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Serious infection hospitalizations have declined in patients with PsA
The rate of U.S. hospitalizations for three types of serious infections in patients with psoriatic arthritis (PsA) appears to have declined from 2012 to 2017, according to research presented at the virtual annual meeting of the American College of Rheumatology.
Several of the standard treatments for PsA have an increased risk of infections, but the rates vary amongst conventional disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, and other therapies.
“Given the uptake of biological therapies has increased over recent years, we sought to investigate the national trends in serious infections in patients with psoriatic arthritis from the years 2012 to 2017,” Vagishwari Murugesan, MBBS, a psoriatic arthritis clinical fellow at the University of Toronto, told attendees in a prerecorded poster presentation. Dr. Murugesan was a fellow at Boston University when she conducted the research.
The researchers analyzed data from 2012 to 2017 in the U.S. National Inpatient Sample (NIS), which includes approximately 20% of all discharges from U.S. community hospitals except rehabilitation and long-term acute care institutions. Using ICD-9 and ICD-10 codes, the researchers identified all discharge records containing a diagnosis of PsA as well as pneumonia, sepsis, urinary tract infection (UTI), and skin and soft-tissue infections. After making adjustments to match U.S. population age distributions over the years, they examined trends in serious infections among patients with PsA for that 6-year period.
Demographics over those years changed little: The average age of discharged patients was 59.5 in 2012 and 60.8 in 2017. Similarly, the patient population was 56% women and 88.5% Whites in 2012 and 57.7% women and 88.4% Whites in 2017. The average length of stay was also similar: 4.7 days in 2012, compared with 4.9 days in 2017.
Among 50,700 discharges of patients with PsA in 2012, the researchers identified 125 with pneumonia, 230 with sepsis, 312 with skin and soft-tissue infections, and 174 with a UTI. Among the 179,400 discharges in 2017 of patients with PsA, 344 had pneumonia, 374 had sepsis, 681 had skin and soft-tissue infections, and 348 had a UTI. After statistical analysis, the researchers found no significant differences in pneumonia diagnoses during the years studied, but they did find a statistically significant decline in sepsis, skin and soft tissue infections, and UTI discharges (P < .001).
A notable limitation of the study is the NIS database’s lack of data on treatments or outpatient data, making it impossible to determine if more infections were occurring but simply being treated in outpatient settings, although it’s not clear why such a substantial shift would occur in just 5 years. It’s also possible that coding practices differ across hospital, but, presumably, the ways they might differ in 2012 would be similar to any differences in 2017.
Arthur Kavanaugh, MD, a professor of medicine and director of the Center for Innovative Therapy at the University of California, San Diego, found the results interesting for what he considers an important topic.
“What makes these data interesting is the same thing that limits their reliability: The authors note that infections decreased ‘despite the increase in use of biologics over this time,’ ” Dr. Kavanaugh said in an interview. “These are claims data, so there is no way to support any association between those serious infections and biologic use. Indeed, multiple factors could have also impacted these data. It is not possible to tell from claims data.”
Dr. Kavanaugh said the question is worth investigating further with data from other sources.
The research was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One study coauthor reported ties to UCB; Dr. Murugesan and her other coauthors reported no disclosures. Dr. Kavanaugh had no disclosures.
The rate of U.S. hospitalizations for three types of serious infections in patients with psoriatic arthritis (PsA) appears to have declined from 2012 to 2017, according to research presented at the virtual annual meeting of the American College of Rheumatology.
Several of the standard treatments for PsA have an increased risk of infections, but the rates vary amongst conventional disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, and other therapies.
“Given the uptake of biological therapies has increased over recent years, we sought to investigate the national trends in serious infections in patients with psoriatic arthritis from the years 2012 to 2017,” Vagishwari Murugesan, MBBS, a psoriatic arthritis clinical fellow at the University of Toronto, told attendees in a prerecorded poster presentation. Dr. Murugesan was a fellow at Boston University when she conducted the research.
The researchers analyzed data from 2012 to 2017 in the U.S. National Inpatient Sample (NIS), which includes approximately 20% of all discharges from U.S. community hospitals except rehabilitation and long-term acute care institutions. Using ICD-9 and ICD-10 codes, the researchers identified all discharge records containing a diagnosis of PsA as well as pneumonia, sepsis, urinary tract infection (UTI), and skin and soft-tissue infections. After making adjustments to match U.S. population age distributions over the years, they examined trends in serious infections among patients with PsA for that 6-year period.
Demographics over those years changed little: The average age of discharged patients was 59.5 in 2012 and 60.8 in 2017. Similarly, the patient population was 56% women and 88.5% Whites in 2012 and 57.7% women and 88.4% Whites in 2017. The average length of stay was also similar: 4.7 days in 2012, compared with 4.9 days in 2017.
Among 50,700 discharges of patients with PsA in 2012, the researchers identified 125 with pneumonia, 230 with sepsis, 312 with skin and soft-tissue infections, and 174 with a UTI. Among the 179,400 discharges in 2017 of patients with PsA, 344 had pneumonia, 374 had sepsis, 681 had skin and soft-tissue infections, and 348 had a UTI. After statistical analysis, the researchers found no significant differences in pneumonia diagnoses during the years studied, but they did find a statistically significant decline in sepsis, skin and soft tissue infections, and UTI discharges (P < .001).
A notable limitation of the study is the NIS database’s lack of data on treatments or outpatient data, making it impossible to determine if more infections were occurring but simply being treated in outpatient settings, although it’s not clear why such a substantial shift would occur in just 5 years. It’s also possible that coding practices differ across hospital, but, presumably, the ways they might differ in 2012 would be similar to any differences in 2017.
Arthur Kavanaugh, MD, a professor of medicine and director of the Center for Innovative Therapy at the University of California, San Diego, found the results interesting for what he considers an important topic.
“What makes these data interesting is the same thing that limits their reliability: The authors note that infections decreased ‘despite the increase in use of biologics over this time,’ ” Dr. Kavanaugh said in an interview. “These are claims data, so there is no way to support any association between those serious infections and biologic use. Indeed, multiple factors could have also impacted these data. It is not possible to tell from claims data.”
Dr. Kavanaugh said the question is worth investigating further with data from other sources.
The research was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One study coauthor reported ties to UCB; Dr. Murugesan and her other coauthors reported no disclosures. Dr. Kavanaugh had no disclosures.
The rate of U.S. hospitalizations for three types of serious infections in patients with psoriatic arthritis (PsA) appears to have declined from 2012 to 2017, according to research presented at the virtual annual meeting of the American College of Rheumatology.
Several of the standard treatments for PsA have an increased risk of infections, but the rates vary amongst conventional disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, and other therapies.
“Given the uptake of biological therapies has increased over recent years, we sought to investigate the national trends in serious infections in patients with psoriatic arthritis from the years 2012 to 2017,” Vagishwari Murugesan, MBBS, a psoriatic arthritis clinical fellow at the University of Toronto, told attendees in a prerecorded poster presentation. Dr. Murugesan was a fellow at Boston University when she conducted the research.
The researchers analyzed data from 2012 to 2017 in the U.S. National Inpatient Sample (NIS), which includes approximately 20% of all discharges from U.S. community hospitals except rehabilitation and long-term acute care institutions. Using ICD-9 and ICD-10 codes, the researchers identified all discharge records containing a diagnosis of PsA as well as pneumonia, sepsis, urinary tract infection (UTI), and skin and soft-tissue infections. After making adjustments to match U.S. population age distributions over the years, they examined trends in serious infections among patients with PsA for that 6-year period.
Demographics over those years changed little: The average age of discharged patients was 59.5 in 2012 and 60.8 in 2017. Similarly, the patient population was 56% women and 88.5% Whites in 2012 and 57.7% women and 88.4% Whites in 2017. The average length of stay was also similar: 4.7 days in 2012, compared with 4.9 days in 2017.
Among 50,700 discharges of patients with PsA in 2012, the researchers identified 125 with pneumonia, 230 with sepsis, 312 with skin and soft-tissue infections, and 174 with a UTI. Among the 179,400 discharges in 2017 of patients with PsA, 344 had pneumonia, 374 had sepsis, 681 had skin and soft-tissue infections, and 348 had a UTI. After statistical analysis, the researchers found no significant differences in pneumonia diagnoses during the years studied, but they did find a statistically significant decline in sepsis, skin and soft tissue infections, and UTI discharges (P < .001).
A notable limitation of the study is the NIS database’s lack of data on treatments or outpatient data, making it impossible to determine if more infections were occurring but simply being treated in outpatient settings, although it’s not clear why such a substantial shift would occur in just 5 years. It’s also possible that coding practices differ across hospital, but, presumably, the ways they might differ in 2012 would be similar to any differences in 2017.
Arthur Kavanaugh, MD, a professor of medicine and director of the Center for Innovative Therapy at the University of California, San Diego, found the results interesting for what he considers an important topic.
“What makes these data interesting is the same thing that limits their reliability: The authors note that infections decreased ‘despite the increase in use of biologics over this time,’ ” Dr. Kavanaugh said in an interview. “These are claims data, so there is no way to support any association between those serious infections and biologic use. Indeed, multiple factors could have also impacted these data. It is not possible to tell from claims data.”
Dr. Kavanaugh said the question is worth investigating further with data from other sources.
The research was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One study coauthor reported ties to UCB; Dr. Murugesan and her other coauthors reported no disclosures. Dr. Kavanaugh had no disclosures.
FROM ACR 2021
CDC: Thirty percent of hospital workers in U.S. still unvaccinated
, according to a new survey by the Centers for Disease Control and Prevention.
The snapshot in time – Jan. 20, 2021 to Sept. 15, 2021 – is based on voluntary weekly reports from hospitals. Only about 48% of the 5,085 hospitals in the U.S. Health and Human Services department’s Unified Hospital Data Surveillance System reported data on vaccination coverage during the period, and, after validation checks, the study included reports from 2,086 facilities, or just 41% of all hospitals, covering 3.35 million workers.
Overall, the number who were fully vaccinated rose from 36.1% in Jan. 2021 to 60.2% in April 2021, and then crept slowly up to 70% by Sept. 15, the CDC researchers reported in the American Journal of Infection Control.
The slowdown among hospital workers seems to mirror the same decline as in the general population.
Arjun Srinivasan, MD, associate director for health care–associated infection prevention programs at the CDC, said the decline in part may be the result of misinformation.
Health care personnel “are not fully immune from vaccine misinformation,” he said, adding that such misinformation “is contributing to decreased vaccine uptake among non–health care personnel.”
“The take-home message is that there is a lot of work to do in health care settings in order to get all of our health care personnel vaccinated,” Dr. Srinivasan told this news organization. “We need them to be vaccinated to protect themselves. It is also really important that we as health care personnel get vaccinated to protect our patients.”
Vaccine mandates
The analysis shows that workers were more likely to be vaccinated if they worked at a children’s hospital (77%), lived in metropolitan counties (71%), or worked in a hospital with lower cumulative admissions of COVID-19 patients, or lower cumulative COVID-19 cases.
The odds of being fully vaccinated were lower if the surrounding community had lower vaccination coverage. Workers in non-metropolitan counties (63.3%) and in rural counties (65.1%) were also less likely to be fully vaccinated, as well as those who were in critical access hospitals (64%) or long-term acute care hospitals (68.8%).
Surveys have shown that health care personnel who are vaccine-hesitant cited concerns they had about vaccine efficacy, adverse effects, the speed of vaccine development, and lack of full Food and Drug Administration approval, the study authors noted. In addition, many reported low trust in the government.
A Medscape survey this past April found that 25% of health care workers said they did not plan to be fully vaccinated. Some 40% of the 9,349 workers who responded said that employers should never require a COVID-19 vaccine for clinicians.
But the Centers for Medicare & Medicaid Services is attempting to require all health care facilities that receive Medicare or Medicaid payment to vaccinate workers. All eligible staff must receive the first dose of a two-dose COVID-19 vaccine or a one-dose vaccine by Dec. 6, and a second dose by Jan. 4, 2022. The policy allows exemptions based on recognized medical conditions or religious beliefs.
Some hospitals and health systems and various states and cities have already begun implementing vaccine mandates. Northwell Health in New York, for instance, lost 1,400 workers (evenly split between clinical and nonclinical staff), or 2% of its 77,000 employees, as a result of the state’s mandate.
Northwell’s workforce is now considered 100% vaccinated, a hospital spokesman said in an interview. In addition, “we have allowed for team members who changed their minds and presented proof of vaccination to return,” said the spokesman, adding that “a couple of hundred employees have done just that.”
Ten states sued the Biden administration recently, aiming to stop the health care worker vaccine mandate. Other challenges to vaccine mandates have generally been unsuccessful. The U.S. Supreme Court, for example, in October declined to hear a challenge to Maine’s mandate for health care workers, even though it did not allow religious exemptions, according to the Washington Post.
“The courts seem to agree that health care personnel are different, and could be subject to these mandates,” said Dr. Srinivasan.
A version of this article first appeared on Medscape.com.
, according to a new survey by the Centers for Disease Control and Prevention.
The snapshot in time – Jan. 20, 2021 to Sept. 15, 2021 – is based on voluntary weekly reports from hospitals. Only about 48% of the 5,085 hospitals in the U.S. Health and Human Services department’s Unified Hospital Data Surveillance System reported data on vaccination coverage during the period, and, after validation checks, the study included reports from 2,086 facilities, or just 41% of all hospitals, covering 3.35 million workers.
Overall, the number who were fully vaccinated rose from 36.1% in Jan. 2021 to 60.2% in April 2021, and then crept slowly up to 70% by Sept. 15, the CDC researchers reported in the American Journal of Infection Control.
The slowdown among hospital workers seems to mirror the same decline as in the general population.
Arjun Srinivasan, MD, associate director for health care–associated infection prevention programs at the CDC, said the decline in part may be the result of misinformation.
Health care personnel “are not fully immune from vaccine misinformation,” he said, adding that such misinformation “is contributing to decreased vaccine uptake among non–health care personnel.”
“The take-home message is that there is a lot of work to do in health care settings in order to get all of our health care personnel vaccinated,” Dr. Srinivasan told this news organization. “We need them to be vaccinated to protect themselves. It is also really important that we as health care personnel get vaccinated to protect our patients.”
Vaccine mandates
The analysis shows that workers were more likely to be vaccinated if they worked at a children’s hospital (77%), lived in metropolitan counties (71%), or worked in a hospital with lower cumulative admissions of COVID-19 patients, or lower cumulative COVID-19 cases.
The odds of being fully vaccinated were lower if the surrounding community had lower vaccination coverage. Workers in non-metropolitan counties (63.3%) and in rural counties (65.1%) were also less likely to be fully vaccinated, as well as those who were in critical access hospitals (64%) or long-term acute care hospitals (68.8%).
Surveys have shown that health care personnel who are vaccine-hesitant cited concerns they had about vaccine efficacy, adverse effects, the speed of vaccine development, and lack of full Food and Drug Administration approval, the study authors noted. In addition, many reported low trust in the government.
A Medscape survey this past April found that 25% of health care workers said they did not plan to be fully vaccinated. Some 40% of the 9,349 workers who responded said that employers should never require a COVID-19 vaccine for clinicians.
But the Centers for Medicare & Medicaid Services is attempting to require all health care facilities that receive Medicare or Medicaid payment to vaccinate workers. All eligible staff must receive the first dose of a two-dose COVID-19 vaccine or a one-dose vaccine by Dec. 6, and a second dose by Jan. 4, 2022. The policy allows exemptions based on recognized medical conditions or religious beliefs.
Some hospitals and health systems and various states and cities have already begun implementing vaccine mandates. Northwell Health in New York, for instance, lost 1,400 workers (evenly split between clinical and nonclinical staff), or 2% of its 77,000 employees, as a result of the state’s mandate.
Northwell’s workforce is now considered 100% vaccinated, a hospital spokesman said in an interview. In addition, “we have allowed for team members who changed their minds and presented proof of vaccination to return,” said the spokesman, adding that “a couple of hundred employees have done just that.”
Ten states sued the Biden administration recently, aiming to stop the health care worker vaccine mandate. Other challenges to vaccine mandates have generally been unsuccessful. The U.S. Supreme Court, for example, in October declined to hear a challenge to Maine’s mandate for health care workers, even though it did not allow religious exemptions, according to the Washington Post.
“The courts seem to agree that health care personnel are different, and could be subject to these mandates,” said Dr. Srinivasan.
A version of this article first appeared on Medscape.com.
, according to a new survey by the Centers for Disease Control and Prevention.
The snapshot in time – Jan. 20, 2021 to Sept. 15, 2021 – is based on voluntary weekly reports from hospitals. Only about 48% of the 5,085 hospitals in the U.S. Health and Human Services department’s Unified Hospital Data Surveillance System reported data on vaccination coverage during the period, and, after validation checks, the study included reports from 2,086 facilities, or just 41% of all hospitals, covering 3.35 million workers.
Overall, the number who were fully vaccinated rose from 36.1% in Jan. 2021 to 60.2% in April 2021, and then crept slowly up to 70% by Sept. 15, the CDC researchers reported in the American Journal of Infection Control.
The slowdown among hospital workers seems to mirror the same decline as in the general population.
Arjun Srinivasan, MD, associate director for health care–associated infection prevention programs at the CDC, said the decline in part may be the result of misinformation.
Health care personnel “are not fully immune from vaccine misinformation,” he said, adding that such misinformation “is contributing to decreased vaccine uptake among non–health care personnel.”
“The take-home message is that there is a lot of work to do in health care settings in order to get all of our health care personnel vaccinated,” Dr. Srinivasan told this news organization. “We need them to be vaccinated to protect themselves. It is also really important that we as health care personnel get vaccinated to protect our patients.”
Vaccine mandates
The analysis shows that workers were more likely to be vaccinated if they worked at a children’s hospital (77%), lived in metropolitan counties (71%), or worked in a hospital with lower cumulative admissions of COVID-19 patients, or lower cumulative COVID-19 cases.
The odds of being fully vaccinated were lower if the surrounding community had lower vaccination coverage. Workers in non-metropolitan counties (63.3%) and in rural counties (65.1%) were also less likely to be fully vaccinated, as well as those who were in critical access hospitals (64%) or long-term acute care hospitals (68.8%).
Surveys have shown that health care personnel who are vaccine-hesitant cited concerns they had about vaccine efficacy, adverse effects, the speed of vaccine development, and lack of full Food and Drug Administration approval, the study authors noted. In addition, many reported low trust in the government.
A Medscape survey this past April found that 25% of health care workers said they did not plan to be fully vaccinated. Some 40% of the 9,349 workers who responded said that employers should never require a COVID-19 vaccine for clinicians.
But the Centers for Medicare & Medicaid Services is attempting to require all health care facilities that receive Medicare or Medicaid payment to vaccinate workers. All eligible staff must receive the first dose of a two-dose COVID-19 vaccine or a one-dose vaccine by Dec. 6, and a second dose by Jan. 4, 2022. The policy allows exemptions based on recognized medical conditions or religious beliefs.
Some hospitals and health systems and various states and cities have already begun implementing vaccine mandates. Northwell Health in New York, for instance, lost 1,400 workers (evenly split between clinical and nonclinical staff), or 2% of its 77,000 employees, as a result of the state’s mandate.
Northwell’s workforce is now considered 100% vaccinated, a hospital spokesman said in an interview. In addition, “we have allowed for team members who changed their minds and presented proof of vaccination to return,” said the spokesman, adding that “a couple of hundred employees have done just that.”
Ten states sued the Biden administration recently, aiming to stop the health care worker vaccine mandate. Other challenges to vaccine mandates have generally been unsuccessful. The U.S. Supreme Court, for example, in October declined to hear a challenge to Maine’s mandate for health care workers, even though it did not allow religious exemptions, according to the Washington Post.
“The courts seem to agree that health care personnel are different, and could be subject to these mandates,” said Dr. Srinivasan.
A version of this article first appeared on Medscape.com.
How to deal with offensive or impaired doctors
Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.
Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .
“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.
She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.
After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
Confront, correct, and/or counsel
The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.
Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.
She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.
She also recommends implementing these strategies to prevent and deal with disruptive physicians:
- Implement a code of conduct and share it during interviews;
- Have zero tolerance policies and procedures for documenting behavior;
- Get advice from a good employment attorney;
- Implement written performance improvement plans;
- Provide resources to change the behavior;
- Follow through with suspension and termination; and
- Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.
Getting impaired doctors help
Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.
Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.
She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”
Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.
Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:
- Include “fit for duty” examinations, especially after age 65.
- Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
- Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
- Establish a voting mechanism for terminating a physician.
Aging doctors who won’t retire
Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.
She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.
Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.
She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”
Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.
“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.
A version of this article first appeared on Medscape.com.
Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.
Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .
“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.
She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.
After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
Confront, correct, and/or counsel
The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.
Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.
She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.
She also recommends implementing these strategies to prevent and deal with disruptive physicians:
- Implement a code of conduct and share it during interviews;
- Have zero tolerance policies and procedures for documenting behavior;
- Get advice from a good employment attorney;
- Implement written performance improvement plans;
- Provide resources to change the behavior;
- Follow through with suspension and termination; and
- Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.
Getting impaired doctors help
Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.
Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.
She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”
Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.
Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:
- Include “fit for duty” examinations, especially after age 65.
- Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
- Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
- Establish a voting mechanism for terminating a physician.
Aging doctors who won’t retire
Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.
She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.
Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.
She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”
Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.
“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.
A version of this article first appeared on Medscape.com.
Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.
Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .
“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.
She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.
After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
Confront, correct, and/or counsel
The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.
Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.
She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.
She also recommends implementing these strategies to prevent and deal with disruptive physicians:
- Implement a code of conduct and share it during interviews;
- Have zero tolerance policies and procedures for documenting behavior;
- Get advice from a good employment attorney;
- Implement written performance improvement plans;
- Provide resources to change the behavior;
- Follow through with suspension and termination; and
- Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.
Getting impaired doctors help
Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.
Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.
She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”
Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.
Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:
- Include “fit for duty” examinations, especially after age 65.
- Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
- Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
- Establish a voting mechanism for terminating a physician.
Aging doctors who won’t retire
Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.
She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.
Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.
She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”
Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.
“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.
A version of this article first appeared on Medscape.com.
Timing of renal-replacement therapy for AKI in the ICU
Background: Acute kidney injury (AKI) in the ICU is associated with high mortality. It is hypothesized that earlier initiation of RRT may benefit patients by controlling fluid overload and reducing metabolic stress caused by electrolyte and acid-base imbalances. However, prior studies have been conflicting, with the IDEAL-ICU study (2018) demonstrating no improvement in 90-day mortality with early RRT in septic shock.
Study design: Open-label randomized controlled trial.
Setting: 168 hospitals in 15 countries.
Synopsis: Of ICU patients with severe AKI, 3,019 were randomized to either early or standard initiation of RRT. Early RRT was defined as occurring within 12 hours of eligibility; in the standard-therapy group, RRT was delayed until specifically indicated or if there was no improvement after 72 hours. Those needing immediate renal replacement or deemed likely to recover without need for RRT were excluded in order to study only those in whom ideal timing of dialysis was uncertain. There was no difference in 90-day mortality between the groups (43.9% vs. 43.7%; P = .92). Early initiation did not improve length of ICU stay, ventilator-free days, days out of the hospital, or quality of life. The early-initiation patients experienced more adverse events related to RRT and were more likely to have continued dependence on RRT at 90 days (10.4% vs. 6.0% in standard initiation). Of note, approximately 40% of those randomized to standard initiation never required RRT.
Bottom line: This large, multicenter, well-conducted trial demonstrates no benefit for early initiation of RRT in critically ill patients.
Citation: STARRT-AKI investigators. Timing of initiation of renal-replacement therapy in acute kidney injury. N Engl J Med. 2020;383:240-51. doi: 10.1056/NEJMoa2000741.
Dr. Lee is a hospitalist at Northwestern Memorial Hospital and Lurie Children’s Hospital and assistant professor of medicine, Feinberg School of Medicine, all in Chicago.
Background: Acute kidney injury (AKI) in the ICU is associated with high mortality. It is hypothesized that earlier initiation of RRT may benefit patients by controlling fluid overload and reducing metabolic stress caused by electrolyte and acid-base imbalances. However, prior studies have been conflicting, with the IDEAL-ICU study (2018) demonstrating no improvement in 90-day mortality with early RRT in septic shock.
Study design: Open-label randomized controlled trial.
Setting: 168 hospitals in 15 countries.
Synopsis: Of ICU patients with severe AKI, 3,019 were randomized to either early or standard initiation of RRT. Early RRT was defined as occurring within 12 hours of eligibility; in the standard-therapy group, RRT was delayed until specifically indicated or if there was no improvement after 72 hours. Those needing immediate renal replacement or deemed likely to recover without need for RRT were excluded in order to study only those in whom ideal timing of dialysis was uncertain. There was no difference in 90-day mortality between the groups (43.9% vs. 43.7%; P = .92). Early initiation did not improve length of ICU stay, ventilator-free days, days out of the hospital, or quality of life. The early-initiation patients experienced more adverse events related to RRT and were more likely to have continued dependence on RRT at 90 days (10.4% vs. 6.0% in standard initiation). Of note, approximately 40% of those randomized to standard initiation never required RRT.
Bottom line: This large, multicenter, well-conducted trial demonstrates no benefit for early initiation of RRT in critically ill patients.
Citation: STARRT-AKI investigators. Timing of initiation of renal-replacement therapy in acute kidney injury. N Engl J Med. 2020;383:240-51. doi: 10.1056/NEJMoa2000741.
Dr. Lee is a hospitalist at Northwestern Memorial Hospital and Lurie Children’s Hospital and assistant professor of medicine, Feinberg School of Medicine, all in Chicago.
Background: Acute kidney injury (AKI) in the ICU is associated with high mortality. It is hypothesized that earlier initiation of RRT may benefit patients by controlling fluid overload and reducing metabolic stress caused by electrolyte and acid-base imbalances. However, prior studies have been conflicting, with the IDEAL-ICU study (2018) demonstrating no improvement in 90-day mortality with early RRT in septic shock.
Study design: Open-label randomized controlled trial.
Setting: 168 hospitals in 15 countries.
Synopsis: Of ICU patients with severe AKI, 3,019 were randomized to either early or standard initiation of RRT. Early RRT was defined as occurring within 12 hours of eligibility; in the standard-therapy group, RRT was delayed until specifically indicated or if there was no improvement after 72 hours. Those needing immediate renal replacement or deemed likely to recover without need for RRT were excluded in order to study only those in whom ideal timing of dialysis was uncertain. There was no difference in 90-day mortality between the groups (43.9% vs. 43.7%; P = .92). Early initiation did not improve length of ICU stay, ventilator-free days, days out of the hospital, or quality of life. The early-initiation patients experienced more adverse events related to RRT and were more likely to have continued dependence on RRT at 90 days (10.4% vs. 6.0% in standard initiation). Of note, approximately 40% of those randomized to standard initiation never required RRT.
Bottom line: This large, multicenter, well-conducted trial demonstrates no benefit for early initiation of RRT in critically ill patients.
Citation: STARRT-AKI investigators. Timing of initiation of renal-replacement therapy in acute kidney injury. N Engl J Med. 2020;383:240-51. doi: 10.1056/NEJMoa2000741.
Dr. Lee is a hospitalist at Northwestern Memorial Hospital and Lurie Children’s Hospital and assistant professor of medicine, Feinberg School of Medicine, all in Chicago.
Ulcerative colitis study: Ozanimod tops adalimumab, equals vedolizumab
LAS VEGAS – In a comparison of data from clinical trials for ulcerative colitis, ozanimod (Zeposia) appeared to be more useful than adalimumab (Humira) and as useful as vedolizumab (Entyvio).
The U.S. Food and Drug Administration approved ozanimod for ulcerative colitis in May of this year, and clinicians are trying to figure out where it fits into the armamentarium, said Marla Dubinsky, MD, professor of pediatrics and medicine in the Division of Pediatric Gastroenterology at Icahn School of Medicine at Mount Sinai, New York.
“It’s an extremely heterogeneous disease,” Dr. Dubinsky told this news organization. “A lot of these indirect comparisons are being done, because these therapies are coming out so quickly.”
No clinical trials have compared either ozanimod to adalimumab or ozanimod to vedolizumab head to head, so Dr. Dubinsky and colleagues pitted the drugs against each other by matching data from individual patients from the True North trial of ozanimod to published data from the ULTRA 1 and 2 trials of adalimumab and the GEMINI 1 trial of vedolizumab.
She presented the findings here at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.
From the 1990s until 2014, physicians relied heavily on tumor necrosis factor (TNF) inhibitors, such as adalimumab, to treat ulcerative colitis, Dr. Dubinsky said. Although often effective, these drugs can increase patients’ vulnerability to infections and malignancies.
Approved by the FDA in 2014, vedolizumab works differently: it blocks α4β7 integrin. “The safety profile was extremely favorable,” Dr. Dubinsky said. “That was a revolution, in my opinion.” Still, vedolizumab isn’t always effective, especially for patients who have already received TNF inhibitors without success.
As reported by this news organization, ozanimod works by yet another mechanism: sphingosine l-phosphate receptor modulation.
How does ozanimod measure up?
To see how ozanimod stacks up to the two older drugs, Dr. Dubinsky and colleagues weighted the data from True North to match the patient populations in the other trials by age, sex, baseline total Mayo score, disease extent, and prior anti-TNF treatment.
They calculated the odds that ozanimod would produce better clinical and endoscopic responses or be associated with more serious or infectious adverse events in comparison with each of the other drugs. The comparisons included both the induction and maintenance phases of the trials.
The researchers compared ozanimod to adalimumab for patients who were anti-TNF naive. They found that the patients who took ozanimod were more likely to experience a clinical response than those who took adalimumab (odds ratio, 1.68; 95% CI, 1.03-2.74). The patients who took ozanimod were also more likely to have endoscopic improvement (OR, 2.73; 95% CI, 1.44-5.17).
They found that the patients who had received a TNF inhibitor were also more likely to experience a clinical response with ozanimod than with adalimumab (OR, 2.53; 95% CI, 1.13-5.67).
In both the induction and the maintenance phases, the other differences in efficacy between ozanimod and adalimumab did not reach statistical significance.
As for safety, in the induction phases of the trials, the researchers found that 11.3% of patients who received ozanimod had infections, compared to 20.2% of those taking adalimumab, which was statistically significant (P < .01). Other differences in safety were not statistically significant.
With regard to vedolizumab, Dr. Dubinsky and colleagues found no statistically significant differences between it and ozanimod in the induction phases.
In the maintenance phases, among patients who were anti-TNF naive, the odds of clinical response were lower with ozanimod than with vedolizumab (OR, 0.40; 95% CI, 0.21-0.76). The odds of endoscopic improvement were very nearly lower (OR, 0.52; 95% CI, 0.27-1.01). The researchers attributed these findings to a higher placebo response in the True North trial (the ozanimod trial) than in GEMINI 1 (the vedolizumab trial).
There were no other significant differences in efficacy between ozanimod and vedolizumab, either in the cohort that had received a TNF inhibitor or in the cohort that had not.
As for safety, there were also no statistically significant differences between vedolizumab and ozanimod in the induction phases. During the maintenance phases, 71.3% of patients who received vedolizumab had infections, compared to 25.0% in the matched cohort of patients who received ozanimod, which was a statistically significant difference (P < .001). The other differences in this phase were not significant.
Dr. Dubinsky acknowledged that the results were not as reliable as would have been the case in a prospective, head-to-head comparison, because the researchers could not be sure that they had fully adjusted for the differences in the populations and the designs of the studies.
“In TNF-inhibitor–naive patients, I could use vedolizumab or ozanimod,” Dr. Dubinsky said. But these are not the only options, she said. She said that “in TNF failure, I would use ustekinumab or even tofacitinib.” Ustekinumab (Stelara) is a human interleukin-12 and -23 antagonist; tofacitinib (Xeljanz) is a Janus kinase inhibitor.
The study’s limitations are significant, said session moderator Jonathan Leighton, MD, a professor of medicine at the Mayo Clinic in Phoenix, Arizona, “but it certainly shows that ozanimod had a positive profile compared to adalimumab and has overall comparable benefits with vedolizumab,” he said in an interview.
Dr. Leighton added that someday researchers may find biomarkers that will identify the best drug for each patient. In the meantime, clinicians are often left choosing therapies on the basis of such factors as which route of administration the patients prefer, he said. Vedolizumab is given by intravenous infusion, ozanimod is taken orally, and adalimumab is given by subcutaneous injection.
The study was funded by Bristol-Myers Squibb. Dr. Leighton has financial relationships with Olympus and Pfizer. Dr. Dubinsky has relationships with all or most of the companies that make drugs for inflammatory bowel disease.
A version of this article first appeared on Medscape.com.
LAS VEGAS – In a comparison of data from clinical trials for ulcerative colitis, ozanimod (Zeposia) appeared to be more useful than adalimumab (Humira) and as useful as vedolizumab (Entyvio).
The U.S. Food and Drug Administration approved ozanimod for ulcerative colitis in May of this year, and clinicians are trying to figure out where it fits into the armamentarium, said Marla Dubinsky, MD, professor of pediatrics and medicine in the Division of Pediatric Gastroenterology at Icahn School of Medicine at Mount Sinai, New York.
“It’s an extremely heterogeneous disease,” Dr. Dubinsky told this news organization. “A lot of these indirect comparisons are being done, because these therapies are coming out so quickly.”
No clinical trials have compared either ozanimod to adalimumab or ozanimod to vedolizumab head to head, so Dr. Dubinsky and colleagues pitted the drugs against each other by matching data from individual patients from the True North trial of ozanimod to published data from the ULTRA 1 and 2 trials of adalimumab and the GEMINI 1 trial of vedolizumab.
She presented the findings here at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.
From the 1990s until 2014, physicians relied heavily on tumor necrosis factor (TNF) inhibitors, such as adalimumab, to treat ulcerative colitis, Dr. Dubinsky said. Although often effective, these drugs can increase patients’ vulnerability to infections and malignancies.
Approved by the FDA in 2014, vedolizumab works differently: it blocks α4β7 integrin. “The safety profile was extremely favorable,” Dr. Dubinsky said. “That was a revolution, in my opinion.” Still, vedolizumab isn’t always effective, especially for patients who have already received TNF inhibitors without success.
As reported by this news organization, ozanimod works by yet another mechanism: sphingosine l-phosphate receptor modulation.
How does ozanimod measure up?
To see how ozanimod stacks up to the two older drugs, Dr. Dubinsky and colleagues weighted the data from True North to match the patient populations in the other trials by age, sex, baseline total Mayo score, disease extent, and prior anti-TNF treatment.
They calculated the odds that ozanimod would produce better clinical and endoscopic responses or be associated with more serious or infectious adverse events in comparison with each of the other drugs. The comparisons included both the induction and maintenance phases of the trials.
The researchers compared ozanimod to adalimumab for patients who were anti-TNF naive. They found that the patients who took ozanimod were more likely to experience a clinical response than those who took adalimumab (odds ratio, 1.68; 95% CI, 1.03-2.74). The patients who took ozanimod were also more likely to have endoscopic improvement (OR, 2.73; 95% CI, 1.44-5.17).
They found that the patients who had received a TNF inhibitor were also more likely to experience a clinical response with ozanimod than with adalimumab (OR, 2.53; 95% CI, 1.13-5.67).
In both the induction and the maintenance phases, the other differences in efficacy between ozanimod and adalimumab did not reach statistical significance.
As for safety, in the induction phases of the trials, the researchers found that 11.3% of patients who received ozanimod had infections, compared to 20.2% of those taking adalimumab, which was statistically significant (P < .01). Other differences in safety were not statistically significant.
With regard to vedolizumab, Dr. Dubinsky and colleagues found no statistically significant differences between it and ozanimod in the induction phases.
In the maintenance phases, among patients who were anti-TNF naive, the odds of clinical response were lower with ozanimod than with vedolizumab (OR, 0.40; 95% CI, 0.21-0.76). The odds of endoscopic improvement were very nearly lower (OR, 0.52; 95% CI, 0.27-1.01). The researchers attributed these findings to a higher placebo response in the True North trial (the ozanimod trial) than in GEMINI 1 (the vedolizumab trial).
There were no other significant differences in efficacy between ozanimod and vedolizumab, either in the cohort that had received a TNF inhibitor or in the cohort that had not.
As for safety, there were also no statistically significant differences between vedolizumab and ozanimod in the induction phases. During the maintenance phases, 71.3% of patients who received vedolizumab had infections, compared to 25.0% in the matched cohort of patients who received ozanimod, which was a statistically significant difference (P < .001). The other differences in this phase were not significant.
Dr. Dubinsky acknowledged that the results were not as reliable as would have been the case in a prospective, head-to-head comparison, because the researchers could not be sure that they had fully adjusted for the differences in the populations and the designs of the studies.
“In TNF-inhibitor–naive patients, I could use vedolizumab or ozanimod,” Dr. Dubinsky said. But these are not the only options, she said. She said that “in TNF failure, I would use ustekinumab or even tofacitinib.” Ustekinumab (Stelara) is a human interleukin-12 and -23 antagonist; tofacitinib (Xeljanz) is a Janus kinase inhibitor.
The study’s limitations are significant, said session moderator Jonathan Leighton, MD, a professor of medicine at the Mayo Clinic in Phoenix, Arizona, “but it certainly shows that ozanimod had a positive profile compared to adalimumab and has overall comparable benefits with vedolizumab,” he said in an interview.
Dr. Leighton added that someday researchers may find biomarkers that will identify the best drug for each patient. In the meantime, clinicians are often left choosing therapies on the basis of such factors as which route of administration the patients prefer, he said. Vedolizumab is given by intravenous infusion, ozanimod is taken orally, and adalimumab is given by subcutaneous injection.
The study was funded by Bristol-Myers Squibb. Dr. Leighton has financial relationships with Olympus and Pfizer. Dr. Dubinsky has relationships with all or most of the companies that make drugs for inflammatory bowel disease.
A version of this article first appeared on Medscape.com.
LAS VEGAS – In a comparison of data from clinical trials for ulcerative colitis, ozanimod (Zeposia) appeared to be more useful than adalimumab (Humira) and as useful as vedolizumab (Entyvio).
The U.S. Food and Drug Administration approved ozanimod for ulcerative colitis in May of this year, and clinicians are trying to figure out where it fits into the armamentarium, said Marla Dubinsky, MD, professor of pediatrics and medicine in the Division of Pediatric Gastroenterology at Icahn School of Medicine at Mount Sinai, New York.
“It’s an extremely heterogeneous disease,” Dr. Dubinsky told this news organization. “A lot of these indirect comparisons are being done, because these therapies are coming out so quickly.”
No clinical trials have compared either ozanimod to adalimumab or ozanimod to vedolizumab head to head, so Dr. Dubinsky and colleagues pitted the drugs against each other by matching data from individual patients from the True North trial of ozanimod to published data from the ULTRA 1 and 2 trials of adalimumab and the GEMINI 1 trial of vedolizumab.
She presented the findings here at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.
From the 1990s until 2014, physicians relied heavily on tumor necrosis factor (TNF) inhibitors, such as adalimumab, to treat ulcerative colitis, Dr. Dubinsky said. Although often effective, these drugs can increase patients’ vulnerability to infections and malignancies.
Approved by the FDA in 2014, vedolizumab works differently: it blocks α4β7 integrin. “The safety profile was extremely favorable,” Dr. Dubinsky said. “That was a revolution, in my opinion.” Still, vedolizumab isn’t always effective, especially for patients who have already received TNF inhibitors without success.
As reported by this news organization, ozanimod works by yet another mechanism: sphingosine l-phosphate receptor modulation.
How does ozanimod measure up?
To see how ozanimod stacks up to the two older drugs, Dr. Dubinsky and colleagues weighted the data from True North to match the patient populations in the other trials by age, sex, baseline total Mayo score, disease extent, and prior anti-TNF treatment.
They calculated the odds that ozanimod would produce better clinical and endoscopic responses or be associated with more serious or infectious adverse events in comparison with each of the other drugs. The comparisons included both the induction and maintenance phases of the trials.
The researchers compared ozanimod to adalimumab for patients who were anti-TNF naive. They found that the patients who took ozanimod were more likely to experience a clinical response than those who took adalimumab (odds ratio, 1.68; 95% CI, 1.03-2.74). The patients who took ozanimod were also more likely to have endoscopic improvement (OR, 2.73; 95% CI, 1.44-5.17).
They found that the patients who had received a TNF inhibitor were also more likely to experience a clinical response with ozanimod than with adalimumab (OR, 2.53; 95% CI, 1.13-5.67).
In both the induction and the maintenance phases, the other differences in efficacy between ozanimod and adalimumab did not reach statistical significance.
As for safety, in the induction phases of the trials, the researchers found that 11.3% of patients who received ozanimod had infections, compared to 20.2% of those taking adalimumab, which was statistically significant (P < .01). Other differences in safety were not statistically significant.
With regard to vedolizumab, Dr. Dubinsky and colleagues found no statistically significant differences between it and ozanimod in the induction phases.
In the maintenance phases, among patients who were anti-TNF naive, the odds of clinical response were lower with ozanimod than with vedolizumab (OR, 0.40; 95% CI, 0.21-0.76). The odds of endoscopic improvement were very nearly lower (OR, 0.52; 95% CI, 0.27-1.01). The researchers attributed these findings to a higher placebo response in the True North trial (the ozanimod trial) than in GEMINI 1 (the vedolizumab trial).
There were no other significant differences in efficacy between ozanimod and vedolizumab, either in the cohort that had received a TNF inhibitor or in the cohort that had not.
As for safety, there were also no statistically significant differences between vedolizumab and ozanimod in the induction phases. During the maintenance phases, 71.3% of patients who received vedolizumab had infections, compared to 25.0% in the matched cohort of patients who received ozanimod, which was a statistically significant difference (P < .001). The other differences in this phase were not significant.
Dr. Dubinsky acknowledged that the results were not as reliable as would have been the case in a prospective, head-to-head comparison, because the researchers could not be sure that they had fully adjusted for the differences in the populations and the designs of the studies.
“In TNF-inhibitor–naive patients, I could use vedolizumab or ozanimod,” Dr. Dubinsky said. But these are not the only options, she said. She said that “in TNF failure, I would use ustekinumab or even tofacitinib.” Ustekinumab (Stelara) is a human interleukin-12 and -23 antagonist; tofacitinib (Xeljanz) is a Janus kinase inhibitor.
The study’s limitations are significant, said session moderator Jonathan Leighton, MD, a professor of medicine at the Mayo Clinic in Phoenix, Arizona, “but it certainly shows that ozanimod had a positive profile compared to adalimumab and has overall comparable benefits with vedolizumab,” he said in an interview.
Dr. Leighton added that someday researchers may find biomarkers that will identify the best drug for each patient. In the meantime, clinicians are often left choosing therapies on the basis of such factors as which route of administration the patients prefer, he said. Vedolizumab is given by intravenous infusion, ozanimod is taken orally, and adalimumab is given by subcutaneous injection.
The study was funded by Bristol-Myers Squibb. Dr. Leighton has financial relationships with Olympus and Pfizer. Dr. Dubinsky has relationships with all or most of the companies that make drugs for inflammatory bowel disease.
A version of this article first appeared on Medscape.com.
Early-in-career family physician shares hopes for future of specialty
I became interested in becoming a physician during my very last semester of college. I volunteered in a hospital psychiatric department in the unit that provided electroconvulsive therapy to patients with severe mental health diagnoses. Although this was about 15 years ago, I still vividly remember the curiosity I had walking around the hospital looking around at all the doctors and nurses and wanting to understand what their day-to-day life was like helping people to optimize their health.
Up until that time, thankfully my family and I had been relatively healthy, and, outside of routine checkups, my time spent in a hospital or clinic was limited. Therefore, those months of volunteering at the hospital were the longest periods of time I’d spent around physicians and other health care professionals really witnessing firsthand the science and the art of medicine.
During my time volunteering I saw one patient over the course of several weeks who was catatonic when I first met her, but by the end of several electroconvulsive therapy treatments she had a subtle smile on her face and we were able to have a conversation. She was a younger Black woman like myself and at that moment I knew that I wanted to become a physician and be involved in people’s lives in such a unique manner.
I worked for several years before applying to medical school. During that time two of my jobs involved doing home visits with children, young adults, and their families. I once again experienced the connection that one can make with someone and their family over a short period of time when you actively listen, understand what is important to them, and work together.
After several years of this work I got accepted into medical school and excitedly started the path to becoming a physician. While the learning curve was difficult, I genuinely enjoyed every block of medical school, including learning the anatomy, pathophysiology, and pharmacology. I could not wait to be in front of patients to use this newfound knowledge to help solve their health problems.
‘There is no such thing as a single issue-struggle’
As I started the third year of medical school and clinical rotations, I found joy in being in hospitals and clinics. I also came to recognize that understanding the pharmacology of why metformin helps improve the hemoglobin A1c in people with diabetes is not necessarily one of the keys to helping people optimize their health. I started to talk with patients and all sorts of questions would come to mind. Where did they grow up? What did they identify as their culture? What did they do in their day to day? Did they have a home and support at that home? Are they someone’s caretaker? What are their hopes for the future? And the list goes on.
I ultimately chose family medicine as a specialty because, as Audre Lorde said, “there is no such thing as a single-issue struggle because we do not live single-issue lives,” and family medicine allows one to look at the intersections of people’s lives and how they affect their health and well-being.
I currently practice as a family medicine physician in a setting in which I provide a lot of sexual and reproductive health care. I welcome patients of all ages and genders, and this care includes preconception counseling, contraceptive counseling, prenatal and postpartum care, STI testing and treatment, abortion care, and routine preventive care – just to name a few.
I decided to specialize in sexual and reproductive health care within family medicine because of the historic discrimination and inequitable treatment that is often experienced by young Black persons when they seek care for their sexual health and/or reproductive choices. In addition, there is often stigma within communities when it comes to talking about sex, bodies, and pleasure.
Recently, after a few minutes with a patient, she shared with me that she just completed nursing school and was studying for her exams. We talked about what type of jobs she was looking to apply for and where she wanted to work. I expressed to her that I was proud of the hard work she put in to complete nursing school and commiserated with her about the challenges in schooling and studying that it takes to start in the health care field. The conversation eventually found its way to talking about her sexual and reproductive health care. She shared with me that she was interested in having a child; however, at this time she put those plans on hold because she was scared about the racism within health care and the unacceptable high rates of maternal mortality among Black women in this country.
I listened and shared that as someone who also identifies as a Black woman, I have similar fears and anxieties surrounding my own reproductive health future. During the visit with this patient, I used my training in family medicine to better understand her physical and mental health needs and reassured her that I was going to partner with her through her health care journey.
Hope for the future of family medicine
As I work on a day-to-day basis I often think about my hopes for patients, as well as my hopes for medicine and the field of family medicine. My hope for the future of family medicine is that we can continue to make meaningful connections with patients to help them optimize their health and well-being.
I imagine a system in which we have the time and support to do this for all of our patients regardless of their immigration status, socioeconomic status, or any other historically excluded status. My hope for the future of family medicine is that I can write a prescription for a medication or physical therapy, and the patient is able to fill the prescription without having to worry about the financial implications of paying for it. My hope for the future of family medicine is that patients can seek out care without the fear of discrimination or racism through an increasingly diverse work force. My hope for the future of family medicine is that these improvements become a reality and that as physicians we can appreciate the connections we make with patients and the impact this has on their overall health and well-being.
Dr. Lockley is a family medicine physician currently living in Harlem, N.Y., and a member of the editorial advisory board of Family Practice News. She currently works for Public Health Solutions’ Sexual and Reproductive Health Centers in Brooklyn, providing primary care and reproductive health care services there, and as an abortion provider throughout the New York region. She completed both medical school and residency in Philadelphia and then did a fellowship in reproductive health care and advocacy through the Family Health Center of Harlem and the Reproductive Health Access Project. She can be reached at [email protected].
I became interested in becoming a physician during my very last semester of college. I volunteered in a hospital psychiatric department in the unit that provided electroconvulsive therapy to patients with severe mental health diagnoses. Although this was about 15 years ago, I still vividly remember the curiosity I had walking around the hospital looking around at all the doctors and nurses and wanting to understand what their day-to-day life was like helping people to optimize their health.
Up until that time, thankfully my family and I had been relatively healthy, and, outside of routine checkups, my time spent in a hospital or clinic was limited. Therefore, those months of volunteering at the hospital were the longest periods of time I’d spent around physicians and other health care professionals really witnessing firsthand the science and the art of medicine.
During my time volunteering I saw one patient over the course of several weeks who was catatonic when I first met her, but by the end of several electroconvulsive therapy treatments she had a subtle smile on her face and we were able to have a conversation. She was a younger Black woman like myself and at that moment I knew that I wanted to become a physician and be involved in people’s lives in such a unique manner.
I worked for several years before applying to medical school. During that time two of my jobs involved doing home visits with children, young adults, and their families. I once again experienced the connection that one can make with someone and their family over a short period of time when you actively listen, understand what is important to them, and work together.
After several years of this work I got accepted into medical school and excitedly started the path to becoming a physician. While the learning curve was difficult, I genuinely enjoyed every block of medical school, including learning the anatomy, pathophysiology, and pharmacology. I could not wait to be in front of patients to use this newfound knowledge to help solve their health problems.
‘There is no such thing as a single issue-struggle’
As I started the third year of medical school and clinical rotations, I found joy in being in hospitals and clinics. I also came to recognize that understanding the pharmacology of why metformin helps improve the hemoglobin A1c in people with diabetes is not necessarily one of the keys to helping people optimize their health. I started to talk with patients and all sorts of questions would come to mind. Where did they grow up? What did they identify as their culture? What did they do in their day to day? Did they have a home and support at that home? Are they someone’s caretaker? What are their hopes for the future? And the list goes on.
I ultimately chose family medicine as a specialty because, as Audre Lorde said, “there is no such thing as a single-issue struggle because we do not live single-issue lives,” and family medicine allows one to look at the intersections of people’s lives and how they affect their health and well-being.
I currently practice as a family medicine physician in a setting in which I provide a lot of sexual and reproductive health care. I welcome patients of all ages and genders, and this care includes preconception counseling, contraceptive counseling, prenatal and postpartum care, STI testing and treatment, abortion care, and routine preventive care – just to name a few.
I decided to specialize in sexual and reproductive health care within family medicine because of the historic discrimination and inequitable treatment that is often experienced by young Black persons when they seek care for their sexual health and/or reproductive choices. In addition, there is often stigma within communities when it comes to talking about sex, bodies, and pleasure.
Recently, after a few minutes with a patient, she shared with me that she just completed nursing school and was studying for her exams. We talked about what type of jobs she was looking to apply for and where she wanted to work. I expressed to her that I was proud of the hard work she put in to complete nursing school and commiserated with her about the challenges in schooling and studying that it takes to start in the health care field. The conversation eventually found its way to talking about her sexual and reproductive health care. She shared with me that she was interested in having a child; however, at this time she put those plans on hold because she was scared about the racism within health care and the unacceptable high rates of maternal mortality among Black women in this country.
I listened and shared that as someone who also identifies as a Black woman, I have similar fears and anxieties surrounding my own reproductive health future. During the visit with this patient, I used my training in family medicine to better understand her physical and mental health needs and reassured her that I was going to partner with her through her health care journey.
Hope for the future of family medicine
As I work on a day-to-day basis I often think about my hopes for patients, as well as my hopes for medicine and the field of family medicine. My hope for the future of family medicine is that we can continue to make meaningful connections with patients to help them optimize their health and well-being.
I imagine a system in which we have the time and support to do this for all of our patients regardless of their immigration status, socioeconomic status, or any other historically excluded status. My hope for the future of family medicine is that I can write a prescription for a medication or physical therapy, and the patient is able to fill the prescription without having to worry about the financial implications of paying for it. My hope for the future of family medicine is that patients can seek out care without the fear of discrimination or racism through an increasingly diverse work force. My hope for the future of family medicine is that these improvements become a reality and that as physicians we can appreciate the connections we make with patients and the impact this has on their overall health and well-being.
Dr. Lockley is a family medicine physician currently living in Harlem, N.Y., and a member of the editorial advisory board of Family Practice News. She currently works for Public Health Solutions’ Sexual and Reproductive Health Centers in Brooklyn, providing primary care and reproductive health care services there, and as an abortion provider throughout the New York region. She completed both medical school and residency in Philadelphia and then did a fellowship in reproductive health care and advocacy through the Family Health Center of Harlem and the Reproductive Health Access Project. She can be reached at [email protected].
I became interested in becoming a physician during my very last semester of college. I volunteered in a hospital psychiatric department in the unit that provided electroconvulsive therapy to patients with severe mental health diagnoses. Although this was about 15 years ago, I still vividly remember the curiosity I had walking around the hospital looking around at all the doctors and nurses and wanting to understand what their day-to-day life was like helping people to optimize their health.
Up until that time, thankfully my family and I had been relatively healthy, and, outside of routine checkups, my time spent in a hospital or clinic was limited. Therefore, those months of volunteering at the hospital were the longest periods of time I’d spent around physicians and other health care professionals really witnessing firsthand the science and the art of medicine.
During my time volunteering I saw one patient over the course of several weeks who was catatonic when I first met her, but by the end of several electroconvulsive therapy treatments she had a subtle smile on her face and we were able to have a conversation. She was a younger Black woman like myself and at that moment I knew that I wanted to become a physician and be involved in people’s lives in such a unique manner.
I worked for several years before applying to medical school. During that time two of my jobs involved doing home visits with children, young adults, and their families. I once again experienced the connection that one can make with someone and their family over a short period of time when you actively listen, understand what is important to them, and work together.
After several years of this work I got accepted into medical school and excitedly started the path to becoming a physician. While the learning curve was difficult, I genuinely enjoyed every block of medical school, including learning the anatomy, pathophysiology, and pharmacology. I could not wait to be in front of patients to use this newfound knowledge to help solve their health problems.
‘There is no such thing as a single issue-struggle’
As I started the third year of medical school and clinical rotations, I found joy in being in hospitals and clinics. I also came to recognize that understanding the pharmacology of why metformin helps improve the hemoglobin A1c in people with diabetes is not necessarily one of the keys to helping people optimize their health. I started to talk with patients and all sorts of questions would come to mind. Where did they grow up? What did they identify as their culture? What did they do in their day to day? Did they have a home and support at that home? Are they someone’s caretaker? What are their hopes for the future? And the list goes on.
I ultimately chose family medicine as a specialty because, as Audre Lorde said, “there is no such thing as a single-issue struggle because we do not live single-issue lives,” and family medicine allows one to look at the intersections of people’s lives and how they affect their health and well-being.
I currently practice as a family medicine physician in a setting in which I provide a lot of sexual and reproductive health care. I welcome patients of all ages and genders, and this care includes preconception counseling, contraceptive counseling, prenatal and postpartum care, STI testing and treatment, abortion care, and routine preventive care – just to name a few.
I decided to specialize in sexual and reproductive health care within family medicine because of the historic discrimination and inequitable treatment that is often experienced by young Black persons when they seek care for their sexual health and/or reproductive choices. In addition, there is often stigma within communities when it comes to talking about sex, bodies, and pleasure.
Recently, after a few minutes with a patient, she shared with me that she just completed nursing school and was studying for her exams. We talked about what type of jobs she was looking to apply for and where she wanted to work. I expressed to her that I was proud of the hard work she put in to complete nursing school and commiserated with her about the challenges in schooling and studying that it takes to start in the health care field. The conversation eventually found its way to talking about her sexual and reproductive health care. She shared with me that she was interested in having a child; however, at this time she put those plans on hold because she was scared about the racism within health care and the unacceptable high rates of maternal mortality among Black women in this country.
I listened and shared that as someone who also identifies as a Black woman, I have similar fears and anxieties surrounding my own reproductive health future. During the visit with this patient, I used my training in family medicine to better understand her physical and mental health needs and reassured her that I was going to partner with her through her health care journey.
Hope for the future of family medicine
As I work on a day-to-day basis I often think about my hopes for patients, as well as my hopes for medicine and the field of family medicine. My hope for the future of family medicine is that we can continue to make meaningful connections with patients to help them optimize their health and well-being.
I imagine a system in which we have the time and support to do this for all of our patients regardless of their immigration status, socioeconomic status, or any other historically excluded status. My hope for the future of family medicine is that I can write a prescription for a medication or physical therapy, and the patient is able to fill the prescription without having to worry about the financial implications of paying for it. My hope for the future of family medicine is that patients can seek out care without the fear of discrimination or racism through an increasingly diverse work force. My hope for the future of family medicine is that these improvements become a reality and that as physicians we can appreciate the connections we make with patients and the impact this has on their overall health and well-being.
Dr. Lockley is a family medicine physician currently living in Harlem, N.Y., and a member of the editorial advisory board of Family Practice News. She currently works for Public Health Solutions’ Sexual and Reproductive Health Centers in Brooklyn, providing primary care and reproductive health care services there, and as an abortion provider throughout the New York region. She completed both medical school and residency in Philadelphia and then did a fellowship in reproductive health care and advocacy through the Family Health Center of Harlem and the Reproductive Health Access Project. She can be reached at [email protected].
Common lung cancer screening tool superior to alternatives
a Dutch clinical trial that measures nodule volume and growth rate instead of linear measurement of nodule size as done in Lung-RADs.
The study, published in the American Journal of Roentgenology on Nov. 10, 2021,was a retrospective study of 185 patients (100 women, 85 men; mean age, 66 years) who underwent lung cancer screening at a single health care system between July 2015 and August 2018. Using Lung-RADS, seven cancers were downgraded to category 2. The weighted cancer risk was 5% for new nodules, 1% for stable existing nodules, and 44% for growing existing nodules.
“Lung-RADS scores exhibited excellent sensitivity and specificity for cancer in existing nodules and excellent sensitivity in new nodules, though low specificity in new nodules,” wrote the authors, led by Mark M. Hammer, MD, a radiologist with Brigham and Women’s Hospital in Boston.
CT scans are increasingly used for lung cancer screening, so accuracy is essential in devising an appropriate treatment plan for patients. Nearly all centers in the United States use the American College of Radiology’s Lung-RADS for lung cancer screening. In Europe, many centers use the volumetric-based approach of NELSON.
Several studies have compared the performance of nodule risk assessment algorithms, but the findings are inconsistent. Lung-RADS was found to be inferior to the Vancouver risk calculator in predicting malignancy in the National Lung Screening Trial for total nodules. Dr. Hammer previously reported that subsolid nodules classified as Lung-RADS categories 2 and 3 have a higher risk of malignancy than reported. Meanwhile, a study that followed 13,195 men and 2,594 women at high risk of lung cancer found that lung cancer mortality was lower among participants who underwent volume CT screening than among those who underwent no screening.
The authors cited the retrospective design and the small sample size as study limitations. They added that pathological proof was not obtained from benign nodules, which may represent undiagnosed cancer.
The authors declared no conflict of interest.
a Dutch clinical trial that measures nodule volume and growth rate instead of linear measurement of nodule size as done in Lung-RADs.
The study, published in the American Journal of Roentgenology on Nov. 10, 2021,was a retrospective study of 185 patients (100 women, 85 men; mean age, 66 years) who underwent lung cancer screening at a single health care system between July 2015 and August 2018. Using Lung-RADS, seven cancers were downgraded to category 2. The weighted cancer risk was 5% for new nodules, 1% for stable existing nodules, and 44% for growing existing nodules.
“Lung-RADS scores exhibited excellent sensitivity and specificity for cancer in existing nodules and excellent sensitivity in new nodules, though low specificity in new nodules,” wrote the authors, led by Mark M. Hammer, MD, a radiologist with Brigham and Women’s Hospital in Boston.
CT scans are increasingly used for lung cancer screening, so accuracy is essential in devising an appropriate treatment plan for patients. Nearly all centers in the United States use the American College of Radiology’s Lung-RADS for lung cancer screening. In Europe, many centers use the volumetric-based approach of NELSON.
Several studies have compared the performance of nodule risk assessment algorithms, but the findings are inconsistent. Lung-RADS was found to be inferior to the Vancouver risk calculator in predicting malignancy in the National Lung Screening Trial for total nodules. Dr. Hammer previously reported that subsolid nodules classified as Lung-RADS categories 2 and 3 have a higher risk of malignancy than reported. Meanwhile, a study that followed 13,195 men and 2,594 women at high risk of lung cancer found that lung cancer mortality was lower among participants who underwent volume CT screening than among those who underwent no screening.
The authors cited the retrospective design and the small sample size as study limitations. They added that pathological proof was not obtained from benign nodules, which may represent undiagnosed cancer.
The authors declared no conflict of interest.
a Dutch clinical trial that measures nodule volume and growth rate instead of linear measurement of nodule size as done in Lung-RADs.
The study, published in the American Journal of Roentgenology on Nov. 10, 2021,was a retrospective study of 185 patients (100 women, 85 men; mean age, 66 years) who underwent lung cancer screening at a single health care system between July 2015 and August 2018. Using Lung-RADS, seven cancers were downgraded to category 2. The weighted cancer risk was 5% for new nodules, 1% for stable existing nodules, and 44% for growing existing nodules.
“Lung-RADS scores exhibited excellent sensitivity and specificity for cancer in existing nodules and excellent sensitivity in new nodules, though low specificity in new nodules,” wrote the authors, led by Mark M. Hammer, MD, a radiologist with Brigham and Women’s Hospital in Boston.
CT scans are increasingly used for lung cancer screening, so accuracy is essential in devising an appropriate treatment plan for patients. Nearly all centers in the United States use the American College of Radiology’s Lung-RADS for lung cancer screening. In Europe, many centers use the volumetric-based approach of NELSON.
Several studies have compared the performance of nodule risk assessment algorithms, but the findings are inconsistent. Lung-RADS was found to be inferior to the Vancouver risk calculator in predicting malignancy in the National Lung Screening Trial for total nodules. Dr. Hammer previously reported that subsolid nodules classified as Lung-RADS categories 2 and 3 have a higher risk of malignancy than reported. Meanwhile, a study that followed 13,195 men and 2,594 women at high risk of lung cancer found that lung cancer mortality was lower among participants who underwent volume CT screening than among those who underwent no screening.
The authors cited the retrospective design and the small sample size as study limitations. They added that pathological proof was not obtained from benign nodules, which may represent undiagnosed cancer.
The authors declared no conflict of interest.
FROM THE AMERICAN JOURNAL OF ROENTGENOLOGY
California plans for a post-Roe world as abortion access shrinks elsewhere
SACRAMENTO – With access to abortion at stake across America, California is preparing to become the nation’s abortion provider.
Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January.
Abortion clinics are already girding themselves for a surge in demand.
Janet Jacobson, MD, medical director of Planned Parenthood of Orange and San Bernardino Counties, said three or four out-of-state patients visit her clinics each day – about double the number that sought treatment before a near-total ban on abortion took effect in Texas in September.
While the nine clinics can absorb that slow trickle, they expect up to 50 out-of-state patients a week if the U.S. Supreme Court’s conservative majority guts abortion rights nationally, Dr. Jacobson said. She bases her estimate on new data from the Guttmacher Institute, a research organization that supports abortion and reproductive health rights.
She is adding staff members and appointment capacity, hoping to accommodate everyone.
“We have to make sure we can still continue to care for all of our California patients,” Dr. Jacobson said. “We don’t want them getting squeezed out” of appointments.
The Texas law banned nearly all abortions after about 6 weeks of pregnancy and empowered private citizens to sue anyone who performs or “aids and abets” an abortion after that time. The Supreme Court heard arguments in that case on Nov. 1 and is expected to announce a ruling on its constitutionality in June. Nonetheless, Florida and Ohio have announced plans for copycat laws.
Next month the high court will hear another abortion case with even broader implications, Dobbs v. Jackson Women’s Health Organization, a lawsuit challenging the constitutionality of a 2018 Mississippi law that prohibited abortion after 15 weeks. If the court sides with Mississippi, its decision could overturn existing abortion rights set by the landmark Roe v. Wade case.
Should that happen, reproductive rights experts predict, 26 states will ban the procedure altogether, and states with stronger protections for abortion, like California, will draw even more patients. There could be up to a 3,000% increase in people who “may drive to California for abortion care” each year, according to the Guttmacher data.
In 2017, the most recent year for which data are available from Guttmacher, California – by far the nation’s most populous state – had more abortion providers than any other state, with 419 hospitals, clinics, or doctors’ offices performing the procedure. The next highest were New York, with 252, and Florida, with 85. Neighboring Arizona and Nevada each had 11. Of the 862,320 abortions performed in the United States that year, 132.680, about 15% were in California.
Planned Parenthood clinics in California say they already serve about 7,000 out-of-state patients a year and are expecting a surge of new ones, especially in travel hubs like the Los Angeles area.
In September, Planned Parenthood and groups such as Black Women for Wellness convened the California Future of Abortion Council with backing from influential Democratic leaders including Gov. Newsom, state Senate leader Toni Atkins, and Assembly Speaker Anthony Rendon.
Ms. Atkins, who was the director of a San Diego women’s health clinic in the 1980s, said she spent time with women from states where it was hard to get an abortion. She said California is committed to ensuring abortion access in the state and beyond.
The council is focused on increasing funding for abortion services, providing logistical and financial help for women who need to travel, increasing the number of health care providers who perform abortions, and strengthening legal protections for them.
Increasing capacity could mean licensing more practitioners to provide abortions or pumping more resources into telehealth so people can see a doctor online to prescribe pills for a medical abortion – a service California doctors currently can provide to patients only in California.
The most important thing the state should do is fix its shortage of providers, especially those who perform second-trimester abortions, which are more expensive and complicated than first-trimester abortions, said council member Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.
It’s not feasible to place an abortion provider in every corner of the state, Dr. Grossman said. Instead, the council should focus on creating “hubs that can provide abortion care for large numbers of people” in easy-to-get-to locations.
California already struggles to provide abortions to all who seek them, especially low-income women covered by Medi-Cal, California’s Medicaid program. For example, 28 counties – home to 10% of Medi-Cal recipients of childbearing age – don’t have facilities that provide abortions to Medi-Cal patients.
A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to an analysis by the California Health Benefits Review Program, but isn’t available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California.
One of the council’s recommendations will likely be to increase the rate Medi-Cal payments for abortions so more providers will perform them, said council member Fabiola Carrión, interim director for reproductive and sexual health at the National Health Law Program.
Medi-Cal pays $354.43 for a second-trimester abortion. A 2020 study in the journal Contraception found that states paid between $79 and $626 for a second-trimester abortion in 2017.
Increasing Medi-Cal rates won’t help patients traveling from outside California. Generally, private insurance doesn’t cover out-of-state abortions, so most women will be on the hook for the full cost, and those enrolled in other states’ Medicaid programs must pay out-of-pocket, too.
The council hopes to reduce costs for state residents and visitors, said Brandon Richards, director of communications for Planned Parenthood Affiliates of California. “It’s about making it easy for people to access abortion in California, whether they reside here or are coming in from out of state,” he said.
One way to target costs is by funding the practical support, like helping to pay for transportation, child care, hotels, or time off work, said council member Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.
Ms. Pinckney said she’s working with Los Angeles County to set up a public abortion fund to cover some of those costs for anyone seeking an abortion in the county. It would be modeled after similar pots maintained by the cities of New York; Austin, Tex.; and Portland, Ore., and could eventually be a template for the first statewide fund, Ms. Pinckney said.
Most Texans seeking abortions since that state’s law took effect are going to nearby states like Colorado, New Mexico, and Oklahoma, said Sierra Harris, deputy director of network strategies for the National Network of Abortion Funds. Women in those states, in turn, are having trouble getting care and are looking to California for appointments.
Practical support is important for out-of-state patients, said Alissa Perrucci, PhD, MPH, operations manager at the Women’s Options Center at Zuckerberg San Francisco General Hospital, one of five abortion clinics inside California hospitals.
Dr. Perrucci’s clinic is focusing on telemedicine, phone counseling, and other ways to save time so it can add appointments for out-of-state patients if necessary.
But more slots are useless if women can’t make it to California. The clinic has booked about 10 appointments for Texans since the state’s ban went into effect, but only half have shown up, mostly women with family connections in California.
“Most people just don’t have the money to get here,” she said. “If the burden of abortion was borne predominantly by the wealthy, yeah, they’d just fly here.”
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
SACRAMENTO – With access to abortion at stake across America, California is preparing to become the nation’s abortion provider.
Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January.
Abortion clinics are already girding themselves for a surge in demand.
Janet Jacobson, MD, medical director of Planned Parenthood of Orange and San Bernardino Counties, said three or four out-of-state patients visit her clinics each day – about double the number that sought treatment before a near-total ban on abortion took effect in Texas in September.
While the nine clinics can absorb that slow trickle, they expect up to 50 out-of-state patients a week if the U.S. Supreme Court’s conservative majority guts abortion rights nationally, Dr. Jacobson said. She bases her estimate on new data from the Guttmacher Institute, a research organization that supports abortion and reproductive health rights.
She is adding staff members and appointment capacity, hoping to accommodate everyone.
“We have to make sure we can still continue to care for all of our California patients,” Dr. Jacobson said. “We don’t want them getting squeezed out” of appointments.
The Texas law banned nearly all abortions after about 6 weeks of pregnancy and empowered private citizens to sue anyone who performs or “aids and abets” an abortion after that time. The Supreme Court heard arguments in that case on Nov. 1 and is expected to announce a ruling on its constitutionality in June. Nonetheless, Florida and Ohio have announced plans for copycat laws.
Next month the high court will hear another abortion case with even broader implications, Dobbs v. Jackson Women’s Health Organization, a lawsuit challenging the constitutionality of a 2018 Mississippi law that prohibited abortion after 15 weeks. If the court sides with Mississippi, its decision could overturn existing abortion rights set by the landmark Roe v. Wade case.
Should that happen, reproductive rights experts predict, 26 states will ban the procedure altogether, and states with stronger protections for abortion, like California, will draw even more patients. There could be up to a 3,000% increase in people who “may drive to California for abortion care” each year, according to the Guttmacher data.
In 2017, the most recent year for which data are available from Guttmacher, California – by far the nation’s most populous state – had more abortion providers than any other state, with 419 hospitals, clinics, or doctors’ offices performing the procedure. The next highest were New York, with 252, and Florida, with 85. Neighboring Arizona and Nevada each had 11. Of the 862,320 abortions performed in the United States that year, 132.680, about 15% were in California.
Planned Parenthood clinics in California say they already serve about 7,000 out-of-state patients a year and are expecting a surge of new ones, especially in travel hubs like the Los Angeles area.
In September, Planned Parenthood and groups such as Black Women for Wellness convened the California Future of Abortion Council with backing from influential Democratic leaders including Gov. Newsom, state Senate leader Toni Atkins, and Assembly Speaker Anthony Rendon.
Ms. Atkins, who was the director of a San Diego women’s health clinic in the 1980s, said she spent time with women from states where it was hard to get an abortion. She said California is committed to ensuring abortion access in the state and beyond.
The council is focused on increasing funding for abortion services, providing logistical and financial help for women who need to travel, increasing the number of health care providers who perform abortions, and strengthening legal protections for them.
Increasing capacity could mean licensing more practitioners to provide abortions or pumping more resources into telehealth so people can see a doctor online to prescribe pills for a medical abortion – a service California doctors currently can provide to patients only in California.
The most important thing the state should do is fix its shortage of providers, especially those who perform second-trimester abortions, which are more expensive and complicated than first-trimester abortions, said council member Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.
It’s not feasible to place an abortion provider in every corner of the state, Dr. Grossman said. Instead, the council should focus on creating “hubs that can provide abortion care for large numbers of people” in easy-to-get-to locations.
California already struggles to provide abortions to all who seek them, especially low-income women covered by Medi-Cal, California’s Medicaid program. For example, 28 counties – home to 10% of Medi-Cal recipients of childbearing age – don’t have facilities that provide abortions to Medi-Cal patients.
A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to an analysis by the California Health Benefits Review Program, but isn’t available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California.
One of the council’s recommendations will likely be to increase the rate Medi-Cal payments for abortions so more providers will perform them, said council member Fabiola Carrión, interim director for reproductive and sexual health at the National Health Law Program.
Medi-Cal pays $354.43 for a second-trimester abortion. A 2020 study in the journal Contraception found that states paid between $79 and $626 for a second-trimester abortion in 2017.
Increasing Medi-Cal rates won’t help patients traveling from outside California. Generally, private insurance doesn’t cover out-of-state abortions, so most women will be on the hook for the full cost, and those enrolled in other states’ Medicaid programs must pay out-of-pocket, too.
The council hopes to reduce costs for state residents and visitors, said Brandon Richards, director of communications for Planned Parenthood Affiliates of California. “It’s about making it easy for people to access abortion in California, whether they reside here or are coming in from out of state,” he said.
One way to target costs is by funding the practical support, like helping to pay for transportation, child care, hotels, or time off work, said council member Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.
Ms. Pinckney said she’s working with Los Angeles County to set up a public abortion fund to cover some of those costs for anyone seeking an abortion in the county. It would be modeled after similar pots maintained by the cities of New York; Austin, Tex.; and Portland, Ore., and could eventually be a template for the first statewide fund, Ms. Pinckney said.
Most Texans seeking abortions since that state’s law took effect are going to nearby states like Colorado, New Mexico, and Oklahoma, said Sierra Harris, deputy director of network strategies for the National Network of Abortion Funds. Women in those states, in turn, are having trouble getting care and are looking to California for appointments.
Practical support is important for out-of-state patients, said Alissa Perrucci, PhD, MPH, operations manager at the Women’s Options Center at Zuckerberg San Francisco General Hospital, one of five abortion clinics inside California hospitals.
Dr. Perrucci’s clinic is focusing on telemedicine, phone counseling, and other ways to save time so it can add appointments for out-of-state patients if necessary.
But more slots are useless if women can’t make it to California. The clinic has booked about 10 appointments for Texans since the state’s ban went into effect, but only half have shown up, mostly women with family connections in California.
“Most people just don’t have the money to get here,” she said. “If the burden of abortion was borne predominantly by the wealthy, yeah, they’d just fly here.”
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
SACRAMENTO – With access to abortion at stake across America, California is preparing to become the nation’s abortion provider.
Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January.
Abortion clinics are already girding themselves for a surge in demand.
Janet Jacobson, MD, medical director of Planned Parenthood of Orange and San Bernardino Counties, said three or four out-of-state patients visit her clinics each day – about double the number that sought treatment before a near-total ban on abortion took effect in Texas in September.
While the nine clinics can absorb that slow trickle, they expect up to 50 out-of-state patients a week if the U.S. Supreme Court’s conservative majority guts abortion rights nationally, Dr. Jacobson said. She bases her estimate on new data from the Guttmacher Institute, a research organization that supports abortion and reproductive health rights.
She is adding staff members and appointment capacity, hoping to accommodate everyone.
“We have to make sure we can still continue to care for all of our California patients,” Dr. Jacobson said. “We don’t want them getting squeezed out” of appointments.
The Texas law banned nearly all abortions after about 6 weeks of pregnancy and empowered private citizens to sue anyone who performs or “aids and abets” an abortion after that time. The Supreme Court heard arguments in that case on Nov. 1 and is expected to announce a ruling on its constitutionality in June. Nonetheless, Florida and Ohio have announced plans for copycat laws.
Next month the high court will hear another abortion case with even broader implications, Dobbs v. Jackson Women’s Health Organization, a lawsuit challenging the constitutionality of a 2018 Mississippi law that prohibited abortion after 15 weeks. If the court sides with Mississippi, its decision could overturn existing abortion rights set by the landmark Roe v. Wade case.
Should that happen, reproductive rights experts predict, 26 states will ban the procedure altogether, and states with stronger protections for abortion, like California, will draw even more patients. There could be up to a 3,000% increase in people who “may drive to California for abortion care” each year, according to the Guttmacher data.
In 2017, the most recent year for which data are available from Guttmacher, California – by far the nation’s most populous state – had more abortion providers than any other state, with 419 hospitals, clinics, or doctors’ offices performing the procedure. The next highest were New York, with 252, and Florida, with 85. Neighboring Arizona and Nevada each had 11. Of the 862,320 abortions performed in the United States that year, 132.680, about 15% were in California.
Planned Parenthood clinics in California say they already serve about 7,000 out-of-state patients a year and are expecting a surge of new ones, especially in travel hubs like the Los Angeles area.
In September, Planned Parenthood and groups such as Black Women for Wellness convened the California Future of Abortion Council with backing from influential Democratic leaders including Gov. Newsom, state Senate leader Toni Atkins, and Assembly Speaker Anthony Rendon.
Ms. Atkins, who was the director of a San Diego women’s health clinic in the 1980s, said she spent time with women from states where it was hard to get an abortion. She said California is committed to ensuring abortion access in the state and beyond.
The council is focused on increasing funding for abortion services, providing logistical and financial help for women who need to travel, increasing the number of health care providers who perform abortions, and strengthening legal protections for them.
Increasing capacity could mean licensing more practitioners to provide abortions or pumping more resources into telehealth so people can see a doctor online to prescribe pills for a medical abortion – a service California doctors currently can provide to patients only in California.
The most important thing the state should do is fix its shortage of providers, especially those who perform second-trimester abortions, which are more expensive and complicated than first-trimester abortions, said council member Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.
It’s not feasible to place an abortion provider in every corner of the state, Dr. Grossman said. Instead, the council should focus on creating “hubs that can provide abortion care for large numbers of people” in easy-to-get-to locations.
California already struggles to provide abortions to all who seek them, especially low-income women covered by Medi-Cal, California’s Medicaid program. For example, 28 counties – home to 10% of Medi-Cal recipients of childbearing age – don’t have facilities that provide abortions to Medi-Cal patients.
A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to an analysis by the California Health Benefits Review Program, but isn’t available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California.
One of the council’s recommendations will likely be to increase the rate Medi-Cal payments for abortions so more providers will perform them, said council member Fabiola Carrión, interim director for reproductive and sexual health at the National Health Law Program.
Medi-Cal pays $354.43 for a second-trimester abortion. A 2020 study in the journal Contraception found that states paid between $79 and $626 for a second-trimester abortion in 2017.
Increasing Medi-Cal rates won’t help patients traveling from outside California. Generally, private insurance doesn’t cover out-of-state abortions, so most women will be on the hook for the full cost, and those enrolled in other states’ Medicaid programs must pay out-of-pocket, too.
The council hopes to reduce costs for state residents and visitors, said Brandon Richards, director of communications for Planned Parenthood Affiliates of California. “It’s about making it easy for people to access abortion in California, whether they reside here or are coming in from out of state,” he said.
One way to target costs is by funding the practical support, like helping to pay for transportation, child care, hotels, or time off work, said council member Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.
Ms. Pinckney said she’s working with Los Angeles County to set up a public abortion fund to cover some of those costs for anyone seeking an abortion in the county. It would be modeled after similar pots maintained by the cities of New York; Austin, Tex.; and Portland, Ore., and could eventually be a template for the first statewide fund, Ms. Pinckney said.
Most Texans seeking abortions since that state’s law took effect are going to nearby states like Colorado, New Mexico, and Oklahoma, said Sierra Harris, deputy director of network strategies for the National Network of Abortion Funds. Women in those states, in turn, are having trouble getting care and are looking to California for appointments.
Practical support is important for out-of-state patients, said Alissa Perrucci, PhD, MPH, operations manager at the Women’s Options Center at Zuckerberg San Francisco General Hospital, one of five abortion clinics inside California hospitals.
Dr. Perrucci’s clinic is focusing on telemedicine, phone counseling, and other ways to save time so it can add appointments for out-of-state patients if necessary.
But more slots are useless if women can’t make it to California. The clinic has booked about 10 appointments for Texans since the state’s ban went into effect, but only half have shown up, mostly women with family connections in California.
“Most people just don’t have the money to get here,” she said. “If the burden of abortion was borne predominantly by the wealthy, yeah, they’d just fly here.”
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
FDA authorizes COVID boosters for all U.S. adults
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.
The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.
“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.
Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.
FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.
A version of this article first appeared on WebMD.com.
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.
The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.
“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.
Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.
FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.
A version of this article first appeared on WebMD.com.
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.
The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.
“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.
Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.
FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.
A version of this article first appeared on WebMD.com.
Mask-wearing cuts new COVID-19 cases by 53%, study says
Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.
“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.
The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.
Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.
In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.
But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.
Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.
Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.
Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.
The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.
That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.
“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.
“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.
A version of this article first appeared on WebMD.com.
Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.
“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.
The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.
Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.
In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.
But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.
Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.
Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.
Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.
The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.
That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.
“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.
“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.
A version of this article first appeared on WebMD.com.
Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.
“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.
The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.
Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.
In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.
But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.
Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.
Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.
Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.
The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.
That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.
“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.
“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.
A version of this article first appeared on WebMD.com.
FROM THE BMJ