Bronchial thermoplasty in severe asthmatics at 5 years: The PAS2 study. By Dr. G. Chupp, et al.

Significant spirometric transitions and preserved ratio-impaired spirometry (PRISm) among ever-smokers. By Dr. E. Wan, et al.

Addressing advance care planning in patients with COPD. By Dr. E. Rose, et al.

The cost of ARDS: A systematic review. By Dr. P. Boucher, et al.

Acute management of high- and intermediate-risk pulmonary embolism in children: A review. By Dr. C. Ross, et al.

Surgical outcomes for early-stage non-small cell lung cancer at facilities with stereotactic body radiation therapy programs. By Dr. Y. Syed, et al.

Bronchial thermoplasty in severe asthmatics at 5 years: The PAS2 study. By Dr. G. Chupp, et al.

Significant spirometric transitions and preserved ratio-impaired spirometry (PRISm) among ever-smokers. By Dr. E. Wan, et al.

Addressing advance care planning in patients with COPD. By Dr. E. Rose, et al.

The cost of ARDS: A systematic review. By Dr. P. Boucher, et al.

Acute management of high- and intermediate-risk pulmonary embolism in children: A review. By Dr. C. Ross, et al.

Surgical outcomes for early-stage non-small cell lung cancer at facilities with stereotactic body radiation therapy programs. By Dr. Y. Syed, et al.

Bronchial thermoplasty in severe asthmatics at 5 years: The PAS2 study. By Dr. G. Chupp, et al.

Significant spirometric transitions and preserved ratio-impaired spirometry (PRISm) among ever-smokers. By Dr. E. Wan, et al.

Addressing advance care planning in patients with COPD. By Dr. E. Rose, et al.

The cost of ARDS: A systematic review. By Dr. P. Boucher, et al.

Acute management of high- and intermediate-risk pulmonary embolism in children: A review. By Dr. C. Ross, et al.

Surgical outcomes for early-stage non-small cell lung cancer at facilities with stereotactic body radiation therapy programs. By Dr. Y. Syed, et al.

The antiseptic methenamine hippurate (MH) is known to sterilize urine and has been suggested to be of use in preventing urinary tract infections (UTIs), but firm evidence has so far been lacking. Now researchers led by clinicians and scientists from Newcastle-upon-Tyne, England, have provided the ALTAR trial (Alternative to Prophylactic Antibiotics for the Treatment of Recurrent UTIs in Women).

Daily low-dose antibiotics as recommended by current guidelines for prophylactic treatment of recurrent UTI have been linked to antibiotic resistance. Using MH as an alternative could play an important role in helping to tackle the global problem of increasing antibiotic resistance, the team said.
 

Study details

They recruited 240 women aged 18 or over with recurrent UTIs requiring prophylactic treatment from eight secondary care urology and urogynecology centers in the United Kingdom from June 2016 to June 2018. Women were randomized to receive MH or daily low-dose antibiotics for 12 months, with follow up for a further 6 months beyond that.

Before trial entry the women had experienced an average of more than six UTI episodes per year. During the 12-month treatment period, in the modified intention-to-treat population, there were 90 symptomatic, antibiotic-treated UTI episodes reported over 101 person-years of follow-up in the antibiotic group, and 141 episodes over 102 person-years in the MH group.

This yielded a UTI rate of 0.89 episodes per person-year in the antibiotic group, compared with 1.38 in the MH group, an absolute difference of 0.49 episodes per person-year. In the 6-month posttreatment follow-up period, the UTI incidence rate was 1.19 episodes per person-year in the antibiotic prophylaxis group versus 1.72 in the MH group, an absolute difference of 0.53.

Before the trial, a patient and public involvement group had predefined the noninferiority margin as one episode of UTI per person-year. The small difference between the two groups was less than this, confirming noninferiority of MH to antibiotic prophylaxis in this setting. This finding was consistent across the modified intention-to-treat, strict intention-to-treat, per protocol, and modified per protocol (post hoc) analyses.

Thus the ALTAR results showed that MH was no worse than antibiotics at preventing UTIs, and MH was also associated with reduced antibiotic consumption.

The vast majority of participants were over 90% adherent with the allocated treatment. Patient satisfaction was generally high and rates of adverse events and adverse reactions generally low, and both were comparable between treatment groups. Adverse reactions were reported by 34/142 (24%) in the antibiotic group and 35/127 (28%) in the MH group, and most reactions were mild. In the antibiotic group there were two serious adverse reactions (severe abdominal pain and raised alanine transaminase), whereas six participants in the MH group reported an episode of febrile UTI and four were admitted to hospital because of UTI.
 

Substantial global health care problem

At least 50% and up to 80% of all women have at least one acute UTI in their lifetime, most often uncomplicated acute cystitis. About a quarter of them go on to suffer recurrent infection, defined as three or more repeat infections in the past year, or two infections in the preceding 6 months. Frequent recurrences thus represent “a substantial global health care problem,” the authors say.

Guidelines from the United Kingdom, Europe, and the United States acknowledge the need for preventive strategies and strongly recommend the use of daily, low-dose antibiotics as standard prophylactic treatment. However, the United Kingdom’s antimicrobial resistance strategy recommends a “strong focus on infection prevention,” and aims to reduce antimicrobial use in humans by 15% before 2024.

“To achieve that, exploration of nonantibiotic preventive treatments in common conditions such as UTI is essential,” the team said.

MH is one such nonantibiotic treatment. It is bactericidal and works by denaturing bacterial proteins and nucleic acids. Although previous Cochrane systematic reviews had concluded that it could be effective for preventing UTI, further large trials were needed.

“This trial adds to the evidence base for the use of MH for prophylactic treatment in adult women with recurrent UTI. Although the MH group had a 55% higher rate of UTI episodes than the antibiotics group, the absolute difference was just 0.49 UTI episodes per year, which has limited clinical consequence,” the team concluded.
 

Results could ‘support a change in practice’

In older patients, particularly, the risks of long-term antibiotic prophylaxis might outweigh the benefits, and the authors said that their results “could support a change in practice in terms of preventive treatments for recurrent UTI and provide patients and clinicians with a credible alternative to daily antibiotics, giving them the confidence to pursue strategies that avoid long-term antibiotic use.”

They acknowledged limitations of the study, including that treatment allocation was not masked, crossover between arms was allowed, and differences in antibiotics prescribed may have affected the results. In addition, data regarding long-term safety of MH are scarce.

However, they said that the trial accurately represented the broad range of women with recurrent UTI, and that its results “might encourage patients and clinicians to consider MH as a first line treatment for UTI prevention in women.”

In a linked editorial, scientists from the Institute for Evidence-Based Healthcare at Bond University in Queensland, Australia, commented: “Although the results need cautious interpretation, they align with others, and this new research increases the confidence with which MH can be offered as an option to women needing prophylaxis against recurrent urinary tract infection.”

References

Harding C et al. Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, noninferiority trial. BMJ 2022 Mar 9;376:e068229.

Hoffmann TC et al. Methenamine hippurate for recurrent urinary tract infections. BMJ 2022 Mar 9;376:o533.

A version of this article first appeared on Medscape.co.uk.

The antiseptic methenamine hippurate (MH) is known to sterilize urine and has been suggested to be of use in preventing urinary tract infections (UTIs), but firm evidence has so far been lacking. Now researchers led by clinicians and scientists from Newcastle-upon-Tyne, England, have provided the ALTAR trial (Alternative to Prophylactic Antibiotics for the Treatment of Recurrent UTIs in Women).

Daily low-dose antibiotics as recommended by current guidelines for prophylactic treatment of recurrent UTI have been linked to antibiotic resistance. Using MH as an alternative could play an important role in helping to tackle the global problem of increasing antibiotic resistance, the team said.
 

Study details

They recruited 240 women aged 18 or over with recurrent UTIs requiring prophylactic treatment from eight secondary care urology and urogynecology centers in the United Kingdom from June 2016 to June 2018. Women were randomized to receive MH or daily low-dose antibiotics for 12 months, with follow up for a further 6 months beyond that.

Before trial entry the women had experienced an average of more than six UTI episodes per year. During the 12-month treatment period, in the modified intention-to-treat population, there were 90 symptomatic, antibiotic-treated UTI episodes reported over 101 person-years of follow-up in the antibiotic group, and 141 episodes over 102 person-years in the MH group.

This yielded a UTI rate of 0.89 episodes per person-year in the antibiotic group, compared with 1.38 in the MH group, an absolute difference of 0.49 episodes per person-year. In the 6-month posttreatment follow-up period, the UTI incidence rate was 1.19 episodes per person-year in the antibiotic prophylaxis group versus 1.72 in the MH group, an absolute difference of 0.53.

Before the trial, a patient and public involvement group had predefined the noninferiority margin as one episode of UTI per person-year. The small difference between the two groups was less than this, confirming noninferiority of MH to antibiotic prophylaxis in this setting. This finding was consistent across the modified intention-to-treat, strict intention-to-treat, per protocol, and modified per protocol (post hoc) analyses.

Thus the ALTAR results showed that MH was no worse than antibiotics at preventing UTIs, and MH was also associated with reduced antibiotic consumption.

The vast majority of participants were over 90% adherent with the allocated treatment. Patient satisfaction was generally high and rates of adverse events and adverse reactions generally low, and both were comparable between treatment groups. Adverse reactions were reported by 34/142 (24%) in the antibiotic group and 35/127 (28%) in the MH group, and most reactions were mild. In the antibiotic group there were two serious adverse reactions (severe abdominal pain and raised alanine transaminase), whereas six participants in the MH group reported an episode of febrile UTI and four were admitted to hospital because of UTI.
 

Substantial global health care problem

At least 50% and up to 80% of all women have at least one acute UTI in their lifetime, most often uncomplicated acute cystitis. About a quarter of them go on to suffer recurrent infection, defined as three or more repeat infections in the past year, or two infections in the preceding 6 months. Frequent recurrences thus represent “a substantial global health care problem,” the authors say.

Guidelines from the United Kingdom, Europe, and the United States acknowledge the need for preventive strategies and strongly recommend the use of daily, low-dose antibiotics as standard prophylactic treatment. However, the United Kingdom’s antimicrobial resistance strategy recommends a “strong focus on infection prevention,” and aims to reduce antimicrobial use in humans by 15% before 2024.

“To achieve that, exploration of nonantibiotic preventive treatments in common conditions such as UTI is essential,” the team said.

MH is one such nonantibiotic treatment. It is bactericidal and works by denaturing bacterial proteins and nucleic acids. Although previous Cochrane systematic reviews had concluded that it could be effective for preventing UTI, further large trials were needed.

“This trial adds to the evidence base for the use of MH for prophylactic treatment in adult women with recurrent UTI. Although the MH group had a 55% higher rate of UTI episodes than the antibiotics group, the absolute difference was just 0.49 UTI episodes per year, which has limited clinical consequence,” the team concluded.
 

Results could ‘support a change in practice’

In older patients, particularly, the risks of long-term antibiotic prophylaxis might outweigh the benefits, and the authors said that their results “could support a change in practice in terms of preventive treatments for recurrent UTI and provide patients and clinicians with a credible alternative to daily antibiotics, giving them the confidence to pursue strategies that avoid long-term antibiotic use.”

They acknowledged limitations of the study, including that treatment allocation was not masked, crossover between arms was allowed, and differences in antibiotics prescribed may have affected the results. In addition, data regarding long-term safety of MH are scarce.

However, they said that the trial accurately represented the broad range of women with recurrent UTI, and that its results “might encourage patients and clinicians to consider MH as a first line treatment for UTI prevention in women.”

In a linked editorial, scientists from the Institute for Evidence-Based Healthcare at Bond University in Queensland, Australia, commented: “Although the results need cautious interpretation, they align with others, and this new research increases the confidence with which MH can be offered as an option to women needing prophylaxis against recurrent urinary tract infection.”

References

Harding C et al. Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, noninferiority trial. BMJ 2022 Mar 9;376:e068229.

Hoffmann TC et al. Methenamine hippurate for recurrent urinary tract infections. BMJ 2022 Mar 9;376:o533.

A version of this article first appeared on Medscape.co.uk.

The antiseptic methenamine hippurate (MH) is known to sterilize urine and has been suggested to be of use in preventing urinary tract infections (UTIs), but firm evidence has so far been lacking. Now researchers led by clinicians and scientists from Newcastle-upon-Tyne, England, have provided the ALTAR trial (Alternative to Prophylactic Antibiotics for the Treatment of Recurrent UTIs in Women).

Daily low-dose antibiotics as recommended by current guidelines for prophylactic treatment of recurrent UTI have been linked to antibiotic resistance. Using MH as an alternative could play an important role in helping to tackle the global problem of increasing antibiotic resistance, the team said.
 

Study details

They recruited 240 women aged 18 or over with recurrent UTIs requiring prophylactic treatment from eight secondary care urology and urogynecology centers in the United Kingdom from June 2016 to June 2018. Women were randomized to receive MH or daily low-dose antibiotics for 12 months, with follow up for a further 6 months beyond that.

Before trial entry the women had experienced an average of more than six UTI episodes per year. During the 12-month treatment period, in the modified intention-to-treat population, there were 90 symptomatic, antibiotic-treated UTI episodes reported over 101 person-years of follow-up in the antibiotic group, and 141 episodes over 102 person-years in the MH group.

This yielded a UTI rate of 0.89 episodes per person-year in the antibiotic group, compared with 1.38 in the MH group, an absolute difference of 0.49 episodes per person-year. In the 6-month posttreatment follow-up period, the UTI incidence rate was 1.19 episodes per person-year in the antibiotic prophylaxis group versus 1.72 in the MH group, an absolute difference of 0.53.

Before the trial, a patient and public involvement group had predefined the noninferiority margin as one episode of UTI per person-year. The small difference between the two groups was less than this, confirming noninferiority of MH to antibiotic prophylaxis in this setting. This finding was consistent across the modified intention-to-treat, strict intention-to-treat, per protocol, and modified per protocol (post hoc) analyses.

Thus the ALTAR results showed that MH was no worse than antibiotics at preventing UTIs, and MH was also associated with reduced antibiotic consumption.

The vast majority of participants were over 90% adherent with the allocated treatment. Patient satisfaction was generally high and rates of adverse events and adverse reactions generally low, and both were comparable between treatment groups. Adverse reactions were reported by 34/142 (24%) in the antibiotic group and 35/127 (28%) in the MH group, and most reactions were mild. In the antibiotic group there were two serious adverse reactions (severe abdominal pain and raised alanine transaminase), whereas six participants in the MH group reported an episode of febrile UTI and four were admitted to hospital because of UTI.
 

Substantial global health care problem

At least 50% and up to 80% of all women have at least one acute UTI in their lifetime, most often uncomplicated acute cystitis. About a quarter of them go on to suffer recurrent infection, defined as three or more repeat infections in the past year, or two infections in the preceding 6 months. Frequent recurrences thus represent “a substantial global health care problem,” the authors say.

Guidelines from the United Kingdom, Europe, and the United States acknowledge the need for preventive strategies and strongly recommend the use of daily, low-dose antibiotics as standard prophylactic treatment. However, the United Kingdom’s antimicrobial resistance strategy recommends a “strong focus on infection prevention,” and aims to reduce antimicrobial use in humans by 15% before 2024.

“To achieve that, exploration of nonantibiotic preventive treatments in common conditions such as UTI is essential,” the team said.

MH is one such nonantibiotic treatment. It is bactericidal and works by denaturing bacterial proteins and nucleic acids. Although previous Cochrane systematic reviews had concluded that it could be effective for preventing UTI, further large trials were needed.

“This trial adds to the evidence base for the use of MH for prophylactic treatment in adult women with recurrent UTI. Although the MH group had a 55% higher rate of UTI episodes than the antibiotics group, the absolute difference was just 0.49 UTI episodes per year, which has limited clinical consequence,” the team concluded.
 

Results could ‘support a change in practice’

In older patients, particularly, the risks of long-term antibiotic prophylaxis might outweigh the benefits, and the authors said that their results “could support a change in practice in terms of preventive treatments for recurrent UTI and provide patients and clinicians with a credible alternative to daily antibiotics, giving them the confidence to pursue strategies that avoid long-term antibiotic use.”

They acknowledged limitations of the study, including that treatment allocation was not masked, crossover between arms was allowed, and differences in antibiotics prescribed may have affected the results. In addition, data regarding long-term safety of MH are scarce.

However, they said that the trial accurately represented the broad range of women with recurrent UTI, and that its results “might encourage patients and clinicians to consider MH as a first line treatment for UTI prevention in women.”

In a linked editorial, scientists from the Institute for Evidence-Based Healthcare at Bond University in Queensland, Australia, commented: “Although the results need cautious interpretation, they align with others, and this new research increases the confidence with which MH can be offered as an option to women needing prophylaxis against recurrent urinary tract infection.”

References

Harding C et al. Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, noninferiority trial. BMJ 2022 Mar 9;376:e068229.

Hoffmann TC et al. Methenamine hippurate for recurrent urinary tract infections. BMJ 2022 Mar 9;376:o533.

A version of this article first appeared on Medscape.co.uk.

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

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

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

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

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

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

Should screening elderly patients for atrial fibrillation (AFib) during primary care visits be as routine as checking blood pressure, respiration, and other vital signs? A new study says the answer is “maybe” for some people.

The use of handheld, single-lead electrocardiograms (ECGs) did not increase diagnoses of AFib overall in patients aged 65 and older, but it did in patients 85 and up, researchers reported in Circulation.

“Incorporating single-lead ECGs into routine medical assessments as a new vital sign was widely feasible. Over 90% of people who were offered screening agreed to it and underwent screening,” said Steven Lubitz, MD, of the Cardiac Arrhythmia Service and Cardiovascular Research Center at Massachusetts General Hospital, Boston, who led the study.

Because advanced age is associated with a substantially increased risk of both AFib and stroke, point-of-care screening might be an efficient use of handheld ECGs, Dr. Lubitz said.

“The technology simply requires patients to place their fingers on the device to record an electrocardiogram and can be easily embedded in the routine clinical practice of primary care physicians,” he said in an interview.

The typical person has a 30% lifetime risk of developing AFib, and the chances of experiencing a stroke associated with the arrhythmia can be reduced significantly with anticoagulants, Dr. Lubitz said.

Professional organizations are split about the utility of screening for AFib. The European Society of Cardiology recommends opportunistic screening with either pulse palpation or ECG rhythm strip at clinic visits for patients 65 and older. The National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand have issued similar guidelines.

However, screening for AFib is not considered standard of care in the United States – although Dr. Lubitz predicted that that would change.

“I think the guidelines in the United States will evolve in the next few years, because I think we’re getting closer to understanding who we should be screening for atrial fibrillation and how we should be screening,” Dr. Lubitz told this news organization.
 

‘Very reassuring’ results

The randomized controlled trial found that for patients 85 and older, use of handheld ECGs led to a nearly 2% increase in new diagnoses of AFib in the screening group compared to conventional care.

The researchers also demonstrated an increased likelihood of diagnosing AFib during the patient’s primary-care encounter than at other sites, such as the emergency department or inpatient settings that might be more costly and resource-intensive. Moreover, the study reported that point-of-care screening was associated with high rates of oral anticoagulation prescriptions written for patients with newly diagnosed AFib, a finding Dr. Lubitz called “very reassuring.”

The Mass General researchers used single-lead devices attached to a tablet computer to screen more than 35,000 men and women from 16 primary care sites affiliated with the hospital’s practice-based research network.

Half the sites were randomly selected to include the screening intervention, where medical assistants used handheld ECGs at the start of the visit while checking routine vital signs.

The 1-year study screened 91% of eligible patients, demonstrating that single-lead rhythm assessment is feasible as part of routine primary care practice, Dr. Lubitz said. This finding supports other studies suggesting that handheld devices can enable rapid and scalable mass screening.

“We demonstrated that integration into routine practice by clinical personnel – in this case, medical assistants – is feasible. No study has measured and demonstrated such a high integration with routine care, reflecting both patient interest in screening and feasibility of incorporating screening into busy clinical practices,” Dr. Lubitz said.

Mobile ECGs with the handheld device take about 30 seconds to perform. In contrast, standard ECGs used in outpatient practices are bulky, and recording the ECG can take roughly 10 minutes.

Anthony Leazzo, DO, chairman of family practice at Northwestern Medicine Delnor Hospital, in Geneva, Ill., noted that smartwatches provide an alternative technology for detecting AFib.

But “a handheld, one-lead device would be more beneficial and should be more sensitive by measuring electrical activity similar to a normal ECG,” he said.

However, Dr. Leazzo said using such technology would need to be cost-effective because the patients at highest risk for AFib usually are on fixed incomes. Consumer versions of the devices can cost under $100. Dr. Lubitz said the actual cost for devices and a software platform used for a medical enterprise may differ.

Handheld ECGs are gradually being integrated into clinical practices, a trend driven by the rapid growth of telemedicine to remotely assess patients, Dr. Lubitz said.

“Our work affirmed that single-lead devices generate information for the physician that is actionable, though the proportion of newly detected AFib cases using a point-of-care ECG screening approach is likely to be very small,” Dr. Lubitz said in an interview. “For that reason, we think handheld devices are best deployed for people at the highest risk of AFib and stroke, and age is an excellent surrogate for that determination.”

The study was funded by Bristol-Myers Squibb–Pfizer Alliance.

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

Should screening elderly patients for atrial fibrillation (AFib) during primary care visits be as routine as checking blood pressure, respiration, and other vital signs? A new study says the answer is “maybe” for some people.

The use of handheld, single-lead electrocardiograms (ECGs) did not increase diagnoses of AFib overall in patients aged 65 and older, but it did in patients 85 and up, researchers reported in Circulation.

“Incorporating single-lead ECGs into routine medical assessments as a new vital sign was widely feasible. Over 90% of people who were offered screening agreed to it and underwent screening,” said Steven Lubitz, MD, of the Cardiac Arrhythmia Service and Cardiovascular Research Center at Massachusetts General Hospital, Boston, who led the study.

Because advanced age is associated with a substantially increased risk of both AFib and stroke, point-of-care screening might be an efficient use of handheld ECGs, Dr. Lubitz said.

“The technology simply requires patients to place their fingers on the device to record an electrocardiogram and can be easily embedded in the routine clinical practice of primary care physicians,” he said in an interview.

The typical person has a 30% lifetime risk of developing AFib, and the chances of experiencing a stroke associated with the arrhythmia can be reduced significantly with anticoagulants, Dr. Lubitz said.

Professional organizations are split about the utility of screening for AFib. The European Society of Cardiology recommends opportunistic screening with either pulse palpation or ECG rhythm strip at clinic visits for patients 65 and older. The National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand have issued similar guidelines.

However, screening for AFib is not considered standard of care in the United States – although Dr. Lubitz predicted that that would change.

“I think the guidelines in the United States will evolve in the next few years, because I think we’re getting closer to understanding who we should be screening for atrial fibrillation and how we should be screening,” Dr. Lubitz told this news organization.
 

‘Very reassuring’ results

The randomized controlled trial found that for patients 85 and older, use of handheld ECGs led to a nearly 2% increase in new diagnoses of AFib in the screening group compared to conventional care.

The researchers also demonstrated an increased likelihood of diagnosing AFib during the patient’s primary-care encounter than at other sites, such as the emergency department or inpatient settings that might be more costly and resource-intensive. Moreover, the study reported that point-of-care screening was associated with high rates of oral anticoagulation prescriptions written for patients with newly diagnosed AFib, a finding Dr. Lubitz called “very reassuring.”

The Mass General researchers used single-lead devices attached to a tablet computer to screen more than 35,000 men and women from 16 primary care sites affiliated with the hospital’s practice-based research network.

Half the sites were randomly selected to include the screening intervention, where medical assistants used handheld ECGs at the start of the visit while checking routine vital signs.

The 1-year study screened 91% of eligible patients, demonstrating that single-lead rhythm assessment is feasible as part of routine primary care practice, Dr. Lubitz said. This finding supports other studies suggesting that handheld devices can enable rapid and scalable mass screening.

“We demonstrated that integration into routine practice by clinical personnel – in this case, medical assistants – is feasible. No study has measured and demonstrated such a high integration with routine care, reflecting both patient interest in screening and feasibility of incorporating screening into busy clinical practices,” Dr. Lubitz said.

Mobile ECGs with the handheld device take about 30 seconds to perform. In contrast, standard ECGs used in outpatient practices are bulky, and recording the ECG can take roughly 10 minutes.

Anthony Leazzo, DO, chairman of family practice at Northwestern Medicine Delnor Hospital, in Geneva, Ill., noted that smartwatches provide an alternative technology for detecting AFib.

But “a handheld, one-lead device would be more beneficial and should be more sensitive by measuring electrical activity similar to a normal ECG,” he said.

However, Dr. Leazzo said using such technology would need to be cost-effective because the patients at highest risk for AFib usually are on fixed incomes. Consumer versions of the devices can cost under $100. Dr. Lubitz said the actual cost for devices and a software platform used for a medical enterprise may differ.

Handheld ECGs are gradually being integrated into clinical practices, a trend driven by the rapid growth of telemedicine to remotely assess patients, Dr. Lubitz said.

“Our work affirmed that single-lead devices generate information for the physician that is actionable, though the proportion of newly detected AFib cases using a point-of-care ECG screening approach is likely to be very small,” Dr. Lubitz said in an interview. “For that reason, we think handheld devices are best deployed for people at the highest risk of AFib and stroke, and age is an excellent surrogate for that determination.”

The study was funded by Bristol-Myers Squibb–Pfizer Alliance.

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

Should screening elderly patients for atrial fibrillation (AFib) during primary care visits be as routine as checking blood pressure, respiration, and other vital signs? A new study says the answer is “maybe” for some people.

The use of handheld, single-lead electrocardiograms (ECGs) did not increase diagnoses of AFib overall in patients aged 65 and older, but it did in patients 85 and up, researchers reported in Circulation.

“Incorporating single-lead ECGs into routine medical assessments as a new vital sign was widely feasible. Over 90% of people who were offered screening agreed to it and underwent screening,” said Steven Lubitz, MD, of the Cardiac Arrhythmia Service and Cardiovascular Research Center at Massachusetts General Hospital, Boston, who led the study.

Because advanced age is associated with a substantially increased risk of both AFib and stroke, point-of-care screening might be an efficient use of handheld ECGs, Dr. Lubitz said.

“The technology simply requires patients to place their fingers on the device to record an electrocardiogram and can be easily embedded in the routine clinical practice of primary care physicians,” he said in an interview.

The typical person has a 30% lifetime risk of developing AFib, and the chances of experiencing a stroke associated with the arrhythmia can be reduced significantly with anticoagulants, Dr. Lubitz said.

Professional organizations are split about the utility of screening for AFib. The European Society of Cardiology recommends opportunistic screening with either pulse palpation or ECG rhythm strip at clinic visits for patients 65 and older. The National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand have issued similar guidelines.

However, screening for AFib is not considered standard of care in the United States – although Dr. Lubitz predicted that that would change.

“I think the guidelines in the United States will evolve in the next few years, because I think we’re getting closer to understanding who we should be screening for atrial fibrillation and how we should be screening,” Dr. Lubitz told this news organization.
 

‘Very reassuring’ results

The randomized controlled trial found that for patients 85 and older, use of handheld ECGs led to a nearly 2% increase in new diagnoses of AFib in the screening group compared to conventional care.

The researchers also demonstrated an increased likelihood of diagnosing AFib during the patient’s primary-care encounter than at other sites, such as the emergency department or inpatient settings that might be more costly and resource-intensive. Moreover, the study reported that point-of-care screening was associated with high rates of oral anticoagulation prescriptions written for patients with newly diagnosed AFib, a finding Dr. Lubitz called “very reassuring.”

The Mass General researchers used single-lead devices attached to a tablet computer to screen more than 35,000 men and women from 16 primary care sites affiliated with the hospital’s practice-based research network.

Half the sites were randomly selected to include the screening intervention, where medical assistants used handheld ECGs at the start of the visit while checking routine vital signs.

The 1-year study screened 91% of eligible patients, demonstrating that single-lead rhythm assessment is feasible as part of routine primary care practice, Dr. Lubitz said. This finding supports other studies suggesting that handheld devices can enable rapid and scalable mass screening.

“We demonstrated that integration into routine practice by clinical personnel – in this case, medical assistants – is feasible. No study has measured and demonstrated such a high integration with routine care, reflecting both patient interest in screening and feasibility of incorporating screening into busy clinical practices,” Dr. Lubitz said.

Mobile ECGs with the handheld device take about 30 seconds to perform. In contrast, standard ECGs used in outpatient practices are bulky, and recording the ECG can take roughly 10 minutes.

Anthony Leazzo, DO, chairman of family practice at Northwestern Medicine Delnor Hospital, in Geneva, Ill., noted that smartwatches provide an alternative technology for detecting AFib.

But “a handheld, one-lead device would be more beneficial and should be more sensitive by measuring electrical activity similar to a normal ECG,” he said.

However, Dr. Leazzo said using such technology would need to be cost-effective because the patients at highest risk for AFib usually are on fixed incomes. Consumer versions of the devices can cost under $100. Dr. Lubitz said the actual cost for devices and a software platform used for a medical enterprise may differ.

Handheld ECGs are gradually being integrated into clinical practices, a trend driven by the rapid growth of telemedicine to remotely assess patients, Dr. Lubitz said.

“Our work affirmed that single-lead devices generate information for the physician that is actionable, though the proportion of newly detected AFib cases using a point-of-care ECG screening approach is likely to be very small,” Dr. Lubitz said in an interview. “For that reason, we think handheld devices are best deployed for people at the highest risk of AFib and stroke, and age is an excellent surrogate for that determination.”

The study was funded by Bristol-Myers Squibb–Pfizer Alliance.

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

Adults with a congenital heart defect (CHD) are at increased risk for serious illness and death when hospitalized with COVID-19, making vaccination and other preventive measures even important in this population, say researchers with the Centers for Disease Control and Prevention.

“We found that hospitalized patients with heart defects are up to twice as likely to have critical outcomes of COVID-19 illness (admission to the intensive care unit, use of a ventilator to help with breathing, or death) compared to hospitalized COVID-19 patients without heart defects,” Karrie Downing, MPH, epidemiologist, with the CDC’s National Center on Birth Defects and Developmental Disabilities, said in an interview.

“Additionally, we learned that people with hearts defects who were older or who also had other conditions like heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity were the most likely to have critical COVID-19 illness, but children and adults with heart defects without these other conditions were still at increased risk,” Ms. Downing said.

The message for health care providers is clear: “Encourage your patients with heart defects to get vaccinated and discuss with your patients the need for other preventive measures to avoid infection that may progress to severe COVID-19 illness,” Ms. Downing added.

The study was published online March 7, 2022, in Circulation.

The researchers analyzed data on 235,638 patients hospitalized with COVID-19 between March 2020 and January 2021, including 421 (0.2%) with CHD. Most CHD patients were older than 30 years (73%) and 61% were men, with 55% non-Hispanic white, 19% Hispanic and 16% non-Hispanic Black.

Overall, 68% of CHD patients had at least one comorbidity, as did 59% of patients without CHD.

Rates of ICU admission were higher in the CHD group (54% vs. 43%), as were rates of invasive mechanical ventilation (24% vs. 15%) and in-hospital death (11% vs. 7%).

After accounting for patient characteristics, ICU admission, invasive mechanical ventilation and death were more prevalent among COVID-19 patients with rather than without CHD, with adjusted prevalence ratios of 1.4, 1.8 and 2.0, respectively.

When stratified by high-risk characteristics, prevalence estimates for ICU admission, invasive mechanical ventilation and death remained higher among patients with COVID-19 and CHD across nearly all strata, including younger age groups and those without heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity, the researchers reported.

Ms. Downing said more work is needed to identify why the clinical course of COVID-19 disease results in admission to the ICU, the need for a ventilator, or death for some hospitalized patients with CHD and not for others.

“There could be a number of social, environmental, economic, medical, and genetic factors playing a role. But staying up to date with COVID-19 vaccines and following preventive measures for COVID-19 are effective ways to reduce the risk of severe illness from COVID-19,” Ms. Downing said.

The study had no specific funding. The authors reported no relevant disclosures.

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

Adults with a congenital heart defect (CHD) are at increased risk for serious illness and death when hospitalized with COVID-19, making vaccination and other preventive measures even important in this population, say researchers with the Centers for Disease Control and Prevention.

“We found that hospitalized patients with heart defects are up to twice as likely to have critical outcomes of COVID-19 illness (admission to the intensive care unit, use of a ventilator to help with breathing, or death) compared to hospitalized COVID-19 patients without heart defects,” Karrie Downing, MPH, epidemiologist, with the CDC’s National Center on Birth Defects and Developmental Disabilities, said in an interview.

“Additionally, we learned that people with hearts defects who were older or who also had other conditions like heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity were the most likely to have critical COVID-19 illness, but children and adults with heart defects without these other conditions were still at increased risk,” Ms. Downing said.

The message for health care providers is clear: “Encourage your patients with heart defects to get vaccinated and discuss with your patients the need for other preventive measures to avoid infection that may progress to severe COVID-19 illness,” Ms. Downing added.

The study was published online March 7, 2022, in Circulation.

The researchers analyzed data on 235,638 patients hospitalized with COVID-19 between March 2020 and January 2021, including 421 (0.2%) with CHD. Most CHD patients were older than 30 years (73%) and 61% were men, with 55% non-Hispanic white, 19% Hispanic and 16% non-Hispanic Black.

Overall, 68% of CHD patients had at least one comorbidity, as did 59% of patients without CHD.

Rates of ICU admission were higher in the CHD group (54% vs. 43%), as were rates of invasive mechanical ventilation (24% vs. 15%) and in-hospital death (11% vs. 7%).

After accounting for patient characteristics, ICU admission, invasive mechanical ventilation and death were more prevalent among COVID-19 patients with rather than without CHD, with adjusted prevalence ratios of 1.4, 1.8 and 2.0, respectively.

When stratified by high-risk characteristics, prevalence estimates for ICU admission, invasive mechanical ventilation and death remained higher among patients with COVID-19 and CHD across nearly all strata, including younger age groups and those without heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity, the researchers reported.

Ms. Downing said more work is needed to identify why the clinical course of COVID-19 disease results in admission to the ICU, the need for a ventilator, or death for some hospitalized patients with CHD and not for others.

“There could be a number of social, environmental, economic, medical, and genetic factors playing a role. But staying up to date with COVID-19 vaccines and following preventive measures for COVID-19 are effective ways to reduce the risk of severe illness from COVID-19,” Ms. Downing said.

The study had no specific funding. The authors reported no relevant disclosures.

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

Adults with a congenital heart defect (CHD) are at increased risk for serious illness and death when hospitalized with COVID-19, making vaccination and other preventive measures even important in this population, say researchers with the Centers for Disease Control and Prevention.

“We found that hospitalized patients with heart defects are up to twice as likely to have critical outcomes of COVID-19 illness (admission to the intensive care unit, use of a ventilator to help with breathing, or death) compared to hospitalized COVID-19 patients without heart defects,” Karrie Downing, MPH, epidemiologist, with the CDC’s National Center on Birth Defects and Developmental Disabilities, said in an interview.

“Additionally, we learned that people with hearts defects who were older or who also had other conditions like heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity were the most likely to have critical COVID-19 illness, but children and adults with heart defects without these other conditions were still at increased risk,” Ms. Downing said.

The message for health care providers is clear: “Encourage your patients with heart defects to get vaccinated and discuss with your patients the need for other preventive measures to avoid infection that may progress to severe COVID-19 illness,” Ms. Downing added.

The study was published online March 7, 2022, in Circulation.

The researchers analyzed data on 235,638 patients hospitalized with COVID-19 between March 2020 and January 2021, including 421 (0.2%) with CHD. Most CHD patients were older than 30 years (73%) and 61% were men, with 55% non-Hispanic white, 19% Hispanic and 16% non-Hispanic Black.

Overall, 68% of CHD patients had at least one comorbidity, as did 59% of patients without CHD.

Rates of ICU admission were higher in the CHD group (54% vs. 43%), as were rates of invasive mechanical ventilation (24% vs. 15%) and in-hospital death (11% vs. 7%).

After accounting for patient characteristics, ICU admission, invasive mechanical ventilation and death were more prevalent among COVID-19 patients with rather than without CHD, with adjusted prevalence ratios of 1.4, 1.8 and 2.0, respectively.

When stratified by high-risk characteristics, prevalence estimates for ICU admission, invasive mechanical ventilation and death remained higher among patients with COVID-19 and CHD across nearly all strata, including younger age groups and those without heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity, the researchers reported.

Ms. Downing said more work is needed to identify why the clinical course of COVID-19 disease results in admission to the ICU, the need for a ventilator, or death for some hospitalized patients with CHD and not for others.

“There could be a number of social, environmental, economic, medical, and genetic factors playing a role. But staying up to date with COVID-19 vaccines and following preventive measures for COVID-19 are effective ways to reduce the risk of severe illness from COVID-19,” Ms. Downing said.

The study had no specific funding. The authors reported no relevant disclosures.

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

People taking immunosuppressive drugs benefit significantly from SARS-CoV-2 vaccines approved in the United States to prevent and reduce the severity of COVID-19, according to the first study to quantify the vaccines’ real-world effectiveness in this population.

Researchers’ analysis of the electronic medical records of more than 150,000 people in the University of Michigan’s health care system showed that even after becoming fully vaccinated, immunosuppressed individuals remain at higher risk for COVID-19 than are vaccinated people in the wider population who aren’t receiving immunosuppressive therapy. However, they still derive benefit from vaccination, particularly when bolstered with a booster dose.

BrianAJackson/Thinkstock

The study, published online in Annals of the Rheumatic Diseases, also claims to be the first to show that the Moderna (mRNA-1273) vaccine is as effective as the Pfizer-BioNTech (BNT162b2) vaccine for people taking immunosuppressants.

“Booster doses are effective and important for individuals on immunosuppressants,” corresponding author Lili Zhao, PhD, a research associate professor in biostatistics at the University of Michigan, Ann Arbor, said in an interview. “Previous studies focused mostly on the Pfizer vaccine, whereas our study is the first that also investigates the Moderna vaccine in a large, immunosuppressed population.”

The epidemiologic study included 154,519 fully vaccinated and unvaccinated adults in the Michigan Medicine electronic health record database. Participants were considered fully vaccinated if they were within 2 weeks of having received a second dose of the Pfizer-BioNTech and Moderna vaccines or the single-dose Johnson & Johnson (Ad26.COV2.S) vaccine. The study population included 5,536 immunosuppressed patients; of those, 4,283 were fully vaccinated, and 1,253 were unvaccinated.

The researchers focused on data collected from Jan. 1 to Dec. 7, 2021, so the study doesn’t cover the Omicron variant. “The conclusions for immunosuppressed individuals are likely to remain the same during the Omicron period,” Dr. Zhao said. “We are currently investigating this.” Johnson & Johnson paused production of its vaccine in February.

The researchers found that, among unvaccinated individuals, the immunosuppressed group had about a 40% higher risk of infection than did the immunocompetent patients (hazard ratio, 1.398; 95% confidence interval, 1.068-1.829; P = .0075) but a similar risk of COVID-19 hospitalization (HR, 0.951; 95% CI, 0.435-2.080; P = .9984). For the fully vaccinated, the gap was significantly wider: Immunosuppressed patients had more than double the risk of infection (HR, 2.173; 95% CI, 1.690-2.794; P < .0001) and almost five times the risk of hospitalization (HR, 4.861; 95% CI, 2.238-10.56; P < .0001), compared with immunocompetent patients.

However, among immunosuppressed individuals, the vaccinations significantly lowered risks, compared with not being vaccinated. There was a statistically significant 45% lower risk of infection (HR, 0.550; 95% CI, 0.387-0.781; P = .001) and similarly lower risk of hospitalization that did not reach statistical significance (HR, 0.534; 95% CI, 0.196-1.452; P = .3724).

When those immunosuppressed patients received a booster dose, their protection against COVID-19 improved, compared with their immunosuppressed counterparts who didn’t get a booster, with a 58% lower risk of infection after adjustment for age, gender, race, and Charlson Comorbidity Index (adjusted HR, 0.42; 95% CI, 0.24-0.76; P = .0037). The study included nearly 4 months of data after the Centers for Disease Control and Prevention recommended a booster dose of the Moderna and Pfizer-BioNTech vaccines for immunocompromised individuals in August 2021. Among the immunosuppressed patients, 38.5% had received a booster dose.

There also was no apparent difference in the effectiveness between the Moderna and Pfizer-BioNTech vaccines, with adjusted hazard ratios showing 41%-48% lower risk of infection. Too few individuals in the study were vaccinated with the Johnson & Johnson vaccine to enable a sufficiently powered calculation of its effectiveness.

Other studies reach similar conclusions

The study findings fall into line with other studies of patient populations on immunosuppressants. A retrospective cohort study of Veterans Affairs patients with inflammatory bowel disease who were taking immunosuppressants, published in Gastroenterology, found that full vaccination with either Moderna and Pfizer-BioNTech vaccines was about 80% effective. Another retrospective cohort study of data from the National COVID Cohort Collaborative, published in JAMA Internal Medicine, reported that full vaccination significantly reduced the risk of COVID-19 breakthrough infection regardless of immune status. Immunosuppressed patients in this study had higher rates of breakthrough infections than immunocompetent patients, but the disparities were in line with what Dr. Zhao and the University of Michigan researchers reported.

A review of 23 studies of COVID-19 vaccinations, published in Lancet Global Health, found that immunocompromised people – 1,722 of whom were included in the studies – had lower rates of producing antibodies after two vaccine doses than did immunocompetent people, ranging from 27% to 92%, depending on the nature of their immunocompromised status, compared with 99% for the immunocompetent.
 

Strengths and limitations

One strength of the Michigan study is the quality of data, which were drawn from the Michigan Medicine electronic health record, Dr. Zhao said. “So, we know who received the vaccine and who didn’t. We also have access to data on patient health conditions, such as comorbidities, in addition to demographic variables (age, gender, and race), which were controlled in making fair comparisons between immunosuppressants and immunocompetent groups.”

Alfred Kim, MD, PhD, an assistant professor of internal medicine and rheumatology at Washington University in St. Louis, who was not involved with the study, credited Dr. Zhao and associates for delivering the first data that specifically quantified COVID-19 risk reduction in a large study population. Although he noted that the large sample size and the design reduced the chances of confounding and were strengths, he said in an interview that “lumping” the patients taking immunosuppressive drugs into one group was a weakness of the study.

“Clearly, there are certain medications (B-cell depleters, mycophenolate, for example) that carry the greatest risk of poor antibody responses post vaccination,” he said. “One would have to guess that the greatest risk of breakthrough infections continues to be in those patients taking these high-risk medications.”

Another possible problem, which the authors acknowledged, is spotty SARS-CoV-2 testing of study participants – “a systemic issue,” Dr. Kim noted.

“The easiest and most durable way to reduce the risk of getting COVID-19 is through vaccination, period,” he said. “Now we have infection-rates data from a real-world study cohort to prove this. Furthermore, boosting clearly provides additional benefit to this population.”

The National Institute of Allergy and Infectious Diseases provided funding for the study. Dr. Zhao, Dr. Zhao’s coauthors, and Kim disclosed no relevant financial relationships.

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

People taking immunosuppressive drugs benefit significantly from SARS-CoV-2 vaccines approved in the United States to prevent and reduce the severity of COVID-19, according to the first study to quantify the vaccines’ real-world effectiveness in this population.

Researchers’ analysis of the electronic medical records of more than 150,000 people in the University of Michigan’s health care system showed that even after becoming fully vaccinated, immunosuppressed individuals remain at higher risk for COVID-19 than are vaccinated people in the wider population who aren’t receiving immunosuppressive therapy. However, they still derive benefit from vaccination, particularly when bolstered with a booster dose.

BrianAJackson/Thinkstock

The study, published online in Annals of the Rheumatic Diseases, also claims to be the first to show that the Moderna (mRNA-1273) vaccine is as effective as the Pfizer-BioNTech (BNT162b2) vaccine for people taking immunosuppressants.

“Booster doses are effective and important for individuals on immunosuppressants,” corresponding author Lili Zhao, PhD, a research associate professor in biostatistics at the University of Michigan, Ann Arbor, said in an interview. “Previous studies focused mostly on the Pfizer vaccine, whereas our study is the first that also investigates the Moderna vaccine in a large, immunosuppressed population.”

The epidemiologic study included 154,519 fully vaccinated and unvaccinated adults in the Michigan Medicine electronic health record database. Participants were considered fully vaccinated if they were within 2 weeks of having received a second dose of the Pfizer-BioNTech and Moderna vaccines or the single-dose Johnson & Johnson (Ad26.COV2.S) vaccine. The study population included 5,536 immunosuppressed patients; of those, 4,283 were fully vaccinated, and 1,253 were unvaccinated.

The researchers focused on data collected from Jan. 1 to Dec. 7, 2021, so the study doesn’t cover the Omicron variant. “The conclusions for immunosuppressed individuals are likely to remain the same during the Omicron period,” Dr. Zhao said. “We are currently investigating this.” Johnson & Johnson paused production of its vaccine in February.

The researchers found that, among unvaccinated individuals, the immunosuppressed group had about a 40% higher risk of infection than did the immunocompetent patients (hazard ratio, 1.398; 95% confidence interval, 1.068-1.829; P = .0075) but a similar risk of COVID-19 hospitalization (HR, 0.951; 95% CI, 0.435-2.080; P = .9984). For the fully vaccinated, the gap was significantly wider: Immunosuppressed patients had more than double the risk of infection (HR, 2.173; 95% CI, 1.690-2.794; P < .0001) and almost five times the risk of hospitalization (HR, 4.861; 95% CI, 2.238-10.56; P < .0001), compared with immunocompetent patients.

However, among immunosuppressed individuals, the vaccinations significantly lowered risks, compared with not being vaccinated. There was a statistically significant 45% lower risk of infection (HR, 0.550; 95% CI, 0.387-0.781; P = .001) and similarly lower risk of hospitalization that did not reach statistical significance (HR, 0.534; 95% CI, 0.196-1.452; P = .3724).

When those immunosuppressed patients received a booster dose, their protection against COVID-19 improved, compared with their immunosuppressed counterparts who didn’t get a booster, with a 58% lower risk of infection after adjustment for age, gender, race, and Charlson Comorbidity Index (adjusted HR, 0.42; 95% CI, 0.24-0.76; P = .0037). The study included nearly 4 months of data after the Centers for Disease Control and Prevention recommended a booster dose of the Moderna and Pfizer-BioNTech vaccines for immunocompromised individuals in August 2021. Among the immunosuppressed patients, 38.5% had received a booster dose.

There also was no apparent difference in the effectiveness between the Moderna and Pfizer-BioNTech vaccines, with adjusted hazard ratios showing 41%-48% lower risk of infection. Too few individuals in the study were vaccinated with the Johnson & Johnson vaccine to enable a sufficiently powered calculation of its effectiveness.

Other studies reach similar conclusions

The study findings fall into line with other studies of patient populations on immunosuppressants. A retrospective cohort study of Veterans Affairs patients with inflammatory bowel disease who were taking immunosuppressants, published in Gastroenterology, found that full vaccination with either Moderna and Pfizer-BioNTech vaccines was about 80% effective. Another retrospective cohort study of data from the National COVID Cohort Collaborative, published in JAMA Internal Medicine, reported that full vaccination significantly reduced the risk of COVID-19 breakthrough infection regardless of immune status. Immunosuppressed patients in this study had higher rates of breakthrough infections than immunocompetent patients, but the disparities were in line with what Dr. Zhao and the University of Michigan researchers reported.

A review of 23 studies of COVID-19 vaccinations, published in Lancet Global Health, found that immunocompromised people – 1,722 of whom were included in the studies – had lower rates of producing antibodies after two vaccine doses than did immunocompetent people, ranging from 27% to 92%, depending on the nature of their immunocompromised status, compared with 99% for the immunocompetent.
 

Strengths and limitations

One strength of the Michigan study is the quality of data, which were drawn from the Michigan Medicine electronic health record, Dr. Zhao said. “So, we know who received the vaccine and who didn’t. We also have access to data on patient health conditions, such as comorbidities, in addition to demographic variables (age, gender, and race), which were controlled in making fair comparisons between immunosuppressants and immunocompetent groups.”

Alfred Kim, MD, PhD, an assistant professor of internal medicine and rheumatology at Washington University in St. Louis, who was not involved with the study, credited Dr. Zhao and associates for delivering the first data that specifically quantified COVID-19 risk reduction in a large study population. Although he noted that the large sample size and the design reduced the chances of confounding and were strengths, he said in an interview that “lumping” the patients taking immunosuppressive drugs into one group was a weakness of the study.

“Clearly, there are certain medications (B-cell depleters, mycophenolate, for example) that carry the greatest risk of poor antibody responses post vaccination,” he said. “One would have to guess that the greatest risk of breakthrough infections continues to be in those patients taking these high-risk medications.”

Another possible problem, which the authors acknowledged, is spotty SARS-CoV-2 testing of study participants – “a systemic issue,” Dr. Kim noted.

“The easiest and most durable way to reduce the risk of getting COVID-19 is through vaccination, period,” he said. “Now we have infection-rates data from a real-world study cohort to prove this. Furthermore, boosting clearly provides additional benefit to this population.”

The National Institute of Allergy and Infectious Diseases provided funding for the study. Dr. Zhao, Dr. Zhao’s coauthors, and Kim disclosed no relevant financial relationships.

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

People taking immunosuppressive drugs benefit significantly from SARS-CoV-2 vaccines approved in the United States to prevent and reduce the severity of COVID-19, according to the first study to quantify the vaccines’ real-world effectiveness in this population.

Researchers’ analysis of the electronic medical records of more than 150,000 people in the University of Michigan’s health care system showed that even after becoming fully vaccinated, immunosuppressed individuals remain at higher risk for COVID-19 than are vaccinated people in the wider population who aren’t receiving immunosuppressive therapy. However, they still derive benefit from vaccination, particularly when bolstered with a booster dose.

BrianAJackson/Thinkstock

The study, published online in Annals of the Rheumatic Diseases, also claims to be the first to show that the Moderna (mRNA-1273) vaccine is as effective as the Pfizer-BioNTech (BNT162b2) vaccine for people taking immunosuppressants.

“Booster doses are effective and important for individuals on immunosuppressants,” corresponding author Lili Zhao, PhD, a research associate professor in biostatistics at the University of Michigan, Ann Arbor, said in an interview. “Previous studies focused mostly on the Pfizer vaccine, whereas our study is the first that also investigates the Moderna vaccine in a large, immunosuppressed population.”

The epidemiologic study included 154,519 fully vaccinated and unvaccinated adults in the Michigan Medicine electronic health record database. Participants were considered fully vaccinated if they were within 2 weeks of having received a second dose of the Pfizer-BioNTech and Moderna vaccines or the single-dose Johnson & Johnson (Ad26.COV2.S) vaccine. The study population included 5,536 immunosuppressed patients; of those, 4,283 were fully vaccinated, and 1,253 were unvaccinated.

The researchers focused on data collected from Jan. 1 to Dec. 7, 2021, so the study doesn’t cover the Omicron variant. “The conclusions for immunosuppressed individuals are likely to remain the same during the Omicron period,” Dr. Zhao said. “We are currently investigating this.” Johnson & Johnson paused production of its vaccine in February.

The researchers found that, among unvaccinated individuals, the immunosuppressed group had about a 40% higher risk of infection than did the immunocompetent patients (hazard ratio, 1.398; 95% confidence interval, 1.068-1.829; P = .0075) but a similar risk of COVID-19 hospitalization (HR, 0.951; 95% CI, 0.435-2.080; P = .9984). For the fully vaccinated, the gap was significantly wider: Immunosuppressed patients had more than double the risk of infection (HR, 2.173; 95% CI, 1.690-2.794; P < .0001) and almost five times the risk of hospitalization (HR, 4.861; 95% CI, 2.238-10.56; P < .0001), compared with immunocompetent patients.

However, among immunosuppressed individuals, the vaccinations significantly lowered risks, compared with not being vaccinated. There was a statistically significant 45% lower risk of infection (HR, 0.550; 95% CI, 0.387-0.781; P = .001) and similarly lower risk of hospitalization that did not reach statistical significance (HR, 0.534; 95% CI, 0.196-1.452; P = .3724).

When those immunosuppressed patients received a booster dose, their protection against COVID-19 improved, compared with their immunosuppressed counterparts who didn’t get a booster, with a 58% lower risk of infection after adjustment for age, gender, race, and Charlson Comorbidity Index (adjusted HR, 0.42; 95% CI, 0.24-0.76; P = .0037). The study included nearly 4 months of data after the Centers for Disease Control and Prevention recommended a booster dose of the Moderna and Pfizer-BioNTech vaccines for immunocompromised individuals in August 2021. Among the immunosuppressed patients, 38.5% had received a booster dose.

There also was no apparent difference in the effectiveness between the Moderna and Pfizer-BioNTech vaccines, with adjusted hazard ratios showing 41%-48% lower risk of infection. Too few individuals in the study were vaccinated with the Johnson & Johnson vaccine to enable a sufficiently powered calculation of its effectiveness.

Other studies reach similar conclusions

The study findings fall into line with other studies of patient populations on immunosuppressants. A retrospective cohort study of Veterans Affairs patients with inflammatory bowel disease who were taking immunosuppressants, published in Gastroenterology, found that full vaccination with either Moderna and Pfizer-BioNTech vaccines was about 80% effective. Another retrospective cohort study of data from the National COVID Cohort Collaborative, published in JAMA Internal Medicine, reported that full vaccination significantly reduced the risk of COVID-19 breakthrough infection regardless of immune status. Immunosuppressed patients in this study had higher rates of breakthrough infections than immunocompetent patients, but the disparities were in line with what Dr. Zhao and the University of Michigan researchers reported.

A review of 23 studies of COVID-19 vaccinations, published in Lancet Global Health, found that immunocompromised people – 1,722 of whom were included in the studies – had lower rates of producing antibodies after two vaccine doses than did immunocompetent people, ranging from 27% to 92%, depending on the nature of their immunocompromised status, compared with 99% for the immunocompetent.
 

Strengths and limitations

One strength of the Michigan study is the quality of data, which were drawn from the Michigan Medicine electronic health record, Dr. Zhao said. “So, we know who received the vaccine and who didn’t. We also have access to data on patient health conditions, such as comorbidities, in addition to demographic variables (age, gender, and race), which were controlled in making fair comparisons between immunosuppressants and immunocompetent groups.”

Alfred Kim, MD, PhD, an assistant professor of internal medicine and rheumatology at Washington University in St. Louis, who was not involved with the study, credited Dr. Zhao and associates for delivering the first data that specifically quantified COVID-19 risk reduction in a large study population. Although he noted that the large sample size and the design reduced the chances of confounding and were strengths, he said in an interview that “lumping” the patients taking immunosuppressive drugs into one group was a weakness of the study.

“Clearly, there are certain medications (B-cell depleters, mycophenolate, for example) that carry the greatest risk of poor antibody responses post vaccination,” he said. “One would have to guess that the greatest risk of breakthrough infections continues to be in those patients taking these high-risk medications.”

Another possible problem, which the authors acknowledged, is spotty SARS-CoV-2 testing of study participants – “a systemic issue,” Dr. Kim noted.

“The easiest and most durable way to reduce the risk of getting COVID-19 is through vaccination, period,” he said. “Now we have infection-rates data from a real-world study cohort to prove this. Furthermore, boosting clearly provides additional benefit to this population.”

The National Institute of Allergy and Infectious Diseases provided funding for the study. Dr. Zhao, Dr. Zhao’s coauthors, and Kim disclosed no relevant financial relationships.

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

At the American College of Cardiology’s 70th annual scientific sessions, 93% of the results from the late-breaking clinical trial sessions and featured clinical research sessions were presented by men.

Although women were well represented on panels, and chaired or cochaired sessions, thanks to the ACC’s ongoing efforts to promote gender diversity and inclusion, they rarely got to give the big talks.

“Unfortunately, women continue to be underrepresented among CV clinical trial leadership, leading to a lack of subject diversity,” Mary Norine Walsh, MD, medical director of heart failure and cardiac transplantation at Ascension St. Vincent Heart Center, Indianapolis, Ind., wrote in a review published online Feb. 28 in the Journal of the American College of Cardiology.

An analysis of cardiovascular trials published during the past 4 years showed that women comprised only 10.1% of clinical trial leadership committees, and more than half of the trials had no women at all as part of the trial leadership team. About 10% of the trials had a woman as first or senior author.

In an interview, Dr. Walsh said she was prompted to write her review because she found the absence of women presenters at ACC 21 so striking.

“ACC 21 was held virtually because of COVID. This gave me the opportunity to easily view all of the research sessions. I attended all of the late-breaking clinical trials and featured clinical research sessions live while they were being presented, and it slowly dawned on me as I was watching that the vast majority of the presenters were men,” she said.

“The ACC does what it can to ensure a good gender mix of panelists and session chairs, but what it cannot control is who presents the data. The fact that 93% of these talks were given by men was astonishing to me,” Dr. Walsh said.

Of the three trials presented by women, one was on sex-specific outcomes in high-risk patients receiving ticagrelor with or without aspirin after percutaneous coronary intervention (a subanalysis of the TWILIGHT study); one was on the impact of COVID-19 on the global cardiovascular workforce (the ACC 2020 Well Being Study); and one was on the prevention of cardiac dysfunction during adjuvanttherapy with candesartan and metoprolol (the PRADA study).

Most of the presenters were regulars at the ACC podium. As Dr. Walsh observed: “This was assuredly not the inaugural turn at the international podium for these male trial presenters.”

So why are women so noticeably absent among the leaders of cardiovascular clinical trials research?

The root cause for this underrepresentation begins with the low number of women who lead clinical trials in cardiovascular medicine and surgery, and the fact that there are fewer female cardiologists than male cardiologists to begin with.

Then there is the lack of mentorship, which, Dr. Walsh said, “really does occur along gendered lines, with men mentoring men.”

In addition, industry-funded trials tend to feed a nondiverse investigator pipeline and other research collaborations often encompass established networks, Dr. Walsh noted.

“When industry is embarking on a new trial of a drug or device, it tends to lean back on who they have had led before. It really gets down to who you know, so getting new people in is fairly difficult,” she said.

Several initiatives to increase diversity in CV clinical trial leadership are ongoing by the ACC and other organizations.

For example, Women as One gives “escalator awards” to boost or escalate the training of highly qualified female cardiologists through targeted funding, mentorship, and networking.

The ACC’s “Clinical Trial Research: Upping Your Game” program aims to develop and train the next generation of a diverse and inclusive clinical trials workforce, focusing not only on women but on other traditionally underrepresented groups.

“We’re now in our third cohort of investigators who are early in their careers. We’re arming them with the skills to become successful in becoming investigators and then going up the chain to trial leadership. We are focusing our efforts on those who are underrepresented in cardiology – women, native Americans, Latinx, and Black investigators. We are hoping to increase diversity through that way, but more still needs to be done,” she said.

Trial sponsors, whether federally funded or industry sponsored, need to insist on diversity of the trial steering committee, and principal investigators need to consider diversity.

“A rethinking of who is eligible to present important trial results is needed,” Dr. Walsh said.

“The informal, or formal, pecking order of CV trial leadership needs to be reworked. All members of the steering committee should be possible presenters, and women should not be asked to report late-breaking results of trials that are reporting sex-specific results or data that are pertinent only to a female population.”

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

At the American College of Cardiology’s 70th annual scientific sessions, 93% of the results from the late-breaking clinical trial sessions and featured clinical research sessions were presented by men.

Although women were well represented on panels, and chaired or cochaired sessions, thanks to the ACC’s ongoing efforts to promote gender diversity and inclusion, they rarely got to give the big talks.

“Unfortunately, women continue to be underrepresented among CV clinical trial leadership, leading to a lack of subject diversity,” Mary Norine Walsh, MD, medical director of heart failure and cardiac transplantation at Ascension St. Vincent Heart Center, Indianapolis, Ind., wrote in a review published online Feb. 28 in the Journal of the American College of Cardiology.

An analysis of cardiovascular trials published during the past 4 years showed that women comprised only 10.1% of clinical trial leadership committees, and more than half of the trials had no women at all as part of the trial leadership team. About 10% of the trials had a woman as first or senior author.

In an interview, Dr. Walsh said she was prompted to write her review because she found the absence of women presenters at ACC 21 so striking.

“ACC 21 was held virtually because of COVID. This gave me the opportunity to easily view all of the research sessions. I attended all of the late-breaking clinical trials and featured clinical research sessions live while they were being presented, and it slowly dawned on me as I was watching that the vast majority of the presenters were men,” she said.

“The ACC does what it can to ensure a good gender mix of panelists and session chairs, but what it cannot control is who presents the data. The fact that 93% of these talks were given by men was astonishing to me,” Dr. Walsh said.

Of the three trials presented by women, one was on sex-specific outcomes in high-risk patients receiving ticagrelor with or without aspirin after percutaneous coronary intervention (a subanalysis of the TWILIGHT study); one was on the impact of COVID-19 on the global cardiovascular workforce (the ACC 2020 Well Being Study); and one was on the prevention of cardiac dysfunction during adjuvanttherapy with candesartan and metoprolol (the PRADA study).

Most of the presenters were regulars at the ACC podium. As Dr. Walsh observed: “This was assuredly not the inaugural turn at the international podium for these male trial presenters.”

So why are women so noticeably absent among the leaders of cardiovascular clinical trials research?

The root cause for this underrepresentation begins with the low number of women who lead clinical trials in cardiovascular medicine and surgery, and the fact that there are fewer female cardiologists than male cardiologists to begin with.

Then there is the lack of mentorship, which, Dr. Walsh said, “really does occur along gendered lines, with men mentoring men.”

In addition, industry-funded trials tend to feed a nondiverse investigator pipeline and other research collaborations often encompass established networks, Dr. Walsh noted.

“When industry is embarking on a new trial of a drug or device, it tends to lean back on who they have had led before. It really gets down to who you know, so getting new people in is fairly difficult,” she said.

Several initiatives to increase diversity in CV clinical trial leadership are ongoing by the ACC and other organizations.

For example, Women as One gives “escalator awards” to boost or escalate the training of highly qualified female cardiologists through targeted funding, mentorship, and networking.

The ACC’s “Clinical Trial Research: Upping Your Game” program aims to develop and train the next generation of a diverse and inclusive clinical trials workforce, focusing not only on women but on other traditionally underrepresented groups.

“We’re now in our third cohort of investigators who are early in their careers. We’re arming them with the skills to become successful in becoming investigators and then going up the chain to trial leadership. We are focusing our efforts on those who are underrepresented in cardiology – women, native Americans, Latinx, and Black investigators. We are hoping to increase diversity through that way, but more still needs to be done,” she said.

Trial sponsors, whether federally funded or industry sponsored, need to insist on diversity of the trial steering committee, and principal investigators need to consider diversity.

“A rethinking of who is eligible to present important trial results is needed,” Dr. Walsh said.

“The informal, or formal, pecking order of CV trial leadership needs to be reworked. All members of the steering committee should be possible presenters, and women should not be asked to report late-breaking results of trials that are reporting sex-specific results or data that are pertinent only to a female population.”

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

At the American College of Cardiology’s 70th annual scientific sessions, 93% of the results from the late-breaking clinical trial sessions and featured clinical research sessions were presented by men.

Although women were well represented on panels, and chaired or cochaired sessions, thanks to the ACC’s ongoing efforts to promote gender diversity and inclusion, they rarely got to give the big talks.

“Unfortunately, women continue to be underrepresented among CV clinical trial leadership, leading to a lack of subject diversity,” Mary Norine Walsh, MD, medical director of heart failure and cardiac transplantation at Ascension St. Vincent Heart Center, Indianapolis, Ind., wrote in a review published online Feb. 28 in the Journal of the American College of Cardiology.

An analysis of cardiovascular trials published during the past 4 years showed that women comprised only 10.1% of clinical trial leadership committees, and more than half of the trials had no women at all as part of the trial leadership team. About 10% of the trials had a woman as first or senior author.

In an interview, Dr. Walsh said she was prompted to write her review because she found the absence of women presenters at ACC 21 so striking.

“ACC 21 was held virtually because of COVID. This gave me the opportunity to easily view all of the research sessions. I attended all of the late-breaking clinical trials and featured clinical research sessions live while they were being presented, and it slowly dawned on me as I was watching that the vast majority of the presenters were men,” she said.

“The ACC does what it can to ensure a good gender mix of panelists and session chairs, but what it cannot control is who presents the data. The fact that 93% of these talks were given by men was astonishing to me,” Dr. Walsh said.

Of the three trials presented by women, one was on sex-specific outcomes in high-risk patients receiving ticagrelor with or without aspirin after percutaneous coronary intervention (a subanalysis of the TWILIGHT study); one was on the impact of COVID-19 on the global cardiovascular workforce (the ACC 2020 Well Being Study); and one was on the prevention of cardiac dysfunction during adjuvanttherapy with candesartan and metoprolol (the PRADA study).

Most of the presenters were regulars at the ACC podium. As Dr. Walsh observed: “This was assuredly not the inaugural turn at the international podium for these male trial presenters.”

So why are women so noticeably absent among the leaders of cardiovascular clinical trials research?

The root cause for this underrepresentation begins with the low number of women who lead clinical trials in cardiovascular medicine and surgery, and the fact that there are fewer female cardiologists than male cardiologists to begin with.

Then there is the lack of mentorship, which, Dr. Walsh said, “really does occur along gendered lines, with men mentoring men.”

In addition, industry-funded trials tend to feed a nondiverse investigator pipeline and other research collaborations often encompass established networks, Dr. Walsh noted.

“When industry is embarking on a new trial of a drug or device, it tends to lean back on who they have had led before. It really gets down to who you know, so getting new people in is fairly difficult,” she said.

Several initiatives to increase diversity in CV clinical trial leadership are ongoing by the ACC and other organizations.

For example, Women as One gives “escalator awards” to boost or escalate the training of highly qualified female cardiologists through targeted funding, mentorship, and networking.

The ACC’s “Clinical Trial Research: Upping Your Game” program aims to develop and train the next generation of a diverse and inclusive clinical trials workforce, focusing not only on women but on other traditionally underrepresented groups.

“We’re now in our third cohort of investigators who are early in their careers. We’re arming them with the skills to become successful in becoming investigators and then going up the chain to trial leadership. We are focusing our efforts on those who are underrepresented in cardiology – women, native Americans, Latinx, and Black investigators. We are hoping to increase diversity through that way, but more still needs to be done,” she said.

Trial sponsors, whether federally funded or industry sponsored, need to insist on diversity of the trial steering committee, and principal investigators need to consider diversity.

“A rethinking of who is eligible to present important trial results is needed,” Dr. Walsh said.

“The informal, or formal, pecking order of CV trial leadership needs to be reworked. All members of the steering committee should be possible presenters, and women should not be asked to report late-breaking results of trials that are reporting sex-specific results or data that are pertinent only to a female population.”

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

AGA’s cutting-edge, trainee and early-career focused e-newsletter The New Gastroenterologist (TNG) is seeking applications for the position of editor-in-chief (EIC). The role will facilitate the communication of the latest clinical advances among peers and build strong leadership skills managing editorial responsibilities as well as working with reviewers and fellow editors at AGA’s journals.

The term is from Oct. 1, 2022 – Sept. 30, 2027, with a transition period starting July 2022.

About TNG

TNG content covers highly relevant clinical topics, such as diverticular hemorrhage as well as microscopic colitis and diarrhea. Also included in each issue are articles that focus on career pathways, financial and legal matters, perspectives from private practice, brief reviews on clinically-relevant topics, issues in clinical medical ethics, and other topics that are relevant to early career GIs. Each issue also contains an introductory letter from the editor as well as a curated list of relevant articles from the AGA Journals.

Honorarium

The EIC will receive an annual honorarium of $5,000.

Qualifications

• AGA member, between second year of fellowship and five years post-fellowship. 
• Experience identifying and promoting newsworthy content that is relevant to the trainee and early-career GI community, as well as excellent judgment that expands the outstanding reputation of TNG and AGA.
• Experience in medical, scientific or news-related publishing is preferred, but not required.
• Familiarity with AGA and its priorities, activities and stances on important issues is ideal, preferably via past volunteer member experience with the association.
• The EIC must be able to devote sufficient time to TNG matters and may not accept editorial appointments to competing publications during their tenure as EIC.
   

For more information or to apply view the full request for applications. If you have questions, please contact Ryan Farrell, managing editor, The New Gastroenterologist, at rfarrell@gastro.org.

AGA’s cutting-edge, trainee and early-career focused e-newsletter The New Gastroenterologist (TNG) is seeking applications for the position of editor-in-chief (EIC). The role will facilitate the communication of the latest clinical advances among peers and build strong leadership skills managing editorial responsibilities as well as working with reviewers and fellow editors at AGA’s journals.

The term is from Oct. 1, 2022 – Sept. 30, 2027, with a transition period starting July 2022.

About TNG

TNG content covers highly relevant clinical topics, such as diverticular hemorrhage as well as microscopic colitis and diarrhea. Also included in each issue are articles that focus on career pathways, financial and legal matters, perspectives from private practice, brief reviews on clinically-relevant topics, issues in clinical medical ethics, and other topics that are relevant to early career GIs. Each issue also contains an introductory letter from the editor as well as a curated list of relevant articles from the AGA Journals.

Honorarium

The EIC will receive an annual honorarium of $5,000.

Qualifications

• AGA member, between second year of fellowship and five years post-fellowship. 
• Experience identifying and promoting newsworthy content that is relevant to the trainee and early-career GI community, as well as excellent judgment that expands the outstanding reputation of TNG and AGA.
• Experience in medical, scientific or news-related publishing is preferred, but not required.
• Familiarity with AGA and its priorities, activities and stances on important issues is ideal, preferably via past volunteer member experience with the association.
• The EIC must be able to devote sufficient time to TNG matters and may not accept editorial appointments to competing publications during their tenure as EIC.
   

For more information or to apply view the full request for applications. If you have questions, please contact Ryan Farrell, managing editor, The New Gastroenterologist, at rfarrell@gastro.org.

AGA’s cutting-edge, trainee and early-career focused e-newsletter The New Gastroenterologist (TNG) is seeking applications for the position of editor-in-chief (EIC). The role will facilitate the communication of the latest clinical advances among peers and build strong leadership skills managing editorial responsibilities as well as working with reviewers and fellow editors at AGA’s journals.

The term is from Oct. 1, 2022 – Sept. 30, 2027, with a transition period starting July 2022.

About TNG

TNG content covers highly relevant clinical topics, such as diverticular hemorrhage as well as microscopic colitis and diarrhea. Also included in each issue are articles that focus on career pathways, financial and legal matters, perspectives from private practice, brief reviews on clinically-relevant topics, issues in clinical medical ethics, and other topics that are relevant to early career GIs. Each issue also contains an introductory letter from the editor as well as a curated list of relevant articles from the AGA Journals.

Honorarium

The EIC will receive an annual honorarium of $5,000.

Qualifications

• AGA member, between second year of fellowship and five years post-fellowship. 
• Experience identifying and promoting newsworthy content that is relevant to the trainee and early-career GI community, as well as excellent judgment that expands the outstanding reputation of TNG and AGA.
• Experience in medical, scientific or news-related publishing is preferred, but not required.
• Familiarity with AGA and its priorities, activities and stances on important issues is ideal, preferably via past volunteer member experience with the association.
• The EIC must be able to devote sufficient time to TNG matters and may not accept editorial appointments to competing publications during their tenure as EIC.
   

For more information or to apply view the full request for applications. If you have questions, please contact Ryan Farrell, managing editor, The New Gastroenterologist, at rfarrell@gastro.org.