TOPLINE:

Doxorubicin increases the risk for breast cancer in women with Hodgkin lymphoma, suggesting the need for increased surveillance.

METHODOLOGY:

• Doxorubicin is a mainstay of Hodgkin lymphoma treatment.
• Studies suggest that girls with Hodgkin lymphoma who receive doxorubicin have a higher risk for breast cancer later in life, but it is unclear if women treated as adults face that same risk.
• To find out, investigators reviewed breast cancer incidence in 1964 Dutch women, ages 15-50, who were treated for Hodgkin lymphoma from 1975 to 2008.
• Patients had survived for at least 5 years, and 57% received doxorubicin.

TAKEAWAY:

• Women treated with doxorubicin had a 40% higher risk for breast cancer, and that risk was independent of age of treatment, receipt of chest radiation, and the use of gonadotoxic agents.
• The risk for breast cancer with doxorubicin was dose-dependent, with each 100 mg/m2 dose increment increasing the risk by 18%.
• The findings held whether women were treated years ago or more recently, despite the evolution of treatment strategies for Hodgkin lymphoma.
• After 30 years of follow-up, nearly one in five survivors (20.8%) developed breast cancer. It took 20 years for the elevated risk for breast cancer following treatment with doxorubicin to emerge.

IN PRACTICE:

The study suggests that adolescent and adult women survivors of Hodgkin lymphoma who received doxorubicin have an increased risk for breast cancer, and this risk is independent of age at first Hodgkin lymphoma treatment, receipt of chest radiotherapy, and gonadotoxic treatment, the authors concluded. “Our results have implications for [breast cancer] surveillance guidelines for [Hodgkin lymphoma] survivors and treatment strategies for patients with newly diagnosed” Hodgkin lymphoma.

SOURCE:

The study, led by Suzanne Neppelenbroek of the Netherlands Cancer Institute, Amsterdam, was published February 15 in the Journal of Clinical Oncology. 

LIMITATIONS:

Recruitment ended in 2008 before the advent of newer treatments such as antibody-drug conjugates and immune checkpoint inhibitors.

DISCLOSURES:

The work was funded by the Dutch Cancer Society. Several authors reported ties to Lilly, AbbVie, Amgen, and other companies.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Doxorubicin increases the risk for breast cancer in women with Hodgkin lymphoma, suggesting the need for increased surveillance.

METHODOLOGY:

• Doxorubicin is a mainstay of Hodgkin lymphoma treatment.
• Studies suggest that girls with Hodgkin lymphoma who receive doxorubicin have a higher risk for breast cancer later in life, but it is unclear if women treated as adults face that same risk.
• To find out, investigators reviewed breast cancer incidence in 1964 Dutch women, ages 15-50, who were treated for Hodgkin lymphoma from 1975 to 2008.
• Patients had survived for at least 5 years, and 57% received doxorubicin.

TAKEAWAY:

• Women treated with doxorubicin had a 40% higher risk for breast cancer, and that risk was independent of age of treatment, receipt of chest radiation, and the use of gonadotoxic agents.
• The risk for breast cancer with doxorubicin was dose-dependent, with each 100 mg/m2 dose increment increasing the risk by 18%.
• The findings held whether women were treated years ago or more recently, despite the evolution of treatment strategies for Hodgkin lymphoma.
• After 30 years of follow-up, nearly one in five survivors (20.8%) developed breast cancer. It took 20 years for the elevated risk for breast cancer following treatment with doxorubicin to emerge.

IN PRACTICE:

The study suggests that adolescent and adult women survivors of Hodgkin lymphoma who received doxorubicin have an increased risk for breast cancer, and this risk is independent of age at first Hodgkin lymphoma treatment, receipt of chest radiotherapy, and gonadotoxic treatment, the authors concluded. “Our results have implications for [breast cancer] surveillance guidelines for [Hodgkin lymphoma] survivors and treatment strategies for patients with newly diagnosed” Hodgkin lymphoma.

SOURCE:

The study, led by Suzanne Neppelenbroek of the Netherlands Cancer Institute, Amsterdam, was published February 15 in the Journal of Clinical Oncology. 

LIMITATIONS:

Recruitment ended in 2008 before the advent of newer treatments such as antibody-drug conjugates and immune checkpoint inhibitors.

DISCLOSURES:

The work was funded by the Dutch Cancer Society. Several authors reported ties to Lilly, AbbVie, Amgen, and other companies.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Doxorubicin increases the risk for breast cancer in women with Hodgkin lymphoma, suggesting the need for increased surveillance.

METHODOLOGY:

• Doxorubicin is a mainstay of Hodgkin lymphoma treatment.
• Studies suggest that girls with Hodgkin lymphoma who receive doxorubicin have a higher risk for breast cancer later in life, but it is unclear if women treated as adults face that same risk.
• To find out, investigators reviewed breast cancer incidence in 1964 Dutch women, ages 15-50, who were treated for Hodgkin lymphoma from 1975 to 2008.
• Patients had survived for at least 5 years, and 57% received doxorubicin.

TAKEAWAY:

• Women treated with doxorubicin had a 40% higher risk for breast cancer, and that risk was independent of age of treatment, receipt of chest radiation, and the use of gonadotoxic agents.
• The risk for breast cancer with doxorubicin was dose-dependent, with each 100 mg/m2 dose increment increasing the risk by 18%.
• The findings held whether women were treated years ago or more recently, despite the evolution of treatment strategies for Hodgkin lymphoma.
• After 30 years of follow-up, nearly one in five survivors (20.8%) developed breast cancer. It took 20 years for the elevated risk for breast cancer following treatment with doxorubicin to emerge.

IN PRACTICE:

The study suggests that adolescent and adult women survivors of Hodgkin lymphoma who received doxorubicin have an increased risk for breast cancer, and this risk is independent of age at first Hodgkin lymphoma treatment, receipt of chest radiotherapy, and gonadotoxic treatment, the authors concluded. “Our results have implications for [breast cancer] surveillance guidelines for [Hodgkin lymphoma] survivors and treatment strategies for patients with newly diagnosed” Hodgkin lymphoma.

SOURCE:

The study, led by Suzanne Neppelenbroek of the Netherlands Cancer Institute, Amsterdam, was published February 15 in the Journal of Clinical Oncology. 

LIMITATIONS:

Recruitment ended in 2008 before the advent of newer treatments such as antibody-drug conjugates and immune checkpoint inhibitors.

DISCLOSURES:

The work was funded by the Dutch Cancer Society. Several authors reported ties to Lilly, AbbVie, Amgen, and other companies.
 

A version of this article appeared on Medscape.com.

Will the new US Department of Veterans Affairs (VA) pharmacy software be safe and effective? That was the topic when David Case, the VA Deputy Inspector General, spoke in the US House of Representatives Veterans Affairs Committee technology modernization subcommittee hearing on February 15.

Questions like that have dogged the project since 2018, when the VA began rolling out the Oracle Cerner electronic health record (EHR) system as the successor to ViSTA.

The Oracle system has been beset by one glitch after another since its arrival. And in that time, Case said, the VA Office of Inspector General (OIG) has been engaging with VA employees at sites in Washington, Oregon, Ohio, Illinois, and other locations where the modernization program has been piloted.

The most recent OIG investigation of pharmacy-related patient safety issues began with a review of an allegation of a prescription backlog at Columbus, Ohio, where the system went live on April 30, 2022. The OIG found that facility leaders took “timely and sustainable steps” to manage that issue. However, other unresolved patient safety issues came to light, such as medication inaccuracies, inaccurate medication data, and insufficient staffing. The OIG also found staff were creating “numerous work arounds” to provide patient care, and that the volume of staff educational materials for pharmacy-related functions was “overwhelming.”

Those problems were just the latest in a long queue. In May 2021, after the first VA deployment of the new EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, a pharmacy patient safety team under the VA National Center for Patient Safety (NCPS) also had identified patient safety issues and “multiple” concerns regarding the system’s usability. For example, updates to a patient’s active medication list were not routinely reflected at the patient’s next appointment. Despite knowing about such challenges, Case noted in his report, VA leaders deployed the new EHR at 4 more VA medical centers.

Cerner/ViSTA Communication

One major cause of the current problems is the way the systems “talk” to each other. EHR information is communicated between VHA facilities through channels that include the Joint Longitudinal Viewer (JLV) and the Health Data Repository, which stores patient-specific clinical information from both the legacy and the new EHR systems. The JLV application allows clinicians to access a read only version of a patient’s EHR from both systems.

Every medication used in VHA has a VA Unique Identifier (VUID). When a patient is prescribed a medication at a new EHR site, that medication’s VUID is sent to the Health Data Repository. If that patient seeks care from a legacy health care practitioner (HCP), and that HCP enters a medication order, a software interface accesses the VUID from the Health Data Repository to verify that the medication being prescribed is safe and compatible with the medications and allergies previously documented in the patient’s record.

However, on March 31, 2023, staff from a ViSTA site found an incorrect medication order when prescribing a new medication to a patient who had received care and medications at a new EHR site. This in turn led to the discovery that an error in Oracle software coding had resulted in the “widespread transmission” of incorrect VUIDs from new EHR sites to legacy EHR sites, the OIG found. VA leaders and HCPs were notified of the potential clinical impact and were given specific instructions on how to mitigate the issue. They were asked to “please share widely.”

On top of that, days later, patient safety managers across the Veterans Health Administration (VHA) were told that drug-to-drug interactions, duplicate medication orders, and allergy checks were not functioning as expected, and they too were provided with remedial actions.

Oracle applied a successful software patch on in April 2023, to ensure accurate VUIDs were attached to all mail order pharmacy–processed prescriptions from that date forward. However, the OIG learned the incorrect VUIDs sent from new EHR sites and stored in the Health Data Repository from as far back as October 2020 had not been corrected. Case told the subcommittee that on November 29, 2023, the VHA Pharmacy Council reported withdrawing a request for Oracle to send corrected medication VUID data to the Health Data Repository, on the presumption that remaining inaccurate VUIDs would expire in early April 2024, and the data would be corrected at that time.

The OIG is concerned, Case said, that patient medication data remains inaccurate almost a year after VA learned of the issue. The mail order pharmacy-related data generated from approximately 120,000 patients served by new EHR sites are still incorrect. These patients face an ongoing risk of an adverse medication-related event if they receive care and medications from a VA medical center using the legacy EHR system.

The OIG also learned of other problems associated with transmission of medication and allergy information, which could have consequences such as:

• Patient medications being discontinued or stopped by new HCPs using Cerner that appear in ViSTA as active and current prescriptions;
• Allergy-warning messages not appearing when intended or inappropriately appearing for the wrong medication;
• Duplicate medication order checks not appearing when intended or inappropriately appearing for the wrong drug;
• Patient active medication lists having incomplete or inaccurate information, such as missing prescriptions, duplicate prescriptions, or incorrect medication order statuses.

The OIG warned VHA employees about the risks, although it wasn’t possible to determine who might actually be at risk. A VHA leader told the OIG that all patients who have been prescribed any medications or have medication allergies documented at a at a Cerner site are at risk. That could mean as many as 250,000 patients: As of September 2023, approximately 190,000 patients had a medication prescribed and 126,000 had an allergy documented at a new EHR site.

Case Example

Not surprisingly, “the OIG is not confident in [EHRM-Integration Office] leaders’ oversight and control of the new systems’ Health Data Repository interface programming,” Case said. He cited the case of a patient with posttraumatic stress disorder and traumatic brain injury with adrenal insufficiency. Four days prior to admission, a ViSTA site pharmacist used the EHR to perform a medication reconciliation for the patient. The data available did not include the patient’s most recent prednisone prescription, which had been ordered by an HCP at a facility using Cerner.

A nurse practitioner performed another reconciliation when the patient was admitted to the residential program, but the patient was unsure of all their medications. Because the most recent prednisone prescription was not visible in ViSTA, the prednisone appeared to have been completed at least 3 months prior to admission and was therefore not prescribed in the admission medication orders.

Five days into the residential program, the patient began exhibiting unusual behaviors associated with the lack of prednisone. The patient realized they needed more prednisone, but the nurse explained there was no prednisone on the patient’s medication list. Eventually, the patient found the active prednisone order on their personal cell phone and was transferred to a local emergency department for care.

Work Arounds

The VHA’s efforts to forestall or mitigate system errors have in some cases had a cascade effect. For example, HCPs must essentially back up what the automated software is intended to do, with “complex, time-consuming” multistep manual safety checks when prescribing new medications for patients previously cared for at a Cerner site. The OIG is concerned that this increased vigilance is “unsustainable” by pharmacists and frontline staff and could lead to burnout and medication-related patient safety events. After the new EHR launched, the OIG found, burnout symptoms for pharmacy staff increased. Nonetheless, Case told the committee, OIG staff “have observed [employees’] unwavering commitment to prioritizing the care of patients while mitigating implementation challenges.”

EHR-related workload burdens have necessitated other adjustments. Columbus, for instance, hired 9 full-time clinical pharmacists—a 62% staffing increase—to help reduce the backlog. Pharmacy leaders created approximately 29 additional work-arounds to support pharmacy staff and prevent delays. Facility pharmacy leaders also developed approximately 25 educational materials, such as tip sheets, reference guides, and job aids. The OIG’s concern—apart from the overwhelming amount of information for staff to implement—is that such prophylactic measures may in fact give rise to inconsistent practices, which increase risks to patient safety.

Committed to Working With the VA

Mike Sicilia, executive vice president of Oracle Corporation, told lawmakers in the hearing, “After the initial deployments, it became clear that the pharmacy system needed to be enhanced to better meet VA’s needs. To that end, in August 2022, shortly after Oracle completed its acquisition of Cerner, VA contracted with us for seven enhancements that overall would adapt the pharmacy system to a more bidirectional system between VA providers placing prescription orders and VA pharmacists fulfilling and dispensing them.” Those enhancements are all live for VA providers and pharmacists to use now, he said, except for one that is undergoing additional testing.

He added, “As with any healthcare technology system, there is a need for continuous improvements but that does not mean the system is not safe and effective in its current state. Oracle is committed to working with VA … throughout the reset period to identify workflows and other items that can be simplified or streamlined to improve the overall user and pharmacy experience.”

Standardizing workflows and ensuring training and communications to pharmacists about the latest updates will discourage use of work-arounds, Sicilia said, and “help with improving morale and satisfaction with the system.” During a visit in early February by VA and the Oracle team to the Lovell Federal Health Care Center in North Chicago, “feedback from pharmacists was positive about the training and readiness for using the new pharmacy system.”

The backlog, at least, may be resolved. Sicilia said on average more than 215,000 outpatient prescriptions are being filled each month. “The current live sites do not have a backlog in filling prescriptions. Recent data from this month show that three of the five live sites have zero prescriptions waiting to be processed that are older than seven days. The two other live sites have an average of two prescriptions older than seven days,” he said.

Although Oracle Health has since resolved some of the identified issues, the OIG is concerned that the new EHR will continue to be deployed at medical facilities despite “myriad” as-yet unresolved issues related to inaccurate medication ordering, reconciliation, and dispensing. The VHA has paused Cerner deployments multiple times.

“It is unclear whether identified problems are being adequately resolved before additional deployments,” Case said. “There is also the question of whether there is sufficient transparency and communication among EHRM-IO, VHA and facility leaders, VA leaders, and Oracle Health needed for quality control and critical coordination. Trust in VA is also dependent on patients being fully and quickly advised when issues affecting them are identified and addressed. As VA moves toward its deployment next month at a complex facility jointly operated with the Department of Defense, transparency, communication, and program management will be essential to getting it right. Failures in these areas risk cascading problems.”

Will the new US Department of Veterans Affairs (VA) pharmacy software be safe and effective? That was the topic when David Case, the VA Deputy Inspector General, spoke in the US House of Representatives Veterans Affairs Committee technology modernization subcommittee hearing on February 15.

Questions like that have dogged the project since 2018, when the VA began rolling out the Oracle Cerner electronic health record (EHR) system as the successor to ViSTA.

The Oracle system has been beset by one glitch after another since its arrival. And in that time, Case said, the VA Office of Inspector General (OIG) has been engaging with VA employees at sites in Washington, Oregon, Ohio, Illinois, and other locations where the modernization program has been piloted.

The most recent OIG investigation of pharmacy-related patient safety issues began with a review of an allegation of a prescription backlog at Columbus, Ohio, where the system went live on April 30, 2022. The OIG found that facility leaders took “timely and sustainable steps” to manage that issue. However, other unresolved patient safety issues came to light, such as medication inaccuracies, inaccurate medication data, and insufficient staffing. The OIG also found staff were creating “numerous work arounds” to provide patient care, and that the volume of staff educational materials for pharmacy-related functions was “overwhelming.”

Those problems were just the latest in a long queue. In May 2021, after the first VA deployment of the new EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, a pharmacy patient safety team under the VA National Center for Patient Safety (NCPS) also had identified patient safety issues and “multiple” concerns regarding the system’s usability. For example, updates to a patient’s active medication list were not routinely reflected at the patient’s next appointment. Despite knowing about such challenges, Case noted in his report, VA leaders deployed the new EHR at 4 more VA medical centers.

Cerner/ViSTA Communication

One major cause of the current problems is the way the systems “talk” to each other. EHR information is communicated between VHA facilities through channels that include the Joint Longitudinal Viewer (JLV) and the Health Data Repository, which stores patient-specific clinical information from both the legacy and the new EHR systems. The JLV application allows clinicians to access a read only version of a patient’s EHR from both systems.

Every medication used in VHA has a VA Unique Identifier (VUID). When a patient is prescribed a medication at a new EHR site, that medication’s VUID is sent to the Health Data Repository. If that patient seeks care from a legacy health care practitioner (HCP), and that HCP enters a medication order, a software interface accesses the VUID from the Health Data Repository to verify that the medication being prescribed is safe and compatible with the medications and allergies previously documented in the patient’s record.

However, on March 31, 2023, staff from a ViSTA site found an incorrect medication order when prescribing a new medication to a patient who had received care and medications at a new EHR site. This in turn led to the discovery that an error in Oracle software coding had resulted in the “widespread transmission” of incorrect VUIDs from new EHR sites to legacy EHR sites, the OIG found. VA leaders and HCPs were notified of the potential clinical impact and were given specific instructions on how to mitigate the issue. They were asked to “please share widely.”

On top of that, days later, patient safety managers across the Veterans Health Administration (VHA) were told that drug-to-drug interactions, duplicate medication orders, and allergy checks were not functioning as expected, and they too were provided with remedial actions.

Oracle applied a successful software patch on in April 2023, to ensure accurate VUIDs were attached to all mail order pharmacy–processed prescriptions from that date forward. However, the OIG learned the incorrect VUIDs sent from new EHR sites and stored in the Health Data Repository from as far back as October 2020 had not been corrected. Case told the subcommittee that on November 29, 2023, the VHA Pharmacy Council reported withdrawing a request for Oracle to send corrected medication VUID data to the Health Data Repository, on the presumption that remaining inaccurate VUIDs would expire in early April 2024, and the data would be corrected at that time.

The OIG is concerned, Case said, that patient medication data remains inaccurate almost a year after VA learned of the issue. The mail order pharmacy-related data generated from approximately 120,000 patients served by new EHR sites are still incorrect. These patients face an ongoing risk of an adverse medication-related event if they receive care and medications from a VA medical center using the legacy EHR system.

The OIG also learned of other problems associated with transmission of medication and allergy information, which could have consequences such as:

• Patient medications being discontinued or stopped by new HCPs using Cerner that appear in ViSTA as active and current prescriptions;
• Allergy-warning messages not appearing when intended or inappropriately appearing for the wrong medication;
• Duplicate medication order checks not appearing when intended or inappropriately appearing for the wrong drug;
• Patient active medication lists having incomplete or inaccurate information, such as missing prescriptions, duplicate prescriptions, or incorrect medication order statuses.

The OIG warned VHA employees about the risks, although it wasn’t possible to determine who might actually be at risk. A VHA leader told the OIG that all patients who have been prescribed any medications or have medication allergies documented at a at a Cerner site are at risk. That could mean as many as 250,000 patients: As of September 2023, approximately 190,000 patients had a medication prescribed and 126,000 had an allergy documented at a new EHR site.

Case Example

Not surprisingly, “the OIG is not confident in [EHRM-Integration Office] leaders’ oversight and control of the new systems’ Health Data Repository interface programming,” Case said. He cited the case of a patient with posttraumatic stress disorder and traumatic brain injury with adrenal insufficiency. Four days prior to admission, a ViSTA site pharmacist used the EHR to perform a medication reconciliation for the patient. The data available did not include the patient’s most recent prednisone prescription, which had been ordered by an HCP at a facility using Cerner.

A nurse practitioner performed another reconciliation when the patient was admitted to the residential program, but the patient was unsure of all their medications. Because the most recent prednisone prescription was not visible in ViSTA, the prednisone appeared to have been completed at least 3 months prior to admission and was therefore not prescribed in the admission medication orders.

Five days into the residential program, the patient began exhibiting unusual behaviors associated with the lack of prednisone. The patient realized they needed more prednisone, but the nurse explained there was no prednisone on the patient’s medication list. Eventually, the patient found the active prednisone order on their personal cell phone and was transferred to a local emergency department for care.

Work Arounds

The VHA’s efforts to forestall or mitigate system errors have in some cases had a cascade effect. For example, HCPs must essentially back up what the automated software is intended to do, with “complex, time-consuming” multistep manual safety checks when prescribing new medications for patients previously cared for at a Cerner site. The OIG is concerned that this increased vigilance is “unsustainable” by pharmacists and frontline staff and could lead to burnout and medication-related patient safety events. After the new EHR launched, the OIG found, burnout symptoms for pharmacy staff increased. Nonetheless, Case told the committee, OIG staff “have observed [employees’] unwavering commitment to prioritizing the care of patients while mitigating implementation challenges.”

EHR-related workload burdens have necessitated other adjustments. Columbus, for instance, hired 9 full-time clinical pharmacists—a 62% staffing increase—to help reduce the backlog. Pharmacy leaders created approximately 29 additional work-arounds to support pharmacy staff and prevent delays. Facility pharmacy leaders also developed approximately 25 educational materials, such as tip sheets, reference guides, and job aids. The OIG’s concern—apart from the overwhelming amount of information for staff to implement—is that such prophylactic measures may in fact give rise to inconsistent practices, which increase risks to patient safety.

Committed to Working With the VA

Mike Sicilia, executive vice president of Oracle Corporation, told lawmakers in the hearing, “After the initial deployments, it became clear that the pharmacy system needed to be enhanced to better meet VA’s needs. To that end, in August 2022, shortly after Oracle completed its acquisition of Cerner, VA contracted with us for seven enhancements that overall would adapt the pharmacy system to a more bidirectional system between VA providers placing prescription orders and VA pharmacists fulfilling and dispensing them.” Those enhancements are all live for VA providers and pharmacists to use now, he said, except for one that is undergoing additional testing.

He added, “As with any healthcare technology system, there is a need for continuous improvements but that does not mean the system is not safe and effective in its current state. Oracle is committed to working with VA … throughout the reset period to identify workflows and other items that can be simplified or streamlined to improve the overall user and pharmacy experience.”

Standardizing workflows and ensuring training and communications to pharmacists about the latest updates will discourage use of work-arounds, Sicilia said, and “help with improving morale and satisfaction with the system.” During a visit in early February by VA and the Oracle team to the Lovell Federal Health Care Center in North Chicago, “feedback from pharmacists was positive about the training and readiness for using the new pharmacy system.”

The backlog, at least, may be resolved. Sicilia said on average more than 215,000 outpatient prescriptions are being filled each month. “The current live sites do not have a backlog in filling prescriptions. Recent data from this month show that three of the five live sites have zero prescriptions waiting to be processed that are older than seven days. The two other live sites have an average of two prescriptions older than seven days,” he said.

Although Oracle Health has since resolved some of the identified issues, the OIG is concerned that the new EHR will continue to be deployed at medical facilities despite “myriad” as-yet unresolved issues related to inaccurate medication ordering, reconciliation, and dispensing. The VHA has paused Cerner deployments multiple times.

“It is unclear whether identified problems are being adequately resolved before additional deployments,” Case said. “There is also the question of whether there is sufficient transparency and communication among EHRM-IO, VHA and facility leaders, VA leaders, and Oracle Health needed for quality control and critical coordination. Trust in VA is also dependent on patients being fully and quickly advised when issues affecting them are identified and addressed. As VA moves toward its deployment next month at a complex facility jointly operated with the Department of Defense, transparency, communication, and program management will be essential to getting it right. Failures in these areas risk cascading problems.”

Will the new US Department of Veterans Affairs (VA) pharmacy software be safe and effective? That was the topic when David Case, the VA Deputy Inspector General, spoke in the US House of Representatives Veterans Affairs Committee technology modernization subcommittee hearing on February 15.

Questions like that have dogged the project since 2018, when the VA began rolling out the Oracle Cerner electronic health record (EHR) system as the successor to ViSTA.

The Oracle system has been beset by one glitch after another since its arrival. And in that time, Case said, the VA Office of Inspector General (OIG) has been engaging with VA employees at sites in Washington, Oregon, Ohio, Illinois, and other locations where the modernization program has been piloted.

The most recent OIG investigation of pharmacy-related patient safety issues began with a review of an allegation of a prescription backlog at Columbus, Ohio, where the system went live on April 30, 2022. The OIG found that facility leaders took “timely and sustainable steps” to manage that issue. However, other unresolved patient safety issues came to light, such as medication inaccuracies, inaccurate medication data, and insufficient staffing. The OIG also found staff were creating “numerous work arounds” to provide patient care, and that the volume of staff educational materials for pharmacy-related functions was “overwhelming.”

Those problems were just the latest in a long queue. In May 2021, after the first VA deployment of the new EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, a pharmacy patient safety team under the VA National Center for Patient Safety (NCPS) also had identified patient safety issues and “multiple” concerns regarding the system’s usability. For example, updates to a patient’s active medication list were not routinely reflected at the patient’s next appointment. Despite knowing about such challenges, Case noted in his report, VA leaders deployed the new EHR at 4 more VA medical centers.

Cerner/ViSTA Communication

One major cause of the current problems is the way the systems “talk” to each other. EHR information is communicated between VHA facilities through channels that include the Joint Longitudinal Viewer (JLV) and the Health Data Repository, which stores patient-specific clinical information from both the legacy and the new EHR systems. The JLV application allows clinicians to access a read only version of a patient’s EHR from both systems.

Every medication used in VHA has a VA Unique Identifier (VUID). When a patient is prescribed a medication at a new EHR site, that medication’s VUID is sent to the Health Data Repository. If that patient seeks care from a legacy health care practitioner (HCP), and that HCP enters a medication order, a software interface accesses the VUID from the Health Data Repository to verify that the medication being prescribed is safe and compatible with the medications and allergies previously documented in the patient’s record.

However, on March 31, 2023, staff from a ViSTA site found an incorrect medication order when prescribing a new medication to a patient who had received care and medications at a new EHR site. This in turn led to the discovery that an error in Oracle software coding had resulted in the “widespread transmission” of incorrect VUIDs from new EHR sites to legacy EHR sites, the OIG found. VA leaders and HCPs were notified of the potential clinical impact and were given specific instructions on how to mitigate the issue. They were asked to “please share widely.”

On top of that, days later, patient safety managers across the Veterans Health Administration (VHA) were told that drug-to-drug interactions, duplicate medication orders, and allergy checks were not functioning as expected, and they too were provided with remedial actions.

Oracle applied a successful software patch on in April 2023, to ensure accurate VUIDs were attached to all mail order pharmacy–processed prescriptions from that date forward. However, the OIG learned the incorrect VUIDs sent from new EHR sites and stored in the Health Data Repository from as far back as October 2020 had not been corrected. Case told the subcommittee that on November 29, 2023, the VHA Pharmacy Council reported withdrawing a request for Oracle to send corrected medication VUID data to the Health Data Repository, on the presumption that remaining inaccurate VUIDs would expire in early April 2024, and the data would be corrected at that time.

The OIG is concerned, Case said, that patient medication data remains inaccurate almost a year after VA learned of the issue. The mail order pharmacy-related data generated from approximately 120,000 patients served by new EHR sites are still incorrect. These patients face an ongoing risk of an adverse medication-related event if they receive care and medications from a VA medical center using the legacy EHR system.

The OIG also learned of other problems associated with transmission of medication and allergy information, which could have consequences such as:

• Patient medications being discontinued or stopped by new HCPs using Cerner that appear in ViSTA as active and current prescriptions;
• Allergy-warning messages not appearing when intended or inappropriately appearing for the wrong medication;
• Duplicate medication order checks not appearing when intended or inappropriately appearing for the wrong drug;
• Patient active medication lists having incomplete or inaccurate information, such as missing prescriptions, duplicate prescriptions, or incorrect medication order statuses.

The OIG warned VHA employees about the risks, although it wasn’t possible to determine who might actually be at risk. A VHA leader told the OIG that all patients who have been prescribed any medications or have medication allergies documented at a at a Cerner site are at risk. That could mean as many as 250,000 patients: As of September 2023, approximately 190,000 patients had a medication prescribed and 126,000 had an allergy documented at a new EHR site.

Case Example

Not surprisingly, “the OIG is not confident in [EHRM-Integration Office] leaders’ oversight and control of the new systems’ Health Data Repository interface programming,” Case said. He cited the case of a patient with posttraumatic stress disorder and traumatic brain injury with adrenal insufficiency. Four days prior to admission, a ViSTA site pharmacist used the EHR to perform a medication reconciliation for the patient. The data available did not include the patient’s most recent prednisone prescription, which had been ordered by an HCP at a facility using Cerner.

A nurse practitioner performed another reconciliation when the patient was admitted to the residential program, but the patient was unsure of all their medications. Because the most recent prednisone prescription was not visible in ViSTA, the prednisone appeared to have been completed at least 3 months prior to admission and was therefore not prescribed in the admission medication orders.

Five days into the residential program, the patient began exhibiting unusual behaviors associated with the lack of prednisone. The patient realized they needed more prednisone, but the nurse explained there was no prednisone on the patient’s medication list. Eventually, the patient found the active prednisone order on their personal cell phone and was transferred to a local emergency department for care.

Work Arounds

The VHA’s efforts to forestall or mitigate system errors have in some cases had a cascade effect. For example, HCPs must essentially back up what the automated software is intended to do, with “complex, time-consuming” multistep manual safety checks when prescribing new medications for patients previously cared for at a Cerner site. The OIG is concerned that this increased vigilance is “unsustainable” by pharmacists and frontline staff and could lead to burnout and medication-related patient safety events. After the new EHR launched, the OIG found, burnout symptoms for pharmacy staff increased. Nonetheless, Case told the committee, OIG staff “have observed [employees’] unwavering commitment to prioritizing the care of patients while mitigating implementation challenges.”

EHR-related workload burdens have necessitated other adjustments. Columbus, for instance, hired 9 full-time clinical pharmacists—a 62% staffing increase—to help reduce the backlog. Pharmacy leaders created approximately 29 additional work-arounds to support pharmacy staff and prevent delays. Facility pharmacy leaders also developed approximately 25 educational materials, such as tip sheets, reference guides, and job aids. The OIG’s concern—apart from the overwhelming amount of information for staff to implement—is that such prophylactic measures may in fact give rise to inconsistent practices, which increase risks to patient safety.

Committed to Working With the VA

Mike Sicilia, executive vice president of Oracle Corporation, told lawmakers in the hearing, “After the initial deployments, it became clear that the pharmacy system needed to be enhanced to better meet VA’s needs. To that end, in August 2022, shortly after Oracle completed its acquisition of Cerner, VA contracted with us for seven enhancements that overall would adapt the pharmacy system to a more bidirectional system between VA providers placing prescription orders and VA pharmacists fulfilling and dispensing them.” Those enhancements are all live for VA providers and pharmacists to use now, he said, except for one that is undergoing additional testing.

He added, “As with any healthcare technology system, there is a need for continuous improvements but that does not mean the system is not safe and effective in its current state. Oracle is committed to working with VA … throughout the reset period to identify workflows and other items that can be simplified or streamlined to improve the overall user and pharmacy experience.”

Standardizing workflows and ensuring training and communications to pharmacists about the latest updates will discourage use of work-arounds, Sicilia said, and “help with improving morale and satisfaction with the system.” During a visit in early February by VA and the Oracle team to the Lovell Federal Health Care Center in North Chicago, “feedback from pharmacists was positive about the training and readiness for using the new pharmacy system.”

The backlog, at least, may be resolved. Sicilia said on average more than 215,000 outpatient prescriptions are being filled each month. “The current live sites do not have a backlog in filling prescriptions. Recent data from this month show that three of the five live sites have zero prescriptions waiting to be processed that are older than seven days. The two other live sites have an average of two prescriptions older than seven days,” he said.

Although Oracle Health has since resolved some of the identified issues, the OIG is concerned that the new EHR will continue to be deployed at medical facilities despite “myriad” as-yet unresolved issues related to inaccurate medication ordering, reconciliation, and dispensing. The VHA has paused Cerner deployments multiple times.

“It is unclear whether identified problems are being adequately resolved before additional deployments,” Case said. “There is also the question of whether there is sufficient transparency and communication among EHRM-IO, VHA and facility leaders, VA leaders, and Oracle Health needed for quality control and critical coordination. Trust in VA is also dependent on patients being fully and quickly advised when issues affecting them are identified and addressed. As VA moves toward its deployment next month at a complex facility jointly operated with the Department of Defense, transparency, communication, and program management will be essential to getting it right. Failures in these areas risk cascading problems.”

An important comorbidity of PsA is vascular inflammation leading to accelerated atherosclerosis, and higher risk for cardiovascular and cerebrovascular disease. Previously, vascular imaging modalities have demonstrated vascular inflammation in PsA. In a cross-sectional study that included 75 patients with active PsA and 40 control individuals without PsA, Kleinrensink and colleagues demonstrated that vascular inflammation of the whole aorta was significantly increased in patients with PsA vs control individuals. Of note, the association remained significant after adjusting for gender, age, body mass index, mean arterial pressure, and aortic calcification, but it was not associated with disease-related parameters. Further studies to determine the contributions of PsA per se and its comorbidities to vascular inflammation are required. Nevertheless, the management of PsA should include close monitoring and aggressive treatment of risk factors for atherosclerotic vascular disease.

Psychotic disorders are known to be associated with psoriasis, but their association with PsA is less well known. Using French health administrative data, Brenaut and colleagues showed that the prevalence of psychotic disorders was higher in individuals with psoriasis but surprisingly lower in individuals with PsA, compared with the general population. Moreover, a co-diagnosis of psoriasis/PsA and psychotic disorders was associated with an increased mortality rate and at a lower age.

Clinical trials have demonstrated that Janus kinase (JAK) inhibitors have a remarkable efficacy in the treatment of the musculoskeletal manifestations of PsA. Observational studies are important to evaluate effectiveness in real-world settings. In a study that included 123 patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry who were treated with tofacitinib, Mease and colleagues observed that a quarter of patients achieved a state of low disease activity, based on the Clinical Disease Activity Index for PsA at 6 ± 3 months of follow-up. A substantial proportion of patients also reported the resolution of dactylitis (29.4%) and enthesitis (42.9%). Although these results are remarkable compared with what was seen with older therapies, one must note that only a quarter of patients achieved remission; more effective regimens for improving outcomes in PsA are required.

The safety of newer therapies is always of concern. It is reassuring that a meta-analysis of six randomized controlled trials that included 5038 patients with PsA who received either risankizumab (an anti-interleukin-23 antibody) or placebo by Su and colleagues demonstrated that the incidences of serious adverse events and serious treatment-emergent adverse events were similar between the risankizumab and placebo groups. Given the excellent safety profile of some of the newer therapies for PsA, trials with combinations of newer targeted therapies in treatment-resistant PsA should be conducted.

An important comorbidity of PsA is vascular inflammation leading to accelerated atherosclerosis, and higher risk for cardiovascular and cerebrovascular disease. Previously, vascular imaging modalities have demonstrated vascular inflammation in PsA. In a cross-sectional study that included 75 patients with active PsA and 40 control individuals without PsA, Kleinrensink and colleagues demonstrated that vascular inflammation of the whole aorta was significantly increased in patients with PsA vs control individuals. Of note, the association remained significant after adjusting for gender, age, body mass index, mean arterial pressure, and aortic calcification, but it was not associated with disease-related parameters. Further studies to determine the contributions of PsA per se and its comorbidities to vascular inflammation are required. Nevertheless, the management of PsA should include close monitoring and aggressive treatment of risk factors for atherosclerotic vascular disease.

Psychotic disorders are known to be associated with psoriasis, but their association with PsA is less well known. Using French health administrative data, Brenaut and colleagues showed that the prevalence of psychotic disorders was higher in individuals with psoriasis but surprisingly lower in individuals with PsA, compared with the general population. Moreover, a co-diagnosis of psoriasis/PsA and psychotic disorders was associated with an increased mortality rate and at a lower age.

Clinical trials have demonstrated that Janus kinase (JAK) inhibitors have a remarkable efficacy in the treatment of the musculoskeletal manifestations of PsA. Observational studies are important to evaluate effectiveness in real-world settings. In a study that included 123 patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry who were treated with tofacitinib, Mease and colleagues observed that a quarter of patients achieved a state of low disease activity, based on the Clinical Disease Activity Index for PsA at 6 ± 3 months of follow-up. A substantial proportion of patients also reported the resolution of dactylitis (29.4%) and enthesitis (42.9%). Although these results are remarkable compared with what was seen with older therapies, one must note that only a quarter of patients achieved remission; more effective regimens for improving outcomes in PsA are required.

The safety of newer therapies is always of concern. It is reassuring that a meta-analysis of six randomized controlled trials that included 5038 patients with PsA who received either risankizumab (an anti-interleukin-23 antibody) or placebo by Su and colleagues demonstrated that the incidences of serious adverse events and serious treatment-emergent adverse events were similar between the risankizumab and placebo groups. Given the excellent safety profile of some of the newer therapies for PsA, trials with combinations of newer targeted therapies in treatment-resistant PsA should be conducted.

An important comorbidity of PsA is vascular inflammation leading to accelerated atherosclerosis, and higher risk for cardiovascular and cerebrovascular disease. Previously, vascular imaging modalities have demonstrated vascular inflammation in PsA. In a cross-sectional study that included 75 patients with active PsA and 40 control individuals without PsA, Kleinrensink and colleagues demonstrated that vascular inflammation of the whole aorta was significantly increased in patients with PsA vs control individuals. Of note, the association remained significant after adjusting for gender, age, body mass index, mean arterial pressure, and aortic calcification, but it was not associated with disease-related parameters. Further studies to determine the contributions of PsA per se and its comorbidities to vascular inflammation are required. Nevertheless, the management of PsA should include close monitoring and aggressive treatment of risk factors for atherosclerotic vascular disease.

Psychotic disorders are known to be associated with psoriasis, but their association with PsA is less well known. Using French health administrative data, Brenaut and colleagues showed that the prevalence of psychotic disorders was higher in individuals with psoriasis but surprisingly lower in individuals with PsA, compared with the general population. Moreover, a co-diagnosis of psoriasis/PsA and psychotic disorders was associated with an increased mortality rate and at a lower age.

Clinical trials have demonstrated that Janus kinase (JAK) inhibitors have a remarkable efficacy in the treatment of the musculoskeletal manifestations of PsA. Observational studies are important to evaluate effectiveness in real-world settings. In a study that included 123 patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry who were treated with tofacitinib, Mease and colleagues observed that a quarter of patients achieved a state of low disease activity, based on the Clinical Disease Activity Index for PsA at 6 ± 3 months of follow-up. A substantial proportion of patients also reported the resolution of dactylitis (29.4%) and enthesitis (42.9%). Although these results are remarkable compared with what was seen with older therapies, one must note that only a quarter of patients achieved remission; more effective regimens for improving outcomes in PsA are required.

The safety of newer therapies is always of concern. It is reassuring that a meta-analysis of six randomized controlled trials that included 5038 patients with PsA who received either risankizumab (an anti-interleukin-23 antibody) or placebo by Su and colleagues demonstrated that the incidences of serious adverse events and serious treatment-emergent adverse events were similar between the risankizumab and placebo groups. Given the excellent safety profile of some of the newer therapies for PsA, trials with combinations of newer targeted therapies in treatment-resistant PsA should be conducted.

The phase 3 KEYNOTE-355 trial established the role of chemotherapy in combination with pembrolizumab in the first-line setting for programmed death-ligand 1 (PD-L1)–positive advanced triple-negative breast cancer (TNBC). Patients unselected for PD-L1 status in this trial who received platinum- or taxane-based chemotherapy with placebo had a median progression-free survival of 5.6 months.^[3] Strategies to improve upon efficacy and tolerability are desired in this space, and various trials have evaluated "switch maintenance" that involves receipt of an intensive induction regimen followed by a switch to an alternative/more tolerable regimen after response is achieved.^[4] The phase II DORA trial randomized 45 patients with advanced TNBC and ongoing stable disease or complete or partial response from first- or second-line platinum-based chemotherapy to a maintenance regimen of olaparib (300 mg orally twice daily) with or without durvalumab (1500 mg on day 1 and every 4 weeks) (Tan et al). At a median follow-up of 9.8 months, median progression-free survival was 4.0 months (95% CI 2.6-6.1) with olaparib and 6.1 months (95% CI 3.7-10.1) with the combination; both were significantly longer than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). Durable disease control appeared more pronounced in patients with complete or partial response to prior platinum therapy, and no new safety signals were observed. Future efforts to study this approach include the phase 2/3 KEYLYNK-009 trial, which is evaluating olaparib plus pembrolizumab maintenance therapy after first-line chemotherapy plus pembrolizumab for TNBC.^[5]

TNBC is a heterogenous subtype, characterized by aggressive biology, and it benefits from chemotherapy and immunotherapy treatment approaches. Presently, the management of early-stage TNBC often involves neoadjuvant systemic therapy; however, a proportion of patients receive treatment in the postoperative setting, highlighting the relevance of time to initiation of adjuvant therapy as well.^[6] Various prior studies have showed that delayed administration of adjuvant chemotherapy for EBC can lead to adverse survival outcomes. Furthermore, this effect is subtype-dependent, with more aggressive tumors (luminal B, triple-negative, human epidermal growth factor receptor 2 [HER2]-positive) exhibiting inferior outcomes with delayed chemotherapy.^[7] A retrospective cohort study that included 245 patients with early TNBC who received adjuvant chemotherapy after surgery evaluated the impact of time to initiation of adjuvant therapy in this population (Hatzipanagiotou et al). Superior survival outcomes were observed for the group receiving systemic therapy 22-28 days after surgery (median overall survival 10.2 years) compared with those receiving adjuvant chemotherapy at later time points (29-35 days, 36-42 days, and >6 weeks after surgery; median overall survival 8.3 years, 7.8 years, and 6.9 years, respectively). Patients receiving chemotherapy 22-28 days after surgery had significantly better survival than those receiving chemotherapy 29-35 days (P = .043) and >6 weeks (P = 0.033) postoperatively. This study emphasizes the importance of timely administration of adjuvant chemotherapy for early TNBC, and efforts aimed to identify potential challenges and propose solutions to optimize outcomes in this space are valuable.

Additional References

1. Gnant M, Frantal S, Pfeiler G, et al, for the Austrian Breast & Colorectal Cancer Study Group. Long-term outcomes of adjuvant denosumab in breast cancer. NEJM Evid. 2022;1:EVIDoa2200162. doi: 10.1056/EVIDoa2200162 Source
2. Fassio A, Idolazzi L, Rossini M, et al. The obesity paradox and osteoporosis. Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity. 2018;23:293-30 doi: 10.1007/s40519-018-0505-2 Source
3. Cortes J, Cescon DW, Rugo HS, et al, for the KEYNOTE-355 Investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): A randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020;396:1817-1828. doi: 10.1016/S0140-6736(20)32531-9 Source
4. Bachelot T, Filleron T, Bieche I, et al. Durvalumab compared to maintenance chemotherapy in metastatic breast cancer: The randomized phase II SAFIR02-BREAST IMMUNO trial. Nat Med. 2021;27:250-255. doi: 10.1038/s41591-020-01189-2 Source
5. Saji S, Cussac AL, Andre F, et al. 68TiP KEYLYNK-009: a phase II/III, open-label, randomized study of pembrolizumab (pembro) + olaparib (ola) vs pembro + chemotherapy after induction with first-line (1L) pembro + chemo in patients (pts) with locally recurrent inoperable or metastatic TNBC (abstract). Ann Oncol. 2020;31(Suppl 6):S1268. doi: 10.1016/j.annonc.2020.10.088 Source
6. Ortmann O, Blohmer JU, Sibert NT, et al for 55 breast cancer centers certified by the German Cancer Society. Current clinical practice and outcome of neoadjuvant chemotherapy for early breast cancer: Analysis of individual data from 94,638 patients treated in 55 breast cancer centers. J Cancer Res Clin Oncol. 2023;149:1195-1209. doi: 10.1007/s00432-022-03938-x Source
7. Yu KD, Fan L, Qiu LX, et al. Influence of delayed initiation of adjuvant chemotherapy on breast cancer survival is subtype-dependent. Oncotarget. 2017;8:46549-46556. doi: 10.18632/oncotarget.10551 Source

The phase 3 KEYNOTE-355 trial established the role of chemotherapy in combination with pembrolizumab in the first-line setting for programmed death-ligand 1 (PD-L1)–positive advanced triple-negative breast cancer (TNBC). Patients unselected for PD-L1 status in this trial who received platinum- or taxane-based chemotherapy with placebo had a median progression-free survival of 5.6 months.^[3] Strategies to improve upon efficacy and tolerability are desired in this space, and various trials have evaluated "switch maintenance" that involves receipt of an intensive induction regimen followed by a switch to an alternative/more tolerable regimen after response is achieved.^[4] The phase II DORA trial randomized 45 patients with advanced TNBC and ongoing stable disease or complete or partial response from first- or second-line platinum-based chemotherapy to a maintenance regimen of olaparib (300 mg orally twice daily) with or without durvalumab (1500 mg on day 1 and every 4 weeks) (Tan et al). At a median follow-up of 9.8 months, median progression-free survival was 4.0 months (95% CI 2.6-6.1) with olaparib and 6.1 months (95% CI 3.7-10.1) with the combination; both were significantly longer than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). Durable disease control appeared more pronounced in patients with complete or partial response to prior platinum therapy, and no new safety signals were observed. Future efforts to study this approach include the phase 2/3 KEYLYNK-009 trial, which is evaluating olaparib plus pembrolizumab maintenance therapy after first-line chemotherapy plus pembrolizumab for TNBC.^[5]

TNBC is a heterogenous subtype, characterized by aggressive biology, and it benefits from chemotherapy and immunotherapy treatment approaches. Presently, the management of early-stage TNBC often involves neoadjuvant systemic therapy; however, a proportion of patients receive treatment in the postoperative setting, highlighting the relevance of time to initiation of adjuvant therapy as well.^[6] Various prior studies have showed that delayed administration of adjuvant chemotherapy for EBC can lead to adverse survival outcomes. Furthermore, this effect is subtype-dependent, with more aggressive tumors (luminal B, triple-negative, human epidermal growth factor receptor 2 [HER2]-positive) exhibiting inferior outcomes with delayed chemotherapy.^[7] A retrospective cohort study that included 245 patients with early TNBC who received adjuvant chemotherapy after surgery evaluated the impact of time to initiation of adjuvant therapy in this population (Hatzipanagiotou et al). Superior survival outcomes were observed for the group receiving systemic therapy 22-28 days after surgery (median overall survival 10.2 years) compared with those receiving adjuvant chemotherapy at later time points (29-35 days, 36-42 days, and >6 weeks after surgery; median overall survival 8.3 years, 7.8 years, and 6.9 years, respectively). Patients receiving chemotherapy 22-28 days after surgery had significantly better survival than those receiving chemotherapy 29-35 days (P = .043) and >6 weeks (P = 0.033) postoperatively. This study emphasizes the importance of timely administration of adjuvant chemotherapy for early TNBC, and efforts aimed to identify potential challenges and propose solutions to optimize outcomes in this space are valuable.

Additional References

1. Gnant M, Frantal S, Pfeiler G, et al, for the Austrian Breast & Colorectal Cancer Study Group. Long-term outcomes of adjuvant denosumab in breast cancer. NEJM Evid. 2022;1:EVIDoa2200162. doi: 10.1056/EVIDoa2200162 Source
2. Fassio A, Idolazzi L, Rossini M, et al. The obesity paradox and osteoporosis. Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity. 2018;23:293-30 doi: 10.1007/s40519-018-0505-2 Source
3. Cortes J, Cescon DW, Rugo HS, et al, for the KEYNOTE-355 Investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): A randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020;396:1817-1828. doi: 10.1016/S0140-6736(20)32531-9 Source
4. Bachelot T, Filleron T, Bieche I, et al. Durvalumab compared to maintenance chemotherapy in metastatic breast cancer: The randomized phase II SAFIR02-BREAST IMMUNO trial. Nat Med. 2021;27:250-255. doi: 10.1038/s41591-020-01189-2 Source
5. Saji S, Cussac AL, Andre F, et al. 68TiP KEYLYNK-009: a phase II/III, open-label, randomized study of pembrolizumab (pembro) + olaparib (ola) vs pembro + chemotherapy after induction with first-line (1L) pembro + chemo in patients (pts) with locally recurrent inoperable or metastatic TNBC (abstract). Ann Oncol. 2020;31(Suppl 6):S1268. doi: 10.1016/j.annonc.2020.10.088 Source
6. Ortmann O, Blohmer JU, Sibert NT, et al for 55 breast cancer centers certified by the German Cancer Society. Current clinical practice and outcome of neoadjuvant chemotherapy for early breast cancer: Analysis of individual data from 94,638 patients treated in 55 breast cancer centers. J Cancer Res Clin Oncol. 2023;149:1195-1209. doi: 10.1007/s00432-022-03938-x Source
7. Yu KD, Fan L, Qiu LX, et al. Influence of delayed initiation of adjuvant chemotherapy on breast cancer survival is subtype-dependent. Oncotarget. 2017;8:46549-46556. doi: 10.18632/oncotarget.10551 Source

The phase 3 KEYNOTE-355 trial established the role of chemotherapy in combination with pembrolizumab in the first-line setting for programmed death-ligand 1 (PD-L1)–positive advanced triple-negative breast cancer (TNBC). Patients unselected for PD-L1 status in this trial who received platinum- or taxane-based chemotherapy with placebo had a median progression-free survival of 5.6 months.^[3] Strategies to improve upon efficacy and tolerability are desired in this space, and various trials have evaluated "switch maintenance" that involves receipt of an intensive induction regimen followed by a switch to an alternative/more tolerable regimen after response is achieved.^[4] The phase II DORA trial randomized 45 patients with advanced TNBC and ongoing stable disease or complete or partial response from first- or second-line platinum-based chemotherapy to a maintenance regimen of olaparib (300 mg orally twice daily) with or without durvalumab (1500 mg on day 1 and every 4 weeks) (Tan et al). At a median follow-up of 9.8 months, median progression-free survival was 4.0 months (95% CI 2.6-6.1) with olaparib and 6.1 months (95% CI 3.7-10.1) with the combination; both were significantly longer than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). Durable disease control appeared more pronounced in patients with complete or partial response to prior platinum therapy, and no new safety signals were observed. Future efforts to study this approach include the phase 2/3 KEYLYNK-009 trial, which is evaluating olaparib plus pembrolizumab maintenance therapy after first-line chemotherapy plus pembrolizumab for TNBC.^[5]

TNBC is a heterogenous subtype, characterized by aggressive biology, and it benefits from chemotherapy and immunotherapy treatment approaches. Presently, the management of early-stage TNBC often involves neoadjuvant systemic therapy; however, a proportion of patients receive treatment in the postoperative setting, highlighting the relevance of time to initiation of adjuvant therapy as well.^[6] Various prior studies have showed that delayed administration of adjuvant chemotherapy for EBC can lead to adverse survival outcomes. Furthermore, this effect is subtype-dependent, with more aggressive tumors (luminal B, triple-negative, human epidermal growth factor receptor 2 [HER2]-positive) exhibiting inferior outcomes with delayed chemotherapy.^[7] A retrospective cohort study that included 245 patients with early TNBC who received adjuvant chemotherapy after surgery evaluated the impact of time to initiation of adjuvant therapy in this population (Hatzipanagiotou et al). Superior survival outcomes were observed for the group receiving systemic therapy 22-28 days after surgery (median overall survival 10.2 years) compared with those receiving adjuvant chemotherapy at later time points (29-35 days, 36-42 days, and >6 weeks after surgery; median overall survival 8.3 years, 7.8 years, and 6.9 years, respectively). Patients receiving chemotherapy 22-28 days after surgery had significantly better survival than those receiving chemotherapy 29-35 days (P = .043) and >6 weeks (P = 0.033) postoperatively. This study emphasizes the importance of timely administration of adjuvant chemotherapy for early TNBC, and efforts aimed to identify potential challenges and propose solutions to optimize outcomes in this space are valuable.

Additional References

1. Gnant M, Frantal S, Pfeiler G, et al, for the Austrian Breast & Colorectal Cancer Study Group. Long-term outcomes of adjuvant denosumab in breast cancer. NEJM Evid. 2022;1:EVIDoa2200162. doi: 10.1056/EVIDoa2200162 Source
2. Fassio A, Idolazzi L, Rossini M, et al. The obesity paradox and osteoporosis. Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity. 2018;23:293-30 doi: 10.1007/s40519-018-0505-2 Source
3. Cortes J, Cescon DW, Rugo HS, et al, for the KEYNOTE-355 Investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): A randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020;396:1817-1828. doi: 10.1016/S0140-6736(20)32531-9 Source
4. Bachelot T, Filleron T, Bieche I, et al. Durvalumab compared to maintenance chemotherapy in metastatic breast cancer: The randomized phase II SAFIR02-BREAST IMMUNO trial. Nat Med. 2021;27:250-255. doi: 10.1038/s41591-020-01189-2 Source
5. Saji S, Cussac AL, Andre F, et al. 68TiP KEYLYNK-009: a phase II/III, open-label, randomized study of pembrolizumab (pembro) + olaparib (ola) vs pembro + chemotherapy after induction with first-line (1L) pembro + chemo in patients (pts) with locally recurrent inoperable or metastatic TNBC (abstract). Ann Oncol. 2020;31(Suppl 6):S1268. doi: 10.1016/j.annonc.2020.10.088 Source
6. Ortmann O, Blohmer JU, Sibert NT, et al for 55 breast cancer centers certified by the German Cancer Society. Current clinical practice and outcome of neoadjuvant chemotherapy for early breast cancer: Analysis of individual data from 94,638 patients treated in 55 breast cancer centers. J Cancer Res Clin Oncol. 2023;149:1195-1209. doi: 10.1007/s00432-022-03938-x Source
7. Yu KD, Fan L, Qiu LX, et al. Influence of delayed initiation of adjuvant chemotherapy on breast cancer survival is subtype-dependent. Oncotarget. 2017;8:46549-46556. doi: 10.18632/oncotarget.10551 Source

People with gout are 58% more likely to develop cardiovascular disease (CVD), according to a new analysis. This increased risk was observed across 12 different cardiovascular conditions, including heart failure, arrhythmias, and valve diseases.

“These findings suggest that the organ damage associated with gout is likely to be much broader than originally thought,” Nathalie Conrad, PhD, senior author of the research and cardiovascular epidemiologist at KU Leuven, Leuven, Belgium, said in an email. This could be useful for future research on underlying biological mechanisms driving CVD risk in gout, she added.

While previous research has tied gout to increased cardiovascular risk, these studies “largely focused on coronary heart disease, stroke, and thromboembolic outcomes,” she explained, and have been smaller in size.

This new study included more than 862,000 individuals, which permitted researchers to investigate rarer CVD outcomes such as myocarditis and pericarditis.

For the study, researchers used electronic health records from the UK Clinical Practice Research Datalink, a primary care database that contains anonymized health data for about 22 million individuals. Using these data, they identified more than 152,600 individuals with gout. Patients included in the analysis were diagnosed between 2000 and 2017, younger than 80 years at diagnosis, and free of CVD for at least 12 months after their gout diagnosis.

Patients with gout were compared with nearly 710,000 controls, matched on demographic factors such as age, sex, and geographic region.

Researchers then investigated the incidence of 12 CVDs, including atherosclerotic diseases, degenerative and thromboembolic diseases, and arrythmias, between the two groups from January 1, 2000, to June 30, 2019.

The findings were published in the March 2024 issue of The Lancet Rheumatology. Overall, patients with gout were 58% more likely to develop any CVD than their matched comparators without gout. There was a higher disease incidence among patients with gout for each of the 12 conditions. This association was more pronounced in women (hazard ratio [HR], 1.88) than in men (HR, 1.49), and gout amplified the risk for CVD in younger individuals to a greater extent.

Individuals younger than 45 years with gout were more than twice as likely to develop CVD compared with similarly aged individuals without gout. For comparison, individuals aged 45-54 years with gout were 84% more likely to develop CVD, and individuals aged 55-64 years were 57% more likely to develop CVD than matched controls.

Conduction system disease had the highest incident risk (HR, 1.88), followed by heart failure and valve disease (HR, 1.85 for both).

Individuals with gout had higher rates of comorbidities than the controls, including hypertension, obesity, and dyslipidemia. Overall, CVD risk was slightly attenuated after adjustment for traditional CVD risk factors such as smoking, blood pressure, and body mass index but still significant: Patients with gout had a 31% higher risk for CVD than comparators.

This shows “that known CVD risk factors only explain part of the CVD risks seen in patients with gout,” Dr. Conrad said. Other factors such as inflammation and other disease activity factors could be at play, she explained, which would need to be explored in future research.

The study “shows the whole landscape” of CVD and gout, Michael H. Pillinger, MD, rheumatologist and professor of medicine, biochemistry, and molecular pharmacology at NYU Grossman School of Medicine in New York City, said in an interview. He was not involved with the research.

“Every possible cardiovascular disease that they could think of was something that gout patients had more of than the non-gout patients,” he added. “I think this is going to be a paper that gets cited a lot, at minimum when describing the background of risk when we look at gout patients.”

The study had some limitations, including that researchers were unable to account for how medications such as nonsteroidal anti-inflammatory drugs, corticosteroids, colchicine, or allopurinol may have affected the association between gout and CVD.

“This is because analyses of nonrandomized treatment can be confounded by indication, wherein it is difficult to differentiate the effects of the treatment from underlying disease severity,” the authors wrote.

There was also a large amount of missing data on blood pressure, body mass index, smoking status, and other health information relevant to cardiovascular risk, so sensitivity analyses adjusting for these factors “should be interpreted with caution,” they added.

Dr. Pillinger also noted that the rates of comorbidities in the gout study population were lower than what have been found in US study populations. For example, about 40% of patients with gout in the analysis had hypertension, while other studies have suggested higher rates of 60%-70%, he said. However, it’s not clear if these differences could have affected outcomes. He added that these limitations do not “in any way weaken [the authors’] conclusion.”

The findings call for better strategies to reduce CVD risk in patients with gout, Dr. Conrad noted.

“Further improvements could come from better recognition and intervention on CVD risk factors (eg, through lifestyle changes or drug therapies where they are indicated), as well as proactive screening for heart disease in patients with gout, which could allow early diagnosis and interventions to delay more severe outcomes,” she added.

This study was funded by Research Foundation Flanders. Dr. Conrad was funded by a personal fellowship from the Research Foundation Flanders and a European Society of Cardiology research grant. She received royalties from Oxford University Innovation. Four of Dr. Conrad’s eight coauthors also reported financial relationships with pharmaceutical companies. Dr. Pillinger served as a consultant to Amgen, Federation Bio, Fortress Biotech, and Scilex, and he holds an investigator-initiated grant from Hikma.

A version of this article appeared on Medscape.com.

People with gout are 58% more likely to develop cardiovascular disease (CVD), according to a new analysis. This increased risk was observed across 12 different cardiovascular conditions, including heart failure, arrhythmias, and valve diseases.

“These findings suggest that the organ damage associated with gout is likely to be much broader than originally thought,” Nathalie Conrad, PhD, senior author of the research and cardiovascular epidemiologist at KU Leuven, Leuven, Belgium, said in an email. This could be useful for future research on underlying biological mechanisms driving CVD risk in gout, she added.

While previous research has tied gout to increased cardiovascular risk, these studies “largely focused on coronary heart disease, stroke, and thromboembolic outcomes,” she explained, and have been smaller in size.

This new study included more than 862,000 individuals, which permitted researchers to investigate rarer CVD outcomes such as myocarditis and pericarditis.

For the study, researchers used electronic health records from the UK Clinical Practice Research Datalink, a primary care database that contains anonymized health data for about 22 million individuals. Using these data, they identified more than 152,600 individuals with gout. Patients included in the analysis were diagnosed between 2000 and 2017, younger than 80 years at diagnosis, and free of CVD for at least 12 months after their gout diagnosis.

Patients with gout were compared with nearly 710,000 controls, matched on demographic factors such as age, sex, and geographic region.

Researchers then investigated the incidence of 12 CVDs, including atherosclerotic diseases, degenerative and thromboembolic diseases, and arrythmias, between the two groups from January 1, 2000, to June 30, 2019.

The findings were published in the March 2024 issue of The Lancet Rheumatology. Overall, patients with gout were 58% more likely to develop any CVD than their matched comparators without gout. There was a higher disease incidence among patients with gout for each of the 12 conditions. This association was more pronounced in women (hazard ratio [HR], 1.88) than in men (HR, 1.49), and gout amplified the risk for CVD in younger individuals to a greater extent.

Individuals younger than 45 years with gout were more than twice as likely to develop CVD compared with similarly aged individuals without gout. For comparison, individuals aged 45-54 years with gout were 84% more likely to develop CVD, and individuals aged 55-64 years were 57% more likely to develop CVD than matched controls.

Conduction system disease had the highest incident risk (HR, 1.88), followed by heart failure and valve disease (HR, 1.85 for both).

Individuals with gout had higher rates of comorbidities than the controls, including hypertension, obesity, and dyslipidemia. Overall, CVD risk was slightly attenuated after adjustment for traditional CVD risk factors such as smoking, blood pressure, and body mass index but still significant: Patients with gout had a 31% higher risk for CVD than comparators.

This shows “that known CVD risk factors only explain part of the CVD risks seen in patients with gout,” Dr. Conrad said. Other factors such as inflammation and other disease activity factors could be at play, she explained, which would need to be explored in future research.

The study “shows the whole landscape” of CVD and gout, Michael H. Pillinger, MD, rheumatologist and professor of medicine, biochemistry, and molecular pharmacology at NYU Grossman School of Medicine in New York City, said in an interview. He was not involved with the research.

“Every possible cardiovascular disease that they could think of was something that gout patients had more of than the non-gout patients,” he added. “I think this is going to be a paper that gets cited a lot, at minimum when describing the background of risk when we look at gout patients.”

The study had some limitations, including that researchers were unable to account for how medications such as nonsteroidal anti-inflammatory drugs, corticosteroids, colchicine, or allopurinol may have affected the association between gout and CVD.

“This is because analyses of nonrandomized treatment can be confounded by indication, wherein it is difficult to differentiate the effects of the treatment from underlying disease severity,” the authors wrote.

There was also a large amount of missing data on blood pressure, body mass index, smoking status, and other health information relevant to cardiovascular risk, so sensitivity analyses adjusting for these factors “should be interpreted with caution,” they added.

Dr. Pillinger also noted that the rates of comorbidities in the gout study population were lower than what have been found in US study populations. For example, about 40% of patients with gout in the analysis had hypertension, while other studies have suggested higher rates of 60%-70%, he said. However, it’s not clear if these differences could have affected outcomes. He added that these limitations do not “in any way weaken [the authors’] conclusion.”

The findings call for better strategies to reduce CVD risk in patients with gout, Dr. Conrad noted.

“Further improvements could come from better recognition and intervention on CVD risk factors (eg, through lifestyle changes or drug therapies where they are indicated), as well as proactive screening for heart disease in patients with gout, which could allow early diagnosis and interventions to delay more severe outcomes,” she added.

This study was funded by Research Foundation Flanders. Dr. Conrad was funded by a personal fellowship from the Research Foundation Flanders and a European Society of Cardiology research grant. She received royalties from Oxford University Innovation. Four of Dr. Conrad’s eight coauthors also reported financial relationships with pharmaceutical companies. Dr. Pillinger served as a consultant to Amgen, Federation Bio, Fortress Biotech, and Scilex, and he holds an investigator-initiated grant from Hikma.

A version of this article appeared on Medscape.com.

People with gout are 58% more likely to develop cardiovascular disease (CVD), according to a new analysis. This increased risk was observed across 12 different cardiovascular conditions, including heart failure, arrhythmias, and valve diseases.

“These findings suggest that the organ damage associated with gout is likely to be much broader than originally thought,” Nathalie Conrad, PhD, senior author of the research and cardiovascular epidemiologist at KU Leuven, Leuven, Belgium, said in an email. This could be useful for future research on underlying biological mechanisms driving CVD risk in gout, she added.

While previous research has tied gout to increased cardiovascular risk, these studies “largely focused on coronary heart disease, stroke, and thromboembolic outcomes,” she explained, and have been smaller in size.

This new study included more than 862,000 individuals, which permitted researchers to investigate rarer CVD outcomes such as myocarditis and pericarditis.

For the study, researchers used electronic health records from the UK Clinical Practice Research Datalink, a primary care database that contains anonymized health data for about 22 million individuals. Using these data, they identified more than 152,600 individuals with gout. Patients included in the analysis were diagnosed between 2000 and 2017, younger than 80 years at diagnosis, and free of CVD for at least 12 months after their gout diagnosis.

Patients with gout were compared with nearly 710,000 controls, matched on demographic factors such as age, sex, and geographic region.

Researchers then investigated the incidence of 12 CVDs, including atherosclerotic diseases, degenerative and thromboembolic diseases, and arrythmias, between the two groups from January 1, 2000, to June 30, 2019.

The findings were published in the March 2024 issue of The Lancet Rheumatology. Overall, patients with gout were 58% more likely to develop any CVD than their matched comparators without gout. There was a higher disease incidence among patients with gout for each of the 12 conditions. This association was more pronounced in women (hazard ratio [HR], 1.88) than in men (HR, 1.49), and gout amplified the risk for CVD in younger individuals to a greater extent.

Individuals younger than 45 years with gout were more than twice as likely to develop CVD compared with similarly aged individuals without gout. For comparison, individuals aged 45-54 years with gout were 84% more likely to develop CVD, and individuals aged 55-64 years were 57% more likely to develop CVD than matched controls.

Conduction system disease had the highest incident risk (HR, 1.88), followed by heart failure and valve disease (HR, 1.85 for both).

Individuals with gout had higher rates of comorbidities than the controls, including hypertension, obesity, and dyslipidemia. Overall, CVD risk was slightly attenuated after adjustment for traditional CVD risk factors such as smoking, blood pressure, and body mass index but still significant: Patients with gout had a 31% higher risk for CVD than comparators.

This shows “that known CVD risk factors only explain part of the CVD risks seen in patients with gout,” Dr. Conrad said. Other factors such as inflammation and other disease activity factors could be at play, she explained, which would need to be explored in future research.

The study “shows the whole landscape” of CVD and gout, Michael H. Pillinger, MD, rheumatologist and professor of medicine, biochemistry, and molecular pharmacology at NYU Grossman School of Medicine in New York City, said in an interview. He was not involved with the research.

“Every possible cardiovascular disease that they could think of was something that gout patients had more of than the non-gout patients,” he added. “I think this is going to be a paper that gets cited a lot, at minimum when describing the background of risk when we look at gout patients.”

The study had some limitations, including that researchers were unable to account for how medications such as nonsteroidal anti-inflammatory drugs, corticosteroids, colchicine, or allopurinol may have affected the association between gout and CVD.

“This is because analyses of nonrandomized treatment can be confounded by indication, wherein it is difficult to differentiate the effects of the treatment from underlying disease severity,” the authors wrote.

There was also a large amount of missing data on blood pressure, body mass index, smoking status, and other health information relevant to cardiovascular risk, so sensitivity analyses adjusting for these factors “should be interpreted with caution,” they added.

Dr. Pillinger also noted that the rates of comorbidities in the gout study population were lower than what have been found in US study populations. For example, about 40% of patients with gout in the analysis had hypertension, while other studies have suggested higher rates of 60%-70%, he said. However, it’s not clear if these differences could have affected outcomes. He added that these limitations do not “in any way weaken [the authors’] conclusion.”

The findings call for better strategies to reduce CVD risk in patients with gout, Dr. Conrad noted.

“Further improvements could come from better recognition and intervention on CVD risk factors (eg, through lifestyle changes or drug therapies where they are indicated), as well as proactive screening for heart disease in patients with gout, which could allow early diagnosis and interventions to delay more severe outcomes,” she added.

This study was funded by Research Foundation Flanders. Dr. Conrad was funded by a personal fellowship from the Research Foundation Flanders and a European Society of Cardiology research grant. She received royalties from Oxford University Innovation. Four of Dr. Conrad’s eight coauthors also reported financial relationships with pharmaceutical companies. Dr. Pillinger served as a consultant to Amgen, Federation Bio, Fortress Biotech, and Scilex, and he holds an investigator-initiated grant from Hikma.

A version of this article appeared on Medscape.com.

For many, stretching is the fitness equivalent of awkward small talk. It’s the opening act, the thing you tolerate because you know it will be over soon. 

Others have challenged the practice, suggesting that stretching isn’t necessary at all. Some research has found that a preworkout stretch may even be disadvantageous, weakening muscles and hindering performance.

To put it plainly, no one seems terribly enthusiastic about touching their toes. 

That’s why a 2020 study on exercise and mortality was such a head-scratcher. The study found that stretching was uniquely associated with a lower risk for all-cause mortality among American adults. That’s after controlling for participation in other types of exercise. 

The finding seemed like a fluke, until a 2023 study found essentially the same thing. 

Among Korean adults, those who did flexibility exercise at least five times a week had a 20% lower risk of dying during the follow-up period than those who didn’t stretch at all. That was slightly better than the risk reduction associated with high volumes of aerobic exercise and resistance training. 

How can that be ? It turns out, stretching is linked to several health benefits that you might not expect.
 

The Surprising Benefits of Stretching

When we talk about stretching, we usually mean static stretching — getting into and holding a position that challenges a muscle, with the goal of improving range of motion around a joint. 

It doesn’t need to be a big challenge. “Research shows you can get increases in flexibility by stretching to the initial point of discomfort,” said David Behm, PhD, an exercise scientist at Memorial University of Newfoundland in Canada who’s published dozens of studies on stretching over the past quarter-century. 

That brings us to the first benefit.
 

Stretching Benefit #1: More Strength

At first glance, flexibility training and strength training have little in common. You lengthen muscles in the former and contract them in the latter. 

But in both cases, Dr. Behm said, you’re applying tension to muscles and connective tissues. Tension activates proteins called integrins, which send and receive signals across cellular membranes. Those signals are the start of a cascade that leads to protein synthesis. That’s how muscles get bigger and stronger when you lift weights. 

That mechanism could explain the small gains in muscle strength and size associated with static stretching, Dr. Behm said. 

But can you really stretch your way to muscle growth? Theoretically, yes. But strength training is far more time-efficient, Dr. Behm says. Studies showing increases in muscle mass have typically stretched a single muscle (usually the calves, using a specialized device) for > 30 min/session, 6 d/wk for 6 weeks. And that’s for just one leg.

Still, stretching may be more accessible for some patients — research suggested that older and more sedentary people are most likely to benefit from stretching-induced gains in strength.

 

Stretching Benefit #2: Reduced Arterial Stiffness

“Most people don’t think about the cardiovascular benefits of stretching,” Dr. Behm said. There are some big ones. 

If your body doesn’t move well, it’s not unreasonable to assume your blood doesn’t flow well. That is indeed the case: Poor flexibility is associated with arterial stiffness. 

Stretching is associated not only with improved arterial function but also with reductions in resting heart rate and blood pressure and increased vasodilation.

Mobility improvements may have an indirect benefit on cardiovascular health as well. 

“Studies show runners are more economical when they’re more flexible,” Dr. Behm said. If your movement is more efficient, you’ll probably do more of it. Doing more, in turn, would lead to improved fitness. 
 

Stretching Benefit #3: Improved Performance

Research is equivocal on whether stretching improves athletic performance, said Joe Yoon, a sports massage therapist in Orlando, Florida, and author of Better Stretching. 

“But I’ve always taken the approach that if you can improve your range of motion and get into positions” required for your sport, you’ll probably perform better, with less risk for injury, Mr. Yoon said. 

It’s worth noting that some research over the past 30 years has linked pre-exercise static stretching with a loss of strength, power, and/or speed. 

But consider this: In a 2016 review, Dr. Behm and his coauthors showed that performance reductions were most likely to occur in two situations: 

When participants did extremely long stretches (duration, ≥ 60 sec per muscle).

When researchers tested the participants’ strength, power, or speed immediately after they stretched.

Avoiding those problems is easy, Dr. Behm said: Stretch each muscle for < 60 sec, and combine static stretches with more active warm-up exercises. 

“Stretching can impair your performance but only if you do it wrong,” he said.
 

Stretching Benefit #4: Fewer Injuries

When you stretch, the point where you feel tension is where the muscle is most vulnerable. “That’s where injuries usually happen,” Dr. Behm said. 

More flexibility in those areas allows your muscles to safely generate force at longer lengths. For an athlete, that means fewer injuries when they’re doing explosive movements or changing direction. 

For nonathletes, flexibility reduces injuries by improving balance. Better balance reduces the risk of falling and helps mitigate the damage if you do take a tumble.
 

Help Your Patients Get the Benefits of Stretching

Stretching, like training for endurance or strength, can be as complex as you want to make it. But Mr. Yoon advocates a simpler approach. 

“You see this flashy stuff online,” he said. “But if you see those trainers in real life or you book a session with them, they go right back to the basics.” 

Ideally, Mr. Yoon said, a flexibility routine will work the entire body. But if that’s too big a stretch for your patient, he recommends starting with one or two stretches for the most problematic area. 

For example, for a stiff back, try doing the puppy pose at least once a day, although twice is better. Hold the position for 30 seconds to 2 minutes, said Mr. Yoon. Even if you combine it with a dynamic movement like the cat-cow, the two exercises would take just a few minutes a day. 

“There’s this misconception that you have to do a lot of it to be successful,” Mr. Yoon said. 

Consistency is far more important than volume. Mr. Yoon recommends “a little bit every day — the minimum viable dose.” 

As a bonus, stretching an area like your upper back will probably improve your shoulder mobility, Mr. Yoon said. Same with your lower body: Stretches for your hips, over time, should also benefit your knees and lower back. 

And thanks to a phenomenon called nonlocal flexibility transfer, lower-body stretches should improve upper-body flexibility, at least temporarily. Shoulder stretches can also have an immediate effect on hip mobility. 

“It’s all connected,” Mr. Yoon said, which brings us back to where we started. 

If stretching can indeed reduce mortality risk, it’s probably because of interconnected pathways, rather than any single mechanism. 

Most obviously, stretching improves flexibility, which makes movement easier, improves balance, and reduces the risk for falls and other types of injuries. It can also lead to small improvements in strength. Less obviously, stretching improves several aspects of cardiovascular function, including circulation. 

“There seems to be a global effect in everything we do,” Dr. Behm said. “Whether you’re stretching or weight training, the message is sent throughout your body."

A version of this article appeared on Medscape.com.

For many, stretching is the fitness equivalent of awkward small talk. It’s the opening act, the thing you tolerate because you know it will be over soon. 

Others have challenged the practice, suggesting that stretching isn’t necessary at all. Some research has found that a preworkout stretch may even be disadvantageous, weakening muscles and hindering performance.

To put it plainly, no one seems terribly enthusiastic about touching their toes. 

That’s why a 2020 study on exercise and mortality was such a head-scratcher. The study found that stretching was uniquely associated with a lower risk for all-cause mortality among American adults. That’s after controlling for participation in other types of exercise. 

The finding seemed like a fluke, until a 2023 study found essentially the same thing. 

Among Korean adults, those who did flexibility exercise at least five times a week had a 20% lower risk of dying during the follow-up period than those who didn’t stretch at all. That was slightly better than the risk reduction associated with high volumes of aerobic exercise and resistance training. 

How can that be ? It turns out, stretching is linked to several health benefits that you might not expect.
 

The Surprising Benefits of Stretching

When we talk about stretching, we usually mean static stretching — getting into and holding a position that challenges a muscle, with the goal of improving range of motion around a joint. 

It doesn’t need to be a big challenge. “Research shows you can get increases in flexibility by stretching to the initial point of discomfort,” said David Behm, PhD, an exercise scientist at Memorial University of Newfoundland in Canada who’s published dozens of studies on stretching over the past quarter-century. 

That brings us to the first benefit.
 

Stretching Benefit #1: More Strength

At first glance, flexibility training and strength training have little in common. You lengthen muscles in the former and contract them in the latter. 

But in both cases, Dr. Behm said, you’re applying tension to muscles and connective tissues. Tension activates proteins called integrins, which send and receive signals across cellular membranes. Those signals are the start of a cascade that leads to protein synthesis. That’s how muscles get bigger and stronger when you lift weights. 

That mechanism could explain the small gains in muscle strength and size associated with static stretching, Dr. Behm said. 

But can you really stretch your way to muscle growth? Theoretically, yes. But strength training is far more time-efficient, Dr. Behm says. Studies showing increases in muscle mass have typically stretched a single muscle (usually the calves, using a specialized device) for > 30 min/session, 6 d/wk for 6 weeks. And that’s for just one leg.

Still, stretching may be more accessible for some patients — research suggested that older and more sedentary people are most likely to benefit from stretching-induced gains in strength.

 

Stretching Benefit #2: Reduced Arterial Stiffness

“Most people don’t think about the cardiovascular benefits of stretching,” Dr. Behm said. There are some big ones. 

If your body doesn’t move well, it’s not unreasonable to assume your blood doesn’t flow well. That is indeed the case: Poor flexibility is associated with arterial stiffness. 

Stretching is associated not only with improved arterial function but also with reductions in resting heart rate and blood pressure and increased vasodilation.

Mobility improvements may have an indirect benefit on cardiovascular health as well. 

“Studies show runners are more economical when they’re more flexible,” Dr. Behm said. If your movement is more efficient, you’ll probably do more of it. Doing more, in turn, would lead to improved fitness. 
 

Stretching Benefit #3: Improved Performance

Research is equivocal on whether stretching improves athletic performance, said Joe Yoon, a sports massage therapist in Orlando, Florida, and author of Better Stretching. 

“But I’ve always taken the approach that if you can improve your range of motion and get into positions” required for your sport, you’ll probably perform better, with less risk for injury, Mr. Yoon said. 

It’s worth noting that some research over the past 30 years has linked pre-exercise static stretching with a loss of strength, power, and/or speed. 

But consider this: In a 2016 review, Dr. Behm and his coauthors showed that performance reductions were most likely to occur in two situations: 

When participants did extremely long stretches (duration, ≥ 60 sec per muscle).

When researchers tested the participants’ strength, power, or speed immediately after they stretched.

Avoiding those problems is easy, Dr. Behm said: Stretch each muscle for < 60 sec, and combine static stretches with more active warm-up exercises. 

“Stretching can impair your performance but only if you do it wrong,” he said.
 

Stretching Benefit #4: Fewer Injuries

When you stretch, the point where you feel tension is where the muscle is most vulnerable. “That’s where injuries usually happen,” Dr. Behm said. 

More flexibility in those areas allows your muscles to safely generate force at longer lengths. For an athlete, that means fewer injuries when they’re doing explosive movements or changing direction. 

For nonathletes, flexibility reduces injuries by improving balance. Better balance reduces the risk of falling and helps mitigate the damage if you do take a tumble.
 

Help Your Patients Get the Benefits of Stretching

Stretching, like training for endurance or strength, can be as complex as you want to make it. But Mr. Yoon advocates a simpler approach. 

“You see this flashy stuff online,” he said. “But if you see those trainers in real life or you book a session with them, they go right back to the basics.” 

Ideally, Mr. Yoon said, a flexibility routine will work the entire body. But if that’s too big a stretch for your patient, he recommends starting with one or two stretches for the most problematic area. 

For example, for a stiff back, try doing the puppy pose at least once a day, although twice is better. Hold the position for 30 seconds to 2 minutes, said Mr. Yoon. Even if you combine it with a dynamic movement like the cat-cow, the two exercises would take just a few minutes a day. 

“There’s this misconception that you have to do a lot of it to be successful,” Mr. Yoon said. 

Consistency is far more important than volume. Mr. Yoon recommends “a little bit every day — the minimum viable dose.” 

As a bonus, stretching an area like your upper back will probably improve your shoulder mobility, Mr. Yoon said. Same with your lower body: Stretches for your hips, over time, should also benefit your knees and lower back. 

And thanks to a phenomenon called nonlocal flexibility transfer, lower-body stretches should improve upper-body flexibility, at least temporarily. Shoulder stretches can also have an immediate effect on hip mobility. 

“It’s all connected,” Mr. Yoon said, which brings us back to where we started. 

If stretching can indeed reduce mortality risk, it’s probably because of interconnected pathways, rather than any single mechanism. 

Most obviously, stretching improves flexibility, which makes movement easier, improves balance, and reduces the risk for falls and other types of injuries. It can also lead to small improvements in strength. Less obviously, stretching improves several aspects of cardiovascular function, including circulation. 

“There seems to be a global effect in everything we do,” Dr. Behm said. “Whether you’re stretching or weight training, the message is sent throughout your body."

A version of this article appeared on Medscape.com.

For many, stretching is the fitness equivalent of awkward small talk. It’s the opening act, the thing you tolerate because you know it will be over soon. 

Others have challenged the practice, suggesting that stretching isn’t necessary at all. Some research has found that a preworkout stretch may even be disadvantageous, weakening muscles and hindering performance.

To put it plainly, no one seems terribly enthusiastic about touching their toes. 

That’s why a 2020 study on exercise and mortality was such a head-scratcher. The study found that stretching was uniquely associated with a lower risk for all-cause mortality among American adults. That’s after controlling for participation in other types of exercise. 

The finding seemed like a fluke, until a 2023 study found essentially the same thing. 

Among Korean adults, those who did flexibility exercise at least five times a week had a 20% lower risk of dying during the follow-up period than those who didn’t stretch at all. That was slightly better than the risk reduction associated with high volumes of aerobic exercise and resistance training. 

How can that be ? It turns out, stretching is linked to several health benefits that you might not expect.
 

The Surprising Benefits of Stretching

When we talk about stretching, we usually mean static stretching — getting into and holding a position that challenges a muscle, with the goal of improving range of motion around a joint. 

It doesn’t need to be a big challenge. “Research shows you can get increases in flexibility by stretching to the initial point of discomfort,” said David Behm, PhD, an exercise scientist at Memorial University of Newfoundland in Canada who’s published dozens of studies on stretching over the past quarter-century. 

That brings us to the first benefit.
 

Stretching Benefit #1: More Strength

At first glance, flexibility training and strength training have little in common. You lengthen muscles in the former and contract them in the latter. 

But in both cases, Dr. Behm said, you’re applying tension to muscles and connective tissues. Tension activates proteins called integrins, which send and receive signals across cellular membranes. Those signals are the start of a cascade that leads to protein synthesis. That’s how muscles get bigger and stronger when you lift weights. 

That mechanism could explain the small gains in muscle strength and size associated with static stretching, Dr. Behm said. 

But can you really stretch your way to muscle growth? Theoretically, yes. But strength training is far more time-efficient, Dr. Behm says. Studies showing increases in muscle mass have typically stretched a single muscle (usually the calves, using a specialized device) for > 30 min/session, 6 d/wk for 6 weeks. And that’s for just one leg.

Still, stretching may be more accessible for some patients — research suggested that older and more sedentary people are most likely to benefit from stretching-induced gains in strength.

 

Stretching Benefit #2: Reduced Arterial Stiffness

“Most people don’t think about the cardiovascular benefits of stretching,” Dr. Behm said. There are some big ones. 

If your body doesn’t move well, it’s not unreasonable to assume your blood doesn’t flow well. That is indeed the case: Poor flexibility is associated with arterial stiffness. 

Stretching is associated not only with improved arterial function but also with reductions in resting heart rate and blood pressure and increased vasodilation.

Mobility improvements may have an indirect benefit on cardiovascular health as well. 

“Studies show runners are more economical when they’re more flexible,” Dr. Behm said. If your movement is more efficient, you’ll probably do more of it. Doing more, in turn, would lead to improved fitness. 
 

Stretching Benefit #3: Improved Performance

Research is equivocal on whether stretching improves athletic performance, said Joe Yoon, a sports massage therapist in Orlando, Florida, and author of Better Stretching. 

“But I’ve always taken the approach that if you can improve your range of motion and get into positions” required for your sport, you’ll probably perform better, with less risk for injury, Mr. Yoon said. 

It’s worth noting that some research over the past 30 years has linked pre-exercise static stretching with a loss of strength, power, and/or speed. 

But consider this: In a 2016 review, Dr. Behm and his coauthors showed that performance reductions were most likely to occur in two situations: 

When participants did extremely long stretches (duration, ≥ 60 sec per muscle).

When researchers tested the participants’ strength, power, or speed immediately after they stretched.

Avoiding those problems is easy, Dr. Behm said: Stretch each muscle for < 60 sec, and combine static stretches with more active warm-up exercises. 

“Stretching can impair your performance but only if you do it wrong,” he said.
 

Stretching Benefit #4: Fewer Injuries

When you stretch, the point where you feel tension is where the muscle is most vulnerable. “That’s where injuries usually happen,” Dr. Behm said. 

More flexibility in those areas allows your muscles to safely generate force at longer lengths. For an athlete, that means fewer injuries when they’re doing explosive movements or changing direction. 

For nonathletes, flexibility reduces injuries by improving balance. Better balance reduces the risk of falling and helps mitigate the damage if you do take a tumble.
 

Help Your Patients Get the Benefits of Stretching

Stretching, like training for endurance or strength, can be as complex as you want to make it. But Mr. Yoon advocates a simpler approach. 

“You see this flashy stuff online,” he said. “But if you see those trainers in real life or you book a session with them, they go right back to the basics.” 

Ideally, Mr. Yoon said, a flexibility routine will work the entire body. But if that’s too big a stretch for your patient, he recommends starting with one or two stretches for the most problematic area. 

For example, for a stiff back, try doing the puppy pose at least once a day, although twice is better. Hold the position for 30 seconds to 2 minutes, said Mr. Yoon. Even if you combine it with a dynamic movement like the cat-cow, the two exercises would take just a few minutes a day. 

“There’s this misconception that you have to do a lot of it to be successful,” Mr. Yoon said. 

Consistency is far more important than volume. Mr. Yoon recommends “a little bit every day — the minimum viable dose.” 

As a bonus, stretching an area like your upper back will probably improve your shoulder mobility, Mr. Yoon said. Same with your lower body: Stretches for your hips, over time, should also benefit your knees and lower back. 

And thanks to a phenomenon called nonlocal flexibility transfer, lower-body stretches should improve upper-body flexibility, at least temporarily. Shoulder stretches can also have an immediate effect on hip mobility. 

“It’s all connected,” Mr. Yoon said, which brings us back to where we started. 

If stretching can indeed reduce mortality risk, it’s probably because of interconnected pathways, rather than any single mechanism. 

Most obviously, stretching improves flexibility, which makes movement easier, improves balance, and reduces the risk for falls and other types of injuries. It can also lead to small improvements in strength. Less obviously, stretching improves several aspects of cardiovascular function, including circulation. 

“There seems to be a global effect in everything we do,” Dr. Behm said. “Whether you’re stretching or weight training, the message is sent throughout your body."

A version of this article appeared on Medscape.com.

When skin diseases affect the palm or sole, they can have a disproportionately large negative effect on patients' lives. Hand and foot dermatitis can be disabling. Simpson and colleagues find that dupilumab is an effective treatment for AD of the hands and feet. Having safe and effective treatment for hand and foot dermatitis will be life-changing for many of our patients.

Patients often do very well with biologic treatment. When they do, they often wonder, Do I need to continue taking the medication? Lasheras-Pérez and colleagues found that the great majority of patients doing well taking dupilumab for AD could stretch out their dosing interval. I suspect a lot of our patients are doing this already. I used to worry that stretching out the dosing interval might lead to antidrug antibodies and loss of activity. Such loss of activity doesn't appear common. Because we also have multiple alternative treatments for severe AD, I think it may be quite reasonable for patients to try spreading out their doses after their disease has been well controlled for a good long time.

Superficial skin infections aren't rare in children, particularly children with AD. Paller and colleagues' study is informative about the safety of dupilumab in children. The drug, which blocks a pathway of the immune system, was associated with fewer infections. This is good news. The reduction in infections could be through restoring "immune balance" (whatever that means) or by improving skin barrier function. Perhaps the low rate of infection explains why dupilumab is not considered immunosuppressive.

I love studies of drug survival because I think that knowing the percentage of patients who stay with drug treatment is a good measure of overall safety and efficacy. Pezzolo and colleagues found — perhaps not surprisingly given the extraordinary efficacy of upadacitinib for AD — that almost no one discontinued the drug over 1.5 years due to lack of efficacy. There were patients who discontinued due to adverse events (and additional patients lost to follow-up who perhaps also discontinued the drug), but 80% of patients were still in the study at the end of 1.5 years. Three patients who weren't vaccinated for shingles developed shingles; encouraging patients to get the shingles vaccine may be a prudent measure when starting patients taking upadacitinib. 
 

When skin diseases affect the palm or sole, they can have a disproportionately large negative effect on patients' lives. Hand and foot dermatitis can be disabling. Simpson and colleagues find that dupilumab is an effective treatment for AD of the hands and feet. Having safe and effective treatment for hand and foot dermatitis will be life-changing for many of our patients.

Patients often do very well with biologic treatment. When they do, they often wonder, Do I need to continue taking the medication? Lasheras-Pérez and colleagues found that the great majority of patients doing well taking dupilumab for AD could stretch out their dosing interval. I suspect a lot of our patients are doing this already. I used to worry that stretching out the dosing interval might lead to antidrug antibodies and loss of activity. Such loss of activity doesn't appear common. Because we also have multiple alternative treatments for severe AD, I think it may be quite reasonable for patients to try spreading out their doses after their disease has been well controlled for a good long time.

Superficial skin infections aren't rare in children, particularly children with AD. Paller and colleagues' study is informative about the safety of dupilumab in children. The drug, which blocks a pathway of the immune system, was associated with fewer infections. This is good news. The reduction in infections could be through restoring "immune balance" (whatever that means) or by improving skin barrier function. Perhaps the low rate of infection explains why dupilumab is not considered immunosuppressive.

I love studies of drug survival because I think that knowing the percentage of patients who stay with drug treatment is a good measure of overall safety and efficacy. Pezzolo and colleagues found — perhaps not surprisingly given the extraordinary efficacy of upadacitinib for AD — that almost no one discontinued the drug over 1.5 years due to lack of efficacy. There were patients who discontinued due to adverse events (and additional patients lost to follow-up who perhaps also discontinued the drug), but 80% of patients were still in the study at the end of 1.5 years. Three patients who weren't vaccinated for shingles developed shingles; encouraging patients to get the shingles vaccine may be a prudent measure when starting patients taking upadacitinib. 
 

When skin diseases affect the palm or sole, they can have a disproportionately large negative effect on patients' lives. Hand and foot dermatitis can be disabling. Simpson and colleagues find that dupilumab is an effective treatment for AD of the hands and feet. Having safe and effective treatment for hand and foot dermatitis will be life-changing for many of our patients.

Patients often do very well with biologic treatment. When they do, they often wonder, Do I need to continue taking the medication? Lasheras-Pérez and colleagues found that the great majority of patients doing well taking dupilumab for AD could stretch out their dosing interval. I suspect a lot of our patients are doing this already. I used to worry that stretching out the dosing interval might lead to antidrug antibodies and loss of activity. Such loss of activity doesn't appear common. Because we also have multiple alternative treatments for severe AD, I think it may be quite reasonable for patients to try spreading out their doses after their disease has been well controlled for a good long time.

Superficial skin infections aren't rare in children, particularly children with AD. Paller and colleagues' study is informative about the safety of dupilumab in children. The drug, which blocks a pathway of the immune system, was associated with fewer infections. This is good news. The reduction in infections could be through restoring "immune balance" (whatever that means) or by improving skin barrier function. Perhaps the low rate of infection explains why dupilumab is not considered immunosuppressive.

I love studies of drug survival because I think that knowing the percentage of patients who stay with drug treatment is a good measure of overall safety and efficacy. Pezzolo and colleagues found — perhaps not surprisingly given the extraordinary efficacy of upadacitinib for AD — that almost no one discontinued the drug over 1.5 years due to lack of efficacy. There were patients who discontinued due to adverse events (and additional patients lost to follow-up who perhaps also discontinued the drug), but 80% of patients were still in the study at the end of 1.5 years. Three patients who weren't vaccinated for shingles developed shingles; encouraging patients to get the shingles vaccine may be a prudent measure when starting patients taking upadacitinib. 
 

TOPLINE:

Scents that trigger specific, vivid autobiographical memories (AMs) could improve deficits in memory recall in patients with major depressive disorder (MDD), new research suggests. Investigators found that odor cues may be a stronger tool than word cues for improving memory, which could help reduce MDD symptoms.

METHODOLOGY:

• Participants included 32 individuals aged 18-55 years (mean age, 30 years; 26 females) with a diagnosis of MDD recruited from the community.
• Those with psychosis, bipolar I or II, neurological disorders, or drug or alcohol abuse were excluded.
• Participants were presented with a series of 12 words and 12 odors, such as cough syrup, tobacco ash, and Vicks VapoRub, and asked to recall a specific memory in response to each cue.
• AMs were rated in terms of vividness, frequency, and whether they were associated with positive or negative emotions.

TAKEAWAY:

• Although participants only guessed correct stimulus odors 30% of the time, they recalled more specific memories from odor cues than from word cues (68% vs 52%; P < .001).
• Odor-cued recall was more arousing and vivid (P < .001) than recall responses generated by word cues.
• Compared with the population mean for responses to word cues in healthy controls, study participants recalled fewer specific memories in response to words (P < .001), but the percentage of specific memories recalled in response to odor cues did not differ from the healthy control population mean.
• Investigators hoped to further their research by investigating the mechanisms underlying odor-cued AMs, particularly to test if the amygdala and hippocampus are activated during recall.

IN PRACTICE:

“This study suggests the potential for increasing autobiographical memory specificity in individuals with MDD, with the future goal of reducing depression symptoms for this population and informing a better understanding of the neural mechanisms influencing odor-based AM recall,” the authors wrote. “We hope this initial study spurs larger studies in more diverse samples that include healthy control participants to further investigate and explain these associations.”

SOURCE:

Kymberly D. Young, PhD, of the University of Pittsburgh, Pennsylvania, led the study, which was published online on February 13, 2024, in JAMA Network Open. 

LIMITATIONS:

Study limitations included the lack of a healthy control group and the small sample size. 

DISCLOSURES:

The study was funded internally by the University of Pittsburgh School of Medicine, Pennsylvania. No disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Scents that trigger specific, vivid autobiographical memories (AMs) could improve deficits in memory recall in patients with major depressive disorder (MDD), new research suggests. Investigators found that odor cues may be a stronger tool than word cues for improving memory, which could help reduce MDD symptoms.

METHODOLOGY:

• Participants included 32 individuals aged 18-55 years (mean age, 30 years; 26 females) with a diagnosis of MDD recruited from the community.
• Those with psychosis, bipolar I or II, neurological disorders, or drug or alcohol abuse were excluded.
• Participants were presented with a series of 12 words and 12 odors, such as cough syrup, tobacco ash, and Vicks VapoRub, and asked to recall a specific memory in response to each cue.
• AMs were rated in terms of vividness, frequency, and whether they were associated with positive or negative emotions.

TAKEAWAY:

• Although participants only guessed correct stimulus odors 30% of the time, they recalled more specific memories from odor cues than from word cues (68% vs 52%; P < .001).
• Odor-cued recall was more arousing and vivid (P < .001) than recall responses generated by word cues.
• Compared with the population mean for responses to word cues in healthy controls, study participants recalled fewer specific memories in response to words (P < .001), but the percentage of specific memories recalled in response to odor cues did not differ from the healthy control population mean.
• Investigators hoped to further their research by investigating the mechanisms underlying odor-cued AMs, particularly to test if the amygdala and hippocampus are activated during recall.

IN PRACTICE:

“This study suggests the potential for increasing autobiographical memory specificity in individuals with MDD, with the future goal of reducing depression symptoms for this population and informing a better understanding of the neural mechanisms influencing odor-based AM recall,” the authors wrote. “We hope this initial study spurs larger studies in more diverse samples that include healthy control participants to further investigate and explain these associations.”

SOURCE:

Kymberly D. Young, PhD, of the University of Pittsburgh, Pennsylvania, led the study, which was published online on February 13, 2024, in JAMA Network Open. 

LIMITATIONS:

Study limitations included the lack of a healthy control group and the small sample size. 

DISCLOSURES:

The study was funded internally by the University of Pittsburgh School of Medicine, Pennsylvania. No disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Scents that trigger specific, vivid autobiographical memories (AMs) could improve deficits in memory recall in patients with major depressive disorder (MDD), new research suggests. Investigators found that odor cues may be a stronger tool than word cues for improving memory, which could help reduce MDD symptoms.

METHODOLOGY:

• Participants included 32 individuals aged 18-55 years (mean age, 30 years; 26 females) with a diagnosis of MDD recruited from the community.
• Those with psychosis, bipolar I or II, neurological disorders, or drug or alcohol abuse were excluded.
• Participants were presented with a series of 12 words and 12 odors, such as cough syrup, tobacco ash, and Vicks VapoRub, and asked to recall a specific memory in response to each cue.
• AMs were rated in terms of vividness, frequency, and whether they were associated with positive or negative emotions.

TAKEAWAY:

• Although participants only guessed correct stimulus odors 30% of the time, they recalled more specific memories from odor cues than from word cues (68% vs 52%; P < .001).
• Odor-cued recall was more arousing and vivid (P < .001) than recall responses generated by word cues.
• Compared with the population mean for responses to word cues in healthy controls, study participants recalled fewer specific memories in response to words (P < .001), but the percentage of specific memories recalled in response to odor cues did not differ from the healthy control population mean.
• Investigators hoped to further their research by investigating the mechanisms underlying odor-cued AMs, particularly to test if the amygdala and hippocampus are activated during recall.

IN PRACTICE:

“This study suggests the potential for increasing autobiographical memory specificity in individuals with MDD, with the future goal of reducing depression symptoms for this population and informing a better understanding of the neural mechanisms influencing odor-based AM recall,” the authors wrote. “We hope this initial study spurs larger studies in more diverse samples that include healthy control participants to further investigate and explain these associations.”

SOURCE:

Kymberly D. Young, PhD, of the University of Pittsburgh, Pennsylvania, led the study, which was published online on February 13, 2024, in JAMA Network Open. 

LIMITATIONS:

Study limitations included the lack of a healthy control group and the small sample size. 

DISCLOSURES:

The study was funded internally by the University of Pittsburgh School of Medicine, Pennsylvania. No disclosures were reported.

A version of this article appeared on Medscape.com.

Calling the matter “a danger the public should not be forced to shoulder,” a federal judge has rejected a plea to temporarily restore the scores of 832 medical graduates from Nepal who are suspected of cheating on the United States Medical Licensing Exam (USMLE). 

In a February 23 order, Judge Christopher R. Cooper, of the US District Court for the District of Columbia, denied Latika Giri’s emergency motion to block the National Board of Medical Examiners (NBME) from invalidating the scores, ruling the public interest plainly weighs against granting the request. 

“First and foremost, is the overriding interest in public safety,” Cooper wrote in his 32-page order. “This is a case about the credentials of doctors applying to medical residency programs…Granting the preliminary injunction would create an unacceptable risk that individuals who lack the requisite knowledge and skills they purport to possess because they achieved their exam scores fraudulently will be administering medical care to unsuspecting patients across the nation.”

Attorneys for Giri did not return messages seeking comment about the order. 

The NBME also did not return messages seeking comment. The board previously said it does not comment on pending litigation. 

The decision is the latest development in a widespread cheating scandal. Giri, an international medical graduate (IMG) from Kathmandu, sued NBME earlier this month claiming the board discriminated against Nepali medical graduates when it invalidated hundreds of exam scores linked to the country. 

Giri also accused NBME of violating its own procedures when it voided the scores before giving examinees a chance to argue and appeal. She asked the district court to block NBME from invalidating her exam scores while the lawsuit continues and restore her original results. 

In court documents, NBME argued that it did not invalidate the scores because the examinees were Nepali but because staff concluded that there was “a good faith basis for questioning the validity of the scores.” 

The invalidations were based on concerns that the results reflected prior access to secure exam content rather than knowledge and understanding of the medical principles and skills the exams are intended to assess, according to the NBME’s legal response. 

“The USMLE program took reasonable and appropriate actions to prevent the significant harm and disruption that would result from allowing potentially unqualified individuals to participate in the 2024 residency Match,” the NBME stated in court documents. “If granted, the requested injunction would cause enormous harm not only to NBME… but also to state licensing authorities, which rely upon USMLE results to help ensure that physicians have the minimum competencies needed to provide safe and effective health care.”

In his order, Cooper wrote that Giri has not proven the board’s actions were discriminatory against Nepali doctors. 

“Nothing in the present record suggests that NBME went looking for a problem in Nepal out of ethnicity-or national-origin based [sic] suspicion,” Cooper wrote. “[It] followed the trail of evidence, including tips about organized cheating taking place in medical schools and at a testing center located in Nepal, and on an online forum for which a ‘nexus to Nepal’ was a ticket to admission.”

NBME: Nepal Outperformed All Other Countries on USMLE 

Court documents shed more light on NBME’s investigation into the suspected cheating and on the anomalous patterns the board allegedly discovered from Nepal medical graduates. 

In response to anonymous tips, the USMLE program in early 2023 asked the NBME Psychometrics and Data Analysis (PADA) unit to analyze examinee performance data for test centers in Jordan, Nepal, and Pakistan, according to court records. Within the initial data analysis, the data involving the single test center in Nepal was “the most extreme,” the unit found. 

Out of more than 400 test centers across the world, including those in the United States, the test center in Nepal produced the highest test scores in the world for Step 1 in 2021 and 2022 and the highest test scores in the world for Step 2 CK in 2022, according to court documents. For the 2022 Step 1 exam for example, the average score of examinees testing in the Nepal test center was 240. No other test center in the world had an average examinee score above 227, according to the NBME’s legal response. 

The median item response time for examinees who tested at the Nepal test center in 2022 was also among the fastest of all international test centers for Step 1 and Step 2 CK, investigators found. 

In addition, the volume of examinees taking the USMLE Step 1 and Step 2 CK at the Nepal test center in Nepal had sharply increased. Step 1 volume more than doubled in the Nepal test center from 281 examinees in 2019 to 662 examinees in 2022, according to court documents. 

The rapid increase continued in 2023, when examinee volume was nearly three-and-a-half times higher than the 2019 volume. The data were consistent with anonymous tips received by the USMLE program office, suggesting there may be wide-scale collection and sharing of live USMLE exam content within Nepal. 

Investigation Finds Similar Correct and Incorrect Answers 

Agreement similarity among the exams analyzed also raised red flags. Investigators ran an “agreement analysis” for all examinees who tested at centers in Jordan, Nepal, and Pakistan as well as two centers in India, according to court documents. 

For the 2022 Step 1 exam and the 2021 and 2022 Step 2 CK exam, the analysis showed a substantially higher percentage of examinees with a statistically significant level of agreement matches in the examine group that tested at centers in Jordan, Nepal, Pakistan, and India compared with the baseline group, according to legal records. 

The vast majority of examinees with a statistically significant number of matching incorrect answers tested at the Nepal test center, data showed. 

Further analysis found that examinee volumes increased considerably at the Nepal test center in the months prior to the USMLE program releasing new test items, “suggesting that candidates who had prior access to disclosed exam questions wanted to test before new questions came into the item pool.”

Investigators also identified posts on social medial and in online chat rooms suggesting groups were collecting and sharing large amounts of secure exam material in private groups. Some posts advised examinees to use the full examination time when taking the USMLE “to avoid raising suspicion about having had prior access to secure exam materials,” according to court documents. 

From its investigation and analysis, the USMLE program identified 832 examinees who had passing level exam results whose validity the USMLE program had a significant and good faith basis for questioning, according to court records. 

Of the total, 618 examinees had one Step score flagged as being of questioned validity, 202 examinees had two Step exam scores flagged, and 12 examinees had scores flagged on all three Step exams. 

NBME Defends Departure From Traditional Procedures

In court documents, NBME disputed claims that it violated its own procedures by invalidating the exam scores. Giri’s report contends that examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal — during which time, their scores are treated as valid. 

But the NBME said the USMLE program is authorized to take any actions it deems appropriate in response to concerns regarding score validity if the USMLE Committee for Individualized Review or the USMLE Composite Committee concludes that alternative or supplemental procedures are warranted in response to a given set of facts or circumstances. 

“Following the month-long investigation and analysis…the USMLE program concluded that alternative procedures were warranted to address the score invalidity concerns identified in the interest of providing a process that is timely, efficient, effective, and fair, and given the large number of examinees involved in the investigation,” the board stated in its legal response. 

In his order, Cooper wrote the current scenario, which implicates that more than 800 test-takers, is “clearly a situation calling for a procedure geared toward efficiency.” No evidence shows the board would not have taken similarly swift action if confronted with evidence of cheating on a comparable scale elsewhere, he wrote. 

The judge also denied Giri’s motion to certify the lawsuit as a class action. The motion was denied without prejudice, meaning the plaintiff has the option to renew the motion should the case proceed. 

A version of this article appeared on Medscape.com.

Calling the matter “a danger the public should not be forced to shoulder,” a federal judge has rejected a plea to temporarily restore the scores of 832 medical graduates from Nepal who are suspected of cheating on the United States Medical Licensing Exam (USMLE). 

In a February 23 order, Judge Christopher R. Cooper, of the US District Court for the District of Columbia, denied Latika Giri’s emergency motion to block the National Board of Medical Examiners (NBME) from invalidating the scores, ruling the public interest plainly weighs against granting the request. 

“First and foremost, is the overriding interest in public safety,” Cooper wrote in his 32-page order. “This is a case about the credentials of doctors applying to medical residency programs…Granting the preliminary injunction would create an unacceptable risk that individuals who lack the requisite knowledge and skills they purport to possess because they achieved their exam scores fraudulently will be administering medical care to unsuspecting patients across the nation.”

Attorneys for Giri did not return messages seeking comment about the order. 

The NBME also did not return messages seeking comment. The board previously said it does not comment on pending litigation. 

The decision is the latest development in a widespread cheating scandal. Giri, an international medical graduate (IMG) from Kathmandu, sued NBME earlier this month claiming the board discriminated against Nepali medical graduates when it invalidated hundreds of exam scores linked to the country. 

Giri also accused NBME of violating its own procedures when it voided the scores before giving examinees a chance to argue and appeal. She asked the district court to block NBME from invalidating her exam scores while the lawsuit continues and restore her original results. 

In court documents, NBME argued that it did not invalidate the scores because the examinees were Nepali but because staff concluded that there was “a good faith basis for questioning the validity of the scores.” 

The invalidations were based on concerns that the results reflected prior access to secure exam content rather than knowledge and understanding of the medical principles and skills the exams are intended to assess, according to the NBME’s legal response. 

“The USMLE program took reasonable and appropriate actions to prevent the significant harm and disruption that would result from allowing potentially unqualified individuals to participate in the 2024 residency Match,” the NBME stated in court documents. “If granted, the requested injunction would cause enormous harm not only to NBME… but also to state licensing authorities, which rely upon USMLE results to help ensure that physicians have the minimum competencies needed to provide safe and effective health care.”

In his order, Cooper wrote that Giri has not proven the board’s actions were discriminatory against Nepali doctors. 

“Nothing in the present record suggests that NBME went looking for a problem in Nepal out of ethnicity-or national-origin based [sic] suspicion,” Cooper wrote. “[It] followed the trail of evidence, including tips about organized cheating taking place in medical schools and at a testing center located in Nepal, and on an online forum for which a ‘nexus to Nepal’ was a ticket to admission.”

NBME: Nepal Outperformed All Other Countries on USMLE 

Court documents shed more light on NBME’s investigation into the suspected cheating and on the anomalous patterns the board allegedly discovered from Nepal medical graduates. 

In response to anonymous tips, the USMLE program in early 2023 asked the NBME Psychometrics and Data Analysis (PADA) unit to analyze examinee performance data for test centers in Jordan, Nepal, and Pakistan, according to court records. Within the initial data analysis, the data involving the single test center in Nepal was “the most extreme,” the unit found. 

Out of more than 400 test centers across the world, including those in the United States, the test center in Nepal produced the highest test scores in the world for Step 1 in 2021 and 2022 and the highest test scores in the world for Step 2 CK in 2022, according to court documents. For the 2022 Step 1 exam for example, the average score of examinees testing in the Nepal test center was 240. No other test center in the world had an average examinee score above 227, according to the NBME’s legal response. 

The median item response time for examinees who tested at the Nepal test center in 2022 was also among the fastest of all international test centers for Step 1 and Step 2 CK, investigators found. 

In addition, the volume of examinees taking the USMLE Step 1 and Step 2 CK at the Nepal test center in Nepal had sharply increased. Step 1 volume more than doubled in the Nepal test center from 281 examinees in 2019 to 662 examinees in 2022, according to court documents. 

The rapid increase continued in 2023, when examinee volume was nearly three-and-a-half times higher than the 2019 volume. The data were consistent with anonymous tips received by the USMLE program office, suggesting there may be wide-scale collection and sharing of live USMLE exam content within Nepal. 

Investigation Finds Similar Correct and Incorrect Answers 

Agreement similarity among the exams analyzed also raised red flags. Investigators ran an “agreement analysis” for all examinees who tested at centers in Jordan, Nepal, and Pakistan as well as two centers in India, according to court documents. 

For the 2022 Step 1 exam and the 2021 and 2022 Step 2 CK exam, the analysis showed a substantially higher percentage of examinees with a statistically significant level of agreement matches in the examine group that tested at centers in Jordan, Nepal, Pakistan, and India compared with the baseline group, according to legal records. 

The vast majority of examinees with a statistically significant number of matching incorrect answers tested at the Nepal test center, data showed. 

Further analysis found that examinee volumes increased considerably at the Nepal test center in the months prior to the USMLE program releasing new test items, “suggesting that candidates who had prior access to disclosed exam questions wanted to test before new questions came into the item pool.”

Investigators also identified posts on social medial and in online chat rooms suggesting groups were collecting and sharing large amounts of secure exam material in private groups. Some posts advised examinees to use the full examination time when taking the USMLE “to avoid raising suspicion about having had prior access to secure exam materials,” according to court documents. 

From its investigation and analysis, the USMLE program identified 832 examinees who had passing level exam results whose validity the USMLE program had a significant and good faith basis for questioning, according to court records. 

Of the total, 618 examinees had one Step score flagged as being of questioned validity, 202 examinees had two Step exam scores flagged, and 12 examinees had scores flagged on all three Step exams. 

NBME Defends Departure From Traditional Procedures

In court documents, NBME disputed claims that it violated its own procedures by invalidating the exam scores. Giri’s report contends that examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal — during which time, their scores are treated as valid. 

But the NBME said the USMLE program is authorized to take any actions it deems appropriate in response to concerns regarding score validity if the USMLE Committee for Individualized Review or the USMLE Composite Committee concludes that alternative or supplemental procedures are warranted in response to a given set of facts or circumstances. 

“Following the month-long investigation and analysis…the USMLE program concluded that alternative procedures were warranted to address the score invalidity concerns identified in the interest of providing a process that is timely, efficient, effective, and fair, and given the large number of examinees involved in the investigation,” the board stated in its legal response. 

In his order, Cooper wrote the current scenario, which implicates that more than 800 test-takers, is “clearly a situation calling for a procedure geared toward efficiency.” No evidence shows the board would not have taken similarly swift action if confronted with evidence of cheating on a comparable scale elsewhere, he wrote. 

The judge also denied Giri’s motion to certify the lawsuit as a class action. The motion was denied without prejudice, meaning the plaintiff has the option to renew the motion should the case proceed. 

A version of this article appeared on Medscape.com.

Calling the matter “a danger the public should not be forced to shoulder,” a federal judge has rejected a plea to temporarily restore the scores of 832 medical graduates from Nepal who are suspected of cheating on the United States Medical Licensing Exam (USMLE). 

In a February 23 order, Judge Christopher R. Cooper, of the US District Court for the District of Columbia, denied Latika Giri’s emergency motion to block the National Board of Medical Examiners (NBME) from invalidating the scores, ruling the public interest plainly weighs against granting the request. 

“First and foremost, is the overriding interest in public safety,” Cooper wrote in his 32-page order. “This is a case about the credentials of doctors applying to medical residency programs…Granting the preliminary injunction would create an unacceptable risk that individuals who lack the requisite knowledge and skills they purport to possess because they achieved their exam scores fraudulently will be administering medical care to unsuspecting patients across the nation.”

Attorneys for Giri did not return messages seeking comment about the order. 

The NBME also did not return messages seeking comment. The board previously said it does not comment on pending litigation. 

The decision is the latest development in a widespread cheating scandal. Giri, an international medical graduate (IMG) from Kathmandu, sued NBME earlier this month claiming the board discriminated against Nepali medical graduates when it invalidated hundreds of exam scores linked to the country. 

Giri also accused NBME of violating its own procedures when it voided the scores before giving examinees a chance to argue and appeal. She asked the district court to block NBME from invalidating her exam scores while the lawsuit continues and restore her original results. 

In court documents, NBME argued that it did not invalidate the scores because the examinees were Nepali but because staff concluded that there was “a good faith basis for questioning the validity of the scores.” 

The invalidations were based on concerns that the results reflected prior access to secure exam content rather than knowledge and understanding of the medical principles and skills the exams are intended to assess, according to the NBME’s legal response. 

“The USMLE program took reasonable and appropriate actions to prevent the significant harm and disruption that would result from allowing potentially unqualified individuals to participate in the 2024 residency Match,” the NBME stated in court documents. “If granted, the requested injunction would cause enormous harm not only to NBME… but also to state licensing authorities, which rely upon USMLE results to help ensure that physicians have the minimum competencies needed to provide safe and effective health care.”

In his order, Cooper wrote that Giri has not proven the board’s actions were discriminatory against Nepali doctors. 

“Nothing in the present record suggests that NBME went looking for a problem in Nepal out of ethnicity-or national-origin based [sic] suspicion,” Cooper wrote. “[It] followed the trail of evidence, including tips about organized cheating taking place in medical schools and at a testing center located in Nepal, and on an online forum for which a ‘nexus to Nepal’ was a ticket to admission.”

NBME: Nepal Outperformed All Other Countries on USMLE 

Court documents shed more light on NBME’s investigation into the suspected cheating and on the anomalous patterns the board allegedly discovered from Nepal medical graduates. 

In response to anonymous tips, the USMLE program in early 2023 asked the NBME Psychometrics and Data Analysis (PADA) unit to analyze examinee performance data for test centers in Jordan, Nepal, and Pakistan, according to court records. Within the initial data analysis, the data involving the single test center in Nepal was “the most extreme,” the unit found. 

Out of more than 400 test centers across the world, including those in the United States, the test center in Nepal produced the highest test scores in the world for Step 1 in 2021 and 2022 and the highest test scores in the world for Step 2 CK in 2022, according to court documents. For the 2022 Step 1 exam for example, the average score of examinees testing in the Nepal test center was 240. No other test center in the world had an average examinee score above 227, according to the NBME’s legal response. 

The median item response time for examinees who tested at the Nepal test center in 2022 was also among the fastest of all international test centers for Step 1 and Step 2 CK, investigators found. 

In addition, the volume of examinees taking the USMLE Step 1 and Step 2 CK at the Nepal test center in Nepal had sharply increased. Step 1 volume more than doubled in the Nepal test center from 281 examinees in 2019 to 662 examinees in 2022, according to court documents. 

The rapid increase continued in 2023, when examinee volume was nearly three-and-a-half times higher than the 2019 volume. The data were consistent with anonymous tips received by the USMLE program office, suggesting there may be wide-scale collection and sharing of live USMLE exam content within Nepal. 

Investigation Finds Similar Correct and Incorrect Answers 

Agreement similarity among the exams analyzed also raised red flags. Investigators ran an “agreement analysis” for all examinees who tested at centers in Jordan, Nepal, and Pakistan as well as two centers in India, according to court documents. 

For the 2022 Step 1 exam and the 2021 and 2022 Step 2 CK exam, the analysis showed a substantially higher percentage of examinees with a statistically significant level of agreement matches in the examine group that tested at centers in Jordan, Nepal, Pakistan, and India compared with the baseline group, according to legal records. 

The vast majority of examinees with a statistically significant number of matching incorrect answers tested at the Nepal test center, data showed. 

Further analysis found that examinee volumes increased considerably at the Nepal test center in the months prior to the USMLE program releasing new test items, “suggesting that candidates who had prior access to disclosed exam questions wanted to test before new questions came into the item pool.”

Investigators also identified posts on social medial and in online chat rooms suggesting groups were collecting and sharing large amounts of secure exam material in private groups. Some posts advised examinees to use the full examination time when taking the USMLE “to avoid raising suspicion about having had prior access to secure exam materials,” according to court documents. 

From its investigation and analysis, the USMLE program identified 832 examinees who had passing level exam results whose validity the USMLE program had a significant and good faith basis for questioning, according to court records. 

Of the total, 618 examinees had one Step score flagged as being of questioned validity, 202 examinees had two Step exam scores flagged, and 12 examinees had scores flagged on all three Step exams. 

NBME Defends Departure From Traditional Procedures

In court documents, NBME disputed claims that it violated its own procedures by invalidating the exam scores. Giri’s report contends that examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal — during which time, their scores are treated as valid. 

But the NBME said the USMLE program is authorized to take any actions it deems appropriate in response to concerns regarding score validity if the USMLE Committee for Individualized Review or the USMLE Composite Committee concludes that alternative or supplemental procedures are warranted in response to a given set of facts or circumstances. 

“Following the month-long investigation and analysis…the USMLE program concluded that alternative procedures were warranted to address the score invalidity concerns identified in the interest of providing a process that is timely, efficient, effective, and fair, and given the large number of examinees involved in the investigation,” the board stated in its legal response. 

In his order, Cooper wrote the current scenario, which implicates that more than 800 test-takers, is “clearly a situation calling for a procedure geared toward efficiency.” No evidence shows the board would not have taken similarly swift action if confronted with evidence of cheating on a comparable scale elsewhere, he wrote. 

The judge also denied Giri’s motion to certify the lawsuit as a class action. The motion was denied without prejudice, meaning the plaintiff has the option to renew the motion should the case proceed. 

A version of this article appeared on Medscape.com.

Imran Ali, MD, is not due for recertification in internal medicine for a few more years, but he already plans to forego the traditional 1-day exam and opt instead for a newer one, and what he hopes will prove less stressful approach to maintaining his credentials: The Longitudinal Knowledge Assessment (LKA).

Dr. Ali, assistant professor at the Icahn School of Medicine at Mount Sinai in New York City, is far from alone. Since the American Board of Internal Medicine (ABIM) launched the new method in 2022, approximately 80% of internists have chosen the LKA to maintain their board certification over the 10-year Maintenance of Certification (MOC) exam coupled with continuing education requirements.

“You have to keep learning. I think the LKA is good in that regard, as long as the questions are relevantly updated,” said Dr. Ali, who was first board-certified in 2018 and obtained his geriatrics certification in 2020.

Many other internists contend the MOC is too time-consuming and expensive and have taken action.

Some specialists, including a group of oncologists, argue the exam contains too much information that has become irrelevant to clinical practice. Members of the American College of Cardiology have even left ABIM over the certification process, as this news organization previously reported. After receiving criticism, the ABIM introduced longitudinal assessment as a less onerous means to maintain certification — although the group denies it succumbed to negative feedback.

One and Done, or More Flexibility?

Both the traditional 10-year exam and the LKA have their advantages and disadvantages, according to Helen Chen, MD, the chair of the Geriatric Medicine Board Exam–Writing Committee at ABIM.

The LKA is arguably easier to access and available for most internal medicine disciplines. It requires no preparation for studying, and internists can complete exam questions on their phone, computer, or tablet.

Participants receive 30 questions per quarter for 5 years. Feedback is immediate and includes links to references for further learning. Once the process is completed and a physician meets the performance standard, the next 5-year cycle begins.

Still, some physicians still prefer the traditional 10-year, long-form exam. Studying for the test can be intense and take months. Physicians also must travel to an exam center on a designated date. However, once the test is over, the certification test does not roll around for another decade.

“It’s really about choice. Some doctors want to sit down and do it all at once and get it over with; others prefer to do a few questions at a time and never feel rushed,” said Dr. Chen, who is triple-boarded in geriatrics, internal medicine, and hospice and palliative medicine.

In 2022, Dr. Chen opted to begin the LKA cycle; a cross-country move and new job would not have allowed her enough time to prepare for the long-form exam, she said.

The new exam challenged her knowledge in smaller bites, provided immediate feedback, and allowed her to satisfy her curiosity through additional reading, she said, even if some questions were not relevant to her clinical practice.

The LKA is not yet as specialized, and ABIM is working to refine questions to be more relevant for some subspecialties.

Questions for both the LKA and long-form exam are developed from physician input, according to Dr. Chen. They are regularly assessed for relevance, accuracy, and changes to practice guidelines.

She acknowledged that questions can sometimes become outdated in a relatively short time, particularly for those taking the 10-year exam. But feedback from physicians helps committees analyze the relevancy of questions and how intensely an area should be tested. Committee members will even throw out questions if the literature changes significantly.

An Unnecessary Exercise

As criticism has mounted over the MOC, physicians have questioned whether recertification is necessary.

According to a survey of 1700 members of the American Society of Clinical Oncology (ASCO), most (64%) backed initial ABIM certification, but three quarters said the recertification process did not benefit their knowledge of clinical practice. More than 80% reported that Continuing Medical Education (CME) credits should suffice for ongoing learning, without having to be supplemented by the MOC exam. ASCO is considering alternative pathways to the current process based on their member feedback and plans to release a proposal to members in the first half of 2024.

Meanwhile, some cardiologists have called the MOC process “an onerous and unnecessary addition to continuing medical education requirements they already must meet at the state and hospital levels.”

The ABIM responded in part in a recent JAMA Viewpoint written by several members of the ABIM board of directors. They said board-certified physicians save the health system about $5 billion annually, compared with those who are not.

“Patients who are cared for by physicians who demonstrate more medical knowledge through certification and MOC have a better prognosis for a host of important outcomes including lower mortality from cardiovascular disease, fewer emergency department visits, and fewer unplanned hospitalizations,” the group wrote.

Certification provides a significant benefit, according to Dr. Ali. Some of his patients do ask about his credentials. He said he also finds keeping up with the latest information essential. Ongoing learning shows patients he is committed to providing the best care, he said. “It benefits me, and I’ve benefited my patients. When they come in with questions, I can speak knowledgeably,” he said.

Maintaining board certification is also not unique to internal medicine physicians or subspecialists. Other physician specialties mandate more frequent exams, include both oral and written portions, or administer exams totally online. The American Academy of Family Physicians (AAFP) has a longitudinal option, similar to the LKA, as an alternative to their 1-day exam.

Margo Savoy, MD, MPH, senior vice president of education, inclusiveness, and physician well-being at AAFP, said physicians should make the best choice for them.

“The AAFP welcomes the opportunity for family physicians to have options for how to demonstrate their competence and strongly encourages a balanced approach that avoids undue administrative burdens and fosters a culture of physician well-being and high-quality care,” Dr. Savoy said.

The ABIM has also been criticized for the fee structure for MOC, which some physicians consider excessive: $220 per year for the first certification and $120 for each additional certification. Physicians choosing to take the 10-year exam are charged an additional $700 testing center fee. Those charges do not include the cost of attending CME-related activities. One analysis estimated the cost of maintaining certification could reach into the tens of thousands of dollars, primarily from the time physicians must spend preparing for the long-form exam.

Dr. Chen pushed back on the contention that the ABIM is making a huge profit off of the 10-year exam. She called MOC fees reasonable when amortized over a 10-year cycle and noted the costs for longitudinal assessment are included in those charges.

Meanwhile, she encouraged physicians who were on the fence about maintaining board certification at all to consider both the benefit to their practice and to their patients, especially since the LKA has already demonstrated such popularity.

“There’s nothing like continuous learning to keep you humble,” Dr. Chen said. “You just don’t know everything.”

A version of this article appeared on Medscape.com.

Imran Ali, MD, is not due for recertification in internal medicine for a few more years, but he already plans to forego the traditional 1-day exam and opt instead for a newer one, and what he hopes will prove less stressful approach to maintaining his credentials: The Longitudinal Knowledge Assessment (LKA).

Dr. Ali, assistant professor at the Icahn School of Medicine at Mount Sinai in New York City, is far from alone. Since the American Board of Internal Medicine (ABIM) launched the new method in 2022, approximately 80% of internists have chosen the LKA to maintain their board certification over the 10-year Maintenance of Certification (MOC) exam coupled with continuing education requirements.

“You have to keep learning. I think the LKA is good in that regard, as long as the questions are relevantly updated,” said Dr. Ali, who was first board-certified in 2018 and obtained his geriatrics certification in 2020.

Many other internists contend the MOC is too time-consuming and expensive and have taken action.

Some specialists, including a group of oncologists, argue the exam contains too much information that has become irrelevant to clinical practice. Members of the American College of Cardiology have even left ABIM over the certification process, as this news organization previously reported. After receiving criticism, the ABIM introduced longitudinal assessment as a less onerous means to maintain certification — although the group denies it succumbed to negative feedback.

One and Done, or More Flexibility?

Both the traditional 10-year exam and the LKA have their advantages and disadvantages, according to Helen Chen, MD, the chair of the Geriatric Medicine Board Exam–Writing Committee at ABIM.

The LKA is arguably easier to access and available for most internal medicine disciplines. It requires no preparation for studying, and internists can complete exam questions on their phone, computer, or tablet.

Participants receive 30 questions per quarter for 5 years. Feedback is immediate and includes links to references for further learning. Once the process is completed and a physician meets the performance standard, the next 5-year cycle begins.

Still, some physicians still prefer the traditional 10-year, long-form exam. Studying for the test can be intense and take months. Physicians also must travel to an exam center on a designated date. However, once the test is over, the certification test does not roll around for another decade.

“It’s really about choice. Some doctors want to sit down and do it all at once and get it over with; others prefer to do a few questions at a time and never feel rushed,” said Dr. Chen, who is triple-boarded in geriatrics, internal medicine, and hospice and palliative medicine.

In 2022, Dr. Chen opted to begin the LKA cycle; a cross-country move and new job would not have allowed her enough time to prepare for the long-form exam, she said.

The new exam challenged her knowledge in smaller bites, provided immediate feedback, and allowed her to satisfy her curiosity through additional reading, she said, even if some questions were not relevant to her clinical practice.

The LKA is not yet as specialized, and ABIM is working to refine questions to be more relevant for some subspecialties.

Questions for both the LKA and long-form exam are developed from physician input, according to Dr. Chen. They are regularly assessed for relevance, accuracy, and changes to practice guidelines.

She acknowledged that questions can sometimes become outdated in a relatively short time, particularly for those taking the 10-year exam. But feedback from physicians helps committees analyze the relevancy of questions and how intensely an area should be tested. Committee members will even throw out questions if the literature changes significantly.

An Unnecessary Exercise

As criticism has mounted over the MOC, physicians have questioned whether recertification is necessary.

According to a survey of 1700 members of the American Society of Clinical Oncology (ASCO), most (64%) backed initial ABIM certification, but three quarters said the recertification process did not benefit their knowledge of clinical practice. More than 80% reported that Continuing Medical Education (CME) credits should suffice for ongoing learning, without having to be supplemented by the MOC exam. ASCO is considering alternative pathways to the current process based on their member feedback and plans to release a proposal to members in the first half of 2024.

Meanwhile, some cardiologists have called the MOC process “an onerous and unnecessary addition to continuing medical education requirements they already must meet at the state and hospital levels.”

The ABIM responded in part in a recent JAMA Viewpoint written by several members of the ABIM board of directors. They said board-certified physicians save the health system about $5 billion annually, compared with those who are not.

“Patients who are cared for by physicians who demonstrate more medical knowledge through certification and MOC have a better prognosis for a host of important outcomes including lower mortality from cardiovascular disease, fewer emergency department visits, and fewer unplanned hospitalizations,” the group wrote.

Certification provides a significant benefit, according to Dr. Ali. Some of his patients do ask about his credentials. He said he also finds keeping up with the latest information essential. Ongoing learning shows patients he is committed to providing the best care, he said. “It benefits me, and I’ve benefited my patients. When they come in with questions, I can speak knowledgeably,” he said.

Maintaining board certification is also not unique to internal medicine physicians or subspecialists. Other physician specialties mandate more frequent exams, include both oral and written portions, or administer exams totally online. The American Academy of Family Physicians (AAFP) has a longitudinal option, similar to the LKA, as an alternative to their 1-day exam.

Margo Savoy, MD, MPH, senior vice president of education, inclusiveness, and physician well-being at AAFP, said physicians should make the best choice for them.

“The AAFP welcomes the opportunity for family physicians to have options for how to demonstrate their competence and strongly encourages a balanced approach that avoids undue administrative burdens and fosters a culture of physician well-being and high-quality care,” Dr. Savoy said.

The ABIM has also been criticized for the fee structure for MOC, which some physicians consider excessive: $220 per year for the first certification and $120 for each additional certification. Physicians choosing to take the 10-year exam are charged an additional $700 testing center fee. Those charges do not include the cost of attending CME-related activities. One analysis estimated the cost of maintaining certification could reach into the tens of thousands of dollars, primarily from the time physicians must spend preparing for the long-form exam.

Dr. Chen pushed back on the contention that the ABIM is making a huge profit off of the 10-year exam. She called MOC fees reasonable when amortized over a 10-year cycle and noted the costs for longitudinal assessment are included in those charges.

Meanwhile, she encouraged physicians who were on the fence about maintaining board certification at all to consider both the benefit to their practice and to their patients, especially since the LKA has already demonstrated such popularity.

“There’s nothing like continuous learning to keep you humble,” Dr. Chen said. “You just don’t know everything.”

A version of this article appeared on Medscape.com.

Imran Ali, MD, is not due for recertification in internal medicine for a few more years, but he already plans to forego the traditional 1-day exam and opt instead for a newer one, and what he hopes will prove less stressful approach to maintaining his credentials: The Longitudinal Knowledge Assessment (LKA).

Dr. Ali, assistant professor at the Icahn School of Medicine at Mount Sinai in New York City, is far from alone. Since the American Board of Internal Medicine (ABIM) launched the new method in 2022, approximately 80% of internists have chosen the LKA to maintain their board certification over the 10-year Maintenance of Certification (MOC) exam coupled with continuing education requirements.

“You have to keep learning. I think the LKA is good in that regard, as long as the questions are relevantly updated,” said Dr. Ali, who was first board-certified in 2018 and obtained his geriatrics certification in 2020.

Many other internists contend the MOC is too time-consuming and expensive and have taken action.

Some specialists, including a group of oncologists, argue the exam contains too much information that has become irrelevant to clinical practice. Members of the American College of Cardiology have even left ABIM over the certification process, as this news organization previously reported. After receiving criticism, the ABIM introduced longitudinal assessment as a less onerous means to maintain certification — although the group denies it succumbed to negative feedback.

One and Done, or More Flexibility?

Both the traditional 10-year exam and the LKA have their advantages and disadvantages, according to Helen Chen, MD, the chair of the Geriatric Medicine Board Exam–Writing Committee at ABIM.

The LKA is arguably easier to access and available for most internal medicine disciplines. It requires no preparation for studying, and internists can complete exam questions on their phone, computer, or tablet.

Participants receive 30 questions per quarter for 5 years. Feedback is immediate and includes links to references for further learning. Once the process is completed and a physician meets the performance standard, the next 5-year cycle begins.

Still, some physicians still prefer the traditional 10-year, long-form exam. Studying for the test can be intense and take months. Physicians also must travel to an exam center on a designated date. However, once the test is over, the certification test does not roll around for another decade.

“It’s really about choice. Some doctors want to sit down and do it all at once and get it over with; others prefer to do a few questions at a time and never feel rushed,” said Dr. Chen, who is triple-boarded in geriatrics, internal medicine, and hospice and palliative medicine.

In 2022, Dr. Chen opted to begin the LKA cycle; a cross-country move and new job would not have allowed her enough time to prepare for the long-form exam, she said.

The new exam challenged her knowledge in smaller bites, provided immediate feedback, and allowed her to satisfy her curiosity through additional reading, she said, even if some questions were not relevant to her clinical practice.

The LKA is not yet as specialized, and ABIM is working to refine questions to be more relevant for some subspecialties.

Questions for both the LKA and long-form exam are developed from physician input, according to Dr. Chen. They are regularly assessed for relevance, accuracy, and changes to practice guidelines.

She acknowledged that questions can sometimes become outdated in a relatively short time, particularly for those taking the 10-year exam. But feedback from physicians helps committees analyze the relevancy of questions and how intensely an area should be tested. Committee members will even throw out questions if the literature changes significantly.

An Unnecessary Exercise

As criticism has mounted over the MOC, physicians have questioned whether recertification is necessary.

According to a survey of 1700 members of the American Society of Clinical Oncology (ASCO), most (64%) backed initial ABIM certification, but three quarters said the recertification process did not benefit their knowledge of clinical practice. More than 80% reported that Continuing Medical Education (CME) credits should suffice for ongoing learning, without having to be supplemented by the MOC exam. ASCO is considering alternative pathways to the current process based on their member feedback and plans to release a proposal to members in the first half of 2024.

Meanwhile, some cardiologists have called the MOC process “an onerous and unnecessary addition to continuing medical education requirements they already must meet at the state and hospital levels.”

The ABIM responded in part in a recent JAMA Viewpoint written by several members of the ABIM board of directors. They said board-certified physicians save the health system about $5 billion annually, compared with those who are not.

“Patients who are cared for by physicians who demonstrate more medical knowledge through certification and MOC have a better prognosis for a host of important outcomes including lower mortality from cardiovascular disease, fewer emergency department visits, and fewer unplanned hospitalizations,” the group wrote.

Certification provides a significant benefit, according to Dr. Ali. Some of his patients do ask about his credentials. He said he also finds keeping up with the latest information essential. Ongoing learning shows patients he is committed to providing the best care, he said. “It benefits me, and I’ve benefited my patients. When they come in with questions, I can speak knowledgeably,” he said.

Maintaining board certification is also not unique to internal medicine physicians or subspecialists. Other physician specialties mandate more frequent exams, include both oral and written portions, or administer exams totally online. The American Academy of Family Physicians (AAFP) has a longitudinal option, similar to the LKA, as an alternative to their 1-day exam.

Margo Savoy, MD, MPH, senior vice president of education, inclusiveness, and physician well-being at AAFP, said physicians should make the best choice for them.

“The AAFP welcomes the opportunity for family physicians to have options for how to demonstrate their competence and strongly encourages a balanced approach that avoids undue administrative burdens and fosters a culture of physician well-being and high-quality care,” Dr. Savoy said.

The ABIM has also been criticized for the fee structure for MOC, which some physicians consider excessive: $220 per year for the first certification and $120 for each additional certification. Physicians choosing to take the 10-year exam are charged an additional $700 testing center fee. Those charges do not include the cost of attending CME-related activities. One analysis estimated the cost of maintaining certification could reach into the tens of thousands of dollars, primarily from the time physicians must spend preparing for the long-form exam.

Dr. Chen pushed back on the contention that the ABIM is making a huge profit off of the 10-year exam. She called MOC fees reasonable when amortized over a 10-year cycle and noted the costs for longitudinal assessment are included in those charges.

Meanwhile, she encouraged physicians who were on the fence about maintaining board certification at all to consider both the benefit to their practice and to their patients, especially since the LKA has already demonstrated such popularity.

“There’s nothing like continuous learning to keep you humble,” Dr. Chen said. “You just don’t know everything.”

A version of this article appeared on Medscape.com.