Key clinical point: Patients with multiple sclerosis (MS) receiving anti-CD20 (aCD20) treatment demonstrate a robust T-cell response to an mRNA COVID-19 vaccines.

Major finding: Thirty days following the second dose of an mRNA COVID-19 vaccine, 89% of patients with MS had antispike antibodies, and 50% had mounted anti-receptor-binding domain responses.

Study details: A study assessed antibody and T-cell responses in 20 patients with MS receiving aCD20 treatment and 10 healthy controls.

Disclosures: The study was supported by individual grants to several authors. SE Hensley, EJ Wherry, A Sette, ET Luning Prak, D Jacobs, and A Bar-Or reported relationships with pharmaceutical companies and/or research organizations. The remaining authors declared no conflict of interests.

Source: Apostolidis SA et al. Nat Med. 2021 Sep 14. doi: 10.1038/s41591-021-01507-2.

Key clinical point: Patients with multiple sclerosis (MS) receiving anti-CD20 (aCD20) treatment demonstrate a robust T-cell response to an mRNA COVID-19 vaccines.

Major finding: Thirty days following the second dose of an mRNA COVID-19 vaccine, 89% of patients with MS had antispike antibodies, and 50% had mounted anti-receptor-binding domain responses.

Study details: A study assessed antibody and T-cell responses in 20 patients with MS receiving aCD20 treatment and 10 healthy controls.

Disclosures: The study was supported by individual grants to several authors. SE Hensley, EJ Wherry, A Sette, ET Luning Prak, D Jacobs, and A Bar-Or reported relationships with pharmaceutical companies and/or research organizations. The remaining authors declared no conflict of interests.

Source: Apostolidis SA et al. Nat Med. 2021 Sep 14. doi: 10.1038/s41591-021-01507-2.

Key clinical point: Patients with multiple sclerosis (MS) receiving anti-CD20 (aCD20) treatment demonstrate a robust T-cell response to an mRNA COVID-19 vaccines.

Major finding: Thirty days following the second dose of an mRNA COVID-19 vaccine, 89% of patients with MS had antispike antibodies, and 50% had mounted anti-receptor-binding domain responses.

Study details: A study assessed antibody and T-cell responses in 20 patients with MS receiving aCD20 treatment and 10 healthy controls.

Disclosures: The study was supported by individual grants to several authors. SE Hensley, EJ Wherry, A Sette, ET Luning Prak, D Jacobs, and A Bar-Or reported relationships with pharmaceutical companies and/or research organizations. The remaining authors declared no conflict of interests.

Source: Apostolidis SA et al. Nat Med. 2021 Sep 14. doi: 10.1038/s41591-021-01507-2.

Key clinical point: A study has identified at least 3 modifiable behaviors that may increase the personal risk for COVID-19.

Major finding: Higher number of nonhousehold contacts (odds ratio [OR], 1.10 per 10 contacts; P = .024), attending events having at least 10 people (OR, 1.26 per 10 events; P = .007), and visiting restaurants (OR, 1.95 per 10 visits; P less than .001) were associated with a significantly increased risk for incident COVID-19.

Study details: The data come from a prospective cohort study of 28,575 individuals across 99 countries.

Disclosures: The study was supported by grants from the National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering to GM Marcus, J Olgin, and M Pletcher. The authors declared no competing interests.

Source: Lin A et al. BMJ Open. 2021 Sep 21. doi: 10.1136/bmjopen-2021-052025.

Key clinical point: A study has identified at least 3 modifiable behaviors that may increase the personal risk for COVID-19.

Major finding: Higher number of nonhousehold contacts (odds ratio [OR], 1.10 per 10 contacts; P = .024), attending events having at least 10 people (OR, 1.26 per 10 events; P = .007), and visiting restaurants (OR, 1.95 per 10 visits; P less than .001) were associated with a significantly increased risk for incident COVID-19.

Study details: The data come from a prospective cohort study of 28,575 individuals across 99 countries.

Disclosures: The study was supported by grants from the National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering to GM Marcus, J Olgin, and M Pletcher. The authors declared no competing interests.

Source: Lin A et al. BMJ Open. 2021 Sep 21. doi: 10.1136/bmjopen-2021-052025.

Key clinical point: A study has identified at least 3 modifiable behaviors that may increase the personal risk for COVID-19.

Major finding: Higher number of nonhousehold contacts (odds ratio [OR], 1.10 per 10 contacts; P = .024), attending events having at least 10 people (OR, 1.26 per 10 events; P = .007), and visiting restaurants (OR, 1.95 per 10 visits; P less than .001) were associated with a significantly increased risk for incident COVID-19.

Study details: The data come from a prospective cohort study of 28,575 individuals across 99 countries.

Disclosures: The study was supported by grants from the National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering to GM Marcus, J Olgin, and M Pletcher. The authors declared no competing interests.

Source: Lin A et al. BMJ Open. 2021 Sep 21. doi: 10.1136/bmjopen-2021-052025.

Key clinical point: The risk of contracting COVID-19 among nonimmune family members decreases as the number of immune family members increases.

Major finding: An inverse dose-response association was seen between the number of immune members in each family and the risk for incident COVID-19 in nonimmune family members. Families with 1 immune member had a 45%-61% lower risk for COVID-19, whereas families with 4 immune members had a 97% lower risk.

Study details: The data come from an analysis of 1,789,728 individuals from 814,806 families, consisting of 2-5 members each.

Disclosures: Information on funding was not available. The authors declared no competing interests.

Source: Nordström P et al. JAMA Intern Med. 2021 Oct 11. doi: 10.1001/jamainternmed.2021.5814.

Key clinical point: The risk of contracting COVID-19 among nonimmune family members decreases as the number of immune family members increases.

Major finding: An inverse dose-response association was seen between the number of immune members in each family and the risk for incident COVID-19 in nonimmune family members. Families with 1 immune member had a 45%-61% lower risk for COVID-19, whereas families with 4 immune members had a 97% lower risk.

Study details: The data come from an analysis of 1,789,728 individuals from 814,806 families, consisting of 2-5 members each.

Disclosures: Information on funding was not available. The authors declared no competing interests.

Source: Nordström P et al. JAMA Intern Med. 2021 Oct 11. doi: 10.1001/jamainternmed.2021.5814.

Key clinical point: The risk of contracting COVID-19 among nonimmune family members decreases as the number of immune family members increases.

Major finding: An inverse dose-response association was seen between the number of immune members in each family and the risk for incident COVID-19 in nonimmune family members. Families with 1 immune member had a 45%-61% lower risk for COVID-19, whereas families with 4 immune members had a 97% lower risk.

Study details: The data come from an analysis of 1,789,728 individuals from 814,806 families, consisting of 2-5 members each.

Disclosures: Information on funding was not available. The authors declared no competing interests.

Source: Nordström P et al. JAMA Intern Med. 2021 Oct 11. doi: 10.1001/jamainternmed.2021.5814.

Key clinical point: In patients receiving high-flow nasal cannula (HFNC) for acute hypoxemic respiratory failure associated with COVID-19, initiating awake prone positioning (proning) soon after HFNC may improve survival.

Major finding: Initiating awake proning within 24 hours of HFNC was associated with lower mortality rates than late proning (26% vs 45%; P = .039).

Study details: The data come from a post hoc analysis of a trial evaluating awake proning in HFNC-treated patients with COVID-19 with respiratory failure (n=125).

Disclosures: The study was supported by the Rice Foundation. R Kaur, DL Vines, JD Scott, MW Trump, and J Li reported relationships with pharmaceutical/medical device companies and/or research organizations. The remaining authors declared no conflict of interests.

Source: Kaur R et al. Crit Care. 2021 Sep 17. doi: 10.1186/s13054-021-03761-9.

Key clinical point: In patients receiving high-flow nasal cannula (HFNC) for acute hypoxemic respiratory failure associated with COVID-19, initiating awake prone positioning (proning) soon after HFNC may improve survival.

Major finding: Initiating awake proning within 24 hours of HFNC was associated with lower mortality rates than late proning (26% vs 45%; P = .039).

Study details: The data come from a post hoc analysis of a trial evaluating awake proning in HFNC-treated patients with COVID-19 with respiratory failure (n=125).

Disclosures: The study was supported by the Rice Foundation. R Kaur, DL Vines, JD Scott, MW Trump, and J Li reported relationships with pharmaceutical/medical device companies and/or research organizations. The remaining authors declared no conflict of interests.

Source: Kaur R et al. Crit Care. 2021 Sep 17. doi: 10.1186/s13054-021-03761-9.

Key clinical point: In patients receiving high-flow nasal cannula (HFNC) for acute hypoxemic respiratory failure associated with COVID-19, initiating awake prone positioning (proning) soon after HFNC may improve survival.

Major finding: Initiating awake proning within 24 hours of HFNC was associated with lower mortality rates than late proning (26% vs 45%; P = .039).

Study details: The data come from a post hoc analysis of a trial evaluating awake proning in HFNC-treated patients with COVID-19 with respiratory failure (n=125).

Disclosures: The study was supported by the Rice Foundation. R Kaur, DL Vines, JD Scott, MW Trump, and J Li reported relationships with pharmaceutical/medical device companies and/or research organizations. The remaining authors declared no conflict of interests.

Source: Kaur R et al. Crit Care. 2021 Sep 17. doi: 10.1186/s13054-021-03761-9.

Key clinical point: Serum albumin levels at presentation may be a potential marker for COVID-19 severity and prognosis.

Major finding: Serum albumin of <3.5 g/dL was an independent risk factor for severe infection (adjusted odds ratio [aOR], 2.924; 95% confidence interval [CI], 1.509-5.664) and 30-day mortality (aOR, 2.615; 95% CI, 1.131-6.051).

Study details: A retrospective observational study included 296 patients with COVID-19 from emergency departments of 3 hospitals in Italy.

Disclosures: The study did not receive any funding. The authors declared no competing interests.

Source: Turcato G et al. Emerg Med J. 2021 Sep 21. doi: 10.1136/emermed-2020-210081.

Key clinical point: Serum albumin levels at presentation may be a potential marker for COVID-19 severity and prognosis.

Major finding: Serum albumin of <3.5 g/dL was an independent risk factor for severe infection (adjusted odds ratio [aOR], 2.924; 95% confidence interval [CI], 1.509-5.664) and 30-day mortality (aOR, 2.615; 95% CI, 1.131-6.051).

Study details: A retrospective observational study included 296 patients with COVID-19 from emergency departments of 3 hospitals in Italy.

Disclosures: The study did not receive any funding. The authors declared no competing interests.

Source: Turcato G et al. Emerg Med J. 2021 Sep 21. doi: 10.1136/emermed-2020-210081.

Key clinical point: Serum albumin levels at presentation may be a potential marker for COVID-19 severity and prognosis.

Major finding: Serum albumin of <3.5 g/dL was an independent risk factor for severe infection (adjusted odds ratio [aOR], 2.924; 95% confidence interval [CI], 1.509-5.664) and 30-day mortality (aOR, 2.615; 95% CI, 1.131-6.051).

Study details: A retrospective observational study included 296 patients with COVID-19 from emergency departments of 3 hospitals in Italy.

Disclosures: The study did not receive any funding. The authors declared no competing interests.

Source: Turcato G et al. Emerg Med J. 2021 Sep 21. doi: 10.1136/emermed-2020-210081.

Black and Latina women are more likely to have an open surgery compared with a minimally invasive procedure to treat ectopic pregnancy, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The researchers found that Black and Latina women had 50% lesser odds of undergoing laparoscopic surgery, a minimally invasive procedure, compared to their White peers.

“We see these disparities in minority populations, [especially in] women with regard to so many other aspects of [gynecologic] surgery,” study author Alexandra Huttler, MD, said in an interview. “The fact that these disparities exist [in the treatment of tubal pregnancies] was unfortunately not surprising to us.”

Dr. Huttler and her team analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program, which followed more than 9,000 patients who had undergone surgical management of a tubal ectopic pregnancy between 2010 and 2019. Of the group, 85% underwent laparoscopic surgery while 14% had open surgery, which requires a longer recovery time.

The proportion of cases performed laparoscopically increased from 81% in 2010 to 91% in 2019. However, a disproportionate number of Black and Latina women underwent open surgery to treat ectopic pregnancies during this time. Because they are more invasive, open surgeries are associated with longer operative times, hospital stays, and increased complications, Dr. Huttler said. They are typically associated with more pain and patients are more likely to be admitted to the hospital for postoperative care.

On the other hand, minimally invasive surgeries are associated with decreased operative time, “less recovery and less pain,” Dr. Huttler explained.

The researchers also looked at trends of the related surgical procedure salpingectomy, which is surgical removal of one or both fallopian tubes versus salpingostomy, a surgical unblocking of the tube. Of the group, 91% underwent salpingectomy and 9% underwent salpingostomy.

Researchers found that Black and Latina women had 78% and 54% greater odds, respectively, of receiving a salpingectomy. However, the clinical significance of these findings are unclear because there are “many factors” that are patient and case specific, Dr. Huttler said.

The study is important and adds to a litany of studies that have shown that women of color do not receive optimal care, said Ruben Alvero, MD, who was not involved in the study.

“Women of color in general have seen compromises in their care at many levels in the system,” Dr. Alvero, professor of obstetrics and gynecology at Stanford (Calif.) University, said in an interview. “We really have to do a massive overhaul of how we treat women of color so they get the same level of treatment that all other populations receive.”

While the factors contributing to these health disparities can be complicated, Dr. Alvero said that one reason for this multivariate discrepancy could be that Black and Latina women tend to seek care at, or only have access to, underresourced hospitals.

Dr. Huttler said she hopes her findings prompt further discussion of these disparities.

“There really are disparities at all levels of care here and figuring out what the root of this is certainly requires further research,” Dr. Huttler said.

The experts interviewed disclosed no conflicts on interests.

Black and Latina women are more likely to have an open surgery compared with a minimally invasive procedure to treat ectopic pregnancy, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The researchers found that Black and Latina women had 50% lesser odds of undergoing laparoscopic surgery, a minimally invasive procedure, compared to their White peers.

“We see these disparities in minority populations, [especially in] women with regard to so many other aspects of [gynecologic] surgery,” study author Alexandra Huttler, MD, said in an interview. “The fact that these disparities exist [in the treatment of tubal pregnancies] was unfortunately not surprising to us.”

Dr. Huttler and her team analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program, which followed more than 9,000 patients who had undergone surgical management of a tubal ectopic pregnancy between 2010 and 2019. Of the group, 85% underwent laparoscopic surgery while 14% had open surgery, which requires a longer recovery time.

The proportion of cases performed laparoscopically increased from 81% in 2010 to 91% in 2019. However, a disproportionate number of Black and Latina women underwent open surgery to treat ectopic pregnancies during this time. Because they are more invasive, open surgeries are associated with longer operative times, hospital stays, and increased complications, Dr. Huttler said. They are typically associated with more pain and patients are more likely to be admitted to the hospital for postoperative care.

On the other hand, minimally invasive surgeries are associated with decreased operative time, “less recovery and less pain,” Dr. Huttler explained.

The researchers also looked at trends of the related surgical procedure salpingectomy, which is surgical removal of one or both fallopian tubes versus salpingostomy, a surgical unblocking of the tube. Of the group, 91% underwent salpingectomy and 9% underwent salpingostomy.

Researchers found that Black and Latina women had 78% and 54% greater odds, respectively, of receiving a salpingectomy. However, the clinical significance of these findings are unclear because there are “many factors” that are patient and case specific, Dr. Huttler said.

The study is important and adds to a litany of studies that have shown that women of color do not receive optimal care, said Ruben Alvero, MD, who was not involved in the study.

“Women of color in general have seen compromises in their care at many levels in the system,” Dr. Alvero, professor of obstetrics and gynecology at Stanford (Calif.) University, said in an interview. “We really have to do a massive overhaul of how we treat women of color so they get the same level of treatment that all other populations receive.”

While the factors contributing to these health disparities can be complicated, Dr. Alvero said that one reason for this multivariate discrepancy could be that Black and Latina women tend to seek care at, or only have access to, underresourced hospitals.

Dr. Huttler said she hopes her findings prompt further discussion of these disparities.

“There really are disparities at all levels of care here and figuring out what the root of this is certainly requires further research,” Dr. Huttler said.

The experts interviewed disclosed no conflicts on interests.

Black and Latina women are more likely to have an open surgery compared with a minimally invasive procedure to treat ectopic pregnancy, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The researchers found that Black and Latina women had 50% lesser odds of undergoing laparoscopic surgery, a minimally invasive procedure, compared to their White peers.

“We see these disparities in minority populations, [especially in] women with regard to so many other aspects of [gynecologic] surgery,” study author Alexandra Huttler, MD, said in an interview. “The fact that these disparities exist [in the treatment of tubal pregnancies] was unfortunately not surprising to us.”

Dr. Huttler and her team analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program, which followed more than 9,000 patients who had undergone surgical management of a tubal ectopic pregnancy between 2010 and 2019. Of the group, 85% underwent laparoscopic surgery while 14% had open surgery, which requires a longer recovery time.

The proportion of cases performed laparoscopically increased from 81% in 2010 to 91% in 2019. However, a disproportionate number of Black and Latina women underwent open surgery to treat ectopic pregnancies during this time. Because they are more invasive, open surgeries are associated with longer operative times, hospital stays, and increased complications, Dr. Huttler said. They are typically associated with more pain and patients are more likely to be admitted to the hospital for postoperative care.

On the other hand, minimally invasive surgeries are associated with decreased operative time, “less recovery and less pain,” Dr. Huttler explained.

The researchers also looked at trends of the related surgical procedure salpingectomy, which is surgical removal of one or both fallopian tubes versus salpingostomy, a surgical unblocking of the tube. Of the group, 91% underwent salpingectomy and 9% underwent salpingostomy.

Researchers found that Black and Latina women had 78% and 54% greater odds, respectively, of receiving a salpingectomy. However, the clinical significance of these findings are unclear because there are “many factors” that are patient and case specific, Dr. Huttler said.

The study is important and adds to a litany of studies that have shown that women of color do not receive optimal care, said Ruben Alvero, MD, who was not involved in the study.

“Women of color in general have seen compromises in their care at many levels in the system,” Dr. Alvero, professor of obstetrics and gynecology at Stanford (Calif.) University, said in an interview. “We really have to do a massive overhaul of how we treat women of color so they get the same level of treatment that all other populations receive.”

While the factors contributing to these health disparities can be complicated, Dr. Alvero said that one reason for this multivariate discrepancy could be that Black and Latina women tend to seek care at, or only have access to, underresourced hospitals.

Dr. Huttler said she hopes her findings prompt further discussion of these disparities.

“There really are disparities at all levels of care here and figuring out what the root of this is certainly requires further research,” Dr. Huttler said.

The experts interviewed disclosed no conflicts on interests.

Key clinical point: Critically ill patients with COVID-19 fail to benefit from convalescent plasma.

Major finding: The trial was stopped early after the probability of futility was calculated at 99.4%. Convalescent plasma vs. no plasma groups had 0 vs 3 organ support-free days, 37.3% vs 38.4% in-hospital mortality rates, and 14 vs 14 median days alive and free of organ support.

Study details: The data come from an open-label, randomized component of the ongoing REMAP-CAP trial (n=2,011). Critically ill adults with COVID-19 were randomly assigned to receive convalescent plasma or not.

Disclosures: The study was funded by nonprofits in multiple countries. Several authors reported relationships with pharmaceutical companies and/or research organizations.

Source: Estcourt LJ et al. JAMA. 2021 Oct 4. doi: 10.1001/jama.2021.18178.

Key clinical point: Critically ill patients with COVID-19 fail to benefit from convalescent plasma.

Major finding: The trial was stopped early after the probability of futility was calculated at 99.4%. Convalescent plasma vs. no plasma groups had 0 vs 3 organ support-free days, 37.3% vs 38.4% in-hospital mortality rates, and 14 vs 14 median days alive and free of organ support.

Study details: The data come from an open-label, randomized component of the ongoing REMAP-CAP trial (n=2,011). Critically ill adults with COVID-19 were randomly assigned to receive convalescent plasma or not.

Disclosures: The study was funded by nonprofits in multiple countries. Several authors reported relationships with pharmaceutical companies and/or research organizations.

Source: Estcourt LJ et al. JAMA. 2021 Oct 4. doi: 10.1001/jama.2021.18178.

Key clinical point: Critically ill patients with COVID-19 fail to benefit from convalescent plasma.

Major finding: The trial was stopped early after the probability of futility was calculated at 99.4%. Convalescent plasma vs. no plasma groups had 0 vs 3 organ support-free days, 37.3% vs 38.4% in-hospital mortality rates, and 14 vs 14 median days alive and free of organ support.

Study details: The data come from an open-label, randomized component of the ongoing REMAP-CAP trial (n=2,011). Critically ill adults with COVID-19 were randomly assigned to receive convalescent plasma or not.

Disclosures: The study was funded by nonprofits in multiple countries. Several authors reported relationships with pharmaceutical companies and/or research organizations.

Source: Estcourt LJ et al. JAMA. 2021 Oct 4. doi: 10.1001/jama.2021.18178.

The Food and Drug Administration issued a long-awaited proposal on Oct. 19 that would offer a new category of affordable over-the-counter hearing aids for nearly 30 million Americans who report mild or moderate hearing loss.

The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.

Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.

In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.

With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.

“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.

The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.

For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.

The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.

“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.

“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.

This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.

The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.

The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.

There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.

About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.

“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.

The FDA has updated its guidance on hearing devices and personal sound amplification products.

Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.

Amplification devices are not regulated by the FDA.

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

The Food and Drug Administration issued a long-awaited proposal on Oct. 19 that would offer a new category of affordable over-the-counter hearing aids for nearly 30 million Americans who report mild or moderate hearing loss.

The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.

Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.

In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.

With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.

“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.

The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.

For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.

The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.

“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.

“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.

This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.

The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.

The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.

There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.

About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.

“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.

The FDA has updated its guidance on hearing devices and personal sound amplification products.

Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.

Amplification devices are not regulated by the FDA.

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

The Food and Drug Administration issued a long-awaited proposal on Oct. 19 that would offer a new category of affordable over-the-counter hearing aids for nearly 30 million Americans who report mild or moderate hearing loss.

The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.

Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.

In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.

With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.

“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.

The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.

For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.

The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.

“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.

“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.

This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.

The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.

The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.

There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.

About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.

“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.

The FDA has updated its guidance on hearing devices and personal sound amplification products.

Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.

Amplification devices are not regulated by the FDA.

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

The success of chimeric antigen receptor T (CAR T)-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has garnered much attention, but the field is still in its infancy – with toxicity and relapse rates remaining unacceptably high.

These and other observations from a review of published data on using CAR T cells for B-ALL shine a spotlight on areas that need optimization in the use of the therapy in this setting, according to review authors Vanessa A. Fabrizio, MD, a fellow at Duke University, Durham, N.C., and Kevin J. Curran, MD, a pediatric oncologist at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York.

Based on their review of early pivotal clinical trials, relapse data, toxicities, and mechanisms to optimize CAR T-cell therapy, Dr. Fabrizio and Dr. Curran outlined several “practice points” and proposed a research agenda aimed at optimizing the use of CAR T-cell therapy for B-ALL (Best Pract Res Clin Haematol. 2021 Aug 27. doi: 10.1016/j.beha.2021.101305).
 

Practice points

CAR T-cell therapy has transformed the treatment of both pediatric and adult patients with relapsed/refractory (R/R) B-ALL, the authors said, adding that “[c]linical trial results across multiple institutions with different CAR constructs report significant response rates in treated patients.”

Dr. Fabrizio and Dr. Curran specifically note that only one product (tisagenlecleucel) is currently approved for the treatment of R/R B-ALL in patients under age 26 years. Further, the successful application of this therapy is limited by high relapse rates, significant toxicity in some cases, and challenges related to collection and production issues.

They contend that areas in which optimization of CAR T-cell therapy can occur include apheresis, production, chemotherapy bridging, pretreatment disease burden management, toxicity management, disease monitoring after therapy, and use of consolidative allogeneic hematopoietic stem cell transplantation.
 

Research agenda

Key ways to heighten the success of CAR T-cell therapy for B-ALL are the development of off-the-shelf CAR T-cell products and the selection of optimal T cells to enhance apheresis and production, they said, adding that research is needed on the use of bridging chemotherapy to reduce tumor burden.

Bridging chemotherapy has been shown to impact outcomes while minimizing toxicity, but it remains undefined.

“Prospective trials are required to determine if the optimization of lymphodepleting chemotherapy can improve outcomes, and if consolidative therapy with transplantation should be considered in select patients,” they wrote. “Continued efforts to improve this technology for patients is ongoing while remaining questions are being investigated.”

The authors acknowledge that CAR T-cell therapy has transformed the treatment landscape for both pediatric and adult patients with R/R B-ALL, but this extensive review of all published data on the subject shows that “the incidence of relapse among responders is unacceptably high, demonstrating the need to improve this therapy.”

In conclusion, they wrote: “To be effective following infusion, CAR T cells must expand, persist, exhibit enduring anti-tumor cytotoxicity, withstand and/or counteract an immunosuppressive tumor microenvironment, and overcome targeted tumor antigen escape. In designing CAR T cells for cancer immunotherapy, all of these factors must be harmonized to generate the optimal therapy,” noting that “[t]oxicity management and, ideally the prediction of toxicity in individualized patients, should continue to be a focus of ongoing efforts.”

Dr. Curran has received research support from Juno Therapeutics and Novartis, and has consulted, participated in advisory boards, or taken part in educational seminars for Juno Therapeutics, Novartis, and Mesoblast. Dr. Fabrizio reported having no conflict of interests.

[email protected]

The success of chimeric antigen receptor T (CAR T)-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has garnered much attention, but the field is still in its infancy – with toxicity and relapse rates remaining unacceptably high.

These and other observations from a review of published data on using CAR T cells for B-ALL shine a spotlight on areas that need optimization in the use of the therapy in this setting, according to review authors Vanessa A. Fabrizio, MD, a fellow at Duke University, Durham, N.C., and Kevin J. Curran, MD, a pediatric oncologist at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York.

Based on their review of early pivotal clinical trials, relapse data, toxicities, and mechanisms to optimize CAR T-cell therapy, Dr. Fabrizio and Dr. Curran outlined several “practice points” and proposed a research agenda aimed at optimizing the use of CAR T-cell therapy for B-ALL (Best Pract Res Clin Haematol. 2021 Aug 27. doi: 10.1016/j.beha.2021.101305).
 

Practice points

CAR T-cell therapy has transformed the treatment of both pediatric and adult patients with relapsed/refractory (R/R) B-ALL, the authors said, adding that “[c]linical trial results across multiple institutions with different CAR constructs report significant response rates in treated patients.”

Dr. Fabrizio and Dr. Curran specifically note that only one product (tisagenlecleucel) is currently approved for the treatment of R/R B-ALL in patients under age 26 years. Further, the successful application of this therapy is limited by high relapse rates, significant toxicity in some cases, and challenges related to collection and production issues.

They contend that areas in which optimization of CAR T-cell therapy can occur include apheresis, production, chemotherapy bridging, pretreatment disease burden management, toxicity management, disease monitoring after therapy, and use of consolidative allogeneic hematopoietic stem cell transplantation.
 

Research agenda

Key ways to heighten the success of CAR T-cell therapy for B-ALL are the development of off-the-shelf CAR T-cell products and the selection of optimal T cells to enhance apheresis and production, they said, adding that research is needed on the use of bridging chemotherapy to reduce tumor burden.

Bridging chemotherapy has been shown to impact outcomes while minimizing toxicity, but it remains undefined.

“Prospective trials are required to determine if the optimization of lymphodepleting chemotherapy can improve outcomes, and if consolidative therapy with transplantation should be considered in select patients,” they wrote. “Continued efforts to improve this technology for patients is ongoing while remaining questions are being investigated.”

The authors acknowledge that CAR T-cell therapy has transformed the treatment landscape for both pediatric and adult patients with R/R B-ALL, but this extensive review of all published data on the subject shows that “the incidence of relapse among responders is unacceptably high, demonstrating the need to improve this therapy.”

In conclusion, they wrote: “To be effective following infusion, CAR T cells must expand, persist, exhibit enduring anti-tumor cytotoxicity, withstand and/or counteract an immunosuppressive tumor microenvironment, and overcome targeted tumor antigen escape. In designing CAR T cells for cancer immunotherapy, all of these factors must be harmonized to generate the optimal therapy,” noting that “[t]oxicity management and, ideally the prediction of toxicity in individualized patients, should continue to be a focus of ongoing efforts.”

Dr. Curran has received research support from Juno Therapeutics and Novartis, and has consulted, participated in advisory boards, or taken part in educational seminars for Juno Therapeutics, Novartis, and Mesoblast. Dr. Fabrizio reported having no conflict of interests.

[email protected]

The success of chimeric antigen receptor T (CAR T)-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has garnered much attention, but the field is still in its infancy – with toxicity and relapse rates remaining unacceptably high.

These and other observations from a review of published data on using CAR T cells for B-ALL shine a spotlight on areas that need optimization in the use of the therapy in this setting, according to review authors Vanessa A. Fabrizio, MD, a fellow at Duke University, Durham, N.C., and Kevin J. Curran, MD, a pediatric oncologist at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York.

Based on their review of early pivotal clinical trials, relapse data, toxicities, and mechanisms to optimize CAR T-cell therapy, Dr. Fabrizio and Dr. Curran outlined several “practice points” and proposed a research agenda aimed at optimizing the use of CAR T-cell therapy for B-ALL (Best Pract Res Clin Haematol. 2021 Aug 27. doi: 10.1016/j.beha.2021.101305).
 

Practice points

CAR T-cell therapy has transformed the treatment of both pediatric and adult patients with relapsed/refractory (R/R) B-ALL, the authors said, adding that “[c]linical trial results across multiple institutions with different CAR constructs report significant response rates in treated patients.”

Dr. Fabrizio and Dr. Curran specifically note that only one product (tisagenlecleucel) is currently approved for the treatment of R/R B-ALL in patients under age 26 years. Further, the successful application of this therapy is limited by high relapse rates, significant toxicity in some cases, and challenges related to collection and production issues.

They contend that areas in which optimization of CAR T-cell therapy can occur include apheresis, production, chemotherapy bridging, pretreatment disease burden management, toxicity management, disease monitoring after therapy, and use of consolidative allogeneic hematopoietic stem cell transplantation.
 

Research agenda

Key ways to heighten the success of CAR T-cell therapy for B-ALL are the development of off-the-shelf CAR T-cell products and the selection of optimal T cells to enhance apheresis and production, they said, adding that research is needed on the use of bridging chemotherapy to reduce tumor burden.

Bridging chemotherapy has been shown to impact outcomes while minimizing toxicity, but it remains undefined.

“Prospective trials are required to determine if the optimization of lymphodepleting chemotherapy can improve outcomes, and if consolidative therapy with transplantation should be considered in select patients,” they wrote. “Continued efforts to improve this technology for patients is ongoing while remaining questions are being investigated.”

The authors acknowledge that CAR T-cell therapy has transformed the treatment landscape for both pediatric and adult patients with R/R B-ALL, but this extensive review of all published data on the subject shows that “the incidence of relapse among responders is unacceptably high, demonstrating the need to improve this therapy.”

In conclusion, they wrote: “To be effective following infusion, CAR T cells must expand, persist, exhibit enduring anti-tumor cytotoxicity, withstand and/or counteract an immunosuppressive tumor microenvironment, and overcome targeted tumor antigen escape. In designing CAR T cells for cancer immunotherapy, all of these factors must be harmonized to generate the optimal therapy,” noting that “[t]oxicity management and, ideally the prediction of toxicity in individualized patients, should continue to be a focus of ongoing efforts.”

Dr. Curran has received research support from Juno Therapeutics and Novartis, and has consulted, participated in advisory boards, or taken part in educational seminars for Juno Therapeutics, Novartis, and Mesoblast. Dr. Fabrizio reported having no conflict of interests.

[email protected]

Key clinical point: Pulmonary sequelae at 6 months after COVID-19 infection are more common in patients with diabetes or hyperglycemia compared with normoglycemic individuals.

Major finding: At 6 months, residual lung abnormalities on computed tomography were seen in 65.4%, 58.3%, and 36.6% of patients with preexisting diabetes, secondary hyperglycemia, and normoglycemia, respectively.

Study details: The data come from a retrospective study of 141 patients with COVID-19 at 2 hospitals in Wuhan, China.

Disclosures: The research was supported by the National Natural Science Foundation of China, National Key Research and Development Project of China, and Zhejiang University. The authors declared no competing interests.

Source: Li Y et al. Eur J Radiol. 2021 Oct 5. doi: 10.1016/j.ejrad.2021.109997.

Key clinical point: Pulmonary sequelae at 6 months after COVID-19 infection are more common in patients with diabetes or hyperglycemia compared with normoglycemic individuals.

Major finding: At 6 months, residual lung abnormalities on computed tomography were seen in 65.4%, 58.3%, and 36.6% of patients with preexisting diabetes, secondary hyperglycemia, and normoglycemia, respectively.

Study details: The data come from a retrospective study of 141 patients with COVID-19 at 2 hospitals in Wuhan, China.

Disclosures: The research was supported by the National Natural Science Foundation of China, National Key Research and Development Project of China, and Zhejiang University. The authors declared no competing interests.

Source: Li Y et al. Eur J Radiol. 2021 Oct 5. doi: 10.1016/j.ejrad.2021.109997.

Key clinical point: Pulmonary sequelae at 6 months after COVID-19 infection are more common in patients with diabetes or hyperglycemia compared with normoglycemic individuals.

Major finding: At 6 months, residual lung abnormalities on computed tomography were seen in 65.4%, 58.3%, and 36.6% of patients with preexisting diabetes, secondary hyperglycemia, and normoglycemia, respectively.

Study details: The data come from a retrospective study of 141 patients with COVID-19 at 2 hospitals in Wuhan, China.

Disclosures: The research was supported by the National Natural Science Foundation of China, National Key Research and Development Project of China, and Zhejiang University. The authors declared no competing interests.

Source: Li Y et al. Eur J Radiol. 2021 Oct 5. doi: 10.1016/j.ejrad.2021.109997.