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AI-assisted colonoscopy doesn’t always improve adenoma detection: Study
In a randomized clinical trial using EndoVigilant, there wasn’t a significant difference in adenomas per colonoscopy (APC) in procedures with the CADe tool versus those without it. In addition, the adenoma detection rate (ADR) and serrated polyp detection rate were similar in the CADe and non-CADe groups.
“Although we were disappointed that AI [artificial intelligence] did not improve detection of adenomas or serrated polyps in our study, we are still optimistic that this exciting technology will eventually impact endoscopy in a very positive way,” senior author Shai Friedland, MD, a professor of medicine at Stanford (Calif.) University and gastroenterologist with the Veterans Affairs Palo Alto Health Care System, said in an interview.
“The ultimate goal should be to improve the ability of colonoscopy to prevent morbidity and mortality from colon cancer, especially for endoscopists who may not be performing as well as they could be,” he said. “AI can potentially help prevent missed lesions due to fatigue or distraction, much like a warning system that averts car accidents. It can also potentially help endoscopists recognize dangerous – but rare – subtle lesions such as small, flat, and depressed cancers.”
The study was published online in the American Journal of Gastroenterology.
Analyzing detection rates
Several studies have evaluated the use of different CADe devices to reduce adenoma miss rates during colonoscopy, and some have found that the technology contributed to significantly higher ADR and APC, the study authors write. However, most of these studies have been performed in academic settings.
Dr. Friedland and colleagues conducted a randomized controlled trial, called AI-SEE, to evaluate the use of CADe during colonoscopy in four community-based endoscopy centers located in California, Connecticut, Maryland, and New Jersey between September 2020 and September 2021. The trial included seven board-certified clinicians, who had ADR of 25%-37% before the study. The participants were randomly assigned to colonoscopies with or without CADe in blocks of 16 patients to ensure masking. Both groups had similar patient demographics.
The research team enrolled patients aged 45 years or older who presented for screening or low-risk surveillance colonoscopy, which was defined as a patient qualifying for a surveillance interval of 3 years or greater based on the U.S. Multi-Society Task Force 2020 Guidelines. Patients were excluded if they had a history of inflammatory bowel disease, known or suspected polyposis or hereditary colon cancer syndrome, history of colon resection, or a referral for a diagnostic colonoscopy.
Among 769 enrolled patients, 387 were randomly assigned to undergo colonoscopy with EndoVigilant, an AI-enabled CADe software for colonoscopy. It augments existing white-light colonoscopy in real time by highlighting colon polyps and displaying a graphic box around the lesion on the monitor. It can be deployed as a single- or dual-monitor device. Although the study was originally designed to use two monitors, three investigators expressed strong preference for the single-monitor mode, so the protocol allowed endoscopists to choose.
Primary outcomes included APC and adenoma per extraction (APE), which is the percentage of polyps removed that are adenomas. Secondary endpoints included procedural time, ADR, serrated polyp detection rate, serrated polyps per colonoscopy, and nonadenomatous, nonserrated polyps per colonoscopy.
Overall, the use of CADe didn’t show a significant difference in APC, at 0.73, compared with 0.67 for non-CADe.
Although the use of CADe didn’t lead to increased identification of serrated polyps per colonoscopy – both at 0.08 – CADe led to increased identification of nonadenomatous, nonserrated polyps per colonoscopy, at 0.90 versus 0.51.
There also wasn’t a significant difference in distribution regarding adenomatous polyp location, size, or morphology. However, there was a trend toward greater identification of 6-9 mm APC using CADe, at 0.13 versus 0.08.
Mean withdrawal time was longer in the CADe group, at 11.7 minutes versus 10.7 minutes. However, when no polyps were identified, the withdrawal times were similar, at 9.1 minutes versus 8.8 minutes.
In addition, there was no difference in ADR for screening colonoscopies between the non-CADe and CADe groups, at 34.6% versus 34.3%, or for surveillance procedures, at 43.9% versus 40%. CADe also didn’t improve serrated polyp detection rates for screening or surveillance.
CADe was also associated with decreased APE in all colonoscopies (44.8 vs. 56.8) as well as in screening colonoscopies (43 vs. 57.8).
A comparison of single-monitor CADe with dual-monitor CADe found no significant difference in the average number of adenomas or serrated polyps identified per colonoscopy. However, dual-monitor CADe identified significantly more non-adenomatous, nonserrated polyps per colonoscopy (1.18 vs. 0.42), more adenomas sized at least 10 mm (0.19 vs. 0.05), and more flat polyps (0.18 vs. 0).
The study was terminated early after the interim analysis point, marked by 769 valid subjects. At this point, the comparison of APC between the two groups resulted in a new sample size estimate required for final analysis of 6,557 per group. This revised large study size estimate made it impractical to continue, the study authors wrote. No adverse events were observed during the study.
“What our study shows is that current systems – and the one we used in this study performs very well when tested on a database of images or videos – don’t make a major impact on very crude outcome measures, such as the total number of adenomas detected by a group of endoscopists at typical private endoscopy centers,” Dr. Friedland said. “I’m not convinced that we have a good answer yet for where to go from here, but we need to keep working with our AI colleagues to figure out how to use this exciting technology to improve outcomes in colon cancer.”
Additional considerations
In a separate evaluation of EndoVigilant, the frame level sensitivity was 0.9 and the frame level specificity was 0.97. These calculations were conducted on a dataset not used in training or validation of this model, the authors noted.
In this study, it’s possible that experienced community-based endoscopists are proficient at detecting the adenomas highlighted by the CADe system, so the technology may not detect a significant number of additional adenomas, the authors wrote. It’s also possible that some endoscopists ignore lesions highlighted by CADe, including small lesions that might be difficult to identify as adenomas or are seen as clinically unimportant, which could reduce the potential benefit of CADe.
“It’s important to remember that these tools are meant to be endoscopist assistance devices, not endoscopist replacements. They provide added benefit by pointing out polyps while we do the best exam we can,” Aasma Shaukat, MD, a professor of medicine and gastroenterologist at NYU Langone Health, New York, said in an interview.
Dr. Shaukat, who wasn’t involved with this study, has researched CADe for screening and surveillance colonoscopies. She and colleagues found that CADe use improved APC without an increase in resection of nonneoplastic lesions.
“Different trials have reported different results, and at the end of the day, it’s an endoscopist assistance tool, like spellcheck in a document,” she said. “It’s nice if spellcheck points to an incorrect spelling, but you don’t have to use it. Similarly, we often don’t know in these studies what an endoscopist felt or believed about the tool when using it.”
The benefits of CADe could vary based on its software, setting, number of patients, patient characteristics, number of clinicians, provider experience and training, dual- versus single-monitor setup, and even time of day, she noted. Future studies could clarify these factors, as well as improve the technology.
“This is just the beginning of AI in this field, and while bounding boxes to indicate potential polyps is a good start, it’s not the be-all, end-all,” Dr. Shaukat said.
“We want AI software to be able to tell us more about the size of the polyp, histology, prep quality, landmarks in the colon, adequacy of resection, and more. There’s some work being geared toward developing the algorithms to do these additional aspects,” she added.
The study was sponsored by EndoVigilant. Some of the authors reported consultant roles with Neptune Medical, AgilTx, Intuitive Surgical, Capsovision, and EndoVigilant. Dr. Shaukat reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized clinical trial using EndoVigilant, there wasn’t a significant difference in adenomas per colonoscopy (APC) in procedures with the CADe tool versus those without it. In addition, the adenoma detection rate (ADR) and serrated polyp detection rate were similar in the CADe and non-CADe groups.
“Although we were disappointed that AI [artificial intelligence] did not improve detection of adenomas or serrated polyps in our study, we are still optimistic that this exciting technology will eventually impact endoscopy in a very positive way,” senior author Shai Friedland, MD, a professor of medicine at Stanford (Calif.) University and gastroenterologist with the Veterans Affairs Palo Alto Health Care System, said in an interview.
“The ultimate goal should be to improve the ability of colonoscopy to prevent morbidity and mortality from colon cancer, especially for endoscopists who may not be performing as well as they could be,” he said. “AI can potentially help prevent missed lesions due to fatigue or distraction, much like a warning system that averts car accidents. It can also potentially help endoscopists recognize dangerous – but rare – subtle lesions such as small, flat, and depressed cancers.”
The study was published online in the American Journal of Gastroenterology.
Analyzing detection rates
Several studies have evaluated the use of different CADe devices to reduce adenoma miss rates during colonoscopy, and some have found that the technology contributed to significantly higher ADR and APC, the study authors write. However, most of these studies have been performed in academic settings.
Dr. Friedland and colleagues conducted a randomized controlled trial, called AI-SEE, to evaluate the use of CADe during colonoscopy in four community-based endoscopy centers located in California, Connecticut, Maryland, and New Jersey between September 2020 and September 2021. The trial included seven board-certified clinicians, who had ADR of 25%-37% before the study. The participants were randomly assigned to colonoscopies with or without CADe in blocks of 16 patients to ensure masking. Both groups had similar patient demographics.
The research team enrolled patients aged 45 years or older who presented for screening or low-risk surveillance colonoscopy, which was defined as a patient qualifying for a surveillance interval of 3 years or greater based on the U.S. Multi-Society Task Force 2020 Guidelines. Patients were excluded if they had a history of inflammatory bowel disease, known or suspected polyposis or hereditary colon cancer syndrome, history of colon resection, or a referral for a diagnostic colonoscopy.
Among 769 enrolled patients, 387 were randomly assigned to undergo colonoscopy with EndoVigilant, an AI-enabled CADe software for colonoscopy. It augments existing white-light colonoscopy in real time by highlighting colon polyps and displaying a graphic box around the lesion on the monitor. It can be deployed as a single- or dual-monitor device. Although the study was originally designed to use two monitors, three investigators expressed strong preference for the single-monitor mode, so the protocol allowed endoscopists to choose.
Primary outcomes included APC and adenoma per extraction (APE), which is the percentage of polyps removed that are adenomas. Secondary endpoints included procedural time, ADR, serrated polyp detection rate, serrated polyps per colonoscopy, and nonadenomatous, nonserrated polyps per colonoscopy.
Overall, the use of CADe didn’t show a significant difference in APC, at 0.73, compared with 0.67 for non-CADe.
Although the use of CADe didn’t lead to increased identification of serrated polyps per colonoscopy – both at 0.08 – CADe led to increased identification of nonadenomatous, nonserrated polyps per colonoscopy, at 0.90 versus 0.51.
There also wasn’t a significant difference in distribution regarding adenomatous polyp location, size, or morphology. However, there was a trend toward greater identification of 6-9 mm APC using CADe, at 0.13 versus 0.08.
Mean withdrawal time was longer in the CADe group, at 11.7 minutes versus 10.7 minutes. However, when no polyps were identified, the withdrawal times were similar, at 9.1 minutes versus 8.8 minutes.
In addition, there was no difference in ADR for screening colonoscopies between the non-CADe and CADe groups, at 34.6% versus 34.3%, or for surveillance procedures, at 43.9% versus 40%. CADe also didn’t improve serrated polyp detection rates for screening or surveillance.
CADe was also associated with decreased APE in all colonoscopies (44.8 vs. 56.8) as well as in screening colonoscopies (43 vs. 57.8).
A comparison of single-monitor CADe with dual-monitor CADe found no significant difference in the average number of adenomas or serrated polyps identified per colonoscopy. However, dual-monitor CADe identified significantly more non-adenomatous, nonserrated polyps per colonoscopy (1.18 vs. 0.42), more adenomas sized at least 10 mm (0.19 vs. 0.05), and more flat polyps (0.18 vs. 0).
The study was terminated early after the interim analysis point, marked by 769 valid subjects. At this point, the comparison of APC between the two groups resulted in a new sample size estimate required for final analysis of 6,557 per group. This revised large study size estimate made it impractical to continue, the study authors wrote. No adverse events were observed during the study.
“What our study shows is that current systems – and the one we used in this study performs very well when tested on a database of images or videos – don’t make a major impact on very crude outcome measures, such as the total number of adenomas detected by a group of endoscopists at typical private endoscopy centers,” Dr. Friedland said. “I’m not convinced that we have a good answer yet for where to go from here, but we need to keep working with our AI colleagues to figure out how to use this exciting technology to improve outcomes in colon cancer.”
Additional considerations
In a separate evaluation of EndoVigilant, the frame level sensitivity was 0.9 and the frame level specificity was 0.97. These calculations were conducted on a dataset not used in training or validation of this model, the authors noted.
In this study, it’s possible that experienced community-based endoscopists are proficient at detecting the adenomas highlighted by the CADe system, so the technology may not detect a significant number of additional adenomas, the authors wrote. It’s also possible that some endoscopists ignore lesions highlighted by CADe, including small lesions that might be difficult to identify as adenomas or are seen as clinically unimportant, which could reduce the potential benefit of CADe.
“It’s important to remember that these tools are meant to be endoscopist assistance devices, not endoscopist replacements. They provide added benefit by pointing out polyps while we do the best exam we can,” Aasma Shaukat, MD, a professor of medicine and gastroenterologist at NYU Langone Health, New York, said in an interview.
Dr. Shaukat, who wasn’t involved with this study, has researched CADe for screening and surveillance colonoscopies. She and colleagues found that CADe use improved APC without an increase in resection of nonneoplastic lesions.
“Different trials have reported different results, and at the end of the day, it’s an endoscopist assistance tool, like spellcheck in a document,” she said. “It’s nice if spellcheck points to an incorrect spelling, but you don’t have to use it. Similarly, we often don’t know in these studies what an endoscopist felt or believed about the tool when using it.”
The benefits of CADe could vary based on its software, setting, number of patients, patient characteristics, number of clinicians, provider experience and training, dual- versus single-monitor setup, and even time of day, she noted. Future studies could clarify these factors, as well as improve the technology.
“This is just the beginning of AI in this field, and while bounding boxes to indicate potential polyps is a good start, it’s not the be-all, end-all,” Dr. Shaukat said.
“We want AI software to be able to tell us more about the size of the polyp, histology, prep quality, landmarks in the colon, adequacy of resection, and more. There’s some work being geared toward developing the algorithms to do these additional aspects,” she added.
The study was sponsored by EndoVigilant. Some of the authors reported consultant roles with Neptune Medical, AgilTx, Intuitive Surgical, Capsovision, and EndoVigilant. Dr. Shaukat reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized clinical trial using EndoVigilant, there wasn’t a significant difference in adenomas per colonoscopy (APC) in procedures with the CADe tool versus those without it. In addition, the adenoma detection rate (ADR) and serrated polyp detection rate were similar in the CADe and non-CADe groups.
“Although we were disappointed that AI [artificial intelligence] did not improve detection of adenomas or serrated polyps in our study, we are still optimistic that this exciting technology will eventually impact endoscopy in a very positive way,” senior author Shai Friedland, MD, a professor of medicine at Stanford (Calif.) University and gastroenterologist with the Veterans Affairs Palo Alto Health Care System, said in an interview.
“The ultimate goal should be to improve the ability of colonoscopy to prevent morbidity and mortality from colon cancer, especially for endoscopists who may not be performing as well as they could be,” he said. “AI can potentially help prevent missed lesions due to fatigue or distraction, much like a warning system that averts car accidents. It can also potentially help endoscopists recognize dangerous – but rare – subtle lesions such as small, flat, and depressed cancers.”
The study was published online in the American Journal of Gastroenterology.
Analyzing detection rates
Several studies have evaluated the use of different CADe devices to reduce adenoma miss rates during colonoscopy, and some have found that the technology contributed to significantly higher ADR and APC, the study authors write. However, most of these studies have been performed in academic settings.
Dr. Friedland and colleagues conducted a randomized controlled trial, called AI-SEE, to evaluate the use of CADe during colonoscopy in four community-based endoscopy centers located in California, Connecticut, Maryland, and New Jersey between September 2020 and September 2021. The trial included seven board-certified clinicians, who had ADR of 25%-37% before the study. The participants were randomly assigned to colonoscopies with or without CADe in blocks of 16 patients to ensure masking. Both groups had similar patient demographics.
The research team enrolled patients aged 45 years or older who presented for screening or low-risk surveillance colonoscopy, which was defined as a patient qualifying for a surveillance interval of 3 years or greater based on the U.S. Multi-Society Task Force 2020 Guidelines. Patients were excluded if they had a history of inflammatory bowel disease, known or suspected polyposis or hereditary colon cancer syndrome, history of colon resection, or a referral for a diagnostic colonoscopy.
Among 769 enrolled patients, 387 were randomly assigned to undergo colonoscopy with EndoVigilant, an AI-enabled CADe software for colonoscopy. It augments existing white-light colonoscopy in real time by highlighting colon polyps and displaying a graphic box around the lesion on the monitor. It can be deployed as a single- or dual-monitor device. Although the study was originally designed to use two monitors, three investigators expressed strong preference for the single-monitor mode, so the protocol allowed endoscopists to choose.
Primary outcomes included APC and adenoma per extraction (APE), which is the percentage of polyps removed that are adenomas. Secondary endpoints included procedural time, ADR, serrated polyp detection rate, serrated polyps per colonoscopy, and nonadenomatous, nonserrated polyps per colonoscopy.
Overall, the use of CADe didn’t show a significant difference in APC, at 0.73, compared with 0.67 for non-CADe.
Although the use of CADe didn’t lead to increased identification of serrated polyps per colonoscopy – both at 0.08 – CADe led to increased identification of nonadenomatous, nonserrated polyps per colonoscopy, at 0.90 versus 0.51.
There also wasn’t a significant difference in distribution regarding adenomatous polyp location, size, or morphology. However, there was a trend toward greater identification of 6-9 mm APC using CADe, at 0.13 versus 0.08.
Mean withdrawal time was longer in the CADe group, at 11.7 minutes versus 10.7 minutes. However, when no polyps were identified, the withdrawal times were similar, at 9.1 minutes versus 8.8 minutes.
In addition, there was no difference in ADR for screening colonoscopies between the non-CADe and CADe groups, at 34.6% versus 34.3%, or for surveillance procedures, at 43.9% versus 40%. CADe also didn’t improve serrated polyp detection rates for screening or surveillance.
CADe was also associated with decreased APE in all colonoscopies (44.8 vs. 56.8) as well as in screening colonoscopies (43 vs. 57.8).
A comparison of single-monitor CADe with dual-monitor CADe found no significant difference in the average number of adenomas or serrated polyps identified per colonoscopy. However, dual-monitor CADe identified significantly more non-adenomatous, nonserrated polyps per colonoscopy (1.18 vs. 0.42), more adenomas sized at least 10 mm (0.19 vs. 0.05), and more flat polyps (0.18 vs. 0).
The study was terminated early after the interim analysis point, marked by 769 valid subjects. At this point, the comparison of APC between the two groups resulted in a new sample size estimate required for final analysis of 6,557 per group. This revised large study size estimate made it impractical to continue, the study authors wrote. No adverse events were observed during the study.
“What our study shows is that current systems – and the one we used in this study performs very well when tested on a database of images or videos – don’t make a major impact on very crude outcome measures, such as the total number of adenomas detected by a group of endoscopists at typical private endoscopy centers,” Dr. Friedland said. “I’m not convinced that we have a good answer yet for where to go from here, but we need to keep working with our AI colleagues to figure out how to use this exciting technology to improve outcomes in colon cancer.”
Additional considerations
In a separate evaluation of EndoVigilant, the frame level sensitivity was 0.9 and the frame level specificity was 0.97. These calculations were conducted on a dataset not used in training or validation of this model, the authors noted.
In this study, it’s possible that experienced community-based endoscopists are proficient at detecting the adenomas highlighted by the CADe system, so the technology may not detect a significant number of additional adenomas, the authors wrote. It’s also possible that some endoscopists ignore lesions highlighted by CADe, including small lesions that might be difficult to identify as adenomas or are seen as clinically unimportant, which could reduce the potential benefit of CADe.
“It’s important to remember that these tools are meant to be endoscopist assistance devices, not endoscopist replacements. They provide added benefit by pointing out polyps while we do the best exam we can,” Aasma Shaukat, MD, a professor of medicine and gastroenterologist at NYU Langone Health, New York, said in an interview.
Dr. Shaukat, who wasn’t involved with this study, has researched CADe for screening and surveillance colonoscopies. She and colleagues found that CADe use improved APC without an increase in resection of nonneoplastic lesions.
“Different trials have reported different results, and at the end of the day, it’s an endoscopist assistance tool, like spellcheck in a document,” she said. “It’s nice if spellcheck points to an incorrect spelling, but you don’t have to use it. Similarly, we often don’t know in these studies what an endoscopist felt or believed about the tool when using it.”
The benefits of CADe could vary based on its software, setting, number of patients, patient characteristics, number of clinicians, provider experience and training, dual- versus single-monitor setup, and even time of day, she noted. Future studies could clarify these factors, as well as improve the technology.
“This is just the beginning of AI in this field, and while bounding boxes to indicate potential polyps is a good start, it’s not the be-all, end-all,” Dr. Shaukat said.
“We want AI software to be able to tell us more about the size of the polyp, histology, prep quality, landmarks in the colon, adequacy of resection, and more. There’s some work being geared toward developing the algorithms to do these additional aspects,” she added.
The study was sponsored by EndoVigilant. Some of the authors reported consultant roles with Neptune Medical, AgilTx, Intuitive Surgical, Capsovision, and EndoVigilant. Dr. Shaukat reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Another FDA class I recall of Cardiosave Hybrid/Rescue IABPs
Datascope/Getinge is recalling certain Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The U.S. Food and Drug Administration has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.
The FDA warns that an unexpected pump shutdown and any interruption to therapy that occurs can lead to hemodynamic instability, organ damage, and/or death, especially in patients who are critically ill and most likely to receive therapy using these devices.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
From June 2019 to August 2022, Datascope/Getinge reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns. There have been no reports of injuries or deaths related to this issue, according to the recall notice posted on the FDA’s website.
The recall includes a total of 2,300 CardioSave Hybrid or Rescue IABP units distributed prior to July 24, 2017, and/or coiled cord part number 0012-00-1801. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
The Cardiosave IABPs have previously been flagged by the FDA for subpar battery performance and fluid leaks.
To address the cable issue, Datascope/Getinge sent an urgent medical device correction letter to customers recommending that the coiled cable cord of the Cardiosave IABP be inspected for visible damage prior to use.
If an unexpected shutdown occurs, an attempt should be made to restart the Cardiosave IABP until an alternative pump is available. If the restart attempt is unsuccessful, an alternative IABP should be used. Any device that remains inoperable after a shutdown should be removed from patient care.
Customers should inspect their inventory to identify any Cardiosave Hybrid and/or Rescue IABPs that have the recalled coiled cord.
The company also asks customers to complete and sign the Medical Device Correction-Response form included with the letter and return it to Datascope/Getinge by emailing a scanned copy to cardiosave-sdhl23.act@getinge.com or by faxing the form to 1-877-660-5841.
Customers with questions about this recall should contact their Datascope/Getinge representative or call Datascope/Getinge technical support at 1-888-943-8872, Monday through Friday, between 8:00 AM and 6:00 PM ET.
The company has developed a hardware correction to address this issue and says a service representative will contact customers to schedule installation of the correction when the correction kit is available.
Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article first appeared on Medscape.com.
Datascope/Getinge is recalling certain Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The U.S. Food and Drug Administration has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.
The FDA warns that an unexpected pump shutdown and any interruption to therapy that occurs can lead to hemodynamic instability, organ damage, and/or death, especially in patients who are critically ill and most likely to receive therapy using these devices.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
From June 2019 to August 2022, Datascope/Getinge reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns. There have been no reports of injuries or deaths related to this issue, according to the recall notice posted on the FDA’s website.
The recall includes a total of 2,300 CardioSave Hybrid or Rescue IABP units distributed prior to July 24, 2017, and/or coiled cord part number 0012-00-1801. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
The Cardiosave IABPs have previously been flagged by the FDA for subpar battery performance and fluid leaks.
To address the cable issue, Datascope/Getinge sent an urgent medical device correction letter to customers recommending that the coiled cable cord of the Cardiosave IABP be inspected for visible damage prior to use.
If an unexpected shutdown occurs, an attempt should be made to restart the Cardiosave IABP until an alternative pump is available. If the restart attempt is unsuccessful, an alternative IABP should be used. Any device that remains inoperable after a shutdown should be removed from patient care.
Customers should inspect their inventory to identify any Cardiosave Hybrid and/or Rescue IABPs that have the recalled coiled cord.
The company also asks customers to complete and sign the Medical Device Correction-Response form included with the letter and return it to Datascope/Getinge by emailing a scanned copy to cardiosave-sdhl23.act@getinge.com or by faxing the form to 1-877-660-5841.
Customers with questions about this recall should contact their Datascope/Getinge representative or call Datascope/Getinge technical support at 1-888-943-8872, Monday through Friday, between 8:00 AM and 6:00 PM ET.
The company has developed a hardware correction to address this issue and says a service representative will contact customers to schedule installation of the correction when the correction kit is available.
Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article first appeared on Medscape.com.
Datascope/Getinge is recalling certain Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The U.S. Food and Drug Administration has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.
The FDA warns that an unexpected pump shutdown and any interruption to therapy that occurs can lead to hemodynamic instability, organ damage, and/or death, especially in patients who are critically ill and most likely to receive therapy using these devices.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
From June 2019 to August 2022, Datascope/Getinge reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns. There have been no reports of injuries or deaths related to this issue, according to the recall notice posted on the FDA’s website.
The recall includes a total of 2,300 CardioSave Hybrid or Rescue IABP units distributed prior to July 24, 2017, and/or coiled cord part number 0012-00-1801. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
The Cardiosave IABPs have previously been flagged by the FDA for subpar battery performance and fluid leaks.
To address the cable issue, Datascope/Getinge sent an urgent medical device correction letter to customers recommending that the coiled cable cord of the Cardiosave IABP be inspected for visible damage prior to use.
If an unexpected shutdown occurs, an attempt should be made to restart the Cardiosave IABP until an alternative pump is available. If the restart attempt is unsuccessful, an alternative IABP should be used. Any device that remains inoperable after a shutdown should be removed from patient care.
Customers should inspect their inventory to identify any Cardiosave Hybrid and/or Rescue IABPs that have the recalled coiled cord.
The company also asks customers to complete and sign the Medical Device Correction-Response form included with the letter and return it to Datascope/Getinge by emailing a scanned copy to cardiosave-sdhl23.act@getinge.com or by faxing the form to 1-877-660-5841.
Customers with questions about this recall should contact their Datascope/Getinge representative or call Datascope/Getinge technical support at 1-888-943-8872, Monday through Friday, between 8:00 AM and 6:00 PM ET.
The company has developed a hardware correction to address this issue and says a service representative will contact customers to schedule installation of the correction when the correction kit is available.
Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article first appeared on Medscape.com.
Screen time and teenagers: Principles for parents
The Centers for Disease Control and Prevention recently released results of the most recent Youth Risk Behavior Survey, their once-a-decade survey of youth mental health and risk-taking behaviors. The headlines aren’t good: Self-reported rates of anxiety, depression, suicidal thoughts, and suicide attempts in adolescents have increased substantially from 2011 to 2021. This echoes epidemiologic data showing increasing rates of anxiety and depression over the last decade in 12- to 24-year-olds, but not in older age cohorts.
This trend started well before COVID, coinciding with the explosive growth in use of smartphones, apps, and social media platforms. Facebook launched in 2004, the iPhone in 2007, Instagram in 2010, and TikTok in 2016. A 2018 Pew Research survey of 13- to 17-year-olds found that 97% of them used at least one social media platform and 45% described themselves as online “almost constantly.” Social media does have great potential benefits for adolescents.
We all experienced how it supported relationships during COVID. It can provide supportive networks for teenagers isolated by exclusion, illness, or disability. It can support exploration of esoteric interests, expression of identity, entertainment, and relaxation. But certain children, as was true before social media, seem vulnerable to the bullying, loneliness, isolation, and disengagement that social media may exacerbate.
Several studies have shown an association between high daily screen time and adolescent anxiety and depression. These findings have not been consistently duplicated, and those that were could not establish causality. There appears to be a strong link between certain illnesses (ADHD, depression, anorexia nervosa) and excessive screen use, which can in turn worsen symptoms. But it is hard to know which came first or how they are related.
Now, a very large long-term observational study has suggested that there may be critical windows in adolescence (11-13 years in girls and 14-16 in boys and again at 19 years for both) during which time excessive screen time can put that child’s developing mental health at risk. This is nuanced and interesting progress, but you don’t have to wait another decade to offer the families in your practice some common sense guidance when they are asking how to balance their children’s needs to be independent and socially connected (and the fact that smartphones and social media are pervasive) with the risks of overuse. Equipped with these guiding principles, parents can set individualized, flexible ground rules, and adjust them as their children grow into young adults.
First: Know your child
Parents are, of course, the experts on their own child – their talents, interests, challenges, vulnerabilities, and developmental progress. Children with poor impulse control (including those with ADHD) are going to have greater difficulty turning away from highly addictive activities on their devices. Children who are anxious and shy may be prone to avoiding the stress of real-life situations, preferring virtual ones. Children with a history of depression may be vulnerable to relapse if their sleep and exercise routines are disrupted by excessive use. And children with eating disorders are especially vulnerable to the superficial social comparisons and “likes” that Instagram offers. Children with these vulnerabilities will benefit if their parents are aware of and can talk about these vulnerabilities, ideally with their child. They should be prepared to work with their teens to develop strategies that can help them learn how to manage their social media usage. These might include stopping screen use after a certain hour, leaving devices outside of bedrooms at night, and setting up apps that monitor and alert them about excessive use. They might use resources such as the AAP’s Family Media Plan (Media and Children [aap.org]), but simply taking the time to have regular, open, honest conversations about what is known and unknown about the potential risks of social media use is very protective.
Second: Use adolescent development as your guide
For those children who do not have a known vulnerability to overuse, consider the following areas that are essential to healthy development in adolescence as guideposts to help parents in setting reasonable ground rules: building independence, cultivating healthy social relationships, learning about their identity, managing their strong emotions, and developing the skills of self-care. If screen time supports these developmental areas, then it’s probably healthy. If it interferes with them, then not. And remember, parents should routinely discuss these principles with their children as well.
Independence
Key questions. Does their use of a device enable them to function more independently – that is, to arrange for rides, manage their schedules, homework, shifts, and so forth – on their own? Could it be done with a “dumb” device (text/call only)?
Social relationships
One-way viewing (Instagram, Facebook) with superficial acquaintances may promote isolation, anxiety, and depression, does not facilitate deepened relationships, and may be using up time that they could be investing in genuine social connections. But if they are using their devices to stay connected to good friends who live far away or just have different schedules, they can promote genuine, satisfying, bilateral social connections.
Key questions. Are they engaged in two-way communication with their devices? Are they staying connected to friends with whom they have a genuine, substantial relationship?
Investigating and experimenting with interests (identity)
Teenagers are supposed to be learning in deep and nuanced ways about their own interests and abilities during these years. This requires a lot of time invested in exploration and experimentation and a considerable amount of failure. Any activity that consumes a lot of their time without deepening meaningful knowledge of their interests and abilities (that is, activity that is only an escape or distraction) will interfere with their discovering their authentic identity.
Key questions. Is their use of devices facilitating this genuine exploration (setting up internships, practicing programming, or exploring interests that must be virtual)? Or is their device use just consuming precious time they could be using to genuinely explore potential interests?
Managing anxiety or distress
Exploring their identity and building social connections will involve a lot of stress, failure, disappointment, and even heartbreak. Learning to manage these uncomfortable feelings is an important part of adolescence. Distraction with a diverting entertainment can be one of several strategies for managing stress and distress. But if it becomes the only strategy, it can keep teens from getting “back in the game” and experiencing the fun, success, meaning, and joy that are also a big part of this exploration.
Key questions. Do they turn to their devices first when sad or stressed? Are they also able to use other strategies, such as talking with friends/family, exercising, or engaging in a meaningful pursuit to help them manage stress? Do they feel better after a little time spent on their device, or as if they will only feel good if they can stay on the device?
Self-care
Getting adequate, restful sleep (8-10 hours/night), finding regular time for exercise, cultivating healthy eating habits, and discovering what healthy strategies help them to unwind or relax is critical to a teenager’s healthiest development, and to healthy adult life. Some screens may help with motivating and tracking exercise, but screens in the bedroom interfere with going to bed, and with falling and staying asleep. Most teenagers are very busy and managing a lot of (normal) stress; the senseless fun or relaxation that are part of video games or surfing the Web are quick, practical, and effective ways to unwind. Don’t discourage your teenager from enjoying them. Instead, focus on also helping them to find other healthy ways to relax: hot baths, exercise, time with pets, crafts, reading, and listening to music are just a few examples. As they are building their identity, they should also be discovering how they best slow down and calm down.
Key questions. How many hours of sleep do they usually get on a school night? Is their phone (or other screen) in their bedroom during sleep? How do they relax? Do they have several strategies that do not require screens? Do they exercise regularly (3-5 times weekly)? Do they complain that they do not have enough time for exercise?
Third: Be mindful of what you model
Many of these principles can apply to our own use of smartphones, computers, and so on. Remind parents that their teenager will ultimately consider and follow their example much more than their commands. They should be prepared to talk about how they are thinking about the risks and benefits of social media use, how they are developing rules and expectations, and why they decided on them. These conversations model thoughtful and flexible decision-making.
It is critical that parents acknowledge that there are wonderful benefits to technology, including senseless fun. Then, it is easier to discuss how escaping into screen use can be hard to resist, and why it is important to practice resisting some temptations. Parents should find ways to follow the same rules they set for their teenager, or making them “family rules.” It’s important for our teenagers to learn about how to set these limits, as eventually they will be setting their own!
Dr. Swick is physician in chief at Ohana Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
The Centers for Disease Control and Prevention recently released results of the most recent Youth Risk Behavior Survey, their once-a-decade survey of youth mental health and risk-taking behaviors. The headlines aren’t good: Self-reported rates of anxiety, depression, suicidal thoughts, and suicide attempts in adolescents have increased substantially from 2011 to 2021. This echoes epidemiologic data showing increasing rates of anxiety and depression over the last decade in 12- to 24-year-olds, but not in older age cohorts.
This trend started well before COVID, coinciding with the explosive growth in use of smartphones, apps, and social media platforms. Facebook launched in 2004, the iPhone in 2007, Instagram in 2010, and TikTok in 2016. A 2018 Pew Research survey of 13- to 17-year-olds found that 97% of them used at least one social media platform and 45% described themselves as online “almost constantly.” Social media does have great potential benefits for adolescents.
We all experienced how it supported relationships during COVID. It can provide supportive networks for teenagers isolated by exclusion, illness, or disability. It can support exploration of esoteric interests, expression of identity, entertainment, and relaxation. But certain children, as was true before social media, seem vulnerable to the bullying, loneliness, isolation, and disengagement that social media may exacerbate.
Several studies have shown an association between high daily screen time and adolescent anxiety and depression. These findings have not been consistently duplicated, and those that were could not establish causality. There appears to be a strong link between certain illnesses (ADHD, depression, anorexia nervosa) and excessive screen use, which can in turn worsen symptoms. But it is hard to know which came first or how they are related.
Now, a very large long-term observational study has suggested that there may be critical windows in adolescence (11-13 years in girls and 14-16 in boys and again at 19 years for both) during which time excessive screen time can put that child’s developing mental health at risk. This is nuanced and interesting progress, but you don’t have to wait another decade to offer the families in your practice some common sense guidance when they are asking how to balance their children’s needs to be independent and socially connected (and the fact that smartphones and social media are pervasive) with the risks of overuse. Equipped with these guiding principles, parents can set individualized, flexible ground rules, and adjust them as their children grow into young adults.
First: Know your child
Parents are, of course, the experts on their own child – their talents, interests, challenges, vulnerabilities, and developmental progress. Children with poor impulse control (including those with ADHD) are going to have greater difficulty turning away from highly addictive activities on their devices. Children who are anxious and shy may be prone to avoiding the stress of real-life situations, preferring virtual ones. Children with a history of depression may be vulnerable to relapse if their sleep and exercise routines are disrupted by excessive use. And children with eating disorders are especially vulnerable to the superficial social comparisons and “likes” that Instagram offers. Children with these vulnerabilities will benefit if their parents are aware of and can talk about these vulnerabilities, ideally with their child. They should be prepared to work with their teens to develop strategies that can help them learn how to manage their social media usage. These might include stopping screen use after a certain hour, leaving devices outside of bedrooms at night, and setting up apps that monitor and alert them about excessive use. They might use resources such as the AAP’s Family Media Plan (Media and Children [aap.org]), but simply taking the time to have regular, open, honest conversations about what is known and unknown about the potential risks of social media use is very protective.
Second: Use adolescent development as your guide
For those children who do not have a known vulnerability to overuse, consider the following areas that are essential to healthy development in adolescence as guideposts to help parents in setting reasonable ground rules: building independence, cultivating healthy social relationships, learning about their identity, managing their strong emotions, and developing the skills of self-care. If screen time supports these developmental areas, then it’s probably healthy. If it interferes with them, then not. And remember, parents should routinely discuss these principles with their children as well.
Independence
Key questions. Does their use of a device enable them to function more independently – that is, to arrange for rides, manage their schedules, homework, shifts, and so forth – on their own? Could it be done with a “dumb” device (text/call only)?
Social relationships
One-way viewing (Instagram, Facebook) with superficial acquaintances may promote isolation, anxiety, and depression, does not facilitate deepened relationships, and may be using up time that they could be investing in genuine social connections. But if they are using their devices to stay connected to good friends who live far away or just have different schedules, they can promote genuine, satisfying, bilateral social connections.
Key questions. Are they engaged in two-way communication with their devices? Are they staying connected to friends with whom they have a genuine, substantial relationship?
Investigating and experimenting with interests (identity)
Teenagers are supposed to be learning in deep and nuanced ways about their own interests and abilities during these years. This requires a lot of time invested in exploration and experimentation and a considerable amount of failure. Any activity that consumes a lot of their time without deepening meaningful knowledge of their interests and abilities (that is, activity that is only an escape or distraction) will interfere with their discovering their authentic identity.
Key questions. Is their use of devices facilitating this genuine exploration (setting up internships, practicing programming, or exploring interests that must be virtual)? Or is their device use just consuming precious time they could be using to genuinely explore potential interests?
Managing anxiety or distress
Exploring their identity and building social connections will involve a lot of stress, failure, disappointment, and even heartbreak. Learning to manage these uncomfortable feelings is an important part of adolescence. Distraction with a diverting entertainment can be one of several strategies for managing stress and distress. But if it becomes the only strategy, it can keep teens from getting “back in the game” and experiencing the fun, success, meaning, and joy that are also a big part of this exploration.
Key questions. Do they turn to their devices first when sad or stressed? Are they also able to use other strategies, such as talking with friends/family, exercising, or engaging in a meaningful pursuit to help them manage stress? Do they feel better after a little time spent on their device, or as if they will only feel good if they can stay on the device?
Self-care
Getting adequate, restful sleep (8-10 hours/night), finding regular time for exercise, cultivating healthy eating habits, and discovering what healthy strategies help them to unwind or relax is critical to a teenager’s healthiest development, and to healthy adult life. Some screens may help with motivating and tracking exercise, but screens in the bedroom interfere with going to bed, and with falling and staying asleep. Most teenagers are very busy and managing a lot of (normal) stress; the senseless fun or relaxation that are part of video games or surfing the Web are quick, practical, and effective ways to unwind. Don’t discourage your teenager from enjoying them. Instead, focus on also helping them to find other healthy ways to relax: hot baths, exercise, time with pets, crafts, reading, and listening to music are just a few examples. As they are building their identity, they should also be discovering how they best slow down and calm down.
Key questions. How many hours of sleep do they usually get on a school night? Is their phone (or other screen) in their bedroom during sleep? How do they relax? Do they have several strategies that do not require screens? Do they exercise regularly (3-5 times weekly)? Do they complain that they do not have enough time for exercise?
Third: Be mindful of what you model
Many of these principles can apply to our own use of smartphones, computers, and so on. Remind parents that their teenager will ultimately consider and follow their example much more than their commands. They should be prepared to talk about how they are thinking about the risks and benefits of social media use, how they are developing rules and expectations, and why they decided on them. These conversations model thoughtful and flexible decision-making.
It is critical that parents acknowledge that there are wonderful benefits to technology, including senseless fun. Then, it is easier to discuss how escaping into screen use can be hard to resist, and why it is important to practice resisting some temptations. Parents should find ways to follow the same rules they set for their teenager, or making them “family rules.” It’s important for our teenagers to learn about how to set these limits, as eventually they will be setting their own!
Dr. Swick is physician in chief at Ohana Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
The Centers for Disease Control and Prevention recently released results of the most recent Youth Risk Behavior Survey, their once-a-decade survey of youth mental health and risk-taking behaviors. The headlines aren’t good: Self-reported rates of anxiety, depression, suicidal thoughts, and suicide attempts in adolescents have increased substantially from 2011 to 2021. This echoes epidemiologic data showing increasing rates of anxiety and depression over the last decade in 12- to 24-year-olds, but not in older age cohorts.
This trend started well before COVID, coinciding with the explosive growth in use of smartphones, apps, and social media platforms. Facebook launched in 2004, the iPhone in 2007, Instagram in 2010, and TikTok in 2016. A 2018 Pew Research survey of 13- to 17-year-olds found that 97% of them used at least one social media platform and 45% described themselves as online “almost constantly.” Social media does have great potential benefits for adolescents.
We all experienced how it supported relationships during COVID. It can provide supportive networks for teenagers isolated by exclusion, illness, or disability. It can support exploration of esoteric interests, expression of identity, entertainment, and relaxation. But certain children, as was true before social media, seem vulnerable to the bullying, loneliness, isolation, and disengagement that social media may exacerbate.
Several studies have shown an association between high daily screen time and adolescent anxiety and depression. These findings have not been consistently duplicated, and those that were could not establish causality. There appears to be a strong link between certain illnesses (ADHD, depression, anorexia nervosa) and excessive screen use, which can in turn worsen symptoms. But it is hard to know which came first or how they are related.
Now, a very large long-term observational study has suggested that there may be critical windows in adolescence (11-13 years in girls and 14-16 in boys and again at 19 years for both) during which time excessive screen time can put that child’s developing mental health at risk. This is nuanced and interesting progress, but you don’t have to wait another decade to offer the families in your practice some common sense guidance when they are asking how to balance their children’s needs to be independent and socially connected (and the fact that smartphones and social media are pervasive) with the risks of overuse. Equipped with these guiding principles, parents can set individualized, flexible ground rules, and adjust them as their children grow into young adults.
First: Know your child
Parents are, of course, the experts on their own child – their talents, interests, challenges, vulnerabilities, and developmental progress. Children with poor impulse control (including those with ADHD) are going to have greater difficulty turning away from highly addictive activities on their devices. Children who are anxious and shy may be prone to avoiding the stress of real-life situations, preferring virtual ones. Children with a history of depression may be vulnerable to relapse if their sleep and exercise routines are disrupted by excessive use. And children with eating disorders are especially vulnerable to the superficial social comparisons and “likes” that Instagram offers. Children with these vulnerabilities will benefit if their parents are aware of and can talk about these vulnerabilities, ideally with their child. They should be prepared to work with their teens to develop strategies that can help them learn how to manage their social media usage. These might include stopping screen use after a certain hour, leaving devices outside of bedrooms at night, and setting up apps that monitor and alert them about excessive use. They might use resources such as the AAP’s Family Media Plan (Media and Children [aap.org]), but simply taking the time to have regular, open, honest conversations about what is known and unknown about the potential risks of social media use is very protective.
Second: Use adolescent development as your guide
For those children who do not have a known vulnerability to overuse, consider the following areas that are essential to healthy development in adolescence as guideposts to help parents in setting reasonable ground rules: building independence, cultivating healthy social relationships, learning about their identity, managing their strong emotions, and developing the skills of self-care. If screen time supports these developmental areas, then it’s probably healthy. If it interferes with them, then not. And remember, parents should routinely discuss these principles with their children as well.
Independence
Key questions. Does their use of a device enable them to function more independently – that is, to arrange for rides, manage their schedules, homework, shifts, and so forth – on their own? Could it be done with a “dumb” device (text/call only)?
Social relationships
One-way viewing (Instagram, Facebook) with superficial acquaintances may promote isolation, anxiety, and depression, does not facilitate deepened relationships, and may be using up time that they could be investing in genuine social connections. But if they are using their devices to stay connected to good friends who live far away or just have different schedules, they can promote genuine, satisfying, bilateral social connections.
Key questions. Are they engaged in two-way communication with their devices? Are they staying connected to friends with whom they have a genuine, substantial relationship?
Investigating and experimenting with interests (identity)
Teenagers are supposed to be learning in deep and nuanced ways about their own interests and abilities during these years. This requires a lot of time invested in exploration and experimentation and a considerable amount of failure. Any activity that consumes a lot of their time without deepening meaningful knowledge of their interests and abilities (that is, activity that is only an escape or distraction) will interfere with their discovering their authentic identity.
Key questions. Is their use of devices facilitating this genuine exploration (setting up internships, practicing programming, or exploring interests that must be virtual)? Or is their device use just consuming precious time they could be using to genuinely explore potential interests?
Managing anxiety or distress
Exploring their identity and building social connections will involve a lot of stress, failure, disappointment, and even heartbreak. Learning to manage these uncomfortable feelings is an important part of adolescence. Distraction with a diverting entertainment can be one of several strategies for managing stress and distress. But if it becomes the only strategy, it can keep teens from getting “back in the game” and experiencing the fun, success, meaning, and joy that are also a big part of this exploration.
Key questions. Do they turn to their devices first when sad or stressed? Are they also able to use other strategies, such as talking with friends/family, exercising, or engaging in a meaningful pursuit to help them manage stress? Do they feel better after a little time spent on their device, or as if they will only feel good if they can stay on the device?
Self-care
Getting adequate, restful sleep (8-10 hours/night), finding regular time for exercise, cultivating healthy eating habits, and discovering what healthy strategies help them to unwind or relax is critical to a teenager’s healthiest development, and to healthy adult life. Some screens may help with motivating and tracking exercise, but screens in the bedroom interfere with going to bed, and with falling and staying asleep. Most teenagers are very busy and managing a lot of (normal) stress; the senseless fun or relaxation that are part of video games or surfing the Web are quick, practical, and effective ways to unwind. Don’t discourage your teenager from enjoying them. Instead, focus on also helping them to find other healthy ways to relax: hot baths, exercise, time with pets, crafts, reading, and listening to music are just a few examples. As they are building their identity, they should also be discovering how they best slow down and calm down.
Key questions. How many hours of sleep do they usually get on a school night? Is their phone (or other screen) in their bedroom during sleep? How do they relax? Do they have several strategies that do not require screens? Do they exercise regularly (3-5 times weekly)? Do they complain that they do not have enough time for exercise?
Third: Be mindful of what you model
Many of these principles can apply to our own use of smartphones, computers, and so on. Remind parents that their teenager will ultimately consider and follow their example much more than their commands. They should be prepared to talk about how they are thinking about the risks and benefits of social media use, how they are developing rules and expectations, and why they decided on them. These conversations model thoughtful and flexible decision-making.
It is critical that parents acknowledge that there are wonderful benefits to technology, including senseless fun. Then, it is easier to discuss how escaping into screen use can be hard to resist, and why it is important to practice resisting some temptations. Parents should find ways to follow the same rules they set for their teenager, or making them “family rules.” It’s important for our teenagers to learn about how to set these limits, as eventually they will be setting their own!
Dr. Swick is physician in chief at Ohana Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
Children with ASD less likely to get vision screening
Children with autism spectrum disorder (ASD) are significantly less likely to have vision screening at well visits for 3- to 5-year-olds than are typically developing children, researchers have found.
The report, by Kimberly Hoover, MD, of Thomas Jefferson University in Philadelphia, and colleagues, was published online in Pediatrics.
While 59.9% of children without ASD got vision screening in these visits, only 36.5% of children with ASD got the screening. Both screening rates miss the mark set by American Academy of Pediatrics guidelines.
The AAP recommends “annual instrument-based vision screening, if available, at well visits for children starting at age 12 months to 3 years, and direct visual acuity testing beginning at 4 years of age. However, in children with developmental delays, the AAP recommends instrument-based screening, such as photoscreening, as a useful alternative at any age.”
Racial, age disparities as well
Racial disparities were evident in the data as well. Of the children who had ASD, Black children had the lowest rates of screening (27.6%), while the rate for White children was 39.7%. The rate for other/multiracial children with ASD was 39.8%.
The lowest rates of screening occurred in the youngest children, at the 3-year visit.
The researchers analyzed data from 63,829 well-child visits between January 2016 and December 2019, collected from the large primary care database PEDSnet.
Photoscreening vs. acuity screening
The authors pointed out that children with ASD are less likely to complete a vision test, which can be problematic in a busy primary care office.
“Children with ASD were significantly less likely to have at least one completed vision screening (43.2%) compared with children without ASD (72.1%; P <. 01),” the authors wrote, “with only 6.9% of children with ASD having had two or more vision screenings compared with 22.3% of children without ASD.”
The researchers saw higher vision test completion rates with photoscreening, using a sophisticated camera, compared with acuity screening, which uses a wall chart and requires responses.
Less patient participation is required for photoscreening and it can be done in less than 2 minutes.
If ability to complete the vision tests is a concern, the authors wrote, photoscreening may be a better solution.
Photoscreening takes 90 seconds
“Photoscreening has high sensitivity in detecting ocular conditions in children with ASD and has an average screening time of 90 seconds, and [it has] been validated in both children with ASD and developmental delays,” the authors wrote.
Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Cohen Children’s Medical Center in New Hyde Park, N.Y., said the authors of this study quantify the gap between need and reality for vision tests for those with ASD.
“Other studies have shown that children on the autism spectrum have more than three times greater risk of having eye disease or vision problems,” he said in an interview. “You’ve got a high-risk population in need of assessment and the likelihood of them getting an assessment is much reduced.”
He said in addition to attention problems in taking the test, vision screening may get lost in the plethora of concerns parents want to talk about in well-child visits.
“If you’re the parent of a child with developmental delays, language delays, poor social engagement, there are a multitude of things the visit could be focused on and it may be that vision screening possibly gets compromised or not done,” Dr. Adesman said.
That, he said, may be a focus area for improving the screening numbers.
Neither parents nor providers should forget that vision screening is important, despite the myriad other issues to address, he said. “They don’t have to take a long time.”
When it comes to vision problems and children, “the earlier they’re identified the better,” Dr. Adesman says, particularly to identify the need for eye muscle surgery or corrective lenses, the two major interventions for strabismus or refractive error.
“If those problems are significant and go untreated, there’s a risk of loss of vision in the affected eye,” he said.
Reimbursement concerns for photoscreening
This study strongly supports the use of routine photoscreening to help eliminate the vision screening gap in children with ASD, the authors wrote.
They noted, however, that would require insurance reimbursement for primary care practices to effectively use that screening.
The researchers advised, “Providers treating patients with race, ethnicity, region, or age categories that reduce the adjusted odds of photoscreening can take steps in their practices to address these disparities, particularly in children with ASD.”
The study authors and Dr. Adesman reported no relevant financial relationships.
Children with autism spectrum disorder (ASD) are significantly less likely to have vision screening at well visits for 3- to 5-year-olds than are typically developing children, researchers have found.
The report, by Kimberly Hoover, MD, of Thomas Jefferson University in Philadelphia, and colleagues, was published online in Pediatrics.
While 59.9% of children without ASD got vision screening in these visits, only 36.5% of children with ASD got the screening. Both screening rates miss the mark set by American Academy of Pediatrics guidelines.
The AAP recommends “annual instrument-based vision screening, if available, at well visits for children starting at age 12 months to 3 years, and direct visual acuity testing beginning at 4 years of age. However, in children with developmental delays, the AAP recommends instrument-based screening, such as photoscreening, as a useful alternative at any age.”
Racial, age disparities as well
Racial disparities were evident in the data as well. Of the children who had ASD, Black children had the lowest rates of screening (27.6%), while the rate for White children was 39.7%. The rate for other/multiracial children with ASD was 39.8%.
The lowest rates of screening occurred in the youngest children, at the 3-year visit.
The researchers analyzed data from 63,829 well-child visits between January 2016 and December 2019, collected from the large primary care database PEDSnet.
Photoscreening vs. acuity screening
The authors pointed out that children with ASD are less likely to complete a vision test, which can be problematic in a busy primary care office.
“Children with ASD were significantly less likely to have at least one completed vision screening (43.2%) compared with children without ASD (72.1%; P <. 01),” the authors wrote, “with only 6.9% of children with ASD having had two or more vision screenings compared with 22.3% of children without ASD.”
The researchers saw higher vision test completion rates with photoscreening, using a sophisticated camera, compared with acuity screening, which uses a wall chart and requires responses.
Less patient participation is required for photoscreening and it can be done in less than 2 minutes.
If ability to complete the vision tests is a concern, the authors wrote, photoscreening may be a better solution.
Photoscreening takes 90 seconds
“Photoscreening has high sensitivity in detecting ocular conditions in children with ASD and has an average screening time of 90 seconds, and [it has] been validated in both children with ASD and developmental delays,” the authors wrote.
Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Cohen Children’s Medical Center in New Hyde Park, N.Y., said the authors of this study quantify the gap between need and reality for vision tests for those with ASD.
“Other studies have shown that children on the autism spectrum have more than three times greater risk of having eye disease or vision problems,” he said in an interview. “You’ve got a high-risk population in need of assessment and the likelihood of them getting an assessment is much reduced.”
He said in addition to attention problems in taking the test, vision screening may get lost in the plethora of concerns parents want to talk about in well-child visits.
“If you’re the parent of a child with developmental delays, language delays, poor social engagement, there are a multitude of things the visit could be focused on and it may be that vision screening possibly gets compromised or not done,” Dr. Adesman said.
That, he said, may be a focus area for improving the screening numbers.
Neither parents nor providers should forget that vision screening is important, despite the myriad other issues to address, he said. “They don’t have to take a long time.”
When it comes to vision problems and children, “the earlier they’re identified the better,” Dr. Adesman says, particularly to identify the need for eye muscle surgery or corrective lenses, the two major interventions for strabismus or refractive error.
“If those problems are significant and go untreated, there’s a risk of loss of vision in the affected eye,” he said.
Reimbursement concerns for photoscreening
This study strongly supports the use of routine photoscreening to help eliminate the vision screening gap in children with ASD, the authors wrote.
They noted, however, that would require insurance reimbursement for primary care practices to effectively use that screening.
The researchers advised, “Providers treating patients with race, ethnicity, region, or age categories that reduce the adjusted odds of photoscreening can take steps in their practices to address these disparities, particularly in children with ASD.”
The study authors and Dr. Adesman reported no relevant financial relationships.
Children with autism spectrum disorder (ASD) are significantly less likely to have vision screening at well visits for 3- to 5-year-olds than are typically developing children, researchers have found.
The report, by Kimberly Hoover, MD, of Thomas Jefferson University in Philadelphia, and colleagues, was published online in Pediatrics.
While 59.9% of children without ASD got vision screening in these visits, only 36.5% of children with ASD got the screening. Both screening rates miss the mark set by American Academy of Pediatrics guidelines.
The AAP recommends “annual instrument-based vision screening, if available, at well visits for children starting at age 12 months to 3 years, and direct visual acuity testing beginning at 4 years of age. However, in children with developmental delays, the AAP recommends instrument-based screening, such as photoscreening, as a useful alternative at any age.”
Racial, age disparities as well
Racial disparities were evident in the data as well. Of the children who had ASD, Black children had the lowest rates of screening (27.6%), while the rate for White children was 39.7%. The rate for other/multiracial children with ASD was 39.8%.
The lowest rates of screening occurred in the youngest children, at the 3-year visit.
The researchers analyzed data from 63,829 well-child visits between January 2016 and December 2019, collected from the large primary care database PEDSnet.
Photoscreening vs. acuity screening
The authors pointed out that children with ASD are less likely to complete a vision test, which can be problematic in a busy primary care office.
“Children with ASD were significantly less likely to have at least one completed vision screening (43.2%) compared with children without ASD (72.1%; P <. 01),” the authors wrote, “with only 6.9% of children with ASD having had two or more vision screenings compared with 22.3% of children without ASD.”
The researchers saw higher vision test completion rates with photoscreening, using a sophisticated camera, compared with acuity screening, which uses a wall chart and requires responses.
Less patient participation is required for photoscreening and it can be done in less than 2 minutes.
If ability to complete the vision tests is a concern, the authors wrote, photoscreening may be a better solution.
Photoscreening takes 90 seconds
“Photoscreening has high sensitivity in detecting ocular conditions in children with ASD and has an average screening time of 90 seconds, and [it has] been validated in both children with ASD and developmental delays,” the authors wrote.
Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Cohen Children’s Medical Center in New Hyde Park, N.Y., said the authors of this study quantify the gap between need and reality for vision tests for those with ASD.
“Other studies have shown that children on the autism spectrum have more than three times greater risk of having eye disease or vision problems,” he said in an interview. “You’ve got a high-risk population in need of assessment and the likelihood of them getting an assessment is much reduced.”
He said in addition to attention problems in taking the test, vision screening may get lost in the plethora of concerns parents want to talk about in well-child visits.
“If you’re the parent of a child with developmental delays, language delays, poor social engagement, there are a multitude of things the visit could be focused on and it may be that vision screening possibly gets compromised or not done,” Dr. Adesman said.
That, he said, may be a focus area for improving the screening numbers.
Neither parents nor providers should forget that vision screening is important, despite the myriad other issues to address, he said. “They don’t have to take a long time.”
When it comes to vision problems and children, “the earlier they’re identified the better,” Dr. Adesman says, particularly to identify the need for eye muscle surgery or corrective lenses, the two major interventions for strabismus or refractive error.
“If those problems are significant and go untreated, there’s a risk of loss of vision in the affected eye,” he said.
Reimbursement concerns for photoscreening
This study strongly supports the use of routine photoscreening to help eliminate the vision screening gap in children with ASD, the authors wrote.
They noted, however, that would require insurance reimbursement for primary care practices to effectively use that screening.
The researchers advised, “Providers treating patients with race, ethnicity, region, or age categories that reduce the adjusted odds of photoscreening can take steps in their practices to address these disparities, particularly in children with ASD.”
The study authors and Dr. Adesman reported no relevant financial relationships.
FROM PEDIATRICS
CLL and surgery are more compatible than ever
In the past decade, as targeted therapies have permitted better management of CLL, a new realm of possibilities has opened up for patients with this blood cancer.
“Previously, patients may not have been candidates for elective surgeries, such as hip replacements,” said hematologist-oncologist Helen Ma, MD, of the University of Irvine (Calif.) and VA Long Beach Healthcare System. She is the lead author of the report, which appeared in the British Journal of Hematology.
“Now that targeted therapies are controlling CLL well, patients may elect to have procedures that they may not have considered if their blood counts were very low or they felt too unwell to go through such invasive surgeries,” said Dr. Ma in an interview. In fact, the study authors noted that, “with currently available treatments, many patients with CLL are living considerably longer than the 1-year life expectancy threshold that proceduralists require.”
But extra surgical risks persist. “Both CLL and its treatment can increase the risk of complications during and after procedures, though available data are not consistently stratified by stage and whether patients are undergoing treatment,” the report authors noted.
Research has linked CLL to higher rates of blood transfusions in cardiac surgeries: One study, conducted partially in the era of targeted therapy, found that 87% of these surgery patients with CLL needed blood products vs. 65% of those who didn’t have CLL (P = .01). Studies didn’t find any extra risk of infections in patients with CLL, however, and there are conflicting findings about whether hospital mortality is higher.
Another study, also conducted partially in the era of targeted therapy, found that patients with CLL who had percutaneous coronary intervention procedures “developed higher rates of in-hospital mortality, any complication, bleeding and postoperative stroke compared to those seen in patients without leukemia.”
The authors of the new report noted that “patients with more advanced stage are at increased risk of bleeding and thromboembolic events relevant to their disease and invasive procedures.” Patients at more than minimal risk should undergo electrocardiograms prior to cardiac procedures, they wrote. Stress tests, coronary angiography, and percutaneous coronary intervention may also be warranted.
“To optimize evaluation and perioperative management, we strongly recommend the prospective collaborative inclusion of a multidisciplinary team including hematologists/oncologists, cardiologists (ideally cardio-oncologists), surgeons and anesthetists, as well as their ongoing involvement during the postoperative period,” the authors wrote.
As for medications, the researchers said that “generally, antibody therapy has no impact on surgery.” They added, “There is no evidence to hold treatment with anti-CD20 monoclonal antibodies prior to procedures unless the patient has cytopenias that may be a contra-indication. If that is the case, we recommend holding until counts recover to the parameters required for the procedure.”
In regard to Bruton’s tyrosine kinase inhibitors such as ibrutinib, “patients undergoing major surgeries with high risk of bleeding should hold Bruton’s tyrosine kinase inhibitors for a week prior to surgery to ensure adequate platelet function recovery given the disruption between collagen and platelet aggregation. Medications can be resumed 3-7 days after achieving postoperative hemostasis, depending on the type of surgery and risk of bleeding.”
As for venetoclax, “prior to surgery, patients should receive granulocyte colony-stimulating factor for neutropenia, blood transfusions for anemia, and platelet transfusions for thrombocytopenia to maintain procedural parameters.”
In the big picture, study lead author Dr. Ma said, “patients with CLL are doing well on continuous targeted treatments, and if there are otherwise no contraindications, they should be considered for procedures to improve their quality of life.”
In an interview, Stanford (Calif.) University surgeon Joe Forrester MD, MSc, who’s familiar with the report findings, said its conclusions are valid. “The nice thing is that a lot of the [CLL] therapies don’t have a lot of surgical side effects. Most should not preclude a patient from going to surgery.”
He advised colleagues to make sure to be open with patients about the heightened surgical risks due to CLL, such when they need emergency procedures. And it’s important to be realistic about whether patients will live long enough to benefit from the rare surgeries – such as weight-loss procedures – that won’t show major benefits for 5-10 years, he said.
The Lymphoma Research Foundation supported the study. Dr. Ma, several coauthors, and Dr. Forrester report no disclosures. One coauthor reports multiple relationships with industry.
In the past decade, as targeted therapies have permitted better management of CLL, a new realm of possibilities has opened up for patients with this blood cancer.
“Previously, patients may not have been candidates for elective surgeries, such as hip replacements,” said hematologist-oncologist Helen Ma, MD, of the University of Irvine (Calif.) and VA Long Beach Healthcare System. She is the lead author of the report, which appeared in the British Journal of Hematology.
“Now that targeted therapies are controlling CLL well, patients may elect to have procedures that they may not have considered if their blood counts were very low or they felt too unwell to go through such invasive surgeries,” said Dr. Ma in an interview. In fact, the study authors noted that, “with currently available treatments, many patients with CLL are living considerably longer than the 1-year life expectancy threshold that proceduralists require.”
But extra surgical risks persist. “Both CLL and its treatment can increase the risk of complications during and after procedures, though available data are not consistently stratified by stage and whether patients are undergoing treatment,” the report authors noted.
Research has linked CLL to higher rates of blood transfusions in cardiac surgeries: One study, conducted partially in the era of targeted therapy, found that 87% of these surgery patients with CLL needed blood products vs. 65% of those who didn’t have CLL (P = .01). Studies didn’t find any extra risk of infections in patients with CLL, however, and there are conflicting findings about whether hospital mortality is higher.
Another study, also conducted partially in the era of targeted therapy, found that patients with CLL who had percutaneous coronary intervention procedures “developed higher rates of in-hospital mortality, any complication, bleeding and postoperative stroke compared to those seen in patients without leukemia.”
The authors of the new report noted that “patients with more advanced stage are at increased risk of bleeding and thromboembolic events relevant to their disease and invasive procedures.” Patients at more than minimal risk should undergo electrocardiograms prior to cardiac procedures, they wrote. Stress tests, coronary angiography, and percutaneous coronary intervention may also be warranted.
“To optimize evaluation and perioperative management, we strongly recommend the prospective collaborative inclusion of a multidisciplinary team including hematologists/oncologists, cardiologists (ideally cardio-oncologists), surgeons and anesthetists, as well as their ongoing involvement during the postoperative period,” the authors wrote.
As for medications, the researchers said that “generally, antibody therapy has no impact on surgery.” They added, “There is no evidence to hold treatment with anti-CD20 monoclonal antibodies prior to procedures unless the patient has cytopenias that may be a contra-indication. If that is the case, we recommend holding until counts recover to the parameters required for the procedure.”
In regard to Bruton’s tyrosine kinase inhibitors such as ibrutinib, “patients undergoing major surgeries with high risk of bleeding should hold Bruton’s tyrosine kinase inhibitors for a week prior to surgery to ensure adequate platelet function recovery given the disruption between collagen and platelet aggregation. Medications can be resumed 3-7 days after achieving postoperative hemostasis, depending on the type of surgery and risk of bleeding.”
As for venetoclax, “prior to surgery, patients should receive granulocyte colony-stimulating factor for neutropenia, blood transfusions for anemia, and platelet transfusions for thrombocytopenia to maintain procedural parameters.”
In the big picture, study lead author Dr. Ma said, “patients with CLL are doing well on continuous targeted treatments, and if there are otherwise no contraindications, they should be considered for procedures to improve their quality of life.”
In an interview, Stanford (Calif.) University surgeon Joe Forrester MD, MSc, who’s familiar with the report findings, said its conclusions are valid. “The nice thing is that a lot of the [CLL] therapies don’t have a lot of surgical side effects. Most should not preclude a patient from going to surgery.”
He advised colleagues to make sure to be open with patients about the heightened surgical risks due to CLL, such when they need emergency procedures. And it’s important to be realistic about whether patients will live long enough to benefit from the rare surgeries – such as weight-loss procedures – that won’t show major benefits for 5-10 years, he said.
The Lymphoma Research Foundation supported the study. Dr. Ma, several coauthors, and Dr. Forrester report no disclosures. One coauthor reports multiple relationships with industry.
In the past decade, as targeted therapies have permitted better management of CLL, a new realm of possibilities has opened up for patients with this blood cancer.
“Previously, patients may not have been candidates for elective surgeries, such as hip replacements,” said hematologist-oncologist Helen Ma, MD, of the University of Irvine (Calif.) and VA Long Beach Healthcare System. She is the lead author of the report, which appeared in the British Journal of Hematology.
“Now that targeted therapies are controlling CLL well, patients may elect to have procedures that they may not have considered if their blood counts were very low or they felt too unwell to go through such invasive surgeries,” said Dr. Ma in an interview. In fact, the study authors noted that, “with currently available treatments, many patients with CLL are living considerably longer than the 1-year life expectancy threshold that proceduralists require.”
But extra surgical risks persist. “Both CLL and its treatment can increase the risk of complications during and after procedures, though available data are not consistently stratified by stage and whether patients are undergoing treatment,” the report authors noted.
Research has linked CLL to higher rates of blood transfusions in cardiac surgeries: One study, conducted partially in the era of targeted therapy, found that 87% of these surgery patients with CLL needed blood products vs. 65% of those who didn’t have CLL (P = .01). Studies didn’t find any extra risk of infections in patients with CLL, however, and there are conflicting findings about whether hospital mortality is higher.
Another study, also conducted partially in the era of targeted therapy, found that patients with CLL who had percutaneous coronary intervention procedures “developed higher rates of in-hospital mortality, any complication, bleeding and postoperative stroke compared to those seen in patients without leukemia.”
The authors of the new report noted that “patients with more advanced stage are at increased risk of bleeding and thromboembolic events relevant to their disease and invasive procedures.” Patients at more than minimal risk should undergo electrocardiograms prior to cardiac procedures, they wrote. Stress tests, coronary angiography, and percutaneous coronary intervention may also be warranted.
“To optimize evaluation and perioperative management, we strongly recommend the prospective collaborative inclusion of a multidisciplinary team including hematologists/oncologists, cardiologists (ideally cardio-oncologists), surgeons and anesthetists, as well as their ongoing involvement during the postoperative period,” the authors wrote.
As for medications, the researchers said that “generally, antibody therapy has no impact on surgery.” They added, “There is no evidence to hold treatment with anti-CD20 monoclonal antibodies prior to procedures unless the patient has cytopenias that may be a contra-indication. If that is the case, we recommend holding until counts recover to the parameters required for the procedure.”
In regard to Bruton’s tyrosine kinase inhibitors such as ibrutinib, “patients undergoing major surgeries with high risk of bleeding should hold Bruton’s tyrosine kinase inhibitors for a week prior to surgery to ensure adequate platelet function recovery given the disruption between collagen and platelet aggregation. Medications can be resumed 3-7 days after achieving postoperative hemostasis, depending on the type of surgery and risk of bleeding.”
As for venetoclax, “prior to surgery, patients should receive granulocyte colony-stimulating factor for neutropenia, blood transfusions for anemia, and platelet transfusions for thrombocytopenia to maintain procedural parameters.”
In the big picture, study lead author Dr. Ma said, “patients with CLL are doing well on continuous targeted treatments, and if there are otherwise no contraindications, they should be considered for procedures to improve their quality of life.”
In an interview, Stanford (Calif.) University surgeon Joe Forrester MD, MSc, who’s familiar with the report findings, said its conclusions are valid. “The nice thing is that a lot of the [CLL] therapies don’t have a lot of surgical side effects. Most should not preclude a patient from going to surgery.”
He advised colleagues to make sure to be open with patients about the heightened surgical risks due to CLL, such when they need emergency procedures. And it’s important to be realistic about whether patients will live long enough to benefit from the rare surgeries – such as weight-loss procedures – that won’t show major benefits for 5-10 years, he said.
The Lymphoma Research Foundation supported the study. Dr. Ma, several coauthors, and Dr. Forrester report no disclosures. One coauthor reports multiple relationships with industry.
FROM THE BRITISH JOURNAL OF HEMATOLOGY
NSCLC- Clinical Presentation
Studies validate IL-17 as hidradenitis suppurativa drug target
NEW ORLEANS – In two phase 3 trials, bimekizumab, a monoclonal antibody targeting two types of interleukin-17 — IL-17A and IL-17F — reduced the abscess and inflammatory nodule count better than placebo in the chronic inflammatory skin condition hidradenitis suppurativa (HS), according to results presented together during a late-breaker session at the annual meeting of the American Academy of Dermatology.
“We are very excited to add this data to what we already have around IL-17 inhibition. This clearly validates this target for the control of HS,” reported lead investigator Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School and Beth Israel Deaconess Medical Center, both in Boston.
The trials, called BE HEARD I and BE HEARD II, enrolled 505 and 509 patients with HS, respectively. About 50% of patients in BE HEARD I and 60% of patients in BE HEARD II had Hurley stage 3 disease, which is the most severe of the three stratifications. The remainder were in Hurley stage 2. The mean duration of HS was 8.3 and 7.1 years, respectively.
Patients in both studies were randomized to one of four groups – either to a dosing regimen of 320 mg of bimekizumab administered by subcutaneous injection or to a placebo group. Both trials comprised double-blind 16-week initial and 32-week maintenance treatment periods.
In one experimental group, bimekizumab was given once every 2 weeks for the full course of the 48-week study (Q2W/Q2W). In another, patients started on the every-2-week schedule for 16 weeks and then were switched to every-4-week dosing (Q2W/Q4W). In the third group, patients started and remained on the every-4-week schedule (Q4W/Q4W). Patients in a fourth group started on placebo and switched at 16 weeks to the every-2-week bimekizumab schedule (placebo/Q2W).
Results at primary endpoint
The primary endpoint was HiSCR50, signifying a 50% reduction from baseline in abscess and inflammatory nodule count on the Hidradenitis Suppurativa Clinical Response (HiSCR) assessment tool. At 16 weeks, the initial Q2W dose in two of the groups outperformed the placebo in both BE HEARD I (47.8% vs. 28.7%) and BE HEARD II (52.0% vs. 32.2%). The response rates in the Q4W arm in BE HEARD I (45.3%) and BE HEARD II (53.8%) were also higher than the placebo, but the difference was only significant in BE HEARD II.
At 48 weeks, the proportion of patients with an HiSCR50 response climbed in all groups in both trials. The patterns were generally the same with slightly higher numerical responses among the groups that received the every-2-week dosing schedule relative to the every-4-week schedule.
In BE HEARD I at 48 weeks, the HiSCR50 response rate was about 60% for those who started and remained on every-2-week bimekizumab (Q2W/Q2W) or were switched at 16 weeks to every-4-week bimekizumab (Q2W/Q4W). For those who started and remained on every-4-week bimekizumab and the group started on placebo and switched to every-2-week bimekizumab, the response rates were 52.7% and 45.3%, respectively.
In BE HEARD II, the HiSCR50 response rates were higher in all groups, including the placebo, and the patterns of response were similar at 48 weeks. Most patients reached the HiSCR50 response – 79.8% (Q2W/Q2W), 78.4% (Q2W/Q4W), 76.7% (Q4W/Q4W), and 65.9 % (placebo/Q2W) of patients.
It is notable that, although there was rapid increase in the proportion of placebo patients reaching HiSCR50 after the switch at 16 weeks, there appeared to be an advantage at 48 weeks for starting on full-dose bimekizumab over starting on placebo.
In this trial, patients were listed as nonresponders if they received antibiotics at any time and for any reason after randomization. This might have concealed an even greater benefit of bimekizumab, Dr. Kimball said, but the study design element was considered necessary to isolate the activity of the study drug.
“In future HS trials, it will be helpful to address the difficulty of handling the impact of antibiotics and pain medications [in assessing results],” Dr. Kimball said.
Clinically meaningful secondary endpoint
For HS patients, the secondary endpoint of HiSCR75 might be considered the most meaningful, according to Dr. Kimball. She said that this higher bar not only documents a higher level of efficacy but correlates with meaningful improvement in quality of life. In the two trials combined, more than 55% of patients on continuous bimekizumab achieved HiSCR75 at week 48 in the observed case analysis, according to a news release from biopharmaceutical company UCB, developer of bimekizumab.
In BE HEARD I, the HiSCR75 rates were 33.4% and 24.7% for the every-2-week and every-4-week bimekizumab doses, respectively. The 33.4% response was statistically superior to placebo (18.4%). In BE HEARD II, both the every-2-week dose (35.7%) and the every-4-week dose (33.7%) were superior to the 15.6% response in placebo patients.
The improvements in quality of life as measured with the Dermatology Life Quality Index (DLQI), reflected the changes in disease activity. Relative to about a 3-point reduction from baseline in the placebo groups of the two trials, the 5-point reduction for either the 2-week or 4-week bimekizumab groups in each clinical trial were highly significant, Dr. Kimball said.
Bimekizumab was relatively well tolerated, although it shares the increased risk for candidiasis observed with this agent when used in psoriasis and with other IL-17 inhibitors, such as secukinumab (Cosentyx), in general. The risk of candidiasis appeared to be dose related, but cases were generally mild and easily managed, according to Dr. Kimball. She noted that only three patients discontinued treatment for this reason. Discontinuations for a treatment-related adverse event overall was less than 4% at 16 weeks.
This is only the third phase 3 trial ever completed in patients with HS. In fact, Dr. Kimball has led all of the phase 3 trials so far, including clinical studies of adalimumab (Humira), published in 2016, and of secukinumab, published earlier this year. All were positive studies.
“This is amazing news for our patients,” Dr. Kimball said. HS remains a challenging disease, even with a growing number of options showing benefit in large studies, she said, and the high rate of response, particularly at the level of HiSCR75, “is a huge milestone for what we can achieve.”
Multiple treatment options important
Her assessment was echoed by other experts, including Christopher J. Sayed, MD, an associate professor of dermatology at the University of North Carolina at Chapel Hill, who publishes frequently about this disease.
“It is incredibly exciting to see the strong phase 3 data on bimekizumab, particularly the deep responses at the HiSCR75 in a majority of patients after the first year,” he said.
Importantly, he does not see the growing array of treatment options as necessarily competitive for a disease with heterogeneous manifestations and variable responses to any one agent.
“While this may be a major step forward, it will still be critical to see more drugs come along for those who do not respond fully enough or have comorbidities that prevent the use of IL-17 and TNF [tumor necrosis factor] antagonists,” he said.
Bimekizumab is not approved for any indication in the United States; it is approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy in the EU/EEA, where it is marketed as Bimzelx, according to UCB. Dr. Kimball reports financial relationships with AbbVie, Janssen, Kymera, Lilly, Novartis, Pfizer, and UCB. Dr. Sayed reports financial relationships with AbbVie, InflaRx, and UCB.
A version of this article first appeared on Medscape.com.
NEW ORLEANS – In two phase 3 trials, bimekizumab, a monoclonal antibody targeting two types of interleukin-17 — IL-17A and IL-17F — reduced the abscess and inflammatory nodule count better than placebo in the chronic inflammatory skin condition hidradenitis suppurativa (HS), according to results presented together during a late-breaker session at the annual meeting of the American Academy of Dermatology.
“We are very excited to add this data to what we already have around IL-17 inhibition. This clearly validates this target for the control of HS,” reported lead investigator Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School and Beth Israel Deaconess Medical Center, both in Boston.
The trials, called BE HEARD I and BE HEARD II, enrolled 505 and 509 patients with HS, respectively. About 50% of patients in BE HEARD I and 60% of patients in BE HEARD II had Hurley stage 3 disease, which is the most severe of the three stratifications. The remainder were in Hurley stage 2. The mean duration of HS was 8.3 and 7.1 years, respectively.
Patients in both studies were randomized to one of four groups – either to a dosing regimen of 320 mg of bimekizumab administered by subcutaneous injection or to a placebo group. Both trials comprised double-blind 16-week initial and 32-week maintenance treatment periods.
In one experimental group, bimekizumab was given once every 2 weeks for the full course of the 48-week study (Q2W/Q2W). In another, patients started on the every-2-week schedule for 16 weeks and then were switched to every-4-week dosing (Q2W/Q4W). In the third group, patients started and remained on the every-4-week schedule (Q4W/Q4W). Patients in a fourth group started on placebo and switched at 16 weeks to the every-2-week bimekizumab schedule (placebo/Q2W).
Results at primary endpoint
The primary endpoint was HiSCR50, signifying a 50% reduction from baseline in abscess and inflammatory nodule count on the Hidradenitis Suppurativa Clinical Response (HiSCR) assessment tool. At 16 weeks, the initial Q2W dose in two of the groups outperformed the placebo in both BE HEARD I (47.8% vs. 28.7%) and BE HEARD II (52.0% vs. 32.2%). The response rates in the Q4W arm in BE HEARD I (45.3%) and BE HEARD II (53.8%) were also higher than the placebo, but the difference was only significant in BE HEARD II.
At 48 weeks, the proportion of patients with an HiSCR50 response climbed in all groups in both trials. The patterns were generally the same with slightly higher numerical responses among the groups that received the every-2-week dosing schedule relative to the every-4-week schedule.
In BE HEARD I at 48 weeks, the HiSCR50 response rate was about 60% for those who started and remained on every-2-week bimekizumab (Q2W/Q2W) or were switched at 16 weeks to every-4-week bimekizumab (Q2W/Q4W). For those who started and remained on every-4-week bimekizumab and the group started on placebo and switched to every-2-week bimekizumab, the response rates were 52.7% and 45.3%, respectively.
In BE HEARD II, the HiSCR50 response rates were higher in all groups, including the placebo, and the patterns of response were similar at 48 weeks. Most patients reached the HiSCR50 response – 79.8% (Q2W/Q2W), 78.4% (Q2W/Q4W), 76.7% (Q4W/Q4W), and 65.9 % (placebo/Q2W) of patients.
It is notable that, although there was rapid increase in the proportion of placebo patients reaching HiSCR50 after the switch at 16 weeks, there appeared to be an advantage at 48 weeks for starting on full-dose bimekizumab over starting on placebo.
In this trial, patients were listed as nonresponders if they received antibiotics at any time and for any reason after randomization. This might have concealed an even greater benefit of bimekizumab, Dr. Kimball said, but the study design element was considered necessary to isolate the activity of the study drug.
“In future HS trials, it will be helpful to address the difficulty of handling the impact of antibiotics and pain medications [in assessing results],” Dr. Kimball said.
Clinically meaningful secondary endpoint
For HS patients, the secondary endpoint of HiSCR75 might be considered the most meaningful, according to Dr. Kimball. She said that this higher bar not only documents a higher level of efficacy but correlates with meaningful improvement in quality of life. In the two trials combined, more than 55% of patients on continuous bimekizumab achieved HiSCR75 at week 48 in the observed case analysis, according to a news release from biopharmaceutical company UCB, developer of bimekizumab.
In BE HEARD I, the HiSCR75 rates were 33.4% and 24.7% for the every-2-week and every-4-week bimekizumab doses, respectively. The 33.4% response was statistically superior to placebo (18.4%). In BE HEARD II, both the every-2-week dose (35.7%) and the every-4-week dose (33.7%) were superior to the 15.6% response in placebo patients.
The improvements in quality of life as measured with the Dermatology Life Quality Index (DLQI), reflected the changes in disease activity. Relative to about a 3-point reduction from baseline in the placebo groups of the two trials, the 5-point reduction for either the 2-week or 4-week bimekizumab groups in each clinical trial were highly significant, Dr. Kimball said.
Bimekizumab was relatively well tolerated, although it shares the increased risk for candidiasis observed with this agent when used in psoriasis and with other IL-17 inhibitors, such as secukinumab (Cosentyx), in general. The risk of candidiasis appeared to be dose related, but cases were generally mild and easily managed, according to Dr. Kimball. She noted that only three patients discontinued treatment for this reason. Discontinuations for a treatment-related adverse event overall was less than 4% at 16 weeks.
This is only the third phase 3 trial ever completed in patients with HS. In fact, Dr. Kimball has led all of the phase 3 trials so far, including clinical studies of adalimumab (Humira), published in 2016, and of secukinumab, published earlier this year. All were positive studies.
“This is amazing news for our patients,” Dr. Kimball said. HS remains a challenging disease, even with a growing number of options showing benefit in large studies, she said, and the high rate of response, particularly at the level of HiSCR75, “is a huge milestone for what we can achieve.”
Multiple treatment options important
Her assessment was echoed by other experts, including Christopher J. Sayed, MD, an associate professor of dermatology at the University of North Carolina at Chapel Hill, who publishes frequently about this disease.
“It is incredibly exciting to see the strong phase 3 data on bimekizumab, particularly the deep responses at the HiSCR75 in a majority of patients after the first year,” he said.
Importantly, he does not see the growing array of treatment options as necessarily competitive for a disease with heterogeneous manifestations and variable responses to any one agent.
“While this may be a major step forward, it will still be critical to see more drugs come along for those who do not respond fully enough or have comorbidities that prevent the use of IL-17 and TNF [tumor necrosis factor] antagonists,” he said.
Bimekizumab is not approved for any indication in the United States; it is approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy in the EU/EEA, where it is marketed as Bimzelx, according to UCB. Dr. Kimball reports financial relationships with AbbVie, Janssen, Kymera, Lilly, Novartis, Pfizer, and UCB. Dr. Sayed reports financial relationships with AbbVie, InflaRx, and UCB.
A version of this article first appeared on Medscape.com.
NEW ORLEANS – In two phase 3 trials, bimekizumab, a monoclonal antibody targeting two types of interleukin-17 — IL-17A and IL-17F — reduced the abscess and inflammatory nodule count better than placebo in the chronic inflammatory skin condition hidradenitis suppurativa (HS), according to results presented together during a late-breaker session at the annual meeting of the American Academy of Dermatology.
“We are very excited to add this data to what we already have around IL-17 inhibition. This clearly validates this target for the control of HS,” reported lead investigator Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School and Beth Israel Deaconess Medical Center, both in Boston.
The trials, called BE HEARD I and BE HEARD II, enrolled 505 and 509 patients with HS, respectively. About 50% of patients in BE HEARD I and 60% of patients in BE HEARD II had Hurley stage 3 disease, which is the most severe of the three stratifications. The remainder were in Hurley stage 2. The mean duration of HS was 8.3 and 7.1 years, respectively.
Patients in both studies were randomized to one of four groups – either to a dosing regimen of 320 mg of bimekizumab administered by subcutaneous injection or to a placebo group. Both trials comprised double-blind 16-week initial and 32-week maintenance treatment periods.
In one experimental group, bimekizumab was given once every 2 weeks for the full course of the 48-week study (Q2W/Q2W). In another, patients started on the every-2-week schedule for 16 weeks and then were switched to every-4-week dosing (Q2W/Q4W). In the third group, patients started and remained on the every-4-week schedule (Q4W/Q4W). Patients in a fourth group started on placebo and switched at 16 weeks to the every-2-week bimekizumab schedule (placebo/Q2W).
Results at primary endpoint
The primary endpoint was HiSCR50, signifying a 50% reduction from baseline in abscess and inflammatory nodule count on the Hidradenitis Suppurativa Clinical Response (HiSCR) assessment tool. At 16 weeks, the initial Q2W dose in two of the groups outperformed the placebo in both BE HEARD I (47.8% vs. 28.7%) and BE HEARD II (52.0% vs. 32.2%). The response rates in the Q4W arm in BE HEARD I (45.3%) and BE HEARD II (53.8%) were also higher than the placebo, but the difference was only significant in BE HEARD II.
At 48 weeks, the proportion of patients with an HiSCR50 response climbed in all groups in both trials. The patterns were generally the same with slightly higher numerical responses among the groups that received the every-2-week dosing schedule relative to the every-4-week schedule.
In BE HEARD I at 48 weeks, the HiSCR50 response rate was about 60% for those who started and remained on every-2-week bimekizumab (Q2W/Q2W) or were switched at 16 weeks to every-4-week bimekizumab (Q2W/Q4W). For those who started and remained on every-4-week bimekizumab and the group started on placebo and switched to every-2-week bimekizumab, the response rates were 52.7% and 45.3%, respectively.
In BE HEARD II, the HiSCR50 response rates were higher in all groups, including the placebo, and the patterns of response were similar at 48 weeks. Most patients reached the HiSCR50 response – 79.8% (Q2W/Q2W), 78.4% (Q2W/Q4W), 76.7% (Q4W/Q4W), and 65.9 % (placebo/Q2W) of patients.
It is notable that, although there was rapid increase in the proportion of placebo patients reaching HiSCR50 after the switch at 16 weeks, there appeared to be an advantage at 48 weeks for starting on full-dose bimekizumab over starting on placebo.
In this trial, patients were listed as nonresponders if they received antibiotics at any time and for any reason after randomization. This might have concealed an even greater benefit of bimekizumab, Dr. Kimball said, but the study design element was considered necessary to isolate the activity of the study drug.
“In future HS trials, it will be helpful to address the difficulty of handling the impact of antibiotics and pain medications [in assessing results],” Dr. Kimball said.
Clinically meaningful secondary endpoint
For HS patients, the secondary endpoint of HiSCR75 might be considered the most meaningful, according to Dr. Kimball. She said that this higher bar not only documents a higher level of efficacy but correlates with meaningful improvement in quality of life. In the two trials combined, more than 55% of patients on continuous bimekizumab achieved HiSCR75 at week 48 in the observed case analysis, according to a news release from biopharmaceutical company UCB, developer of bimekizumab.
In BE HEARD I, the HiSCR75 rates were 33.4% and 24.7% for the every-2-week and every-4-week bimekizumab doses, respectively. The 33.4% response was statistically superior to placebo (18.4%). In BE HEARD II, both the every-2-week dose (35.7%) and the every-4-week dose (33.7%) were superior to the 15.6% response in placebo patients.
The improvements in quality of life as measured with the Dermatology Life Quality Index (DLQI), reflected the changes in disease activity. Relative to about a 3-point reduction from baseline in the placebo groups of the two trials, the 5-point reduction for either the 2-week or 4-week bimekizumab groups in each clinical trial were highly significant, Dr. Kimball said.
Bimekizumab was relatively well tolerated, although it shares the increased risk for candidiasis observed with this agent when used in psoriasis and with other IL-17 inhibitors, such as secukinumab (Cosentyx), in general. The risk of candidiasis appeared to be dose related, but cases were generally mild and easily managed, according to Dr. Kimball. She noted that only three patients discontinued treatment for this reason. Discontinuations for a treatment-related adverse event overall was less than 4% at 16 weeks.
This is only the third phase 3 trial ever completed in patients with HS. In fact, Dr. Kimball has led all of the phase 3 trials so far, including clinical studies of adalimumab (Humira), published in 2016, and of secukinumab, published earlier this year. All were positive studies.
“This is amazing news for our patients,” Dr. Kimball said. HS remains a challenging disease, even with a growing number of options showing benefit in large studies, she said, and the high rate of response, particularly at the level of HiSCR75, “is a huge milestone for what we can achieve.”
Multiple treatment options important
Her assessment was echoed by other experts, including Christopher J. Sayed, MD, an associate professor of dermatology at the University of North Carolina at Chapel Hill, who publishes frequently about this disease.
“It is incredibly exciting to see the strong phase 3 data on bimekizumab, particularly the deep responses at the HiSCR75 in a majority of patients after the first year,” he said.
Importantly, he does not see the growing array of treatment options as necessarily competitive for a disease with heterogeneous manifestations and variable responses to any one agent.
“While this may be a major step forward, it will still be critical to see more drugs come along for those who do not respond fully enough or have comorbidities that prevent the use of IL-17 and TNF [tumor necrosis factor] antagonists,” he said.
Bimekizumab is not approved for any indication in the United States; it is approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy in the EU/EEA, where it is marketed as Bimzelx, according to UCB. Dr. Kimball reports financial relationships with AbbVie, Janssen, Kymera, Lilly, Novartis, Pfizer, and UCB. Dr. Sayed reports financial relationships with AbbVie, InflaRx, and UCB.
A version of this article first appeared on Medscape.com.
AT AAD 2023
Early exercise intervention improves knee osteoarthritis
DENVER – Initiating exercise therapy early on in people who develop symptoms of knee osteoarthritis – even within their first year of pain or reduced function – is associated with modestly lower pain scores and modestly better function than in those whose symptoms have lasted longer, according to a study presented at the OARSI 2023 World Congress.
Although the benefits of exercise therapy for advanced knee osteoarthritis had already been well established, this study looked specifically at benefits from exercise therapy earlier on, in patients with a shorter duration of symptoms.
“Exercise indeed seems especially beneficial in patients with shorter symptom duration and should therefore be encouraged at first symptom presentation,” Marienke van Middelkoop, PhD, of Erasmus MC Medical University in Rotterdam, the Netherlands, told attendees at the meeting, sponsored by Osteoarthritis Research Society International. “It is, however, still a challenge how we can identify patients but also how we can motivate these patients with early symptoms of osteoarthritis.” She noted that a separate pilot study had experienced difficulty recruiting people with short-term symptom duration.
The researchers compared the effect of exercise therapy and no exercise among adults at least 45 years old with knee osteoarthritis, relying on individual participant data from the STEER OA study, a meta-analysis of 31 studies that involved 4,241 participants. After excluding studies that didn’t report symptom duration, lacked a control group or consent, or focused on hip osteoarthritis, the researchers ended up with 10 studies involving 1,895 participants. These participants were stratified based on the duration of their symptoms: up to 1 year (14.4%), 1-2 years (11%), and 2 years or longer (74%).
About two-thirds of the participants were women (65.9%), with an average age of 65 years and an average body mass index (BMI) of 30.7 kg/m2. Any land-based or water-based therapeutic exercise counted for the 62% of participants in the intervention group, while the control group had no exercise. Outcomes were assessed based on self-reported pain or physical function at short-term and long-term follow-up, which were as close as possible to 3 months for short-term and the closest date to 12 months for longer term. At baseline, the participants reported an average pain score of 41.7 on a 0-to-100 scale and an average physical function score of 37.4 on a 0-to-100 scale where lower scores indicate better function.
Among those doing exercise therapy, average pain scores dropped 4.56 points in the short term and 7.43 points in the long term. Short-term and long-term pain scores were lower among those whose symptom durations were shorter. For example, those with symptoms for less than a year reported a short-term pain score of 29, compared with 30 for those with 1-2 years of pain and 32 for those with at least 2 years of pain. Results were similar for long-term pain (a score of 26, compared with 28 and 33, respectively).
Participants engaging in exercise therapy also improved average function scores, with a pattern of improvement that was similar to pain scores based on patients’ symptom duration. The average short-term function score was 26 among those with less than a year of symptoms, compared with 28 for those with symptoms for 1-2 years, and 30 for those with symptoms for at least 2 years. Longer-term function scores were 21, 24, and 29, respectively, based on increasing symptom durations.
Chris Yun Lane, PT, DPT, a physical therapist and a fourth-year PhD student at the University of North Carolina at Chapel Hill, was not surprised at the exercise benefit given the extensive evidence already showing that exercise is beneficial for patients with osteoarthritis whose symptoms have lasted longer.
“Just spending a little bit of time on education, designing kind of simple exercise programs, such as walking programs, can be very helpful,” Dr. Lane said in an interview. “Of course, some of it is dependent on the patient itself, but strengthening range of motion is often very helpful.” Dr. Lane said it’s particularly important for physicians and physical therapists to emphasize the importance of exercise to their patients because that guidance doesn’t always occur as often as it should.
Ron Ellis Jr., DO, MBA, chief strategy officer of Pacira BioSciences in Tampa, Fla., noted that a lot of patients with knee osteoarthritis have weakness in their quads, so quad strengthening is “a typical part of our improvement program for patients with osteoarthritis,” he said in an interview. Dr. Ellis also referenced a session he attended the previous day that showed exercise results in reduced inflammation.
“So you may not have weight loss, but you can lower the inflammatory state of the overall body and of the specific joints,” Dr. Ellis said, “so that would support [this study’s] conclusion.”
The STEER OA study was funded by the Chartered Society of Physiotherapy Charitable Trust and the National Institute for Health Research School of Primary Care Research. Dr. van Middelkoop and Dr. Lane both reported having no relevant financial relationships.
DENVER – Initiating exercise therapy early on in people who develop symptoms of knee osteoarthritis – even within their first year of pain or reduced function – is associated with modestly lower pain scores and modestly better function than in those whose symptoms have lasted longer, according to a study presented at the OARSI 2023 World Congress.
Although the benefits of exercise therapy for advanced knee osteoarthritis had already been well established, this study looked specifically at benefits from exercise therapy earlier on, in patients with a shorter duration of symptoms.
“Exercise indeed seems especially beneficial in patients with shorter symptom duration and should therefore be encouraged at first symptom presentation,” Marienke van Middelkoop, PhD, of Erasmus MC Medical University in Rotterdam, the Netherlands, told attendees at the meeting, sponsored by Osteoarthritis Research Society International. “It is, however, still a challenge how we can identify patients but also how we can motivate these patients with early symptoms of osteoarthritis.” She noted that a separate pilot study had experienced difficulty recruiting people with short-term symptom duration.
The researchers compared the effect of exercise therapy and no exercise among adults at least 45 years old with knee osteoarthritis, relying on individual participant data from the STEER OA study, a meta-analysis of 31 studies that involved 4,241 participants. After excluding studies that didn’t report symptom duration, lacked a control group or consent, or focused on hip osteoarthritis, the researchers ended up with 10 studies involving 1,895 participants. These participants were stratified based on the duration of their symptoms: up to 1 year (14.4%), 1-2 years (11%), and 2 years or longer (74%).
About two-thirds of the participants were women (65.9%), with an average age of 65 years and an average body mass index (BMI) of 30.7 kg/m2. Any land-based or water-based therapeutic exercise counted for the 62% of participants in the intervention group, while the control group had no exercise. Outcomes were assessed based on self-reported pain or physical function at short-term and long-term follow-up, which were as close as possible to 3 months for short-term and the closest date to 12 months for longer term. At baseline, the participants reported an average pain score of 41.7 on a 0-to-100 scale and an average physical function score of 37.4 on a 0-to-100 scale where lower scores indicate better function.
Among those doing exercise therapy, average pain scores dropped 4.56 points in the short term and 7.43 points in the long term. Short-term and long-term pain scores were lower among those whose symptom durations were shorter. For example, those with symptoms for less than a year reported a short-term pain score of 29, compared with 30 for those with 1-2 years of pain and 32 for those with at least 2 years of pain. Results were similar for long-term pain (a score of 26, compared with 28 and 33, respectively).
Participants engaging in exercise therapy also improved average function scores, with a pattern of improvement that was similar to pain scores based on patients’ symptom duration. The average short-term function score was 26 among those with less than a year of symptoms, compared with 28 for those with symptoms for 1-2 years, and 30 for those with symptoms for at least 2 years. Longer-term function scores were 21, 24, and 29, respectively, based on increasing symptom durations.
Chris Yun Lane, PT, DPT, a physical therapist and a fourth-year PhD student at the University of North Carolina at Chapel Hill, was not surprised at the exercise benefit given the extensive evidence already showing that exercise is beneficial for patients with osteoarthritis whose symptoms have lasted longer.
“Just spending a little bit of time on education, designing kind of simple exercise programs, such as walking programs, can be very helpful,” Dr. Lane said in an interview. “Of course, some of it is dependent on the patient itself, but strengthening range of motion is often very helpful.” Dr. Lane said it’s particularly important for physicians and physical therapists to emphasize the importance of exercise to their patients because that guidance doesn’t always occur as often as it should.
Ron Ellis Jr., DO, MBA, chief strategy officer of Pacira BioSciences in Tampa, Fla., noted that a lot of patients with knee osteoarthritis have weakness in their quads, so quad strengthening is “a typical part of our improvement program for patients with osteoarthritis,” he said in an interview. Dr. Ellis also referenced a session he attended the previous day that showed exercise results in reduced inflammation.
“So you may not have weight loss, but you can lower the inflammatory state of the overall body and of the specific joints,” Dr. Ellis said, “so that would support [this study’s] conclusion.”
The STEER OA study was funded by the Chartered Society of Physiotherapy Charitable Trust and the National Institute for Health Research School of Primary Care Research. Dr. van Middelkoop and Dr. Lane both reported having no relevant financial relationships.
DENVER – Initiating exercise therapy early on in people who develop symptoms of knee osteoarthritis – even within their first year of pain or reduced function – is associated with modestly lower pain scores and modestly better function than in those whose symptoms have lasted longer, according to a study presented at the OARSI 2023 World Congress.
Although the benefits of exercise therapy for advanced knee osteoarthritis had already been well established, this study looked specifically at benefits from exercise therapy earlier on, in patients with a shorter duration of symptoms.
“Exercise indeed seems especially beneficial in patients with shorter symptom duration and should therefore be encouraged at first symptom presentation,” Marienke van Middelkoop, PhD, of Erasmus MC Medical University in Rotterdam, the Netherlands, told attendees at the meeting, sponsored by Osteoarthritis Research Society International. “It is, however, still a challenge how we can identify patients but also how we can motivate these patients with early symptoms of osteoarthritis.” She noted that a separate pilot study had experienced difficulty recruiting people with short-term symptom duration.
The researchers compared the effect of exercise therapy and no exercise among adults at least 45 years old with knee osteoarthritis, relying on individual participant data from the STEER OA study, a meta-analysis of 31 studies that involved 4,241 participants. After excluding studies that didn’t report symptom duration, lacked a control group or consent, or focused on hip osteoarthritis, the researchers ended up with 10 studies involving 1,895 participants. These participants were stratified based on the duration of their symptoms: up to 1 year (14.4%), 1-2 years (11%), and 2 years or longer (74%).
About two-thirds of the participants were women (65.9%), with an average age of 65 years and an average body mass index (BMI) of 30.7 kg/m2. Any land-based or water-based therapeutic exercise counted for the 62% of participants in the intervention group, while the control group had no exercise. Outcomes were assessed based on self-reported pain or physical function at short-term and long-term follow-up, which were as close as possible to 3 months for short-term and the closest date to 12 months for longer term. At baseline, the participants reported an average pain score of 41.7 on a 0-to-100 scale and an average physical function score of 37.4 on a 0-to-100 scale where lower scores indicate better function.
Among those doing exercise therapy, average pain scores dropped 4.56 points in the short term and 7.43 points in the long term. Short-term and long-term pain scores were lower among those whose symptom durations were shorter. For example, those with symptoms for less than a year reported a short-term pain score of 29, compared with 30 for those with 1-2 years of pain and 32 for those with at least 2 years of pain. Results were similar for long-term pain (a score of 26, compared with 28 and 33, respectively).
Participants engaging in exercise therapy also improved average function scores, with a pattern of improvement that was similar to pain scores based on patients’ symptom duration. The average short-term function score was 26 among those with less than a year of symptoms, compared with 28 for those with symptoms for 1-2 years, and 30 for those with symptoms for at least 2 years. Longer-term function scores were 21, 24, and 29, respectively, based on increasing symptom durations.
Chris Yun Lane, PT, DPT, a physical therapist and a fourth-year PhD student at the University of North Carolina at Chapel Hill, was not surprised at the exercise benefit given the extensive evidence already showing that exercise is beneficial for patients with osteoarthritis whose symptoms have lasted longer.
“Just spending a little bit of time on education, designing kind of simple exercise programs, such as walking programs, can be very helpful,” Dr. Lane said in an interview. “Of course, some of it is dependent on the patient itself, but strengthening range of motion is often very helpful.” Dr. Lane said it’s particularly important for physicians and physical therapists to emphasize the importance of exercise to their patients because that guidance doesn’t always occur as often as it should.
Ron Ellis Jr., DO, MBA, chief strategy officer of Pacira BioSciences in Tampa, Fla., noted that a lot of patients with knee osteoarthritis have weakness in their quads, so quad strengthening is “a typical part of our improvement program for patients with osteoarthritis,” he said in an interview. Dr. Ellis also referenced a session he attended the previous day that showed exercise results in reduced inflammation.
“So you may not have weight loss, but you can lower the inflammatory state of the overall body and of the specific joints,” Dr. Ellis said, “so that would support [this study’s] conclusion.”
The STEER OA study was funded by the Chartered Society of Physiotherapy Charitable Trust and the National Institute for Health Research School of Primary Care Research. Dr. van Middelkoop and Dr. Lane both reported having no relevant financial relationships.
AT OARSI 2023
Complaints of cough and fatigue
The history and findings in this case are suggestive of non–small cell lung cancer (NSCLC) large cell carcinoma.
Lung cancer is the most common cancer worldwide and has the highest mortality rate of all cancers. It comprises two major subtypes: NSCLC and small cell lung cancer (SCLC). Histologically, NSCLC is further classified as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma with or without neuroendocrine features. Large cell carcinoma accounts for 9% of all cases and is frequently associated with poor prognosis. Most patients with NSCLC large cell carcinoma are older than 60 years and are diagnosed with stage III or IV disease. NSCLC large cell carcinoma appears to occur more commonly in men than in women and in patients with a history of smoking. It often presents as a large mass with central necrosis.
NSCLC is often asymptomatic in its early stages. The most frequently reported signs and symptoms of lung cancer include:
• Cough
• Chest pain
• Shortness of breath
• Coughing up blood
• Wheezing
• Hoarseness
• Recurring infections, such as bronchitis and pneumonia
• Weight loss and loss of appetite
• Fatigue
Signs and symptoms of metastatic disease may include bone pain, spinal cord impingement, or neurologic problems, such as headache, weakness or numbness of limbs, dizziness, and seizures.
All patients with NSCLC require a complete staging workup to evaluate the extent of disease because stage plays a central role in treatment selection. After physical examination and a complete blood count, a chest radiograph is often the first test performed. Chest radiographs may show a pulmonary nodule, mass, or infiltrate; mediastinal widening; atelectasis; hilar enlargement; and/or pleural effusion.
Various methods are available to confirm the diagnosis, and the method chosen may be determined at least in part by lesion location. These include:
• Bronchoscopy
• Sputum cytology
• Mediastinoscopy
• Thoracentesis
• Thoracoscopy
• Transthoracic needle biopsy (CT- or fluoroscopy-guided)
According to 2023 guidelines from the National Comprehensive Cancer Network (NCCN), the diagnosis of NSCLC large cell carcinoma requires a thoroughly sampled resected tumor with immunohistochemical stains that exclude adenocarcinoma (TTF-1, napsin A) and squamous cell (p40, p63) carcinoma. Nonresected specimens or cytology specimens are insufficient for its diagnosis. NSCLC large cell carcinoma lacks the cytologic, architectural, and histochemical features of small cell carcinoma, adenocarcinoma, or squamous cell carcinoma and is undifferentiated.
When the NSCLC histologic subtype is determined, molecular testing should be performed as part of broad molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available or to appropriately counsel patients regarding the availability of clinical trials. NSCLC diagnostic standards include the detection of EGFR, BRAF, and MET mutations, ERBB2 (HER2) expression, and the analysis of ALK, ROS1, RET, and NTRK translocations. In addition, analysis of programmed death-ligand 1 expression is necessary to identify patients who may benefit from the use of immune checkpoint inhibitors.
Surgery combined with chemotherapy has been shown to improve the prognosis of patients with NSCLC large cell carcinoma. Preferred regimens in various lines of treatment and according to molecular characteristics can be found in the NCCN guidelines.
Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.
Karl J. D'Silva, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
The history and findings in this case are suggestive of non–small cell lung cancer (NSCLC) large cell carcinoma.
Lung cancer is the most common cancer worldwide and has the highest mortality rate of all cancers. It comprises two major subtypes: NSCLC and small cell lung cancer (SCLC). Histologically, NSCLC is further classified as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma with or without neuroendocrine features. Large cell carcinoma accounts for 9% of all cases and is frequently associated with poor prognosis. Most patients with NSCLC large cell carcinoma are older than 60 years and are diagnosed with stage III or IV disease. NSCLC large cell carcinoma appears to occur more commonly in men than in women and in patients with a history of smoking. It often presents as a large mass with central necrosis.
NSCLC is often asymptomatic in its early stages. The most frequently reported signs and symptoms of lung cancer include:
• Cough
• Chest pain
• Shortness of breath
• Coughing up blood
• Wheezing
• Hoarseness
• Recurring infections, such as bronchitis and pneumonia
• Weight loss and loss of appetite
• Fatigue
Signs and symptoms of metastatic disease may include bone pain, spinal cord impingement, or neurologic problems, such as headache, weakness or numbness of limbs, dizziness, and seizures.
All patients with NSCLC require a complete staging workup to evaluate the extent of disease because stage plays a central role in treatment selection. After physical examination and a complete blood count, a chest radiograph is often the first test performed. Chest radiographs may show a pulmonary nodule, mass, or infiltrate; mediastinal widening; atelectasis; hilar enlargement; and/or pleural effusion.
Various methods are available to confirm the diagnosis, and the method chosen may be determined at least in part by lesion location. These include:
• Bronchoscopy
• Sputum cytology
• Mediastinoscopy
• Thoracentesis
• Thoracoscopy
• Transthoracic needle biopsy (CT- or fluoroscopy-guided)
According to 2023 guidelines from the National Comprehensive Cancer Network (NCCN), the diagnosis of NSCLC large cell carcinoma requires a thoroughly sampled resected tumor with immunohistochemical stains that exclude adenocarcinoma (TTF-1, napsin A) and squamous cell (p40, p63) carcinoma. Nonresected specimens or cytology specimens are insufficient for its diagnosis. NSCLC large cell carcinoma lacks the cytologic, architectural, and histochemical features of small cell carcinoma, adenocarcinoma, or squamous cell carcinoma and is undifferentiated.
When the NSCLC histologic subtype is determined, molecular testing should be performed as part of broad molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available or to appropriately counsel patients regarding the availability of clinical trials. NSCLC diagnostic standards include the detection of EGFR, BRAF, and MET mutations, ERBB2 (HER2) expression, and the analysis of ALK, ROS1, RET, and NTRK translocations. In addition, analysis of programmed death-ligand 1 expression is necessary to identify patients who may benefit from the use of immune checkpoint inhibitors.
Surgery combined with chemotherapy has been shown to improve the prognosis of patients with NSCLC large cell carcinoma. Preferred regimens in various lines of treatment and according to molecular characteristics can be found in the NCCN guidelines.
Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.
Karl J. D'Silva, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
The history and findings in this case are suggestive of non–small cell lung cancer (NSCLC) large cell carcinoma.
Lung cancer is the most common cancer worldwide and has the highest mortality rate of all cancers. It comprises two major subtypes: NSCLC and small cell lung cancer (SCLC). Histologically, NSCLC is further classified as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma with or without neuroendocrine features. Large cell carcinoma accounts for 9% of all cases and is frequently associated with poor prognosis. Most patients with NSCLC large cell carcinoma are older than 60 years and are diagnosed with stage III or IV disease. NSCLC large cell carcinoma appears to occur more commonly in men than in women and in patients with a history of smoking. It often presents as a large mass with central necrosis.
NSCLC is often asymptomatic in its early stages. The most frequently reported signs and symptoms of lung cancer include:
• Cough
• Chest pain
• Shortness of breath
• Coughing up blood
• Wheezing
• Hoarseness
• Recurring infections, such as bronchitis and pneumonia
• Weight loss and loss of appetite
• Fatigue
Signs and symptoms of metastatic disease may include bone pain, spinal cord impingement, or neurologic problems, such as headache, weakness or numbness of limbs, dizziness, and seizures.
All patients with NSCLC require a complete staging workup to evaluate the extent of disease because stage plays a central role in treatment selection. After physical examination and a complete blood count, a chest radiograph is often the first test performed. Chest radiographs may show a pulmonary nodule, mass, or infiltrate; mediastinal widening; atelectasis; hilar enlargement; and/or pleural effusion.
Various methods are available to confirm the diagnosis, and the method chosen may be determined at least in part by lesion location. These include:
• Bronchoscopy
• Sputum cytology
• Mediastinoscopy
• Thoracentesis
• Thoracoscopy
• Transthoracic needle biopsy (CT- or fluoroscopy-guided)
According to 2023 guidelines from the National Comprehensive Cancer Network (NCCN), the diagnosis of NSCLC large cell carcinoma requires a thoroughly sampled resected tumor with immunohistochemical stains that exclude adenocarcinoma (TTF-1, napsin A) and squamous cell (p40, p63) carcinoma. Nonresected specimens or cytology specimens are insufficient for its diagnosis. NSCLC large cell carcinoma lacks the cytologic, architectural, and histochemical features of small cell carcinoma, adenocarcinoma, or squamous cell carcinoma and is undifferentiated.
When the NSCLC histologic subtype is determined, molecular testing should be performed as part of broad molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available or to appropriately counsel patients regarding the availability of clinical trials. NSCLC diagnostic standards include the detection of EGFR, BRAF, and MET mutations, ERBB2 (HER2) expression, and the analysis of ALK, ROS1, RET, and NTRK translocations. In addition, analysis of programmed death-ligand 1 expression is necessary to identify patients who may benefit from the use of immune checkpoint inhibitors.
Surgery combined with chemotherapy has been shown to improve the prognosis of patients with NSCLC large cell carcinoma. Preferred regimens in various lines of treatment and according to molecular characteristics can be found in the NCCN guidelines.
Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.
Karl J. D'Silva, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
A 67-year-old White man presents to the emergency department with reports of cough, dyspnea, fatigue, hoarseness, and unintentional weight loss. The patient states that his symptoms began approximately 3 weeks earlier and have progressively worsened. In the past year, he has been treated twice for respiratory infections (bronchitis and pneumonia approximately 6 and 9 months before the current presentation, respectively). He has a 45-year history of smoking (45 pack-years). The patient's vital signs include temperature of 100.4 °F, blood pressure of 142/80 mm Hg, and pulse ox of 95%. Physical examination reveals rales in the left side of the chest and decreased breath sounds in bilateral bases of the lungs. The patient appears cachexic. He is 6 ft 2 in and weighs 163 lb.
A chest radiograph reveals a large mass in the left lung field. A subsequent CT of the chest reveals encasement of the left upper and lower lobe bronchus with extensive mediastinal lymphadenopathy and areas of necrosis. Immunohistochemical analysis of the resected tumor reveals a malignant, poorly differentiated epithelial neoplasm composed of large, atypical cells. There is no morphologic or immunohistochemical evidence of glandular, squamous, or neuroendocrine differentiation.
Holy smoke: Air pollution link to bone damage confirmed
Air pollution appears to contribute independently to bone damage in postmenopausal women, new data suggest.
The findings come from a new analysis of data from the Women’s Health Initiative (WHI) and location-specific air particulate information from the U.S. Environmental Protection Agency.
“Our findings confirm that poor air quality may be a risk factor for bone loss, independent of socioeconomic or demographic factors, and expands previous findings to postmenopausal women. Indeed, to our knowledge, this is the first study of the impact of criteria air pollutants on bone health in postmenopausal women,” Diddier Prada, MD, PhD, Columbia University, New York, and colleagues wrote.
The results are also the first to show that “nitrogen oxides contribute the most to bone damage and that the lumbar spine is one of the most susceptible sites,” they added.
Public health policies should aim to reduce air pollution in general, they wrote, and reducing nitrogen oxides, in particular, will reduce bone damage in postmenopausal women, prevent bone fractures, and reduce the health cost burden associated with osteoporosis in this population.
The findings were recently published in eClinicalMedicine.
Asked to comment, Giovanni Adami, MD, PhD, said in an interview that the study “adds to the body of literature on air pollution and bone health. The study confirms and provides further evidence linking air pollution exposure and osteoporosis.”
Dr. Adami, of the University of Verona (Italy), who also studies this topic, said that these new findings align with those from his group and others.
“The scientific literature in the field is clearly pointing toward a negative effect of chronic pollution exposure on bone health.”
He pointed to one study from his group that found chronic exposure to ultrafine particulate matter is associated with low BMD, and consequently, bone fragility, and another study that showed acute exposure to high levels of pollutants could actually cause fractures.
As for what might be done clinically, Dr. Adami said: “It is difficult to extrapolate direct and immediate recommendations for patients.
“However, it might be acceptable to say that patients at risk of osteoporosis, such as older women or those with prior bone fractures, should avoid chronic exposure to air pollution, perhaps using masks when walking in traffic or using air filters for indoor ventilation.”
Dr. Adami also said that this evidence so far might spur the future inclusion of chronic exposure to air pollution in fracture risk assessment tools, although this isn’t likely to come about in the near future.
Particulates linked to whole-body, hip, lumbar, and femoral neck BMD
The prospective observational study included 9,041 WHI participants seen over 32,663 visits who were an average of 63 years old at baseline. More than 70% were White, and just under half were college graduates.
With geocoded address data used to estimate particulate matter concentrations, mean levels of particulate matter of 10 mcm or less, nitrogen oxide nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years were all negatively associated with whole-body, total hip, femoral neck, and lumbar spine BMD.
In the multivariate analysis, the highest correlations were found between nitrogen oxide and nitrogen dioxide. For example, lumbar spine BMD decreased by 0.026 g/cm2 per year per 10% increase in 3-year mean nitrogen dioxide concentration.
“Our findings show that both particulate matter and gases may adversely impact BMD and that nitrogen oxides may play a critical role in bone damage and osteoporosis risk,” Dr. Prada and colleagues wrote.
Dr. Adami added: “We need more data to understand the precise magnitude of effect of air pollution on fractures, which might depend on levels of exposure but also on genetics and lifestyle.”
The study was funded by the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Adami reported receiving fees from Amgen, Eli Lilly, UCB, Fresenius Kabi, Galapagos, and Theramex.
A version of this article originally appeared on Medscape.com.
Air pollution appears to contribute independently to bone damage in postmenopausal women, new data suggest.
The findings come from a new analysis of data from the Women’s Health Initiative (WHI) and location-specific air particulate information from the U.S. Environmental Protection Agency.
“Our findings confirm that poor air quality may be a risk factor for bone loss, independent of socioeconomic or demographic factors, and expands previous findings to postmenopausal women. Indeed, to our knowledge, this is the first study of the impact of criteria air pollutants on bone health in postmenopausal women,” Diddier Prada, MD, PhD, Columbia University, New York, and colleagues wrote.
The results are also the first to show that “nitrogen oxides contribute the most to bone damage and that the lumbar spine is one of the most susceptible sites,” they added.
Public health policies should aim to reduce air pollution in general, they wrote, and reducing nitrogen oxides, in particular, will reduce bone damage in postmenopausal women, prevent bone fractures, and reduce the health cost burden associated with osteoporosis in this population.
The findings were recently published in eClinicalMedicine.
Asked to comment, Giovanni Adami, MD, PhD, said in an interview that the study “adds to the body of literature on air pollution and bone health. The study confirms and provides further evidence linking air pollution exposure and osteoporosis.”
Dr. Adami, of the University of Verona (Italy), who also studies this topic, said that these new findings align with those from his group and others.
“The scientific literature in the field is clearly pointing toward a negative effect of chronic pollution exposure on bone health.”
He pointed to one study from his group that found chronic exposure to ultrafine particulate matter is associated with low BMD, and consequently, bone fragility, and another study that showed acute exposure to high levels of pollutants could actually cause fractures.
As for what might be done clinically, Dr. Adami said: “It is difficult to extrapolate direct and immediate recommendations for patients.
“However, it might be acceptable to say that patients at risk of osteoporosis, such as older women or those with prior bone fractures, should avoid chronic exposure to air pollution, perhaps using masks when walking in traffic or using air filters for indoor ventilation.”
Dr. Adami also said that this evidence so far might spur the future inclusion of chronic exposure to air pollution in fracture risk assessment tools, although this isn’t likely to come about in the near future.
Particulates linked to whole-body, hip, lumbar, and femoral neck BMD
The prospective observational study included 9,041 WHI participants seen over 32,663 visits who were an average of 63 years old at baseline. More than 70% were White, and just under half were college graduates.
With geocoded address data used to estimate particulate matter concentrations, mean levels of particulate matter of 10 mcm or less, nitrogen oxide nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years were all negatively associated with whole-body, total hip, femoral neck, and lumbar spine BMD.
In the multivariate analysis, the highest correlations were found between nitrogen oxide and nitrogen dioxide. For example, lumbar spine BMD decreased by 0.026 g/cm2 per year per 10% increase in 3-year mean nitrogen dioxide concentration.
“Our findings show that both particulate matter and gases may adversely impact BMD and that nitrogen oxides may play a critical role in bone damage and osteoporosis risk,” Dr. Prada and colleagues wrote.
Dr. Adami added: “We need more data to understand the precise magnitude of effect of air pollution on fractures, which might depend on levels of exposure but also on genetics and lifestyle.”
The study was funded by the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Adami reported receiving fees from Amgen, Eli Lilly, UCB, Fresenius Kabi, Galapagos, and Theramex.
A version of this article originally appeared on Medscape.com.
Air pollution appears to contribute independently to bone damage in postmenopausal women, new data suggest.
The findings come from a new analysis of data from the Women’s Health Initiative (WHI) and location-specific air particulate information from the U.S. Environmental Protection Agency.
“Our findings confirm that poor air quality may be a risk factor for bone loss, independent of socioeconomic or demographic factors, and expands previous findings to postmenopausal women. Indeed, to our knowledge, this is the first study of the impact of criteria air pollutants on bone health in postmenopausal women,” Diddier Prada, MD, PhD, Columbia University, New York, and colleagues wrote.
The results are also the first to show that “nitrogen oxides contribute the most to bone damage and that the lumbar spine is one of the most susceptible sites,” they added.
Public health policies should aim to reduce air pollution in general, they wrote, and reducing nitrogen oxides, in particular, will reduce bone damage in postmenopausal women, prevent bone fractures, and reduce the health cost burden associated with osteoporosis in this population.
The findings were recently published in eClinicalMedicine.
Asked to comment, Giovanni Adami, MD, PhD, said in an interview that the study “adds to the body of literature on air pollution and bone health. The study confirms and provides further evidence linking air pollution exposure and osteoporosis.”
Dr. Adami, of the University of Verona (Italy), who also studies this topic, said that these new findings align with those from his group and others.
“The scientific literature in the field is clearly pointing toward a negative effect of chronic pollution exposure on bone health.”
He pointed to one study from his group that found chronic exposure to ultrafine particulate matter is associated with low BMD, and consequently, bone fragility, and another study that showed acute exposure to high levels of pollutants could actually cause fractures.
As for what might be done clinically, Dr. Adami said: “It is difficult to extrapolate direct and immediate recommendations for patients.
“However, it might be acceptable to say that patients at risk of osteoporosis, such as older women or those with prior bone fractures, should avoid chronic exposure to air pollution, perhaps using masks when walking in traffic or using air filters for indoor ventilation.”
Dr. Adami also said that this evidence so far might spur the future inclusion of chronic exposure to air pollution in fracture risk assessment tools, although this isn’t likely to come about in the near future.
Particulates linked to whole-body, hip, lumbar, and femoral neck BMD
The prospective observational study included 9,041 WHI participants seen over 32,663 visits who were an average of 63 years old at baseline. More than 70% were White, and just under half were college graduates.
With geocoded address data used to estimate particulate matter concentrations, mean levels of particulate matter of 10 mcm or less, nitrogen oxide nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years were all negatively associated with whole-body, total hip, femoral neck, and lumbar spine BMD.
In the multivariate analysis, the highest correlations were found between nitrogen oxide and nitrogen dioxide. For example, lumbar spine BMD decreased by 0.026 g/cm2 per year per 10% increase in 3-year mean nitrogen dioxide concentration.
“Our findings show that both particulate matter and gases may adversely impact BMD and that nitrogen oxides may play a critical role in bone damage and osteoporosis risk,” Dr. Prada and colleagues wrote.
Dr. Adami added: “We need more data to understand the precise magnitude of effect of air pollution on fractures, which might depend on levels of exposure but also on genetics and lifestyle.”
The study was funded by the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Adami reported receiving fees from Amgen, Eli Lilly, UCB, Fresenius Kabi, Galapagos, and Theramex.
A version of this article originally appeared on Medscape.com.
FROM ECLINICALMEDICINE