Feature

Several new clinical trials in prostate cancer have started recruiting in recent months. Maybe one of your patients could benefit from enrolling?

Metastatic castration-sensitive prostate cancer 

Adults with this diagnosis may be interested in a randomized, double-blind, phase 3 study examining whether an experimental poly (ADP-ribose) polymerase (PARP) inhibitor called saruparib can further delay disease progression when added to a next-generation hormonal agent such as abiraterone (Zytiga), darolutamide (Nubeqa), or enzalutamide (Xtandi).

One group of participants will take daily oral doses of saruparib plus physician’s choice of a next-generation hormonal agent until disease progression or another reason for stopping therapy. The other group will add a placebo to a next-generation hormonal agent.

Sites in Rhode Island, Arkansas, California, Michigan, Australia, Canada, Japan, Taiwan, Thailand, the United Kingdom, and South Korea began seeking the trial’s 1800 participants in November 2023. Research centers in 31 other US states and 18 other countries are gearing up. The primary endpoint is radiographic progression-free survival. Overall survival and quality of life (QoL) are secondary endpoints. More details at clinicaltrials.gov.

This news organization asked Marc Garnick, MD, professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, for his take on the trial. “The study is interesting since it is adding to the evaluations of continued intensification for first-line therapy and will help further elucidate the role of PARP inhibition regardless of homologous repair status,” Dr. Garnick said. “Plus, saruparib is supposedly more selective on PARP1, which in-and-of-itself is of potential benefit.”

Metastatic castration-resistant prostate cancer

People with this type of cancer who have progressed on a next-generation hormonal agent may be eligible for a randomized, open-label, phase 3 trial testing an investigational oral treatment called MK-5684 to see if it increases survival more effectively than switching to an alternative next-generation hormonal agent.

MK-5684 is designed to inhibit the CYP11A1 enzyme, thereby disrupting the androgen-receptor signaling pathway.

One group will take twice-daily tablets of MK-5684 plus hormone replacement therapy, oral dexamethasone, and oral fludrocortisone acetate (Florinef), with rescue hydrocortisone as needed. The other participants will take daily tablets of a next-generation hormonal agent: Either enzalutamide or abiraterone. Patients assigned to abiraterone will also be given prednisone tablets.

US-based sites in nine states and Puerto Rico started looking for the trial’s 1500 participants in December 2023 in partnership with study centers in Australia, Israel, South Korea, and Taiwan. The primary endpoints are radiographic progression-free survival and overall survival. QoL will not be tracked. More details at clinicaltrials.gov.

Metastatic castration-resistant prostate cancer

Patients in this situation who have progressed on taxane-based chemotherapy as well as a next-generation hormonal agent have the option to enroll in another phase 3 MK-5684 study.

Like the trial described above, all patients will remain on their respective therapy until disease progression. In this trial, one group will take twice-daily tablets of MK-5684 without hormone replacement therapy but the same mix of oral dexamethasone and fludrocortisone. Rescue hydrocortisone will also be available. The second group will be assigned either enzalutamide or abiraterone plus prednisone.

Sites in Puerto Rico, Colorado, Nevada, and Virginia, and five other countries outside the United States, opened their doors to the first of 1200 patients in December 2023. The primary endpoints are radiographic progression-free survival and overall survival, analyzed separately for patients with and without an androgen receptor ligand-binding domain mutation. QoL will not be measured. More details at clinicaltrials.gov.

High-risk prostate cancer

People with this diagnosis can join a randomized, open-label, phase 3 National Cancer Institute study to test whether stereotactic body radiation therapy (SBRT) is as effective as conventional external beam radiation therapy (EBRT) at preventing metastasis.

SBRT delivers radiation to tumors with higher precision than EBRT. The advantage of SBRT is the ability to deliver fewer doses over a shorter duration with less collateral damage to surrounding tissues.

In the trial, half of participants will undergo five treatments of SBRT over 2 weeks, while the other half will receive 20-45 treatments of EBRT over 4-9 weeks. Study sites in 14 US states began recruiting the trial’s 1209 participants in November 2023. Metastasis-free survival over 15 years is the primary endpoint, overall survival is a secondary endpoint, and QoL measures, apart from fatigue, will not be tracked. More details at clinicaltrials.gov.

Dr. Garnick viewed this study as “problematic because patient accrual ends in 2036 with a readout in 2041.” He added, “What its relevance will be at that time is unlikely to provide practice changes, since in that interval there will undoubtedly be multiple advances in place.”

Newly diagnosed favorable intermediate risk prostate cancer

People with this type of cancer are eligible for an open-label, phase 4 real-world study of a radioactive diagnostic agent called piflufolastat F 18 (Pylarify) that targets prostate-specific membrane antigen (PSMA)–positive lesions. Piflufolastat is designed to enhance detection of metastases during PSMA-targeted PET.

Participants will receive a single injection of piflufolastat followed 1-2 hours later by a single whole-body PET-CT or PET-MRI scan. A study site at the Hoag Cancer Center in Irvine, California, welcomed the first of the trial’s 274 participants in February 2024. Sites in Tower Urology, Los Angeles, and the Cleveland Clinic, Ohio, are gearing up. Detection rate is the primary endpoint. Overall survival and QoL are not measured. More details at clinicaltrials.gov

Stages I-IV prostate cancer without bone metastases. People 60 years or older with this type of prostate cancer who are just starting androgen deprivation therapy are eligible for a phase 3, placebo-controlled trial investigating whether high-dose vitamin D can prevent or reduce androgen-deprivation therapy-induced bone loss.

For 1 year, participants will take tablets of high-dose vitamin D or a placebo and then undergo dual x-ray absorptiometry. The Ochsner Medical Center in Jefferson, Louisiana, started recruiting 366 trial participants in December 2023. Reduction in bone mineral density loss in the hip and spine over 1 year is the primary objective. QoL is a secondary objective, and overall survival will not be measured. More details at clinicaltrials.gov

Dr. Garnick expressed some concerns with the trial design so far, including that “the dose of vitamin D is not delineated nor is the target vitamin D level.”

All trial information is from the National Institutes of Health’s National Library of Medicine (online at clinicaltrials.gov). Dr. Garnick did not report conflicts with any of the trials.
 

A version of this article appeared on Medscape.com.

Several new clinical trials in prostate cancer have started recruiting in recent months. Maybe one of your patients could benefit from enrolling?

Metastatic castration-sensitive prostate cancer 

Adults with this diagnosis may be interested in a randomized, double-blind, phase 3 study examining whether an experimental poly (ADP-ribose) polymerase (PARP) inhibitor called saruparib can further delay disease progression when added to a next-generation hormonal agent such as abiraterone (Zytiga), darolutamide (Nubeqa), or enzalutamide (Xtandi).

One group of participants will take daily oral doses of saruparib plus physician’s choice of a next-generation hormonal agent until disease progression or another reason for stopping therapy. The other group will add a placebo to a next-generation hormonal agent.

Sites in Rhode Island, Arkansas, California, Michigan, Australia, Canada, Japan, Taiwan, Thailand, the United Kingdom, and South Korea began seeking the trial’s 1800 participants in November 2023. Research centers in 31 other US states and 18 other countries are gearing up. The primary endpoint is radiographic progression-free survival. Overall survival and quality of life (QoL) are secondary endpoints. More details at clinicaltrials.gov.

This news organization asked Marc Garnick, MD, professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, for his take on the trial. “The study is interesting since it is adding to the evaluations of continued intensification for first-line therapy and will help further elucidate the role of PARP inhibition regardless of homologous repair status,” Dr. Garnick said. “Plus, saruparib is supposedly more selective on PARP1, which in-and-of-itself is of potential benefit.”

Metastatic castration-resistant prostate cancer

People with this type of cancer who have progressed on a next-generation hormonal agent may be eligible for a randomized, open-label, phase 3 trial testing an investigational oral treatment called MK-5684 to see if it increases survival more effectively than switching to an alternative next-generation hormonal agent.

MK-5684 is designed to inhibit the CYP11A1 enzyme, thereby disrupting the androgen-receptor signaling pathway.

One group will take twice-daily tablets of MK-5684 plus hormone replacement therapy, oral dexamethasone, and oral fludrocortisone acetate (Florinef), with rescue hydrocortisone as needed. The other participants will take daily tablets of a next-generation hormonal agent: Either enzalutamide or abiraterone. Patients assigned to abiraterone will also be given prednisone tablets.

US-based sites in nine states and Puerto Rico started looking for the trial’s 1500 participants in December 2023 in partnership with study centers in Australia, Israel, South Korea, and Taiwan. The primary endpoints are radiographic progression-free survival and overall survival. QoL will not be tracked. More details at clinicaltrials.gov.

Metastatic castration-resistant prostate cancer

Patients in this situation who have progressed on taxane-based chemotherapy as well as a next-generation hormonal agent have the option to enroll in another phase 3 MK-5684 study.

Like the trial described above, all patients will remain on their respective therapy until disease progression. In this trial, one group will take twice-daily tablets of MK-5684 without hormone replacement therapy but the same mix of oral dexamethasone and fludrocortisone. Rescue hydrocortisone will also be available. The second group will be assigned either enzalutamide or abiraterone plus prednisone.

Sites in Puerto Rico, Colorado, Nevada, and Virginia, and five other countries outside the United States, opened their doors to the first of 1200 patients in December 2023. The primary endpoints are radiographic progression-free survival and overall survival, analyzed separately for patients with and without an androgen receptor ligand-binding domain mutation. QoL will not be measured. More details at clinicaltrials.gov.

High-risk prostate cancer

People with this diagnosis can join a randomized, open-label, phase 3 National Cancer Institute study to test whether stereotactic body radiation therapy (SBRT) is as effective as conventional external beam radiation therapy (EBRT) at preventing metastasis.

SBRT delivers radiation to tumors with higher precision than EBRT. The advantage of SBRT is the ability to deliver fewer doses over a shorter duration with less collateral damage to surrounding tissues.

In the trial, half of participants will undergo five treatments of SBRT over 2 weeks, while the other half will receive 20-45 treatments of EBRT over 4-9 weeks. Study sites in 14 US states began recruiting the trial’s 1209 participants in November 2023. Metastasis-free survival over 15 years is the primary endpoint, overall survival is a secondary endpoint, and QoL measures, apart from fatigue, will not be tracked. More details at clinicaltrials.gov.

Dr. Garnick viewed this study as “problematic because patient accrual ends in 2036 with a readout in 2041.” He added, “What its relevance will be at that time is unlikely to provide practice changes, since in that interval there will undoubtedly be multiple advances in place.”

Newly diagnosed favorable intermediate risk prostate cancer

People with this type of cancer are eligible for an open-label, phase 4 real-world study of a radioactive diagnostic agent called piflufolastat F 18 (Pylarify) that targets prostate-specific membrane antigen (PSMA)–positive lesions. Piflufolastat is designed to enhance detection of metastases during PSMA-targeted PET.

Participants will receive a single injection of piflufolastat followed 1-2 hours later by a single whole-body PET-CT or PET-MRI scan. A study site at the Hoag Cancer Center in Irvine, California, welcomed the first of the trial’s 274 participants in February 2024. Sites in Tower Urology, Los Angeles, and the Cleveland Clinic, Ohio, are gearing up. Detection rate is the primary endpoint. Overall survival and QoL are not measured. More details at clinicaltrials.gov

Stages I-IV prostate cancer without bone metastases. People 60 years or older with this type of prostate cancer who are just starting androgen deprivation therapy are eligible for a phase 3, placebo-controlled trial investigating whether high-dose vitamin D can prevent or reduce androgen-deprivation therapy-induced bone loss.

For 1 year, participants will take tablets of high-dose vitamin D or a placebo and then undergo dual x-ray absorptiometry. The Ochsner Medical Center in Jefferson, Louisiana, started recruiting 366 trial participants in December 2023. Reduction in bone mineral density loss in the hip and spine over 1 year is the primary objective. QoL is a secondary objective, and overall survival will not be measured. More details at clinicaltrials.gov

Dr. Garnick expressed some concerns with the trial design so far, including that “the dose of vitamin D is not delineated nor is the target vitamin D level.”

All trial information is from the National Institutes of Health’s National Library of Medicine (online at clinicaltrials.gov). Dr. Garnick did not report conflicts with any of the trials.
 

A version of this article appeared on Medscape.com.

Several new clinical trials in prostate cancer have started recruiting in recent months. Maybe one of your patients could benefit from enrolling?

Metastatic castration-sensitive prostate cancer 

Adults with this diagnosis may be interested in a randomized, double-blind, phase 3 study examining whether an experimental poly (ADP-ribose) polymerase (PARP) inhibitor called saruparib can further delay disease progression when added to a next-generation hormonal agent such as abiraterone (Zytiga), darolutamide (Nubeqa), or enzalutamide (Xtandi).

One group of participants will take daily oral doses of saruparib plus physician’s choice of a next-generation hormonal agent until disease progression or another reason for stopping therapy. The other group will add a placebo to a next-generation hormonal agent.

Sites in Rhode Island, Arkansas, California, Michigan, Australia, Canada, Japan, Taiwan, Thailand, the United Kingdom, and South Korea began seeking the trial’s 1800 participants in November 2023. Research centers in 31 other US states and 18 other countries are gearing up. The primary endpoint is radiographic progression-free survival. Overall survival and quality of life (QoL) are secondary endpoints. More details at clinicaltrials.gov.

This news organization asked Marc Garnick, MD, professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, for his take on the trial. “The study is interesting since it is adding to the evaluations of continued intensification for first-line therapy and will help further elucidate the role of PARP inhibition regardless of homologous repair status,” Dr. Garnick said. “Plus, saruparib is supposedly more selective on PARP1, which in-and-of-itself is of potential benefit.”

Metastatic castration-resistant prostate cancer

People with this type of cancer who have progressed on a next-generation hormonal agent may be eligible for a randomized, open-label, phase 3 trial testing an investigational oral treatment called MK-5684 to see if it increases survival more effectively than switching to an alternative next-generation hormonal agent.

MK-5684 is designed to inhibit the CYP11A1 enzyme, thereby disrupting the androgen-receptor signaling pathway.

One group will take twice-daily tablets of MK-5684 plus hormone replacement therapy, oral dexamethasone, and oral fludrocortisone acetate (Florinef), with rescue hydrocortisone as needed. The other participants will take daily tablets of a next-generation hormonal agent: Either enzalutamide or abiraterone. Patients assigned to abiraterone will also be given prednisone tablets.

US-based sites in nine states and Puerto Rico started looking for the trial’s 1500 participants in December 2023 in partnership with study centers in Australia, Israel, South Korea, and Taiwan. The primary endpoints are radiographic progression-free survival and overall survival. QoL will not be tracked. More details at clinicaltrials.gov.

Metastatic castration-resistant prostate cancer

Patients in this situation who have progressed on taxane-based chemotherapy as well as a next-generation hormonal agent have the option to enroll in another phase 3 MK-5684 study.

Like the trial described above, all patients will remain on their respective therapy until disease progression. In this trial, one group will take twice-daily tablets of MK-5684 without hormone replacement therapy but the same mix of oral dexamethasone and fludrocortisone. Rescue hydrocortisone will also be available. The second group will be assigned either enzalutamide or abiraterone plus prednisone.

Sites in Puerto Rico, Colorado, Nevada, and Virginia, and five other countries outside the United States, opened their doors to the first of 1200 patients in December 2023. The primary endpoints are radiographic progression-free survival and overall survival, analyzed separately for patients with and without an androgen receptor ligand-binding domain mutation. QoL will not be measured. More details at clinicaltrials.gov.

High-risk prostate cancer

People with this diagnosis can join a randomized, open-label, phase 3 National Cancer Institute study to test whether stereotactic body radiation therapy (SBRT) is as effective as conventional external beam radiation therapy (EBRT) at preventing metastasis.

SBRT delivers radiation to tumors with higher precision than EBRT. The advantage of SBRT is the ability to deliver fewer doses over a shorter duration with less collateral damage to surrounding tissues.

In the trial, half of participants will undergo five treatments of SBRT over 2 weeks, while the other half will receive 20-45 treatments of EBRT over 4-9 weeks. Study sites in 14 US states began recruiting the trial’s 1209 participants in November 2023. Metastasis-free survival over 15 years is the primary endpoint, overall survival is a secondary endpoint, and QoL measures, apart from fatigue, will not be tracked. More details at clinicaltrials.gov.

Dr. Garnick viewed this study as “problematic because patient accrual ends in 2036 with a readout in 2041.” He added, “What its relevance will be at that time is unlikely to provide practice changes, since in that interval there will undoubtedly be multiple advances in place.”

Newly diagnosed favorable intermediate risk prostate cancer

People with this type of cancer are eligible for an open-label, phase 4 real-world study of a radioactive diagnostic agent called piflufolastat F 18 (Pylarify) that targets prostate-specific membrane antigen (PSMA)–positive lesions. Piflufolastat is designed to enhance detection of metastases during PSMA-targeted PET.

Participants will receive a single injection of piflufolastat followed 1-2 hours later by a single whole-body PET-CT or PET-MRI scan. A study site at the Hoag Cancer Center in Irvine, California, welcomed the first of the trial’s 274 participants in February 2024. Sites in Tower Urology, Los Angeles, and the Cleveland Clinic, Ohio, are gearing up. Detection rate is the primary endpoint. Overall survival and QoL are not measured. More details at clinicaltrials.gov

Stages I-IV prostate cancer without bone metastases. People 60 years or older with this type of prostate cancer who are just starting androgen deprivation therapy are eligible for a phase 3, placebo-controlled trial investigating whether high-dose vitamin D can prevent or reduce androgen-deprivation therapy-induced bone loss.

For 1 year, participants will take tablets of high-dose vitamin D or a placebo and then undergo dual x-ray absorptiometry. The Ochsner Medical Center in Jefferson, Louisiana, started recruiting 366 trial participants in December 2023. Reduction in bone mineral density loss in the hip and spine over 1 year is the primary objective. QoL is a secondary objective, and overall survival will not be measured. More details at clinicaltrials.gov

Dr. Garnick expressed some concerns with the trial design so far, including that “the dose of vitamin D is not delineated nor is the target vitamin D level.”

All trial information is from the National Institutes of Health’s National Library of Medicine (online at clinicaltrials.gov). Dr. Garnick did not report conflicts with any of the trials.
 

A version of this article appeared on Medscape.com.

High levels of tumor-infiltrating lymphocytes predicted increased survival in patients with early-stage triple-negative breast cancer who did not receive chemotherapy, a new analysis finds.

The association of abundant tumor-infiltrating lymphocytes (TILs) in breast cancer tissue with outcomes in patients with early-stage triple-negative breast cancer (TNBC) who do not receive chemotherapy has not been well studied, wrote Roberto A. Leon-Ferre, MD, of the Mayo Clinic, Rochester, Minnesota, and colleagues, in JAMA.

Biomarkers to guide systemic treatment and avoid overtreatment are lacking, and such markers could help identify patients who could achieve increased survival with less intensive therapy, continued the authors of the new study of nearly 2000 individuals.

“TNBC is the most aggressive subtype of breast cancer, and for this reason, current treatment guidelines recommend chemotherapy using multiple drugs either before or after surgery,” Dr. Leon-Ferre said in an interview. “We have learned over the last several years that TNBC is not a single disease, but that there are several subtypes of TNBC that have different risks and different vulnerabilities, and treating all patients similarly may not be optimal.”

  

What is Known About Tumor-Infiltrating Lymphocytes and Cancer?

Previous studies have shown improved survival in patients with early-stage TNBC and high levels of TILs who were treated with adjuvant and neoadjuvant chemotherapy, compared with those with lower TILs. In a pooled analysis of 2148 patients from nine studies published in the Journal of Clinical Oncology in 2019, a higher percentage of TILs in the stroma surrounding a tumor was significantly associated with improved survival in TNBC patients after adjuvant chemotherapy.

Another study published in the Journal of Clinical Oncology in 2022 showed that elevated TILs were significant predictors of overall survival, but the study included fewer than 500 patients.

The potential mechanisms that drive the association between elevated TILs and improved survival include the ability of TILs to attack cancer cells, Dr. Leon-Ferre said in an interview. 

The goal of this study was to evaluate whether TILs could identify a subset of patients with TNBC who had a very low risk of cancer recurrence even if chemotherapy was not given.

“Indeed, we found that patients with stage I TNBC and high TILs had a very low risk of recurrence even when chemotherapy was not administered. These findings will pave the way for future studies aiming to reduce the need for multiple chemotherapy drugs in patients with stage I TNBC and decrease the side effects that patients face,” he said.

 

What Does the New Study Add?

The current study included 1966 individuals from 13 sites in North America, Europe, and Asia who were diagnosed with TNBC between 1979 and 2017 and were treated with surgery, with or without radiotherapy but with no adjuvant or neoadjuvant chemotherapy. The researchers examined the abundance of TILs in the breast tissue of resected primary tumors; the primary outcome was invasive disease-free survival (iDFS), with recurrence-free survival, distant recurrence-free survival, and overall survival as secondary outcomes.

The median age of the patients was 56 years, 55% had stage I TNBC, and the median TIL level was 15%.

A total of 417 patients had a TIL level of 50% or more, and the 5-year iDFS for these patients was 94%, compared with 78% for those with a TIL level less than 30%. Similarly, 5-year overall survival was 95% in patients with a TIL level of 50% or more, compared with 82% for patients with TIL levels of less than 30%.

Additionally, each 10% increase in TILs was independently associated not only with improved iDFS (hazard ratio[HR], 0.92), but also improved recurrence-free survival (HR, 0.90), distant recurrence-free survival (HR, 0.87), and overall survival (HR, 0.88) over a median follow-up of 18 years.

The current study shows that cancer stage based on tumor size and the number of lymph nodes should not be the only considerations for making treatment decisions and predicting outcomes, Dr. Leon-Ferre said in an interview.

“In fact, our study shows that for tumors of the same stage (particularly for stage I), the risk of recurrence is different depending on the number of TILs seen in the breast cancer tissue. When chemo is not given, those with high TILs have lower risk of recurrence, whereas those with low TILs have a higher risk of recurrence,” he said.
 

What are the Limitations of This Research?

The current study findings are limited by the retrospective design and use of observational data, so the researchers could not make conclusions about causality. Other limitations included lack of data on germline mutations and race or ethnicity, and the potential irrelevance of data from patients treated as long as 45 years ago.

“Because most patients with TNBC receive chemotherapy in the modern times, we needed to work with 13 hospitals around the world to find data on patients with TNBC who never received chemotherapy for various reasons,” Dr. Leon-Ferre said.

To address these limitations, Dr. Leone-Ferre and his colleagues are planning prospective studies where TILs will be used to make treatment decisions.

“Many of the patients in our cohort were treated many years ago, when chemotherapy was not routinely given. Advances in cancer detection, surgical and radiation techniques may lead to different results in patients treated today,” he added.

What Do Oncologists Need to Know?

The current study findings may provide additional information on prognosis that is important to share with patients for decision-making on the risks versus benefits of chemotherapy, Dr. Leon-Ferre said.

“Like any test, TILs should not be used in isolation to make decisions, but should be integrated with other factors including the cancer stage, the overall patient health, patient preferences, and concerns about treatment complications,” he emphasized. “The results of this study allow oncologists to offer a more refined calculation of recurrence risk if patients opt to not receive chemotherapy.”

In the current study, although younger age was associated with higher TIL levels, a finding consistent with previous studies, increased TIL, remained significantly associated with improved survival after adjusting for age, tumor size, nodal status, and histological grade.

Overall, “the findings suggest that for patients with stage I TNBC and TILs greater than 50%, chemotherapy may not be as necessary as it was previously thought,” Dr. Leon-Ferre said.

What Additional Research is Needed?

Prospective studies are needed to validate the findings, including studies in diverse populations, and additional studies may investigate whether early TBNC patients with high TIL levels could achieve high cure rates with less intensive and less toxic chemotherapy regiments than those currently recommended, the researchers wrote in their discussion.

“There are many additional research questions that we need to answer, and look forward to working on,” Dr. Leon-Ferre said, in an interview. These topics include whether TILs can be used to decide on the number of chemotherapy drugs a patient really needs and whether artificial intelligence can be used to evaluate TILs more quickly and effectively than the human eye, he said. Other research topics include identifying which particular type of TILs attack cancer cells most effectively and whether TILs could be increased in patients with low levels in order to improve their prognosis, he added.

The study was supported by the National Research Agency and General Secretariat for Investment, Clinical and Translational Science Awards, the Mayo Clinic Breast Cancer SPORE grant, the Cancer Research Society of Canada, institutional grants from the Dutch Cancer Society, The Netherlands Organization for Health Research, and several foundations. Dr. Leon-Ferre disclosed consulting honoraria to his institution for research activities from AstraZeneca, Gilead Sciences, and Lyell Immunopharma, with no personal fees outside the submitted work.

High levels of tumor-infiltrating lymphocytes predicted increased survival in patients with early-stage triple-negative breast cancer who did not receive chemotherapy, a new analysis finds.

The association of abundant tumor-infiltrating lymphocytes (TILs) in breast cancer tissue with outcomes in patients with early-stage triple-negative breast cancer (TNBC) who do not receive chemotherapy has not been well studied, wrote Roberto A. Leon-Ferre, MD, of the Mayo Clinic, Rochester, Minnesota, and colleagues, in JAMA.

Biomarkers to guide systemic treatment and avoid overtreatment are lacking, and such markers could help identify patients who could achieve increased survival with less intensive therapy, continued the authors of the new study of nearly 2000 individuals.

“TNBC is the most aggressive subtype of breast cancer, and for this reason, current treatment guidelines recommend chemotherapy using multiple drugs either before or after surgery,” Dr. Leon-Ferre said in an interview. “We have learned over the last several years that TNBC is not a single disease, but that there are several subtypes of TNBC that have different risks and different vulnerabilities, and treating all patients similarly may not be optimal.”

  

What is Known About Tumor-Infiltrating Lymphocytes and Cancer?

Previous studies have shown improved survival in patients with early-stage TNBC and high levels of TILs who were treated with adjuvant and neoadjuvant chemotherapy, compared with those with lower TILs. In a pooled analysis of 2148 patients from nine studies published in the Journal of Clinical Oncology in 2019, a higher percentage of TILs in the stroma surrounding a tumor was significantly associated with improved survival in TNBC patients after adjuvant chemotherapy.

Another study published in the Journal of Clinical Oncology in 2022 showed that elevated TILs were significant predictors of overall survival, but the study included fewer than 500 patients.

The potential mechanisms that drive the association between elevated TILs and improved survival include the ability of TILs to attack cancer cells, Dr. Leon-Ferre said in an interview. 

The goal of this study was to evaluate whether TILs could identify a subset of patients with TNBC who had a very low risk of cancer recurrence even if chemotherapy was not given.

“Indeed, we found that patients with stage I TNBC and high TILs had a very low risk of recurrence even when chemotherapy was not administered. These findings will pave the way for future studies aiming to reduce the need for multiple chemotherapy drugs in patients with stage I TNBC and decrease the side effects that patients face,” he said.

 

What Does the New Study Add?

The current study included 1966 individuals from 13 sites in North America, Europe, and Asia who were diagnosed with TNBC between 1979 and 2017 and were treated with surgery, with or without radiotherapy but with no adjuvant or neoadjuvant chemotherapy. The researchers examined the abundance of TILs in the breast tissue of resected primary tumors; the primary outcome was invasive disease-free survival (iDFS), with recurrence-free survival, distant recurrence-free survival, and overall survival as secondary outcomes.

The median age of the patients was 56 years, 55% had stage I TNBC, and the median TIL level was 15%.

A total of 417 patients had a TIL level of 50% or more, and the 5-year iDFS for these patients was 94%, compared with 78% for those with a TIL level less than 30%. Similarly, 5-year overall survival was 95% in patients with a TIL level of 50% or more, compared with 82% for patients with TIL levels of less than 30%.

Additionally, each 10% increase in TILs was independently associated not only with improved iDFS (hazard ratio[HR], 0.92), but also improved recurrence-free survival (HR, 0.90), distant recurrence-free survival (HR, 0.87), and overall survival (HR, 0.88) over a median follow-up of 18 years.

The current study shows that cancer stage based on tumor size and the number of lymph nodes should not be the only considerations for making treatment decisions and predicting outcomes, Dr. Leon-Ferre said in an interview.

“In fact, our study shows that for tumors of the same stage (particularly for stage I), the risk of recurrence is different depending on the number of TILs seen in the breast cancer tissue. When chemo is not given, those with high TILs have lower risk of recurrence, whereas those with low TILs have a higher risk of recurrence,” he said.
 

What are the Limitations of This Research?

The current study findings are limited by the retrospective design and use of observational data, so the researchers could not make conclusions about causality. Other limitations included lack of data on germline mutations and race or ethnicity, and the potential irrelevance of data from patients treated as long as 45 years ago.

“Because most patients with TNBC receive chemotherapy in the modern times, we needed to work with 13 hospitals around the world to find data on patients with TNBC who never received chemotherapy for various reasons,” Dr. Leon-Ferre said.

To address these limitations, Dr. Leone-Ferre and his colleagues are planning prospective studies where TILs will be used to make treatment decisions.

“Many of the patients in our cohort were treated many years ago, when chemotherapy was not routinely given. Advances in cancer detection, surgical and radiation techniques may lead to different results in patients treated today,” he added.

What Do Oncologists Need to Know?

The current study findings may provide additional information on prognosis that is important to share with patients for decision-making on the risks versus benefits of chemotherapy, Dr. Leon-Ferre said.

“Like any test, TILs should not be used in isolation to make decisions, but should be integrated with other factors including the cancer stage, the overall patient health, patient preferences, and concerns about treatment complications,” he emphasized. “The results of this study allow oncologists to offer a more refined calculation of recurrence risk if patients opt to not receive chemotherapy.”

In the current study, although younger age was associated with higher TIL levels, a finding consistent with previous studies, increased TIL, remained significantly associated with improved survival after adjusting for age, tumor size, nodal status, and histological grade.

Overall, “the findings suggest that for patients with stage I TNBC and TILs greater than 50%, chemotherapy may not be as necessary as it was previously thought,” Dr. Leon-Ferre said.

What Additional Research is Needed?

Prospective studies are needed to validate the findings, including studies in diverse populations, and additional studies may investigate whether early TBNC patients with high TIL levels could achieve high cure rates with less intensive and less toxic chemotherapy regiments than those currently recommended, the researchers wrote in their discussion.

“There are many additional research questions that we need to answer, and look forward to working on,” Dr. Leon-Ferre said, in an interview. These topics include whether TILs can be used to decide on the number of chemotherapy drugs a patient really needs and whether artificial intelligence can be used to evaluate TILs more quickly and effectively than the human eye, he said. Other research topics include identifying which particular type of TILs attack cancer cells most effectively and whether TILs could be increased in patients with low levels in order to improve their prognosis, he added.

The study was supported by the National Research Agency and General Secretariat for Investment, Clinical and Translational Science Awards, the Mayo Clinic Breast Cancer SPORE grant, the Cancer Research Society of Canada, institutional grants from the Dutch Cancer Society, The Netherlands Organization for Health Research, and several foundations. Dr. Leon-Ferre disclosed consulting honoraria to his institution for research activities from AstraZeneca, Gilead Sciences, and Lyell Immunopharma, with no personal fees outside the submitted work.

High levels of tumor-infiltrating lymphocytes predicted increased survival in patients with early-stage triple-negative breast cancer who did not receive chemotherapy, a new analysis finds.

The association of abundant tumor-infiltrating lymphocytes (TILs) in breast cancer tissue with outcomes in patients with early-stage triple-negative breast cancer (TNBC) who do not receive chemotherapy has not been well studied, wrote Roberto A. Leon-Ferre, MD, of the Mayo Clinic, Rochester, Minnesota, and colleagues, in JAMA.

Biomarkers to guide systemic treatment and avoid overtreatment are lacking, and such markers could help identify patients who could achieve increased survival with less intensive therapy, continued the authors of the new study of nearly 2000 individuals.

“TNBC is the most aggressive subtype of breast cancer, and for this reason, current treatment guidelines recommend chemotherapy using multiple drugs either before or after surgery,” Dr. Leon-Ferre said in an interview. “We have learned over the last several years that TNBC is not a single disease, but that there are several subtypes of TNBC that have different risks and different vulnerabilities, and treating all patients similarly may not be optimal.”

  

What is Known About Tumor-Infiltrating Lymphocytes and Cancer?

Previous studies have shown improved survival in patients with early-stage TNBC and high levels of TILs who were treated with adjuvant and neoadjuvant chemotherapy, compared with those with lower TILs. In a pooled analysis of 2148 patients from nine studies published in the Journal of Clinical Oncology in 2019, a higher percentage of TILs in the stroma surrounding a tumor was significantly associated with improved survival in TNBC patients after adjuvant chemotherapy.

Another study published in the Journal of Clinical Oncology in 2022 showed that elevated TILs were significant predictors of overall survival, but the study included fewer than 500 patients.

The potential mechanisms that drive the association between elevated TILs and improved survival include the ability of TILs to attack cancer cells, Dr. Leon-Ferre said in an interview. 

The goal of this study was to evaluate whether TILs could identify a subset of patients with TNBC who had a very low risk of cancer recurrence even if chemotherapy was not given.

“Indeed, we found that patients with stage I TNBC and high TILs had a very low risk of recurrence even when chemotherapy was not administered. These findings will pave the way for future studies aiming to reduce the need for multiple chemotherapy drugs in patients with stage I TNBC and decrease the side effects that patients face,” he said.

 

What Does the New Study Add?

The current study included 1966 individuals from 13 sites in North America, Europe, and Asia who were diagnosed with TNBC between 1979 and 2017 and were treated with surgery, with or without radiotherapy but with no adjuvant or neoadjuvant chemotherapy. The researchers examined the abundance of TILs in the breast tissue of resected primary tumors; the primary outcome was invasive disease-free survival (iDFS), with recurrence-free survival, distant recurrence-free survival, and overall survival as secondary outcomes.

The median age of the patients was 56 years, 55% had stage I TNBC, and the median TIL level was 15%.

A total of 417 patients had a TIL level of 50% or more, and the 5-year iDFS for these patients was 94%, compared with 78% for those with a TIL level less than 30%. Similarly, 5-year overall survival was 95% in patients with a TIL level of 50% or more, compared with 82% for patients with TIL levels of less than 30%.

Additionally, each 10% increase in TILs was independently associated not only with improved iDFS (hazard ratio[HR], 0.92), but also improved recurrence-free survival (HR, 0.90), distant recurrence-free survival (HR, 0.87), and overall survival (HR, 0.88) over a median follow-up of 18 years.

The current study shows that cancer stage based on tumor size and the number of lymph nodes should not be the only considerations for making treatment decisions and predicting outcomes, Dr. Leon-Ferre said in an interview.

“In fact, our study shows that for tumors of the same stage (particularly for stage I), the risk of recurrence is different depending on the number of TILs seen in the breast cancer tissue. When chemo is not given, those with high TILs have lower risk of recurrence, whereas those with low TILs have a higher risk of recurrence,” he said.
 

What are the Limitations of This Research?

The current study findings are limited by the retrospective design and use of observational data, so the researchers could not make conclusions about causality. Other limitations included lack of data on germline mutations and race or ethnicity, and the potential irrelevance of data from patients treated as long as 45 years ago.

“Because most patients with TNBC receive chemotherapy in the modern times, we needed to work with 13 hospitals around the world to find data on patients with TNBC who never received chemotherapy for various reasons,” Dr. Leon-Ferre said.

To address these limitations, Dr. Leone-Ferre and his colleagues are planning prospective studies where TILs will be used to make treatment decisions.

“Many of the patients in our cohort were treated many years ago, when chemotherapy was not routinely given. Advances in cancer detection, surgical and radiation techniques may lead to different results in patients treated today,” he added.

What Do Oncologists Need to Know?

The current study findings may provide additional information on prognosis that is important to share with patients for decision-making on the risks versus benefits of chemotherapy, Dr. Leon-Ferre said.

“Like any test, TILs should not be used in isolation to make decisions, but should be integrated with other factors including the cancer stage, the overall patient health, patient preferences, and concerns about treatment complications,” he emphasized. “The results of this study allow oncologists to offer a more refined calculation of recurrence risk if patients opt to not receive chemotherapy.”

In the current study, although younger age was associated with higher TIL levels, a finding consistent with previous studies, increased TIL, remained significantly associated with improved survival after adjusting for age, tumor size, nodal status, and histological grade.

Overall, “the findings suggest that for patients with stage I TNBC and TILs greater than 50%, chemotherapy may not be as necessary as it was previously thought,” Dr. Leon-Ferre said.

What Additional Research is Needed?

Prospective studies are needed to validate the findings, including studies in diverse populations, and additional studies may investigate whether early TBNC patients with high TIL levels could achieve high cure rates with less intensive and less toxic chemotherapy regiments than those currently recommended, the researchers wrote in their discussion.

“There are many additional research questions that we need to answer, and look forward to working on,” Dr. Leon-Ferre said, in an interview. These topics include whether TILs can be used to decide on the number of chemotherapy drugs a patient really needs and whether artificial intelligence can be used to evaluate TILs more quickly and effectively than the human eye, he said. Other research topics include identifying which particular type of TILs attack cancer cells most effectively and whether TILs could be increased in patients with low levels in order to improve their prognosis, he added.

The study was supported by the National Research Agency and General Secretariat for Investment, Clinical and Translational Science Awards, the Mayo Clinic Breast Cancer SPORE grant, the Cancer Research Society of Canada, institutional grants from the Dutch Cancer Society, The Netherlands Organization for Health Research, and several foundations. Dr. Leon-Ferre disclosed consulting honoraria to his institution for research activities from AstraZeneca, Gilead Sciences, and Lyell Immunopharma, with no personal fees outside the submitted work.

A San Antonio oncology practice and diagnostic reference laboratory have agreed to settle a federal lawsuit, which alleged the two entities had entered an unlawful kickback arrangement.

The US Department of Justice (DOJ) announced on April 2 that Oncology San Antonio, PA, and its physicians have agreed to pay $1.3 million, and CorePath Laboratories, PA, has agreed to pay nearly $2.75 million plus accrued interest in civil settlements with the United States and Texas for alleged violations of the False Claims Act.

According to the DOJ, the diagnostic reference laboratory, CorePath Laboratories, conducted in-office bone marrow biopsies at Oncology San Antonio practice locations and performed diagnostic testing on the samples. CorePath Laboratories agreed to pay $115 for each biopsy referred by Oncology San Antonio physicians, and these biopsy payments were allegedly paid to the private practices of three physicians at Oncology San Antonio. This arrangement allegedly began in August 2016.

The DOJ claimed that the payments for referring biopsies constituted illegal kickbacks under the Anti-Kickback Statute, which prohibits offering or receiving payments to encourage referrals of services covered by federal healthcare programs like Medicare and Medicaid.

“Violations of the Anti-Kickback Statute involving oncology services can waste scarce federal healthcare program funds and corrupt the medical decision-making process,” Special Agent in Charge Jason E. Meadows with the US Department of Health and Human Services Office of Inspector General said in a statement.

Oncology San Antonio told this news organization that the cost and distraction of prolonged litigation were the primary factors in its decision to settle. “The decision to settle was an extremely difficult one because Oncology San Antonio was confident that it would have prevailed in any action,” the practice said via email.

This civil settlement with Oncology San Antonio also resolved allegations that a physician affiliated with the practice, Jayasree Rao, MD, provided unnecessary tests, services, and treatments to patients covered by Medicare, TRICARE, and Texas Medicaid in the San Antonio Metro Area and billed these federal healthcare programs for the unnecessary services.

The DOJ identified Slavisa Gasic, MD, a physician formerly employed by Dr. Rao, as a whistleblower in the investigation. When asked for comment, Oncology San Antonio alleged Dr. Gasic was “disgruntled for not being promoted.”

According to Oncology San Antonio, the contract for bone marrow biopsies was negotiated and signed by a former nonphysician officer of the company without the input of Oncology San Antonio physicians. The contract permitted bone marrow biopsies at Oncology San Antonio clinics instead of requiring older adult and sick patients to go to a different facility for these services.

“Oncology San Antonio and Rao vehemently denied Gasic’s allegations as wholly unfounded,” the company told this news organization.

Dr. Rao retired in March and is no longer practicing. CorePath Laboratories, PA, did not respond to this news organization’s request for comment.

According to the DOJ press release, the “investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.”
 

A version of this article appeared on Medscape.com.

A San Antonio oncology practice and diagnostic reference laboratory have agreed to settle a federal lawsuit, which alleged the two entities had entered an unlawful kickback arrangement.

The US Department of Justice (DOJ) announced on April 2 that Oncology San Antonio, PA, and its physicians have agreed to pay $1.3 million, and CorePath Laboratories, PA, has agreed to pay nearly $2.75 million plus accrued interest in civil settlements with the United States and Texas for alleged violations of the False Claims Act.

According to the DOJ, the diagnostic reference laboratory, CorePath Laboratories, conducted in-office bone marrow biopsies at Oncology San Antonio practice locations and performed diagnostic testing on the samples. CorePath Laboratories agreed to pay $115 for each biopsy referred by Oncology San Antonio physicians, and these biopsy payments were allegedly paid to the private practices of three physicians at Oncology San Antonio. This arrangement allegedly began in August 2016.

The DOJ claimed that the payments for referring biopsies constituted illegal kickbacks under the Anti-Kickback Statute, which prohibits offering or receiving payments to encourage referrals of services covered by federal healthcare programs like Medicare and Medicaid.

“Violations of the Anti-Kickback Statute involving oncology services can waste scarce federal healthcare program funds and corrupt the medical decision-making process,” Special Agent in Charge Jason E. Meadows with the US Department of Health and Human Services Office of Inspector General said in a statement.

Oncology San Antonio told this news organization that the cost and distraction of prolonged litigation were the primary factors in its decision to settle. “The decision to settle was an extremely difficult one because Oncology San Antonio was confident that it would have prevailed in any action,” the practice said via email.

This civil settlement with Oncology San Antonio also resolved allegations that a physician affiliated with the practice, Jayasree Rao, MD, provided unnecessary tests, services, and treatments to patients covered by Medicare, TRICARE, and Texas Medicaid in the San Antonio Metro Area and billed these federal healthcare programs for the unnecessary services.

The DOJ identified Slavisa Gasic, MD, a physician formerly employed by Dr. Rao, as a whistleblower in the investigation. When asked for comment, Oncology San Antonio alleged Dr. Gasic was “disgruntled for not being promoted.”

According to Oncology San Antonio, the contract for bone marrow biopsies was negotiated and signed by a former nonphysician officer of the company without the input of Oncology San Antonio physicians. The contract permitted bone marrow biopsies at Oncology San Antonio clinics instead of requiring older adult and sick patients to go to a different facility for these services.

“Oncology San Antonio and Rao vehemently denied Gasic’s allegations as wholly unfounded,” the company told this news organization.

Dr. Rao retired in March and is no longer practicing. CorePath Laboratories, PA, did not respond to this news organization’s request for comment.

According to the DOJ press release, the “investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.”
 

A version of this article appeared on Medscape.com.

A San Antonio oncology practice and diagnostic reference laboratory have agreed to settle a federal lawsuit, which alleged the two entities had entered an unlawful kickback arrangement.

The US Department of Justice (DOJ) announced on April 2 that Oncology San Antonio, PA, and its physicians have agreed to pay $1.3 million, and CorePath Laboratories, PA, has agreed to pay nearly $2.75 million plus accrued interest in civil settlements with the United States and Texas for alleged violations of the False Claims Act.

According to the DOJ, the diagnostic reference laboratory, CorePath Laboratories, conducted in-office bone marrow biopsies at Oncology San Antonio practice locations and performed diagnostic testing on the samples. CorePath Laboratories agreed to pay $115 for each biopsy referred by Oncology San Antonio physicians, and these biopsy payments were allegedly paid to the private practices of three physicians at Oncology San Antonio. This arrangement allegedly began in August 2016.

The DOJ claimed that the payments for referring biopsies constituted illegal kickbacks under the Anti-Kickback Statute, which prohibits offering or receiving payments to encourage referrals of services covered by federal healthcare programs like Medicare and Medicaid.

“Violations of the Anti-Kickback Statute involving oncology services can waste scarce federal healthcare program funds and corrupt the medical decision-making process,” Special Agent in Charge Jason E. Meadows with the US Department of Health and Human Services Office of Inspector General said in a statement.

Oncology San Antonio told this news organization that the cost and distraction of prolonged litigation were the primary factors in its decision to settle. “The decision to settle was an extremely difficult one because Oncology San Antonio was confident that it would have prevailed in any action,” the practice said via email.

This civil settlement with Oncology San Antonio also resolved allegations that a physician affiliated with the practice, Jayasree Rao, MD, provided unnecessary tests, services, and treatments to patients covered by Medicare, TRICARE, and Texas Medicaid in the San Antonio Metro Area and billed these federal healthcare programs for the unnecessary services.

The DOJ identified Slavisa Gasic, MD, a physician formerly employed by Dr. Rao, as a whistleblower in the investigation. When asked for comment, Oncology San Antonio alleged Dr. Gasic was “disgruntled for not being promoted.”

According to Oncology San Antonio, the contract for bone marrow biopsies was negotiated and signed by a former nonphysician officer of the company without the input of Oncology San Antonio physicians. The contract permitted bone marrow biopsies at Oncology San Antonio clinics instead of requiring older adult and sick patients to go to a different facility for these services.

“Oncology San Antonio and Rao vehemently denied Gasic’s allegations as wholly unfounded,” the company told this news organization.

Dr. Rao retired in March and is no longer practicing. CorePath Laboratories, PA, did not respond to this news organization’s request for comment.

According to the DOJ press release, the “investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.”
 

A version of this article appeared on Medscape.com.

An “inevitable” global surge in prostate cancer is coming, with a worldwide doubling of cases to 2.9 million and an 85% increase in deaths to nearly 700,000 by the year 2040, the Lancet Commission on Prostate Cancer warned this week.

At a meeting of urologists in Paris, the commission said that the acceleration is already underway in high-income countries such as the United States and the United Kingdom but will gain momentum in low- and medium-income countries.

Nick James, MD, lead author of The Lancet report and professor of prostate and bladder cancer research at The Institute of Cancer Research in London, said that the surge, in part, is a medical success story.

“Prostate cancer paradoxically is a problem baked into the biology. Men get prostate cancer as they age,” Dr. James told this news organization. 

“There is a big rise in the high-income countries. But we’re going to see a big rise in the number of 50-, 60-, 70-year-olds in the coming decades in the poorer countries, and with that comes more prostate cancer. High-income countries such as the UK and USA will also see smaller increases for the same reason.”

According to the report, to be presented April 6 at the 2024 European Association of Urology Congress in Paris, “The case for prostate cancer screening for all men aged 50-70 years (and all men of African origin aged 45–70 years) in high-income countries is strengthening with improved use of technologies such as MRI and growing evidence for the safety of active surveillance.”

Andrew Vickers, PhD, a biostatistician at Memorial Sloan Kettering Cancer Center in New York City, said that the Lancet Commission came to similar conclusions as he and an international group of researchers did in a 2023 policy paper in The BMJ. A major gap, Dr. Vickers said, is misuse of prostate-specific antigen (PSA) screening. 

“We found that the ubiquitous policy compromise of letting patients decide for themselves about PSA has led to the worst possible outcomes of overuse in men unlikely to benefit, high rates of overdiagnosis and overtreatment, and economic and racial inequity,” Dr. Vickers said. “Our view is that PSA screening should be done well — by implementing straightforward harm-reduction strategies like restricting screening in older men and use of secondary tests before biopsy — or not at all.”

Dr. James said that undertreatment of advanced disease is widespread; only about 30%-40% of men in the United States receive combination hormone therapy for metastatic disease, for example. “Simply doing what we know works would improve outcomes,” he said.

Dr. James said that men of African ancestry are twice as likely to develop prostate cancer, but whether treatment should follow a different approach in these men is unclear. The new report stressed the need to include more men of African ancestry in research.

Brandon Mahal, MD, vice chair of research in radiation oncology the University of Miami Sylvester Comprehensive Cancer Center and a coauthor of the report, said that new approaches are needed to enable earlier diagnosis of prostate cancer in men in low- to middle-income countries, where most patients present with metastatic disease and are less likely to survive for long periods.

Dr. James recommended pop-up clinics and mobile testing to encourage men who are at high risk for prostate cancer but feel well to detect lethal cancers early.

In England, for example, Dr. James helped introduce an outreach program called The Man Van which provided free health checks, including PSA tests, to high-risk men in London. 

“By bringing a van with quick and easy testing straight to men at work and in the community, and targeting those who have a higher risk of prostate cancer, we provided thousands of health checks which resulted in almost 100 cancer diagnoses in men who might otherwise have only seen a doctor once their cancer has progressed to a more advanced stage,” he said.

He noted that the medical community worldwide is ill-prepared for the onslaught of prostate cancer cases.

“The solution cannot be training more urologists, radiation oncologists, pathologists, and radiologists because it simply takes too long,” Dr. James said. However, increased use of nurses and artificial intelligence may help. “In my own hospital, biopsies are a nurse-led and -delivered service. AI is extraordinarily good at diagnosis already and will only get better,” he said.

In poorer countries, smartphones could fill gaps too. “The same technology that does face recognition already can say that’s a Gleason 7 prostate cancer,” Dr. James said. “It’s not being rolled out in countries like America of course because pathologists’ income is at risk.”

Dr. James, Dr. Vickers, and Dr. Mahal reported no relevant financial conflicts of interest. 
 

A version of this article appeared on Medscape.com.

An “inevitable” global surge in prostate cancer is coming, with a worldwide doubling of cases to 2.9 million and an 85% increase in deaths to nearly 700,000 by the year 2040, the Lancet Commission on Prostate Cancer warned this week.

At a meeting of urologists in Paris, the commission said that the acceleration is already underway in high-income countries such as the United States and the United Kingdom but will gain momentum in low- and medium-income countries.

Nick James, MD, lead author of The Lancet report and professor of prostate and bladder cancer research at The Institute of Cancer Research in London, said that the surge, in part, is a medical success story.

“Prostate cancer paradoxically is a problem baked into the biology. Men get prostate cancer as they age,” Dr. James told this news organization. 

“There is a big rise in the high-income countries. But we’re going to see a big rise in the number of 50-, 60-, 70-year-olds in the coming decades in the poorer countries, and with that comes more prostate cancer. High-income countries such as the UK and USA will also see smaller increases for the same reason.”

According to the report, to be presented April 6 at the 2024 European Association of Urology Congress in Paris, “The case for prostate cancer screening for all men aged 50-70 years (and all men of African origin aged 45–70 years) in high-income countries is strengthening with improved use of technologies such as MRI and growing evidence for the safety of active surveillance.”

Andrew Vickers, PhD, a biostatistician at Memorial Sloan Kettering Cancer Center in New York City, said that the Lancet Commission came to similar conclusions as he and an international group of researchers did in a 2023 policy paper in The BMJ. A major gap, Dr. Vickers said, is misuse of prostate-specific antigen (PSA) screening. 

“We found that the ubiquitous policy compromise of letting patients decide for themselves about PSA has led to the worst possible outcomes of overuse in men unlikely to benefit, high rates of overdiagnosis and overtreatment, and economic and racial inequity,” Dr. Vickers said. “Our view is that PSA screening should be done well — by implementing straightforward harm-reduction strategies like restricting screening in older men and use of secondary tests before biopsy — or not at all.”

Dr. James said that undertreatment of advanced disease is widespread; only about 30%-40% of men in the United States receive combination hormone therapy for metastatic disease, for example. “Simply doing what we know works would improve outcomes,” he said.

Dr. James said that men of African ancestry are twice as likely to develop prostate cancer, but whether treatment should follow a different approach in these men is unclear. The new report stressed the need to include more men of African ancestry in research.

Brandon Mahal, MD, vice chair of research in radiation oncology the University of Miami Sylvester Comprehensive Cancer Center and a coauthor of the report, said that new approaches are needed to enable earlier diagnosis of prostate cancer in men in low- to middle-income countries, where most patients present with metastatic disease and are less likely to survive for long periods.

Dr. James recommended pop-up clinics and mobile testing to encourage men who are at high risk for prostate cancer but feel well to detect lethal cancers early.

In England, for example, Dr. James helped introduce an outreach program called The Man Van which provided free health checks, including PSA tests, to high-risk men in London. 

“By bringing a van with quick and easy testing straight to men at work and in the community, and targeting those who have a higher risk of prostate cancer, we provided thousands of health checks which resulted in almost 100 cancer diagnoses in men who might otherwise have only seen a doctor once their cancer has progressed to a more advanced stage,” he said.

He noted that the medical community worldwide is ill-prepared for the onslaught of prostate cancer cases.

“The solution cannot be training more urologists, radiation oncologists, pathologists, and radiologists because it simply takes too long,” Dr. James said. However, increased use of nurses and artificial intelligence may help. “In my own hospital, biopsies are a nurse-led and -delivered service. AI is extraordinarily good at diagnosis already and will only get better,” he said.

In poorer countries, smartphones could fill gaps too. “The same technology that does face recognition already can say that’s a Gleason 7 prostate cancer,” Dr. James said. “It’s not being rolled out in countries like America of course because pathologists’ income is at risk.”

Dr. James, Dr. Vickers, and Dr. Mahal reported no relevant financial conflicts of interest. 
 

A version of this article appeared on Medscape.com.

An “inevitable” global surge in prostate cancer is coming, with a worldwide doubling of cases to 2.9 million and an 85% increase in deaths to nearly 700,000 by the year 2040, the Lancet Commission on Prostate Cancer warned this week.

At a meeting of urologists in Paris, the commission said that the acceleration is already underway in high-income countries such as the United States and the United Kingdom but will gain momentum in low- and medium-income countries.

Nick James, MD, lead author of The Lancet report and professor of prostate and bladder cancer research at The Institute of Cancer Research in London, said that the surge, in part, is a medical success story.

“Prostate cancer paradoxically is a problem baked into the biology. Men get prostate cancer as they age,” Dr. James told this news organization. 

“There is a big rise in the high-income countries. But we’re going to see a big rise in the number of 50-, 60-, 70-year-olds in the coming decades in the poorer countries, and with that comes more prostate cancer. High-income countries such as the UK and USA will also see smaller increases for the same reason.”

According to the report, to be presented April 6 at the 2024 European Association of Urology Congress in Paris, “The case for prostate cancer screening for all men aged 50-70 years (and all men of African origin aged 45–70 years) in high-income countries is strengthening with improved use of technologies such as MRI and growing evidence for the safety of active surveillance.”

Andrew Vickers, PhD, a biostatistician at Memorial Sloan Kettering Cancer Center in New York City, said that the Lancet Commission came to similar conclusions as he and an international group of researchers did in a 2023 policy paper in The BMJ. A major gap, Dr. Vickers said, is misuse of prostate-specific antigen (PSA) screening. 

“We found that the ubiquitous policy compromise of letting patients decide for themselves about PSA has led to the worst possible outcomes of overuse in men unlikely to benefit, high rates of overdiagnosis and overtreatment, and economic and racial inequity,” Dr. Vickers said. “Our view is that PSA screening should be done well — by implementing straightforward harm-reduction strategies like restricting screening in older men and use of secondary tests before biopsy — or not at all.”

Dr. James said that undertreatment of advanced disease is widespread; only about 30%-40% of men in the United States receive combination hormone therapy for metastatic disease, for example. “Simply doing what we know works would improve outcomes,” he said.

Dr. James said that men of African ancestry are twice as likely to develop prostate cancer, but whether treatment should follow a different approach in these men is unclear. The new report stressed the need to include more men of African ancestry in research.

Brandon Mahal, MD, vice chair of research in radiation oncology the University of Miami Sylvester Comprehensive Cancer Center and a coauthor of the report, said that new approaches are needed to enable earlier diagnosis of prostate cancer in men in low- to middle-income countries, where most patients present with metastatic disease and are less likely to survive for long periods.

Dr. James recommended pop-up clinics and mobile testing to encourage men who are at high risk for prostate cancer but feel well to detect lethal cancers early.

In England, for example, Dr. James helped introduce an outreach program called The Man Van which provided free health checks, including PSA tests, to high-risk men in London. 

“By bringing a van with quick and easy testing straight to men at work and in the community, and targeting those who have a higher risk of prostate cancer, we provided thousands of health checks which resulted in almost 100 cancer diagnoses in men who might otherwise have only seen a doctor once their cancer has progressed to a more advanced stage,” he said.

He noted that the medical community worldwide is ill-prepared for the onslaught of prostate cancer cases.

“The solution cannot be training more urologists, radiation oncologists, pathologists, and radiologists because it simply takes too long,” Dr. James said. However, increased use of nurses and artificial intelligence may help. “In my own hospital, biopsies are a nurse-led and -delivered service. AI is extraordinarily good at diagnosis already and will only get better,” he said.

In poorer countries, smartphones could fill gaps too. “The same technology that does face recognition already can say that’s a Gleason 7 prostate cancer,” Dr. James said. “It’s not being rolled out in countries like America of course because pathologists’ income is at risk.”

Dr. James, Dr. Vickers, and Dr. Mahal reported no relevant financial conflicts of interest. 
 

A version of this article appeared on Medscape.com.

Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.

Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.

For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.

“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”

A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.

The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”

The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.

Necessary Evil or Burdensome Time Suck?

The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.

Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.

Standards ACP Used for Validating Depression Measurement

A committee with ACP used a modified appropriateness method from RAND and UCLA.

They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.

They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.

A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.

“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.

Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.

In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.

“You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”

The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.

Implementing Measurement

At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.

Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.

“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.

Suggestions From ACP for Improvement in MDD Metrics

• Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
• Add methods for clinicians to measure and indicate severity of MDD.
• Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
• Allow clinicians to document changes in treatment plan.

Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.

Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.

“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.

Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.

Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.

At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.

“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”

Takeaways for Depression Screening and Follow-Up in Clinical Settings

Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.

Patients have the right to refuse a screener and their wishes should be respected.

Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.

Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.

A version of this article appeared on Medscape.com.

Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.

Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.

For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.

“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”

A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.

The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”

The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.

Necessary Evil or Burdensome Time Suck?

The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.

Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.

Standards ACP Used for Validating Depression Measurement

A committee with ACP used a modified appropriateness method from RAND and UCLA.

They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.

They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.

A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.

“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.

Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.

In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.

“You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”

The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.

Implementing Measurement

At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.

Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.

“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.

Suggestions From ACP for Improvement in MDD Metrics

• Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
• Add methods for clinicians to measure and indicate severity of MDD.
• Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
• Allow clinicians to document changes in treatment plan.

Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.

Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.

“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.

Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.

Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.

At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.

“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”

Takeaways for Depression Screening and Follow-Up in Clinical Settings

Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.

Patients have the right to refuse a screener and their wishes should be respected.

Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.

Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.

A version of this article appeared on Medscape.com.

Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.

Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.

For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.

“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”

A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.

The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”

The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.

Necessary Evil or Burdensome Time Suck?

The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.

Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.

Standards ACP Used for Validating Depression Measurement

A committee with ACP used a modified appropriateness method from RAND and UCLA.

They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.

They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.

A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.

“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.

Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.

In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.

“You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”

The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.

Implementing Measurement

At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.

Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.

“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.

Suggestions From ACP for Improvement in MDD Metrics

• Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
• Add methods for clinicians to measure and indicate severity of MDD.
• Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
• Allow clinicians to document changes in treatment plan.

Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.

Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.

“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.

Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.

Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.

At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.

“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”

Takeaways for Depression Screening and Follow-Up in Clinical Settings

Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.

Patients have the right to refuse a screener and their wishes should be respected.

Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.

Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.

A version of this article appeared on Medscape.com.

Dhaval Desai, MD, was teaching his 4-year-old to ride a bike after another exhausting shift at the hospital during the summer after the first COVID-19 surge. He was putting on a happy face and forcing out a “Yay!” he did not feel. The pandemic had taken its toll, and he just wanted to lie down and be alone. Realizing that he was “scraping to find joy” was when he knew something was wrong.

“I was giving, giving, giving at work a lot, and I had little left to give at home,” said Dr. Desai, director of hospital medicine at Emory Saint Joseph’s Hospital and an assistant professor of medicine at Emory University in Atlanta, Georgia.

At work, he worried about his wife managing two kids — including a newborn — during the pandemic. At home, he stressed about work and the crush of patients with COVID the hospital was grappling to handle. He was exhausted, resentful, and angry, and it was jeopardizing what mattered most to him: His home life.

“It was all colliding…I realized, OK, I’m struggling,” he said.

Dr. Desai is one of thousands of physicians across the United States who have experienced burnout and depression, exacerbated by the pandemic. After 4 years, the impact is still being felt. Medscape’s 2024 annual report on this issue found that burnout and depression among doctors — while encouragingly better than the prior year — remain higher than before COVID. For doctors caring for patients with long COVID, those suffering from the debilitating aftereffects of an infection, the sense of helplessness when recovery is elusive can also weigh heavily.

Overall, more female physicians reported feeling burned out and depressed. Experts attributed this gap to issues including fewer women in supportive leadership and mentoring roles, compensation disparities, fewer career advancement opportunities, and more responsibilities caring for children and elders.

Multiple international studies and reports have highlighted the surge in burnout experienced by physicians and healthcare workers globally during the pandemic. Even before COVID, studies found the suicide rate among male and female US physicians was higher than the general population and higher than any other profession, including the military. The risk among female physicians, in particular, was 250%-400% higher.

“That’s really, on average, one a day, and that’s really unacceptable. No one should die by suicide, but a physician who knows the risks and knows that, should never do that,” said Dr. Desai about suicides overall among doctors.

The story of Lorna Breen had rattled Dr. Desai. Dr. Breen was a Manhattan physician who died by suicide in April 2020 after grappling with the city’s devastating first wave and then contracting COVID-19 herself. While Dr. Desai did not have thoughts of suicide, he was facing his own battles. Those experiences and the stigma around mental health prompted him to write his book, Burning Out on the Covid Front Lines: A Doctor’s Memoir of Fatherhood, Race and Perseverance in the Pandemic, with the hope that it can help others like him.
 

Mental Health Stigma

But despite the body of research and growing awareness toward addressing mental health among physicians, almost four in 10 doctors are wary of revealing their personal struggles.

More than half of those surveyed in the Medscape Medical News report said they had not consulted a mental health professional before and would not do so going forward either. The fear of tarnishing their reputation or even losing their license keeps doctors silent. Advocates and groups like the Dr. Lorna Breen Heroes’ Foundation are pushing for hospitals and healthcare systems to remove and rephrase invasive and stigmatizing language around mental health in licensure, credentialing, or insurance applications.
 

Burnout Triggers: Systemic Problems, Social Tensions

Burnout can make a person feel “depleted and used up” and is characterized by extreme tiredness, low energy, frustration about work, emotional distance or numbness, and difficulty with concentration, responsibilities, or creativity. It can make an individual feel helpless, alone, defeated, cynical, and without purpose and can also cause physical symptoms such as headaches, loss of appetite, insomnia, and body aches. Unaddressed, it can lead to depression, anxiety, and a variety of physical health issues.

“We can still be highly functional and not okay,” said Dr. Desai.

For doctors, burnout often builds over time from large and small systemic problems and inefficiencies, multiplied by a dozen or more patients each day: Not enough time for documentation, complicated paperwork, navigating byzantine health and insurance systems, and hitting roadblocks. The administrative work, combined with an enormous patient load, and staffing and resource shortages create barriers to care and cuts into the amount of time they can spend providing actual care.

These existing problems worsened as patients with COVID overwhelmed hospitals and clinics. At the same time, healthcare workers worried about caring for the sick, getting infected themselves, or having multiple staff falling ill at once. As each surge came and went, backlash, hostility, abuse, and even violence toward healthcare workers also increased. The discrimination some medical staff were subjected to compounded the burnout.

“When we’re not getting the support we need as physicians and healthcare workers, that adds to burnout, and I saw that in my colleagues,” said Dr. Desai.
 

Impact of Burnout

At the Mount Sinai Center for Post-COVID Care in New York City, doctors grapple with feelings of helplessness in caring for patients with long COVID who show little sign of recovery. That emotional toll can also be difficult, said director Zijian Chen, MD, who helped launch the clinic in May 2020.

“Sometimes you’re faced with patients who you’re trying to do everything for, but they’re not just not getting better,” said Dr. Chen. “It’s really frustrating because we want everybody to get better. So, there’s that lack of fulfillment there that can cause a sense of burnout.”

While the worst outcomes and death rates initially brought on by acute infections have lessened, long COVID clinics exemplify some of the ongoing challenges within healthcare. Many operate with insufficient financial and staffing resources despite wait-lists and a steady flow of new and returning patients. Even with the demand, a number of these clinics have shuttered, leaving patients without access to much-needed medical help.

“There are clinicians who are burning out. That is definitely something that I’ve seen,” said Monica Verduzco-Gutierrez, MD, a professor and chair of the Department of Rehabilitation Medicine at the University of Texas Health Science Center in San Antonio, Texas.

“[It] takes a lot of resources for a successful long COVID clinic. A lot of special funding may be drying up and couple that with clinicians burning out, then they’re going to shut their doors.”

And it’s not just long COVID clinics. Data have shown an overall exodus in healthcare, especially during the pandemic. One study found burnout was one of the “most impactful” predictors of a physician’s intention to leave the profession during the pandemic. The loss of talent and skills during a major health crisis can put the entire system under stress, with patients ultimately suffering from poorer care.

“Healthcare system fragility and the chaos is far worse than it was before. We are continuing to be forced to do more with less,” said Dr. Desai.
 

Alleviating Burnout

While it is difficult to assess whether burnout from the pandemic is transient, experts say this is an opportunity for health institutions to learn from these experiences and implement policies and actions that can help reduce the mental health strain on staff. One study found that changes made by organizations had a bigger positive impact on reducing burnout than individual changes.

Advocates say more support staff, more work flexibility, and higher compensation would significantly ease the burden that drives burnout and depression.

In addition, half the physicians surveyed in the Medscape Medical News report felt their employers were not acknowledging how pervasive burnout is at their workplace. Having a trusted peer or leader set an example by sharing his or her own challenging experiences and saying it›s time to address these struggles can be an enormously validating step forward, said Dr. Desai. Acknowledging his own difficulties was not only a huge weight off his shoulders but also helped surpris colleagues who sought him out for counsel.

“I’m not suggesting everybody get on medication,” he said. “But talking to a therapist, acknowledging there’s issues, restructuring your life to realize something’s off, and just knowing that you’re not alone? That’s huge.”

Dr. Desai said he still faces personal challenges but is in a much better place, doing well at work and at home. He talks to a therapist, is taking medication, and has developed better coping mechanisms. He is spending more time with his family, detaching for a few hours from work-related emails, learning to draw boundaries and say no, and trying to be more present and “intentional” in connecting with colleagues and patients.

“It’s okay to not be okay,” said Dr. Desai. “It’s okay to be vulnerable and acknowledge when we can’t do more.”

Are you in a crisis? Call or text 988 or text TALK to 741741. For immediate support for healthcare professionals, as well as resources for institutions and organizations, visit: afsp.org/suicide-prevention-for-healthcare-professionals/#facts-about-mental-health-and-suicide.

A version of this article appeared on Medscape.com.

Dhaval Desai, MD, was teaching his 4-year-old to ride a bike after another exhausting shift at the hospital during the summer after the first COVID-19 surge. He was putting on a happy face and forcing out a “Yay!” he did not feel. The pandemic had taken its toll, and he just wanted to lie down and be alone. Realizing that he was “scraping to find joy” was when he knew something was wrong.

“I was giving, giving, giving at work a lot, and I had little left to give at home,” said Dr. Desai, director of hospital medicine at Emory Saint Joseph’s Hospital and an assistant professor of medicine at Emory University in Atlanta, Georgia.

At work, he worried about his wife managing two kids — including a newborn — during the pandemic. At home, he stressed about work and the crush of patients with COVID the hospital was grappling to handle. He was exhausted, resentful, and angry, and it was jeopardizing what mattered most to him: His home life.

“It was all colliding…I realized, OK, I’m struggling,” he said.

Dr. Desai is one of thousands of physicians across the United States who have experienced burnout and depression, exacerbated by the pandemic. After 4 years, the impact is still being felt. Medscape’s 2024 annual report on this issue found that burnout and depression among doctors — while encouragingly better than the prior year — remain higher than before COVID. For doctors caring for patients with long COVID, those suffering from the debilitating aftereffects of an infection, the sense of helplessness when recovery is elusive can also weigh heavily.

Overall, more female physicians reported feeling burned out and depressed. Experts attributed this gap to issues including fewer women in supportive leadership and mentoring roles, compensation disparities, fewer career advancement opportunities, and more responsibilities caring for children and elders.

Multiple international studies and reports have highlighted the surge in burnout experienced by physicians and healthcare workers globally during the pandemic. Even before COVID, studies found the suicide rate among male and female US physicians was higher than the general population and higher than any other profession, including the military. The risk among female physicians, in particular, was 250%-400% higher.

“That’s really, on average, one a day, and that’s really unacceptable. No one should die by suicide, but a physician who knows the risks and knows that, should never do that,” said Dr. Desai about suicides overall among doctors.

The story of Lorna Breen had rattled Dr. Desai. Dr. Breen was a Manhattan physician who died by suicide in April 2020 after grappling with the city’s devastating first wave and then contracting COVID-19 herself. While Dr. Desai did not have thoughts of suicide, he was facing his own battles. Those experiences and the stigma around mental health prompted him to write his book, Burning Out on the Covid Front Lines: A Doctor’s Memoir of Fatherhood, Race and Perseverance in the Pandemic, with the hope that it can help others like him.
 

Mental Health Stigma

But despite the body of research and growing awareness toward addressing mental health among physicians, almost four in 10 doctors are wary of revealing their personal struggles.

More than half of those surveyed in the Medscape Medical News report said they had not consulted a mental health professional before and would not do so going forward either. The fear of tarnishing their reputation or even losing their license keeps doctors silent. Advocates and groups like the Dr. Lorna Breen Heroes’ Foundation are pushing for hospitals and healthcare systems to remove and rephrase invasive and stigmatizing language around mental health in licensure, credentialing, or insurance applications.
 

Burnout Triggers: Systemic Problems, Social Tensions

Burnout can make a person feel “depleted and used up” and is characterized by extreme tiredness, low energy, frustration about work, emotional distance or numbness, and difficulty with concentration, responsibilities, or creativity. It can make an individual feel helpless, alone, defeated, cynical, and without purpose and can also cause physical symptoms such as headaches, loss of appetite, insomnia, and body aches. Unaddressed, it can lead to depression, anxiety, and a variety of physical health issues.

“We can still be highly functional and not okay,” said Dr. Desai.

For doctors, burnout often builds over time from large and small systemic problems and inefficiencies, multiplied by a dozen or more patients each day: Not enough time for documentation, complicated paperwork, navigating byzantine health and insurance systems, and hitting roadblocks. The administrative work, combined with an enormous patient load, and staffing and resource shortages create barriers to care and cuts into the amount of time they can spend providing actual care.

These existing problems worsened as patients with COVID overwhelmed hospitals and clinics. At the same time, healthcare workers worried about caring for the sick, getting infected themselves, or having multiple staff falling ill at once. As each surge came and went, backlash, hostility, abuse, and even violence toward healthcare workers also increased. The discrimination some medical staff were subjected to compounded the burnout.

“When we’re not getting the support we need as physicians and healthcare workers, that adds to burnout, and I saw that in my colleagues,” said Dr. Desai.
 

Impact of Burnout

At the Mount Sinai Center for Post-COVID Care in New York City, doctors grapple with feelings of helplessness in caring for patients with long COVID who show little sign of recovery. That emotional toll can also be difficult, said director Zijian Chen, MD, who helped launch the clinic in May 2020.

“Sometimes you’re faced with patients who you’re trying to do everything for, but they’re not just not getting better,” said Dr. Chen. “It’s really frustrating because we want everybody to get better. So, there’s that lack of fulfillment there that can cause a sense of burnout.”

While the worst outcomes and death rates initially brought on by acute infections have lessened, long COVID clinics exemplify some of the ongoing challenges within healthcare. Many operate with insufficient financial and staffing resources despite wait-lists and a steady flow of new and returning patients. Even with the demand, a number of these clinics have shuttered, leaving patients without access to much-needed medical help.

“There are clinicians who are burning out. That is definitely something that I’ve seen,” said Monica Verduzco-Gutierrez, MD, a professor and chair of the Department of Rehabilitation Medicine at the University of Texas Health Science Center in San Antonio, Texas.

“[It] takes a lot of resources for a successful long COVID clinic. A lot of special funding may be drying up and couple that with clinicians burning out, then they’re going to shut their doors.”

And it’s not just long COVID clinics. Data have shown an overall exodus in healthcare, especially during the pandemic. One study found burnout was one of the “most impactful” predictors of a physician’s intention to leave the profession during the pandemic. The loss of talent and skills during a major health crisis can put the entire system under stress, with patients ultimately suffering from poorer care.

“Healthcare system fragility and the chaos is far worse than it was before. We are continuing to be forced to do more with less,” said Dr. Desai.
 

Alleviating Burnout

While it is difficult to assess whether burnout from the pandemic is transient, experts say this is an opportunity for health institutions to learn from these experiences and implement policies and actions that can help reduce the mental health strain on staff. One study found that changes made by organizations had a bigger positive impact on reducing burnout than individual changes.

Advocates say more support staff, more work flexibility, and higher compensation would significantly ease the burden that drives burnout and depression.

In addition, half the physicians surveyed in the Medscape Medical News report felt their employers were not acknowledging how pervasive burnout is at their workplace. Having a trusted peer or leader set an example by sharing his or her own challenging experiences and saying it›s time to address these struggles can be an enormously validating step forward, said Dr. Desai. Acknowledging his own difficulties was not only a huge weight off his shoulders but also helped surpris colleagues who sought him out for counsel.

“I’m not suggesting everybody get on medication,” he said. “But talking to a therapist, acknowledging there’s issues, restructuring your life to realize something’s off, and just knowing that you’re not alone? That’s huge.”

Dr. Desai said he still faces personal challenges but is in a much better place, doing well at work and at home. He talks to a therapist, is taking medication, and has developed better coping mechanisms. He is spending more time with his family, detaching for a few hours from work-related emails, learning to draw boundaries and say no, and trying to be more present and “intentional” in connecting with colleagues and patients.

“It’s okay to not be okay,” said Dr. Desai. “It’s okay to be vulnerable and acknowledge when we can’t do more.”

Are you in a crisis? Call or text 988 or text TALK to 741741. For immediate support for healthcare professionals, as well as resources for institutions and organizations, visit: afsp.org/suicide-prevention-for-healthcare-professionals/#facts-about-mental-health-and-suicide.

A version of this article appeared on Medscape.com.

Dhaval Desai, MD, was teaching his 4-year-old to ride a bike after another exhausting shift at the hospital during the summer after the first COVID-19 surge. He was putting on a happy face and forcing out a “Yay!” he did not feel. The pandemic had taken its toll, and he just wanted to lie down and be alone. Realizing that he was “scraping to find joy” was when he knew something was wrong.

“I was giving, giving, giving at work a lot, and I had little left to give at home,” said Dr. Desai, director of hospital medicine at Emory Saint Joseph’s Hospital and an assistant professor of medicine at Emory University in Atlanta, Georgia.

At work, he worried about his wife managing two kids — including a newborn — during the pandemic. At home, he stressed about work and the crush of patients with COVID the hospital was grappling to handle. He was exhausted, resentful, and angry, and it was jeopardizing what mattered most to him: His home life.

“It was all colliding…I realized, OK, I’m struggling,” he said.

Dr. Desai is one of thousands of physicians across the United States who have experienced burnout and depression, exacerbated by the pandemic. After 4 years, the impact is still being felt. Medscape’s 2024 annual report on this issue found that burnout and depression among doctors — while encouragingly better than the prior year — remain higher than before COVID. For doctors caring for patients with long COVID, those suffering from the debilitating aftereffects of an infection, the sense of helplessness when recovery is elusive can also weigh heavily.

Overall, more female physicians reported feeling burned out and depressed. Experts attributed this gap to issues including fewer women in supportive leadership and mentoring roles, compensation disparities, fewer career advancement opportunities, and more responsibilities caring for children and elders.

Multiple international studies and reports have highlighted the surge in burnout experienced by physicians and healthcare workers globally during the pandemic. Even before COVID, studies found the suicide rate among male and female US physicians was higher than the general population and higher than any other profession, including the military. The risk among female physicians, in particular, was 250%-400% higher.

“That’s really, on average, one a day, and that’s really unacceptable. No one should die by suicide, but a physician who knows the risks and knows that, should never do that,” said Dr. Desai about suicides overall among doctors.

The story of Lorna Breen had rattled Dr. Desai. Dr. Breen was a Manhattan physician who died by suicide in April 2020 after grappling with the city’s devastating first wave and then contracting COVID-19 herself. While Dr. Desai did not have thoughts of suicide, he was facing his own battles. Those experiences and the stigma around mental health prompted him to write his book, Burning Out on the Covid Front Lines: A Doctor’s Memoir of Fatherhood, Race and Perseverance in the Pandemic, with the hope that it can help others like him.
 

Mental Health Stigma

But despite the body of research and growing awareness toward addressing mental health among physicians, almost four in 10 doctors are wary of revealing their personal struggles.

More than half of those surveyed in the Medscape Medical News report said they had not consulted a mental health professional before and would not do so going forward either. The fear of tarnishing their reputation or even losing their license keeps doctors silent. Advocates and groups like the Dr. Lorna Breen Heroes’ Foundation are pushing for hospitals and healthcare systems to remove and rephrase invasive and stigmatizing language around mental health in licensure, credentialing, or insurance applications.
 

Burnout Triggers: Systemic Problems, Social Tensions

Burnout can make a person feel “depleted and used up” and is characterized by extreme tiredness, low energy, frustration about work, emotional distance or numbness, and difficulty with concentration, responsibilities, or creativity. It can make an individual feel helpless, alone, defeated, cynical, and without purpose and can also cause physical symptoms such as headaches, loss of appetite, insomnia, and body aches. Unaddressed, it can lead to depression, anxiety, and a variety of physical health issues.

“We can still be highly functional and not okay,” said Dr. Desai.

For doctors, burnout often builds over time from large and small systemic problems and inefficiencies, multiplied by a dozen or more patients each day: Not enough time for documentation, complicated paperwork, navigating byzantine health and insurance systems, and hitting roadblocks. The administrative work, combined with an enormous patient load, and staffing and resource shortages create barriers to care and cuts into the amount of time they can spend providing actual care.

These existing problems worsened as patients with COVID overwhelmed hospitals and clinics. At the same time, healthcare workers worried about caring for the sick, getting infected themselves, or having multiple staff falling ill at once. As each surge came and went, backlash, hostility, abuse, and even violence toward healthcare workers also increased. The discrimination some medical staff were subjected to compounded the burnout.

“When we’re not getting the support we need as physicians and healthcare workers, that adds to burnout, and I saw that in my colleagues,” said Dr. Desai.
 

Impact of Burnout

At the Mount Sinai Center for Post-COVID Care in New York City, doctors grapple with feelings of helplessness in caring for patients with long COVID who show little sign of recovery. That emotional toll can also be difficult, said director Zijian Chen, MD, who helped launch the clinic in May 2020.

“Sometimes you’re faced with patients who you’re trying to do everything for, but they’re not just not getting better,” said Dr. Chen. “It’s really frustrating because we want everybody to get better. So, there’s that lack of fulfillment there that can cause a sense of burnout.”

While the worst outcomes and death rates initially brought on by acute infections have lessened, long COVID clinics exemplify some of the ongoing challenges within healthcare. Many operate with insufficient financial and staffing resources despite wait-lists and a steady flow of new and returning patients. Even with the demand, a number of these clinics have shuttered, leaving patients without access to much-needed medical help.

“There are clinicians who are burning out. That is definitely something that I’ve seen,” said Monica Verduzco-Gutierrez, MD, a professor and chair of the Department of Rehabilitation Medicine at the University of Texas Health Science Center in San Antonio, Texas.

“[It] takes a lot of resources for a successful long COVID clinic. A lot of special funding may be drying up and couple that with clinicians burning out, then they’re going to shut their doors.”

And it’s not just long COVID clinics. Data have shown an overall exodus in healthcare, especially during the pandemic. One study found burnout was one of the “most impactful” predictors of a physician’s intention to leave the profession during the pandemic. The loss of talent and skills during a major health crisis can put the entire system under stress, with patients ultimately suffering from poorer care.

“Healthcare system fragility and the chaos is far worse than it was before. We are continuing to be forced to do more with less,” said Dr. Desai.
 

Alleviating Burnout

While it is difficult to assess whether burnout from the pandemic is transient, experts say this is an opportunity for health institutions to learn from these experiences and implement policies and actions that can help reduce the mental health strain on staff. One study found that changes made by organizations had a bigger positive impact on reducing burnout than individual changes.

Advocates say more support staff, more work flexibility, and higher compensation would significantly ease the burden that drives burnout and depression.

In addition, half the physicians surveyed in the Medscape Medical News report felt their employers were not acknowledging how pervasive burnout is at their workplace. Having a trusted peer or leader set an example by sharing his or her own challenging experiences and saying it›s time to address these struggles can be an enormously validating step forward, said Dr. Desai. Acknowledging his own difficulties was not only a huge weight off his shoulders but also helped surpris colleagues who sought him out for counsel.

“I’m not suggesting everybody get on medication,” he said. “But talking to a therapist, acknowledging there’s issues, restructuring your life to realize something’s off, and just knowing that you’re not alone? That’s huge.”

Dr. Desai said he still faces personal challenges but is in a much better place, doing well at work and at home. He talks to a therapist, is taking medication, and has developed better coping mechanisms. He is spending more time with his family, detaching for a few hours from work-related emails, learning to draw boundaries and say no, and trying to be more present and “intentional” in connecting with colleagues and patients.

“It’s okay to not be okay,” said Dr. Desai. “It’s okay to be vulnerable and acknowledge when we can’t do more.”

Are you in a crisis? Call or text 988 or text TALK to 741741. For immediate support for healthcare professionals, as well as resources for institutions and organizations, visit: afsp.org/suicide-prevention-for-healthcare-professionals/#facts-about-mental-health-and-suicide.

A version of this article appeared on Medscape.com.

Healthcare providers hold wide-ranging opinions about prescribing opioids for chronic cancer pain, and many are haunted by the conflicting factors driving their views, from legal concerns to threats of violence, say the authors of new research.

These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.

“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
 

Who Should Manage Chronic Cancer Pain?

Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.

“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
 

What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?

To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.

These interviews yielded three themes.

First, no “medical home” exists for chronic pain management in cancer survivors.

“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.

Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.

“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”

The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.

“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”

Meanwhile, a palliative care provider described legal pressure from the opposite direction:

“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”

Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
 

What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?

After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.

They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.

Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.

This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.

Healthcare providers hold wide-ranging opinions about prescribing opioids for chronic cancer pain, and many are haunted by the conflicting factors driving their views, from legal concerns to threats of violence, say the authors of new research.

These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.

“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
 

Who Should Manage Chronic Cancer Pain?

Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.

“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
 

What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?

To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.

These interviews yielded three themes.

First, no “medical home” exists for chronic pain management in cancer survivors.

“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.

Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.

“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”

The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.

“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”

Meanwhile, a palliative care provider described legal pressure from the opposite direction:

“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”

Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
 

What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?

After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.

They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.

Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.

This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.

Healthcare providers hold wide-ranging opinions about prescribing opioids for chronic cancer pain, and many are haunted by the conflicting factors driving their views, from legal concerns to threats of violence, say the authors of new research.

These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.

“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
 

Who Should Manage Chronic Cancer Pain?

Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.

“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
 

What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?

To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.

These interviews yielded three themes.

First, no “medical home” exists for chronic pain management in cancer survivors.

“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.

Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.

“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”

The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.

“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”

Meanwhile, a palliative care provider described legal pressure from the opposite direction:

“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”

Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
 

What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?

After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.

They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.

Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.

This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.

When her obstetrician-gynecologist recommended a mammogram, Emily Legg didn’t hesitate to schedule an appointment for the screening.

Her grandmother had been diagnosed with breast cancer and her father died of prostate cancer in his mid-50s. Ms. Legg also has polycystic ovary syndrome (PCOS), which increases the risk of some cancers.

Having just turned 40, Ms. Legg said she was determined to be as proactive as possible with cancer screenings.

Before the mammogram, she arranged for childcare for her 6-month-old daughter and filled out a required questionnaire online that asked about her history and health conditions. When the appointment day arrived, Ms. Legg made the 30-minute drive to the clinic where she was prepped for the procedure and escorted to the mammography room.

But just before the screening started, Ms. Legg happened to mention to the technician that she was breastfeeding. The surprised tech immediately halted the procedure, Ms. Legg said. Because of increased breast density caused by nursing, Ms. Legg was told to wait at least 6 weeks after weaning for a mammogram.

“I didn’t even consider that breastfeeding might prevent me from getting a mammogram,” said Ms. Legg, a writing professor from Hamilton, Ohio. “I had to go home. I was frustrated, mostly because I had driven all that way. I had hyped myself up. I had childcare in line. And now I had to wait until my daughter weaned? At the time, I didn’t know if my daughter was going to breastfeed for 2 years or be done at 6 months.”

Considering her family background, Ms. Legg worried about not receiving the screening. Her sister had recently undergone a mammogram while she was breastfeeding without any problems.

When she did research, Ms. Legg found conflicting information about the subject online so she turned to Reddit, where she started a thread asking if other moms over 40 had experienced similar issues. Dozens of moms responded with questions and concerns on the subject. Some wrote about being denied a mammogram while breastfeeding, while others wrote they received the procedure without question. Guidance from health professionals on the topic appeared to vastly differ.

“That’s why I turned to [social media] because I wasn’t finding anything else,” Ms. Legg said. “There’s just a lack of clear information. As an older mom, there’s less information out there for being postpartum and being over 40.”

Confusion over screenings during breastfeeding comes at the intersection of national guidelines lowering the recommended age for first mammograms, more women having babies later in life, and women getting breast cancer earlier.

Legg family

Most physician specialty associations agree that mammography is safe for breastfeeding patients and that they need not delay routine screenings. However, the safety of breast imaging during pregnancy and lactation is not well advertised, said Molly Peterson, MD, a radiologist based in St. Frances, Wisconsin, and lead author of a 2023 article about breast imaging during pregnancy and lactation in RadioGraphics, a journal of the Radiological Society of North America.

Conflicting information from nonscientific resources adds to the confusion, Dr. Peterson said. At the same time, health providers along the care spectrum may be uncertain about what imaging is safe and reasonable. Recommendations about mammography and lactation can also vary by institution, screening experts say.

“I’ve talked with pregnant and breastfeeding patients, both younger and older, who were unsure if they could have mammograms,” Dr. Peterson said. “I’ve also fielded questions from technologists, unclear what imaging we can offer these patients. ... Educating health professionals about evidence-based guidelines for screening and diagnostic imaging and reassuring patients about the safety of breast imaging during pregnancy and lactation is thus more important than ever.”
 

Differing Guidelines, Case-by-Case Considerations

The RadioGraphics paper emphasizes that both screening and diagnostic imaging can be safely performed using protocols based on age, breast cancer risk, and whether the patient is pregnant or lactating.

The American College of Radiology (ACR) Appropriateness Criteria also support mammography for certain patients during lactation. The guidelines state there is no contraindication to performing mammography during lactation, but note that challenges in evaluation can arise because of the unique physiological and structural breast changes that can occur.

“Hormones can change breast density and size of the breast, which could limit the clinical examination, mimic pathology, and obscure mammographic findings,” said Stamatia V. Destounis, MD, FACR, chair of the ACR Breast Imaging Commission. “It is important the patient pumps right before the mammogram or brings the baby to breastfeed prior to the imaging examination to offer the best imaging evaluation and reduce breast density as much as possible.”

In those patients who choose to prolong breastfeeding and are of the age to be screened, it is important they undergo yearly clinical breast exams, perform breast self-exams, and discuss breast cancer screening with their healthcare provider, she said. “They should not delay a routine screening mammogram. Most patients have dense breast tissue at this time, and frequently a breast ultrasound may be performed also.”

The American College of Obstetricians and Gynecologists (ACOG) does not have specific guidelines about breastfeeding mothers and mammography recommendations. Breastfeeding patients should discuss with their physicians or midwives the pros and cons of mammography, taking into account personal risk factors and how long they plan to nurse, said Joshua Copel, MD, vice chair of obstetrics, gynecology and reproductive sciences at Yale Medicine, New Haven, Connecticut, and a member of ACOG’s Committee on Obstetric Practice.

“The question for anybody to address with their physician will be, ‘Is my risk of breast cancer high enough that I should take that small risk that they’re going to over- or underread the mammogram because of my nursing status? Or should I wait until I wean the baby and have the mammogram then?’” he said.

Institutional and practice protocols meanwhile, can depend on a patient’s cancer risk.

Guidelines at the University of Wisconsin, for instance, advise that lactating patients 40 or over who are at average risk, wait 6-8 weeks after cessation of breastfeeding, said Alison Gegios, MD, a radiologist and assistant professor in breast imaging at the University of Wisconsin School of Medicine and Public Health. Average risk is defined as less than a 15% lifetime risk of breast cancer, she said.

Dr. Gegios, a coauthor on the RadioGraphics paper, said her institution recommends screening mammography if lactating patients are at intermediate or high risk, and are over 30. In such cases however, screening is generally deferred until 3-6 months after delivery, she noted.

“If patients are high risk, it’s also important to do screening breast MRIs,” Dr. Gegios said. “Studies have shown that screening breast MRIs are effective in breastfeeding patients despite their increased background parenchymal enhancement because breast cancer still stands out on our maximum intensity projections and stands out on the exam from the background.”
 

How to Clear Up Confusion, Promote Consistency

After her experience at the mammography practice, Ms. Legg went home and immediately sent a message to her ob.gyn. about what happened.

The doctor was similarly surprised and frustrated that Ms. Legg wasn’t able to get the mammogram, she said. To get around the difference in protocols, Ms. Legg’s ob.gyn. referred her to a high-risk clinic in Cincinnati. Ms. Legg’s history qualified her as high risk and she received genetic testing and a breast ultrasound at the clinic, she said.

“The ultrasound showed some shady spots,” Ms. Legg recalled. “They weren’t quite sure what they were. Another ultrasound later, they determined the spots were symmetrical and it ended up not being anything [serious]. Genetic-wise, I did not have any markers for cancer.”

Ms. Legg was relieved and she eventually received a mammogram when she finished breastfeeding, she said. However, she feels the overlap of older, breastfeeding moms and mammography guidelines deserves more attention.

“I would encourage all of us in the ‘geriatric mother’s club,’ to advocate for yourself, do your research, and also turn to your medical professionals and ask questions,” she said. “Make sure you know what they recommend for moms who are older and just had a baby.”

On the provider side, Dr. Destounis said physicians should revisit with patients the most updated guidelines about breastfeeding and mammography at routine appointments.

“Patients and their physicians have to have communication about screening for breast cancer if they are of screening age,” she said.

Dr. Copel advises physicians to run through the risks and benefits of mammograms with older, breastfeeding patients and make a shared decision. “It’s all going to vary with the individual circumstances,” he said. “If someone [has] a BRCA gene and their sister and mother had breast cancer, maybe it’s worth it. If somebody has absolutely no family history and just crossed the threshold for meeting a mammogram [recommendation], then sure, wait.”

Ms. Legg would like to see more professional literature and educational material directed toward the older, breastfeeding population about mammograms.

“At minimum, work together across departments to create an intake form, a questionnaire that is inclusive of everything,” she said. “There should be a question before you even get to the tech that asks, ‘Are you breastfeeding?’ ”

When her obstetrician-gynecologist recommended a mammogram, Emily Legg didn’t hesitate to schedule an appointment for the screening.

Her grandmother had been diagnosed with breast cancer and her father died of prostate cancer in his mid-50s. Ms. Legg also has polycystic ovary syndrome (PCOS), which increases the risk of some cancers.

Having just turned 40, Ms. Legg said she was determined to be as proactive as possible with cancer screenings.

Before the mammogram, she arranged for childcare for her 6-month-old daughter and filled out a required questionnaire online that asked about her history and health conditions. When the appointment day arrived, Ms. Legg made the 30-minute drive to the clinic where she was prepped for the procedure and escorted to the mammography room.

But just before the screening started, Ms. Legg happened to mention to the technician that she was breastfeeding. The surprised tech immediately halted the procedure, Ms. Legg said. Because of increased breast density caused by nursing, Ms. Legg was told to wait at least 6 weeks after weaning for a mammogram.

“I didn’t even consider that breastfeeding might prevent me from getting a mammogram,” said Ms. Legg, a writing professor from Hamilton, Ohio. “I had to go home. I was frustrated, mostly because I had driven all that way. I had hyped myself up. I had childcare in line. And now I had to wait until my daughter weaned? At the time, I didn’t know if my daughter was going to breastfeed for 2 years or be done at 6 months.”

Considering her family background, Ms. Legg worried about not receiving the screening. Her sister had recently undergone a mammogram while she was breastfeeding without any problems.

When she did research, Ms. Legg found conflicting information about the subject online so she turned to Reddit, where she started a thread asking if other moms over 40 had experienced similar issues. Dozens of moms responded with questions and concerns on the subject. Some wrote about being denied a mammogram while breastfeeding, while others wrote they received the procedure without question. Guidance from health professionals on the topic appeared to vastly differ.

“That’s why I turned to [social media] because I wasn’t finding anything else,” Ms. Legg said. “There’s just a lack of clear information. As an older mom, there’s less information out there for being postpartum and being over 40.”

Confusion over screenings during breastfeeding comes at the intersection of national guidelines lowering the recommended age for first mammograms, more women having babies later in life, and women getting breast cancer earlier.

Legg family

Most physician specialty associations agree that mammography is safe for breastfeeding patients and that they need not delay routine screenings. However, the safety of breast imaging during pregnancy and lactation is not well advertised, said Molly Peterson, MD, a radiologist based in St. Frances, Wisconsin, and lead author of a 2023 article about breast imaging during pregnancy and lactation in RadioGraphics, a journal of the Radiological Society of North America.

Conflicting information from nonscientific resources adds to the confusion, Dr. Peterson said. At the same time, health providers along the care spectrum may be uncertain about what imaging is safe and reasonable. Recommendations about mammography and lactation can also vary by institution, screening experts say.

“I’ve talked with pregnant and breastfeeding patients, both younger and older, who were unsure if they could have mammograms,” Dr. Peterson said. “I’ve also fielded questions from technologists, unclear what imaging we can offer these patients. ... Educating health professionals about evidence-based guidelines for screening and diagnostic imaging and reassuring patients about the safety of breast imaging during pregnancy and lactation is thus more important than ever.”
 

Differing Guidelines, Case-by-Case Considerations

The RadioGraphics paper emphasizes that both screening and diagnostic imaging can be safely performed using protocols based on age, breast cancer risk, and whether the patient is pregnant or lactating.

The American College of Radiology (ACR) Appropriateness Criteria also support mammography for certain patients during lactation. The guidelines state there is no contraindication to performing mammography during lactation, but note that challenges in evaluation can arise because of the unique physiological and structural breast changes that can occur.

“Hormones can change breast density and size of the breast, which could limit the clinical examination, mimic pathology, and obscure mammographic findings,” said Stamatia V. Destounis, MD, FACR, chair of the ACR Breast Imaging Commission. “It is important the patient pumps right before the mammogram or brings the baby to breastfeed prior to the imaging examination to offer the best imaging evaluation and reduce breast density as much as possible.”

In those patients who choose to prolong breastfeeding and are of the age to be screened, it is important they undergo yearly clinical breast exams, perform breast self-exams, and discuss breast cancer screening with their healthcare provider, she said. “They should not delay a routine screening mammogram. Most patients have dense breast tissue at this time, and frequently a breast ultrasound may be performed also.”

The American College of Obstetricians and Gynecologists (ACOG) does not have specific guidelines about breastfeeding mothers and mammography recommendations. Breastfeeding patients should discuss with their physicians or midwives the pros and cons of mammography, taking into account personal risk factors and how long they plan to nurse, said Joshua Copel, MD, vice chair of obstetrics, gynecology and reproductive sciences at Yale Medicine, New Haven, Connecticut, and a member of ACOG’s Committee on Obstetric Practice.

“The question for anybody to address with their physician will be, ‘Is my risk of breast cancer high enough that I should take that small risk that they’re going to over- or underread the mammogram because of my nursing status? Or should I wait until I wean the baby and have the mammogram then?’” he said.

Institutional and practice protocols meanwhile, can depend on a patient’s cancer risk.

Guidelines at the University of Wisconsin, for instance, advise that lactating patients 40 or over who are at average risk, wait 6-8 weeks after cessation of breastfeeding, said Alison Gegios, MD, a radiologist and assistant professor in breast imaging at the University of Wisconsin School of Medicine and Public Health. Average risk is defined as less than a 15% lifetime risk of breast cancer, she said.

Dr. Gegios, a coauthor on the RadioGraphics paper, said her institution recommends screening mammography if lactating patients are at intermediate or high risk, and are over 30. In such cases however, screening is generally deferred until 3-6 months after delivery, she noted.

“If patients are high risk, it’s also important to do screening breast MRIs,” Dr. Gegios said. “Studies have shown that screening breast MRIs are effective in breastfeeding patients despite their increased background parenchymal enhancement because breast cancer still stands out on our maximum intensity projections and stands out on the exam from the background.”
 

How to Clear Up Confusion, Promote Consistency

After her experience at the mammography practice, Ms. Legg went home and immediately sent a message to her ob.gyn. about what happened.

The doctor was similarly surprised and frustrated that Ms. Legg wasn’t able to get the mammogram, she said. To get around the difference in protocols, Ms. Legg’s ob.gyn. referred her to a high-risk clinic in Cincinnati. Ms. Legg’s history qualified her as high risk and she received genetic testing and a breast ultrasound at the clinic, she said.

“The ultrasound showed some shady spots,” Ms. Legg recalled. “They weren’t quite sure what they were. Another ultrasound later, they determined the spots were symmetrical and it ended up not being anything [serious]. Genetic-wise, I did not have any markers for cancer.”

Ms. Legg was relieved and she eventually received a mammogram when she finished breastfeeding, she said. However, she feels the overlap of older, breastfeeding moms and mammography guidelines deserves more attention.

“I would encourage all of us in the ‘geriatric mother’s club,’ to advocate for yourself, do your research, and also turn to your medical professionals and ask questions,” she said. “Make sure you know what they recommend for moms who are older and just had a baby.”

On the provider side, Dr. Destounis said physicians should revisit with patients the most updated guidelines about breastfeeding and mammography at routine appointments.

“Patients and their physicians have to have communication about screening for breast cancer if they are of screening age,” she said.

Dr. Copel advises physicians to run through the risks and benefits of mammograms with older, breastfeeding patients and make a shared decision. “It’s all going to vary with the individual circumstances,” he said. “If someone [has] a BRCA gene and their sister and mother had breast cancer, maybe it’s worth it. If somebody has absolutely no family history and just crossed the threshold for meeting a mammogram [recommendation], then sure, wait.”

Ms. Legg would like to see more professional literature and educational material directed toward the older, breastfeeding population about mammograms.

“At minimum, work together across departments to create an intake form, a questionnaire that is inclusive of everything,” she said. “There should be a question before you even get to the tech that asks, ‘Are you breastfeeding?’ ”

When her obstetrician-gynecologist recommended a mammogram, Emily Legg didn’t hesitate to schedule an appointment for the screening.

Her grandmother had been diagnosed with breast cancer and her father died of prostate cancer in his mid-50s. Ms. Legg also has polycystic ovary syndrome (PCOS), which increases the risk of some cancers.

Having just turned 40, Ms. Legg said she was determined to be as proactive as possible with cancer screenings.

Before the mammogram, she arranged for childcare for her 6-month-old daughter and filled out a required questionnaire online that asked about her history and health conditions. When the appointment day arrived, Ms. Legg made the 30-minute drive to the clinic where she was prepped for the procedure and escorted to the mammography room.

But just before the screening started, Ms. Legg happened to mention to the technician that she was breastfeeding. The surprised tech immediately halted the procedure, Ms. Legg said. Because of increased breast density caused by nursing, Ms. Legg was told to wait at least 6 weeks after weaning for a mammogram.

“I didn’t even consider that breastfeeding might prevent me from getting a mammogram,” said Ms. Legg, a writing professor from Hamilton, Ohio. “I had to go home. I was frustrated, mostly because I had driven all that way. I had hyped myself up. I had childcare in line. And now I had to wait until my daughter weaned? At the time, I didn’t know if my daughter was going to breastfeed for 2 years or be done at 6 months.”

Considering her family background, Ms. Legg worried about not receiving the screening. Her sister had recently undergone a mammogram while she was breastfeeding without any problems.

When she did research, Ms. Legg found conflicting information about the subject online so she turned to Reddit, where she started a thread asking if other moms over 40 had experienced similar issues. Dozens of moms responded with questions and concerns on the subject. Some wrote about being denied a mammogram while breastfeeding, while others wrote they received the procedure without question. Guidance from health professionals on the topic appeared to vastly differ.

“That’s why I turned to [social media] because I wasn’t finding anything else,” Ms. Legg said. “There’s just a lack of clear information. As an older mom, there’s less information out there for being postpartum and being over 40.”

Confusion over screenings during breastfeeding comes at the intersection of national guidelines lowering the recommended age for first mammograms, more women having babies later in life, and women getting breast cancer earlier.

Legg family

Most physician specialty associations agree that mammography is safe for breastfeeding patients and that they need not delay routine screenings. However, the safety of breast imaging during pregnancy and lactation is not well advertised, said Molly Peterson, MD, a radiologist based in St. Frances, Wisconsin, and lead author of a 2023 article about breast imaging during pregnancy and lactation in RadioGraphics, a journal of the Radiological Society of North America.

Conflicting information from nonscientific resources adds to the confusion, Dr. Peterson said. At the same time, health providers along the care spectrum may be uncertain about what imaging is safe and reasonable. Recommendations about mammography and lactation can also vary by institution, screening experts say.

“I’ve talked with pregnant and breastfeeding patients, both younger and older, who were unsure if they could have mammograms,” Dr. Peterson said. “I’ve also fielded questions from technologists, unclear what imaging we can offer these patients. ... Educating health professionals about evidence-based guidelines for screening and diagnostic imaging and reassuring patients about the safety of breast imaging during pregnancy and lactation is thus more important than ever.”
 

Differing Guidelines, Case-by-Case Considerations

The RadioGraphics paper emphasizes that both screening and diagnostic imaging can be safely performed using protocols based on age, breast cancer risk, and whether the patient is pregnant or lactating.

The American College of Radiology (ACR) Appropriateness Criteria also support mammography for certain patients during lactation. The guidelines state there is no contraindication to performing mammography during lactation, but note that challenges in evaluation can arise because of the unique physiological and structural breast changes that can occur.

“Hormones can change breast density and size of the breast, which could limit the clinical examination, mimic pathology, and obscure mammographic findings,” said Stamatia V. Destounis, MD, FACR, chair of the ACR Breast Imaging Commission. “It is important the patient pumps right before the mammogram or brings the baby to breastfeed prior to the imaging examination to offer the best imaging evaluation and reduce breast density as much as possible.”

In those patients who choose to prolong breastfeeding and are of the age to be screened, it is important they undergo yearly clinical breast exams, perform breast self-exams, and discuss breast cancer screening with their healthcare provider, she said. “They should not delay a routine screening mammogram. Most patients have dense breast tissue at this time, and frequently a breast ultrasound may be performed also.”

The American College of Obstetricians and Gynecologists (ACOG) does not have specific guidelines about breastfeeding mothers and mammography recommendations. Breastfeeding patients should discuss with their physicians or midwives the pros and cons of mammography, taking into account personal risk factors and how long they plan to nurse, said Joshua Copel, MD, vice chair of obstetrics, gynecology and reproductive sciences at Yale Medicine, New Haven, Connecticut, and a member of ACOG’s Committee on Obstetric Practice.

“The question for anybody to address with their physician will be, ‘Is my risk of breast cancer high enough that I should take that small risk that they’re going to over- or underread the mammogram because of my nursing status? Or should I wait until I wean the baby and have the mammogram then?’” he said.

Institutional and practice protocols meanwhile, can depend on a patient’s cancer risk.

Guidelines at the University of Wisconsin, for instance, advise that lactating patients 40 or over who are at average risk, wait 6-8 weeks after cessation of breastfeeding, said Alison Gegios, MD, a radiologist and assistant professor in breast imaging at the University of Wisconsin School of Medicine and Public Health. Average risk is defined as less than a 15% lifetime risk of breast cancer, she said.

Dr. Gegios, a coauthor on the RadioGraphics paper, said her institution recommends screening mammography if lactating patients are at intermediate or high risk, and are over 30. In such cases however, screening is generally deferred until 3-6 months after delivery, she noted.

“If patients are high risk, it’s also important to do screening breast MRIs,” Dr. Gegios said. “Studies have shown that screening breast MRIs are effective in breastfeeding patients despite their increased background parenchymal enhancement because breast cancer still stands out on our maximum intensity projections and stands out on the exam from the background.”
 

How to Clear Up Confusion, Promote Consistency

After her experience at the mammography practice, Ms. Legg went home and immediately sent a message to her ob.gyn. about what happened.

The doctor was similarly surprised and frustrated that Ms. Legg wasn’t able to get the mammogram, she said. To get around the difference in protocols, Ms. Legg’s ob.gyn. referred her to a high-risk clinic in Cincinnati. Ms. Legg’s history qualified her as high risk and she received genetic testing and a breast ultrasound at the clinic, she said.

“The ultrasound showed some shady spots,” Ms. Legg recalled. “They weren’t quite sure what they were. Another ultrasound later, they determined the spots were symmetrical and it ended up not being anything [serious]. Genetic-wise, I did not have any markers for cancer.”

Ms. Legg was relieved and she eventually received a mammogram when she finished breastfeeding, she said. However, she feels the overlap of older, breastfeeding moms and mammography guidelines deserves more attention.

“I would encourage all of us in the ‘geriatric mother’s club,’ to advocate for yourself, do your research, and also turn to your medical professionals and ask questions,” she said. “Make sure you know what they recommend for moms who are older and just had a baby.”

On the provider side, Dr. Destounis said physicians should revisit with patients the most updated guidelines about breastfeeding and mammography at routine appointments.

“Patients and their physicians have to have communication about screening for breast cancer if they are of screening age,” she said.

Dr. Copel advises physicians to run through the risks and benefits of mammograms with older, breastfeeding patients and make a shared decision. “It’s all going to vary with the individual circumstances,” he said. “If someone [has] a BRCA gene and their sister and mother had breast cancer, maybe it’s worth it. If somebody has absolutely no family history and just crossed the threshold for meeting a mammogram [recommendation], then sure, wait.”

Ms. Legg would like to see more professional literature and educational material directed toward the older, breastfeeding population about mammograms.

“At minimum, work together across departments to create an intake form, a questionnaire that is inclusive of everything,” she said. “There should be a question before you even get to the tech that asks, ‘Are you breastfeeding?’ ”

The second-floor operating rooms at Lehigh Valley Hospital in Allentown, Pennsylvania, are numbered sequentially — except when you get to what should be operation room (OR) 13. It’s OR M. The M doesn’t stand for Maternity or any other specialty. Rather in this high-tech, state-of-the art healthcare center, it’s there to ward off bad juju and evil spirits.

“Just as taller buildings usually don’t have a 13th floor or hotels don’t have a room 13, it revolves around the common superstition of the unlucky nature of number 13,” said a hospital spokesperson.

During the pandemic, the public was told repeatedly that modern medicine is science-based. But when I started talking to surgeons and other physicians for this article, I uncovered something decidedly unscientific.

In ORs and emergency rooms (ERs), small-town doctor’s offices, and mega hospitals, there’s a measure of dread before full moons and Friday the 13th, and no one dares utter the Q word (as in, “It sure is quiet today.”) That would risk bringing the wrath of the medical gods, and you’d earn the reputation of being a jinx or “black cloud.” Likewise, the songs “Stairway to Heaven” or “Another One Bites the Dust” will never be heard in any waiting room, elevator, or OR.

Indeed, when it comes to superstitions and rituals in medicine, it seems everyone has a story or a belief. …
 

A 2-Hour Ritual

Carmen Fong, MD, a colorectal surgeon in New York City, had a presurgical ritual that took her nearly 2 hours to complete. “I’d wake up at the same time every day, pack two hard-boiled eggs and a thermos of coffee in my small leather bag, walk to work via the same route, and swipe into the preop area while waving hi to the front desk,” she recounted. “I’d talk to the patient, sign the consent with the same ballpoint pen, go upstairs to my office, change into my scrubs [same cap and Danskos], then turn on my computer, and take a sip of coffee before heading back down to the OR. I’d always remove my badge and place it near the nurses’ workstation, then put on the patient’s SCDs [sequential compression devices] myself. I’d hold the oxygen mask while telling the patient, ‘See you later.’ Never ‘It will be okay’ or ‘Have a good sleep.’ Always ‘See you later.’ ”

Dr. Fong did this for 5 years prior to more than a thousand surgeries. She did it because it made her feel calm and in control, which translated to more successful operations. “It never failed me.”
 

Wonder Woman Clogs

Anureet Bajaj, MD, a plastic surgeon in Oklahoma City, wore Wonder Woman clogs in the OR for years because “they made me feel stronger, and my surgeries went better.” She’s also very specific about her OR playlist; “it must be ‘80s music.” And for a time, she wore a friendship bracelet that one of her employees made to commemorate getting through a particularly hard day. “If I forgot it, my heart sank, and my anxiety rose,” she said. “Wearing it gave me security and confidence that the day would go well.”

A Moment of Silence

Juliet Emamaullee, MD, PhD, is a liver and kidney transplant surgeon at Keck Hospital and Children’s Hospital Los Angeles. Because of the complexity of her operations, she must know every aspect of her patients’ medical history. This leads to a level of intimacy that most people never have with their doctors. “Transplant surgeons are playing god in many ways,” she said. “During procurement, after we prep and drape the donor and right before I make the incision, everyone in the OR has a moment of silence to acknowledge the donation. If the organ has been transported, then I’ll say a prayer to myself that I do good work with this generous gift of life.”

Magical Thinking

Before we go any further, I should clarify that there’s a difference between rituals and superstitions like the ones just shared and routines and practices such as handwashing or doublechecking that it’s the right hip and not the left. All pilots have a preflight checklist that’s necessary for safety, but some might also make the sign of the cross.

Lester Gottesman, MD, has been a surgeon at the Icahn School of Medicine at Mount Sinai Hospital in New York City for nearly 50 years. He believes rituals and superstitions are more prevalent in medicine than in any other profession, despite there being no definitive research confirming their effectiveness.

In fact, it’s the opposite.

One of the few studies to examine superstitions among physicians was published in the Annals of Surgery in 2021. Researchers analyzed the operational records of 27,914 consecutive patients who underwent general, visceral, or vascular surgery. They found no association of moon phases, zodiac signs, or Friday the 13th with poor outcomes. Having acute coronary syndrome on Friday the 13th also did not influence the 13-year mortality rate compared to other dates in the year. And although 70% of physicians believe that some colleagues are “black clouds,” an analysis of 96 physicians and 6149 admissions found no such pattern.

Granted, this is just one analysis, but the results aren’t surprising. No one really believes in this stuff. So, why does it persist?

Dr. Gottesman cited an episode from the popular medical TV show Grey’s Anatomy, in which chief surgeon Meredith Grey puts it this way: “Superstition lies in the space between what we can control and what we can’t. …We rely on superstitions because we are smart enough to know we don’t have all the answers and that life works in mysterious ways. Don’t diss the juju from wherever it comes.”

“Superstition and science both start at the same place — to explain an unexplainable event,” said Dr. Gottesman, who always checks his suture lines at the end of a surgery in the order in which he did them. “If science provides a coherent answer, so be it. If not, the human’s need for order will assign causality to otherwise inanimate objects, noncausal events, or divine influence.”

In other words, the more unknowns and trepidation, the greater the tendency toward what Dr. Gottesman called “magical thinking.” And when you consider healing’s long history, you realize that ritual and superstition defined medicine for centuries. Gottesman pointed out that it wasn’t until Hippocrates separated religion and superstition from disease around 430 BC that modern medicine was born. But because doctors still don’t know everything, an element of magic endures.

The question is, in this high-tech age, do these stubborn beliefs still have a place? Do they help or hinder doctors, and, most important, do they have any effect on patient outcomes?
 

Five Benefits

To reiterate, there are no studies showing that Wonder Woman clogs convey surgical superpowers or that eating two hard-boiled eggs boosts OR performance. But anecdotally, many doctors admit to experiencing noticeable perks from their quirks. Let’s start with the supposed benefits:

• Less stress: A quarter of US clinicians are considering switching careers, primarily due to burnout, according to a 2022 Bain survey. “The fact that [rituals and superstitions] are so prevalent in such a high-stress field can’t be coincidence,” said Dr. Fong. “Offloading some of the responsibility to whatever gods there may be is a way of taming our anxieties so we can function better.”
• Hyperfocus: Dr. Emamaullee played volleyball in high school and college. She suggested that her presurgical routine isn’t all that different from her warmup before a championship match. It’s habitual behavior that helps induce a state of heightened concentration, confidence, and immersion. Athletes call it being “in the zone” or in a “state of flow,” and Dr. Emamaullee said she experiences the same thing in the OR.
• More control: Remember those horrific images of patients with COVID-19 overwhelming ERs in Brooklyn and Queens during the pandemic? Dr. Fong was in the middle of that. “In crisis situations where there are more unknowns, rituals and superstitions become even more important,” she said. “I may not be able to control what’s happening, but I can control myself. Rituals help restore some normalcy and organization, and they give me a sense of calm.”
• Better performance: A series of general-population experiments published in the journal Psychological Science in 2010 concluded that “good-luck–related superstitions” boosted self-confidence in mastering upcoming tasks and improved motor dexterity, memory, and overall performance.
• Placebo effect: This phenomenon is well-established in medicine. Give someone a special pill or treatment, and a significant portion will claim benefit. “Placebo is magical thinking,” said Dr. Gottesman. “It has identifiable and quantifiable effects on human disease.” And perhaps on medical practitioners, too. If a doctor believes her friendship bracelet has special powers and helps her be a better physician, then it just might.

Four Drawbacks

• Compulsive behavior: When superstitious beliefs or repetitive behaviors begin causing personal distress, interfering with daily duties, or negatively affecting patient outcomes, then there’s a problem. There’s a story on Quora about a neurosurgeon who always ate two Hostess Ho Hos chocolate cakes before operations. When he forgot to do so one day, he supposedly left his patient on the table and ran off to eat them. Even if it’s urban legend, it’s a useful illustration of quirk disrupting work.
• Less flexibility: Every human body and every surgery is different. “When ritualistic behaviors or habits become so rigid that you lose the ability to adapt, then that becomes dangerous for the patient,” said Dr. Fong. “The art of medicine, not unlike jazz, often comes from the improvisation.”
• Self-fulfilling: Just as rituals and superstitions can empower and provide a sense of control, they can quickly turn on physicians who forget a part of their routine or leave their talisman on the bureau. Instead of confidence, they supply doubt. The karma becomes kryptonite.
• Avoiding responsibility: After years of friendship bracelets and Wonder Woman clogs, Dr. Bajaj is making a deliberate effort to excise magical thinking from her practice. “It can hold you back if you’re not careful,” she said. “If you start using it as a crutch when something goes wrong — like ‘Oh, I wasn’t wearing my clogs today and that’s why my flap failed’ — then you’re not doing your due diligence and figuring out what really happened.” Rather than placing the responsibility for her day going well on superstition, she’s trying to own it herself by living with more intent.

The Diagnosis

Most of the medical experts I spoke with didn’t think there was anything wrong with rituals or superstitions as long as they didn’t become compulsive or a convenient repository of blame.

“Rituals and superstitions are an acknowledgment that forces external to ourselves exist,” concluded Dr. Fong. “They’re like tiny offerings to whatever gods are out there to please be on our side. And we keep doing them because there’s a reward — better patient outcomes, which is all we want to achieve in the end. I say embrace them.”

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

The second-floor operating rooms at Lehigh Valley Hospital in Allentown, Pennsylvania, are numbered sequentially — except when you get to what should be operation room (OR) 13. It’s OR M. The M doesn’t stand for Maternity or any other specialty. Rather in this high-tech, state-of-the art healthcare center, it’s there to ward off bad juju and evil spirits.

“Just as taller buildings usually don’t have a 13th floor or hotels don’t have a room 13, it revolves around the common superstition of the unlucky nature of number 13,” said a hospital spokesperson.

During the pandemic, the public was told repeatedly that modern medicine is science-based. But when I started talking to surgeons and other physicians for this article, I uncovered something decidedly unscientific.

In ORs and emergency rooms (ERs), small-town doctor’s offices, and mega hospitals, there’s a measure of dread before full moons and Friday the 13th, and no one dares utter the Q word (as in, “It sure is quiet today.”) That would risk bringing the wrath of the medical gods, and you’d earn the reputation of being a jinx or “black cloud.” Likewise, the songs “Stairway to Heaven” or “Another One Bites the Dust” will never be heard in any waiting room, elevator, or OR.

Indeed, when it comes to superstitions and rituals in medicine, it seems everyone has a story or a belief. …
 

A 2-Hour Ritual

Carmen Fong, MD, a colorectal surgeon in New York City, had a presurgical ritual that took her nearly 2 hours to complete. “I’d wake up at the same time every day, pack two hard-boiled eggs and a thermos of coffee in my small leather bag, walk to work via the same route, and swipe into the preop area while waving hi to the front desk,” she recounted. “I’d talk to the patient, sign the consent with the same ballpoint pen, go upstairs to my office, change into my scrubs [same cap and Danskos], then turn on my computer, and take a sip of coffee before heading back down to the OR. I’d always remove my badge and place it near the nurses’ workstation, then put on the patient’s SCDs [sequential compression devices] myself. I’d hold the oxygen mask while telling the patient, ‘See you later.’ Never ‘It will be okay’ or ‘Have a good sleep.’ Always ‘See you later.’ ”

Dr. Fong did this for 5 years prior to more than a thousand surgeries. She did it because it made her feel calm and in control, which translated to more successful operations. “It never failed me.”
 

Wonder Woman Clogs

Anureet Bajaj, MD, a plastic surgeon in Oklahoma City, wore Wonder Woman clogs in the OR for years because “they made me feel stronger, and my surgeries went better.” She’s also very specific about her OR playlist; “it must be ‘80s music.” And for a time, she wore a friendship bracelet that one of her employees made to commemorate getting through a particularly hard day. “If I forgot it, my heart sank, and my anxiety rose,” she said. “Wearing it gave me security and confidence that the day would go well.”

A Moment of Silence

Juliet Emamaullee, MD, PhD, is a liver and kidney transplant surgeon at Keck Hospital and Children’s Hospital Los Angeles. Because of the complexity of her operations, she must know every aspect of her patients’ medical history. This leads to a level of intimacy that most people never have with their doctors. “Transplant surgeons are playing god in many ways,” she said. “During procurement, after we prep and drape the donor and right before I make the incision, everyone in the OR has a moment of silence to acknowledge the donation. If the organ has been transported, then I’ll say a prayer to myself that I do good work with this generous gift of life.”

Magical Thinking

Before we go any further, I should clarify that there’s a difference between rituals and superstitions like the ones just shared and routines and practices such as handwashing or doublechecking that it’s the right hip and not the left. All pilots have a preflight checklist that’s necessary for safety, but some might also make the sign of the cross.

Lester Gottesman, MD, has been a surgeon at the Icahn School of Medicine at Mount Sinai Hospital in New York City for nearly 50 years. He believes rituals and superstitions are more prevalent in medicine than in any other profession, despite there being no definitive research confirming their effectiveness.

In fact, it’s the opposite.

One of the few studies to examine superstitions among physicians was published in the Annals of Surgery in 2021. Researchers analyzed the operational records of 27,914 consecutive patients who underwent general, visceral, or vascular surgery. They found no association of moon phases, zodiac signs, or Friday the 13th with poor outcomes. Having acute coronary syndrome on Friday the 13th also did not influence the 13-year mortality rate compared to other dates in the year. And although 70% of physicians believe that some colleagues are “black clouds,” an analysis of 96 physicians and 6149 admissions found no such pattern.

Granted, this is just one analysis, but the results aren’t surprising. No one really believes in this stuff. So, why does it persist?

Dr. Gottesman cited an episode from the popular medical TV show Grey’s Anatomy, in which chief surgeon Meredith Grey puts it this way: “Superstition lies in the space between what we can control and what we can’t. …We rely on superstitions because we are smart enough to know we don’t have all the answers and that life works in mysterious ways. Don’t diss the juju from wherever it comes.”

“Superstition and science both start at the same place — to explain an unexplainable event,” said Dr. Gottesman, who always checks his suture lines at the end of a surgery in the order in which he did them. “If science provides a coherent answer, so be it. If not, the human’s need for order will assign causality to otherwise inanimate objects, noncausal events, or divine influence.”

In other words, the more unknowns and trepidation, the greater the tendency toward what Dr. Gottesman called “magical thinking.” And when you consider healing’s long history, you realize that ritual and superstition defined medicine for centuries. Gottesman pointed out that it wasn’t until Hippocrates separated religion and superstition from disease around 430 BC that modern medicine was born. But because doctors still don’t know everything, an element of magic endures.

The question is, in this high-tech age, do these stubborn beliefs still have a place? Do they help or hinder doctors, and, most important, do they have any effect on patient outcomes?
 

Five Benefits

To reiterate, there are no studies showing that Wonder Woman clogs convey surgical superpowers or that eating two hard-boiled eggs boosts OR performance. But anecdotally, many doctors admit to experiencing noticeable perks from their quirks. Let’s start with the supposed benefits:

• Less stress: A quarter of US clinicians are considering switching careers, primarily due to burnout, according to a 2022 Bain survey. “The fact that [rituals and superstitions] are so prevalent in such a high-stress field can’t be coincidence,” said Dr. Fong. “Offloading some of the responsibility to whatever gods there may be is a way of taming our anxieties so we can function better.”
• Hyperfocus: Dr. Emamaullee played volleyball in high school and college. She suggested that her presurgical routine isn’t all that different from her warmup before a championship match. It’s habitual behavior that helps induce a state of heightened concentration, confidence, and immersion. Athletes call it being “in the zone” or in a “state of flow,” and Dr. Emamaullee said she experiences the same thing in the OR.
• More control: Remember those horrific images of patients with COVID-19 overwhelming ERs in Brooklyn and Queens during the pandemic? Dr. Fong was in the middle of that. “In crisis situations where there are more unknowns, rituals and superstitions become even more important,” she said. “I may not be able to control what’s happening, but I can control myself. Rituals help restore some normalcy and organization, and they give me a sense of calm.”
• Better performance: A series of general-population experiments published in the journal Psychological Science in 2010 concluded that “good-luck–related superstitions” boosted self-confidence in mastering upcoming tasks and improved motor dexterity, memory, and overall performance.
• Placebo effect: This phenomenon is well-established in medicine. Give someone a special pill or treatment, and a significant portion will claim benefit. “Placebo is magical thinking,” said Dr. Gottesman. “It has identifiable and quantifiable effects on human disease.” And perhaps on medical practitioners, too. If a doctor believes her friendship bracelet has special powers and helps her be a better physician, then it just might.

Four Drawbacks

• Compulsive behavior: When superstitious beliefs or repetitive behaviors begin causing personal distress, interfering with daily duties, or negatively affecting patient outcomes, then there’s a problem. There’s a story on Quora about a neurosurgeon who always ate two Hostess Ho Hos chocolate cakes before operations. When he forgot to do so one day, he supposedly left his patient on the table and ran off to eat them. Even if it’s urban legend, it’s a useful illustration of quirk disrupting work.
• Less flexibility: Every human body and every surgery is different. “When ritualistic behaviors or habits become so rigid that you lose the ability to adapt, then that becomes dangerous for the patient,” said Dr. Fong. “The art of medicine, not unlike jazz, often comes from the improvisation.”
• Self-fulfilling: Just as rituals and superstitions can empower and provide a sense of control, they can quickly turn on physicians who forget a part of their routine or leave their talisman on the bureau. Instead of confidence, they supply doubt. The karma becomes kryptonite.
• Avoiding responsibility: After years of friendship bracelets and Wonder Woman clogs, Dr. Bajaj is making a deliberate effort to excise magical thinking from her practice. “It can hold you back if you’re not careful,” she said. “If you start using it as a crutch when something goes wrong — like ‘Oh, I wasn’t wearing my clogs today and that’s why my flap failed’ — then you’re not doing your due diligence and figuring out what really happened.” Rather than placing the responsibility for her day going well on superstition, she’s trying to own it herself by living with more intent.

The Diagnosis

Most of the medical experts I spoke with didn’t think there was anything wrong with rituals or superstitions as long as they didn’t become compulsive or a convenient repository of blame.

“Rituals and superstitions are an acknowledgment that forces external to ourselves exist,” concluded Dr. Fong. “They’re like tiny offerings to whatever gods are out there to please be on our side. And we keep doing them because there’s a reward — better patient outcomes, which is all we want to achieve in the end. I say embrace them.”

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

The second-floor operating rooms at Lehigh Valley Hospital in Allentown, Pennsylvania, are numbered sequentially — except when you get to what should be operation room (OR) 13. It’s OR M. The M doesn’t stand for Maternity or any other specialty. Rather in this high-tech, state-of-the art healthcare center, it’s there to ward off bad juju and evil spirits.

“Just as taller buildings usually don’t have a 13th floor or hotels don’t have a room 13, it revolves around the common superstition of the unlucky nature of number 13,” said a hospital spokesperson.

During the pandemic, the public was told repeatedly that modern medicine is science-based. But when I started talking to surgeons and other physicians for this article, I uncovered something decidedly unscientific.

In ORs and emergency rooms (ERs), small-town doctor’s offices, and mega hospitals, there’s a measure of dread before full moons and Friday the 13th, and no one dares utter the Q word (as in, “It sure is quiet today.”) That would risk bringing the wrath of the medical gods, and you’d earn the reputation of being a jinx or “black cloud.” Likewise, the songs “Stairway to Heaven” or “Another One Bites the Dust” will never be heard in any waiting room, elevator, or OR.

Indeed, when it comes to superstitions and rituals in medicine, it seems everyone has a story or a belief. …
 

A 2-Hour Ritual

Carmen Fong, MD, a colorectal surgeon in New York City, had a presurgical ritual that took her nearly 2 hours to complete. “I’d wake up at the same time every day, pack two hard-boiled eggs and a thermos of coffee in my small leather bag, walk to work via the same route, and swipe into the preop area while waving hi to the front desk,” she recounted. “I’d talk to the patient, sign the consent with the same ballpoint pen, go upstairs to my office, change into my scrubs [same cap and Danskos], then turn on my computer, and take a sip of coffee before heading back down to the OR. I’d always remove my badge and place it near the nurses’ workstation, then put on the patient’s SCDs [sequential compression devices] myself. I’d hold the oxygen mask while telling the patient, ‘See you later.’ Never ‘It will be okay’ or ‘Have a good sleep.’ Always ‘See you later.’ ”

Dr. Fong did this for 5 years prior to more than a thousand surgeries. She did it because it made her feel calm and in control, which translated to more successful operations. “It never failed me.”
 

Wonder Woman Clogs

Anureet Bajaj, MD, a plastic surgeon in Oklahoma City, wore Wonder Woman clogs in the OR for years because “they made me feel stronger, and my surgeries went better.” She’s also very specific about her OR playlist; “it must be ‘80s music.” And for a time, she wore a friendship bracelet that one of her employees made to commemorate getting through a particularly hard day. “If I forgot it, my heart sank, and my anxiety rose,” she said. “Wearing it gave me security and confidence that the day would go well.”

A Moment of Silence

Juliet Emamaullee, MD, PhD, is a liver and kidney transplant surgeon at Keck Hospital and Children’s Hospital Los Angeles. Because of the complexity of her operations, she must know every aspect of her patients’ medical history. This leads to a level of intimacy that most people never have with their doctors. “Transplant surgeons are playing god in many ways,” she said. “During procurement, after we prep and drape the donor and right before I make the incision, everyone in the OR has a moment of silence to acknowledge the donation. If the organ has been transported, then I’ll say a prayer to myself that I do good work with this generous gift of life.”

Magical Thinking

Before we go any further, I should clarify that there’s a difference between rituals and superstitions like the ones just shared and routines and practices such as handwashing or doublechecking that it’s the right hip and not the left. All pilots have a preflight checklist that’s necessary for safety, but some might also make the sign of the cross.

Lester Gottesman, MD, has been a surgeon at the Icahn School of Medicine at Mount Sinai Hospital in New York City for nearly 50 years. He believes rituals and superstitions are more prevalent in medicine than in any other profession, despite there being no definitive research confirming their effectiveness.

In fact, it’s the opposite.

One of the few studies to examine superstitions among physicians was published in the Annals of Surgery in 2021. Researchers analyzed the operational records of 27,914 consecutive patients who underwent general, visceral, or vascular surgery. They found no association of moon phases, zodiac signs, or Friday the 13th with poor outcomes. Having acute coronary syndrome on Friday the 13th also did not influence the 13-year mortality rate compared to other dates in the year. And although 70% of physicians believe that some colleagues are “black clouds,” an analysis of 96 physicians and 6149 admissions found no such pattern.

Granted, this is just one analysis, but the results aren’t surprising. No one really believes in this stuff. So, why does it persist?

Dr. Gottesman cited an episode from the popular medical TV show Grey’s Anatomy, in which chief surgeon Meredith Grey puts it this way: “Superstition lies in the space between what we can control and what we can’t. …We rely on superstitions because we are smart enough to know we don’t have all the answers and that life works in mysterious ways. Don’t diss the juju from wherever it comes.”

“Superstition and science both start at the same place — to explain an unexplainable event,” said Dr. Gottesman, who always checks his suture lines at the end of a surgery in the order in which he did them. “If science provides a coherent answer, so be it. If not, the human’s need for order will assign causality to otherwise inanimate objects, noncausal events, or divine influence.”

In other words, the more unknowns and trepidation, the greater the tendency toward what Dr. Gottesman called “magical thinking.” And when you consider healing’s long history, you realize that ritual and superstition defined medicine for centuries. Gottesman pointed out that it wasn’t until Hippocrates separated religion and superstition from disease around 430 BC that modern medicine was born. But because doctors still don’t know everything, an element of magic endures.

The question is, in this high-tech age, do these stubborn beliefs still have a place? Do they help or hinder doctors, and, most important, do they have any effect on patient outcomes?
 

Five Benefits

To reiterate, there are no studies showing that Wonder Woman clogs convey surgical superpowers or that eating two hard-boiled eggs boosts OR performance. But anecdotally, many doctors admit to experiencing noticeable perks from their quirks. Let’s start with the supposed benefits:

• Less stress: A quarter of US clinicians are considering switching careers, primarily due to burnout, according to a 2022 Bain survey. “The fact that [rituals and superstitions] are so prevalent in such a high-stress field can’t be coincidence,” said Dr. Fong. “Offloading some of the responsibility to whatever gods there may be is a way of taming our anxieties so we can function better.”
• Hyperfocus: Dr. Emamaullee played volleyball in high school and college. She suggested that her presurgical routine isn’t all that different from her warmup before a championship match. It’s habitual behavior that helps induce a state of heightened concentration, confidence, and immersion. Athletes call it being “in the zone” or in a “state of flow,” and Dr. Emamaullee said she experiences the same thing in the OR.
• More control: Remember those horrific images of patients with COVID-19 overwhelming ERs in Brooklyn and Queens during the pandemic? Dr. Fong was in the middle of that. “In crisis situations where there are more unknowns, rituals and superstitions become even more important,” she said. “I may not be able to control what’s happening, but I can control myself. Rituals help restore some normalcy and organization, and they give me a sense of calm.”
• Better performance: A series of general-population experiments published in the journal Psychological Science in 2010 concluded that “good-luck–related superstitions” boosted self-confidence in mastering upcoming tasks and improved motor dexterity, memory, and overall performance.
• Placebo effect: This phenomenon is well-established in medicine. Give someone a special pill or treatment, and a significant portion will claim benefit. “Placebo is magical thinking,” said Dr. Gottesman. “It has identifiable and quantifiable effects on human disease.” And perhaps on medical practitioners, too. If a doctor believes her friendship bracelet has special powers and helps her be a better physician, then it just might.

Four Drawbacks

• Compulsive behavior: When superstitious beliefs or repetitive behaviors begin causing personal distress, interfering with daily duties, or negatively affecting patient outcomes, then there’s a problem. There’s a story on Quora about a neurosurgeon who always ate two Hostess Ho Hos chocolate cakes before operations. When he forgot to do so one day, he supposedly left his patient on the table and ran off to eat them. Even if it’s urban legend, it’s a useful illustration of quirk disrupting work.
• Less flexibility: Every human body and every surgery is different. “When ritualistic behaviors or habits become so rigid that you lose the ability to adapt, then that becomes dangerous for the patient,” said Dr. Fong. “The art of medicine, not unlike jazz, often comes from the improvisation.”
• Self-fulfilling: Just as rituals and superstitions can empower and provide a sense of control, they can quickly turn on physicians who forget a part of their routine or leave their talisman on the bureau. Instead of confidence, they supply doubt. The karma becomes kryptonite.
• Avoiding responsibility: After years of friendship bracelets and Wonder Woman clogs, Dr. Bajaj is making a deliberate effort to excise magical thinking from her practice. “It can hold you back if you’re not careful,” she said. “If you start using it as a crutch when something goes wrong — like ‘Oh, I wasn’t wearing my clogs today and that’s why my flap failed’ — then you’re not doing your due diligence and figuring out what really happened.” Rather than placing the responsibility for her day going well on superstition, she’s trying to own it herself by living with more intent.

The Diagnosis

Most of the medical experts I spoke with didn’t think there was anything wrong with rituals or superstitions as long as they didn’t become compulsive or a convenient repository of blame.

“Rituals and superstitions are an acknowledgment that forces external to ourselves exist,” concluded Dr. Fong. “They’re like tiny offerings to whatever gods are out there to please be on our side. And we keep doing them because there’s a reward — better patient outcomes, which is all we want to achieve in the end. I say embrace them.”

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

Immunoglobulin A (IgA) nephropathy, also known as Berger disease, is a kidney disorder characterized by the deposition of IgA in the glomeruli, leading to inflammation and potential damage. It is the most common primary glomerulonephritis worldwide. Here are five things to know about IgA nephropathy.

1. Disease-modifying therapies for IgA nephropathy have become available only recently.

The past few years have brought development of the first disease-modifying therapies to reduce proteinuria for adults with primary IgA nephropathy who are at risk for rapid disease progression. In 2021, the US Food and Drug Administration (FDA) approved a targeted-release formulation of the corticosteroid budesonide for these patients. This formulation delivers the drug to the distal ileum, targeting Peyer patches — the site of IgA production — while minimizing the adverse effects associated with systemic corticosteroid therapy.

The FDA most recently approved sparsentan, a nonimmunosuppressive therapy that combines an endothelin type A receptor antagonist with an angiotensin II type 1 receptor antagonist, for the same indication in 2023.

In addition, several studies have reported benefits with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in the treatment of patients with IgA nephropathy at high risk for progression, although this use is still investigational.

2. The most common sign in patients with IgA nephropathy is blood in the urine.

The most common clinical manifestation of IgA nephropathy is microscopic or gross hematuria. Hematuria is often recurrent and may follow upper respiratory tract or other infections. The presence of blood in the urine may be episodic and can vary in severity.

Proteinuria is another key feature of IgA nephropathy. It may range from mild to moderate and, in some cases, can even progress to nephrotic-range proteinuria. The level of proteinuria is an important indicator of disease severity and prognosis. Persistent and significant proteinuria may be associated with an increased risk for progression to chronic kidney disease.

3. Five histologic features are widely used to predict clinical outcomes.

The Oxford classification of IgA nephropathy, or MEST score, published in 2009, comprises four histologic features that are independent predictors of clinical outcome: mesangial and endocapillary hypercellularity, segmental glomerulosclerosis, and interstitial fibrosis/tubular atrophy. In 2017, the IgA Nephropathy Classification Working Group added glomerular crescent formation to the Oxford classification, to form the MEST-C score.

If any of these features are seen, the prognosis can generally be assumed to be poor. Proteinuria, hypertension, elevated creatinine, and a decreased estimated glomerular filtration rate are some of the other factors that can contribute to poor clinical outcomes in patients with IgA nephropathy.

4. IgA nephropathy can eventually progress to end-stage kidney disease.

Progressive kidney dysfunction can occur in some individuals with IgA nephropathy. This may manifest as a gradual decline in glomerular filtration rate, leading to chronic kidney disease over time. In addition, up to 20% of patients progress to end-stage kidney disease within 10 years. The risk for renal impairment varies among individuals, and certain clinical and histologic features may influence the prognosis.

Hypertension is a common complication of IgA nephropathy. The mechanisms underlying hypertension in IgA nephropathy are complex and may involve alterations in the renin-angiotensin-aldosterone system and salt-water balance. Controlling blood pressure is important in managing IgA nephropathy to help slow the progression of kidney damage.

5. Definitive diagnosis requires a renal biopsy.

There are currently no validated diagnostic serum or urine biomarkers for IgA nephropathy, which, according to KDIGO (Kidney Disease: Improving Global Outcomes), requires a renal biopsy to make a definitive diagnosis. The characteristic finding is the deposition of IgA in the glomeruli, typically in the mesangial area. The biopsy can also provide information about the degree of inflammation, scarring, and other histologic features that help guide treatment decisions and predict outcomes.

Dr. Alper, associate professor, department of medicine, section of nephrology, Tulane University School of Medicine, New Orleans, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Immunoglobulin A (IgA) nephropathy, also known as Berger disease, is a kidney disorder characterized by the deposition of IgA in the glomeruli, leading to inflammation and potential damage. It is the most common primary glomerulonephritis worldwide. Here are five things to know about IgA nephropathy.

1. Disease-modifying therapies for IgA nephropathy have become available only recently.

The past few years have brought development of the first disease-modifying therapies to reduce proteinuria for adults with primary IgA nephropathy who are at risk for rapid disease progression. In 2021, the US Food and Drug Administration (FDA) approved a targeted-release formulation of the corticosteroid budesonide for these patients. This formulation delivers the drug to the distal ileum, targeting Peyer patches — the site of IgA production — while minimizing the adverse effects associated with systemic corticosteroid therapy.

The FDA most recently approved sparsentan, a nonimmunosuppressive therapy that combines an endothelin type A receptor antagonist with an angiotensin II type 1 receptor antagonist, for the same indication in 2023.

In addition, several studies have reported benefits with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in the treatment of patients with IgA nephropathy at high risk for progression, although this use is still investigational.

2. The most common sign in patients with IgA nephropathy is blood in the urine.

The most common clinical manifestation of IgA nephropathy is microscopic or gross hematuria. Hematuria is often recurrent and may follow upper respiratory tract or other infections. The presence of blood in the urine may be episodic and can vary in severity.

Proteinuria is another key feature of IgA nephropathy. It may range from mild to moderate and, in some cases, can even progress to nephrotic-range proteinuria. The level of proteinuria is an important indicator of disease severity and prognosis. Persistent and significant proteinuria may be associated with an increased risk for progression to chronic kidney disease.

3. Five histologic features are widely used to predict clinical outcomes.

The Oxford classification of IgA nephropathy, or MEST score, published in 2009, comprises four histologic features that are independent predictors of clinical outcome: mesangial and endocapillary hypercellularity, segmental glomerulosclerosis, and interstitial fibrosis/tubular atrophy. In 2017, the IgA Nephropathy Classification Working Group added glomerular crescent formation to the Oxford classification, to form the MEST-C score.

If any of these features are seen, the prognosis can generally be assumed to be poor. Proteinuria, hypertension, elevated creatinine, and a decreased estimated glomerular filtration rate are some of the other factors that can contribute to poor clinical outcomes in patients with IgA nephropathy.

4. IgA nephropathy can eventually progress to end-stage kidney disease.

Progressive kidney dysfunction can occur in some individuals with IgA nephropathy. This may manifest as a gradual decline in glomerular filtration rate, leading to chronic kidney disease over time. In addition, up to 20% of patients progress to end-stage kidney disease within 10 years. The risk for renal impairment varies among individuals, and certain clinical and histologic features may influence the prognosis.

Hypertension is a common complication of IgA nephropathy. The mechanisms underlying hypertension in IgA nephropathy are complex and may involve alterations in the renin-angiotensin-aldosterone system and salt-water balance. Controlling blood pressure is important in managing IgA nephropathy to help slow the progression of kidney damage.

5. Definitive diagnosis requires a renal biopsy.

There are currently no validated diagnostic serum or urine biomarkers for IgA nephropathy, which, according to KDIGO (Kidney Disease: Improving Global Outcomes), requires a renal biopsy to make a definitive diagnosis. The characteristic finding is the deposition of IgA in the glomeruli, typically in the mesangial area. The biopsy can also provide information about the degree of inflammation, scarring, and other histologic features that help guide treatment decisions and predict outcomes.

Dr. Alper, associate professor, department of medicine, section of nephrology, Tulane University School of Medicine, New Orleans, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Immunoglobulin A (IgA) nephropathy, also known as Berger disease, is a kidney disorder characterized by the deposition of IgA in the glomeruli, leading to inflammation and potential damage. It is the most common primary glomerulonephritis worldwide. Here are five things to know about IgA nephropathy.

1. Disease-modifying therapies for IgA nephropathy have become available only recently.

The past few years have brought development of the first disease-modifying therapies to reduce proteinuria for adults with primary IgA nephropathy who are at risk for rapid disease progression. In 2021, the US Food and Drug Administration (FDA) approved a targeted-release formulation of the corticosteroid budesonide for these patients. This formulation delivers the drug to the distal ileum, targeting Peyer patches — the site of IgA production — while minimizing the adverse effects associated with systemic corticosteroid therapy.

The FDA most recently approved sparsentan, a nonimmunosuppressive therapy that combines an endothelin type A receptor antagonist with an angiotensin II type 1 receptor antagonist, for the same indication in 2023.

In addition, several studies have reported benefits with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in the treatment of patients with IgA nephropathy at high risk for progression, although this use is still investigational.

2. The most common sign in patients with IgA nephropathy is blood in the urine.

The most common clinical manifestation of IgA nephropathy is microscopic or gross hematuria. Hematuria is often recurrent and may follow upper respiratory tract or other infections. The presence of blood in the urine may be episodic and can vary in severity.

Proteinuria is another key feature of IgA nephropathy. It may range from mild to moderate and, in some cases, can even progress to nephrotic-range proteinuria. The level of proteinuria is an important indicator of disease severity and prognosis. Persistent and significant proteinuria may be associated with an increased risk for progression to chronic kidney disease.

3. Five histologic features are widely used to predict clinical outcomes.

The Oxford classification of IgA nephropathy, or MEST score, published in 2009, comprises four histologic features that are independent predictors of clinical outcome: mesangial and endocapillary hypercellularity, segmental glomerulosclerosis, and interstitial fibrosis/tubular atrophy. In 2017, the IgA Nephropathy Classification Working Group added glomerular crescent formation to the Oxford classification, to form the MEST-C score.

If any of these features are seen, the prognosis can generally be assumed to be poor. Proteinuria, hypertension, elevated creatinine, and a decreased estimated glomerular filtration rate are some of the other factors that can contribute to poor clinical outcomes in patients with IgA nephropathy.

4. IgA nephropathy can eventually progress to end-stage kidney disease.

Progressive kidney dysfunction can occur in some individuals with IgA nephropathy. This may manifest as a gradual decline in glomerular filtration rate, leading to chronic kidney disease over time. In addition, up to 20% of patients progress to end-stage kidney disease within 10 years. The risk for renal impairment varies among individuals, and certain clinical and histologic features may influence the prognosis.

Hypertension is a common complication of IgA nephropathy. The mechanisms underlying hypertension in IgA nephropathy are complex and may involve alterations in the renin-angiotensin-aldosterone system and salt-water balance. Controlling blood pressure is important in managing IgA nephropathy to help slow the progression of kidney damage.

5. Definitive diagnosis requires a renal biopsy.

There are currently no validated diagnostic serum or urine biomarkers for IgA nephropathy, which, according to KDIGO (Kidney Disease: Improving Global Outcomes), requires a renal biopsy to make a definitive diagnosis. The characteristic finding is the deposition of IgA in the glomeruli, typically in the mesangial area. The biopsy can also provide information about the degree of inflammation, scarring, and other histologic features that help guide treatment decisions and predict outcomes.

Dr. Alper, associate professor, department of medicine, section of nephrology, Tulane University School of Medicine, New Orleans, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.