Background: Management of primary spontaneous pneumothorax is usually with the insertion of a chest tube and typically requires hospitalization. This procedure can result in pain, organ injury, bleeding, and infection, and, if unresolved, may require surgery, introducing additional risks and complications. Few data exist from randomized trials comparing conservative versus interventional management.

In complete-case analysis, 129 out of 131 (98.5%) patients in the intervention group had resolution within 8 weeks, compared with 118 of 125 (94.4%) in the conservative group (risk difference, –4.1 percentage points; 95% confidence interval, –8.6 to 0.5, P = .02 for noninferiority).

In sensitivity analysis, in which missing data after the 8-week period were imputed as treatment failures, re-expansion occurred in 129 out of 138 (93.5%) patients in the intervention group and 118 out of 143 (82.5%) in the conservative group (risk difference, –11.0 percentage points; 95% CI, –18.4 to –3.5), which is outside the noninferiority margin of –9.0.

Overall, 41 patients in the intervention group and 13 in the conservative group had at least one adverse event.

Bottom line: Missing data limit the ability to make strong conclusions, but this trial suggests that conservative management of primary spontaneous pneumothorax was noninferior to interventional management with lower risk of serious adverse events.

Citation: Brown SG et al. Conservative versus interventional treatment for spontaneous pneumothorax. N Engl J Med. 2020; 382:405-15.

Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: Management of primary spontaneous pneumothorax is usually with the insertion of a chest tube and typically requires hospitalization. This procedure can result in pain, organ injury, bleeding, and infection, and, if unresolved, may require surgery, introducing additional risks and complications. Few data exist from randomized trials comparing conservative versus interventional management.

In complete-case analysis, 129 out of 131 (98.5%) patients in the intervention group had resolution within 8 weeks, compared with 118 of 125 (94.4%) in the conservative group (risk difference, –4.1 percentage points; 95% confidence interval, –8.6 to 0.5, P = .02 for noninferiority).

In sensitivity analysis, in which missing data after the 8-week period were imputed as treatment failures, re-expansion occurred in 129 out of 138 (93.5%) patients in the intervention group and 118 out of 143 (82.5%) in the conservative group (risk difference, –11.0 percentage points; 95% CI, –18.4 to –3.5), which is outside the noninferiority margin of –9.0.

Overall, 41 patients in the intervention group and 13 in the conservative group had at least one adverse event.

Bottom line: Missing data limit the ability to make strong conclusions, but this trial suggests that conservative management of primary spontaneous pneumothorax was noninferior to interventional management with lower risk of serious adverse events.

Citation: Brown SG et al. Conservative versus interventional treatment for spontaneous pneumothorax. N Engl J Med. 2020; 382:405-15.

Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: Management of primary spontaneous pneumothorax is usually with the insertion of a chest tube and typically requires hospitalization. This procedure can result in pain, organ injury, bleeding, and infection, and, if unresolved, may require surgery, introducing additional risks and complications. Few data exist from randomized trials comparing conservative versus interventional management.

In complete-case analysis, 129 out of 131 (98.5%) patients in the intervention group had resolution within 8 weeks, compared with 118 of 125 (94.4%) in the conservative group (risk difference, –4.1 percentage points; 95% confidence interval, –8.6 to 0.5, P = .02 for noninferiority).

In sensitivity analysis, in which missing data after the 8-week period were imputed as treatment failures, re-expansion occurred in 129 out of 138 (93.5%) patients in the intervention group and 118 out of 143 (82.5%) in the conservative group (risk difference, –11.0 percentage points; 95% CI, –18.4 to –3.5), which is outside the noninferiority margin of –9.0.

Overall, 41 patients in the intervention group and 13 in the conservative group had at least one adverse event.

Bottom line: Missing data limit the ability to make strong conclusions, but this trial suggests that conservative management of primary spontaneous pneumothorax was noninferior to interventional management with lower risk of serious adverse events.

Citation: Brown SG et al. Conservative versus interventional treatment for spontaneous pneumothorax. N Engl J Med. 2020; 382:405-15.

Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Individuals diagnosed with primary colorectal cancer (CRC) at less than 50 years of age have better survival outcomes than individuals diagnosed at 51-55 years, based on data from more than 750,000 patients.

This finding emphasizes the importance of early CRC detection in younger individuals, reported lead author En Cheng, MD, PhD, of Yale University, New Haven, Conn., and colleagues.

“Early-onset CRC (i.e., CRC diagnosed at age less than 50 years) has been characterized by unique clinical, genetic, and epigenetic characteristics, and thus it may be associated with different survival from CRC diagnosed among individuals older than 50 years,” the investigators wrote in JAMA Network Open. Previous studies comparing survival times across age groups have yielded inconsistent results.

To gain a better understanding, the investigator conducted a retrospective study using data from the National Cancer Database. Excluding patients with primary CRC who had concomitant diagnosis, history of other malignant tumors, noninvasive adenocarcinoma, or missing data, the final dataset included 769,871 patients. Early-onset CRC was defined by age less than 50 years, whereas later-onset CRC was defined by ages 51-55 years.

“Individuals diagnosed at age 50 years were excluded to minimize an apparent screening detection bias at age 50 years in our population, given that these individuals disproportionately presented with earlier stages,” the investigators wrote.

Initial comparisons across groups revealed several significant differences. Individuals in the early-onset group were more often women (47.3% vs. 43.8%; P < .001), members of races in the “other” category (6.9% vs. 5.9%; P < .001), and Medicaid patients (12.3% vs. 10.3%; P < .001). They were also more likely to be diagnosed with stage IV cancer (27.8% vs 24.1%; P < .001) and have rectal tumors (29.3% vs. 28.7%; P = .004).

In the unadjusted Kaplan-Meier analysis, patients with early-onset CRC had a lower 10-year survival rate (53.6%; 95% CI, 53.2%-54.0% vs. 54.3%; 95% CI, 53.8%-54.8%; P < .001). The fully adjusted model revealed significantly higher survival for early-onset patients, compared with later-onset patients (adjusted hazard ratio, 0.95; 95% CI, 0.93-0.96; P < .001) . This disparity deepened when adjusting only for stage (HR, 0.89; 95% CI, 0.88-0.90; P < .001).

Survival was longest among patients 35-39 years (aHR, 0.88; 95% CI, 0.84-0.92; P < .001), compared with those aged 51-55, and among early-onset individuals with stage I disease (a HR, 0.87; 95% CI, 0.81-0.93; P < .001) or stage II disease (a HR, 0.86; 95% CI, 0.82-0.90; P < .001), compared with those having the same stages of later-onset CRC. No survival advantage was observed among patients diagnosed at age 25 or younger or those with stage III or IV disease.

“Interestingly, hereditary nonpolyposis colorectal cancer, owing to underlying mismatch repair deficiency, is associated with superior survival and is often diagnosed in individuals from ages 35-45 years,” the investigators noted. “In contrast, adenomatous polyposis coli syndrome is more common in individuals who are diagnosed with CRC at age younger than 20 years (10%), compared with those diagnosed at later ages (0.1%), and adenomatous polyposis coli syndrome is not associated with a survival advantage. These high penetrance syndromes could partly account for the relative heterogeneity in survival across ages among individuals with early-onset CRC.”
 

Cautious about interpretation

Dr. Cheng and colleagues concluded their publication with a disclaimer: “Our finding of a survival advantage associated with early-onset CRC among younger individuals should be interpreted cautiously, given that the advantage had a small magnitude and was heterogeneous by age and stage,” they wrote. “Further study is needed to understand the underlying heterogeneity of survival by age and stage among individuals with early-onset CRC.”

Kirbi L. Yelorda, MD, of Stanford (Calif.) University, and colleagues, had a similar interpretation.

“These results offer support for effectiveness of treatment in patients diagnosed with CRC at younger ages; however, they must be interpreted within the context of epidemiological and biological factors,” Dr. Yelorda and colleagues wrote in an accompanying editorial.

The findings also suggest that the recent reduction in recommended screening age by the U.S. Preventive Services Task Force – from 50 years to 45 years – is warranted, they added, but screening younger patients remains unnecessary.

“While these results do not suggest that screening should start for patients younger than 45 years, they do support the benefit of early detection in young patients,” Dr. Yelorda and colleagues wrote, noting a “fairly low incidence rate” among individuals younger than 45, which is insufficient to justify the risk-to-benefit ratio and increased costs associated with expanded screening.
 

Important but not surprising

It’s “not surprising” that early-onset patients typically have better survival than later-onset patients, according to Joseph C. Anderson, MD, associate professor at White River Junction Veterans Affairs Medical Center, Hartford, Vt.; Geisel School of Medicine at Dartmouth, Hanover, N.H.; and the University of Connecticut, Farmington.

“They’re younger, have less comorbidities, and can tolerate chemotherapy,” Dr. Anderson said in an interview. “It’s not surprising that people do poorly with later stages. Younger people are no exception.”

Dr. Anderson, who previously coauthored an editorial weighing the pros and cons of earlier screening, noted that earlier screening is needed because of the rising incidence of late-stage diagnoses among younger patients, which, as the study found, are associated with worse outcomes.

Beyond adherence to screening recommendations, Dr. Anderson urged clinicians to be aggressive when doing a workup of CRC symptoms in younger patients, among whom delayed diagnoses are more common.

“We can’t just say it’s something more benign, like hemorrhoids, like we used to,” Dr. Anderson said. “Somebody who’s 30 years old and having rectal bleeding needs to be evaluated promptly – there can’t be a delay.”

The study was supported by the National Institutes of Health and Stand Up To Cancer (grant administered by the American Association for Cancer Research). The investigators disclosed relationships with Evergrande Group, Janssen, Revolution Medicines, and others. One editorialist reported serving as a member of the USPSTF when the guideline for colorectal cancer was developed, and being a coauthor on the guideline. No other disclosures were reported among editorialists. Dr. Anderson reported no relevant conflicts of interest.

Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

Individuals diagnosed with primary colorectal cancer (CRC) at less than 50 years of age have better survival outcomes than individuals diagnosed at 51-55 years, based on data from more than 750,000 patients.

This finding emphasizes the importance of early CRC detection in younger individuals, reported lead author En Cheng, MD, PhD, of Yale University, New Haven, Conn., and colleagues.

“Early-onset CRC (i.e., CRC diagnosed at age less than 50 years) has been characterized by unique clinical, genetic, and epigenetic characteristics, and thus it may be associated with different survival from CRC diagnosed among individuals older than 50 years,” the investigators wrote in JAMA Network Open. Previous studies comparing survival times across age groups have yielded inconsistent results.

To gain a better understanding, the investigator conducted a retrospective study using data from the National Cancer Database. Excluding patients with primary CRC who had concomitant diagnosis, history of other malignant tumors, noninvasive adenocarcinoma, or missing data, the final dataset included 769,871 patients. Early-onset CRC was defined by age less than 50 years, whereas later-onset CRC was defined by ages 51-55 years.

“Individuals diagnosed at age 50 years were excluded to minimize an apparent screening detection bias at age 50 years in our population, given that these individuals disproportionately presented with earlier stages,” the investigators wrote.

Initial comparisons across groups revealed several significant differences. Individuals in the early-onset group were more often women (47.3% vs. 43.8%; P < .001), members of races in the “other” category (6.9% vs. 5.9%; P < .001), and Medicaid patients (12.3% vs. 10.3%; P < .001). They were also more likely to be diagnosed with stage IV cancer (27.8% vs 24.1%; P < .001) and have rectal tumors (29.3% vs. 28.7%; P = .004).

In the unadjusted Kaplan-Meier analysis, patients with early-onset CRC had a lower 10-year survival rate (53.6%; 95% CI, 53.2%-54.0% vs. 54.3%; 95% CI, 53.8%-54.8%; P < .001). The fully adjusted model revealed significantly higher survival for early-onset patients, compared with later-onset patients (adjusted hazard ratio, 0.95; 95% CI, 0.93-0.96; P < .001) . This disparity deepened when adjusting only for stage (HR, 0.89; 95% CI, 0.88-0.90; P < .001).

Survival was longest among patients 35-39 years (aHR, 0.88; 95% CI, 0.84-0.92; P < .001), compared with those aged 51-55, and among early-onset individuals with stage I disease (a HR, 0.87; 95% CI, 0.81-0.93; P < .001) or stage II disease (a HR, 0.86; 95% CI, 0.82-0.90; P < .001), compared with those having the same stages of later-onset CRC. No survival advantage was observed among patients diagnosed at age 25 or younger or those with stage III or IV disease.

“Interestingly, hereditary nonpolyposis colorectal cancer, owing to underlying mismatch repair deficiency, is associated with superior survival and is often diagnosed in individuals from ages 35-45 years,” the investigators noted. “In contrast, adenomatous polyposis coli syndrome is more common in individuals who are diagnosed with CRC at age younger than 20 years (10%), compared with those diagnosed at later ages (0.1%), and adenomatous polyposis coli syndrome is not associated with a survival advantage. These high penetrance syndromes could partly account for the relative heterogeneity in survival across ages among individuals with early-onset CRC.”
 

Cautious about interpretation

Dr. Cheng and colleagues concluded their publication with a disclaimer: “Our finding of a survival advantage associated with early-onset CRC among younger individuals should be interpreted cautiously, given that the advantage had a small magnitude and was heterogeneous by age and stage,” they wrote. “Further study is needed to understand the underlying heterogeneity of survival by age and stage among individuals with early-onset CRC.”

Kirbi L. Yelorda, MD, of Stanford (Calif.) University, and colleagues, had a similar interpretation.

“These results offer support for effectiveness of treatment in patients diagnosed with CRC at younger ages; however, they must be interpreted within the context of epidemiological and biological factors,” Dr. Yelorda and colleagues wrote in an accompanying editorial.

The findings also suggest that the recent reduction in recommended screening age by the U.S. Preventive Services Task Force – from 50 years to 45 years – is warranted, they added, but screening younger patients remains unnecessary.

“While these results do not suggest that screening should start for patients younger than 45 years, they do support the benefit of early detection in young patients,” Dr. Yelorda and colleagues wrote, noting a “fairly low incidence rate” among individuals younger than 45, which is insufficient to justify the risk-to-benefit ratio and increased costs associated with expanded screening.
 

Important but not surprising

It’s “not surprising” that early-onset patients typically have better survival than later-onset patients, according to Joseph C. Anderson, MD, associate professor at White River Junction Veterans Affairs Medical Center, Hartford, Vt.; Geisel School of Medicine at Dartmouth, Hanover, N.H.; and the University of Connecticut, Farmington.

“They’re younger, have less comorbidities, and can tolerate chemotherapy,” Dr. Anderson said in an interview. “It’s not surprising that people do poorly with later stages. Younger people are no exception.”

Dr. Anderson, who previously coauthored an editorial weighing the pros and cons of earlier screening, noted that earlier screening is needed because of the rising incidence of late-stage diagnoses among younger patients, which, as the study found, are associated with worse outcomes.

Beyond adherence to screening recommendations, Dr. Anderson urged clinicians to be aggressive when doing a workup of CRC symptoms in younger patients, among whom delayed diagnoses are more common.

“We can’t just say it’s something more benign, like hemorrhoids, like we used to,” Dr. Anderson said. “Somebody who’s 30 years old and having rectal bleeding needs to be evaluated promptly – there can’t be a delay.”

The study was supported by the National Institutes of Health and Stand Up To Cancer (grant administered by the American Association for Cancer Research). The investigators disclosed relationships with Evergrande Group, Janssen, Revolution Medicines, and others. One editorialist reported serving as a member of the USPSTF when the guideline for colorectal cancer was developed, and being a coauthor on the guideline. No other disclosures were reported among editorialists. Dr. Anderson reported no relevant conflicts of interest.

Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

Individuals diagnosed with primary colorectal cancer (CRC) at less than 50 years of age have better survival outcomes than individuals diagnosed at 51-55 years, based on data from more than 750,000 patients.

This finding emphasizes the importance of early CRC detection in younger individuals, reported lead author En Cheng, MD, PhD, of Yale University, New Haven, Conn., and colleagues.

“Early-onset CRC (i.e., CRC diagnosed at age less than 50 years) has been characterized by unique clinical, genetic, and epigenetic characteristics, and thus it may be associated with different survival from CRC diagnosed among individuals older than 50 years,” the investigators wrote in JAMA Network Open. Previous studies comparing survival times across age groups have yielded inconsistent results.

To gain a better understanding, the investigator conducted a retrospective study using data from the National Cancer Database. Excluding patients with primary CRC who had concomitant diagnosis, history of other malignant tumors, noninvasive adenocarcinoma, or missing data, the final dataset included 769,871 patients. Early-onset CRC was defined by age less than 50 years, whereas later-onset CRC was defined by ages 51-55 years.

“Individuals diagnosed at age 50 years were excluded to minimize an apparent screening detection bias at age 50 years in our population, given that these individuals disproportionately presented with earlier stages,” the investigators wrote.

Initial comparisons across groups revealed several significant differences. Individuals in the early-onset group were more often women (47.3% vs. 43.8%; P < .001), members of races in the “other” category (6.9% vs. 5.9%; P < .001), and Medicaid patients (12.3% vs. 10.3%; P < .001). They were also more likely to be diagnosed with stage IV cancer (27.8% vs 24.1%; P < .001) and have rectal tumors (29.3% vs. 28.7%; P = .004).

In the unadjusted Kaplan-Meier analysis, patients with early-onset CRC had a lower 10-year survival rate (53.6%; 95% CI, 53.2%-54.0% vs. 54.3%; 95% CI, 53.8%-54.8%; P < .001). The fully adjusted model revealed significantly higher survival for early-onset patients, compared with later-onset patients (adjusted hazard ratio, 0.95; 95% CI, 0.93-0.96; P < .001) . This disparity deepened when adjusting only for stage (HR, 0.89; 95% CI, 0.88-0.90; P < .001).

Survival was longest among patients 35-39 years (aHR, 0.88; 95% CI, 0.84-0.92; P < .001), compared with those aged 51-55, and among early-onset individuals with stage I disease (a HR, 0.87; 95% CI, 0.81-0.93; P < .001) or stage II disease (a HR, 0.86; 95% CI, 0.82-0.90; P < .001), compared with those having the same stages of later-onset CRC. No survival advantage was observed among patients diagnosed at age 25 or younger or those with stage III or IV disease.

“Interestingly, hereditary nonpolyposis colorectal cancer, owing to underlying mismatch repair deficiency, is associated with superior survival and is often diagnosed in individuals from ages 35-45 years,” the investigators noted. “In contrast, adenomatous polyposis coli syndrome is more common in individuals who are diagnosed with CRC at age younger than 20 years (10%), compared with those diagnosed at later ages (0.1%), and adenomatous polyposis coli syndrome is not associated with a survival advantage. These high penetrance syndromes could partly account for the relative heterogeneity in survival across ages among individuals with early-onset CRC.”
 

Cautious about interpretation

Dr. Cheng and colleagues concluded their publication with a disclaimer: “Our finding of a survival advantage associated with early-onset CRC among younger individuals should be interpreted cautiously, given that the advantage had a small magnitude and was heterogeneous by age and stage,” they wrote. “Further study is needed to understand the underlying heterogeneity of survival by age and stage among individuals with early-onset CRC.”

Kirbi L. Yelorda, MD, of Stanford (Calif.) University, and colleagues, had a similar interpretation.

“These results offer support for effectiveness of treatment in patients diagnosed with CRC at younger ages; however, they must be interpreted within the context of epidemiological and biological factors,” Dr. Yelorda and colleagues wrote in an accompanying editorial.

The findings also suggest that the recent reduction in recommended screening age by the U.S. Preventive Services Task Force – from 50 years to 45 years – is warranted, they added, but screening younger patients remains unnecessary.

“While these results do not suggest that screening should start for patients younger than 45 years, they do support the benefit of early detection in young patients,” Dr. Yelorda and colleagues wrote, noting a “fairly low incidence rate” among individuals younger than 45, which is insufficient to justify the risk-to-benefit ratio and increased costs associated with expanded screening.
 

Important but not surprising

It’s “not surprising” that early-onset patients typically have better survival than later-onset patients, according to Joseph C. Anderson, MD, associate professor at White River Junction Veterans Affairs Medical Center, Hartford, Vt.; Geisel School of Medicine at Dartmouth, Hanover, N.H.; and the University of Connecticut, Farmington.

“They’re younger, have less comorbidities, and can tolerate chemotherapy,” Dr. Anderson said in an interview. “It’s not surprising that people do poorly with later stages. Younger people are no exception.”

Dr. Anderson, who previously coauthored an editorial weighing the pros and cons of earlier screening, noted that earlier screening is needed because of the rising incidence of late-stage diagnoses among younger patients, which, as the study found, are associated with worse outcomes.

Beyond adherence to screening recommendations, Dr. Anderson urged clinicians to be aggressive when doing a workup of CRC symptoms in younger patients, among whom delayed diagnoses are more common.

“We can’t just say it’s something more benign, like hemorrhoids, like we used to,” Dr. Anderson said. “Somebody who’s 30 years old and having rectal bleeding needs to be evaluated promptly – there can’t be a delay.”

The study was supported by the National Institutes of Health and Stand Up To Cancer (grant administered by the American Association for Cancer Research). The investigators disclosed relationships with Evergrande Group, Janssen, Revolution Medicines, and others. One editorialist reported serving as a member of the USPSTF when the guideline for colorectal cancer was developed, and being a coauthor on the guideline. No other disclosures were reported among editorialists. Dr. Anderson reported no relevant conflicts of interest.

Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

Pop icon Britney Spears spoke out recently against the conservatorship that she’s lived under for 13 years, telling a Los Angeles probate judge that she wants her life back.

In a 24-minute statement, Ms. Spears told the judge overseeing the conservatorship that she wants it to end “without having to be evaluated.” She called the arrangement “abusive” and said she’s been “traumatized” and “in denial” despite the upbeat messages that she’s posted on Instagram during the past year, according to Reuters.

“I just want my life back,” she said. “I’m not here to be anyone’s slave.”

After the statement, the court recessed, and the audio transmission was stopped, Reuters reported. Full transcripts have been published by several news outlets, including this lightly edited version by Variety.

Ms. Spears’ statement came as a shock after years of silence about the conservatorship. Public speculation about the arrangement has resurfaced during the past year because of the #FreeBritney movement on social media, news reports of leaked court documents, and a 2021 documentary that showed she may feel trapped.

During the hearing, Ms. Spears spoke by phone to Los Angeles Superior Court Judge Brenda Penny about the court-approved arrangement that began in 2008 after she had a mental health breakdown. Judge Penny said Ms. Spears would need to submit a petition to the court to ask for the conservatorship to be terminated.

Under the terms of the conservatorship, Ms. Spears would have to demonstrate that she can take responsibility for her personal and financial affairs, Reuters reported. During the hearing, Judge Penny supported Ms. Spears for speaking out.

“I know it took a lot of courage for you to say everything you have to say today,” she said. “I want to let you know that the court does appreciate your coming on the line and sharing how you’re feeling.”

Ms. Spears, 39, said she wanted to get married again and have a baby but that she’s not allowed to go to the doctor to get a contraceptive device removed. She spoke up about her mental health and said doctors had put her on the drug lithium, which made her less able to function. Ms. Spears also said she was forced to perform in the past and is now required to attend numerous therapy sessions each week against her will.

“I’m not happy. I can’t sleep. I’m so angry, it’s insane,” she said. “And I’m depressed. I cry every day.”

Ms. Spears last spoke with the court in May 2019, but the hearing was closed to the public and her testimony was sealed. Ms. Spears recently said she wanted people to hear her thoughts.

“I feel ganged-up on and I feel bullied and I feel left out and alone,” she said. “I deserve to have the same rights as anybody does, by having a child, a family, any of those things, and more so.”

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

Pop icon Britney Spears spoke out recently against the conservatorship that she’s lived under for 13 years, telling a Los Angeles probate judge that she wants her life back.

In a 24-minute statement, Ms. Spears told the judge overseeing the conservatorship that she wants it to end “without having to be evaluated.” She called the arrangement “abusive” and said she’s been “traumatized” and “in denial” despite the upbeat messages that she’s posted on Instagram during the past year, according to Reuters.

“I just want my life back,” she said. “I’m not here to be anyone’s slave.”

After the statement, the court recessed, and the audio transmission was stopped, Reuters reported. Full transcripts have been published by several news outlets, including this lightly edited version by Variety.

Ms. Spears’ statement came as a shock after years of silence about the conservatorship. Public speculation about the arrangement has resurfaced during the past year because of the #FreeBritney movement on social media, news reports of leaked court documents, and a 2021 documentary that showed she may feel trapped.

During the hearing, Ms. Spears spoke by phone to Los Angeles Superior Court Judge Brenda Penny about the court-approved arrangement that began in 2008 after she had a mental health breakdown. Judge Penny said Ms. Spears would need to submit a petition to the court to ask for the conservatorship to be terminated.

Under the terms of the conservatorship, Ms. Spears would have to demonstrate that she can take responsibility for her personal and financial affairs, Reuters reported. During the hearing, Judge Penny supported Ms. Spears for speaking out.

“I know it took a lot of courage for you to say everything you have to say today,” she said. “I want to let you know that the court does appreciate your coming on the line and sharing how you’re feeling.”

Ms. Spears, 39, said she wanted to get married again and have a baby but that she’s not allowed to go to the doctor to get a contraceptive device removed. She spoke up about her mental health and said doctors had put her on the drug lithium, which made her less able to function. Ms. Spears also said she was forced to perform in the past and is now required to attend numerous therapy sessions each week against her will.

“I’m not happy. I can’t sleep. I’m so angry, it’s insane,” she said. “And I’m depressed. I cry every day.”

Ms. Spears last spoke with the court in May 2019, but the hearing was closed to the public and her testimony was sealed. Ms. Spears recently said she wanted people to hear her thoughts.

“I feel ganged-up on and I feel bullied and I feel left out and alone,” she said. “I deserve to have the same rights as anybody does, by having a child, a family, any of those things, and more so.”

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

Pop icon Britney Spears spoke out recently against the conservatorship that she’s lived under for 13 years, telling a Los Angeles probate judge that she wants her life back.

In a 24-minute statement, Ms. Spears told the judge overseeing the conservatorship that she wants it to end “without having to be evaluated.” She called the arrangement “abusive” and said she’s been “traumatized” and “in denial” despite the upbeat messages that she’s posted on Instagram during the past year, according to Reuters.

“I just want my life back,” she said. “I’m not here to be anyone’s slave.”

After the statement, the court recessed, and the audio transmission was stopped, Reuters reported. Full transcripts have been published by several news outlets, including this lightly edited version by Variety.

Ms. Spears’ statement came as a shock after years of silence about the conservatorship. Public speculation about the arrangement has resurfaced during the past year because of the #FreeBritney movement on social media, news reports of leaked court documents, and a 2021 documentary that showed she may feel trapped.

During the hearing, Ms. Spears spoke by phone to Los Angeles Superior Court Judge Brenda Penny about the court-approved arrangement that began in 2008 after she had a mental health breakdown. Judge Penny said Ms. Spears would need to submit a petition to the court to ask for the conservatorship to be terminated.

Under the terms of the conservatorship, Ms. Spears would have to demonstrate that she can take responsibility for her personal and financial affairs, Reuters reported. During the hearing, Judge Penny supported Ms. Spears for speaking out.

“I know it took a lot of courage for you to say everything you have to say today,” she said. “I want to let you know that the court does appreciate your coming on the line and sharing how you’re feeling.”

Ms. Spears, 39, said she wanted to get married again and have a baby but that she’s not allowed to go to the doctor to get a contraceptive device removed. She spoke up about her mental health and said doctors had put her on the drug lithium, which made her less able to function. Ms. Spears also said she was forced to perform in the past and is now required to attend numerous therapy sessions each week against her will.

“I’m not happy. I can’t sleep. I’m so angry, it’s insane,” she said. “And I’m depressed. I cry every day.”

Ms. Spears last spoke with the court in May 2019, but the hearing was closed to the public and her testimony was sealed. Ms. Spears recently said she wanted people to hear her thoughts.

“I feel ganged-up on and I feel bullied and I feel left out and alone,” she said. “I deserve to have the same rights as anybody does, by having a child, a family, any of those things, and more so.”

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

Tim Oswalt had been in a Fort Worth, Texas, hospital for over a month, receiving treatment for a grapefruit-sized tumor in his chest that was pressing on his heart and lungs. It turned out to be stage 3 non-Hodgkin lymphoma. 

Then one day in January, he was moved from his semi-private room to an isolated one with special ventilation. The staff explained he had been infected by the virus that was once again surging in many areas of the country, including Texas.

“How the hell did I catch COVID?” he asked the staff, who now approached him in full moon-suit personal protective equipment (PPE).

The hospital was locked down, and Mr. Oswalt hadn’t had any visitors in weeks. Neither of his two roommates tested positive. He’d been tested for COVID several times over the course of his nearly 5-week stay and was always negative.

“‘Well, you know, it’s easy to [catch it] in a hospital,’” Mr. Oswalt said he was told by hospital staff. “‘We’re having a bad outbreak. So you were just exposed somehow.’”

Courtesy Tim Oswalt

Refusing vaccinations

In fact, nationwide, 1 in 4 hospital workers who have direct contact with patients had not yet received a single dose of a COVID vaccine by the end of May, according to a WebMD and Medscape Medical News analysis of data collected by the U.S. Department of Health and Human Services (HHS) from 2,500 hospitals across the United States.

Among the nation’s 50 largest hospitals, the percentage of unvaccinated health care workers appears to be even larger, about 1 in 3. Vaccination rates range from a high of 99% at Houston Methodist Hospital, which was the first in the nation to mandate the shots for its workers, to a low between 30% and 40% at some hospitals in Florida.

Memorial Hermann Texas Medical Center in Houston has 1,180 beds and sits less than half a mile from Houston Methodist Hospital. But in terms of worker vaccinations, it is farther away. 

Memorial Hermann reported to HHS that about 32% of its 28,000 workers haven’t been inoculated. The hospital’s PR office contests that figure, putting it closer to 25% unvaccinated across their health system. The hospital said it is boosting participation by offering a $300 “shot of hope” bonus to workers who start their vaccination series by the end of June.

Lakeland Regional Medical Center in Lakeland, Fla., reported to HHS that 63% of its health care personnel are still unvaccinated. The hospital did not return a call to verify that number.

To boost vaccination rates, more hospitals are starting to require the shots, after the Equal Employment Opportunity Commission gave its green light to mandates in May.

“It’s a real problem that you have such high levels of unvaccinated individuals in hospitals,” said Lawrence Gostin, JD, director of the O’Neill Institute for National and Global Health Law at Georgetown University, Washington.  

“We have to protect our health workforce, and we have to protect our patients. Hospitals should be the safest places in the country, and the only way to make them safe is to have a fully vaccinated workforce,” Mr. Gostin said.
 

Is the data misleading?

The HHS system designed to amass hospital data was set up quickly, to respond to an emergency. For that reason, experts say the information hasn’t been as carefully collected or vetted as it normally would have been. Some hospitals may have misunderstood how to report their vaccination numbers.

In addition, reporting data on worker vaccinations is voluntary. Only about half of hospitals have chosen to share their numbers. In other cases, like Texas, states have blocked the public release of these statistics.

AdventHealth Orlando, a 1,300-bed hospital in Florida, reported to HHS that 56% of its staff have not started their shots. But spokesman Jeff Grainger said the figures probably overstate the number of unvaccinated workers because the hospital doesn’t always know when people get vaccinated outside of its campus, at a local pharmacy, for example.  

For those reasons, the picture of health care worker vaccinations across the country is incomplete.
 

Where hospitals fall behind

Even if the data are flawed, the vaccination rates from hospitals mirror the general population. A May Gallup poll, for example, found 24% of Americans said they definitely won’t get the vaccine. Another 12% say they plan to get it but are waiting.

The data also align with recent studies. A review of 35 studies by researchers at New Mexico State University that assessed hesitancy in more than 76,000 health care workers around the world found about 23% of them were reluctant to get the shots. 

An ongoing monthly survey of more than 1.9 million U.S. Facebook users led by researchers at Carnegie Mellon University, Pittsburgh recently looked at vaccine hesitancy by occupation. It revealed a spectrum of hesitancy among health care workers corresponding to income and education, ranging from a low of 9% among pharmacists to highs of 20%-23% among nursing aides and emergency medical technicians. About 12% of registered nurses and doctors admitted to being hesitant to get a shot.

“Health care workers are not monolithic,” said study author Jagdish Khubchandani, professor of public health sciences at New Mexico State. 

“There’s a big divide between males, doctoral degree holders, older people and the younger low-income, low-education frontline, female, health care workers. They are the most hesitant,” he said. Support staff typically outnumbers doctors at hospitals about 3 to 1.

‘I am not vaccinated’ 

One reason some hospital staff say they are resisting COVID vaccination is because it’s so new and not yet fully approved by the FDA.

“I am not vaccinated,” said a social services worker for AdventHealth Gordon who asked that her name not be used because she was unauthorized to speak to this news organization and Georgia Health News (who collaborated on this project). “I just have not felt the need to do that at this time.”

The woman said she doesn’t have a problem with vaccines. She gets the flu shot every year. “I’ve been vaccinated all my life,” she said. But she doesn’t view COVID-19 vaccination in the same way.

“I want to see more testing done,” she said. “It took a long time to get a flu vaccine, and we made a COVID vaccine in 6 months. I want to know, before I start putting something into my body, that the testing is done.”

Staff at her hospital were given the option to be vaccinated or wear a mask. She chose the mask.

Many of her coworkers share her feelings, she said.

Mask expert Linsey Marr, PhD, a professor of civil and environmental engineering at Virginia Tech University, Blacksburg, Va., said N95 masks and vaccines are both highly effective, but the protection from the vaccine is superior because it is continuous.

“It’s hard to wear an N95 at all times. You have to take it off to eat, for example, in a break room in a hospital. I should point out that you can be exposed to the virus in other buildings besides a hospital – restaurants, stores, people’s homes – and because someone can be infected without symptoms, you could easily be around an infected person without knowing it,” she said.

Eventually, staff at AdventHealth Gordon may get a stronger nudge to get the shots. Chief Medical Officer Joseph Joyave, MD, said AdventHealth asks workers to get flu vaccines or provide the hospital with a reason why they won’t. He expects a similar policy will be adopted for COVID vaccines once they are fully licensed by the FDA.

In the meantime, he does not believe that the hospital is putting patients at risk with its low vaccination rate. “We continue to use PPE, masking in all clinical areas, and continue to screen daily all employees and visitors,” he said.

AdventHealth, the 12th largest hospital system in the nation with 49 hospitals, has at least 20 hospitals with vaccination rates lower than 50%, according to HHS data.

Other hospital systems have approached hesitation around the COVID vaccines differently.

When infectious disease experts at Vanderbilt Hospital in Nashville realized early on that many of their workers felt unsure about the vaccines, they set out to provide a wealth of information. 

“There was a lot of hesitancy and skepticism,” said William Schaffner, MD, a professor of preventive medicine and infectious disease at Vanderbilt. So the infectious disease division put together a multifaceted program including Q&As, educational sessions, and one-on-one visits with employees “from the custodians all the way up to the C-Suite,” he said.

Today, HHS data shows the hospital is 83% vaccinated. Dr. Schaffner thinks the true number is probably higher, about 90%. “We’re very pleased with that,” he said.

In his experience with flu vaccinations, it was extremely difficult in the first year to get workers to take flu shots. The second year it was easier. By the third year it was humdrum, he said, because it had become a cultural norm.  

Dr. Schaffner expects winning people over to the COVID vaccines will follow a similar course, but “we’re not there yet,” he said.
 

Protecting patients and caregivers

There is no question that health care workers carried a heavy load through the worst months of the pandemic. Many of them worked to the point of exhaustion and burnout. Some were the only conduits between isolated patients and their families, holding hands and mobile phones so distanced loved ones could video chat. Many were left inadequately protected because of shortages of masks, gowns, gloves, and other gear.

An investigation by Kaiser Health News and The Guardian recently revealed that more than 3,600 health care workers died in COVID’s first year in the United States.

Vaccination of health care workers is important to protect these frontline workers and their families who will continue to be at risk of coming into contact with the infection, even as the number of cases falls.

Hesitancy in health care is also dangerous because these clinicians and allied health workers – who may not show any symptoms – can also carry the virus to someone who wouldn’t survive an infection, including patients with organ transplants, those with autoimmune diseases, premature infants, and the elderly.  

It is not known how often patients in the United States are infected with COVID in health care settings, but case reports reveal that hospitals are still experiencing outbreaks.

On June 1, Northern Lights A.R. Gould Hospital in Presque Isle, Maine, announced a COVID outbreak on its medical-surgical unit. As of June 22, 13 residents and staff have caught the virus, according to the Maine Centers for Disease Control, which is investigating. Four of the first five staff members to test positive had not been fully vaccinated. 

According to HHS data, about 20% of the health care workers at that hospital are still unvaccinated.

Oregon Health & Science University experienced a COVID outbreak connected to the hospital’s cardiovascular care unit from April to mid-May of this year. According to hospital spokesperson Tracy Brawley, a patient visitor brought the infection to campus, where it ultimately spread to 14 others, including “patients, visitors, employees, and learners.” 

In a written statement, the hospital said “nearly all” health care workers who tested positive were previously vaccinated and experienced no symptoms or only minor ones. The hospital said it hasn’t identified any onward transmission from health care workers to patients, and also stated: “It is not yet understood how transmission may have occurred between patients, visitors, and health care workers.”

In March, an unvaccinated health care worker in Kentucky carried a SARS-CoV-2 variant back to the nursing home where the person worked. Some 90% of the residents were fully vaccinated. Ultimately, 26 patients were infected; 18 of them were fully vaccinated. And 20 health care workers, four of whom were vaccinated, were infected.   

Vaccines slowed the virus down and made infections less severe, but in this fragile population, they couldn’t stop it completely. One resident, who had survived a bout of COVID almost a year earlier, died. According to the CDC’s Morbidity and Mortality Weekly Report, 47% of the workers in that facility were unvaccinated.

In the United Kingdom, statistics collected through that country’s National Health Service also suggest a heavy toll. More than 32,300 patients caught COVID in English hospitals since March 2020. Up to 8,700 of them died, according to a recent analysis by The Guardian. The U.K. government recently made COVID vaccinations mandatory for health care workers.
 

COVID delays cancer care

When Mr. Oswalt, the Fort Worth, Texas man with non-Hodgkin lymphoma, contracted COVID-19, the virus took down his kidneys first. Toxins were building up in his blood, so doctors prescribed dialysis to support his body and buy his kidneys time to heal.

He was in one of these dialysis treatments when his lungs succumbed.

“Look, I can’t breathe,” he told the nurse who was supervising his treatment. The nurse gestured to an oxygen tank already hanging by his side, and said, “You should be OK.”

But he wasn’t.

“I can’t breathe,” Mr. Oswalt said again. Then the air hunger hit. Mr. Oswalt began gasping and couldn’t stop. Today, his voice breaks when he describes this moment. “A lot of it becomes a blur.”

When Mr. Oswalt, 61, regained consciousness, he was hooked up to a ventilator to ease his breathing.

For days, Mr. Oswalt clung to the edge of life. His wife, Molly, who wasn’t allowed to see him in the hospital, got a call that he might not make it through the night. She made frantic phone calls to her brother and sister and prayed.

Mr. Oswalt was on a ventilator for about a week. His kidneys and lungs healed enough so that he could restart his chemotherapy. He was eventually discharged home on January 22.

The last time he was scanned, the large tumor in his chest had shrunk from the size of a grapefruit to the size of a dime.

But having COVID on top of cancer has had a devastating effect on his life. Before he got sick, Molly said, he couldn’t stay still. He was busy all the time. After spending months in the hospital, his energy was depleted. He couldn’t keep his swimming pool installation business going.  

He and Molly had to give up their house in Fort Worth and move in with family in Amarillo. He has had to pause his cancer treatments while doctors wait for his kidneys to heal. Relatives have been raising money on GoFundMe to pay their bills.

Months after moving across the state to Amarillo and hoping for better days, Tim said he got good news this week: He no longer needs dialysis. A new round of tests found no signs of cancer. His white blood cell count is back to normal. His lymph nodes are no longer swollen.

He goes back for another scan in a few weeks, but the doctor told him she isn’t going to recommend any further chemo at this point.

“It was shocking, to tell you the truth. It still is. When I talk about it, I get kind of emotional” about his recovery, he said.

Tim said he was really dreading more chemotherapy. His hair has just started growing back. He can finally taste food again. He wasn’t ready to face more side effects from the treatments, or the COVID – he no longer knows exactly which diagnosis led to his most debilitating symptoms.

He said his ordeal has left him with no patience for health care workers who don’t think they need to be vaccinated.

The way he sees it, it’s no different than the electrical training he had to get before he could wire the lights and pumps in a swimming pool.

“You know, if I don’t certify and keep my license, I can’t work on anything electrical. So, if I’ve made the choice not to go down and take the test and get a license, then I made the choice not to work on electrical stuff,” he said.

He supports the growing number of hospitals that have made vaccination mandatory for their workers.

“They don’t let electricians put people at risk. And they shouldn’t let health care workers for sure,” he said.

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

Tim Oswalt had been in a Fort Worth, Texas, hospital for over a month, receiving treatment for a grapefruit-sized tumor in his chest that was pressing on his heart and lungs. It turned out to be stage 3 non-Hodgkin lymphoma. 

Then one day in January, he was moved from his semi-private room to an isolated one with special ventilation. The staff explained he had been infected by the virus that was once again surging in many areas of the country, including Texas.

“How the hell did I catch COVID?” he asked the staff, who now approached him in full moon-suit personal protective equipment (PPE).

The hospital was locked down, and Mr. Oswalt hadn’t had any visitors in weeks. Neither of his two roommates tested positive. He’d been tested for COVID several times over the course of his nearly 5-week stay and was always negative.

“‘Well, you know, it’s easy to [catch it] in a hospital,’” Mr. Oswalt said he was told by hospital staff. “‘We’re having a bad outbreak. So you were just exposed somehow.’”

Courtesy Tim Oswalt

Refusing vaccinations

In fact, nationwide, 1 in 4 hospital workers who have direct contact with patients had not yet received a single dose of a COVID vaccine by the end of May, according to a WebMD and Medscape Medical News analysis of data collected by the U.S. Department of Health and Human Services (HHS) from 2,500 hospitals across the United States.

Among the nation’s 50 largest hospitals, the percentage of unvaccinated health care workers appears to be even larger, about 1 in 3. Vaccination rates range from a high of 99% at Houston Methodist Hospital, which was the first in the nation to mandate the shots for its workers, to a low between 30% and 40% at some hospitals in Florida.

Memorial Hermann Texas Medical Center in Houston has 1,180 beds and sits less than half a mile from Houston Methodist Hospital. But in terms of worker vaccinations, it is farther away. 

Memorial Hermann reported to HHS that about 32% of its 28,000 workers haven’t been inoculated. The hospital’s PR office contests that figure, putting it closer to 25% unvaccinated across their health system. The hospital said it is boosting participation by offering a $300 “shot of hope” bonus to workers who start their vaccination series by the end of June.

Lakeland Regional Medical Center in Lakeland, Fla., reported to HHS that 63% of its health care personnel are still unvaccinated. The hospital did not return a call to verify that number.

To boost vaccination rates, more hospitals are starting to require the shots, after the Equal Employment Opportunity Commission gave its green light to mandates in May.

“It’s a real problem that you have such high levels of unvaccinated individuals in hospitals,” said Lawrence Gostin, JD, director of the O’Neill Institute for National and Global Health Law at Georgetown University, Washington.  

“We have to protect our health workforce, and we have to protect our patients. Hospitals should be the safest places in the country, and the only way to make them safe is to have a fully vaccinated workforce,” Mr. Gostin said.
 

Is the data misleading?

The HHS system designed to amass hospital data was set up quickly, to respond to an emergency. For that reason, experts say the information hasn’t been as carefully collected or vetted as it normally would have been. Some hospitals may have misunderstood how to report their vaccination numbers.

In addition, reporting data on worker vaccinations is voluntary. Only about half of hospitals have chosen to share their numbers. In other cases, like Texas, states have blocked the public release of these statistics.

AdventHealth Orlando, a 1,300-bed hospital in Florida, reported to HHS that 56% of its staff have not started their shots. But spokesman Jeff Grainger said the figures probably overstate the number of unvaccinated workers because the hospital doesn’t always know when people get vaccinated outside of its campus, at a local pharmacy, for example.  

For those reasons, the picture of health care worker vaccinations across the country is incomplete.
 

Where hospitals fall behind

Even if the data are flawed, the vaccination rates from hospitals mirror the general population. A May Gallup poll, for example, found 24% of Americans said they definitely won’t get the vaccine. Another 12% say they plan to get it but are waiting.

The data also align with recent studies. A review of 35 studies by researchers at New Mexico State University that assessed hesitancy in more than 76,000 health care workers around the world found about 23% of them were reluctant to get the shots. 

An ongoing monthly survey of more than 1.9 million U.S. Facebook users led by researchers at Carnegie Mellon University, Pittsburgh recently looked at vaccine hesitancy by occupation. It revealed a spectrum of hesitancy among health care workers corresponding to income and education, ranging from a low of 9% among pharmacists to highs of 20%-23% among nursing aides and emergency medical technicians. About 12% of registered nurses and doctors admitted to being hesitant to get a shot.

“Health care workers are not monolithic,” said study author Jagdish Khubchandani, professor of public health sciences at New Mexico State. 

“There’s a big divide between males, doctoral degree holders, older people and the younger low-income, low-education frontline, female, health care workers. They are the most hesitant,” he said. Support staff typically outnumbers doctors at hospitals about 3 to 1.

‘I am not vaccinated’ 

One reason some hospital staff say they are resisting COVID vaccination is because it’s so new and not yet fully approved by the FDA.

“I am not vaccinated,” said a social services worker for AdventHealth Gordon who asked that her name not be used because she was unauthorized to speak to this news organization and Georgia Health News (who collaborated on this project). “I just have not felt the need to do that at this time.”

The woman said she doesn’t have a problem with vaccines. She gets the flu shot every year. “I’ve been vaccinated all my life,” she said. But she doesn’t view COVID-19 vaccination in the same way.

“I want to see more testing done,” she said. “It took a long time to get a flu vaccine, and we made a COVID vaccine in 6 months. I want to know, before I start putting something into my body, that the testing is done.”

Staff at her hospital were given the option to be vaccinated or wear a mask. She chose the mask.

Many of her coworkers share her feelings, she said.

Mask expert Linsey Marr, PhD, a professor of civil and environmental engineering at Virginia Tech University, Blacksburg, Va., said N95 masks and vaccines are both highly effective, but the protection from the vaccine is superior because it is continuous.

“It’s hard to wear an N95 at all times. You have to take it off to eat, for example, in a break room in a hospital. I should point out that you can be exposed to the virus in other buildings besides a hospital – restaurants, stores, people’s homes – and because someone can be infected without symptoms, you could easily be around an infected person without knowing it,” she said.

Eventually, staff at AdventHealth Gordon may get a stronger nudge to get the shots. Chief Medical Officer Joseph Joyave, MD, said AdventHealth asks workers to get flu vaccines or provide the hospital with a reason why they won’t. He expects a similar policy will be adopted for COVID vaccines once they are fully licensed by the FDA.

In the meantime, he does not believe that the hospital is putting patients at risk with its low vaccination rate. “We continue to use PPE, masking in all clinical areas, and continue to screen daily all employees and visitors,” he said.

AdventHealth, the 12th largest hospital system in the nation with 49 hospitals, has at least 20 hospitals with vaccination rates lower than 50%, according to HHS data.

Other hospital systems have approached hesitation around the COVID vaccines differently.

When infectious disease experts at Vanderbilt Hospital in Nashville realized early on that many of their workers felt unsure about the vaccines, they set out to provide a wealth of information. 

“There was a lot of hesitancy and skepticism,” said William Schaffner, MD, a professor of preventive medicine and infectious disease at Vanderbilt. So the infectious disease division put together a multifaceted program including Q&As, educational sessions, and one-on-one visits with employees “from the custodians all the way up to the C-Suite,” he said.

Today, HHS data shows the hospital is 83% vaccinated. Dr. Schaffner thinks the true number is probably higher, about 90%. “We’re very pleased with that,” he said.

In his experience with flu vaccinations, it was extremely difficult in the first year to get workers to take flu shots. The second year it was easier. By the third year it was humdrum, he said, because it had become a cultural norm.  

Dr. Schaffner expects winning people over to the COVID vaccines will follow a similar course, but “we’re not there yet,” he said.
 

Protecting patients and caregivers

There is no question that health care workers carried a heavy load through the worst months of the pandemic. Many of them worked to the point of exhaustion and burnout. Some were the only conduits between isolated patients and their families, holding hands and mobile phones so distanced loved ones could video chat. Many were left inadequately protected because of shortages of masks, gowns, gloves, and other gear.

An investigation by Kaiser Health News and The Guardian recently revealed that more than 3,600 health care workers died in COVID’s first year in the United States.

Vaccination of health care workers is important to protect these frontline workers and their families who will continue to be at risk of coming into contact with the infection, even as the number of cases falls.

Hesitancy in health care is also dangerous because these clinicians and allied health workers – who may not show any symptoms – can also carry the virus to someone who wouldn’t survive an infection, including patients with organ transplants, those with autoimmune diseases, premature infants, and the elderly.  

It is not known how often patients in the United States are infected with COVID in health care settings, but case reports reveal that hospitals are still experiencing outbreaks.

On June 1, Northern Lights A.R. Gould Hospital in Presque Isle, Maine, announced a COVID outbreak on its medical-surgical unit. As of June 22, 13 residents and staff have caught the virus, according to the Maine Centers for Disease Control, which is investigating. Four of the first five staff members to test positive had not been fully vaccinated. 

According to HHS data, about 20% of the health care workers at that hospital are still unvaccinated.

Oregon Health & Science University experienced a COVID outbreak connected to the hospital’s cardiovascular care unit from April to mid-May of this year. According to hospital spokesperson Tracy Brawley, a patient visitor brought the infection to campus, where it ultimately spread to 14 others, including “patients, visitors, employees, and learners.” 

In a written statement, the hospital said “nearly all” health care workers who tested positive were previously vaccinated and experienced no symptoms or only minor ones. The hospital said it hasn’t identified any onward transmission from health care workers to patients, and also stated: “It is not yet understood how transmission may have occurred between patients, visitors, and health care workers.”

In March, an unvaccinated health care worker in Kentucky carried a SARS-CoV-2 variant back to the nursing home where the person worked. Some 90% of the residents were fully vaccinated. Ultimately, 26 patients were infected; 18 of them were fully vaccinated. And 20 health care workers, four of whom were vaccinated, were infected.   

Vaccines slowed the virus down and made infections less severe, but in this fragile population, they couldn’t stop it completely. One resident, who had survived a bout of COVID almost a year earlier, died. According to the CDC’s Morbidity and Mortality Weekly Report, 47% of the workers in that facility were unvaccinated.

In the United Kingdom, statistics collected through that country’s National Health Service also suggest a heavy toll. More than 32,300 patients caught COVID in English hospitals since March 2020. Up to 8,700 of them died, according to a recent analysis by The Guardian. The U.K. government recently made COVID vaccinations mandatory for health care workers.
 

COVID delays cancer care

When Mr. Oswalt, the Fort Worth, Texas man with non-Hodgkin lymphoma, contracted COVID-19, the virus took down his kidneys first. Toxins were building up in his blood, so doctors prescribed dialysis to support his body and buy his kidneys time to heal.

He was in one of these dialysis treatments when his lungs succumbed.

“Look, I can’t breathe,” he told the nurse who was supervising his treatment. The nurse gestured to an oxygen tank already hanging by his side, and said, “You should be OK.”

But he wasn’t.

“I can’t breathe,” Mr. Oswalt said again. Then the air hunger hit. Mr. Oswalt began gasping and couldn’t stop. Today, his voice breaks when he describes this moment. “A lot of it becomes a blur.”

When Mr. Oswalt, 61, regained consciousness, he was hooked up to a ventilator to ease his breathing.

For days, Mr. Oswalt clung to the edge of life. His wife, Molly, who wasn’t allowed to see him in the hospital, got a call that he might not make it through the night. She made frantic phone calls to her brother and sister and prayed.

Mr. Oswalt was on a ventilator for about a week. His kidneys and lungs healed enough so that he could restart his chemotherapy. He was eventually discharged home on January 22.

The last time he was scanned, the large tumor in his chest had shrunk from the size of a grapefruit to the size of a dime.

But having COVID on top of cancer has had a devastating effect on his life. Before he got sick, Molly said, he couldn’t stay still. He was busy all the time. After spending months in the hospital, his energy was depleted. He couldn’t keep his swimming pool installation business going.  

He and Molly had to give up their house in Fort Worth and move in with family in Amarillo. He has had to pause his cancer treatments while doctors wait for his kidneys to heal. Relatives have been raising money on GoFundMe to pay their bills.

Months after moving across the state to Amarillo and hoping for better days, Tim said he got good news this week: He no longer needs dialysis. A new round of tests found no signs of cancer. His white blood cell count is back to normal. His lymph nodes are no longer swollen.

He goes back for another scan in a few weeks, but the doctor told him she isn’t going to recommend any further chemo at this point.

“It was shocking, to tell you the truth. It still is. When I talk about it, I get kind of emotional” about his recovery, he said.

Tim said he was really dreading more chemotherapy. His hair has just started growing back. He can finally taste food again. He wasn’t ready to face more side effects from the treatments, or the COVID – he no longer knows exactly which diagnosis led to his most debilitating symptoms.

He said his ordeal has left him with no patience for health care workers who don’t think they need to be vaccinated.

The way he sees it, it’s no different than the electrical training he had to get before he could wire the lights and pumps in a swimming pool.

“You know, if I don’t certify and keep my license, I can’t work on anything electrical. So, if I’ve made the choice not to go down and take the test and get a license, then I made the choice not to work on electrical stuff,” he said.

He supports the growing number of hospitals that have made vaccination mandatory for their workers.

“They don’t let electricians put people at risk. And they shouldn’t let health care workers for sure,” he said.

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

Tim Oswalt had been in a Fort Worth, Texas, hospital for over a month, receiving treatment for a grapefruit-sized tumor in his chest that was pressing on his heart and lungs. It turned out to be stage 3 non-Hodgkin lymphoma. 

Then one day in January, he was moved from his semi-private room to an isolated one with special ventilation. The staff explained he had been infected by the virus that was once again surging in many areas of the country, including Texas.

“How the hell did I catch COVID?” he asked the staff, who now approached him in full moon-suit personal protective equipment (PPE).

The hospital was locked down, and Mr. Oswalt hadn’t had any visitors in weeks. Neither of his two roommates tested positive. He’d been tested for COVID several times over the course of his nearly 5-week stay and was always negative.

“‘Well, you know, it’s easy to [catch it] in a hospital,’” Mr. Oswalt said he was told by hospital staff. “‘We’re having a bad outbreak. So you were just exposed somehow.’”

Courtesy Tim Oswalt

Refusing vaccinations

In fact, nationwide, 1 in 4 hospital workers who have direct contact with patients had not yet received a single dose of a COVID vaccine by the end of May, according to a WebMD and Medscape Medical News analysis of data collected by the U.S. Department of Health and Human Services (HHS) from 2,500 hospitals across the United States.

Among the nation’s 50 largest hospitals, the percentage of unvaccinated health care workers appears to be even larger, about 1 in 3. Vaccination rates range from a high of 99% at Houston Methodist Hospital, which was the first in the nation to mandate the shots for its workers, to a low between 30% and 40% at some hospitals in Florida.

Memorial Hermann Texas Medical Center in Houston has 1,180 beds and sits less than half a mile from Houston Methodist Hospital. But in terms of worker vaccinations, it is farther away. 

Memorial Hermann reported to HHS that about 32% of its 28,000 workers haven’t been inoculated. The hospital’s PR office contests that figure, putting it closer to 25% unvaccinated across their health system. The hospital said it is boosting participation by offering a $300 “shot of hope” bonus to workers who start their vaccination series by the end of June.

Lakeland Regional Medical Center in Lakeland, Fla., reported to HHS that 63% of its health care personnel are still unvaccinated. The hospital did not return a call to verify that number.

To boost vaccination rates, more hospitals are starting to require the shots, after the Equal Employment Opportunity Commission gave its green light to mandates in May.

“It’s a real problem that you have such high levels of unvaccinated individuals in hospitals,” said Lawrence Gostin, JD, director of the O’Neill Institute for National and Global Health Law at Georgetown University, Washington.  

“We have to protect our health workforce, and we have to protect our patients. Hospitals should be the safest places in the country, and the only way to make them safe is to have a fully vaccinated workforce,” Mr. Gostin said.
 

Is the data misleading?

The HHS system designed to amass hospital data was set up quickly, to respond to an emergency. For that reason, experts say the information hasn’t been as carefully collected or vetted as it normally would have been. Some hospitals may have misunderstood how to report their vaccination numbers.

In addition, reporting data on worker vaccinations is voluntary. Only about half of hospitals have chosen to share their numbers. In other cases, like Texas, states have blocked the public release of these statistics.

AdventHealth Orlando, a 1,300-bed hospital in Florida, reported to HHS that 56% of its staff have not started their shots. But spokesman Jeff Grainger said the figures probably overstate the number of unvaccinated workers because the hospital doesn’t always know when people get vaccinated outside of its campus, at a local pharmacy, for example.  

For those reasons, the picture of health care worker vaccinations across the country is incomplete.
 

Where hospitals fall behind

Even if the data are flawed, the vaccination rates from hospitals mirror the general population. A May Gallup poll, for example, found 24% of Americans said they definitely won’t get the vaccine. Another 12% say they plan to get it but are waiting.

The data also align with recent studies. A review of 35 studies by researchers at New Mexico State University that assessed hesitancy in more than 76,000 health care workers around the world found about 23% of them were reluctant to get the shots. 

An ongoing monthly survey of more than 1.9 million U.S. Facebook users led by researchers at Carnegie Mellon University, Pittsburgh recently looked at vaccine hesitancy by occupation. It revealed a spectrum of hesitancy among health care workers corresponding to income and education, ranging from a low of 9% among pharmacists to highs of 20%-23% among nursing aides and emergency medical technicians. About 12% of registered nurses and doctors admitted to being hesitant to get a shot.

“Health care workers are not monolithic,” said study author Jagdish Khubchandani, professor of public health sciences at New Mexico State. 

“There’s a big divide between males, doctoral degree holders, older people and the younger low-income, low-education frontline, female, health care workers. They are the most hesitant,” he said. Support staff typically outnumbers doctors at hospitals about 3 to 1.

‘I am not vaccinated’ 

One reason some hospital staff say they are resisting COVID vaccination is because it’s so new and not yet fully approved by the FDA.

“I am not vaccinated,” said a social services worker for AdventHealth Gordon who asked that her name not be used because she was unauthorized to speak to this news organization and Georgia Health News (who collaborated on this project). “I just have not felt the need to do that at this time.”

The woman said she doesn’t have a problem with vaccines. She gets the flu shot every year. “I’ve been vaccinated all my life,” she said. But she doesn’t view COVID-19 vaccination in the same way.

“I want to see more testing done,” she said. “It took a long time to get a flu vaccine, and we made a COVID vaccine in 6 months. I want to know, before I start putting something into my body, that the testing is done.”

Staff at her hospital were given the option to be vaccinated or wear a mask. She chose the mask.

Many of her coworkers share her feelings, she said.

Mask expert Linsey Marr, PhD, a professor of civil and environmental engineering at Virginia Tech University, Blacksburg, Va., said N95 masks and vaccines are both highly effective, but the protection from the vaccine is superior because it is continuous.

“It’s hard to wear an N95 at all times. You have to take it off to eat, for example, in a break room in a hospital. I should point out that you can be exposed to the virus in other buildings besides a hospital – restaurants, stores, people’s homes – and because someone can be infected without symptoms, you could easily be around an infected person without knowing it,” she said.

Eventually, staff at AdventHealth Gordon may get a stronger nudge to get the shots. Chief Medical Officer Joseph Joyave, MD, said AdventHealth asks workers to get flu vaccines or provide the hospital with a reason why they won’t. He expects a similar policy will be adopted for COVID vaccines once they are fully licensed by the FDA.

In the meantime, he does not believe that the hospital is putting patients at risk with its low vaccination rate. “We continue to use PPE, masking in all clinical areas, and continue to screen daily all employees and visitors,” he said.

AdventHealth, the 12th largest hospital system in the nation with 49 hospitals, has at least 20 hospitals with vaccination rates lower than 50%, according to HHS data.

Other hospital systems have approached hesitation around the COVID vaccines differently.

When infectious disease experts at Vanderbilt Hospital in Nashville realized early on that many of their workers felt unsure about the vaccines, they set out to provide a wealth of information. 

“There was a lot of hesitancy and skepticism,” said William Schaffner, MD, a professor of preventive medicine and infectious disease at Vanderbilt. So the infectious disease division put together a multifaceted program including Q&As, educational sessions, and one-on-one visits with employees “from the custodians all the way up to the C-Suite,” he said.

Today, HHS data shows the hospital is 83% vaccinated. Dr. Schaffner thinks the true number is probably higher, about 90%. “We’re very pleased with that,” he said.

In his experience with flu vaccinations, it was extremely difficult in the first year to get workers to take flu shots. The second year it was easier. By the third year it was humdrum, he said, because it had become a cultural norm.  

Dr. Schaffner expects winning people over to the COVID vaccines will follow a similar course, but “we’re not there yet,” he said.
 

Protecting patients and caregivers

There is no question that health care workers carried a heavy load through the worst months of the pandemic. Many of them worked to the point of exhaustion and burnout. Some were the only conduits between isolated patients and their families, holding hands and mobile phones so distanced loved ones could video chat. Many were left inadequately protected because of shortages of masks, gowns, gloves, and other gear.

An investigation by Kaiser Health News and The Guardian recently revealed that more than 3,600 health care workers died in COVID’s first year in the United States.

Vaccination of health care workers is important to protect these frontline workers and their families who will continue to be at risk of coming into contact with the infection, even as the number of cases falls.

Hesitancy in health care is also dangerous because these clinicians and allied health workers – who may not show any symptoms – can also carry the virus to someone who wouldn’t survive an infection, including patients with organ transplants, those with autoimmune diseases, premature infants, and the elderly.  

It is not known how often patients in the United States are infected with COVID in health care settings, but case reports reveal that hospitals are still experiencing outbreaks.

On June 1, Northern Lights A.R. Gould Hospital in Presque Isle, Maine, announced a COVID outbreak on its medical-surgical unit. As of June 22, 13 residents and staff have caught the virus, according to the Maine Centers for Disease Control, which is investigating. Four of the first five staff members to test positive had not been fully vaccinated. 

According to HHS data, about 20% of the health care workers at that hospital are still unvaccinated.

Oregon Health & Science University experienced a COVID outbreak connected to the hospital’s cardiovascular care unit from April to mid-May of this year. According to hospital spokesperson Tracy Brawley, a patient visitor brought the infection to campus, where it ultimately spread to 14 others, including “patients, visitors, employees, and learners.” 

In a written statement, the hospital said “nearly all” health care workers who tested positive were previously vaccinated and experienced no symptoms or only minor ones. The hospital said it hasn’t identified any onward transmission from health care workers to patients, and also stated: “It is not yet understood how transmission may have occurred between patients, visitors, and health care workers.”

In March, an unvaccinated health care worker in Kentucky carried a SARS-CoV-2 variant back to the nursing home where the person worked. Some 90% of the residents were fully vaccinated. Ultimately, 26 patients were infected; 18 of them were fully vaccinated. And 20 health care workers, four of whom were vaccinated, were infected.   

Vaccines slowed the virus down and made infections less severe, but in this fragile population, they couldn’t stop it completely. One resident, who had survived a bout of COVID almost a year earlier, died. According to the CDC’s Morbidity and Mortality Weekly Report, 47% of the workers in that facility were unvaccinated.

In the United Kingdom, statistics collected through that country’s National Health Service also suggest a heavy toll. More than 32,300 patients caught COVID in English hospitals since March 2020. Up to 8,700 of them died, according to a recent analysis by The Guardian. The U.K. government recently made COVID vaccinations mandatory for health care workers.
 

COVID delays cancer care

When Mr. Oswalt, the Fort Worth, Texas man with non-Hodgkin lymphoma, contracted COVID-19, the virus took down his kidneys first. Toxins were building up in his blood, so doctors prescribed dialysis to support his body and buy his kidneys time to heal.

He was in one of these dialysis treatments when his lungs succumbed.

“Look, I can’t breathe,” he told the nurse who was supervising his treatment. The nurse gestured to an oxygen tank already hanging by his side, and said, “You should be OK.”

But he wasn’t.

“I can’t breathe,” Mr. Oswalt said again. Then the air hunger hit. Mr. Oswalt began gasping and couldn’t stop. Today, his voice breaks when he describes this moment. “A lot of it becomes a blur.”

When Mr. Oswalt, 61, regained consciousness, he was hooked up to a ventilator to ease his breathing.

For days, Mr. Oswalt clung to the edge of life. His wife, Molly, who wasn’t allowed to see him in the hospital, got a call that he might not make it through the night. She made frantic phone calls to her brother and sister and prayed.

Mr. Oswalt was on a ventilator for about a week. His kidneys and lungs healed enough so that he could restart his chemotherapy. He was eventually discharged home on January 22.

The last time he was scanned, the large tumor in his chest had shrunk from the size of a grapefruit to the size of a dime.

But having COVID on top of cancer has had a devastating effect on his life. Before he got sick, Molly said, he couldn’t stay still. He was busy all the time. After spending months in the hospital, his energy was depleted. He couldn’t keep his swimming pool installation business going.  

He and Molly had to give up their house in Fort Worth and move in with family in Amarillo. He has had to pause his cancer treatments while doctors wait for his kidneys to heal. Relatives have been raising money on GoFundMe to pay their bills.

Months after moving across the state to Amarillo and hoping for better days, Tim said he got good news this week: He no longer needs dialysis. A new round of tests found no signs of cancer. His white blood cell count is back to normal. His lymph nodes are no longer swollen.

He goes back for another scan in a few weeks, but the doctor told him she isn’t going to recommend any further chemo at this point.

“It was shocking, to tell you the truth. It still is. When I talk about it, I get kind of emotional” about his recovery, he said.

Tim said he was really dreading more chemotherapy. His hair has just started growing back. He can finally taste food again. He wasn’t ready to face more side effects from the treatments, or the COVID – he no longer knows exactly which diagnosis led to his most debilitating symptoms.

He said his ordeal has left him with no patience for health care workers who don’t think they need to be vaccinated.

The way he sees it, it’s no different than the electrical training he had to get before he could wire the lights and pumps in a swimming pool.

“You know, if I don’t certify and keep my license, I can’t work on anything electrical. So, if I’ve made the choice not to go down and take the test and get a license, then I made the choice not to work on electrical stuff,” he said.

He supports the growing number of hospitals that have made vaccination mandatory for their workers.

“They don’t let electricians put people at risk. And they shouldn’t let health care workers for sure,” he said.

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

The recently licensed weight-loss drug semaglutide 2.4 mg/week (Wegovy, Novo Nordisk) “is likely to usher in a new era in the medical treatment of obesity,” Lee M. Kaplan, MD, PhD, stated at the annual scientific sessions of the American Diabetes Association, held virtually.

Dr. Kaplan discussed the clinical implications of caring for patients with obesity now that the glucagon-like peptide-1 (GLP-1) receptor agonist is approved in the United States for weight loss.

Weight loss with semaglutide 2.4 mg was twice that achieved with liraglutide 3 mg (Saxenda, Novo Nordisk) – that is, roughly a 10%-15% weight loss at 68 weeks, said Dr. Kaplan, who was not involved in the pivotal STEP clinical trials of the agent.  

“I think as we start to see more data come in over the next couple of years,” including from the cardiovascular outcome trial SELECT, he continued, “we’ll be able to use the data to create a nuanced [individualized patient treatment] approach, but we’ll also be able to use our clinical experience, which will grow rapidly over the next few years.”

In the future, semaglutide is likely to be combined with other drugs to provide even greater weight loss, predicts Dr. Kaplan, director of the Obesity, Metabolism, and Nutrition Institute at Massachusetts General Hospital in Boston.

In the meantime, “to be effective, semaglutide needs to be used,” he stressed, while noting that responses to the drug vary by individual, and so this will need to be taken into account.

“Obesity needs to be recognized as a disease in its own right, as well as a risk factor for numerous other diseases, [and] equitable access to obesity treatment needs to be broadened,” he emphasized.
 

Four pivotal phase 3 trials

As previously reported, four pivotal 68-week, phase 3 clinical trials in the Semaglutide Treatment Effect in People With Obesity (STEP) program tested the safety and efficacy of subcutaneous semaglutide 2.4 mg/week in more than 4,500 adults with overweight or obesity.

The trials have been published in high profile journals – the New England Journal of Medicine (STEP 1), The Lancet (STEP 2), and JAMA (STEP 3 and STEP 4) – said Robert F. Kushner, MD.

“I would encourage all of you to download and read each of these trials on your own,” Dr. Kushner, professor of medicine and medicine education at Northwestern University, Chicago, and coauthor of STEP 1, said before presenting a top-level review of key results.

STEP 1 examined weight management, STEP 3 added a background of intensive behavioral therapy, STEP 4 investigated sustained weight management, and STEP 2 (unlike the others) investigated weight management in patients with type 2 diabetes, he summarized.

In STEP 1, patients who received semaglutide had an average 15% weight loss, and those who stayed on the drug had a 17% weight loss, compared with the 2.4% weight loss in the placebo group.

“One-third of individuals in the trial achieved at least a 20% weight loss or more,” Dr. Kushner said, which is “really phenomenal.”

The results of STEP 3 “suggest that semaglutide with monthly brief lifestyle counseling alone is sufficient to produce a mean weight loss of 15%,” he noted, as adding a low-calorie diet and intensive behavior therapy sped up the initial weight loss but did not increase the final weight loss.

A post hoc analysis of STEP 2 showed “it’s clear that improvement in A1c” is greater with at least a 10% weight loss versus a smaller weight loss, Dr. Kushner said. A1c dropped by 2.2% versus 1.3%, with these two weight losses, respectively.

In STEP 4, after dose escalation to 2.4 mg at 20 weeks, patients had lost 10.6% of their initial weight. At 68 weeks, those who were switched to placebo at 20 weeks had lost 5.4% of their initial weight, whereas those who remained on semaglutide had lost 17.7% of their initial weight.

This shows that “if you remove the drug, the disease starts to come back,” Dr. Kushner pointed out.

Nausea, the most common side effect, occurred in 20% of patients, but was mostly mild or moderate, and gastrointestinal effects including constipation, vomiting, and diarrhea were transient and occurred early in the dose escalation phase.
 

Large individual variability, combination therapies on horizon

Dr. Kaplan pointed out, however, that “like [with] other antiobesity therapies ... there’s a large patient-to-patient variability.”

A third of patients exhibit more than 20% weight loss, and 10% exhibit more than 30% weight loss – approaching the efficacy of bariatric surgery.

However, nearly 10% of patients without diabetes and upwards of 30% of patients with diabetes will experience less than 5% weight loss, he said.

Therefore, “success or failure in one patient doesn’t predict response in another, and we should always remember that as we treat different patients with these medications,” Dr. Kaplan advised.

A recent phase 1b study suggests that combination therapy with semaglutide and the amylin agonist cagrilintide ups weight loss, as previously reported.

In this short trial with no lifestyle modification, it took 16 weeks for patients to reach full dosing, and at 20 weeks, patients on semaglutide had lost 8% of their initial weight, whereas those on combination therapy had lost 17% of their initial weight.

“There’s hope that, in combination with cagrilintide and probably with several other agents that are still in early development, we’ll be seeing average weight loss that is in the range of that seen with bariatric surgery,” Dr. Kushner said.
 

Doctors discuss two hypothetical cases

Session moderator Julio Rosenstock, MD, of the University of Texas, Dallas, a coinvestigator in several of the STEP trials, invited Dr. Kaplan and two other panelists to explain how they would manage two hypothetical patients.

Case 1

You have a patient with type 2 diabetes, a body mass index of 32, 33 kg/m², and an A1c of 7.5% or 8% on metformin. Would you use semaglutide 1 mg (Ozempic, Novo Nordisk) that is indicated for type 2 diabetes, or would you use semaglutide 2.4 mg that is indicated for obesity and risk factors?

“We have the answer to that from STEP 2,” said Melanie J. Davies, MB ChB, MD, professor of diabetes medicine at the University of Leicester, England, who led the STEP 2 trial.

Sara Freeman/MDedge News

“For some patients, the 1-mg dose, which we use routinely in the clinic, may be reasonable to get good glycemic control for cardiovascular protection and will obviously achieve some weight loss. But if you really want to go for the weight-related comorbidities, then the 2.4-mg dose is what you need,” she said.

“A lot of [clinicians] might say: ‘I’ll see how [the patient goes] with the 1-mg dose, and then maybe if they’re not losing the weight and not getting to glycemic target, then maybe I’ll switch to 2.4 mg,’” said John Wilding, MD, who leads clinical research into obesity, diabetes, and endocrinology at the University of Liverpool, England, and led the STEP 1 trial.

“But the STEP 2 data show very clearly that you get almost the same A1c,” Dr. Rosenstock interjected. “I would go for 2.4 mg. The patient has a BMI of 32, 33 kg/m². I would hit hard the BMI. We need to change that paradigm.”

“For other diseases we don’t always go to the maximum dose that’s available. We go to the dose that’s necessary to achieve the clinical endpoint that we want,” Dr. Kaplan noted. “I think one of the challenges is going to be to learn how to clinically nuance our therapy the way we do for other diseases.”

“That is the usual thinking,” Dr. Rosenstock agreed. But “with the 2.4-mg dose, one third get a 20% reduction of BMI, and 10% get almost a 30% reduction – and you [aren’t] going to see that with semaglutide 1 mg!”

“That’s true,” Dr. Kaplan conceded. However, a patient with a relatively low BMI of 32, 33 kg/m² may not need the higher dose, unlike a patient who has a BMI of 45 kg/m² and diabetes. But we’re going to find that out over the next couple of years, he expects.

Case 2

You have a patient with a BMI of 31 kg/m² who is newly diagnosed with type 2 diabetes. Why should you start that patient with metformin? Why won’t you start with something that will directly tackle obesity and get the patient to lose 20 pounds and for sure the blood sugar is going to be better?

“I think if I have someone who is really keen to put their diabetes into remission,” Dr. Wilding said, “this would be a fantastic approach because they would have a really high chance of doing that.”

The prediabetes data from STEP showed that “we can put a lot of people from prediabetes back to normal glucose tolerance,” Dr. Wilding noted. “Maybe we can put people with early diabetes back to normal as well. I think that’s a trial that really does need to be done,” he said.

“We’re going to have to figure out the best pathway forward,” Dr. Kaplan observed, noting that multiple stakeholders, including payers, patients, and providers, play a role in the uptake of new obesity drugs.

“Do you think we will see less bariatric surgery with these drugs?” Dr. Rosenstock asked Dr. Kaplan.

“I think you have to remember that of the millions and millions of people with obesity, a very small portion are currently treated with antiobesity medication, and an even smaller portion are getting bariatric surgery,” Dr. Kaplan replied.

“In the United States, 90% of people who get bariatric surgery are self-referred,” he said, so, “I think initially we are not going to see much of a change” in rates of bariatric surgery.

Dr. Rosenstock, Dr. Kaplan, Dr. Wilding, and Dr. Davies disclosed ties with Novo Nordisk and numerous other companies.

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

The recently licensed weight-loss drug semaglutide 2.4 mg/week (Wegovy, Novo Nordisk) “is likely to usher in a new era in the medical treatment of obesity,” Lee M. Kaplan, MD, PhD, stated at the annual scientific sessions of the American Diabetes Association, held virtually.

Dr. Kaplan discussed the clinical implications of caring for patients with obesity now that the glucagon-like peptide-1 (GLP-1) receptor agonist is approved in the United States for weight loss.

Weight loss with semaglutide 2.4 mg was twice that achieved with liraglutide 3 mg (Saxenda, Novo Nordisk) – that is, roughly a 10%-15% weight loss at 68 weeks, said Dr. Kaplan, who was not involved in the pivotal STEP clinical trials of the agent.  

“I think as we start to see more data come in over the next couple of years,” including from the cardiovascular outcome trial SELECT, he continued, “we’ll be able to use the data to create a nuanced [individualized patient treatment] approach, but we’ll also be able to use our clinical experience, which will grow rapidly over the next few years.”

In the future, semaglutide is likely to be combined with other drugs to provide even greater weight loss, predicts Dr. Kaplan, director of the Obesity, Metabolism, and Nutrition Institute at Massachusetts General Hospital in Boston.

In the meantime, “to be effective, semaglutide needs to be used,” he stressed, while noting that responses to the drug vary by individual, and so this will need to be taken into account.

“Obesity needs to be recognized as a disease in its own right, as well as a risk factor for numerous other diseases, [and] equitable access to obesity treatment needs to be broadened,” he emphasized.
 

Four pivotal phase 3 trials

As previously reported, four pivotal 68-week, phase 3 clinical trials in the Semaglutide Treatment Effect in People With Obesity (STEP) program tested the safety and efficacy of subcutaneous semaglutide 2.4 mg/week in more than 4,500 adults with overweight or obesity.

The trials have been published in high profile journals – the New England Journal of Medicine (STEP 1), The Lancet (STEP 2), and JAMA (STEP 3 and STEP 4) – said Robert F. Kushner, MD.

“I would encourage all of you to download and read each of these trials on your own,” Dr. Kushner, professor of medicine and medicine education at Northwestern University, Chicago, and coauthor of STEP 1, said before presenting a top-level review of key results.

STEP 1 examined weight management, STEP 3 added a background of intensive behavioral therapy, STEP 4 investigated sustained weight management, and STEP 2 (unlike the others) investigated weight management in patients with type 2 diabetes, he summarized.

In STEP 1, patients who received semaglutide had an average 15% weight loss, and those who stayed on the drug had a 17% weight loss, compared with the 2.4% weight loss in the placebo group.

“One-third of individuals in the trial achieved at least a 20% weight loss or more,” Dr. Kushner said, which is “really phenomenal.”

The results of STEP 3 “suggest that semaglutide with monthly brief lifestyle counseling alone is sufficient to produce a mean weight loss of 15%,” he noted, as adding a low-calorie diet and intensive behavior therapy sped up the initial weight loss but did not increase the final weight loss.

A post hoc analysis of STEP 2 showed “it’s clear that improvement in A1c” is greater with at least a 10% weight loss versus a smaller weight loss, Dr. Kushner said. A1c dropped by 2.2% versus 1.3%, with these two weight losses, respectively.

In STEP 4, after dose escalation to 2.4 mg at 20 weeks, patients had lost 10.6% of their initial weight. At 68 weeks, those who were switched to placebo at 20 weeks had lost 5.4% of their initial weight, whereas those who remained on semaglutide had lost 17.7% of their initial weight.

This shows that “if you remove the drug, the disease starts to come back,” Dr. Kushner pointed out.

Nausea, the most common side effect, occurred in 20% of patients, but was mostly mild or moderate, and gastrointestinal effects including constipation, vomiting, and diarrhea were transient and occurred early in the dose escalation phase.
 

Large individual variability, combination therapies on horizon

Dr. Kaplan pointed out, however, that “like [with] other antiobesity therapies ... there’s a large patient-to-patient variability.”

A third of patients exhibit more than 20% weight loss, and 10% exhibit more than 30% weight loss – approaching the efficacy of bariatric surgery.

However, nearly 10% of patients without diabetes and upwards of 30% of patients with diabetes will experience less than 5% weight loss, he said.

Therefore, “success or failure in one patient doesn’t predict response in another, and we should always remember that as we treat different patients with these medications,” Dr. Kaplan advised.

A recent phase 1b study suggests that combination therapy with semaglutide and the amylin agonist cagrilintide ups weight loss, as previously reported.

In this short trial with no lifestyle modification, it took 16 weeks for patients to reach full dosing, and at 20 weeks, patients on semaglutide had lost 8% of their initial weight, whereas those on combination therapy had lost 17% of their initial weight.

“There’s hope that, in combination with cagrilintide and probably with several other agents that are still in early development, we’ll be seeing average weight loss that is in the range of that seen with bariatric surgery,” Dr. Kushner said.
 

Doctors discuss two hypothetical cases

Session moderator Julio Rosenstock, MD, of the University of Texas, Dallas, a coinvestigator in several of the STEP trials, invited Dr. Kaplan and two other panelists to explain how they would manage two hypothetical patients.

Case 1

You have a patient with type 2 diabetes, a body mass index of 32, 33 kg/m², and an A1c of 7.5% or 8% on metformin. Would you use semaglutide 1 mg (Ozempic, Novo Nordisk) that is indicated for type 2 diabetes, or would you use semaglutide 2.4 mg that is indicated for obesity and risk factors?

“We have the answer to that from STEP 2,” said Melanie J. Davies, MB ChB, MD, professor of diabetes medicine at the University of Leicester, England, who led the STEP 2 trial.

Sara Freeman/MDedge News

“For some patients, the 1-mg dose, which we use routinely in the clinic, may be reasonable to get good glycemic control for cardiovascular protection and will obviously achieve some weight loss. But if you really want to go for the weight-related comorbidities, then the 2.4-mg dose is what you need,” she said.

“A lot of [clinicians] might say: ‘I’ll see how [the patient goes] with the 1-mg dose, and then maybe if they’re not losing the weight and not getting to glycemic target, then maybe I’ll switch to 2.4 mg,’” said John Wilding, MD, who leads clinical research into obesity, diabetes, and endocrinology at the University of Liverpool, England, and led the STEP 1 trial.

“But the STEP 2 data show very clearly that you get almost the same A1c,” Dr. Rosenstock interjected. “I would go for 2.4 mg. The patient has a BMI of 32, 33 kg/m². I would hit hard the BMI. We need to change that paradigm.”

“For other diseases we don’t always go to the maximum dose that’s available. We go to the dose that’s necessary to achieve the clinical endpoint that we want,” Dr. Kaplan noted. “I think one of the challenges is going to be to learn how to clinically nuance our therapy the way we do for other diseases.”

“That is the usual thinking,” Dr. Rosenstock agreed. But “with the 2.4-mg dose, one third get a 20% reduction of BMI, and 10% get almost a 30% reduction – and you [aren’t] going to see that with semaglutide 1 mg!”

“That’s true,” Dr. Kaplan conceded. However, a patient with a relatively low BMI of 32, 33 kg/m² may not need the higher dose, unlike a patient who has a BMI of 45 kg/m² and diabetes. But we’re going to find that out over the next couple of years, he expects.

Case 2

You have a patient with a BMI of 31 kg/m² who is newly diagnosed with type 2 diabetes. Why should you start that patient with metformin? Why won’t you start with something that will directly tackle obesity and get the patient to lose 20 pounds and for sure the blood sugar is going to be better?

“I think if I have someone who is really keen to put their diabetes into remission,” Dr. Wilding said, “this would be a fantastic approach because they would have a really high chance of doing that.”

The prediabetes data from STEP showed that “we can put a lot of people from prediabetes back to normal glucose tolerance,” Dr. Wilding noted. “Maybe we can put people with early diabetes back to normal as well. I think that’s a trial that really does need to be done,” he said.

“We’re going to have to figure out the best pathway forward,” Dr. Kaplan observed, noting that multiple stakeholders, including payers, patients, and providers, play a role in the uptake of new obesity drugs.

“Do you think we will see less bariatric surgery with these drugs?” Dr. Rosenstock asked Dr. Kaplan.

“I think you have to remember that of the millions and millions of people with obesity, a very small portion are currently treated with antiobesity medication, and an even smaller portion are getting bariatric surgery,” Dr. Kaplan replied.

“In the United States, 90% of people who get bariatric surgery are self-referred,” he said, so, “I think initially we are not going to see much of a change” in rates of bariatric surgery.

Dr. Rosenstock, Dr. Kaplan, Dr. Wilding, and Dr. Davies disclosed ties with Novo Nordisk and numerous other companies.

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

The recently licensed weight-loss drug semaglutide 2.4 mg/week (Wegovy, Novo Nordisk) “is likely to usher in a new era in the medical treatment of obesity,” Lee M. Kaplan, MD, PhD, stated at the annual scientific sessions of the American Diabetes Association, held virtually.

Dr. Kaplan discussed the clinical implications of caring for patients with obesity now that the glucagon-like peptide-1 (GLP-1) receptor agonist is approved in the United States for weight loss.

Weight loss with semaglutide 2.4 mg was twice that achieved with liraglutide 3 mg (Saxenda, Novo Nordisk) – that is, roughly a 10%-15% weight loss at 68 weeks, said Dr. Kaplan, who was not involved in the pivotal STEP clinical trials of the agent.  

“I think as we start to see more data come in over the next couple of years,” including from the cardiovascular outcome trial SELECT, he continued, “we’ll be able to use the data to create a nuanced [individualized patient treatment] approach, but we’ll also be able to use our clinical experience, which will grow rapidly over the next few years.”

In the future, semaglutide is likely to be combined with other drugs to provide even greater weight loss, predicts Dr. Kaplan, director of the Obesity, Metabolism, and Nutrition Institute at Massachusetts General Hospital in Boston.

In the meantime, “to be effective, semaglutide needs to be used,” he stressed, while noting that responses to the drug vary by individual, and so this will need to be taken into account.

“Obesity needs to be recognized as a disease in its own right, as well as a risk factor for numerous other diseases, [and] equitable access to obesity treatment needs to be broadened,” he emphasized.
 

Four pivotal phase 3 trials

As previously reported, four pivotal 68-week, phase 3 clinical trials in the Semaglutide Treatment Effect in People With Obesity (STEP) program tested the safety and efficacy of subcutaneous semaglutide 2.4 mg/week in more than 4,500 adults with overweight or obesity.

The trials have been published in high profile journals – the New England Journal of Medicine (STEP 1), The Lancet (STEP 2), and JAMA (STEP 3 and STEP 4) – said Robert F. Kushner, MD.

“I would encourage all of you to download and read each of these trials on your own,” Dr. Kushner, professor of medicine and medicine education at Northwestern University, Chicago, and coauthor of STEP 1, said before presenting a top-level review of key results.

STEP 1 examined weight management, STEP 3 added a background of intensive behavioral therapy, STEP 4 investigated sustained weight management, and STEP 2 (unlike the others) investigated weight management in patients with type 2 diabetes, he summarized.

In STEP 1, patients who received semaglutide had an average 15% weight loss, and those who stayed on the drug had a 17% weight loss, compared with the 2.4% weight loss in the placebo group.

“One-third of individuals in the trial achieved at least a 20% weight loss or more,” Dr. Kushner said, which is “really phenomenal.”

The results of STEP 3 “suggest that semaglutide with monthly brief lifestyle counseling alone is sufficient to produce a mean weight loss of 15%,” he noted, as adding a low-calorie diet and intensive behavior therapy sped up the initial weight loss but did not increase the final weight loss.

A post hoc analysis of STEP 2 showed “it’s clear that improvement in A1c” is greater with at least a 10% weight loss versus a smaller weight loss, Dr. Kushner said. A1c dropped by 2.2% versus 1.3%, with these two weight losses, respectively.

In STEP 4, after dose escalation to 2.4 mg at 20 weeks, patients had lost 10.6% of their initial weight. At 68 weeks, those who were switched to placebo at 20 weeks had lost 5.4% of their initial weight, whereas those who remained on semaglutide had lost 17.7% of their initial weight.

This shows that “if you remove the drug, the disease starts to come back,” Dr. Kushner pointed out.

Nausea, the most common side effect, occurred in 20% of patients, but was mostly mild or moderate, and gastrointestinal effects including constipation, vomiting, and diarrhea were transient and occurred early in the dose escalation phase.
 

Large individual variability, combination therapies on horizon

Dr. Kaplan pointed out, however, that “like [with] other antiobesity therapies ... there’s a large patient-to-patient variability.”

A third of patients exhibit more than 20% weight loss, and 10% exhibit more than 30% weight loss – approaching the efficacy of bariatric surgery.

However, nearly 10% of patients without diabetes and upwards of 30% of patients with diabetes will experience less than 5% weight loss, he said.

Therefore, “success or failure in one patient doesn’t predict response in another, and we should always remember that as we treat different patients with these medications,” Dr. Kaplan advised.

A recent phase 1b study suggests that combination therapy with semaglutide and the amylin agonist cagrilintide ups weight loss, as previously reported.

In this short trial with no lifestyle modification, it took 16 weeks for patients to reach full dosing, and at 20 weeks, patients on semaglutide had lost 8% of their initial weight, whereas those on combination therapy had lost 17% of their initial weight.

“There’s hope that, in combination with cagrilintide and probably with several other agents that are still in early development, we’ll be seeing average weight loss that is in the range of that seen with bariatric surgery,” Dr. Kushner said.
 

Doctors discuss two hypothetical cases

Session moderator Julio Rosenstock, MD, of the University of Texas, Dallas, a coinvestigator in several of the STEP trials, invited Dr. Kaplan and two other panelists to explain how they would manage two hypothetical patients.

Case 1

You have a patient with type 2 diabetes, a body mass index of 32, 33 kg/m², and an A1c of 7.5% or 8% on metformin. Would you use semaglutide 1 mg (Ozempic, Novo Nordisk) that is indicated for type 2 diabetes, or would you use semaglutide 2.4 mg that is indicated for obesity and risk factors?

“We have the answer to that from STEP 2,” said Melanie J. Davies, MB ChB, MD, professor of diabetes medicine at the University of Leicester, England, who led the STEP 2 trial.

Sara Freeman/MDedge News

“For some patients, the 1-mg dose, which we use routinely in the clinic, may be reasonable to get good glycemic control for cardiovascular protection and will obviously achieve some weight loss. But if you really want to go for the weight-related comorbidities, then the 2.4-mg dose is what you need,” she said.

“A lot of [clinicians] might say: ‘I’ll see how [the patient goes] with the 1-mg dose, and then maybe if they’re not losing the weight and not getting to glycemic target, then maybe I’ll switch to 2.4 mg,’” said John Wilding, MD, who leads clinical research into obesity, diabetes, and endocrinology at the University of Liverpool, England, and led the STEP 1 trial.

“But the STEP 2 data show very clearly that you get almost the same A1c,” Dr. Rosenstock interjected. “I would go for 2.4 mg. The patient has a BMI of 32, 33 kg/m². I would hit hard the BMI. We need to change that paradigm.”

“For other diseases we don’t always go to the maximum dose that’s available. We go to the dose that’s necessary to achieve the clinical endpoint that we want,” Dr. Kaplan noted. “I think one of the challenges is going to be to learn how to clinically nuance our therapy the way we do for other diseases.”

“That is the usual thinking,” Dr. Rosenstock agreed. But “with the 2.4-mg dose, one third get a 20% reduction of BMI, and 10% get almost a 30% reduction – and you [aren’t] going to see that with semaglutide 1 mg!”

“That’s true,” Dr. Kaplan conceded. However, a patient with a relatively low BMI of 32, 33 kg/m² may not need the higher dose, unlike a patient who has a BMI of 45 kg/m² and diabetes. But we’re going to find that out over the next couple of years, he expects.

Case 2

You have a patient with a BMI of 31 kg/m² who is newly diagnosed with type 2 diabetes. Why should you start that patient with metformin? Why won’t you start with something that will directly tackle obesity and get the patient to lose 20 pounds and for sure the blood sugar is going to be better?

“I think if I have someone who is really keen to put their diabetes into remission,” Dr. Wilding said, “this would be a fantastic approach because they would have a really high chance of doing that.”

The prediabetes data from STEP showed that “we can put a lot of people from prediabetes back to normal glucose tolerance,” Dr. Wilding noted. “Maybe we can put people with early diabetes back to normal as well. I think that’s a trial that really does need to be done,” he said.

“We’re going to have to figure out the best pathway forward,” Dr. Kaplan observed, noting that multiple stakeholders, including payers, patients, and providers, play a role in the uptake of new obesity drugs.

“Do you think we will see less bariatric surgery with these drugs?” Dr. Rosenstock asked Dr. Kaplan.

“I think you have to remember that of the millions and millions of people with obesity, a very small portion are currently treated with antiobesity medication, and an even smaller portion are getting bariatric surgery,” Dr. Kaplan replied.

“In the United States, 90% of people who get bariatric surgery are self-referred,” he said, so, “I think initially we are not going to see much of a change” in rates of bariatric surgery.

Dr. Rosenstock, Dr. Kaplan, Dr. Wilding, and Dr. Davies disclosed ties with Novo Nordisk and numerous other companies.

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

No link between fertility treatment and an increase in the risk for breast cancer was found in the largest study of the issue to date.

This study “provides the evidence needed to reassure women and couples seeking fertility treatments,” commented senior author Sesh Sunkara, MD, a reproductive medicine specialist at King’s College London in a press release.

With an increasing number of women seeking help to become mothers, the question “is a matter of great importance” and a source of considerable concern among patients, the study authors comment.

This is the largest meta-analysis to date, involving 1.8 million women who were followed for an average of 27 years. The investigators found no link with the use of gonadotropins or clomiphene citrate to increase egg production in fertility cycles.

There has been concern over the years that fertility treatment could stimulate estrogen-sensitive precursor breast cancer cells.

More than 4,000 studies of this issue have been conducted since 1990, and results have been conflicting. The investigators analyzed results from the 20 strongest ones.

The new meta-analysis included nine retrospective studies, five case-control studies, five prospective studies, and one comparative study

The team cautioned that the quality of evidence in even these top 20 studies was “very low” but that such an approach is perhaps the best possible on this issue because a randomized trial among women seeking help to have children would be “ethically challenging.”

In the study, the team compared breast cancer incidence among women who underwent ovarian stimulation with the incidence in both age-matched unexposed women in the general population and unexposed infertile women.

There was no significant increase in the risk for breast cancer among women treated with any ovarian stimulation drug (pooled odds ratio, 1.03; 95% confidence interval, 0.86-1.23, but with substantial heterogeneity between study outcomes).

There was also no increased risk when the analysis was limited to the eight studies in which women were treated with both gonadotropins and clomiphene citrate (pooled OR, 0.92; 95% CI, 0.52-1.60, with substantial heterogeneity).

The authors noted that, among the many study limitations, no distinction was made between physiological dosing for anovulation and supraphysiological dosing for in vitro fertilization cycles. In addition, because the treated women were generally young, the follow-up period fell short of the age at which they’d be most at risk for breast cancer.

Individual patient data were also not available, but 14 studies did adjust for confounders, including weight, race, parity, age at first birth, age at menarche, and family history of breast cancer.

Although the findings are reassuring, “further long-term and detailed studies are now needed to confirm” them, Kotryna Temcinaite, PhD, senior research communications manager at the U.K. charity Breast Cancer Now, said in the press release.

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

No link between fertility treatment and an increase in the risk for breast cancer was found in the largest study of the issue to date.

This study “provides the evidence needed to reassure women and couples seeking fertility treatments,” commented senior author Sesh Sunkara, MD, a reproductive medicine specialist at King’s College London in a press release.

With an increasing number of women seeking help to become mothers, the question “is a matter of great importance” and a source of considerable concern among patients, the study authors comment.

This is the largest meta-analysis to date, involving 1.8 million women who were followed for an average of 27 years. The investigators found no link with the use of gonadotropins or clomiphene citrate to increase egg production in fertility cycles.

There has been concern over the years that fertility treatment could stimulate estrogen-sensitive precursor breast cancer cells.

More than 4,000 studies of this issue have been conducted since 1990, and results have been conflicting. The investigators analyzed results from the 20 strongest ones.

The new meta-analysis included nine retrospective studies, five case-control studies, five prospective studies, and one comparative study

The team cautioned that the quality of evidence in even these top 20 studies was “very low” but that such an approach is perhaps the best possible on this issue because a randomized trial among women seeking help to have children would be “ethically challenging.”

In the study, the team compared breast cancer incidence among women who underwent ovarian stimulation with the incidence in both age-matched unexposed women in the general population and unexposed infertile women.

There was no significant increase in the risk for breast cancer among women treated with any ovarian stimulation drug (pooled odds ratio, 1.03; 95% confidence interval, 0.86-1.23, but with substantial heterogeneity between study outcomes).

There was also no increased risk when the analysis was limited to the eight studies in which women were treated with both gonadotropins and clomiphene citrate (pooled OR, 0.92; 95% CI, 0.52-1.60, with substantial heterogeneity).

The authors noted that, among the many study limitations, no distinction was made between physiological dosing for anovulation and supraphysiological dosing for in vitro fertilization cycles. In addition, because the treated women were generally young, the follow-up period fell short of the age at which they’d be most at risk for breast cancer.

Individual patient data were also not available, but 14 studies did adjust for confounders, including weight, race, parity, age at first birth, age at menarche, and family history of breast cancer.

Although the findings are reassuring, “further long-term and detailed studies are now needed to confirm” them, Kotryna Temcinaite, PhD, senior research communications manager at the U.K. charity Breast Cancer Now, said in the press release.

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

No link between fertility treatment and an increase in the risk for breast cancer was found in the largest study of the issue to date.

This study “provides the evidence needed to reassure women and couples seeking fertility treatments,” commented senior author Sesh Sunkara, MD, a reproductive medicine specialist at King’s College London in a press release.

With an increasing number of women seeking help to become mothers, the question “is a matter of great importance” and a source of considerable concern among patients, the study authors comment.

This is the largest meta-analysis to date, involving 1.8 million women who were followed for an average of 27 years. The investigators found no link with the use of gonadotropins or clomiphene citrate to increase egg production in fertility cycles.

There has been concern over the years that fertility treatment could stimulate estrogen-sensitive precursor breast cancer cells.

More than 4,000 studies of this issue have been conducted since 1990, and results have been conflicting. The investigators analyzed results from the 20 strongest ones.

The new meta-analysis included nine retrospective studies, five case-control studies, five prospective studies, and one comparative study

The team cautioned that the quality of evidence in even these top 20 studies was “very low” but that such an approach is perhaps the best possible on this issue because a randomized trial among women seeking help to have children would be “ethically challenging.”

In the study, the team compared breast cancer incidence among women who underwent ovarian stimulation with the incidence in both age-matched unexposed women in the general population and unexposed infertile women.

There was no significant increase in the risk for breast cancer among women treated with any ovarian stimulation drug (pooled odds ratio, 1.03; 95% confidence interval, 0.86-1.23, but with substantial heterogeneity between study outcomes).

There was also no increased risk when the analysis was limited to the eight studies in which women were treated with both gonadotropins and clomiphene citrate (pooled OR, 0.92; 95% CI, 0.52-1.60, with substantial heterogeneity).

The authors noted that, among the many study limitations, no distinction was made between physiological dosing for anovulation and supraphysiological dosing for in vitro fertilization cycles. In addition, because the treated women were generally young, the follow-up period fell short of the age at which they’d be most at risk for breast cancer.

Individual patient data were also not available, but 14 studies did adjust for confounders, including weight, race, parity, age at first birth, age at menarche, and family history of breast cancer.

Although the findings are reassuring, “further long-term and detailed studies are now needed to confirm” them, Kotryna Temcinaite, PhD, senior research communications manager at the U.K. charity Breast Cancer Now, said in the press release.

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

Women who were Black, Latina, American Indian, or Alaska Native were significantly less likely than White women to receive guidelines-adherent treatment for endometrial cancer, based on data from more than 80,000 women.

The incidence of uterine cancer has increased across all ethnicities in recent decades, and adherence to the National Comprehensive Cancer Network treatment guidelines has been associated with improved survival, wrote Victoria A. Rodriguez, MSW, MPH, of the University of California, Irvine, and colleagues. “To date, however, there are few studies that have looked at endometrial cancer disparities with adherence to National Comprehensive Cancer Network treatment guidelines.”

In a retrospective study published in Obstetrics & Gynecology, the researchers used data from the SEER (Surveillance, Epidemiology, and End Results) database between Jan. 1, 2006, and Dec. 31, 2015. The study population included 83,883 women aged 18 years and older who were diagnosed with their first or only endometrial carcinoma. The primary dependent variable was adherence to the NCCN guidelines for the initial course of treatment, which included a combination of therapies based on cancer subtype and the extent of the disease, the researchers said.

The researchers combined the guidelines and the corresponding data from the SEER database to create “a binary variable representing adherence to [NCCN] guidelines (1 = adherent treatment, 0 = nonadherent treatment).”

Approximately 60% of the total patient population received guidelines-adherent treatment. In a multivariate analysis, Black women, Latina women, and American Indian or Alaska Native women were significantly less likely than White women to receive such treatment (odds ratios, 0.88, 0.92, and 0.82, respectively), controlling for factors including neighborhood socioeconomic status, age, and stage at diagnosis, year of diagnosis, histology, and disease grade. Asian women and Native Hawaiian/Pacific Islander women were significantly more likely to received guidelines-adherent treatment, compared with White women (OR, 1.14 and 1.19, respectively).

The researchers also found a significant gradient in guidelines-adherent treatment based on neighborhood socioeconomic status. Relative to the highest neighborhood socioeconomic status group, women in the lower groups had significantly lower odds of receiving guidelines-adherent treatment, with ORs of 0.89, 0.84, 0.80, and 0.73, respectively, for the high-middle neighborhood socioeconomic group, the middle group, the low-middle group, and the lowest group (P < .001 for all).

“Our study is novel in that it examines neighborhood socioeconomic disparities in the understudied context of treatment adherence for endometrial cancer,” the researchers noted.

The study findings were limited by several factors in including the retrospective design and potential for unmeasured confounding variables not included in SEER, such as hospital and physician characteristics, the researchers said. Also, the SEER data set was limited to only the first course of treatment, and did not include information on patient comorbidities that might affect treatment.

“Future research should qualitatively explore reasons for nonadherent treatment within endometrial cancer and other cancer sites among various racial-ethnic groups and socioeconomic status groups, with special attention to low-income women of color,” the researchers emphasized. More research on the impact of comorbidities on a patient’s ability to receive guidelines-based care should be used to inform whether comorbidities should be part of the NCCN guidelines.

However, the results were strengthened by the large sample size and diverse population, so the findings are generalizable to the overall U.S. population, the researchers said.

“Interventions are needed to ensure that equitable cancer treatment practices are available for all individuals regardless of their racial-ethnic or socioeconomic backgrounds,” they concluded.
 

Pursue optimal treatment to curb mortality

Even more concerning than the increase in the incidence of endometrial cancer in the United States is the increase in mortality from this disease, said Emma C. Rossi, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Therefore, it is critical that we identify factors which might be contributing to the increasing lethality of this cancer,” she emphasized. “One such potential factor is race, as it has been observed that Black race is associated with an increased risk of death from endometrial cancer. Historically, this was attributed to the more aggressive subtypes of endometrial cancer (such as serous) which have a higher incidence among Black women. However, more recently, population-based studies have identified that this worse prognosis is independent of histologic cell type,” which suggests that something in our health care delivery is contributing to these worse outcomes.

“The present study helps to confirm these concerning associations, shedding some light on contributory factors, in this case, modifiable (adherence to recommended guidelines) and less modifiable (neighborhood socioeconomic environments) [ones],” Dr. Rossi noted. “The guidelines that are established by the NCCN are chosen after they have been shown to be associated with improved outcomes (including either survival or quality of life), and therefore lack of adherence to these outcomes may suggest inferior quality care is being delivered.”

Studies such as this are helpful in exposing the problem of treatment disparity to help identify sources of problems to develop solutions, she added.

The results should inspire clinicians “to feel agency in changing these outcomes, albeit by tackling very difficult social, political, and health system shortfalls,” she said.
 

Identify barriers to care

Barriers to greater adherence to guidelines-based care include varying definitions of such care, Dr. Rossi said.

“This is particularly true for surgical management of endometrial cancer, which remains controversial with respect to lymph node assessment. Lack of surgical staging with lymph node assessment was considered noncompliant care for this study; however, lymphadenectomy has not specifically, in and of itself, been associated with improved outcomes, and therefore some surgeons argue against performing it routinely,” she explained.

“Lack of access to sophisticated surgical tools and advanced surgical techniques may account for nonguidelines-based care in the patients with early-stage endometrial cancer; however, there are likely other differences in the ability to deliver guideline-concordant care (such as chemotherapy and radiation therapy) for advanced-stage cancers,” Dr. Rossi said. “Patient and provider positive attitudes toward adjuvant therapy, access to transportation, supportive home environments, paid sick leave, well-controlled or minimal comorbidities are all factors which promote the administration of complex adjuvant therapies such as chemotherapy and radiation. In low-resource neighborhoods and minority communities, barriers to these factors may be contributing to nonguidelines-concordant care.”

Dr. Rossi emphasized the need to “dive deeper into these data at individual health-system and provider levels.” For example, research is needed to compare the practice patterns and models of high-performing clinical practices with lower-performing practices in terms of factors such as tumor boards, journal review, peer review, dashboards, and metrics. By doing so, “we can ensure that we are understanding where and why variations in care are occurring,” Dr. Rossi said.

The study was supported in part by the Faculty Mentor Program Fellowship from the University of California, Irvine, graduate division. Ms. Rodriguez was supported in part by a grant from the National Cancer Institute. The researchers had no financial conflicts to disclose. Dr. Rossi had no financial conflicts to disclose.

Women who were Black, Latina, American Indian, or Alaska Native were significantly less likely than White women to receive guidelines-adherent treatment for endometrial cancer, based on data from more than 80,000 women.

The incidence of uterine cancer has increased across all ethnicities in recent decades, and adherence to the National Comprehensive Cancer Network treatment guidelines has been associated with improved survival, wrote Victoria A. Rodriguez, MSW, MPH, of the University of California, Irvine, and colleagues. “To date, however, there are few studies that have looked at endometrial cancer disparities with adherence to National Comprehensive Cancer Network treatment guidelines.”

In a retrospective study published in Obstetrics & Gynecology, the researchers used data from the SEER (Surveillance, Epidemiology, and End Results) database between Jan. 1, 2006, and Dec. 31, 2015. The study population included 83,883 women aged 18 years and older who were diagnosed with their first or only endometrial carcinoma. The primary dependent variable was adherence to the NCCN guidelines for the initial course of treatment, which included a combination of therapies based on cancer subtype and the extent of the disease, the researchers said.

The researchers combined the guidelines and the corresponding data from the SEER database to create “a binary variable representing adherence to [NCCN] guidelines (1 = adherent treatment, 0 = nonadherent treatment).”

Approximately 60% of the total patient population received guidelines-adherent treatment. In a multivariate analysis, Black women, Latina women, and American Indian or Alaska Native women were significantly less likely than White women to receive such treatment (odds ratios, 0.88, 0.92, and 0.82, respectively), controlling for factors including neighborhood socioeconomic status, age, and stage at diagnosis, year of diagnosis, histology, and disease grade. Asian women and Native Hawaiian/Pacific Islander women were significantly more likely to received guidelines-adherent treatment, compared with White women (OR, 1.14 and 1.19, respectively).

The researchers also found a significant gradient in guidelines-adherent treatment based on neighborhood socioeconomic status. Relative to the highest neighborhood socioeconomic status group, women in the lower groups had significantly lower odds of receiving guidelines-adherent treatment, with ORs of 0.89, 0.84, 0.80, and 0.73, respectively, for the high-middle neighborhood socioeconomic group, the middle group, the low-middle group, and the lowest group (P < .001 for all).

“Our study is novel in that it examines neighborhood socioeconomic disparities in the understudied context of treatment adherence for endometrial cancer,” the researchers noted.

The study findings were limited by several factors in including the retrospective design and potential for unmeasured confounding variables not included in SEER, such as hospital and physician characteristics, the researchers said. Also, the SEER data set was limited to only the first course of treatment, and did not include information on patient comorbidities that might affect treatment.

“Future research should qualitatively explore reasons for nonadherent treatment within endometrial cancer and other cancer sites among various racial-ethnic groups and socioeconomic status groups, with special attention to low-income women of color,” the researchers emphasized. More research on the impact of comorbidities on a patient’s ability to receive guidelines-based care should be used to inform whether comorbidities should be part of the NCCN guidelines.

However, the results were strengthened by the large sample size and diverse population, so the findings are generalizable to the overall U.S. population, the researchers said.

“Interventions are needed to ensure that equitable cancer treatment practices are available for all individuals regardless of their racial-ethnic or socioeconomic backgrounds,” they concluded.
 

Pursue optimal treatment to curb mortality

Even more concerning than the increase in the incidence of endometrial cancer in the United States is the increase in mortality from this disease, said Emma C. Rossi, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Therefore, it is critical that we identify factors which might be contributing to the increasing lethality of this cancer,” she emphasized. “One such potential factor is race, as it has been observed that Black race is associated with an increased risk of death from endometrial cancer. Historically, this was attributed to the more aggressive subtypes of endometrial cancer (such as serous) which have a higher incidence among Black women. However, more recently, population-based studies have identified that this worse prognosis is independent of histologic cell type,” which suggests that something in our health care delivery is contributing to these worse outcomes.

“The present study helps to confirm these concerning associations, shedding some light on contributory factors, in this case, modifiable (adherence to recommended guidelines) and less modifiable (neighborhood socioeconomic environments) [ones],” Dr. Rossi noted. “The guidelines that are established by the NCCN are chosen after they have been shown to be associated with improved outcomes (including either survival or quality of life), and therefore lack of adherence to these outcomes may suggest inferior quality care is being delivered.”

Studies such as this are helpful in exposing the problem of treatment disparity to help identify sources of problems to develop solutions, she added.

The results should inspire clinicians “to feel agency in changing these outcomes, albeit by tackling very difficult social, political, and health system shortfalls,” she said.
 

Identify barriers to care

Barriers to greater adherence to guidelines-based care include varying definitions of such care, Dr. Rossi said.

“This is particularly true for surgical management of endometrial cancer, which remains controversial with respect to lymph node assessment. Lack of surgical staging with lymph node assessment was considered noncompliant care for this study; however, lymphadenectomy has not specifically, in and of itself, been associated with improved outcomes, and therefore some surgeons argue against performing it routinely,” she explained.

“Lack of access to sophisticated surgical tools and advanced surgical techniques may account for nonguidelines-based care in the patients with early-stage endometrial cancer; however, there are likely other differences in the ability to deliver guideline-concordant care (such as chemotherapy and radiation therapy) for advanced-stage cancers,” Dr. Rossi said. “Patient and provider positive attitudes toward adjuvant therapy, access to transportation, supportive home environments, paid sick leave, well-controlled or minimal comorbidities are all factors which promote the administration of complex adjuvant therapies such as chemotherapy and radiation. In low-resource neighborhoods and minority communities, barriers to these factors may be contributing to nonguidelines-concordant care.”

Dr. Rossi emphasized the need to “dive deeper into these data at individual health-system and provider levels.” For example, research is needed to compare the practice patterns and models of high-performing clinical practices with lower-performing practices in terms of factors such as tumor boards, journal review, peer review, dashboards, and metrics. By doing so, “we can ensure that we are understanding where and why variations in care are occurring,” Dr. Rossi said.

The study was supported in part by the Faculty Mentor Program Fellowship from the University of California, Irvine, graduate division. Ms. Rodriguez was supported in part by a grant from the National Cancer Institute. The researchers had no financial conflicts to disclose. Dr. Rossi had no financial conflicts to disclose.

Women who were Black, Latina, American Indian, or Alaska Native were significantly less likely than White women to receive guidelines-adherent treatment for endometrial cancer, based on data from more than 80,000 women.

The incidence of uterine cancer has increased across all ethnicities in recent decades, and adherence to the National Comprehensive Cancer Network treatment guidelines has been associated with improved survival, wrote Victoria A. Rodriguez, MSW, MPH, of the University of California, Irvine, and colleagues. “To date, however, there are few studies that have looked at endometrial cancer disparities with adherence to National Comprehensive Cancer Network treatment guidelines.”

In a retrospective study published in Obstetrics & Gynecology, the researchers used data from the SEER (Surveillance, Epidemiology, and End Results) database between Jan. 1, 2006, and Dec. 31, 2015. The study population included 83,883 women aged 18 years and older who were diagnosed with their first or only endometrial carcinoma. The primary dependent variable was adherence to the NCCN guidelines for the initial course of treatment, which included a combination of therapies based on cancer subtype and the extent of the disease, the researchers said.

The researchers combined the guidelines and the corresponding data from the SEER database to create “a binary variable representing adherence to [NCCN] guidelines (1 = adherent treatment, 0 = nonadherent treatment).”

Approximately 60% of the total patient population received guidelines-adherent treatment. In a multivariate analysis, Black women, Latina women, and American Indian or Alaska Native women were significantly less likely than White women to receive such treatment (odds ratios, 0.88, 0.92, and 0.82, respectively), controlling for factors including neighborhood socioeconomic status, age, and stage at diagnosis, year of diagnosis, histology, and disease grade. Asian women and Native Hawaiian/Pacific Islander women were significantly more likely to received guidelines-adherent treatment, compared with White women (OR, 1.14 and 1.19, respectively).

The researchers also found a significant gradient in guidelines-adherent treatment based on neighborhood socioeconomic status. Relative to the highest neighborhood socioeconomic status group, women in the lower groups had significantly lower odds of receiving guidelines-adherent treatment, with ORs of 0.89, 0.84, 0.80, and 0.73, respectively, for the high-middle neighborhood socioeconomic group, the middle group, the low-middle group, and the lowest group (P < .001 for all).

“Our study is novel in that it examines neighborhood socioeconomic disparities in the understudied context of treatment adherence for endometrial cancer,” the researchers noted.

The study findings were limited by several factors in including the retrospective design and potential for unmeasured confounding variables not included in SEER, such as hospital and physician characteristics, the researchers said. Also, the SEER data set was limited to only the first course of treatment, and did not include information on patient comorbidities that might affect treatment.

“Future research should qualitatively explore reasons for nonadherent treatment within endometrial cancer and other cancer sites among various racial-ethnic groups and socioeconomic status groups, with special attention to low-income women of color,” the researchers emphasized. More research on the impact of comorbidities on a patient’s ability to receive guidelines-based care should be used to inform whether comorbidities should be part of the NCCN guidelines.

However, the results were strengthened by the large sample size and diverse population, so the findings are generalizable to the overall U.S. population, the researchers said.

“Interventions are needed to ensure that equitable cancer treatment practices are available for all individuals regardless of their racial-ethnic or socioeconomic backgrounds,” they concluded.
 

Pursue optimal treatment to curb mortality

Even more concerning than the increase in the incidence of endometrial cancer in the United States is the increase in mortality from this disease, said Emma C. Rossi, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Therefore, it is critical that we identify factors which might be contributing to the increasing lethality of this cancer,” she emphasized. “One such potential factor is race, as it has been observed that Black race is associated with an increased risk of death from endometrial cancer. Historically, this was attributed to the more aggressive subtypes of endometrial cancer (such as serous) which have a higher incidence among Black women. However, more recently, population-based studies have identified that this worse prognosis is independent of histologic cell type,” which suggests that something in our health care delivery is contributing to these worse outcomes.

“The present study helps to confirm these concerning associations, shedding some light on contributory factors, in this case, modifiable (adherence to recommended guidelines) and less modifiable (neighborhood socioeconomic environments) [ones],” Dr. Rossi noted. “The guidelines that are established by the NCCN are chosen after they have been shown to be associated with improved outcomes (including either survival or quality of life), and therefore lack of adherence to these outcomes may suggest inferior quality care is being delivered.”

Studies such as this are helpful in exposing the problem of treatment disparity to help identify sources of problems to develop solutions, she added.

The results should inspire clinicians “to feel agency in changing these outcomes, albeit by tackling very difficult social, political, and health system shortfalls,” she said.
 

Identify barriers to care

Barriers to greater adherence to guidelines-based care include varying definitions of such care, Dr. Rossi said.

“This is particularly true for surgical management of endometrial cancer, which remains controversial with respect to lymph node assessment. Lack of surgical staging with lymph node assessment was considered noncompliant care for this study; however, lymphadenectomy has not specifically, in and of itself, been associated with improved outcomes, and therefore some surgeons argue against performing it routinely,” she explained.

“Lack of access to sophisticated surgical tools and advanced surgical techniques may account for nonguidelines-based care in the patients with early-stage endometrial cancer; however, there are likely other differences in the ability to deliver guideline-concordant care (such as chemotherapy and radiation therapy) for advanced-stage cancers,” Dr. Rossi said. “Patient and provider positive attitudes toward adjuvant therapy, access to transportation, supportive home environments, paid sick leave, well-controlled or minimal comorbidities are all factors which promote the administration of complex adjuvant therapies such as chemotherapy and radiation. In low-resource neighborhoods and minority communities, barriers to these factors may be contributing to nonguidelines-concordant care.”

Dr. Rossi emphasized the need to “dive deeper into these data at individual health-system and provider levels.” For example, research is needed to compare the practice patterns and models of high-performing clinical practices with lower-performing practices in terms of factors such as tumor boards, journal review, peer review, dashboards, and metrics. By doing so, “we can ensure that we are understanding where and why variations in care are occurring,” Dr. Rossi said.

The study was supported in part by the Faculty Mentor Program Fellowship from the University of California, Irvine, graduate division. Ms. Rodriguez was supported in part by a grant from the National Cancer Institute. The researchers had no financial conflicts to disclose. Dr. Rossi had no financial conflicts to disclose.

Baricitinib, at a dose of 2 mg a day, demonstrated efficacy in adults with moderate to severe atopic dermatitis up to 52 weeks, integrated data from two trials demonstrated.

Bruce Jancin/MDEdge News

“With long-term therapy, the baricitinib 2 mg response remains stable or slightly improved, compared with week 16 for skin inflammation, itch, sleep, and quality of life,” presenting study author Eric L. Simpson, MD, said during the Revolutionizing Atopic Dermatitis symposium.

Baricitinib is an oral selective Janus kinase 1/JAK2 inhibitor being developed for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. The drug is already approved for AD in Europe at the 2-mg and 4-mg doses. A 16-week placebo-controlled study conducted in North America known as BREEZE-AD5 found that 2 mg of baricitinib improved disease in adults with moderate to severe AD.

For the current analysis, Dr. Simpson, professor of dermatology at Oregon Health and Science University, Portland, and colleagues integrated data from BREEZE-AD5 and BREEZE-AD6, an ongoing, open-label study of BREEZE-AD5, to evaluate the long-term efficacy and safety of baricitinib 2 mg in patients with moderate to severe AD.

At week 16, patients from BREEZE-AD5 who were on baricitinib 2 mg could either continue the trial out to week 52, or they could transition to BREEZE-AD6 if they were nonresponders. The use of low-potency corticosteroids was permitted after week 16 in BREEZE-AD5 and throughout BREEZE-AD6. Endpoints of interest at week 52 in both trials were the proportions of patients with 75% or greater improvement from baseline in the Eczema and Severity Index (EASI75), a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1, a Dermatology Life Quality Index (DLQI) score of 5 or less, as well as mean SCORing AD (SCORAD) visual analog scales of itch and sleeplessness scores, and the mean percent change from baseline in EASI score.

Dr. Simpson presented data on 146 patients from both trials who were randomized to baricitinib 2 mg. Their mean age was 40 years, 53% were female, 58% were White, 21% were Black, 15% were Asian, and the remainder were from other backgrounds. Their mean duration of AD was 16 years and their average EASI score was 26.6. At weeks 16, 32, and 52, the proportion of patients who achieved an EASI75 response was 40%, 51%, and 49%, respectively, while the mean percent change from baseline in EASI score was –50%, –59%, and –57%.

At weeks 16, 32, and 52, the vIGA-AD responses of 0 or 1 were observed in 27%, 38%, and 31% of patients. The mean SCORAD pruritus score improved from 7.7 at baseline to 4.8 at week 16 and was maintained at weeks 32 (3.8) and 52 (4.3). The mean SCORAD sleeplessness score also improved from 6.5 at baseline to 3.9 at week 16 and remained stable through weeks 32 (3.4) and 52 (3.7).

Finally, among 129 patients who had a baseline DLQI of greater than 5, 39% had DLQI scores of 5 or lower at week 16, compared with 49% at week 32 and 45% at week 52, indicating a small or no effect of AD on quality of life.

The study was sponsored by Eli Lilly, which is developing baricitinib. Dr. Simpson disclosed that he is a consultant to and/or an investigator for several pharmaceutical companies, including Eli Lilly.

[email protected]

Baricitinib, at a dose of 2 mg a day, demonstrated efficacy in adults with moderate to severe atopic dermatitis up to 52 weeks, integrated data from two trials demonstrated.

Bruce Jancin/MDEdge News

“With long-term therapy, the baricitinib 2 mg response remains stable or slightly improved, compared with week 16 for skin inflammation, itch, sleep, and quality of life,” presenting study author Eric L. Simpson, MD, said during the Revolutionizing Atopic Dermatitis symposium.

Baricitinib is an oral selective Janus kinase 1/JAK2 inhibitor being developed for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. The drug is already approved for AD in Europe at the 2-mg and 4-mg doses. A 16-week placebo-controlled study conducted in North America known as BREEZE-AD5 found that 2 mg of baricitinib improved disease in adults with moderate to severe AD.

For the current analysis, Dr. Simpson, professor of dermatology at Oregon Health and Science University, Portland, and colleagues integrated data from BREEZE-AD5 and BREEZE-AD6, an ongoing, open-label study of BREEZE-AD5, to evaluate the long-term efficacy and safety of baricitinib 2 mg in patients with moderate to severe AD.

At week 16, patients from BREEZE-AD5 who were on baricitinib 2 mg could either continue the trial out to week 52, or they could transition to BREEZE-AD6 if they were nonresponders. The use of low-potency corticosteroids was permitted after week 16 in BREEZE-AD5 and throughout BREEZE-AD6. Endpoints of interest at week 52 in both trials were the proportions of patients with 75% or greater improvement from baseline in the Eczema and Severity Index (EASI75), a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1, a Dermatology Life Quality Index (DLQI) score of 5 or less, as well as mean SCORing AD (SCORAD) visual analog scales of itch and sleeplessness scores, and the mean percent change from baseline in EASI score.

Dr. Simpson presented data on 146 patients from both trials who were randomized to baricitinib 2 mg. Their mean age was 40 years, 53% were female, 58% were White, 21% were Black, 15% were Asian, and the remainder were from other backgrounds. Their mean duration of AD was 16 years and their average EASI score was 26.6. At weeks 16, 32, and 52, the proportion of patients who achieved an EASI75 response was 40%, 51%, and 49%, respectively, while the mean percent change from baseline in EASI score was –50%, –59%, and –57%.

At weeks 16, 32, and 52, the vIGA-AD responses of 0 or 1 were observed in 27%, 38%, and 31% of patients. The mean SCORAD pruritus score improved from 7.7 at baseline to 4.8 at week 16 and was maintained at weeks 32 (3.8) and 52 (4.3). The mean SCORAD sleeplessness score also improved from 6.5 at baseline to 3.9 at week 16 and remained stable through weeks 32 (3.4) and 52 (3.7).

Finally, among 129 patients who had a baseline DLQI of greater than 5, 39% had DLQI scores of 5 or lower at week 16, compared with 49% at week 32 and 45% at week 52, indicating a small or no effect of AD on quality of life.

The study was sponsored by Eli Lilly, which is developing baricitinib. Dr. Simpson disclosed that he is a consultant to and/or an investigator for several pharmaceutical companies, including Eli Lilly.

[email protected]

Baricitinib, at a dose of 2 mg a day, demonstrated efficacy in adults with moderate to severe atopic dermatitis up to 52 weeks, integrated data from two trials demonstrated.

Bruce Jancin/MDEdge News

“With long-term therapy, the baricitinib 2 mg response remains stable or slightly improved, compared with week 16 for skin inflammation, itch, sleep, and quality of life,” presenting study author Eric L. Simpson, MD, said during the Revolutionizing Atopic Dermatitis symposium.

Baricitinib is an oral selective Janus kinase 1/JAK2 inhibitor being developed for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. The drug is already approved for AD in Europe at the 2-mg and 4-mg doses. A 16-week placebo-controlled study conducted in North America known as BREEZE-AD5 found that 2 mg of baricitinib improved disease in adults with moderate to severe AD.

For the current analysis, Dr. Simpson, professor of dermatology at Oregon Health and Science University, Portland, and colleagues integrated data from BREEZE-AD5 and BREEZE-AD6, an ongoing, open-label study of BREEZE-AD5, to evaluate the long-term efficacy and safety of baricitinib 2 mg in patients with moderate to severe AD.

At week 16, patients from BREEZE-AD5 who were on baricitinib 2 mg could either continue the trial out to week 52, or they could transition to BREEZE-AD6 if they were nonresponders. The use of low-potency corticosteroids was permitted after week 16 in BREEZE-AD5 and throughout BREEZE-AD6. Endpoints of interest at week 52 in both trials were the proportions of patients with 75% or greater improvement from baseline in the Eczema and Severity Index (EASI75), a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1, a Dermatology Life Quality Index (DLQI) score of 5 or less, as well as mean SCORing AD (SCORAD) visual analog scales of itch and sleeplessness scores, and the mean percent change from baseline in EASI score.

Dr. Simpson presented data on 146 patients from both trials who were randomized to baricitinib 2 mg. Their mean age was 40 years, 53% were female, 58% were White, 21% were Black, 15% were Asian, and the remainder were from other backgrounds. Their mean duration of AD was 16 years and their average EASI score was 26.6. At weeks 16, 32, and 52, the proportion of patients who achieved an EASI75 response was 40%, 51%, and 49%, respectively, while the mean percent change from baseline in EASI score was –50%, –59%, and –57%.

At weeks 16, 32, and 52, the vIGA-AD responses of 0 or 1 were observed in 27%, 38%, and 31% of patients. The mean SCORAD pruritus score improved from 7.7 at baseline to 4.8 at week 16 and was maintained at weeks 32 (3.8) and 52 (4.3). The mean SCORAD sleeplessness score also improved from 6.5 at baseline to 3.9 at week 16 and remained stable through weeks 32 (3.4) and 52 (3.7).

Finally, among 129 patients who had a baseline DLQI of greater than 5, 39% had DLQI scores of 5 or lower at week 16, compared with 49% at week 32 and 45% at week 52, indicating a small or no effect of AD on quality of life.

The study was sponsored by Eli Lilly, which is developing baricitinib. Dr. Simpson disclosed that he is a consultant to and/or an investigator for several pharmaceutical companies, including Eli Lilly.

[email protected]

When it comes to medical therapy after a coronary revascularization procedure, more is better. Patients started and then maintained indefinitely on more rather than fewer of the drugs identified as optimal medical therapy (OMT) achieve a major survival benefit 10 years later, according to long-term follow-up from an extended analysis of the SYNTAX trial.

Courtesy Cardiovascular Research Foundation

For the survival benefit at 10 years, “the present study suggests that at least three types of optimal medical therapy should be maintained for at least 5 years after revascularization,” reported a multinational team of cardiovascular specialists led by Hideyuki Kawashima, MD and Patrick Serruys, MD, who both have affiliations with the department of cardiology of the National University of Ireland, Galway.

The SYNTAX trial was conducted to compare percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) for patients with previously untreated three-vessel and/or left main disease (N Engl J Med 2009;360:961-72). The conclusion from that study, published in 2009 and subsequently reinforced by a 5-year follow-up, was that CABG should remain the standard of care for complex lesions.
 

Optimal medical therapy defined

In the course of SYNTAX, the impact of OMT on outcome was also evaluated in a subanalysis. At 5 years, there was a mortality advantage for those receiving an antiplatelet drug, a statin, a renin-angiotensin system inhibitor (ACE inhibitor or angiotensin receptor blocker), and a beta-blocker when compared with fewer of these agents.

When an investigator-initiated extension of SYNTAX, called SYNTAXES, was conducted to compare the outcomes of PCI and CABG at 10 years, it also permitted an extended analysis of OMT. Although the primary comparison of SYNTAXES, reported 2 years ago, did not show a significant difference between PCI and CABG for mortality at 10 years, there was a difference for OMT.

When investigators compared treatment with three or more OMT agents with that with two or fewer OMT drugs at 5 years, the result for all-cause death at 10 years translated into a more than 50% relative reduction (hazard ratio, 0.47; P = .002). The absolute difference in mortality was a more than 6% reduction (13.1% vs. 19.9%).
 

OMT data offer major message

The current study is considered to have a major message for patients as well as physicians.

“OMT even outweighs the survival benefit from revascularization alone, so our patients should convince themselves of the value of rigorous adherence and compliance,” Dr. Serruys said in an interview. According to him, these are compelling data for telling patients that OMT “is the best insurance for extended survival.” We now know from these data “the longer, the better.”

The same message from these data extends to physicians.

“I wish I could understand the apparent blind spot physicians have with respect to prescribing OMT despite the overwhelming benefit from multiple clinical trials,” said William E. Boden, MD, professor of medicine, Boston University.

Dr. Boden was a coauthor of an editorial accompanying the newly published SYNTAXES subanalysis. In the editorial, he noted that OMT following revascularization and in other high-risk patients “has been unacceptably low,” but he was asked to expand on the lessons from the newly released SYNTAXES subanalysis in an interview.

“There has often been a belief that revascularization negates the need for OMT and that’s why the SYNTAXES trial 10-year mortality reduction – which builds upon an earlier 5-year mortality reduction analysis – is so important,” he said.
 

Patients should take OMT long term

These data “should be both a motivator for physicians to prescribe OMT and for patients to remain adherent to OMT,” he said. “It is the best warranty to blunt the progression of atherosclerosis and to reduce subsequent cardiac events.”

For the 10-year subanalysis of OMT in SYNTAXES, the patients were stratified by the number of OMTs they were taking at 5 years after revascularization and then evaluated for survival at 10 years. Of the 1,472 patients available for analysis at 5 years, only 678 (46%) were on OMT. The other 794 patients were not.

Graphically, the Kaplan-Meier survival curve for those on three types of OMT was consistently beneath that of those on four OMTs, but the gap narrowed over time. At the end of 10 years, the advantage of the four-drug OMT was not statistically significant relative to three or fewer (13.1% vs. 12.7%).
 

Statins and antiplatelets show largest effect

When analyzed individually and in different combinations, the agents with OMT did not appear to be equal. For example, the biggest survival gap at 10 years was for those who were on an antiplatelet therapy and a statin at 5 years relative to those who were not on either (13.2% vs. 22.6%; P = .006). Even after adjustment, there was nearly 45% survival benefit for these two agents (HR, 0.556; P = .02).

Conversely, the 10-year survival advantage for being on a renin-angiotensin system inhibitor at 5 years versus not being exposed to this therapy was small and nonsignificant (14.7% vs. 13.7%; P = .651).

The precise proportion of patients who were prescribed and adhered to OMT between 5 years and 10 years is unknown, acknowledged the authors, so conclusions are limited about the added benefit of 10- versus 5-year OMT, although the authors presume that a substantial proportion of those adherent for 5 years would likely continue on these therapies.

It can be said with confidence that those adherent for at least 5 years are more likely to be alive at 10 years than those who are not, according to Dr. Boden. He considers these data a call for physicians and all high-risk patients, not just those who have undergone revascularization, to take these standard therapies.

There are plenty of data to “show how poorly we treat patients with OMT,” said Dr. Boden, citing several studies. In one, which looked at OMT in a nationally representative sample in the United States, only a third of patients with angina were taking an antiplatelet, a statin, and a beta-blocker, all of which are indicated.

“Hospitalization for revascularization provides an opportune time to capture the attention of patients and their physicians,” he wrote in his editorial. He called OMT “an imperative to optimize clinical outcomes.”

Many of the investigators involved in the SYNTAXES subanalysis, including Dr. Serruys, have financial relationships with multiple pharmaceutical companies, including Boston Scientific, which provided the initial funding for the SYNTAX trial. Dr. Boden reports no potential conflicts of interest.

When it comes to medical therapy after a coronary revascularization procedure, more is better. Patients started and then maintained indefinitely on more rather than fewer of the drugs identified as optimal medical therapy (OMT) achieve a major survival benefit 10 years later, according to long-term follow-up from an extended analysis of the SYNTAX trial.

Courtesy Cardiovascular Research Foundation

For the survival benefit at 10 years, “the present study suggests that at least three types of optimal medical therapy should be maintained for at least 5 years after revascularization,” reported a multinational team of cardiovascular specialists led by Hideyuki Kawashima, MD and Patrick Serruys, MD, who both have affiliations with the department of cardiology of the National University of Ireland, Galway.

The SYNTAX trial was conducted to compare percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) for patients with previously untreated three-vessel and/or left main disease (N Engl J Med 2009;360:961-72). The conclusion from that study, published in 2009 and subsequently reinforced by a 5-year follow-up, was that CABG should remain the standard of care for complex lesions.
 

Optimal medical therapy defined

In the course of SYNTAX, the impact of OMT on outcome was also evaluated in a subanalysis. At 5 years, there was a mortality advantage for those receiving an antiplatelet drug, a statin, a renin-angiotensin system inhibitor (ACE inhibitor or angiotensin receptor blocker), and a beta-blocker when compared with fewer of these agents.

When an investigator-initiated extension of SYNTAX, called SYNTAXES, was conducted to compare the outcomes of PCI and CABG at 10 years, it also permitted an extended analysis of OMT. Although the primary comparison of SYNTAXES, reported 2 years ago, did not show a significant difference between PCI and CABG for mortality at 10 years, there was a difference for OMT.

When investigators compared treatment with three or more OMT agents with that with two or fewer OMT drugs at 5 years, the result for all-cause death at 10 years translated into a more than 50% relative reduction (hazard ratio, 0.47; P = .002). The absolute difference in mortality was a more than 6% reduction (13.1% vs. 19.9%).
 

OMT data offer major message

The current study is considered to have a major message for patients as well as physicians.

“OMT even outweighs the survival benefit from revascularization alone, so our patients should convince themselves of the value of rigorous adherence and compliance,” Dr. Serruys said in an interview. According to him, these are compelling data for telling patients that OMT “is the best insurance for extended survival.” We now know from these data “the longer, the better.”

The same message from these data extends to physicians.

“I wish I could understand the apparent blind spot physicians have with respect to prescribing OMT despite the overwhelming benefit from multiple clinical trials,” said William E. Boden, MD, professor of medicine, Boston University.

Dr. Boden was a coauthor of an editorial accompanying the newly published SYNTAXES subanalysis. In the editorial, he noted that OMT following revascularization and in other high-risk patients “has been unacceptably low,” but he was asked to expand on the lessons from the newly released SYNTAXES subanalysis in an interview.

“There has often been a belief that revascularization negates the need for OMT and that’s why the SYNTAXES trial 10-year mortality reduction – which builds upon an earlier 5-year mortality reduction analysis – is so important,” he said.
 

Patients should take OMT long term

These data “should be both a motivator for physicians to prescribe OMT and for patients to remain adherent to OMT,” he said. “It is the best warranty to blunt the progression of atherosclerosis and to reduce subsequent cardiac events.”

For the 10-year subanalysis of OMT in SYNTAXES, the patients were stratified by the number of OMTs they were taking at 5 years after revascularization and then evaluated for survival at 10 years. Of the 1,472 patients available for analysis at 5 years, only 678 (46%) were on OMT. The other 794 patients were not.

Graphically, the Kaplan-Meier survival curve for those on three types of OMT was consistently beneath that of those on four OMTs, but the gap narrowed over time. At the end of 10 years, the advantage of the four-drug OMT was not statistically significant relative to three or fewer (13.1% vs. 12.7%).
 

Statins and antiplatelets show largest effect

When analyzed individually and in different combinations, the agents with OMT did not appear to be equal. For example, the biggest survival gap at 10 years was for those who were on an antiplatelet therapy and a statin at 5 years relative to those who were not on either (13.2% vs. 22.6%; P = .006). Even after adjustment, there was nearly 45% survival benefit for these two agents (HR, 0.556; P = .02).

Conversely, the 10-year survival advantage for being on a renin-angiotensin system inhibitor at 5 years versus not being exposed to this therapy was small and nonsignificant (14.7% vs. 13.7%; P = .651).

The precise proportion of patients who were prescribed and adhered to OMT between 5 years and 10 years is unknown, acknowledged the authors, so conclusions are limited about the added benefit of 10- versus 5-year OMT, although the authors presume that a substantial proportion of those adherent for 5 years would likely continue on these therapies.

It can be said with confidence that those adherent for at least 5 years are more likely to be alive at 10 years than those who are not, according to Dr. Boden. He considers these data a call for physicians and all high-risk patients, not just those who have undergone revascularization, to take these standard therapies.

There are plenty of data to “show how poorly we treat patients with OMT,” said Dr. Boden, citing several studies. In one, which looked at OMT in a nationally representative sample in the United States, only a third of patients with angina were taking an antiplatelet, a statin, and a beta-blocker, all of which are indicated.

“Hospitalization for revascularization provides an opportune time to capture the attention of patients and their physicians,” he wrote in his editorial. He called OMT “an imperative to optimize clinical outcomes.”

Many of the investigators involved in the SYNTAXES subanalysis, including Dr. Serruys, have financial relationships with multiple pharmaceutical companies, including Boston Scientific, which provided the initial funding for the SYNTAX trial. Dr. Boden reports no potential conflicts of interest.

When it comes to medical therapy after a coronary revascularization procedure, more is better. Patients started and then maintained indefinitely on more rather than fewer of the drugs identified as optimal medical therapy (OMT) achieve a major survival benefit 10 years later, according to long-term follow-up from an extended analysis of the SYNTAX trial.

Courtesy Cardiovascular Research Foundation

For the survival benefit at 10 years, “the present study suggests that at least three types of optimal medical therapy should be maintained for at least 5 years after revascularization,” reported a multinational team of cardiovascular specialists led by Hideyuki Kawashima, MD and Patrick Serruys, MD, who both have affiliations with the department of cardiology of the National University of Ireland, Galway.

The SYNTAX trial was conducted to compare percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) for patients with previously untreated three-vessel and/or left main disease (N Engl J Med 2009;360:961-72). The conclusion from that study, published in 2009 and subsequently reinforced by a 5-year follow-up, was that CABG should remain the standard of care for complex lesions.
 

Optimal medical therapy defined

In the course of SYNTAX, the impact of OMT on outcome was also evaluated in a subanalysis. At 5 years, there was a mortality advantage for those receiving an antiplatelet drug, a statin, a renin-angiotensin system inhibitor (ACE inhibitor or angiotensin receptor blocker), and a beta-blocker when compared with fewer of these agents.

When an investigator-initiated extension of SYNTAX, called SYNTAXES, was conducted to compare the outcomes of PCI and CABG at 10 years, it also permitted an extended analysis of OMT. Although the primary comparison of SYNTAXES, reported 2 years ago, did not show a significant difference between PCI and CABG for mortality at 10 years, there was a difference for OMT.

When investigators compared treatment with three or more OMT agents with that with two or fewer OMT drugs at 5 years, the result for all-cause death at 10 years translated into a more than 50% relative reduction (hazard ratio, 0.47; P = .002). The absolute difference in mortality was a more than 6% reduction (13.1% vs. 19.9%).
 

OMT data offer major message

The current study is considered to have a major message for patients as well as physicians.

“OMT even outweighs the survival benefit from revascularization alone, so our patients should convince themselves of the value of rigorous adherence and compliance,” Dr. Serruys said in an interview. According to him, these are compelling data for telling patients that OMT “is the best insurance for extended survival.” We now know from these data “the longer, the better.”

The same message from these data extends to physicians.

“I wish I could understand the apparent blind spot physicians have with respect to prescribing OMT despite the overwhelming benefit from multiple clinical trials,” said William E. Boden, MD, professor of medicine, Boston University.

Dr. Boden was a coauthor of an editorial accompanying the newly published SYNTAXES subanalysis. In the editorial, he noted that OMT following revascularization and in other high-risk patients “has been unacceptably low,” but he was asked to expand on the lessons from the newly released SYNTAXES subanalysis in an interview.

“There has often been a belief that revascularization negates the need for OMT and that’s why the SYNTAXES trial 10-year mortality reduction – which builds upon an earlier 5-year mortality reduction analysis – is so important,” he said.
 

Patients should take OMT long term

These data “should be both a motivator for physicians to prescribe OMT and for patients to remain adherent to OMT,” he said. “It is the best warranty to blunt the progression of atherosclerosis and to reduce subsequent cardiac events.”

For the 10-year subanalysis of OMT in SYNTAXES, the patients were stratified by the number of OMTs they were taking at 5 years after revascularization and then evaluated for survival at 10 years. Of the 1,472 patients available for analysis at 5 years, only 678 (46%) were on OMT. The other 794 patients were not.

Graphically, the Kaplan-Meier survival curve for those on three types of OMT was consistently beneath that of those on four OMTs, but the gap narrowed over time. At the end of 10 years, the advantage of the four-drug OMT was not statistically significant relative to three or fewer (13.1% vs. 12.7%).
 

Statins and antiplatelets show largest effect

When analyzed individually and in different combinations, the agents with OMT did not appear to be equal. For example, the biggest survival gap at 10 years was for those who were on an antiplatelet therapy and a statin at 5 years relative to those who were not on either (13.2% vs. 22.6%; P = .006). Even after adjustment, there was nearly 45% survival benefit for these two agents (HR, 0.556; P = .02).

Conversely, the 10-year survival advantage for being on a renin-angiotensin system inhibitor at 5 years versus not being exposed to this therapy was small and nonsignificant (14.7% vs. 13.7%; P = .651).

The precise proportion of patients who were prescribed and adhered to OMT between 5 years and 10 years is unknown, acknowledged the authors, so conclusions are limited about the added benefit of 10- versus 5-year OMT, although the authors presume that a substantial proportion of those adherent for 5 years would likely continue on these therapies.

It can be said with confidence that those adherent for at least 5 years are more likely to be alive at 10 years than those who are not, according to Dr. Boden. He considers these data a call for physicians and all high-risk patients, not just those who have undergone revascularization, to take these standard therapies.

There are plenty of data to “show how poorly we treat patients with OMT,” said Dr. Boden, citing several studies. In one, which looked at OMT in a nationally representative sample in the United States, only a third of patients with angina were taking an antiplatelet, a statin, and a beta-blocker, all of which are indicated.

“Hospitalization for revascularization provides an opportune time to capture the attention of patients and their physicians,” he wrote in his editorial. He called OMT “an imperative to optimize clinical outcomes.”

Many of the investigators involved in the SYNTAXES subanalysis, including Dr. Serruys, have financial relationships with multiple pharmaceutical companies, including Boston Scientific, which provided the initial funding for the SYNTAX trial. Dr. Boden reports no potential conflicts of interest.

Automotive-themed workshops that refer to doctor visits as “tune-ups” and nutritious food as “high-performance fuel” are showing promise as a strategy to better explain diabetes self-management to Mexican American men, an investigator has reported.

Ronnie Kaufman/DigitalVision

The workshops, which started out in person and transitioned online because of the COVID-19 pandemic, have improved self-care behaviors among Mexican American men with diabetes, said Jeannie Belinda Concha, PhD, MPH, of the University of Texas, El Paso.

After participating in the workshops, known as The Diabetes Garage, men more often measured food portions and counted carbohydrates, and had improved confidence in their ability to self-manage their diabetes, Dr. Concha said in a virtual presentation on the study.

Although those improvements in self-care behaviors didn’t translate into significant improvements in blood pressure or hemoglobin A1c, she said, they could be predecessors to improved physical health outcomes with longer follow-up.

”We know it takes some time to move those numbers, but they are going in the right direction,” Dr. Concha said in her presentation, which took place during the annual scientific sessions of the American Diabetes Association.
 

Meeting Mexican American men where they’re at

Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA, said The Diabetes Garage is an “innovative” approach to tailoring diabetes self-care message for a specific of individuals.

“It’s such a wonderful example of something that we believe so strongly, which is that you’ve got to meet people where they’re at,” Dr. Gabbay said in an interview.

“We know that people learn in different ways, and people and with different backgrounds have different things that resonate with them,” he continued. “For better or worse, one size doesn’t fit all, and that in a sense is one of the challenges around diabetes, because we’re really trying to help everybody.”
 

Unmet needs for diabetes education

The prevalence of diabetes in the United States is high among Hispanics, higher among Mexican Americans, and even higher still among Mexican-American men, according to Dr. Concha.

The age-adjusted prevalence of diabetes is 16.2% among Mexican-American men, as compared with 12.8% for Mexican American women, and 8.6% for White non-Hispanic men, according to 2018 data from the Centers for Disease Control and Prevention that Dr. Concha highlighted in her presentation.

Moreover, only 25% of participants in diabetes education are men, highlighting another disparity that needs to be addressed, she said.
 

Infusing diabetes self-management with car culture

The Diabetes Garage leverages a positive “car culture” that is prevalent in Mexican American communities in general, and cities like El Paso in particular, Dr. Concha said.

This culture brings Mexican American people together at numerous car shows, and is viewed as a form of family identification for enthusiasts, who will illustrate their own pride by customizing their cars with cultural symbols, according to Dr. Concha.

The diabetes education intervention consists of four workshops delivered as 2-hour weekly sessions that include a diabetes educator and an automotive instructor:

In the first session, men learn about “starting and operating” their body with diabetes, and checking their “gauges” when it comes to blood pressure, cholesterol, and other measures, according to Dr. Concha.

The second session stresses the importance of physical activity (“using all your gears”) and of managing stress (“full throttle”).

The third session highlights medication as a tool (“to keep your battery charged”) and the importance of diabetes complications (“catastrophic failure”) as well as visiting the doctor (“tune ups and inspections”).

Finally, men learn about nutrition (high-performance fuel) in a workshop on eating well with diabetes. “We ask them to invite their family and friends, and they do,” said Dr. Concha.
 

Rubber hits the road

Since 2018, 16 workshops have been completed in El Paso, San Antonio, and Harlingen, Tex., of which 9 were in English, 5 were in Spanish, and 2 were bilingual. Due to the COVID-19 pandemic, 10 of the workshops were completed online, Dr. Concha said.

In total, 97 men engaged in the workshops, of whom 91% were Hispanic/Latino; 71% were employed, 71% were married, and 84% had health insurance. Eighty-six percent completed all four workshops, while 89% completed at least three workshops.

The number of days men measured food portions increased significantly from pre- to postworkshop assessment, from a mean of 2.1 days to 2.74 days, Dr. Concha reported. Similarly, the mean number of days counting carbohydrate portions increased significantly, from 1.92 to 2.64 days.

The proportion of men agreeing or strongly agreeing they were confident they could manage diabetes increased from 74% before the intervention to 93% afterward, according to Dr. Concha’s presentation.

By contrast, there were no statistically significant increases in physical outcomes including physical activity, weight, waist circumference, A1c, or blood pressure from before the workshop to after, though outcomes trended in an improved direction, according to Dr. Concha.

Postactivity satisfaction survey results showed that 86%of men said the automotive analogies in the program helped them understand the importance of diabetes management. “I am looking forward to better managing my human-mobile for a long, long time with a good quality of life,” one of the men wrote in survey feedback.

Dr. Concha and coauthors reported no conflicts of interest related to the study.

Automotive-themed workshops that refer to doctor visits as “tune-ups” and nutritious food as “high-performance fuel” are showing promise as a strategy to better explain diabetes self-management to Mexican American men, an investigator has reported.

Ronnie Kaufman/DigitalVision

The workshops, which started out in person and transitioned online because of the COVID-19 pandemic, have improved self-care behaviors among Mexican American men with diabetes, said Jeannie Belinda Concha, PhD, MPH, of the University of Texas, El Paso.

After participating in the workshops, known as The Diabetes Garage, men more often measured food portions and counted carbohydrates, and had improved confidence in their ability to self-manage their diabetes, Dr. Concha said in a virtual presentation on the study.

Although those improvements in self-care behaviors didn’t translate into significant improvements in blood pressure or hemoglobin A1c, she said, they could be predecessors to improved physical health outcomes with longer follow-up.

”We know it takes some time to move those numbers, but they are going in the right direction,” Dr. Concha said in her presentation, which took place during the annual scientific sessions of the American Diabetes Association.
 

Meeting Mexican American men where they’re at

Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA, said The Diabetes Garage is an “innovative” approach to tailoring diabetes self-care message for a specific of individuals.

“It’s such a wonderful example of something that we believe so strongly, which is that you’ve got to meet people where they’re at,” Dr. Gabbay said in an interview.

“We know that people learn in different ways, and people and with different backgrounds have different things that resonate with them,” he continued. “For better or worse, one size doesn’t fit all, and that in a sense is one of the challenges around diabetes, because we’re really trying to help everybody.”
 

Unmet needs for diabetes education

The prevalence of diabetes in the United States is high among Hispanics, higher among Mexican Americans, and even higher still among Mexican-American men, according to Dr. Concha.

The age-adjusted prevalence of diabetes is 16.2% among Mexican-American men, as compared with 12.8% for Mexican American women, and 8.6% for White non-Hispanic men, according to 2018 data from the Centers for Disease Control and Prevention that Dr. Concha highlighted in her presentation.

Moreover, only 25% of participants in diabetes education are men, highlighting another disparity that needs to be addressed, she said.
 

Infusing diabetes self-management with car culture

The Diabetes Garage leverages a positive “car culture” that is prevalent in Mexican American communities in general, and cities like El Paso in particular, Dr. Concha said.

This culture brings Mexican American people together at numerous car shows, and is viewed as a form of family identification for enthusiasts, who will illustrate their own pride by customizing their cars with cultural symbols, according to Dr. Concha.

The diabetes education intervention consists of four workshops delivered as 2-hour weekly sessions that include a diabetes educator and an automotive instructor:

In the first session, men learn about “starting and operating” their body with diabetes, and checking their “gauges” when it comes to blood pressure, cholesterol, and other measures, according to Dr. Concha.

The second session stresses the importance of physical activity (“using all your gears”) and of managing stress (“full throttle”).

The third session highlights medication as a tool (“to keep your battery charged”) and the importance of diabetes complications (“catastrophic failure”) as well as visiting the doctor (“tune ups and inspections”).

Finally, men learn about nutrition (high-performance fuel) in a workshop on eating well with diabetes. “We ask them to invite their family and friends, and they do,” said Dr. Concha.
 

Rubber hits the road

Since 2018, 16 workshops have been completed in El Paso, San Antonio, and Harlingen, Tex., of which 9 were in English, 5 were in Spanish, and 2 were bilingual. Due to the COVID-19 pandemic, 10 of the workshops were completed online, Dr. Concha said.

In total, 97 men engaged in the workshops, of whom 91% were Hispanic/Latino; 71% were employed, 71% were married, and 84% had health insurance. Eighty-six percent completed all four workshops, while 89% completed at least three workshops.

The number of days men measured food portions increased significantly from pre- to postworkshop assessment, from a mean of 2.1 days to 2.74 days, Dr. Concha reported. Similarly, the mean number of days counting carbohydrate portions increased significantly, from 1.92 to 2.64 days.

The proportion of men agreeing or strongly agreeing they were confident they could manage diabetes increased from 74% before the intervention to 93% afterward, according to Dr. Concha’s presentation.

By contrast, there were no statistically significant increases in physical outcomes including physical activity, weight, waist circumference, A1c, or blood pressure from before the workshop to after, though outcomes trended in an improved direction, according to Dr. Concha.

Postactivity satisfaction survey results showed that 86%of men said the automotive analogies in the program helped them understand the importance of diabetes management. “I am looking forward to better managing my human-mobile for a long, long time with a good quality of life,” one of the men wrote in survey feedback.

Dr. Concha and coauthors reported no conflicts of interest related to the study.

Automotive-themed workshops that refer to doctor visits as “tune-ups” and nutritious food as “high-performance fuel” are showing promise as a strategy to better explain diabetes self-management to Mexican American men, an investigator has reported.

Ronnie Kaufman/DigitalVision

The workshops, which started out in person and transitioned online because of the COVID-19 pandemic, have improved self-care behaviors among Mexican American men with diabetes, said Jeannie Belinda Concha, PhD, MPH, of the University of Texas, El Paso.

After participating in the workshops, known as The Diabetes Garage, men more often measured food portions and counted carbohydrates, and had improved confidence in their ability to self-manage their diabetes, Dr. Concha said in a virtual presentation on the study.

Although those improvements in self-care behaviors didn’t translate into significant improvements in blood pressure or hemoglobin A1c, she said, they could be predecessors to improved physical health outcomes with longer follow-up.

”We know it takes some time to move those numbers, but they are going in the right direction,” Dr. Concha said in her presentation, which took place during the annual scientific sessions of the American Diabetes Association.
 

Meeting Mexican American men where they’re at

Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA, said The Diabetes Garage is an “innovative” approach to tailoring diabetes self-care message for a specific of individuals.

“It’s such a wonderful example of something that we believe so strongly, which is that you’ve got to meet people where they’re at,” Dr. Gabbay said in an interview.

“We know that people learn in different ways, and people and with different backgrounds have different things that resonate with them,” he continued. “For better or worse, one size doesn’t fit all, and that in a sense is one of the challenges around diabetes, because we’re really trying to help everybody.”
 

Unmet needs for diabetes education

The prevalence of diabetes in the United States is high among Hispanics, higher among Mexican Americans, and even higher still among Mexican-American men, according to Dr. Concha.

The age-adjusted prevalence of diabetes is 16.2% among Mexican-American men, as compared with 12.8% for Mexican American women, and 8.6% for White non-Hispanic men, according to 2018 data from the Centers for Disease Control and Prevention that Dr. Concha highlighted in her presentation.

Moreover, only 25% of participants in diabetes education are men, highlighting another disparity that needs to be addressed, she said.
 

Infusing diabetes self-management with car culture

The Diabetes Garage leverages a positive “car culture” that is prevalent in Mexican American communities in general, and cities like El Paso in particular, Dr. Concha said.

This culture brings Mexican American people together at numerous car shows, and is viewed as a form of family identification for enthusiasts, who will illustrate their own pride by customizing their cars with cultural symbols, according to Dr. Concha.

The diabetes education intervention consists of four workshops delivered as 2-hour weekly sessions that include a diabetes educator and an automotive instructor:

In the first session, men learn about “starting and operating” their body with diabetes, and checking their “gauges” when it comes to blood pressure, cholesterol, and other measures, according to Dr. Concha.

The second session stresses the importance of physical activity (“using all your gears”) and of managing stress (“full throttle”).

The third session highlights medication as a tool (“to keep your battery charged”) and the importance of diabetes complications (“catastrophic failure”) as well as visiting the doctor (“tune ups and inspections”).

Finally, men learn about nutrition (high-performance fuel) in a workshop on eating well with diabetes. “We ask them to invite their family and friends, and they do,” said Dr. Concha.
 

Rubber hits the road

Since 2018, 16 workshops have been completed in El Paso, San Antonio, and Harlingen, Tex., of which 9 were in English, 5 were in Spanish, and 2 were bilingual. Due to the COVID-19 pandemic, 10 of the workshops were completed online, Dr. Concha said.

In total, 97 men engaged in the workshops, of whom 91% were Hispanic/Latino; 71% were employed, 71% were married, and 84% had health insurance. Eighty-six percent completed all four workshops, while 89% completed at least three workshops.

The number of days men measured food portions increased significantly from pre- to postworkshop assessment, from a mean of 2.1 days to 2.74 days, Dr. Concha reported. Similarly, the mean number of days counting carbohydrate portions increased significantly, from 1.92 to 2.64 days.

The proportion of men agreeing or strongly agreeing they were confident they could manage diabetes increased from 74% before the intervention to 93% afterward, according to Dr. Concha’s presentation.

By contrast, there were no statistically significant increases in physical outcomes including physical activity, weight, waist circumference, A1c, or blood pressure from before the workshop to after, though outcomes trended in an improved direction, according to Dr. Concha.

Postactivity satisfaction survey results showed that 86%of men said the automotive analogies in the program helped them understand the importance of diabetes management. “I am looking forward to better managing my human-mobile for a long, long time with a good quality of life,” one of the men wrote in survey feedback.

Dr. Concha and coauthors reported no conflicts of interest related to the study.