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Tamoxifen Reduces Risk for Invasive Recurrence of Ductal Carcinoma

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Mon, 12/16/2024 - 15:33

— For patients with so-called “good-risk” ductal carcinoma in situ (DCIS) who did not have radiation therapy after breast-conserving surgery, adjuvant tamoxifen reduced their overall risks for invasive recurrence, but not their risks for recurrence in either the same or contralateral breast.

These findings come from an exploratory analysis of combined data from two clinical trials. They suggest that, for this select group of patients, the choice to forgo radiation following definitive surgery may be an acceptable option, assuming that they follow a full course of endocrine therapy.

“In the absence of survival impact for adjuvant therapy, the decision to recommend radiation therapy or endocrine therapy should be part of a shared decision process, and I think that this data helps us provide clearer data points to our patients to help them make choices between endocrine therapy and radiation therapy in the setting of good-risk [ductal carcinoma in situ],” said Jean L. Wright, MD, from the University of North Carolina at Chapel Hill.

She presented the findings in an oral abstract session and media briefing at San Antonio Breast Cancer Symposium (SABCS) 2024.

 

Trial Results Combined

Wright and colleagues looked at pooled data from two clinical trials that enrolled patients with low- or intermediate-grade DCIS with tumor size no larger than 2.5 cm, grade 1 or 2 lesions, and with surgical margins ≥ 3 mm.

The trials included NRG/RTOG 9804, with 317 patients who fit the “good-risk category,” and ECOG-ACRIN E5194, which included a cohort of 561 patients that met the good-risk definition used for the exploratory analysis.

In each trial, tamoxifen use was optional, and choices were tracked. In the NRG/RTOG trial, 66% of patients used tamoxifen and 34% did not. The respective percentages in the ECOG/ACRIN trial were 30% and 70%.

The majority of patients were adherent to the 5-year prescribed course of tamoxifen, Wright said.

 

Analysis Details

In the combined data, the median age of patients who used tamoxifen vs who did not use tamoxifen was 58 vs 61 years.

In all, 23% of women in both the tamoxifen yes or no groups were premenopausal, with the remainder either postmenopausal or of unknown menopausal status.

After a median follow-up of 14.85 years, the rate of 15-year ipsilateral breast recurrence (IBR) was 19% for patients who did not receive tamoxifen vs 11.4% for those who did. This translated into a hazard ratio for IBR on tamoxifen of 0.52 (P = .001).

Tamoxifen also reduced the risk for invasive recurrence in the same breast, with a 15-year invasive IBR rate of 11.5% in the no tamoxifen group vs 6% in the yes tamoxifen group.

However, as noted before, tamoxifen use was not associated with significant reduction in the risk for noninvasive DCIS recurrence in the same breast, as evidenced by a 15-year DCIS IBR rate of 8.1% without tamoxifen and 5.5% with tamoxifen, a difference that did not reach statistical significance.

 

A Surprising Result

One finding from the data that seemed to defy clinical wisdom was that tamoxifen use did not appear to significantly reduce the risk for events in the other breast. The 15-year rate of contralateral breast events was 8.8% in the no-tamoxifen group vs 5.6% in the yes tamoxifen group, a difference that was not statically significant.

“It was surprising that there was so little effect on contralateral disease,” commented Elinor Sawyer, MBBS, PhD, the invited discussant.

“But I think it’s really important, this decrease in ipsilateral invasive recurrence [with tamoxifen] because there are studies such as the Sloane study from the United Kingdom that show that if you develop an invasive recurrence after DCIS, you have a worse survival than those who develop a pure DCIS recurrence,” she said.

At the media briefing held prior to Wright’s presentation, moderator Virginia Kaklamani, MD, leader of the breast cancer program at UT Health San Antonio in Texas, also said that she found it surprising that tamoxifen did not reduce risk for contralateral breast cancer “since every study that we’ve done has shown that.”

“I also found that result a little bit surprising,” Wright agreed.

“I think the main feature that we want to focus on is that this was a group of patients with a very clear inclusion criteria of this good-risk DCIS, and even though the definition of good-risk DCIS included patients with [tumors] up to 2.5 cm in DCIS, we saw that, in reality, the patients enrolled had very small DCIS. So I’m wondering if it’s perhaps that it’s related to the fact that patients that were enrolled in these studies had really low-risk features and perhaps just had a lower risk of contralateral breast events as compared to a broader population of patients with DCIS,” she said.

The analysis by Wright and colleagues was supported by grants from the National Cancer Institute. Wright reported receiving honoraria from ASTRO and PER. Sawyer disclosed receiving grants/research support from Pfizer, Seagen, and IQIVIA. Kaklamani disclosed serving as a speaker and/or consultant for AstraZeneca, Celldex Therapeutics, Daiichi Sankyo, Genentech, Gilead, Lilly, Menarini, and Novartis and receiving research support from Eisai.

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

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— For patients with so-called “good-risk” ductal carcinoma in situ (DCIS) who did not have radiation therapy after breast-conserving surgery, adjuvant tamoxifen reduced their overall risks for invasive recurrence, but not their risks for recurrence in either the same or contralateral breast.

These findings come from an exploratory analysis of combined data from two clinical trials. They suggest that, for this select group of patients, the choice to forgo radiation following definitive surgery may be an acceptable option, assuming that they follow a full course of endocrine therapy.

“In the absence of survival impact for adjuvant therapy, the decision to recommend radiation therapy or endocrine therapy should be part of a shared decision process, and I think that this data helps us provide clearer data points to our patients to help them make choices between endocrine therapy and radiation therapy in the setting of good-risk [ductal carcinoma in situ],” said Jean L. Wright, MD, from the University of North Carolina at Chapel Hill.

She presented the findings in an oral abstract session and media briefing at San Antonio Breast Cancer Symposium (SABCS) 2024.

 

Trial Results Combined

Wright and colleagues looked at pooled data from two clinical trials that enrolled patients with low- or intermediate-grade DCIS with tumor size no larger than 2.5 cm, grade 1 or 2 lesions, and with surgical margins ≥ 3 mm.

The trials included NRG/RTOG 9804, with 317 patients who fit the “good-risk category,” and ECOG-ACRIN E5194, which included a cohort of 561 patients that met the good-risk definition used for the exploratory analysis.

In each trial, tamoxifen use was optional, and choices were tracked. In the NRG/RTOG trial, 66% of patients used tamoxifen and 34% did not. The respective percentages in the ECOG/ACRIN trial were 30% and 70%.

The majority of patients were adherent to the 5-year prescribed course of tamoxifen, Wright said.

 

Analysis Details

In the combined data, the median age of patients who used tamoxifen vs who did not use tamoxifen was 58 vs 61 years.

In all, 23% of women in both the tamoxifen yes or no groups were premenopausal, with the remainder either postmenopausal or of unknown menopausal status.

After a median follow-up of 14.85 years, the rate of 15-year ipsilateral breast recurrence (IBR) was 19% for patients who did not receive tamoxifen vs 11.4% for those who did. This translated into a hazard ratio for IBR on tamoxifen of 0.52 (P = .001).

Tamoxifen also reduced the risk for invasive recurrence in the same breast, with a 15-year invasive IBR rate of 11.5% in the no tamoxifen group vs 6% in the yes tamoxifen group.

However, as noted before, tamoxifen use was not associated with significant reduction in the risk for noninvasive DCIS recurrence in the same breast, as evidenced by a 15-year DCIS IBR rate of 8.1% without tamoxifen and 5.5% with tamoxifen, a difference that did not reach statistical significance.

 

A Surprising Result

One finding from the data that seemed to defy clinical wisdom was that tamoxifen use did not appear to significantly reduce the risk for events in the other breast. The 15-year rate of contralateral breast events was 8.8% in the no-tamoxifen group vs 5.6% in the yes tamoxifen group, a difference that was not statically significant.

“It was surprising that there was so little effect on contralateral disease,” commented Elinor Sawyer, MBBS, PhD, the invited discussant.

“But I think it’s really important, this decrease in ipsilateral invasive recurrence [with tamoxifen] because there are studies such as the Sloane study from the United Kingdom that show that if you develop an invasive recurrence after DCIS, you have a worse survival than those who develop a pure DCIS recurrence,” she said.

At the media briefing held prior to Wright’s presentation, moderator Virginia Kaklamani, MD, leader of the breast cancer program at UT Health San Antonio in Texas, also said that she found it surprising that tamoxifen did not reduce risk for contralateral breast cancer “since every study that we’ve done has shown that.”

“I also found that result a little bit surprising,” Wright agreed.

“I think the main feature that we want to focus on is that this was a group of patients with a very clear inclusion criteria of this good-risk DCIS, and even though the definition of good-risk DCIS included patients with [tumors] up to 2.5 cm in DCIS, we saw that, in reality, the patients enrolled had very small DCIS. So I’m wondering if it’s perhaps that it’s related to the fact that patients that were enrolled in these studies had really low-risk features and perhaps just had a lower risk of contralateral breast events as compared to a broader population of patients with DCIS,” she said.

The analysis by Wright and colleagues was supported by grants from the National Cancer Institute. Wright reported receiving honoraria from ASTRO and PER. Sawyer disclosed receiving grants/research support from Pfizer, Seagen, and IQIVIA. Kaklamani disclosed serving as a speaker and/or consultant for AstraZeneca, Celldex Therapeutics, Daiichi Sankyo, Genentech, Gilead, Lilly, Menarini, and Novartis and receiving research support from Eisai.

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

— For patients with so-called “good-risk” ductal carcinoma in situ (DCIS) who did not have radiation therapy after breast-conserving surgery, adjuvant tamoxifen reduced their overall risks for invasive recurrence, but not their risks for recurrence in either the same or contralateral breast.

These findings come from an exploratory analysis of combined data from two clinical trials. They suggest that, for this select group of patients, the choice to forgo radiation following definitive surgery may be an acceptable option, assuming that they follow a full course of endocrine therapy.

“In the absence of survival impact for adjuvant therapy, the decision to recommend radiation therapy or endocrine therapy should be part of a shared decision process, and I think that this data helps us provide clearer data points to our patients to help them make choices between endocrine therapy and radiation therapy in the setting of good-risk [ductal carcinoma in situ],” said Jean L. Wright, MD, from the University of North Carolina at Chapel Hill.

She presented the findings in an oral abstract session and media briefing at San Antonio Breast Cancer Symposium (SABCS) 2024.

 

Trial Results Combined

Wright and colleagues looked at pooled data from two clinical trials that enrolled patients with low- or intermediate-grade DCIS with tumor size no larger than 2.5 cm, grade 1 or 2 lesions, and with surgical margins ≥ 3 mm.

The trials included NRG/RTOG 9804, with 317 patients who fit the “good-risk category,” and ECOG-ACRIN E5194, which included a cohort of 561 patients that met the good-risk definition used for the exploratory analysis.

In each trial, tamoxifen use was optional, and choices were tracked. In the NRG/RTOG trial, 66% of patients used tamoxifen and 34% did not. The respective percentages in the ECOG/ACRIN trial were 30% and 70%.

The majority of patients were adherent to the 5-year prescribed course of tamoxifen, Wright said.

 

Analysis Details

In the combined data, the median age of patients who used tamoxifen vs who did not use tamoxifen was 58 vs 61 years.

In all, 23% of women in both the tamoxifen yes or no groups were premenopausal, with the remainder either postmenopausal or of unknown menopausal status.

After a median follow-up of 14.85 years, the rate of 15-year ipsilateral breast recurrence (IBR) was 19% for patients who did not receive tamoxifen vs 11.4% for those who did. This translated into a hazard ratio for IBR on tamoxifen of 0.52 (P = .001).

Tamoxifen also reduced the risk for invasive recurrence in the same breast, with a 15-year invasive IBR rate of 11.5% in the no tamoxifen group vs 6% in the yes tamoxifen group.

However, as noted before, tamoxifen use was not associated with significant reduction in the risk for noninvasive DCIS recurrence in the same breast, as evidenced by a 15-year DCIS IBR rate of 8.1% without tamoxifen and 5.5% with tamoxifen, a difference that did not reach statistical significance.

 

A Surprising Result

One finding from the data that seemed to defy clinical wisdom was that tamoxifen use did not appear to significantly reduce the risk for events in the other breast. The 15-year rate of contralateral breast events was 8.8% in the no-tamoxifen group vs 5.6% in the yes tamoxifen group, a difference that was not statically significant.

“It was surprising that there was so little effect on contralateral disease,” commented Elinor Sawyer, MBBS, PhD, the invited discussant.

“But I think it’s really important, this decrease in ipsilateral invasive recurrence [with tamoxifen] because there are studies such as the Sloane study from the United Kingdom that show that if you develop an invasive recurrence after DCIS, you have a worse survival than those who develop a pure DCIS recurrence,” she said.

At the media briefing held prior to Wright’s presentation, moderator Virginia Kaklamani, MD, leader of the breast cancer program at UT Health San Antonio in Texas, also said that she found it surprising that tamoxifen did not reduce risk for contralateral breast cancer “since every study that we’ve done has shown that.”

“I also found that result a little bit surprising,” Wright agreed.

“I think the main feature that we want to focus on is that this was a group of patients with a very clear inclusion criteria of this good-risk DCIS, and even though the definition of good-risk DCIS included patients with [tumors] up to 2.5 cm in DCIS, we saw that, in reality, the patients enrolled had very small DCIS. So I’m wondering if it’s perhaps that it’s related to the fact that patients that were enrolled in these studies had really low-risk features and perhaps just had a lower risk of contralateral breast events as compared to a broader population of patients with DCIS,” she said.

The analysis by Wright and colleagues was supported by grants from the National Cancer Institute. Wright reported receiving honoraria from ASTRO and PER. Sawyer disclosed receiving grants/research support from Pfizer, Seagen, and IQIVIA. Kaklamani disclosed serving as a speaker and/or consultant for AstraZeneca, Celldex Therapeutics, Daiichi Sankyo, Genentech, Gilead, Lilly, Menarini, and Novartis and receiving research support from Eisai.

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

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Imlunestrant Shows PFS Benefit in Advanced Breast Cancer

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— Second-line treatment with imlunestrant improved progression-free survival compared with standard endocrine monotherapy in patients with advanced estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer who had ESR1 mutations, according to recent findings from the EMBER-3 trial.

This progression-free survival benefit with imlunestrant did not extend to the overall population, but a combination of imlunestrant plus abemaciclib did lead to a significant improvement in progression-free survival compared with imlunestrant alone, regardless of patients’ ESR1 mutation status.

Lead author Komal Jhaveri, MD, a breast oncologist at Memorial Sloan Kettering Cancer Center in New York City, called the findings “encouraging.”

The phase 3 results raise the possibility of a second-line all-oral targeted therapy option for patients with ER–positive, HER2–negative advanced breast cancer, said Jhaveri, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024, which were published simultaneously in The New England Journal of Medicine.

However, outside experts provided a note of caution that the trial design may limit how relevant the findings are to clinical practice.

First-line treatment for advanced ER–positive, HER2–negative breast cancer includes an aromatase inhibitor, such as exemestane, and a CDK4/6 inhibitor, such as abemaciclib. However, an ESR1 mutation may develop, which can undermine the effectiveness of the aromatase inhibitor. These patients may swap in a selective estrogen receptor degrader (SERD) — typically, the injectable fulvestrant — in place of the aromatase inhibitor.

Over the past several years, researchers have searched for a better agent than fulvestrant because this injectable drug has limited efficacy in patients with ESR1 mutations, and the monthly intramuscular shots are painful and inconvenient for patients.

The oral SERD imlunestrant is one such candidate.

The EMBER-3 trial initially randomized 661 patients after progression/recurrence evenly to either imlunestrant monotherapy (400 mg once daily) or a standard treatment arm that included either exemestane or fulvestrant, with 90% of these patients receiving fulvestrant. Investigators added a third combination arm shortly after the trial started, which included 213 patients who received imlunestrant plus abemaciclib.

About 60% of the overall population had received prior CDK4/6 inhibitors, primarily palbociclib and ribociclib. About 37% of the study population had ESR1 mutations.

Among patients with ESR1 mutations, imlunestrant monotherapy led to a significant improvement in median progression-free survival of 5.5 months vs 3.8 months in the standard care arm (P < .001). Among all patients, however, progression-free survival was no different between the two arms — 5.6 months in the imlunestrant group vs 5.5 months in the standard care group.

When comparing the two treatment arms in the overall population, the median progression-free survival was significantly better in patients who received imlunestrant plus abemaciclib — 9.4 months vs 5.5 months in the imlunestrant group (hazard ratio [HR] for progression or death, 0.57; P < .001). The progression-free survival benefit held across most patient subgroups, regardless of ESR1 mutation status, as well as among patients who had received a CDK4/6 inhibitor previously.

Data from other studies presented at SABCS indicate that another SERD, elacestrant, in combination with abemaciclib, may provide a similar progression-free survival benefit in this patient population. Elacestrant was approved by the US Food and Drug Administration (FDA) in January 2023 for second-line treatment of patients with advanced breast cancer and ESR1 mutations.

The EMBER trial also reported early overall survival findings. Although immature, overall survival trends favored imlunestrant over the standard treatment. The estimated overall survival at 18 months was 77% in the imlunestrant group and 58.6% in the standard therapy group among patients with ESR1 mutations (HR, 0.55), and 78.6% in the imlunestrant group vs 71.8% in the standard-therapy group for all patients (HR, 0.69).

Common all-grade adverse events with imlunestrant vs standard therapy included fatigue (22.6% vs 13.3%), diarrhea (21.4% vs 11.7%), and nausea (17% vs 13%). Grade 3 or higher anemia and neutropenia were low and similar in both arms.

All-grade diarrhea (86%) and nausea (49%) were more common with the combination of imlunestrant and abemaciclib.

The incidence of grade 3 or higher events was 17% with imlunestrant monotherapy, 21% for standard treatment, and 49% for imlunestrant plus abemaciclib.

EMBER-3 discussant Harold Burstein, MD, PhD, a breast oncologist at the Dana-Farber Cancer Institute, Boston, said that, overall, oral SERDs are starting to “break out from the ESR1 mutation box,” perhaps reflecting the idea that an agent more active than fulvestrant in combination with a non-cross–resistant CDK4/6 inhibitor like abemaciclib might lead to a better long-term outcome, regardless of ESR1 status.

A major limit of EMBER-3, however, is that it did not compare imlunestrant/abemaciclib with fulvestrant/abemaciclib, which would have been a true standard-of-care control, said Burstein.

Kathy Miller, MD, a breast oncologist at Indiana University, Indianapolis, agreed.

She was also concerned about the use of monotherapy in the standard care arm.

“Monotherapy hormone therapy is not what people would be treated with,” Miller said. Patients would typically get fulvestrant with either a targeted therapy or everolimus.

Without appropriate controls, “the data are impossible to interpret” in the context of current practice, Miller told Medscape Medical News.

Eli Lilly, maker of imlunestrant, funded, designed, and largely conducted the trial. Jhaveri is a consultant and researcher for the company. Burstein and Miller had no disclosures. Miller is an editorial advisor for Medscape Oncology.
 

A version of this article appeared on Medscape.com.

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— Second-line treatment with imlunestrant improved progression-free survival compared with standard endocrine monotherapy in patients with advanced estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer who had ESR1 mutations, according to recent findings from the EMBER-3 trial.

This progression-free survival benefit with imlunestrant did not extend to the overall population, but a combination of imlunestrant plus abemaciclib did lead to a significant improvement in progression-free survival compared with imlunestrant alone, regardless of patients’ ESR1 mutation status.

Lead author Komal Jhaveri, MD, a breast oncologist at Memorial Sloan Kettering Cancer Center in New York City, called the findings “encouraging.”

The phase 3 results raise the possibility of a second-line all-oral targeted therapy option for patients with ER–positive, HER2–negative advanced breast cancer, said Jhaveri, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024, which were published simultaneously in The New England Journal of Medicine.

However, outside experts provided a note of caution that the trial design may limit how relevant the findings are to clinical practice.

First-line treatment for advanced ER–positive, HER2–negative breast cancer includes an aromatase inhibitor, such as exemestane, and a CDK4/6 inhibitor, such as abemaciclib. However, an ESR1 mutation may develop, which can undermine the effectiveness of the aromatase inhibitor. These patients may swap in a selective estrogen receptor degrader (SERD) — typically, the injectable fulvestrant — in place of the aromatase inhibitor.

Over the past several years, researchers have searched for a better agent than fulvestrant because this injectable drug has limited efficacy in patients with ESR1 mutations, and the monthly intramuscular shots are painful and inconvenient for patients.

The oral SERD imlunestrant is one such candidate.

The EMBER-3 trial initially randomized 661 patients after progression/recurrence evenly to either imlunestrant monotherapy (400 mg once daily) or a standard treatment arm that included either exemestane or fulvestrant, with 90% of these patients receiving fulvestrant. Investigators added a third combination arm shortly after the trial started, which included 213 patients who received imlunestrant plus abemaciclib.

About 60% of the overall population had received prior CDK4/6 inhibitors, primarily palbociclib and ribociclib. About 37% of the study population had ESR1 mutations.

Among patients with ESR1 mutations, imlunestrant monotherapy led to a significant improvement in median progression-free survival of 5.5 months vs 3.8 months in the standard care arm (P < .001). Among all patients, however, progression-free survival was no different between the two arms — 5.6 months in the imlunestrant group vs 5.5 months in the standard care group.

When comparing the two treatment arms in the overall population, the median progression-free survival was significantly better in patients who received imlunestrant plus abemaciclib — 9.4 months vs 5.5 months in the imlunestrant group (hazard ratio [HR] for progression or death, 0.57; P < .001). The progression-free survival benefit held across most patient subgroups, regardless of ESR1 mutation status, as well as among patients who had received a CDK4/6 inhibitor previously.

Data from other studies presented at SABCS indicate that another SERD, elacestrant, in combination with abemaciclib, may provide a similar progression-free survival benefit in this patient population. Elacestrant was approved by the US Food and Drug Administration (FDA) in January 2023 for second-line treatment of patients with advanced breast cancer and ESR1 mutations.

The EMBER trial also reported early overall survival findings. Although immature, overall survival trends favored imlunestrant over the standard treatment. The estimated overall survival at 18 months was 77% in the imlunestrant group and 58.6% in the standard therapy group among patients with ESR1 mutations (HR, 0.55), and 78.6% in the imlunestrant group vs 71.8% in the standard-therapy group for all patients (HR, 0.69).

Common all-grade adverse events with imlunestrant vs standard therapy included fatigue (22.6% vs 13.3%), diarrhea (21.4% vs 11.7%), and nausea (17% vs 13%). Grade 3 or higher anemia and neutropenia were low and similar in both arms.

All-grade diarrhea (86%) and nausea (49%) were more common with the combination of imlunestrant and abemaciclib.

The incidence of grade 3 or higher events was 17% with imlunestrant monotherapy, 21% for standard treatment, and 49% for imlunestrant plus abemaciclib.

EMBER-3 discussant Harold Burstein, MD, PhD, a breast oncologist at the Dana-Farber Cancer Institute, Boston, said that, overall, oral SERDs are starting to “break out from the ESR1 mutation box,” perhaps reflecting the idea that an agent more active than fulvestrant in combination with a non-cross–resistant CDK4/6 inhibitor like abemaciclib might lead to a better long-term outcome, regardless of ESR1 status.

A major limit of EMBER-3, however, is that it did not compare imlunestrant/abemaciclib with fulvestrant/abemaciclib, which would have been a true standard-of-care control, said Burstein.

Kathy Miller, MD, a breast oncologist at Indiana University, Indianapolis, agreed.

She was also concerned about the use of monotherapy in the standard care arm.

“Monotherapy hormone therapy is not what people would be treated with,” Miller said. Patients would typically get fulvestrant with either a targeted therapy or everolimus.

Without appropriate controls, “the data are impossible to interpret” in the context of current practice, Miller told Medscape Medical News.

Eli Lilly, maker of imlunestrant, funded, designed, and largely conducted the trial. Jhaveri is a consultant and researcher for the company. Burstein and Miller had no disclosures. Miller is an editorial advisor for Medscape Oncology.
 

A version of this article appeared on Medscape.com.

— Second-line treatment with imlunestrant improved progression-free survival compared with standard endocrine monotherapy in patients with advanced estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer who had ESR1 mutations, according to recent findings from the EMBER-3 trial.

This progression-free survival benefit with imlunestrant did not extend to the overall population, but a combination of imlunestrant plus abemaciclib did lead to a significant improvement in progression-free survival compared with imlunestrant alone, regardless of patients’ ESR1 mutation status.

Lead author Komal Jhaveri, MD, a breast oncologist at Memorial Sloan Kettering Cancer Center in New York City, called the findings “encouraging.”

The phase 3 results raise the possibility of a second-line all-oral targeted therapy option for patients with ER–positive, HER2–negative advanced breast cancer, said Jhaveri, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024, which were published simultaneously in The New England Journal of Medicine.

However, outside experts provided a note of caution that the trial design may limit how relevant the findings are to clinical practice.

First-line treatment for advanced ER–positive, HER2–negative breast cancer includes an aromatase inhibitor, such as exemestane, and a CDK4/6 inhibitor, such as abemaciclib. However, an ESR1 mutation may develop, which can undermine the effectiveness of the aromatase inhibitor. These patients may swap in a selective estrogen receptor degrader (SERD) — typically, the injectable fulvestrant — in place of the aromatase inhibitor.

Over the past several years, researchers have searched for a better agent than fulvestrant because this injectable drug has limited efficacy in patients with ESR1 mutations, and the monthly intramuscular shots are painful and inconvenient for patients.

The oral SERD imlunestrant is one such candidate.

The EMBER-3 trial initially randomized 661 patients after progression/recurrence evenly to either imlunestrant monotherapy (400 mg once daily) or a standard treatment arm that included either exemestane or fulvestrant, with 90% of these patients receiving fulvestrant. Investigators added a third combination arm shortly after the trial started, which included 213 patients who received imlunestrant plus abemaciclib.

About 60% of the overall population had received prior CDK4/6 inhibitors, primarily palbociclib and ribociclib. About 37% of the study population had ESR1 mutations.

Among patients with ESR1 mutations, imlunestrant monotherapy led to a significant improvement in median progression-free survival of 5.5 months vs 3.8 months in the standard care arm (P < .001). Among all patients, however, progression-free survival was no different between the two arms — 5.6 months in the imlunestrant group vs 5.5 months in the standard care group.

When comparing the two treatment arms in the overall population, the median progression-free survival was significantly better in patients who received imlunestrant plus abemaciclib — 9.4 months vs 5.5 months in the imlunestrant group (hazard ratio [HR] for progression or death, 0.57; P < .001). The progression-free survival benefit held across most patient subgroups, regardless of ESR1 mutation status, as well as among patients who had received a CDK4/6 inhibitor previously.

Data from other studies presented at SABCS indicate that another SERD, elacestrant, in combination with abemaciclib, may provide a similar progression-free survival benefit in this patient population. Elacestrant was approved by the US Food and Drug Administration (FDA) in January 2023 for second-line treatment of patients with advanced breast cancer and ESR1 mutations.

The EMBER trial also reported early overall survival findings. Although immature, overall survival trends favored imlunestrant over the standard treatment. The estimated overall survival at 18 months was 77% in the imlunestrant group and 58.6% in the standard therapy group among patients with ESR1 mutations (HR, 0.55), and 78.6% in the imlunestrant group vs 71.8% in the standard-therapy group for all patients (HR, 0.69).

Common all-grade adverse events with imlunestrant vs standard therapy included fatigue (22.6% vs 13.3%), diarrhea (21.4% vs 11.7%), and nausea (17% vs 13%). Grade 3 or higher anemia and neutropenia were low and similar in both arms.

All-grade diarrhea (86%) and nausea (49%) were more common with the combination of imlunestrant and abemaciclib.

The incidence of grade 3 or higher events was 17% with imlunestrant monotherapy, 21% for standard treatment, and 49% for imlunestrant plus abemaciclib.

EMBER-3 discussant Harold Burstein, MD, PhD, a breast oncologist at the Dana-Farber Cancer Institute, Boston, said that, overall, oral SERDs are starting to “break out from the ESR1 mutation box,” perhaps reflecting the idea that an agent more active than fulvestrant in combination with a non-cross–resistant CDK4/6 inhibitor like abemaciclib might lead to a better long-term outcome, regardless of ESR1 status.

A major limit of EMBER-3, however, is that it did not compare imlunestrant/abemaciclib with fulvestrant/abemaciclib, which would have been a true standard-of-care control, said Burstein.

Kathy Miller, MD, a breast oncologist at Indiana University, Indianapolis, agreed.

She was also concerned about the use of monotherapy in the standard care arm.

“Monotherapy hormone therapy is not what people would be treated with,” Miller said. Patients would typically get fulvestrant with either a targeted therapy or everolimus.

Without appropriate controls, “the data are impossible to interpret” in the context of current practice, Miller told Medscape Medical News.

Eli Lilly, maker of imlunestrant, funded, designed, and largely conducted the trial. Jhaveri is a consultant and researcher for the company. Burstein and Miller had no disclosures. Miller is an editorial advisor for Medscape Oncology.
 

A version of this article appeared on Medscape.com.

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What to Know About Sexually Transmitted Ringworm

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Ringworm (also known as tinea, jock itch, or athlete’s foot) is a common infection caused by dermatophyte fungi, known to affect skin, hair, or nails. It causes skin infections that are typically mild and are often treated with topical antifungals.

However, in recent years, newly emerging dermatophyte strains have been causing more severe and harder-to-treat ringworm. Notably, one emerging strain, Trichophyton mentagrophytes genotype VII(TMVII), is associated with sexual contact. In recent years, TMVII infections linked to sexual contact have been reported among men who have sex with men in Europe and in travelers returning from Southeast Asia. The first US case of TMVII was reported in June 2024, after which public health authorities were alerted to additional cases; all were associated with recent sexual contact. Other dermatophyte species have also been reported to cause ringworm transmitted through sexual contact. 

Here are some key points to know about sexually transmitted ringworm. 

Tell me more about sexually transmitted ringworm: What is causing it?

Skin-to-skin contact is a common mode of ringworm transmission. In recent years, transmission of ringworm via intimate or sexual contact has been increasingly recognized. However, clinicians may not immediately consider ringworm when evaluating genital, facial, or perianal lesions. Infections with sexually transmitted TMVII commonly cause lesions on anatomical sites that may be exposed during intimate or sexual contact, such as the face, genitals, and perianal region. Sexual transmission of TMVII has been reported in Europe, predominantly among men who have sex with men, for several years. Other dermatophyte strains have been reported in association with sexual contact, including the emerging strain Trichophyton indotineae. However, sexual transmission is not the main mode of transmission for T indotineae and other dermatophyte strains. 

When should clinicians suspect a potential case of sexually transmitted ringworm?

Providers should consider sexually transmitted ringworm when seeing ringworm in locations associated with intimate contact (for example, a rash on or around the genitals, perianal area, or mouth). 

The typical appearance of ringworm is a raised, ring-like, erythematous rash with a scaly border that grows over time. The rash may appear pink, brown, or gray on different types of skin. Patients may note itching and flaking of the rash. In areas with hair such as the beard area, ringworm can present as pustules and be associated with hair loss.

Emerging ringworm infections can present in atypical or more severe ways, including a highly inflammatory (painful, scarring, or otherwise severe) rash, a rash affecting a large area or multiple sites, nodules, and pustules. 

Sexually transmitted ringworm may be considered based on sexual history and recent sexual contact with someone with known TMVII. Recent history of travel to a region with reported sexually transmitted ringworm may increase suspicion of TMVII. In patients with a travel history to South Asia, T indotineae should be considered, especially if the rash does not improve with oral terbinafine

How can testing help guide the diagnosis of sexually transmitted ringworm infection?

When evaluating a rash that may represent ringworm, providers should use a confirmatory test such as potassium hydroxide (KOH) preparation when possible. KOH prep can confirm the presence of a fungus that causes ringworm, but it does not identify the species or type of ringworm. Testing such as fungal culture and molecular testing can help identify specific types of ringworm, but these tests are not often performed and may take a long time to yield results.

Routine fungal cultures cannot identify TMVII and T indotineae; these tests may identify the genus Trichophyton, but only advanced molecular testing, which is available at selected US laboratories, can identify TMVII and T indotineae

We recommend confirmatory testing because ringworm can easily be misdiagnosed as skin conditions such as psoriasis or eczema. The use of topical steroids can worsen a ringworm infection, so clinicians should be cautious about treating a rash with topical steroids if the etiology is unclear. Treatment should not be delayed if testing is not available. 

Clinicians who suspect a case of TMVII infection or infection with another emerging type of severe or antifungal-resistant ringworm can contact the Centers for Disease Control and Prevention (CDC) at fungaloutbreaks@cdc.gov. More details on how clinicians can pursue testing to identify emerging strains of ringworm can be found on the American Academy of Dermatology (AAD) emerging diseases task force website. 

How should clinicians treat and manage sexually transmitted ringworm? 

If TMVII infection is suspected, providers can consider starting empirical treatment with oral terbinafine. Although data are limited, experience from case series suggests that TMVII may require oral antifungal treatment because it can cause severe skin infections and often does not improve with topical antifungals. Clinicians should advise patients that they may need prolonged treatment courses until the rash resolves, with possible need for treatment courses of 6-8 weeks or longer. 

Any diagnosis of a sexually transmitted infection is an opportunity to engage patients in comprehensive sexual health services. Patients with suspected sexually transmitted ringworm should be evaluated for HIV and other sexually transmitted infections, including syphilischlamydia, and gonorrhea; clinicians should discuss and facilitate access to other preventive services, such as HIV pre-exposure prophylaxis if the patient is HIV negative and at risk for HIV. Patients should also notify their partner(s) about the diagnosis. 

Is sexually transmitted ringworm a public health concern? 

It is important to know that very few cases of TMVII have been reported in the United States thus far. CDC continues to monitor emerging dermatophyte strains because these types of ringworm can cause more severe or difficult-to-treat infections. Clinicians should be aware of the potential severity of sexually transmitted ringworm infections and of how diagnosis and treatment of these infections may differ from typical management of ringworm.

So far, TMVII, the dermatophyte strain most associated with spread through sexual contact, has not been documented to have antifungal resistance. More rarely, sexually transmitted ringworm may be caused by other emerging dermatophyte strains that are antifungal resistant, such as T indotineaeItraconazole is the recommended first-line treatment for T indotineae infections. 

How can clinicians counsel patients with sexually transmitted ringworm?

Ringworm can spread with skin-to-skin contact, so patients should avoid such contact with others while they have a rash. They should also avoid sharing personal items (such as razors or towels) and clothing, and launder their clothing, towels, and bedding in a high heat cycle. 

People can reduce their risk of getting all types of ringworm infection by keeping their skin clean and dry, changing their socks and underwear daily, and wearing sandals in public locker rooms and other public spaces. People should avoid skin-to-skin contact with anyone with ringworm or an unexplained rash. Before having sex, people can check in with their partners and be aware of unexplained rashes on their partners’ bodies.

Where can clinicians go to learn more about sexually transmitted and other emerging types of ringworm?

CDC has partnered with the AAD to create set of online resources for clinicians for diagnosing and managing emerging dermatophyte infections. Clinicians who suspect or confirm antimicrobial resistant ringworm infection are also encouraged to submit cases to the AAD’s Emerging Diseases Registry. Clinicians wanting further guidance on how to manage suspected or confirmed ringworm infection with an emerging dermatophyte strain can also contact the CDC at fungaloutbreaks@cdc.gov. Useful information on emerging dermatophyte infections for providers and patients is also available on CDC’s website.

Relevant Reading

Zucker J et al. MMWR Morb Mortal Wkly Rep. 2024;73:985-988.Spivack S et al. Emerg Infect Dis. 2024;30:807-809.Jabet A et al. Emerg Infect Dis. 2023;29:1411-1414.

A version of this article appeared on Medscape.com. 

Dr Anand is Epidemic Intelligence Service Officer, Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia. Dr Gold is Medical Officer, Mycotic Diseases Branch, Centers for Disease Control and Prevention. Dr Quilter is Medical Officer, Division of STD Prevention, Centers for Disease Control and Prevention. None reported any relevant conflicts of interest. 

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Ringworm (also known as tinea, jock itch, or athlete’s foot) is a common infection caused by dermatophyte fungi, known to affect skin, hair, or nails. It causes skin infections that are typically mild and are often treated with topical antifungals.

However, in recent years, newly emerging dermatophyte strains have been causing more severe and harder-to-treat ringworm. Notably, one emerging strain, Trichophyton mentagrophytes genotype VII(TMVII), is associated with sexual contact. In recent years, TMVII infections linked to sexual contact have been reported among men who have sex with men in Europe and in travelers returning from Southeast Asia. The first US case of TMVII was reported in June 2024, after which public health authorities were alerted to additional cases; all were associated with recent sexual contact. Other dermatophyte species have also been reported to cause ringworm transmitted through sexual contact. 

Here are some key points to know about sexually transmitted ringworm. 

Tell me more about sexually transmitted ringworm: What is causing it?

Skin-to-skin contact is a common mode of ringworm transmission. In recent years, transmission of ringworm via intimate or sexual contact has been increasingly recognized. However, clinicians may not immediately consider ringworm when evaluating genital, facial, or perianal lesions. Infections with sexually transmitted TMVII commonly cause lesions on anatomical sites that may be exposed during intimate or sexual contact, such as the face, genitals, and perianal region. Sexual transmission of TMVII has been reported in Europe, predominantly among men who have sex with men, for several years. Other dermatophyte strains have been reported in association with sexual contact, including the emerging strain Trichophyton indotineae. However, sexual transmission is not the main mode of transmission for T indotineae and other dermatophyte strains. 

When should clinicians suspect a potential case of sexually transmitted ringworm?

Providers should consider sexually transmitted ringworm when seeing ringworm in locations associated with intimate contact (for example, a rash on or around the genitals, perianal area, or mouth). 

The typical appearance of ringworm is a raised, ring-like, erythematous rash with a scaly border that grows over time. The rash may appear pink, brown, or gray on different types of skin. Patients may note itching and flaking of the rash. In areas with hair such as the beard area, ringworm can present as pustules and be associated with hair loss.

Emerging ringworm infections can present in atypical or more severe ways, including a highly inflammatory (painful, scarring, or otherwise severe) rash, a rash affecting a large area or multiple sites, nodules, and pustules. 

Sexually transmitted ringworm may be considered based on sexual history and recent sexual contact with someone with known TMVII. Recent history of travel to a region with reported sexually transmitted ringworm may increase suspicion of TMVII. In patients with a travel history to South Asia, T indotineae should be considered, especially if the rash does not improve with oral terbinafine

How can testing help guide the diagnosis of sexually transmitted ringworm infection?

When evaluating a rash that may represent ringworm, providers should use a confirmatory test such as potassium hydroxide (KOH) preparation when possible. KOH prep can confirm the presence of a fungus that causes ringworm, but it does not identify the species or type of ringworm. Testing such as fungal culture and molecular testing can help identify specific types of ringworm, but these tests are not often performed and may take a long time to yield results.

Routine fungal cultures cannot identify TMVII and T indotineae; these tests may identify the genus Trichophyton, but only advanced molecular testing, which is available at selected US laboratories, can identify TMVII and T indotineae

We recommend confirmatory testing because ringworm can easily be misdiagnosed as skin conditions such as psoriasis or eczema. The use of topical steroids can worsen a ringworm infection, so clinicians should be cautious about treating a rash with topical steroids if the etiology is unclear. Treatment should not be delayed if testing is not available. 

Clinicians who suspect a case of TMVII infection or infection with another emerging type of severe or antifungal-resistant ringworm can contact the Centers for Disease Control and Prevention (CDC) at fungaloutbreaks@cdc.gov. More details on how clinicians can pursue testing to identify emerging strains of ringworm can be found on the American Academy of Dermatology (AAD) emerging diseases task force website. 

How should clinicians treat and manage sexually transmitted ringworm? 

If TMVII infection is suspected, providers can consider starting empirical treatment with oral terbinafine. Although data are limited, experience from case series suggests that TMVII may require oral antifungal treatment because it can cause severe skin infections and often does not improve with topical antifungals. Clinicians should advise patients that they may need prolonged treatment courses until the rash resolves, with possible need for treatment courses of 6-8 weeks or longer. 

Any diagnosis of a sexually transmitted infection is an opportunity to engage patients in comprehensive sexual health services. Patients with suspected sexually transmitted ringworm should be evaluated for HIV and other sexually transmitted infections, including syphilischlamydia, and gonorrhea; clinicians should discuss and facilitate access to other preventive services, such as HIV pre-exposure prophylaxis if the patient is HIV negative and at risk for HIV. Patients should also notify their partner(s) about the diagnosis. 

Is sexually transmitted ringworm a public health concern? 

It is important to know that very few cases of TMVII have been reported in the United States thus far. CDC continues to monitor emerging dermatophyte strains because these types of ringworm can cause more severe or difficult-to-treat infections. Clinicians should be aware of the potential severity of sexually transmitted ringworm infections and of how diagnosis and treatment of these infections may differ from typical management of ringworm.

So far, TMVII, the dermatophyte strain most associated with spread through sexual contact, has not been documented to have antifungal resistance. More rarely, sexually transmitted ringworm may be caused by other emerging dermatophyte strains that are antifungal resistant, such as T indotineaeItraconazole is the recommended first-line treatment for T indotineae infections. 

How can clinicians counsel patients with sexually transmitted ringworm?

Ringworm can spread with skin-to-skin contact, so patients should avoid such contact with others while they have a rash. They should also avoid sharing personal items (such as razors or towels) and clothing, and launder their clothing, towels, and bedding in a high heat cycle. 

People can reduce their risk of getting all types of ringworm infection by keeping their skin clean and dry, changing their socks and underwear daily, and wearing sandals in public locker rooms and other public spaces. People should avoid skin-to-skin contact with anyone with ringworm or an unexplained rash. Before having sex, people can check in with their partners and be aware of unexplained rashes on their partners’ bodies.

Where can clinicians go to learn more about sexually transmitted and other emerging types of ringworm?

CDC has partnered with the AAD to create set of online resources for clinicians for diagnosing and managing emerging dermatophyte infections. Clinicians who suspect or confirm antimicrobial resistant ringworm infection are also encouraged to submit cases to the AAD’s Emerging Diseases Registry. Clinicians wanting further guidance on how to manage suspected or confirmed ringworm infection with an emerging dermatophyte strain can also contact the CDC at fungaloutbreaks@cdc.gov. Useful information on emerging dermatophyte infections for providers and patients is also available on CDC’s website.

Relevant Reading

Zucker J et al. MMWR Morb Mortal Wkly Rep. 2024;73:985-988.Spivack S et al. Emerg Infect Dis. 2024;30:807-809.Jabet A et al. Emerg Infect Dis. 2023;29:1411-1414.

A version of this article appeared on Medscape.com. 

Dr Anand is Epidemic Intelligence Service Officer, Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia. Dr Gold is Medical Officer, Mycotic Diseases Branch, Centers for Disease Control and Prevention. Dr Quilter is Medical Officer, Division of STD Prevention, Centers for Disease Control and Prevention. None reported any relevant conflicts of interest. 

Ringworm (also known as tinea, jock itch, or athlete’s foot) is a common infection caused by dermatophyte fungi, known to affect skin, hair, or nails. It causes skin infections that are typically mild and are often treated with topical antifungals.

However, in recent years, newly emerging dermatophyte strains have been causing more severe and harder-to-treat ringworm. Notably, one emerging strain, Trichophyton mentagrophytes genotype VII(TMVII), is associated with sexual contact. In recent years, TMVII infections linked to sexual contact have been reported among men who have sex with men in Europe and in travelers returning from Southeast Asia. The first US case of TMVII was reported in June 2024, after which public health authorities were alerted to additional cases; all were associated with recent sexual contact. Other dermatophyte species have also been reported to cause ringworm transmitted through sexual contact. 

Here are some key points to know about sexually transmitted ringworm. 

Tell me more about sexually transmitted ringworm: What is causing it?

Skin-to-skin contact is a common mode of ringworm transmission. In recent years, transmission of ringworm via intimate or sexual contact has been increasingly recognized. However, clinicians may not immediately consider ringworm when evaluating genital, facial, or perianal lesions. Infections with sexually transmitted TMVII commonly cause lesions on anatomical sites that may be exposed during intimate or sexual contact, such as the face, genitals, and perianal region. Sexual transmission of TMVII has been reported in Europe, predominantly among men who have sex with men, for several years. Other dermatophyte strains have been reported in association with sexual contact, including the emerging strain Trichophyton indotineae. However, sexual transmission is not the main mode of transmission for T indotineae and other dermatophyte strains. 

When should clinicians suspect a potential case of sexually transmitted ringworm?

Providers should consider sexually transmitted ringworm when seeing ringworm in locations associated with intimate contact (for example, a rash on or around the genitals, perianal area, or mouth). 

The typical appearance of ringworm is a raised, ring-like, erythematous rash with a scaly border that grows over time. The rash may appear pink, brown, or gray on different types of skin. Patients may note itching and flaking of the rash. In areas with hair such as the beard area, ringworm can present as pustules and be associated with hair loss.

Emerging ringworm infections can present in atypical or more severe ways, including a highly inflammatory (painful, scarring, or otherwise severe) rash, a rash affecting a large area or multiple sites, nodules, and pustules. 

Sexually transmitted ringworm may be considered based on sexual history and recent sexual contact with someone with known TMVII. Recent history of travel to a region with reported sexually transmitted ringworm may increase suspicion of TMVII. In patients with a travel history to South Asia, T indotineae should be considered, especially if the rash does not improve with oral terbinafine

How can testing help guide the diagnosis of sexually transmitted ringworm infection?

When evaluating a rash that may represent ringworm, providers should use a confirmatory test such as potassium hydroxide (KOH) preparation when possible. KOH prep can confirm the presence of a fungus that causes ringworm, but it does not identify the species or type of ringworm. Testing such as fungal culture and molecular testing can help identify specific types of ringworm, but these tests are not often performed and may take a long time to yield results.

Routine fungal cultures cannot identify TMVII and T indotineae; these tests may identify the genus Trichophyton, but only advanced molecular testing, which is available at selected US laboratories, can identify TMVII and T indotineae

We recommend confirmatory testing because ringworm can easily be misdiagnosed as skin conditions such as psoriasis or eczema. The use of topical steroids can worsen a ringworm infection, so clinicians should be cautious about treating a rash with topical steroids if the etiology is unclear. Treatment should not be delayed if testing is not available. 

Clinicians who suspect a case of TMVII infection or infection with another emerging type of severe or antifungal-resistant ringworm can contact the Centers for Disease Control and Prevention (CDC) at fungaloutbreaks@cdc.gov. More details on how clinicians can pursue testing to identify emerging strains of ringworm can be found on the American Academy of Dermatology (AAD) emerging diseases task force website. 

How should clinicians treat and manage sexually transmitted ringworm? 

If TMVII infection is suspected, providers can consider starting empirical treatment with oral terbinafine. Although data are limited, experience from case series suggests that TMVII may require oral antifungal treatment because it can cause severe skin infections and often does not improve with topical antifungals. Clinicians should advise patients that they may need prolonged treatment courses until the rash resolves, with possible need for treatment courses of 6-8 weeks or longer. 

Any diagnosis of a sexually transmitted infection is an opportunity to engage patients in comprehensive sexual health services. Patients with suspected sexually transmitted ringworm should be evaluated for HIV and other sexually transmitted infections, including syphilischlamydia, and gonorrhea; clinicians should discuss and facilitate access to other preventive services, such as HIV pre-exposure prophylaxis if the patient is HIV negative and at risk for HIV. Patients should also notify their partner(s) about the diagnosis. 

Is sexually transmitted ringworm a public health concern? 

It is important to know that very few cases of TMVII have been reported in the United States thus far. CDC continues to monitor emerging dermatophyte strains because these types of ringworm can cause more severe or difficult-to-treat infections. Clinicians should be aware of the potential severity of sexually transmitted ringworm infections and of how diagnosis and treatment of these infections may differ from typical management of ringworm.

So far, TMVII, the dermatophyte strain most associated with spread through sexual contact, has not been documented to have antifungal resistance. More rarely, sexually transmitted ringworm may be caused by other emerging dermatophyte strains that are antifungal resistant, such as T indotineaeItraconazole is the recommended first-line treatment for T indotineae infections. 

How can clinicians counsel patients with sexually transmitted ringworm?

Ringworm can spread with skin-to-skin contact, so patients should avoid such contact with others while they have a rash. They should also avoid sharing personal items (such as razors or towels) and clothing, and launder their clothing, towels, and bedding in a high heat cycle. 

People can reduce their risk of getting all types of ringworm infection by keeping their skin clean and dry, changing their socks and underwear daily, and wearing sandals in public locker rooms and other public spaces. People should avoid skin-to-skin contact with anyone with ringworm or an unexplained rash. Before having sex, people can check in with their partners and be aware of unexplained rashes on their partners’ bodies.

Where can clinicians go to learn more about sexually transmitted and other emerging types of ringworm?

CDC has partnered with the AAD to create set of online resources for clinicians for diagnosing and managing emerging dermatophyte infections. Clinicians who suspect or confirm antimicrobial resistant ringworm infection are also encouraged to submit cases to the AAD’s Emerging Diseases Registry. Clinicians wanting further guidance on how to manage suspected or confirmed ringworm infection with an emerging dermatophyte strain can also contact the CDC at fungaloutbreaks@cdc.gov. Useful information on emerging dermatophyte infections for providers and patients is also available on CDC’s website.

Relevant Reading

Zucker J et al. MMWR Morb Mortal Wkly Rep. 2024;73:985-988.Spivack S et al. Emerg Infect Dis. 2024;30:807-809.Jabet A et al. Emerg Infect Dis. 2023;29:1411-1414.

A version of this article appeared on Medscape.com. 

Dr Anand is Epidemic Intelligence Service Officer, Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia. Dr Gold is Medical Officer, Mycotic Diseases Branch, Centers for Disease Control and Prevention. Dr Quilter is Medical Officer, Division of STD Prevention, Centers for Disease Control and Prevention. None reported any relevant conflicts of interest. 

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Malpractice in the Age of AI

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Instead of sitting behind a laptop during patient visits, the pediatrician directly faces the patient and parent, relying on an ambient artificial intelligence (AI) scribe to capture the conversation for the electronic health record (EHR). A geriatrician doing rounds at the senior living facility plugs each patient’s medications into an AI tool, checking for drug interactions. And a busy hospital radiology department runs all its emergency head CTs through an AI algorithm, triaging potential stroke patients to ensure they receive the highest priority. None of these physicians have been sued for malpractice for AI usage, but they wonder if they’re at risk.

In a recent Medscape report, AI Adoption in Healthcare, 224 physicians responded to the statement: “I want to do more with AI but I worry about malpractice risk if I move too fast.” Seventeen percent said that they strongly agreed while 23% said they agreed — a full 40% were concerned about using the technology for legal reasons.  

Malpractice and AI are on many minds in healthcare, especially in large health systems, Deepika Srivastava, chief operating officer at The Doctors Company, told this news organization. “AI is at the forefront of the conversation, and they’re [large health systems] raising questions. Larger systems want to protect themselves.” 

The good news is there’s currently no sign of legal action over the clinical use of AI. “We’re not seeing even a few AI-related suits just yet,” but the risk is growing, Srivastava said, “and that’s why we’re talking about it. The legal system will need to adapt to address the role of AI in healthcare.”

 

How Doctors Are Using AI

Healthcare is incorporating AI in multiple ways based on the type of tool and function needed. Narrow AI is popular in fields like radiology, comparing two large data sets to find differences between them. Narrow AI can help differentiate between normal and abnormal tissue, such as breast or lung tumors. Almost 900 AI health tools have Food and Drug Administration approval as of July 2024, discerning abnormalities and recognizing patterns better than many humans, said Robert Pearl, MD, author of ChatGPT, MD: How AI-Empowered Patients & Doctors Can Take Back Control of American Medicine and former CEO of The Permanente Medical Group.

Narrow AI can improve diagnostic speed and accuracy for other specialties, too, including dermatology and ophthalmology, Pearl said. “It’s less clear to me if it will be very beneficial in primary care, neurology, and psychiatry, areas of medicine that involve a lot of words.” In those specialties, some may use generative AI as a repository of resources. In clinical practice, ambient AI is also used to create health records based on patient/clinician conversations.

In clinical administration, AI is used for scheduling, billing, and submitting insurance claims. On the insurer side, denying claims based on AI algorithms has been at the heart of legal actions, making recent headlines. 

 

Malpractice Risks When Using AI

Accuracy and privacy should be at the top of the list for malpractice concerns with AI. With accuracy, liability could partially be determined by use type. If a diagnostic application makes the wrong diagnosis, “the company has legal accountability because it created and had to test it specific to the application that it’s being recommended for,” Pearl said. 

However, keeping a human in the loop is a smart move when using AI diagnostic tools. The physician should still choose the AI-suggested diagnosis or a different one. If it’s the wrong diagnosis, “it’s really hard to currently say where is the source of the error? Was it the physician? Was it the tool?” Srivastava added.

With an incorrect diagnosis by generative AI, liability is more apparent. “You’re taking that accountability,” Pearl said. Generative AI operates in a black box, predicting the correct answer based on information stored in a database. “Generative AI tries to draw a correlation between what it has seen and predicting the next output,” said Alex Shahrestani, managing partner of Promise Legal PLLC, a law firm in Austin, Texas. He serves on the State Bar of Texas’s Taskforce on AI and the Law and has participated in advisory groups related to AI policies with the National Institute of Standards and Technology. “A doctor should know to validate information given back to them by AI,” applying their own medical training and judgment.

Generative AI can provide ideas. Pearl shared a story about a surgeon who was unable to remove a breathing tube that was stuck in a patients’ throat at the end of a procedure. The surgeon checked ChatGPT in the operating room, finding a similar case. Adrenaline in the anesthetic restricted the blood vessels, causing the vocal cords to stick together. Following the AI information, the surgeon allowed more time for the anesthesia to diffuse. As it wore off, the vocal cords separated, easing the removal of the breathing tube. “That is the kind of expertise it can provide,” Pearl said.

Privacy is a common AI concern, but it may be more problematic than it should be. “Many think if you talk to an AI system, you’re surrendering personal information the model can learn from,” said Shahrestani. Platforms offer opt-outs. Even without opting out, the model won’t automatically ingest your interactions. That’s not a privacy feature, but a concern by the developer that the information may not help the model. 

“If you do use these opt-out mechanisms, and you have the requisite amount of confidentiality, you can use ChatGPT without too much concern about the patient information being released into the wild,” Shahrestani said. Or use systems with stricter requirements that keep all data on site.

 

Malpractice Insurance Policies and AI

Currently, malpractice policies do not specify AI coverage. “We don’t ask right now to list all the technology you’re using,” said Srivastava. Many EHR systems already incorporate AI. If a human provider is in the loop, already vetted and insured, “we should be okay when it comes to the risk of malpractice when doctors are using AI because it’s still the risk that we’re ensuring.”

Insurers are paying attention, though. “Traditional medical malpractice law does require re-evaluation because the rapid pace of AI development has outpaced the efforts to integrate it into the legal system,” Srivastava said.

Some, including Pearl, believe AI will actually lower the malpractice risk. Having more data points to consider can make doctors’ jobs faster, easier, and more accurate. “I believe the technology will decrease lawsuits, not increase them,” said Pearl.

 

Meanwhile, How Can Doctors Protect Themselves From an AI Malpractice Suit?

Know your tool: Providers should understand the tool they’re deploying, what it provides, how it was built and trained (including potential biases), how it was tested, and the guidelines for how to use it or not use it, said Srivastava. Evaluate each tool, use case, and risk separately. “Don’t just say it’s all AI.” 

With generative AI, users will have better success requesting information that has been available longer and is more widely accessed. “It’s more likely to come back correctly,” said Shahrestani. If the information sought is fairly new or not widespread, the tool may try to draw problematic conclusions. 

Document: “Document, document, document. Just making sure you have good documentation can really help you if litigation comes up and it’s related to the AI tools,” Srivastava said.

Try it out: “I recommend you use [generative AI] a lot so you understand its strengths and shortcomings,” said Shahrestani. “If you wait until things settle, you’ll be further behind.” 

Pretend you’re the patient and give the tool the information you’d give a doctor and see the results, said Pearl. It will provide you with an idea of what it can do. “No one would sue you because you went to the library to look up information in the textbooks,” he said — using generative AI is similar. Try the free versions first; if you begin relying on it more, the paid versions have better features and are inexpensive. 

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

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Instead of sitting behind a laptop during patient visits, the pediatrician directly faces the patient and parent, relying on an ambient artificial intelligence (AI) scribe to capture the conversation for the electronic health record (EHR). A geriatrician doing rounds at the senior living facility plugs each patient’s medications into an AI tool, checking for drug interactions. And a busy hospital radiology department runs all its emergency head CTs through an AI algorithm, triaging potential stroke patients to ensure they receive the highest priority. None of these physicians have been sued for malpractice for AI usage, but they wonder if they’re at risk.

In a recent Medscape report, AI Adoption in Healthcare, 224 physicians responded to the statement: “I want to do more with AI but I worry about malpractice risk if I move too fast.” Seventeen percent said that they strongly agreed while 23% said they agreed — a full 40% were concerned about using the technology for legal reasons.  

Malpractice and AI are on many minds in healthcare, especially in large health systems, Deepika Srivastava, chief operating officer at The Doctors Company, told this news organization. “AI is at the forefront of the conversation, and they’re [large health systems] raising questions. Larger systems want to protect themselves.” 

The good news is there’s currently no sign of legal action over the clinical use of AI. “We’re not seeing even a few AI-related suits just yet,” but the risk is growing, Srivastava said, “and that’s why we’re talking about it. The legal system will need to adapt to address the role of AI in healthcare.”

 

How Doctors Are Using AI

Healthcare is incorporating AI in multiple ways based on the type of tool and function needed. Narrow AI is popular in fields like radiology, comparing two large data sets to find differences between them. Narrow AI can help differentiate between normal and abnormal tissue, such as breast or lung tumors. Almost 900 AI health tools have Food and Drug Administration approval as of July 2024, discerning abnormalities and recognizing patterns better than many humans, said Robert Pearl, MD, author of ChatGPT, MD: How AI-Empowered Patients & Doctors Can Take Back Control of American Medicine and former CEO of The Permanente Medical Group.

Narrow AI can improve diagnostic speed and accuracy for other specialties, too, including dermatology and ophthalmology, Pearl said. “It’s less clear to me if it will be very beneficial in primary care, neurology, and psychiatry, areas of medicine that involve a lot of words.” In those specialties, some may use generative AI as a repository of resources. In clinical practice, ambient AI is also used to create health records based on patient/clinician conversations.

In clinical administration, AI is used for scheduling, billing, and submitting insurance claims. On the insurer side, denying claims based on AI algorithms has been at the heart of legal actions, making recent headlines. 

 

Malpractice Risks When Using AI

Accuracy and privacy should be at the top of the list for malpractice concerns with AI. With accuracy, liability could partially be determined by use type. If a diagnostic application makes the wrong diagnosis, “the company has legal accountability because it created and had to test it specific to the application that it’s being recommended for,” Pearl said. 

However, keeping a human in the loop is a smart move when using AI diagnostic tools. The physician should still choose the AI-suggested diagnosis or a different one. If it’s the wrong diagnosis, “it’s really hard to currently say where is the source of the error? Was it the physician? Was it the tool?” Srivastava added.

With an incorrect diagnosis by generative AI, liability is more apparent. “You’re taking that accountability,” Pearl said. Generative AI operates in a black box, predicting the correct answer based on information stored in a database. “Generative AI tries to draw a correlation between what it has seen and predicting the next output,” said Alex Shahrestani, managing partner of Promise Legal PLLC, a law firm in Austin, Texas. He serves on the State Bar of Texas’s Taskforce on AI and the Law and has participated in advisory groups related to AI policies with the National Institute of Standards and Technology. “A doctor should know to validate information given back to them by AI,” applying their own medical training and judgment.

Generative AI can provide ideas. Pearl shared a story about a surgeon who was unable to remove a breathing tube that was stuck in a patients’ throat at the end of a procedure. The surgeon checked ChatGPT in the operating room, finding a similar case. Adrenaline in the anesthetic restricted the blood vessels, causing the vocal cords to stick together. Following the AI information, the surgeon allowed more time for the anesthesia to diffuse. As it wore off, the vocal cords separated, easing the removal of the breathing tube. “That is the kind of expertise it can provide,” Pearl said.

Privacy is a common AI concern, but it may be more problematic than it should be. “Many think if you talk to an AI system, you’re surrendering personal information the model can learn from,” said Shahrestani. Platforms offer opt-outs. Even without opting out, the model won’t automatically ingest your interactions. That’s not a privacy feature, but a concern by the developer that the information may not help the model. 

“If you do use these opt-out mechanisms, and you have the requisite amount of confidentiality, you can use ChatGPT without too much concern about the patient information being released into the wild,” Shahrestani said. Or use systems with stricter requirements that keep all data on site.

 

Malpractice Insurance Policies and AI

Currently, malpractice policies do not specify AI coverage. “We don’t ask right now to list all the technology you’re using,” said Srivastava. Many EHR systems already incorporate AI. If a human provider is in the loop, already vetted and insured, “we should be okay when it comes to the risk of malpractice when doctors are using AI because it’s still the risk that we’re ensuring.”

Insurers are paying attention, though. “Traditional medical malpractice law does require re-evaluation because the rapid pace of AI development has outpaced the efforts to integrate it into the legal system,” Srivastava said.

Some, including Pearl, believe AI will actually lower the malpractice risk. Having more data points to consider can make doctors’ jobs faster, easier, and more accurate. “I believe the technology will decrease lawsuits, not increase them,” said Pearl.

 

Meanwhile, How Can Doctors Protect Themselves From an AI Malpractice Suit?

Know your tool: Providers should understand the tool they’re deploying, what it provides, how it was built and trained (including potential biases), how it was tested, and the guidelines for how to use it or not use it, said Srivastava. Evaluate each tool, use case, and risk separately. “Don’t just say it’s all AI.” 

With generative AI, users will have better success requesting information that has been available longer and is more widely accessed. “It’s more likely to come back correctly,” said Shahrestani. If the information sought is fairly new or not widespread, the tool may try to draw problematic conclusions. 

Document: “Document, document, document. Just making sure you have good documentation can really help you if litigation comes up and it’s related to the AI tools,” Srivastava said.

Try it out: “I recommend you use [generative AI] a lot so you understand its strengths and shortcomings,” said Shahrestani. “If you wait until things settle, you’ll be further behind.” 

Pretend you’re the patient and give the tool the information you’d give a doctor and see the results, said Pearl. It will provide you with an idea of what it can do. “No one would sue you because you went to the library to look up information in the textbooks,” he said — using generative AI is similar. Try the free versions first; if you begin relying on it more, the paid versions have better features and are inexpensive. 

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

Instead of sitting behind a laptop during patient visits, the pediatrician directly faces the patient and parent, relying on an ambient artificial intelligence (AI) scribe to capture the conversation for the electronic health record (EHR). A geriatrician doing rounds at the senior living facility plugs each patient’s medications into an AI tool, checking for drug interactions. And a busy hospital radiology department runs all its emergency head CTs through an AI algorithm, triaging potential stroke patients to ensure they receive the highest priority. None of these physicians have been sued for malpractice for AI usage, but they wonder if they’re at risk.

In a recent Medscape report, AI Adoption in Healthcare, 224 physicians responded to the statement: “I want to do more with AI but I worry about malpractice risk if I move too fast.” Seventeen percent said that they strongly agreed while 23% said they agreed — a full 40% were concerned about using the technology for legal reasons.  

Malpractice and AI are on many minds in healthcare, especially in large health systems, Deepika Srivastava, chief operating officer at The Doctors Company, told this news organization. “AI is at the forefront of the conversation, and they’re [large health systems] raising questions. Larger systems want to protect themselves.” 

The good news is there’s currently no sign of legal action over the clinical use of AI. “We’re not seeing even a few AI-related suits just yet,” but the risk is growing, Srivastava said, “and that’s why we’re talking about it. The legal system will need to adapt to address the role of AI in healthcare.”

 

How Doctors Are Using AI

Healthcare is incorporating AI in multiple ways based on the type of tool and function needed. Narrow AI is popular in fields like radiology, comparing two large data sets to find differences between them. Narrow AI can help differentiate between normal and abnormal tissue, such as breast or lung tumors. Almost 900 AI health tools have Food and Drug Administration approval as of July 2024, discerning abnormalities and recognizing patterns better than many humans, said Robert Pearl, MD, author of ChatGPT, MD: How AI-Empowered Patients & Doctors Can Take Back Control of American Medicine and former CEO of The Permanente Medical Group.

Narrow AI can improve diagnostic speed and accuracy for other specialties, too, including dermatology and ophthalmology, Pearl said. “It’s less clear to me if it will be very beneficial in primary care, neurology, and psychiatry, areas of medicine that involve a lot of words.” In those specialties, some may use generative AI as a repository of resources. In clinical practice, ambient AI is also used to create health records based on patient/clinician conversations.

In clinical administration, AI is used for scheduling, billing, and submitting insurance claims. On the insurer side, denying claims based on AI algorithms has been at the heart of legal actions, making recent headlines. 

 

Malpractice Risks When Using AI

Accuracy and privacy should be at the top of the list for malpractice concerns with AI. With accuracy, liability could partially be determined by use type. If a diagnostic application makes the wrong diagnosis, “the company has legal accountability because it created and had to test it specific to the application that it’s being recommended for,” Pearl said. 

However, keeping a human in the loop is a smart move when using AI diagnostic tools. The physician should still choose the AI-suggested diagnosis or a different one. If it’s the wrong diagnosis, “it’s really hard to currently say where is the source of the error? Was it the physician? Was it the tool?” Srivastava added.

With an incorrect diagnosis by generative AI, liability is more apparent. “You’re taking that accountability,” Pearl said. Generative AI operates in a black box, predicting the correct answer based on information stored in a database. “Generative AI tries to draw a correlation between what it has seen and predicting the next output,” said Alex Shahrestani, managing partner of Promise Legal PLLC, a law firm in Austin, Texas. He serves on the State Bar of Texas’s Taskforce on AI and the Law and has participated in advisory groups related to AI policies with the National Institute of Standards and Technology. “A doctor should know to validate information given back to them by AI,” applying their own medical training and judgment.

Generative AI can provide ideas. Pearl shared a story about a surgeon who was unable to remove a breathing tube that was stuck in a patients’ throat at the end of a procedure. The surgeon checked ChatGPT in the operating room, finding a similar case. Adrenaline in the anesthetic restricted the blood vessels, causing the vocal cords to stick together. Following the AI information, the surgeon allowed more time for the anesthesia to diffuse. As it wore off, the vocal cords separated, easing the removal of the breathing tube. “That is the kind of expertise it can provide,” Pearl said.

Privacy is a common AI concern, but it may be more problematic than it should be. “Many think if you talk to an AI system, you’re surrendering personal information the model can learn from,” said Shahrestani. Platforms offer opt-outs. Even without opting out, the model won’t automatically ingest your interactions. That’s not a privacy feature, but a concern by the developer that the information may not help the model. 

“If you do use these opt-out mechanisms, and you have the requisite amount of confidentiality, you can use ChatGPT without too much concern about the patient information being released into the wild,” Shahrestani said. Or use systems with stricter requirements that keep all data on site.

 

Malpractice Insurance Policies and AI

Currently, malpractice policies do not specify AI coverage. “We don’t ask right now to list all the technology you’re using,” said Srivastava. Many EHR systems already incorporate AI. If a human provider is in the loop, already vetted and insured, “we should be okay when it comes to the risk of malpractice when doctors are using AI because it’s still the risk that we’re ensuring.”

Insurers are paying attention, though. “Traditional medical malpractice law does require re-evaluation because the rapid pace of AI development has outpaced the efforts to integrate it into the legal system,” Srivastava said.

Some, including Pearl, believe AI will actually lower the malpractice risk. Having more data points to consider can make doctors’ jobs faster, easier, and more accurate. “I believe the technology will decrease lawsuits, not increase them,” said Pearl.

 

Meanwhile, How Can Doctors Protect Themselves From an AI Malpractice Suit?

Know your tool: Providers should understand the tool they’re deploying, what it provides, how it was built and trained (including potential biases), how it was tested, and the guidelines for how to use it or not use it, said Srivastava. Evaluate each tool, use case, and risk separately. “Don’t just say it’s all AI.” 

With generative AI, users will have better success requesting information that has been available longer and is more widely accessed. “It’s more likely to come back correctly,” said Shahrestani. If the information sought is fairly new or not widespread, the tool may try to draw problematic conclusions. 

Document: “Document, document, document. Just making sure you have good documentation can really help you if litigation comes up and it’s related to the AI tools,” Srivastava said.

Try it out: “I recommend you use [generative AI] a lot so you understand its strengths and shortcomings,” said Shahrestani. “If you wait until things settle, you’ll be further behind.” 

Pretend you’re the patient and give the tool the information you’d give a doctor and see the results, said Pearl. It will provide you with an idea of what it can do. “No one would sue you because you went to the library to look up information in the textbooks,” he said — using generative AI is similar. Try the free versions first; if you begin relying on it more, the paid versions have better features and are inexpensive. 

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

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Women Largely Unaware of Anti-Seizure Med Risks, More Education Needed

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— The majority of women with epilepsy are inadequately educated about the potential risks associated with anti-seizure medications (ASMs), which include teratogenicity and a reduction in the efficacy of hormonal birth control, early results of a new survey suggested.

In addition, only about a third of survey respondents indicated that they were taking folic acid if pregnant or planning to be or using an effective contraceptive if they wanted to avoid pregnancy.

“Physicians should see it as inside their scope to ask about the family planning aspect of things because it’s relevant to their patients’ neurologic care,” first study author Tori Valachovic, a fourth-year medical student at the University of Rochester School of Medicine, New York, told this news organization.

She noted patients may be taking ASMs not just for seizures but potentially to manage migraines or a mood disorder.

The findings were presented on December 8 at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

 

Unique Survey

Research shows that about half of pregnancies in the United States are unplanned, and the number is even higher among people with epilepsy, said senior author Sarah Betstadt, MD, associate professor of obstetrics and gynecology, University of Rochester. That may be because women aren’t appropriately counseled about ASMs, possibly reducing the effectiveness of their hormonal birth control, she said.

The American Academy of Neurology recommends women with seizure disorders who could become pregnant receive yearly counseling about reproductive health, including ASM teratogenicity and interactions with hormonal contraceptive medications.

The study included 107 women aged 18-49 years at two general neurology outpatient clinics who were taking an ASM and completed a survey between July 2023 and May 2024. Of these, six were pregnant or planning to become pregnant, and 69 were using a barrier, hormonal, or implant form of contraception.

Researchers collected medical histories for each respondent, including how long they had had a seizure disorder, how often they experienced seizures, what anti-seizure drugs they were taking, the type of birth control they used, their pregnancy intentions, and whether they were taking folic acid.

The survey was unique in that questions were personalized. Previous surveys have asked general questions, but for the current survey, patients were required to input their specific ASM and specific birth control, so it was also a test of their knowledge of their specific medications, said Valachovic.

When responding to questions about the safety of their ASMs for pregnancy or whether there were interactions between ASMs and birth control, about two thirds (67.3%) of the participants answered at least one question incorrectly.

The study found 36.2% of those using a barrier, hormonal, or implant contraceptive answered at least one question incorrectly regarding whether their ASM decreased birth control effectiveness.

ASMs such as carbamazepine, phenytoin, phenobarbital, higher doses of topiramate (over 200 mg daily), and oxcarbazepine can make hormonal contraceptives such as pills, patches, and rings less effective, noted Valachovic.

There’s also a bidirectional relationship at play, she added. Hormonal contraceptives can make ASMs such as lamotrigine, valproate, zonisamide, and rufinamide less effective because they decrease the levels of the ASMs.

For questions specifically about the teratogenicity of their medications, about 56.1% of participants did not answer correctly.

ASMs that increase the risk for birth defects include valproic acid (a drug that would be at the top of the list), topiramate, carbamazepine, phenobarbital, and phenytoin, said Valachovic.

However, she added, “It’s a little bit more nuanced” than simply saying, “Don’t take this medication during pregnancy” because the first aim is to control seizures. “Uncontrolled seizures are more dangerous for the fetus and the expectant mother than any ASM,” she explained.

Neurologists and reproductive healthcare providers should work together to better disseminate relevant information to their female patients who could become pregnant, said Betstadt. “We need to have better ways to collaborate. And I think we have to start with educating neurologists,” who care for these women throughout their journey with epilepsy and who during that time may become pregnant.

They “should be talking to their patients annually about whether they plan to be pregnant,” so they can educate them and make them aware of dangers to the fetus with certain medications and the effect of ASMs on birth control, added Betstadt, whose practice focuses on complex family planning.

“Our hope is that patients will have better care that’s in line with their reproductive goals,” she said.

 

No Trickle-Down Effect

Commenting for this news organization, Alison M. Pack, MD, professor of neurology and Epilepsy Division Chief, Columbia University, New York City, said the study underlines an important quandary: Despite guidelines on risks of combining ASMs and hormonal birth control, this information doesn’t seem to be “trickling down” to women with epilepsy.

“I think part of it is just the state of healthcare delivery these days,” where clinicians are expected to accomplish more and more within a 20-30–minute follow-up visit. It’s tough, too, to keep up with all the potential drug interactions involved with newer ASMs, she said.

“I also think it speaks to the complexity” of healthcare for young women with epilepsy, which involves not just neurologists but obstetricians, gynecologists, and primary care doctors, she added.

Pack doesn’t think epilepsy specialists “integrate” enough with these other specialties. “You need to communicate with the gynecologist; you need to open that line of communication.”

She believes advanced practice providers could play a role in reducing the complexity of treating young women with epilepsy by regularly reviewing how patients are adhering to recommended protocols.

But she pointed out that “in the overall picture, most women with epilepsy do have normal, healthy pregnancies.”

The investigators and Pack reported no relevant conflicts of interest.

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

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— The majority of women with epilepsy are inadequately educated about the potential risks associated with anti-seizure medications (ASMs), which include teratogenicity and a reduction in the efficacy of hormonal birth control, early results of a new survey suggested.

In addition, only about a third of survey respondents indicated that they were taking folic acid if pregnant or planning to be or using an effective contraceptive if they wanted to avoid pregnancy.

“Physicians should see it as inside their scope to ask about the family planning aspect of things because it’s relevant to their patients’ neurologic care,” first study author Tori Valachovic, a fourth-year medical student at the University of Rochester School of Medicine, New York, told this news organization.

She noted patients may be taking ASMs not just for seizures but potentially to manage migraines or a mood disorder.

The findings were presented on December 8 at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

 

Unique Survey

Research shows that about half of pregnancies in the United States are unplanned, and the number is even higher among people with epilepsy, said senior author Sarah Betstadt, MD, associate professor of obstetrics and gynecology, University of Rochester. That may be because women aren’t appropriately counseled about ASMs, possibly reducing the effectiveness of their hormonal birth control, she said.

The American Academy of Neurology recommends women with seizure disorders who could become pregnant receive yearly counseling about reproductive health, including ASM teratogenicity and interactions with hormonal contraceptive medications.

The study included 107 women aged 18-49 years at two general neurology outpatient clinics who were taking an ASM and completed a survey between July 2023 and May 2024. Of these, six were pregnant or planning to become pregnant, and 69 were using a barrier, hormonal, or implant form of contraception.

Researchers collected medical histories for each respondent, including how long they had had a seizure disorder, how often they experienced seizures, what anti-seizure drugs they were taking, the type of birth control they used, their pregnancy intentions, and whether they were taking folic acid.

The survey was unique in that questions were personalized. Previous surveys have asked general questions, but for the current survey, patients were required to input their specific ASM and specific birth control, so it was also a test of their knowledge of their specific medications, said Valachovic.

When responding to questions about the safety of their ASMs for pregnancy or whether there were interactions between ASMs and birth control, about two thirds (67.3%) of the participants answered at least one question incorrectly.

The study found 36.2% of those using a barrier, hormonal, or implant contraceptive answered at least one question incorrectly regarding whether their ASM decreased birth control effectiveness.

ASMs such as carbamazepine, phenytoin, phenobarbital, higher doses of topiramate (over 200 mg daily), and oxcarbazepine can make hormonal contraceptives such as pills, patches, and rings less effective, noted Valachovic.

There’s also a bidirectional relationship at play, she added. Hormonal contraceptives can make ASMs such as lamotrigine, valproate, zonisamide, and rufinamide less effective because they decrease the levels of the ASMs.

For questions specifically about the teratogenicity of their medications, about 56.1% of participants did not answer correctly.

ASMs that increase the risk for birth defects include valproic acid (a drug that would be at the top of the list), topiramate, carbamazepine, phenobarbital, and phenytoin, said Valachovic.

However, she added, “It’s a little bit more nuanced” than simply saying, “Don’t take this medication during pregnancy” because the first aim is to control seizures. “Uncontrolled seizures are more dangerous for the fetus and the expectant mother than any ASM,” she explained.

Neurologists and reproductive healthcare providers should work together to better disseminate relevant information to their female patients who could become pregnant, said Betstadt. “We need to have better ways to collaborate. And I think we have to start with educating neurologists,” who care for these women throughout their journey with epilepsy and who during that time may become pregnant.

They “should be talking to their patients annually about whether they plan to be pregnant,” so they can educate them and make them aware of dangers to the fetus with certain medications and the effect of ASMs on birth control, added Betstadt, whose practice focuses on complex family planning.

“Our hope is that patients will have better care that’s in line with their reproductive goals,” she said.

 

No Trickle-Down Effect

Commenting for this news organization, Alison M. Pack, MD, professor of neurology and Epilepsy Division Chief, Columbia University, New York City, said the study underlines an important quandary: Despite guidelines on risks of combining ASMs and hormonal birth control, this information doesn’t seem to be “trickling down” to women with epilepsy.

“I think part of it is just the state of healthcare delivery these days,” where clinicians are expected to accomplish more and more within a 20-30–minute follow-up visit. It’s tough, too, to keep up with all the potential drug interactions involved with newer ASMs, she said.

“I also think it speaks to the complexity” of healthcare for young women with epilepsy, which involves not just neurologists but obstetricians, gynecologists, and primary care doctors, she added.

Pack doesn’t think epilepsy specialists “integrate” enough with these other specialties. “You need to communicate with the gynecologist; you need to open that line of communication.”

She believes advanced practice providers could play a role in reducing the complexity of treating young women with epilepsy by regularly reviewing how patients are adhering to recommended protocols.

But she pointed out that “in the overall picture, most women with epilepsy do have normal, healthy pregnancies.”

The investigators and Pack reported no relevant conflicts of interest.

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

— The majority of women with epilepsy are inadequately educated about the potential risks associated with anti-seizure medications (ASMs), which include teratogenicity and a reduction in the efficacy of hormonal birth control, early results of a new survey suggested.

In addition, only about a third of survey respondents indicated that they were taking folic acid if pregnant or planning to be or using an effective contraceptive if they wanted to avoid pregnancy.

“Physicians should see it as inside their scope to ask about the family planning aspect of things because it’s relevant to their patients’ neurologic care,” first study author Tori Valachovic, a fourth-year medical student at the University of Rochester School of Medicine, New York, told this news organization.

She noted patients may be taking ASMs not just for seizures but potentially to manage migraines or a mood disorder.

The findings were presented on December 8 at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

 

Unique Survey

Research shows that about half of pregnancies in the United States are unplanned, and the number is even higher among people with epilepsy, said senior author Sarah Betstadt, MD, associate professor of obstetrics and gynecology, University of Rochester. That may be because women aren’t appropriately counseled about ASMs, possibly reducing the effectiveness of their hormonal birth control, she said.

The American Academy of Neurology recommends women with seizure disorders who could become pregnant receive yearly counseling about reproductive health, including ASM teratogenicity and interactions with hormonal contraceptive medications.

The study included 107 women aged 18-49 years at two general neurology outpatient clinics who were taking an ASM and completed a survey between July 2023 and May 2024. Of these, six were pregnant or planning to become pregnant, and 69 were using a barrier, hormonal, or implant form of contraception.

Researchers collected medical histories for each respondent, including how long they had had a seizure disorder, how often they experienced seizures, what anti-seizure drugs they were taking, the type of birth control they used, their pregnancy intentions, and whether they were taking folic acid.

The survey was unique in that questions were personalized. Previous surveys have asked general questions, but for the current survey, patients were required to input their specific ASM and specific birth control, so it was also a test of their knowledge of their specific medications, said Valachovic.

When responding to questions about the safety of their ASMs for pregnancy or whether there were interactions between ASMs and birth control, about two thirds (67.3%) of the participants answered at least one question incorrectly.

The study found 36.2% of those using a barrier, hormonal, or implant contraceptive answered at least one question incorrectly regarding whether their ASM decreased birth control effectiveness.

ASMs such as carbamazepine, phenytoin, phenobarbital, higher doses of topiramate (over 200 mg daily), and oxcarbazepine can make hormonal contraceptives such as pills, patches, and rings less effective, noted Valachovic.

There’s also a bidirectional relationship at play, she added. Hormonal contraceptives can make ASMs such as lamotrigine, valproate, zonisamide, and rufinamide less effective because they decrease the levels of the ASMs.

For questions specifically about the teratogenicity of their medications, about 56.1% of participants did not answer correctly.

ASMs that increase the risk for birth defects include valproic acid (a drug that would be at the top of the list), topiramate, carbamazepine, phenobarbital, and phenytoin, said Valachovic.

However, she added, “It’s a little bit more nuanced” than simply saying, “Don’t take this medication during pregnancy” because the first aim is to control seizures. “Uncontrolled seizures are more dangerous for the fetus and the expectant mother than any ASM,” she explained.

Neurologists and reproductive healthcare providers should work together to better disseminate relevant information to their female patients who could become pregnant, said Betstadt. “We need to have better ways to collaborate. And I think we have to start with educating neurologists,” who care for these women throughout their journey with epilepsy and who during that time may become pregnant.

They “should be talking to their patients annually about whether they plan to be pregnant,” so they can educate them and make them aware of dangers to the fetus with certain medications and the effect of ASMs on birth control, added Betstadt, whose practice focuses on complex family planning.

“Our hope is that patients will have better care that’s in line with their reproductive goals,” she said.

 

No Trickle-Down Effect

Commenting for this news organization, Alison M. Pack, MD, professor of neurology and Epilepsy Division Chief, Columbia University, New York City, said the study underlines an important quandary: Despite guidelines on risks of combining ASMs and hormonal birth control, this information doesn’t seem to be “trickling down” to women with epilepsy.

“I think part of it is just the state of healthcare delivery these days,” where clinicians are expected to accomplish more and more within a 20-30–minute follow-up visit. It’s tough, too, to keep up with all the potential drug interactions involved with newer ASMs, she said.

“I also think it speaks to the complexity” of healthcare for young women with epilepsy, which involves not just neurologists but obstetricians, gynecologists, and primary care doctors, she added.

Pack doesn’t think epilepsy specialists “integrate” enough with these other specialties. “You need to communicate with the gynecologist; you need to open that line of communication.”

She believes advanced practice providers could play a role in reducing the complexity of treating young women with epilepsy by regularly reviewing how patients are adhering to recommended protocols.

But she pointed out that “in the overall picture, most women with epilepsy do have normal, healthy pregnancies.”

The investigators and Pack reported no relevant conflicts of interest.

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

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Lights, Action, Bodycams in the ED

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Working as an emergency physician can be demanding. It’s also dangerous. In a 2022 study, two thirds of emergency physicians were assaulted in the past 12 months, and one third of those assaults resulted in an injury.

The attacks included verbal assaults with threats of violence (64%), hits/slaps (40%), being spit on (31%), kicked (26%), and punched (25%). Nearly one in four physicians said they were assaulted multiple times. 

The same survey found that 85% of emergency physicians believe that violence in the emergency department (ED) has increased over the past 5 years; nearly half (45%) say it has greatly increased.

To offset this disturbing trend, healthcare systems are trying new measures to reduce or prevent violence in the ED and protect staff and patients. EDs have security cameras, metal detectors, panic alarms, and security guards. And now more security guards are using body-worn cameras (bodycams) like police wear, to protect ED doctors and staff.

 

Bodycams in the ED

Scott Hill, EdD, CPP, CHPA, a board member of the International Association for Healthcare Security and Safety Foundation, recently published a study on the impact of hospital security officers using bodycams. The study surveyed more than 100 hospitals. Fifty-three had security guards wearing bodycams; 57 had security guards without them.

The study supported the benefits of implementing body-worn cameras in a healthcare environment, said Hill, the former director of safety and security for King’s Daughters Health System in Ashland, Kentucky. “We were a little surprised by the data, but basically there was a positive impact…on the safety of hospital staff. There was higher officer confidence, better record-keeping, improved customer service, better training ... and better protection from false allegations.”

Hill told Medscape Medical News that bodycams can make for a safer ED. “The body-worn camera group believed that the cameras would have a positive impact that would make patients and staff feel safer,” said Hill. The idea is that security guards will use force more appropriately because the bodycam provides protection from false accusations.

Appropriate, timely intervention with disruptive or violent patients (or their family members) creates a safer environment for doctors, nurses, and other staff. (While the study found that hospital personnel felt safer with security guards wearing bodycams, physicians and healthcare staff were not surveyed in the study.)

 

Should Doctors Wear Bodycams?

While the idea of ED physicians or nurses wearing bodycams has been suggested, it’s a novel one to Jeffrey Goodloe, MD, an emergency physician in Tulsa, Oklahoma, and member of the American College of Emergency Physicians’ board of directors. “Even with a very vast network of colleagues, both professional and personal friends…I am personally not aware of an ER physician who wears a bodycam,” said Goodloe.

However, there’s no consensus on whether they should, he added. “If you ask 10 emergency room physicians [about wearing bodycams], some will say, ‘That would help’; some would say, ‘from an academic perspective, we don’t have the data,’ some would say, ‘what about privacy concerns?’ You’ll get all those responses,” said Goodloe.

“If a doctor is wearing a bodycam, one of the risks is that patients may not want to be upfront because they see a camera and they see it’s being recorded,” said Edward Wright, MD, a board-certified emergency medicine physician who owns freestanding emergency rooms (ERs) in San Antonio. “It could cause a lot of damage to the relationship between the patient and the physician.”

 

Other Potential Drawbacks of Bodycams

When it comes to patient care, “the presence of a body camera [on a security guard] in and of itself is not intrusive or detrimental to the professional actions of an emergency physician,” said Goodloe, who often sees police officers and security guards with bodycams in the ED. “However, when we are in the process of treating patients, there is a certain amount of privacy that patients and their families and loved ones have a reasonable right to expect in an ED.”

Wright has seen police officers wearing body cameras as well as patients using their phones to record in the ED. “That happens a lot…in Texas, anyone in a public place can record audio and video,” said Wright. “I would say the concern with anyone recording things is patient’s privacy and HIPPA concerns.” While some areas, like the waiting room and hallways, are considered public, the patient care areas are typically private — and a bodycam could violate that privacy.

“The biggest concern we have with bodycams is the unintended violation of someone else’s privacy,” said Goodloe. In an ER setting, he explains that it’s difficult for someone wearing a bodycam to prevent unintentionally recording multiple other patients in the footage. “How do we provide care and protect patient privacy?”

And while a camera makes a record, it may not always be an accurate reflection of what happened. “You might have a video record of what I said and what the patient said, but the camera doesn’t tell the whole story,” said Wright. “There are nuances, and there may be family members who are not on camera…you have to consider that something may be missing.”

Most EDs have wall-mounted security cameras; a 2023 study found that 94.7% had security cameras in key locations. Signage alerting patients of cameras is also common; more than half of EDs have signage warning patients and visitors that they are being recorded, so there may be little expectation of privacy in public areas. But unfortunately, sometimes, patients must be triaged, and treated, in the hallways of busy EDs, where they are subject to being recorded either on stationary or body-worn cameras.

 

Keeping the ED Safe

Putting aside privacy concerns, security measures meant to protect staff and patients can only do so much. “Some security measures are more of a feel-good measure,” said Wright. “We have automatic door locks for our doors, but the whole side of the building is glass…my personal feeling is that cameras can be a deterrent, but if someone has an intention to hurt someone else or is psychotic, you aren’t going to be able to stop them from what they’re going to do.”

Regardless, we’re likely to see more security measures like body-worn cameras in the ED. “Workplace safety is very much on the minds of ER physicians and ER nurses,” said Goodloe. “EDs have become sites of workplace violence with unacceptable increasing frequency…how do we solve this, [while] simultaneously not discouraging or preventing access to emergency care when and where people need it most?”

“We truly care about patient safety and our colleagues’ safety, and we want to be able to come in and make a positive difference,” said Goodloe. But ultimately, doctors want to go home safely to their families, and they want their patients to be able to do that, too.

 

A version of this article appeared on Medscape.com.

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Working as an emergency physician can be demanding. It’s also dangerous. In a 2022 study, two thirds of emergency physicians were assaulted in the past 12 months, and one third of those assaults resulted in an injury.

The attacks included verbal assaults with threats of violence (64%), hits/slaps (40%), being spit on (31%), kicked (26%), and punched (25%). Nearly one in four physicians said they were assaulted multiple times. 

The same survey found that 85% of emergency physicians believe that violence in the emergency department (ED) has increased over the past 5 years; nearly half (45%) say it has greatly increased.

To offset this disturbing trend, healthcare systems are trying new measures to reduce or prevent violence in the ED and protect staff and patients. EDs have security cameras, metal detectors, panic alarms, and security guards. And now more security guards are using body-worn cameras (bodycams) like police wear, to protect ED doctors and staff.

 

Bodycams in the ED

Scott Hill, EdD, CPP, CHPA, a board member of the International Association for Healthcare Security and Safety Foundation, recently published a study on the impact of hospital security officers using bodycams. The study surveyed more than 100 hospitals. Fifty-three had security guards wearing bodycams; 57 had security guards without them.

The study supported the benefits of implementing body-worn cameras in a healthcare environment, said Hill, the former director of safety and security for King’s Daughters Health System in Ashland, Kentucky. “We were a little surprised by the data, but basically there was a positive impact…on the safety of hospital staff. There was higher officer confidence, better record-keeping, improved customer service, better training ... and better protection from false allegations.”

Hill told Medscape Medical News that bodycams can make for a safer ED. “The body-worn camera group believed that the cameras would have a positive impact that would make patients and staff feel safer,” said Hill. The idea is that security guards will use force more appropriately because the bodycam provides protection from false accusations.

Appropriate, timely intervention with disruptive or violent patients (or their family members) creates a safer environment for doctors, nurses, and other staff. (While the study found that hospital personnel felt safer with security guards wearing bodycams, physicians and healthcare staff were not surveyed in the study.)

 

Should Doctors Wear Bodycams?

While the idea of ED physicians or nurses wearing bodycams has been suggested, it’s a novel one to Jeffrey Goodloe, MD, an emergency physician in Tulsa, Oklahoma, and member of the American College of Emergency Physicians’ board of directors. “Even with a very vast network of colleagues, both professional and personal friends…I am personally not aware of an ER physician who wears a bodycam,” said Goodloe.

However, there’s no consensus on whether they should, he added. “If you ask 10 emergency room physicians [about wearing bodycams], some will say, ‘That would help’; some would say, ‘from an academic perspective, we don’t have the data,’ some would say, ‘what about privacy concerns?’ You’ll get all those responses,” said Goodloe.

“If a doctor is wearing a bodycam, one of the risks is that patients may not want to be upfront because they see a camera and they see it’s being recorded,” said Edward Wright, MD, a board-certified emergency medicine physician who owns freestanding emergency rooms (ERs) in San Antonio. “It could cause a lot of damage to the relationship between the patient and the physician.”

 

Other Potential Drawbacks of Bodycams

When it comes to patient care, “the presence of a body camera [on a security guard] in and of itself is not intrusive or detrimental to the professional actions of an emergency physician,” said Goodloe, who often sees police officers and security guards with bodycams in the ED. “However, when we are in the process of treating patients, there is a certain amount of privacy that patients and their families and loved ones have a reasonable right to expect in an ED.”

Wright has seen police officers wearing body cameras as well as patients using their phones to record in the ED. “That happens a lot…in Texas, anyone in a public place can record audio and video,” said Wright. “I would say the concern with anyone recording things is patient’s privacy and HIPPA concerns.” While some areas, like the waiting room and hallways, are considered public, the patient care areas are typically private — and a bodycam could violate that privacy.

“The biggest concern we have with bodycams is the unintended violation of someone else’s privacy,” said Goodloe. In an ER setting, he explains that it’s difficult for someone wearing a bodycam to prevent unintentionally recording multiple other patients in the footage. “How do we provide care and protect patient privacy?”

And while a camera makes a record, it may not always be an accurate reflection of what happened. “You might have a video record of what I said and what the patient said, but the camera doesn’t tell the whole story,” said Wright. “There are nuances, and there may be family members who are not on camera…you have to consider that something may be missing.”

Most EDs have wall-mounted security cameras; a 2023 study found that 94.7% had security cameras in key locations. Signage alerting patients of cameras is also common; more than half of EDs have signage warning patients and visitors that they are being recorded, so there may be little expectation of privacy in public areas. But unfortunately, sometimes, patients must be triaged, and treated, in the hallways of busy EDs, where they are subject to being recorded either on stationary or body-worn cameras.

 

Keeping the ED Safe

Putting aside privacy concerns, security measures meant to protect staff and patients can only do so much. “Some security measures are more of a feel-good measure,” said Wright. “We have automatic door locks for our doors, but the whole side of the building is glass…my personal feeling is that cameras can be a deterrent, but if someone has an intention to hurt someone else or is psychotic, you aren’t going to be able to stop them from what they’re going to do.”

Regardless, we’re likely to see more security measures like body-worn cameras in the ED. “Workplace safety is very much on the minds of ER physicians and ER nurses,” said Goodloe. “EDs have become sites of workplace violence with unacceptable increasing frequency…how do we solve this, [while] simultaneously not discouraging or preventing access to emergency care when and where people need it most?”

“We truly care about patient safety and our colleagues’ safety, and we want to be able to come in and make a positive difference,” said Goodloe. But ultimately, doctors want to go home safely to their families, and they want their patients to be able to do that, too.

 

A version of this article appeared on Medscape.com.

Working as an emergency physician can be demanding. It’s also dangerous. In a 2022 study, two thirds of emergency physicians were assaulted in the past 12 months, and one third of those assaults resulted in an injury.

The attacks included verbal assaults with threats of violence (64%), hits/slaps (40%), being spit on (31%), kicked (26%), and punched (25%). Nearly one in four physicians said they were assaulted multiple times. 

The same survey found that 85% of emergency physicians believe that violence in the emergency department (ED) has increased over the past 5 years; nearly half (45%) say it has greatly increased.

To offset this disturbing trend, healthcare systems are trying new measures to reduce or prevent violence in the ED and protect staff and patients. EDs have security cameras, metal detectors, panic alarms, and security guards. And now more security guards are using body-worn cameras (bodycams) like police wear, to protect ED doctors and staff.

 

Bodycams in the ED

Scott Hill, EdD, CPP, CHPA, a board member of the International Association for Healthcare Security and Safety Foundation, recently published a study on the impact of hospital security officers using bodycams. The study surveyed more than 100 hospitals. Fifty-three had security guards wearing bodycams; 57 had security guards without them.

The study supported the benefits of implementing body-worn cameras in a healthcare environment, said Hill, the former director of safety and security for King’s Daughters Health System in Ashland, Kentucky. “We were a little surprised by the data, but basically there was a positive impact…on the safety of hospital staff. There was higher officer confidence, better record-keeping, improved customer service, better training ... and better protection from false allegations.”

Hill told Medscape Medical News that bodycams can make for a safer ED. “The body-worn camera group believed that the cameras would have a positive impact that would make patients and staff feel safer,” said Hill. The idea is that security guards will use force more appropriately because the bodycam provides protection from false accusations.

Appropriate, timely intervention with disruptive or violent patients (or their family members) creates a safer environment for doctors, nurses, and other staff. (While the study found that hospital personnel felt safer with security guards wearing bodycams, physicians and healthcare staff were not surveyed in the study.)

 

Should Doctors Wear Bodycams?

While the idea of ED physicians or nurses wearing bodycams has been suggested, it’s a novel one to Jeffrey Goodloe, MD, an emergency physician in Tulsa, Oklahoma, and member of the American College of Emergency Physicians’ board of directors. “Even with a very vast network of colleagues, both professional and personal friends…I am personally not aware of an ER physician who wears a bodycam,” said Goodloe.

However, there’s no consensus on whether they should, he added. “If you ask 10 emergency room physicians [about wearing bodycams], some will say, ‘That would help’; some would say, ‘from an academic perspective, we don’t have the data,’ some would say, ‘what about privacy concerns?’ You’ll get all those responses,” said Goodloe.

“If a doctor is wearing a bodycam, one of the risks is that patients may not want to be upfront because they see a camera and they see it’s being recorded,” said Edward Wright, MD, a board-certified emergency medicine physician who owns freestanding emergency rooms (ERs) in San Antonio. “It could cause a lot of damage to the relationship between the patient and the physician.”

 

Other Potential Drawbacks of Bodycams

When it comes to patient care, “the presence of a body camera [on a security guard] in and of itself is not intrusive or detrimental to the professional actions of an emergency physician,” said Goodloe, who often sees police officers and security guards with bodycams in the ED. “However, when we are in the process of treating patients, there is a certain amount of privacy that patients and their families and loved ones have a reasonable right to expect in an ED.”

Wright has seen police officers wearing body cameras as well as patients using their phones to record in the ED. “That happens a lot…in Texas, anyone in a public place can record audio and video,” said Wright. “I would say the concern with anyone recording things is patient’s privacy and HIPPA concerns.” While some areas, like the waiting room and hallways, are considered public, the patient care areas are typically private — and a bodycam could violate that privacy.

“The biggest concern we have with bodycams is the unintended violation of someone else’s privacy,” said Goodloe. In an ER setting, he explains that it’s difficult for someone wearing a bodycam to prevent unintentionally recording multiple other patients in the footage. “How do we provide care and protect patient privacy?”

And while a camera makes a record, it may not always be an accurate reflection of what happened. “You might have a video record of what I said and what the patient said, but the camera doesn’t tell the whole story,” said Wright. “There are nuances, and there may be family members who are not on camera…you have to consider that something may be missing.”

Most EDs have wall-mounted security cameras; a 2023 study found that 94.7% had security cameras in key locations. Signage alerting patients of cameras is also common; more than half of EDs have signage warning patients and visitors that they are being recorded, so there may be little expectation of privacy in public areas. But unfortunately, sometimes, patients must be triaged, and treated, in the hallways of busy EDs, where they are subject to being recorded either on stationary or body-worn cameras.

 

Keeping the ED Safe

Putting aside privacy concerns, security measures meant to protect staff and patients can only do so much. “Some security measures are more of a feel-good measure,” said Wright. “We have automatic door locks for our doors, but the whole side of the building is glass…my personal feeling is that cameras can be a deterrent, but if someone has an intention to hurt someone else or is psychotic, you aren’t going to be able to stop them from what they’re going to do.”

Regardless, we’re likely to see more security measures like body-worn cameras in the ED. “Workplace safety is very much on the minds of ER physicians and ER nurses,” said Goodloe. “EDs have become sites of workplace violence with unacceptable increasing frequency…how do we solve this, [while] simultaneously not discouraging or preventing access to emergency care when and where people need it most?”

“We truly care about patient safety and our colleagues’ safety, and we want to be able to come in and make a positive difference,” said Goodloe. But ultimately, doctors want to go home safely to their families, and they want their patients to be able to do that, too.

 

A version of this article appeared on Medscape.com.

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Updated Guidelines on Contraception Choice and Body Weight

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As family doctors, we often provide contraception care for our patients and they ask many questions about what is the best choice for them. There are many factors that may contribute to our discussion with our patients, a patient’s body weight being just one of them.

We all know that some contraception methods have been shown to be less effective in patients with a body mass index (BMI) over 30. Additionally, many hormonal therapies are known to contribute to weight gain.

 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.
Dr. Linda Girgis

In August 2024, the Society of Family Planning set forth guidelines regarding contraception and body weight. The authors suggest that BMI may not be the best measure to use to reflect body size but suggest that it is the best we have. They state that we should refrain using the classification names contained within the BMI system: “healthy weight,” “obese,” etc. They caution against stigmatizing patients and bringing our own biases into the discussion.

It should be noted that no contraceptive method is contraindicated based on a patient’s body size. However, physicians should use evidence-based information to reach a shared decision with the patient. This should include risks based on body weight/size and its effect on contraception.

Although oral contraceptive pills (OCPs) affect the way steroid hormones are processed, efficacy is thought to be the same in all patients regardless of weight. Most contraception failures in patients taking OCPs are the result of incorrect use of the medication. It is important to note that in women with BMIs greater than 30 the risk of venous thromboembolism is increased with combined hormonal contraceptives. 

It is suggested that women with BMIs greater than 30 avoid hormonal transdermal patches because of higher rates of contraception failure. Vaginal rings have not been adequately studied regarding their effectiveness in patients with BMIs greater than 30.

Contraceptive implants are another good choice for women with BMIs greater than 30. Despite the serum level of etonogestrel being lower than in women with BMIs under 30, most remained high enough to suppress ovulation. IUDs and depo medroxyprogesterone shots also appear to be effective in those with higher BMIs, although there is a slight increased risk of venous thromboembolism in those utilizing depo medroxyprogesterone shots.

It is important for us to be very familiar with all methods of contraception and we need to be comfortable discussing the options with our patients. If a patient desires contraception to avoid pregnancy, she must be informed when effectiveness may be reduced. We also need to be aware of the side effects and let our patients know what to expect. They need as much data as possible to make an informed decision about which method they choose. We may not agree with their decision, but if a patient is aware of what may happen, it is her choice to make.

Many women feel uncomfortable bringing up the discussion of contraception. We need to address this with women of child-bearing age. Often, broaching the topic will open the door to a whole host of concerns. Women with overweight may avoid seeking care because they were made uncomfortable in the medical setting or were made to feel stigmatized. We will never fix the obesity epidemic in the United States if our patients avoid coming into the office.

The guidelines also discuss contraception choices that may lead to weight gain. The medication alone may not be responsible but rather it is a combination of genetic, environmental, and lifestyle factors. Along with the warning about weight gain, we should be counseling our patients regarding their lifestyle choices, such as diet and exercise.

The authors of this guideline paper do a great job exploring each contraception method for women with BMI over 30. However, many factors go into deciding which choice is the best for an individual patient. A patient may do poorly at taking pills every day. Another may dislike the concept of inserting a vaginal ring. Each patient should be approached individually and all these factors need to be taken into consideration. Weight is an important factor to consider, but there are many others. If we fail to acknowledge the complexity of our patients, we can never do our best for them.

 

Dr. Girgis is a family medicine practitioner, South River, New Jersey, and clinical assistant professor of family medicine, Robert Wood Johnson Medical School, New Brunswick, New Jersey. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

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As family doctors, we often provide contraception care for our patients and they ask many questions about what is the best choice for them. There are many factors that may contribute to our discussion with our patients, a patient’s body weight being just one of them.

We all know that some contraception methods have been shown to be less effective in patients with a body mass index (BMI) over 30. Additionally, many hormonal therapies are known to contribute to weight gain.

 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.
Dr. Linda Girgis

In August 2024, the Society of Family Planning set forth guidelines regarding contraception and body weight. The authors suggest that BMI may not be the best measure to use to reflect body size but suggest that it is the best we have. They state that we should refrain using the classification names contained within the BMI system: “healthy weight,” “obese,” etc. They caution against stigmatizing patients and bringing our own biases into the discussion.

It should be noted that no contraceptive method is contraindicated based on a patient’s body size. However, physicians should use evidence-based information to reach a shared decision with the patient. This should include risks based on body weight/size and its effect on contraception.

Although oral contraceptive pills (OCPs) affect the way steroid hormones are processed, efficacy is thought to be the same in all patients regardless of weight. Most contraception failures in patients taking OCPs are the result of incorrect use of the medication. It is important to note that in women with BMIs greater than 30 the risk of venous thromboembolism is increased with combined hormonal contraceptives. 

It is suggested that women with BMIs greater than 30 avoid hormonal transdermal patches because of higher rates of contraception failure. Vaginal rings have not been adequately studied regarding their effectiveness in patients with BMIs greater than 30.

Contraceptive implants are another good choice for women with BMIs greater than 30. Despite the serum level of etonogestrel being lower than in women with BMIs under 30, most remained high enough to suppress ovulation. IUDs and depo medroxyprogesterone shots also appear to be effective in those with higher BMIs, although there is a slight increased risk of venous thromboembolism in those utilizing depo medroxyprogesterone shots.

It is important for us to be very familiar with all methods of contraception and we need to be comfortable discussing the options with our patients. If a patient desires contraception to avoid pregnancy, she must be informed when effectiveness may be reduced. We also need to be aware of the side effects and let our patients know what to expect. They need as much data as possible to make an informed decision about which method they choose. We may not agree with their decision, but if a patient is aware of what may happen, it is her choice to make.

Many women feel uncomfortable bringing up the discussion of contraception. We need to address this with women of child-bearing age. Often, broaching the topic will open the door to a whole host of concerns. Women with overweight may avoid seeking care because they were made uncomfortable in the medical setting or were made to feel stigmatized. We will never fix the obesity epidemic in the United States if our patients avoid coming into the office.

The guidelines also discuss contraception choices that may lead to weight gain. The medication alone may not be responsible but rather it is a combination of genetic, environmental, and lifestyle factors. Along with the warning about weight gain, we should be counseling our patients regarding their lifestyle choices, such as diet and exercise.

The authors of this guideline paper do a great job exploring each contraception method for women with BMI over 30. However, many factors go into deciding which choice is the best for an individual patient. A patient may do poorly at taking pills every day. Another may dislike the concept of inserting a vaginal ring. Each patient should be approached individually and all these factors need to be taken into consideration. Weight is an important factor to consider, but there are many others. If we fail to acknowledge the complexity of our patients, we can never do our best for them.

 

Dr. Girgis is a family medicine practitioner, South River, New Jersey, and clinical assistant professor of family medicine, Robert Wood Johnson Medical School, New Brunswick, New Jersey. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

As family doctors, we often provide contraception care for our patients and they ask many questions about what is the best choice for them. There are many factors that may contribute to our discussion with our patients, a patient’s body weight being just one of them.

We all know that some contraception methods have been shown to be less effective in patients with a body mass index (BMI) over 30. Additionally, many hormonal therapies are known to contribute to weight gain.

 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.
Dr. Linda Girgis

In August 2024, the Society of Family Planning set forth guidelines regarding contraception and body weight. The authors suggest that BMI may not be the best measure to use to reflect body size but suggest that it is the best we have. They state that we should refrain using the classification names contained within the BMI system: “healthy weight,” “obese,” etc. They caution against stigmatizing patients and bringing our own biases into the discussion.

It should be noted that no contraceptive method is contraindicated based on a patient’s body size. However, physicians should use evidence-based information to reach a shared decision with the patient. This should include risks based on body weight/size and its effect on contraception.

Although oral contraceptive pills (OCPs) affect the way steroid hormones are processed, efficacy is thought to be the same in all patients regardless of weight. Most contraception failures in patients taking OCPs are the result of incorrect use of the medication. It is important to note that in women with BMIs greater than 30 the risk of venous thromboembolism is increased with combined hormonal contraceptives. 

It is suggested that women with BMIs greater than 30 avoid hormonal transdermal patches because of higher rates of contraception failure. Vaginal rings have not been adequately studied regarding their effectiveness in patients with BMIs greater than 30.

Contraceptive implants are another good choice for women with BMIs greater than 30. Despite the serum level of etonogestrel being lower than in women with BMIs under 30, most remained high enough to suppress ovulation. IUDs and depo medroxyprogesterone shots also appear to be effective in those with higher BMIs, although there is a slight increased risk of venous thromboembolism in those utilizing depo medroxyprogesterone shots.

It is important for us to be very familiar with all methods of contraception and we need to be comfortable discussing the options with our patients. If a patient desires contraception to avoid pregnancy, she must be informed when effectiveness may be reduced. We also need to be aware of the side effects and let our patients know what to expect. They need as much data as possible to make an informed decision about which method they choose. We may not agree with their decision, but if a patient is aware of what may happen, it is her choice to make.

Many women feel uncomfortable bringing up the discussion of contraception. We need to address this with women of child-bearing age. Often, broaching the topic will open the door to a whole host of concerns. Women with overweight may avoid seeking care because they were made uncomfortable in the medical setting or were made to feel stigmatized. We will never fix the obesity epidemic in the United States if our patients avoid coming into the office.

The guidelines also discuss contraception choices that may lead to weight gain. The medication alone may not be responsible but rather it is a combination of genetic, environmental, and lifestyle factors. Along with the warning about weight gain, we should be counseling our patients regarding their lifestyle choices, such as diet and exercise.

The authors of this guideline paper do a great job exploring each contraception method for women with BMI over 30. However, many factors go into deciding which choice is the best for an individual patient. A patient may do poorly at taking pills every day. Another may dislike the concept of inserting a vaginal ring. Each patient should be approached individually and all these factors need to be taken into consideration. Weight is an important factor to consider, but there are many others. If we fail to acknowledge the complexity of our patients, we can never do our best for them.

 

Dr. Girgis is a family medicine practitioner, South River, New Jersey, and clinical assistant professor of family medicine, Robert Wood Johnson Medical School, New Brunswick, New Jersey. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

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Do Risk-Reducing Surgeries Benefit BRCA Carriers With Early-Onset Breast Cancer History?

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Thu, 12/12/2024 - 15:39

Patients with BRCA mutations and a history of early-onset breast cancer benefited from risk-reducing surgeries, according to new data presented at the San Antonio Breast Cancer Symposium (SABCS) 2024.

Having a risk-reducing mastectomy or salpingo-oophorectomy was associated with significantly improved overall survival and disease-free survival in BRCA-mutation carriers who had been diagnosed with a first breast cancer at age ≤ 40 years.

“This global study provides the first evidence that risk-reducing surgeries improve survival outcomes among young BRCA-mutation carriers with a prior history of early-onset breast cancer,” study investigator Matteo Lambertini, MD, PhD, oncologist with the University of Genova–IRCCS Policlinico San Martino Hospital in Genoa, Italy, said in a statement from the SABCS, where he presented the findings. “Considering the unique traits and needs of this younger population, and their high risk for secondary malignancies, it is critical to understand how risk-reducing surgeries affect patient outcomes, so that the risks and benefits of these procedures can be carefully weighed.”

“We hope these findings may help to improve the counseling on cancer-risk management strategies for BRCA carriers with young-onset of breast cancer below the age of 40 years,” Lambertini added during a press briefing. 

Various risk-reducing strategies, including risk-reducing surgeries, are recommended for BRCA-mutation carriers without a prior history of cancer, but the impact of these surgeries among younger populations with a history of early-onset breast cancer has been less clear.

The new findings come from the BRCA BCY Collaboration, an international, multicenter, retrospective cohort study of 5290 patients with likely pathogenic/pathogenic germline BRCA1 and/or BRCA2 mutations who were diagnosed with stages I-III breast cancer at ≤ 40 years. The risk-reducing mastectomy analysis included 2910 patients (55%) who underwent the surgery less than 1 year from diagnosis and 2380 who opted not to have the surgery. 

Primary endpoint was overall survival, and disease-free survival and breast cancer-free interval were secondary endpoints. Overall survival models were adjusted for the development of distant recurrences or second primary malignancies.

During median follow-up of 5.1 years, patients who underwent risk-reducing mastectomy had a 35% lower risk of dying (adjusted hazard ratio [aHR], 0.65) as well as a significant improvement in both disease-free survival (aHR, 0.58) and breast cancer-free interval (aHR, 0.55). The improved outcomes were seen in both BRCA1 and BRCA2 carriers, Lambertini reported. 

The risk-reducing salpingo-oophorectomy analysis included 2782 patients who underwent this surgery a median of 3 years from diagnosis and 2508 who did not. 

During median follow up of 4.9 years, risk-reducing salpingo-oophorectomy was associated with a 42% lower risk for death (aHR, 0.58) as well as an improvement in both disease-free survival (aHR, 0.68) and breast cancer-free interval (aHR, 0.65).

For risk-reducing salpingo-oophorectomy, there was an interaction based on breast cancer subtype and BRCA mutation.

“Specifically, the benefit of risk-reducing salpingo-oophorectomy was greater for patients with BRCA1 pathogenic variants and for those with triple-negative disease, as compared to those with BRCA2 pathogenic variants or luminal disease,” Lambertini reported.

Overall survival results were similar in patients who underwent one or both surgeries.

Briefing moderator Kate Lathrop, MD, with the University of Texas Health Science Center at San Antonio, noted that this study provides valuable information for counseling younger patients. Having datasets like this helps us give patients “potentially our best estimate of the amount of reduction of risk you could have by having the surgery now.”

In an interview, Freya Schnabel, MD, director of breast surgery at NYU Langone Health’s Perlmutter Cancer Center, New York City, emphasized the importance of early, well-informed decision-making upfront at the time of diagnosis in this patient population.

The benefit of “risk-reducing oophorectomy cannot be overemphasized, even in the presence of a known breast cancer because, as my colleagues and I say — we don’t want to cure their breast cancer and then have them die of ovarian cancer,” said Schnabel, who was not involved in the study.

In terms of prophylactic contralateral mastectomy, Schnabel noted that BRCA-mutation carriers have a “very high” risk for a second primary breast cancer. In her experience, “that’s what drives patients frequently at the time of diagnosis to have bilateral mastectomy because who wants to go through this more than once?” 

This is especially true for BRCA1 carriers who have a higher risk for triple-negative breast cancer, which is associated with a worse prognosis and is harder to treat, Schnabel said. 

“For these patients, having surgery prevents the patient from getting into a situation where their second primary tumor winds up being biologically more aggressive and then affects their survival,” Schnabel said.

The study was supported by the Italian Association for Cancer Research and the European Society for Medical Oncology. Lambertini reported advisory roles for Roche, Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead, MSD, Exact Sciences, Pierre Fabre, and Menarini. Lathrop consults for TeraSera Pharmaceuticals. Schnabel had no relevant disclosures.

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

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Patients with BRCA mutations and a history of early-onset breast cancer benefited from risk-reducing surgeries, according to new data presented at the San Antonio Breast Cancer Symposium (SABCS) 2024.

Having a risk-reducing mastectomy or salpingo-oophorectomy was associated with significantly improved overall survival and disease-free survival in BRCA-mutation carriers who had been diagnosed with a first breast cancer at age ≤ 40 years.

“This global study provides the first evidence that risk-reducing surgeries improve survival outcomes among young BRCA-mutation carriers with a prior history of early-onset breast cancer,” study investigator Matteo Lambertini, MD, PhD, oncologist with the University of Genova–IRCCS Policlinico San Martino Hospital in Genoa, Italy, said in a statement from the SABCS, where he presented the findings. “Considering the unique traits and needs of this younger population, and their high risk for secondary malignancies, it is critical to understand how risk-reducing surgeries affect patient outcomes, so that the risks and benefits of these procedures can be carefully weighed.”

“We hope these findings may help to improve the counseling on cancer-risk management strategies for BRCA carriers with young-onset of breast cancer below the age of 40 years,” Lambertini added during a press briefing. 

Various risk-reducing strategies, including risk-reducing surgeries, are recommended for BRCA-mutation carriers without a prior history of cancer, but the impact of these surgeries among younger populations with a history of early-onset breast cancer has been less clear.

The new findings come from the BRCA BCY Collaboration, an international, multicenter, retrospective cohort study of 5290 patients with likely pathogenic/pathogenic germline BRCA1 and/or BRCA2 mutations who were diagnosed with stages I-III breast cancer at ≤ 40 years. The risk-reducing mastectomy analysis included 2910 patients (55%) who underwent the surgery less than 1 year from diagnosis and 2380 who opted not to have the surgery. 

Primary endpoint was overall survival, and disease-free survival and breast cancer-free interval were secondary endpoints. Overall survival models were adjusted for the development of distant recurrences or second primary malignancies.

During median follow-up of 5.1 years, patients who underwent risk-reducing mastectomy had a 35% lower risk of dying (adjusted hazard ratio [aHR], 0.65) as well as a significant improvement in both disease-free survival (aHR, 0.58) and breast cancer-free interval (aHR, 0.55). The improved outcomes were seen in both BRCA1 and BRCA2 carriers, Lambertini reported. 

The risk-reducing salpingo-oophorectomy analysis included 2782 patients who underwent this surgery a median of 3 years from diagnosis and 2508 who did not. 

During median follow up of 4.9 years, risk-reducing salpingo-oophorectomy was associated with a 42% lower risk for death (aHR, 0.58) as well as an improvement in both disease-free survival (aHR, 0.68) and breast cancer-free interval (aHR, 0.65).

For risk-reducing salpingo-oophorectomy, there was an interaction based on breast cancer subtype and BRCA mutation.

“Specifically, the benefit of risk-reducing salpingo-oophorectomy was greater for patients with BRCA1 pathogenic variants and for those with triple-negative disease, as compared to those with BRCA2 pathogenic variants or luminal disease,” Lambertini reported.

Overall survival results were similar in patients who underwent one or both surgeries.

Briefing moderator Kate Lathrop, MD, with the University of Texas Health Science Center at San Antonio, noted that this study provides valuable information for counseling younger patients. Having datasets like this helps us give patients “potentially our best estimate of the amount of reduction of risk you could have by having the surgery now.”

In an interview, Freya Schnabel, MD, director of breast surgery at NYU Langone Health’s Perlmutter Cancer Center, New York City, emphasized the importance of early, well-informed decision-making upfront at the time of diagnosis in this patient population.

The benefit of “risk-reducing oophorectomy cannot be overemphasized, even in the presence of a known breast cancer because, as my colleagues and I say — we don’t want to cure their breast cancer and then have them die of ovarian cancer,” said Schnabel, who was not involved in the study.

In terms of prophylactic contralateral mastectomy, Schnabel noted that BRCA-mutation carriers have a “very high” risk for a second primary breast cancer. In her experience, “that’s what drives patients frequently at the time of diagnosis to have bilateral mastectomy because who wants to go through this more than once?” 

This is especially true for BRCA1 carriers who have a higher risk for triple-negative breast cancer, which is associated with a worse prognosis and is harder to treat, Schnabel said. 

“For these patients, having surgery prevents the patient from getting into a situation where their second primary tumor winds up being biologically more aggressive and then affects their survival,” Schnabel said.

The study was supported by the Italian Association for Cancer Research and the European Society for Medical Oncology. Lambertini reported advisory roles for Roche, Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead, MSD, Exact Sciences, Pierre Fabre, and Menarini. Lathrop consults for TeraSera Pharmaceuticals. Schnabel had no relevant disclosures.

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

Patients with BRCA mutations and a history of early-onset breast cancer benefited from risk-reducing surgeries, according to new data presented at the San Antonio Breast Cancer Symposium (SABCS) 2024.

Having a risk-reducing mastectomy or salpingo-oophorectomy was associated with significantly improved overall survival and disease-free survival in BRCA-mutation carriers who had been diagnosed with a first breast cancer at age ≤ 40 years.

“This global study provides the first evidence that risk-reducing surgeries improve survival outcomes among young BRCA-mutation carriers with a prior history of early-onset breast cancer,” study investigator Matteo Lambertini, MD, PhD, oncologist with the University of Genova–IRCCS Policlinico San Martino Hospital in Genoa, Italy, said in a statement from the SABCS, where he presented the findings. “Considering the unique traits and needs of this younger population, and their high risk for secondary malignancies, it is critical to understand how risk-reducing surgeries affect patient outcomes, so that the risks and benefits of these procedures can be carefully weighed.”

“We hope these findings may help to improve the counseling on cancer-risk management strategies for BRCA carriers with young-onset of breast cancer below the age of 40 years,” Lambertini added during a press briefing. 

Various risk-reducing strategies, including risk-reducing surgeries, are recommended for BRCA-mutation carriers without a prior history of cancer, but the impact of these surgeries among younger populations with a history of early-onset breast cancer has been less clear.

The new findings come from the BRCA BCY Collaboration, an international, multicenter, retrospective cohort study of 5290 patients with likely pathogenic/pathogenic germline BRCA1 and/or BRCA2 mutations who were diagnosed with stages I-III breast cancer at ≤ 40 years. The risk-reducing mastectomy analysis included 2910 patients (55%) who underwent the surgery less than 1 year from diagnosis and 2380 who opted not to have the surgery. 

Primary endpoint was overall survival, and disease-free survival and breast cancer-free interval were secondary endpoints. Overall survival models were adjusted for the development of distant recurrences or second primary malignancies.

During median follow-up of 5.1 years, patients who underwent risk-reducing mastectomy had a 35% lower risk of dying (adjusted hazard ratio [aHR], 0.65) as well as a significant improvement in both disease-free survival (aHR, 0.58) and breast cancer-free interval (aHR, 0.55). The improved outcomes were seen in both BRCA1 and BRCA2 carriers, Lambertini reported. 

The risk-reducing salpingo-oophorectomy analysis included 2782 patients who underwent this surgery a median of 3 years from diagnosis and 2508 who did not. 

During median follow up of 4.9 years, risk-reducing salpingo-oophorectomy was associated with a 42% lower risk for death (aHR, 0.58) as well as an improvement in both disease-free survival (aHR, 0.68) and breast cancer-free interval (aHR, 0.65).

For risk-reducing salpingo-oophorectomy, there was an interaction based on breast cancer subtype and BRCA mutation.

“Specifically, the benefit of risk-reducing salpingo-oophorectomy was greater for patients with BRCA1 pathogenic variants and for those with triple-negative disease, as compared to those with BRCA2 pathogenic variants or luminal disease,” Lambertini reported.

Overall survival results were similar in patients who underwent one or both surgeries.

Briefing moderator Kate Lathrop, MD, with the University of Texas Health Science Center at San Antonio, noted that this study provides valuable information for counseling younger patients. Having datasets like this helps us give patients “potentially our best estimate of the amount of reduction of risk you could have by having the surgery now.”

In an interview, Freya Schnabel, MD, director of breast surgery at NYU Langone Health’s Perlmutter Cancer Center, New York City, emphasized the importance of early, well-informed decision-making upfront at the time of diagnosis in this patient population.

The benefit of “risk-reducing oophorectomy cannot be overemphasized, even in the presence of a known breast cancer because, as my colleagues and I say — we don’t want to cure their breast cancer and then have them die of ovarian cancer,” said Schnabel, who was not involved in the study.

In terms of prophylactic contralateral mastectomy, Schnabel noted that BRCA-mutation carriers have a “very high” risk for a second primary breast cancer. In her experience, “that’s what drives patients frequently at the time of diagnosis to have bilateral mastectomy because who wants to go through this more than once?” 

This is especially true for BRCA1 carriers who have a higher risk for triple-negative breast cancer, which is associated with a worse prognosis and is harder to treat, Schnabel said. 

“For these patients, having surgery prevents the patient from getting into a situation where their second primary tumor winds up being biologically more aggressive and then affects their survival,” Schnabel said.

The study was supported by the Italian Association for Cancer Research and the European Society for Medical Oncology. Lambertini reported advisory roles for Roche, Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead, MSD, Exact Sciences, Pierre Fabre, and Menarini. Lathrop consults for TeraSera Pharmaceuticals. Schnabel had no relevant disclosures.

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

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Roshan Bransden didn’t count how many job offers she received during her recently completed training in family medicine. “It was pretty nonstop throughout all of my PGY-3 year,” she said.

Most of the job opportunities were different from the type of position she sought or where she wanted to work. Bransden graduated from residency at Montefiore Hospital in New York and accepted a position as a primary care doctor in Miami, close to where she grew up and where her family lives.

If the number of recruiting offers residents received last year is any indication, newly trained physicians will have no trouble finding work. More than half (56%) of all residents in AMN Healthcare’s 2023 Survey of Final-Year Medical Residents received 100 or more job solicitations during their training, the highest figure since the survey began more than 30 years ago, the staffing agency reported.

Employers are recruiting residents earlier, offering residency stipends of $1500 to $2500 up to 18 months before they finish their training if they commit to an employment contract, said Leah Grant, president of AMN Healthcare’s Physician Permanent Solutions division, specializing in doctor recruitment. She said that the company’s clients are already eyeing residents completing their training in 2026.

“The key for residents is not about finding a position but choosing the right one out of many.” Grant added that residents typically aren’t taught negotiation skills or how to evaluate job offers. They tend to choose a position based on location, but they should also consider work–life balance issues such as call schedules and whether incentives such as signing bonuses, relocation allowances, and student loan reimbursement offset the job’s time commitment.

“If you are a physician and you are willing to go anywhere, you will have hundreds of opportunities,” said Tibor Nagy, DO, an emergency medicine fellow who recently searched for jobs. “It depends on what they want out of their careers.”

 

Location Is a Key Consideration

Nagy said he had fewer options because he was limited by location, staying close to where his wife is finishing her internal medicine residency. He is completing his fellowship at Atrium Health Carolinas Medical Center in Charlotte, North Carolina, and preparing to return to Prisma Health in Greenville, South Carolina, where he did his residency.

He said that the job search was easier than he anticipated considering the tight market following a job report from the American College of Emergency Physicians in 2021 that predicted an oversupply of 8000 emergency medicine physicians by 2030.

Halfway through Nagy’s residency, he sought a fellowship in emergency medical services (EMS) to be more competitive in the job market. After that, “Every door I knocked on was open to hiring. Maybe it’s a regional thing. They were happy to interview me.” 

In addition to location, Nagy’s top priorities when choosing a job were stability and being able to use his EMS fellowship to become a medical director of an EMS system, agency, or fire department. He wanted to work for a hospital system with an academic focus without much employee turnover.

 

Salary vs Benefits 

AMN Healthcare received the most physician searches for family medicine doctors, followed by OB/GYNs. The staffing agency reported that close to two thirds (63%) of its search engagements during the 2023-2024 review period were for specialists, reflecting the needs of an aging population.

The highest average starting salaries were for surgical and internal medicine subspecialties, according to AMN Healthcare’s 2024 Physician and Advanced Practitioner Recruiting Incentives. Orthopedic surgery averaged $633,000; urology, $540,000; gastroenterology, $506,000; and pulmonary medicine, $418,000. For comparison, the average starting salaries for primary care doctors were family medicine, $255,000; internal medicine, $255,000; and pediatrics, $233,000.

In addition to starting salaries, many physicians receive signing bonuses, relocation allowances, and continuing medical education (CME) allowances. According to the report, the average signing bonus for physicians was $31,473. The average relocation allowance for physicians was $11,284 and the average CME allowance was $3969.

Salary wasn’t Nagy’s top priority when choosing a job, though he admits that the ability to pay back thousands of dollars in medical school loans will be helpful. Instead of focusing on higher pay to offset student loans, Nagy said he sought nonprofit positions to help him qualify for public service loan forgiveness.

The federal program forgives loan balances after the recipient makes monthly payments for 10 years while working for a government or nonprofit organization. He also racked up 3 years of residency and his fellowship year at nonprofit hospitals toward that commitment.

He said jobs that pay more may require doctors to see more patients. “The hustle may be different. There are definitely tradeoffs,” he said.

Bransden said the position she begins in January will allow her to work part-time with full benefits, among other perks. “My employer is a membership-based practice, so I’ll be able to gift a few memberships to family and friends.” 

 

Going Solo

Mohammad Ibrahim, DO, is among a minority of new physicians who have chosen to set up their own practice.

Only 6% of residents in AMN Healthcare’s 2024 report indicated that a solo practice was among their top two choices, while 20% listed partnering with another physician.

Ibrahim is a sports medicine fellow at the University of Michigan Health-West in Wyoming, after finishing his family medicine residency at Trinity Health Livingston Hospital in Howell, Michigan.

After his fellowship ends, he said he plans to stay in Michigan, where his family lives.

Ibrahim said he began his medical education knowing he wanted to become a solo clinician in private practice. He sees it as a way to have more control over his decisions about patient care and business practices.

Working in a hospital often requires doctors to gain approval from several levels of authority for decisions such as ordering new equipment or forgiving part of a service payment. He also wanted to set his schedule to take Friday afternoons off for Muslim prayer.

Although he realizes the challenges of starting a private practice, Ibrahim said those who go through graduate medical education can figure out how to adapt and overcome any obstacles. “I think it’s more doable than we are led to believe.” 

He said that if more residents were exposed to private practice, they might pursue that path. During his training, Ibrahim did a rotation with a private practice physician. “It’s nice to see people proud of what they built, what they contributed.”

Most residents don’t choose private practice. In the AMN Healthcare survey, 68% of residents said that employment by a hospital was among their top two choices for a practice setting, 42% said employment by a single-specialty group, and 32%, employment by a multispecialty group.

Of the majority of job searches AMN Healthcare conducted, 28% were to fill positions in hospital settings, followed by 26% for medical groups, 22% for academic medical centers, 13% for urgent care centers and retail clinics, 6% for solo practices, partnerships, or concierge practice settings, and 5% for Federally Qualified Health Centers/Community Health Centers or Indian Health facilities.

Still, the report noted an increase in recruiting for independent medical practice ownership, which dwindled in recent years, with the majority of doctors today employed likely due to financial obstacles of starting a practice.

The increase in recruiting indicates possible renewed interest in these practice settings, particularly concierge medicine, which allows doctors to avoid the challenges of third-party payments, the report stated.

Grant said that despite the flexibility and financial autonomy of starting their own practice, new providers who choose this path face obstacles, such as competing with urgent care centers and retail health clinics, which have been on the rise in the past year.

Saddled with debt from medical training, most graduating residents will choose to work toward financial stability and then consider their own practice later in their career, she said.

 

Flexible Schedules

Work schedule/call hours or work-life balance was the biggest factor (36%) guiding residents’ choice of first post-residency positions compared with starting salary (19%), according to the Medscape Resident Salary & Debt Report 2024.

Grant said that larger practices and those closer to rural communities tend to offer more innovative work schedules, especially for certain specialists. Some solo practices that form partnerships could potentially allow flexible schedules such as 4-day work weeks or week-on-week-off arrangements, she added.

Physicians are also opting for the flexibility of temporary, locum tenens work to improve job conditions and address feelings of burnout. Dr. Kaydo, DO, as she’s known on Instagram, posts about her experiences as locum tenens. “I found that I could have more flexibility as a locum. I want to be able to take time off when I want and as long as I wanted,” said the full-time family medicine doctor who practices at an outpatient clinic in Philadelphia.

“Basically, I’m contract-working, and they pay me as much as I work, and I can also take more time off.” Her employer for the past year also allowed her to work 10 hours a day, 4 days a week instead of the more traditional 8-hour, 5-day schedule.

Dr. Kaydo said she believes many young doctors think contract employees don’t have a permanent job, are not guaranteed a certain salary, and could easily lose their jobs. “I’ve found that most places really need doctors and are willing to negotiate.”

She said primary care locum doctors are particularly in demand in rural clinics and urban underserved areas.

Nagy said he is considering being a nocturnist, an emergency medicine doctor who works nights, to have more control over his schedule, higher pay, and more flexible shifts. “I switch days and nights and that can be tiring.” 

Bransden said job flexibility was her primary job criterion. “I have a young child, so I wanted to work part-time with the potential for even more flexibility down the line. I am working 3 days a week, 8-hour days with a 1-hour break. A 3-day work week came with a pay cut, but for me, it works and is what I need right now.”

 

A version of this article appeared on Medscape.com.

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Roshan Bransden didn’t count how many job offers she received during her recently completed training in family medicine. “It was pretty nonstop throughout all of my PGY-3 year,” she said.

Most of the job opportunities were different from the type of position she sought or where she wanted to work. Bransden graduated from residency at Montefiore Hospital in New York and accepted a position as a primary care doctor in Miami, close to where she grew up and where her family lives.

If the number of recruiting offers residents received last year is any indication, newly trained physicians will have no trouble finding work. More than half (56%) of all residents in AMN Healthcare’s 2023 Survey of Final-Year Medical Residents received 100 or more job solicitations during their training, the highest figure since the survey began more than 30 years ago, the staffing agency reported.

Employers are recruiting residents earlier, offering residency stipends of $1500 to $2500 up to 18 months before they finish their training if they commit to an employment contract, said Leah Grant, president of AMN Healthcare’s Physician Permanent Solutions division, specializing in doctor recruitment. She said that the company’s clients are already eyeing residents completing their training in 2026.

“The key for residents is not about finding a position but choosing the right one out of many.” Grant added that residents typically aren’t taught negotiation skills or how to evaluate job offers. They tend to choose a position based on location, but they should also consider work–life balance issues such as call schedules and whether incentives such as signing bonuses, relocation allowances, and student loan reimbursement offset the job’s time commitment.

“If you are a physician and you are willing to go anywhere, you will have hundreds of opportunities,” said Tibor Nagy, DO, an emergency medicine fellow who recently searched for jobs. “It depends on what they want out of their careers.”

 

Location Is a Key Consideration

Nagy said he had fewer options because he was limited by location, staying close to where his wife is finishing her internal medicine residency. He is completing his fellowship at Atrium Health Carolinas Medical Center in Charlotte, North Carolina, and preparing to return to Prisma Health in Greenville, South Carolina, where he did his residency.

He said that the job search was easier than he anticipated considering the tight market following a job report from the American College of Emergency Physicians in 2021 that predicted an oversupply of 8000 emergency medicine physicians by 2030.

Halfway through Nagy’s residency, he sought a fellowship in emergency medical services (EMS) to be more competitive in the job market. After that, “Every door I knocked on was open to hiring. Maybe it’s a regional thing. They were happy to interview me.” 

In addition to location, Nagy’s top priorities when choosing a job were stability and being able to use his EMS fellowship to become a medical director of an EMS system, agency, or fire department. He wanted to work for a hospital system with an academic focus without much employee turnover.

 

Salary vs Benefits 

AMN Healthcare received the most physician searches for family medicine doctors, followed by OB/GYNs. The staffing agency reported that close to two thirds (63%) of its search engagements during the 2023-2024 review period were for specialists, reflecting the needs of an aging population.

The highest average starting salaries were for surgical and internal medicine subspecialties, according to AMN Healthcare’s 2024 Physician and Advanced Practitioner Recruiting Incentives. Orthopedic surgery averaged $633,000; urology, $540,000; gastroenterology, $506,000; and pulmonary medicine, $418,000. For comparison, the average starting salaries for primary care doctors were family medicine, $255,000; internal medicine, $255,000; and pediatrics, $233,000.

In addition to starting salaries, many physicians receive signing bonuses, relocation allowances, and continuing medical education (CME) allowances. According to the report, the average signing bonus for physicians was $31,473. The average relocation allowance for physicians was $11,284 and the average CME allowance was $3969.

Salary wasn’t Nagy’s top priority when choosing a job, though he admits that the ability to pay back thousands of dollars in medical school loans will be helpful. Instead of focusing on higher pay to offset student loans, Nagy said he sought nonprofit positions to help him qualify for public service loan forgiveness.

The federal program forgives loan balances after the recipient makes monthly payments for 10 years while working for a government or nonprofit organization. He also racked up 3 years of residency and his fellowship year at nonprofit hospitals toward that commitment.

He said jobs that pay more may require doctors to see more patients. “The hustle may be different. There are definitely tradeoffs,” he said.

Bransden said the position she begins in January will allow her to work part-time with full benefits, among other perks. “My employer is a membership-based practice, so I’ll be able to gift a few memberships to family and friends.” 

 

Going Solo

Mohammad Ibrahim, DO, is among a minority of new physicians who have chosen to set up their own practice.

Only 6% of residents in AMN Healthcare’s 2024 report indicated that a solo practice was among their top two choices, while 20% listed partnering with another physician.

Ibrahim is a sports medicine fellow at the University of Michigan Health-West in Wyoming, after finishing his family medicine residency at Trinity Health Livingston Hospital in Howell, Michigan.

After his fellowship ends, he said he plans to stay in Michigan, where his family lives.

Ibrahim said he began his medical education knowing he wanted to become a solo clinician in private practice. He sees it as a way to have more control over his decisions about patient care and business practices.

Working in a hospital often requires doctors to gain approval from several levels of authority for decisions such as ordering new equipment or forgiving part of a service payment. He also wanted to set his schedule to take Friday afternoons off for Muslim prayer.

Although he realizes the challenges of starting a private practice, Ibrahim said those who go through graduate medical education can figure out how to adapt and overcome any obstacles. “I think it’s more doable than we are led to believe.” 

He said that if more residents were exposed to private practice, they might pursue that path. During his training, Ibrahim did a rotation with a private practice physician. “It’s nice to see people proud of what they built, what they contributed.”

Most residents don’t choose private practice. In the AMN Healthcare survey, 68% of residents said that employment by a hospital was among their top two choices for a practice setting, 42% said employment by a single-specialty group, and 32%, employment by a multispecialty group.

Of the majority of job searches AMN Healthcare conducted, 28% were to fill positions in hospital settings, followed by 26% for medical groups, 22% for academic medical centers, 13% for urgent care centers and retail clinics, 6% for solo practices, partnerships, or concierge practice settings, and 5% for Federally Qualified Health Centers/Community Health Centers or Indian Health facilities.

Still, the report noted an increase in recruiting for independent medical practice ownership, which dwindled in recent years, with the majority of doctors today employed likely due to financial obstacles of starting a practice.

The increase in recruiting indicates possible renewed interest in these practice settings, particularly concierge medicine, which allows doctors to avoid the challenges of third-party payments, the report stated.

Grant said that despite the flexibility and financial autonomy of starting their own practice, new providers who choose this path face obstacles, such as competing with urgent care centers and retail health clinics, which have been on the rise in the past year.

Saddled with debt from medical training, most graduating residents will choose to work toward financial stability and then consider their own practice later in their career, she said.

 

Flexible Schedules

Work schedule/call hours or work-life balance was the biggest factor (36%) guiding residents’ choice of first post-residency positions compared with starting salary (19%), according to the Medscape Resident Salary & Debt Report 2024.

Grant said that larger practices and those closer to rural communities tend to offer more innovative work schedules, especially for certain specialists. Some solo practices that form partnerships could potentially allow flexible schedules such as 4-day work weeks or week-on-week-off arrangements, she added.

Physicians are also opting for the flexibility of temporary, locum tenens work to improve job conditions and address feelings of burnout. Dr. Kaydo, DO, as she’s known on Instagram, posts about her experiences as locum tenens. “I found that I could have more flexibility as a locum. I want to be able to take time off when I want and as long as I wanted,” said the full-time family medicine doctor who practices at an outpatient clinic in Philadelphia.

“Basically, I’m contract-working, and they pay me as much as I work, and I can also take more time off.” Her employer for the past year also allowed her to work 10 hours a day, 4 days a week instead of the more traditional 8-hour, 5-day schedule.

Dr. Kaydo said she believes many young doctors think contract employees don’t have a permanent job, are not guaranteed a certain salary, and could easily lose their jobs. “I’ve found that most places really need doctors and are willing to negotiate.”

She said primary care locum doctors are particularly in demand in rural clinics and urban underserved areas.

Nagy said he is considering being a nocturnist, an emergency medicine doctor who works nights, to have more control over his schedule, higher pay, and more flexible shifts. “I switch days and nights and that can be tiring.” 

Bransden said job flexibility was her primary job criterion. “I have a young child, so I wanted to work part-time with the potential for even more flexibility down the line. I am working 3 days a week, 8-hour days with a 1-hour break. A 3-day work week came with a pay cut, but for me, it works and is what I need right now.”

 

A version of this article appeared on Medscape.com.

Roshan Bransden didn’t count how many job offers she received during her recently completed training in family medicine. “It was pretty nonstop throughout all of my PGY-3 year,” she said.

Most of the job opportunities were different from the type of position she sought or where she wanted to work. Bransden graduated from residency at Montefiore Hospital in New York and accepted a position as a primary care doctor in Miami, close to where she grew up and where her family lives.

If the number of recruiting offers residents received last year is any indication, newly trained physicians will have no trouble finding work. More than half (56%) of all residents in AMN Healthcare’s 2023 Survey of Final-Year Medical Residents received 100 or more job solicitations during their training, the highest figure since the survey began more than 30 years ago, the staffing agency reported.

Employers are recruiting residents earlier, offering residency stipends of $1500 to $2500 up to 18 months before they finish their training if they commit to an employment contract, said Leah Grant, president of AMN Healthcare’s Physician Permanent Solutions division, specializing in doctor recruitment. She said that the company’s clients are already eyeing residents completing their training in 2026.

“The key for residents is not about finding a position but choosing the right one out of many.” Grant added that residents typically aren’t taught negotiation skills or how to evaluate job offers. They tend to choose a position based on location, but they should also consider work–life balance issues such as call schedules and whether incentives such as signing bonuses, relocation allowances, and student loan reimbursement offset the job’s time commitment.

“If you are a physician and you are willing to go anywhere, you will have hundreds of opportunities,” said Tibor Nagy, DO, an emergency medicine fellow who recently searched for jobs. “It depends on what they want out of their careers.”

 

Location Is a Key Consideration

Nagy said he had fewer options because he was limited by location, staying close to where his wife is finishing her internal medicine residency. He is completing his fellowship at Atrium Health Carolinas Medical Center in Charlotte, North Carolina, and preparing to return to Prisma Health in Greenville, South Carolina, where he did his residency.

He said that the job search was easier than he anticipated considering the tight market following a job report from the American College of Emergency Physicians in 2021 that predicted an oversupply of 8000 emergency medicine physicians by 2030.

Halfway through Nagy’s residency, he sought a fellowship in emergency medical services (EMS) to be more competitive in the job market. After that, “Every door I knocked on was open to hiring. Maybe it’s a regional thing. They were happy to interview me.” 

In addition to location, Nagy’s top priorities when choosing a job were stability and being able to use his EMS fellowship to become a medical director of an EMS system, agency, or fire department. He wanted to work for a hospital system with an academic focus without much employee turnover.

 

Salary vs Benefits 

AMN Healthcare received the most physician searches for family medicine doctors, followed by OB/GYNs. The staffing agency reported that close to two thirds (63%) of its search engagements during the 2023-2024 review period were for specialists, reflecting the needs of an aging population.

The highest average starting salaries were for surgical and internal medicine subspecialties, according to AMN Healthcare’s 2024 Physician and Advanced Practitioner Recruiting Incentives. Orthopedic surgery averaged $633,000; urology, $540,000; gastroenterology, $506,000; and pulmonary medicine, $418,000. For comparison, the average starting salaries for primary care doctors were family medicine, $255,000; internal medicine, $255,000; and pediatrics, $233,000.

In addition to starting salaries, many physicians receive signing bonuses, relocation allowances, and continuing medical education (CME) allowances. According to the report, the average signing bonus for physicians was $31,473. The average relocation allowance for physicians was $11,284 and the average CME allowance was $3969.

Salary wasn’t Nagy’s top priority when choosing a job, though he admits that the ability to pay back thousands of dollars in medical school loans will be helpful. Instead of focusing on higher pay to offset student loans, Nagy said he sought nonprofit positions to help him qualify for public service loan forgiveness.

The federal program forgives loan balances after the recipient makes monthly payments for 10 years while working for a government or nonprofit organization. He also racked up 3 years of residency and his fellowship year at nonprofit hospitals toward that commitment.

He said jobs that pay more may require doctors to see more patients. “The hustle may be different. There are definitely tradeoffs,” he said.

Bransden said the position she begins in January will allow her to work part-time with full benefits, among other perks. “My employer is a membership-based practice, so I’ll be able to gift a few memberships to family and friends.” 

 

Going Solo

Mohammad Ibrahim, DO, is among a minority of new physicians who have chosen to set up their own practice.

Only 6% of residents in AMN Healthcare’s 2024 report indicated that a solo practice was among their top two choices, while 20% listed partnering with another physician.

Ibrahim is a sports medicine fellow at the University of Michigan Health-West in Wyoming, after finishing his family medicine residency at Trinity Health Livingston Hospital in Howell, Michigan.

After his fellowship ends, he said he plans to stay in Michigan, where his family lives.

Ibrahim said he began his medical education knowing he wanted to become a solo clinician in private practice. He sees it as a way to have more control over his decisions about patient care and business practices.

Working in a hospital often requires doctors to gain approval from several levels of authority for decisions such as ordering new equipment or forgiving part of a service payment. He also wanted to set his schedule to take Friday afternoons off for Muslim prayer.

Although he realizes the challenges of starting a private practice, Ibrahim said those who go through graduate medical education can figure out how to adapt and overcome any obstacles. “I think it’s more doable than we are led to believe.” 

He said that if more residents were exposed to private practice, they might pursue that path. During his training, Ibrahim did a rotation with a private practice physician. “It’s nice to see people proud of what they built, what they contributed.”

Most residents don’t choose private practice. In the AMN Healthcare survey, 68% of residents said that employment by a hospital was among their top two choices for a practice setting, 42% said employment by a single-specialty group, and 32%, employment by a multispecialty group.

Of the majority of job searches AMN Healthcare conducted, 28% were to fill positions in hospital settings, followed by 26% for medical groups, 22% for academic medical centers, 13% for urgent care centers and retail clinics, 6% for solo practices, partnerships, or concierge practice settings, and 5% for Federally Qualified Health Centers/Community Health Centers or Indian Health facilities.

Still, the report noted an increase in recruiting for independent medical practice ownership, which dwindled in recent years, with the majority of doctors today employed likely due to financial obstacles of starting a practice.

The increase in recruiting indicates possible renewed interest in these practice settings, particularly concierge medicine, which allows doctors to avoid the challenges of third-party payments, the report stated.

Grant said that despite the flexibility and financial autonomy of starting their own practice, new providers who choose this path face obstacles, such as competing with urgent care centers and retail health clinics, which have been on the rise in the past year.

Saddled with debt from medical training, most graduating residents will choose to work toward financial stability and then consider their own practice later in their career, she said.

 

Flexible Schedules

Work schedule/call hours or work-life balance was the biggest factor (36%) guiding residents’ choice of first post-residency positions compared with starting salary (19%), according to the Medscape Resident Salary & Debt Report 2024.

Grant said that larger practices and those closer to rural communities tend to offer more innovative work schedules, especially for certain specialists. Some solo practices that form partnerships could potentially allow flexible schedules such as 4-day work weeks or week-on-week-off arrangements, she added.

Physicians are also opting for the flexibility of temporary, locum tenens work to improve job conditions and address feelings of burnout. Dr. Kaydo, DO, as she’s known on Instagram, posts about her experiences as locum tenens. “I found that I could have more flexibility as a locum. I want to be able to take time off when I want and as long as I wanted,” said the full-time family medicine doctor who practices at an outpatient clinic in Philadelphia.

“Basically, I’m contract-working, and they pay me as much as I work, and I can also take more time off.” Her employer for the past year also allowed her to work 10 hours a day, 4 days a week instead of the more traditional 8-hour, 5-day schedule.

Dr. Kaydo said she believes many young doctors think contract employees don’t have a permanent job, are not guaranteed a certain salary, and could easily lose their jobs. “I’ve found that most places really need doctors and are willing to negotiate.”

She said primary care locum doctors are particularly in demand in rural clinics and urban underserved areas.

Nagy said he is considering being a nocturnist, an emergency medicine doctor who works nights, to have more control over his schedule, higher pay, and more flexible shifts. “I switch days and nights and that can be tiring.” 

Bransden said job flexibility was her primary job criterion. “I have a young child, so I wanted to work part-time with the potential for even more flexibility down the line. I am working 3 days a week, 8-hour days with a 1-hour break. A 3-day work week came with a pay cut, but for me, it works and is what I need right now.”

 

A version of this article appeared on Medscape.com.

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Thu, 12/12/2024 - 13:48

New Cancer Drugs: Do Patients Prefer Faster Access or Clinical Benefit?

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Tue, 12/17/2024 - 06:11

When the Food and Drug Administration (FDA) grants cancer drugs accelerated approval, a key aim is to provide patients faster access to therapies that can benefit them. 

The downside of a speedier approval timeline, however, is that it’s often not yet clear whether the new drugs will actually allow a patient to live longer or better. Information on overall survival and quality of life typically comes years later, after drugs undergo confirmatory trials, or sometimes not at all, if companies fail to conduct these trials. 

During this waiting period, patients may be receiving a cancer drug that provides no real clinical benefit but comes with a host of toxicities. 

In fact, the odds are about as good as a coin flip. For cancer drugs that have confirmatory trial data, more than half don’t ultimately provide an overall survival or quality of life benefit.

Inherent to the accelerated approval process is the assumption that patients are willing to accept this uncertainty in exchange for faster access.

But is that really the case? 

A recent survey published in The Lancet Oncology aimed to tease out people’s preferences for confirmed clinical benefit vs speedier access. The researchers asked about 870 adults with experience of cancer challenges — either their own cancer diagnosis or that of family or a close friend — whether they valued faster access or certainty that a drug really works. 

In the study, participants imagined they had been diagnosed with cancer and could choose between two cancer drugs under investigation in clinical trials but with uncertain effectiveness, and a current standard treatment. Participants had to make a series of choices based on five scenarios. 

The first two scenarios were based on the impact of the current standard treatment: A patient’s life expectancy on the standard treatment (6 months up to 3 years), and a patient’s physical health on the standard treatment (functional status restricted only during strenuous activities up to completely disabled).

The remaining three scenarios dealt with the two new drugs: The effect of the new drugs on a surrogate endpoint, progression-free survival (whether the drugs slowed tumor growth for an extra month or 5 additional months compared with the standard treatment), certainty that slowing tumor growth will improve survival (very low to high), and the wait time to access the drugs (immediately to as long as 2 years).

The researchers assessed the relative importance of survival benefit certainty vs wait time and how that balance shifted depending on the different scenarios. 

Overall, the researchers found that, if there was no evidence linking the surrogate endpoint (progression-free survival) to overall survival, patients were willing to wait about 8 months for weak evidence of an overall survival benefit (ie, low certainty the drug will extend survival by 1-5 months), about 16 months for moderate certainty, and almost 22 months for high certainty. 

Despite a willingness to wait for greater certainty, participants did value speed as well. Overall, respondents showed a strong preference against a 1-year delay in FDA approval time. People who were aged 55 years or more and were non-White individuals made less than $40,000 year as well as those with the lowest life expectancy on a current standard treatment were most sensitive to wait times while those with better functional status and longer life expectancies on a current treatment were less sensitive to longer wait times.

“Our results indicate that some patients (except those with the poorest prognoses) would find the additional time required to generate evidence on the survival benefit of new cancer drugs an acceptable tradeoff,” the study authors concluded.

Although people do place high value on timely access to new cancer drugs, especially if there are limited treatment options, many are willing to wait for greater certainty that a new drug provides an overall survival benefit, lead author Robin Forrest, MSc, with the Department of Health Policy, London School of Economics in England, said in an interview. 

In the study, respondents also did not place significant value on whether the drug substantially slowed cancer growth. “In other words, substantial progression-free survival benefit of a drug did not compensate for lack of certainty about a drug’s benefit on survival in respondents’ drug choices,” the authors explained.

“In an effort to move quickly, we have accepted progression-free survival [as a surrogate endpoint],” Jyoti D. Patel, MD, oncologist with Northwestern Memorial Hospital, Chicago, Illinois, who wasn’t involved in the study. But a growing body of evidence indicates that progression-free survival is often a poor surrogate for overall survival. And what this study suggests is that “patients uniformly care about improvements in overall survival and the quality of that survival,” Patel said.

Bishal Gyawali, MD, PhD, was not surprised by the findings. 

“I always thought this was the real-world scenario, but the problem is the voices of ordinary patients are not heard,” Gyawali, with Queen’s University, Kingston, Ontario, Canada, who also wasn’t involved in the study, said in an interview. 

“What is heard is the loud noise of ‘we need access now, today, yesterday’ — ‘we don’t care if the drug doesn’t improve overall survival, we just need a drug, any drug’ — ‘we don’t care how much it costs, we need access today,’ ” Gyawali said. “Not saying this is wrong, but this is not the representation of all patients.”

However, the voices of patients who are more cautious and want evidence of benefit before accepting toxicities don’t make headlines, he added. 

What this survey means from a policy perspective, said Gyawali, is that accelerated approvals that do not mandate survival endpoint in confirmatory trials are ignoring the need of many patients who prioritize certainty of benefit over speed of access.

The study was funded by the London School of Economics and Political Science Phelan United States Centre. Forrest had no relevant disclosures. Gyawali has received consulting fees from Vivio Health. Patel has various relationships with AbbVie, Anheart, AstraZeneca, Bristol-Myers Squibb, Guardant, Tempus, Sanofi, BluePrint, Takeda, and Gilead.

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

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When the Food and Drug Administration (FDA) grants cancer drugs accelerated approval, a key aim is to provide patients faster access to therapies that can benefit them. 

The downside of a speedier approval timeline, however, is that it’s often not yet clear whether the new drugs will actually allow a patient to live longer or better. Information on overall survival and quality of life typically comes years later, after drugs undergo confirmatory trials, or sometimes not at all, if companies fail to conduct these trials. 

During this waiting period, patients may be receiving a cancer drug that provides no real clinical benefit but comes with a host of toxicities. 

In fact, the odds are about as good as a coin flip. For cancer drugs that have confirmatory trial data, more than half don’t ultimately provide an overall survival or quality of life benefit.

Inherent to the accelerated approval process is the assumption that patients are willing to accept this uncertainty in exchange for faster access.

But is that really the case? 

A recent survey published in The Lancet Oncology aimed to tease out people’s preferences for confirmed clinical benefit vs speedier access. The researchers asked about 870 adults with experience of cancer challenges — either their own cancer diagnosis or that of family or a close friend — whether they valued faster access or certainty that a drug really works. 

In the study, participants imagined they had been diagnosed with cancer and could choose between two cancer drugs under investigation in clinical trials but with uncertain effectiveness, and a current standard treatment. Participants had to make a series of choices based on five scenarios. 

The first two scenarios were based on the impact of the current standard treatment: A patient’s life expectancy on the standard treatment (6 months up to 3 years), and a patient’s physical health on the standard treatment (functional status restricted only during strenuous activities up to completely disabled).

The remaining three scenarios dealt with the two new drugs: The effect of the new drugs on a surrogate endpoint, progression-free survival (whether the drugs slowed tumor growth for an extra month or 5 additional months compared with the standard treatment), certainty that slowing tumor growth will improve survival (very low to high), and the wait time to access the drugs (immediately to as long as 2 years).

The researchers assessed the relative importance of survival benefit certainty vs wait time and how that balance shifted depending on the different scenarios. 

Overall, the researchers found that, if there was no evidence linking the surrogate endpoint (progression-free survival) to overall survival, patients were willing to wait about 8 months for weak evidence of an overall survival benefit (ie, low certainty the drug will extend survival by 1-5 months), about 16 months for moderate certainty, and almost 22 months for high certainty. 

Despite a willingness to wait for greater certainty, participants did value speed as well. Overall, respondents showed a strong preference against a 1-year delay in FDA approval time. People who were aged 55 years or more and were non-White individuals made less than $40,000 year as well as those with the lowest life expectancy on a current standard treatment were most sensitive to wait times while those with better functional status and longer life expectancies on a current treatment were less sensitive to longer wait times.

“Our results indicate that some patients (except those with the poorest prognoses) would find the additional time required to generate evidence on the survival benefit of new cancer drugs an acceptable tradeoff,” the study authors concluded.

Although people do place high value on timely access to new cancer drugs, especially if there are limited treatment options, many are willing to wait for greater certainty that a new drug provides an overall survival benefit, lead author Robin Forrest, MSc, with the Department of Health Policy, London School of Economics in England, said in an interview. 

In the study, respondents also did not place significant value on whether the drug substantially slowed cancer growth. “In other words, substantial progression-free survival benefit of a drug did not compensate for lack of certainty about a drug’s benefit on survival in respondents’ drug choices,” the authors explained.

“In an effort to move quickly, we have accepted progression-free survival [as a surrogate endpoint],” Jyoti D. Patel, MD, oncologist with Northwestern Memorial Hospital, Chicago, Illinois, who wasn’t involved in the study. But a growing body of evidence indicates that progression-free survival is often a poor surrogate for overall survival. And what this study suggests is that “patients uniformly care about improvements in overall survival and the quality of that survival,” Patel said.

Bishal Gyawali, MD, PhD, was not surprised by the findings. 

“I always thought this was the real-world scenario, but the problem is the voices of ordinary patients are not heard,” Gyawali, with Queen’s University, Kingston, Ontario, Canada, who also wasn’t involved in the study, said in an interview. 

“What is heard is the loud noise of ‘we need access now, today, yesterday’ — ‘we don’t care if the drug doesn’t improve overall survival, we just need a drug, any drug’ — ‘we don’t care how much it costs, we need access today,’ ” Gyawali said. “Not saying this is wrong, but this is not the representation of all patients.”

However, the voices of patients who are more cautious and want evidence of benefit before accepting toxicities don’t make headlines, he added. 

What this survey means from a policy perspective, said Gyawali, is that accelerated approvals that do not mandate survival endpoint in confirmatory trials are ignoring the need of many patients who prioritize certainty of benefit over speed of access.

The study was funded by the London School of Economics and Political Science Phelan United States Centre. Forrest had no relevant disclosures. Gyawali has received consulting fees from Vivio Health. Patel has various relationships with AbbVie, Anheart, AstraZeneca, Bristol-Myers Squibb, Guardant, Tempus, Sanofi, BluePrint, Takeda, and Gilead.

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

When the Food and Drug Administration (FDA) grants cancer drugs accelerated approval, a key aim is to provide patients faster access to therapies that can benefit them. 

The downside of a speedier approval timeline, however, is that it’s often not yet clear whether the new drugs will actually allow a patient to live longer or better. Information on overall survival and quality of life typically comes years later, after drugs undergo confirmatory trials, or sometimes not at all, if companies fail to conduct these trials. 

During this waiting period, patients may be receiving a cancer drug that provides no real clinical benefit but comes with a host of toxicities. 

In fact, the odds are about as good as a coin flip. For cancer drugs that have confirmatory trial data, more than half don’t ultimately provide an overall survival or quality of life benefit.

Inherent to the accelerated approval process is the assumption that patients are willing to accept this uncertainty in exchange for faster access.

But is that really the case? 

A recent survey published in The Lancet Oncology aimed to tease out people’s preferences for confirmed clinical benefit vs speedier access. The researchers asked about 870 adults with experience of cancer challenges — either their own cancer diagnosis or that of family or a close friend — whether they valued faster access or certainty that a drug really works. 

In the study, participants imagined they had been diagnosed with cancer and could choose between two cancer drugs under investigation in clinical trials but with uncertain effectiveness, and a current standard treatment. Participants had to make a series of choices based on five scenarios. 

The first two scenarios were based on the impact of the current standard treatment: A patient’s life expectancy on the standard treatment (6 months up to 3 years), and a patient’s physical health on the standard treatment (functional status restricted only during strenuous activities up to completely disabled).

The remaining three scenarios dealt with the two new drugs: The effect of the new drugs on a surrogate endpoint, progression-free survival (whether the drugs slowed tumor growth for an extra month or 5 additional months compared with the standard treatment), certainty that slowing tumor growth will improve survival (very low to high), and the wait time to access the drugs (immediately to as long as 2 years).

The researchers assessed the relative importance of survival benefit certainty vs wait time and how that balance shifted depending on the different scenarios. 

Overall, the researchers found that, if there was no evidence linking the surrogate endpoint (progression-free survival) to overall survival, patients were willing to wait about 8 months for weak evidence of an overall survival benefit (ie, low certainty the drug will extend survival by 1-5 months), about 16 months for moderate certainty, and almost 22 months for high certainty. 

Despite a willingness to wait for greater certainty, participants did value speed as well. Overall, respondents showed a strong preference against a 1-year delay in FDA approval time. People who were aged 55 years or more and were non-White individuals made less than $40,000 year as well as those with the lowest life expectancy on a current standard treatment were most sensitive to wait times while those with better functional status and longer life expectancies on a current treatment were less sensitive to longer wait times.

“Our results indicate that some patients (except those with the poorest prognoses) would find the additional time required to generate evidence on the survival benefit of new cancer drugs an acceptable tradeoff,” the study authors concluded.

Although people do place high value on timely access to new cancer drugs, especially if there are limited treatment options, many are willing to wait for greater certainty that a new drug provides an overall survival benefit, lead author Robin Forrest, MSc, with the Department of Health Policy, London School of Economics in England, said in an interview. 

In the study, respondents also did not place significant value on whether the drug substantially slowed cancer growth. “In other words, substantial progression-free survival benefit of a drug did not compensate for lack of certainty about a drug’s benefit on survival in respondents’ drug choices,” the authors explained.

“In an effort to move quickly, we have accepted progression-free survival [as a surrogate endpoint],” Jyoti D. Patel, MD, oncologist with Northwestern Memorial Hospital, Chicago, Illinois, who wasn’t involved in the study. But a growing body of evidence indicates that progression-free survival is often a poor surrogate for overall survival. And what this study suggests is that “patients uniformly care about improvements in overall survival and the quality of that survival,” Patel said.

Bishal Gyawali, MD, PhD, was not surprised by the findings. 

“I always thought this was the real-world scenario, but the problem is the voices of ordinary patients are not heard,” Gyawali, with Queen’s University, Kingston, Ontario, Canada, who also wasn’t involved in the study, said in an interview. 

“What is heard is the loud noise of ‘we need access now, today, yesterday’ — ‘we don’t care if the drug doesn’t improve overall survival, we just need a drug, any drug’ — ‘we don’t care how much it costs, we need access today,’ ” Gyawali said. “Not saying this is wrong, but this is not the representation of all patients.”

However, the voices of patients who are more cautious and want evidence of benefit before accepting toxicities don’t make headlines, he added. 

What this survey means from a policy perspective, said Gyawali, is that accelerated approvals that do not mandate survival endpoint in confirmatory trials are ignoring the need of many patients who prioritize certainty of benefit over speed of access.

The study was funded by the London School of Economics and Political Science Phelan United States Centre. Forrest had no relevant disclosures. Gyawali has received consulting fees from Vivio Health. Patel has various relationships with AbbVie, Anheart, AstraZeneca, Bristol-Myers Squibb, Guardant, Tempus, Sanofi, BluePrint, Takeda, and Gilead.

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

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