News

Chemotherapy has fallen out of favor for treating cancer toward the end of life. The toxicity is too high, and the benefit, if any, is often too low.

Immunotherapy, however, has been taking its place. Checkpoint inhibitors are increasingly being initiated to treat metastatic cancer in patients approaching the end of life and have become the leading driver of end-of-life cancer spending.

This means “there are patients who are getting immunotherapy who shouldn’t,” said Yale University, New Haven, Connecticut, surgical oncologist Sajid Khan, MD, senior investigator on a recent study that highlighted the growing use of these agents in patients’ last month of life.

What’s driving this trend, and how can oncologists avoid overtreatment with immunotherapy at the end of life?
 

The N-of-1 Patient

With immunotherapy at the end of life, “each of us has had our N-of-1” where a patient bounces back with a remarkable and durable response, said Don Dizon, MD, a gynecologic oncologist at Brown University, Providence, Rhode Island.

He recalled a patient with sarcoma who did not respond to chemotherapy. But after Dr. Dizon started her on immunotherapy, everything turned around. She has now been in remission for 8 years and counting.

The possibility of an unexpected or remarkable responder is seductive. And the improved safety of immunotherapy over chemotherapy adds to the allure.

Meanwhile, patients are often desperate. It’s rare for someone to be ready to stop treatment, Dr. Dizon said. Everybody “hopes that they’re going to be the exceptional responder.”

At the end of the day, the question often becomes: “Why not try immunotherapy? What’s there to lose?”

This thinking may be prompting broader use of immunotherapy in late-stage disease, even in instances with no Food and Drug Administration indication and virtually no supportive data, such as for metastatic ovarian cancer, Dr. Dizon said.
 

Back to Earth

The problem with the hopeful approach is that end-of-life turnarounds with immunotherapy are rare, and there’s no way at the moment to predict who will have one, said Laura Petrillo, MD, a palliative care physician at Massachusetts General Hospital, Boston.

Even though immunotherapy generally comes with fewer adverse events than chemotherapy, catastrophic side effects are still possible.

Dr. Petrillo recalled a 95-year-old woman with metastatic cancer who was largely asymptomatic.

She had a qualifying mutation for a checkpoint inhibitor, so her oncologist started her on one. The patient never bounced back from the severe colitis the agent caused, and she died of complications in the hospital.

Although such reactions with immunotherapy are uncommon, less serious problems caused by the agents can still have a major impact on a person’s quality of life. Low-grade diarrhea, for instance, may not sound too bad, but in a patient’s daily life, it can translate to six or more episodes a day.

Even with no side effects, prescribing immunotherapy can mean that patients with limited time left spend a good portion of it at an infusion clinic instead of at home. These patients are also less likely to be referred to hospice and more likely to be admitted to and die in the hospital.

And with treatments that can cost $20,000 per dose, financial toxicity becomes a big concern.

In short, some of the reasons why chemotherapy is not recommended at the end of life also apply to immunotherapy, Dr. Petrillo said.
 

Prescribing Decisions

Recent research highlights the growing use of immunotherapy at the end of life.

Dr. Khan’s retrospective study found, for instance, that the percentage of patients starting immunotherapy in the last 30 days of life increased by about fourfold to fivefold over the study period for the three cancers analyzed — stage IV melanoma, lung, and kidney cancers.

Among the population that died within 30 days, the percentage receiving immunotherapy increased over the study periods — 0.8%-4.3% for melanoma, 0.9%-3.2% for NSCLC, and 0.5%-2.6% for kidney cell carcinoma — prompting the conclusion that immunotherapy prescriptions in the last month of life are on the rise.

Prescribing immunotherapy in patients who ultimately died within 1 month occurred more frequently at low-volume, nonacademic centers than at academic or high-volume centers, and outcomes varied by practice setting.

Patients had better survival outcomes overall when receiving immunotherapy at academic or high-volume centers — a finding Dr. Khan said is worth investigating further. Possible explanations include better management of severe immune-related side effects at larger centers and more caution when prescribing immunotherapy to “borderline” candidates, such as those with several comorbidities.

Importantly, given the retrospective design, Dr. Khan and colleagues already knew which patients prescribed immunotherapy died within 30 days of initiating treatment.

More specifically, 5192 of 71,204 patients who received immunotherapy (7.3%) died within a month of initiating therapy, while 66,012 (92.7%) lived beyond that point.

The study, however, did not assess how the remaining 92.7% who lived beyond 30 days fared on immunotherapy and the differences between those who lived less than 30 days and those who survived longer.

Knowing the outcome of patients at the outset of the analysis still leaves open the question of when immunotherapy can extend life and when it can’t for the patient in front of you.

To avoid overtreating at the end of life, it’s important to have “the same standard that you have for giving chemotherapy. You have to treat it with the same respect,” said Moshe Chasky, MD, a community medical oncologist with Alliance Cancer Specialists in Philadelphia, Pennsylvania. “You can’t just be throwing” immunotherapy around “at the end of life.”

While there are no clear predictors of risk and benefit, there are some factors to help guide decisions.

As with chemotherapy, Dr. Petrillo said performance status is key. Dr. Petrillo and colleagues found that median overall survival with immune checkpoint inhibitors for advanced non–small cell lung cancer was 14.3 months in patients with an Eastern Cooperative Oncology Group performance score of 0-1 but only 4.5 months with scores of ≥ 2.

Dr. Khan also found that immunotherapy survival is, unsurprisingly, worse in patients with high metastatic burdens and more comorbidities.

“You should still consider immunotherapy for metastatic melanoma, non–small cell lung cancer, and renal cell carcinoma,” Dr. Khan said. The message here is to “think twice before using” it, especially in comorbid patients with widespread metastases.

“Just because something can be done doesn’t always mean it should be done,” he said.

At Yale, when Dr. Khan works, immunotherapy decisions are considered by a multidisciplinary tumor board. At Mass General, immunotherapy has generally moved to the frontline setting, and the hospital no longer prescribes checkpoint inhibitors to hospitalized patients because the cost is too high relative to the potential benefit, Dr. Petrillo explained.

Still, with all the uncertainties about risk and benefit, counseling patients is a challenge. Dr. Dizon called it “the epitome of shared decision-making.”

Dr. Petrillo noted that it’s critical not to counsel patients based solely on the anecdotal patients who do surprisingly well.

“It’s hard to mention that and not have that be what somebody anchors on,” she said. But that speaks to “how desperate people can feel, how hopeful they can be.”

Dr. Khan, Dr. Petrillo, and Dr. Chasky all reported no relevant conflicts of interest.

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

Chemotherapy has fallen out of favor for treating cancer toward the end of life. The toxicity is too high, and the benefit, if any, is often too low.

Immunotherapy, however, has been taking its place. Checkpoint inhibitors are increasingly being initiated to treat metastatic cancer in patients approaching the end of life and have become the leading driver of end-of-life cancer spending.

This means “there are patients who are getting immunotherapy who shouldn’t,” said Yale University, New Haven, Connecticut, surgical oncologist Sajid Khan, MD, senior investigator on a recent study that highlighted the growing use of these agents in patients’ last month of life.

What’s driving this trend, and how can oncologists avoid overtreatment with immunotherapy at the end of life?
 

The N-of-1 Patient

With immunotherapy at the end of life, “each of us has had our N-of-1” where a patient bounces back with a remarkable and durable response, said Don Dizon, MD, a gynecologic oncologist at Brown University, Providence, Rhode Island.

He recalled a patient with sarcoma who did not respond to chemotherapy. But after Dr. Dizon started her on immunotherapy, everything turned around. She has now been in remission for 8 years and counting.

The possibility of an unexpected or remarkable responder is seductive. And the improved safety of immunotherapy over chemotherapy adds to the allure.

Meanwhile, patients are often desperate. It’s rare for someone to be ready to stop treatment, Dr. Dizon said. Everybody “hopes that they’re going to be the exceptional responder.”

At the end of the day, the question often becomes: “Why not try immunotherapy? What’s there to lose?”

This thinking may be prompting broader use of immunotherapy in late-stage disease, even in instances with no Food and Drug Administration indication and virtually no supportive data, such as for metastatic ovarian cancer, Dr. Dizon said.
 

Back to Earth

The problem with the hopeful approach is that end-of-life turnarounds with immunotherapy are rare, and there’s no way at the moment to predict who will have one, said Laura Petrillo, MD, a palliative care physician at Massachusetts General Hospital, Boston.

Even though immunotherapy generally comes with fewer adverse events than chemotherapy, catastrophic side effects are still possible.

Dr. Petrillo recalled a 95-year-old woman with metastatic cancer who was largely asymptomatic.

She had a qualifying mutation for a checkpoint inhibitor, so her oncologist started her on one. The patient never bounced back from the severe colitis the agent caused, and she died of complications in the hospital.

Although such reactions with immunotherapy are uncommon, less serious problems caused by the agents can still have a major impact on a person’s quality of life. Low-grade diarrhea, for instance, may not sound too bad, but in a patient’s daily life, it can translate to six or more episodes a day.

Even with no side effects, prescribing immunotherapy can mean that patients with limited time left spend a good portion of it at an infusion clinic instead of at home. These patients are also less likely to be referred to hospice and more likely to be admitted to and die in the hospital.

And with treatments that can cost $20,000 per dose, financial toxicity becomes a big concern.

In short, some of the reasons why chemotherapy is not recommended at the end of life also apply to immunotherapy, Dr. Petrillo said.
 

Prescribing Decisions

Recent research highlights the growing use of immunotherapy at the end of life.

Dr. Khan’s retrospective study found, for instance, that the percentage of patients starting immunotherapy in the last 30 days of life increased by about fourfold to fivefold over the study period for the three cancers analyzed — stage IV melanoma, lung, and kidney cancers.

Among the population that died within 30 days, the percentage receiving immunotherapy increased over the study periods — 0.8%-4.3% for melanoma, 0.9%-3.2% for NSCLC, and 0.5%-2.6% for kidney cell carcinoma — prompting the conclusion that immunotherapy prescriptions in the last month of life are on the rise.

Prescribing immunotherapy in patients who ultimately died within 1 month occurred more frequently at low-volume, nonacademic centers than at academic or high-volume centers, and outcomes varied by practice setting.

Patients had better survival outcomes overall when receiving immunotherapy at academic or high-volume centers — a finding Dr. Khan said is worth investigating further. Possible explanations include better management of severe immune-related side effects at larger centers and more caution when prescribing immunotherapy to “borderline” candidates, such as those with several comorbidities.

Importantly, given the retrospective design, Dr. Khan and colleagues already knew which patients prescribed immunotherapy died within 30 days of initiating treatment.

More specifically, 5192 of 71,204 patients who received immunotherapy (7.3%) died within a month of initiating therapy, while 66,012 (92.7%) lived beyond that point.

The study, however, did not assess how the remaining 92.7% who lived beyond 30 days fared on immunotherapy and the differences between those who lived less than 30 days and those who survived longer.

Knowing the outcome of patients at the outset of the analysis still leaves open the question of when immunotherapy can extend life and when it can’t for the patient in front of you.

To avoid overtreating at the end of life, it’s important to have “the same standard that you have for giving chemotherapy. You have to treat it with the same respect,” said Moshe Chasky, MD, a community medical oncologist with Alliance Cancer Specialists in Philadelphia, Pennsylvania. “You can’t just be throwing” immunotherapy around “at the end of life.”

While there are no clear predictors of risk and benefit, there are some factors to help guide decisions.

As with chemotherapy, Dr. Petrillo said performance status is key. Dr. Petrillo and colleagues found that median overall survival with immune checkpoint inhibitors for advanced non–small cell lung cancer was 14.3 months in patients with an Eastern Cooperative Oncology Group performance score of 0-1 but only 4.5 months with scores of ≥ 2.

Dr. Khan also found that immunotherapy survival is, unsurprisingly, worse in patients with high metastatic burdens and more comorbidities.

“You should still consider immunotherapy for metastatic melanoma, non–small cell lung cancer, and renal cell carcinoma,” Dr. Khan said. The message here is to “think twice before using” it, especially in comorbid patients with widespread metastases.

“Just because something can be done doesn’t always mean it should be done,” he said.

At Yale, when Dr. Khan works, immunotherapy decisions are considered by a multidisciplinary tumor board. At Mass General, immunotherapy has generally moved to the frontline setting, and the hospital no longer prescribes checkpoint inhibitors to hospitalized patients because the cost is too high relative to the potential benefit, Dr. Petrillo explained.

Still, with all the uncertainties about risk and benefit, counseling patients is a challenge. Dr. Dizon called it “the epitome of shared decision-making.”

Dr. Petrillo noted that it’s critical not to counsel patients based solely on the anecdotal patients who do surprisingly well.

“It’s hard to mention that and not have that be what somebody anchors on,” she said. But that speaks to “how desperate people can feel, how hopeful they can be.”

Dr. Khan, Dr. Petrillo, and Dr. Chasky all reported no relevant conflicts of interest.

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

Chemotherapy has fallen out of favor for treating cancer toward the end of life. The toxicity is too high, and the benefit, if any, is often too low.

Immunotherapy, however, has been taking its place. Checkpoint inhibitors are increasingly being initiated to treat metastatic cancer in patients approaching the end of life and have become the leading driver of end-of-life cancer spending.

This means “there are patients who are getting immunotherapy who shouldn’t,” said Yale University, New Haven, Connecticut, surgical oncologist Sajid Khan, MD, senior investigator on a recent study that highlighted the growing use of these agents in patients’ last month of life.

What’s driving this trend, and how can oncologists avoid overtreatment with immunotherapy at the end of life?
 

The N-of-1 Patient

With immunotherapy at the end of life, “each of us has had our N-of-1” where a patient bounces back with a remarkable and durable response, said Don Dizon, MD, a gynecologic oncologist at Brown University, Providence, Rhode Island.

He recalled a patient with sarcoma who did not respond to chemotherapy. But after Dr. Dizon started her on immunotherapy, everything turned around. She has now been in remission for 8 years and counting.

The possibility of an unexpected or remarkable responder is seductive. And the improved safety of immunotherapy over chemotherapy adds to the allure.

Meanwhile, patients are often desperate. It’s rare for someone to be ready to stop treatment, Dr. Dizon said. Everybody “hopes that they’re going to be the exceptional responder.”

At the end of the day, the question often becomes: “Why not try immunotherapy? What’s there to lose?”

This thinking may be prompting broader use of immunotherapy in late-stage disease, even in instances with no Food and Drug Administration indication and virtually no supportive data, such as for metastatic ovarian cancer, Dr. Dizon said.
 

Back to Earth

The problem with the hopeful approach is that end-of-life turnarounds with immunotherapy are rare, and there’s no way at the moment to predict who will have one, said Laura Petrillo, MD, a palliative care physician at Massachusetts General Hospital, Boston.

Even though immunotherapy generally comes with fewer adverse events than chemotherapy, catastrophic side effects are still possible.

Dr. Petrillo recalled a 95-year-old woman with metastatic cancer who was largely asymptomatic.

She had a qualifying mutation for a checkpoint inhibitor, so her oncologist started her on one. The patient never bounced back from the severe colitis the agent caused, and she died of complications in the hospital.

Although such reactions with immunotherapy are uncommon, less serious problems caused by the agents can still have a major impact on a person’s quality of life. Low-grade diarrhea, for instance, may not sound too bad, but in a patient’s daily life, it can translate to six or more episodes a day.

Even with no side effects, prescribing immunotherapy can mean that patients with limited time left spend a good portion of it at an infusion clinic instead of at home. These patients are also less likely to be referred to hospice and more likely to be admitted to and die in the hospital.

And with treatments that can cost $20,000 per dose, financial toxicity becomes a big concern.

In short, some of the reasons why chemotherapy is not recommended at the end of life also apply to immunotherapy, Dr. Petrillo said.
 

Prescribing Decisions

Recent research highlights the growing use of immunotherapy at the end of life.

Dr. Khan’s retrospective study found, for instance, that the percentage of patients starting immunotherapy in the last 30 days of life increased by about fourfold to fivefold over the study period for the three cancers analyzed — stage IV melanoma, lung, and kidney cancers.

Among the population that died within 30 days, the percentage receiving immunotherapy increased over the study periods — 0.8%-4.3% for melanoma, 0.9%-3.2% for NSCLC, and 0.5%-2.6% for kidney cell carcinoma — prompting the conclusion that immunotherapy prescriptions in the last month of life are on the rise.

Prescribing immunotherapy in patients who ultimately died within 1 month occurred more frequently at low-volume, nonacademic centers than at academic or high-volume centers, and outcomes varied by practice setting.

Patients had better survival outcomes overall when receiving immunotherapy at academic or high-volume centers — a finding Dr. Khan said is worth investigating further. Possible explanations include better management of severe immune-related side effects at larger centers and more caution when prescribing immunotherapy to “borderline” candidates, such as those with several comorbidities.

Importantly, given the retrospective design, Dr. Khan and colleagues already knew which patients prescribed immunotherapy died within 30 days of initiating treatment.

More specifically, 5192 of 71,204 patients who received immunotherapy (7.3%) died within a month of initiating therapy, while 66,012 (92.7%) lived beyond that point.

The study, however, did not assess how the remaining 92.7% who lived beyond 30 days fared on immunotherapy and the differences between those who lived less than 30 days and those who survived longer.

Knowing the outcome of patients at the outset of the analysis still leaves open the question of when immunotherapy can extend life and when it can’t for the patient in front of you.

To avoid overtreating at the end of life, it’s important to have “the same standard that you have for giving chemotherapy. You have to treat it with the same respect,” said Moshe Chasky, MD, a community medical oncologist with Alliance Cancer Specialists in Philadelphia, Pennsylvania. “You can’t just be throwing” immunotherapy around “at the end of life.”

While there are no clear predictors of risk and benefit, there are some factors to help guide decisions.

As with chemotherapy, Dr. Petrillo said performance status is key. Dr. Petrillo and colleagues found that median overall survival with immune checkpoint inhibitors for advanced non–small cell lung cancer was 14.3 months in patients with an Eastern Cooperative Oncology Group performance score of 0-1 but only 4.5 months with scores of ≥ 2.

Dr. Khan also found that immunotherapy survival is, unsurprisingly, worse in patients with high metastatic burdens and more comorbidities.

“You should still consider immunotherapy for metastatic melanoma, non–small cell lung cancer, and renal cell carcinoma,” Dr. Khan said. The message here is to “think twice before using” it, especially in comorbid patients with widespread metastases.

“Just because something can be done doesn’t always mean it should be done,” he said.

At Yale, when Dr. Khan works, immunotherapy decisions are considered by a multidisciplinary tumor board. At Mass General, immunotherapy has generally moved to the frontline setting, and the hospital no longer prescribes checkpoint inhibitors to hospitalized patients because the cost is too high relative to the potential benefit, Dr. Petrillo explained.

Still, with all the uncertainties about risk and benefit, counseling patients is a challenge. Dr. Dizon called it “the epitome of shared decision-making.”

Dr. Petrillo noted that it’s critical not to counsel patients based solely on the anecdotal patients who do surprisingly well.

“It’s hard to mention that and not have that be what somebody anchors on,” she said. But that speaks to “how desperate people can feel, how hopeful they can be.”

Dr. Khan, Dr. Petrillo, and Dr. Chasky all reported no relevant conflicts of interest.

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

TOPLINE:

Elevated depression symptoms are linked to an increased risk for severe chemotherapy toxicity in older adults with cancer. This risk is mitigated by geriatric assessment (GA)-driven interventions.

METHODOLOGY:

• Researchers conducted a secondary analysis of a randomized controlled trial to evaluate whether greater reductions in grade 3 chemotherapy-related toxicities occurred with geriatric assessment-driven interventions vs standard care.
• A total of 605 patients aged 65 years and older with any stage of solid malignancy were included, with 402 randomized to the intervention arm and 203 to the standard-of-care arm.
• Mental health was assessed using the Mental Health Inventory 13, and chemotherapy toxicity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
• Patients in the intervention arm received recommendations from a multidisciplinary team based on their baseline GA, while those in the standard-of-care arm received only the baseline assessment results.
• The study was conducted at City of Hope National Medical Center in Duarte, California, and patients were followed throughout treatment or for up to 6 months from starting chemotherapy.

TAKEAWAY:

• According to the authors, patients with depression had increased chemotherapy toxicity in the standard-of-care arm (70.7% vs 54.3%; P = .02) but not in the GA-driven intervention arm (54.3% vs 48.5%; P = .27).
• The association between depression and chemotherapy toxicity was also seen after adjustment for the Cancer and Aging Research Group toxicity score (odds ratio, [OR], 1.98; 95% CI, 1.07-3.65) and for demographic, disease, and treatment factors (OR, 2.00; 95% CI, 1.03-3.85).
• No significant association was found between anxiety and chemotherapy toxicity in either the standard-of-care arm (univariate OR, 1.07; 95% CI, 0.61-1.88) or the GA-driven intervention arm (univariate OR, 1.15; 95% CI, 0.78-1.71).
• The authors stated that depression was associated with increased odds of hematologic-only toxicities (OR, 2.50; 95% CI, 1.13-5.56) in the standard-of-care arm.
• An analysis of a small subgroup found associations between elevated anxiety symptoms and increased risk for hematologic and nonhematologic chemotherapy toxicities.

IN PRACTICE:

“The current study showed that elevated depression symptoms are associated with increased risk of severe chemotherapy toxicities in older adults with cancer. This risk was mitigated in those in the GA intervention arm, which suggests that addressing elevated depression symptoms may lower the risk of toxicities,” the authors wrote. “Overall, elevated anxiety symptoms were not associated with risk for severe chemotherapy toxicity.”

SOURCE:

Reena V. Jayani, MD, MSCI, of Vanderbilt University Medical Center in Nashville, Tennessee, was the first and corresponding author for this paper. This study was published online August 4, 2024, in Cancer. 

LIMITATIONS:

The thresholds for depression and anxiety used in the Mental Health Inventory 13 were based on an English-speaking population, which may not be fully applicable to Chinese- and Spanish-speaking patients included in the study. Depression and anxiety were not evaluated by a mental health professional or with a structured interview to assess formal diagnostic criteria. Psychiatric medication used at the time of baseline GA was not included in the analysis. The study is a secondary analysis of a randomized controlled trial, and it is not known which components of the interventions affected mental health.

DISCLOSURES:

This research project was supported by the UniHealth Foundation, the City of Hope Center for Cancer and Aging, and the National Institutes of Health. One coauthor disclosed receiving institutional research funding from AstraZeneca and Brooklyn ImmunoTherapeutics and consulting for multiple pharmaceutical companies, including AbbVie, Adagene, and Bayer HealthCare Pharmaceuticals. William Dale, MD, PhD, of City of Hope National Medical Center, served as senior author and a principal investigator. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Elevated depression symptoms are linked to an increased risk for severe chemotherapy toxicity in older adults with cancer. This risk is mitigated by geriatric assessment (GA)-driven interventions.

METHODOLOGY:

• Researchers conducted a secondary analysis of a randomized controlled trial to evaluate whether greater reductions in grade 3 chemotherapy-related toxicities occurred with geriatric assessment-driven interventions vs standard care.
• A total of 605 patients aged 65 years and older with any stage of solid malignancy were included, with 402 randomized to the intervention arm and 203 to the standard-of-care arm.
• Mental health was assessed using the Mental Health Inventory 13, and chemotherapy toxicity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
• Patients in the intervention arm received recommendations from a multidisciplinary team based on their baseline GA, while those in the standard-of-care arm received only the baseline assessment results.
• The study was conducted at City of Hope National Medical Center in Duarte, California, and patients were followed throughout treatment or for up to 6 months from starting chemotherapy.

TAKEAWAY:

• According to the authors, patients with depression had increased chemotherapy toxicity in the standard-of-care arm (70.7% vs 54.3%; P = .02) but not in the GA-driven intervention arm (54.3% vs 48.5%; P = .27).
• The association between depression and chemotherapy toxicity was also seen after adjustment for the Cancer and Aging Research Group toxicity score (odds ratio, [OR], 1.98; 95% CI, 1.07-3.65) and for demographic, disease, and treatment factors (OR, 2.00; 95% CI, 1.03-3.85).
• No significant association was found between anxiety and chemotherapy toxicity in either the standard-of-care arm (univariate OR, 1.07; 95% CI, 0.61-1.88) or the GA-driven intervention arm (univariate OR, 1.15; 95% CI, 0.78-1.71).
• The authors stated that depression was associated with increased odds of hematologic-only toxicities (OR, 2.50; 95% CI, 1.13-5.56) in the standard-of-care arm.
• An analysis of a small subgroup found associations between elevated anxiety symptoms and increased risk for hematologic and nonhematologic chemotherapy toxicities.

IN PRACTICE:

“The current study showed that elevated depression symptoms are associated with increased risk of severe chemotherapy toxicities in older adults with cancer. This risk was mitigated in those in the GA intervention arm, which suggests that addressing elevated depression symptoms may lower the risk of toxicities,” the authors wrote. “Overall, elevated anxiety symptoms were not associated with risk for severe chemotherapy toxicity.”

SOURCE:

Reena V. Jayani, MD, MSCI, of Vanderbilt University Medical Center in Nashville, Tennessee, was the first and corresponding author for this paper. This study was published online August 4, 2024, in Cancer. 

LIMITATIONS:

The thresholds for depression and anxiety used in the Mental Health Inventory 13 were based on an English-speaking population, which may not be fully applicable to Chinese- and Spanish-speaking patients included in the study. Depression and anxiety were not evaluated by a mental health professional or with a structured interview to assess formal diagnostic criteria. Psychiatric medication used at the time of baseline GA was not included in the analysis. The study is a secondary analysis of a randomized controlled trial, and it is not known which components of the interventions affected mental health.

DISCLOSURES:

This research project was supported by the UniHealth Foundation, the City of Hope Center for Cancer and Aging, and the National Institutes of Health. One coauthor disclosed receiving institutional research funding from AstraZeneca and Brooklyn ImmunoTherapeutics and consulting for multiple pharmaceutical companies, including AbbVie, Adagene, and Bayer HealthCare Pharmaceuticals. William Dale, MD, PhD, of City of Hope National Medical Center, served as senior author and a principal investigator. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Elevated depression symptoms are linked to an increased risk for severe chemotherapy toxicity in older adults with cancer. This risk is mitigated by geriatric assessment (GA)-driven interventions.

METHODOLOGY:

• Researchers conducted a secondary analysis of a randomized controlled trial to evaluate whether greater reductions in grade 3 chemotherapy-related toxicities occurred with geriatric assessment-driven interventions vs standard care.
• A total of 605 patients aged 65 years and older with any stage of solid malignancy were included, with 402 randomized to the intervention arm and 203 to the standard-of-care arm.
• Mental health was assessed using the Mental Health Inventory 13, and chemotherapy toxicity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
• Patients in the intervention arm received recommendations from a multidisciplinary team based on their baseline GA, while those in the standard-of-care arm received only the baseline assessment results.
• The study was conducted at City of Hope National Medical Center in Duarte, California, and patients were followed throughout treatment or for up to 6 months from starting chemotherapy.

TAKEAWAY:

• According to the authors, patients with depression had increased chemotherapy toxicity in the standard-of-care arm (70.7% vs 54.3%; P = .02) but not in the GA-driven intervention arm (54.3% vs 48.5%; P = .27).
• The association between depression and chemotherapy toxicity was also seen after adjustment for the Cancer and Aging Research Group toxicity score (odds ratio, [OR], 1.98; 95% CI, 1.07-3.65) and for demographic, disease, and treatment factors (OR, 2.00; 95% CI, 1.03-3.85).
• No significant association was found between anxiety and chemotherapy toxicity in either the standard-of-care arm (univariate OR, 1.07; 95% CI, 0.61-1.88) or the GA-driven intervention arm (univariate OR, 1.15; 95% CI, 0.78-1.71).
• The authors stated that depression was associated with increased odds of hematologic-only toxicities (OR, 2.50; 95% CI, 1.13-5.56) in the standard-of-care arm.
• An analysis of a small subgroup found associations between elevated anxiety symptoms and increased risk for hematologic and nonhematologic chemotherapy toxicities.

IN PRACTICE:

“The current study showed that elevated depression symptoms are associated with increased risk of severe chemotherapy toxicities in older adults with cancer. This risk was mitigated in those in the GA intervention arm, which suggests that addressing elevated depression symptoms may lower the risk of toxicities,” the authors wrote. “Overall, elevated anxiety symptoms were not associated with risk for severe chemotherapy toxicity.”

SOURCE:

Reena V. Jayani, MD, MSCI, of Vanderbilt University Medical Center in Nashville, Tennessee, was the first and corresponding author for this paper. This study was published online August 4, 2024, in Cancer. 

LIMITATIONS:

The thresholds for depression and anxiety used in the Mental Health Inventory 13 were based on an English-speaking population, which may not be fully applicable to Chinese- and Spanish-speaking patients included in the study. Depression and anxiety were not evaluated by a mental health professional or with a structured interview to assess formal diagnostic criteria. Psychiatric medication used at the time of baseline GA was not included in the analysis. The study is a secondary analysis of a randomized controlled trial, and it is not known which components of the interventions affected mental health.

DISCLOSURES:

This research project was supported by the UniHealth Foundation, the City of Hope Center for Cancer and Aging, and the National Institutes of Health. One coauthor disclosed receiving institutional research funding from AstraZeneca and Brooklyn ImmunoTherapeutics and consulting for multiple pharmaceutical companies, including AbbVie, Adagene, and Bayer HealthCare Pharmaceuticals. William Dale, MD, PhD, of City of Hope National Medical Center, served as senior author and a principal investigator. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

In late July, the US Food and Drug Administration (FDA) approved the first use of a liquid biopsy (blood test) for colorectal cancer (CRC) screening. The test, called Shield, launched commercially the first week of August and is the first blood test to be approved by the FDA as a primary screening option for CRC that meets requirements for Medicare reimbursement.

While the convenience of a blood test could potentially encourage more people to get screened, expert consensus is that blood tests can’t prevent CRC and should not be considered a replacement for a colonoscopy. Modeling studies and expert consensus published earlier this year in Gastroenterology and in Clinical Gastroenterology and Hepatology shed light on the perils of liquid biopsy.

“Based on their current characteristics, blood tests should not be recommended to replace established colorectal cancer screening tests, since blood tests are neither as effective nor as cost-effective, and would worsen outcomes,” said David Lieberman, MD, AGAF, chair, AGA CRC Workshop chair and lead author of an expert commentary on liquid biopsy for CRC screening.

Five Key Takeaways

• A blood test for CRC that meets minimal CMS criteria for sensitivity and performed every 3 years would likely result in better outcomes than no screening.
• A blood test for CRC offers a simple process that could encourage more people to participate in screening. Patients who may have declined colonoscopy should understand the need for a colonoscopy if findings are abnormal.
• Because blood tests for CRC are predicted to be less effective and more costly than currently established screening programs, they cannot be recommended to replace established effective screening methods.
• Although blood tests would improve outcomes in currently unscreened people, substituting blood tests for a currently effective test would worsen patient outcomes and increase cost.
• Potential benchmarks that industry might use to assess an effective blood test for CRC going forward would be sensitivity for stage I-III CRC of > 90%, with sensitivity for advanced adenomas of > 40%-50%.

University of California San Diego

“Unless we have the expectation of high sensitivity and specificity, blood-based colorectal cancer tests could lead to false positive and false negative results, which are both bad for patient outcomes,” said John M. Carethers, MD, AGAF, AGA past president and vice chancellor for health sciences at the University of California San Diego.

In late July, the US Food and Drug Administration (FDA) approved the first use of a liquid biopsy (blood test) for colorectal cancer (CRC) screening. The test, called Shield, launched commercially the first week of August and is the first blood test to be approved by the FDA as a primary screening option for CRC that meets requirements for Medicare reimbursement.

While the convenience of a blood test could potentially encourage more people to get screened, expert consensus is that blood tests can’t prevent CRC and should not be considered a replacement for a colonoscopy. Modeling studies and expert consensus published earlier this year in Gastroenterology and in Clinical Gastroenterology and Hepatology shed light on the perils of liquid biopsy.

“Based on their current characteristics, blood tests should not be recommended to replace established colorectal cancer screening tests, since blood tests are neither as effective nor as cost-effective, and would worsen outcomes,” said David Lieberman, MD, AGAF, chair, AGA CRC Workshop chair and lead author of an expert commentary on liquid biopsy for CRC screening.

Five Key Takeaways

• A blood test for CRC that meets minimal CMS criteria for sensitivity and performed every 3 years would likely result in better outcomes than no screening.
• A blood test for CRC offers a simple process that could encourage more people to participate in screening. Patients who may have declined colonoscopy should understand the need for a colonoscopy if findings are abnormal.
• Because blood tests for CRC are predicted to be less effective and more costly than currently established screening programs, they cannot be recommended to replace established effective screening methods.
• Although blood tests would improve outcomes in currently unscreened people, substituting blood tests for a currently effective test would worsen patient outcomes and increase cost.
• Potential benchmarks that industry might use to assess an effective blood test for CRC going forward would be sensitivity for stage I-III CRC of > 90%, with sensitivity for advanced adenomas of > 40%-50%.

University of California San Diego

“Unless we have the expectation of high sensitivity and specificity, blood-based colorectal cancer tests could lead to false positive and false negative results, which are both bad for patient outcomes,” said John M. Carethers, MD, AGAF, AGA past president and vice chancellor for health sciences at the University of California San Diego.

In late July, the US Food and Drug Administration (FDA) approved the first use of a liquid biopsy (blood test) for colorectal cancer (CRC) screening. The test, called Shield, launched commercially the first week of August and is the first blood test to be approved by the FDA as a primary screening option for CRC that meets requirements for Medicare reimbursement.

While the convenience of a blood test could potentially encourage more people to get screened, expert consensus is that blood tests can’t prevent CRC and should not be considered a replacement for a colonoscopy. Modeling studies and expert consensus published earlier this year in Gastroenterology and in Clinical Gastroenterology and Hepatology shed light on the perils of liquid biopsy.

“Based on their current characteristics, blood tests should not be recommended to replace established colorectal cancer screening tests, since blood tests are neither as effective nor as cost-effective, and would worsen outcomes,” said David Lieberman, MD, AGAF, chair, AGA CRC Workshop chair and lead author of an expert commentary on liquid biopsy for CRC screening.

Five Key Takeaways

• A blood test for CRC that meets minimal CMS criteria for sensitivity and performed every 3 years would likely result in better outcomes than no screening.
• A blood test for CRC offers a simple process that could encourage more people to participate in screening. Patients who may have declined colonoscopy should understand the need for a colonoscopy if findings are abnormal.
• Because blood tests for CRC are predicted to be less effective and more costly than currently established screening programs, they cannot be recommended to replace established effective screening methods.
• Although blood tests would improve outcomes in currently unscreened people, substituting blood tests for a currently effective test would worsen patient outcomes and increase cost.
• Potential benchmarks that industry might use to assess an effective blood test for CRC going forward would be sensitivity for stage I-III CRC of > 90%, with sensitivity for advanced adenomas of > 40%-50%.

University of California San Diego

“Unless we have the expectation of high sensitivity and specificity, blood-based colorectal cancer tests could lead to false positive and false negative results, which are both bad for patient outcomes,” said John M. Carethers, MD, AGAF, AGA past president and vice chancellor for health sciences at the University of California San Diego.

Jeffrey E. Janis, MD, is on a mission. The professor of plastic surgery, surgery, neurosurgery, and neurology at The Ohio State University Wexner Medical Center, Columbus, Ohio, wants to convince neurologists of the safety and efficacy of nerve decompression surgery for treatment-resistant headache. However, many neurologists remain unconvinced.

“Headache surgery is a viable alternative for complex patients who have failed medical management and who could benefit from this treatment approach. There’s 24 years of evidence behind this surgical technique across hundreds of different studies with different study designs,” Dr. Janis said. 

Yet this treatment approach — surgery on peripheral nerves rather than the brain or spinal cord — hasn’t garnered much support from neurologists. A scan of the agenda of topics at the recently held 2024 annual meeting of the American Headache Society showed few if any studies or presentations on this topic. And neurologists this news organization spoke to said they believe the surgery is experimental and unproven.

Experts do agree drugs don’t work for all patients with migraines. Up to 30% of patients don’t respond to the “laundry list of medications” available to treat the condition, said Dr. Janis.

Many patients have also tried, and failed, alternative treatment approaches such as massage, acupuncture, craniosacral therapy, transdermal patches, electrical stimulation, cryoablation, neurostimulation, and radiofrequency ablation.

If nothing else works, is surgery for headaches the answer?
 

Long-Held Theory

The idea that pinched, irritated, or compressed peripheral nerves can trigger migraine attacks has been around for nearly 25 years. Studies suggest that in addition to migraine, nerve compression can lead to other headache conditions, including occipital neuralgia, supraorbital neuralgia , and post-traumatic headaches.

This has led to the development of surgical techniques to deactivate various compression trigger sites — what Dr. Janis calls “pinch points” — which could involve muscles, bone, fascia, blood vessels, or scar tissue from prior trauma or surgery.

The procedure is predominantly performed by plastic surgeons, but to a lesser degree by neurosurgeons and ear, nose, and throat specialists.

Target nerves in surgical interventions include those in the frontal region of the head above the eye, temporal region, neck region, and nasal region. Affected areas are usually identified either through patient self-reports or by using a nerve block agent such as lidocaine or Botox at specific points, Dr. Janis noted. If pain subsides after an injection, that location is marked as a target.

One of the barriers to referring complicated patients for surgery is that neurologists evaluating migraine treatments “speak a different language” than surgeons performing the procedure, said Dr. Janis.

Neurologists tend to focus on reduction in monthly migraine days (MMD), while surgeons typically use the Migraine Headache Index that incorporates the frequency, intensity, and duration of migraine attacks.

“Rather than try to convince somebody to speak a different language, we thought, why don’t we just learn their language so we can build bridges and take down barriers,” said Dr. Janis, coauthor of a systematic review and meta-analysis published online recently in Plastic and Reconstructive Surgery.

Investigators examined 19 studies in the review, including five randomized controlled trials (RCTs), published from January 2020 to September 2023, with a total of 1603 participants who were mostly female and ranged in age from 9 to 72 years. Study follow-ups extended from 6 to 38 months. All but three studies were carried out in the United States, and six different compression sites were addressed during surgery.

Investigators found that across studies and by a number of measures, migraine frequency and severity improved after surgery.

Monthly migraine days decreased by 36%-92% and the number of overall migraine attacks per month dropped 25%-87.5%. Patients also reported decreases in attack duration of 41%-75% and intensity of 28%-82% across studies.

“Even using the neurologist-standard language of monthly migraine days, this surgery works,” said Dr. Janis. “Now this is documented both in the surgical literature and the nonsurgical literature.”

The most common complications were ecchymosis, hair loss or thinning, itching, dryness, and rhinorrhea, all of which Dr. Janis described as “fairly minor.” Major complications such as intraoperative bleeding and wound dehiscence were rare, occurring in 1% or less of participants.
 

‘One And Done?’

These surgeries are usually done on an outpatient basis and generally offer long-term results, Dr. Janis said.

“The idea is one and done,” he said. “The literature around this type of surgery says that whatever type of effect you get at 1 year is likely to be permanent.”

The American Society of Plastic Surgeons agrees. A 2018 position paper developed by experts and commissioned by the society reports that the intervention is safe and effective for appropriate patients, based on a comprehensive literature search and review of a large body of peer-reviewed scientific evidence.

“There is substantial, extensively replicated clinical data that demonstrates a significant reduction in [migraine headache] symptoms and frequency (even complete elimination of headache pain) following trigger site surgery,” the authors noted.

Pamela Blake, MD, a neurologist, board-certified headache specialist, and medical director at the Headache Center of River Oaks, Houston, is a proponent of what she said can be “lifesaving” headache surgery.

“If a doctor told you that you can either treat this problem with medications that you’ll need to take for the rest of your life or you can have a surgical procedure as an outpatient that has extremely low risk and has, in my experience, a 75% chance of reducing or eliminating your pain, you probably would be interested in surgery,” she said.
 

Continued Skepticism

However, other neurologists and clinicians appear doubtful about this intervention, including Hans-Christoph Diener, MD, PhD, professor of neurology and director, Essen Headache Centre, University of Duisburg-Essen in Germany.

During a debate on the topic a decade ago at the International Headache Congress, Dr. Diener argued that, as migraine is a complex multigene-related disorder of the brain, it doesn’t make sense that surgery would affect the epigenetics of 22 different genes.

Recently, he said that his views have not changed.

The topic remains controversial, and some neurologists are uncomfortable even openly discussing the procedure. Two clinicians who previously commented on this article later asked not to be included.

One neurologist, who asked to remain anonymous, said that Dr. Janis’s review article is “merely a review collecting 19 studies over the previous 10-plus years.”

Other limitations cited by this neurologist are the lack of consistency in procedures among the various studies and the inclusion of only four RCTs, the most recent of which was published 8 years ago, suggesting “the study was probably done closer to 9 or 10 years ago,” the neurologist said.

Dr. Blake suggested some neurologists’ reluctance could be due to limited background on the procedure, which she said isn’t widely discussed at headache meetings and is covered mostly in plastic surgery journals, not neurology literature. Access to surgery is further limited by a lack of specialists who perform the procedure and inconsistent insurance coverage.

A closer collaboration between neurologists and surgeons who perform the procedure could benefit patients, Dr. Blake noted.

“The headache doctor’s role is to identify who’s a candidate for surgery, who meets the criteria for nerve compression, and then follow that patient postoperatively, managing their medications, although usually we get them off their medications,” she added.

From Dr. Janis’s perspective, things are starting to change.

“I’m definitely seeing a greater comfort level among neurologists who are understanding where this sits in the algorithm for treatment, especially for complicated patients,” he said.

Dr. Janis receives royalties from Thieme and Springer Publishing. Dr. Blake reported no relevant conflicts. Dr. Diener received research support from the German Research Council; serves on the editorial boards of Cephalalgia, Lancet Neurology, and Drugs; and has received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from AbbVie, Lilly, Lundbeck, Novartis, Pfizer, Teva, Weber & Weber, and WebMD.

A version of this article appeared on Medscape.com.

Jeffrey E. Janis, MD, is on a mission. The professor of plastic surgery, surgery, neurosurgery, and neurology at The Ohio State University Wexner Medical Center, Columbus, Ohio, wants to convince neurologists of the safety and efficacy of nerve decompression surgery for treatment-resistant headache. However, many neurologists remain unconvinced.

“Headache surgery is a viable alternative for complex patients who have failed medical management and who could benefit from this treatment approach. There’s 24 years of evidence behind this surgical technique across hundreds of different studies with different study designs,” Dr. Janis said. 

Yet this treatment approach — surgery on peripheral nerves rather than the brain or spinal cord — hasn’t garnered much support from neurologists. A scan of the agenda of topics at the recently held 2024 annual meeting of the American Headache Society showed few if any studies or presentations on this topic. And neurologists this news organization spoke to said they believe the surgery is experimental and unproven.

Experts do agree drugs don’t work for all patients with migraines. Up to 30% of patients don’t respond to the “laundry list of medications” available to treat the condition, said Dr. Janis.

Many patients have also tried, and failed, alternative treatment approaches such as massage, acupuncture, craniosacral therapy, transdermal patches, electrical stimulation, cryoablation, neurostimulation, and radiofrequency ablation.

If nothing else works, is surgery for headaches the answer?
 

Long-Held Theory

The idea that pinched, irritated, or compressed peripheral nerves can trigger migraine attacks has been around for nearly 25 years. Studies suggest that in addition to migraine, nerve compression can lead to other headache conditions, including occipital neuralgia, supraorbital neuralgia , and post-traumatic headaches.

This has led to the development of surgical techniques to deactivate various compression trigger sites — what Dr. Janis calls “pinch points” — which could involve muscles, bone, fascia, blood vessels, or scar tissue from prior trauma or surgery.

The procedure is predominantly performed by plastic surgeons, but to a lesser degree by neurosurgeons and ear, nose, and throat specialists.

Target nerves in surgical interventions include those in the frontal region of the head above the eye, temporal region, neck region, and nasal region. Affected areas are usually identified either through patient self-reports or by using a nerve block agent such as lidocaine or Botox at specific points, Dr. Janis noted. If pain subsides after an injection, that location is marked as a target.

One of the barriers to referring complicated patients for surgery is that neurologists evaluating migraine treatments “speak a different language” than surgeons performing the procedure, said Dr. Janis.

Neurologists tend to focus on reduction in monthly migraine days (MMD), while surgeons typically use the Migraine Headache Index that incorporates the frequency, intensity, and duration of migraine attacks.

“Rather than try to convince somebody to speak a different language, we thought, why don’t we just learn their language so we can build bridges and take down barriers,” said Dr. Janis, coauthor of a systematic review and meta-analysis published online recently in Plastic and Reconstructive Surgery.

Investigators examined 19 studies in the review, including five randomized controlled trials (RCTs), published from January 2020 to September 2023, with a total of 1603 participants who were mostly female and ranged in age from 9 to 72 years. Study follow-ups extended from 6 to 38 months. All but three studies were carried out in the United States, and six different compression sites were addressed during surgery.

Investigators found that across studies and by a number of measures, migraine frequency and severity improved after surgery.

Monthly migraine days decreased by 36%-92% and the number of overall migraine attacks per month dropped 25%-87.5%. Patients also reported decreases in attack duration of 41%-75% and intensity of 28%-82% across studies.

“Even using the neurologist-standard language of monthly migraine days, this surgery works,” said Dr. Janis. “Now this is documented both in the surgical literature and the nonsurgical literature.”

The most common complications were ecchymosis, hair loss or thinning, itching, dryness, and rhinorrhea, all of which Dr. Janis described as “fairly minor.” Major complications such as intraoperative bleeding and wound dehiscence were rare, occurring in 1% or less of participants.
 

‘One And Done?’

These surgeries are usually done on an outpatient basis and generally offer long-term results, Dr. Janis said.

“The idea is one and done,” he said. “The literature around this type of surgery says that whatever type of effect you get at 1 year is likely to be permanent.”

The American Society of Plastic Surgeons agrees. A 2018 position paper developed by experts and commissioned by the society reports that the intervention is safe and effective for appropriate patients, based on a comprehensive literature search and review of a large body of peer-reviewed scientific evidence.

“There is substantial, extensively replicated clinical data that demonstrates a significant reduction in [migraine headache] symptoms and frequency (even complete elimination of headache pain) following trigger site surgery,” the authors noted.

Pamela Blake, MD, a neurologist, board-certified headache specialist, and medical director at the Headache Center of River Oaks, Houston, is a proponent of what she said can be “lifesaving” headache surgery.

“If a doctor told you that you can either treat this problem with medications that you’ll need to take for the rest of your life or you can have a surgical procedure as an outpatient that has extremely low risk and has, in my experience, a 75% chance of reducing or eliminating your pain, you probably would be interested in surgery,” she said.
 

Continued Skepticism

However, other neurologists and clinicians appear doubtful about this intervention, including Hans-Christoph Diener, MD, PhD, professor of neurology and director, Essen Headache Centre, University of Duisburg-Essen in Germany.

During a debate on the topic a decade ago at the International Headache Congress, Dr. Diener argued that, as migraine is a complex multigene-related disorder of the brain, it doesn’t make sense that surgery would affect the epigenetics of 22 different genes.

Recently, he said that his views have not changed.

The topic remains controversial, and some neurologists are uncomfortable even openly discussing the procedure. Two clinicians who previously commented on this article later asked not to be included.

One neurologist, who asked to remain anonymous, said that Dr. Janis’s review article is “merely a review collecting 19 studies over the previous 10-plus years.”

Other limitations cited by this neurologist are the lack of consistency in procedures among the various studies and the inclusion of only four RCTs, the most recent of which was published 8 years ago, suggesting “the study was probably done closer to 9 or 10 years ago,” the neurologist said.

Dr. Blake suggested some neurologists’ reluctance could be due to limited background on the procedure, which she said isn’t widely discussed at headache meetings and is covered mostly in plastic surgery journals, not neurology literature. Access to surgery is further limited by a lack of specialists who perform the procedure and inconsistent insurance coverage.

A closer collaboration between neurologists and surgeons who perform the procedure could benefit patients, Dr. Blake noted.

“The headache doctor’s role is to identify who’s a candidate for surgery, who meets the criteria for nerve compression, and then follow that patient postoperatively, managing their medications, although usually we get them off their medications,” she added.

From Dr. Janis’s perspective, things are starting to change.

“I’m definitely seeing a greater comfort level among neurologists who are understanding where this sits in the algorithm for treatment, especially for complicated patients,” he said.

Dr. Janis receives royalties from Thieme and Springer Publishing. Dr. Blake reported no relevant conflicts. Dr. Diener received research support from the German Research Council; serves on the editorial boards of Cephalalgia, Lancet Neurology, and Drugs; and has received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from AbbVie, Lilly, Lundbeck, Novartis, Pfizer, Teva, Weber & Weber, and WebMD.

A version of this article appeared on Medscape.com.

Jeffrey E. Janis, MD, is on a mission. The professor of plastic surgery, surgery, neurosurgery, and neurology at The Ohio State University Wexner Medical Center, Columbus, Ohio, wants to convince neurologists of the safety and efficacy of nerve decompression surgery for treatment-resistant headache. However, many neurologists remain unconvinced.

“Headache surgery is a viable alternative for complex patients who have failed medical management and who could benefit from this treatment approach. There’s 24 years of evidence behind this surgical technique across hundreds of different studies with different study designs,” Dr. Janis said. 

Yet this treatment approach — surgery on peripheral nerves rather than the brain or spinal cord — hasn’t garnered much support from neurologists. A scan of the agenda of topics at the recently held 2024 annual meeting of the American Headache Society showed few if any studies or presentations on this topic. And neurologists this news organization spoke to said they believe the surgery is experimental and unproven.

Experts do agree drugs don’t work for all patients with migraines. Up to 30% of patients don’t respond to the “laundry list of medications” available to treat the condition, said Dr. Janis.

Many patients have also tried, and failed, alternative treatment approaches such as massage, acupuncture, craniosacral therapy, transdermal patches, electrical stimulation, cryoablation, neurostimulation, and radiofrequency ablation.

If nothing else works, is surgery for headaches the answer?
 

Long-Held Theory

The idea that pinched, irritated, or compressed peripheral nerves can trigger migraine attacks has been around for nearly 25 years. Studies suggest that in addition to migraine, nerve compression can lead to other headache conditions, including occipital neuralgia, supraorbital neuralgia , and post-traumatic headaches.

This has led to the development of surgical techniques to deactivate various compression trigger sites — what Dr. Janis calls “pinch points” — which could involve muscles, bone, fascia, blood vessels, or scar tissue from prior trauma or surgery.

The procedure is predominantly performed by plastic surgeons, but to a lesser degree by neurosurgeons and ear, nose, and throat specialists.

Target nerves in surgical interventions include those in the frontal region of the head above the eye, temporal region, neck region, and nasal region. Affected areas are usually identified either through patient self-reports or by using a nerve block agent such as lidocaine or Botox at specific points, Dr. Janis noted. If pain subsides after an injection, that location is marked as a target.

One of the barriers to referring complicated patients for surgery is that neurologists evaluating migraine treatments “speak a different language” than surgeons performing the procedure, said Dr. Janis.

Neurologists tend to focus on reduction in monthly migraine days (MMD), while surgeons typically use the Migraine Headache Index that incorporates the frequency, intensity, and duration of migraine attacks.

“Rather than try to convince somebody to speak a different language, we thought, why don’t we just learn their language so we can build bridges and take down barriers,” said Dr. Janis, coauthor of a systematic review and meta-analysis published online recently in Plastic and Reconstructive Surgery.

Investigators examined 19 studies in the review, including five randomized controlled trials (RCTs), published from January 2020 to September 2023, with a total of 1603 participants who were mostly female and ranged in age from 9 to 72 years. Study follow-ups extended from 6 to 38 months. All but three studies were carried out in the United States, and six different compression sites were addressed during surgery.

Investigators found that across studies and by a number of measures, migraine frequency and severity improved after surgery.

Monthly migraine days decreased by 36%-92% and the number of overall migraine attacks per month dropped 25%-87.5%. Patients also reported decreases in attack duration of 41%-75% and intensity of 28%-82% across studies.

“Even using the neurologist-standard language of monthly migraine days, this surgery works,” said Dr. Janis. “Now this is documented both in the surgical literature and the nonsurgical literature.”

The most common complications were ecchymosis, hair loss or thinning, itching, dryness, and rhinorrhea, all of which Dr. Janis described as “fairly minor.” Major complications such as intraoperative bleeding and wound dehiscence were rare, occurring in 1% or less of participants.
 

‘One And Done?’

These surgeries are usually done on an outpatient basis and generally offer long-term results, Dr. Janis said.

“The idea is one and done,” he said. “The literature around this type of surgery says that whatever type of effect you get at 1 year is likely to be permanent.”

The American Society of Plastic Surgeons agrees. A 2018 position paper developed by experts and commissioned by the society reports that the intervention is safe and effective for appropriate patients, based on a comprehensive literature search and review of a large body of peer-reviewed scientific evidence.

“There is substantial, extensively replicated clinical data that demonstrates a significant reduction in [migraine headache] symptoms and frequency (even complete elimination of headache pain) following trigger site surgery,” the authors noted.

Pamela Blake, MD, a neurologist, board-certified headache specialist, and medical director at the Headache Center of River Oaks, Houston, is a proponent of what she said can be “lifesaving” headache surgery.

“If a doctor told you that you can either treat this problem with medications that you’ll need to take for the rest of your life or you can have a surgical procedure as an outpatient that has extremely low risk and has, in my experience, a 75% chance of reducing or eliminating your pain, you probably would be interested in surgery,” she said.
 

Continued Skepticism

However, other neurologists and clinicians appear doubtful about this intervention, including Hans-Christoph Diener, MD, PhD, professor of neurology and director, Essen Headache Centre, University of Duisburg-Essen in Germany.

During a debate on the topic a decade ago at the International Headache Congress, Dr. Diener argued that, as migraine is a complex multigene-related disorder of the brain, it doesn’t make sense that surgery would affect the epigenetics of 22 different genes.

Recently, he said that his views have not changed.

The topic remains controversial, and some neurologists are uncomfortable even openly discussing the procedure. Two clinicians who previously commented on this article later asked not to be included.

One neurologist, who asked to remain anonymous, said that Dr. Janis’s review article is “merely a review collecting 19 studies over the previous 10-plus years.”

Other limitations cited by this neurologist are the lack of consistency in procedures among the various studies and the inclusion of only four RCTs, the most recent of which was published 8 years ago, suggesting “the study was probably done closer to 9 or 10 years ago,” the neurologist said.

Dr. Blake suggested some neurologists’ reluctance could be due to limited background on the procedure, which she said isn’t widely discussed at headache meetings and is covered mostly in plastic surgery journals, not neurology literature. Access to surgery is further limited by a lack of specialists who perform the procedure and inconsistent insurance coverage.

A closer collaboration between neurologists and surgeons who perform the procedure could benefit patients, Dr. Blake noted.

“The headache doctor’s role is to identify who’s a candidate for surgery, who meets the criteria for nerve compression, and then follow that patient postoperatively, managing their medications, although usually we get them off their medications,” she added.

From Dr. Janis’s perspective, things are starting to change.

“I’m definitely seeing a greater comfort level among neurologists who are understanding where this sits in the algorithm for treatment, especially for complicated patients,” he said.

Dr. Janis receives royalties from Thieme and Springer Publishing. Dr. Blake reported no relevant conflicts. Dr. Diener received research support from the German Research Council; serves on the editorial boards of Cephalalgia, Lancet Neurology, and Drugs; and has received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from AbbVie, Lilly, Lundbeck, Novartis, Pfizer, Teva, Weber & Weber, and WebMD.

A version of this article appeared on Medscape.com.

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

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

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

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

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

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

PHILADELPHIA – Drinking more than three cups of coffee a day is linked to more rapid cognitive decline over time, results from a large study suggest.

Investigators examined the impact of different amounts of coffee and tea on fluid intelligence — a measure of cognitive functions including abstract reasoning, pattern recognition, and logical thinking.

“It’s the old adage that too much of anything isn’t good. It’s all about balance, so moderate coffee consumption is okay but too much is probably not recommended,” said study investigator Kelsey R. Sewell, PhD, Advent Health Research Institute, Orlando, Florida. 

The findings of the study were presented at the 2024 Alzheimer’s Association International Conference (AAIC).
 

One of the World’s Most Widely Consumed Beverages

Coffee is one of the most widely consumed beverages around the world. The beans contain a range of bioactive compounds, including caffeine, chlorogenic acid, and small amounts of vitamins and minerals.

Consistent evidence from observational and epidemiologic studies indicates that intake of both coffee and tea has beneficial effects on stroke, heart failure, cancers, diabetes, and Parkinson’s disease.  

Several studies also suggest that coffee may reduce the risk for Alzheimer’s disease, said Dr. Sewell. However, there are limited longitudinal data on associations between coffee and tea intake and cognitive decline, particularly in distinct cognitive domains.

Dr. Sewell’s group previously published a study of cognitively unimpaired older adults that found greater coffee consumption was associated with slower cognitive decline and slower accumulation of brain beta-amyloid.

Their current study extends some of the prior findings and investigates the relationship between both coffee and tea intake and cognitive decline over time in a larger sample of older adults.

This new study included 8451 mostly female (60%) and White (97%) cognitively unimpaired adults older than 60 (mean age, 67.8 years) in the UK Biobank, a large-scale research resource containing in-depth, deidentified genetic and health information from half a million UK participants. Study subjects had a mean body mass index (BMI) of 26, and about 26% were apolipoprotein epsilon 4 (APOE e4) gene carriers.

Researchers divided coffee and tea consumption into tertiles: high, moderate, and no consumption.

For daily coffee consumption, 18% reported drinking four or more cups (high consumption), 58% reported drinking one to three cups (moderate consumption), and 25% reported that they never drink coffee. For daily tea consumption, 47% reported drinking four or more cups (high consumption), 38% reported drinking one to three cups (moderate consumption), and 15% reported that they never drink tea.

The study assessed cognitive function at baseline and at least two additional patient visits. 

Researchers used linear mixed models to assess the relationships between coffee and tea intake and cognitive outcomes. The models adjusted for age, sex, Townsend deprivation index (reflecting socioeconomic status), ethnicity, APOE e4 status, and BMI.
 

Steeper Decline 

Compared with high coffee consumption (four or more cups daily), people who never consumed coffee (beta, 0.06; standard error [SE], 0.02; P = .005) and those with moderate consumption (beta, 0.07; SE, 0.02; P = < .001) had slower decline in fluid intelligence after an average of 8.83 years of follow-up.

“We can see that those with high coffee consumption showed the steepest decline in fluid intelligence across the follow up, compared to those with moderate coffee consumption and those never consuming coffee,” said Dr. Sewell, referring to illustrative graphs.

At the same time, “our data suggest that across this time period, moderate coffee consumption can serve as some kind of protective factor against cognitive decline,” she added.

For tea, there was a somewhat different pattern. People who never drank tea had a greater decline in fluid intelligence, compared with those who had moderate consumption (beta, 0.06; SE, 0.02; P = .0090) or high consumption (beta, 0.06; SE, 0.02; P = .003).

Because this is an observational study, “we still need randomized controlled trials to better understand the neuroprotective mechanism of coffee and tea compounds,” said Dr. Sewell.

Responding later to a query from a meeting delegate about how moderate coffee drinking could be protective, Dr. Sewell said there are probably “different levels of mechanisms,” including at the molecular level (possibly involving amyloid toxicity) and the behavioral level (possibly involving sleep patterns).

Dr. Sewell said that she hopes this line of investigation will lead to new avenues of research in preventive strategies for Alzheimer’s disease. 

“We hope that coffee and tea intake could contribute to the development of a safe and inexpensive strategy for delaying the onset and reducing the incidence for Alzheimer’s disease.”

A limitation of the study is possible recall bias, because coffee and tea consumption were self-reported. However, this may not be much of an issue because coffee and tea consumption “is usually quite a habitual behavior,” said Dr. Sewell.

The study also had no data on midlife coffee or tea consumption and did not compare the effect of different preparation methods or types of coffee and tea — for example, green tea versus black tea. 

When asked if the study controlled for smoking, Dr. Sewell said it didn’t but added that it would be interesting to explore its impact on cognition.

Dr. Sewell reported no relevant conflicts of interest.

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

PHILADELPHIA – Drinking more than three cups of coffee a day is linked to more rapid cognitive decline over time, results from a large study suggest.

Investigators examined the impact of different amounts of coffee and tea on fluid intelligence — a measure of cognitive functions including abstract reasoning, pattern recognition, and logical thinking.

“It’s the old adage that too much of anything isn’t good. It’s all about balance, so moderate coffee consumption is okay but too much is probably not recommended,” said study investigator Kelsey R. Sewell, PhD, Advent Health Research Institute, Orlando, Florida. 

The findings of the study were presented at the 2024 Alzheimer’s Association International Conference (AAIC).
 

One of the World’s Most Widely Consumed Beverages

Coffee is one of the most widely consumed beverages around the world. The beans contain a range of bioactive compounds, including caffeine, chlorogenic acid, and small amounts of vitamins and minerals.

Consistent evidence from observational and epidemiologic studies indicates that intake of both coffee and tea has beneficial effects on stroke, heart failure, cancers, diabetes, and Parkinson’s disease.  

Several studies also suggest that coffee may reduce the risk for Alzheimer’s disease, said Dr. Sewell. However, there are limited longitudinal data on associations between coffee and tea intake and cognitive decline, particularly in distinct cognitive domains.

Dr. Sewell’s group previously published a study of cognitively unimpaired older adults that found greater coffee consumption was associated with slower cognitive decline and slower accumulation of brain beta-amyloid.

Their current study extends some of the prior findings and investigates the relationship between both coffee and tea intake and cognitive decline over time in a larger sample of older adults.

This new study included 8451 mostly female (60%) and White (97%) cognitively unimpaired adults older than 60 (mean age, 67.8 years) in the UK Biobank, a large-scale research resource containing in-depth, deidentified genetic and health information from half a million UK participants. Study subjects had a mean body mass index (BMI) of 26, and about 26% were apolipoprotein epsilon 4 (APOE e4) gene carriers.

Researchers divided coffee and tea consumption into tertiles: high, moderate, and no consumption.

For daily coffee consumption, 18% reported drinking four or more cups (high consumption), 58% reported drinking one to three cups (moderate consumption), and 25% reported that they never drink coffee. For daily tea consumption, 47% reported drinking four or more cups (high consumption), 38% reported drinking one to three cups (moderate consumption), and 15% reported that they never drink tea.

The study assessed cognitive function at baseline and at least two additional patient visits. 

Researchers used linear mixed models to assess the relationships between coffee and tea intake and cognitive outcomes. The models adjusted for age, sex, Townsend deprivation index (reflecting socioeconomic status), ethnicity, APOE e4 status, and BMI.
 

Steeper Decline 

Compared with high coffee consumption (four or more cups daily), people who never consumed coffee (beta, 0.06; standard error [SE], 0.02; P = .005) and those with moderate consumption (beta, 0.07; SE, 0.02; P = < .001) had slower decline in fluid intelligence after an average of 8.83 years of follow-up.

“We can see that those with high coffee consumption showed the steepest decline in fluid intelligence across the follow up, compared to those with moderate coffee consumption and those never consuming coffee,” said Dr. Sewell, referring to illustrative graphs.

At the same time, “our data suggest that across this time period, moderate coffee consumption can serve as some kind of protective factor against cognitive decline,” she added.

For tea, there was a somewhat different pattern. People who never drank tea had a greater decline in fluid intelligence, compared with those who had moderate consumption (beta, 0.06; SE, 0.02; P = .0090) or high consumption (beta, 0.06; SE, 0.02; P = .003).

Because this is an observational study, “we still need randomized controlled trials to better understand the neuroprotective mechanism of coffee and tea compounds,” said Dr. Sewell.

Responding later to a query from a meeting delegate about how moderate coffee drinking could be protective, Dr. Sewell said there are probably “different levels of mechanisms,” including at the molecular level (possibly involving amyloid toxicity) and the behavioral level (possibly involving sleep patterns).

Dr. Sewell said that she hopes this line of investigation will lead to new avenues of research in preventive strategies for Alzheimer’s disease. 

“We hope that coffee and tea intake could contribute to the development of a safe and inexpensive strategy for delaying the onset and reducing the incidence for Alzheimer’s disease.”

A limitation of the study is possible recall bias, because coffee and tea consumption were self-reported. However, this may not be much of an issue because coffee and tea consumption “is usually quite a habitual behavior,” said Dr. Sewell.

The study also had no data on midlife coffee or tea consumption and did not compare the effect of different preparation methods or types of coffee and tea — for example, green tea versus black tea. 

When asked if the study controlled for smoking, Dr. Sewell said it didn’t but added that it would be interesting to explore its impact on cognition.

Dr. Sewell reported no relevant conflicts of interest.

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

PHILADELPHIA – Drinking more than three cups of coffee a day is linked to more rapid cognitive decline over time, results from a large study suggest.

Investigators examined the impact of different amounts of coffee and tea on fluid intelligence — a measure of cognitive functions including abstract reasoning, pattern recognition, and logical thinking.

“It’s the old adage that too much of anything isn’t good. It’s all about balance, so moderate coffee consumption is okay but too much is probably not recommended,” said study investigator Kelsey R. Sewell, PhD, Advent Health Research Institute, Orlando, Florida. 

The findings of the study were presented at the 2024 Alzheimer’s Association International Conference (AAIC).
 

One of the World’s Most Widely Consumed Beverages

Coffee is one of the most widely consumed beverages around the world. The beans contain a range of bioactive compounds, including caffeine, chlorogenic acid, and small amounts of vitamins and minerals.

Consistent evidence from observational and epidemiologic studies indicates that intake of both coffee and tea has beneficial effects on stroke, heart failure, cancers, diabetes, and Parkinson’s disease.  

Several studies also suggest that coffee may reduce the risk for Alzheimer’s disease, said Dr. Sewell. However, there are limited longitudinal data on associations between coffee and tea intake and cognitive decline, particularly in distinct cognitive domains.

Dr. Sewell’s group previously published a study of cognitively unimpaired older adults that found greater coffee consumption was associated with slower cognitive decline and slower accumulation of brain beta-amyloid.

Their current study extends some of the prior findings and investigates the relationship between both coffee and tea intake and cognitive decline over time in a larger sample of older adults.

This new study included 8451 mostly female (60%) and White (97%) cognitively unimpaired adults older than 60 (mean age, 67.8 years) in the UK Biobank, a large-scale research resource containing in-depth, deidentified genetic and health information from half a million UK participants. Study subjects had a mean body mass index (BMI) of 26, and about 26% were apolipoprotein epsilon 4 (APOE e4) gene carriers.

Researchers divided coffee and tea consumption into tertiles: high, moderate, and no consumption.

For daily coffee consumption, 18% reported drinking four or more cups (high consumption), 58% reported drinking one to three cups (moderate consumption), and 25% reported that they never drink coffee. For daily tea consumption, 47% reported drinking four or more cups (high consumption), 38% reported drinking one to three cups (moderate consumption), and 15% reported that they never drink tea.

The study assessed cognitive function at baseline and at least two additional patient visits. 

Researchers used linear mixed models to assess the relationships between coffee and tea intake and cognitive outcomes. The models adjusted for age, sex, Townsend deprivation index (reflecting socioeconomic status), ethnicity, APOE e4 status, and BMI.
 

Steeper Decline 

Compared with high coffee consumption (four or more cups daily), people who never consumed coffee (beta, 0.06; standard error [SE], 0.02; P = .005) and those with moderate consumption (beta, 0.07; SE, 0.02; P = < .001) had slower decline in fluid intelligence after an average of 8.83 years of follow-up.

“We can see that those with high coffee consumption showed the steepest decline in fluid intelligence across the follow up, compared to those with moderate coffee consumption and those never consuming coffee,” said Dr. Sewell, referring to illustrative graphs.

At the same time, “our data suggest that across this time period, moderate coffee consumption can serve as some kind of protective factor against cognitive decline,” she added.

For tea, there was a somewhat different pattern. People who never drank tea had a greater decline in fluid intelligence, compared with those who had moderate consumption (beta, 0.06; SE, 0.02; P = .0090) or high consumption (beta, 0.06; SE, 0.02; P = .003).

Because this is an observational study, “we still need randomized controlled trials to better understand the neuroprotective mechanism of coffee and tea compounds,” said Dr. Sewell.

Responding later to a query from a meeting delegate about how moderate coffee drinking could be protective, Dr. Sewell said there are probably “different levels of mechanisms,” including at the molecular level (possibly involving amyloid toxicity) and the behavioral level (possibly involving sleep patterns).

Dr. Sewell said that she hopes this line of investigation will lead to new avenues of research in preventive strategies for Alzheimer’s disease. 

“We hope that coffee and tea intake could contribute to the development of a safe and inexpensive strategy for delaying the onset and reducing the incidence for Alzheimer’s disease.”

A limitation of the study is possible recall bias, because coffee and tea consumption were self-reported. However, this may not be much of an issue because coffee and tea consumption “is usually quite a habitual behavior,” said Dr. Sewell.

The study also had no data on midlife coffee or tea consumption and did not compare the effect of different preparation methods or types of coffee and tea — for example, green tea versus black tea. 

When asked if the study controlled for smoking, Dr. Sewell said it didn’t but added that it would be interesting to explore its impact on cognition.

Dr. Sewell reported no relevant conflicts of interest.

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

TOPLINE:

People with knee osteoarthritis and symptoms for less than 1 year benefit more from exercise therapy than do those with longer symptom duration, especially when long-term outcomes are considered.

METHODOLOGY:

• Researchers conducted an individual participant data meta-analysis using data from the OA Trial Bank, including 1769 participants (mean age, 65.1 years; 66% women) with knee osteoarthritis from 10 randomized controlled trials.
• The participants were categorized on the basis of their symptom duration: ≤ 1 year, > 1 and ≤ 2 years, and > 2 years.
• This study included an exercise therapy group comprising land- and water-based therapeutic exercise interventions and a control group comprising no exercise or sham treatment.
• The primary outcomes were self-reported pain and physical function, standardized to a 0-100 scale, at short-term (closest to 3 months) and long-term (closest to 12 months) follow-ups.

TAKEAWAY:

• The overall pain and physical function associated with osteoarthritis improved in the exercise therapy group at both short- and long-term follow-ups compared with in the control group.
• Exercise therapy led to a greater improvement in short-term (mean difference [MD], −3.57; P = .028) and long-term (MD, −8.33; P < .001) pain among participants with a symptom duration ≤ 1 year vs > 1 year.
• Similarly, those with a symptom duration ≤ 2 years vs > 2 years who underwent exercise therapy showed greater benefits in terms of short-term (P = .001) and long-term (P < .001) pain.
• Exercise therapy improved long-term physical function in those with a symptom duration ≤ 1 year vs > 1 year (MD, −5.46; P = .005) and ≤ 2 years vs > 2 years (MD, −4.56; P = .001).

IN PRACTICE:

“Exercise should be encouraged as early as possible once symptoms emerge in the disease process to take advantage of its effects in potentially [slowing] disease progression within the suggested ‘window of opportunity,’ ” the authors wrote.

SOURCE:

The study was led by Marienke van Middelkoop, PhD, Erasmus MC Medical University, Rotterdam, the Netherlands. It was published online in Osteoarthritis and Cartilage.

LIMITATIONS:

The dataset of most studies included in the meta-analysis lacked information on the radiographic severity of osteoarthritis. The relatively short follow-up time hindered interpreting the impact of exercise on the long-term progression of osteoarthritis. The reliance on patient recall for recording symptom duration may have led to misclassification.

DISCLOSURES:

The Netherlands Organisation for Health Research and Development supported this study. Three authors received funding from the Dutch Arthritis Society for the program grant Center of Excellence “OA prevention and early treatment – OA Pearl.” One author declared receiving royalties for the UpToDate knee osteoarthritis clinical guidelines.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

People with knee osteoarthritis and symptoms for less than 1 year benefit more from exercise therapy than do those with longer symptom duration, especially when long-term outcomes are considered.

METHODOLOGY:

• Researchers conducted an individual participant data meta-analysis using data from the OA Trial Bank, including 1769 participants (mean age, 65.1 years; 66% women) with knee osteoarthritis from 10 randomized controlled trials.
• The participants were categorized on the basis of their symptom duration: ≤ 1 year, > 1 and ≤ 2 years, and > 2 years.
• This study included an exercise therapy group comprising land- and water-based therapeutic exercise interventions and a control group comprising no exercise or sham treatment.
• The primary outcomes were self-reported pain and physical function, standardized to a 0-100 scale, at short-term (closest to 3 months) and long-term (closest to 12 months) follow-ups.

TAKEAWAY:

• The overall pain and physical function associated with osteoarthritis improved in the exercise therapy group at both short- and long-term follow-ups compared with in the control group.
• Exercise therapy led to a greater improvement in short-term (mean difference [MD], −3.57; P = .028) and long-term (MD, −8.33; P < .001) pain among participants with a symptom duration ≤ 1 year vs > 1 year.
• Similarly, those with a symptom duration ≤ 2 years vs > 2 years who underwent exercise therapy showed greater benefits in terms of short-term (P = .001) and long-term (P < .001) pain.
• Exercise therapy improved long-term physical function in those with a symptom duration ≤ 1 year vs > 1 year (MD, −5.46; P = .005) and ≤ 2 years vs > 2 years (MD, −4.56; P = .001).

IN PRACTICE:

“Exercise should be encouraged as early as possible once symptoms emerge in the disease process to take advantage of its effects in potentially [slowing] disease progression within the suggested ‘window of opportunity,’ ” the authors wrote.

SOURCE:

The study was led by Marienke van Middelkoop, PhD, Erasmus MC Medical University, Rotterdam, the Netherlands. It was published online in Osteoarthritis and Cartilage.

LIMITATIONS:

The dataset of most studies included in the meta-analysis lacked information on the radiographic severity of osteoarthritis. The relatively short follow-up time hindered interpreting the impact of exercise on the long-term progression of osteoarthritis. The reliance on patient recall for recording symptom duration may have led to misclassification.

DISCLOSURES:

The Netherlands Organisation for Health Research and Development supported this study. Three authors received funding from the Dutch Arthritis Society for the program grant Center of Excellence “OA prevention and early treatment – OA Pearl.” One author declared receiving royalties for the UpToDate knee osteoarthritis clinical guidelines.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

People with knee osteoarthritis and symptoms for less than 1 year benefit more from exercise therapy than do those with longer symptom duration, especially when long-term outcomes are considered.

METHODOLOGY:

• Researchers conducted an individual participant data meta-analysis using data from the OA Trial Bank, including 1769 participants (mean age, 65.1 years; 66% women) with knee osteoarthritis from 10 randomized controlled trials.
• The participants were categorized on the basis of their symptom duration: ≤ 1 year, > 1 and ≤ 2 years, and > 2 years.
• This study included an exercise therapy group comprising land- and water-based therapeutic exercise interventions and a control group comprising no exercise or sham treatment.
• The primary outcomes were self-reported pain and physical function, standardized to a 0-100 scale, at short-term (closest to 3 months) and long-term (closest to 12 months) follow-ups.

TAKEAWAY:

• The overall pain and physical function associated with osteoarthritis improved in the exercise therapy group at both short- and long-term follow-ups compared with in the control group.
• Exercise therapy led to a greater improvement in short-term (mean difference [MD], −3.57; P = .028) and long-term (MD, −8.33; P < .001) pain among participants with a symptom duration ≤ 1 year vs > 1 year.
• Similarly, those with a symptom duration ≤ 2 years vs > 2 years who underwent exercise therapy showed greater benefits in terms of short-term (P = .001) and long-term (P < .001) pain.
• Exercise therapy improved long-term physical function in those with a symptom duration ≤ 1 year vs > 1 year (MD, −5.46; P = .005) and ≤ 2 years vs > 2 years (MD, −4.56; P = .001).

IN PRACTICE:

“Exercise should be encouraged as early as possible once symptoms emerge in the disease process to take advantage of its effects in potentially [slowing] disease progression within the suggested ‘window of opportunity,’ ” the authors wrote.

SOURCE:

The study was led by Marienke van Middelkoop, PhD, Erasmus MC Medical University, Rotterdam, the Netherlands. It was published online in Osteoarthritis and Cartilage.

LIMITATIONS:

The dataset of most studies included in the meta-analysis lacked information on the radiographic severity of osteoarthritis. The relatively short follow-up time hindered interpreting the impact of exercise on the long-term progression of osteoarthritis. The reliance on patient recall for recording symptom duration may have led to misclassification.

DISCLOSURES:

The Netherlands Organisation for Health Research and Development supported this study. Three authors received funding from the Dutch Arthritis Society for the program grant Center of Excellence “OA prevention and early treatment – OA Pearl.” One author declared receiving royalties for the UpToDate knee osteoarthritis clinical guidelines.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

The lowest point in the nascent career of Neelendu Dey, MD, helped seal his fate as a physician-scientist.

He had just started his first year as a resident at University of California, San Francisco. One of his patients was a 30-year-old woman who was dying of metastatic colorectal cancer. “I was in my mid-20s interacting with an individual just a few years older than I am, going through one of the most terrible health outcomes one could imagine,” Dr. Dey said.

He remembers asking the patient what he could do for her, how he could make her feel more comfortable. “That feeling of helplessness, particularly as we think about young people developing cancer, it really stuck with me through the years,” he said.

Dr. Dey, a graduate of the AGA Future Leaders Program, is now a gastroenterologist and researcher at the Fred Hutch Cancer Center in Seattle. In an interview, he talked about his dual role as a physician and scientist, and how those two interests are guiding his research in precancerous conditions of the colon.

Cases like that of the young woman with colon cancer “really help drive the urgency of the work we do, and the research questions we ask, as we try to move the ball forward and help folks at earlier stages,” he said.

Fred Hutch Cancer Center

Q: Why did you choose GI?

When you think about what sorts of chronic diseases really impact your quality of life, gut health is one of the chief contributors among various aspects of health. And that really appealed to me — the ability to take someone who is essentially handicapped by a series of illnesses and symptoms that derive from the GI tract and enable them to return to the person they want to be, to be productive in the way that they want to be, and have a rewarding life.

As I thought about how I wanted to contribute to the future of medicine, one of the ways in which I’ve always thought that I would do that is through research. When I considered the fields that really appealed to me, both from that clinical standpoint and research standpoint, GI was one that really stood out. There has been a lot of exciting research going on in GI. My lab currently studies the microbiome, and I feel like this is an area in which we can contribute.
 

Q: What role does digestive health play in overall health?

Obviously, the direct answer is gut health is so critical in something like nutritional intake. Some GI symptoms, if your gut health has gone awry, can really be detrimental in terms of quality of life. But one less obvious role that digestive health plays is its long-term effects. We’re starting to appreciate that gut health, the gut microbiome, and gut immune education are probably long-term players. Some experiences in early life might shape our immunity in ways that have consequences for us much later in life. Whether we get early life antibiotics, for example, may potentially contribute to colorectal cancer down the line. Thinking about the long-term players is more challenging, but it’s also an appealing opportunity as we think about how we can shape medicine moving forward.

Q: What practice challenges have you faced in your career?

First, being a physician-scientist. It’s challenging to be either a physician alone or to be a researcher alone. And trying to do both includes the challenges of both individual worlds. It just takes more time to get all the prerequisite training. And second, there are just challenges with getting the opportunities to contribute in the ways that you want — to get the research funding, to get the papers out, things like that.

Q: Tell me about the work you’ve been doing in your lab to develop microbiome-based strategies for preventing and treating cancer.

The microbiome presents several opportunities when it comes to cancer prevention. One is identifying markers of cancer risk, or of general good health down the line. Some of those biomarkers could — potentially — feed directly into personalized risk assessment and maybe even inform a future screening strategy. The second opportunity the microbiome presents is if we identify a microbe that influences your cancer risk, can we then understand and exploit, or utilize, that mechanism to mitigate cancer risk in the future? Our lab has done work looking at subspecies levels of microbes that track with health or cancer. We’ve done some work to identify what these subspecies groupings are and have identified some links to certain precancerous changes in the colon. We think that there’s an opportunity here for future interventions.

Q: Have you published other papers?

We recently published another paper describing how some microbes can interact with a tumor suppressor gene and are influenced in a sex-biased manner to drive tumorigenesis in a mouse model. We think, based on what we’re seeing in human data, that there may be some relationships and we’re exploring that now as well. 

Q: What is your vision for the future in GI, and in your career?

The vision that I have is to create clinical tools that can expand our reach and our effectiveness and cancer prevention. I think that there are opportunities for leveraging microbiome research to accomplish this. And one outcome I could imagine is leveraging some of these insights to expand noninvasive screening at even earlier ages than we do now. I mean, we just dialed back the recommended age for colonoscopy for average risk individuals to 45. But I could envision a future in which noninvasive screening starts earlier, in which the first stool-based tests that we deploy to assess personalized risk are used in the pediatric clinic.

Lightning Round

Texting or talking?

Talking

Favorite city in the United States besides the one you live in?

St. Louis

Cat or dog person?

Both

If you weren’t a GI, what would you be?

Musician

Best place you went on vacation?

Borneo

Favorite sport?

Soccer

Favorite ice cream?

Cashew-based salted caramel

What song do you have to sing along with when you hear it?

Sweet Child of Mine

Favorite movie or TV show?

25th Hour or Shawshank Redemption

Optimist or Pessimist?

Optimist

The lowest point in the nascent career of Neelendu Dey, MD, helped seal his fate as a physician-scientist.

He had just started his first year as a resident at University of California, San Francisco. One of his patients was a 30-year-old woman who was dying of metastatic colorectal cancer. “I was in my mid-20s interacting with an individual just a few years older than I am, going through one of the most terrible health outcomes one could imagine,” Dr. Dey said.

He remembers asking the patient what he could do for her, how he could make her feel more comfortable. “That feeling of helplessness, particularly as we think about young people developing cancer, it really stuck with me through the years,” he said.

Dr. Dey, a graduate of the AGA Future Leaders Program, is now a gastroenterologist and researcher at the Fred Hutch Cancer Center in Seattle. In an interview, he talked about his dual role as a physician and scientist, and how those two interests are guiding his research in precancerous conditions of the colon.

Cases like that of the young woman with colon cancer “really help drive the urgency of the work we do, and the research questions we ask, as we try to move the ball forward and help folks at earlier stages,” he said.

Fred Hutch Cancer Center

Q: Why did you choose GI?

When you think about what sorts of chronic diseases really impact your quality of life, gut health is one of the chief contributors among various aspects of health. And that really appealed to me — the ability to take someone who is essentially handicapped by a series of illnesses and symptoms that derive from the GI tract and enable them to return to the person they want to be, to be productive in the way that they want to be, and have a rewarding life.

As I thought about how I wanted to contribute to the future of medicine, one of the ways in which I’ve always thought that I would do that is through research. When I considered the fields that really appealed to me, both from that clinical standpoint and research standpoint, GI was one that really stood out. There has been a lot of exciting research going on in GI. My lab currently studies the microbiome, and I feel like this is an area in which we can contribute.
 

Q: What role does digestive health play in overall health?

Obviously, the direct answer is gut health is so critical in something like nutritional intake. Some GI symptoms, if your gut health has gone awry, can really be detrimental in terms of quality of life. But one less obvious role that digestive health plays is its long-term effects. We’re starting to appreciate that gut health, the gut microbiome, and gut immune education are probably long-term players. Some experiences in early life might shape our immunity in ways that have consequences for us much later in life. Whether we get early life antibiotics, for example, may potentially contribute to colorectal cancer down the line. Thinking about the long-term players is more challenging, but it’s also an appealing opportunity as we think about how we can shape medicine moving forward.

Q: What practice challenges have you faced in your career?

First, being a physician-scientist. It’s challenging to be either a physician alone or to be a researcher alone. And trying to do both includes the challenges of both individual worlds. It just takes more time to get all the prerequisite training. And second, there are just challenges with getting the opportunities to contribute in the ways that you want — to get the research funding, to get the papers out, things like that.

Q: Tell me about the work you’ve been doing in your lab to develop microbiome-based strategies for preventing and treating cancer.

The microbiome presents several opportunities when it comes to cancer prevention. One is identifying markers of cancer risk, or of general good health down the line. Some of those biomarkers could — potentially — feed directly into personalized risk assessment and maybe even inform a future screening strategy. The second opportunity the microbiome presents is if we identify a microbe that influences your cancer risk, can we then understand and exploit, or utilize, that mechanism to mitigate cancer risk in the future? Our lab has done work looking at subspecies levels of microbes that track with health or cancer. We’ve done some work to identify what these subspecies groupings are and have identified some links to certain precancerous changes in the colon. We think that there’s an opportunity here for future interventions.

Q: Have you published other papers?

We recently published another paper describing how some microbes can interact with a tumor suppressor gene and are influenced in a sex-biased manner to drive tumorigenesis in a mouse model. We think, based on what we’re seeing in human data, that there may be some relationships and we’re exploring that now as well. 

Q: What is your vision for the future in GI, and in your career?

The vision that I have is to create clinical tools that can expand our reach and our effectiveness and cancer prevention. I think that there are opportunities for leveraging microbiome research to accomplish this. And one outcome I could imagine is leveraging some of these insights to expand noninvasive screening at even earlier ages than we do now. I mean, we just dialed back the recommended age for colonoscopy for average risk individuals to 45. But I could envision a future in which noninvasive screening starts earlier, in which the first stool-based tests that we deploy to assess personalized risk are used in the pediatric clinic.

Lightning Round

Texting or talking?

Talking

Favorite city in the United States besides the one you live in?

St. Louis

Cat or dog person?

Both

If you weren’t a GI, what would you be?

Musician

Best place you went on vacation?

Borneo

Favorite sport?

Soccer

Favorite ice cream?

Cashew-based salted caramel

What song do you have to sing along with when you hear it?

Sweet Child of Mine

Favorite movie or TV show?

25th Hour or Shawshank Redemption

Optimist or Pessimist?

Optimist

The lowest point in the nascent career of Neelendu Dey, MD, helped seal his fate as a physician-scientist.

He had just started his first year as a resident at University of California, San Francisco. One of his patients was a 30-year-old woman who was dying of metastatic colorectal cancer. “I was in my mid-20s interacting with an individual just a few years older than I am, going through one of the most terrible health outcomes one could imagine,” Dr. Dey said.

He remembers asking the patient what he could do for her, how he could make her feel more comfortable. “That feeling of helplessness, particularly as we think about young people developing cancer, it really stuck with me through the years,” he said.

Dr. Dey, a graduate of the AGA Future Leaders Program, is now a gastroenterologist and researcher at the Fred Hutch Cancer Center in Seattle. In an interview, he talked about his dual role as a physician and scientist, and how those two interests are guiding his research in precancerous conditions of the colon.

Cases like that of the young woman with colon cancer “really help drive the urgency of the work we do, and the research questions we ask, as we try to move the ball forward and help folks at earlier stages,” he said.

Fred Hutch Cancer Center

Q: Why did you choose GI?

When you think about what sorts of chronic diseases really impact your quality of life, gut health is one of the chief contributors among various aspects of health. And that really appealed to me — the ability to take someone who is essentially handicapped by a series of illnesses and symptoms that derive from the GI tract and enable them to return to the person they want to be, to be productive in the way that they want to be, and have a rewarding life.

As I thought about how I wanted to contribute to the future of medicine, one of the ways in which I’ve always thought that I would do that is through research. When I considered the fields that really appealed to me, both from that clinical standpoint and research standpoint, GI was one that really stood out. There has been a lot of exciting research going on in GI. My lab currently studies the microbiome, and I feel like this is an area in which we can contribute.
 

Q: What role does digestive health play in overall health?

Obviously, the direct answer is gut health is so critical in something like nutritional intake. Some GI symptoms, if your gut health has gone awry, can really be detrimental in terms of quality of life. But one less obvious role that digestive health plays is its long-term effects. We’re starting to appreciate that gut health, the gut microbiome, and gut immune education are probably long-term players. Some experiences in early life might shape our immunity in ways that have consequences for us much later in life. Whether we get early life antibiotics, for example, may potentially contribute to colorectal cancer down the line. Thinking about the long-term players is more challenging, but it’s also an appealing opportunity as we think about how we can shape medicine moving forward.

Q: What practice challenges have you faced in your career?

First, being a physician-scientist. It’s challenging to be either a physician alone or to be a researcher alone. And trying to do both includes the challenges of both individual worlds. It just takes more time to get all the prerequisite training. And second, there are just challenges with getting the opportunities to contribute in the ways that you want — to get the research funding, to get the papers out, things like that.

Q: Tell me about the work you’ve been doing in your lab to develop microbiome-based strategies for preventing and treating cancer.

The microbiome presents several opportunities when it comes to cancer prevention. One is identifying markers of cancer risk, or of general good health down the line. Some of those biomarkers could — potentially — feed directly into personalized risk assessment and maybe even inform a future screening strategy. The second opportunity the microbiome presents is if we identify a microbe that influences your cancer risk, can we then understand and exploit, or utilize, that mechanism to mitigate cancer risk in the future? Our lab has done work looking at subspecies levels of microbes that track with health or cancer. We’ve done some work to identify what these subspecies groupings are and have identified some links to certain precancerous changes in the colon. We think that there’s an opportunity here for future interventions.

Q: Have you published other papers?

We recently published another paper describing how some microbes can interact with a tumor suppressor gene and are influenced in a sex-biased manner to drive tumorigenesis in a mouse model. We think, based on what we’re seeing in human data, that there may be some relationships and we’re exploring that now as well. 

Q: What is your vision for the future in GI, and in your career?

The vision that I have is to create clinical tools that can expand our reach and our effectiveness and cancer prevention. I think that there are opportunities for leveraging microbiome research to accomplish this. And one outcome I could imagine is leveraging some of these insights to expand noninvasive screening at even earlier ages than we do now. I mean, we just dialed back the recommended age for colonoscopy for average risk individuals to 45. But I could envision a future in which noninvasive screening starts earlier, in which the first stool-based tests that we deploy to assess personalized risk are used in the pediatric clinic.

Lightning Round

Texting or talking?

Talking

Favorite city in the United States besides the one you live in?

St. Louis

Cat or dog person?

Both

If you weren’t a GI, what would you be?

Musician

Best place you went on vacation?

Borneo

Favorite sport?

Soccer

Favorite ice cream?

Cashew-based salted caramel

What song do you have to sing along with when you hear it?

Sweet Child of Mine

Favorite movie or TV show?

25th Hour or Shawshank Redemption

Optimist or Pessimist?

Optimist

A breakthrough in medical testing now allows for colorectal cancer screening with just a simple blood test, promising a more accessible and less invasive way to catch the disease early. 

The FDA on July 29 approved the test, called Shield, which can accurately detect tumors in the colon or rectum about 87% of the time when the cancer is in treatable early stages. The approval was announced July 29 by the test’s maker, Guardant Health, and comes just months after promising clinical trial results were published in The New England Journal of Medicine.

Colorectal cancer is among the most common types of cancer diagnosed in the United States each year, along with being one of the leading causes of cancer deaths. The condition is treatable in early stages, but about 1 in 3 people don’t stay up to date on regular screenings, which should begin at age 45.

The simplicity of a blood test could make it more likely for people to be screened for and, ultimately, survive the disease. Other primary screening options include feces-based tests or colonoscopy. The 5-year survival rate for colorectal cancer is 64%.

While highly accurate at detecting DNA shed by tumors during treatable stages of colorectal cancer, the Shield test was not as effective at detecting precancerous areas of tissue, which are typically removed after being detected.

In its news release, Guardant Health officials said they anticipate the test to be covered under Medicare. The out-of-pocket cost for people whose insurance does not cover the test has not yet been announced. The test is expected to be available by next week, The New York Times reported.

If someone’s Shield test comes back positive, the person would then get more tests to confirm the result. Shield was shown in trials to have a 10% false positive rate.

“I was in for a routine physical, and my doctor asked when I had my last colonoscopy,” said John Gormly, a 77-year-old business executive in Newport Beach, California, according to a Guardant Health news release. “I said it’s been a long time, so he offered to give me the Shield blood test. A few days later, the result came back positive, so he referred me for a colonoscopy. It turned out I had stage II colon cancer. The tumor was removed, and I recovered very quickly. Thank God I had taken that blood test.”
 

A version of this article appeared on WebMD.com.

A breakthrough in medical testing now allows for colorectal cancer screening with just a simple blood test, promising a more accessible and less invasive way to catch the disease early. 

The FDA on July 29 approved the test, called Shield, which can accurately detect tumors in the colon or rectum about 87% of the time when the cancer is in treatable early stages. The approval was announced July 29 by the test’s maker, Guardant Health, and comes just months after promising clinical trial results were published in The New England Journal of Medicine.

Colorectal cancer is among the most common types of cancer diagnosed in the United States each year, along with being one of the leading causes of cancer deaths. The condition is treatable in early stages, but about 1 in 3 people don’t stay up to date on regular screenings, which should begin at age 45.

The simplicity of a blood test could make it more likely for people to be screened for and, ultimately, survive the disease. Other primary screening options include feces-based tests or colonoscopy. The 5-year survival rate for colorectal cancer is 64%.

While highly accurate at detecting DNA shed by tumors during treatable stages of colorectal cancer, the Shield test was not as effective at detecting precancerous areas of tissue, which are typically removed after being detected.

In its news release, Guardant Health officials said they anticipate the test to be covered under Medicare. The out-of-pocket cost for people whose insurance does not cover the test has not yet been announced. The test is expected to be available by next week, The New York Times reported.

If someone’s Shield test comes back positive, the person would then get more tests to confirm the result. Shield was shown in trials to have a 10% false positive rate.

“I was in for a routine physical, and my doctor asked when I had my last colonoscopy,” said John Gormly, a 77-year-old business executive in Newport Beach, California, according to a Guardant Health news release. “I said it’s been a long time, so he offered to give me the Shield blood test. A few days later, the result came back positive, so he referred me for a colonoscopy. It turned out I had stage II colon cancer. The tumor was removed, and I recovered very quickly. Thank God I had taken that blood test.”
 

A version of this article appeared on WebMD.com.

A breakthrough in medical testing now allows for colorectal cancer screening with just a simple blood test, promising a more accessible and less invasive way to catch the disease early. 

The FDA on July 29 approved the test, called Shield, which can accurately detect tumors in the colon or rectum about 87% of the time when the cancer is in treatable early stages. The approval was announced July 29 by the test’s maker, Guardant Health, and comes just months after promising clinical trial results were published in The New England Journal of Medicine.

Colorectal cancer is among the most common types of cancer diagnosed in the United States each year, along with being one of the leading causes of cancer deaths. The condition is treatable in early stages, but about 1 in 3 people don’t stay up to date on regular screenings, which should begin at age 45.

The simplicity of a blood test could make it more likely for people to be screened for and, ultimately, survive the disease. Other primary screening options include feces-based tests or colonoscopy. The 5-year survival rate for colorectal cancer is 64%.

While highly accurate at detecting DNA shed by tumors during treatable stages of colorectal cancer, the Shield test was not as effective at detecting precancerous areas of tissue, which are typically removed after being detected.

In its news release, Guardant Health officials said they anticipate the test to be covered under Medicare. The out-of-pocket cost for people whose insurance does not cover the test has not yet been announced. The test is expected to be available by next week, The New York Times reported.

If someone’s Shield test comes back positive, the person would then get more tests to confirm the result. Shield was shown in trials to have a 10% false positive rate.

“I was in for a routine physical, and my doctor asked when I had my last colonoscopy,” said John Gormly, a 77-year-old business executive in Newport Beach, California, according to a Guardant Health news release. “I said it’s been a long time, so he offered to give me the Shield blood test. A few days later, the result came back positive, so he referred me for a colonoscopy. It turned out I had stage II colon cancer. The tumor was removed, and I recovered very quickly. Thank God I had taken that blood test.”
 

A version of this article appeared on WebMD.com.

Recognizing the increasing importance of digital pathology and its potential impact to transform federal health care, government, military, and university digital pathology specialists convened in May 2023 to share expertise to advance the use of digital pathology in federal health care. 

The seminar was hosted by the University of Pittsburgh and led by Ronald Poropatich, MD, Director of the Center for Military Medicine Research, Health Sciences, and Professor of Medicine at the University of Pittsburgh Medical Center, and Douglas Hartman, MD, Vice Chair of Pathology Informatics, Associate Director of the Center for AI Innovation in Medical Imaging, and Professor of Pathology at the University of Pittsburgh/University of Pittsburgh Medical Center (UPMC).

Invitees included senior federal government pathologists, laboratory scientists, IT leaders, and stakeholders from the VA, DoD, HHS (NIH, CDC, IHS, FDA) and other federal agencies. The speakers for the conference were CDR Roger Boodoo, MD, Chief of Innovation, Defense Health Agency; Ryan Collins, MD, Pathologist, Williamsport Pathology Association; Pat Flanders, Chief Information Officer, J6, Defense Health Agency; Matthew Hanna, MD, Director, Digital Pathology Informatics, Memorial Sloan Kettering Cancer Center; Stephanie Harmon, PhD, Staff Scientist, NIH NCI, Imaging/Data Scientist in Molecular Imaging; Douglas Hartman, MD, Vice Chair of Pathology Informatics, University of Pittsburgh; Stephen Hewitt, MD, PhD, Head, Experimental Pathology Laboratory, NIH NCI, Center for Cancer Research; Jason Hipp, MD, PhD, Chief Digital Innovation Officer, Mayo Collaborate Services,  Mayo Clinic; Brian Lein, MD, Assistant Director, Healthcare Administration, Defense Health Agency; Col Mark Lyman, MD, Pathology Consultant to the US Air Force Surgeon General; COL Joel Moncur, MD, Director, Joint Pathology Center; Ronald Poropatich, MD, Director of the Center for Military Medicine Research, Health Sciences; Professor of Medicine, University of Pittsburgh; David Shulkin, MD, Ninth U.S. Secretary of Veterans Affairs; Eliot Siegel, MD, Chief of Radiology and Nuclear Medicine, Veterans Affairs Maryland Healthcare System; Professor and Vice Chair, University of Maryland School of Medicine; CDR Jenny Smith, DO, Pathologist, US Naval Medical Center Portsmouth; Shandong Wu, PhD, Associate Professor, Departments of Radiology, Biomedical Informatics, and Bioengineering, Director of Center for Artificial Intelligence Innovation in Medical Imaging, University of Pittsburgh; LCDR Victoria Mahar MD, Pathologist, US Army. 

Throughout the 1.5-day meeting, topics such as the integration of systems, the value of single vendor solutions vs multiple vendors, and the interconnectedness of radiology and pathology in health care were discussed. The speakers addressed the challenges of adopting digital pathology, including workflow improvement, quality control, and the generalizability of algorithms. The importance of collaboration, leadership, data analytics, compliance with clinical practice guidelines, and research and development efforts were stressed. The increasingly important role of artificial intelligence (AI) in digital pathology, its applications, and its benefits were also highlighted. Continuing education credits were offered to participants. 

Overall, the meeting provided valuable insights into the advancements, challenges, and potential of digital pathology, AI, and technology integration in the federal health care ecosystem. However, this cannot be achieved without leadership from and close collaboration between key industry, academic, and government stakeholders.

Uses of Digital Pathology

Digital pathology refers to the practice of digitizing glass slides containing tissue samples and using digital imaging technology to analyze and interpret them. It involves capturing high-resolution images of microscopic slides and storing them in a digital format. These digitized images can be accessed and analyzed using computer-based tools and software.

While traditional pathology involves examining tissue samples under a microscope to make diagnoses and provide insights into diseases and conditions, digital pathology uses digital scanners that capture all relevant tissue on the glass slide at high magnification. This process generates a high-fidelity digital representation of the tissue sample that can be navigated akin to how glass slides are reviewed on a brightfield microscope in current practice (eg, panning, zooming, etc). Microscopic review of patient specimens in pathology allows for identifying patterns and markers that may not be easily detectable with manual examination alone. 

The digitized slides can be stored in a database or a slide management system, allowing pathologists and other healthcare professionals to access and review them remotely, thus creating the potential to improve collaboration among pathologists, facilitate second opinions, and enable easier access to archived slides for research purposes. 

Potential Benefits

Digital pathology also opens the door to advanced image analysis techniques, such as computer-aided diagnosis, machine learning, and AI algorithms, with the potential for the following outcomes and benefits:

• Improved accuracy AI algorithms can analyze large volumes of digital pathology data with great precision, reducing the chances of human error and subjective interpretation. This can lead to more accurate and consistent diagnoses, especially in challenging cases where subtle patterns or features may be difficult to detect.
• Automated detection and classification AI algorithms can be trained to detect and classify specific features or abnormalities in digital pathology images. For example, AI models can identify cancerous cells, tissue patterns associated with different diseases, or specific biomarkers. This can assist pathologists in diagnosing diseases more accurately and efficiently.
• Quantitative analysis AI can analyze large quantities of digital pathology data and extract quantitative measurements. For instance, it can calculate the percentage of tumor cells in a sample, assess the density of immune cells, or measure the extent of tissue damage. These objective measurements can aid in prognosis prediction and treatment planning.
• Image segmentation AI algorithms can segment digital pathology images into different regions or structures, such as nuclei, cytoplasm, or blood vessels. This segmentation allows for precise analysis and extraction of features for further study. It can also facilitate the identification of specific cell types or tissue components.
• Image enhancement AI techniques can enhance the quality of digital pathology images by improving clarity and reducing noise or artifacts. This can help pathologists visualize and interpret slides more effectively, especially in challenging cases with low-quality or complex images.
• Decision support systems AI-powered decision support systems can assist pathologists by providing recommendations or second opinions based on the analysis of digital pathology data. These systems can offer insights, suggest potential diagnoses, or provide relevant research references, augmenting the pathologist’s expertise and improving diagnostic accuracy.
• Collaboration and second opinions Digital pathology, combined with AI, facilitates remote access to digitized slides, enabling pathologists to seek second opinions or collaborate with experts from around the world. This can enhance the quality of diagnoses by leveraging the collective expertise of pathologists and fostering knowledge sharing.
• Education and training AI algorithms can be utilized in virtual microscopy platforms to create interactive and educational experiences. Pathology residents and students can learn from annotated cases, receive real-time feedback, and develop their skills in a digital environment.
• Research and discovery AI can assist in identifying patterns, correlations, and novel biomarkers in digital pathology data. By analyzing large datasets, AI algorithms can help uncover new insights, contribute to research advancements, and aid in the development of personalized medicine approaches.
• Predictive modeling AI can analyze vast amounts of digital pathology data, patient records, and outcomes to develop predictive models. These models can estimate disease progression, treatment response, or patient survival rates based on various factors. They can contribute to personalized medicine by assisting in treatment decisions and prognosis assessment.

It is important to note that while AI has shown promising results, it is not intended to replace human pathologists but to augment their capabilities. Overall, the combination of AI technology with the expertise of pathologists can lead to improved diagnosis, better patient care, and more efficient workflows in digital pathology.
 

Recognizing the increasing importance of digital pathology and its potential impact to transform federal health care, government, military, and university digital pathology specialists convened in May 2023 to share expertise to advance the use of digital pathology in federal health care. 

The seminar was hosted by the University of Pittsburgh and led by Ronald Poropatich, MD, Director of the Center for Military Medicine Research, Health Sciences, and Professor of Medicine at the University of Pittsburgh Medical Center, and Douglas Hartman, MD, Vice Chair of Pathology Informatics, Associate Director of the Center for AI Innovation in Medical Imaging, and Professor of Pathology at the University of Pittsburgh/University of Pittsburgh Medical Center (UPMC).

Invitees included senior federal government pathologists, laboratory scientists, IT leaders, and stakeholders from the VA, DoD, HHS (NIH, CDC, IHS, FDA) and other federal agencies. The speakers for the conference were CDR Roger Boodoo, MD, Chief of Innovation, Defense Health Agency; Ryan Collins, MD, Pathologist, Williamsport Pathology Association; Pat Flanders, Chief Information Officer, J6, Defense Health Agency; Matthew Hanna, MD, Director, Digital Pathology Informatics, Memorial Sloan Kettering Cancer Center; Stephanie Harmon, PhD, Staff Scientist, NIH NCI, Imaging/Data Scientist in Molecular Imaging; Douglas Hartman, MD, Vice Chair of Pathology Informatics, University of Pittsburgh; Stephen Hewitt, MD, PhD, Head, Experimental Pathology Laboratory, NIH NCI, Center for Cancer Research; Jason Hipp, MD, PhD, Chief Digital Innovation Officer, Mayo Collaborate Services,  Mayo Clinic; Brian Lein, MD, Assistant Director, Healthcare Administration, Defense Health Agency; Col Mark Lyman, MD, Pathology Consultant to the US Air Force Surgeon General; COL Joel Moncur, MD, Director, Joint Pathology Center; Ronald Poropatich, MD, Director of the Center for Military Medicine Research, Health Sciences; Professor of Medicine, University of Pittsburgh; David Shulkin, MD, Ninth U.S. Secretary of Veterans Affairs; Eliot Siegel, MD, Chief of Radiology and Nuclear Medicine, Veterans Affairs Maryland Healthcare System; Professor and Vice Chair, University of Maryland School of Medicine; CDR Jenny Smith, DO, Pathologist, US Naval Medical Center Portsmouth; Shandong Wu, PhD, Associate Professor, Departments of Radiology, Biomedical Informatics, and Bioengineering, Director of Center for Artificial Intelligence Innovation in Medical Imaging, University of Pittsburgh; LCDR Victoria Mahar MD, Pathologist, US Army. 

Throughout the 1.5-day meeting, topics such as the integration of systems, the value of single vendor solutions vs multiple vendors, and the interconnectedness of radiology and pathology in health care were discussed. The speakers addressed the challenges of adopting digital pathology, including workflow improvement, quality control, and the generalizability of algorithms. The importance of collaboration, leadership, data analytics, compliance with clinical practice guidelines, and research and development efforts were stressed. The increasingly important role of artificial intelligence (AI) in digital pathology, its applications, and its benefits were also highlighted. Continuing education credits were offered to participants. 

Overall, the meeting provided valuable insights into the advancements, challenges, and potential of digital pathology, AI, and technology integration in the federal health care ecosystem. However, this cannot be achieved without leadership from and close collaboration between key industry, academic, and government stakeholders.

Uses of Digital Pathology

Digital pathology refers to the practice of digitizing glass slides containing tissue samples and using digital imaging technology to analyze and interpret them. It involves capturing high-resolution images of microscopic slides and storing them in a digital format. These digitized images can be accessed and analyzed using computer-based tools and software.

While traditional pathology involves examining tissue samples under a microscope to make diagnoses and provide insights into diseases and conditions, digital pathology uses digital scanners that capture all relevant tissue on the glass slide at high magnification. This process generates a high-fidelity digital representation of the tissue sample that can be navigated akin to how glass slides are reviewed on a brightfield microscope in current practice (eg, panning, zooming, etc). Microscopic review of patient specimens in pathology allows for identifying patterns and markers that may not be easily detectable with manual examination alone. 

The digitized slides can be stored in a database or a slide management system, allowing pathologists and other healthcare professionals to access and review them remotely, thus creating the potential to improve collaboration among pathologists, facilitate second opinions, and enable easier access to archived slides for research purposes. 

Potential Benefits

Digital pathology also opens the door to advanced image analysis techniques, such as computer-aided diagnosis, machine learning, and AI algorithms, with the potential for the following outcomes and benefits:

• Improved accuracy AI algorithms can analyze large volumes of digital pathology data with great precision, reducing the chances of human error and subjective interpretation. This can lead to more accurate and consistent diagnoses, especially in challenging cases where subtle patterns or features may be difficult to detect.
• Automated detection and classification AI algorithms can be trained to detect and classify specific features or abnormalities in digital pathology images. For example, AI models can identify cancerous cells, tissue patterns associated with different diseases, or specific biomarkers. This can assist pathologists in diagnosing diseases more accurately and efficiently.
• Quantitative analysis AI can analyze large quantities of digital pathology data and extract quantitative measurements. For instance, it can calculate the percentage of tumor cells in a sample, assess the density of immune cells, or measure the extent of tissue damage. These objective measurements can aid in prognosis prediction and treatment planning.
• Image segmentation AI algorithms can segment digital pathology images into different regions or structures, such as nuclei, cytoplasm, or blood vessels. This segmentation allows for precise analysis and extraction of features for further study. It can also facilitate the identification of specific cell types or tissue components.
• Image enhancement AI techniques can enhance the quality of digital pathology images by improving clarity and reducing noise or artifacts. This can help pathologists visualize and interpret slides more effectively, especially in challenging cases with low-quality or complex images.
• Decision support systems AI-powered decision support systems can assist pathologists by providing recommendations or second opinions based on the analysis of digital pathology data. These systems can offer insights, suggest potential diagnoses, or provide relevant research references, augmenting the pathologist’s expertise and improving diagnostic accuracy.
• Collaboration and second opinions Digital pathology, combined with AI, facilitates remote access to digitized slides, enabling pathologists to seek second opinions or collaborate with experts from around the world. This can enhance the quality of diagnoses by leveraging the collective expertise of pathologists and fostering knowledge sharing.
• Education and training AI algorithms can be utilized in virtual microscopy platforms to create interactive and educational experiences. Pathology residents and students can learn from annotated cases, receive real-time feedback, and develop their skills in a digital environment.
• Research and discovery AI can assist in identifying patterns, correlations, and novel biomarkers in digital pathology data. By analyzing large datasets, AI algorithms can help uncover new insights, contribute to research advancements, and aid in the development of personalized medicine approaches.
• Predictive modeling AI can analyze vast amounts of digital pathology data, patient records, and outcomes to develop predictive models. These models can estimate disease progression, treatment response, or patient survival rates based on various factors. They can contribute to personalized medicine by assisting in treatment decisions and prognosis assessment.

It is important to note that while AI has shown promising results, it is not intended to replace human pathologists but to augment their capabilities. Overall, the combination of AI technology with the expertise of pathologists can lead to improved diagnosis, better patient care, and more efficient workflows in digital pathology.
 

Recognizing the increasing importance of digital pathology and its potential impact to transform federal health care, government, military, and university digital pathology specialists convened in May 2023 to share expertise to advance the use of digital pathology in federal health care. 

The seminar was hosted by the University of Pittsburgh and led by Ronald Poropatich, MD, Director of the Center for Military Medicine Research, Health Sciences, and Professor of Medicine at the University of Pittsburgh Medical Center, and Douglas Hartman, MD, Vice Chair of Pathology Informatics, Associate Director of the Center for AI Innovation in Medical Imaging, and Professor of Pathology at the University of Pittsburgh/University of Pittsburgh Medical Center (UPMC).

Invitees included senior federal government pathologists, laboratory scientists, IT leaders, and stakeholders from the VA, DoD, HHS (NIH, CDC, IHS, FDA) and other federal agencies. The speakers for the conference were CDR Roger Boodoo, MD, Chief of Innovation, Defense Health Agency; Ryan Collins, MD, Pathologist, Williamsport Pathology Association; Pat Flanders, Chief Information Officer, J6, Defense Health Agency; Matthew Hanna, MD, Director, Digital Pathology Informatics, Memorial Sloan Kettering Cancer Center; Stephanie Harmon, PhD, Staff Scientist, NIH NCI, Imaging/Data Scientist in Molecular Imaging; Douglas Hartman, MD, Vice Chair of Pathology Informatics, University of Pittsburgh; Stephen Hewitt, MD, PhD, Head, Experimental Pathology Laboratory, NIH NCI, Center for Cancer Research; Jason Hipp, MD, PhD, Chief Digital Innovation Officer, Mayo Collaborate Services,  Mayo Clinic; Brian Lein, MD, Assistant Director, Healthcare Administration, Defense Health Agency; Col Mark Lyman, MD, Pathology Consultant to the US Air Force Surgeon General; COL Joel Moncur, MD, Director, Joint Pathology Center; Ronald Poropatich, MD, Director of the Center for Military Medicine Research, Health Sciences; Professor of Medicine, University of Pittsburgh; David Shulkin, MD, Ninth U.S. Secretary of Veterans Affairs; Eliot Siegel, MD, Chief of Radiology and Nuclear Medicine, Veterans Affairs Maryland Healthcare System; Professor and Vice Chair, University of Maryland School of Medicine; CDR Jenny Smith, DO, Pathologist, US Naval Medical Center Portsmouth; Shandong Wu, PhD, Associate Professor, Departments of Radiology, Biomedical Informatics, and Bioengineering, Director of Center for Artificial Intelligence Innovation in Medical Imaging, University of Pittsburgh; LCDR Victoria Mahar MD, Pathologist, US Army. 

Throughout the 1.5-day meeting, topics such as the integration of systems, the value of single vendor solutions vs multiple vendors, and the interconnectedness of radiology and pathology in health care were discussed. The speakers addressed the challenges of adopting digital pathology, including workflow improvement, quality control, and the generalizability of algorithms. The importance of collaboration, leadership, data analytics, compliance with clinical practice guidelines, and research and development efforts were stressed. The increasingly important role of artificial intelligence (AI) in digital pathology, its applications, and its benefits were also highlighted. Continuing education credits were offered to participants. 

Overall, the meeting provided valuable insights into the advancements, challenges, and potential of digital pathology, AI, and technology integration in the federal health care ecosystem. However, this cannot be achieved without leadership from and close collaboration between key industry, academic, and government stakeholders.

Uses of Digital Pathology

Digital pathology refers to the practice of digitizing glass slides containing tissue samples and using digital imaging technology to analyze and interpret them. It involves capturing high-resolution images of microscopic slides and storing them in a digital format. These digitized images can be accessed and analyzed using computer-based tools and software.

While traditional pathology involves examining tissue samples under a microscope to make diagnoses and provide insights into diseases and conditions, digital pathology uses digital scanners that capture all relevant tissue on the glass slide at high magnification. This process generates a high-fidelity digital representation of the tissue sample that can be navigated akin to how glass slides are reviewed on a brightfield microscope in current practice (eg, panning, zooming, etc). Microscopic review of patient specimens in pathology allows for identifying patterns and markers that may not be easily detectable with manual examination alone. 

The digitized slides can be stored in a database or a slide management system, allowing pathologists and other healthcare professionals to access and review them remotely, thus creating the potential to improve collaboration among pathologists, facilitate second opinions, and enable easier access to archived slides for research purposes. 

Potential Benefits

Digital pathology also opens the door to advanced image analysis techniques, such as computer-aided diagnosis, machine learning, and AI algorithms, with the potential for the following outcomes and benefits:

• Improved accuracy AI algorithms can analyze large volumes of digital pathology data with great precision, reducing the chances of human error and subjective interpretation. This can lead to more accurate and consistent diagnoses, especially in challenging cases where subtle patterns or features may be difficult to detect.
• Automated detection and classification AI algorithms can be trained to detect and classify specific features or abnormalities in digital pathology images. For example, AI models can identify cancerous cells, tissue patterns associated with different diseases, or specific biomarkers. This can assist pathologists in diagnosing diseases more accurately and efficiently.
• Quantitative analysis AI can analyze large quantities of digital pathology data and extract quantitative measurements. For instance, it can calculate the percentage of tumor cells in a sample, assess the density of immune cells, or measure the extent of tissue damage. These objective measurements can aid in prognosis prediction and treatment planning.
• Image segmentation AI algorithms can segment digital pathology images into different regions or structures, such as nuclei, cytoplasm, or blood vessels. This segmentation allows for precise analysis and extraction of features for further study. It can also facilitate the identification of specific cell types or tissue components.
• Image enhancement AI techniques can enhance the quality of digital pathology images by improving clarity and reducing noise or artifacts. This can help pathologists visualize and interpret slides more effectively, especially in challenging cases with low-quality or complex images.
• Decision support systems AI-powered decision support systems can assist pathologists by providing recommendations or second opinions based on the analysis of digital pathology data. These systems can offer insights, suggest potential diagnoses, or provide relevant research references, augmenting the pathologist’s expertise and improving diagnostic accuracy.
• Collaboration and second opinions Digital pathology, combined with AI, facilitates remote access to digitized slides, enabling pathologists to seek second opinions or collaborate with experts from around the world. This can enhance the quality of diagnoses by leveraging the collective expertise of pathologists and fostering knowledge sharing.
• Education and training AI algorithms can be utilized in virtual microscopy platforms to create interactive and educational experiences. Pathology residents and students can learn from annotated cases, receive real-time feedback, and develop their skills in a digital environment.
• Research and discovery AI can assist in identifying patterns, correlations, and novel biomarkers in digital pathology data. By analyzing large datasets, AI algorithms can help uncover new insights, contribute to research advancements, and aid in the development of personalized medicine approaches.
• Predictive modeling AI can analyze vast amounts of digital pathology data, patient records, and outcomes to develop predictive models. These models can estimate disease progression, treatment response, or patient survival rates based on various factors. They can contribute to personalized medicine by assisting in treatment decisions and prognosis assessment.

It is important to note that while AI has shown promising results, it is not intended to replace human pathologists but to augment their capabilities. Overall, the combination of AI technology with the expertise of pathologists can lead to improved diagnosis, better patient care, and more efficient workflows in digital pathology.