The percentage of low-income pregnant mothers who received influenza and Tdap vaccinations fell sharply during the COVID-19 pandemic, especially in Black and Hispanic patients, a new study finds.

The percentage of patients who received the influenza vaccines at two Medicaid clinics in Houston dropped from 78% before the pandemic to 61% during it (adjusted odds ratio, 0.38; 95% CI, 0.26-0.53; P < .01), researchers reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The percentage receiving the Tdap vaccine dipped from 85% to 76% (aOR, 0.56; 95% CI, 0.40-0.79; P < .01).

New York–Presbyterian/Weill Cornell Medical Center pediatrician Sallie Permar, MD, PhD, who’s familiar with the study findings, called them “alarming” and said in an interview that they should be “a call to action for providers.”

“Continuing the status quo in our routine preventative health care and clinic operations means that we are losing ground in reduction and elimination of vaccine-preventable diseases,” Dr. Permar said in an interview.

According to corresponding author Bani Ratan, MD, an ob.gyn. with the Baylor College of Medicine, Houston, there’s been little if any previous research into routine, non-COVID vaccination in pregnant women during the pandemic.

For the study, researchers retrospectively analyzed the records of 939 pregnant women who entered prenatal care before 20 weeks (462 from May–November 2019, and 477 from May–November 2020) and delivered at full term.

Among ethnic groups, non-Hispanic Blacks saw the largest decline in influenza vaccines. Among them, the percentage who got them fell from 64% (73/114) to 35% (35/101; aOR, 0.30; 95% CI, 0.17-0.52; P < .01). Only Hispanics had a statistically significant decline in Tdap vaccination (OR, 0.52, 95% CI, 0.34-0.80; P < .01, percentages not provided).

Another study presented at ACOG examined vaccination rates during the pandemic and found that Tdap vaccination rates dipped among pregnant women in a Philadelphia-area health care system.

Possible causes for the decline in routine vaccination include hesitancy linked to the COVID-19 vaccines and fewer office visits because of telemedicine, said Dr. Batan in an interview.

Dr. Permar blamed the role of vaccine misinformation during the pandemic and the mistrust caused by the exclusion of pregnant women from early vaccine trials. She added that “challenges in health care staffing and issues of health care provider burnout that worsened during the pandemic likely contributed to a fraying of the focus on preventive health maintenance simply due to bandwidth of health professionals.”

In a separate study presented at ACOG, researchers at the State University of New York, Syracuse, reported on a survey of 157 pregnant women of whom just 38.2% were vaccinated against COVID-19. Among the unvaccinated, who were more likely to have less education, 66% reported that lack of data about vaccination was their primary concern.

No funding or disclosures are reported by study authors. Dr. Permar reported consulting for Merck, Moderna, GlaxoSmithKline, Pfizer, Dynavax, and Hookipa on cytomegalovirus vaccine programs.

*This story was updated on 5/11/2022.

The percentage of low-income pregnant mothers who received influenza and Tdap vaccinations fell sharply during the COVID-19 pandemic, especially in Black and Hispanic patients, a new study finds.

The percentage of patients who received the influenza vaccines at two Medicaid clinics in Houston dropped from 78% before the pandemic to 61% during it (adjusted odds ratio, 0.38; 95% CI, 0.26-0.53; P < .01), researchers reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The percentage receiving the Tdap vaccine dipped from 85% to 76% (aOR, 0.56; 95% CI, 0.40-0.79; P < .01).

New York–Presbyterian/Weill Cornell Medical Center pediatrician Sallie Permar, MD, PhD, who’s familiar with the study findings, called them “alarming” and said in an interview that they should be “a call to action for providers.”

“Continuing the status quo in our routine preventative health care and clinic operations means that we are losing ground in reduction and elimination of vaccine-preventable diseases,” Dr. Permar said in an interview.

According to corresponding author Bani Ratan, MD, an ob.gyn. with the Baylor College of Medicine, Houston, there’s been little if any previous research into routine, non-COVID vaccination in pregnant women during the pandemic.

For the study, researchers retrospectively analyzed the records of 939 pregnant women who entered prenatal care before 20 weeks (462 from May–November 2019, and 477 from May–November 2020) and delivered at full term.

Among ethnic groups, non-Hispanic Blacks saw the largest decline in influenza vaccines. Among them, the percentage who got them fell from 64% (73/114) to 35% (35/101; aOR, 0.30; 95% CI, 0.17-0.52; P < .01). Only Hispanics had a statistically significant decline in Tdap vaccination (OR, 0.52, 95% CI, 0.34-0.80; P < .01, percentages not provided).

Another study presented at ACOG examined vaccination rates during the pandemic and found that Tdap vaccination rates dipped among pregnant women in a Philadelphia-area health care system.

Possible causes for the decline in routine vaccination include hesitancy linked to the COVID-19 vaccines and fewer office visits because of telemedicine, said Dr. Batan in an interview.

Dr. Permar blamed the role of vaccine misinformation during the pandemic and the mistrust caused by the exclusion of pregnant women from early vaccine trials. She added that “challenges in health care staffing and issues of health care provider burnout that worsened during the pandemic likely contributed to a fraying of the focus on preventive health maintenance simply due to bandwidth of health professionals.”

In a separate study presented at ACOG, researchers at the State University of New York, Syracuse, reported on a survey of 157 pregnant women of whom just 38.2% were vaccinated against COVID-19. Among the unvaccinated, who were more likely to have less education, 66% reported that lack of data about vaccination was their primary concern.

No funding or disclosures are reported by study authors. Dr. Permar reported consulting for Merck, Moderna, GlaxoSmithKline, Pfizer, Dynavax, and Hookipa on cytomegalovirus vaccine programs.

*This story was updated on 5/11/2022.

The percentage of low-income pregnant mothers who received influenza and Tdap vaccinations fell sharply during the COVID-19 pandemic, especially in Black and Hispanic patients, a new study finds.

The percentage of patients who received the influenza vaccines at two Medicaid clinics in Houston dropped from 78% before the pandemic to 61% during it (adjusted odds ratio, 0.38; 95% CI, 0.26-0.53; P < .01), researchers reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The percentage receiving the Tdap vaccine dipped from 85% to 76% (aOR, 0.56; 95% CI, 0.40-0.79; P < .01).

New York–Presbyterian/Weill Cornell Medical Center pediatrician Sallie Permar, MD, PhD, who’s familiar with the study findings, called them “alarming” and said in an interview that they should be “a call to action for providers.”

“Continuing the status quo in our routine preventative health care and clinic operations means that we are losing ground in reduction and elimination of vaccine-preventable diseases,” Dr. Permar said in an interview.

According to corresponding author Bani Ratan, MD, an ob.gyn. with the Baylor College of Medicine, Houston, there’s been little if any previous research into routine, non-COVID vaccination in pregnant women during the pandemic.

For the study, researchers retrospectively analyzed the records of 939 pregnant women who entered prenatal care before 20 weeks (462 from May–November 2019, and 477 from May–November 2020) and delivered at full term.

Among ethnic groups, non-Hispanic Blacks saw the largest decline in influenza vaccines. Among them, the percentage who got them fell from 64% (73/114) to 35% (35/101; aOR, 0.30; 95% CI, 0.17-0.52; P < .01). Only Hispanics had a statistically significant decline in Tdap vaccination (OR, 0.52, 95% CI, 0.34-0.80; P < .01, percentages not provided).

Another study presented at ACOG examined vaccination rates during the pandemic and found that Tdap vaccination rates dipped among pregnant women in a Philadelphia-area health care system.

Possible causes for the decline in routine vaccination include hesitancy linked to the COVID-19 vaccines and fewer office visits because of telemedicine, said Dr. Batan in an interview.

Dr. Permar blamed the role of vaccine misinformation during the pandemic and the mistrust caused by the exclusion of pregnant women from early vaccine trials. She added that “challenges in health care staffing and issues of health care provider burnout that worsened during the pandemic likely contributed to a fraying of the focus on preventive health maintenance simply due to bandwidth of health professionals.”

In a separate study presented at ACOG, researchers at the State University of New York, Syracuse, reported on a survey of 157 pregnant women of whom just 38.2% were vaccinated against COVID-19. Among the unvaccinated, who were more likely to have less education, 66% reported that lack of data about vaccination was their primary concern.

No funding or disclosures are reported by study authors. Dr. Permar reported consulting for Merck, Moderna, GlaxoSmithKline, Pfizer, Dynavax, and Hookipa on cytomegalovirus vaccine programs.

*This story was updated on 5/11/2022.

Coronavirus-related hospital admissions and deaths in the United States are projected to increase over the next four weeks, according to a national forecast used by the Centers for Disease Control and Prevention.

The national model also predicts that about 5,000 deaths will occur over the next two weeks, with Ohio, New Jersey, and New York projected to see the largest totals of daily deaths in upcoming weeks.

The numbers follow several weeks of steady increases in infections across the country. More than 67,000 new cases are being reported daily, according to the data tracker from The New York Times, marking a 59% increase in the past two weeks.

In the Northeast, infection rates have risen by nearly 65%. In the New York and New Jersey region, infection rates are up about 55% in the past two weeks.

Hospitalizations have already begun to climb as well, with about 19,000 COVID-19 patients hospitalized nationwide and 1,725 in intensive care, according to the latest data from the Department of Health and Human Services. In the last week, hospital admissions have jumped by 20%, and emergency department visits are up by 18%.

The CDC forecast shows that 42 states and territories will see increases in hospital admissions during the next two weeks. Florida, Minnesota, New York, and Wisconsin will see some of the largest increases.

On average, more than 2,200 COVID-19 patients are entering the hospital each day, which has increased about 20% in the last week, according to ABC News. This also marks the highest number of COVID-19 patients needing hospital care since mid-March.

Public health officials have cited several factors for the increase in cases, such as states lifting mask mandates and other safety restrictions, ABC News reported. Highly contagious Omicron subvariants, such as BA.2 and BA.2.12.1, continue to spread in the United States and escape immunity from previous infections.

The BA.2 subvariant accounts for 62% of new national cases, according to the latest CDC data. The BA.2.12.1 subvariant makes up about 36% of new cases across the United States but 62% in the New York area.

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

Coronavirus-related hospital admissions and deaths in the United States are projected to increase over the next four weeks, according to a national forecast used by the Centers for Disease Control and Prevention.

The national model also predicts that about 5,000 deaths will occur over the next two weeks, with Ohio, New Jersey, and New York projected to see the largest totals of daily deaths in upcoming weeks.

The numbers follow several weeks of steady increases in infections across the country. More than 67,000 new cases are being reported daily, according to the data tracker from The New York Times, marking a 59% increase in the past two weeks.

In the Northeast, infection rates have risen by nearly 65%. In the New York and New Jersey region, infection rates are up about 55% in the past two weeks.

Hospitalizations have already begun to climb as well, with about 19,000 COVID-19 patients hospitalized nationwide and 1,725 in intensive care, according to the latest data from the Department of Health and Human Services. In the last week, hospital admissions have jumped by 20%, and emergency department visits are up by 18%.

The CDC forecast shows that 42 states and territories will see increases in hospital admissions during the next two weeks. Florida, Minnesota, New York, and Wisconsin will see some of the largest increases.

On average, more than 2,200 COVID-19 patients are entering the hospital each day, which has increased about 20% in the last week, according to ABC News. This also marks the highest number of COVID-19 patients needing hospital care since mid-March.

Public health officials have cited several factors for the increase in cases, such as states lifting mask mandates and other safety restrictions, ABC News reported. Highly contagious Omicron subvariants, such as BA.2 and BA.2.12.1, continue to spread in the United States and escape immunity from previous infections.

The BA.2 subvariant accounts for 62% of new national cases, according to the latest CDC data. The BA.2.12.1 subvariant makes up about 36% of new cases across the United States but 62% in the New York area.

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

Coronavirus-related hospital admissions and deaths in the United States are projected to increase over the next four weeks, according to a national forecast used by the Centers for Disease Control and Prevention.

The national model also predicts that about 5,000 deaths will occur over the next two weeks, with Ohio, New Jersey, and New York projected to see the largest totals of daily deaths in upcoming weeks.

The numbers follow several weeks of steady increases in infections across the country. More than 67,000 new cases are being reported daily, according to the data tracker from The New York Times, marking a 59% increase in the past two weeks.

In the Northeast, infection rates have risen by nearly 65%. In the New York and New Jersey region, infection rates are up about 55% in the past two weeks.

Hospitalizations have already begun to climb as well, with about 19,000 COVID-19 patients hospitalized nationwide and 1,725 in intensive care, according to the latest data from the Department of Health and Human Services. In the last week, hospital admissions have jumped by 20%, and emergency department visits are up by 18%.

The CDC forecast shows that 42 states and territories will see increases in hospital admissions during the next two weeks. Florida, Minnesota, New York, and Wisconsin will see some of the largest increases.

On average, more than 2,200 COVID-19 patients are entering the hospital each day, which has increased about 20% in the last week, according to ABC News. This also marks the highest number of COVID-19 patients needing hospital care since mid-March.

Public health officials have cited several factors for the increase in cases, such as states lifting mask mandates and other safety restrictions, ABC News reported. Highly contagious Omicron subvariants, such as BA.2 and BA.2.12.1, continue to spread in the United States and escape immunity from previous infections.

The BA.2 subvariant accounts for 62% of new national cases, according to the latest CDC data. The BA.2.12.1 subvariant makes up about 36% of new cases across the United States but 62% in the New York area.

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

Patients with cancer enrolled in Medicare Advantage Organizations (MAOs) may be denied needed care, leading to delays in treatment and administrative headaches for oncology practices, a recent analysis suggests.

The report from the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services found that 13% of prior authorization denials were for service requests, which included cancer care, that met Medicare coverage rules and 18% of payment denials were for claims that met Medicare coverage and MAO billing rules, delaying or halting payments for services that clinicians had provided.

MAO denials are the “bane of my existence,” said Michael Buckstein, MD, PhD, a radiation oncologist at Mount Sinai Hospital in New York.

“Working at a large hospital in a metropolitan city, we spend enormous and increasing amounts of time on prior approvals and we get denials quite frequently, which certainly can lead to delays in treatment,” said Dr. Buckstein, who reviewed the OIG report for this news organization.

According to Dr. Buckstein, once a claim is denied, staff must spend time filing and scheduling an appeal, and if the appeal is denied in a physician peer-to-peer review, staff could face secondary and tertiary appeals. “We have been living with this frustration for a long time,” Dr. Buckstein said.
 

Widespread and persistent problems

Medicare Advantage plans, which are approved by the Centers for Medicare & Medicaid Services but run by private companies, continue to grow in popularity.

In 2021, 26.4 million Medicare beneficiaries (42%) were enrolled in a Medicare Advantage plan, and by 2030, about 51% of all Medicare beneficiaries will be enrolled, according to estimates from the Kaiser Family Foundation.

“Although MAOs approve the vast majority of prior authorization requests and provider payment requests, MAOs also deny millions of requests each year,” the OIG wrote. “CMS’s annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payment.”

In the current report, the OIG reviewed case files for 247 denials of prior authorization requests and 183 payment denials issued by 15 of the largest MAOs during 1 week in June of 2019. 

The authors found that 13% of prior authorization denials occurred for service requests that met Medicare coverage rules, meaning these services would likely have been approved had the patient been enrolled in traditional Medicare.

The most prominent service types among these denials included imaging services, stays in postacute facilities, and injections.

In one case, for example, the MAO stated that a beneficiary would need to wait at least 1 year for a follow-up MRI because the size of the patient’s adrenal lesion (< 2 cm) was too small to warrant follow-up before 1 year. However, this restriction is not included in Medicare coverage rules. And an OIG physician panel found that the documentation in the original request demonstrated that the MRI was medically necessary to determine whether the lesion seen on an earlier CT scan was malignant.

Upon appeal, the MAO reversed its original denial.

Among the payment requests that MAOs denied, almost one in five were for claims that met Medicare coverage and billing rules, which delayed or prevented payments for services already delivered. Most payment denials were caused by human error during manual claims-processing reviews and system processing errors, the OIG report found.

In one case, for example, a MAO denied payment for radiation treatment for a patient with a tumor on the pancreas, incorrectly claiming that no prior authorization had been submitted for the service. However, the physician subsequently provided a screenshot demonstrating that the MAO had granted prior authorization for the billed claim, and the MAO reversed the denial.

Most of these prior authorization denial reversals occurred because of an appeal filed by the beneficiary or the provider, which can take weeks.

In one case, an MAO denied a request for a CT scan of the chest and pelvis for a beneficiary with endometrial cancer. It took 5 weeks for the provider to get the denial reversed. The OIG panel determined that the original request included sufficient documentation to demonstrate the CT was needed to assess the stage of the cancer and determine the appropriate course of treatment.

These denials and reversals not only waste time but may also cause harm. In a 2021 American Medical Association survey, 34% of physicians reported that prior authorization led to a serious adverse event for a patient in their care, including hospitalization, medical intervention to prevent permanent impairment, and even disability or death.

Almost 90% of the physicians surveyed described the burden associated with prior authorizations as ‘high’ or ‘extremely high.’ More specifically, physicians and their staff spend nearly 2 days a week on prior authorizations and 40% of physicians have staff who work exclusively on prior authorizations.

“It’s just not the way medicine should be practiced, especially for cancer patients who are very vulnerable and want rapid care,” Dr. Buckstein said.
 

Time for action

Weighing in on the OIG report, Robert E. Wailes, MD, president of the California Medical Association, noted that “it has become common practice for health insurance companies to create obstacles for patients in hopes of not having to pay for essential healthcare.”

The reason for these obstacles is simple, he said: “Fewer procedures performed translates to larger insurance company profits.”

America’s Health Insurance Plans (AHIP) defended prior authorization, saying it is “an important patient safety, cost-saving, and waste-prevention tool.”

The group also called out the OIG review for its “extraordinarily small” sample of 247 prior authorization requests over 1 week. 

“Drawing far-reaching conclusions based on a very small sample of data and misleading headlines is not a productive way to improve our healthcare system for patients,” the AHIP statement reads.

But, according to Anna Schwamlein Howard, who works on policy development at the American Cancer Society Cancer Action Network, the recent OIG report is in line with previous OIG reports.

And, Ms. Howard emphasized, the current report and others like it “highlight the need for CMS to utilize its audit authority and ensure that beneficiaries have access to medically necessary treatments, particularly cancer treatments.”

Along those lines, the OIG report recommends that the CMS should issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in the report, and direct MAOs to take additional steps to identify and address vulnerabilities that can lead to manual review and system errors.

In a statement, the CMS said it is committed to oversight and enforcement of the requirements of the Medicare Advantage program and agreed with the OIG recommendations.

“Lawmakers must act now to place patient needs before corporate profits and simplify by streamlining prior authorization processes,” Dr. Wailes said.

The ACS recently released a paper on this topic entitled, “The Medicare Appeals Process: Reforms Needed to Ensure Beneficiary Access.” 

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

Patients with cancer enrolled in Medicare Advantage Organizations (MAOs) may be denied needed care, leading to delays in treatment and administrative headaches for oncology practices, a recent analysis suggests.

The report from the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services found that 13% of prior authorization denials were for service requests, which included cancer care, that met Medicare coverage rules and 18% of payment denials were for claims that met Medicare coverage and MAO billing rules, delaying or halting payments for services that clinicians had provided.

MAO denials are the “bane of my existence,” said Michael Buckstein, MD, PhD, a radiation oncologist at Mount Sinai Hospital in New York.

“Working at a large hospital in a metropolitan city, we spend enormous and increasing amounts of time on prior approvals and we get denials quite frequently, which certainly can lead to delays in treatment,” said Dr. Buckstein, who reviewed the OIG report for this news organization.

According to Dr. Buckstein, once a claim is denied, staff must spend time filing and scheduling an appeal, and if the appeal is denied in a physician peer-to-peer review, staff could face secondary and tertiary appeals. “We have been living with this frustration for a long time,” Dr. Buckstein said.
 

Widespread and persistent problems

Medicare Advantage plans, which are approved by the Centers for Medicare & Medicaid Services but run by private companies, continue to grow in popularity.

In 2021, 26.4 million Medicare beneficiaries (42%) were enrolled in a Medicare Advantage plan, and by 2030, about 51% of all Medicare beneficiaries will be enrolled, according to estimates from the Kaiser Family Foundation.

“Although MAOs approve the vast majority of prior authorization requests and provider payment requests, MAOs also deny millions of requests each year,” the OIG wrote. “CMS’s annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payment.”

In the current report, the OIG reviewed case files for 247 denials of prior authorization requests and 183 payment denials issued by 15 of the largest MAOs during 1 week in June of 2019. 

The authors found that 13% of prior authorization denials occurred for service requests that met Medicare coverage rules, meaning these services would likely have been approved had the patient been enrolled in traditional Medicare.

The most prominent service types among these denials included imaging services, stays in postacute facilities, and injections.

In one case, for example, the MAO stated that a beneficiary would need to wait at least 1 year for a follow-up MRI because the size of the patient’s adrenal lesion (< 2 cm) was too small to warrant follow-up before 1 year. However, this restriction is not included in Medicare coverage rules. And an OIG physician panel found that the documentation in the original request demonstrated that the MRI was medically necessary to determine whether the lesion seen on an earlier CT scan was malignant.

Upon appeal, the MAO reversed its original denial.

Among the payment requests that MAOs denied, almost one in five were for claims that met Medicare coverage and billing rules, which delayed or prevented payments for services already delivered. Most payment denials were caused by human error during manual claims-processing reviews and system processing errors, the OIG report found.

In one case, for example, a MAO denied payment for radiation treatment for a patient with a tumor on the pancreas, incorrectly claiming that no prior authorization had been submitted for the service. However, the physician subsequently provided a screenshot demonstrating that the MAO had granted prior authorization for the billed claim, and the MAO reversed the denial.

Most of these prior authorization denial reversals occurred because of an appeal filed by the beneficiary or the provider, which can take weeks.

In one case, an MAO denied a request for a CT scan of the chest and pelvis for a beneficiary with endometrial cancer. It took 5 weeks for the provider to get the denial reversed. The OIG panel determined that the original request included sufficient documentation to demonstrate the CT was needed to assess the stage of the cancer and determine the appropriate course of treatment.

These denials and reversals not only waste time but may also cause harm. In a 2021 American Medical Association survey, 34% of physicians reported that prior authorization led to a serious adverse event for a patient in their care, including hospitalization, medical intervention to prevent permanent impairment, and even disability or death.

Almost 90% of the physicians surveyed described the burden associated with prior authorizations as ‘high’ or ‘extremely high.’ More specifically, physicians and their staff spend nearly 2 days a week on prior authorizations and 40% of physicians have staff who work exclusively on prior authorizations.

“It’s just not the way medicine should be practiced, especially for cancer patients who are very vulnerable and want rapid care,” Dr. Buckstein said.
 

Time for action

Weighing in on the OIG report, Robert E. Wailes, MD, president of the California Medical Association, noted that “it has become common practice for health insurance companies to create obstacles for patients in hopes of not having to pay for essential healthcare.”

The reason for these obstacles is simple, he said: “Fewer procedures performed translates to larger insurance company profits.”

America’s Health Insurance Plans (AHIP) defended prior authorization, saying it is “an important patient safety, cost-saving, and waste-prevention tool.”

The group also called out the OIG review for its “extraordinarily small” sample of 247 prior authorization requests over 1 week. 

“Drawing far-reaching conclusions based on a very small sample of data and misleading headlines is not a productive way to improve our healthcare system for patients,” the AHIP statement reads.

But, according to Anna Schwamlein Howard, who works on policy development at the American Cancer Society Cancer Action Network, the recent OIG report is in line with previous OIG reports.

And, Ms. Howard emphasized, the current report and others like it “highlight the need for CMS to utilize its audit authority and ensure that beneficiaries have access to medically necessary treatments, particularly cancer treatments.”

Along those lines, the OIG report recommends that the CMS should issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in the report, and direct MAOs to take additional steps to identify and address vulnerabilities that can lead to manual review and system errors.

In a statement, the CMS said it is committed to oversight and enforcement of the requirements of the Medicare Advantage program and agreed with the OIG recommendations.

“Lawmakers must act now to place patient needs before corporate profits and simplify by streamlining prior authorization processes,” Dr. Wailes said.

The ACS recently released a paper on this topic entitled, “The Medicare Appeals Process: Reforms Needed to Ensure Beneficiary Access.” 

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

Patients with cancer enrolled in Medicare Advantage Organizations (MAOs) may be denied needed care, leading to delays in treatment and administrative headaches for oncology practices, a recent analysis suggests.

The report from the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services found that 13% of prior authorization denials were for service requests, which included cancer care, that met Medicare coverage rules and 18% of payment denials were for claims that met Medicare coverage and MAO billing rules, delaying or halting payments for services that clinicians had provided.

MAO denials are the “bane of my existence,” said Michael Buckstein, MD, PhD, a radiation oncologist at Mount Sinai Hospital in New York.

“Working at a large hospital in a metropolitan city, we spend enormous and increasing amounts of time on prior approvals and we get denials quite frequently, which certainly can lead to delays in treatment,” said Dr. Buckstein, who reviewed the OIG report for this news organization.

According to Dr. Buckstein, once a claim is denied, staff must spend time filing and scheduling an appeal, and if the appeal is denied in a physician peer-to-peer review, staff could face secondary and tertiary appeals. “We have been living with this frustration for a long time,” Dr. Buckstein said.
 

Widespread and persistent problems

Medicare Advantage plans, which are approved by the Centers for Medicare & Medicaid Services but run by private companies, continue to grow in popularity.

In 2021, 26.4 million Medicare beneficiaries (42%) were enrolled in a Medicare Advantage plan, and by 2030, about 51% of all Medicare beneficiaries will be enrolled, according to estimates from the Kaiser Family Foundation.

“Although MAOs approve the vast majority of prior authorization requests and provider payment requests, MAOs also deny millions of requests each year,” the OIG wrote. “CMS’s annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payment.”

In the current report, the OIG reviewed case files for 247 denials of prior authorization requests and 183 payment denials issued by 15 of the largest MAOs during 1 week in June of 2019. 

The authors found that 13% of prior authorization denials occurred for service requests that met Medicare coverage rules, meaning these services would likely have been approved had the patient been enrolled in traditional Medicare.

The most prominent service types among these denials included imaging services, stays in postacute facilities, and injections.

In one case, for example, the MAO stated that a beneficiary would need to wait at least 1 year for a follow-up MRI because the size of the patient’s adrenal lesion (< 2 cm) was too small to warrant follow-up before 1 year. However, this restriction is not included in Medicare coverage rules. And an OIG physician panel found that the documentation in the original request demonstrated that the MRI was medically necessary to determine whether the lesion seen on an earlier CT scan was malignant.

Upon appeal, the MAO reversed its original denial.

Among the payment requests that MAOs denied, almost one in five were for claims that met Medicare coverage and billing rules, which delayed or prevented payments for services already delivered. Most payment denials were caused by human error during manual claims-processing reviews and system processing errors, the OIG report found.

In one case, for example, a MAO denied payment for radiation treatment for a patient with a tumor on the pancreas, incorrectly claiming that no prior authorization had been submitted for the service. However, the physician subsequently provided a screenshot demonstrating that the MAO had granted prior authorization for the billed claim, and the MAO reversed the denial.

Most of these prior authorization denial reversals occurred because of an appeal filed by the beneficiary or the provider, which can take weeks.

In one case, an MAO denied a request for a CT scan of the chest and pelvis for a beneficiary with endometrial cancer. It took 5 weeks for the provider to get the denial reversed. The OIG panel determined that the original request included sufficient documentation to demonstrate the CT was needed to assess the stage of the cancer and determine the appropriate course of treatment.

These denials and reversals not only waste time but may also cause harm. In a 2021 American Medical Association survey, 34% of physicians reported that prior authorization led to a serious adverse event for a patient in their care, including hospitalization, medical intervention to prevent permanent impairment, and even disability or death.

Almost 90% of the physicians surveyed described the burden associated with prior authorizations as ‘high’ or ‘extremely high.’ More specifically, physicians and their staff spend nearly 2 days a week on prior authorizations and 40% of physicians have staff who work exclusively on prior authorizations.

“It’s just not the way medicine should be practiced, especially for cancer patients who are very vulnerable and want rapid care,” Dr. Buckstein said.
 

Time for action

Weighing in on the OIG report, Robert E. Wailes, MD, president of the California Medical Association, noted that “it has become common practice for health insurance companies to create obstacles for patients in hopes of not having to pay for essential healthcare.”

The reason for these obstacles is simple, he said: “Fewer procedures performed translates to larger insurance company profits.”

America’s Health Insurance Plans (AHIP) defended prior authorization, saying it is “an important patient safety, cost-saving, and waste-prevention tool.”

The group also called out the OIG review for its “extraordinarily small” sample of 247 prior authorization requests over 1 week. 

“Drawing far-reaching conclusions based on a very small sample of data and misleading headlines is not a productive way to improve our healthcare system for patients,” the AHIP statement reads.

But, according to Anna Schwamlein Howard, who works on policy development at the American Cancer Society Cancer Action Network, the recent OIG report is in line with previous OIG reports.

And, Ms. Howard emphasized, the current report and others like it “highlight the need for CMS to utilize its audit authority and ensure that beneficiaries have access to medically necessary treatments, particularly cancer treatments.”

Along those lines, the OIG report recommends that the CMS should issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in the report, and direct MAOs to take additional steps to identify and address vulnerabilities that can lead to manual review and system errors.

In a statement, the CMS said it is committed to oversight and enforcement of the requirements of the Medicare Advantage program and agreed with the OIG recommendations.

“Lawmakers must act now to place patient needs before corporate profits and simplify by streamlining prior authorization processes,” Dr. Wailes said.

The ACS recently released a paper on this topic entitled, “The Medicare Appeals Process: Reforms Needed to Ensure Beneficiary Access.” 

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

Recently, I encountered a study in Pediatrics that hoped to answer the question of whether there was any benefit to tactile stimulation in those nerve-rattling moments when a newborn didn’t seem to take much interest in breathing: “Tactile stimulation in newborn infants with inadequate respiration at birth: A systematic review.” Now there is a title that grabs the attention of every frontline pediatrician who has sweated through those minutes that seemed like hours in the delivery room when some little rascal has decided that breathing isn’t a priority.

Of course, your great grandmother and everyone else knew what needed to be done – the obstetrician hung the baby by his or her ankles and slapped it on the bottom a couple of times. But you went to medical school and learned that was barbaric. Instead, you modeled the behavior of the residents and delivery room nurses who had more refined techniques such as heel flicking and vigorous spine rubbing. You never thought to ask if there was any science behind those activities because everyone did them.

Well, the authors of the article in Pediatrics, writing on behalf of the International Liaison Committee on Resuscitation and Neonatal Life Support Task Force, thought the time had come to turn over a few stones and see if tactile stimulation was a benefit in resuscitation. Beginning with 2,455 possibly relevant articles, they quickly (I suspect they would quibble with the “quickly” part) winnowed these down to two observational studies, one of which was rejected because of “critical risk of bias.” The surviving study showed a reduction in tracheal intubation in infants who had received tactile stimulation. However, the authors felt that the “certainty of evidence was very low.”

So, there you have it. Aren’t you glad you didn’t invest 15 or 20 minutes discovering what you probably had guessed already? You can thank me later.

You already suspected that it may not help. However, like any good physician, what you really wanted to know is whether were you doing any harm by heel flicking and spine rubbing. And I bet you already had an opinion about the answer to that question. During your training, you may have seen delivery room personnel who were clearly too vigorous in their tactile stimulation and/or too persistent in their heel flicking and spine rubbing when the next steps in resuscitation needed to be taken. That’s the next study that needs to be done. I hope that study finds that tactile stimulation may not help but as long as it is done using specific techniques and within certain temporal parameters it does no harm.

I was never much for heel flicking. My favorite tactile stimulation was encircling the pokey infant’s chest in my hand, gently compressing and then quickly releasing a couple of times. My hope was that by mimicking the birth process the sensors in the infant’s chest wall would remind him it was time to breathe. That, and a silent plea to Mother Nature, worked most of the time.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Recently, I encountered a study in Pediatrics that hoped to answer the question of whether there was any benefit to tactile stimulation in those nerve-rattling moments when a newborn didn’t seem to take much interest in breathing: “Tactile stimulation in newborn infants with inadequate respiration at birth: A systematic review.” Now there is a title that grabs the attention of every frontline pediatrician who has sweated through those minutes that seemed like hours in the delivery room when some little rascal has decided that breathing isn’t a priority.

Of course, your great grandmother and everyone else knew what needed to be done – the obstetrician hung the baby by his or her ankles and slapped it on the bottom a couple of times. But you went to medical school and learned that was barbaric. Instead, you modeled the behavior of the residents and delivery room nurses who had more refined techniques such as heel flicking and vigorous spine rubbing. You never thought to ask if there was any science behind those activities because everyone did them.

Well, the authors of the article in Pediatrics, writing on behalf of the International Liaison Committee on Resuscitation and Neonatal Life Support Task Force, thought the time had come to turn over a few stones and see if tactile stimulation was a benefit in resuscitation. Beginning with 2,455 possibly relevant articles, they quickly (I suspect they would quibble with the “quickly” part) winnowed these down to two observational studies, one of which was rejected because of “critical risk of bias.” The surviving study showed a reduction in tracheal intubation in infants who had received tactile stimulation. However, the authors felt that the “certainty of evidence was very low.”

So, there you have it. Aren’t you glad you didn’t invest 15 or 20 minutes discovering what you probably had guessed already? You can thank me later.

You already suspected that it may not help. However, like any good physician, what you really wanted to know is whether were you doing any harm by heel flicking and spine rubbing. And I bet you already had an opinion about the answer to that question. During your training, you may have seen delivery room personnel who were clearly too vigorous in their tactile stimulation and/or too persistent in their heel flicking and spine rubbing when the next steps in resuscitation needed to be taken. That’s the next study that needs to be done. I hope that study finds that tactile stimulation may not help but as long as it is done using specific techniques and within certain temporal parameters it does no harm.

I was never much for heel flicking. My favorite tactile stimulation was encircling the pokey infant’s chest in my hand, gently compressing and then quickly releasing a couple of times. My hope was that by mimicking the birth process the sensors in the infant’s chest wall would remind him it was time to breathe. That, and a silent plea to Mother Nature, worked most of the time.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Recently, I encountered a study in Pediatrics that hoped to answer the question of whether there was any benefit to tactile stimulation in those nerve-rattling moments when a newborn didn’t seem to take much interest in breathing: “Tactile stimulation in newborn infants with inadequate respiration at birth: A systematic review.” Now there is a title that grabs the attention of every frontline pediatrician who has sweated through those minutes that seemed like hours in the delivery room when some little rascal has decided that breathing isn’t a priority.

Of course, your great grandmother and everyone else knew what needed to be done – the obstetrician hung the baby by his or her ankles and slapped it on the bottom a couple of times. But you went to medical school and learned that was barbaric. Instead, you modeled the behavior of the residents and delivery room nurses who had more refined techniques such as heel flicking and vigorous spine rubbing. You never thought to ask if there was any science behind those activities because everyone did them.

Well, the authors of the article in Pediatrics, writing on behalf of the International Liaison Committee on Resuscitation and Neonatal Life Support Task Force, thought the time had come to turn over a few stones and see if tactile stimulation was a benefit in resuscitation. Beginning with 2,455 possibly relevant articles, they quickly (I suspect they would quibble with the “quickly” part) winnowed these down to two observational studies, one of which was rejected because of “critical risk of bias.” The surviving study showed a reduction in tracheal intubation in infants who had received tactile stimulation. However, the authors felt that the “certainty of evidence was very low.”

So, there you have it. Aren’t you glad you didn’t invest 15 or 20 minutes discovering what you probably had guessed already? You can thank me later.

You already suspected that it may not help. However, like any good physician, what you really wanted to know is whether were you doing any harm by heel flicking and spine rubbing. And I bet you already had an opinion about the answer to that question. During your training, you may have seen delivery room personnel who were clearly too vigorous in their tactile stimulation and/or too persistent in their heel flicking and spine rubbing when the next steps in resuscitation needed to be taken. That’s the next study that needs to be done. I hope that study finds that tactile stimulation may not help but as long as it is done using specific techniques and within certain temporal parameters it does no harm.

I was never much for heel flicking. My favorite tactile stimulation was encircling the pokey infant’s chest in my hand, gently compressing and then quickly releasing a couple of times. My hope was that by mimicking the birth process the sensors in the infant’s chest wall would remind him it was time to breathe. That, and a silent plea to Mother Nature, worked most of the time.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Use of race-based diabetes screening thresholds could reduce the disparity that arises from current screening guidelines in the United States, new research suggests.

In August 2021, the U.S. Preventive Services Task Force (USPSTF) lowered the recommended age for type 2 diabetes screening from 40 to 35 years among people with a body mass index of 25 kg/m² or greater.

However, the diabetes rate among ethnic minorities aged 35-70 years in the United States is not just higher overall but, in certain populations, also occurs more frequently at a younger age and at lower BMIs, the new study indicates.

Among people with a BMI below 25 kg/m², the diabetes prevalence is two to four times higher among Asian, Black, and Hispanic Americans than among the U.S. White population.

And the authors of the new study, led by Rahul Aggarwal, MD, predict that if screening begins at age 35 years, the BMI cut-off equivalent to 25 kg/m² for White Americans would be 18.5 kg/m2 for Hispanic and Black Americans and 20 kg/m² for Asian Americans.

“While diabetes has often been thought of as a disease that primarily affects adults with overweight or [obesity], our findings suggest that normal-weight adults in minority groups have surprisingly high rates of diabetes,” Dr. Aggarwal, senior resident physician in internal medicine at Harvard Medical School, Boston, told this news organization.

“Assessing diabetes risks in certain racial/ethnic groups will be necessary, even if these adults do not have overweight or [obesity],” he added.

Not screening in this way “is a missed opportunity for early intervention,” he noted.  

And both the authors and an editorialist stress that the issue isn’t just theoretical.

“USPSTF recommendations influence what payers choose to cover, which in turn determines access to preventative services ... Addressing the staggering inequities in diabetes outcomes will require substantial investments in diabetes prevention and treatment, but making screening more equitable is a good place to start,” said senior author Dhruv S. Kazi, MD, of the Smith Center for Outcomes Research in Cardiology and director of the Cardiac Critical Care Unit at Beth Israel, Boston.
 

Screen minorities at a younger age if current BMI threshold kept

In their study, based on data from the National Health and Nutrition Examination Survey (NHANES) for 2011-2018, Dr. Aggarwal and colleagues also calculated that, if the BMI threshold is kept at 25 kg/m², then the equivalent age cut-offs for Asian, Black, and Hispanic Americans would be 23, 21, and 25 years, respectively, compared with 35 years for White Americans.

The findings were published online  in the Annals of Internal Medicine.

The prevalence of diabetes in those aged 35-70 years in the NHANES population was 17.3% for Asian Americans and 12.5% for those who were White (odds ratio, 1.51 vs. Whites). Among Black Americans and Mexican Americans, the prevalence was 20.7% and 20.6%, respectively, almost twice the prevalence in Whites (OR, 1.85 and 1.80). For other Hispanic Americans, the prevalence was 16.4% (OR, 1.37 vs. Whites). All of those differences were significant, compared with White Americans.

Undiagnosed diabetes was also significantly more common among minority populations, at 27.6%, 22.8%, 21.2%, and 23.5% for Asian, Black, Mexican, and other Hispanic Americans, respectively, versus 12.5% for White Americans.
 

‘The time has come for USPSTF to offer more concrete guidance’

“While there is more work to be done on carefully examining the long-term risk–benefit trade-off of various diabetes screening, I believe the time has come for USPSTF to offer more concrete guidance on the use of lower thresholds for screening higher-risk individuals,” Dr. Kazi told this news organization.

The author of an accompanying editorial agrees, noting that in a recent commentary the USPSTF, itself, “acknowledged the persistent inequalities across the screening-to-treatment continuum that result in racial/ethnic health disparities in the United States.”

And the USPSTF “emphasized the need to improve systems of care to ensure equitable and consistent delivery of high-quality preventive and treatment services, with special attention to racial/ethnic groups who may experience worse health outcomes,” continues Quyen Ngo-Metzger, MD, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, California.

For other conditions, including cancer, cardiovascular disease, and infectious disease, the USPSTF already recommends risk-based preventive services.

“To address the current inequity in diabetes screening, the USPSTF should apply the same consideration to its diabetes screening recommendation,” she notes.
 

‘Implementation will require an eye for pragmatism’

Asked about how this recommendation might be carried out in the real world, Dr. Aggarwal said in an interview that, because all three minority groups with normal weight had similar diabetes risk profiles to White adults with overweight, “one way for clinicians to easily implement these findings is by screening all Asian, Black, and Hispanic adults ages 35-70 years with normal weight for diabetes, similarly to how all White adults ages 35-70 years with overweight are currently recommended for screening.”

Dr. Kazi said: “I believe that implementation will require an eye for pragmatism,” noting that another option would be to have screening algorithms embedded in the electronic health record to flag individuals who qualify.

In any case, “the simplicity of the current one-size-fits-all approach is alluring, but it is profoundly inequitable. The more I look at the empiric evidence on diabetes burden in our communities, the more the status quo becomes untenable.”

However, Dr. Kazi also noted, “the benefit of any screening program relates to what we do with the information. The key is to ensure that folks identified as having diabetes – or better still prediabetes – receive timely lifestyle and pharmacological interventions to avert its long-term complications.”

This study was supported by institutional funds from the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology. Dr. Aggarwal, Dr. Kazi, and Dr. Ngo-Metzger have reported no relevant relationships.

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

Use of race-based diabetes screening thresholds could reduce the disparity that arises from current screening guidelines in the United States, new research suggests.

In August 2021, the U.S. Preventive Services Task Force (USPSTF) lowered the recommended age for type 2 diabetes screening from 40 to 35 years among people with a body mass index of 25 kg/m² or greater.

However, the diabetes rate among ethnic minorities aged 35-70 years in the United States is not just higher overall but, in certain populations, also occurs more frequently at a younger age and at lower BMIs, the new study indicates.

Among people with a BMI below 25 kg/m², the diabetes prevalence is two to four times higher among Asian, Black, and Hispanic Americans than among the U.S. White population.

And the authors of the new study, led by Rahul Aggarwal, MD, predict that if screening begins at age 35 years, the BMI cut-off equivalent to 25 kg/m² for White Americans would be 18.5 kg/m2 for Hispanic and Black Americans and 20 kg/m² for Asian Americans.

“While diabetes has often been thought of as a disease that primarily affects adults with overweight or [obesity], our findings suggest that normal-weight adults in minority groups have surprisingly high rates of diabetes,” Dr. Aggarwal, senior resident physician in internal medicine at Harvard Medical School, Boston, told this news organization.

“Assessing diabetes risks in certain racial/ethnic groups will be necessary, even if these adults do not have overweight or [obesity],” he added.

Not screening in this way “is a missed opportunity for early intervention,” he noted.  

And both the authors and an editorialist stress that the issue isn’t just theoretical.

“USPSTF recommendations influence what payers choose to cover, which in turn determines access to preventative services ... Addressing the staggering inequities in diabetes outcomes will require substantial investments in diabetes prevention and treatment, but making screening more equitable is a good place to start,” said senior author Dhruv S. Kazi, MD, of the Smith Center for Outcomes Research in Cardiology and director of the Cardiac Critical Care Unit at Beth Israel, Boston.
 

Screen minorities at a younger age if current BMI threshold kept

In their study, based on data from the National Health and Nutrition Examination Survey (NHANES) for 2011-2018, Dr. Aggarwal and colleagues also calculated that, if the BMI threshold is kept at 25 kg/m², then the equivalent age cut-offs for Asian, Black, and Hispanic Americans would be 23, 21, and 25 years, respectively, compared with 35 years for White Americans.

The findings were published online  in the Annals of Internal Medicine.

The prevalence of diabetes in those aged 35-70 years in the NHANES population was 17.3% for Asian Americans and 12.5% for those who were White (odds ratio, 1.51 vs. Whites). Among Black Americans and Mexican Americans, the prevalence was 20.7% and 20.6%, respectively, almost twice the prevalence in Whites (OR, 1.85 and 1.80). For other Hispanic Americans, the prevalence was 16.4% (OR, 1.37 vs. Whites). All of those differences were significant, compared with White Americans.

Undiagnosed diabetes was also significantly more common among minority populations, at 27.6%, 22.8%, 21.2%, and 23.5% for Asian, Black, Mexican, and other Hispanic Americans, respectively, versus 12.5% for White Americans.
 

‘The time has come for USPSTF to offer more concrete guidance’

“While there is more work to be done on carefully examining the long-term risk–benefit trade-off of various diabetes screening, I believe the time has come for USPSTF to offer more concrete guidance on the use of lower thresholds for screening higher-risk individuals,” Dr. Kazi told this news organization.

The author of an accompanying editorial agrees, noting that in a recent commentary the USPSTF, itself, “acknowledged the persistent inequalities across the screening-to-treatment continuum that result in racial/ethnic health disparities in the United States.”

And the USPSTF “emphasized the need to improve systems of care to ensure equitable and consistent delivery of high-quality preventive and treatment services, with special attention to racial/ethnic groups who may experience worse health outcomes,” continues Quyen Ngo-Metzger, MD, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, California.

For other conditions, including cancer, cardiovascular disease, and infectious disease, the USPSTF already recommends risk-based preventive services.

“To address the current inequity in diabetes screening, the USPSTF should apply the same consideration to its diabetes screening recommendation,” she notes.
 

‘Implementation will require an eye for pragmatism’

Asked about how this recommendation might be carried out in the real world, Dr. Aggarwal said in an interview that, because all three minority groups with normal weight had similar diabetes risk profiles to White adults with overweight, “one way for clinicians to easily implement these findings is by screening all Asian, Black, and Hispanic adults ages 35-70 years with normal weight for diabetes, similarly to how all White adults ages 35-70 years with overweight are currently recommended for screening.”

Dr. Kazi said: “I believe that implementation will require an eye for pragmatism,” noting that another option would be to have screening algorithms embedded in the electronic health record to flag individuals who qualify.

In any case, “the simplicity of the current one-size-fits-all approach is alluring, but it is profoundly inequitable. The more I look at the empiric evidence on diabetes burden in our communities, the more the status quo becomes untenable.”

However, Dr. Kazi also noted, “the benefit of any screening program relates to what we do with the information. The key is to ensure that folks identified as having diabetes – or better still prediabetes – receive timely lifestyle and pharmacological interventions to avert its long-term complications.”

This study was supported by institutional funds from the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology. Dr. Aggarwal, Dr. Kazi, and Dr. Ngo-Metzger have reported no relevant relationships.

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

Use of race-based diabetes screening thresholds could reduce the disparity that arises from current screening guidelines in the United States, new research suggests.

In August 2021, the U.S. Preventive Services Task Force (USPSTF) lowered the recommended age for type 2 diabetes screening from 40 to 35 years among people with a body mass index of 25 kg/m² or greater.

However, the diabetes rate among ethnic minorities aged 35-70 years in the United States is not just higher overall but, in certain populations, also occurs more frequently at a younger age and at lower BMIs, the new study indicates.

Among people with a BMI below 25 kg/m², the diabetes prevalence is two to four times higher among Asian, Black, and Hispanic Americans than among the U.S. White population.

And the authors of the new study, led by Rahul Aggarwal, MD, predict that if screening begins at age 35 years, the BMI cut-off equivalent to 25 kg/m² for White Americans would be 18.5 kg/m2 for Hispanic and Black Americans and 20 kg/m² for Asian Americans.

“While diabetes has often been thought of as a disease that primarily affects adults with overweight or [obesity], our findings suggest that normal-weight adults in minority groups have surprisingly high rates of diabetes,” Dr. Aggarwal, senior resident physician in internal medicine at Harvard Medical School, Boston, told this news organization.

“Assessing diabetes risks in certain racial/ethnic groups will be necessary, even if these adults do not have overweight or [obesity],” he added.

Not screening in this way “is a missed opportunity for early intervention,” he noted.  

And both the authors and an editorialist stress that the issue isn’t just theoretical.

“USPSTF recommendations influence what payers choose to cover, which in turn determines access to preventative services ... Addressing the staggering inequities in diabetes outcomes will require substantial investments in diabetes prevention and treatment, but making screening more equitable is a good place to start,” said senior author Dhruv S. Kazi, MD, of the Smith Center for Outcomes Research in Cardiology and director of the Cardiac Critical Care Unit at Beth Israel, Boston.
 

Screen minorities at a younger age if current BMI threshold kept

In their study, based on data from the National Health and Nutrition Examination Survey (NHANES) for 2011-2018, Dr. Aggarwal and colleagues also calculated that, if the BMI threshold is kept at 25 kg/m², then the equivalent age cut-offs for Asian, Black, and Hispanic Americans would be 23, 21, and 25 years, respectively, compared with 35 years for White Americans.

The findings were published online  in the Annals of Internal Medicine.

The prevalence of diabetes in those aged 35-70 years in the NHANES population was 17.3% for Asian Americans and 12.5% for those who were White (odds ratio, 1.51 vs. Whites). Among Black Americans and Mexican Americans, the prevalence was 20.7% and 20.6%, respectively, almost twice the prevalence in Whites (OR, 1.85 and 1.80). For other Hispanic Americans, the prevalence was 16.4% (OR, 1.37 vs. Whites). All of those differences were significant, compared with White Americans.

Undiagnosed diabetes was also significantly more common among minority populations, at 27.6%, 22.8%, 21.2%, and 23.5% for Asian, Black, Mexican, and other Hispanic Americans, respectively, versus 12.5% for White Americans.
 

‘The time has come for USPSTF to offer more concrete guidance’

“While there is more work to be done on carefully examining the long-term risk–benefit trade-off of various diabetes screening, I believe the time has come for USPSTF to offer more concrete guidance on the use of lower thresholds for screening higher-risk individuals,” Dr. Kazi told this news organization.

The author of an accompanying editorial agrees, noting that in a recent commentary the USPSTF, itself, “acknowledged the persistent inequalities across the screening-to-treatment continuum that result in racial/ethnic health disparities in the United States.”

And the USPSTF “emphasized the need to improve systems of care to ensure equitable and consistent delivery of high-quality preventive and treatment services, with special attention to racial/ethnic groups who may experience worse health outcomes,” continues Quyen Ngo-Metzger, MD, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, California.

For other conditions, including cancer, cardiovascular disease, and infectious disease, the USPSTF already recommends risk-based preventive services.

“To address the current inequity in diabetes screening, the USPSTF should apply the same consideration to its diabetes screening recommendation,” she notes.
 

‘Implementation will require an eye for pragmatism’

Asked about how this recommendation might be carried out in the real world, Dr. Aggarwal said in an interview that, because all three minority groups with normal weight had similar diabetes risk profiles to White adults with overweight, “one way for clinicians to easily implement these findings is by screening all Asian, Black, and Hispanic adults ages 35-70 years with normal weight for diabetes, similarly to how all White adults ages 35-70 years with overweight are currently recommended for screening.”

Dr. Kazi said: “I believe that implementation will require an eye for pragmatism,” noting that another option would be to have screening algorithms embedded in the electronic health record to flag individuals who qualify.

In any case, “the simplicity of the current one-size-fits-all approach is alluring, but it is profoundly inequitable. The more I look at the empiric evidence on diabetes burden in our communities, the more the status quo becomes untenable.”

However, Dr. Kazi also noted, “the benefit of any screening program relates to what we do with the information. The key is to ensure that folks identified as having diabetes – or better still prediabetes – receive timely lifestyle and pharmacological interventions to avert its long-term complications.”

This study was supported by institutional funds from the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology. Dr. Aggarwal, Dr. Kazi, and Dr. Ngo-Metzger have reported no relevant relationships.

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

I believe that the most important recommendation from the American Heart Association in recent years is to confirm office blood pressure (BP) readings with repeated home BP measurements, for both diagnosis and management of hypertension. Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting. Even when measured correctly, the office BP does not accurately reflect a person’s BP throughout the day, which is the best predictor of cardiovascular damage from hypertension.

Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting.

Among the problems with relying on office BP readings:We would treat many people for hypertension who are not hypertensive, because 15% to 30% of those with elevated office BP readings have “white-coat” hypertension, which does not require medication.¹ White-coat hypertension can only be diagnosed with home BP readings or 24-hour ambulatory BP monitoring.

We would miss the diagnosis of hypertension in patients with “masked” hypertension—that is, people who have normal BP in the office but elevated ambulatory BP. It is estimated that 12% of US adults have masked hypertension.²

We would overtreat some patients who have hypertension and undertreat others, since office BP measurements can underestimate BP by an average of 24/14 mm Hg and overestimate BP by an average of 33/23 mm Hg.³

In this issue of JFP, Spaulding and colleagues⁴ provide an extensive summary of the research that supports the recommendation for home BP measurements. Here are 3 key takeaways:

1. Use an automated BP monitor to measure BP in the office. Automated BP monitors that take repeated BPs over the course of about 5 minutes and average the results provide a much better estimate of 24-hour BP. It is worth the extra time and may be the only basis for making decisions about medications if a patient is unwilling or unable to take home BP readings.
2. Provide training to patients who are willing to monitor their BP at home. Explain how to take their BP properly and instruct them to record at least 12 readings over the course of 3 days prior to office visits.
3. Recommend patients use a validated BP monitor that uses the brachial artery for measurement, not the wrist (visit www.stridebp.org/bp-monitors and choose “Home”).

I believe that the most important recommendation from the American Heart Association in recent years is to confirm office blood pressure (BP) readings with repeated home BP measurements, for both diagnosis and management of hypertension. Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting. Even when measured correctly, the office BP does not accurately reflect a person’s BP throughout the day, which is the best predictor of cardiovascular damage from hypertension.

Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting.

Among the problems with relying on office BP readings:We would treat many people for hypertension who are not hypertensive, because 15% to 30% of those with elevated office BP readings have “white-coat” hypertension, which does not require medication.¹ White-coat hypertension can only be diagnosed with home BP readings or 24-hour ambulatory BP monitoring.

We would miss the diagnosis of hypertension in patients with “masked” hypertension—that is, people who have normal BP in the office but elevated ambulatory BP. It is estimated that 12% of US adults have masked hypertension.²

We would overtreat some patients who have hypertension and undertreat others, since office BP measurements can underestimate BP by an average of 24/14 mm Hg and overestimate BP by an average of 33/23 mm Hg.³

In this issue of JFP, Spaulding and colleagues⁴ provide an extensive summary of the research that supports the recommendation for home BP measurements. Here are 3 key takeaways:

1. Use an automated BP monitor to measure BP in the office. Automated BP monitors that take repeated BPs over the course of about 5 minutes and average the results provide a much better estimate of 24-hour BP. It is worth the extra time and may be the only basis for making decisions about medications if a patient is unwilling or unable to take home BP readings.
2. Provide training to patients who are willing to monitor their BP at home. Explain how to take their BP properly and instruct them to record at least 12 readings over the course of 3 days prior to office visits.
3. Recommend patients use a validated BP monitor that uses the brachial artery for measurement, not the wrist (visit www.stridebp.org/bp-monitors and choose “Home”).

I believe that the most important recommendation from the American Heart Association in recent years is to confirm office blood pressure (BP) readings with repeated home BP measurements, for both diagnosis and management of hypertension. Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting. Even when measured correctly, the office BP does not accurately reflect a person’s BP throughout the day, which is the best predictor of cardiovascular damage from hypertension.

Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting.

Among the problems with relying on office BP readings:We would treat many people for hypertension who are not hypertensive, because 15% to 30% of those with elevated office BP readings have “white-coat” hypertension, which does not require medication.¹ White-coat hypertension can only be diagnosed with home BP readings or 24-hour ambulatory BP monitoring.

We would miss the diagnosis of hypertension in patients with “masked” hypertension—that is, people who have normal BP in the office but elevated ambulatory BP. It is estimated that 12% of US adults have masked hypertension.²

We would overtreat some patients who have hypertension and undertreat others, since office BP measurements can underestimate BP by an average of 24/14 mm Hg and overestimate BP by an average of 33/23 mm Hg.³

In this issue of JFP, Spaulding and colleagues⁴ provide an extensive summary of the research that supports the recommendation for home BP measurements. Here are 3 key takeaways:

1. Use an automated BP monitor to measure BP in the office. Automated BP monitors that take repeated BPs over the course of about 5 minutes and average the results provide a much better estimate of 24-hour BP. It is worth the extra time and may be the only basis for making decisions about medications if a patient is unwilling or unable to take home BP readings.
2. Provide training to patients who are willing to monitor their BP at home. Explain how to take their BP properly and instruct them to record at least 12 readings over the course of 3 days prior to office visits.
3. Recommend patients use a validated BP monitor that uses the brachial artery for measurement, not the wrist (visit www.stridebp.org/bp-monitors and choose “Home”).

In 2021, the US Preventive Services Task Force (USPSTF) considered 13 topics and made a total of 23 recommendations. They reviewed only 1 new topic. The other 12 were updates of topics previously addressed; no changes were made in 9 of them. In 3, the recommended age of screening or the criteria for screening were expanded. This Practice Alert will review the recommendations made and highlight new recommendations and any changes to previous ones. All complete recommendation statements, rationales, clinical considerations, and evidence reports can be found on the USPSTF website at https://uspreventiveservicestaskforce.org/uspstf/home.¹

Dental caries in children

Dental caries affect about 23% of children between the ages of 2 and 5 years and are associated with multiple adverse social outcomes and medical conditions.² The best way to prevent tooth decay, other than regular brushing with fluoride toothpaste, is to drink water with recommended amounts of fluoride (≥ 0.6 parts fluoride per million parts water).² The USPSTF reaffirmed its recommendation from 2014 that stated when a local water supply lacks sufficient fluoride, primary care clinicians should prescribe oral supplementation for infants and children in the form of fluoride drops starting at age 6 months. The dosage of fluoride depends on patient age and fluoride concentration in the local water (TABLE 1³). The USPSTF also recommends applying topical fluoride as 5% sodium fluoride varnish, every 6 months, starting when the primary teeth erupt.²

BREAKING NEWS At press time, the USPSTF issued its final recommendation on the use of aspirin for primary prevention of cardiovascular disease; see https:// bit.ly/3vklQEe for details.

In addition to fluoride supplements and topical varnish, should clinicians perform screening examinations looking for dental caries? The USPSTF feels there is not enough evidence to assess this practice and gives it an “I” rating (insufficient evidence).

Preventive interventions in pregnancy 

In 2021, the USPSTF assessed 3 topics related to pregnancy and prenatal care.

Screening for gestational diabetes. The USPSTF gave a “B” recommendation for screening at 24 weeks of pregnancy or after, but an “I” statement for screening prior to 24 weeks.⁴ Screening can involve a 1-step or 2-step protocol.

The 2-step protocol is most commonly used in the United States. It involves first measuring serum glucose after a nonfasting 50-g oral glucose challenge; if the resulting level is high, the second step is a 75- or 100-g oral glucose tolerance test lasting 3 hours. The 1-step protocol involves measuring a fasting glucose level, followed by a 75-g oral glucose challenge with glucose levels measured at 1 and 2 hours.

Healthy weight gain in pregnancy. This was the only new topic the USPSTF assessed last year. The resulting recommendation is to offer pregnant women behavioral counseling to promote healthy weight gain and to prevent excessive weight gain in pregnancy. The recommended weight gain depends on the mother’s prepregnancy weight status: 28 to 40 lbs if the mother is underweight; 25 to 35 lbs if she is not under- or overweight; 15 to 25 lbs if she is overweight; and 11 to 20 lbs if she is obese.⁵ Healthy weight gain contributes to preventing gestational diabetes, emergency cesarean sections, and infant macrosomia.

Continue to: Low-dose aspirin

Low-dose aspirin. Reaffirming a recommendation from 2014, the USPSTF advises low-dose aspirin (81 mg/d) starting after 12 weeks’ gestation for all pregnant women who are at high risk for preeclampsia. TABLE 2⁶ lists high- and moderate-risk conditions for preeclampsia and the recommendation for the use of low-dose aspirin.

Sexually transmitted infections

Screening for both chlamydia and gonorrhea in sexually active females through age 24 years was given a “B” recommendation, reaffirming the 2014 recommendation.⁷ Screening for these 2 sexually transmitted infections (STIs) is also recommended for women 25 years and older who are at increased risk of STIs. Risk is defined as having a new sex partner, more than 1 sex partner, a sex partner who has other sex partners, or a sex partner who has an STI; not using condoms consistently; having a previous STI; exchanging sex for money or drugs; or having a history of incarceration.

Screen for both infections simultaneously using a nucleic acid amplification test, testing all sites of sexual exposure. Urine testing can replace cervical, vaginal, and urethral testing. Those found to be positive for either STI should be treated according to the most recent treatment guidelines from the Centers for Disease Control and Prevention (CDC). And sexual partners should be advised to undergo testing.^8,9

The USPSTF could not find evidence for the benefits and harms of screening for STIs in men. Remember that screening applies to those who are asymptomatic. Male sex partners of those found to be infected should be tested, as should those who show any signs or symptoms of an STI. A recent Practice Alert described the most current CDC guidance for diagnosing and treating STIs.⁹

Type 2 diabetes and prediabetes

Screening for type 2 diabetes (T2D) and prediabetes is now recommended for adults ages 35 to 70 years who are overweight or obese.¹⁰ The age to start screening has been lowered to 35 years from the previous recommendation in 2015, which recommended starting at age 40. In addition, the recommendation states that patients with prediabetes should be referred for preventive interventions. It is important that referral is included in the statement because the Affordable Care Act mandates that USPSTF “A” and “B” recommendations must be covered by commercial health insurance with no copay or deductible.

Continue to: Screening can be conducted...

Screening can be conducted using a fasting plasma glucose or A1C level, or with an oral glucose tolerance test. Interventions that can prevent or delay the onset of T2D in those with prediabetes include lifestyle interventions that focus on diet and physical activity, and the use of metformin (although metformin has not been approved for this by the US Food and Drug Administration).

Changes to cancer screening recommendations

In 2021, the USPSTF reviewed and modified its recommendations on screening for 2 types of cancer: colorectal and lung.

For colorectal cancer, the age at which to start screening was lowered from 50 years to 45 years.¹¹ Screening at this earlier age is a “B” recommendation, because, while there is benefit from screening, it is less than for older age groups. Screening individuals ages 50 to 75 years remains an “A” recommendation, and for those ages 76 to 85 years it remains a “C” recommendation. A “C” recommendation means that the overall benefits are small but some individuals might benefit based on their overall health and prior screening results. In its clinical considerations, the USPSTF recommends against screening in those ages 85 and older but, curiously, does not list it as a “D” recommendation. The screening methods and recommended screening intervals for each appear in TABLE 3.¹¹

For lung cancer, annual screening using low-dose computed tomography (CT) was first recommended by the USPSTF in 2013 for adults ages 55 to 80 years with a 30-pack-year smoking history. Screening could stop once 15 years had passed since smoking cessation. In 2021, the USPSTF lowered the age to initiate screening to 50 years, and the smoking history threshold to 20 pack-years.¹² If these recommendations are followed, a current smoker who does not quit smoking could possibly receive 30 annual CT scans. The recommendation does state that screening should stop once a person develops a health condition that significantly affects life expectancy or ability to have lung surgery.

For primary prevention of lung cancer and other chronic diseases through smoking cessation, the USPSTF also reassessed its 2015 recommendations. It reaffirmed the “A” recommendation to ask adults about tobacco use and, for tobacco users, to recommend cessation and provide behavioral therapy and approved pharmacotherapy.¹³ The recommendation differed for pregnant adults in that the USPSTF is unsure about the potential harms of pharmacotherapy in pregnancy and gives that an “I” statement.¹³ An additional “I” statement was made about the use of electronic cigarettes for smoking cessation; the USPSTF recommends using behavioral and pharmacotherapy interventions with proven effectiveness and safety instead.

Continue to: 4 additional recommendation updates with no changes

4 additional recommendation updates with no changes

Screening for high blood pressure in adults ages 18 years and older continues to receive an “A” recommendation.¹⁴ Importantly, the recommendation states that confirmation of high blood pressure should be made in an out-of-­office setting before initiating treatment. Screening for vitamin D deficiency in adults and hearing loss in older adults both continue with “I” statements,^15,16 and screening for asymptomatic carotid artery stenosis continues to receive a “D” recommendation.¹⁷ The implications of the vitamin D “I” statement were discussed in a previous Practice Alert.¹⁸

Continuing value of the USPSTF

The USPSTF continues to set the gold standard for assessment of preventive interventions, and its decisions affect first-dollar coverage by commercial health insurance. The reaffirmation of past recommendations demonstrates the value of adhering to rigorous evidence-based methods (if they are done correctly, they rarely must be markedly changed). And the updating of screening criteria shows the need to constantly review the evolving evidence for current recommendations. Once again, however, funding and staffing limitations allowed the USPSTF to assess only 1 new topic. A listing of all the 2021 recommendations is in TABLE 4.¹

In 2021, the US Preventive Services Task Force (USPSTF) considered 13 topics and made a total of 23 recommendations. They reviewed only 1 new topic. The other 12 were updates of topics previously addressed; no changes were made in 9 of them. In 3, the recommended age of screening or the criteria for screening were expanded. This Practice Alert will review the recommendations made and highlight new recommendations and any changes to previous ones. All complete recommendation statements, rationales, clinical considerations, and evidence reports can be found on the USPSTF website at https://uspreventiveservicestaskforce.org/uspstf/home.¹

Dental caries in children

Dental caries affect about 23% of children between the ages of 2 and 5 years and are associated with multiple adverse social outcomes and medical conditions.² The best way to prevent tooth decay, other than regular brushing with fluoride toothpaste, is to drink water with recommended amounts of fluoride (≥ 0.6 parts fluoride per million parts water).² The USPSTF reaffirmed its recommendation from 2014 that stated when a local water supply lacks sufficient fluoride, primary care clinicians should prescribe oral supplementation for infants and children in the form of fluoride drops starting at age 6 months. The dosage of fluoride depends on patient age and fluoride concentration in the local water (TABLE 1³). The USPSTF also recommends applying topical fluoride as 5% sodium fluoride varnish, every 6 months, starting when the primary teeth erupt.²

BREAKING NEWS At press time, the USPSTF issued its final recommendation on the use of aspirin for primary prevention of cardiovascular disease; see https:// bit.ly/3vklQEe for details.

In addition to fluoride supplements and topical varnish, should clinicians perform screening examinations looking for dental caries? The USPSTF feels there is not enough evidence to assess this practice and gives it an “I” rating (insufficient evidence).

Preventive interventions in pregnancy 

In 2021, the USPSTF assessed 3 topics related to pregnancy and prenatal care.

Screening for gestational diabetes. The USPSTF gave a “B” recommendation for screening at 24 weeks of pregnancy or after, but an “I” statement for screening prior to 24 weeks.⁴ Screening can involve a 1-step or 2-step protocol.

The 2-step protocol is most commonly used in the United States. It involves first measuring serum glucose after a nonfasting 50-g oral glucose challenge; if the resulting level is high, the second step is a 75- or 100-g oral glucose tolerance test lasting 3 hours. The 1-step protocol involves measuring a fasting glucose level, followed by a 75-g oral glucose challenge with glucose levels measured at 1 and 2 hours.

Healthy weight gain in pregnancy. This was the only new topic the USPSTF assessed last year. The resulting recommendation is to offer pregnant women behavioral counseling to promote healthy weight gain and to prevent excessive weight gain in pregnancy. The recommended weight gain depends on the mother’s prepregnancy weight status: 28 to 40 lbs if the mother is underweight; 25 to 35 lbs if she is not under- or overweight; 15 to 25 lbs if she is overweight; and 11 to 20 lbs if she is obese.⁵ Healthy weight gain contributes to preventing gestational diabetes, emergency cesarean sections, and infant macrosomia.

Continue to: Low-dose aspirin

Low-dose aspirin. Reaffirming a recommendation from 2014, the USPSTF advises low-dose aspirin (81 mg/d) starting after 12 weeks’ gestation for all pregnant women who are at high risk for preeclampsia. TABLE 2⁶ lists high- and moderate-risk conditions for preeclampsia and the recommendation for the use of low-dose aspirin.

Sexually transmitted infections

Screening for both chlamydia and gonorrhea in sexually active females through age 24 years was given a “B” recommendation, reaffirming the 2014 recommendation.⁷ Screening for these 2 sexually transmitted infections (STIs) is also recommended for women 25 years and older who are at increased risk of STIs. Risk is defined as having a new sex partner, more than 1 sex partner, a sex partner who has other sex partners, or a sex partner who has an STI; not using condoms consistently; having a previous STI; exchanging sex for money or drugs; or having a history of incarceration.

Screen for both infections simultaneously using a nucleic acid amplification test, testing all sites of sexual exposure. Urine testing can replace cervical, vaginal, and urethral testing. Those found to be positive for either STI should be treated according to the most recent treatment guidelines from the Centers for Disease Control and Prevention (CDC). And sexual partners should be advised to undergo testing.^8,9

The USPSTF could not find evidence for the benefits and harms of screening for STIs in men. Remember that screening applies to those who are asymptomatic. Male sex partners of those found to be infected should be tested, as should those who show any signs or symptoms of an STI. A recent Practice Alert described the most current CDC guidance for diagnosing and treating STIs.⁹

Type 2 diabetes and prediabetes

Screening for type 2 diabetes (T2D) and prediabetes is now recommended for adults ages 35 to 70 years who are overweight or obese.¹⁰ The age to start screening has been lowered to 35 years from the previous recommendation in 2015, which recommended starting at age 40. In addition, the recommendation states that patients with prediabetes should be referred for preventive interventions. It is important that referral is included in the statement because the Affordable Care Act mandates that USPSTF “A” and “B” recommendations must be covered by commercial health insurance with no copay or deductible.

Continue to: Screening can be conducted...

Screening can be conducted using a fasting plasma glucose or A1C level, or with an oral glucose tolerance test. Interventions that can prevent or delay the onset of T2D in those with prediabetes include lifestyle interventions that focus on diet and physical activity, and the use of metformin (although metformin has not been approved for this by the US Food and Drug Administration).

Changes to cancer screening recommendations

In 2021, the USPSTF reviewed and modified its recommendations on screening for 2 types of cancer: colorectal and lung.

For colorectal cancer, the age at which to start screening was lowered from 50 years to 45 years.¹¹ Screening at this earlier age is a “B” recommendation, because, while there is benefit from screening, it is less than for older age groups. Screening individuals ages 50 to 75 years remains an “A” recommendation, and for those ages 76 to 85 years it remains a “C” recommendation. A “C” recommendation means that the overall benefits are small but some individuals might benefit based on their overall health and prior screening results. In its clinical considerations, the USPSTF recommends against screening in those ages 85 and older but, curiously, does not list it as a “D” recommendation. The screening methods and recommended screening intervals for each appear in TABLE 3.¹¹

For lung cancer, annual screening using low-dose computed tomography (CT) was first recommended by the USPSTF in 2013 for adults ages 55 to 80 years with a 30-pack-year smoking history. Screening could stop once 15 years had passed since smoking cessation. In 2021, the USPSTF lowered the age to initiate screening to 50 years, and the smoking history threshold to 20 pack-years.¹² If these recommendations are followed, a current smoker who does not quit smoking could possibly receive 30 annual CT scans. The recommendation does state that screening should stop once a person develops a health condition that significantly affects life expectancy or ability to have lung surgery.

For primary prevention of lung cancer and other chronic diseases through smoking cessation, the USPSTF also reassessed its 2015 recommendations. It reaffirmed the “A” recommendation to ask adults about tobacco use and, for tobacco users, to recommend cessation and provide behavioral therapy and approved pharmacotherapy.¹³ The recommendation differed for pregnant adults in that the USPSTF is unsure about the potential harms of pharmacotherapy in pregnancy and gives that an “I” statement.¹³ An additional “I” statement was made about the use of electronic cigarettes for smoking cessation; the USPSTF recommends using behavioral and pharmacotherapy interventions with proven effectiveness and safety instead.

Continue to: 4 additional recommendation updates with no changes

4 additional recommendation updates with no changes

Screening for high blood pressure in adults ages 18 years and older continues to receive an “A” recommendation.¹⁴ Importantly, the recommendation states that confirmation of high blood pressure should be made in an out-of-­office setting before initiating treatment. Screening for vitamin D deficiency in adults and hearing loss in older adults both continue with “I” statements,^15,16 and screening for asymptomatic carotid artery stenosis continues to receive a “D” recommendation.¹⁷ The implications of the vitamin D “I” statement were discussed in a previous Practice Alert.¹⁸

Continuing value of the USPSTF

The USPSTF continues to set the gold standard for assessment of preventive interventions, and its decisions affect first-dollar coverage by commercial health insurance. The reaffirmation of past recommendations demonstrates the value of adhering to rigorous evidence-based methods (if they are done correctly, they rarely must be markedly changed). And the updating of screening criteria shows the need to constantly review the evolving evidence for current recommendations. Once again, however, funding and staffing limitations allowed the USPSTF to assess only 1 new topic. A listing of all the 2021 recommendations is in TABLE 4.¹

In 2021, the US Preventive Services Task Force (USPSTF) considered 13 topics and made a total of 23 recommendations. They reviewed only 1 new topic. The other 12 were updates of topics previously addressed; no changes were made in 9 of them. In 3, the recommended age of screening or the criteria for screening were expanded. This Practice Alert will review the recommendations made and highlight new recommendations and any changes to previous ones. All complete recommendation statements, rationales, clinical considerations, and evidence reports can be found on the USPSTF website at https://uspreventiveservicestaskforce.org/uspstf/home.¹

Dental caries in children

Dental caries affect about 23% of children between the ages of 2 and 5 years and are associated with multiple adverse social outcomes and medical conditions.² The best way to prevent tooth decay, other than regular brushing with fluoride toothpaste, is to drink water with recommended amounts of fluoride (≥ 0.6 parts fluoride per million parts water).² The USPSTF reaffirmed its recommendation from 2014 that stated when a local water supply lacks sufficient fluoride, primary care clinicians should prescribe oral supplementation for infants and children in the form of fluoride drops starting at age 6 months. The dosage of fluoride depends on patient age and fluoride concentration in the local water (TABLE 1³). The USPSTF also recommends applying topical fluoride as 5% sodium fluoride varnish, every 6 months, starting when the primary teeth erupt.²

BREAKING NEWS At press time, the USPSTF issued its final recommendation on the use of aspirin for primary prevention of cardiovascular disease; see https:// bit.ly/3vklQEe for details.

In addition to fluoride supplements and topical varnish, should clinicians perform screening examinations looking for dental caries? The USPSTF feels there is not enough evidence to assess this practice and gives it an “I” rating (insufficient evidence).

Preventive interventions in pregnancy 

In 2021, the USPSTF assessed 3 topics related to pregnancy and prenatal care.

Screening for gestational diabetes. The USPSTF gave a “B” recommendation for screening at 24 weeks of pregnancy or after, but an “I” statement for screening prior to 24 weeks.⁴ Screening can involve a 1-step or 2-step protocol.

The 2-step protocol is most commonly used in the United States. It involves first measuring serum glucose after a nonfasting 50-g oral glucose challenge; if the resulting level is high, the second step is a 75- or 100-g oral glucose tolerance test lasting 3 hours. The 1-step protocol involves measuring a fasting glucose level, followed by a 75-g oral glucose challenge with glucose levels measured at 1 and 2 hours.

Healthy weight gain in pregnancy. This was the only new topic the USPSTF assessed last year. The resulting recommendation is to offer pregnant women behavioral counseling to promote healthy weight gain and to prevent excessive weight gain in pregnancy. The recommended weight gain depends on the mother’s prepregnancy weight status: 28 to 40 lbs if the mother is underweight; 25 to 35 lbs if she is not under- or overweight; 15 to 25 lbs if she is overweight; and 11 to 20 lbs if she is obese.⁵ Healthy weight gain contributes to preventing gestational diabetes, emergency cesarean sections, and infant macrosomia.

Continue to: Low-dose aspirin

Low-dose aspirin. Reaffirming a recommendation from 2014, the USPSTF advises low-dose aspirin (81 mg/d) starting after 12 weeks’ gestation for all pregnant women who are at high risk for preeclampsia. TABLE 2⁶ lists high- and moderate-risk conditions for preeclampsia and the recommendation for the use of low-dose aspirin.

Sexually transmitted infections

Screening for both chlamydia and gonorrhea in sexually active females through age 24 years was given a “B” recommendation, reaffirming the 2014 recommendation.⁷ Screening for these 2 sexually transmitted infections (STIs) is also recommended for women 25 years and older who are at increased risk of STIs. Risk is defined as having a new sex partner, more than 1 sex partner, a sex partner who has other sex partners, or a sex partner who has an STI; not using condoms consistently; having a previous STI; exchanging sex for money or drugs; or having a history of incarceration.

Screen for both infections simultaneously using a nucleic acid amplification test, testing all sites of sexual exposure. Urine testing can replace cervical, vaginal, and urethral testing. Those found to be positive for either STI should be treated according to the most recent treatment guidelines from the Centers for Disease Control and Prevention (CDC). And sexual partners should be advised to undergo testing.^8,9

The USPSTF could not find evidence for the benefits and harms of screening for STIs in men. Remember that screening applies to those who are asymptomatic. Male sex partners of those found to be infected should be tested, as should those who show any signs or symptoms of an STI. A recent Practice Alert described the most current CDC guidance for diagnosing and treating STIs.⁹

Type 2 diabetes and prediabetes

Screening for type 2 diabetes (T2D) and prediabetes is now recommended for adults ages 35 to 70 years who are overweight or obese.¹⁰ The age to start screening has been lowered to 35 years from the previous recommendation in 2015, which recommended starting at age 40. In addition, the recommendation states that patients with prediabetes should be referred for preventive interventions. It is important that referral is included in the statement because the Affordable Care Act mandates that USPSTF “A” and “B” recommendations must be covered by commercial health insurance with no copay or deductible.

Continue to: Screening can be conducted...

Screening can be conducted using a fasting plasma glucose or A1C level, or with an oral glucose tolerance test. Interventions that can prevent or delay the onset of T2D in those with prediabetes include lifestyle interventions that focus on diet and physical activity, and the use of metformin (although metformin has not been approved for this by the US Food and Drug Administration).

Changes to cancer screening recommendations

In 2021, the USPSTF reviewed and modified its recommendations on screening for 2 types of cancer: colorectal and lung.

For colorectal cancer, the age at which to start screening was lowered from 50 years to 45 years.¹¹ Screening at this earlier age is a “B” recommendation, because, while there is benefit from screening, it is less than for older age groups. Screening individuals ages 50 to 75 years remains an “A” recommendation, and for those ages 76 to 85 years it remains a “C” recommendation. A “C” recommendation means that the overall benefits are small but some individuals might benefit based on their overall health and prior screening results. In its clinical considerations, the USPSTF recommends against screening in those ages 85 and older but, curiously, does not list it as a “D” recommendation. The screening methods and recommended screening intervals for each appear in TABLE 3.¹¹

For lung cancer, annual screening using low-dose computed tomography (CT) was first recommended by the USPSTF in 2013 for adults ages 55 to 80 years with a 30-pack-year smoking history. Screening could stop once 15 years had passed since smoking cessation. In 2021, the USPSTF lowered the age to initiate screening to 50 years, and the smoking history threshold to 20 pack-years.¹² If these recommendations are followed, a current smoker who does not quit smoking could possibly receive 30 annual CT scans. The recommendation does state that screening should stop once a person develops a health condition that significantly affects life expectancy or ability to have lung surgery.

For primary prevention of lung cancer and other chronic diseases through smoking cessation, the USPSTF also reassessed its 2015 recommendations. It reaffirmed the “A” recommendation to ask adults about tobacco use and, for tobacco users, to recommend cessation and provide behavioral therapy and approved pharmacotherapy.¹³ The recommendation differed for pregnant adults in that the USPSTF is unsure about the potential harms of pharmacotherapy in pregnancy and gives that an “I” statement.¹³ An additional “I” statement was made about the use of electronic cigarettes for smoking cessation; the USPSTF recommends using behavioral and pharmacotherapy interventions with proven effectiveness and safety instead.

Continue to: 4 additional recommendation updates with no changes

4 additional recommendation updates with no changes

Screening for high blood pressure in adults ages 18 years and older continues to receive an “A” recommendation.¹⁴ Importantly, the recommendation states that confirmation of high blood pressure should be made in an out-of-­office setting before initiating treatment. Screening for vitamin D deficiency in adults and hearing loss in older adults both continue with “I” statements,^15,16 and screening for asymptomatic carotid artery stenosis continues to receive a “D” recommendation.¹⁷ The implications of the vitamin D “I” statement were discussed in a previous Practice Alert.¹⁸

Continuing value of the USPSTF

The USPSTF continues to set the gold standard for assessment of preventive interventions, and its decisions affect first-dollar coverage by commercial health insurance. The reaffirmation of past recommendations demonstrates the value of adhering to rigorous evidence-based methods (if they are done correctly, they rarely must be markedly changed). And the updating of screening criteria shows the need to constantly review the evolving evidence for current recommendations. Once again, however, funding and staffing limitations allowed the USPSTF to assess only 1 new topic. A listing of all the 2021 recommendations is in TABLE 4.¹

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; [email protected]

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; [email protected]

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; [email protected]

Obesity, in combination with other risk factors, is associated with increased morbidity and mortality in acute pancreatitis (AP); however, body mass index (BMI) alone is not a successful predictor of disease severity, new research shows.

“As there was no agreement or consistency between BMI and AP severity, it can be concluded that AP severity cannot be predicted successfully by examining BMI only,” reported the authors in research published recently in Pancreatology.

iStock/ThinkStock

The course of acute pancreatitis is typically mild in the majority (80%-85%) of cases; however, in severe cases, permanent organ failure can occur, with much worse outcomes and mortality rates of up to 35%.

Research has previously shown not only a link between obesity and acute pancreatitis but also an increased risk for complications and in-hospital mortality in obese patients with severe cases of acute pancreatitis – though a wide range of factors and comorbidities may complicate the association.

To more closely evaluate the course and outcomes of acute pancreatitis based on BMI classification, study authors led by Ali Tuzun Ince, MD, of the department of internal medicine, Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, analyzed retrospective data from 2010 to 2020 on 1,334 adult patients (720 female, 614 male) who were diagnosed with acute pancreatitis per the Revised Atlanta Classification (RAC) criteria.

The patients were stratified based on their BMI as normal weight, overweight, or obese and whether they had mild, moderate, or severe (with permanent organ failure) acute pancreatitis.

In terms of acute pancreatitis severity, based on RAC criteria, 57.1% of patients had mild disease, 20.4% had moderate disease, and 22.5% had severe disease.

The overall mortality rate was 9.9% (n = 132); half of these patients were obese, and 87% had severe acute pancreatitis.

The overall rate of complications was 42.9%, including 20.8% in the normal weight group, 40.6% in the overweight group, and 38.6% in the obese group.

Patients in the overweight and obese groups also had higher mortality rates (3.7% and 4.9%, respectively), interventional procedures (36% and 39%, respectively), and length of hospital stay (11.6% and 9.8%, respectively), compared with the normal-weight group.

Other factors that were significantly associated with an increased mortality risk, in addition to obesity (P = .046), included old age (P = .000), male sex (P = .05), alcohol use (P = .014), low hematocrit (P = .044), high C-reactive protein (P = .024), moderate to severe and severe acute pancreatitis (P = .02 and P < .001, respectively), and any complications (P < .001).

Risk factors associated with increased admission to the ICU differed from those for mortality, and included female gender (P = .024), smoking (P = .021), hypertriglyceridemia (P = .047), idiopathic etiology (P = .023), and moderate to severe and severe acute pancreatitis (P < .001).

Of note, there were no significant associations between BMI and either the RAC score or Balthazar CT severity index (Balthazar CTSI) groups.

Specifically, among patients considered to have severe acute pancreatitis per Balthazar CTSI, 6.3% were of normal weight, 5% were overweight, and 7.1% were obese.

“In addition, since agreement and consistency between BMI and Balthazar score cannot be determined, the Balthazar score cannot be estimated from BMI,” the authors reported.

While the prediction of prognosis in acute pancreatitis is gaining interest, the findings underscore the role of combined factors, they added.

“Although many scoring systems are currently in use attempt to estimate the severity [in acute pancreatitis], none is 100% accurate yet,” the authors noted. “Each risk factor exacerbates the course of disease. Therefore, it would be better to consider the combined effects of risk factors.”

That being said, the findings show “mortality is increased significantly by the combined presence of risk factors such as male sex, OB [obesity], alcohol, MSAP [moderate to severe acute pancreatitis] and SAP [severe acute pancreatitis], all kinds of complications, old age, low Hct, and high CRP,” they wrote.
 

Obesity’s complex interactions

Commenting on the study, Vijay P. Singh, MD, a professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Scottsdale, Ariz., agreed that the complexities risk factors, particularly with obesity, can be tricky to detangle.

“Broadly, the study confirms several previous reports from different parts of the world that obesity was associated with increased mortality in acute pancreatitis,” he said in an interview.

“However, obesity had two complex interactions, the first that obesity is also associated with increased diabetes, and hypertriglyceridemia, which may themselves be risk factors for severity,” he explained.

“The second one is that intermediary severity markers [e.g., Balthazar score on imaging] did not correlate with the BMI categories.”

Dr. Singh noted that is “likely because therapies like IV fluids that may get more intense in predicted severe disease alter the natural course of pancreatitis.”

The findings are a reminder that “BMI is only a number that attempts to quantify fat,” Dr. Singh said, noting that BMI doesn’t address either the location of fat, such as being in close proximity to the pancreas, or fat composition, such as the proportion of unsaturated fat.

“When the unsaturated fat proportion is higher, the pancreatitis is worse, even at smaller total fat amounts [for example, at a lower BMI],” he said. “Taking these aspects into account may help in risk assessment.”

The authors and Dr. Singh had no disclosures to report.

Obesity, in combination with other risk factors, is associated with increased morbidity and mortality in acute pancreatitis (AP); however, body mass index (BMI) alone is not a successful predictor of disease severity, new research shows.

“As there was no agreement or consistency between BMI and AP severity, it can be concluded that AP severity cannot be predicted successfully by examining BMI only,” reported the authors in research published recently in Pancreatology.

iStock/ThinkStock

The course of acute pancreatitis is typically mild in the majority (80%-85%) of cases; however, in severe cases, permanent organ failure can occur, with much worse outcomes and mortality rates of up to 35%.

Research has previously shown not only a link between obesity and acute pancreatitis but also an increased risk for complications and in-hospital mortality in obese patients with severe cases of acute pancreatitis – though a wide range of factors and comorbidities may complicate the association.

To more closely evaluate the course and outcomes of acute pancreatitis based on BMI classification, study authors led by Ali Tuzun Ince, MD, of the department of internal medicine, Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, analyzed retrospective data from 2010 to 2020 on 1,334 adult patients (720 female, 614 male) who were diagnosed with acute pancreatitis per the Revised Atlanta Classification (RAC) criteria.

The patients were stratified based on their BMI as normal weight, overweight, or obese and whether they had mild, moderate, or severe (with permanent organ failure) acute pancreatitis.

In terms of acute pancreatitis severity, based on RAC criteria, 57.1% of patients had mild disease, 20.4% had moderate disease, and 22.5% had severe disease.

The overall mortality rate was 9.9% (n = 132); half of these patients were obese, and 87% had severe acute pancreatitis.

The overall rate of complications was 42.9%, including 20.8% in the normal weight group, 40.6% in the overweight group, and 38.6% in the obese group.

Patients in the overweight and obese groups also had higher mortality rates (3.7% and 4.9%, respectively), interventional procedures (36% and 39%, respectively), and length of hospital stay (11.6% and 9.8%, respectively), compared with the normal-weight group.

Other factors that were significantly associated with an increased mortality risk, in addition to obesity (P = .046), included old age (P = .000), male sex (P = .05), alcohol use (P = .014), low hematocrit (P = .044), high C-reactive protein (P = .024), moderate to severe and severe acute pancreatitis (P = .02 and P < .001, respectively), and any complications (P < .001).

Risk factors associated with increased admission to the ICU differed from those for mortality, and included female gender (P = .024), smoking (P = .021), hypertriglyceridemia (P = .047), idiopathic etiology (P = .023), and moderate to severe and severe acute pancreatitis (P < .001).

Of note, there were no significant associations between BMI and either the RAC score or Balthazar CT severity index (Balthazar CTSI) groups.

Specifically, among patients considered to have severe acute pancreatitis per Balthazar CTSI, 6.3% were of normal weight, 5% were overweight, and 7.1% were obese.

“In addition, since agreement and consistency between BMI and Balthazar score cannot be determined, the Balthazar score cannot be estimated from BMI,” the authors reported.

While the prediction of prognosis in acute pancreatitis is gaining interest, the findings underscore the role of combined factors, they added.

“Although many scoring systems are currently in use attempt to estimate the severity [in acute pancreatitis], none is 100% accurate yet,” the authors noted. “Each risk factor exacerbates the course of disease. Therefore, it would be better to consider the combined effects of risk factors.”

That being said, the findings show “mortality is increased significantly by the combined presence of risk factors such as male sex, OB [obesity], alcohol, MSAP [moderate to severe acute pancreatitis] and SAP [severe acute pancreatitis], all kinds of complications, old age, low Hct, and high CRP,” they wrote.
 

Obesity’s complex interactions

Commenting on the study, Vijay P. Singh, MD, a professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Scottsdale, Ariz., agreed that the complexities risk factors, particularly with obesity, can be tricky to detangle.

“Broadly, the study confirms several previous reports from different parts of the world that obesity was associated with increased mortality in acute pancreatitis,” he said in an interview.

“However, obesity had two complex interactions, the first that obesity is also associated with increased diabetes, and hypertriglyceridemia, which may themselves be risk factors for severity,” he explained.

“The second one is that intermediary severity markers [e.g., Balthazar score on imaging] did not correlate with the BMI categories.”

Dr. Singh noted that is “likely because therapies like IV fluids that may get more intense in predicted severe disease alter the natural course of pancreatitis.”

The findings are a reminder that “BMI is only a number that attempts to quantify fat,” Dr. Singh said, noting that BMI doesn’t address either the location of fat, such as being in close proximity to the pancreas, or fat composition, such as the proportion of unsaturated fat.

“When the unsaturated fat proportion is higher, the pancreatitis is worse, even at smaller total fat amounts [for example, at a lower BMI],” he said. “Taking these aspects into account may help in risk assessment.”

The authors and Dr. Singh had no disclosures to report.

Obesity, in combination with other risk factors, is associated with increased morbidity and mortality in acute pancreatitis (AP); however, body mass index (BMI) alone is not a successful predictor of disease severity, new research shows.

“As there was no agreement or consistency between BMI and AP severity, it can be concluded that AP severity cannot be predicted successfully by examining BMI only,” reported the authors in research published recently in Pancreatology.

iStock/ThinkStock

The course of acute pancreatitis is typically mild in the majority (80%-85%) of cases; however, in severe cases, permanent organ failure can occur, with much worse outcomes and mortality rates of up to 35%.

Research has previously shown not only a link between obesity and acute pancreatitis but also an increased risk for complications and in-hospital mortality in obese patients with severe cases of acute pancreatitis – though a wide range of factors and comorbidities may complicate the association.

To more closely evaluate the course and outcomes of acute pancreatitis based on BMI classification, study authors led by Ali Tuzun Ince, MD, of the department of internal medicine, Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, analyzed retrospective data from 2010 to 2020 on 1,334 adult patients (720 female, 614 male) who were diagnosed with acute pancreatitis per the Revised Atlanta Classification (RAC) criteria.

The patients were stratified based on their BMI as normal weight, overweight, or obese and whether they had mild, moderate, or severe (with permanent organ failure) acute pancreatitis.

In terms of acute pancreatitis severity, based on RAC criteria, 57.1% of patients had mild disease, 20.4% had moderate disease, and 22.5% had severe disease.

The overall mortality rate was 9.9% (n = 132); half of these patients were obese, and 87% had severe acute pancreatitis.

The overall rate of complications was 42.9%, including 20.8% in the normal weight group, 40.6% in the overweight group, and 38.6% in the obese group.

Patients in the overweight and obese groups also had higher mortality rates (3.7% and 4.9%, respectively), interventional procedures (36% and 39%, respectively), and length of hospital stay (11.6% and 9.8%, respectively), compared with the normal-weight group.

Other factors that were significantly associated with an increased mortality risk, in addition to obesity (P = .046), included old age (P = .000), male sex (P = .05), alcohol use (P = .014), low hematocrit (P = .044), high C-reactive protein (P = .024), moderate to severe and severe acute pancreatitis (P = .02 and P < .001, respectively), and any complications (P < .001).

Risk factors associated with increased admission to the ICU differed from those for mortality, and included female gender (P = .024), smoking (P = .021), hypertriglyceridemia (P = .047), idiopathic etiology (P = .023), and moderate to severe and severe acute pancreatitis (P < .001).

Of note, there were no significant associations between BMI and either the RAC score or Balthazar CT severity index (Balthazar CTSI) groups.

Specifically, among patients considered to have severe acute pancreatitis per Balthazar CTSI, 6.3% were of normal weight, 5% were overweight, and 7.1% were obese.

“In addition, since agreement and consistency between BMI and Balthazar score cannot be determined, the Balthazar score cannot be estimated from BMI,” the authors reported.

While the prediction of prognosis in acute pancreatitis is gaining interest, the findings underscore the role of combined factors, they added.

“Although many scoring systems are currently in use attempt to estimate the severity [in acute pancreatitis], none is 100% accurate yet,” the authors noted. “Each risk factor exacerbates the course of disease. Therefore, it would be better to consider the combined effects of risk factors.”

That being said, the findings show “mortality is increased significantly by the combined presence of risk factors such as male sex, OB [obesity], alcohol, MSAP [moderate to severe acute pancreatitis] and SAP [severe acute pancreatitis], all kinds of complications, old age, low Hct, and high CRP,” they wrote.
 

Obesity’s complex interactions

Commenting on the study, Vijay P. Singh, MD, a professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Scottsdale, Ariz., agreed that the complexities risk factors, particularly with obesity, can be tricky to detangle.

“Broadly, the study confirms several previous reports from different parts of the world that obesity was associated with increased mortality in acute pancreatitis,” he said in an interview.

“However, obesity had two complex interactions, the first that obesity is also associated with increased diabetes, and hypertriglyceridemia, which may themselves be risk factors for severity,” he explained.

“The second one is that intermediary severity markers [e.g., Balthazar score on imaging] did not correlate with the BMI categories.”

Dr. Singh noted that is “likely because therapies like IV fluids that may get more intense in predicted severe disease alter the natural course of pancreatitis.”

The findings are a reminder that “BMI is only a number that attempts to quantify fat,” Dr. Singh said, noting that BMI doesn’t address either the location of fat, such as being in close proximity to the pancreas, or fat composition, such as the proportion of unsaturated fat.

“When the unsaturated fat proportion is higher, the pancreatitis is worse, even at smaller total fat amounts [for example, at a lower BMI],” he said. “Taking these aspects into account may help in risk assessment.”

The authors and Dr. Singh had no disclosures to report.

The Diagnosis: Calciphylaxis

Histopathology revealed epidermal and dermal necrosis, a perivascular neutrophilic infiltrate, and scattered microcalcifications within small- and medium-sized subcutaneous vessels, consistent with a diagnosis of calciphylaxis (Figure). Calciphylaxis (also known as calcific uremic arteriolopathy) is a rare, severe, and often fatal vasculopathy that predominately occurs in patients with end-stage renal failure.¹ The pathogenesis of calciphylaxis remains poorly understood; however, it generally is thought that an imbalance in calcium homeostasis in susceptible hosts results in the precipitation of calcium phosphate within vessel walls leading to endothelial damage with subsequent thrombotic vasculopathy and ischemic tissue damage. Acquired and congenital hypercoagulable states have been implicated in the pathogenesis of calciphylaxis.²

Treatment of calciphylaxis is directed at normalizing abnormal calcium metabolism; removing possible exacerbating agents, such as warfarin, systemic corticosteroids, calcium, and iron; and transitioning patients with end-stage renal disease to hemodialysis, if not already initiated. The treatment approach is multifaceted, and numerous therapies usually are attempted simultaneously. Vitamin K supplementation, low-calcium dialysate, non–calcium carbonate phosphate binders, cinacalcet, becaplermin, bisphosphonates, hyperbaric oxygen, and intravenous sodium thiosulfate all have been utilized with some success. Currently, intravenous sodium thiosulfate is the mainstay therapy for the treatment of calciphylaxis.² Although the mechanism of sodium thiosulfate is not entirely understood, it is known to have anticalcification, vasodilatory, and antioxidant properties.

Retiform purpura clinically is characterized by reticulated, branching, purpuric skin lesions. It occurs following vascular insult by way of vessel lumen occlusion (thrombotic vasculopathy) and less frequently by vessel wall inflammation (vasculitis). The differential diagnosis for retiform purpura includes various causes of microvascular occlusion, including hypercoagulable states and type I cryoglobulinemia, calciphylaxis, infections, autoimmune vasculitic conditions, and embolic causes.³

Cutaneous disease in individuals with antiphospholipid antibodies may present similarly with retiform purpura in the form of necrotizing livedo reticularis, leg ulcers, or widespread cutaneous necrosis. Histopathologic findings include vascular thrombi with partial or complete obstruction of the small- to medium-sized arteries at the dermoepidermal junction, often in the absence of an inflammatory infiltrate.⁴ True vasculitis is not typical of antiphospholipid syndrome.

Medium vessel vasculitides, such as polyarteritis nodosa, clinically present with livedo reticularis, subcutaneous nodules, and tissue necrosis. Dermatopathologic evaluation of a medium-sized vessel vasculitis would demonstrate a neutrophilic vasculitis involving vessels within the deep dermis and septa of subcutaneous fat.⁵ Tissue sampling should be deep and wide enough to visualize the pathology, as shallow biopsies may show intraluminal thrombi of the superficial dermal plexus only, while a narrow specimen may result in falsenegative findings due to the focal nature of vessel involvement in conditions such as polyarteritis nodosa.

Type I cryoglobulinemia often is a manifestation of plasma cell dyscrasia and commonly presents with Raynaud phenomenon, livedo reticularis, and acrocyanosis of helices⁶ ; pathology demonstrates vessel occlusion and erythrocyte extravasation. In contrast, types II and III, also known as mixed cryoglobulinemia, are associated with hepatitis C and autoimmune connective tissue disease. They clinically present as purpuric plaques and nodules that have a propensity to vesiculate and ulcerate.⁷ Histopathologically, features of leukocytoclastic vasculitis are seen, and direct immunofluorescence demonstrates perivascular granular deposits consisting predominantly of IgM and C3 in the papillary dermis.⁸

Warfarin therapy, particularly in high initial doses, can induce lesions of cutaneous necrosis, which clinically may resemble the appearance of calciphylaxis. Warfarininduced skin necrosis typically occurs 3 to 5 days after the initiation of therapy and is the result of a temporary prothrombotic state.9 The half-life of antithrombotic protein C is shorter than vitamin K–dependent prothrombotic factors II, X, and IX. Early in warfarin treatment, an acquired state of reduced protein C level exists, which can lead to vessel thrombosis and subsequent cutaneous necrosis. Treatment of warfarin-induced skin necrosis involves cessation of warfarin, supplementation with vitamin K to reverse the effects of warfarin, and the initiation of heparin or low-molecular-weight heparin.⁹

The Diagnosis: Calciphylaxis

Histopathology revealed epidermal and dermal necrosis, a perivascular neutrophilic infiltrate, and scattered microcalcifications within small- and medium-sized subcutaneous vessels, consistent with a diagnosis of calciphylaxis (Figure). Calciphylaxis (also known as calcific uremic arteriolopathy) is a rare, severe, and often fatal vasculopathy that predominately occurs in patients with end-stage renal failure.¹ The pathogenesis of calciphylaxis remains poorly understood; however, it generally is thought that an imbalance in calcium homeostasis in susceptible hosts results in the precipitation of calcium phosphate within vessel walls leading to endothelial damage with subsequent thrombotic vasculopathy and ischemic tissue damage. Acquired and congenital hypercoagulable states have been implicated in the pathogenesis of calciphylaxis.²

Treatment of calciphylaxis is directed at normalizing abnormal calcium metabolism; removing possible exacerbating agents, such as warfarin, systemic corticosteroids, calcium, and iron; and transitioning patients with end-stage renal disease to hemodialysis, if not already initiated. The treatment approach is multifaceted, and numerous therapies usually are attempted simultaneously. Vitamin K supplementation, low-calcium dialysate, non–calcium carbonate phosphate binders, cinacalcet, becaplermin, bisphosphonates, hyperbaric oxygen, and intravenous sodium thiosulfate all have been utilized with some success. Currently, intravenous sodium thiosulfate is the mainstay therapy for the treatment of calciphylaxis.² Although the mechanism of sodium thiosulfate is not entirely understood, it is known to have anticalcification, vasodilatory, and antioxidant properties.

Retiform purpura clinically is characterized by reticulated, branching, purpuric skin lesions. It occurs following vascular insult by way of vessel lumen occlusion (thrombotic vasculopathy) and less frequently by vessel wall inflammation (vasculitis). The differential diagnosis for retiform purpura includes various causes of microvascular occlusion, including hypercoagulable states and type I cryoglobulinemia, calciphylaxis, infections, autoimmune vasculitic conditions, and embolic causes.³

Cutaneous disease in individuals with antiphospholipid antibodies may present similarly with retiform purpura in the form of necrotizing livedo reticularis, leg ulcers, or widespread cutaneous necrosis. Histopathologic findings include vascular thrombi with partial or complete obstruction of the small- to medium-sized arteries at the dermoepidermal junction, often in the absence of an inflammatory infiltrate.⁴ True vasculitis is not typical of antiphospholipid syndrome.

Medium vessel vasculitides, such as polyarteritis nodosa, clinically present with livedo reticularis, subcutaneous nodules, and tissue necrosis. Dermatopathologic evaluation of a medium-sized vessel vasculitis would demonstrate a neutrophilic vasculitis involving vessels within the deep dermis and septa of subcutaneous fat.⁵ Tissue sampling should be deep and wide enough to visualize the pathology, as shallow biopsies may show intraluminal thrombi of the superficial dermal plexus only, while a narrow specimen may result in falsenegative findings due to the focal nature of vessel involvement in conditions such as polyarteritis nodosa.

Type I cryoglobulinemia often is a manifestation of plasma cell dyscrasia and commonly presents with Raynaud phenomenon, livedo reticularis, and acrocyanosis of helices⁶ ; pathology demonstrates vessel occlusion and erythrocyte extravasation. In contrast, types II and III, also known as mixed cryoglobulinemia, are associated with hepatitis C and autoimmune connective tissue disease. They clinically present as purpuric plaques and nodules that have a propensity to vesiculate and ulcerate.⁷ Histopathologically, features of leukocytoclastic vasculitis are seen, and direct immunofluorescence demonstrates perivascular granular deposits consisting predominantly of IgM and C3 in the papillary dermis.⁸

Warfarin therapy, particularly in high initial doses, can induce lesions of cutaneous necrosis, which clinically may resemble the appearance of calciphylaxis. Warfarininduced skin necrosis typically occurs 3 to 5 days after the initiation of therapy and is the result of a temporary prothrombotic state.9 The half-life of antithrombotic protein C is shorter than vitamin K–dependent prothrombotic factors II, X, and IX. Early in warfarin treatment, an acquired state of reduced protein C level exists, which can lead to vessel thrombosis and subsequent cutaneous necrosis. Treatment of warfarin-induced skin necrosis involves cessation of warfarin, supplementation with vitamin K to reverse the effects of warfarin, and the initiation of heparin or low-molecular-weight heparin.⁹

The Diagnosis: Calciphylaxis

Histopathology revealed epidermal and dermal necrosis, a perivascular neutrophilic infiltrate, and scattered microcalcifications within small- and medium-sized subcutaneous vessels, consistent with a diagnosis of calciphylaxis (Figure). Calciphylaxis (also known as calcific uremic arteriolopathy) is a rare, severe, and often fatal vasculopathy that predominately occurs in patients with end-stage renal failure.¹ The pathogenesis of calciphylaxis remains poorly understood; however, it generally is thought that an imbalance in calcium homeostasis in susceptible hosts results in the precipitation of calcium phosphate within vessel walls leading to endothelial damage with subsequent thrombotic vasculopathy and ischemic tissue damage. Acquired and congenital hypercoagulable states have been implicated in the pathogenesis of calciphylaxis.²

Treatment of calciphylaxis is directed at normalizing abnormal calcium metabolism; removing possible exacerbating agents, such as warfarin, systemic corticosteroids, calcium, and iron; and transitioning patients with end-stage renal disease to hemodialysis, if not already initiated. The treatment approach is multifaceted, and numerous therapies usually are attempted simultaneously. Vitamin K supplementation, low-calcium dialysate, non–calcium carbonate phosphate binders, cinacalcet, becaplermin, bisphosphonates, hyperbaric oxygen, and intravenous sodium thiosulfate all have been utilized with some success. Currently, intravenous sodium thiosulfate is the mainstay therapy for the treatment of calciphylaxis.² Although the mechanism of sodium thiosulfate is not entirely understood, it is known to have anticalcification, vasodilatory, and antioxidant properties.

Retiform purpura clinically is characterized by reticulated, branching, purpuric skin lesions. It occurs following vascular insult by way of vessel lumen occlusion (thrombotic vasculopathy) and less frequently by vessel wall inflammation (vasculitis). The differential diagnosis for retiform purpura includes various causes of microvascular occlusion, including hypercoagulable states and type I cryoglobulinemia, calciphylaxis, infections, autoimmune vasculitic conditions, and embolic causes.³

Cutaneous disease in individuals with antiphospholipid antibodies may present similarly with retiform purpura in the form of necrotizing livedo reticularis, leg ulcers, or widespread cutaneous necrosis. Histopathologic findings include vascular thrombi with partial or complete obstruction of the small- to medium-sized arteries at the dermoepidermal junction, often in the absence of an inflammatory infiltrate.⁴ True vasculitis is not typical of antiphospholipid syndrome.

Medium vessel vasculitides, such as polyarteritis nodosa, clinically present with livedo reticularis, subcutaneous nodules, and tissue necrosis. Dermatopathologic evaluation of a medium-sized vessel vasculitis would demonstrate a neutrophilic vasculitis involving vessels within the deep dermis and septa of subcutaneous fat.⁵ Tissue sampling should be deep and wide enough to visualize the pathology, as shallow biopsies may show intraluminal thrombi of the superficial dermal plexus only, while a narrow specimen may result in falsenegative findings due to the focal nature of vessel involvement in conditions such as polyarteritis nodosa.

Type I cryoglobulinemia often is a manifestation of plasma cell dyscrasia and commonly presents with Raynaud phenomenon, livedo reticularis, and acrocyanosis of helices⁶ ; pathology demonstrates vessel occlusion and erythrocyte extravasation. In contrast, types II and III, also known as mixed cryoglobulinemia, are associated with hepatitis C and autoimmune connective tissue disease. They clinically present as purpuric plaques and nodules that have a propensity to vesiculate and ulcerate.⁷ Histopathologically, features of leukocytoclastic vasculitis are seen, and direct immunofluorescence demonstrates perivascular granular deposits consisting predominantly of IgM and C3 in the papillary dermis.⁸

Warfarin therapy, particularly in high initial doses, can induce lesions of cutaneous necrosis, which clinically may resemble the appearance of calciphylaxis. Warfarininduced skin necrosis typically occurs 3 to 5 days after the initiation of therapy and is the result of a temporary prothrombotic state.9 The half-life of antithrombotic protein C is shorter than vitamin K–dependent prothrombotic factors II, X, and IX. Early in warfarin treatment, an acquired state of reduced protein C level exists, which can lead to vessel thrombosis and subsequent cutaneous necrosis. Treatment of warfarin-induced skin necrosis involves cessation of warfarin, supplementation with vitamin K to reverse the effects of warfarin, and the initiation of heparin or low-molecular-weight heparin.⁹