The use of isotretinoin to treat acne was not associated with an increase in adverse neuropsychiatric outcomes, compared with the use of oral antibiotics, in a large retrospective cohort study published in the British Journal of Dermatology.

Although severe neuropsychiatric effects associated with isotretinoin therapy in patients with acne have been reported, “the evidence base ... is mixed and inconclusive,” and many studies are small, Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, England, and co-authors write in the study.

The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne, Dr. Fazel, professor of forensic psychiatry at Oxford University and the study’s senior author, said in an interview.

In the study, the investigators reviewed electronic health records (2013-2019) from a primarily United States–based dataset (TriNetX) of patients with acne aged 12-27 who had been followed for up to 1 year after their prescriptions had been dispensed.

There were four arms: those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical anti-acne treatments (108,367), and those who had not been prescribed any acne treatment (78,666). The primary outcomes were diagnoses of a neuropsychiatric disorder (psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and non-fatal self-harm) within one year of being prescribed treatment.

After using propensity score matching to adjust for confounders at baseline, the investigators determined that the odds ratio for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% confidence interval, 0.74-0.87), compared with patients on oral antibiotics; 0.94 (95% CI, 0.87-1.02), compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97-1.16), compared with those without a prescription for anti-acne medicines.

Side effects of isotretinoin – such as headache, dry mouth, and fatigue – were higher among those on isotretinoin than in the other three groups.

The authors concluded that isotretinoin was not independently linked to excess adverse neuropsychiatric outcomes at a population level. “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of adverse neuropsychiatric outcomes, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics,” they write.

Isotretinoin treatment “appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne,” they add.

The dermatology community has been interested in the impact isotretinoin has on mental health, and “I think clinically, they see that people get better on isotretinoin and their mental health improves,” Dr. Fazel told this news organization.

Asked to comment on the study results, John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital, Boston, commended the investigators for the design of the trial.

“One of the strengths of this study is that they use a technique called propensity-score matching, where you try to make the groups of patients similar with respect to their other characteristics to minimize the risks of confounding and bias in the study, which I think is a real strength,” he told this news organization. “The other thing that they do, which I think is a strength, is to think about the impact of acne severity on these outcomes, because we know acne itself is associated with depression and risk for suicide and other neuropsychiatric outcomes.”

Including a cohort of patients who had acne and received oral antibiotics for comparison “is a nice way to address the potential for confounding by severity and confounding by indication,” Dr. Barbieri said. “Those who get antibiotics usually have more severe acne. They may not have it as severely as those who get isotretinoin, but it is a nice approach to account for background levels of depression and neuropsychiatric outcomes in patients with acne. I think that is a real strength of the study. This is one of the best studies to have looked at this question.” 

However, although the study found that isotretinoin decreased the excess psychiatric risk associated with refractory moderate-to-severe acne, it does not rule out the possibility that individuals may experience an adverse psychiatric outcome while on isotretinoin, Dr. Barbieri said.

“While I think on a population level, we absolutely can feel reassured by these data, I do think there are individual patients who have idiosyncratic, unpredictable reactions to isotretinoin where they have mood changes, whether it be irritability, depression, or other mood changes,” he cautioned. “Given the association of acne itself with mental health comorbidities, it is important to screen for comorbidities such as depression in all patients with acne.”

The study was funded by the Wellcome Trust, which provided Dr. Fazel and the first author with financial support for the study. One author is an employee of TriNetX; the other authors had no relevant disclosures. Dr. Barbieri reported no financial disclosures. He is cochair of the AAD’s Acne Guidelines Workgroup and associate editor at JAMA Dermatology.

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

The use of isotretinoin to treat acne was not associated with an increase in adverse neuropsychiatric outcomes, compared with the use of oral antibiotics, in a large retrospective cohort study published in the British Journal of Dermatology.

Although severe neuropsychiatric effects associated with isotretinoin therapy in patients with acne have been reported, “the evidence base ... is mixed and inconclusive,” and many studies are small, Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, England, and co-authors write in the study.

The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne, Dr. Fazel, professor of forensic psychiatry at Oxford University and the study’s senior author, said in an interview.

In the study, the investigators reviewed electronic health records (2013-2019) from a primarily United States–based dataset (TriNetX) of patients with acne aged 12-27 who had been followed for up to 1 year after their prescriptions had been dispensed.

There were four arms: those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical anti-acne treatments (108,367), and those who had not been prescribed any acne treatment (78,666). The primary outcomes were diagnoses of a neuropsychiatric disorder (psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and non-fatal self-harm) within one year of being prescribed treatment.

After using propensity score matching to adjust for confounders at baseline, the investigators determined that the odds ratio for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% confidence interval, 0.74-0.87), compared with patients on oral antibiotics; 0.94 (95% CI, 0.87-1.02), compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97-1.16), compared with those without a prescription for anti-acne medicines.

Side effects of isotretinoin – such as headache, dry mouth, and fatigue – were higher among those on isotretinoin than in the other three groups.

The authors concluded that isotretinoin was not independently linked to excess adverse neuropsychiatric outcomes at a population level. “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of adverse neuropsychiatric outcomes, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics,” they write.

Isotretinoin treatment “appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne,” they add.

The dermatology community has been interested in the impact isotretinoin has on mental health, and “I think clinically, they see that people get better on isotretinoin and their mental health improves,” Dr. Fazel told this news organization.

Asked to comment on the study results, John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital, Boston, commended the investigators for the design of the trial.

“One of the strengths of this study is that they use a technique called propensity-score matching, where you try to make the groups of patients similar with respect to their other characteristics to minimize the risks of confounding and bias in the study, which I think is a real strength,” he told this news organization. “The other thing that they do, which I think is a strength, is to think about the impact of acne severity on these outcomes, because we know acne itself is associated with depression and risk for suicide and other neuropsychiatric outcomes.”

Including a cohort of patients who had acne and received oral antibiotics for comparison “is a nice way to address the potential for confounding by severity and confounding by indication,” Dr. Barbieri said. “Those who get antibiotics usually have more severe acne. They may not have it as severely as those who get isotretinoin, but it is a nice approach to account for background levels of depression and neuropsychiatric outcomes in patients with acne. I think that is a real strength of the study. This is one of the best studies to have looked at this question.” 

However, although the study found that isotretinoin decreased the excess psychiatric risk associated with refractory moderate-to-severe acne, it does not rule out the possibility that individuals may experience an adverse psychiatric outcome while on isotretinoin, Dr. Barbieri said.

“While I think on a population level, we absolutely can feel reassured by these data, I do think there are individual patients who have idiosyncratic, unpredictable reactions to isotretinoin where they have mood changes, whether it be irritability, depression, or other mood changes,” he cautioned. “Given the association of acne itself with mental health comorbidities, it is important to screen for comorbidities such as depression in all patients with acne.”

The study was funded by the Wellcome Trust, which provided Dr. Fazel and the first author with financial support for the study. One author is an employee of TriNetX; the other authors had no relevant disclosures. Dr. Barbieri reported no financial disclosures. He is cochair of the AAD’s Acne Guidelines Workgroup and associate editor at JAMA Dermatology.

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

The use of isotretinoin to treat acne was not associated with an increase in adverse neuropsychiatric outcomes, compared with the use of oral antibiotics, in a large retrospective cohort study published in the British Journal of Dermatology.

Although severe neuropsychiatric effects associated with isotretinoin therapy in patients with acne have been reported, “the evidence base ... is mixed and inconclusive,” and many studies are small, Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, England, and co-authors write in the study.

The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne, Dr. Fazel, professor of forensic psychiatry at Oxford University and the study’s senior author, said in an interview.

In the study, the investigators reviewed electronic health records (2013-2019) from a primarily United States–based dataset (TriNetX) of patients with acne aged 12-27 who had been followed for up to 1 year after their prescriptions had been dispensed.

There were four arms: those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical anti-acne treatments (108,367), and those who had not been prescribed any acne treatment (78,666). The primary outcomes were diagnoses of a neuropsychiatric disorder (psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and non-fatal self-harm) within one year of being prescribed treatment.

After using propensity score matching to adjust for confounders at baseline, the investigators determined that the odds ratio for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% confidence interval, 0.74-0.87), compared with patients on oral antibiotics; 0.94 (95% CI, 0.87-1.02), compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97-1.16), compared with those without a prescription for anti-acne medicines.

Side effects of isotretinoin – such as headache, dry mouth, and fatigue – were higher among those on isotretinoin than in the other three groups.

The authors concluded that isotretinoin was not independently linked to excess adverse neuropsychiatric outcomes at a population level. “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of adverse neuropsychiatric outcomes, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics,” they write.

Isotretinoin treatment “appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne,” they add.

The dermatology community has been interested in the impact isotretinoin has on mental health, and “I think clinically, they see that people get better on isotretinoin and their mental health improves,” Dr. Fazel told this news organization.

Asked to comment on the study results, John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital, Boston, commended the investigators for the design of the trial.

“One of the strengths of this study is that they use a technique called propensity-score matching, where you try to make the groups of patients similar with respect to their other characteristics to minimize the risks of confounding and bias in the study, which I think is a real strength,” he told this news organization. “The other thing that they do, which I think is a strength, is to think about the impact of acne severity on these outcomes, because we know acne itself is associated with depression and risk for suicide and other neuropsychiatric outcomes.”

Including a cohort of patients who had acne and received oral antibiotics for comparison “is a nice way to address the potential for confounding by severity and confounding by indication,” Dr. Barbieri said. “Those who get antibiotics usually have more severe acne. They may not have it as severely as those who get isotretinoin, but it is a nice approach to account for background levels of depression and neuropsychiatric outcomes in patients with acne. I think that is a real strength of the study. This is one of the best studies to have looked at this question.” 

However, although the study found that isotretinoin decreased the excess psychiatric risk associated with refractory moderate-to-severe acne, it does not rule out the possibility that individuals may experience an adverse psychiatric outcome while on isotretinoin, Dr. Barbieri said.

“While I think on a population level, we absolutely can feel reassured by these data, I do think there are individual patients who have idiosyncratic, unpredictable reactions to isotretinoin where they have mood changes, whether it be irritability, depression, or other mood changes,” he cautioned. “Given the association of acne itself with mental health comorbidities, it is important to screen for comorbidities such as depression in all patients with acne.”

The study was funded by the Wellcome Trust, which provided Dr. Fazel and the first author with financial support for the study. One author is an employee of TriNetX; the other authors had no relevant disclosures. Dr. Barbieri reported no financial disclosures. He is cochair of the AAD’s Acne Guidelines Workgroup and associate editor at JAMA Dermatology.

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

The Food and Drug Administration has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

In its statement, the FDA notes that there is an “unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”

The agency goes on to state that this new test may eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” to visualize amyloid plaques for the diagnosis of AD.

The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid (CSF). A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

However, the FDA notes that the test is not a stand-alone assay and should be used in conjunction with other clinical evaluations and additional tests to determine treatment options.

The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false-positive and false-negative test results.

False-positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for AD.

False-negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment for AD.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The agency says this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 

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

The Food and Drug Administration has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

In its statement, the FDA notes that there is an “unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”

The agency goes on to state that this new test may eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” to visualize amyloid plaques for the diagnosis of AD.

The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid (CSF). A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

However, the FDA notes that the test is not a stand-alone assay and should be used in conjunction with other clinical evaluations and additional tests to determine treatment options.

The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false-positive and false-negative test results.

False-positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for AD.

False-negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment for AD.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The agency says this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 

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

The Food and Drug Administration has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

In its statement, the FDA notes that there is an “unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”

The agency goes on to state that this new test may eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” to visualize amyloid plaques for the diagnosis of AD.

The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid (CSF). A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

However, the FDA notes that the test is not a stand-alone assay and should be used in conjunction with other clinical evaluations and additional tests to determine treatment options.

The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false-positive and false-negative test results.

False-positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for AD.

False-negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment for AD.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The agency says this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 

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

A rise in esophageal adenocarcinoma (EAC) cases and deaths showcases a need for noninvasive screening methods that can be performed by nonendoscopists, such as nurses or technicians, according to a presentation at the 2022 AGA Tech Summit that reviewed the new approaches. AGA’s annual innovation summit is sponsored by the AGA Center for GI Innovation and Technology.

Mortality rates are high, because the cancer is usually found after obstructive symptoms. Screening for Barrett’s esophagus (BE) and associated dysplasia could lead to earlier diagnosis and better prognoses, but endoscopic screening is costly and invasive, and few at-risk patients take advantage of it.

Some new approaches have the potential to screen more patients and detect earlier stages of disease, according to Prasad Iyer, MD, director of the esophageal interest group in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.

The estimated rise in EAC ranges from 400% to 600% between 1975 and 2000. The 5-year survival of EAC hovers at around 20%. “Not only is the incidence increasing, but the mortality associated with the disease is also increasing at a similar pace,” said Dr. Iyer during his presentation.

The only known precursor to EAC is BE, which has made the condition a focal point in screening. “If we can screen those with risk factors, we can identify those with prevalent Barrett’s. We then can put those with known Barrett’s into surveillance to detect cancer or high-grade or low-grade dysplasia. And then we when we find dysplasia or early cancer, we can intervene hopefully endoscopically to prevent or treat this progression from Barrett’s to adenocarcinoma,” said Dr. Iyer.

Endoscopic treatment of dysplasia achieves similar long-term survival outcomes to esophagectomy,Dr. Iyer said. Clinical studies have shown that radiofrequency ablation of high-grade and low-grade dysplasia reduces progression to cancer.
 

Low screening rates miss at-risk patients

Unfortunately, only 10%-12% of esophageal cancers are detected during surveillance, partly because many with BE are unaware of the condition and therefore don’t enter surveillance. “Two-thirds of the patients with Barrett’s are not under surveillance, so it’s not surprising that most esophageal cancers, unfortunately, are still being diagnosed after the onset of obstructive symptoms,” said Dr. Iyer.

A key issue is that sedated endoscopy is the only available screening tool, and it is expensive and invasive. “Only 10% of those who should get evaluated for the presence of Barrett’s are currently getting evaluated,” said Dr. Iyer.

Those issues have led to a movement to develop noninvasive methods for screening that could be performed by nonendoscopists, such as nurses or technicians. Dr. Iyer noted the importance of sensitivity and specificity of any test, but access to the test and participation are often overlooked factors.

“We hope that, by developing a nonendoscopic, minimally invasive test, we can increase access by allowing nonphysicians to perform this test. By keeping the costs low, we make this strategy cost effective, and hopefully get buy in for reimbursement from payers,” said Dr. Iyer.
 

New screening methods on horizon

He reviewed several noninvasive screening methodologies in development.

Unsedated transnasal endoscopy has been used successfully to diagnose BE, but the technique has not gained much traction in the United States.

Some devices collect esophageal cells, and then test them for various biomarkers. These include EsophaCap, CytoSponge, and the ESOCHEK Balloon. The procedure requires the patient to swallow a device, which is attached to a string or cord. After a few minutes, the device expands into a sphere or balloon, and the operator pulls it out through the esophagus, collecting 3-4 million esophageal cells in the process.

Biomarker analysis of the cells can include the protein trefoil factor 3 and methylated DNA markers. Case-control studies have shown this approach can achieve sensitivities of 76%-94%, and specificities of 62%-92%. “At least in case-control studies, this technology has been shown in thousands of patients now to be well tolerated, very safe, with a low risk of detachment, and can be done by a nurse in an office setting in less than 10 minutes,” said Dr. Iyer.
 

Earlier detection of Barrett’s

He summarized a randomized, controlled trial, published in 2020 in The Lancet, which tested this approach in patients who had taken proton pump inhibitors for at least 6 months. It compared 6,983 patients screened using the CytoSponge/TFF3 with 6,531 usual-care patients who only underwent screening if their physicians recommended it.

In the screening group, 140 patients were diagnosed with Barrett’s Esophagus, compared with 13 in the usual-care group. There were nine cases of dysplastic Barrett’s and five cases of stage I EAC in the screening group, versus no dysplastic Barrett’s and three advanced stage EAC cases in the usual care group. “You can see how we can shift the spectrum of patients with Barrett’s if we go for early detection,” said Dr. Iyer.

Another noninvasive strategy relies on sensors to detect exhaled volatile organic compounds. After a patient breathes into the detector for about 5 minutes, an artificial neural network distinguishes molecular patterns indicative of the presence or absence of BE. The technique had just moderate sensitivity and specificity, “But this is very noninvasive and even less invasive than [sponge or balloon]-based technology,” said Dr. Iyer.

Other efforts are underway to identify plasma biomarkers for screening. Dr. Iyer and colleagues have developed methylated DNA markers for EAC and squamous cell cancer. So far, they have achieved sensitivity and specificity just above 80%. “Not where we would want it to be, but certainly not terrible,” said Dr. Iyer, adding that they are performing a larger prospective study.

He described a potential screening program that could draw from electronic medical records or even apps to identify patients with risk above a defined threshold who would then be tested with minimally invasive techniques. Those with positive results would go on to confirmatory endoscopy. His group found that such a strategy would be cost effective even if reflux was not used as a qualifying criterion for screening.

Answering audience questions after the talk, Dr. Iyer was asked if noninvasive methods would directly compete with endoscopy, or if some patients would be better candidates for one or the other.

“That’s something we need to think through. It’s going to be very difficult for us to say every patient at risk should get an endoscopy. I just don’t think that strategy is probably practical or cost effective. On the other hand, I think an all-of-the-above strategy is probably just fine. It’s like elections. You have to be very local, your message has to be cost effective, available, and have adequate patient as well as provider buy-in,” he said.

Dr. Iyer has received research funding from Exact Sciences, Pentax Medical, and Cernostics. He has consulted for Exact Sciences, Pentax Medical, Medtronic, Ambu, Cernostics, CDx Diagnostics, and Symple Surgical. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

A rise in esophageal adenocarcinoma (EAC) cases and deaths showcases a need for noninvasive screening methods that can be performed by nonendoscopists, such as nurses or technicians, according to a presentation at the 2022 AGA Tech Summit that reviewed the new approaches. AGA’s annual innovation summit is sponsored by the AGA Center for GI Innovation and Technology.

Mortality rates are high, because the cancer is usually found after obstructive symptoms. Screening for Barrett’s esophagus (BE) and associated dysplasia could lead to earlier diagnosis and better prognoses, but endoscopic screening is costly and invasive, and few at-risk patients take advantage of it.

Some new approaches have the potential to screen more patients and detect earlier stages of disease, according to Prasad Iyer, MD, director of the esophageal interest group in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.

The estimated rise in EAC ranges from 400% to 600% between 1975 and 2000. The 5-year survival of EAC hovers at around 20%. “Not only is the incidence increasing, but the mortality associated with the disease is also increasing at a similar pace,” said Dr. Iyer during his presentation.

The only known precursor to EAC is BE, which has made the condition a focal point in screening. “If we can screen those with risk factors, we can identify those with prevalent Barrett’s. We then can put those with known Barrett’s into surveillance to detect cancer or high-grade or low-grade dysplasia. And then we when we find dysplasia or early cancer, we can intervene hopefully endoscopically to prevent or treat this progression from Barrett’s to adenocarcinoma,” said Dr. Iyer.

Endoscopic treatment of dysplasia achieves similar long-term survival outcomes to esophagectomy,Dr. Iyer said. Clinical studies have shown that radiofrequency ablation of high-grade and low-grade dysplasia reduces progression to cancer.
 

Low screening rates miss at-risk patients

Unfortunately, only 10%-12% of esophageal cancers are detected during surveillance, partly because many with BE are unaware of the condition and therefore don’t enter surveillance. “Two-thirds of the patients with Barrett’s are not under surveillance, so it’s not surprising that most esophageal cancers, unfortunately, are still being diagnosed after the onset of obstructive symptoms,” said Dr. Iyer.

A key issue is that sedated endoscopy is the only available screening tool, and it is expensive and invasive. “Only 10% of those who should get evaluated for the presence of Barrett’s are currently getting evaluated,” said Dr. Iyer.

Those issues have led to a movement to develop noninvasive methods for screening that could be performed by nonendoscopists, such as nurses or technicians. Dr. Iyer noted the importance of sensitivity and specificity of any test, but access to the test and participation are often overlooked factors.

“We hope that, by developing a nonendoscopic, minimally invasive test, we can increase access by allowing nonphysicians to perform this test. By keeping the costs low, we make this strategy cost effective, and hopefully get buy in for reimbursement from payers,” said Dr. Iyer.
 

New screening methods on horizon

He reviewed several noninvasive screening methodologies in development.

Unsedated transnasal endoscopy has been used successfully to diagnose BE, but the technique has not gained much traction in the United States.

Some devices collect esophageal cells, and then test them for various biomarkers. These include EsophaCap, CytoSponge, and the ESOCHEK Balloon. The procedure requires the patient to swallow a device, which is attached to a string or cord. After a few minutes, the device expands into a sphere or balloon, and the operator pulls it out through the esophagus, collecting 3-4 million esophageal cells in the process.

Biomarker analysis of the cells can include the protein trefoil factor 3 and methylated DNA markers. Case-control studies have shown this approach can achieve sensitivities of 76%-94%, and specificities of 62%-92%. “At least in case-control studies, this technology has been shown in thousands of patients now to be well tolerated, very safe, with a low risk of detachment, and can be done by a nurse in an office setting in less than 10 minutes,” said Dr. Iyer.
 

Earlier detection of Barrett’s

He summarized a randomized, controlled trial, published in 2020 in The Lancet, which tested this approach in patients who had taken proton pump inhibitors for at least 6 months. It compared 6,983 patients screened using the CytoSponge/TFF3 with 6,531 usual-care patients who only underwent screening if their physicians recommended it.

In the screening group, 140 patients were diagnosed with Barrett’s Esophagus, compared with 13 in the usual-care group. There were nine cases of dysplastic Barrett’s and five cases of stage I EAC in the screening group, versus no dysplastic Barrett’s and three advanced stage EAC cases in the usual care group. “You can see how we can shift the spectrum of patients with Barrett’s if we go for early detection,” said Dr. Iyer.

Another noninvasive strategy relies on sensors to detect exhaled volatile organic compounds. After a patient breathes into the detector for about 5 minutes, an artificial neural network distinguishes molecular patterns indicative of the presence or absence of BE. The technique had just moderate sensitivity and specificity, “But this is very noninvasive and even less invasive than [sponge or balloon]-based technology,” said Dr. Iyer.

Other efforts are underway to identify plasma biomarkers for screening. Dr. Iyer and colleagues have developed methylated DNA markers for EAC and squamous cell cancer. So far, they have achieved sensitivity and specificity just above 80%. “Not where we would want it to be, but certainly not terrible,” said Dr. Iyer, adding that they are performing a larger prospective study.

He described a potential screening program that could draw from electronic medical records or even apps to identify patients with risk above a defined threshold who would then be tested with minimally invasive techniques. Those with positive results would go on to confirmatory endoscopy. His group found that such a strategy would be cost effective even if reflux was not used as a qualifying criterion for screening.

Answering audience questions after the talk, Dr. Iyer was asked if noninvasive methods would directly compete with endoscopy, or if some patients would be better candidates for one or the other.

“That’s something we need to think through. It’s going to be very difficult for us to say every patient at risk should get an endoscopy. I just don’t think that strategy is probably practical or cost effective. On the other hand, I think an all-of-the-above strategy is probably just fine. It’s like elections. You have to be very local, your message has to be cost effective, available, and have adequate patient as well as provider buy-in,” he said.

Dr. Iyer has received research funding from Exact Sciences, Pentax Medical, and Cernostics. He has consulted for Exact Sciences, Pentax Medical, Medtronic, Ambu, Cernostics, CDx Diagnostics, and Symple Surgical. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

A rise in esophageal adenocarcinoma (EAC) cases and deaths showcases a need for noninvasive screening methods that can be performed by nonendoscopists, such as nurses or technicians, according to a presentation at the 2022 AGA Tech Summit that reviewed the new approaches. AGA’s annual innovation summit is sponsored by the AGA Center for GI Innovation and Technology.

Mortality rates are high, because the cancer is usually found after obstructive symptoms. Screening for Barrett’s esophagus (BE) and associated dysplasia could lead to earlier diagnosis and better prognoses, but endoscopic screening is costly and invasive, and few at-risk patients take advantage of it.

Some new approaches have the potential to screen more patients and detect earlier stages of disease, according to Prasad Iyer, MD, director of the esophageal interest group in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.

The estimated rise in EAC ranges from 400% to 600% between 1975 and 2000. The 5-year survival of EAC hovers at around 20%. “Not only is the incidence increasing, but the mortality associated with the disease is also increasing at a similar pace,” said Dr. Iyer during his presentation.

The only known precursor to EAC is BE, which has made the condition a focal point in screening. “If we can screen those with risk factors, we can identify those with prevalent Barrett’s. We then can put those with known Barrett’s into surveillance to detect cancer or high-grade or low-grade dysplasia. And then we when we find dysplasia or early cancer, we can intervene hopefully endoscopically to prevent or treat this progression from Barrett’s to adenocarcinoma,” said Dr. Iyer.

Endoscopic treatment of dysplasia achieves similar long-term survival outcomes to esophagectomy,Dr. Iyer said. Clinical studies have shown that radiofrequency ablation of high-grade and low-grade dysplasia reduces progression to cancer.
 

Low screening rates miss at-risk patients

Unfortunately, only 10%-12% of esophageal cancers are detected during surveillance, partly because many with BE are unaware of the condition and therefore don’t enter surveillance. “Two-thirds of the patients with Barrett’s are not under surveillance, so it’s not surprising that most esophageal cancers, unfortunately, are still being diagnosed after the onset of obstructive symptoms,” said Dr. Iyer.

A key issue is that sedated endoscopy is the only available screening tool, and it is expensive and invasive. “Only 10% of those who should get evaluated for the presence of Barrett’s are currently getting evaluated,” said Dr. Iyer.

Those issues have led to a movement to develop noninvasive methods for screening that could be performed by nonendoscopists, such as nurses or technicians. Dr. Iyer noted the importance of sensitivity and specificity of any test, but access to the test and participation are often overlooked factors.

“We hope that, by developing a nonendoscopic, minimally invasive test, we can increase access by allowing nonphysicians to perform this test. By keeping the costs low, we make this strategy cost effective, and hopefully get buy in for reimbursement from payers,” said Dr. Iyer.
 

New screening methods on horizon

He reviewed several noninvasive screening methodologies in development.

Unsedated transnasal endoscopy has been used successfully to diagnose BE, but the technique has not gained much traction in the United States.

Some devices collect esophageal cells, and then test them for various biomarkers. These include EsophaCap, CytoSponge, and the ESOCHEK Balloon. The procedure requires the patient to swallow a device, which is attached to a string or cord. After a few minutes, the device expands into a sphere or balloon, and the operator pulls it out through the esophagus, collecting 3-4 million esophageal cells in the process.

Biomarker analysis of the cells can include the protein trefoil factor 3 and methylated DNA markers. Case-control studies have shown this approach can achieve sensitivities of 76%-94%, and specificities of 62%-92%. “At least in case-control studies, this technology has been shown in thousands of patients now to be well tolerated, very safe, with a low risk of detachment, and can be done by a nurse in an office setting in less than 10 minutes,” said Dr. Iyer.
 

Earlier detection of Barrett’s

He summarized a randomized, controlled trial, published in 2020 in The Lancet, which tested this approach in patients who had taken proton pump inhibitors for at least 6 months. It compared 6,983 patients screened using the CytoSponge/TFF3 with 6,531 usual-care patients who only underwent screening if their physicians recommended it.

In the screening group, 140 patients were diagnosed with Barrett’s Esophagus, compared with 13 in the usual-care group. There were nine cases of dysplastic Barrett’s and five cases of stage I EAC in the screening group, versus no dysplastic Barrett’s and three advanced stage EAC cases in the usual care group. “You can see how we can shift the spectrum of patients with Barrett’s if we go for early detection,” said Dr. Iyer.

Another noninvasive strategy relies on sensors to detect exhaled volatile organic compounds. After a patient breathes into the detector for about 5 minutes, an artificial neural network distinguishes molecular patterns indicative of the presence or absence of BE. The technique had just moderate sensitivity and specificity, “But this is very noninvasive and even less invasive than [sponge or balloon]-based technology,” said Dr. Iyer.

Other efforts are underway to identify plasma biomarkers for screening. Dr. Iyer and colleagues have developed methylated DNA markers for EAC and squamous cell cancer. So far, they have achieved sensitivity and specificity just above 80%. “Not where we would want it to be, but certainly not terrible,” said Dr. Iyer, adding that they are performing a larger prospective study.

He described a potential screening program that could draw from electronic medical records or even apps to identify patients with risk above a defined threshold who would then be tested with minimally invasive techniques. Those with positive results would go on to confirmatory endoscopy. His group found that such a strategy would be cost effective even if reflux was not used as a qualifying criterion for screening.

Answering audience questions after the talk, Dr. Iyer was asked if noninvasive methods would directly compete with endoscopy, or if some patients would be better candidates for one or the other.

“That’s something we need to think through. It’s going to be very difficult for us to say every patient at risk should get an endoscopy. I just don’t think that strategy is probably practical or cost effective. On the other hand, I think an all-of-the-above strategy is probably just fine. It’s like elections. You have to be very local, your message has to be cost effective, available, and have adequate patient as well as provider buy-in,” he said.

Dr. Iyer has received research funding from Exact Sciences, Pentax Medical, and Cernostics. He has consulted for Exact Sciences, Pentax Medical, Medtronic, Ambu, Cernostics, CDx Diagnostics, and Symple Surgical. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

The findings of smooth, round alopecia occurring rapidly without associated scarring, pain, or itching, is consistent with the diagnosis of alopecia areata.

Alopecia areata is a common autoimmune disease caused by T lymphocytes targeting hair follicles and resulting in rapid and nonscarring hair loss. It is usually self-resolving and about 2% of all individuals are affected at some point during their lifetime, with an average age of onset of 33 years.¹ Some patients may progress to loss of all scalp hair (alopecia totalis) or all hair on the scalp and body (alopecia universalis).¹

It is important to inspect a patient’s scalp, face, and body for more subtle areas of loss that could signal other disorders, such as lichen planopilaris, discoid lupus, or telogen effluvium. It is worth noting that alopecia areata is not associated with scalp lesions, crusting, or scars without follicles. Such findings should be further investigated with a 4-mm punch biopsy of affected and adjacent follicular units. Carefully labeling biopsy specimens as scalp specimens for hair loss will aid in a correct histopathologic diagnosis.

Systematic data comparing treatments for alopecia areata are lacking. For localized disease, topical or intradermal triamcinolone injections at a concentration of 5 to 10 mg/mL, with about 0.1 mL to 0.05 mL injected every square centimeter of affected area (up to 40 mg per visit), can provide rapid regrowth.¹ Within 4 months of the monthly injections, 63% of patients experience complete regrowth.¹ Despite this favorable outcome, there is also a high rate of recurrence.

For more widespread disease, contact immunotherapy with squaric acid dibutyl ester or diphencyprone can provoke a low-grade contact allergy and induce antigenic completion. This therapy is painless but can be itchy; medications must be compounded and titrated to activity.

The patient in this case opted to receive monthly triamcinolone injections in an undiluted concentration of 10 mg/mL for 3 months, at which point she experienced excellent hair regrowth. A small patch of recurrence was noted a year later and treated twice with monthly triamcinolone injections.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

The findings of smooth, round alopecia occurring rapidly without associated scarring, pain, or itching, is consistent with the diagnosis of alopecia areata.

Alopecia areata is a common autoimmune disease caused by T lymphocytes targeting hair follicles and resulting in rapid and nonscarring hair loss. It is usually self-resolving and about 2% of all individuals are affected at some point during their lifetime, with an average age of onset of 33 years.¹ Some patients may progress to loss of all scalp hair (alopecia totalis) or all hair on the scalp and body (alopecia universalis).¹

It is important to inspect a patient’s scalp, face, and body for more subtle areas of loss that could signal other disorders, such as lichen planopilaris, discoid lupus, or telogen effluvium. It is worth noting that alopecia areata is not associated with scalp lesions, crusting, or scars without follicles. Such findings should be further investigated with a 4-mm punch biopsy of affected and adjacent follicular units. Carefully labeling biopsy specimens as scalp specimens for hair loss will aid in a correct histopathologic diagnosis.

Systematic data comparing treatments for alopecia areata are lacking. For localized disease, topical or intradermal triamcinolone injections at a concentration of 5 to 10 mg/mL, with about 0.1 mL to 0.05 mL injected every square centimeter of affected area (up to 40 mg per visit), can provide rapid regrowth.¹ Within 4 months of the monthly injections, 63% of patients experience complete regrowth.¹ Despite this favorable outcome, there is also a high rate of recurrence.

For more widespread disease, contact immunotherapy with squaric acid dibutyl ester or diphencyprone can provoke a low-grade contact allergy and induce antigenic completion. This therapy is painless but can be itchy; medications must be compounded and titrated to activity.

The patient in this case opted to receive monthly triamcinolone injections in an undiluted concentration of 10 mg/mL for 3 months, at which point she experienced excellent hair regrowth. A small patch of recurrence was noted a year later and treated twice with monthly triamcinolone injections.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

The findings of smooth, round alopecia occurring rapidly without associated scarring, pain, or itching, is consistent with the diagnosis of alopecia areata.

Alopecia areata is a common autoimmune disease caused by T lymphocytes targeting hair follicles and resulting in rapid and nonscarring hair loss. It is usually self-resolving and about 2% of all individuals are affected at some point during their lifetime, with an average age of onset of 33 years.¹ Some patients may progress to loss of all scalp hair (alopecia totalis) or all hair on the scalp and body (alopecia universalis).¹

It is important to inspect a patient’s scalp, face, and body for more subtle areas of loss that could signal other disorders, such as lichen planopilaris, discoid lupus, or telogen effluvium. It is worth noting that alopecia areata is not associated with scalp lesions, crusting, or scars without follicles. Such findings should be further investigated with a 4-mm punch biopsy of affected and adjacent follicular units. Carefully labeling biopsy specimens as scalp specimens for hair loss will aid in a correct histopathologic diagnosis.

Systematic data comparing treatments for alopecia areata are lacking. For localized disease, topical or intradermal triamcinolone injections at a concentration of 5 to 10 mg/mL, with about 0.1 mL to 0.05 mL injected every square centimeter of affected area (up to 40 mg per visit), can provide rapid regrowth.¹ Within 4 months of the monthly injections, 63% of patients experience complete regrowth.¹ Despite this favorable outcome, there is also a high rate of recurrence.

For more widespread disease, contact immunotherapy with squaric acid dibutyl ester or diphencyprone can provoke a low-grade contact allergy and induce antigenic completion. This therapy is painless but can be itchy; medications must be compounded and titrated to activity.

The patient in this case opted to receive monthly triamcinolone injections in an undiluted concentration of 10 mg/mL for 3 months, at which point she experienced excellent hair regrowth. A small patch of recurrence was noted a year later and treated twice with monthly triamcinolone injections.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

Mood instability, or sudden, unpredictable, and frequent shifts in emotional states, characterizes many types of psychiatric disorder, including attention-deficit/hyperactivity disorder (ADHD), personality disorders, depression, and posttraumatic stress disorder. To say that individuals with bipolar disorder (BD) have mood instability sounds like a tautology. Nonetheless, mood instability has particular relevance to BD: Many patients have irregular or labile moods even when they are between major episodes of mania and depression.¹

Children of parents with BD who have high levels of mood instability are at particularly high risk for developing BD (types I or II) in late adolescence or early adulthood.² The following case provides an illustration:

Patrick, age 14, entered treatment with diagnoses of ADHD and other specified bipolar disorder. His mother felt that his behavior resembled that of his father, who had been treated for manic episodes. During the COVID-19 pandemic, Patrick had become increasingly difficult at home, with significant oppositionality, impulsive behavior, and difficulty following through on school assignments or household tasks. His mother’s most significant complaints concerned Patrick’s sudden outbursts of anger and abrupt verbal abuse when she asked him to stop playing video games. When interrupted, he cursed loudly and sometimes turned violent; he had broken a window and a door at home and had on one occasion physically attacked his younger brother. Patrick agreed that he became angry at times, but felt that others provoked him. When queried about depression, he described anxiety and worry. He was unable to describe a particular trigger for his anxiety except for being interrupted in online games with his friends, which made him “feel like a total loser.”

His mother reported that Patrick had multiple 1- to 2-day intervals in which he became “really silly, laughing at nothing,” talking rapidly, jumping from one topic to another, and becoming annoyed when others didn’t share his enthusiasm. In these activated intervals, he slept little and seemed to be full of energy; his mother would hear him talking loudly into his phone throughout the night. During one such interval he had become verbally aggressive with a peer, which had ruined their friendship. Both Patrick and his mother reported that they had been fighting constantly and, in her words, “our house has become a war zone.”

In our recent article in the Journal of the American Academy of Child and Adolescent Psychiatry,³ my coauthors and I examined the association between parents’ ratings of mood instability and clinicians’ longitudinal ratings of symptoms and functioning among youth (ages 9-17 years) who were at high risk for BD. The participants met DSM-5 diagnostic criteria for major depressive disorder or other specified BD, defined as recurrent and brief periods of elevation and activation that did not meet syndromal mania or hypomania criteria. All participants had at least one first- or second-degree family member with a history of BD I or II. Following a period of evaluation, participants were randomly assigned to one of two 4-month psychological therapies: Family-focused therapy (12 sessions of psychoeducation, communication training, and problem-solving skills training) or enhanced usual care (6 sessions of family and individual psychoeducation and support). They also received pharmacological management from study-affiliated psychiatrists when warranted.

We measured mood instability at intake and every 4-6 months over an average of 2 years (range 0-255 weeks). We used a brief parent questionnaire – the Children’s Affective Lability Scale⁴ – which enables measurement of lability on the dimensions of elevation or activation (e.g., bursts of silliness or hilarity, excessive familiarity with others), irritability (e.g., temper outbursts), or anxious-depression (e.g., sudden bouts of crying).

Over the 1- to 4-year period of follow-up, mood instability was associated with poor prognosis indicators in high-risk youth: Being younger, having younger ages at first symptom onset, being diagnosed with other specified BD (vs. major depression), and having more complex patterns of comorbid disorders. Mood instability tracked closely with levels of mania, depression, and global functioning over the follow-up. There was a temporal pathway between a diagnosis of other specified bipolar disorder at intake and higher levels of mood instability at follow-up, which in turn predicted higher levels of parent/child conflict. High levels of mood lability may lead to isolation from peers and tension within family relationships, which may fuel further children’s expressions of frustration, rage, depression, or impulsive behavior.

Youth with higher levels of mood instability required more complex medication regimens over 1 year than did those with lower instability. There was an overall reduction in mood instability as children aged (or spent more time in treatment). Over the 1- to 4-year follow-up, family-focused therapy was associated with longer intervals prior to new mood episodes than was enhanced usual care, but reductions in mood instability were independent of the type of psychosocial treatment assigned to children.

The participants in this study could not be followed long enough to determine whether levels of mood instability were associated with the later development of syndromal BD. Other studies, however, have documented this relationship. Large-scale longitudinal studies of high-risk children find that measures of mood lability – along with early onset manic symptoms, depression, anxiety, and a family history of mania or hypomania – can be combined to calculate the risk that any individual child will develop BD I or II over the next 5-8 years.^2,5

Clinicians should include measurement of the severity and psychosocial determinants of persistent mood shifts in youth under their care, particularly those with a family history of BD. Mood instability is associated with more severe symptom trajectories, more social isolation, and greater distress and conflict within the family. It may require a greater intensity of both pharmacological and psychosocial treatments to treat existing symptoms and functional impairments, and to prevent further mood deterioration.

Dr. Miklowitz is Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior. He is the author of “The Bipolar Disorder Survival Guide, 3rd Ed.” (New York: Guilford Press, 2019) and “Bipolar Disorder: A Family-Focused Treatment Approach, 2nd Ed” (New York: Guilford Press, 2010). He has no conflicts of interest to disclose. Contact Dr. Miklowitz at [email protected].

References

1. Bonsall MB, et al. Nonlinear time-series approaches in characterizing mood stability and mood instability in bipolar disorder. Proc Biol Sci. Mar 7 2012;279(1730):916-24. doi: 10.1098/rspb.2011.1246.

2. Hafeman DM, et al. Toward the definition of a bipolar prodrome: Dimensional predictors of bipolar spectrum disorders in at-risk youths. Am J Psychiatry. 2016;173(7):695-704. doi: 10.1176/appi.ajp.2015.15040414.

3. Miklowitz DJ, et al. Mood instability in youth at high risk for bipolar disorder. J Am Acad Child Adol Psychiatry. 2022 Mar 17;S0890-8567(22)00118-6. doi: 10.1016/j.jaac.2022.03.009.

4. Gerson AC, et al. The Children’s Affective Lability Scale: a psychometric evaluation of reliability. Psychiatry Res. Dec 20 1996;65(3):189-98. doi: 10.1016/s0165-1781(96)02851-x.

5. Birmaher B, et al. A risk calculator to predict the individual risk of conversion from subthreshold bipolar symptoms to bipolar disorder I or II in youth. J Am Acad Child Adol Psychiatry. 2018;57(10):755-63. doi: 10.1016/j.jaac.2018.05.023.

Mood instability, or sudden, unpredictable, and frequent shifts in emotional states, characterizes many types of psychiatric disorder, including attention-deficit/hyperactivity disorder (ADHD), personality disorders, depression, and posttraumatic stress disorder. To say that individuals with bipolar disorder (BD) have mood instability sounds like a tautology. Nonetheless, mood instability has particular relevance to BD: Many patients have irregular or labile moods even when they are between major episodes of mania and depression.¹

Children of parents with BD who have high levels of mood instability are at particularly high risk for developing BD (types I or II) in late adolescence or early adulthood.² The following case provides an illustration:

Patrick, age 14, entered treatment with diagnoses of ADHD and other specified bipolar disorder. His mother felt that his behavior resembled that of his father, who had been treated for manic episodes. During the COVID-19 pandemic, Patrick had become increasingly difficult at home, with significant oppositionality, impulsive behavior, and difficulty following through on school assignments or household tasks. His mother’s most significant complaints concerned Patrick’s sudden outbursts of anger and abrupt verbal abuse when she asked him to stop playing video games. When interrupted, he cursed loudly and sometimes turned violent; he had broken a window and a door at home and had on one occasion physically attacked his younger brother. Patrick agreed that he became angry at times, but felt that others provoked him. When queried about depression, he described anxiety and worry. He was unable to describe a particular trigger for his anxiety except for being interrupted in online games with his friends, which made him “feel like a total loser.”

His mother reported that Patrick had multiple 1- to 2-day intervals in which he became “really silly, laughing at nothing,” talking rapidly, jumping from one topic to another, and becoming annoyed when others didn’t share his enthusiasm. In these activated intervals, he slept little and seemed to be full of energy; his mother would hear him talking loudly into his phone throughout the night. During one such interval he had become verbally aggressive with a peer, which had ruined their friendship. Both Patrick and his mother reported that they had been fighting constantly and, in her words, “our house has become a war zone.”

In our recent article in the Journal of the American Academy of Child and Adolescent Psychiatry,³ my coauthors and I examined the association between parents’ ratings of mood instability and clinicians’ longitudinal ratings of symptoms and functioning among youth (ages 9-17 years) who were at high risk for BD. The participants met DSM-5 diagnostic criteria for major depressive disorder or other specified BD, defined as recurrent and brief periods of elevation and activation that did not meet syndromal mania or hypomania criteria. All participants had at least one first- or second-degree family member with a history of BD I or II. Following a period of evaluation, participants were randomly assigned to one of two 4-month psychological therapies: Family-focused therapy (12 sessions of psychoeducation, communication training, and problem-solving skills training) or enhanced usual care (6 sessions of family and individual psychoeducation and support). They also received pharmacological management from study-affiliated psychiatrists when warranted.

We measured mood instability at intake and every 4-6 months over an average of 2 years (range 0-255 weeks). We used a brief parent questionnaire – the Children’s Affective Lability Scale⁴ – which enables measurement of lability on the dimensions of elevation or activation (e.g., bursts of silliness or hilarity, excessive familiarity with others), irritability (e.g., temper outbursts), or anxious-depression (e.g., sudden bouts of crying).

Over the 1- to 4-year period of follow-up, mood instability was associated with poor prognosis indicators in high-risk youth: Being younger, having younger ages at first symptom onset, being diagnosed with other specified BD (vs. major depression), and having more complex patterns of comorbid disorders. Mood instability tracked closely with levels of mania, depression, and global functioning over the follow-up. There was a temporal pathway between a diagnosis of other specified bipolar disorder at intake and higher levels of mood instability at follow-up, which in turn predicted higher levels of parent/child conflict. High levels of mood lability may lead to isolation from peers and tension within family relationships, which may fuel further children’s expressions of frustration, rage, depression, or impulsive behavior.

Youth with higher levels of mood instability required more complex medication regimens over 1 year than did those with lower instability. There was an overall reduction in mood instability as children aged (or spent more time in treatment). Over the 1- to 4-year follow-up, family-focused therapy was associated with longer intervals prior to new mood episodes than was enhanced usual care, but reductions in mood instability were independent of the type of psychosocial treatment assigned to children.

The participants in this study could not be followed long enough to determine whether levels of mood instability were associated with the later development of syndromal BD. Other studies, however, have documented this relationship. Large-scale longitudinal studies of high-risk children find that measures of mood lability – along with early onset manic symptoms, depression, anxiety, and a family history of mania or hypomania – can be combined to calculate the risk that any individual child will develop BD I or II over the next 5-8 years.^2,5

Clinicians should include measurement of the severity and psychosocial determinants of persistent mood shifts in youth under their care, particularly those with a family history of BD. Mood instability is associated with more severe symptom trajectories, more social isolation, and greater distress and conflict within the family. It may require a greater intensity of both pharmacological and psychosocial treatments to treat existing symptoms and functional impairments, and to prevent further mood deterioration.

Dr. Miklowitz is Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior. He is the author of “The Bipolar Disorder Survival Guide, 3rd Ed.” (New York: Guilford Press, 2019) and “Bipolar Disorder: A Family-Focused Treatment Approach, 2nd Ed” (New York: Guilford Press, 2010). He has no conflicts of interest to disclose. Contact Dr. Miklowitz at [email protected].

References

1. Bonsall MB, et al. Nonlinear time-series approaches in characterizing mood stability and mood instability in bipolar disorder. Proc Biol Sci. Mar 7 2012;279(1730):916-24. doi: 10.1098/rspb.2011.1246.

2. Hafeman DM, et al. Toward the definition of a bipolar prodrome: Dimensional predictors of bipolar spectrum disorders in at-risk youths. Am J Psychiatry. 2016;173(7):695-704. doi: 10.1176/appi.ajp.2015.15040414.

3. Miklowitz DJ, et al. Mood instability in youth at high risk for bipolar disorder. J Am Acad Child Adol Psychiatry. 2022 Mar 17;S0890-8567(22)00118-6. doi: 10.1016/j.jaac.2022.03.009.

4. Gerson AC, et al. The Children’s Affective Lability Scale: a psychometric evaluation of reliability. Psychiatry Res. Dec 20 1996;65(3):189-98. doi: 10.1016/s0165-1781(96)02851-x.

5. Birmaher B, et al. A risk calculator to predict the individual risk of conversion from subthreshold bipolar symptoms to bipolar disorder I or II in youth. J Am Acad Child Adol Psychiatry. 2018;57(10):755-63. doi: 10.1016/j.jaac.2018.05.023.

Mood instability, or sudden, unpredictable, and frequent shifts in emotional states, characterizes many types of psychiatric disorder, including attention-deficit/hyperactivity disorder (ADHD), personality disorders, depression, and posttraumatic stress disorder. To say that individuals with bipolar disorder (BD) have mood instability sounds like a tautology. Nonetheless, mood instability has particular relevance to BD: Many patients have irregular or labile moods even when they are between major episodes of mania and depression.¹

Children of parents with BD who have high levels of mood instability are at particularly high risk for developing BD (types I or II) in late adolescence or early adulthood.² The following case provides an illustration:

Patrick, age 14, entered treatment with diagnoses of ADHD and other specified bipolar disorder. His mother felt that his behavior resembled that of his father, who had been treated for manic episodes. During the COVID-19 pandemic, Patrick had become increasingly difficult at home, with significant oppositionality, impulsive behavior, and difficulty following through on school assignments or household tasks. His mother’s most significant complaints concerned Patrick’s sudden outbursts of anger and abrupt verbal abuse when she asked him to stop playing video games. When interrupted, he cursed loudly and sometimes turned violent; he had broken a window and a door at home and had on one occasion physically attacked his younger brother. Patrick agreed that he became angry at times, but felt that others provoked him. When queried about depression, he described anxiety and worry. He was unable to describe a particular trigger for his anxiety except for being interrupted in online games with his friends, which made him “feel like a total loser.”

His mother reported that Patrick had multiple 1- to 2-day intervals in which he became “really silly, laughing at nothing,” talking rapidly, jumping from one topic to another, and becoming annoyed when others didn’t share his enthusiasm. In these activated intervals, he slept little and seemed to be full of energy; his mother would hear him talking loudly into his phone throughout the night. During one such interval he had become verbally aggressive with a peer, which had ruined their friendship. Both Patrick and his mother reported that they had been fighting constantly and, in her words, “our house has become a war zone.”

In our recent article in the Journal of the American Academy of Child and Adolescent Psychiatry,³ my coauthors and I examined the association between parents’ ratings of mood instability and clinicians’ longitudinal ratings of symptoms and functioning among youth (ages 9-17 years) who were at high risk for BD. The participants met DSM-5 diagnostic criteria for major depressive disorder or other specified BD, defined as recurrent and brief periods of elevation and activation that did not meet syndromal mania or hypomania criteria. All participants had at least one first- or second-degree family member with a history of BD I or II. Following a period of evaluation, participants were randomly assigned to one of two 4-month psychological therapies: Family-focused therapy (12 sessions of psychoeducation, communication training, and problem-solving skills training) or enhanced usual care (6 sessions of family and individual psychoeducation and support). They also received pharmacological management from study-affiliated psychiatrists when warranted.

We measured mood instability at intake and every 4-6 months over an average of 2 years (range 0-255 weeks). We used a brief parent questionnaire – the Children’s Affective Lability Scale⁴ – which enables measurement of lability on the dimensions of elevation or activation (e.g., bursts of silliness or hilarity, excessive familiarity with others), irritability (e.g., temper outbursts), or anxious-depression (e.g., sudden bouts of crying).

Over the 1- to 4-year period of follow-up, mood instability was associated with poor prognosis indicators in high-risk youth: Being younger, having younger ages at first symptom onset, being diagnosed with other specified BD (vs. major depression), and having more complex patterns of comorbid disorders. Mood instability tracked closely with levels of mania, depression, and global functioning over the follow-up. There was a temporal pathway between a diagnosis of other specified bipolar disorder at intake and higher levels of mood instability at follow-up, which in turn predicted higher levels of parent/child conflict. High levels of mood lability may lead to isolation from peers and tension within family relationships, which may fuel further children’s expressions of frustration, rage, depression, or impulsive behavior.

Youth with higher levels of mood instability required more complex medication regimens over 1 year than did those with lower instability. There was an overall reduction in mood instability as children aged (or spent more time in treatment). Over the 1- to 4-year follow-up, family-focused therapy was associated with longer intervals prior to new mood episodes than was enhanced usual care, but reductions in mood instability were independent of the type of psychosocial treatment assigned to children.

The participants in this study could not be followed long enough to determine whether levels of mood instability were associated with the later development of syndromal BD. Other studies, however, have documented this relationship. Large-scale longitudinal studies of high-risk children find that measures of mood lability – along with early onset manic symptoms, depression, anxiety, and a family history of mania or hypomania – can be combined to calculate the risk that any individual child will develop BD I or II over the next 5-8 years.^2,5

Clinicians should include measurement of the severity and psychosocial determinants of persistent mood shifts in youth under their care, particularly those with a family history of BD. Mood instability is associated with more severe symptom trajectories, more social isolation, and greater distress and conflict within the family. It may require a greater intensity of both pharmacological and psychosocial treatments to treat existing symptoms and functional impairments, and to prevent further mood deterioration.

Dr. Miklowitz is Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior. He is the author of “The Bipolar Disorder Survival Guide, 3rd Ed.” (New York: Guilford Press, 2019) and “Bipolar Disorder: A Family-Focused Treatment Approach, 2nd Ed” (New York: Guilford Press, 2010). He has no conflicts of interest to disclose. Contact Dr. Miklowitz at [email protected].

References

1. Bonsall MB, et al. Nonlinear time-series approaches in characterizing mood stability and mood instability in bipolar disorder. Proc Biol Sci. Mar 7 2012;279(1730):916-24. doi: 10.1098/rspb.2011.1246.

2. Hafeman DM, et al. Toward the definition of a bipolar prodrome: Dimensional predictors of bipolar spectrum disorders in at-risk youths. Am J Psychiatry. 2016;173(7):695-704. doi: 10.1176/appi.ajp.2015.15040414.

3. Miklowitz DJ, et al. Mood instability in youth at high risk for bipolar disorder. J Am Acad Child Adol Psychiatry. 2022 Mar 17;S0890-8567(22)00118-6. doi: 10.1016/j.jaac.2022.03.009.

4. Gerson AC, et al. The Children’s Affective Lability Scale: a psychometric evaluation of reliability. Psychiatry Res. Dec 20 1996;65(3):189-98. doi: 10.1016/s0165-1781(96)02851-x.

5. Birmaher B, et al. A risk calculator to predict the individual risk of conversion from subthreshold bipolar symptoms to bipolar disorder I or II in youth. J Am Acad Child Adol Psychiatry. 2018;57(10):755-63. doi: 10.1016/j.jaac.2018.05.023.

After a 3-year, pandemic-induced hiatus, the American Gastroenterological Association’s Tech Summit returned to a live meeting in San Francisco. As usual, the highlight of the 2-day event, which is sponsored by the AGA Center for GI Innovation and Technology, was the Shark Tank, where selected companies presented lightning-round overviews of their technology and business plans. A panel of sharks and the audience voted for their favorite.

The contestants presented technologies such as a cell phone app to improve gut health (Agora Health), a polypectomy suite (IzoMed), an implantable weight-loss device (Lean Medical), a device to alleviate gastric obstruction in pancreatic cancer (Myka Labs), a pill designed to map out the gastrointestinal system to aid in diagnosis (Rock West Medical Devices), and an endoscopic ultrasound device (EndoSound). 

Six finalists were selected from 20 submissions, and EndoSound was the winner. According to Raman Muthusamy, MD, medical director of endoscopy at UCLA Health and professor of clinical medicine at the University of California, Los Angeles, and past chair of the AGA Center for GI Innovation and Technology, the quality of presentations and the sophistication of the companies have increased year after year. “This was really the very best,” said Dr. Muthusamy.

Both the judges and the audience chose EndoSound. Endoscopic ultrasound (EUS) focuses on diagnosis and treatment of chest and abdomen disorders, particularly the pancreas. The EndoSound device attaches to an upper endoscope and converts it to a fully therapeutic endoscope that can perform all standard EUS procedures. Moreover, it does not use an elevator, which has been linked to infection risk.

Most clinical facilities lack EUS capability: 97% of ambulatory surgical centers and 80% of hospitals. EUS systems have hardly changed since the late 20th century, and they cost about $450,000. The projected cost of the EndoSound device is closer to $50,000.

“Just like colonoscopies and upper endoscopies, most endoscopic ultrasounds ought to be done in surgical centers. The idea that they can do them efficiently, and at lower cost and greater convenience to their patients and themselves, seems to me the way everything is going, and the way this procedure ought to go as well. The only obstacle to that has been the cost of the equipment. If we can take away that obstacle, then people who are already doing procedures in hospitals where it’s not convenient and not efficient, will be able to do the procedures in surgical centers,” said Stephen Steinberg, MD, founder and President of EndoSound.

“It’s a radical redesign. You’ve cut cost and you’ve cut space. And it’s something that could be put on at a moment’s notice. Rather than referring the patient for [ultrasound], it could allow you to do it on the spot, and perhaps save a second trip for a patient. It allows flexibility in terms of site of service,” said Dr. Muthusamy.

Dr. Muthusamy called it a “godsend” for low-resource institutions in the United States or abroad who have the expertise, but not the equipment, to perform EUS. “There’s no question that more EUS procedures could be done than are currently being done because of issues of availability, and this device takes a significant step to alleviate that.”

The Food and Drug Administration has granted a breakthrough device designation to EndoSound, which allows the company to forgo human clinical trials to support the application. “We’re hoping and expecting to have our application in the beginning of the fourth quarter, and with a little bit of luck to be approved by the end of the year. That’s our goal,” said Dr. Steinberg.

The technology started out as a challenge that Dr. Steinberg set for himself. His career overlapped with some of the earliest innovators of therapeutic endoscopy. “They were the stars. I wasn’t, but I was there,” said Dr. Steinberg. In his practice, Dr. Steinberg was doing procedures that included endoscopic ultrasound.

By the new millennium, EUS had gained a lot of interest, but there was a problem. “It was expensive, and it could only be done in hospitals. I started wondering if we couldn’t get it into a different environment by having a simpler solution,” said Dr. Steinberg.

But success didn’t come quickly. “I started drawing on the back of napkins to see if there wasn’t some solution,” said Dr. Steinberg. It wasn’t until a serendipitous meeting occurred that the concept took shape. Dr. Steinberg’s wife was the CEO and provost of Oregon Health Sciences University, Portland, as well as head of the technology transfer program. Dr. Steinberg’s practice, however, was in Florida so he commuted to Oregon every weekend.

One day, she told him about a presentation by Scott Corbett, MD. “My wife said: ‘Hey, they’re doing ultrasound. Why don’t you come and sit in [on the meeting] because I don’t know anything about it.’ [Dr.] Corbett was working with Sonivate, a point-of-care ultrasound company that was developing an ultrasound that could be placed over the end of the finger, to be used in battlefield triage. I thought, well, if you could put it on a finger, why couldn’t you put it on a scope? So, Scott and I got to talking, and went through a couple of iterations that didn’t work, and then finally came up with one that seemed like it was suitable.”

The device has been tested in five animal models with 20 EUS physicians who concluded that the images were equivalent to legacy devices and that they could be adopted quickly. The company also presented results from a human study that demonstrated noninferiority to the latest EUS system from Pentax.

Dr. Steinberg is an employee and stockholder of Sonivate. Dr. Muthusamy has no relevant financial disclosures. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

*Correction, 5/17/22: An earlier version of this article stated that Geneoscopy was a finalist in the competition. It was not. Also, EndoSound should have been listed as a finalist in this paragraph.

After a 3-year, pandemic-induced hiatus, the American Gastroenterological Association’s Tech Summit returned to a live meeting in San Francisco. As usual, the highlight of the 2-day event, which is sponsored by the AGA Center for GI Innovation and Technology, was the Shark Tank, where selected companies presented lightning-round overviews of their technology and business plans. A panel of sharks and the audience voted for their favorite.

The contestants presented technologies such as a cell phone app to improve gut health (Agora Health), a polypectomy suite (IzoMed), an implantable weight-loss device (Lean Medical), a device to alleviate gastric obstruction in pancreatic cancer (Myka Labs), a pill designed to map out the gastrointestinal system to aid in diagnosis (Rock West Medical Devices), and an endoscopic ultrasound device (EndoSound). 

Six finalists were selected from 20 submissions, and EndoSound was the winner. According to Raman Muthusamy, MD, medical director of endoscopy at UCLA Health and professor of clinical medicine at the University of California, Los Angeles, and past chair of the AGA Center for GI Innovation and Technology, the quality of presentations and the sophistication of the companies have increased year after year. “This was really the very best,” said Dr. Muthusamy.

Both the judges and the audience chose EndoSound. Endoscopic ultrasound (EUS) focuses on diagnosis and treatment of chest and abdomen disorders, particularly the pancreas. The EndoSound device attaches to an upper endoscope and converts it to a fully therapeutic endoscope that can perform all standard EUS procedures. Moreover, it does not use an elevator, which has been linked to infection risk.

Most clinical facilities lack EUS capability: 97% of ambulatory surgical centers and 80% of hospitals. EUS systems have hardly changed since the late 20th century, and they cost about $450,000. The projected cost of the EndoSound device is closer to $50,000.

“Just like colonoscopies and upper endoscopies, most endoscopic ultrasounds ought to be done in surgical centers. The idea that they can do them efficiently, and at lower cost and greater convenience to their patients and themselves, seems to me the way everything is going, and the way this procedure ought to go as well. The only obstacle to that has been the cost of the equipment. If we can take away that obstacle, then people who are already doing procedures in hospitals where it’s not convenient and not efficient, will be able to do the procedures in surgical centers,” said Stephen Steinberg, MD, founder and President of EndoSound.

“It’s a radical redesign. You’ve cut cost and you’ve cut space. And it’s something that could be put on at a moment’s notice. Rather than referring the patient for [ultrasound], it could allow you to do it on the spot, and perhaps save a second trip for a patient. It allows flexibility in terms of site of service,” said Dr. Muthusamy.

Dr. Muthusamy called it a “godsend” for low-resource institutions in the United States or abroad who have the expertise, but not the equipment, to perform EUS. “There’s no question that more EUS procedures could be done than are currently being done because of issues of availability, and this device takes a significant step to alleviate that.”

The Food and Drug Administration has granted a breakthrough device designation to EndoSound, which allows the company to forgo human clinical trials to support the application. “We’re hoping and expecting to have our application in the beginning of the fourth quarter, and with a little bit of luck to be approved by the end of the year. That’s our goal,” said Dr. Steinberg.

The technology started out as a challenge that Dr. Steinberg set for himself. His career overlapped with some of the earliest innovators of therapeutic endoscopy. “They were the stars. I wasn’t, but I was there,” said Dr. Steinberg. In his practice, Dr. Steinberg was doing procedures that included endoscopic ultrasound.

By the new millennium, EUS had gained a lot of interest, but there was a problem. “It was expensive, and it could only be done in hospitals. I started wondering if we couldn’t get it into a different environment by having a simpler solution,” said Dr. Steinberg.

But success didn’t come quickly. “I started drawing on the back of napkins to see if there wasn’t some solution,” said Dr. Steinberg. It wasn’t until a serendipitous meeting occurred that the concept took shape. Dr. Steinberg’s wife was the CEO and provost of Oregon Health Sciences University, Portland, as well as head of the technology transfer program. Dr. Steinberg’s practice, however, was in Florida so he commuted to Oregon every weekend.

One day, she told him about a presentation by Scott Corbett, MD. “My wife said: ‘Hey, they’re doing ultrasound. Why don’t you come and sit in [on the meeting] because I don’t know anything about it.’ [Dr.] Corbett was working with Sonivate, a point-of-care ultrasound company that was developing an ultrasound that could be placed over the end of the finger, to be used in battlefield triage. I thought, well, if you could put it on a finger, why couldn’t you put it on a scope? So, Scott and I got to talking, and went through a couple of iterations that didn’t work, and then finally came up with one that seemed like it was suitable.”

The device has been tested in five animal models with 20 EUS physicians who concluded that the images were equivalent to legacy devices and that they could be adopted quickly. The company also presented results from a human study that demonstrated noninferiority to the latest EUS system from Pentax.

Dr. Steinberg is an employee and stockholder of Sonivate. Dr. Muthusamy has no relevant financial disclosures. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

*Correction, 5/17/22: An earlier version of this article stated that Geneoscopy was a finalist in the competition. It was not. Also, EndoSound should have been listed as a finalist in this paragraph.

After a 3-year, pandemic-induced hiatus, the American Gastroenterological Association’s Tech Summit returned to a live meeting in San Francisco. As usual, the highlight of the 2-day event, which is sponsored by the AGA Center for GI Innovation and Technology, was the Shark Tank, where selected companies presented lightning-round overviews of their technology and business plans. A panel of sharks and the audience voted for their favorite.

The contestants presented technologies such as a cell phone app to improve gut health (Agora Health), a polypectomy suite (IzoMed), an implantable weight-loss device (Lean Medical), a device to alleviate gastric obstruction in pancreatic cancer (Myka Labs), a pill designed to map out the gastrointestinal system to aid in diagnosis (Rock West Medical Devices), and an endoscopic ultrasound device (EndoSound). 

Six finalists were selected from 20 submissions, and EndoSound was the winner. According to Raman Muthusamy, MD, medical director of endoscopy at UCLA Health and professor of clinical medicine at the University of California, Los Angeles, and past chair of the AGA Center for GI Innovation and Technology, the quality of presentations and the sophistication of the companies have increased year after year. “This was really the very best,” said Dr. Muthusamy.

Both the judges and the audience chose EndoSound. Endoscopic ultrasound (EUS) focuses on diagnosis and treatment of chest and abdomen disorders, particularly the pancreas. The EndoSound device attaches to an upper endoscope and converts it to a fully therapeutic endoscope that can perform all standard EUS procedures. Moreover, it does not use an elevator, which has been linked to infection risk.

Most clinical facilities lack EUS capability: 97% of ambulatory surgical centers and 80% of hospitals. EUS systems have hardly changed since the late 20th century, and they cost about $450,000. The projected cost of the EndoSound device is closer to $50,000.

“Just like colonoscopies and upper endoscopies, most endoscopic ultrasounds ought to be done in surgical centers. The idea that they can do them efficiently, and at lower cost and greater convenience to their patients and themselves, seems to me the way everything is going, and the way this procedure ought to go as well. The only obstacle to that has been the cost of the equipment. If we can take away that obstacle, then people who are already doing procedures in hospitals where it’s not convenient and not efficient, will be able to do the procedures in surgical centers,” said Stephen Steinberg, MD, founder and President of EndoSound.

“It’s a radical redesign. You’ve cut cost and you’ve cut space. And it’s something that could be put on at a moment’s notice. Rather than referring the patient for [ultrasound], it could allow you to do it on the spot, and perhaps save a second trip for a patient. It allows flexibility in terms of site of service,” said Dr. Muthusamy.

Dr. Muthusamy called it a “godsend” for low-resource institutions in the United States or abroad who have the expertise, but not the equipment, to perform EUS. “There’s no question that more EUS procedures could be done than are currently being done because of issues of availability, and this device takes a significant step to alleviate that.”

The Food and Drug Administration has granted a breakthrough device designation to EndoSound, which allows the company to forgo human clinical trials to support the application. “We’re hoping and expecting to have our application in the beginning of the fourth quarter, and with a little bit of luck to be approved by the end of the year. That’s our goal,” said Dr. Steinberg.

The technology started out as a challenge that Dr. Steinberg set for himself. His career overlapped with some of the earliest innovators of therapeutic endoscopy. “They were the stars. I wasn’t, but I was there,” said Dr. Steinberg. In his practice, Dr. Steinberg was doing procedures that included endoscopic ultrasound.

By the new millennium, EUS had gained a lot of interest, but there was a problem. “It was expensive, and it could only be done in hospitals. I started wondering if we couldn’t get it into a different environment by having a simpler solution,” said Dr. Steinberg.

But success didn’t come quickly. “I started drawing on the back of napkins to see if there wasn’t some solution,” said Dr. Steinberg. It wasn’t until a serendipitous meeting occurred that the concept took shape. Dr. Steinberg’s wife was the CEO and provost of Oregon Health Sciences University, Portland, as well as head of the technology transfer program. Dr. Steinberg’s practice, however, was in Florida so he commuted to Oregon every weekend.

One day, she told him about a presentation by Scott Corbett, MD. “My wife said: ‘Hey, they’re doing ultrasound. Why don’t you come and sit in [on the meeting] because I don’t know anything about it.’ [Dr.] Corbett was working with Sonivate, a point-of-care ultrasound company that was developing an ultrasound that could be placed over the end of the finger, to be used in battlefield triage. I thought, well, if you could put it on a finger, why couldn’t you put it on a scope? So, Scott and I got to talking, and went through a couple of iterations that didn’t work, and then finally came up with one that seemed like it was suitable.”

The device has been tested in five animal models with 20 EUS physicians who concluded that the images were equivalent to legacy devices and that they could be adopted quickly. The company also presented results from a human study that demonstrated noninferiority to the latest EUS system from Pentax.

Dr. Steinberg is an employee and stockholder of Sonivate. Dr. Muthusamy has no relevant financial disclosures. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

*Correction, 5/17/22: An earlier version of this article stated that Geneoscopy was a finalist in the competition. It was not. Also, EndoSound should have been listed as a finalist in this paragraph.

Fecal matter may be in the fountain of youth

Yes, you read that headline correctly. New research by scientists at Quadram Institute and the University of East Anglia, both in Norwich, England, supports the claim that transferring fecal microbes might actually have some positive effects on reversing the aging process in the eyes, brain, and gut.

How do they know? Mice, of course. In the study, scientists took the gut microbes from older mice and transferred them into the younger mince. The young mice displayed inflamed signs of aging in their guts, brains, and eyes, which, we all know, decline in function as we age. What happens is a chronic inflammation of cells as we get older that can be found in the brain or gut that leads to a degenerative state over time.

Albrecht Fietz/Pixabay

When the older mice received the gut microbes from younger mice, the investigators saw the reverse: Gut, brain, and eye functionality improved. In a way, minimizing the inflammation.

There’s tons of research out there that suggests gut health is the key to a healthy life, but this study points directly to an improvement in brain and vision functionality as a result of the transfer.

Now, we’re not insinuating you get a poo transfer as you reach old age. And the shift to human studies on microbiota replacement therapy is still in the works. But this definitely is a topic to watch and could be a game changer in the age-old quest to bottle youth or at least improve quality of life as we age.

For now, the scientists did find some connections between the beneficial bacteria in the transplants and the human diet that could have similar effects, like changes in the metabolism of certain fats and vitamin that could have effects on the inflammatory cells in the eye and brain.

The more you know!
 

It’s not lying, it’s preemptive truth

Lying is bad. Bold statement, we know, but a true one. After all, God spent an entire commandment telling people not to do the whole bearing false witness thing, and God is generally known for not joking around. He’s a pretty serious dude.

In case you’ve been wandering around the desert for a while and haven’t had wifi, we have a bit of a misinformation problem these days. People lie all the time about a lot of things, and a lot of people believe the lies. According to new research, however, there are also a lot of people who recognize the lies but accept them anyway because they believe that the lies will become true in the future.

Peter Timmerhues/Pixabay

Imagine the following scenario: A friend gets a job he’s not qualified for because he listed a skill he doesn’t have. That’s bad, right? And the people the researchers interviewed agreed, at least initially. But when informed that our friend is planning on obtaining the skill in summer classes in the near future, the study participants became far more willing to excuse the initial lie.

A friend jumping the gun on training he doesn’t have yet is fairly innocuous as far as lying goes, but as the researchers found, this willingness to forgive lies because they could become true extends far further. For example, millions of people do not vote illegally in U.S. elections, nor do White people get approved for mortgages at rates 300% higher than minorities, but when asked to imagine scenarios in which those statements could be true, study participants were less likely to condemn the lie and prevent it from spreading further, especially if their political viewpoints aligned with the respective falsehood.

It seems, then, that while we may aspire to not tell lies, we take after another guy with magic powers who spent too much time in the desert: “What I told you was true, from a certain point of view.”
 

It tastes like feng shui, but it’s not

You know about biomes. You’ve read about various microbiomes. Allow us to introduce you to the envirome,

The envirome “includes all the natural and man-made elements of our environment throughout the lifespan, notably the built environment,” said Robert Schneider, dean of the College of Integrative Medicine at Maharishi International University. Located in – you guessed it – Fairfield, Iowa, and home of the Fighting Transcendentalists. MAHARISHI RULES!

Free-Photos/Pixabay

• The headboard of a bed should be oriented to the east or south when you sleep. This will improve mental health.
• While sitting at a desk or work area, a person should face east or north to improve brain coherence.
• The main entrance of a house should face east because morning light is superior to afternoon light.

And you were worried about feng shui. Well, forget feng shui. Feng shui is for amateurs. MVA is the way to go. MVA is the GOAT. MAHARISHI RULES!

Fecal matter may be in the fountain of youth

Yes, you read that headline correctly. New research by scientists at Quadram Institute and the University of East Anglia, both in Norwich, England, supports the claim that transferring fecal microbes might actually have some positive effects on reversing the aging process in the eyes, brain, and gut.

How do they know? Mice, of course. In the study, scientists took the gut microbes from older mice and transferred them into the younger mince. The young mice displayed inflamed signs of aging in their guts, brains, and eyes, which, we all know, decline in function as we age. What happens is a chronic inflammation of cells as we get older that can be found in the brain or gut that leads to a degenerative state over time.

Albrecht Fietz/Pixabay

When the older mice received the gut microbes from younger mice, the investigators saw the reverse: Gut, brain, and eye functionality improved. In a way, minimizing the inflammation.

There’s tons of research out there that suggests gut health is the key to a healthy life, but this study points directly to an improvement in brain and vision functionality as a result of the transfer.

Now, we’re not insinuating you get a poo transfer as you reach old age. And the shift to human studies on microbiota replacement therapy is still in the works. But this definitely is a topic to watch and could be a game changer in the age-old quest to bottle youth or at least improve quality of life as we age.

For now, the scientists did find some connections between the beneficial bacteria in the transplants and the human diet that could have similar effects, like changes in the metabolism of certain fats and vitamin that could have effects on the inflammatory cells in the eye and brain.

The more you know!
 

It’s not lying, it’s preemptive truth

Lying is bad. Bold statement, we know, but a true one. After all, God spent an entire commandment telling people not to do the whole bearing false witness thing, and God is generally known for not joking around. He’s a pretty serious dude.

In case you’ve been wandering around the desert for a while and haven’t had wifi, we have a bit of a misinformation problem these days. People lie all the time about a lot of things, and a lot of people believe the lies. According to new research, however, there are also a lot of people who recognize the lies but accept them anyway because they believe that the lies will become true in the future.

Peter Timmerhues/Pixabay

Imagine the following scenario: A friend gets a job he’s not qualified for because he listed a skill he doesn’t have. That’s bad, right? And the people the researchers interviewed agreed, at least initially. But when informed that our friend is planning on obtaining the skill in summer classes in the near future, the study participants became far more willing to excuse the initial lie.

A friend jumping the gun on training he doesn’t have yet is fairly innocuous as far as lying goes, but as the researchers found, this willingness to forgive lies because they could become true extends far further. For example, millions of people do not vote illegally in U.S. elections, nor do White people get approved for mortgages at rates 300% higher than minorities, but when asked to imagine scenarios in which those statements could be true, study participants were less likely to condemn the lie and prevent it from spreading further, especially if their political viewpoints aligned with the respective falsehood.

It seems, then, that while we may aspire to not tell lies, we take after another guy with magic powers who spent too much time in the desert: “What I told you was true, from a certain point of view.”
 

It tastes like feng shui, but it’s not

You know about biomes. You’ve read about various microbiomes. Allow us to introduce you to the envirome,

The envirome “includes all the natural and man-made elements of our environment throughout the lifespan, notably the built environment,” said Robert Schneider, dean of the College of Integrative Medicine at Maharishi International University. Located in – you guessed it – Fairfield, Iowa, and home of the Fighting Transcendentalists. MAHARISHI RULES!

Free-Photos/Pixabay

• The headboard of a bed should be oriented to the east or south when you sleep. This will improve mental health.
• While sitting at a desk or work area, a person should face east or north to improve brain coherence.
• The main entrance of a house should face east because morning light is superior to afternoon light.

And you were worried about feng shui. Well, forget feng shui. Feng shui is for amateurs. MVA is the way to go. MVA is the GOAT. MAHARISHI RULES!

Fecal matter may be in the fountain of youth

Yes, you read that headline correctly. New research by scientists at Quadram Institute and the University of East Anglia, both in Norwich, England, supports the claim that transferring fecal microbes might actually have some positive effects on reversing the aging process in the eyes, brain, and gut.

How do they know? Mice, of course. In the study, scientists took the gut microbes from older mice and transferred them into the younger mince. The young mice displayed inflamed signs of aging in their guts, brains, and eyes, which, we all know, decline in function as we age. What happens is a chronic inflammation of cells as we get older that can be found in the brain or gut that leads to a degenerative state over time.

Albrecht Fietz/Pixabay

When the older mice received the gut microbes from younger mice, the investigators saw the reverse: Gut, brain, and eye functionality improved. In a way, minimizing the inflammation.

There’s tons of research out there that suggests gut health is the key to a healthy life, but this study points directly to an improvement in brain and vision functionality as a result of the transfer.

Now, we’re not insinuating you get a poo transfer as you reach old age. And the shift to human studies on microbiota replacement therapy is still in the works. But this definitely is a topic to watch and could be a game changer in the age-old quest to bottle youth or at least improve quality of life as we age.

For now, the scientists did find some connections between the beneficial bacteria in the transplants and the human diet that could have similar effects, like changes in the metabolism of certain fats and vitamin that could have effects on the inflammatory cells in the eye and brain.

The more you know!
 

It’s not lying, it’s preemptive truth

Lying is bad. Bold statement, we know, but a true one. After all, God spent an entire commandment telling people not to do the whole bearing false witness thing, and God is generally known for not joking around. He’s a pretty serious dude.

In case you’ve been wandering around the desert for a while and haven’t had wifi, we have a bit of a misinformation problem these days. People lie all the time about a lot of things, and a lot of people believe the lies. According to new research, however, there are also a lot of people who recognize the lies but accept them anyway because they believe that the lies will become true in the future.

Peter Timmerhues/Pixabay

Imagine the following scenario: A friend gets a job he’s not qualified for because he listed a skill he doesn’t have. That’s bad, right? And the people the researchers interviewed agreed, at least initially. But when informed that our friend is planning on obtaining the skill in summer classes in the near future, the study participants became far more willing to excuse the initial lie.

A friend jumping the gun on training he doesn’t have yet is fairly innocuous as far as lying goes, but as the researchers found, this willingness to forgive lies because they could become true extends far further. For example, millions of people do not vote illegally in U.S. elections, nor do White people get approved for mortgages at rates 300% higher than minorities, but when asked to imagine scenarios in which those statements could be true, study participants were less likely to condemn the lie and prevent it from spreading further, especially if their political viewpoints aligned with the respective falsehood.

It seems, then, that while we may aspire to not tell lies, we take after another guy with magic powers who spent too much time in the desert: “What I told you was true, from a certain point of view.”
 

It tastes like feng shui, but it’s not

You know about biomes. You’ve read about various microbiomes. Allow us to introduce you to the envirome,

The envirome “includes all the natural and man-made elements of our environment throughout the lifespan, notably the built environment,” said Robert Schneider, dean of the College of Integrative Medicine at Maharishi International University. Located in – you guessed it – Fairfield, Iowa, and home of the Fighting Transcendentalists. MAHARISHI RULES!

Free-Photos/Pixabay

• The headboard of a bed should be oriented to the east or south when you sleep. This will improve mental health.
• While sitting at a desk or work area, a person should face east or north to improve brain coherence.
• The main entrance of a house should face east because morning light is superior to afternoon light.

And you were worried about feng shui. Well, forget feng shui. Feng shui is for amateurs. MVA is the way to go. MVA is the GOAT. MAHARISHI RULES!

CHICAGO – Geno Merli, MD, associate chief medical officer at Thomas Jefferson University Hospital, Philadelphia, and long-time hospital medicine expert, recalled a recent situation at his center, during a panel discussion.

It involved a 70-year-old man who had a history of prostate cancer, obstructive sleep apnea, and hernias. In January, he had a surgery for hernia repair. On the 3rd day after the procedure, he was transferred to the hospital medicine service at about 9 p.m. and was on a patient-controlled pump for pain and had abdominal drains. Because of the extensive surgery and because he had begun to walk shortly after the procedure, he wasn’t on thrombosis prevention medication, Dr. Merli explained at the annual meeting of the American College of Physicians.

The day after his transfer he was walking with a physical therapist when he became short of breath, his oxygen saturation dropped, and his heart rate soared. Bilateral pulmonary emboli were found, along with thrombosis in the right leg.

What was remarkable, Dr. Merli noted, was what the patient’s medical record was lacking.

He added, “I think if we start looking at this at our sites, we may find out that communication needs to be improved, and I believe standardized.”

This situation underscores the continuing need to refine handoffs between surgery and hospital medicine, a point in care that is primed for potential errors, the other panelists noted during the session.

Most important information is often not communicated

A 2010 study in pediatrics that looked at intern-to-intern handoffs found that the most important piece of information wasn’t communicated successfully 60% of the time – in other words, more often than not, the person on the receiving end didn’t really understand that crucial part of the scenario. Since then, the literature has been regularly populated with studies attempting to refine handoff procedures.

 Lily Ackermann, MD, hospitalist and clinical associate professor of medicine at Jefferson, said in the session that hospitalists need to be sure to reach out to surgery at important junctures in care.

 “I would say the No. 1 biggest mistake we make is not calling the surgery attending directly when clinical questions arise,” she said. “I think this is very important – attending [physician in hospital medicine] to attending [physician in surgery].”

 Murray Cohen, MD, director of acute care surgery at Jefferson, said he shared that concern.

“We want to be called, we want to be called for our patients,” he said in the session. “And we’re upset when you don’t call for our patients.”

Hospitalists should discuss blood loss, pain management, management of drains, deep vein thrombosis prevention, nutrition, infectious disease concerns, and timing of vaccines post procedure, Dr. Ackermann said during the presentation,

The panelists also emphasized that understanding the follow-up care that surgery was planning after a procedure is important, and to not just expect surgeons to actively follow a patient. They also reminded hospitalists to look at the wounds and make sure they understand how to handle the wounds going forward. Plus, when transferring a patient to surgery, hospitalists should understand when getting someone to surgery is urgent and not to order unnecessary tests as a formality when time is of the essence, they said.

IPASS: a formalized handoff process

The panelists all spoke highly of a formalized handoff process known as IPASS. This acronym reminds physicians to ask specific questions.

The I represents illness severity and calls for asking: “Is the patient stable or unstable?

The P stands for patient summary and is meant to prompt physicians to seek details about the procedure.

The A is for action list, which is meant to remind the physician to get the post-op plan for neurological, cardiovascular, gastrointestinal, and other areas.

The first S is for situational awareness, and calls for asking: What is the biggest concern over the next 24 hours?

The final S represents synthesis by the receiver, prompting a physician to summarize the information he or she has received about the patient.

Natalie Margules, MD, a clinical instructor and hospitalist at Jefferson who did not present in the session, reiterated the value of the IPASS system. Before it was used for handoffs, she said, “I was never taught anything formalized – basically, just ‘Tell them what’s important.’

Dr. Margules noted that she considers the framework’s call for the synthesis to be one of it most useful parts.

 Dr. Merli, Dr. Ackermann, and Dr. Cohen reported no relevant financial disclosures.

CHICAGO – Geno Merli, MD, associate chief medical officer at Thomas Jefferson University Hospital, Philadelphia, and long-time hospital medicine expert, recalled a recent situation at his center, during a panel discussion.

It involved a 70-year-old man who had a history of prostate cancer, obstructive sleep apnea, and hernias. In January, he had a surgery for hernia repair. On the 3rd day after the procedure, he was transferred to the hospital medicine service at about 9 p.m. and was on a patient-controlled pump for pain and had abdominal drains. Because of the extensive surgery and because he had begun to walk shortly after the procedure, he wasn’t on thrombosis prevention medication, Dr. Merli explained at the annual meeting of the American College of Physicians.

The day after his transfer he was walking with a physical therapist when he became short of breath, his oxygen saturation dropped, and his heart rate soared. Bilateral pulmonary emboli were found, along with thrombosis in the right leg.

What was remarkable, Dr. Merli noted, was what the patient’s medical record was lacking.

He added, “I think if we start looking at this at our sites, we may find out that communication needs to be improved, and I believe standardized.”

This situation underscores the continuing need to refine handoffs between surgery and hospital medicine, a point in care that is primed for potential errors, the other panelists noted during the session.

Most important information is often not communicated

A 2010 study in pediatrics that looked at intern-to-intern handoffs found that the most important piece of information wasn’t communicated successfully 60% of the time – in other words, more often than not, the person on the receiving end didn’t really understand that crucial part of the scenario. Since then, the literature has been regularly populated with studies attempting to refine handoff procedures.

 Lily Ackermann, MD, hospitalist and clinical associate professor of medicine at Jefferson, said in the session that hospitalists need to be sure to reach out to surgery at important junctures in care.

 “I would say the No. 1 biggest mistake we make is not calling the surgery attending directly when clinical questions arise,” she said. “I think this is very important – attending [physician in hospital medicine] to attending [physician in surgery].”

 Murray Cohen, MD, director of acute care surgery at Jefferson, said he shared that concern.

“We want to be called, we want to be called for our patients,” he said in the session. “And we’re upset when you don’t call for our patients.”

Hospitalists should discuss blood loss, pain management, management of drains, deep vein thrombosis prevention, nutrition, infectious disease concerns, and timing of vaccines post procedure, Dr. Ackermann said during the presentation,

The panelists also emphasized that understanding the follow-up care that surgery was planning after a procedure is important, and to not just expect surgeons to actively follow a patient. They also reminded hospitalists to look at the wounds and make sure they understand how to handle the wounds going forward. Plus, when transferring a patient to surgery, hospitalists should understand when getting someone to surgery is urgent and not to order unnecessary tests as a formality when time is of the essence, they said.

IPASS: a formalized handoff process

The panelists all spoke highly of a formalized handoff process known as IPASS. This acronym reminds physicians to ask specific questions.

The I represents illness severity and calls for asking: “Is the patient stable or unstable?

The P stands for patient summary and is meant to prompt physicians to seek details about the procedure.

The A is for action list, which is meant to remind the physician to get the post-op plan for neurological, cardiovascular, gastrointestinal, and other areas.

The first S is for situational awareness, and calls for asking: What is the biggest concern over the next 24 hours?

The final S represents synthesis by the receiver, prompting a physician to summarize the information he or she has received about the patient.

Natalie Margules, MD, a clinical instructor and hospitalist at Jefferson who did not present in the session, reiterated the value of the IPASS system. Before it was used for handoffs, she said, “I was never taught anything formalized – basically, just ‘Tell them what’s important.’

Dr. Margules noted that she considers the framework’s call for the synthesis to be one of it most useful parts.

 Dr. Merli, Dr. Ackermann, and Dr. Cohen reported no relevant financial disclosures.

CHICAGO – Geno Merli, MD, associate chief medical officer at Thomas Jefferson University Hospital, Philadelphia, and long-time hospital medicine expert, recalled a recent situation at his center, during a panel discussion.

It involved a 70-year-old man who had a history of prostate cancer, obstructive sleep apnea, and hernias. In January, he had a surgery for hernia repair. On the 3rd day after the procedure, he was transferred to the hospital medicine service at about 9 p.m. and was on a patient-controlled pump for pain and had abdominal drains. Because of the extensive surgery and because he had begun to walk shortly after the procedure, he wasn’t on thrombosis prevention medication, Dr. Merli explained at the annual meeting of the American College of Physicians.

The day after his transfer he was walking with a physical therapist when he became short of breath, his oxygen saturation dropped, and his heart rate soared. Bilateral pulmonary emboli were found, along with thrombosis in the right leg.

What was remarkable, Dr. Merli noted, was what the patient’s medical record was lacking.

He added, “I think if we start looking at this at our sites, we may find out that communication needs to be improved, and I believe standardized.”

This situation underscores the continuing need to refine handoffs between surgery and hospital medicine, a point in care that is primed for potential errors, the other panelists noted during the session.

Most important information is often not communicated

A 2010 study in pediatrics that looked at intern-to-intern handoffs found that the most important piece of information wasn’t communicated successfully 60% of the time – in other words, more often than not, the person on the receiving end didn’t really understand that crucial part of the scenario. Since then, the literature has been regularly populated with studies attempting to refine handoff procedures.

 Lily Ackermann, MD, hospitalist and clinical associate professor of medicine at Jefferson, said in the session that hospitalists need to be sure to reach out to surgery at important junctures in care.

 “I would say the No. 1 biggest mistake we make is not calling the surgery attending directly when clinical questions arise,” she said. “I think this is very important – attending [physician in hospital medicine] to attending [physician in surgery].”

 Murray Cohen, MD, director of acute care surgery at Jefferson, said he shared that concern.

“We want to be called, we want to be called for our patients,” he said in the session. “And we’re upset when you don’t call for our patients.”

Hospitalists should discuss blood loss, pain management, management of drains, deep vein thrombosis prevention, nutrition, infectious disease concerns, and timing of vaccines post procedure, Dr. Ackermann said during the presentation,

The panelists also emphasized that understanding the follow-up care that surgery was planning after a procedure is important, and to not just expect surgeons to actively follow a patient. They also reminded hospitalists to look at the wounds and make sure they understand how to handle the wounds going forward. Plus, when transferring a patient to surgery, hospitalists should understand when getting someone to surgery is urgent and not to order unnecessary tests as a formality when time is of the essence, they said.

IPASS: a formalized handoff process

The panelists all spoke highly of a formalized handoff process known as IPASS. This acronym reminds physicians to ask specific questions.

The I represents illness severity and calls for asking: “Is the patient stable or unstable?

The P stands for patient summary and is meant to prompt physicians to seek details about the procedure.

The A is for action list, which is meant to remind the physician to get the post-op plan for neurological, cardiovascular, gastrointestinal, and other areas.

The first S is for situational awareness, and calls for asking: What is the biggest concern over the next 24 hours?

The final S represents synthesis by the receiver, prompting a physician to summarize the information he or she has received about the patient.

Natalie Margules, MD, a clinical instructor and hospitalist at Jefferson who did not present in the session, reiterated the value of the IPASS system. Before it was used for handoffs, she said, “I was never taught anything formalized – basically, just ‘Tell them what’s important.’

Dr. Margules noted that she considers the framework’s call for the synthesis to be one of it most useful parts.

 Dr. Merli, Dr. Ackermann, and Dr. Cohen reported no relevant financial disclosures.

A South African study based on blood samples found that the BA.4 and BA.5 sublineages of Omicron were more likely to evade antibodies produced by previous Omicron infections than the immunity provided by vaccinations.

Scientists took blood samples from 39 people infected with Omicron, with 24 people not vaccinated and 15 vaccinated with the Pfizer or the Johnson & Johnson vaccines, Reuters reported.

“The vaccinated group showed about a fivefold higher neutralization capacity ... and should be better protected,” the investigators found, according to Reuters.

There was an eightfold decrease in antibody protection in unvaccinated blood samples when exposed to the subvariants compared to a threefold decrease in the blood samples from vaccinated people.

“Based on neutralization escape, BA.4 and BA.5 have potential to result in a new infection wave,” the investigators found.

The finding is important because health authorities say cases caused by the sublineages are increasing in South Africa to a degree that the nation may be entering a fifth wave of COVID, Reuters said.

Health Minister Joe Phaahla said recently that hospitalizations were increasing but that ICU admissions had not greatly gone up yet.

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

A South African study based on blood samples found that the BA.4 and BA.5 sublineages of Omicron were more likely to evade antibodies produced by previous Omicron infections than the immunity provided by vaccinations.

Scientists took blood samples from 39 people infected with Omicron, with 24 people not vaccinated and 15 vaccinated with the Pfizer or the Johnson & Johnson vaccines, Reuters reported.

“The vaccinated group showed about a fivefold higher neutralization capacity ... and should be better protected,” the investigators found, according to Reuters.

There was an eightfold decrease in antibody protection in unvaccinated blood samples when exposed to the subvariants compared to a threefold decrease in the blood samples from vaccinated people.

“Based on neutralization escape, BA.4 and BA.5 have potential to result in a new infection wave,” the investigators found.

The finding is important because health authorities say cases caused by the sublineages are increasing in South Africa to a degree that the nation may be entering a fifth wave of COVID, Reuters said.

Health Minister Joe Phaahla said recently that hospitalizations were increasing but that ICU admissions had not greatly gone up yet.

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

A South African study based on blood samples found that the BA.4 and BA.5 sublineages of Omicron were more likely to evade antibodies produced by previous Omicron infections than the immunity provided by vaccinations.

Scientists took blood samples from 39 people infected with Omicron, with 24 people not vaccinated and 15 vaccinated with the Pfizer or the Johnson & Johnson vaccines, Reuters reported.

“The vaccinated group showed about a fivefold higher neutralization capacity ... and should be better protected,” the investigators found, according to Reuters.

There was an eightfold decrease in antibody protection in unvaccinated blood samples when exposed to the subvariants compared to a threefold decrease in the blood samples from vaccinated people.

“Based on neutralization escape, BA.4 and BA.5 have potential to result in a new infection wave,” the investigators found.

The finding is important because health authorities say cases caused by the sublineages are increasing in South Africa to a degree that the nation may be entering a fifth wave of COVID, Reuters said.

Health Minister Joe Phaahla said recently that hospitalizations were increasing but that ICU admissions had not greatly gone up yet.

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