MDedge Pediatrics

SAN DIEGO — In two different phase 2b trial extensions, oral treatment with Janus kinase (JAK) inhibitors showed improved skin clearance in patients with vitiligo, according to presentations at a late-breaking session at the annual meeting of the American Academy of Dermatology (AAD).

In one, the addition of narrow-band ultraviolet-B (NB-UVB) light therapy to ritlecitinib appears more effective than ritlecitinib alone. In the other study, the effectiveness of upadacitinib appears to improve over time.

Based on the ritlecitinib data, “if you have phototherapy in your office, it might be good to couple it with ritlecitinib for vitiligo patients,” said Emma Guttman-Yassky, MD, PhD, chair of the Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, who presented the findings.

However, because of the relatively small numbers in the extension study, Dr. Guttman-Yassky characterized the evidence as preliminary and in need of further investigation.

For vitiligo, the only approved JAK inhibitor is ruxolitinib, 1.5%, in a cream formulation. In June, ritlecitinib (Litfulo) was approved by the Food and Drug Administration (FDA) for alopecia areata. Phototherapy, which has been used for decades in the treatment of vitiligo, has an established efficacy and safety profile as a stand-alone vitiligo treatment. Upadacitinib has numerous indications for inflammatory diseases, such as rheumatoid arthritis, and was granted FDA approval for atopic dermatitis in 2022.
 

NB-UVB Arm Added in Ritlecitinib Extension

The ritlecitinib study population was drawn from patients with non-segmental vitiligo who initially participated in a 24-week dose-ranging period of a phase 2b trial published last year. In that study, 364 patients were randomized to doses of once-daily ritlecitinib ranging from 10 to 50 mg with or without a 4-week loading regimen. Higher doses were generally associated with greater efficacy on the primary endpoint of facial vitiligo area scoring index (F-VASI) but not with a greater risk for adverse events.

In the 24-week extension study, 187 patients received a 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib for the remaining 20 weeks. Another 43 patients were randomized to one of two arms: The same 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib or to 50-mg daily ritlecitinib without a loading dose but combined with NB-UVB delivered twice per week.

Important to interpretation of results, there was an additional twist. Patients in the randomized arm who had < 10% improvement in the total vitiligo area severity index (T-VASI) at week 12 of the extension were discontinued from the study.

The endpoints considered when comparing ritlecitinib with or without NB-UVB at the end of the extension study were F-VASI, T-VASI, patient global impression of change, and adverse events. Responses were assessed on the basis of both observed and last observation carried forward (LOCF).

Of the 43 people, who were randomized in the extension study, nine (21%) had < 10% improvement in T-VASI and were therefore discontinued from the study.

At the end of 24 weeks, both groups had a substantial response to their assigned therapy, but the addition of NB-UVB increased rates of response, although not always at a level of statistical significance, according to Dr. Guttman-Yassky.

For the percent improvement in F-VASI, specifically, the increase did not reach significance on the basis of LOCF (57.9% vs 51.5%; P = .158) but was highly significant on the basis of observed responses (69.6% vs 55.1%; P = .009). For T-VASI, differences for adjunctive NB-UVB over monotherapy did not reach significance for either observed or LOCF responses, but it was significant for observed responses in a patient global impression of change.
 

Small Numbers Limit Strength of Ritlecitinib, NB-UVB Evidence

However, Dr. Guttman-Yassky said it is important “to pay attention to the sample sizes” when noting the lack of significance.

The combination appeared safe, and there were no side effects associated with the addition of twice-weekly NB-UVB to ritlecitinib.

She acknowledged that the design of this analysis was “complicated” and that the number of randomized patients was small. She suggested the findings support the potential for benefit from the combination of a JAK inhibitor and NB-UVB, both of which have shown efficacy as monotherapy in previous studies. She indicated that a trial of this combination is reasonable while awaiting a more definitive study.

One of the questions that might be posed in a larger study is the timing of NB-UVB, such as whether it is best reserved for those with inadequate early response to a JAK inhibitor or if optimal results are achieved when a JAK inhibitor and NB-UVB are initiated simultaneously.

Upadacitinib Monotherapy Results

One rationale for initiating therapy with the combination of a JAK inhibitor and NB-UVB is the potential for a more rapid response, but extended results from a second phase 2b study with a different oral JAK inhibitor, upadacitinib, suggested responses on JAK inhibitor monotherapy improve steadily over time.

“The overall efficacy continued to improve without reaching a plateau at 1 year,” reported Thierry Passeron, MD, PhD, professor and chair, Department of Dermatology, Université Côte d’Azur, Nice, France. He spoke at the same AAD late-breaking session as Dr. Guttman-Yassky.

The 24-week dose-ranging data from the upadacitinib trial were previously reported at the 2023 annual meeting of the European Association of Dermatology and Venereology. In the placebo-controlled portion, which randomized 185 patients with extensive non-segmental vitiligo to 6 mg, 11 mg, or 22 mg, the two higher doses were significantly more effective than placebo.

In the extension, patients in the placebo group were randomized to 11 mg or 22 mg, while those in the higher dose groups remained on their assigned therapies.
 

F-VASI Almost Doubled in Extension Trial

From week 24 to week 52, there was nearly a doubling of the percent F-VASI reduction, climbing from 32% to 60.8% in the 11-mg group and from 38.7% to 64.9% in the 22-mg group, Dr. Passeron said. Placebo groups who were switched to active therapy at 24 weeks rapidly approached the rates of F-VASI response of those initiated on upadacitinib.

The percent reductions in T-VASI, although lower, followed the same pattern. For the 11-mg group, the reduction climbed from 16% at 24 weeks to 44.7% at 52 weeks. For the 22-mg group, the reduction climbed from 22.9% to 44.4%. Patients who were switched from placebo to 11 mg or to 22 mg also experienced improvements in T-VASI up to 52 weeks, although the level of improvement was lower than that in patients initially randomized to the higher doses of upadacitinib.

There were “no new safety signals” for upadacitinib, which is FDA-approved for multiple indications, according to Dr. Passeron. He said acne-like lesions were the most bothersome adverse event, and cases of herpes zoster were “rare.”

A version of these data was published in a British Journal of Dermatology supplement just prior to the AAD meeting.

Phase 3 vitiligo trials are planned for both ritlecitinib and upadacitinib.

Dr. Guttman-Yassky reported financial relationships with approximately 45 pharmaceutical companies, including Pfizer, which makes ritlecitinib and provided funding for the study she discussed. Dr. Passeron reported financial relationships with approximately 40 pharmaceutical companies, including AbbVie, which makes upadacitinib and provided funding for the study he discussed.

A version of this article appeared on Medscape.com.

SAN DIEGO — In two different phase 2b trial extensions, oral treatment with Janus kinase (JAK) inhibitors showed improved skin clearance in patients with vitiligo, according to presentations at a late-breaking session at the annual meeting of the American Academy of Dermatology (AAD).

In one, the addition of narrow-band ultraviolet-B (NB-UVB) light therapy to ritlecitinib appears more effective than ritlecitinib alone. In the other study, the effectiveness of upadacitinib appears to improve over time.

Based on the ritlecitinib data, “if you have phototherapy in your office, it might be good to couple it with ritlecitinib for vitiligo patients,” said Emma Guttman-Yassky, MD, PhD, chair of the Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, who presented the findings.

However, because of the relatively small numbers in the extension study, Dr. Guttman-Yassky characterized the evidence as preliminary and in need of further investigation.

For vitiligo, the only approved JAK inhibitor is ruxolitinib, 1.5%, in a cream formulation. In June, ritlecitinib (Litfulo) was approved by the Food and Drug Administration (FDA) for alopecia areata. Phototherapy, which has been used for decades in the treatment of vitiligo, has an established efficacy and safety profile as a stand-alone vitiligo treatment. Upadacitinib has numerous indications for inflammatory diseases, such as rheumatoid arthritis, and was granted FDA approval for atopic dermatitis in 2022.
 

NB-UVB Arm Added in Ritlecitinib Extension

The ritlecitinib study population was drawn from patients with non-segmental vitiligo who initially participated in a 24-week dose-ranging period of a phase 2b trial published last year. In that study, 364 patients were randomized to doses of once-daily ritlecitinib ranging from 10 to 50 mg with or without a 4-week loading regimen. Higher doses were generally associated with greater efficacy on the primary endpoint of facial vitiligo area scoring index (F-VASI) but not with a greater risk for adverse events.

In the 24-week extension study, 187 patients received a 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib for the remaining 20 weeks. Another 43 patients were randomized to one of two arms: The same 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib or to 50-mg daily ritlecitinib without a loading dose but combined with NB-UVB delivered twice per week.

Important to interpretation of results, there was an additional twist. Patients in the randomized arm who had < 10% improvement in the total vitiligo area severity index (T-VASI) at week 12 of the extension were discontinued from the study.

The endpoints considered when comparing ritlecitinib with or without NB-UVB at the end of the extension study were F-VASI, T-VASI, patient global impression of change, and adverse events. Responses were assessed on the basis of both observed and last observation carried forward (LOCF).

Of the 43 people, who were randomized in the extension study, nine (21%) had < 10% improvement in T-VASI and were therefore discontinued from the study.

At the end of 24 weeks, both groups had a substantial response to their assigned therapy, but the addition of NB-UVB increased rates of response, although not always at a level of statistical significance, according to Dr. Guttman-Yassky.

For the percent improvement in F-VASI, specifically, the increase did not reach significance on the basis of LOCF (57.9% vs 51.5%; P = .158) but was highly significant on the basis of observed responses (69.6% vs 55.1%; P = .009). For T-VASI, differences for adjunctive NB-UVB over monotherapy did not reach significance for either observed or LOCF responses, but it was significant for observed responses in a patient global impression of change.
 

Small Numbers Limit Strength of Ritlecitinib, NB-UVB Evidence

However, Dr. Guttman-Yassky said it is important “to pay attention to the sample sizes” when noting the lack of significance.

The combination appeared safe, and there were no side effects associated with the addition of twice-weekly NB-UVB to ritlecitinib.

She acknowledged that the design of this analysis was “complicated” and that the number of randomized patients was small. She suggested the findings support the potential for benefit from the combination of a JAK inhibitor and NB-UVB, both of which have shown efficacy as monotherapy in previous studies. She indicated that a trial of this combination is reasonable while awaiting a more definitive study.

One of the questions that might be posed in a larger study is the timing of NB-UVB, such as whether it is best reserved for those with inadequate early response to a JAK inhibitor or if optimal results are achieved when a JAK inhibitor and NB-UVB are initiated simultaneously.

Upadacitinib Monotherapy Results

One rationale for initiating therapy with the combination of a JAK inhibitor and NB-UVB is the potential for a more rapid response, but extended results from a second phase 2b study with a different oral JAK inhibitor, upadacitinib, suggested responses on JAK inhibitor monotherapy improve steadily over time.

“The overall efficacy continued to improve without reaching a plateau at 1 year,” reported Thierry Passeron, MD, PhD, professor and chair, Department of Dermatology, Université Côte d’Azur, Nice, France. He spoke at the same AAD late-breaking session as Dr. Guttman-Yassky.

The 24-week dose-ranging data from the upadacitinib trial were previously reported at the 2023 annual meeting of the European Association of Dermatology and Venereology. In the placebo-controlled portion, which randomized 185 patients with extensive non-segmental vitiligo to 6 mg, 11 mg, or 22 mg, the two higher doses were significantly more effective than placebo.

In the extension, patients in the placebo group were randomized to 11 mg or 22 mg, while those in the higher dose groups remained on their assigned therapies.
 

F-VASI Almost Doubled in Extension Trial

From week 24 to week 52, there was nearly a doubling of the percent F-VASI reduction, climbing from 32% to 60.8% in the 11-mg group and from 38.7% to 64.9% in the 22-mg group, Dr. Passeron said. Placebo groups who were switched to active therapy at 24 weeks rapidly approached the rates of F-VASI response of those initiated on upadacitinib.

The percent reductions in T-VASI, although lower, followed the same pattern. For the 11-mg group, the reduction climbed from 16% at 24 weeks to 44.7% at 52 weeks. For the 22-mg group, the reduction climbed from 22.9% to 44.4%. Patients who were switched from placebo to 11 mg or to 22 mg also experienced improvements in T-VASI up to 52 weeks, although the level of improvement was lower than that in patients initially randomized to the higher doses of upadacitinib.

There were “no new safety signals” for upadacitinib, which is FDA-approved for multiple indications, according to Dr. Passeron. He said acne-like lesions were the most bothersome adverse event, and cases of herpes zoster were “rare.”

A version of these data was published in a British Journal of Dermatology supplement just prior to the AAD meeting.

Phase 3 vitiligo trials are planned for both ritlecitinib and upadacitinib.

Dr. Guttman-Yassky reported financial relationships with approximately 45 pharmaceutical companies, including Pfizer, which makes ritlecitinib and provided funding for the study she discussed. Dr. Passeron reported financial relationships with approximately 40 pharmaceutical companies, including AbbVie, which makes upadacitinib and provided funding for the study he discussed.

A version of this article appeared on Medscape.com.

SAN DIEGO — In two different phase 2b trial extensions, oral treatment with Janus kinase (JAK) inhibitors showed improved skin clearance in patients with vitiligo, according to presentations at a late-breaking session at the annual meeting of the American Academy of Dermatology (AAD).

In one, the addition of narrow-band ultraviolet-B (NB-UVB) light therapy to ritlecitinib appears more effective than ritlecitinib alone. In the other study, the effectiveness of upadacitinib appears to improve over time.

Based on the ritlecitinib data, “if you have phototherapy in your office, it might be good to couple it with ritlecitinib for vitiligo patients,” said Emma Guttman-Yassky, MD, PhD, chair of the Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, who presented the findings.

However, because of the relatively small numbers in the extension study, Dr. Guttman-Yassky characterized the evidence as preliminary and in need of further investigation.

For vitiligo, the only approved JAK inhibitor is ruxolitinib, 1.5%, in a cream formulation. In June, ritlecitinib (Litfulo) was approved by the Food and Drug Administration (FDA) for alopecia areata. Phototherapy, which has been used for decades in the treatment of vitiligo, has an established efficacy and safety profile as a stand-alone vitiligo treatment. Upadacitinib has numerous indications for inflammatory diseases, such as rheumatoid arthritis, and was granted FDA approval for atopic dermatitis in 2022.
 

NB-UVB Arm Added in Ritlecitinib Extension

The ritlecitinib study population was drawn from patients with non-segmental vitiligo who initially participated in a 24-week dose-ranging period of a phase 2b trial published last year. In that study, 364 patients were randomized to doses of once-daily ritlecitinib ranging from 10 to 50 mg with or without a 4-week loading regimen. Higher doses were generally associated with greater efficacy on the primary endpoint of facial vitiligo area scoring index (F-VASI) but not with a greater risk for adverse events.

In the 24-week extension study, 187 patients received a 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib for the remaining 20 weeks. Another 43 patients were randomized to one of two arms: The same 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib or to 50-mg daily ritlecitinib without a loading dose but combined with NB-UVB delivered twice per week.

Important to interpretation of results, there was an additional twist. Patients in the randomized arm who had < 10% improvement in the total vitiligo area severity index (T-VASI) at week 12 of the extension were discontinued from the study.

The endpoints considered when comparing ritlecitinib with or without NB-UVB at the end of the extension study were F-VASI, T-VASI, patient global impression of change, and adverse events. Responses were assessed on the basis of both observed and last observation carried forward (LOCF).

Of the 43 people, who were randomized in the extension study, nine (21%) had < 10% improvement in T-VASI and were therefore discontinued from the study.

At the end of 24 weeks, both groups had a substantial response to their assigned therapy, but the addition of NB-UVB increased rates of response, although not always at a level of statistical significance, according to Dr. Guttman-Yassky.

For the percent improvement in F-VASI, specifically, the increase did not reach significance on the basis of LOCF (57.9% vs 51.5%; P = .158) but was highly significant on the basis of observed responses (69.6% vs 55.1%; P = .009). For T-VASI, differences for adjunctive NB-UVB over monotherapy did not reach significance for either observed or LOCF responses, but it was significant for observed responses in a patient global impression of change.
 

Small Numbers Limit Strength of Ritlecitinib, NB-UVB Evidence

However, Dr. Guttman-Yassky said it is important “to pay attention to the sample sizes” when noting the lack of significance.

The combination appeared safe, and there were no side effects associated with the addition of twice-weekly NB-UVB to ritlecitinib.

She acknowledged that the design of this analysis was “complicated” and that the number of randomized patients was small. She suggested the findings support the potential for benefit from the combination of a JAK inhibitor and NB-UVB, both of which have shown efficacy as monotherapy in previous studies. She indicated that a trial of this combination is reasonable while awaiting a more definitive study.

One of the questions that might be posed in a larger study is the timing of NB-UVB, such as whether it is best reserved for those with inadequate early response to a JAK inhibitor or if optimal results are achieved when a JAK inhibitor and NB-UVB are initiated simultaneously.

Upadacitinib Monotherapy Results

One rationale for initiating therapy with the combination of a JAK inhibitor and NB-UVB is the potential for a more rapid response, but extended results from a second phase 2b study with a different oral JAK inhibitor, upadacitinib, suggested responses on JAK inhibitor monotherapy improve steadily over time.

“The overall efficacy continued to improve without reaching a plateau at 1 year,” reported Thierry Passeron, MD, PhD, professor and chair, Department of Dermatology, Université Côte d’Azur, Nice, France. He spoke at the same AAD late-breaking session as Dr. Guttman-Yassky.

The 24-week dose-ranging data from the upadacitinib trial were previously reported at the 2023 annual meeting of the European Association of Dermatology and Venereology. In the placebo-controlled portion, which randomized 185 patients with extensive non-segmental vitiligo to 6 mg, 11 mg, or 22 mg, the two higher doses were significantly more effective than placebo.

In the extension, patients in the placebo group were randomized to 11 mg or 22 mg, while those in the higher dose groups remained on their assigned therapies.
 

F-VASI Almost Doubled in Extension Trial

From week 24 to week 52, there was nearly a doubling of the percent F-VASI reduction, climbing from 32% to 60.8% in the 11-mg group and from 38.7% to 64.9% in the 22-mg group, Dr. Passeron said. Placebo groups who were switched to active therapy at 24 weeks rapidly approached the rates of F-VASI response of those initiated on upadacitinib.

The percent reductions in T-VASI, although lower, followed the same pattern. For the 11-mg group, the reduction climbed from 16% at 24 weeks to 44.7% at 52 weeks. For the 22-mg group, the reduction climbed from 22.9% to 44.4%. Patients who were switched from placebo to 11 mg or to 22 mg also experienced improvements in T-VASI up to 52 weeks, although the level of improvement was lower than that in patients initially randomized to the higher doses of upadacitinib.

There were “no new safety signals” for upadacitinib, which is FDA-approved for multiple indications, according to Dr. Passeron. He said acne-like lesions were the most bothersome adverse event, and cases of herpes zoster were “rare.”

A version of these data was published in a British Journal of Dermatology supplement just prior to the AAD meeting.

Phase 3 vitiligo trials are planned for both ritlecitinib and upadacitinib.

Dr. Guttman-Yassky reported financial relationships with approximately 45 pharmaceutical companies, including Pfizer, which makes ritlecitinib and provided funding for the study she discussed. Dr. Passeron reported financial relationships with approximately 40 pharmaceutical companies, including AbbVie, which makes upadacitinib and provided funding for the study he discussed.

A version of this article appeared on Medscape.com.

One in three Black men in rural America experienced suicidal or death ideation (SDI) in the past week, new research showed.

A developmental model used in the study showed a direct association between experiences pertaining to threat, deprivation, and racial discrimination during childhood and suicide risk in adulthood, suggesting that a broad range of adverse experiences in early life may affect SDI risk among Black men.

“During the past 20-30 years, young Black men have evinced increasing levels of suicidal behavior and related cognitions,” lead author Steven Kogan, PhD, professor of family and consumer sciences at the University of Georgia, Athens, Georgia, and colleagues wrote.

“By controlling for depressive symptoms in assessing increases in SDI over time, our study’s design directly informed the extent to which social adversities affect SDI independent of other depressive problems,” they added.

The findings were published online in Cultural Diversity and Ethnic Minority Psychology.
 

Second Leading Cause of Death

Suicide is the second leading cause of death for Black Americans ages 15-24, according to the Centers for Disease Control and Prevention. The outlook is worse for Black men, whose death rate from suicide is about four times greater than for Black women.

Previous research suggests Black men are disproportionately exposed to social adversity, including poverty and discrimination, which may increase the risk for SDI. In addition, racial discrimination has been shown to increase the risks for depression, anxiety, and psychological distress among Black youth and adults.

But little research exists to better understand how these negative experiences affect vulnerability to SDI. The new study tested a model linking adversity during childhood and emerging exposure to racial discrimination to increases in suicidal thoughts.

Researchers analyzed data from 504 participants in the African American Men’s Project, which included a series of surveys completed by young men in rural Georgia at three different time points over a period of about 3 years.

Composite scores for childhood threat and deprivation were developed using the Adverse Childhood Experiences Scale and Childhood Trauma Questionnaire. Everyday discrimination was measured on the Schedule of Racist Events response scale.

To assess their experience with childhood threats, the men in the study, who were about 21 years old on average when they enrolled, were asked if they experienced a series of adverse childhood experiences and deprivation through age 16. Questions explored issues such as directly experiencing physical violence or witnessing abuse in the home and whether the men felt loved and “important or special” as children.

The investigators also asked the men about their experiences of racial discrimination, the quality of their relationships, their belief that aggression is a means of gaining respect, and their cynicism regarding romantic relationships.
 

Targeted Prevention

Overall, 33.6% of participants reported SDI in the previous week. A history of childhood threats and deprivation was associated with an increased likelihood of SDI (P < .001).

Researchers also found that a history of racial discrimination was significantly associated with the development of negative relational schemas, which are characterized by beliefs that other people are untrustworthy, uncaring, and/or hostile. Negative schemas were in turn associated with an increased risk for suicidal thoughts (P = .03).

“Clinical and preventive interventions for suicidality should target the influence of racism and adverse experiences and the negative relational schemas they induce,” the investigators noted.

“Policy efforts designed to dismantle systemic racism are critically needed. Interventions that address SDI, including programming designed to support Black men through their experiences with racial discrimination and processing of childhood experiences of adversity, may help young Black men resist the psychological impacts of racism, expand their positive support networks, and decrease their risk of SDI,” they added.

The study authors reported no funding sources or relevant financial relationships.

A version of this article appeared on Medscape.com.

One in three Black men in rural America experienced suicidal or death ideation (SDI) in the past week, new research showed.

A developmental model used in the study showed a direct association between experiences pertaining to threat, deprivation, and racial discrimination during childhood and suicide risk in adulthood, suggesting that a broad range of adverse experiences in early life may affect SDI risk among Black men.

“During the past 20-30 years, young Black men have evinced increasing levels of suicidal behavior and related cognitions,” lead author Steven Kogan, PhD, professor of family and consumer sciences at the University of Georgia, Athens, Georgia, and colleagues wrote.

“By controlling for depressive symptoms in assessing increases in SDI over time, our study’s design directly informed the extent to which social adversities affect SDI independent of other depressive problems,” they added.

The findings were published online in Cultural Diversity and Ethnic Minority Psychology.
 

Second Leading Cause of Death

Suicide is the second leading cause of death for Black Americans ages 15-24, according to the Centers for Disease Control and Prevention. The outlook is worse for Black men, whose death rate from suicide is about four times greater than for Black women.

Previous research suggests Black men are disproportionately exposed to social adversity, including poverty and discrimination, which may increase the risk for SDI. In addition, racial discrimination has been shown to increase the risks for depression, anxiety, and psychological distress among Black youth and adults.

But little research exists to better understand how these negative experiences affect vulnerability to SDI. The new study tested a model linking adversity during childhood and emerging exposure to racial discrimination to increases in suicidal thoughts.

Researchers analyzed data from 504 participants in the African American Men’s Project, which included a series of surveys completed by young men in rural Georgia at three different time points over a period of about 3 years.

Composite scores for childhood threat and deprivation were developed using the Adverse Childhood Experiences Scale and Childhood Trauma Questionnaire. Everyday discrimination was measured on the Schedule of Racist Events response scale.

To assess their experience with childhood threats, the men in the study, who were about 21 years old on average when they enrolled, were asked if they experienced a series of adverse childhood experiences and deprivation through age 16. Questions explored issues such as directly experiencing physical violence or witnessing abuse in the home and whether the men felt loved and “important or special” as children.

The investigators also asked the men about their experiences of racial discrimination, the quality of their relationships, their belief that aggression is a means of gaining respect, and their cynicism regarding romantic relationships.
 

Targeted Prevention

Overall, 33.6% of participants reported SDI in the previous week. A history of childhood threats and deprivation was associated with an increased likelihood of SDI (P < .001).

Researchers also found that a history of racial discrimination was significantly associated with the development of negative relational schemas, which are characterized by beliefs that other people are untrustworthy, uncaring, and/or hostile. Negative schemas were in turn associated with an increased risk for suicidal thoughts (P = .03).

“Clinical and preventive interventions for suicidality should target the influence of racism and adverse experiences and the negative relational schemas they induce,” the investigators noted.

“Policy efforts designed to dismantle systemic racism are critically needed. Interventions that address SDI, including programming designed to support Black men through their experiences with racial discrimination and processing of childhood experiences of adversity, may help young Black men resist the psychological impacts of racism, expand their positive support networks, and decrease their risk of SDI,” they added.

The study authors reported no funding sources or relevant financial relationships.

A version of this article appeared on Medscape.com.

One in three Black men in rural America experienced suicidal or death ideation (SDI) in the past week, new research showed.

A developmental model used in the study showed a direct association between experiences pertaining to threat, deprivation, and racial discrimination during childhood and suicide risk in adulthood, suggesting that a broad range of adverse experiences in early life may affect SDI risk among Black men.

“During the past 20-30 years, young Black men have evinced increasing levels of suicidal behavior and related cognitions,” lead author Steven Kogan, PhD, professor of family and consumer sciences at the University of Georgia, Athens, Georgia, and colleagues wrote.

“By controlling for depressive symptoms in assessing increases in SDI over time, our study’s design directly informed the extent to which social adversities affect SDI independent of other depressive problems,” they added.

The findings were published online in Cultural Diversity and Ethnic Minority Psychology.
 

Second Leading Cause of Death

Suicide is the second leading cause of death for Black Americans ages 15-24, according to the Centers for Disease Control and Prevention. The outlook is worse for Black men, whose death rate from suicide is about four times greater than for Black women.

Previous research suggests Black men are disproportionately exposed to social adversity, including poverty and discrimination, which may increase the risk for SDI. In addition, racial discrimination has been shown to increase the risks for depression, anxiety, and psychological distress among Black youth and adults.

But little research exists to better understand how these negative experiences affect vulnerability to SDI. The new study tested a model linking adversity during childhood and emerging exposure to racial discrimination to increases in suicidal thoughts.

Researchers analyzed data from 504 participants in the African American Men’s Project, which included a series of surveys completed by young men in rural Georgia at three different time points over a period of about 3 years.

Composite scores for childhood threat and deprivation were developed using the Adverse Childhood Experiences Scale and Childhood Trauma Questionnaire. Everyday discrimination was measured on the Schedule of Racist Events response scale.

To assess their experience with childhood threats, the men in the study, who were about 21 years old on average when they enrolled, were asked if they experienced a series of adverse childhood experiences and deprivation through age 16. Questions explored issues such as directly experiencing physical violence or witnessing abuse in the home and whether the men felt loved and “important or special” as children.

The investigators also asked the men about their experiences of racial discrimination, the quality of their relationships, their belief that aggression is a means of gaining respect, and their cynicism regarding romantic relationships.
 

Targeted Prevention

Overall, 33.6% of participants reported SDI in the previous week. A history of childhood threats and deprivation was associated with an increased likelihood of SDI (P < .001).

Researchers also found that a history of racial discrimination was significantly associated with the development of negative relational schemas, which are characterized by beliefs that other people are untrustworthy, uncaring, and/or hostile. Negative schemas were in turn associated with an increased risk for suicidal thoughts (P = .03).

“Clinical and preventive interventions for suicidality should target the influence of racism and adverse experiences and the negative relational schemas they induce,” the investigators noted.

“Policy efforts designed to dismantle systemic racism are critically needed. Interventions that address SDI, including programming designed to support Black men through their experiences with racial discrimination and processing of childhood experiences of adversity, may help young Black men resist the psychological impacts of racism, expand their positive support networks, and decrease their risk of SDI,” they added.

The study authors reported no funding sources or relevant financial relationships.

A version of this article appeared on Medscape.com.

Experts say pediatricians and primary care clinicians should do more to prevent the toxic effects of lead in their young patients following a 2023 outbreak of elevated levels of lead in children associated with consumption of contaminated applesauce.

Federal legislation in the 1970s eliminated lead from gasoline, paints, and other consumer products, and resulted in significantly reduced blood lead levels (BLLs) in children throughout the United States.

But recently published studies highlight persistent issues with lead in drinking water and consumer products, suggesting that the fight is not over.
 

It’s in the Water

In 2014 the city of Flint, Michigan, changed its water supply and high levels of lead were later found in the municipal water supply.

Effects of that crisis still plague the city today. An initial study found that elevated BLLs had doubled among children between 2013 and 2015.

Lead exposure in young children is associated with several negative outcomes, including decreased cognitive ability, brain volume, and social mobility, and increased anxiety/depression and impulsivity, and higher rates of criminal offenses later in life. 

Many other water systems still contain lead pipes, despite a 1986 ban by the US Environmental Protection Agency on using them for installing or repairing public water systems. The mayor of Chicago announced a plan to start replacing lead service lines in 2020; however, 400,000 households are still served by these pipes, the most in the nation.

Benjamin Huynh, a native of Chicago, was curious about the impact of all those lead service lines. Now an assistant professor in the Department of Environmental Health and Engineering at Johns Hopkins University in Baltimore, Maryland, he and his colleagues researched how many children under the age of 6 years were exposed to contaminated water.

The results showed that lead contamination of water is widespread. 

“We’re estimating that 68% of kids under the age of 6 in Chicago were exposed to lead-contaminated drinking water,” Mr. Huynh said. 

He added that residents in predominantly Black and Latino neighborhoods had the highest risk for lead contamination in their water, but children living on these blocks were less likely to get tested, suggesting a need for more outreach to raise awareness.

Meanwhile, a little over one third of Chicago residents reported drinking bottled water as their main source of drinking water.

But even bottled water could contain lead. The US Food and Drug Administration (FDA) has set a limit for lead in bottled water to five parts per billion. The FDA threshold for taking action in public drinking water systems is 15 parts per billion. But the American Academy of Pediatrics states that no amount of lead in drinking water is considered safe for drinking. 

Mr. Huynh also pointed out that not all home water filters remove lead. Only devices that meet National Sanitation Foundation 53 standards are certified for lead removal. Consumers should verify that the filter package specifically lists the device as certified for removing contaminant lead.
 

Lead-tainted Cinnamon 

Last fall, the North Carolina Department of Health and Human Services identified several children with elevated levels of lead who had consumed WanaBana Apple Cinnamon Fruit Puree pouches.

An investigation by the FDA identified additional brands containing lead and issued a recall of applesauce pouches sold by retailers like Dollar Tree and Amazon.

According to the US Centers for Disease Control and Prevention, nearly 500 children were affected by the tainted applesauce. The FDA traced the source of the lead to cinnamon from a supplier in Ecuador.

An FDA spokesperson told this news organization the episode appears to have resulted from “economically motivated adulteration,” which occurs when a manufacturer leaves out or substitutes a valuable ingredient or part of a food. In the case of spices, lead may be added as a coloring agent or to increase the product weight.

“When we look at domestically made products from large, reputable companies, in general, they do a pretty good job of following safe product guidelines and regulations,” said Kevin Osterhoudt, MD, professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. “But when we use third-party sellers and we import things from other countries that aren’t regulated as closely, we certainly take a lot more risk in the products that we receive.”

While the Food Safety Modernization Act of 2011 aimed to improve agency’s capacity to manage the ever-rising volume of food produced domestically and imported from overseas, the funding has stayed flat while the volume of inspections has increased. In the early 1990s, the number of shipments screened by the agency numbered in the thousands annually. Last year the FDA screened 15 million shipments from more than 200 countries, according to the agency.

Prompted by the finding of lead in applesauce, the FDA began a wider investigation into ground cinnamon by sampling the product from discount retail stores. It recalled an additional six brands of cinnamon sold in the United States containing lead.

Dr. Osterhoudt’s message to families who think their child might have been exposed to a contaminated product is to dispose of it as directed by FDA and CDC guidelines. 

In Philadelphia, where Dr. Osterhoudt practices as an emergency room physician, baseline rates of childhood lead poisoning are already high, so he advises families to “do a larger inventory of all the source potential sources of lead in their life and to reduce all the exposures as low as possible.” 

He also advises parents that a nutritious diet high in calcium and iron can protect their children from the deleterious effects of lead.
 

Current Standards for Lead Screening and Testing

Lead is ubiquitous. The common routes of exposure to humans include use of fossil fuels such as leaded gasoline, some types of industrial facilities, and past use of lead-based paint in homes. In addition to spices, lead has been found in a wide variety of products such as toys, jewelry, antiques, cosmetics, and dietary supplements imported from other countries.

Noah Buncher, DO, is a primary care pediatrician in South Philadelphia at Children’s Hospital of Pennsylvania and the former director of a lead clinic in Boston that provides care for children with lead poisoning. He follows guidelines from the American Academy of Pediatrics that define an elevated BLL as ≥ 3.5 µg/dL. The guidelines recommend screening children for lead exposures during well child visits starting at age 6 months up to 6 years and obtaining a BLL if risks for lead exposure are present. 

Dr. Buncher starts with a basic environmental history that covers items like the age, condition, zip code of home, parental occupations, or hobbies that might result in exposing family members to lead, and if another child in the home has a history of elevated BLLs. 

But a careful history for potential lead exposures can be time-consuming. 

“There’s a lot to cover in a routine well child visit,” Dr. Buncher said. “We have maybe 15-20 minutes to cover a lot.” 

Clinics also vary on whether lead screening questions are put into workflows in the electronic medical record. Although parents can complete a written questionnaire about possible lead exposures, they may have difficulty answering questions about the age of their home or not know whether their occupation is high risk.

Transportation to a clinic is often a barrier for families, and sometimes patients must travel to a separate lab to be tested for lead. 

Dr. Buncher also pointed to the patchwork of local and state requirements that can lead to confusion among providers. Massachusetts, where he formerly practiced, has a universal requirement to test all children at ages 1, 2, and 3 years. But in Pennsylvania, screening laws vary from county to county. 

“Pennsylvania should implement universal screening recommendations for all kids under 6 regardless of what county you live in,” Dr. Buncher said.
 

Protective Measures 

Alan Woolf, MD, a professor of pediatrics at Harvard Medical School, Boston, Massachusetts, and director of the Pediatric Environmental Health Center at Boston Children’s Hospital, has a few ideas about how providers can step up their lead game, including partnering with their local health department. 

The CDC funds Childhood Lead Poisoning Prevention Programs based in state and local health departments to work with clinicians to improve rates of blood lead testing, monitor the prevalence of lead in their jurisdictions, and ensure that a system of referral is available for treatment and lead remediation services in the home.

Dr. Woolf also suggested that clinicians refer patients under age 3 years with high BLLs to their local Early Intervention Program. 

“They’ll assess their child’s development, their speech, their motor skills, their social skills, and if they qualify, it’s free,” Dr. Woolf said. 

He cited research showing children with elevated lead levels who received early intervention services performed better in grade school than equally exposed children who did not access similar services.

Another key strategy for pediatric clinicians is to learn local or state regulations for testing children for lead and how to access lead surveillance data in their practice area. Children who reside in high-risk areas are automatic candidates for screening. 

Dr. Woolf pointed out that big cities are not the only localities with lead in the drinking water. If families are drawing water from their own well, they should collect that water annually to have it tested for lead and microbes.

At the clinic-wide level, Dr. Woolf recommends the use of blood lead testing as a quality improvement measure. For example, Akron Children’s Hospital developed a quality improvement initiative using a clinical decision support tool to raise screening rates in their network of 30 clinics. One year after beginning the project, lead screenings during 12-month well visits increased from 71% to 96%. 

“What we’re interested in as pediatric health professionals is eliminating all background sources of lead in a child’s environment,” Dr. Woolf said. “Whether that’s applesauce pouches, whether that’s lead-containing paint, lead in water, lead in spices, or lead in imported pottery or cookware — there are just a tremendous number of sources of lead that we can do something about.”

None of the subjects reported financial conflicts of interest.

A former pediatrician, Dr. Thomas is a freelance science writer living in Portland, Oregon.

A version of this article appeared on Medscape.com.

Experts say pediatricians and primary care clinicians should do more to prevent the toxic effects of lead in their young patients following a 2023 outbreak of elevated levels of lead in children associated with consumption of contaminated applesauce.

Federal legislation in the 1970s eliminated lead from gasoline, paints, and other consumer products, and resulted in significantly reduced blood lead levels (BLLs) in children throughout the United States.

But recently published studies highlight persistent issues with lead in drinking water and consumer products, suggesting that the fight is not over.
 

It’s in the Water

In 2014 the city of Flint, Michigan, changed its water supply and high levels of lead were later found in the municipal water supply.

Effects of that crisis still plague the city today. An initial study found that elevated BLLs had doubled among children between 2013 and 2015.

Lead exposure in young children is associated with several negative outcomes, including decreased cognitive ability, brain volume, and social mobility, and increased anxiety/depression and impulsivity, and higher rates of criminal offenses later in life. 

Many other water systems still contain lead pipes, despite a 1986 ban by the US Environmental Protection Agency on using them for installing or repairing public water systems. The mayor of Chicago announced a plan to start replacing lead service lines in 2020; however, 400,000 households are still served by these pipes, the most in the nation.

Benjamin Huynh, a native of Chicago, was curious about the impact of all those lead service lines. Now an assistant professor in the Department of Environmental Health and Engineering at Johns Hopkins University in Baltimore, Maryland, he and his colleagues researched how many children under the age of 6 years were exposed to contaminated water.

The results showed that lead contamination of water is widespread. 

“We’re estimating that 68% of kids under the age of 6 in Chicago were exposed to lead-contaminated drinking water,” Mr. Huynh said. 

He added that residents in predominantly Black and Latino neighborhoods had the highest risk for lead contamination in their water, but children living on these blocks were less likely to get tested, suggesting a need for more outreach to raise awareness.

Meanwhile, a little over one third of Chicago residents reported drinking bottled water as their main source of drinking water.

But even bottled water could contain lead. The US Food and Drug Administration (FDA) has set a limit for lead in bottled water to five parts per billion. The FDA threshold for taking action in public drinking water systems is 15 parts per billion. But the American Academy of Pediatrics states that no amount of lead in drinking water is considered safe for drinking. 

Mr. Huynh also pointed out that not all home water filters remove lead. Only devices that meet National Sanitation Foundation 53 standards are certified for lead removal. Consumers should verify that the filter package specifically lists the device as certified for removing contaminant lead.
 

Lead-tainted Cinnamon 

Last fall, the North Carolina Department of Health and Human Services identified several children with elevated levels of lead who had consumed WanaBana Apple Cinnamon Fruit Puree pouches.

An investigation by the FDA identified additional brands containing lead and issued a recall of applesauce pouches sold by retailers like Dollar Tree and Amazon.

According to the US Centers for Disease Control and Prevention, nearly 500 children were affected by the tainted applesauce. The FDA traced the source of the lead to cinnamon from a supplier in Ecuador.

An FDA spokesperson told this news organization the episode appears to have resulted from “economically motivated adulteration,” which occurs when a manufacturer leaves out or substitutes a valuable ingredient or part of a food. In the case of spices, lead may be added as a coloring agent or to increase the product weight.

“When we look at domestically made products from large, reputable companies, in general, they do a pretty good job of following safe product guidelines and regulations,” said Kevin Osterhoudt, MD, professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. “But when we use third-party sellers and we import things from other countries that aren’t regulated as closely, we certainly take a lot more risk in the products that we receive.”

While the Food Safety Modernization Act of 2011 aimed to improve agency’s capacity to manage the ever-rising volume of food produced domestically and imported from overseas, the funding has stayed flat while the volume of inspections has increased. In the early 1990s, the number of shipments screened by the agency numbered in the thousands annually. Last year the FDA screened 15 million shipments from more than 200 countries, according to the agency.

Prompted by the finding of lead in applesauce, the FDA began a wider investigation into ground cinnamon by sampling the product from discount retail stores. It recalled an additional six brands of cinnamon sold in the United States containing lead.

Dr. Osterhoudt’s message to families who think their child might have been exposed to a contaminated product is to dispose of it as directed by FDA and CDC guidelines. 

In Philadelphia, where Dr. Osterhoudt practices as an emergency room physician, baseline rates of childhood lead poisoning are already high, so he advises families to “do a larger inventory of all the source potential sources of lead in their life and to reduce all the exposures as low as possible.” 

He also advises parents that a nutritious diet high in calcium and iron can protect their children from the deleterious effects of lead.
 

Current Standards for Lead Screening and Testing

Lead is ubiquitous. The common routes of exposure to humans include use of fossil fuels such as leaded gasoline, some types of industrial facilities, and past use of lead-based paint in homes. In addition to spices, lead has been found in a wide variety of products such as toys, jewelry, antiques, cosmetics, and dietary supplements imported from other countries.

Noah Buncher, DO, is a primary care pediatrician in South Philadelphia at Children’s Hospital of Pennsylvania and the former director of a lead clinic in Boston that provides care for children with lead poisoning. He follows guidelines from the American Academy of Pediatrics that define an elevated BLL as ≥ 3.5 µg/dL. The guidelines recommend screening children for lead exposures during well child visits starting at age 6 months up to 6 years and obtaining a BLL if risks for lead exposure are present. 

Dr. Buncher starts with a basic environmental history that covers items like the age, condition, zip code of home, parental occupations, or hobbies that might result in exposing family members to lead, and if another child in the home has a history of elevated BLLs. 

But a careful history for potential lead exposures can be time-consuming. 

“There’s a lot to cover in a routine well child visit,” Dr. Buncher said. “We have maybe 15-20 minutes to cover a lot.” 

Clinics also vary on whether lead screening questions are put into workflows in the electronic medical record. Although parents can complete a written questionnaire about possible lead exposures, they may have difficulty answering questions about the age of their home or not know whether their occupation is high risk.

Transportation to a clinic is often a barrier for families, and sometimes patients must travel to a separate lab to be tested for lead. 

Dr. Buncher also pointed to the patchwork of local and state requirements that can lead to confusion among providers. Massachusetts, where he formerly practiced, has a universal requirement to test all children at ages 1, 2, and 3 years. But in Pennsylvania, screening laws vary from county to county. 

“Pennsylvania should implement universal screening recommendations for all kids under 6 regardless of what county you live in,” Dr. Buncher said.
 

Protective Measures 

Alan Woolf, MD, a professor of pediatrics at Harvard Medical School, Boston, Massachusetts, and director of the Pediatric Environmental Health Center at Boston Children’s Hospital, has a few ideas about how providers can step up their lead game, including partnering with their local health department. 

The CDC funds Childhood Lead Poisoning Prevention Programs based in state and local health departments to work with clinicians to improve rates of blood lead testing, monitor the prevalence of lead in their jurisdictions, and ensure that a system of referral is available for treatment and lead remediation services in the home.

Dr. Woolf also suggested that clinicians refer patients under age 3 years with high BLLs to their local Early Intervention Program. 

“They’ll assess their child’s development, their speech, their motor skills, their social skills, and if they qualify, it’s free,” Dr. Woolf said. 

He cited research showing children with elevated lead levels who received early intervention services performed better in grade school than equally exposed children who did not access similar services.

Another key strategy for pediatric clinicians is to learn local or state regulations for testing children for lead and how to access lead surveillance data in their practice area. Children who reside in high-risk areas are automatic candidates for screening. 

Dr. Woolf pointed out that big cities are not the only localities with lead in the drinking water. If families are drawing water from their own well, they should collect that water annually to have it tested for lead and microbes.

At the clinic-wide level, Dr. Woolf recommends the use of blood lead testing as a quality improvement measure. For example, Akron Children’s Hospital developed a quality improvement initiative using a clinical decision support tool to raise screening rates in their network of 30 clinics. One year after beginning the project, lead screenings during 12-month well visits increased from 71% to 96%. 

“What we’re interested in as pediatric health professionals is eliminating all background sources of lead in a child’s environment,” Dr. Woolf said. “Whether that’s applesauce pouches, whether that’s lead-containing paint, lead in water, lead in spices, or lead in imported pottery or cookware — there are just a tremendous number of sources of lead that we can do something about.”

None of the subjects reported financial conflicts of interest.

A former pediatrician, Dr. Thomas is a freelance science writer living in Portland, Oregon.

A version of this article appeared on Medscape.com.

Experts say pediatricians and primary care clinicians should do more to prevent the toxic effects of lead in their young patients following a 2023 outbreak of elevated levels of lead in children associated with consumption of contaminated applesauce.

Federal legislation in the 1970s eliminated lead from gasoline, paints, and other consumer products, and resulted in significantly reduced blood lead levels (BLLs) in children throughout the United States.

But recently published studies highlight persistent issues with lead in drinking water and consumer products, suggesting that the fight is not over.
 

It’s in the Water

In 2014 the city of Flint, Michigan, changed its water supply and high levels of lead were later found in the municipal water supply.

Effects of that crisis still plague the city today. An initial study found that elevated BLLs had doubled among children between 2013 and 2015.

Lead exposure in young children is associated with several negative outcomes, including decreased cognitive ability, brain volume, and social mobility, and increased anxiety/depression and impulsivity, and higher rates of criminal offenses later in life. 

Many other water systems still contain lead pipes, despite a 1986 ban by the US Environmental Protection Agency on using them for installing or repairing public water systems. The mayor of Chicago announced a plan to start replacing lead service lines in 2020; however, 400,000 households are still served by these pipes, the most in the nation.

Benjamin Huynh, a native of Chicago, was curious about the impact of all those lead service lines. Now an assistant professor in the Department of Environmental Health and Engineering at Johns Hopkins University in Baltimore, Maryland, he and his colleagues researched how many children under the age of 6 years were exposed to contaminated water.

The results showed that lead contamination of water is widespread. 

“We’re estimating that 68% of kids under the age of 6 in Chicago were exposed to lead-contaminated drinking water,” Mr. Huynh said. 

He added that residents in predominantly Black and Latino neighborhoods had the highest risk for lead contamination in their water, but children living on these blocks were less likely to get tested, suggesting a need for more outreach to raise awareness.

Meanwhile, a little over one third of Chicago residents reported drinking bottled water as their main source of drinking water.

But even bottled water could contain lead. The US Food and Drug Administration (FDA) has set a limit for lead in bottled water to five parts per billion. The FDA threshold for taking action in public drinking water systems is 15 parts per billion. But the American Academy of Pediatrics states that no amount of lead in drinking water is considered safe for drinking. 

Mr. Huynh also pointed out that not all home water filters remove lead. Only devices that meet National Sanitation Foundation 53 standards are certified for lead removal. Consumers should verify that the filter package specifically lists the device as certified for removing contaminant lead.
 

Lead-tainted Cinnamon 

Last fall, the North Carolina Department of Health and Human Services identified several children with elevated levels of lead who had consumed WanaBana Apple Cinnamon Fruit Puree pouches.

An investigation by the FDA identified additional brands containing lead and issued a recall of applesauce pouches sold by retailers like Dollar Tree and Amazon.

According to the US Centers for Disease Control and Prevention, nearly 500 children were affected by the tainted applesauce. The FDA traced the source of the lead to cinnamon from a supplier in Ecuador.

An FDA spokesperson told this news organization the episode appears to have resulted from “economically motivated adulteration,” which occurs when a manufacturer leaves out or substitutes a valuable ingredient or part of a food. In the case of spices, lead may be added as a coloring agent or to increase the product weight.

“When we look at domestically made products from large, reputable companies, in general, they do a pretty good job of following safe product guidelines and regulations,” said Kevin Osterhoudt, MD, professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. “But when we use third-party sellers and we import things from other countries that aren’t regulated as closely, we certainly take a lot more risk in the products that we receive.”

While the Food Safety Modernization Act of 2011 aimed to improve agency’s capacity to manage the ever-rising volume of food produced domestically and imported from overseas, the funding has stayed flat while the volume of inspections has increased. In the early 1990s, the number of shipments screened by the agency numbered in the thousands annually. Last year the FDA screened 15 million shipments from more than 200 countries, according to the agency.

Prompted by the finding of lead in applesauce, the FDA began a wider investigation into ground cinnamon by sampling the product from discount retail stores. It recalled an additional six brands of cinnamon sold in the United States containing lead.

Dr. Osterhoudt’s message to families who think their child might have been exposed to a contaminated product is to dispose of it as directed by FDA and CDC guidelines. 

In Philadelphia, where Dr. Osterhoudt practices as an emergency room physician, baseline rates of childhood lead poisoning are already high, so he advises families to “do a larger inventory of all the source potential sources of lead in their life and to reduce all the exposures as low as possible.” 

He also advises parents that a nutritious diet high in calcium and iron can protect their children from the deleterious effects of lead.
 

Current Standards for Lead Screening and Testing

Lead is ubiquitous. The common routes of exposure to humans include use of fossil fuels such as leaded gasoline, some types of industrial facilities, and past use of lead-based paint in homes. In addition to spices, lead has been found in a wide variety of products such as toys, jewelry, antiques, cosmetics, and dietary supplements imported from other countries.

Noah Buncher, DO, is a primary care pediatrician in South Philadelphia at Children’s Hospital of Pennsylvania and the former director of a lead clinic in Boston that provides care for children with lead poisoning. He follows guidelines from the American Academy of Pediatrics that define an elevated BLL as ≥ 3.5 µg/dL. The guidelines recommend screening children for lead exposures during well child visits starting at age 6 months up to 6 years and obtaining a BLL if risks for lead exposure are present. 

Dr. Buncher starts with a basic environmental history that covers items like the age, condition, zip code of home, parental occupations, or hobbies that might result in exposing family members to lead, and if another child in the home has a history of elevated BLLs. 

But a careful history for potential lead exposures can be time-consuming. 

“There’s a lot to cover in a routine well child visit,” Dr. Buncher said. “We have maybe 15-20 minutes to cover a lot.” 

Clinics also vary on whether lead screening questions are put into workflows in the electronic medical record. Although parents can complete a written questionnaire about possible lead exposures, they may have difficulty answering questions about the age of their home or not know whether their occupation is high risk.

Transportation to a clinic is often a barrier for families, and sometimes patients must travel to a separate lab to be tested for lead. 

Dr. Buncher also pointed to the patchwork of local and state requirements that can lead to confusion among providers. Massachusetts, where he formerly practiced, has a universal requirement to test all children at ages 1, 2, and 3 years. But in Pennsylvania, screening laws vary from county to county. 

“Pennsylvania should implement universal screening recommendations for all kids under 6 regardless of what county you live in,” Dr. Buncher said.
 

Protective Measures 

Alan Woolf, MD, a professor of pediatrics at Harvard Medical School, Boston, Massachusetts, and director of the Pediatric Environmental Health Center at Boston Children’s Hospital, has a few ideas about how providers can step up their lead game, including partnering with their local health department. 

The CDC funds Childhood Lead Poisoning Prevention Programs based in state and local health departments to work with clinicians to improve rates of blood lead testing, monitor the prevalence of lead in their jurisdictions, and ensure that a system of referral is available for treatment and lead remediation services in the home.

Dr. Woolf also suggested that clinicians refer patients under age 3 years with high BLLs to their local Early Intervention Program. 

“They’ll assess their child’s development, their speech, their motor skills, their social skills, and if they qualify, it’s free,” Dr. Woolf said. 

He cited research showing children with elevated lead levels who received early intervention services performed better in grade school than equally exposed children who did not access similar services.

Another key strategy for pediatric clinicians is to learn local or state regulations for testing children for lead and how to access lead surveillance data in their practice area. Children who reside in high-risk areas are automatic candidates for screening. 

Dr. Woolf pointed out that big cities are not the only localities with lead in the drinking water. If families are drawing water from their own well, they should collect that water annually to have it tested for lead and microbes.

At the clinic-wide level, Dr. Woolf recommends the use of blood lead testing as a quality improvement measure. For example, Akron Children’s Hospital developed a quality improvement initiative using a clinical decision support tool to raise screening rates in their network of 30 clinics. One year after beginning the project, lead screenings during 12-month well visits increased from 71% to 96%. 

“What we’re interested in as pediatric health professionals is eliminating all background sources of lead in a child’s environment,” Dr. Woolf said. “Whether that’s applesauce pouches, whether that’s lead-containing paint, lead in water, lead in spices, or lead in imported pottery or cookware — there are just a tremendous number of sources of lead that we can do something about.”

None of the subjects reported financial conflicts of interest.

A former pediatrician, Dr. Thomas is a freelance science writer living in Portland, Oregon.

A version of this article appeared on Medscape.com.

Immersive virtual reality (VR) distraction therapy may be more effective at controlling pain in hospitalized patients with cancer than a two-dimensional guided imagery experience, suggests a new randomized controlled trial.

While both interventions brought some pain relief, VR therapy yielded greater, longer-lasting comfort, reported lead author Hunter Groninger, MD, of MedStar Health Research Institute, Hyattsville, Maryland, and colleagues.

MedStar Health

“Investigators have explored immersive VR interventions in cancer populations for a variety of indications including anxiety, depression, fatigue, and procedure‐associated pain, particularly among patients with pediatric cancer and adult breast cancer,” the investigators wrote in Cancer. “Nevertheless, despite growing evidence supporting the efficacy of VR‐delivered interventions for analgesia, few data address its role to mitigate cancer‐related pain specifically.”

To address this knowledge gap, Dr. Groninger and colleagues enrolled 128 adult hospitalized patients with cancer of any kind, all of whom had moderate to severe pain (self-reported score at least 4 out of 10) within the past 24 hours.
 

Study Methods and Results

Patients were randomized to receive either 10 minutes of immersive VR distraction therapy or 10 minutes of two-dimensional guided imagery distraction therapy.

“[The VR therapy] provides noncompetitive experiences in which the user can move around and explore natural environments (e.g., beachscape, forest) from standing, seated, or fixed positions, including within a hospital bed or chair,” the investigators wrote. “We provided over‐the‐ear headphones to assure high sound quality for the experience in the virtual natural environment.”

The two-dimensional intervention, delivered via electronic tablet, featured a meditation with images of natural landscapes and instrumental background music.

“We chose this active control because it is readily available and reflects content similar to relaxation‐focused television channels that are increasingly common in hospital settings,” the investigators noted.

Compared with this more common approach, patients who received VR therapy had significantly greater immediate reduction in pain (mean change in pain score, –1.4 vs –0.7; P = .03). Twenty-four hours later, improvements in the VR group generally persisted, while pain level in the two-dimensional group returned almost to baseline (P = .004). In addition, patients in the VR group reported significantly greater improvements in general distress and pain bothersomeness.

“VR therapies may modulate the pain experience by reducing the level of attention paid to noxious stimuli, thereby suppressing transmission of painful sensations via pain processing pathways to the cerebral cortex, particularly with more active VR experiences compared to passive experiences,” the investigators wrote.
 

Downsides to Using VR

Although VR brought more benefit, participants in the VR group more often reported difficulty using the intervention compared with those who interacted with an electronic tablet.

Plus, one VR user described mild dizziness that resolved with pharmacologic intervention. Still, approximately 9 out of 10 participants in each group reported willingness to try the intervention again.
 

Future VR Research

“Virtual reality is a rapidly evolving technology with a wealth of potential patient‐facing applications,” the investigators wrote. “Future studies should explore repeated use, optimal dosing, and impact on VR therapy on opioid analgesic requirements as well as usability testing, VR content preferences and facilitators of analgesia, and barriers and facilitators to use in acute care settings.”

This study was supported by the American Cancer Society. The investigators disclosed no conflicts of interest.

Immersive virtual reality (VR) distraction therapy may be more effective at controlling pain in hospitalized patients with cancer than a two-dimensional guided imagery experience, suggests a new randomized controlled trial.

While both interventions brought some pain relief, VR therapy yielded greater, longer-lasting comfort, reported lead author Hunter Groninger, MD, of MedStar Health Research Institute, Hyattsville, Maryland, and colleagues.

MedStar Health

“Investigators have explored immersive VR interventions in cancer populations for a variety of indications including anxiety, depression, fatigue, and procedure‐associated pain, particularly among patients with pediatric cancer and adult breast cancer,” the investigators wrote in Cancer. “Nevertheless, despite growing evidence supporting the efficacy of VR‐delivered interventions for analgesia, few data address its role to mitigate cancer‐related pain specifically.”

To address this knowledge gap, Dr. Groninger and colleagues enrolled 128 adult hospitalized patients with cancer of any kind, all of whom had moderate to severe pain (self-reported score at least 4 out of 10) within the past 24 hours.
 

Study Methods and Results

Patients were randomized to receive either 10 minutes of immersive VR distraction therapy or 10 minutes of two-dimensional guided imagery distraction therapy.

“[The VR therapy] provides noncompetitive experiences in which the user can move around and explore natural environments (e.g., beachscape, forest) from standing, seated, or fixed positions, including within a hospital bed or chair,” the investigators wrote. “We provided over‐the‐ear headphones to assure high sound quality for the experience in the virtual natural environment.”

The two-dimensional intervention, delivered via electronic tablet, featured a meditation with images of natural landscapes and instrumental background music.

“We chose this active control because it is readily available and reflects content similar to relaxation‐focused television channels that are increasingly common in hospital settings,” the investigators noted.

Compared with this more common approach, patients who received VR therapy had significantly greater immediate reduction in pain (mean change in pain score, –1.4 vs –0.7; P = .03). Twenty-four hours later, improvements in the VR group generally persisted, while pain level in the two-dimensional group returned almost to baseline (P = .004). In addition, patients in the VR group reported significantly greater improvements in general distress and pain bothersomeness.

“VR therapies may modulate the pain experience by reducing the level of attention paid to noxious stimuli, thereby suppressing transmission of painful sensations via pain processing pathways to the cerebral cortex, particularly with more active VR experiences compared to passive experiences,” the investigators wrote.
 

Downsides to Using VR

Although VR brought more benefit, participants in the VR group more often reported difficulty using the intervention compared with those who interacted with an electronic tablet.

Plus, one VR user described mild dizziness that resolved with pharmacologic intervention. Still, approximately 9 out of 10 participants in each group reported willingness to try the intervention again.
 

Future VR Research

“Virtual reality is a rapidly evolving technology with a wealth of potential patient‐facing applications,” the investigators wrote. “Future studies should explore repeated use, optimal dosing, and impact on VR therapy on opioid analgesic requirements as well as usability testing, VR content preferences and facilitators of analgesia, and barriers and facilitators to use in acute care settings.”

This study was supported by the American Cancer Society. The investigators disclosed no conflicts of interest.

Immersive virtual reality (VR) distraction therapy may be more effective at controlling pain in hospitalized patients with cancer than a two-dimensional guided imagery experience, suggests a new randomized controlled trial.

While both interventions brought some pain relief, VR therapy yielded greater, longer-lasting comfort, reported lead author Hunter Groninger, MD, of MedStar Health Research Institute, Hyattsville, Maryland, and colleagues.

MedStar Health

“Investigators have explored immersive VR interventions in cancer populations for a variety of indications including anxiety, depression, fatigue, and procedure‐associated pain, particularly among patients with pediatric cancer and adult breast cancer,” the investigators wrote in Cancer. “Nevertheless, despite growing evidence supporting the efficacy of VR‐delivered interventions for analgesia, few data address its role to mitigate cancer‐related pain specifically.”

To address this knowledge gap, Dr. Groninger and colleagues enrolled 128 adult hospitalized patients with cancer of any kind, all of whom had moderate to severe pain (self-reported score at least 4 out of 10) within the past 24 hours.
 

Study Methods and Results

Patients were randomized to receive either 10 minutes of immersive VR distraction therapy or 10 minutes of two-dimensional guided imagery distraction therapy.

“[The VR therapy] provides noncompetitive experiences in which the user can move around and explore natural environments (e.g., beachscape, forest) from standing, seated, or fixed positions, including within a hospital bed or chair,” the investigators wrote. “We provided over‐the‐ear headphones to assure high sound quality for the experience in the virtual natural environment.”

The two-dimensional intervention, delivered via electronic tablet, featured a meditation with images of natural landscapes and instrumental background music.

“We chose this active control because it is readily available and reflects content similar to relaxation‐focused television channels that are increasingly common in hospital settings,” the investigators noted.

Compared with this more common approach, patients who received VR therapy had significantly greater immediate reduction in pain (mean change in pain score, –1.4 vs –0.7; P = .03). Twenty-four hours later, improvements in the VR group generally persisted, while pain level in the two-dimensional group returned almost to baseline (P = .004). In addition, patients in the VR group reported significantly greater improvements in general distress and pain bothersomeness.

“VR therapies may modulate the pain experience by reducing the level of attention paid to noxious stimuli, thereby suppressing transmission of painful sensations via pain processing pathways to the cerebral cortex, particularly with more active VR experiences compared to passive experiences,” the investigators wrote.
 

Downsides to Using VR

Although VR brought more benefit, participants in the VR group more often reported difficulty using the intervention compared with those who interacted with an electronic tablet.

Plus, one VR user described mild dizziness that resolved with pharmacologic intervention. Still, approximately 9 out of 10 participants in each group reported willingness to try the intervention again.
 

Future VR Research

“Virtual reality is a rapidly evolving technology with a wealth of potential patient‐facing applications,” the investigators wrote. “Future studies should explore repeated use, optimal dosing, and impact on VR therapy on opioid analgesic requirements as well as usability testing, VR content preferences and facilitators of analgesia, and barriers and facilitators to use in acute care settings.”

This study was supported by the American Cancer Society. The investigators disclosed no conflicts of interest.

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.

TOPLINE:

A review of 22 articles found a higher incidence of “altered skin sensations” and alopecia in individuals receiving oral semaglutide than in those receiving placebo.

METHODOLOGY:

• The Food and Drug Administration’s  has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
• In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.

TAKEAWAY:

• Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
• Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
• Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
• On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.

IN PRACTICE:

“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.

SOURCE:

Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.

DISCLOSURES:

This study did not report any funding sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A review of 22 articles found a higher incidence of “altered skin sensations” and alopecia in individuals receiving oral semaglutide than in those receiving placebo.

METHODOLOGY:

• The Food and Drug Administration’s  has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
• In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.

TAKEAWAY:

• Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
• Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
• Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
• On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.

IN PRACTICE:

“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.

SOURCE:

Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.

DISCLOSURES:

This study did not report any funding sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A review of 22 articles found a higher incidence of “altered skin sensations” and alopecia in individuals receiving oral semaglutide than in those receiving placebo.

METHODOLOGY:

• The Food and Drug Administration’s  has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
• In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.

TAKEAWAY:

• Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
• Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
• Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
• On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.

IN PRACTICE:

“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.

SOURCE:

Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.

DISCLOSURES:

This study did not report any funding sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Exposure to pesticides is associated with an increased risk for pancreatic adenocarcinoma, according to two French studies presented at the Francophone Days of Hepatology, Gastroenterology, and Digestive Oncology. One of them, a case-control study, showed an elevated risk in individuals whose adipose tissue contained substances that are now banned.

“The association between pesticides and pancreatic cancer exists. It is of low magnitude but robust, concerning cumulative pesticides and three substances: Mancozeb, glyphosate, and sulfur in spray form,” said Mathias Brugel, MD, hospital practitioner at Basque Coast Hospital Center in Bayonne, France, during his presentation.

Regarding the four other liposoluble substances associated with an increased risk for pancreatic cancer in the second study, “their use has been banned since the 1990s, but they are still present in soils and in the air,” Dr. Brugel told this news organization.

For example, in Reims, France, the assessment of air quality by ATMO Grand Est revealed the presence of banned pesticides in the air, he added. However, Dr. Brugel stressed that a cause-effect relationship between pesticide exposure and the risk for pancreatic cancer cannot be established with these studies.
 

Incidence Rising Constantly

The incidence of pancreatic adenocarcinoma has been increasing steadily for more than 30 years. In France, nearly 16,000 new cases were reported in 2023, which represented an annual increase of about 2%. According to the National Cancer Institute, “pancreatic adenocarcinoma could become the second leading cause of cancer mortality by 2030.”

“This increase in incidence is particularly strong in France compared with other Western countries. The causes are still poorly understood. One might wonder whether environmental factors like pesticides are involved,” said Dr. Brugel.

Known to have a mechanism of action favoring oncogenesis, pesticides are suspected of being responsible for the rise in certain cancers, especially given their extensive use in France. In total, around 300 substances are authorized, and 65,000 tons are applied each year, making France the largest consumer of pesticides in Europe.

“Contamination is ubiquitous, meaning they are found in soil, water, air, and in individuals,” said Dr. Brugel. According to a study by the Institute for Scientific Expertise Research, pesticide residues were detected in 64% of hair samples taken from French volunteers.

The literature increasingly reported data suggesting a link between pesticide exposure and the development of certain diseases like cancer. A 2021 document by Inserm notably confirmed the strong presumption of a link between occupational pesticide exposure and pathologies such as non-Hodgkin’s lymphoma and prostate cancer.
 

High-Incidence Zones

To explore the link between pesticide exposure and pancreatic cancer, Dr. Brugel and his colleagues conducted the EcoPESTIPAC and PESTIPAC studies, the results of which were presented at this year’s conference.

In EcoPESTIPAC, researchers conducted a national ecological regression by dividing the entire French territory into 5529 spatial units. The number of pancreatic cancer cases per spatial unit per year (disease-mapping) was determined using the National Health Data System.

Nine chemicals, including glyphosate, were included, thus covering half of pesticide purchases in France. The cumulative quantity of pesticides, regardless of molecule, was also examined. Pesticide exposure was estimated by the median ratio between pesticide purchase and agricultural area per spatial unit over an 11-year period from early 2011 to the end of 2021.

Mor than 134,000 cases of pancreatic cancer were reported during this period. The analysis revealed three high-incidence zones located around Paris, in central France, and in the Mediterranean basin, while spatial units in the western region showed the lowest incidences.

The heterogeneous distribution of the disease suggests the involvement of risk factors, said Dr. Brugel. After adjusting for confounding factors such as smoking, the study showed an increased risk for pancreatic cancer associated with the cumulative quantity of pesticides and three specific substances: Sulfur in spray form, mancozeb, and glyphosate.
 

Risk Increases

A dose-response relationship was evident. For an increase in pesticide use of 2.5 kg/hectare over 11 years, the risk for pancreatic adenocarcinoma increased from 0.9% to 1.4%. “The increase is relatively small, but one must not forget that this risk applies to all of France,” said Dr. Brugel. Indeed, the risk appeared homogeneous across the entire territory.

This was the first study to explore this link at the national level. Although the association between the four identified factors and pancreatic risk was robust, the study had some limitations. It relied on the quantities of pesticides purchased to estimate the quantities used, Dr. Brugel pointed out.

The second study, PESTIPAC, was a case-control study conducted at the Reims University Hospital to explore the association between pancreatic adenocarcinoma and concentrations of organochlorine pesticides in fat and urine.

The study included 26 patients with pancreatic cancer who had abdominal surgery that allowed for adipose tissue sampling (minimum 10 g). Urine was collected in the morning on an empty stomach.

A control group was formed by including 26 other patients who underwent surgery for a benign abdominal condition such as gallstones or hernia, thus allowing for the same sampling. Individuals in both groups were matched for age and body mass index, two risk factors for pancreatic cancer.
 

Banned Substances

In total, 345 substances were searched for using chromatography and mass spectrometry. Analyses revealed the presence of five banned substances in all patients, while nine substances were found in half of the samples.

“Contamination is very widespread, both in patients with pancreatic cancer and in the controls,” said Dr. Brugel. Consequently, for this study, between-group comparisons of substances present in all individuals could not be performed.

After adjustment, an association with an increased risk for pancreatic cancer was nonetheless observed with four liposoluble substances: 4,4-DDE, mirex or perchlordecone, trans-nonachlor, and cis-nonachlor. All four substances are herbicides that have been banned for at least 30 years.

The study also aimed to assess the effect of pesticide presence in the body on survival after pancreatic cancer. The results showed no significant difference for overall survival or progression-free survival.

“Pesticides are a credible candidate to explain the increase in the incidence of pancreatic adenocarcinoma,” said Dr. Brugel. However, “if associations between pancreatic cancer and pesticides exist, they remain poorly understood, and it is difficult to establish clear causality.”

Further large-scale studies will be needed to confirm these associations. An evaluation of the general population’s exposure to banned substances also appears justified, according to the researchers.

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

Exposure to pesticides is associated with an increased risk for pancreatic adenocarcinoma, according to two French studies presented at the Francophone Days of Hepatology, Gastroenterology, and Digestive Oncology. One of them, a case-control study, showed an elevated risk in individuals whose adipose tissue contained substances that are now banned.

“The association between pesticides and pancreatic cancer exists. It is of low magnitude but robust, concerning cumulative pesticides and three substances: Mancozeb, glyphosate, and sulfur in spray form,” said Mathias Brugel, MD, hospital practitioner at Basque Coast Hospital Center in Bayonne, France, during his presentation.

Regarding the four other liposoluble substances associated with an increased risk for pancreatic cancer in the second study, “their use has been banned since the 1990s, but they are still present in soils and in the air,” Dr. Brugel told this news organization.

For example, in Reims, France, the assessment of air quality by ATMO Grand Est revealed the presence of banned pesticides in the air, he added. However, Dr. Brugel stressed that a cause-effect relationship between pesticide exposure and the risk for pancreatic cancer cannot be established with these studies.
 

Incidence Rising Constantly

The incidence of pancreatic adenocarcinoma has been increasing steadily for more than 30 years. In France, nearly 16,000 new cases were reported in 2023, which represented an annual increase of about 2%. According to the National Cancer Institute, “pancreatic adenocarcinoma could become the second leading cause of cancer mortality by 2030.”

“This increase in incidence is particularly strong in France compared with other Western countries. The causes are still poorly understood. One might wonder whether environmental factors like pesticides are involved,” said Dr. Brugel.

Known to have a mechanism of action favoring oncogenesis, pesticides are suspected of being responsible for the rise in certain cancers, especially given their extensive use in France. In total, around 300 substances are authorized, and 65,000 tons are applied each year, making France the largest consumer of pesticides in Europe.

“Contamination is ubiquitous, meaning they are found in soil, water, air, and in individuals,” said Dr. Brugel. According to a study by the Institute for Scientific Expertise Research, pesticide residues were detected in 64% of hair samples taken from French volunteers.

The literature increasingly reported data suggesting a link between pesticide exposure and the development of certain diseases like cancer. A 2021 document by Inserm notably confirmed the strong presumption of a link between occupational pesticide exposure and pathologies such as non-Hodgkin’s lymphoma and prostate cancer.
 

High-Incidence Zones

To explore the link between pesticide exposure and pancreatic cancer, Dr. Brugel and his colleagues conducted the EcoPESTIPAC and PESTIPAC studies, the results of which were presented at this year’s conference.

In EcoPESTIPAC, researchers conducted a national ecological regression by dividing the entire French territory into 5529 spatial units. The number of pancreatic cancer cases per spatial unit per year (disease-mapping) was determined using the National Health Data System.

Nine chemicals, including glyphosate, were included, thus covering half of pesticide purchases in France. The cumulative quantity of pesticides, regardless of molecule, was also examined. Pesticide exposure was estimated by the median ratio between pesticide purchase and agricultural area per spatial unit over an 11-year period from early 2011 to the end of 2021.

Mor than 134,000 cases of pancreatic cancer were reported during this period. The analysis revealed three high-incidence zones located around Paris, in central France, and in the Mediterranean basin, while spatial units in the western region showed the lowest incidences.

The heterogeneous distribution of the disease suggests the involvement of risk factors, said Dr. Brugel. After adjusting for confounding factors such as smoking, the study showed an increased risk for pancreatic cancer associated with the cumulative quantity of pesticides and three specific substances: Sulfur in spray form, mancozeb, and glyphosate.
 

Risk Increases

A dose-response relationship was evident. For an increase in pesticide use of 2.5 kg/hectare over 11 years, the risk for pancreatic adenocarcinoma increased from 0.9% to 1.4%. “The increase is relatively small, but one must not forget that this risk applies to all of France,” said Dr. Brugel. Indeed, the risk appeared homogeneous across the entire territory.

This was the first study to explore this link at the national level. Although the association between the four identified factors and pancreatic risk was robust, the study had some limitations. It relied on the quantities of pesticides purchased to estimate the quantities used, Dr. Brugel pointed out.

The second study, PESTIPAC, was a case-control study conducted at the Reims University Hospital to explore the association between pancreatic adenocarcinoma and concentrations of organochlorine pesticides in fat and urine.

The study included 26 patients with pancreatic cancer who had abdominal surgery that allowed for adipose tissue sampling (minimum 10 g). Urine was collected in the morning on an empty stomach.

A control group was formed by including 26 other patients who underwent surgery for a benign abdominal condition such as gallstones or hernia, thus allowing for the same sampling. Individuals in both groups were matched for age and body mass index, two risk factors for pancreatic cancer.
 

Banned Substances

In total, 345 substances were searched for using chromatography and mass spectrometry. Analyses revealed the presence of five banned substances in all patients, while nine substances were found in half of the samples.

“Contamination is very widespread, both in patients with pancreatic cancer and in the controls,” said Dr. Brugel. Consequently, for this study, between-group comparisons of substances present in all individuals could not be performed.

After adjustment, an association with an increased risk for pancreatic cancer was nonetheless observed with four liposoluble substances: 4,4-DDE, mirex or perchlordecone, trans-nonachlor, and cis-nonachlor. All four substances are herbicides that have been banned for at least 30 years.

The study also aimed to assess the effect of pesticide presence in the body on survival after pancreatic cancer. The results showed no significant difference for overall survival or progression-free survival.

“Pesticides are a credible candidate to explain the increase in the incidence of pancreatic adenocarcinoma,” said Dr. Brugel. However, “if associations between pancreatic cancer and pesticides exist, they remain poorly understood, and it is difficult to establish clear causality.”

Further large-scale studies will be needed to confirm these associations. An evaluation of the general population’s exposure to banned substances also appears justified, according to the researchers.

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

Exposure to pesticides is associated with an increased risk for pancreatic adenocarcinoma, according to two French studies presented at the Francophone Days of Hepatology, Gastroenterology, and Digestive Oncology. One of them, a case-control study, showed an elevated risk in individuals whose adipose tissue contained substances that are now banned.

“The association between pesticides and pancreatic cancer exists. It is of low magnitude but robust, concerning cumulative pesticides and three substances: Mancozeb, glyphosate, and sulfur in spray form,” said Mathias Brugel, MD, hospital practitioner at Basque Coast Hospital Center in Bayonne, France, during his presentation.

Regarding the four other liposoluble substances associated with an increased risk for pancreatic cancer in the second study, “their use has been banned since the 1990s, but they are still present in soils and in the air,” Dr. Brugel told this news organization.

For example, in Reims, France, the assessment of air quality by ATMO Grand Est revealed the presence of banned pesticides in the air, he added. However, Dr. Brugel stressed that a cause-effect relationship between pesticide exposure and the risk for pancreatic cancer cannot be established with these studies.
 

Incidence Rising Constantly

The incidence of pancreatic adenocarcinoma has been increasing steadily for more than 30 years. In France, nearly 16,000 new cases were reported in 2023, which represented an annual increase of about 2%. According to the National Cancer Institute, “pancreatic adenocarcinoma could become the second leading cause of cancer mortality by 2030.”

“This increase in incidence is particularly strong in France compared with other Western countries. The causes are still poorly understood. One might wonder whether environmental factors like pesticides are involved,” said Dr. Brugel.

Known to have a mechanism of action favoring oncogenesis, pesticides are suspected of being responsible for the rise in certain cancers, especially given their extensive use in France. In total, around 300 substances are authorized, and 65,000 tons are applied each year, making France the largest consumer of pesticides in Europe.

“Contamination is ubiquitous, meaning they are found in soil, water, air, and in individuals,” said Dr. Brugel. According to a study by the Institute for Scientific Expertise Research, pesticide residues were detected in 64% of hair samples taken from French volunteers.

The literature increasingly reported data suggesting a link between pesticide exposure and the development of certain diseases like cancer. A 2021 document by Inserm notably confirmed the strong presumption of a link between occupational pesticide exposure and pathologies such as non-Hodgkin’s lymphoma and prostate cancer.
 

High-Incidence Zones

To explore the link between pesticide exposure and pancreatic cancer, Dr. Brugel and his colleagues conducted the EcoPESTIPAC and PESTIPAC studies, the results of which were presented at this year’s conference.

In EcoPESTIPAC, researchers conducted a national ecological regression by dividing the entire French territory into 5529 spatial units. The number of pancreatic cancer cases per spatial unit per year (disease-mapping) was determined using the National Health Data System.

Nine chemicals, including glyphosate, were included, thus covering half of pesticide purchases in France. The cumulative quantity of pesticides, regardless of molecule, was also examined. Pesticide exposure was estimated by the median ratio between pesticide purchase and agricultural area per spatial unit over an 11-year period from early 2011 to the end of 2021.

Mor than 134,000 cases of pancreatic cancer were reported during this period. The analysis revealed three high-incidence zones located around Paris, in central France, and in the Mediterranean basin, while spatial units in the western region showed the lowest incidences.

The heterogeneous distribution of the disease suggests the involvement of risk factors, said Dr. Brugel. After adjusting for confounding factors such as smoking, the study showed an increased risk for pancreatic cancer associated with the cumulative quantity of pesticides and three specific substances: Sulfur in spray form, mancozeb, and glyphosate.
 

Risk Increases

A dose-response relationship was evident. For an increase in pesticide use of 2.5 kg/hectare over 11 years, the risk for pancreatic adenocarcinoma increased from 0.9% to 1.4%. “The increase is relatively small, but one must not forget that this risk applies to all of France,” said Dr. Brugel. Indeed, the risk appeared homogeneous across the entire territory.

This was the first study to explore this link at the national level. Although the association between the four identified factors and pancreatic risk was robust, the study had some limitations. It relied on the quantities of pesticides purchased to estimate the quantities used, Dr. Brugel pointed out.

The second study, PESTIPAC, was a case-control study conducted at the Reims University Hospital to explore the association between pancreatic adenocarcinoma and concentrations of organochlorine pesticides in fat and urine.

The study included 26 patients with pancreatic cancer who had abdominal surgery that allowed for adipose tissue sampling (minimum 10 g). Urine was collected in the morning on an empty stomach.

A control group was formed by including 26 other patients who underwent surgery for a benign abdominal condition such as gallstones or hernia, thus allowing for the same sampling. Individuals in both groups were matched for age and body mass index, two risk factors for pancreatic cancer.
 

Banned Substances

In total, 345 substances were searched for using chromatography and mass spectrometry. Analyses revealed the presence of five banned substances in all patients, while nine substances were found in half of the samples.

“Contamination is very widespread, both in patients with pancreatic cancer and in the controls,” said Dr. Brugel. Consequently, for this study, between-group comparisons of substances present in all individuals could not be performed.

After adjustment, an association with an increased risk for pancreatic cancer was nonetheless observed with four liposoluble substances: 4,4-DDE, mirex or perchlordecone, trans-nonachlor, and cis-nonachlor. All four substances are herbicides that have been banned for at least 30 years.

The study also aimed to assess the effect of pesticide presence in the body on survival after pancreatic cancer. The results showed no significant difference for overall survival or progression-free survival.

“Pesticides are a credible candidate to explain the increase in the incidence of pancreatic adenocarcinoma,” said Dr. Brugel. However, “if associations between pancreatic cancer and pesticides exist, they remain poorly understood, and it is difficult to establish clear causality.”

Further large-scale studies will be needed to confirm these associations. An evaluation of the general population’s exposure to banned substances also appears justified, according to the researchers.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article 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.

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.

TOPLINE:

Insulin resistance and obesity in adolescents may lead to increased abdominal fibrogenesis, impairing the capacity of the abdominal subcutaneous adipose tissue (SAT) to store lipids, which may cause fat accumulation in the visceral adipose tissue (VAT) depot and in other organs such as the liver.

METHODOLOGY:

• Abdominal fibrogenesis, but not adipose tissue expandability, is known to increase in adults with obesity and reduce insulin sensitivity; however, little is known about fibrogenesis in adolescents with obesity.
• In this study, researchers investigated if lipid dynamics, fibrogenesis, and abdominal and gluteal adipocyte turnover show dysregulation to a greater extent in insulin-resistant adolescents with obesity than in insulin-sensitive adolescents with obesity.
• They recruited 14 individuals between 12 and 20 years with a body mass index over 30 from the Yale  Clinic, of whom seven participants were classified as insulin resistant.
• Deuterated water methodologies were used to study the indices of adipocyte turnover, lipid dynamics, and fibrogenesis in abdominal and gluteal fat deposits.
• A 3-hour oral glucose tolerance test and multisection MRI scan of the abdominal region were used to assess the indices of glucose metabolism, abdominal fat distribution patterns, and liver fat content.

TAKEAWAY:

• The abdominal and gluteal SAT turnover rate of lipid components (triglyceride production and breakdown as well as de novo lipogenesis contribution) was similar in insulin-resistant and insulin-sensitive adolescents with obesity.
• The insoluble collagen (type I, subunit alpha2) level was higher in the abdominal adipose tissue of insulin-resistant adolescents than in insulin-sensitive adolescents (difference in fractional synthesis rate, 0.611; P < .001), indicating increased abdominal fibrogenesis.
• Abdominal insoluble collagen I alpha2 was associated with higher fasting plasma insulin levels (correlation [r], 0.579; P = .015), a higher visceral to total adipose tissue ratio (r, 0.643; P = .007), and a lower whole-body insulin sensitivity index (r, -0.540; P = .023).
• There was no evidence of increased collagen production in the gluteal adipose tissue, and as a result, fibrogenesis was observed.

IN PRACTICE:

“The increased formation of insoluble collagen observed in insulin-resistant compared with insulin-sensitive individuals contributes to lipid spillover from SAT to VAT and, in turn, serves as a critically important mechanism involved in the complex sequelae of obesity-related metabolic and liver disease pathology,” the authors wrote.

SOURCE:

This study, led by Aaron L. Slusher, Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut, was published online in Obesity.

LIMITATIONS:

The researchers did not measure hepatic collagen synthesis rates. The analysis was performed on a small study population. The authors were also unable to assess potential sex differences.

DISCLOSURES:

The study was funded by the Foundation for the National Institutes of Health and Clara Guthrie Patterson Trust Mentored Research Award. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Insulin resistance and obesity in adolescents may lead to increased abdominal fibrogenesis, impairing the capacity of the abdominal subcutaneous adipose tissue (SAT) to store lipids, which may cause fat accumulation in the visceral adipose tissue (VAT) depot and in other organs such as the liver.

METHODOLOGY:

• Abdominal fibrogenesis, but not adipose tissue expandability, is known to increase in adults with obesity and reduce insulin sensitivity; however, little is known about fibrogenesis in adolescents with obesity.
• In this study, researchers investigated if lipid dynamics, fibrogenesis, and abdominal and gluteal adipocyte turnover show dysregulation to a greater extent in insulin-resistant adolescents with obesity than in insulin-sensitive adolescents with obesity.
• They recruited 14 individuals between 12 and 20 years with a body mass index over 30 from the Yale  Clinic, of whom seven participants were classified as insulin resistant.
• Deuterated water methodologies were used to study the indices of adipocyte turnover, lipid dynamics, and fibrogenesis in abdominal and gluteal fat deposits.
• A 3-hour oral glucose tolerance test and multisection MRI scan of the abdominal region were used to assess the indices of glucose metabolism, abdominal fat distribution patterns, and liver fat content.

TAKEAWAY:

• The abdominal and gluteal SAT turnover rate of lipid components (triglyceride production and breakdown as well as de novo lipogenesis contribution) was similar in insulin-resistant and insulin-sensitive adolescents with obesity.
• The insoluble collagen (type I, subunit alpha2) level was higher in the abdominal adipose tissue of insulin-resistant adolescents than in insulin-sensitive adolescents (difference in fractional synthesis rate, 0.611; P < .001), indicating increased abdominal fibrogenesis.
• Abdominal insoluble collagen I alpha2 was associated with higher fasting plasma insulin levels (correlation [r], 0.579; P = .015), a higher visceral to total adipose tissue ratio (r, 0.643; P = .007), and a lower whole-body insulin sensitivity index (r, -0.540; P = .023).
• There was no evidence of increased collagen production in the gluteal adipose tissue, and as a result, fibrogenesis was observed.

IN PRACTICE:

“The increased formation of insoluble collagen observed in insulin-resistant compared with insulin-sensitive individuals contributes to lipid spillover from SAT to VAT and, in turn, serves as a critically important mechanism involved in the complex sequelae of obesity-related metabolic and liver disease pathology,” the authors wrote.

SOURCE:

This study, led by Aaron L. Slusher, Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut, was published online in Obesity.

LIMITATIONS:

The researchers did not measure hepatic collagen synthesis rates. The analysis was performed on a small study population. The authors were also unable to assess potential sex differences.

DISCLOSURES:

The study was funded by the Foundation for the National Institutes of Health and Clara Guthrie Patterson Trust Mentored Research Award. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Insulin resistance and obesity in adolescents may lead to increased abdominal fibrogenesis, impairing the capacity of the abdominal subcutaneous adipose tissue (SAT) to store lipids, which may cause fat accumulation in the visceral adipose tissue (VAT) depot and in other organs such as the liver.

METHODOLOGY:

• Abdominal fibrogenesis, but not adipose tissue expandability, is known to increase in adults with obesity and reduce insulin sensitivity; however, little is known about fibrogenesis in adolescents with obesity.
• In this study, researchers investigated if lipid dynamics, fibrogenesis, and abdominal and gluteal adipocyte turnover show dysregulation to a greater extent in insulin-resistant adolescents with obesity than in insulin-sensitive adolescents with obesity.
• They recruited 14 individuals between 12 and 20 years with a body mass index over 30 from the Yale  Clinic, of whom seven participants were classified as insulin resistant.
• Deuterated water methodologies were used to study the indices of adipocyte turnover, lipid dynamics, and fibrogenesis in abdominal and gluteal fat deposits.
• A 3-hour oral glucose tolerance test and multisection MRI scan of the abdominal region were used to assess the indices of glucose metabolism, abdominal fat distribution patterns, and liver fat content.

TAKEAWAY:

• The abdominal and gluteal SAT turnover rate of lipid components (triglyceride production and breakdown as well as de novo lipogenesis contribution) was similar in insulin-resistant and insulin-sensitive adolescents with obesity.
• The insoluble collagen (type I, subunit alpha2) level was higher in the abdominal adipose tissue of insulin-resistant adolescents than in insulin-sensitive adolescents (difference in fractional synthesis rate, 0.611; P < .001), indicating increased abdominal fibrogenesis.
• Abdominal insoluble collagen I alpha2 was associated with higher fasting plasma insulin levels (correlation [r], 0.579; P = .015), a higher visceral to total adipose tissue ratio (r, 0.643; P = .007), and a lower whole-body insulin sensitivity index (r, -0.540; P = .023).
• There was no evidence of increased collagen production in the gluteal adipose tissue, and as a result, fibrogenesis was observed.

IN PRACTICE:

“The increased formation of insoluble collagen observed in insulin-resistant compared with insulin-sensitive individuals contributes to lipid spillover from SAT to VAT and, in turn, serves as a critically important mechanism involved in the complex sequelae of obesity-related metabolic and liver disease pathology,” the authors wrote.

SOURCE:

This study, led by Aaron L. Slusher, Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut, was published online in Obesity.

LIMITATIONS:

The researchers did not measure hepatic collagen synthesis rates. The analysis was performed on a small study population. The authors were also unable to assess potential sex differences.

DISCLOSURES:

The study was funded by the Foundation for the National Institutes of Health and Clara Guthrie Patterson Trust Mentored Research Award. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.

It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.

Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.

Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold. Concierge fees provide new revenue directly and serve as a tool to help recruit and retain physicians. Those doctors then provide lucrative referrals of their well-heeled patients to the hospitals that employ them.

“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, a hospital finance expert at Johns Hopkins University.

“They are the ideal patient, from the hospitals’ perspective.”

Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.

“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, associate dean for health equity at the University of Texas-Austin’s Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” she said.

Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.

Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.

“High-end donors wanted to make sure they have doctors to care for them,” he said.

Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.

“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.

Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.

One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.

Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.

Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.

For hospitals, “this is an extension of them consolidating the market,” said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.

George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.

“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.

Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.

Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.

“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”

Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.

NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized health care experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.

NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.

KFF Health News  is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about  KFF .

Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.

It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.

Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.

Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold. Concierge fees provide new revenue directly and serve as a tool to help recruit and retain physicians. Those doctors then provide lucrative referrals of their well-heeled patients to the hospitals that employ them.

“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, a hospital finance expert at Johns Hopkins University.

“They are the ideal patient, from the hospitals’ perspective.”

Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.

“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, associate dean for health equity at the University of Texas-Austin’s Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” she said.

Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.

Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.

“High-end donors wanted to make sure they have doctors to care for them,” he said.

Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.

“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.

Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.

One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.

Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.

Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.

For hospitals, “this is an extension of them consolidating the market,” said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.

George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.

“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.

Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.

Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.

“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”

Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.

NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized health care experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.

NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.

KFF Health News  is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about  KFF .

Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.

It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.

Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.

Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold. Concierge fees provide new revenue directly and serve as a tool to help recruit and retain physicians. Those doctors then provide lucrative referrals of their well-heeled patients to the hospitals that employ them.

“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, a hospital finance expert at Johns Hopkins University.

“They are the ideal patient, from the hospitals’ perspective.”

Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.

“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, associate dean for health equity at the University of Texas-Austin’s Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” she said.

Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.

Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.

“High-end donors wanted to make sure they have doctors to care for them,” he said.

Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.

“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.

Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.

One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.

Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.

Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.

For hospitals, “this is an extension of them consolidating the market,” said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.

George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.

“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.

Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.

Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.

“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”

Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.

NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized health care experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.

NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.

KFF Health News  is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about  KFF .