TOPLINE:

Recurrence-free survival (RFS) is not a strong surrogate for overall survival in randomized trials of adjuvant immunotherapy for cancer.

METHODOLOGY:

• FDA approvals in the adjuvant setting for cancer immunotherapy are increasingly based on trials that use RFS as a surrogate endpoint for overall survival, largely because such a design allows for smaller, speedier trials.
• To test the validity of using RFS as a surrogate for overall survival in this setting, investigators conducted a meta-analysis of 15 phase 2 and 3 randomized controlled trials (RCTs) of adjuvant CTLA4 and anti–PD-1/PD-L1 blockers for melanoma, non–small cell lung cancer, renal cell cancer, and other tumors.
• The team used weighted regression at the arm and trial levels to assess the efficacy of RFS as a surrogate for overall survival.
• The strength of the association was quantified by weighted coefficients of determination (R²)12Dante MT Stdplz make sure all mentions of R’2’ are superscript, with a strong correlation considered to be R² of 0.7 or higher.
• If there were strong correlations at both the arm and trial levels, RFS would be considered a robust surrogate endpoint for overall survival; however, if one of the correlations at the arm or trial level was not strong, RFS would not be considered a surrogate endpoint for overall survival.

TAKEAWAY:

• At the arm level, moderate and strong associations were observed between 2-year RFS and 3-year overall survival (R², 0.58) and between 3-year RFS and 5-year overall survival (R², 0.72; 95% confidence interval, 0.38-.00).
• At the trial level, a moderate association was observed between effect of treatment on RFS and overall survival (R², 0.63).
• The findings were confirmed in several sensitivity analyses that were based on different trial phases, experimental arms, cancer types, and treatment strategies.

IN PRACTICE:

“Our meta-analysis failed to find a significantly strong association between RFS and OS in RCTs of adjuvant immunotherapy,” the authors concluded. “RFS should not be used as a surrogate endpoint for OS in this clinical context.” Instead, the finding indicates that overall survival is “the ideal primary endpoint” in this setting.

SOURCE:

The study, led by Yuanfang Li, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China, was published in the Journal of the National Cancer Institute.

LIMITATIONS:

• Correlations were calculated from a relatively limited number of RCTs that involved different types of cancer, and overall survival data were not fully mature in some of the trials.
• The analysis did not include patient-level data.

DISCLOSURES:

• The work was funded by the National Natural Science Foundation of China and others.
• The investigators had no disclosures.

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

TOPLINE:

Recurrence-free survival (RFS) is not a strong surrogate for overall survival in randomized trials of adjuvant immunotherapy for cancer.

METHODOLOGY:

• FDA approvals in the adjuvant setting for cancer immunotherapy are increasingly based on trials that use RFS as a surrogate endpoint for overall survival, largely because such a design allows for smaller, speedier trials.
• To test the validity of using RFS as a surrogate for overall survival in this setting, investigators conducted a meta-analysis of 15 phase 2 and 3 randomized controlled trials (RCTs) of adjuvant CTLA4 and anti–PD-1/PD-L1 blockers for melanoma, non–small cell lung cancer, renal cell cancer, and other tumors.
• The team used weighted regression at the arm and trial levels to assess the efficacy of RFS as a surrogate for overall survival.
• The strength of the association was quantified by weighted coefficients of determination (R²)12Dante MT Stdplz make sure all mentions of R’2’ are superscript, with a strong correlation considered to be R² of 0.7 or higher.
• If there were strong correlations at both the arm and trial levels, RFS would be considered a robust surrogate endpoint for overall survival; however, if one of the correlations at the arm or trial level was not strong, RFS would not be considered a surrogate endpoint for overall survival.

TAKEAWAY:

• At the arm level, moderate and strong associations were observed between 2-year RFS and 3-year overall survival (R², 0.58) and between 3-year RFS and 5-year overall survival (R², 0.72; 95% confidence interval, 0.38-.00).
• At the trial level, a moderate association was observed between effect of treatment on RFS and overall survival (R², 0.63).
• The findings were confirmed in several sensitivity analyses that were based on different trial phases, experimental arms, cancer types, and treatment strategies.

IN PRACTICE:

“Our meta-analysis failed to find a significantly strong association between RFS and OS in RCTs of adjuvant immunotherapy,” the authors concluded. “RFS should not be used as a surrogate endpoint for OS in this clinical context.” Instead, the finding indicates that overall survival is “the ideal primary endpoint” in this setting.

SOURCE:

The study, led by Yuanfang Li, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China, was published in the Journal of the National Cancer Institute.

LIMITATIONS:

• Correlations were calculated from a relatively limited number of RCTs that involved different types of cancer, and overall survival data were not fully mature in some of the trials.
• The analysis did not include patient-level data.

DISCLOSURES:

• The work was funded by the National Natural Science Foundation of China and others.
• The investigators had no disclosures.

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

TOPLINE:

Recurrence-free survival (RFS) is not a strong surrogate for overall survival in randomized trials of adjuvant immunotherapy for cancer.

METHODOLOGY:

• FDA approvals in the adjuvant setting for cancer immunotherapy are increasingly based on trials that use RFS as a surrogate endpoint for overall survival, largely because such a design allows for smaller, speedier trials.
• To test the validity of using RFS as a surrogate for overall survival in this setting, investigators conducted a meta-analysis of 15 phase 2 and 3 randomized controlled trials (RCTs) of adjuvant CTLA4 and anti–PD-1/PD-L1 blockers for melanoma, non–small cell lung cancer, renal cell cancer, and other tumors.
• The team used weighted regression at the arm and trial levels to assess the efficacy of RFS as a surrogate for overall survival.
• The strength of the association was quantified by weighted coefficients of determination (R²)12Dante MT Stdplz make sure all mentions of R’2’ are superscript, with a strong correlation considered to be R² of 0.7 or higher.
• If there were strong correlations at both the arm and trial levels, RFS would be considered a robust surrogate endpoint for overall survival; however, if one of the correlations at the arm or trial level was not strong, RFS would not be considered a surrogate endpoint for overall survival.

TAKEAWAY:

• At the arm level, moderate and strong associations were observed between 2-year RFS and 3-year overall survival (R², 0.58) and between 3-year RFS and 5-year overall survival (R², 0.72; 95% confidence interval, 0.38-.00).
• At the trial level, a moderate association was observed between effect of treatment on RFS and overall survival (R², 0.63).
• The findings were confirmed in several sensitivity analyses that were based on different trial phases, experimental arms, cancer types, and treatment strategies.

IN PRACTICE:

“Our meta-analysis failed to find a significantly strong association between RFS and OS in RCTs of adjuvant immunotherapy,” the authors concluded. “RFS should not be used as a surrogate endpoint for OS in this clinical context.” Instead, the finding indicates that overall survival is “the ideal primary endpoint” in this setting.

SOURCE:

The study, led by Yuanfang Li, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China, was published in the Journal of the National Cancer Institute.

LIMITATIONS:

• Correlations were calculated from a relatively limited number of RCTs that involved different types of cancer, and overall survival data were not fully mature in some of the trials.
• The analysis did not include patient-level data.

DISCLOSURES:

• The work was funded by the National Natural Science Foundation of China and others.
• The investigators had no disclosures.

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

The patient’s toenail thickening appeared consistent with possible onychomycosis—but in addition, there was a marked inflammatory and vesicular eruption consistent with an allergic contact dermatitis.

TTO, also known as melaleuca oil, is a popular product used to treat many disorders including alopecia, seborrheic dermatitis, and onychomycosis.¹ Unfortunately, it is a complex compound, and the rate of positive reactions to patch testing ranges from 0.1% to 3.5%.²

There are 2 types of contact dermatitis: irritant and allergic. Irritant contact dermatitis results from an irritating or relatively caustic substance causing direct damage and inflammation to the skin. In allergic contact dermatitis, as occurred here, there is sensitization to a substance that causes a type IV delayed cell-mediated immune response. Although radioallergosorbent blood testing will usually show immunoglobulin E antibodies to the inciting substance, patch testing is more specific and will show a reaction to the imputed substance on direct skin application. This usually is performed as a panel of antigens tested at the same time.

The mainstay of treatment is to identify, stop use of, and then avoid the sensitizing substance. Topical steroids (triamcinolone 0.1% ointment or clobetasol 0.05% ointment twice daily) are helpful in most cases. If the condition is severe or does not respond to initial therapy, systemic steroids (prednisone 40 mg/d for 5 days for most cases or a 2- to 3-week taper for Rhus dermatitis [eg, poison ivy]) are often effective.³

This patient was instructed to stop using TTO and counseled to avoid it in the future. She was told that her nails might fall off due to the inflammation, which might cure her onychomycosis, and that it takes 12 to 18 months to grow new toenails. She was advised to return for evaluation if the new nails developed any abnormalities or if her onychomycosis recurred. Oral terbinafine 250 mg/d for 90 days is usually a safe and effective therapy.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

The patient’s toenail thickening appeared consistent with possible onychomycosis—but in addition, there was a marked inflammatory and vesicular eruption consistent with an allergic contact dermatitis.

TTO, also known as melaleuca oil, is a popular product used to treat many disorders including alopecia, seborrheic dermatitis, and onychomycosis.¹ Unfortunately, it is a complex compound, and the rate of positive reactions to patch testing ranges from 0.1% to 3.5%.²

There are 2 types of contact dermatitis: irritant and allergic. Irritant contact dermatitis results from an irritating or relatively caustic substance causing direct damage and inflammation to the skin. In allergic contact dermatitis, as occurred here, there is sensitization to a substance that causes a type IV delayed cell-mediated immune response. Although radioallergosorbent blood testing will usually show immunoglobulin E antibodies to the inciting substance, patch testing is more specific and will show a reaction to the imputed substance on direct skin application. This usually is performed as a panel of antigens tested at the same time.

The mainstay of treatment is to identify, stop use of, and then avoid the sensitizing substance. Topical steroids (triamcinolone 0.1% ointment or clobetasol 0.05% ointment twice daily) are helpful in most cases. If the condition is severe or does not respond to initial therapy, systemic steroids (prednisone 40 mg/d for 5 days for most cases or a 2- to 3-week taper for Rhus dermatitis [eg, poison ivy]) are often effective.³

This patient was instructed to stop using TTO and counseled to avoid it in the future. She was told that her nails might fall off due to the inflammation, which might cure her onychomycosis, and that it takes 12 to 18 months to grow new toenails. She was advised to return for evaluation if the new nails developed any abnormalities or if her onychomycosis recurred. Oral terbinafine 250 mg/d for 90 days is usually a safe and effective therapy.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

The patient’s toenail thickening appeared consistent with possible onychomycosis—but in addition, there was a marked inflammatory and vesicular eruption consistent with an allergic contact dermatitis.

TTO, also known as melaleuca oil, is a popular product used to treat many disorders including alopecia, seborrheic dermatitis, and onychomycosis.¹ Unfortunately, it is a complex compound, and the rate of positive reactions to patch testing ranges from 0.1% to 3.5%.²

There are 2 types of contact dermatitis: irritant and allergic. Irritant contact dermatitis results from an irritating or relatively caustic substance causing direct damage and inflammation to the skin. In allergic contact dermatitis, as occurred here, there is sensitization to a substance that causes a type IV delayed cell-mediated immune response. Although radioallergosorbent blood testing will usually show immunoglobulin E antibodies to the inciting substance, patch testing is more specific and will show a reaction to the imputed substance on direct skin application. This usually is performed as a panel of antigens tested at the same time.

The mainstay of treatment is to identify, stop use of, and then avoid the sensitizing substance. Topical steroids (triamcinolone 0.1% ointment or clobetasol 0.05% ointment twice daily) are helpful in most cases. If the condition is severe or does not respond to initial therapy, systemic steroids (prednisone 40 mg/d for 5 days for most cases or a 2- to 3-week taper for Rhus dermatitis [eg, poison ivy]) are often effective.³

This patient was instructed to stop using TTO and counseled to avoid it in the future. She was told that her nails might fall off due to the inflammation, which might cure her onychomycosis, and that it takes 12 to 18 months to grow new toenails. She was advised to return for evaluation if the new nails developed any abnormalities or if her onychomycosis recurred. Oral terbinafine 250 mg/d for 90 days is usually a safe and effective therapy.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

The Food and Drug Administration is considering approving a postpartum depression medication that can start working rapidly – in as little as 3 days. Promising results for the drug, zuranolone, were published recently in The American Journal of Psychiatry.

Approximately 17% of women are affected by postpartum depression (PPD) during pregnancy or after birth, study authors noted. The condition often results in reduced breastfeeding, poor maternal-infant bonding, and hindering behavioral, emotional and brain development of the baby. Severe PPD can lead to suicide of the mother, which accounts for 20% of all postpartum deaths, they wrote.

The study included 196 people who had given birth in the past year, and were between the ages of 18 and 45 years old. Participants had major depression that began in the 3rd trimester of pregnancy or during the first 4 weeks of the postpartum period. Among participants, 22% were Black and 38% were Hispanic.

Of those who took zuranolone, 57% had significantly improved depression symptoms after taking the drug for 14 days, and 27% were in remission at the conclusion of the 14-day treatment. The average time it took for symptoms to significantly decline was 9 days. Most people who saw improvements had them continue for the entire 45-day follow-up period. The most common side effects were drowsiness, dizziness, and sleepiness.

Currently, PPD treatment includes taking antidepressants, which can take up to 12 weeks to work. 

Researchers noted that the limitations of the study were that it only included women with severe PPD, and that women with a history of bipolar or psychotic disorders were excluded. Women in the study were not allowed to breastfeed, so the effect of zuranolone on lactation is unknown, they wrote.

A February news release from drugmaker Biogen indicated the FDA may decide whether to approve the medicine by Aug. 5.

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

The Food and Drug Administration is considering approving a postpartum depression medication that can start working rapidly – in as little as 3 days. Promising results for the drug, zuranolone, were published recently in The American Journal of Psychiatry.

Approximately 17% of women are affected by postpartum depression (PPD) during pregnancy or after birth, study authors noted. The condition often results in reduced breastfeeding, poor maternal-infant bonding, and hindering behavioral, emotional and brain development of the baby. Severe PPD can lead to suicide of the mother, which accounts for 20% of all postpartum deaths, they wrote.

The study included 196 people who had given birth in the past year, and were between the ages of 18 and 45 years old. Participants had major depression that began in the 3rd trimester of pregnancy or during the first 4 weeks of the postpartum period. Among participants, 22% were Black and 38% were Hispanic.

Of those who took zuranolone, 57% had significantly improved depression symptoms after taking the drug for 14 days, and 27% were in remission at the conclusion of the 14-day treatment. The average time it took for symptoms to significantly decline was 9 days. Most people who saw improvements had them continue for the entire 45-day follow-up period. The most common side effects were drowsiness, dizziness, and sleepiness.

Currently, PPD treatment includes taking antidepressants, which can take up to 12 weeks to work. 

Researchers noted that the limitations of the study were that it only included women with severe PPD, and that women with a history of bipolar or psychotic disorders were excluded. Women in the study were not allowed to breastfeed, so the effect of zuranolone on lactation is unknown, they wrote.

A February news release from drugmaker Biogen indicated the FDA may decide whether to approve the medicine by Aug. 5.

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

The Food and Drug Administration is considering approving a postpartum depression medication that can start working rapidly – in as little as 3 days. Promising results for the drug, zuranolone, were published recently in The American Journal of Psychiatry.

Approximately 17% of women are affected by postpartum depression (PPD) during pregnancy or after birth, study authors noted. The condition often results in reduced breastfeeding, poor maternal-infant bonding, and hindering behavioral, emotional and brain development of the baby. Severe PPD can lead to suicide of the mother, which accounts for 20% of all postpartum deaths, they wrote.

The study included 196 people who had given birth in the past year, and were between the ages of 18 and 45 years old. Participants had major depression that began in the 3rd trimester of pregnancy or during the first 4 weeks of the postpartum period. Among participants, 22% were Black and 38% were Hispanic.

Of those who took zuranolone, 57% had significantly improved depression symptoms after taking the drug for 14 days, and 27% were in remission at the conclusion of the 14-day treatment. The average time it took for symptoms to significantly decline was 9 days. Most people who saw improvements had them continue for the entire 45-day follow-up period. The most common side effects were drowsiness, dizziness, and sleepiness.

Currently, PPD treatment includes taking antidepressants, which can take up to 12 weeks to work. 

Researchers noted that the limitations of the study were that it only included women with severe PPD, and that women with a history of bipolar or psychotic disorders were excluded. Women in the study were not allowed to breastfeed, so the effect of zuranolone on lactation is unknown, they wrote.

A February news release from drugmaker Biogen indicated the FDA may decide whether to approve the medicine by Aug. 5.

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

Most plant-based milks, such as almond or oat milk, have less calcium, vitamin D, and protein than what is found in cow’s milk, a cornerstone beverage for meeting nutritional needs, according to research from the University of Minnesota, Minneapolis. 

To make up for it, many plant-based milks are fortified with calcium and vitamin D, but most still lack the same level of protein found in cow’s milk, researchers found. The analysis included more than 200 plant-based milk alternatives, including those made from almonds, cashews, coconuts, flax, hazelnuts, hemp, oats, pistachios, rice, soy, and walnuts. The findings, which have not been published, were presented at the American Society for Nutrition’s annual conference in Boston.

“About half were fortified with vitamin D, two-thirds were fortified with calcium, and nearly 20% had protein levels similar to cow’s milk,” said lead study author Abigail Johnson, PhD, RD.

Dr. Johnson is the director of the University of Minnesota Nutrition Coordinating Center, which maintains a database of 19,000 foods for dietary research.

“I’m not seriously concerned about this, as it’s easy to get these nutrients from other sources, and cow’s milk certainly isn’t perfect and infallible,” Dr. Johnson said. “But if a consumer thinks plant-based milks are a one-to-one substitution for dairy, many of them are not.”

Consumers should read product labels and choose those that list calcium and vitamin D as ingredients, as well as consider adding other sources of calcium and vitamin D to their diets, Dr. Johnson said in a statement.

The research team plans to study plant-based milk alternatives further, such as how the products contain fiber, which cow’s milk does not. Nutrition experts explained that plant-based products have attractive features such as less fat, lower cholesterol, and higher fiber, in addition to being produced using more environmentally friendly methods, compared with cow’s milk.

Current U.S. dietary guidelines state that most plant-based milks don’t contribute to meeting recommended amounts of dairy nutrients, because their nutritional content is not similar to dairy milk or to fortified soy beverages. As many as 9 in 10 people in the U.S. don’t meet the current recommendations for dairy intake, the USDA says. An estimated 65% of U.S. children drink milk daily, and just 20% of adults drink dairy milk. Many dairy products contain high levels of added sugar, saturated fat, and sodium, the guidelines warn.

“Most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt,” the guidelines state. “Strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks.”

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

Most plant-based milks, such as almond or oat milk, have less calcium, vitamin D, and protein than what is found in cow’s milk, a cornerstone beverage for meeting nutritional needs, according to research from the University of Minnesota, Minneapolis. 

To make up for it, many plant-based milks are fortified with calcium and vitamin D, but most still lack the same level of protein found in cow’s milk, researchers found. The analysis included more than 200 plant-based milk alternatives, including those made from almonds, cashews, coconuts, flax, hazelnuts, hemp, oats, pistachios, rice, soy, and walnuts. The findings, which have not been published, were presented at the American Society for Nutrition’s annual conference in Boston.

“About half were fortified with vitamin D, two-thirds were fortified with calcium, and nearly 20% had protein levels similar to cow’s milk,” said lead study author Abigail Johnson, PhD, RD.

Dr. Johnson is the director of the University of Minnesota Nutrition Coordinating Center, which maintains a database of 19,000 foods for dietary research.

“I’m not seriously concerned about this, as it’s easy to get these nutrients from other sources, and cow’s milk certainly isn’t perfect and infallible,” Dr. Johnson said. “But if a consumer thinks plant-based milks are a one-to-one substitution for dairy, many of them are not.”

Consumers should read product labels and choose those that list calcium and vitamin D as ingredients, as well as consider adding other sources of calcium and vitamin D to their diets, Dr. Johnson said in a statement.

The research team plans to study plant-based milk alternatives further, such as how the products contain fiber, which cow’s milk does not. Nutrition experts explained that plant-based products have attractive features such as less fat, lower cholesterol, and higher fiber, in addition to being produced using more environmentally friendly methods, compared with cow’s milk.

Current U.S. dietary guidelines state that most plant-based milks don’t contribute to meeting recommended amounts of dairy nutrients, because their nutritional content is not similar to dairy milk or to fortified soy beverages. As many as 9 in 10 people in the U.S. don’t meet the current recommendations for dairy intake, the USDA says. An estimated 65% of U.S. children drink milk daily, and just 20% of adults drink dairy milk. Many dairy products contain high levels of added sugar, saturated fat, and sodium, the guidelines warn.

“Most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt,” the guidelines state. “Strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks.”

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

Most plant-based milks, such as almond or oat milk, have less calcium, vitamin D, and protein than what is found in cow’s milk, a cornerstone beverage for meeting nutritional needs, according to research from the University of Minnesota, Minneapolis. 

To make up for it, many plant-based milks are fortified with calcium and vitamin D, but most still lack the same level of protein found in cow’s milk, researchers found. The analysis included more than 200 plant-based milk alternatives, including those made from almonds, cashews, coconuts, flax, hazelnuts, hemp, oats, pistachios, rice, soy, and walnuts. The findings, which have not been published, were presented at the American Society for Nutrition’s annual conference in Boston.

“About half were fortified with vitamin D, two-thirds were fortified with calcium, and nearly 20% had protein levels similar to cow’s milk,” said lead study author Abigail Johnson, PhD, RD.

Dr. Johnson is the director of the University of Minnesota Nutrition Coordinating Center, which maintains a database of 19,000 foods for dietary research.

“I’m not seriously concerned about this, as it’s easy to get these nutrients from other sources, and cow’s milk certainly isn’t perfect and infallible,” Dr. Johnson said. “But if a consumer thinks plant-based milks are a one-to-one substitution for dairy, many of them are not.”

Consumers should read product labels and choose those that list calcium and vitamin D as ingredients, as well as consider adding other sources of calcium and vitamin D to their diets, Dr. Johnson said in a statement.

The research team plans to study plant-based milk alternatives further, such as how the products contain fiber, which cow’s milk does not. Nutrition experts explained that plant-based products have attractive features such as less fat, lower cholesterol, and higher fiber, in addition to being produced using more environmentally friendly methods, compared with cow’s milk.

Current U.S. dietary guidelines state that most plant-based milks don’t contribute to meeting recommended amounts of dairy nutrients, because their nutritional content is not similar to dairy milk or to fortified soy beverages. As many as 9 in 10 people in the U.S. don’t meet the current recommendations for dairy intake, the USDA says. An estimated 65% of U.S. children drink milk daily, and just 20% of adults drink dairy milk. Many dairy products contain high levels of added sugar, saturated fat, and sodium, the guidelines warn.

“Most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt,” the guidelines state. “Strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks.”

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

Traditionally, the presence of ductal carcinoma in situ with invasive HER2-positive breast cancer has made surgeons hesitant to offer women breast conserving surgery following neoadjuvant therapy.

The concern has been that ductal carcinoma in situ (DCIS) doesn’t respond well to neoadjuvant treatment, so leaving it behind could increase the risk of recurrence.

A new study, however, calls that thinking into question.

In a nationwide review of over 5,000 women in the Netherlands, Dutch investigators found that neoadjuvant therapy eradicates DCIS about half of the time in women with invasive HER2-positive breast cancer.

The study is the largest look into the issue to date and confirms similar reports from a handful of smaller studies.

“These findings are important to create awareness that the presence of a DCIS component ... should not necessarily indicate the need for mastectomy,” said Roxanne Ploumen, PhD, of Maastricht (the Netherlands) University Medical Centre and colleagues.

The study was published in Breast Cancer Research and Treatment.

The research team compared biopsy results before neoadjuvant therapy with pathology reports following surgery. DCIS had a pathologic complete response rate of 52%. Neoadjuvant therapy generally consisted of anthracyclines followed by docetaxel or paclitaxel, in combination with trastuzumab.

The study also supports the assertion that women with DCIS are less likely to have breast-conserving surgery. Patients with DCIS were more likely to get mastectomies in the study (53.6% vs. 41%; P < .001) although the exact reasons are unclear because the data didn’t capture information relevant to surgical decision-making, including patient preferences and the extent of calcifications on mammography.

The key now is to find a way to assess how well DCIS responds to neoadjuvant therapy to better guide surgical decisions. Future studies should “investigate the evaluation of DCIS response by imaging” to increase the chance of breast-conserving surgery. “Moreover, a thorough investigation of pathologic characteristics” that predict response “could be useful,” Dr. Ploumen and associates said.

The investigators did find a few correlations that might help with response prediction; complete resolution of DCIS was associated with a complete response of the primary tumor to neoadjuvant therapy as well as negative estrogen receptor status and more recent breast cancer diagnosis, likely because of recent improvements in neoadjuvant therapy, including dual anti-HER2 blockade from 2017 onward, the team said.

Asked for comment, Kathy Miller, MD, a breast medical oncologist at Indiana University, Indianapolis, called the findings “interesting.”

“I suspect the challenge is that DCIS is often associated with microcalcifications” that don’t go away with therapy, “so it is common for [surgeons] to remove all areas” with microcalcifications. For now, “we can’t determine if the DCIS has” resolved with neoadjuvant therapy, so leaving calcifications behind “means accepting the possibility that you might be leaving residual disease behind,” she said.

The analysis included 5,598 women diagnosed with HER2-positive invasive breast cancer treated with neoadjuvant therapy and surgery between 2010 and 2020. The investigators coupled the Netherlands Cancer Registry with the Dutch Nationwide Pathology Databank to conduct their analysis.

About a quarter of the women had a DCIS component to their breast tumors.

The work was funded by the Jules Coenegracht Senior Foundation. Dr. Ploumen and Dr. Miller reported no conflicts of interest. Three investigators reported ties to Servier Pharmaceuticals, Bayer, Novartis, and other companies.

Traditionally, the presence of ductal carcinoma in situ with invasive HER2-positive breast cancer has made surgeons hesitant to offer women breast conserving surgery following neoadjuvant therapy.

The concern has been that ductal carcinoma in situ (DCIS) doesn’t respond well to neoadjuvant treatment, so leaving it behind could increase the risk of recurrence.

A new study, however, calls that thinking into question.

In a nationwide review of over 5,000 women in the Netherlands, Dutch investigators found that neoadjuvant therapy eradicates DCIS about half of the time in women with invasive HER2-positive breast cancer.

The study is the largest look into the issue to date and confirms similar reports from a handful of smaller studies.

“These findings are important to create awareness that the presence of a DCIS component ... should not necessarily indicate the need for mastectomy,” said Roxanne Ploumen, PhD, of Maastricht (the Netherlands) University Medical Centre and colleagues.

The study was published in Breast Cancer Research and Treatment.

The research team compared biopsy results before neoadjuvant therapy with pathology reports following surgery. DCIS had a pathologic complete response rate of 52%. Neoadjuvant therapy generally consisted of anthracyclines followed by docetaxel or paclitaxel, in combination with trastuzumab.

The study also supports the assertion that women with DCIS are less likely to have breast-conserving surgery. Patients with DCIS were more likely to get mastectomies in the study (53.6% vs. 41%; P < .001) although the exact reasons are unclear because the data didn’t capture information relevant to surgical decision-making, including patient preferences and the extent of calcifications on mammography.

The key now is to find a way to assess how well DCIS responds to neoadjuvant therapy to better guide surgical decisions. Future studies should “investigate the evaluation of DCIS response by imaging” to increase the chance of breast-conserving surgery. “Moreover, a thorough investigation of pathologic characteristics” that predict response “could be useful,” Dr. Ploumen and associates said.

The investigators did find a few correlations that might help with response prediction; complete resolution of DCIS was associated with a complete response of the primary tumor to neoadjuvant therapy as well as negative estrogen receptor status and more recent breast cancer diagnosis, likely because of recent improvements in neoadjuvant therapy, including dual anti-HER2 blockade from 2017 onward, the team said.

Asked for comment, Kathy Miller, MD, a breast medical oncologist at Indiana University, Indianapolis, called the findings “interesting.”

“I suspect the challenge is that DCIS is often associated with microcalcifications” that don’t go away with therapy, “so it is common for [surgeons] to remove all areas” with microcalcifications. For now, “we can’t determine if the DCIS has” resolved with neoadjuvant therapy, so leaving calcifications behind “means accepting the possibility that you might be leaving residual disease behind,” she said.

The analysis included 5,598 women diagnosed with HER2-positive invasive breast cancer treated with neoadjuvant therapy and surgery between 2010 and 2020. The investigators coupled the Netherlands Cancer Registry with the Dutch Nationwide Pathology Databank to conduct their analysis.

About a quarter of the women had a DCIS component to their breast tumors.

The work was funded by the Jules Coenegracht Senior Foundation. Dr. Ploumen and Dr. Miller reported no conflicts of interest. Three investigators reported ties to Servier Pharmaceuticals, Bayer, Novartis, and other companies.

Traditionally, the presence of ductal carcinoma in situ with invasive HER2-positive breast cancer has made surgeons hesitant to offer women breast conserving surgery following neoadjuvant therapy.

The concern has been that ductal carcinoma in situ (DCIS) doesn’t respond well to neoadjuvant treatment, so leaving it behind could increase the risk of recurrence.

A new study, however, calls that thinking into question.

In a nationwide review of over 5,000 women in the Netherlands, Dutch investigators found that neoadjuvant therapy eradicates DCIS about half of the time in women with invasive HER2-positive breast cancer.

The study is the largest look into the issue to date and confirms similar reports from a handful of smaller studies.

“These findings are important to create awareness that the presence of a DCIS component ... should not necessarily indicate the need for mastectomy,” said Roxanne Ploumen, PhD, of Maastricht (the Netherlands) University Medical Centre and colleagues.

The study was published in Breast Cancer Research and Treatment.

The research team compared biopsy results before neoadjuvant therapy with pathology reports following surgery. DCIS had a pathologic complete response rate of 52%. Neoadjuvant therapy generally consisted of anthracyclines followed by docetaxel or paclitaxel, in combination with trastuzumab.

The study also supports the assertion that women with DCIS are less likely to have breast-conserving surgery. Patients with DCIS were more likely to get mastectomies in the study (53.6% vs. 41%; P < .001) although the exact reasons are unclear because the data didn’t capture information relevant to surgical decision-making, including patient preferences and the extent of calcifications on mammography.

The key now is to find a way to assess how well DCIS responds to neoadjuvant therapy to better guide surgical decisions. Future studies should “investigate the evaluation of DCIS response by imaging” to increase the chance of breast-conserving surgery. “Moreover, a thorough investigation of pathologic characteristics” that predict response “could be useful,” Dr. Ploumen and associates said.

The investigators did find a few correlations that might help with response prediction; complete resolution of DCIS was associated with a complete response of the primary tumor to neoadjuvant therapy as well as negative estrogen receptor status and more recent breast cancer diagnosis, likely because of recent improvements in neoadjuvant therapy, including dual anti-HER2 blockade from 2017 onward, the team said.

Asked for comment, Kathy Miller, MD, a breast medical oncologist at Indiana University, Indianapolis, called the findings “interesting.”

“I suspect the challenge is that DCIS is often associated with microcalcifications” that don’t go away with therapy, “so it is common for [surgeons] to remove all areas” with microcalcifications. For now, “we can’t determine if the DCIS has” resolved with neoadjuvant therapy, so leaving calcifications behind “means accepting the possibility that you might be leaving residual disease behind,” she said.

The analysis included 5,598 women diagnosed with HER2-positive invasive breast cancer treated with neoadjuvant therapy and surgery between 2010 and 2020. The investigators coupled the Netherlands Cancer Registry with the Dutch Nationwide Pathology Databank to conduct their analysis.

About a quarter of the women had a DCIS component to their breast tumors.

The work was funded by the Jules Coenegracht Senior Foundation. Dr. Ploumen and Dr. Miller reported no conflicts of interest. Three investigators reported ties to Servier Pharmaceuticals, Bayer, Novartis, and other companies.

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

Women in the United States are dying of alcohol-related causes at a much faster rate than are U.S. men, according to a new study that tracked these deaths for 20 years. The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.

“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.

Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”

Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men. 

“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:

• 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
• 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said. 
• 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.

The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year. 
 

Explaining the increase

“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.

Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.

The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
 

Other findings on women, alcohol

Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men. 

A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.  
 

Expert perspectives

Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.

“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.” 

In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually. 

While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.  

However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.” 

Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies. 

Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”  

Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.

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

Women in the United States are dying of alcohol-related causes at a much faster rate than are U.S. men, according to a new study that tracked these deaths for 20 years. The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.

“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.

Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”

Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men. 

“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:

• 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
• 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said. 
• 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.

The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year. 
 

Explaining the increase

“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.

Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.

The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
 

Other findings on women, alcohol

Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men. 

A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.  
 

Expert perspectives

Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.

“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.” 

In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually. 

While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.  

However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.” 

Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies. 

Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”  

Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.

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

Women in the United States are dying of alcohol-related causes at a much faster rate than are U.S. men, according to a new study that tracked these deaths for 20 years. The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.

“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.

Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”

Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men. 

“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:

• 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
• 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said. 
• 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.

The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year. 
 

Explaining the increase

“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.

Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.

The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
 

Other findings on women, alcohol

Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men. 

A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.  
 

Expert perspectives

Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.

“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.” 

In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually. 

While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.  

However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.” 

Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies. 

Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”  

Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.

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

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

People who do 4-5 minutes of vigorous physical activity daily can reduce their cancer risk by up to 32%, a new study published in  JAMA Oncology says.

Researchers at the University of Sydney studied data from wearable fitness devices worn by more than 22,000 “non-exercisers,” then examined their health records for 6 or 7 years. 

The scientists found that people who did 4-5 minutes of “vigorous intermittent lifestyle physical activity” (VILPA) had a “substantially” lower cancer risk than people who did no VILPA. 

Examples of VILPA are vigorous housework, carrying heavy shopping bags around the grocery store, bursts of power walking, and playing high-energy games with children. The activities could occur in 1-minute bursts, instead of all at once.

Getty Images/Kentaroo Tryman

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

People who do 4-5 minutes of vigorous physical activity daily can reduce their cancer risk by up to 32%, a new study published in  JAMA Oncology says.

Researchers at the University of Sydney studied data from wearable fitness devices worn by more than 22,000 “non-exercisers,” then examined their health records for 6 or 7 years. 

The scientists found that people who did 4-5 minutes of “vigorous intermittent lifestyle physical activity” (VILPA) had a “substantially” lower cancer risk than people who did no VILPA. 

Examples of VILPA are vigorous housework, carrying heavy shopping bags around the grocery store, bursts of power walking, and playing high-energy games with children. The activities could occur in 1-minute bursts, instead of all at once.

Getty Images/Kentaroo Tryman

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

People who do 4-5 minutes of vigorous physical activity daily can reduce their cancer risk by up to 32%, a new study published in  JAMA Oncology says.

Researchers at the University of Sydney studied data from wearable fitness devices worn by more than 22,000 “non-exercisers,” then examined their health records for 6 or 7 years. 

The scientists found that people who did 4-5 minutes of “vigorous intermittent lifestyle physical activity” (VILPA) had a “substantially” lower cancer risk than people who did no VILPA. 

Examples of VILPA are vigorous housework, carrying heavy shopping bags around the grocery store, bursts of power walking, and playing high-energy games with children. The activities could occur in 1-minute bursts, instead of all at once.

Getty Images/Kentaroo Tryman

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

Although there are several treatment options for PsA, there have been few head-to-head studies conducted to determine comparative efficacy. Ustekinumab, a biologic agent targeting IL-p40, and therefore both IL-12 and IL-23, has proven efficacy in PsA, but the impression is that this drug is less effective than are TNF inhibitors for the treatment of the peripheral arthritis domain. However, in a prospective, observational study, Gossec and colleagues report that the improvements in patient-reported outcomes were generally comparable between ustekinumab and TNF inhibitor treatments. This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n = 219) or TNF inhibitors (n = 218) and continued the initial treatment for 3 years. At 3 years, ustekinumab and TNF inhibitors were associated with comparable improvements in the EuroQol-5 dimensions health state visual analog scale scores, Psoriatic Arthritis Impact of Disease 12-item scores, and work productivity, although the improvements were generally greater in the TNF inhibitor–treated group. A randomized trial comparing ustekinumab to TNF inhibitors in PsA is warranted to confirm these findings and inform treatment decisions.

Targeted therapies, such as biologics, are proven to be more efficacious than are conventional therapies; however, only about 60% of patients initiating targeted therapies demonstrate treatment response. Identifying the predictors of treatment response is an active area of research. Linde and colleagues looked at data from 13,369 biologic-naive patients registered with a PsA diagnosis from 13 European registries who initiated a first TNF inhibitor treatment. The study demonstrated that sex, disease duration, C-reactive protein level, age at treatment initiation, and fatigue predicted the achievement of the Disease Activity in Psoriatic Arthritis in 28 joints remission at 6 months.

Could biomarkers help predict response beyond clinical predictors? An interesting study indicates that beta–defensin 2 (BD-2) may serve as a predictive biomarker for clinical response to secukinumab in PsA. BD-2 is an antimicrobial peptide and an important protein in innate immune response. Cardner and colleagues analyzed protein expression data in serum samples from the phase 3 FUTURE 1-5 trials that included 1989 patients with PsA who received secukinumab or placebo. Baseline BD-2 levels were associated with early as well as sustained PsA treatment response to secukinumab, independent of psoriasis severity. BD-2 levels did not predict response to adalimumab in PsA nor was it associated with treatment response to secukinumab in RA. The addition of BD-2 to the clinical prediction model significantly improved the prediction of the 16-week American College of Rheumatology 20 response. Thus, BD-2 seems to be a secukinumab treatment response biomarker and requires further evaluation.

Although there are several treatment options for PsA, there have been few head-to-head studies conducted to determine comparative efficacy. Ustekinumab, a biologic agent targeting IL-p40, and therefore both IL-12 and IL-23, has proven efficacy in PsA, but the impression is that this drug is less effective than are TNF inhibitors for the treatment of the peripheral arthritis domain. However, in a prospective, observational study, Gossec and colleagues report that the improvements in patient-reported outcomes were generally comparable between ustekinumab and TNF inhibitor treatments. This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n = 219) or TNF inhibitors (n = 218) and continued the initial treatment for 3 years. At 3 years, ustekinumab and TNF inhibitors were associated with comparable improvements in the EuroQol-5 dimensions health state visual analog scale scores, Psoriatic Arthritis Impact of Disease 12-item scores, and work productivity, although the improvements were generally greater in the TNF inhibitor–treated group. A randomized trial comparing ustekinumab to TNF inhibitors in PsA is warranted to confirm these findings and inform treatment decisions.

Targeted therapies, such as biologics, are proven to be more efficacious than are conventional therapies; however, only about 60% of patients initiating targeted therapies demonstrate treatment response. Identifying the predictors of treatment response is an active area of research. Linde and colleagues looked at data from 13,369 biologic-naive patients registered with a PsA diagnosis from 13 European registries who initiated a first TNF inhibitor treatment. The study demonstrated that sex, disease duration, C-reactive protein level, age at treatment initiation, and fatigue predicted the achievement of the Disease Activity in Psoriatic Arthritis in 28 joints remission at 6 months.

Could biomarkers help predict response beyond clinical predictors? An interesting study indicates that beta–defensin 2 (BD-2) may serve as a predictive biomarker for clinical response to secukinumab in PsA. BD-2 is an antimicrobial peptide and an important protein in innate immune response. Cardner and colleagues analyzed protein expression data in serum samples from the phase 3 FUTURE 1-5 trials that included 1989 patients with PsA who received secukinumab or placebo. Baseline BD-2 levels were associated with early as well as sustained PsA treatment response to secukinumab, independent of psoriasis severity. BD-2 levels did not predict response to adalimumab in PsA nor was it associated with treatment response to secukinumab in RA. The addition of BD-2 to the clinical prediction model significantly improved the prediction of the 16-week American College of Rheumatology 20 response. Thus, BD-2 seems to be a secukinumab treatment response biomarker and requires further evaluation.

Although there are several treatment options for PsA, there have been few head-to-head studies conducted to determine comparative efficacy. Ustekinumab, a biologic agent targeting IL-p40, and therefore both IL-12 and IL-23, has proven efficacy in PsA, but the impression is that this drug is less effective than are TNF inhibitors for the treatment of the peripheral arthritis domain. However, in a prospective, observational study, Gossec and colleagues report that the improvements in patient-reported outcomes were generally comparable between ustekinumab and TNF inhibitor treatments. This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n = 219) or TNF inhibitors (n = 218) and continued the initial treatment for 3 years. At 3 years, ustekinumab and TNF inhibitors were associated with comparable improvements in the EuroQol-5 dimensions health state visual analog scale scores, Psoriatic Arthritis Impact of Disease 12-item scores, and work productivity, although the improvements were generally greater in the TNF inhibitor–treated group. A randomized trial comparing ustekinumab to TNF inhibitors in PsA is warranted to confirm these findings and inform treatment decisions.

Targeted therapies, such as biologics, are proven to be more efficacious than are conventional therapies; however, only about 60% of patients initiating targeted therapies demonstrate treatment response. Identifying the predictors of treatment response is an active area of research. Linde and colleagues looked at data from 13,369 biologic-naive patients registered with a PsA diagnosis from 13 European registries who initiated a first TNF inhibitor treatment. The study demonstrated that sex, disease duration, C-reactive protein level, age at treatment initiation, and fatigue predicted the achievement of the Disease Activity in Psoriatic Arthritis in 28 joints remission at 6 months.

Could biomarkers help predict response beyond clinical predictors? An interesting study indicates that beta–defensin 2 (BD-2) may serve as a predictive biomarker for clinical response to secukinumab in PsA. BD-2 is an antimicrobial peptide and an important protein in innate immune response. Cardner and colleagues analyzed protein expression data in serum samples from the phase 3 FUTURE 1-5 trials that included 1989 patients with PsA who received secukinumab or placebo. Baseline BD-2 levels were associated with early as well as sustained PsA treatment response to secukinumab, independent of psoriasis severity. BD-2 levels did not predict response to adalimumab in PsA nor was it associated with treatment response to secukinumab in RA. The addition of BD-2 to the clinical prediction model significantly improved the prediction of the 16-week American College of Rheumatology 20 response. Thus, BD-2 seems to be a secukinumab treatment response biomarker and requires further evaluation.