁵ However, shared medical appointments are different from weight loss groups in that they combine an educational session and a medical appointment in a peer-group setting, which requires a provider with prescribing privileges to be present. Thus, shared medical appointments can manage medications as well as weight-related comorbidities such as diabetes, hypertension, polycystic ovarian syndrome, and hyperlipidemia.

One more point is that continued attendance at shared medical appointments, even after successful weight loss, may help to maintain the weight loss, which has otherwise been found to be extremely challenging using traditional medical approaches.

WHO SHOULD BE ON THE TEAM?

Because obesity is multifactorial, it requires a comprehensive treatment approach that can be difficult to deliver given the limited time of an individual appointment. In a shared appointment, providers across multiple specialties can meet with patients at the same time to coordinate approaches to obesity treatment.

A multidisciplinary team for shared medical appointments for obesity needs a physician or a nurse practitioner—or ideally, both— who specializes in obesity to facilitate the session. Other key providers include a registered dietitian, an exercise physiologist, a behavioral health specialist, a sleep specialist, and a social worker to participate as needed in the educational component of the appointment or act as outside consultants.

WHAT ARE REALISTIC TARGETS?

• Nutrition
• Physical activity
• Appetite control
• Sleep
• Stress and mood disorders.

Nutrition

A calorie deficit of 500 to 750 calories per day is recommended for weight loss.^7,8 Although there is no consensus on the best nutritional content of a diet, adherence to a diet is a significant predictor of weight loss.³⁶ One reason diets fail to bring about weight loss is that patients tend to underestimate their caloric intake by almost 50%.³⁷ Thus, they may benefit from a structured and supervised diet plan.

A dietitian can help patients develop an individualized diet plan that will promote adherence, which includes specific information on food choices, portion sizes, and timing of meals.

Physical activity

At least 150 minutes of physical activity per week is recommended for weight loss, and 200 to 300 minutes per week is recommended for long-term weight maintenance.^7,8

An exercise physiologist can help patients design a personalized exercise plan to help achieve these goals. This plan should take into account the patient’s cardiac status, activity level, degree of mobility, and lifestyle.

Most patients are not able to achieve the recommended physical activity goals initially, and activity levels need to be gradually increased over a period of weeks to months. Patients who were previously inactive or have evidence of cardiovascular, renal, or metabolic disease may require a cardiopulmonary assessment, including an electrocardiogram and cardiac stress test, before starting an exercise program.

It is very difficult for patients to lose weight without appetite control. Weight loss that results from diet and exercise is often accompanied by a change in weight-regulating hormones (eg, leptin, ghrelin, peptide YY, and cholecystokinin) that promote weight regain.³⁸ Thus, multiple compensatory mechanisms promote weight regain through increases in appetite and decreases in energy expenditure, resisting weight loss efforts.

Antiobesity drugs can help mitigate these adaptive weight-promoting responses through several mechanisms. They are indicated for use with lifestyle interventions for patients with a BMI of at least 30 mg/kg² or a BMI of at least 27 kg/m² with an obesity-related comorbidity.

These drugs promote an additional 3% to 7% weight loss when added to lifestyle interventions.¹⁸ But their effects are limited without appropriate lifestyle interventions.

Sleep

Adequate sleep is an often-overlooked component of obesity treatment. Inadequate sleep is associated with weight gain and an appetite-inducing hormone profile.³⁹ Just 2 days of sleep deprivation in healthy normal-weight adult men was associated with a 70% increase in the ghrelin-to-leptin ratio, which showed a linear relationship with self-reported increased hunger.³⁹ Sleep disorders, especially obstructive sleep apnea, are common in patients with obesity but are often underdiagnosed and undertreated.⁴⁰

Healthy sleep habits and sleep quality should be addressed in shared medical appointments for obesity, as patients may be unaware of the impact that sleep may be having on their obesity treatment. The STOP-BANG questionnaire (­snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference, and male sex) is a simple and reliable tool to screen for obstructive sleep apnea.⁴¹ Patients with symptoms of a sleep disorder should be referred to a sleep specialist for diagnosis and management.

Stress management and mood disorders

Stress and psychiatric disorders are underappreciated contributors to obesity. All patients receiving obesity treatment need to be screened for mood disorders and suicidal ideation.⁸

Chronic stress promotes weight gain through activation of the hypothalamic-pituitary-adrenocortical axis, whereby increased cortisol levels enhance appetite and accumulation of visceral fat.⁴² In addition, obesity is associated with a 25% increased risk of mood disorders, although the mechanism and direction of this association are unclear.⁴³ Weight gain as a side effect of antidepressant or other psychiatric medications is another important consideration.

Management of stress and psychiatric disorders through goal-setting, self-monitoring, and patient education is vital to help patients fully participate in lifestyle changes and maximize weight loss. Patients participating in shared medical appointments usually benefit from consultations with psychiatrists or psychologists to manage psychiatric comorbidities and assist with adherence to behavior modification. 


IN FAVOR OF SHARED MEDICAL APPOINTMENTS FOR OBESITY

Shared medical appointments can be an effective method of addressing the challenges of treating patients with obesity, using a multidisciplinary approach that combines nutrition, physical activity, appetite suppression, sleep improvement, and stress management. In addition, shared appointments allow practitioners to treat the primary problem of excess weight, rather than just its comorbidities, recognizing that obesity is a chronic disease that requires long-term, individualized treatment. Satisfaction rates are high for both patients and providers. Overall, education is essential to implementing and maintaining a successful shared medical appointment program.

Obesity is a major health problem in the United States. The facts are well known:

• Its prevalence has almost tripled since the early 1960s¹
• More than 35% of US adults are obese (body mass index [BMI] ≥ 30 kg/m²)²
• It increases the risk of comorbid conditions including type 2 diabetes mellitus, heart disease, hypertension, obstructive sleep apnea, certain cancers, asthma, and osteoarthritis^3,4
• It decreases life expectancy⁵
• Medical costs are up to 6 times higher per patient.⁶

Moreover, obesity is often not appropriately managed, owing to a variety of factors. In this article, we describe use of shared medical appointments as a strategy to improve the efficiency and effectiveness of treating patients with obesity.

Big benefits from small changes in weight

As little as 3% to 5% weight loss is associated with significant clinical benefits, such as improved glycemic control, reduced blood pressure, and reduced cholesterol levels.^7,8 However, many patients are unable to reach this modest goal using current approaches to obesity management.

This failure is partially related to the complexity and chronic nature of obesity, which requires continued medical management from a multidisciplinary team. We believe this is an area of care that can be appropriately addressed through shared medical appointments.

CURRENT APPROACHES

Interventions for obesity have increased along with the prevalence of the disease. Hundreds of diets, exercise plans, natural products, and behavioral interventions are marketed, all claiming to be successful. More-intense treatment options include antiobesity medications, intra-abdominal weight loss devices, and bariatric surgery. Despite the availability of treatments, rates of obesity have not declined.

Counseling is important, but underused

Lifestyle modifications that encompass nutrition, physical activity, and behavioral interventions are the mainstay of obesity treatment.

Intensive interventions work better than less-intensive ones. In large clinical trials in overweight patients with diabetes, those who received intensive lifestyle interventions lost 3 to 5 kg more (3% to 8% of body weight) than those who received brief diet and nutrition counseling, as is often performed in a physician’s office.^9–12 The US Preventive Services Task Force recommends that patients whose BMI is 30 kg/m² or higher be offered intensive lifestyle intervention consisting of at least 12 sessions in 1 year.¹³

But fewer than half of primary care practitioners consistently provide specific guidance on diet, exercise, or weight control to patients with obesity, including those with a weight-related comorbidity.¹⁴ The rate has decreased since the 1990s despite the increase in obesity.¹⁵

One reason for the underuse is that many primary care practitioners do not have the training or time to deliver the recommended high-intensity obesity treatment.¹⁴ Plus, evidence does not clearly show a weight loss benefit from low-intensity interventions. Even when patients lose weight, most regain it, and only 20% are able to maintain their weight loss 1 year after treatment ends.¹⁶

Drugs and surgery also underused

Antiobesity medications and bariatric surgery are effective when added to lifestyle interventions, but they are also underused.

Bariatric surgery provides the greatest and most durable weight loss—15% to 30% of body weight—along with improvement in comorbidities such as type 2 diabetes, and its benefits are sustained for at least 10 years.¹⁷ However, fewer than 1% of eligible patients undergo bariatric surgery because of its limited availability, invasive nature, potential complications, limited insurance coverage, and high cost.¹⁷

The story is similar for antiobesity drugs. They are useful adjuncts to lifestyle interventions, providing an additional 3% to 7% weight loss,¹⁸ but fewer than 2% of eligible patients receive them.¹⁹ This may be attributed to their modest effectiveness, weight regain after discontinuation, potential adverse effects, and expense due to lack of insurance coverage.

ARE SHARED MEDICAL APPOINTMEMNTS AN ANSWER?

Although treatments have shown some effectiveness at producing weight loss, none has had a widespread impact on obesity. Lifestyle interventions, drugs, and bariatric surgery continue to be underused. Current treatment models are not providing patients with the intensive interventions needed.

Providers often find themselves offering repetitive advice to patients with obesity regarding nutrition and exercise, while simultaneously trying to manage obesity-related comorbidities, all in a 20-minute appointment. Too often, a patient returns home with prescriptions for hypertension or diabetes but no clear plan for weight management.

What can a shared medical appointment do?

A shared medical appointment is a group medical visit in which several patients with a similar clinical diagnosis, such as obesity, see a multidisciplinary team of healthcare providers. Typically, 5 to 10 patients have consultations with providers during a 60- to 90-minute appointment.²⁰

Part of the session is dedicated to education on the patients’ common medical condition with the goal of improving their self-management, but most of the time is spent addressing individual patient concerns.

Each patient takes a turn consulting with a provider, as in a traditional medical appointment, but in a group setting. This allows others in the group to observe and learn from their peers’ experiences. During this consultation, the patient’s concerns are addressed, medications are managed, necessary tests are ordered, and a treatment plan is made.

Patients can continue to receive follow-up care through shared medical appointments at predetermined times, instead of traditional individual medical appointments.

Shared medical appointments could improve patient access, clinical outcomes, and patient and provider satisfaction and decrease costs.^20,21 Since being introduced in the 1990s, their use has dramatically increased. For example, in the first 2 years of conducting shared medical appointments at Cleveland Clinic (2002–2004), there were just 385 shared medical appointments,²¹ but in 2017 there were approximately 12,300. They are used in a variety of medical and surgical specialties, and have been studied most for treating diabetes.^22–24

Increased face time and access

Individual patient follow-up visits typically last 15 to 20 minutes, limiting the provider to seeing a maximum of 6 patients in 90 minutes. In that same time in the setting of a shared appointment, a multidisciplinary team can see up to 10 patients, and the patients receive up to 90 minutes of time with multiple providers.

Additionally, shared medical appointments can improve patient access to timely appointments. In a busy bariatric surgery practice, implementing shared medical appointments reduced patients’ wait time for an appointment by more than half.²⁵ This is particularly important for patients with obesity, who usually require 12 to 26 appointments per year.

Improved patient outcomes

Use of shared medical appointments has improved clinical outcomes compared with traditional care. Patients with type 2 diabetes who attend shared medical appointments are more likely to reach target hemoglobin A_1c and blood pressure levels.^22­­−24 These benefits may be attributed to increased access to care, improved self-management skills, more frequent visits, peer support of the group, and the synergistic knowledge of multiple providers on the shared medical appointment team.

Although some trials reported patient retention rates of 75% to 90% in shared medical appointments, many trials did not report their rates. It is likely that some patients declined randomization to avoid shared medical appointments, which could have led to potential attrition and selection biases.²³

Increased patient and provider satisfaction

Both patients and providers report high satisfaction with shared medical appointments.^22,26 Although patients may initially hesitate to participate, their opinions significantly improve after attending 1 session.²⁶ From 85% to 90% of patients who attend a shared medical appointment schedule their next follow-up appointment as a shared appointment as well.^21,25

In comparative studies, patients who attended shared medical appointments had satisfaction rates equal to or higher than rates in patients who participated in usual care,²² noting better access to care and more sensitivity to their needs.²⁷ Providers report greater satisfaction from working more directly with a team of providers, clearing up a backlogged schedule, and adding variety to their practice.^21,24

Decreased costs

Data on the cost-effectiveness of shared medical appointments are mixed; however, some studies have shown that they are associated with a decrease in hospital admissions and emergency department visits.²² It seems reasonable to assume that, in an appropriate patient population, shared medical appointments can be cost-effective owing to increased provider productivity, but more research is needed to verify this.

CHALLENGES TO STARTING SHARED APPOINTMENTS FOR OBESITY

Despite their potential to provide comprehensive care to patients, shared medical appointments have limitations. These need to be addressed before implementing a shared medical appointment program.

Adequate resources and staff training

To be successful, a shared medical appointment program needs to have intensive physical and staffing resources. You need a space large enough to accommodate the group and access to the necessary equipment (eg, projector, whiteboard) for educational sessions. Larger or armless chairs may better accommodate patients with obesity. Facilitators need training in how to lead the group sessions, including time management and handling conflicts between patients. Schedulers and clinical intake staff need training in answering patient questions regarding these appointments.

Maintaining patient attendance

The benefits of provider efficiency rest on having an adequate number of patients attend the shared appointments.²¹ Patient cancellations and no-shows decrease both the efficiency and cost-effectiveness of this model, and they detract from the peer support and group learning that occurs in the group dynamic. To help minimize patient dropout, a discussion of patient expectations should take place prior to enrollment in shared medical appointments. This should include information on the concept of shared appointments, frequency and duration of appointments, and realistic weight loss goals.

Logistical challenges

A shared medical appointment requires a longer patient time slot and is usually less flexible than an individual appointment. Not all patients can take the time for a prescheduled 60- to 90-minute appointment. However, reduced waiting-room time and increased face time with a provider offset some of these challenges.

Recruiting patients

A shared medical appointment is a novel experience for some, and concerns about it may make it a challenge to recruit patients. Patients might worry that the presence of the group will compromise the patient-doctor relationship. Other concerns include potential irrelevance of other patients’ medical issues and reluctance to participate because of body image and the stigma of obesity.

One solution is to select patients from your existing practice so that the individual patient-provider relationship is established before introducing the concept of shared appointments. You will need to explain how shared appointments work, discuss their pros and cons, stress your expectations about attendance and confidentiality, and address any concerns of the patient. It is also important to emphasize that nearly all patients find shared medical appointments useful.

Once a group is established, it may be a challenge to keep a constant group membership to promote positive group dynamics. In practice, patients may drop out or be added, and facilitators need to be able to integrate new members into the group. It is important to emphasize to the group that obesity is chronic and that patients at all stages and levels of treatment can contribute to group learning.

Despite the advantages of shared medical appointments, some patients may not find them useful, even after attending several sessions. These patients should be offered individual follow-up visits. Also, shared appointments may not be suitable for patients who cannot speak English very well, are hearing-impaired, have significant cognitive impairment, or have acute medical issues.

Maintaining confidentiality of personal and health information in a shared medical appointment is an important concern for patients but can be appropriately managed. In a survey of patients attending pulmonary hypertension shared medical appointments, 24% had concerns about confidentiality before participating, but after a few sessions, this rate was cut in half.²⁸

Patients have reported initially withholding some information, but over time, they usually become more comfortable with the group and disclose more helpful information.²⁹ Strategies to ensure confidentiality include having patients sign a confidentiality agreement at each appointment, providing specific instruction on what characterizes confidentiality breaches, and allowing patients the opportunity to schedule individual appointments as needed.

Ensuring insurance coverage

A shared medical appointment should be billed as an individual medical appointment for level of care, rather than time spent with the provider. This ensures that insurance coverage and copayments are the same as for individual medical appointments.

Lack of insurance coverage is a major barrier to obesity treatment in general. The US Centers for Medicare and Medicaid Services reimburses intensive behavioral obesity treatment delivered by a primary care practitioner, but limits it to 1 year of treatment and requires patients to meet weight loss goals. Some individual and employer-based healthcare plans do not cover dietitian visits, weight management programs, or antiobesity prescriptions.

EVIDENCE OF EFFECTIVENESS IN OBESITY

Few studies have investigated the use of shared medical appointments in obesity treatment. In the pediatric population, these programs significantly decreased BMI and some other anthropometric measurements,^30–32 but they did not consistently involve a prescribing provider. This means they did not manage medications or comorbidities as would be expected in a shared medical appointment.

In adults, reported effects have been encouraging, although the studies are not particularly robust. In a 2-year observational study of a single physician conducting biweekly weight management shared medical appointments, participants lost 1% of their baseline weight, while those continuing with usual care gained 0.8%, a statistically significant difference.³³ However, participation rates were low, with patients attending an average of only 3 shared medical appointments during the study.

In a meta-analysis of 13 randomized controlled trials of shared medical appointments for patients with type 2 diabetes, only 3 studies reported weight outcomes.²³ These results indicated a trend toward weight loss among patients attending shared appointments, but they were not statistically significant.

Positive results also were reported by the Veterans Administration’s MOVE! (Managing Overweight/obesity for Veterans Everywhere) program.³⁴ Participants in shared medical appointments reported that they felt empowered to make positive lifestyle changes, gained knowledge about obesity, were held accountable by their peers, and appreciated the individualized care they received from the multidisciplinary healthcare teams.

A systematic review involving 336 participants in group-based obesity interventions found group treatment produced more robust weight loss than individual treatment.³⁵ However, shared medical appointments are different from weight loss groups in that they combine an educational session and a medical appointment in a peer-group setting, which requires a provider with prescribing privileges to be present. Thus, shared medical appointments can manage medications as well as weight-related comorbidities such as diabetes, hypertension, polycystic ovarian syndrome, and hyperlipidemia.

One more point is that continued attendance at shared medical appointments, even after successful weight loss, may help to maintain the weight loss, which has otherwise been found to be extremely challenging using traditional medical approaches.

WHO SHOULD BE ON THE TEAM?

Because obesity is multifactorial, it requires a comprehensive treatment approach that can be difficult to deliver given the limited time of an individual appointment. In a shared appointment, providers across multiple specialties can meet with patients at the same time to coordinate approaches to obesity treatment.

A multidisciplinary team for shared medical appointments for obesity needs a physician or a nurse practitioner—or ideally, both— who specializes in obesity to facilitate the session. Other key providers include a registered dietitian, an exercise physiologist, a behavioral health specialist, a sleep specialist, and a social worker to participate as needed in the educational component of the appointment or act as outside consultants.

WHAT ARE REALISTIC TARGETS?

• Nutrition
• Physical activity
• Appetite control
• Sleep
• Stress and mood disorders.

Nutrition

A calorie deficit of 500 to 750 calories per day is recommended for weight loss.^7,8 Although there is no consensus on the best nutritional content of a diet, adherence to a diet is a significant predictor of weight loss.³⁶ One reason diets fail to bring about weight loss is that patients tend to underestimate their caloric intake by almost 50%.³⁷ Thus, they may benefit from a structured and supervised diet plan.

A dietitian can help patients develop an individualized diet plan that will promote adherence, which includes specific information on food choices, portion sizes, and timing of meals.

Physical activity

At least 150 minutes of physical activity per week is recommended for weight loss, and 200 to 300 minutes per week is recommended for long-term weight maintenance.^7,8

An exercise physiologist can help patients design a personalized exercise plan to help achieve these goals. This plan should take into account the patient’s cardiac status, activity level, degree of mobility, and lifestyle.

Most patients are not able to achieve the recommended physical activity goals initially, and activity levels need to be gradually increased over a period of weeks to months. Patients who were previously inactive or have evidence of cardiovascular, renal, or metabolic disease may require a cardiopulmonary assessment, including an electrocardiogram and cardiac stress test, before starting an exercise program.

It is very difficult for patients to lose weight without appetite control. Weight loss that results from diet and exercise is often accompanied by a change in weight-regulating hormones (eg, leptin, ghrelin, peptide YY, and cholecystokinin) that promote weight regain.³⁸ Thus, multiple compensatory mechanisms promote weight regain through increases in appetite and decreases in energy expenditure, resisting weight loss efforts.

Antiobesity drugs can help mitigate these adaptive weight-promoting responses through several mechanisms. They are indicated for use with lifestyle interventions for patients with a BMI of at least 30 mg/kg² or a BMI of at least 27 kg/m² with an obesity-related comorbidity.

These drugs promote an additional 3% to 7% weight loss when added to lifestyle interventions.¹⁸ But their effects are limited without appropriate lifestyle interventions.

Sleep

Adequate sleep is an often-overlooked component of obesity treatment. Inadequate sleep is associated with weight gain and an appetite-inducing hormone profile.³⁹ Just 2 days of sleep deprivation in healthy normal-weight adult men was associated with a 70% increase in the ghrelin-to-leptin ratio, which showed a linear relationship with self-reported increased hunger.³⁹ Sleep disorders, especially obstructive sleep apnea, are common in patients with obesity but are often underdiagnosed and undertreated.⁴⁰

Healthy sleep habits and sleep quality should be addressed in shared medical appointments for obesity, as patients may be unaware of the impact that sleep may be having on their obesity treatment. The STOP-BANG questionnaire (­snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference, and male sex) is a simple and reliable tool to screen for obstructive sleep apnea.⁴¹ Patients with symptoms of a sleep disorder should be referred to a sleep specialist for diagnosis and management.

Stress management and mood disorders

Stress and psychiatric disorders are underappreciated contributors to obesity. All patients receiving obesity treatment need to be screened for mood disorders and suicidal ideation.⁸

Chronic stress promotes weight gain through activation of the hypothalamic-pituitary-adrenocortical axis, whereby increased cortisol levels enhance appetite and accumulation of visceral fat.⁴² In addition, obesity is associated with a 25% increased risk of mood disorders, although the mechanism and direction of this association are unclear.⁴³ Weight gain as a side effect of antidepressant or other psychiatric medications is another important consideration.

Management of stress and psychiatric disorders through goal-setting, self-monitoring, and patient education is vital to help patients fully participate in lifestyle changes and maximize weight loss. Patients participating in shared medical appointments usually benefit from consultations with psychiatrists or psychologists to manage psychiatric comorbidities and assist with adherence to behavior modification. 


IN FAVOR OF SHARED MEDICAL APPOINTMENTS FOR OBESITY

Shared medical appointments can be an effective method of addressing the challenges of treating patients with obesity, using a multidisciplinary approach that combines nutrition, physical activity, appetite suppression, sleep improvement, and stress management. In addition, shared appointments allow practitioners to treat the primary problem of excess weight, rather than just its comorbidities, recognizing that obesity is a chronic disease that requires long-term, individualized treatment. Satisfaction rates are high for both patients and providers. Overall, education is essential to implementing and maintaining a successful shared medical appointment program.

The United States has seen a decline in fatal myocardial infarctions, largely thanks to early detection of coronary artery disease. Current guidelines on assessment of cardiovascular risk still rely on the traditional 10-year risk model in clinical practice. However, the predictive value of this approach is only moderate, and many coronary events occur in people considered to be at low or intermediate risk.

See related editorial

Coronary artery calcium scoring has emerged as a means of risk stratification by direct measurement of disease. Primary care providers are either using it or are seeing it used by consulting physicians, and its relatively low cost and ease of performance have contributed to its widespread use. However, downstream costs, radiation exposure, and lack of randomized controlled trials have raised concerns.

This article reviews the usefulness and pitfalls of coronary artery calcium scoring, providing a better understanding of the test, its limitations, and the interpretation of results.

ATHEROSCLEROSIS AND CALCIUM

As the calcium deposits grow, they can be detected by imaging tests such as computed tomography (CT), and quantified to assess the extent of disease.⁴

CALCIFICATION AND CORONARY ARTERY DISEASE

Coronary calcification occurs almost exclusively in atherosclerosis. Several autopsy studies^5,6 and histopathologic studies⁷ have shown a direct relationship between the extent of calcification and atherosclerotic disease.

Sangiorgi et al⁷ performed a histologic analysis of 723 coronary artery segments. The amount of calcium correlated well with the area of plaque:

• r = 0.89, P < .0001 in the left anterior descending artery
• r = 0.7, P < .001 in the left circumflex artery
• r = 0.89, P < .0001 in the right coronary artery.

Coronary artery calcium has also been associated with obstructive coronary artery disease in studies using intravascular ultrasonography and optical coherence tomography.^8,9

TECHNICAL INFORMATION ABOUT THE TEST

First-generation CT scanners used for calcium scoring in the 1980s were electron-beam systems in which a stationary x-ray tube generated an oscillating electron beam, which was reflected around the patient table.¹⁰ A single, stationary detector ring captured the images.

These systems have been replaced by multidetector scanners, in which the x-ray tube and multiple rows of detectors are combined in a gantry that rotates at high speed around the patient.

Coronary calcium is measured by noncontrast CT of the heart. Thus, there is no risk of contrast-induced nephropathy or allergic reactions. Images are acquired while the patient holds his or her breath for 3 to 5 seconds. Electrocardiographic gating is used to reduce motion artifact.^11,12 With modern scanners, the effective radiation dose associated with calcium testing is as low as 0.5 to 1.5 mSv,^13,14 ie, about the same dose as that with mammography. The entire test takes 10 to 15 minutes.

The results fall into 4 categories, which correlate with the severity of coronary artery disease, ranging from no significant disease to severe disease (Table 1). Other scores, which are not commonly used, include the calcium volume score¹⁶ and the calcium mass score.¹⁷Figure 2 shows a screenshot from a coronary artery calcium scoring program. 

Early multicenter studies evaluated the utility of calcium scoring to predict coronary stenosis in patients who underwent both cardiac CT and coronary angiography. The sensitivity of calcium scoring for angiographically significant disease was high (95%), but its specificity was low (about 44%).¹⁸

Budoff et al,¹⁹ reviewing these and subsequent results, concluded that the value of calcium scoring is its high negative predictive value (about 98%); a negative score (no calcification) is strongly associated with the absence of obstructive coronary disease.

Blaha et al²⁰ concluded that a score of 0 would indicate that the patient had a low risk of cardiovascular disease. A test with these characteristics is helpful in excluding cardiovascular disease or at least in determining that it is less likely to be present in a patient deemed to be at intermediate risk.

CALCIUM SCORING AS A PROGNOSTIC TOOL

Early on, investigators recognized the value of calcium scoring in predicting the risk of future cardiovascular events and death.^21–25

Predicting cardiovascular events

Pletcher et al21 performed a meta-analysis of studies that measured calcification in asymptomatic patients with subsequent follow-up. The summary-adjusted relative risk of cardiac events such as myocardial infarction, coronary artery revascularization, and coronary heart disease-related death rose with the calcium score:

• 2.1 (95% confidence interval [CI] 1.6–2.9) with a score of 1 to 100
• 4.2 (95% CI 2.5–7.2) with scores of 101 to 400
• 7.2 (95% CI 3.9-13.0) with scores greater than 400.

The meta-analysis was limited in that it included only 4 studies, which were observational.

Kavousi et al,²² in a subsequent meta-analysis of 6,739 women at low risk of atherosclerotic cardiovascular disease based on the American College of Cardiology/American Heart Association (ACC/AHA) pooled cohort equation (10-year risk < 7.5%), found that 36.1% had calcium scores greater than 0. Compared with those whose score was 0, those with higher scores had a higher risk of atherosclerotic cardiovascular disease events. The incidence rates per 1,000 person-years were 1.41 vs 4.33 (relative risk 2.92, 95% CI 2.02–3.83; multivariable-adjusted hazard ratio 2.04, 95% CI 1.44–2.90). This study was limited because the population was mostly of European descent, making it less generalizable to non-European populations.

Calcium scoring has also been shown to be a strong predictor of incident cardiovascular events across different races beyond traditional risk factors such as hypertension, hyperlipidemia, and tobacco use.

Detrano et al,²³ in a study of 6,722 patients with diverse ethnic backgrounds, found that the adjusted risk of a coronary event was increased by a factor of 7.73 for calcium scores between 101 and 300 and by a factor of 9.67 for scores above 300 (P < .001). A limitation of this study was that the patients and physicians were informed of the scores, which could have led to bias.

Carr et al²⁴ found an association between calcium and coronary heart disease in a younger population (ages 32–46). In 12.5 years of follow-up, the hazard ratio for cardiovascular events increased exponentially with the calcium score:

• 2.6 (95% CI 1.0–5.7, P = .03) with calcium scores of 1 through 19
• 9.8 (95% CI 4.5–20.5, P < .001) with scores greater than 100.

Predicting mortality

Budoff et al,²⁵ in an observational study of 25,253 patients, found coronary calcium to be an independent predictor of mortality in a multivariable model controlling for age, sex, ethnicity, and cardiac risk factors (model chi-square = 2,017, P < .0001). However, most of the patients were already known to have cardiac risk factors, making the study findings less generalizable to the general population.

Nasir et al²⁶ found that mortality rates rose with the calcium score in a study with 44,052 participants. The annualized mortality rates per 1,000 person-years were:

• 0.87 (95% CI 0.72–1.06) with a score of 0
• 2.97 (95% CI 2.61–3.37) with scores of 1–100
• 6.90 (95% CI 6.02–7.90) with scores of 101–400
• 17.68 (95% CI 5.93–19.62) with scores higher than 400.

The mortality rate also rose with the number of traditional risk factors present, ie, current tobacco use, dyslipidemia, diabetes mellitus, hypertension, and family history of coronary artery disease. Interestingly, those with no risk factors but a calcium score greater than 400 had a higher mortality rate than those with no coronary calcium but more than 3 risk factors (16.89 per 1,000 person-years vs 2.72 per 1,000 person years). As in the previous study, the patient population that was analyzed was at high risk and therefore the findings are not generalizable.

Shaw et al²⁷ found that patients without symptoms but with elevated coronary calcium scores had higher all-cause mortality rates at 15 years than those with a score of 0. The difference remained significant after Cox regression was performed, adjusting for traditional risk factors.

Current guidelines on assessing risk still rely on the traditional 10-year risk model in clinical practice.²⁵ Patients are thus classified as being at low, intermediate, or high risk based on their probability of developing a cardiovascular event or cardiovascular disease-related death in the subsequent 10 years.

However, the predictive value of this approach is only moderate,²⁸ and a significant number of cardiovascular events, including sudden cardiac death, occur in people who were believed to be at low or intermediate risk according to traditional risk factor-based predictions. Because risk scores are strongly influenced by age,²⁹ they are least reliable in young adults.³⁰

Akosah et al³¹ reviewed the records of 222 young adults (women age 55 or younger, men age 65 or younger) who presented with their first myocardial infarction, and found that only 25% would have qualified for primary prevention pharmacologic treatments according to the National Cholesterol Education Program III guidelines.^32,33 Similar findings have been reported regarding previous versions of the risk scores.³³

Thus, risk predictions based exclusively on traditional risk factors are not sensitive for detecting young individuals at increased risk, and lead to late treatment of young adults with atherosclerosis, which may be a less effective strategy.³⁴

The reliance on age in risk algorithms also results in low specificity in elderly adults. Using risk scores, elderly adults are systematically stratified in higher risk categories, expanding the indication for statin therapy to almost all men age 65 or older regardless of their actual vascular health, according to current clinical practice guidelines.^35,36

Risk scores are based on self-reported history and single-day measurements, since this kind of information is readily available to the physician in the clinic. Moreover, our knowledge about genetic and epigenetic factors associated with the development of atherosclerosis is still in its infancy, with current guidelines not supporting genetic testing as part of cardiovascular risk assessment.³⁷ Thus, a reliable measure of an individual’s lifelong exposure to a number of environmental and genetic factors that may affect cardiovascular health appears unfeasible.

Atherosclerosis is a process in which interactions between genetic, epigenetic, environmental, and traditional risk factors result in subclinical inflammation that could develop into clinically significant disease. Therefore, subclinical coronary atherosclerosis has been shown to be a strong predictor of future incident cardiovascular disease events and death. Thus, alternative approaches that directly measure disease, such as calcium scoring, may help further refine risk stratification of cardiovascular disease.

The MESA trial (Multi-Ethnic Study of Atherosclerosis), for instance, in 6,814 participants, found coronary calcium to provide better discrimination and risk reclassification than the ankle-brachial index, high sensitivity C-reactive protein level, and family history.³⁸ Coronary calcium also had the highest incremental improvement of the area under the receiver operating curve when added to the Framingham Risk Score (0.623 vs 0.784).

Reclassifying cardiovascular risk also has implications regarding whether to start therapies such as statins and aspirin.

For considering statin therapy

Nasir et al³⁹ showed that, in patients eligible for statin therapy by the pooled cohort equation, the absence of coronary artery calcium reclassified approximately one-half of candidates as not eligible for statin therapy. The number needed to treat to prevent an atherosclerotic cardiovascular event in the population who were recommended a statin was 64 with a calcium score of 0, and 24 with a calcium score greater than 100. In the population for whom a statin was considered, the number needed to treat was 223 with a calcium score of 0 and 46 for those with a score greater than 100. Moreover, 57% of intermediate-risk patients and 41% of high-risk patients based on the Framingham Risk Score were found to have a calcium score of 0, implying that these patients may actually be at a lower risk.

The Society of Cardiovascular Computed Tomography guidelines⁴⁰ say that statin therapy can be considered in patients who have a calcium score greater than 0.

For considering aspirin therapy

Miedema et al⁴¹ studied the role of coronary artery calcium in guiding aspirin therapy in 4,229 participants in the MESA trial who were not taking aspirin at baseline. Those with a calcium score higher than 100 had a number needed to treat of 173 in the group with a Framingham Risk Score less than 10% and 92 with a Framingham Risk Score of 10% or higher. The estimated number needed to harm for a major bleeding event was 442. For those who had a score of 0, the estimated number needed to treat was 2,036 for a Framingham Risk Score less than 10% and 808 for a Framingham Risk Score of 10% or higher, with an estimated number needed to harm of 442 for a major bleeding event.

The Society of Cardiovascular Computed Tomography guidelines⁴⁰ recommend considering aspirin therapy for patients with a coronary calcium score of more than 100.

McClelland et al⁴² developed a MESA risk score to predict 10-year risk of coronary heart disease using the traditional risk factors along with coronary calcium. The score was validated externally with 2 separate longitudinal studies. Thus, this may serve as another tool to help providers further risk-stratify patients.

COST-EFFECTIVENESS OF THE TEST

As coronary calcium measurement began to be widely used, concerns were raised about the lack of data on its cost-effectiveness.

Cost-effectiveness depends not only on patient selection but also on the cost of therapy. For example, if the cost of a generic statin is $85 per year, then calcium scoring would not be beneficial. However, if the cost of a statin is more than $200, then calcium scoring would be much more cost-effective, offering a way to avoid treating some patients who do not need to be treated.⁴³

Hong et al⁴³ showed that coronary calcium testing was cost-effective when the patient and physician share decision-making about initiating statin therapy. This is especially important if the patient has financial limitations, is concerned about side effects, or wants to avoid taking unnecessary medications.

According to some reports, $8.5 billion is spent annually for low-value care.⁴⁴ Many of the 80 million CT scans performed annually in the United States are believed to be unnecessary and may lead to additional testing to investigate incidental findings.⁴⁵

Growing use of coronary calcium measurement has raised similar concerns about radiation exposure, healthcare costs, and increased downstream testing triggered by the detection of incidental noncardiac findings. For instance, Onuma et al⁴⁶ reported that, in 503 patients undergoing CT to evaluate coronary artery disease, noncardiac findings were seen in 58.1% of them, but only 22.7% of the 503 had clinically significant findings.

Some of these concerns have been addressed. Modern scanners can acquire images in only a few seconds, entailing lower radiation doses than in the past.^13,14 The cost of the test is currently less than $100 in many US metropolitan areas.⁴⁷ However, further studies are needed to adequately and cost-effectively guide follow-up imaging of incidental noncardiac findings.⁴⁸

An important limitation of calcium scoring for risk assessment is that no randomized controlled trial has evaluated the impact of preventive interventions guided by calcium scores on hard event outcomes. It can be argued that there have been plenty of observational studies that have shown the benefit of coronary calcium scoring when judiciously done in the appropriate population.⁴⁹ Similarly, no randomized controlled trial has tested the pooled cohort equation and the application of statins based on its use with the current guidelines. The feasibility and cost of a large randomized controlled trial to assess outcomes after coronary artery calcium measurement must also be considered.

Another limitation of coronary calcium scoring is that it cannot rule out the presence of noncalcified atherosclerotic plaque, which often is more unstable and prone to rupture.

In addition, calcification in the coronary vascular bed (even if severe) does not necessarily mean there is clinically relevant coronary stenosis. For instance, an asymptomatic patient could have a coronary artery calcium score higher than 100 and then get a coronary angiogram that reveals only a 30% lesion in the left anterior descending coronary artery. This is because accumulation of (calcified) plaque in the vessel wall is accommodated by expansion of vessel diameter, maintaining luminal dimensions (positive remodeling). By definition, this patient does have coronary artery disease but would be best served by medical management. This could have been determined without an invasive test in an otherwise asymptomatic patient. Thus, performing coronary angiography based on a coronary artery calcium score alone would not have changed this patient’s management and may have exposed the patient to risks of procedural complications, in addition to extra healthcare costs. Therefore, the presence or absence of symptoms should guide the clinician on whether to pursue stress testing for invasive coronary angiography based on the appropriate use criteria.^50,51

WHO SHOULD BE TESTED?

In the ACC/AHA 2013 guidelines,³⁷ coronary calcium scoring has a class IIB recommendation in scenarios where it may appear that the risk-based treatment decision is uncertain after formal risk estimation has been done. As discussed above, a score higher than 100 could be a rationale for starting aspirin therapy, and a score higher than 0 for statin therapy. The current guidelines also mention that the coronary calcium score is comparable to other predictors such as the C-reactive protein level and the ankle-brachial index.

Compared with the ACC/AHA guidelines, the 2016 Society of Cardiovascular Computed Tomography guidelines and expert consensus recently have added more specifics in terms of using this test for asymptomatic patients at intermediate risk (10-year risk of atherosclerotic cardiovascular disease 5%–20%) and in selected patients with a family history of premature coronary artery disease and 10-year risk less than 5%.^40,52 The 2010 ACC/AHA guidelines were more specific, offering a class IIA recommendation for patients who were at intermediate risk (Framingham Risk Score 10%–20%).⁵³

The ACC/AHA cited cost and radiation exposure as reasons they did not give coronary calcium measurement a stronger recommendation.³⁷ However, as data continue to come in, the guidelines may change, especially since low-dose radiation tools are being used for cancer screening (lungs and breast) and since the cost has declined over the past decade.

OUR APPROACH

Given the negative predictive value of the coronary calcium score, our approach has been to use this test in asymptomatic patients who are found to be at intermediate risk of atherosclerotic cardiovascular disease based on the ACC/AHA risk calculation and are reluctant to start pharmacologic therapy, or who want a more personalized measure of coronary artery disease. This is preceded by a lengthy patient-physician discussion about the risks and benefits of the test.⁵⁴

The patient’s risk can then be further clarified and possibly reclassified as either low or high if it doesn’t remain intermediate. A discussion can then take place on potentially starting pharmacologic therapy, intensive lifestyle modifications, or both.^54,55 If an electronic medical record is available, CT results can be shown to the patient in the office to point out coronary calcifications. Seeing the lesions may serve an as additional motivating factor as patients embark on primary preventive efforts.⁵⁶

Below, we describe cases of what we would consider appropriate and inappropriate use of coronary artery calcium scoring.

A 55-year-old man presents for an annual physical and is found to have a 10-year risk of atherosclerotic cardiovascular disease of 7%, placing him in the intermediate-risk category. Despite an extensive conversation about lifestyle modifications and pharmacologic therapy, he is reluctant to initiate these measures. He is otherwise asymptomatic. Would calcium scoring be reasonable?

Yes, it would be reasonable to perform coronary artery calcium scoring in an otherwise asymptomatic man to help reclassify his risk for a coronary vascular event. The objective data provided by the test could motivate the patient to undertake primary prevention efforts or, if his score is 0, to show that he may not need drug therapy.

Example 2

A 55-year-old man who has a family history of coronary artery disease, is an active smoker, and has diabetes mellitus presents to the clinic with 2 months of exertional chest pain that resolves with rest. Would coronary artery calcium scoring be reasonable?

This patient is symptomatic and is at high risk of coronary artery disease. Statin therapy is already indicated in the AHA/ACC guidelines, since he has diabetes. Therefore, calcium scoring would not be helpful, as it would not change this patient’s management. Instead, he would be best served by stress testing or coronary angiography based on the stability of his symptoms and cardiac biomarkers.

Example 3

A 30-year-old woman with no medical history presents with on-and-off chest pain at both exertion and rest. Her electrocardiogram is unremarkable, and cardiac enzyme tests are negative. Would coronary calcium scoring be reasonable?

This young patient’s story is not typical for coronary artery disease. Therefore, she has a low pretest probability of obstructive coronary artery disease. Moreover, calcium scoring may not be helpful because at her young age there has not been enough time for calcification to develop (median age is the fifth decade of life). Thus, she would be exposed to radiation unnecessarily at a young age.

What to do with an elevated calcium score?

Coronary artery calcification is now being incidentally detected as patients undergo CT for other reasons such as screening for lung cancer based on the US Preventive Services Task Force guidelines. Patients may also get the test done on their own and then present to a provider with an elevated score.

It is important to consider the entire clinical scenario in such patients and not just the score. If a patient presents with an elevated calcium score but has no symptoms and falls in the intermediate-risk group, there is evidence to suggest that he or she should be started on statin or aspirin therapy or both.

As mentioned above, an abnormal test result does not mean that the patient should undergo more-invasive testing such as cardiac catheterization or even stress testing, especially if he or she has no symptoms. However, if the patient is symptomatic, then further cardiac evaluation would be recommended.

SUMMARY

Measuring coronary artery calcium has been found to be valuable in detecting coronary artery disease and in predicting cardiovascular events and death. The test is relatively easy to perform, with newer technology allowing for less radiation and cost. It serves as a more personalized measure of disease and can help facilitate patient-physician discussions about starting pharmacologic therapy, especially if a patient is reluctant.

Currently, coronary calcium scoring has a class IIB recommendation in scenarios in which the risk-based treatment decision is uncertain after formal risk estimation has been done according to the ACC/AHA guideline. The Society of Cardiovascular Computed Tomography guideline and expert consensus documents are more specific in recommending the test in asymptomatic patients in the intermediate-risk group.

Limitations of calcium scoring include the possibility of unnecessary cardiovascular testing such as cardiac catheterization or stress testing being driven by the calcium score alone, as well as the impact of incidental findings. With increased reporting of the coronary calcium score in patients undergoing CT for lung cancer screening, the score should be interpreted in view of the entire clinical scenario.

The United States has seen a decline in fatal myocardial infarctions, largely thanks to early detection of coronary artery disease. Current guidelines on assessment of cardiovascular risk still rely on the traditional 10-year risk model in clinical practice. However, the predictive value of this approach is only moderate, and many coronary events occur in people considered to be at low or intermediate risk.

See related editorial

Coronary artery calcium scoring has emerged as a means of risk stratification by direct measurement of disease. Primary care providers are either using it or are seeing it used by consulting physicians, and its relatively low cost and ease of performance have contributed to its widespread use. However, downstream costs, radiation exposure, and lack of randomized controlled trials have raised concerns.

This article reviews the usefulness and pitfalls of coronary artery calcium scoring, providing a better understanding of the test, its limitations, and the interpretation of results.

ATHEROSCLEROSIS AND CALCIUM

As the calcium deposits grow, they can be detected by imaging tests such as computed tomography (CT), and quantified to assess the extent of disease.⁴

CALCIFICATION AND CORONARY ARTERY DISEASE

Coronary calcification occurs almost exclusively in atherosclerosis. Several autopsy studies^5,6 and histopathologic studies⁷ have shown a direct relationship between the extent of calcification and atherosclerotic disease.

Sangiorgi et al⁷ performed a histologic analysis of 723 coronary artery segments. The amount of calcium correlated well with the area of plaque:

• r = 0.89, P < .0001 in the left anterior descending artery
• r = 0.7, P < .001 in the left circumflex artery
• r = 0.89, P < .0001 in the right coronary artery.

Coronary artery calcium has also been associated with obstructive coronary artery disease in studies using intravascular ultrasonography and optical coherence tomography.^8,9

TECHNICAL INFORMATION ABOUT THE TEST

First-generation CT scanners used for calcium scoring in the 1980s were electron-beam systems in which a stationary x-ray tube generated an oscillating electron beam, which was reflected around the patient table.¹⁰ A single, stationary detector ring captured the images.

These systems have been replaced by multidetector scanners, in which the x-ray tube and multiple rows of detectors are combined in a gantry that rotates at high speed around the patient.

Coronary calcium is measured by noncontrast CT of the heart. Thus, there is no risk of contrast-induced nephropathy or allergic reactions. Images are acquired while the patient holds his or her breath for 3 to 5 seconds. Electrocardiographic gating is used to reduce motion artifact.^11,12 With modern scanners, the effective radiation dose associated with calcium testing is as low as 0.5 to 1.5 mSv,^13,14 ie, about the same dose as that with mammography. The entire test takes 10 to 15 minutes.

The results fall into 4 categories, which correlate with the severity of coronary artery disease, ranging from no significant disease to severe disease (Table 1). Other scores, which are not commonly used, include the calcium volume score¹⁶ and the calcium mass score.¹⁷Figure 2 shows a screenshot from a coronary artery calcium scoring program. 

Early multicenter studies evaluated the utility of calcium scoring to predict coronary stenosis in patients who underwent both cardiac CT and coronary angiography. The sensitivity of calcium scoring for angiographically significant disease was high (95%), but its specificity was low (about 44%).¹⁸

Budoff et al,¹⁹ reviewing these and subsequent results, concluded that the value of calcium scoring is its high negative predictive value (about 98%); a negative score (no calcification) is strongly associated with the absence of obstructive coronary disease.

Blaha et al²⁰ concluded that a score of 0 would indicate that the patient had a low risk of cardiovascular disease. A test with these characteristics is helpful in excluding cardiovascular disease or at least in determining that it is less likely to be present in a patient deemed to be at intermediate risk.

CALCIUM SCORING AS A PROGNOSTIC TOOL

Early on, investigators recognized the value of calcium scoring in predicting the risk of future cardiovascular events and death.^21–25

Predicting cardiovascular events

Pletcher et al21 performed a meta-analysis of studies that measured calcification in asymptomatic patients with subsequent follow-up. The summary-adjusted relative risk of cardiac events such as myocardial infarction, coronary artery revascularization, and coronary heart disease-related death rose with the calcium score:

• 2.1 (95% confidence interval [CI] 1.6–2.9) with a score of 1 to 100
• 4.2 (95% CI 2.5–7.2) with scores of 101 to 400
• 7.2 (95% CI 3.9-13.0) with scores greater than 400.

The meta-analysis was limited in that it included only 4 studies, which were observational.

Kavousi et al,²² in a subsequent meta-analysis of 6,739 women at low risk of atherosclerotic cardiovascular disease based on the American College of Cardiology/American Heart Association (ACC/AHA) pooled cohort equation (10-year risk < 7.5%), found that 36.1% had calcium scores greater than 0. Compared with those whose score was 0, those with higher scores had a higher risk of atherosclerotic cardiovascular disease events. The incidence rates per 1,000 person-years were 1.41 vs 4.33 (relative risk 2.92, 95% CI 2.02–3.83; multivariable-adjusted hazard ratio 2.04, 95% CI 1.44–2.90). This study was limited because the population was mostly of European descent, making it less generalizable to non-European populations.

Calcium scoring has also been shown to be a strong predictor of incident cardiovascular events across different races beyond traditional risk factors such as hypertension, hyperlipidemia, and tobacco use.

Detrano et al,²³ in a study of 6,722 patients with diverse ethnic backgrounds, found that the adjusted risk of a coronary event was increased by a factor of 7.73 for calcium scores between 101 and 300 and by a factor of 9.67 for scores above 300 (P < .001). A limitation of this study was that the patients and physicians were informed of the scores, which could have led to bias.

Carr et al²⁴ found an association between calcium and coronary heart disease in a younger population (ages 32–46). In 12.5 years of follow-up, the hazard ratio for cardiovascular events increased exponentially with the calcium score:

• 2.6 (95% CI 1.0–5.7, P = .03) with calcium scores of 1 through 19
• 9.8 (95% CI 4.5–20.5, P < .001) with scores greater than 100.

Predicting mortality

Budoff et al,²⁵ in an observational study of 25,253 patients, found coronary calcium to be an independent predictor of mortality in a multivariable model controlling for age, sex, ethnicity, and cardiac risk factors (model chi-square = 2,017, P < .0001). However, most of the patients were already known to have cardiac risk factors, making the study findings less generalizable to the general population.

Nasir et al²⁶ found that mortality rates rose with the calcium score in a study with 44,052 participants. The annualized mortality rates per 1,000 person-years were:

• 0.87 (95% CI 0.72–1.06) with a score of 0
• 2.97 (95% CI 2.61–3.37) with scores of 1–100
• 6.90 (95% CI 6.02–7.90) with scores of 101–400
• 17.68 (95% CI 5.93–19.62) with scores higher than 400.

The mortality rate also rose with the number of traditional risk factors present, ie, current tobacco use, dyslipidemia, diabetes mellitus, hypertension, and family history of coronary artery disease. Interestingly, those with no risk factors but a calcium score greater than 400 had a higher mortality rate than those with no coronary calcium but more than 3 risk factors (16.89 per 1,000 person-years vs 2.72 per 1,000 person years). As in the previous study, the patient population that was analyzed was at high risk and therefore the findings are not generalizable.

Shaw et al²⁷ found that patients without symptoms but with elevated coronary calcium scores had higher all-cause mortality rates at 15 years than those with a score of 0. The difference remained significant after Cox regression was performed, adjusting for traditional risk factors.

Current guidelines on assessing risk still rely on the traditional 10-year risk model in clinical practice.²⁵ Patients are thus classified as being at low, intermediate, or high risk based on their probability of developing a cardiovascular event or cardiovascular disease-related death in the subsequent 10 years.

However, the predictive value of this approach is only moderate,²⁸ and a significant number of cardiovascular events, including sudden cardiac death, occur in people who were believed to be at low or intermediate risk according to traditional risk factor-based predictions. Because risk scores are strongly influenced by age,²⁹ they are least reliable in young adults.³⁰

Akosah et al³¹ reviewed the records of 222 young adults (women age 55 or younger, men age 65 or younger) who presented with their first myocardial infarction, and found that only 25% would have qualified for primary prevention pharmacologic treatments according to the National Cholesterol Education Program III guidelines.^32,33 Similar findings have been reported regarding previous versions of the risk scores.³³

Thus, risk predictions based exclusively on traditional risk factors are not sensitive for detecting young individuals at increased risk, and lead to late treatment of young adults with atherosclerosis, which may be a less effective strategy.³⁴

The reliance on age in risk algorithms also results in low specificity in elderly adults. Using risk scores, elderly adults are systematically stratified in higher risk categories, expanding the indication for statin therapy to almost all men age 65 or older regardless of their actual vascular health, according to current clinical practice guidelines.^35,36

Risk scores are based on self-reported history and single-day measurements, since this kind of information is readily available to the physician in the clinic. Moreover, our knowledge about genetic and epigenetic factors associated with the development of atherosclerosis is still in its infancy, with current guidelines not supporting genetic testing as part of cardiovascular risk assessment.³⁷ Thus, a reliable measure of an individual’s lifelong exposure to a number of environmental and genetic factors that may affect cardiovascular health appears unfeasible.

Atherosclerosis is a process in which interactions between genetic, epigenetic, environmental, and traditional risk factors result in subclinical inflammation that could develop into clinically significant disease. Therefore, subclinical coronary atherosclerosis has been shown to be a strong predictor of future incident cardiovascular disease events and death. Thus, alternative approaches that directly measure disease, such as calcium scoring, may help further refine risk stratification of cardiovascular disease.

The MESA trial (Multi-Ethnic Study of Atherosclerosis), for instance, in 6,814 participants, found coronary calcium to provide better discrimination and risk reclassification than the ankle-brachial index, high sensitivity C-reactive protein level, and family history.³⁸ Coronary calcium also had the highest incremental improvement of the area under the receiver operating curve when added to the Framingham Risk Score (0.623 vs 0.784).

Reclassifying cardiovascular risk also has implications regarding whether to start therapies such as statins and aspirin.

For considering statin therapy

Nasir et al³⁹ showed that, in patients eligible for statin therapy by the pooled cohort equation, the absence of coronary artery calcium reclassified approximately one-half of candidates as not eligible for statin therapy. The number needed to treat to prevent an atherosclerotic cardiovascular event in the population who were recommended a statin was 64 with a calcium score of 0, and 24 with a calcium score greater than 100. In the population for whom a statin was considered, the number needed to treat was 223 with a calcium score of 0 and 46 for those with a score greater than 100. Moreover, 57% of intermediate-risk patients and 41% of high-risk patients based on the Framingham Risk Score were found to have a calcium score of 0, implying that these patients may actually be at a lower risk.

The Society of Cardiovascular Computed Tomography guidelines⁴⁰ say that statin therapy can be considered in patients who have a calcium score greater than 0.

For considering aspirin therapy

Miedema et al⁴¹ studied the role of coronary artery calcium in guiding aspirin therapy in 4,229 participants in the MESA trial who were not taking aspirin at baseline. Those with a calcium score higher than 100 had a number needed to treat of 173 in the group with a Framingham Risk Score less than 10% and 92 with a Framingham Risk Score of 10% or higher. The estimated number needed to harm for a major bleeding event was 442. For those who had a score of 0, the estimated number needed to treat was 2,036 for a Framingham Risk Score less than 10% and 808 for a Framingham Risk Score of 10% or higher, with an estimated number needed to harm of 442 for a major bleeding event.

The Society of Cardiovascular Computed Tomography guidelines⁴⁰ recommend considering aspirin therapy for patients with a coronary calcium score of more than 100.

McClelland et al⁴² developed a MESA risk score to predict 10-year risk of coronary heart disease using the traditional risk factors along with coronary calcium. The score was validated externally with 2 separate longitudinal studies. Thus, this may serve as another tool to help providers further risk-stratify patients.

COST-EFFECTIVENESS OF THE TEST

As coronary calcium measurement began to be widely used, concerns were raised about the lack of data on its cost-effectiveness.

Cost-effectiveness depends not only on patient selection but also on the cost of therapy. For example, if the cost of a generic statin is $85 per year, then calcium scoring would not be beneficial. However, if the cost of a statin is more than $200, then calcium scoring would be much more cost-effective, offering a way to avoid treating some patients who do not need to be treated.⁴³

Hong et al⁴³ showed that coronary calcium testing was cost-effective when the patient and physician share decision-making about initiating statin therapy. This is especially important if the patient has financial limitations, is concerned about side effects, or wants to avoid taking unnecessary medications.

According to some reports, $8.5 billion is spent annually for low-value care.⁴⁴ Many of the 80 million CT scans performed annually in the United States are believed to be unnecessary and may lead to additional testing to investigate incidental findings.⁴⁵

Growing use of coronary calcium measurement has raised similar concerns about radiation exposure, healthcare costs, and increased downstream testing triggered by the detection of incidental noncardiac findings. For instance, Onuma et al⁴⁶ reported that, in 503 patients undergoing CT to evaluate coronary artery disease, noncardiac findings were seen in 58.1% of them, but only 22.7% of the 503 had clinically significant findings.

Some of these concerns have been addressed. Modern scanners can acquire images in only a few seconds, entailing lower radiation doses than in the past.^13,14 The cost of the test is currently less than $100 in many US metropolitan areas.⁴⁷ However, further studies are needed to adequately and cost-effectively guide follow-up imaging of incidental noncardiac findings.⁴⁸

An important limitation of calcium scoring for risk assessment is that no randomized controlled trial has evaluated the impact of preventive interventions guided by calcium scores on hard event outcomes. It can be argued that there have been plenty of observational studies that have shown the benefit of coronary calcium scoring when judiciously done in the appropriate population.⁴⁹ Similarly, no randomized controlled trial has tested the pooled cohort equation and the application of statins based on its use with the current guidelines. The feasibility and cost of a large randomized controlled trial to assess outcomes after coronary artery calcium measurement must also be considered.

Another limitation of coronary calcium scoring is that it cannot rule out the presence of noncalcified atherosclerotic plaque, which often is more unstable and prone to rupture.

In addition, calcification in the coronary vascular bed (even if severe) does not necessarily mean there is clinically relevant coronary stenosis. For instance, an asymptomatic patient could have a coronary artery calcium score higher than 100 and then get a coronary angiogram that reveals only a 30% lesion in the left anterior descending coronary artery. This is because accumulation of (calcified) plaque in the vessel wall is accommodated by expansion of vessel diameter, maintaining luminal dimensions (positive remodeling). By definition, this patient does have coronary artery disease but would be best served by medical management. This could have been determined without an invasive test in an otherwise asymptomatic patient. Thus, performing coronary angiography based on a coronary artery calcium score alone would not have changed this patient’s management and may have exposed the patient to risks of procedural complications, in addition to extra healthcare costs. Therefore, the presence or absence of symptoms should guide the clinician on whether to pursue stress testing for invasive coronary angiography based on the appropriate use criteria.^50,51

WHO SHOULD BE TESTED?

In the ACC/AHA 2013 guidelines,³⁷ coronary calcium scoring has a class IIB recommendation in scenarios where it may appear that the risk-based treatment decision is uncertain after formal risk estimation has been done. As discussed above, a score higher than 100 could be a rationale for starting aspirin therapy, and a score higher than 0 for statin therapy. The current guidelines also mention that the coronary calcium score is comparable to other predictors such as the C-reactive protein level and the ankle-brachial index.

Compared with the ACC/AHA guidelines, the 2016 Society of Cardiovascular Computed Tomography guidelines and expert consensus recently have added more specifics in terms of using this test for asymptomatic patients at intermediate risk (10-year risk of atherosclerotic cardiovascular disease 5%–20%) and in selected patients with a family history of premature coronary artery disease and 10-year risk less than 5%.^40,52 The 2010 ACC/AHA guidelines were more specific, offering a class IIA recommendation for patients who were at intermediate risk (Framingham Risk Score 10%–20%).⁵³

The ACC/AHA cited cost and radiation exposure as reasons they did not give coronary calcium measurement a stronger recommendation.³⁷ However, as data continue to come in, the guidelines may change, especially since low-dose radiation tools are being used for cancer screening (lungs and breast) and since the cost has declined over the past decade.

OUR APPROACH

Given the negative predictive value of the coronary calcium score, our approach has been to use this test in asymptomatic patients who are found to be at intermediate risk of atherosclerotic cardiovascular disease based on the ACC/AHA risk calculation and are reluctant to start pharmacologic therapy, or who want a more personalized measure of coronary artery disease. This is preceded by a lengthy patient-physician discussion about the risks and benefits of the test.⁵⁴

The patient’s risk can then be further clarified and possibly reclassified as either low or high if it doesn’t remain intermediate. A discussion can then take place on potentially starting pharmacologic therapy, intensive lifestyle modifications, or both.^54,55 If an electronic medical record is available, CT results can be shown to the patient in the office to point out coronary calcifications. Seeing the lesions may serve an as additional motivating factor as patients embark on primary preventive efforts.⁵⁶

Below, we describe cases of what we would consider appropriate and inappropriate use of coronary artery calcium scoring.

A 55-year-old man presents for an annual physical and is found to have a 10-year risk of atherosclerotic cardiovascular disease of 7%, placing him in the intermediate-risk category. Despite an extensive conversation about lifestyle modifications and pharmacologic therapy, he is reluctant to initiate these measures. He is otherwise asymptomatic. Would calcium scoring be reasonable?

Yes, it would be reasonable to perform coronary artery calcium scoring in an otherwise asymptomatic man to help reclassify his risk for a coronary vascular event. The objective data provided by the test could motivate the patient to undertake primary prevention efforts or, if his score is 0, to show that he may not need drug therapy.

Example 2

A 55-year-old man who has a family history of coronary artery disease, is an active smoker, and has diabetes mellitus presents to the clinic with 2 months of exertional chest pain that resolves with rest. Would coronary artery calcium scoring be reasonable?

This patient is symptomatic and is at high risk of coronary artery disease. Statin therapy is already indicated in the AHA/ACC guidelines, since he has diabetes. Therefore, calcium scoring would not be helpful, as it would not change this patient’s management. Instead, he would be best served by stress testing or coronary angiography based on the stability of his symptoms and cardiac biomarkers.

Example 3

A 30-year-old woman with no medical history presents with on-and-off chest pain at both exertion and rest. Her electrocardiogram is unremarkable, and cardiac enzyme tests are negative. Would coronary calcium scoring be reasonable?

This young patient’s story is not typical for coronary artery disease. Therefore, she has a low pretest probability of obstructive coronary artery disease. Moreover, calcium scoring may not be helpful because at her young age there has not been enough time for calcification to develop (median age is the fifth decade of life). Thus, she would be exposed to radiation unnecessarily at a young age.

What to do with an elevated calcium score?

Coronary artery calcification is now being incidentally detected as patients undergo CT for other reasons such as screening for lung cancer based on the US Preventive Services Task Force guidelines. Patients may also get the test done on their own and then present to a provider with an elevated score.

It is important to consider the entire clinical scenario in such patients and not just the score. If a patient presents with an elevated calcium score but has no symptoms and falls in the intermediate-risk group, there is evidence to suggest that he or she should be started on statin or aspirin therapy or both.

As mentioned above, an abnormal test result does not mean that the patient should undergo more-invasive testing such as cardiac catheterization or even stress testing, especially if he or she has no symptoms. However, if the patient is symptomatic, then further cardiac evaluation would be recommended.

SUMMARY

Measuring coronary artery calcium has been found to be valuable in detecting coronary artery disease and in predicting cardiovascular events and death. The test is relatively easy to perform, with newer technology allowing for less radiation and cost. It serves as a more personalized measure of disease and can help facilitate patient-physician discussions about starting pharmacologic therapy, especially if a patient is reluctant.

Currently, coronary calcium scoring has a class IIB recommendation in scenarios in which the risk-based treatment decision is uncertain after formal risk estimation has been done according to the ACC/AHA guideline. The Society of Cardiovascular Computed Tomography guideline and expert consensus documents are more specific in recommending the test in asymptomatic patients in the intermediate-risk group.

Limitations of calcium scoring include the possibility of unnecessary cardiovascular testing such as cardiac catheterization or stress testing being driven by the calcium score alone, as well as the impact of incidental findings. With increased reporting of the coronary calcium score in patients undergoing CT for lung cancer screening, the score should be interpreted in view of the entire clinical scenario.

The United States has seen a decline in fatal myocardial infarctions, largely thanks to early detection of coronary artery disease. Current guidelines on assessment of cardiovascular risk still rely on the traditional 10-year risk model in clinical practice. However, the predictive value of this approach is only moderate, and many coronary events occur in people considered to be at low or intermediate risk.

See related editorial

Coronary artery calcium scoring has emerged as a means of risk stratification by direct measurement of disease. Primary care providers are either using it or are seeing it used by consulting physicians, and its relatively low cost and ease of performance have contributed to its widespread use. However, downstream costs, radiation exposure, and lack of randomized controlled trials have raised concerns.

This article reviews the usefulness and pitfalls of coronary artery calcium scoring, providing a better understanding of the test, its limitations, and the interpretation of results.

ATHEROSCLEROSIS AND CALCIUM

As the calcium deposits grow, they can be detected by imaging tests such as computed tomography (CT), and quantified to assess the extent of disease.⁴

CALCIFICATION AND CORONARY ARTERY DISEASE

Coronary calcification occurs almost exclusively in atherosclerosis. Several autopsy studies^5,6 and histopathologic studies⁷ have shown a direct relationship between the extent of calcification and atherosclerotic disease.

Sangiorgi et al⁷ performed a histologic analysis of 723 coronary artery segments. The amount of calcium correlated well with the area of plaque:

• r = 0.89, P < .0001 in the left anterior descending artery
• r = 0.7, P < .001 in the left circumflex artery
• r = 0.89, P < .0001 in the right coronary artery.

Coronary artery calcium has also been associated with obstructive coronary artery disease in studies using intravascular ultrasonography and optical coherence tomography.^8,9

TECHNICAL INFORMATION ABOUT THE TEST

First-generation CT scanners used for calcium scoring in the 1980s were electron-beam systems in which a stationary x-ray tube generated an oscillating electron beam, which was reflected around the patient table.¹⁰ A single, stationary detector ring captured the images.

These systems have been replaced by multidetector scanners, in which the x-ray tube and multiple rows of detectors are combined in a gantry that rotates at high speed around the patient.

Coronary calcium is measured by noncontrast CT of the heart. Thus, there is no risk of contrast-induced nephropathy or allergic reactions. Images are acquired while the patient holds his or her breath for 3 to 5 seconds. Electrocardiographic gating is used to reduce motion artifact.^11,12 With modern scanners, the effective radiation dose associated with calcium testing is as low as 0.5 to 1.5 mSv,^13,14 ie, about the same dose as that with mammography. The entire test takes 10 to 15 minutes.

The results fall into 4 categories, which correlate with the severity of coronary artery disease, ranging from no significant disease to severe disease (Table 1). Other scores, which are not commonly used, include the calcium volume score¹⁶ and the calcium mass score.¹⁷Figure 2 shows a screenshot from a coronary artery calcium scoring program. 

Early multicenter studies evaluated the utility of calcium scoring to predict coronary stenosis in patients who underwent both cardiac CT and coronary angiography. The sensitivity of calcium scoring for angiographically significant disease was high (95%), but its specificity was low (about 44%).¹⁸

Budoff et al,¹⁹ reviewing these and subsequent results, concluded that the value of calcium scoring is its high negative predictive value (about 98%); a negative score (no calcification) is strongly associated with the absence of obstructive coronary disease.

Blaha et al²⁰ concluded that a score of 0 would indicate that the patient had a low risk of cardiovascular disease. A test with these characteristics is helpful in excluding cardiovascular disease or at least in determining that it is less likely to be present in a patient deemed to be at intermediate risk.

CALCIUM SCORING AS A PROGNOSTIC TOOL

Early on, investigators recognized the value of calcium scoring in predicting the risk of future cardiovascular events and death.^21–25

Predicting cardiovascular events

Pletcher et al21 performed a meta-analysis of studies that measured calcification in asymptomatic patients with subsequent follow-up. The summary-adjusted relative risk of cardiac events such as myocardial infarction, coronary artery revascularization, and coronary heart disease-related death rose with the calcium score:

• 2.1 (95% confidence interval [CI] 1.6–2.9) with a score of 1 to 100
• 4.2 (95% CI 2.5–7.2) with scores of 101 to 400
• 7.2 (95% CI 3.9-13.0) with scores greater than 400.

The meta-analysis was limited in that it included only 4 studies, which were observational.

Kavousi et al,²² in a subsequent meta-analysis of 6,739 women at low risk of atherosclerotic cardiovascular disease based on the American College of Cardiology/American Heart Association (ACC/AHA) pooled cohort equation (10-year risk < 7.5%), found that 36.1% had calcium scores greater than 0. Compared with those whose score was 0, those with higher scores had a higher risk of atherosclerotic cardiovascular disease events. The incidence rates per 1,000 person-years were 1.41 vs 4.33 (relative risk 2.92, 95% CI 2.02–3.83; multivariable-adjusted hazard ratio 2.04, 95% CI 1.44–2.90). This study was limited because the population was mostly of European descent, making it less generalizable to non-European populations.

Calcium scoring has also been shown to be a strong predictor of incident cardiovascular events across different races beyond traditional risk factors such as hypertension, hyperlipidemia, and tobacco use.

Detrano et al,²³ in a study of 6,722 patients with diverse ethnic backgrounds, found that the adjusted risk of a coronary event was increased by a factor of 7.73 for calcium scores between 101 and 300 and by a factor of 9.67 for scores above 300 (P < .001). A limitation of this study was that the patients and physicians were informed of the scores, which could have led to bias.

Carr et al²⁴ found an association between calcium and coronary heart disease in a younger population (ages 32–46). In 12.5 years of follow-up, the hazard ratio for cardiovascular events increased exponentially with the calcium score:

• 2.6 (95% CI 1.0–5.7, P = .03) with calcium scores of 1 through 19
• 9.8 (95% CI 4.5–20.5, P < .001) with scores greater than 100.

Predicting mortality

Budoff et al,²⁵ in an observational study of 25,253 patients, found coronary calcium to be an independent predictor of mortality in a multivariable model controlling for age, sex, ethnicity, and cardiac risk factors (model chi-square = 2,017, P < .0001). However, most of the patients were already known to have cardiac risk factors, making the study findings less generalizable to the general population.

Nasir et al²⁶ found that mortality rates rose with the calcium score in a study with 44,052 participants. The annualized mortality rates per 1,000 person-years were:

• 0.87 (95% CI 0.72–1.06) with a score of 0
• 2.97 (95% CI 2.61–3.37) with scores of 1–100
• 6.90 (95% CI 6.02–7.90) with scores of 101–400
• 17.68 (95% CI 5.93–19.62) with scores higher than 400.

The mortality rate also rose with the number of traditional risk factors present, ie, current tobacco use, dyslipidemia, diabetes mellitus, hypertension, and family history of coronary artery disease. Interestingly, those with no risk factors but a calcium score greater than 400 had a higher mortality rate than those with no coronary calcium but more than 3 risk factors (16.89 per 1,000 person-years vs 2.72 per 1,000 person years). As in the previous study, the patient population that was analyzed was at high risk and therefore the findings are not generalizable.

Shaw et al²⁷ found that patients without symptoms but with elevated coronary calcium scores had higher all-cause mortality rates at 15 years than those with a score of 0. The difference remained significant after Cox regression was performed, adjusting for traditional risk factors.

Current guidelines on assessing risk still rely on the traditional 10-year risk model in clinical practice.²⁵ Patients are thus classified as being at low, intermediate, or high risk based on their probability of developing a cardiovascular event or cardiovascular disease-related death in the subsequent 10 years.

However, the predictive value of this approach is only moderate,²⁸ and a significant number of cardiovascular events, including sudden cardiac death, occur in people who were believed to be at low or intermediate risk according to traditional risk factor-based predictions. Because risk scores are strongly influenced by age,²⁹ they are least reliable in young adults.³⁰

Akosah et al³¹ reviewed the records of 222 young adults (women age 55 or younger, men age 65 or younger) who presented with their first myocardial infarction, and found that only 25% would have qualified for primary prevention pharmacologic treatments according to the National Cholesterol Education Program III guidelines.^32,33 Similar findings have been reported regarding previous versions of the risk scores.³³

Thus, risk predictions based exclusively on traditional risk factors are not sensitive for detecting young individuals at increased risk, and lead to late treatment of young adults with atherosclerosis, which may be a less effective strategy.³⁴

The reliance on age in risk algorithms also results in low specificity in elderly adults. Using risk scores, elderly adults are systematically stratified in higher risk categories, expanding the indication for statin therapy to almost all men age 65 or older regardless of their actual vascular health, according to current clinical practice guidelines.^35,36

Risk scores are based on self-reported history and single-day measurements, since this kind of information is readily available to the physician in the clinic. Moreover, our knowledge about genetic and epigenetic factors associated with the development of atherosclerosis is still in its infancy, with current guidelines not supporting genetic testing as part of cardiovascular risk assessment.³⁷ Thus, a reliable measure of an individual’s lifelong exposure to a number of environmental and genetic factors that may affect cardiovascular health appears unfeasible.

Atherosclerosis is a process in which interactions between genetic, epigenetic, environmental, and traditional risk factors result in subclinical inflammation that could develop into clinically significant disease. Therefore, subclinical coronary atherosclerosis has been shown to be a strong predictor of future incident cardiovascular disease events and death. Thus, alternative approaches that directly measure disease, such as calcium scoring, may help further refine risk stratification of cardiovascular disease.

The MESA trial (Multi-Ethnic Study of Atherosclerosis), for instance, in 6,814 participants, found coronary calcium to provide better discrimination and risk reclassification than the ankle-brachial index, high sensitivity C-reactive protein level, and family history.³⁸ Coronary calcium also had the highest incremental improvement of the area under the receiver operating curve when added to the Framingham Risk Score (0.623 vs 0.784).

Reclassifying cardiovascular risk also has implications regarding whether to start therapies such as statins and aspirin.

For considering statin therapy

Nasir et al³⁹ showed that, in patients eligible for statin therapy by the pooled cohort equation, the absence of coronary artery calcium reclassified approximately one-half of candidates as not eligible for statin therapy. The number needed to treat to prevent an atherosclerotic cardiovascular event in the population who were recommended a statin was 64 with a calcium score of 0, and 24 with a calcium score greater than 100. In the population for whom a statin was considered, the number needed to treat was 223 with a calcium score of 0 and 46 for those with a score greater than 100. Moreover, 57% of intermediate-risk patients and 41% of high-risk patients based on the Framingham Risk Score were found to have a calcium score of 0, implying that these patients may actually be at a lower risk.

The Society of Cardiovascular Computed Tomography guidelines⁴⁰ say that statin therapy can be considered in patients who have a calcium score greater than 0.

For considering aspirin therapy

Miedema et al⁴¹ studied the role of coronary artery calcium in guiding aspirin therapy in 4,229 participants in the MESA trial who were not taking aspirin at baseline. Those with a calcium score higher than 100 had a number needed to treat of 173 in the group with a Framingham Risk Score less than 10% and 92 with a Framingham Risk Score of 10% or higher. The estimated number needed to harm for a major bleeding event was 442. For those who had a score of 0, the estimated number needed to treat was 2,036 for a Framingham Risk Score less than 10% and 808 for a Framingham Risk Score of 10% or higher, with an estimated number needed to harm of 442 for a major bleeding event.

The Society of Cardiovascular Computed Tomography guidelines⁴⁰ recommend considering aspirin therapy for patients with a coronary calcium score of more than 100.

McClelland et al⁴² developed a MESA risk score to predict 10-year risk of coronary heart disease using the traditional risk factors along with coronary calcium. The score was validated externally with 2 separate longitudinal studies. Thus, this may serve as another tool to help providers further risk-stratify patients.

COST-EFFECTIVENESS OF THE TEST

As coronary calcium measurement began to be widely used, concerns were raised about the lack of data on its cost-effectiveness.

Cost-effectiveness depends not only on patient selection but also on the cost of therapy. For example, if the cost of a generic statin is $85 per year, then calcium scoring would not be beneficial. However, if the cost of a statin is more than $200, then calcium scoring would be much more cost-effective, offering a way to avoid treating some patients who do not need to be treated.⁴³

Hong et al⁴³ showed that coronary calcium testing was cost-effective when the patient and physician share decision-making about initiating statin therapy. This is especially important if the patient has financial limitations, is concerned about side effects, or wants to avoid taking unnecessary medications.

According to some reports, $8.5 billion is spent annually for low-value care.⁴⁴ Many of the 80 million CT scans performed annually in the United States are believed to be unnecessary and may lead to additional testing to investigate incidental findings.⁴⁵

Growing use of coronary calcium measurement has raised similar concerns about radiation exposure, healthcare costs, and increased downstream testing triggered by the detection of incidental noncardiac findings. For instance, Onuma et al⁴⁶ reported that, in 503 patients undergoing CT to evaluate coronary artery disease, noncardiac findings were seen in 58.1% of them, but only 22.7% of the 503 had clinically significant findings.

Some of these concerns have been addressed. Modern scanners can acquire images in only a few seconds, entailing lower radiation doses than in the past.^13,14 The cost of the test is currently less than $100 in many US metropolitan areas.⁴⁷ However, further studies are needed to adequately and cost-effectively guide follow-up imaging of incidental noncardiac findings.⁴⁸

An important limitation of calcium scoring for risk assessment is that no randomized controlled trial has evaluated the impact of preventive interventions guided by calcium scores on hard event outcomes. It can be argued that there have been plenty of observational studies that have shown the benefit of coronary calcium scoring when judiciously done in the appropriate population.⁴⁹ Similarly, no randomized controlled trial has tested the pooled cohort equation and the application of statins based on its use with the current guidelines. The feasibility and cost of a large randomized controlled trial to assess outcomes after coronary artery calcium measurement must also be considered.

Another limitation of coronary calcium scoring is that it cannot rule out the presence of noncalcified atherosclerotic plaque, which often is more unstable and prone to rupture.

In addition, calcification in the coronary vascular bed (even if severe) does not necessarily mean there is clinically relevant coronary stenosis. For instance, an asymptomatic patient could have a coronary artery calcium score higher than 100 and then get a coronary angiogram that reveals only a 30% lesion in the left anterior descending coronary artery. This is because accumulation of (calcified) plaque in the vessel wall is accommodated by expansion of vessel diameter, maintaining luminal dimensions (positive remodeling). By definition, this patient does have coronary artery disease but would be best served by medical management. This could have been determined without an invasive test in an otherwise asymptomatic patient. Thus, performing coronary angiography based on a coronary artery calcium score alone would not have changed this patient’s management and may have exposed the patient to risks of procedural complications, in addition to extra healthcare costs. Therefore, the presence or absence of symptoms should guide the clinician on whether to pursue stress testing for invasive coronary angiography based on the appropriate use criteria.^50,51

WHO SHOULD BE TESTED?

In the ACC/AHA 2013 guidelines,³⁷ coronary calcium scoring has a class IIB recommendation in scenarios where it may appear that the risk-based treatment decision is uncertain after formal risk estimation has been done. As discussed above, a score higher than 100 could be a rationale for starting aspirin therapy, and a score higher than 0 for statin therapy. The current guidelines also mention that the coronary calcium score is comparable to other predictors such as the C-reactive protein level and the ankle-brachial index.

Compared with the ACC/AHA guidelines, the 2016 Society of Cardiovascular Computed Tomography guidelines and expert consensus recently have added more specifics in terms of using this test for asymptomatic patients at intermediate risk (10-year risk of atherosclerotic cardiovascular disease 5%–20%) and in selected patients with a family history of premature coronary artery disease and 10-year risk less than 5%.^40,52 The 2010 ACC/AHA guidelines were more specific, offering a class IIA recommendation for patients who were at intermediate risk (Framingham Risk Score 10%–20%).⁵³

The ACC/AHA cited cost and radiation exposure as reasons they did not give coronary calcium measurement a stronger recommendation.³⁷ However, as data continue to come in, the guidelines may change, especially since low-dose radiation tools are being used for cancer screening (lungs and breast) and since the cost has declined over the past decade.

OUR APPROACH

Given the negative predictive value of the coronary calcium score, our approach has been to use this test in asymptomatic patients who are found to be at intermediate risk of atherosclerotic cardiovascular disease based on the ACC/AHA risk calculation and are reluctant to start pharmacologic therapy, or who want a more personalized measure of coronary artery disease. This is preceded by a lengthy patient-physician discussion about the risks and benefits of the test.⁵⁴

The patient’s risk can then be further clarified and possibly reclassified as either low or high if it doesn’t remain intermediate. A discussion can then take place on potentially starting pharmacologic therapy, intensive lifestyle modifications, or both.^54,55 If an electronic medical record is available, CT results can be shown to the patient in the office to point out coronary calcifications. Seeing the lesions may serve an as additional motivating factor as patients embark on primary preventive efforts.⁵⁶

Below, we describe cases of what we would consider appropriate and inappropriate use of coronary artery calcium scoring.

A 55-year-old man presents for an annual physical and is found to have a 10-year risk of atherosclerotic cardiovascular disease of 7%, placing him in the intermediate-risk category. Despite an extensive conversation about lifestyle modifications and pharmacologic therapy, he is reluctant to initiate these measures. He is otherwise asymptomatic. Would calcium scoring be reasonable?

Yes, it would be reasonable to perform coronary artery calcium scoring in an otherwise asymptomatic man to help reclassify his risk for a coronary vascular event. The objective data provided by the test could motivate the patient to undertake primary prevention efforts or, if his score is 0, to show that he may not need drug therapy.

Example 2

A 55-year-old man who has a family history of coronary artery disease, is an active smoker, and has diabetes mellitus presents to the clinic with 2 months of exertional chest pain that resolves with rest. Would coronary artery calcium scoring be reasonable?

This patient is symptomatic and is at high risk of coronary artery disease. Statin therapy is already indicated in the AHA/ACC guidelines, since he has diabetes. Therefore, calcium scoring would not be helpful, as it would not change this patient’s management. Instead, he would be best served by stress testing or coronary angiography based on the stability of his symptoms and cardiac biomarkers.

Example 3

A 30-year-old woman with no medical history presents with on-and-off chest pain at both exertion and rest. Her electrocardiogram is unremarkable, and cardiac enzyme tests are negative. Would coronary calcium scoring be reasonable?

This young patient’s story is not typical for coronary artery disease. Therefore, she has a low pretest probability of obstructive coronary artery disease. Moreover, calcium scoring may not be helpful because at her young age there has not been enough time for calcification to develop (median age is the fifth decade of life). Thus, she would be exposed to radiation unnecessarily at a young age.

What to do with an elevated calcium score?

Coronary artery calcification is now being incidentally detected as patients undergo CT for other reasons such as screening for lung cancer based on the US Preventive Services Task Force guidelines. Patients may also get the test done on their own and then present to a provider with an elevated score.

It is important to consider the entire clinical scenario in such patients and not just the score. If a patient presents with an elevated calcium score but has no symptoms and falls in the intermediate-risk group, there is evidence to suggest that he or she should be started on statin or aspirin therapy or both.

As mentioned above, an abnormal test result does not mean that the patient should undergo more-invasive testing such as cardiac catheterization or even stress testing, especially if he or she has no symptoms. However, if the patient is symptomatic, then further cardiac evaluation would be recommended.

SUMMARY

Measuring coronary artery calcium has been found to be valuable in detecting coronary artery disease and in predicting cardiovascular events and death. The test is relatively easy to perform, with newer technology allowing for less radiation and cost. It serves as a more personalized measure of disease and can help facilitate patient-physician discussions about starting pharmacologic therapy, especially if a patient is reluctant.

Currently, coronary calcium scoring has a class IIB recommendation in scenarios in which the risk-based treatment decision is uncertain after formal risk estimation has been done according to the ACC/AHA guideline. The Society of Cardiovascular Computed Tomography guideline and expert consensus documents are more specific in recommending the test in asymptomatic patients in the intermediate-risk group.

Limitations of calcium scoring include the possibility of unnecessary cardiovascular testing such as cardiac catheterization or stress testing being driven by the calcium score alone, as well as the impact of incidental findings. With increased reporting of the coronary calcium score in patients undergoing CT for lung cancer screening, the score should be interpreted in view of the entire clinical scenario.