Fasting during breast cancer chemo improves quality of life

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Tue, 10/24/2023 - 00:32

 

Short-term fasting during chemotherapy enhances health-related quality of life in patients with early breast cancer, with no untoward effects, according to late-breaking research presented on day 1 of the annual meeting of the European Society for Medical Oncology.

“Strikingly,” fasting also appeared to prevent fatigue, something patients with breast cancer struggle with, Daniela A. Koppold, MD, Charité University Medicine Berlin, noted in her oral presentation.

The study adds to other evidence suggesting that fasting around chemotherapy cycles may reduce toxicity and adverse effects associated with chemotherapy.

The invited discussant, Jann Arends, MD, with Freiburg (Germany) University Medical Center, said that the findings fit “very well” with previous observations. “Short-term fasting in subjects not at risk for malnutrition is feasible, well tolerated, and appears to improve several parameters of quality of life,” Dr. Arends said.
 

Promising supportive therapy

The randomized controlled trial assessed the feasibility and impact of short-term fasting on health-related quality of life, compared with a plant-based, low-sugar diet (active comparator) in 106 women with early breast cancer.

The chemotherapy regimens in the trial included four cycles of doxorubicin or epirubicin, followed by taxane therapy. The interventions for both groups occurred about 2 days before chemotherapy plus 24 hours after each cycle ended (about 60-72 hours total).

For the fasting group, this meant about 200 kcal/day through vegetable juices and vegetable broths. In between chemotherapy sessions, both groups were advised to eat a more vegetarian-focused diet, but that was not mandatory.

Health-related quality of life assessments occurred at baseline and after each chemotherapy session (cycle four at day 7) as well as after 4 and 6 months.

The investigators assessed health-related quality of life using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) that measured the domains of physical, social/familial, emotional, and functional well-being.

At baseline, the two groups had similar FACT-G scores (fasting, 82.9 vs. plant diet, 81.9; P = .523). By day 7, the short-term–fasting group had a significantly better FACT-G score, compared with the plant-based–diet group (fasting, 78.3 vs. plant, 69.5; P = .021).

Although the two groups “started out from the same point, the fasting group had an incremental effect, which quite startled us,” Dr. Koppold told the audience. “Over the course of the chemotherapies, [fasting] had additive effects” and by cycle four of chemotherapy, the difference became statistically and clinically significant, indicating “much better” quality of life in the short-term–fasting group.

What was “even more striking,” said Dr. Koppold, was the impact fasting had on the secondary outcome of fatigue (Functional Assessment of Chronic Illness Therapy–Fatigue).

“Short-term fasting not only had a protective effect on fatigue, compared to the control group, but the short-term–fasting group didn’t develop any clinically visible fatigue,” Dr. Koppold said. “They were in a normal range by cycle four while the control group developed fatigue as we would have expected.”

Importantly, she noted, fasting had no significant impact on weight. The study excluded women who were underweight or had a history of eating disorder or relevant psychopathology.

Summing up, Dr. Koppold said that short-term fasting represents a “promising” supportive therapy during breast cancer chemotherapy to enhance quality of life.

Commenting on the study, Rebecca Guterman, a registered dietitian at Perlmutter Cancer Center at NYU Langone Health, New York, said that it’s well known that a healthy diet plays “a key role during anticancer treatments.” Dietary changes can, for instance, help alleviate common chemotherapy side effects such as loss of appetite, nausea, fatigue, or diarrhea, she said.

These new findings support fasting for 60-72 hours around chemotherapy for some patients with breast cancer who may experience more rapid recovery and better quality of life, said Ms. Guterman.

However, she noted, the results should not be applied to patient populations outside of breast cancer or treatment regimens outside this study. And, she noted, “how the patient feels during the 60-72 hour fast also has to be considered.”

An individual’s “nutritional status must be considered. If a patient has poor appetite and loses weight between treatments, fasting should not be done before next treatment,” Ms. Guterman said.

The study was funded by a private sponsor (G. Müller, Munich, Germany) and a grant from the Günter and Regine KelmFoundation (Zurich). Dr. Koppold is a member of the steering board of ÄGHE e.V. (German-speaking Medical Association for Fasting and Nutrition); cofounder of the Academy for Integrative Fasting GbR; and consults for a mobile app on intermittent fasting (Fastic) as well as a company producing plant-based supplements (EVERYYIN). Dr. Arends has disclosed relationships with Baxter. Ms. Guterman has no relevant disclosures.

 

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

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Short-term fasting during chemotherapy enhances health-related quality of life in patients with early breast cancer, with no untoward effects, according to late-breaking research presented on day 1 of the annual meeting of the European Society for Medical Oncology.

“Strikingly,” fasting also appeared to prevent fatigue, something patients with breast cancer struggle with, Daniela A. Koppold, MD, Charité University Medicine Berlin, noted in her oral presentation.

The study adds to other evidence suggesting that fasting around chemotherapy cycles may reduce toxicity and adverse effects associated with chemotherapy.

The invited discussant, Jann Arends, MD, with Freiburg (Germany) University Medical Center, said that the findings fit “very well” with previous observations. “Short-term fasting in subjects not at risk for malnutrition is feasible, well tolerated, and appears to improve several parameters of quality of life,” Dr. Arends said.
 

Promising supportive therapy

The randomized controlled trial assessed the feasibility and impact of short-term fasting on health-related quality of life, compared with a plant-based, low-sugar diet (active comparator) in 106 women with early breast cancer.

The chemotherapy regimens in the trial included four cycles of doxorubicin or epirubicin, followed by taxane therapy. The interventions for both groups occurred about 2 days before chemotherapy plus 24 hours after each cycle ended (about 60-72 hours total).

For the fasting group, this meant about 200 kcal/day through vegetable juices and vegetable broths. In between chemotherapy sessions, both groups were advised to eat a more vegetarian-focused diet, but that was not mandatory.

Health-related quality of life assessments occurred at baseline and after each chemotherapy session (cycle four at day 7) as well as after 4 and 6 months.

The investigators assessed health-related quality of life using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) that measured the domains of physical, social/familial, emotional, and functional well-being.

At baseline, the two groups had similar FACT-G scores (fasting, 82.9 vs. plant diet, 81.9; P = .523). By day 7, the short-term–fasting group had a significantly better FACT-G score, compared with the plant-based–diet group (fasting, 78.3 vs. plant, 69.5; P = .021).

Although the two groups “started out from the same point, the fasting group had an incremental effect, which quite startled us,” Dr. Koppold told the audience. “Over the course of the chemotherapies, [fasting] had additive effects” and by cycle four of chemotherapy, the difference became statistically and clinically significant, indicating “much better” quality of life in the short-term–fasting group.

What was “even more striking,” said Dr. Koppold, was the impact fasting had on the secondary outcome of fatigue (Functional Assessment of Chronic Illness Therapy–Fatigue).

“Short-term fasting not only had a protective effect on fatigue, compared to the control group, but the short-term–fasting group didn’t develop any clinically visible fatigue,” Dr. Koppold said. “They were in a normal range by cycle four while the control group developed fatigue as we would have expected.”

Importantly, she noted, fasting had no significant impact on weight. The study excluded women who were underweight or had a history of eating disorder or relevant psychopathology.

Summing up, Dr. Koppold said that short-term fasting represents a “promising” supportive therapy during breast cancer chemotherapy to enhance quality of life.

Commenting on the study, Rebecca Guterman, a registered dietitian at Perlmutter Cancer Center at NYU Langone Health, New York, said that it’s well known that a healthy diet plays “a key role during anticancer treatments.” Dietary changes can, for instance, help alleviate common chemotherapy side effects such as loss of appetite, nausea, fatigue, or diarrhea, she said.

These new findings support fasting for 60-72 hours around chemotherapy for some patients with breast cancer who may experience more rapid recovery and better quality of life, said Ms. Guterman.

However, she noted, the results should not be applied to patient populations outside of breast cancer or treatment regimens outside this study. And, she noted, “how the patient feels during the 60-72 hour fast also has to be considered.”

An individual’s “nutritional status must be considered. If a patient has poor appetite and loses weight between treatments, fasting should not be done before next treatment,” Ms. Guterman said.

The study was funded by a private sponsor (G. Müller, Munich, Germany) and a grant from the Günter and Regine KelmFoundation (Zurich). Dr. Koppold is a member of the steering board of ÄGHE e.V. (German-speaking Medical Association for Fasting and Nutrition); cofounder of the Academy for Integrative Fasting GbR; and consults for a mobile app on intermittent fasting (Fastic) as well as a company producing plant-based supplements (EVERYYIN). Dr. Arends has disclosed relationships with Baxter. Ms. Guterman has no relevant disclosures.

 

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

 

Short-term fasting during chemotherapy enhances health-related quality of life in patients with early breast cancer, with no untoward effects, according to late-breaking research presented on day 1 of the annual meeting of the European Society for Medical Oncology.

“Strikingly,” fasting also appeared to prevent fatigue, something patients with breast cancer struggle with, Daniela A. Koppold, MD, Charité University Medicine Berlin, noted in her oral presentation.

The study adds to other evidence suggesting that fasting around chemotherapy cycles may reduce toxicity and adverse effects associated with chemotherapy.

The invited discussant, Jann Arends, MD, with Freiburg (Germany) University Medical Center, said that the findings fit “very well” with previous observations. “Short-term fasting in subjects not at risk for malnutrition is feasible, well tolerated, and appears to improve several parameters of quality of life,” Dr. Arends said.
 

Promising supportive therapy

The randomized controlled trial assessed the feasibility and impact of short-term fasting on health-related quality of life, compared with a plant-based, low-sugar diet (active comparator) in 106 women with early breast cancer.

The chemotherapy regimens in the trial included four cycles of doxorubicin or epirubicin, followed by taxane therapy. The interventions for both groups occurred about 2 days before chemotherapy plus 24 hours after each cycle ended (about 60-72 hours total).

For the fasting group, this meant about 200 kcal/day through vegetable juices and vegetable broths. In between chemotherapy sessions, both groups were advised to eat a more vegetarian-focused diet, but that was not mandatory.

Health-related quality of life assessments occurred at baseline and after each chemotherapy session (cycle four at day 7) as well as after 4 and 6 months.

The investigators assessed health-related quality of life using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) that measured the domains of physical, social/familial, emotional, and functional well-being.

At baseline, the two groups had similar FACT-G scores (fasting, 82.9 vs. plant diet, 81.9; P = .523). By day 7, the short-term–fasting group had a significantly better FACT-G score, compared with the plant-based–diet group (fasting, 78.3 vs. plant, 69.5; P = .021).

Although the two groups “started out from the same point, the fasting group had an incremental effect, which quite startled us,” Dr. Koppold told the audience. “Over the course of the chemotherapies, [fasting] had additive effects” and by cycle four of chemotherapy, the difference became statistically and clinically significant, indicating “much better” quality of life in the short-term–fasting group.

What was “even more striking,” said Dr. Koppold, was the impact fasting had on the secondary outcome of fatigue (Functional Assessment of Chronic Illness Therapy–Fatigue).

“Short-term fasting not only had a protective effect on fatigue, compared to the control group, but the short-term–fasting group didn’t develop any clinically visible fatigue,” Dr. Koppold said. “They were in a normal range by cycle four while the control group developed fatigue as we would have expected.”

Importantly, she noted, fasting had no significant impact on weight. The study excluded women who were underweight or had a history of eating disorder or relevant psychopathology.

Summing up, Dr. Koppold said that short-term fasting represents a “promising” supportive therapy during breast cancer chemotherapy to enhance quality of life.

Commenting on the study, Rebecca Guterman, a registered dietitian at Perlmutter Cancer Center at NYU Langone Health, New York, said that it’s well known that a healthy diet plays “a key role during anticancer treatments.” Dietary changes can, for instance, help alleviate common chemotherapy side effects such as loss of appetite, nausea, fatigue, or diarrhea, she said.

These new findings support fasting for 60-72 hours around chemotherapy for some patients with breast cancer who may experience more rapid recovery and better quality of life, said Ms. Guterman.

However, she noted, the results should not be applied to patient populations outside of breast cancer or treatment regimens outside this study. And, she noted, “how the patient feels during the 60-72 hour fast also has to be considered.”

An individual’s “nutritional status must be considered. If a patient has poor appetite and loses weight between treatments, fasting should not be done before next treatment,” Ms. Guterman said.

The study was funded by a private sponsor (G. Müller, Munich, Germany) and a grant from the Günter and Regine KelmFoundation (Zurich). Dr. Koppold is a member of the steering board of ÄGHE e.V. (German-speaking Medical Association for Fasting and Nutrition); cofounder of the Academy for Integrative Fasting GbR; and consults for a mobile app on intermittent fasting (Fastic) as well as a company producing plant-based supplements (EVERYYIN). Dr. Arends has disclosed relationships with Baxter. Ms. Guterman has no relevant disclosures.

 

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

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Stair climbing tied to reduced risk for heart disease

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Changed
Mon, 10/23/2023 - 23:58

 

TOPLINE:

Climbing more than five flights of stairs daily is associated with a reduced risk of atherosclerotic cardiovascular disease (ASCVD) of about 20%, new observational data suggest.

METHODOLOGY:

  • The prospective cohort study used data from 458,860 adults in the UK Biobank cohort who were 38-73 years old at baseline (2006-2010).
  • Information about stair climbing, sociodemographic, and lifestyle factors was collected at baseline and 5 years later.
  • Cases of ASCVD – defined as coronary artery disease (CAD), ischemic stroke, or acute complications – were identified via hospital records and death registry.
  • Associations between stair climbing and ASCVD were examined as hazard ratios from Cox proportional hazards model. Analyses were stratified by susceptibility to ASCVD based on family history, genetic risk, and established risk factors.

TAKEAWAY:

  • A total of 39,043 ASCVD, 30,718 CAD, and 10,521 ischemic stroke cases were recorded during a median follow-up of 12.5 years.
  • Compared with no-stair climbing, climbing 6-10 flights of stairs daily was associated with a 7% lower ASCVD risk (multivariable-adjusted HR, 0.93; 95% confidence interval, 0.90-0.96) and climbing 16-20 flights daily was associated with a 10% lower risk (HR, 0.90; 95% CI, 0.85-0.94).
  • The benefits plateaued at 20 flights daily; comparable results were obtained for CAD and ischemic stroke; the protective effect of stair climbing was attenuated by increasing levels of disease susceptibility.
  • Adults who stopped climbing stairs daily during the study had a 32% higher risk of ASCVD (HR, 1.32; 95% CI,1.06-1.65), compared with peers who never reported stair climbing.

IN PRACTICE:

“These findings highlight the potential advantages of stair climbing as a primary preventive measure for ASCVD in the general population. Short bursts of high-intensity stair climbing are a time-efficient way to improve cardiorespiratory fitness and lipid profile, especially among those unable to achieve the current physical activity recommendations,” study author Lu Qi, with Tulane University, New Orleans, said in a news release.

SOURCE:

The study was published online in Atherosclerosis.

LIMITATIONS:

The observational design limits causal inferences. Stair climbing was self-reported via questionnaires and recall bias is a possibility. The UK Biobank participants do not represent the entire population of the country, with a healthy volunteer selection bias previously reported.

DISCLOSURES:

The study was supported by grants from the National Key R&D Program of China. The authors disclosed no relevant financial relationships.

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

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TOPLINE:

Climbing more than five flights of stairs daily is associated with a reduced risk of atherosclerotic cardiovascular disease (ASCVD) of about 20%, new observational data suggest.

METHODOLOGY:

  • The prospective cohort study used data from 458,860 adults in the UK Biobank cohort who were 38-73 years old at baseline (2006-2010).
  • Information about stair climbing, sociodemographic, and lifestyle factors was collected at baseline and 5 years later.
  • Cases of ASCVD – defined as coronary artery disease (CAD), ischemic stroke, or acute complications – were identified via hospital records and death registry.
  • Associations between stair climbing and ASCVD were examined as hazard ratios from Cox proportional hazards model. Analyses were stratified by susceptibility to ASCVD based on family history, genetic risk, and established risk factors.

TAKEAWAY:

  • A total of 39,043 ASCVD, 30,718 CAD, and 10,521 ischemic stroke cases were recorded during a median follow-up of 12.5 years.
  • Compared with no-stair climbing, climbing 6-10 flights of stairs daily was associated with a 7% lower ASCVD risk (multivariable-adjusted HR, 0.93; 95% confidence interval, 0.90-0.96) and climbing 16-20 flights daily was associated with a 10% lower risk (HR, 0.90; 95% CI, 0.85-0.94).
  • The benefits plateaued at 20 flights daily; comparable results were obtained for CAD and ischemic stroke; the protective effect of stair climbing was attenuated by increasing levels of disease susceptibility.
  • Adults who stopped climbing stairs daily during the study had a 32% higher risk of ASCVD (HR, 1.32; 95% CI,1.06-1.65), compared with peers who never reported stair climbing.

IN PRACTICE:

“These findings highlight the potential advantages of stair climbing as a primary preventive measure for ASCVD in the general population. Short bursts of high-intensity stair climbing are a time-efficient way to improve cardiorespiratory fitness and lipid profile, especially among those unable to achieve the current physical activity recommendations,” study author Lu Qi, with Tulane University, New Orleans, said in a news release.

SOURCE:

The study was published online in Atherosclerosis.

LIMITATIONS:

The observational design limits causal inferences. Stair climbing was self-reported via questionnaires and recall bias is a possibility. The UK Biobank participants do not represent the entire population of the country, with a healthy volunteer selection bias previously reported.

DISCLOSURES:

The study was supported by grants from the National Key R&D Program of China. The authors disclosed no relevant financial relationships.

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

 

TOPLINE:

Climbing more than five flights of stairs daily is associated with a reduced risk of atherosclerotic cardiovascular disease (ASCVD) of about 20%, new observational data suggest.

METHODOLOGY:

  • The prospective cohort study used data from 458,860 adults in the UK Biobank cohort who were 38-73 years old at baseline (2006-2010).
  • Information about stair climbing, sociodemographic, and lifestyle factors was collected at baseline and 5 years later.
  • Cases of ASCVD – defined as coronary artery disease (CAD), ischemic stroke, or acute complications – were identified via hospital records and death registry.
  • Associations between stair climbing and ASCVD were examined as hazard ratios from Cox proportional hazards model. Analyses were stratified by susceptibility to ASCVD based on family history, genetic risk, and established risk factors.

TAKEAWAY:

  • A total of 39,043 ASCVD, 30,718 CAD, and 10,521 ischemic stroke cases were recorded during a median follow-up of 12.5 years.
  • Compared with no-stair climbing, climbing 6-10 flights of stairs daily was associated with a 7% lower ASCVD risk (multivariable-adjusted HR, 0.93; 95% confidence interval, 0.90-0.96) and climbing 16-20 flights daily was associated with a 10% lower risk (HR, 0.90; 95% CI, 0.85-0.94).
  • The benefits plateaued at 20 flights daily; comparable results were obtained for CAD and ischemic stroke; the protective effect of stair climbing was attenuated by increasing levels of disease susceptibility.
  • Adults who stopped climbing stairs daily during the study had a 32% higher risk of ASCVD (HR, 1.32; 95% CI,1.06-1.65), compared with peers who never reported stair climbing.

IN PRACTICE:

“These findings highlight the potential advantages of stair climbing as a primary preventive measure for ASCVD in the general population. Short bursts of high-intensity stair climbing are a time-efficient way to improve cardiorespiratory fitness and lipid profile, especially among those unable to achieve the current physical activity recommendations,” study author Lu Qi, with Tulane University, New Orleans, said in a news release.

SOURCE:

The study was published online in Atherosclerosis.

LIMITATIONS:

The observational design limits causal inferences. Stair climbing was self-reported via questionnaires and recall bias is a possibility. The UK Biobank participants do not represent the entire population of the country, with a healthy volunteer selection bias previously reported.

DISCLOSURES:

The study was supported by grants from the National Key R&D Program of China. The authors disclosed no relevant financial relationships.

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

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AI chatbot ‘hallucinates’ faulty medical intelligence

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Thu, 10/19/2023 - 09:26

Artificial intelligence (AI) models are typically a year out of date and have this “charming problem of hallucinating made-up data and saying it with all the certainty of an attending on rounds,” Isaac Kohane, MD, PhD, Harvard Medical School, Boston, told a packed audience at plenary at an annual scientific meeting on infectious diseases.

Dr. Kohane, chair of the department of biomedical informatics, says the future intersection between AI and health care is “muddy.”

Echoing questions about the accuracy of new AI tools, researchers at the meeting presented the results of their new test of ChatGPT.

The AI chatbot is designed for language processing – not scientific accuracy – and does not guarantee that responses to medical queries are fully factual.

To test the accuracy of ChatGPT’s version 3.5, the researchers asked it if there are any boxed warnings on the U.S. Food and Drug Administration’s label for common antibiotics, and if so, what they are.

ChatGPT provided correct answers about FDA boxed warnings for only 12 of the 41 antibiotics queried – a matching rate of just 29%.

For the other 29 antibiotics, ChatGPT either “incorrectly reported that there was an FDA boxed warning when there was not, or inaccurately or incorrectly reported the boxed warning,” Rebecca Linfield, MD, infectious diseases fellow, Stanford (Calif.) University, said in an interview.
 

Uncritical AI use risky

Nine of the 41 antibiotics included in the query have boxed warnings. And ChatGPT correctly identified all nine, but only three were the matching adverse event (33%). For the 32 antibiotics without an FDA boxed warning, ChatGPT correctly reported that 28% (9 of 32) do not have a boxed warning.

For example, ChatGPT stated that the antibiotic fidaxomicin has a boxed warning for increased risk for Clostridioides difficile, “but it is the first-line antibiotic used to treat C. difficile,” Dr. Linfield pointed out.

ChatGPT also reported that cefepime increased the risk for death in those with pneumonia and fabricated a study supporting that assertion. “However, cefepime is a first-line drug for those with hospital-acquired pneumonia,” Dr. Linfield explained.

“I can imagine a worried family member finding this through ChatGPT, and needing to have extensive reassurances from the patient’s physicians about why this antibiotic was chosen,” she said.

ChatGPT also incorrectly stated that aztreonam has a boxed warning for increased mortality.

“The risk is that both physicians and the public uncritically use ChatGPT as an easily accessible, readable source of clinically validated information, when these large language models are meant to generate fluid text, and not necessarily accurate information,” Dr. Linfield told this news organization.

Dr. Linfield said that the next step is to compare the ChatGPT 3.5 used in this analysis with ChatGPT 4, as well as with Google’s Med-PaLM 2 after it is released to the public.
 

Advancing fast

At plenary, Dr. Kohane pointed out that AI is a quick learner and improvements in tools are coming fast.

As an example, just 3 years ago, the best AI tool could score about as well as the worst student taking the medical boards, he told the audience. “Three years later, the leading large language models are scoring better than 90% of all the candidates. What’s it going to be doing next year?” he asked.

“I don’t know,” Dr. Kohane said, “but it will be better than this year.” AI will “transform health care.”

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

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Artificial intelligence (AI) models are typically a year out of date and have this “charming problem of hallucinating made-up data and saying it with all the certainty of an attending on rounds,” Isaac Kohane, MD, PhD, Harvard Medical School, Boston, told a packed audience at plenary at an annual scientific meeting on infectious diseases.

Dr. Kohane, chair of the department of biomedical informatics, says the future intersection between AI and health care is “muddy.”

Echoing questions about the accuracy of new AI tools, researchers at the meeting presented the results of their new test of ChatGPT.

The AI chatbot is designed for language processing – not scientific accuracy – and does not guarantee that responses to medical queries are fully factual.

To test the accuracy of ChatGPT’s version 3.5, the researchers asked it if there are any boxed warnings on the U.S. Food and Drug Administration’s label for common antibiotics, and if so, what they are.

ChatGPT provided correct answers about FDA boxed warnings for only 12 of the 41 antibiotics queried – a matching rate of just 29%.

For the other 29 antibiotics, ChatGPT either “incorrectly reported that there was an FDA boxed warning when there was not, or inaccurately or incorrectly reported the boxed warning,” Rebecca Linfield, MD, infectious diseases fellow, Stanford (Calif.) University, said in an interview.
 

Uncritical AI use risky

Nine of the 41 antibiotics included in the query have boxed warnings. And ChatGPT correctly identified all nine, but only three were the matching adverse event (33%). For the 32 antibiotics without an FDA boxed warning, ChatGPT correctly reported that 28% (9 of 32) do not have a boxed warning.

For example, ChatGPT stated that the antibiotic fidaxomicin has a boxed warning for increased risk for Clostridioides difficile, “but it is the first-line antibiotic used to treat C. difficile,” Dr. Linfield pointed out.

ChatGPT also reported that cefepime increased the risk for death in those with pneumonia and fabricated a study supporting that assertion. “However, cefepime is a first-line drug for those with hospital-acquired pneumonia,” Dr. Linfield explained.

“I can imagine a worried family member finding this through ChatGPT, and needing to have extensive reassurances from the patient’s physicians about why this antibiotic was chosen,” she said.

ChatGPT also incorrectly stated that aztreonam has a boxed warning for increased mortality.

“The risk is that both physicians and the public uncritically use ChatGPT as an easily accessible, readable source of clinically validated information, when these large language models are meant to generate fluid text, and not necessarily accurate information,” Dr. Linfield told this news organization.

Dr. Linfield said that the next step is to compare the ChatGPT 3.5 used in this analysis with ChatGPT 4, as well as with Google’s Med-PaLM 2 after it is released to the public.
 

Advancing fast

At plenary, Dr. Kohane pointed out that AI is a quick learner and improvements in tools are coming fast.

As an example, just 3 years ago, the best AI tool could score about as well as the worst student taking the medical boards, he told the audience. “Three years later, the leading large language models are scoring better than 90% of all the candidates. What’s it going to be doing next year?” he asked.

“I don’t know,” Dr. Kohane said, “but it will be better than this year.” AI will “transform health care.”

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

Artificial intelligence (AI) models are typically a year out of date and have this “charming problem of hallucinating made-up data and saying it with all the certainty of an attending on rounds,” Isaac Kohane, MD, PhD, Harvard Medical School, Boston, told a packed audience at plenary at an annual scientific meeting on infectious diseases.

Dr. Kohane, chair of the department of biomedical informatics, says the future intersection between AI and health care is “muddy.”

Echoing questions about the accuracy of new AI tools, researchers at the meeting presented the results of their new test of ChatGPT.

The AI chatbot is designed for language processing – not scientific accuracy – and does not guarantee that responses to medical queries are fully factual.

To test the accuracy of ChatGPT’s version 3.5, the researchers asked it if there are any boxed warnings on the U.S. Food and Drug Administration’s label for common antibiotics, and if so, what they are.

ChatGPT provided correct answers about FDA boxed warnings for only 12 of the 41 antibiotics queried – a matching rate of just 29%.

For the other 29 antibiotics, ChatGPT either “incorrectly reported that there was an FDA boxed warning when there was not, or inaccurately or incorrectly reported the boxed warning,” Rebecca Linfield, MD, infectious diseases fellow, Stanford (Calif.) University, said in an interview.
 

Uncritical AI use risky

Nine of the 41 antibiotics included in the query have boxed warnings. And ChatGPT correctly identified all nine, but only three were the matching adverse event (33%). For the 32 antibiotics without an FDA boxed warning, ChatGPT correctly reported that 28% (9 of 32) do not have a boxed warning.

For example, ChatGPT stated that the antibiotic fidaxomicin has a boxed warning for increased risk for Clostridioides difficile, “but it is the first-line antibiotic used to treat C. difficile,” Dr. Linfield pointed out.

ChatGPT also reported that cefepime increased the risk for death in those with pneumonia and fabricated a study supporting that assertion. “However, cefepime is a first-line drug for those with hospital-acquired pneumonia,” Dr. Linfield explained.

“I can imagine a worried family member finding this through ChatGPT, and needing to have extensive reassurances from the patient’s physicians about why this antibiotic was chosen,” she said.

ChatGPT also incorrectly stated that aztreonam has a boxed warning for increased mortality.

“The risk is that both physicians and the public uncritically use ChatGPT as an easily accessible, readable source of clinically validated information, when these large language models are meant to generate fluid text, and not necessarily accurate information,” Dr. Linfield told this news organization.

Dr. Linfield said that the next step is to compare the ChatGPT 3.5 used in this analysis with ChatGPT 4, as well as with Google’s Med-PaLM 2 after it is released to the public.
 

Advancing fast

At plenary, Dr. Kohane pointed out that AI is a quick learner and improvements in tools are coming fast.

As an example, just 3 years ago, the best AI tool could score about as well as the worst student taking the medical boards, he told the audience. “Three years later, the leading large language models are scoring better than 90% of all the candidates. What’s it going to be doing next year?” he asked.

“I don’t know,” Dr. Kohane said, “but it will be better than this year.” AI will “transform health care.”

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

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Narcolepsy med shows early promise for adult ADHD

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Changed
Thu, 10/19/2023 - 23:32

 

TOPLINE:

Solriamfetol – a medication approved for excessive daytime sleepiness caused by narcolepsy or obstructive sleep apnea – significantly improved symptoms of attention-deficit/hyperactivity disorder (ADHD) and clinical impression of ADHD severity in a pilot study of adults with ADHD.

METHODOLOGY:

  • Solriamfetol is a dopamine and norepinephrine reuptake inhibitor that shares some of the properties of current ADHD medications.
  • Researchers conducted a randomized, double-blind, placebo-controlled, dose-optimization trial of 75- or 150-mg solriamfetol in 60 adults with ADHD. For nearly all of the individuals who received solriamfetol, doses increased to 150 mg after the first week.
  • The primary outcome was change in scores on the Adult ADHD Investigator Symptom Rating Scale (AISRS).
  • Secondary outcomes included scores on the Clinical Global Impressions (CGI) scale and standard measures of executive function, behavior, and sleep.

TAKEAWAY:

  • By week 6, total AISRS score improved 25% for 52% of individuals to took solriamfetol, vs. 17% of those who received placebo. Total AISRS score improved 50% by week 6 in 28% of those who took solriamfetol, vs. 3.4% of those who received placebo.
  • By week 6, CGI ratings of “much improved” or “very much improved” occurred in significantly more individuals who received solriamfetol than those who took placebo (45% vs. 7%).
  • Significantly more individuals who received solriamfetol than placebo self-reported improvements in executive function (69% vs. 34%). Improvement in wakefulness was noted with solriamfetol, but that did not moderate the change in ADHD symptom burden.
  • Solriamfetol was well tolerated, with no significant effect on sleep quality or blood pressure. Adverse effects that occurred at a higher rate in the treatment group than in the placebo group were typical for solriamfetol and sympathomimetic agents used for ADHD.

IN PRACTICE:

Dr. Craig Surman, director of the Clinical and Research Program in Adult ADHD, Massachusetts General Hospital, Boston
Massachusetts General Hospital
Dr. Craig B.H. Surman

“Solriamfetol may be a safe and effective treatment for ADHD in adults. Larger studies replicating these findings could confirm the strong evidence of benefit and the tolerability of this agent as a treatment,” lead author Craig B.H. Surman, MD, director of the clinical and research program in adult ADHD, Massachusetts General Hospital, Boston, said in a statement.

SOURCE:

The study was published online in The Journal of Clinical Psychiatry.

LIMITATIONS:

Limitations include the small sample size and short 6-week duration. More women than men received solriamfetol; it’s unclear how this could have affected the results.

DISCLOSURES:

The study was an investigator-initiated trial supported by Jazz Pharmaceuticals and Axsome Therapeutics. Dr. Surman has received consultant fees, research support, and royalties from multiple companies.

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

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TOPLINE:

Solriamfetol – a medication approved for excessive daytime sleepiness caused by narcolepsy or obstructive sleep apnea – significantly improved symptoms of attention-deficit/hyperactivity disorder (ADHD) and clinical impression of ADHD severity in a pilot study of adults with ADHD.

METHODOLOGY:

  • Solriamfetol is a dopamine and norepinephrine reuptake inhibitor that shares some of the properties of current ADHD medications.
  • Researchers conducted a randomized, double-blind, placebo-controlled, dose-optimization trial of 75- or 150-mg solriamfetol in 60 adults with ADHD. For nearly all of the individuals who received solriamfetol, doses increased to 150 mg after the first week.
  • The primary outcome was change in scores on the Adult ADHD Investigator Symptom Rating Scale (AISRS).
  • Secondary outcomes included scores on the Clinical Global Impressions (CGI) scale and standard measures of executive function, behavior, and sleep.

TAKEAWAY:

  • By week 6, total AISRS score improved 25% for 52% of individuals to took solriamfetol, vs. 17% of those who received placebo. Total AISRS score improved 50% by week 6 in 28% of those who took solriamfetol, vs. 3.4% of those who received placebo.
  • By week 6, CGI ratings of “much improved” or “very much improved” occurred in significantly more individuals who received solriamfetol than those who took placebo (45% vs. 7%).
  • Significantly more individuals who received solriamfetol than placebo self-reported improvements in executive function (69% vs. 34%). Improvement in wakefulness was noted with solriamfetol, but that did not moderate the change in ADHD symptom burden.
  • Solriamfetol was well tolerated, with no significant effect on sleep quality or blood pressure. Adverse effects that occurred at a higher rate in the treatment group than in the placebo group were typical for solriamfetol and sympathomimetic agents used for ADHD.

IN PRACTICE:

Dr. Craig Surman, director of the Clinical and Research Program in Adult ADHD, Massachusetts General Hospital, Boston
Massachusetts General Hospital
Dr. Craig B.H. Surman

“Solriamfetol may be a safe and effective treatment for ADHD in adults. Larger studies replicating these findings could confirm the strong evidence of benefit and the tolerability of this agent as a treatment,” lead author Craig B.H. Surman, MD, director of the clinical and research program in adult ADHD, Massachusetts General Hospital, Boston, said in a statement.

SOURCE:

The study was published online in The Journal of Clinical Psychiatry.

LIMITATIONS:

Limitations include the small sample size and short 6-week duration. More women than men received solriamfetol; it’s unclear how this could have affected the results.

DISCLOSURES:

The study was an investigator-initiated trial supported by Jazz Pharmaceuticals and Axsome Therapeutics. Dr. Surman has received consultant fees, research support, and royalties from multiple companies.

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

 

TOPLINE:

Solriamfetol – a medication approved for excessive daytime sleepiness caused by narcolepsy or obstructive sleep apnea – significantly improved symptoms of attention-deficit/hyperactivity disorder (ADHD) and clinical impression of ADHD severity in a pilot study of adults with ADHD.

METHODOLOGY:

  • Solriamfetol is a dopamine and norepinephrine reuptake inhibitor that shares some of the properties of current ADHD medications.
  • Researchers conducted a randomized, double-blind, placebo-controlled, dose-optimization trial of 75- or 150-mg solriamfetol in 60 adults with ADHD. For nearly all of the individuals who received solriamfetol, doses increased to 150 mg after the first week.
  • The primary outcome was change in scores on the Adult ADHD Investigator Symptom Rating Scale (AISRS).
  • Secondary outcomes included scores on the Clinical Global Impressions (CGI) scale and standard measures of executive function, behavior, and sleep.

TAKEAWAY:

  • By week 6, total AISRS score improved 25% for 52% of individuals to took solriamfetol, vs. 17% of those who received placebo. Total AISRS score improved 50% by week 6 in 28% of those who took solriamfetol, vs. 3.4% of those who received placebo.
  • By week 6, CGI ratings of “much improved” or “very much improved” occurred in significantly more individuals who received solriamfetol than those who took placebo (45% vs. 7%).
  • Significantly more individuals who received solriamfetol than placebo self-reported improvements in executive function (69% vs. 34%). Improvement in wakefulness was noted with solriamfetol, but that did not moderate the change in ADHD symptom burden.
  • Solriamfetol was well tolerated, with no significant effect on sleep quality or blood pressure. Adverse effects that occurred at a higher rate in the treatment group than in the placebo group were typical for solriamfetol and sympathomimetic agents used for ADHD.

IN PRACTICE:

Dr. Craig Surman, director of the Clinical and Research Program in Adult ADHD, Massachusetts General Hospital, Boston
Massachusetts General Hospital
Dr. Craig B.H. Surman

“Solriamfetol may be a safe and effective treatment for ADHD in adults. Larger studies replicating these findings could confirm the strong evidence of benefit and the tolerability of this agent as a treatment,” lead author Craig B.H. Surman, MD, director of the clinical and research program in adult ADHD, Massachusetts General Hospital, Boston, said in a statement.

SOURCE:

The study was published online in The Journal of Clinical Psychiatry.

LIMITATIONS:

Limitations include the small sample size and short 6-week duration. More women than men received solriamfetol; it’s unclear how this could have affected the results.

DISCLOSURES:

The study was an investigator-initiated trial supported by Jazz Pharmaceuticals and Axsome Therapeutics. Dr. Surman has received consultant fees, research support, and royalties from multiple companies.

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

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Doublet therapy ups survival in metastatic prostate cancer

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Tue, 10/24/2023 - 00:40

 

TOPLINE:

Adoption of doublet therapy – androgen deprivation therapy (ADT) combined with either docetaxel or an androgen receptor pathway inhibitor – has led to a clinically meaningful increase in long-term survival in men with de novo metastatic castration-sensitive prostate cancer, Swedish registry data show.

METHODOLOGY:

  • The use of doublet therapy has increased significantly in Sweden in recent years given the growing body of evidence demonstrating that doublet therapy improves survival in individuals with de novo metastatic castration-sensitive prostate cancer.
  • Investigators wanted to see whether the increasing use of doublet therapy in this patient population has improved survival when taking various other factors into consideration.
  • The analysis, which included 11,382 men diagnosed with metastatic castration-sensitive prostate cancer in Sweden from 2008-2020 and registered in the country’s National Prostate Cancer Register, explored the use of doublet therapy over time and its association with survival, adjusting for age, comorbidities, and cancer characteristics.
  • The researchers estimated average 5-year and 10-year survival over time using a survival model.

TAKEAWAY:

  • During the study period, patients exhibited a shift toward less advanced prostate cancer, with median prostate-specific antigen (PSA) levels at diagnosis decreasing from 145 to 107 ng/mL in men with metastatic disease.
  • Upfront treatment with doublet therapy in these men simultaneously increased from 1% in 2016 to 44% in 2020.
  • Adjusted 5-year overall survival increased from 26% between 2008-2012 to 35% in the period 2017-2020; in the 5 years following diagnosis, patients’ mean survival increased by about 6 months between 2008-2012 and 2017-2020.
  • The percentage of patients still alive at 10 years doubled from 9% in 2008 to 18% in 2020. Improvements were greater in men younger than 80 years old.

IN PRACTICE:

“A clinically meaningful increase in long-term survival was observed in men diagnosed with de novo [metastatic castration-sensitive prostate cancer] between 2008 and 2020 in Sweden. We argue that the main reason for this improvement was the increased upfront use of doublet therapy,” the authors concluded.

SOURCE:

The study, with first author Christian Corsini, MD, of Uppsala (Sweden) University, was published online in JAMA Network Open.

LIMITATIONS:

Although there were no substantial changes in the diagnostic workup, unmeasured and unknown changes over the years may have affected survival.  The researchers lacked information on PSA levels during follow-up, and therefore could not assess progression-free survival. Some upfront docetaxel use was not captured before 2017.

DISCLOSURES:

The study received funding from the Swedish Cancer Society and Region Uppsala. The authors reported no relevant financial relationships.

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

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TOPLINE:

Adoption of doublet therapy – androgen deprivation therapy (ADT) combined with either docetaxel or an androgen receptor pathway inhibitor – has led to a clinically meaningful increase in long-term survival in men with de novo metastatic castration-sensitive prostate cancer, Swedish registry data show.

METHODOLOGY:

  • The use of doublet therapy has increased significantly in Sweden in recent years given the growing body of evidence demonstrating that doublet therapy improves survival in individuals with de novo metastatic castration-sensitive prostate cancer.
  • Investigators wanted to see whether the increasing use of doublet therapy in this patient population has improved survival when taking various other factors into consideration.
  • The analysis, which included 11,382 men diagnosed with metastatic castration-sensitive prostate cancer in Sweden from 2008-2020 and registered in the country’s National Prostate Cancer Register, explored the use of doublet therapy over time and its association with survival, adjusting for age, comorbidities, and cancer characteristics.
  • The researchers estimated average 5-year and 10-year survival over time using a survival model.

TAKEAWAY:

  • During the study period, patients exhibited a shift toward less advanced prostate cancer, with median prostate-specific antigen (PSA) levels at diagnosis decreasing from 145 to 107 ng/mL in men with metastatic disease.
  • Upfront treatment with doublet therapy in these men simultaneously increased from 1% in 2016 to 44% in 2020.
  • Adjusted 5-year overall survival increased from 26% between 2008-2012 to 35% in the period 2017-2020; in the 5 years following diagnosis, patients’ mean survival increased by about 6 months between 2008-2012 and 2017-2020.
  • The percentage of patients still alive at 10 years doubled from 9% in 2008 to 18% in 2020. Improvements were greater in men younger than 80 years old.

IN PRACTICE:

“A clinically meaningful increase in long-term survival was observed in men diagnosed with de novo [metastatic castration-sensitive prostate cancer] between 2008 and 2020 in Sweden. We argue that the main reason for this improvement was the increased upfront use of doublet therapy,” the authors concluded.

SOURCE:

The study, with first author Christian Corsini, MD, of Uppsala (Sweden) University, was published online in JAMA Network Open.

LIMITATIONS:

Although there were no substantial changes in the diagnostic workup, unmeasured and unknown changes over the years may have affected survival.  The researchers lacked information on PSA levels during follow-up, and therefore could not assess progression-free survival. Some upfront docetaxel use was not captured before 2017.

DISCLOSURES:

The study received funding from the Swedish Cancer Society and Region Uppsala. The authors reported no relevant financial relationships.

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

 

TOPLINE:

Adoption of doublet therapy – androgen deprivation therapy (ADT) combined with either docetaxel or an androgen receptor pathway inhibitor – has led to a clinically meaningful increase in long-term survival in men with de novo metastatic castration-sensitive prostate cancer, Swedish registry data show.

METHODOLOGY:

  • The use of doublet therapy has increased significantly in Sweden in recent years given the growing body of evidence demonstrating that doublet therapy improves survival in individuals with de novo metastatic castration-sensitive prostate cancer.
  • Investigators wanted to see whether the increasing use of doublet therapy in this patient population has improved survival when taking various other factors into consideration.
  • The analysis, which included 11,382 men diagnosed with metastatic castration-sensitive prostate cancer in Sweden from 2008-2020 and registered in the country’s National Prostate Cancer Register, explored the use of doublet therapy over time and its association with survival, adjusting for age, comorbidities, and cancer characteristics.
  • The researchers estimated average 5-year and 10-year survival over time using a survival model.

TAKEAWAY:

  • During the study period, patients exhibited a shift toward less advanced prostate cancer, with median prostate-specific antigen (PSA) levels at diagnosis decreasing from 145 to 107 ng/mL in men with metastatic disease.
  • Upfront treatment with doublet therapy in these men simultaneously increased from 1% in 2016 to 44% in 2020.
  • Adjusted 5-year overall survival increased from 26% between 2008-2012 to 35% in the period 2017-2020; in the 5 years following diagnosis, patients’ mean survival increased by about 6 months between 2008-2012 and 2017-2020.
  • The percentage of patients still alive at 10 years doubled from 9% in 2008 to 18% in 2020. Improvements were greater in men younger than 80 years old.

IN PRACTICE:

“A clinically meaningful increase in long-term survival was observed in men diagnosed with de novo [metastatic castration-sensitive prostate cancer] between 2008 and 2020 in Sweden. We argue that the main reason for this improvement was the increased upfront use of doublet therapy,” the authors concluded.

SOURCE:

The study, with first author Christian Corsini, MD, of Uppsala (Sweden) University, was published online in JAMA Network Open.

LIMITATIONS:

Although there were no substantial changes in the diagnostic workup, unmeasured and unknown changes over the years may have affected survival.  The researchers lacked information on PSA levels during follow-up, and therefore could not assess progression-free survival. Some upfront docetaxel use was not captured before 2017.

DISCLOSURES:

The study received funding from the Swedish Cancer Society and Region Uppsala. The authors reported no relevant financial relationships.

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

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Antibiotics ‘like gold’ for some, driving inappropriate use

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Thu, 10/26/2023 - 08:14

 

Personal beliefs and health care system barriers contribute to inappropriate antibiotic use by patients, report researchers presenting results at an annual scientific meeting on infectious diseases.

Nonprescription antibiotic use includes accessing medication left over from a prior prescribed course, obtained from social networks, and purchased over-the-counter in other countries or illegally in stores and markets in the United States.

Overuse and misuse of antibiotics contributes to a growing threat of antimicrobial resistance, and it is tough to say how common it is, Lindsey A. Laytner, PhD, MPH, with Baylor College of Medicine, Houston, pointed out in her presentation.

“This is an understudied area. We don’t routinely collect these data, so we don’t actually know what the true prevalence is. The factors that contribute to this unsafe practice in the U.S. are also underexplored,” Dr. Laytner said.

To investigate, the researchers conducted in-depth interviews with 86 adults (median age, 49 years; 62% women) to identify patients’ motivations to use antibiotics without a prescription. All of them answered “yes” when asked in a previous survey whether they would use antibiotics without contacting a doctor, nurse, dentist, or clinic.

Dr. Laytner said several prominent themes emerged.

Nearly all interviewees reported nonprescription antibiotic use for symptoms that mostly do not warrant antibiotics. These included symptoms of COVID-19, influenza, and the common cold, as well as for pain management, allergies, and even wounds.
 

Ineffectively treating symptoms

Many felt they “knew their body, knew what they had, and knew how to treat themselves” without a health care provider, Dr. Laytner said.

They also felt the over-the-counter medicines “don’t always work and that antibiotics are like gold or this cure-all and because they are difficult to get a prescription for, they should be kept on hand,” she explained.

A variety of health care system barriers also contribute to inappropriate antibiotic use, including long wait times to schedule appointments and to see the doctor while at their appointments; high costs for clinic visits and prescriptions; and transportation issues.

Many patients opted to use nonprescription antibiotics out of “convenience,” Laytner added.

She explains that the findings could help inform community-level education efforts on inappropriate use of antibiotics and help shape policies to promote antibiotic stewardship.
 

Access to care, education

Commenting on the study, Emily Sydnor Spivak, MD, associate professor of medicine at University of Utah, Salt Lake City, said she “wasn’t totally surprised by the results, but found it very interesting how there was a theme of autonomy, or ‘I know my body,’ that seemed to drive patients to get antibiotics for relief of symptoms.”

“There is patient education that needs to happen about the role of antibiotics, how they act, and how they don’t actually provide symptom relief and have downsides and side effects,” said Dr. Spivak, who is also medical director of antimicrobial stewardship programs at University of Utah Health and VA Salt Lake City Health Care System.

“Given the lack of access to health care as a reason some patients use nonprescription antibiotics, we need to think about access to the health care system and process changes and policy changes to allow better access. Without better access or interaction with the health care system, we can’t educate patients,” Dr. Spivak said.

The study had no commercial funding. Dr. Laytner and Dr. Spivak report no relevant financial disclosures.

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

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Personal beliefs and health care system barriers contribute to inappropriate antibiotic use by patients, report researchers presenting results at an annual scientific meeting on infectious diseases.

Nonprescription antibiotic use includes accessing medication left over from a prior prescribed course, obtained from social networks, and purchased over-the-counter in other countries or illegally in stores and markets in the United States.

Overuse and misuse of antibiotics contributes to a growing threat of antimicrobial resistance, and it is tough to say how common it is, Lindsey A. Laytner, PhD, MPH, with Baylor College of Medicine, Houston, pointed out in her presentation.

“This is an understudied area. We don’t routinely collect these data, so we don’t actually know what the true prevalence is. The factors that contribute to this unsafe practice in the U.S. are also underexplored,” Dr. Laytner said.

To investigate, the researchers conducted in-depth interviews with 86 adults (median age, 49 years; 62% women) to identify patients’ motivations to use antibiotics without a prescription. All of them answered “yes” when asked in a previous survey whether they would use antibiotics without contacting a doctor, nurse, dentist, or clinic.

Dr. Laytner said several prominent themes emerged.

Nearly all interviewees reported nonprescription antibiotic use for symptoms that mostly do not warrant antibiotics. These included symptoms of COVID-19, influenza, and the common cold, as well as for pain management, allergies, and even wounds.
 

Ineffectively treating symptoms

Many felt they “knew their body, knew what they had, and knew how to treat themselves” without a health care provider, Dr. Laytner said.

They also felt the over-the-counter medicines “don’t always work and that antibiotics are like gold or this cure-all and because they are difficult to get a prescription for, they should be kept on hand,” she explained.

A variety of health care system barriers also contribute to inappropriate antibiotic use, including long wait times to schedule appointments and to see the doctor while at their appointments; high costs for clinic visits and prescriptions; and transportation issues.

Many patients opted to use nonprescription antibiotics out of “convenience,” Laytner added.

She explains that the findings could help inform community-level education efforts on inappropriate use of antibiotics and help shape policies to promote antibiotic stewardship.
 

Access to care, education

Commenting on the study, Emily Sydnor Spivak, MD, associate professor of medicine at University of Utah, Salt Lake City, said she “wasn’t totally surprised by the results, but found it very interesting how there was a theme of autonomy, or ‘I know my body,’ that seemed to drive patients to get antibiotics for relief of symptoms.”

“There is patient education that needs to happen about the role of antibiotics, how they act, and how they don’t actually provide symptom relief and have downsides and side effects,” said Dr. Spivak, who is also medical director of antimicrobial stewardship programs at University of Utah Health and VA Salt Lake City Health Care System.

“Given the lack of access to health care as a reason some patients use nonprescription antibiotics, we need to think about access to the health care system and process changes and policy changes to allow better access. Without better access or interaction with the health care system, we can’t educate patients,” Dr. Spivak said.

The study had no commercial funding. Dr. Laytner and Dr. Spivak report no relevant financial disclosures.

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

 

Personal beliefs and health care system barriers contribute to inappropriate antibiotic use by patients, report researchers presenting results at an annual scientific meeting on infectious diseases.

Nonprescription antibiotic use includes accessing medication left over from a prior prescribed course, obtained from social networks, and purchased over-the-counter in other countries or illegally in stores and markets in the United States.

Overuse and misuse of antibiotics contributes to a growing threat of antimicrobial resistance, and it is tough to say how common it is, Lindsey A. Laytner, PhD, MPH, with Baylor College of Medicine, Houston, pointed out in her presentation.

“This is an understudied area. We don’t routinely collect these data, so we don’t actually know what the true prevalence is. The factors that contribute to this unsafe practice in the U.S. are also underexplored,” Dr. Laytner said.

To investigate, the researchers conducted in-depth interviews with 86 adults (median age, 49 years; 62% women) to identify patients’ motivations to use antibiotics without a prescription. All of them answered “yes” when asked in a previous survey whether they would use antibiotics without contacting a doctor, nurse, dentist, or clinic.

Dr. Laytner said several prominent themes emerged.

Nearly all interviewees reported nonprescription antibiotic use for symptoms that mostly do not warrant antibiotics. These included symptoms of COVID-19, influenza, and the common cold, as well as for pain management, allergies, and even wounds.
 

Ineffectively treating symptoms

Many felt they “knew their body, knew what they had, and knew how to treat themselves” without a health care provider, Dr. Laytner said.

They also felt the over-the-counter medicines “don’t always work and that antibiotics are like gold or this cure-all and because they are difficult to get a prescription for, they should be kept on hand,” she explained.

A variety of health care system barriers also contribute to inappropriate antibiotic use, including long wait times to schedule appointments and to see the doctor while at their appointments; high costs for clinic visits and prescriptions; and transportation issues.

Many patients opted to use nonprescription antibiotics out of “convenience,” Laytner added.

She explains that the findings could help inform community-level education efforts on inappropriate use of antibiotics and help shape policies to promote antibiotic stewardship.
 

Access to care, education

Commenting on the study, Emily Sydnor Spivak, MD, associate professor of medicine at University of Utah, Salt Lake City, said she “wasn’t totally surprised by the results, but found it very interesting how there was a theme of autonomy, or ‘I know my body,’ that seemed to drive patients to get antibiotics for relief of symptoms.”

“There is patient education that needs to happen about the role of antibiotics, how they act, and how they don’t actually provide symptom relief and have downsides and side effects,” said Dr. Spivak, who is also medical director of antimicrobial stewardship programs at University of Utah Health and VA Salt Lake City Health Care System.

“Given the lack of access to health care as a reason some patients use nonprescription antibiotics, we need to think about access to the health care system and process changes and policy changes to allow better access. Without better access or interaction with the health care system, we can’t educate patients,” Dr. Spivak said.

The study had no commercial funding. Dr. Laytner and Dr. Spivak report no relevant financial disclosures.

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

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FDA approves new drug for ulcerative colitis

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Thu, 10/19/2023 - 23:36

 

The Food and Drug Administration has approved etrasimod (Velsipity, Pfizer) for treating moderate to severe active ulcerative colitis (UC) in adults, Pfizer announced on Oct. 13.

Etrasimod is an oral sphingosine-1-phosphate (S1P) receptor that binds with high affinity to receptors 1, 4, and 5. The approved recommended dose is 2 mg once daily.

Etrasimod is the second agent in the S1P class approved for UC in the United States. The other agent, ozanimod (Zeposia, Bristol-Myers Squibb), received FDA approval for moderately to severely active UC in May 2021.

The approval of etrasimod was based on safety and efficacy data from two randomized, double-blind, placebo-controlled phase 3 trials: ELEVATE UC 52 trial and the ELEVATE UC 12 trial. The Lancet published full results from the two trials in March.

Both trials enrolled patients with UC who had previously failed or were intolerant of at least one conventional, biologic, or Janus kinase inhibitor therapy.

In ELEVATE UC 52, clinical remission at 12 weeks occurred in 27% of patients taking etrasimod versus 7% of patients taking a placebo (20% difference; P < .001). At week 52, remission rates were 32% with active treatment verus 7% with placebo (26% difference; P < .001).

In ELEVATE UC 12, clinical remission was achieved among 26% of patients who received etrasimod versus 15.0% of patients who received placebo (11% difference; P < .05).

Statistically significant improvements were also observed with etrasimod (vs. placebo) on all key secondary endpoints, including endoscopic improvement and mucosal healing at weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at week 52.

The most common side effects of etrasimod were found to be headache, elevated values on liver tests, worsening of UC, SARS-CoV-2 infection, dizziness, pyrexia, arthralgia, abdominal pain, and nausea. Full prescribing information is available online.

Etrasimod is “a proven advanced treatment with a favorable benefit-risk profile,” Michael Chiorean, MD, codirector of the IBD Center at Swedish Medical Center, Seattle, who is an investigator in the ELEVATE studies, said in a Pfizer news release.

“UC can affect patients differently and many people living with this disease struggle with ongoing symptoms. The introduction of a new treatment for UC could increase options for patients, and we look forward to seeing the impact of Velsipity for patients across the U.S.,” added Michael Osso, president and CEO of the Crohn’s & Colitis Foundation.

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

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The Food and Drug Administration has approved etrasimod (Velsipity, Pfizer) for treating moderate to severe active ulcerative colitis (UC) in adults, Pfizer announced on Oct. 13.

Etrasimod is an oral sphingosine-1-phosphate (S1P) receptor that binds with high affinity to receptors 1, 4, and 5. The approved recommended dose is 2 mg once daily.

Etrasimod is the second agent in the S1P class approved for UC in the United States. The other agent, ozanimod (Zeposia, Bristol-Myers Squibb), received FDA approval for moderately to severely active UC in May 2021.

The approval of etrasimod was based on safety and efficacy data from two randomized, double-blind, placebo-controlled phase 3 trials: ELEVATE UC 52 trial and the ELEVATE UC 12 trial. The Lancet published full results from the two trials in March.

Both trials enrolled patients with UC who had previously failed or were intolerant of at least one conventional, biologic, or Janus kinase inhibitor therapy.

In ELEVATE UC 52, clinical remission at 12 weeks occurred in 27% of patients taking etrasimod versus 7% of patients taking a placebo (20% difference; P < .001). At week 52, remission rates were 32% with active treatment verus 7% with placebo (26% difference; P < .001).

In ELEVATE UC 12, clinical remission was achieved among 26% of patients who received etrasimod versus 15.0% of patients who received placebo (11% difference; P < .05).

Statistically significant improvements were also observed with etrasimod (vs. placebo) on all key secondary endpoints, including endoscopic improvement and mucosal healing at weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at week 52.

The most common side effects of etrasimod were found to be headache, elevated values on liver tests, worsening of UC, SARS-CoV-2 infection, dizziness, pyrexia, arthralgia, abdominal pain, and nausea. Full prescribing information is available online.

Etrasimod is “a proven advanced treatment with a favorable benefit-risk profile,” Michael Chiorean, MD, codirector of the IBD Center at Swedish Medical Center, Seattle, who is an investigator in the ELEVATE studies, said in a Pfizer news release.

“UC can affect patients differently and many people living with this disease struggle with ongoing symptoms. The introduction of a new treatment for UC could increase options for patients, and we look forward to seeing the impact of Velsipity for patients across the U.S.,” added Michael Osso, president and CEO of the Crohn’s & Colitis Foundation.

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

 

The Food and Drug Administration has approved etrasimod (Velsipity, Pfizer) for treating moderate to severe active ulcerative colitis (UC) in adults, Pfizer announced on Oct. 13.

Etrasimod is an oral sphingosine-1-phosphate (S1P) receptor that binds with high affinity to receptors 1, 4, and 5. The approved recommended dose is 2 mg once daily.

Etrasimod is the second agent in the S1P class approved for UC in the United States. The other agent, ozanimod (Zeposia, Bristol-Myers Squibb), received FDA approval for moderately to severely active UC in May 2021.

The approval of etrasimod was based on safety and efficacy data from two randomized, double-blind, placebo-controlled phase 3 trials: ELEVATE UC 52 trial and the ELEVATE UC 12 trial. The Lancet published full results from the two trials in March.

Both trials enrolled patients with UC who had previously failed or were intolerant of at least one conventional, biologic, or Janus kinase inhibitor therapy.

In ELEVATE UC 52, clinical remission at 12 weeks occurred in 27% of patients taking etrasimod versus 7% of patients taking a placebo (20% difference; P < .001). At week 52, remission rates were 32% with active treatment verus 7% with placebo (26% difference; P < .001).

In ELEVATE UC 12, clinical remission was achieved among 26% of patients who received etrasimod versus 15.0% of patients who received placebo (11% difference; P < .05).

Statistically significant improvements were also observed with etrasimod (vs. placebo) on all key secondary endpoints, including endoscopic improvement and mucosal healing at weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at week 52.

The most common side effects of etrasimod were found to be headache, elevated values on liver tests, worsening of UC, SARS-CoV-2 infection, dizziness, pyrexia, arthralgia, abdominal pain, and nausea. Full prescribing information is available online.

Etrasimod is “a proven advanced treatment with a favorable benefit-risk profile,” Michael Chiorean, MD, codirector of the IBD Center at Swedish Medical Center, Seattle, who is an investigator in the ELEVATE studies, said in a Pfizer news release.

“UC can affect patients differently and many people living with this disease struggle with ongoing symptoms. The introduction of a new treatment for UC could increase options for patients, and we look forward to seeing the impact of Velsipity for patients across the U.S.,” added Michael Osso, president and CEO of the Crohn’s & Colitis Foundation.

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

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New RSV vaccine will cut hospitalizations, study shows

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Wed, 10/18/2023 - 19:20

The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at an annual scientific meeting on infectious diseases.

“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.

“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.

This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.

The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
 

Strong efficacy data

Most children are infected with RSV at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis.

As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
 

New modeling study

Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.

According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.

With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.

Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.

Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.

Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.

Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”

In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.

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

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The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at an annual scientific meeting on infectious diseases.

“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.

“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.

This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.

The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
 

Strong efficacy data

Most children are infected with RSV at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis.

As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
 

New modeling study

Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.

According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.

With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.

Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.

Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.

Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.

Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”

In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.

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

The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at an annual scientific meeting on infectious diseases.

“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.

“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.

This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.

The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
 

Strong efficacy data

Most children are infected with RSV at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis.

As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
 

New modeling study

Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.

According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.

With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.

Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.

Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.

Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.

Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”

In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.

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

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Wastewater can signal upswing in flu, RSV

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Mon, 10/16/2023 - 11:59

Wastewater monitoring can accurately gauge influenza A and B and respiratory syncytial virus (RSV) at the population level, and help inform public response to common seasonal illnesses, according to new research reported at an annual scientific meeting on infectious diseases.

The analysis of wastewater in Calgary (Alta.) found a “positive correlation” between positivity rates for these three viruses in wastewater and weekly laboratory-confirmed clinical cases and test positivity rates, study investigator Kristine Du, with Cumming School of Medicine, University of Calgary, told this news organization.

Wastewater monitoring of viral activity has become an established tool for COVID-19 pandemic monitoring, providing a leading indicator to cases and hospitalizations. However, less is known about its potential for monitoring endemic respiratory viruses.

The new study shows that wastewater-based surveillance is a “robust and adaptable” tool for community-level surveillance of seasonal respiratory viruses – “one that can complement health care clinical testing because it’s independent from testing biases, and we can actually correlate our cases very well with it,” Ms. Du said during a preconference media briefing.
 

Tracking community trends

For the study, Ms. Du and colleagues assessed the occurrence of influenza A, influenza B, and RSV RNA in all three wastewater treatment plants in Calgary between March 2022 and April 2023 and its correlation with clinical disease.

They found that viral signals in Calgary’s wastewater for influenza A and B and RSV correlated significantly with weekly confirmed clinical cases in Calgary residents.

Influenza A peaked in Calgary’s wastewater between November and December 2022; influenza B peaked between February and April 2023; and RSV between November 2022 and February 2023.

“Wastewater gives us unbiased, objective, and comprehensive data. It can be used in addition to other testing for assessing the community burden that disease may have, and it is complementary to clinical testing,” Ms. Du said.

Their team, Ms. Du said, is continuing to proactively monitor wastewater for influenza and RSV, as well as other agents of “pandemic potential to make sure we know what could affect humans – and make sure everyone is aware of that.”

Commenting on the research, briefing moderator Belinda Ostrowsky, MD, MPH, Albert Einstein College of Medicine, New York, said, “Wastewater surveillance illustrates how understanding community levels of viral trends can identify hotspots, inform local public health decision-making, and prepare clinicians and hospitals for potential outreach. This topic is particularly timely as we head into the flu and RSV season.”

The study had no commercial funding. Ms. Du and Dr. Ostrowsky report no relevant financial relationships.

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

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Wastewater monitoring can accurately gauge influenza A and B and respiratory syncytial virus (RSV) at the population level, and help inform public response to common seasonal illnesses, according to new research reported at an annual scientific meeting on infectious diseases.

The analysis of wastewater in Calgary (Alta.) found a “positive correlation” between positivity rates for these three viruses in wastewater and weekly laboratory-confirmed clinical cases and test positivity rates, study investigator Kristine Du, with Cumming School of Medicine, University of Calgary, told this news organization.

Wastewater monitoring of viral activity has become an established tool for COVID-19 pandemic monitoring, providing a leading indicator to cases and hospitalizations. However, less is known about its potential for monitoring endemic respiratory viruses.

The new study shows that wastewater-based surveillance is a “robust and adaptable” tool for community-level surveillance of seasonal respiratory viruses – “one that can complement health care clinical testing because it’s independent from testing biases, and we can actually correlate our cases very well with it,” Ms. Du said during a preconference media briefing.
 

Tracking community trends

For the study, Ms. Du and colleagues assessed the occurrence of influenza A, influenza B, and RSV RNA in all three wastewater treatment plants in Calgary between March 2022 and April 2023 and its correlation with clinical disease.

They found that viral signals in Calgary’s wastewater for influenza A and B and RSV correlated significantly with weekly confirmed clinical cases in Calgary residents.

Influenza A peaked in Calgary’s wastewater between November and December 2022; influenza B peaked between February and April 2023; and RSV between November 2022 and February 2023.

“Wastewater gives us unbiased, objective, and comprehensive data. It can be used in addition to other testing for assessing the community burden that disease may have, and it is complementary to clinical testing,” Ms. Du said.

Their team, Ms. Du said, is continuing to proactively monitor wastewater for influenza and RSV, as well as other agents of “pandemic potential to make sure we know what could affect humans – and make sure everyone is aware of that.”

Commenting on the research, briefing moderator Belinda Ostrowsky, MD, MPH, Albert Einstein College of Medicine, New York, said, “Wastewater surveillance illustrates how understanding community levels of viral trends can identify hotspots, inform local public health decision-making, and prepare clinicians and hospitals for potential outreach. This topic is particularly timely as we head into the flu and RSV season.”

The study had no commercial funding. Ms. Du and Dr. Ostrowsky report no relevant financial relationships.

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

Wastewater monitoring can accurately gauge influenza A and B and respiratory syncytial virus (RSV) at the population level, and help inform public response to common seasonal illnesses, according to new research reported at an annual scientific meeting on infectious diseases.

The analysis of wastewater in Calgary (Alta.) found a “positive correlation” between positivity rates for these three viruses in wastewater and weekly laboratory-confirmed clinical cases and test positivity rates, study investigator Kristine Du, with Cumming School of Medicine, University of Calgary, told this news organization.

Wastewater monitoring of viral activity has become an established tool for COVID-19 pandemic monitoring, providing a leading indicator to cases and hospitalizations. However, less is known about its potential for monitoring endemic respiratory viruses.

The new study shows that wastewater-based surveillance is a “robust and adaptable” tool for community-level surveillance of seasonal respiratory viruses – “one that can complement health care clinical testing because it’s independent from testing biases, and we can actually correlate our cases very well with it,” Ms. Du said during a preconference media briefing.
 

Tracking community trends

For the study, Ms. Du and colleagues assessed the occurrence of influenza A, influenza B, and RSV RNA in all three wastewater treatment plants in Calgary between March 2022 and April 2023 and its correlation with clinical disease.

They found that viral signals in Calgary’s wastewater for influenza A and B and RSV correlated significantly with weekly confirmed clinical cases in Calgary residents.

Influenza A peaked in Calgary’s wastewater between November and December 2022; influenza B peaked between February and April 2023; and RSV between November 2022 and February 2023.

“Wastewater gives us unbiased, objective, and comprehensive data. It can be used in addition to other testing for assessing the community burden that disease may have, and it is complementary to clinical testing,” Ms. Du said.

Their team, Ms. Du said, is continuing to proactively monitor wastewater for influenza and RSV, as well as other agents of “pandemic potential to make sure we know what could affect humans – and make sure everyone is aware of that.”

Commenting on the research, briefing moderator Belinda Ostrowsky, MD, MPH, Albert Einstein College of Medicine, New York, said, “Wastewater surveillance illustrates how understanding community levels of viral trends can identify hotspots, inform local public health decision-making, and prepare clinicians and hospitals for potential outreach. This topic is particularly timely as we head into the flu and RSV season.”

The study had no commercial funding. Ms. Du and Dr. Ostrowsky report no relevant financial relationships.

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

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Breast reconstruction post mastectomy: What matters most to women?

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Wed, 10/11/2023 - 12:19

 

TOPLINE:

The risk for abdominal morbidity, complications, and additional operations are the most important factors weighing on women who are considering postmastectomy breast reconstruction, a new survey suggests.

METHODOLOGY:

  • As many as 40% of women feel dissatisfied after breast reconstruction because of unexpected outcomes that are poorly aligned with their personal preferences. Identifying what women value when considering breast reconstruction surgery could improve shared decision-making.
  • Researchers used an adaptive choice-based conjoint analysis, a survey-based method used in marketing research, to identify attributes of breast reconstruction that are most important to women considering it.
  • A total of 406 women completed the survey, which assessed the relative importance of breast appearance (flap or implant), abdominal morbidity, recovery time, additional operations, and complications of breast reconstruction.
  • The survey included 105 women from Duke University, Durham, N.C., who had a new diagnosis of, or genetic predisposition to, breast cancer and were considering mastectomy with reconstruction. The survey also included another 301 women, identified through the Love Research Army registry, who had a history of breast cancer or a genetic predisposition.

TAKEAWAY:

  • Overall, the risk for abdominal morbidity was most important to patients (mean relative importance, 28%); women also rated the chance for major complications (RI, 25%), the number of additional surgeries (RI, 23%), breast appearance (RI, 13%), and recovery time (RI, 11%) as important factors.
  • Most women preferred implant-based reconstruction (85%), and these women cared most about abdominal morbidity (RI, 30%), risk for complications (RI, 26%), and added operations (RI, 21%).
  • Women who preferred flap reconstruction cared most about additional operations (RI, 31%), followed by breast appearance (RI, 27%) and risk of complications (RI, 18%), which suggests that the appearance of the reconstruction procedure was particularly important, the authors noted.
  • Participants who preferred the flap appearance were willing to accept an increased risk for abdominal morbidity and a slightly higher risk for complications; among the participants who preferred the implant option, one-third actually preferred the flap appearance.

IN PRACTICE:

“This study provides information on how women value different aspects of their care when making decisions for breast reconstruction,” the authors conclude, adding that “developing decision aids that elicit individual-level preferences and align patient values with treatment may provide an avenue to improve patient-centered care.”

SOURCE:

The study, led by first author Ronnie Shammas, MD, of Duke University, Durham, N.C., was published online in JAMA Surgery.

LIMITATIONS:

The attributes included in the survey may not represent all factors that women consider during the decision-making process. The cohort was composed of predominately upper-middle class and White women, which may reflect an increased preference toward implant, compared with flap reconstruction, as suggested in previous studies.

DISCLOSURES:

Funding for the research was provided by a grant from the National Endowment for Plastic Surgery awarded by the Plastic Surgery Foundation. The authors report no relevant financial relationships.

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

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TOPLINE:

The risk for abdominal morbidity, complications, and additional operations are the most important factors weighing on women who are considering postmastectomy breast reconstruction, a new survey suggests.

METHODOLOGY:

  • As many as 40% of women feel dissatisfied after breast reconstruction because of unexpected outcomes that are poorly aligned with their personal preferences. Identifying what women value when considering breast reconstruction surgery could improve shared decision-making.
  • Researchers used an adaptive choice-based conjoint analysis, a survey-based method used in marketing research, to identify attributes of breast reconstruction that are most important to women considering it.
  • A total of 406 women completed the survey, which assessed the relative importance of breast appearance (flap or implant), abdominal morbidity, recovery time, additional operations, and complications of breast reconstruction.
  • The survey included 105 women from Duke University, Durham, N.C., who had a new diagnosis of, or genetic predisposition to, breast cancer and were considering mastectomy with reconstruction. The survey also included another 301 women, identified through the Love Research Army registry, who had a history of breast cancer or a genetic predisposition.

TAKEAWAY:

  • Overall, the risk for abdominal morbidity was most important to patients (mean relative importance, 28%); women also rated the chance for major complications (RI, 25%), the number of additional surgeries (RI, 23%), breast appearance (RI, 13%), and recovery time (RI, 11%) as important factors.
  • Most women preferred implant-based reconstruction (85%), and these women cared most about abdominal morbidity (RI, 30%), risk for complications (RI, 26%), and added operations (RI, 21%).
  • Women who preferred flap reconstruction cared most about additional operations (RI, 31%), followed by breast appearance (RI, 27%) and risk of complications (RI, 18%), which suggests that the appearance of the reconstruction procedure was particularly important, the authors noted.
  • Participants who preferred the flap appearance were willing to accept an increased risk for abdominal morbidity and a slightly higher risk for complications; among the participants who preferred the implant option, one-third actually preferred the flap appearance.

IN PRACTICE:

“This study provides information on how women value different aspects of their care when making decisions for breast reconstruction,” the authors conclude, adding that “developing decision aids that elicit individual-level preferences and align patient values with treatment may provide an avenue to improve patient-centered care.”

SOURCE:

The study, led by first author Ronnie Shammas, MD, of Duke University, Durham, N.C., was published online in JAMA Surgery.

LIMITATIONS:

The attributes included in the survey may not represent all factors that women consider during the decision-making process. The cohort was composed of predominately upper-middle class and White women, which may reflect an increased preference toward implant, compared with flap reconstruction, as suggested in previous studies.

DISCLOSURES:

Funding for the research was provided by a grant from the National Endowment for Plastic Surgery awarded by the Plastic Surgery Foundation. The authors report no relevant financial relationships.

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

 

TOPLINE:

The risk for abdominal morbidity, complications, and additional operations are the most important factors weighing on women who are considering postmastectomy breast reconstruction, a new survey suggests.

METHODOLOGY:

  • As many as 40% of women feel dissatisfied after breast reconstruction because of unexpected outcomes that are poorly aligned with their personal preferences. Identifying what women value when considering breast reconstruction surgery could improve shared decision-making.
  • Researchers used an adaptive choice-based conjoint analysis, a survey-based method used in marketing research, to identify attributes of breast reconstruction that are most important to women considering it.
  • A total of 406 women completed the survey, which assessed the relative importance of breast appearance (flap or implant), abdominal morbidity, recovery time, additional operations, and complications of breast reconstruction.
  • The survey included 105 women from Duke University, Durham, N.C., who had a new diagnosis of, or genetic predisposition to, breast cancer and were considering mastectomy with reconstruction. The survey also included another 301 women, identified through the Love Research Army registry, who had a history of breast cancer or a genetic predisposition.

TAKEAWAY:

  • Overall, the risk for abdominal morbidity was most important to patients (mean relative importance, 28%); women also rated the chance for major complications (RI, 25%), the number of additional surgeries (RI, 23%), breast appearance (RI, 13%), and recovery time (RI, 11%) as important factors.
  • Most women preferred implant-based reconstruction (85%), and these women cared most about abdominal morbidity (RI, 30%), risk for complications (RI, 26%), and added operations (RI, 21%).
  • Women who preferred flap reconstruction cared most about additional operations (RI, 31%), followed by breast appearance (RI, 27%) and risk of complications (RI, 18%), which suggests that the appearance of the reconstruction procedure was particularly important, the authors noted.
  • Participants who preferred the flap appearance were willing to accept an increased risk for abdominal morbidity and a slightly higher risk for complications; among the participants who preferred the implant option, one-third actually preferred the flap appearance.

IN PRACTICE:

“This study provides information on how women value different aspects of their care when making decisions for breast reconstruction,” the authors conclude, adding that “developing decision aids that elicit individual-level preferences and align patient values with treatment may provide an avenue to improve patient-centered care.”

SOURCE:

The study, led by first author Ronnie Shammas, MD, of Duke University, Durham, N.C., was published online in JAMA Surgery.

LIMITATIONS:

The attributes included in the survey may not represent all factors that women consider during the decision-making process. The cohort was composed of predominately upper-middle class and White women, which may reflect an increased preference toward implant, compared with flap reconstruction, as suggested in previous studies.

DISCLOSURES:

Funding for the research was provided by a grant from the National Endowment for Plastic Surgery awarded by the Plastic Surgery Foundation. The authors report no relevant financial relationships.

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

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