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Are You Using the Correct Medication or a Look-Alike?
Five years have passed since the member states of the World Health Organization (WHO) gathered at the 72nd World Health Assembly and decided that September 17 should be recognized as World Patient Safety Day, acknowledging it as a global health priority.
WHO data indicate the following findings related to medical safety:
- One in 10 patients is harmed while receiving healthcare, and 3 million die as a result.
- More than half of these incidents could be prevented.
- Indirect costs could amount to several billion US dollars annually.
Given the magnitude of preventable harm related to medication use, in 2017, the WHO launched the third Global Patient Safety Challenge: Medication Without Harm with the goal of reducing serious and preventable harm related to medication by 50%. In addition, considering the volume of medication packages prescribed in 2023 by physicians in Spain’s National Health System, it is necessary to understand the most common types of medication errors to provide an effective and efficient response.
According to Spain’s Institute for Safe Medication Practices (ISMP), the 10 types of medication errors detected in 2020 with the most serious consequences were the following:
- Errors due to omission or delay in medication.
- Administration of medication to the wrong patient.
- Errors related to allergies or known adverse effects of medications.
- Dosing errors in pediatric patients.
- Errors due to similarities in the labeling or packaging of marketed medications.
- Errors associated with the lack of use of smart infusion pumps.
- Errors due to accidental administration of neuromuscular blocking agents.
- Incorrect intravenous administration of oral liquid medications.
- Errors in medication reconciliation upon hospital admission and discharge.
- Errors due to patient misunderstandings regarding medication use.
I would like to focus on the fifth item, errors due to similarities in the labeling or packaging of marketed medications.
Medications with similar names or with similar labeling or packaging are known as “look alike–sound alike” medications. They are estimated to account for between 6.2% and 14.7% of all medication errors. Confusion can arise due to spelling and phonetic similarities.
As shown in bulletin no. 50 of the ISMP, difficulties in distinguishing different medications or different presentations of the same medication due to similar packaging and labeling have frequently been associated with reported incidents.
Most cases involve either medications marketed by the same laboratory with a design based on brand image or different medications marketed by different laboratories in screen-printed ampoules used in the same settings.
In 2020, the ISMP published 11 new cases of labeling or packaging that may promote errors on its website. It reported 49 incidents to the Spanish Agency for Medicines and Medical Devices.
Shortages caused by the COVID-19 pandemic have further contributed to these incidents, as healthcare facilities sometimes had to change the medications they usually acquired and purchase whatever was available, without being able to select products that would not be confused with existing medications in the facility.
The ISMP recommends the following general practices for healthcare institutions, professionals, and patients to prevent these errors:
- Develop short lists of easily confused medication names and distribute them among all healthcare professionals.
- Prioritize medication names by active ingredient instead of brand name.
- For similar names, highlight the differences in capital letters, eg, DOBUTamine, DOPamine.
- For similar active ingredients, use brand names.
- Avoid placing similar medications near each other.
- Prescribe all medications electronically to minimize the risk of selecting the wrong medication.
- Make manual prescriptions legible, with clearly written dosages and pharmaceutical forms.
- Encourage patients to actively participate in their treatment and consult a clinician if they have any questions about the medications they are receiving.
- Raise awareness among patients, family members, and caregivers about the issues caused by medication name confusion and inform them about how to avoid these errors.
- Instruct patients to focus on and always use the active ingredient name as an identifying element for the medications they are taking.
- Review treatments with patients to ensure they know the medications they are taking.
Julia María Ruiz Redondo is the regional nursing advisor inspector of Spanish Society of General and Family Physicians of Castilla-La Mancha (SEMG-CLM), coordinator of the National Working Group on Public Health in the SEMG, and director of the international public health master’s degree at TECH Technological University. This article is the result of an editorial collaboration between the SEMG and Univadis, which you can access here.
This story was translated from Univadis Spain, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Five years have passed since the member states of the World Health Organization (WHO) gathered at the 72nd World Health Assembly and decided that September 17 should be recognized as World Patient Safety Day, acknowledging it as a global health priority.
WHO data indicate the following findings related to medical safety:
- One in 10 patients is harmed while receiving healthcare, and 3 million die as a result.
- More than half of these incidents could be prevented.
- Indirect costs could amount to several billion US dollars annually.
Given the magnitude of preventable harm related to medication use, in 2017, the WHO launched the third Global Patient Safety Challenge: Medication Without Harm with the goal of reducing serious and preventable harm related to medication by 50%. In addition, considering the volume of medication packages prescribed in 2023 by physicians in Spain’s National Health System, it is necessary to understand the most common types of medication errors to provide an effective and efficient response.
According to Spain’s Institute for Safe Medication Practices (ISMP), the 10 types of medication errors detected in 2020 with the most serious consequences were the following:
- Errors due to omission or delay in medication.
- Administration of medication to the wrong patient.
- Errors related to allergies or known adverse effects of medications.
- Dosing errors in pediatric patients.
- Errors due to similarities in the labeling or packaging of marketed medications.
- Errors associated with the lack of use of smart infusion pumps.
- Errors due to accidental administration of neuromuscular blocking agents.
- Incorrect intravenous administration of oral liquid medications.
- Errors in medication reconciliation upon hospital admission and discharge.
- Errors due to patient misunderstandings regarding medication use.
I would like to focus on the fifth item, errors due to similarities in the labeling or packaging of marketed medications.
Medications with similar names or with similar labeling or packaging are known as “look alike–sound alike” medications. They are estimated to account for between 6.2% and 14.7% of all medication errors. Confusion can arise due to spelling and phonetic similarities.
As shown in bulletin no. 50 of the ISMP, difficulties in distinguishing different medications or different presentations of the same medication due to similar packaging and labeling have frequently been associated with reported incidents.
Most cases involve either medications marketed by the same laboratory with a design based on brand image or different medications marketed by different laboratories in screen-printed ampoules used in the same settings.
In 2020, the ISMP published 11 new cases of labeling or packaging that may promote errors on its website. It reported 49 incidents to the Spanish Agency for Medicines and Medical Devices.
Shortages caused by the COVID-19 pandemic have further contributed to these incidents, as healthcare facilities sometimes had to change the medications they usually acquired and purchase whatever was available, without being able to select products that would not be confused with existing medications in the facility.
The ISMP recommends the following general practices for healthcare institutions, professionals, and patients to prevent these errors:
- Develop short lists of easily confused medication names and distribute them among all healthcare professionals.
- Prioritize medication names by active ingredient instead of brand name.
- For similar names, highlight the differences in capital letters, eg, DOBUTamine, DOPamine.
- For similar active ingredients, use brand names.
- Avoid placing similar medications near each other.
- Prescribe all medications electronically to minimize the risk of selecting the wrong medication.
- Make manual prescriptions legible, with clearly written dosages and pharmaceutical forms.
- Encourage patients to actively participate in their treatment and consult a clinician if they have any questions about the medications they are receiving.
- Raise awareness among patients, family members, and caregivers about the issues caused by medication name confusion and inform them about how to avoid these errors.
- Instruct patients to focus on and always use the active ingredient name as an identifying element for the medications they are taking.
- Review treatments with patients to ensure they know the medications they are taking.
Julia María Ruiz Redondo is the regional nursing advisor inspector of Spanish Society of General and Family Physicians of Castilla-La Mancha (SEMG-CLM), coordinator of the National Working Group on Public Health in the SEMG, and director of the international public health master’s degree at TECH Technological University. This article is the result of an editorial collaboration between the SEMG and Univadis, which you can access here.
This story was translated from Univadis Spain, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Five years have passed since the member states of the World Health Organization (WHO) gathered at the 72nd World Health Assembly and decided that September 17 should be recognized as World Patient Safety Day, acknowledging it as a global health priority.
WHO data indicate the following findings related to medical safety:
- One in 10 patients is harmed while receiving healthcare, and 3 million die as a result.
- More than half of these incidents could be prevented.
- Indirect costs could amount to several billion US dollars annually.
Given the magnitude of preventable harm related to medication use, in 2017, the WHO launched the third Global Patient Safety Challenge: Medication Without Harm with the goal of reducing serious and preventable harm related to medication by 50%. In addition, considering the volume of medication packages prescribed in 2023 by physicians in Spain’s National Health System, it is necessary to understand the most common types of medication errors to provide an effective and efficient response.
According to Spain’s Institute for Safe Medication Practices (ISMP), the 10 types of medication errors detected in 2020 with the most serious consequences were the following:
- Errors due to omission or delay in medication.
- Administration of medication to the wrong patient.
- Errors related to allergies or known adverse effects of medications.
- Dosing errors in pediatric patients.
- Errors due to similarities in the labeling or packaging of marketed medications.
- Errors associated with the lack of use of smart infusion pumps.
- Errors due to accidental administration of neuromuscular blocking agents.
- Incorrect intravenous administration of oral liquid medications.
- Errors in medication reconciliation upon hospital admission and discharge.
- Errors due to patient misunderstandings regarding medication use.
I would like to focus on the fifth item, errors due to similarities in the labeling or packaging of marketed medications.
Medications with similar names or with similar labeling or packaging are known as “look alike–sound alike” medications. They are estimated to account for between 6.2% and 14.7% of all medication errors. Confusion can arise due to spelling and phonetic similarities.
As shown in bulletin no. 50 of the ISMP, difficulties in distinguishing different medications or different presentations of the same medication due to similar packaging and labeling have frequently been associated with reported incidents.
Most cases involve either medications marketed by the same laboratory with a design based on brand image or different medications marketed by different laboratories in screen-printed ampoules used in the same settings.
In 2020, the ISMP published 11 new cases of labeling or packaging that may promote errors on its website. It reported 49 incidents to the Spanish Agency for Medicines and Medical Devices.
Shortages caused by the COVID-19 pandemic have further contributed to these incidents, as healthcare facilities sometimes had to change the medications they usually acquired and purchase whatever was available, without being able to select products that would not be confused with existing medications in the facility.
The ISMP recommends the following general practices for healthcare institutions, professionals, and patients to prevent these errors:
- Develop short lists of easily confused medication names and distribute them among all healthcare professionals.
- Prioritize medication names by active ingredient instead of brand name.
- For similar names, highlight the differences in capital letters, eg, DOBUTamine, DOPamine.
- For similar active ingredients, use brand names.
- Avoid placing similar medications near each other.
- Prescribe all medications electronically to minimize the risk of selecting the wrong medication.
- Make manual prescriptions legible, with clearly written dosages and pharmaceutical forms.
- Encourage patients to actively participate in their treatment and consult a clinician if they have any questions about the medications they are receiving.
- Raise awareness among patients, family members, and caregivers about the issues caused by medication name confusion and inform them about how to avoid these errors.
- Instruct patients to focus on and always use the active ingredient name as an identifying element for the medications they are taking.
- Review treatments with patients to ensure they know the medications they are taking.
Julia María Ruiz Redondo is the regional nursing advisor inspector of Spanish Society of General and Family Physicians of Castilla-La Mancha (SEMG-CLM), coordinator of the National Working Group on Public Health in the SEMG, and director of the international public health master’s degree at TECH Technological University. This article is the result of an editorial collaboration between the SEMG and Univadis, which you can access here.
This story was translated from Univadis Spain, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
A CRC Blood Test Is Here. What Does it Mean for Screening?
In July, the US Food and Drug Administration (FDA) approved the first blood-based test to screen for colorectal cancer (CRC).
The FDA’s approval of Shield (Guardant Health) marks a notable achievement, as individuals at average risk now have the option to receive a simple blood test for CRC screening, starting at age 45.
“No one has an excuse anymore not to be screened,” said John Marshall, MD, director of The Ruesch Center for the Cure of Gastrointestinal Cancers and chief medical officer of the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center in Washington, DC.
The approval was based on findings from the ECLIPSE study, which reported that Shield had 83% sensitivity for CRC and 90% specificity for advanced neoplasia, though only 13% sensitivity for advanced precancerous lesions.
While an exciting option, the test has its pros and cons.
The bad news, however, is that it does a poor job of detecting precancerous lesions. This could snowball if patients decide to replace a colonoscopy — which helps both detect and prevent CRC — with the blood test.
This news organization spoke to experts across three core specialties involved in the screening and treatment of CRC — primary care, gastroenterology, and oncology — to better understand both the potential value and potential pitfalls of this new option.
The interview responses have been condensed and edited for clarity.
What does this FDA approval mean for CRC screening?
David Lieberman, MD, gastroenterologist and professor emeritus at Oregon Health & Science University: Detecting circulating-free DNA associated with CRC in blood is a major scientific breakthrough. The ease of blood testing will appeal to patients and providers.
Folasade May, MD, director of the gastroenterology quality improvement program at the University of California, Los Angeles: The FDA approval means that we continue to broaden the scope of available tools to help reduce the impact of this largely preventable disease.
Dr. Marshall: Colonoscopy is still the gold standard, but we have to recognize that not everyone does it. And that not everyone wants to send their poop in the mail (with a stool-based test). Now there are no more excuses.
Alan Venook, MD, gastrointestinal medical oncologist at the University of California, San Francisco: Although it’s good to have a blood test that’s approved for CRC screening, I don’t think it moves the bar much in terms of screening. I worry about it overpromising and under-delivering. If it could find polyps or premalignant lesions, that would make a big difference; however, at 13%, that doesn’t really register, so this doesn’t really change anything.
Kenny Lin, MD, a family physician at Penn Medicine Lancaster General Health: I see this test as a good option for the 30% people of CRC screening age who are either not being screened or out of date for screening. I’m a little concerned about the people who are already getting recommended screening and may try to switch to this option.
William Golden, MD, internist and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, Arkansas: On a scale of 1-10, I give it a 2. It’s expensive ($900 per test without insurance). It’s also not sensitive for early cancers, which would be its main value. Frankly, there are better strategies to get patients engaged.
What do you see as the pros and cons of this test?
Dr. Lin: The pros are that it’s very convenient for patients, and it’s especially easy for physicians if they have a lab in their office and can avoid a referral where patients may never get the test. However, the data I saw were disappointing, with sensitivity and specificity falling short of the stool-based Cologuard test, which is also not invasive and less likely to miss early cancers, precancerous lesions, and polyps.
Dr. Lieberman: A major con is the detection rate of only 13% for advanced precancerous lesions, which means that this test is not likely to result in much cancer prevention. There is good evidence that if advanced precancerous lesions are detected and removed, many — if not most — CRCs can be prevented.
Dr. Marshall: Another issue is the potential for a false-positive result (which occurs for 1 in every 10 tests). With this result, you would do a scope but can’t find what’s going on. This is a big deal. It’s the first of the blood tests that will be used for cancer screening, and it could be scary for a patient to receive a positive result but not be able to figure out where it’s coming from.
Will you be recommending this test or relying on its results?
Dr. Lieberman: Patients need to understand that the blood test is inferior to every other screening test and, if selected, would result in less protection against developing CRC or dying from CRC than other screening tests. But models suggest that this test will perform better than no screening. Therefore, it is reasonable to offer the test to individuals who decline any other form of screening.
Dr. May: I will do what I’ve always done — after the FDA approval, I wait for the US Preventive Services Task Force (USPSTF) to endorse it. If it does, then I feel it’s my responsibility to tell my patients about all the options they have and stay up to date on how the tests perform, what the pros and cons are, and what reliable information will help patients make the best decision.
Dr. Venook: No, but I could potentially see us moving it into surveillance mode, where CRC survivors or patients undergoing therapy could take it, which might give us a unique second bite of the apple. The test could potentially be of value in identifying early relapse or recurrence, which might give us a heads-up or jump start on follow-up.
Are you concerned that patients won’t return for a colonoscopy after a positive result?
Dr. Golden: This concern is relevant for all tests, including fecal immunochemical test (FIT), but I’ve found that if the patient is willing to do the initial test and it comes back positive, most are willing to do the follow-up. Of course, some folks have issues with this, but now we’ll have a marker in their medical records and can re-engage them through outreach.
Dr. Lieberman: I am concerned that a patient who previously declined to have a colonoscopy may not follow up an abnormal blood test with a colonoscopy. If this occurs, it will render a blood test program ineffective for those patients. Patients should be told upfront that if the test is abnormal, a colonoscopy would be recommended.
Dr. May: This is a big concern that I have. We already have two-step screening processes with FIT, Cologuard, and CT colonography, and strong data show there is attrition. All doctors and companies will need to make it clear that if patients have an abnormal test result, they must undergo a colonoscopy. We must have activated and involved systems of patient follow-up and navigation.
Dr. Lin: I already have some concerns, given that some patients with positive FIT tests don’t get timely follow-up. I see it in my own practice where we call patients to get a colonoscopy, but they don’t take it seriously or their initial counseling wasn’t clear about the possibility of needing a follow-up colonoscopy. If people aren’t being screened for whatever reason in the first place and they get a positive result on the Shield blood test, they might be even less likely to get the necessary follow-up testing afterward.
What might this mean for insurance coverage and costs for patients?
Dr. May: This is an important question because if we don’t have equal access, we create or widen disparities. For insurers to cover Shield, it’ll need to be endorsed by major medical societies, including USPSTF. But what will happen in the beginning is that wealthy patients who can pay out of pocket will use it, while lower-income individuals won’t have access until insurers cover it.
Dr. Golden: I could do 70 (or more) FIT tests for the cost of this one blood test. A FIT test should be offered first. We’re advising the Medicaid program that physicians should be required to explain why a patient doesn’t want a FIT test, prior to covering this blood test.
Dr. Venook: It’s too early to say. Although it’s approved, we now have to look at the monetization factor. At the end of the day, we still need a colonoscopy. The science is impressive, but it doesn’t mean we need to spend $900 doing a blood test.
Dr. Lin: I could see the coverage trajectory being similar to that for Cologuard, which had little coverage when it came out 10 years ago, but eventually, Medicare and commercial coverage happened. With Shield, initially, there will be some coverage gaps, especially with commercial insurance, and I can see insurance companies having concerns, especially because the test is expensive compared with other tests and the return isn’t well known. It could also be a waste of money if people with positive tests don’t receive follow-up colonoscopies.
What else would you like to share that people may not have considered?
Dr. Marshall: These tests could pick up other genes from other cancers. My worry is that people could have another cancer detected but not find it on a colonoscopy and think the blood test must be wrong. Or they’ll do a scan, which could lead to more scans and tests.
Dr. Golden: This test has received a lot of attention and coverage that didn’t discuss other screening options, limitations, or nuances. Let’s face it — we’ll see lots of TV ads about it, but once we start dealing with the total cost of care and alternate payment models, it’s going to be hard for this test to find a niche.
Dr. Venook: This test has only been validated in a population of ages 45 years or older, which is the conventional screening population. We desperately need something that can work in younger people, where CRC rates are increasing. I’d like to see the research move in that direction.
Dr. Lin: I thought it was unique that the FDA Advisory Panel clearly stated this was better than nothing but also should be used as second-line screening. The agency took pains to say this is not a colonoscopy or even equivalent to the fecal tests in use. But they appropriately did approve it because a lot of people aren’t getting anything at all, which is the biggest problem with CRC screening.
A version of this article first appeared on Medscape.com.
In July, the US Food and Drug Administration (FDA) approved the first blood-based test to screen for colorectal cancer (CRC).
The FDA’s approval of Shield (Guardant Health) marks a notable achievement, as individuals at average risk now have the option to receive a simple blood test for CRC screening, starting at age 45.
“No one has an excuse anymore not to be screened,” said John Marshall, MD, director of The Ruesch Center for the Cure of Gastrointestinal Cancers and chief medical officer of the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center in Washington, DC.
The approval was based on findings from the ECLIPSE study, which reported that Shield had 83% sensitivity for CRC and 90% specificity for advanced neoplasia, though only 13% sensitivity for advanced precancerous lesions.
While an exciting option, the test has its pros and cons.
The bad news, however, is that it does a poor job of detecting precancerous lesions. This could snowball if patients decide to replace a colonoscopy — which helps both detect and prevent CRC — with the blood test.
This news organization spoke to experts across three core specialties involved in the screening and treatment of CRC — primary care, gastroenterology, and oncology — to better understand both the potential value and potential pitfalls of this new option.
The interview responses have been condensed and edited for clarity.
What does this FDA approval mean for CRC screening?
David Lieberman, MD, gastroenterologist and professor emeritus at Oregon Health & Science University: Detecting circulating-free DNA associated with CRC in blood is a major scientific breakthrough. The ease of blood testing will appeal to patients and providers.
Folasade May, MD, director of the gastroenterology quality improvement program at the University of California, Los Angeles: The FDA approval means that we continue to broaden the scope of available tools to help reduce the impact of this largely preventable disease.
Dr. Marshall: Colonoscopy is still the gold standard, but we have to recognize that not everyone does it. And that not everyone wants to send their poop in the mail (with a stool-based test). Now there are no more excuses.
Alan Venook, MD, gastrointestinal medical oncologist at the University of California, San Francisco: Although it’s good to have a blood test that’s approved for CRC screening, I don’t think it moves the bar much in terms of screening. I worry about it overpromising and under-delivering. If it could find polyps or premalignant lesions, that would make a big difference; however, at 13%, that doesn’t really register, so this doesn’t really change anything.
Kenny Lin, MD, a family physician at Penn Medicine Lancaster General Health: I see this test as a good option for the 30% people of CRC screening age who are either not being screened or out of date for screening. I’m a little concerned about the people who are already getting recommended screening and may try to switch to this option.
William Golden, MD, internist and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, Arkansas: On a scale of 1-10, I give it a 2. It’s expensive ($900 per test without insurance). It’s also not sensitive for early cancers, which would be its main value. Frankly, there are better strategies to get patients engaged.
What do you see as the pros and cons of this test?
Dr. Lin: The pros are that it’s very convenient for patients, and it’s especially easy for physicians if they have a lab in their office and can avoid a referral where patients may never get the test. However, the data I saw were disappointing, with sensitivity and specificity falling short of the stool-based Cologuard test, which is also not invasive and less likely to miss early cancers, precancerous lesions, and polyps.
Dr. Lieberman: A major con is the detection rate of only 13% for advanced precancerous lesions, which means that this test is not likely to result in much cancer prevention. There is good evidence that if advanced precancerous lesions are detected and removed, many — if not most — CRCs can be prevented.
Dr. Marshall: Another issue is the potential for a false-positive result (which occurs for 1 in every 10 tests). With this result, you would do a scope but can’t find what’s going on. This is a big deal. It’s the first of the blood tests that will be used for cancer screening, and it could be scary for a patient to receive a positive result but not be able to figure out where it’s coming from.
Will you be recommending this test or relying on its results?
Dr. Lieberman: Patients need to understand that the blood test is inferior to every other screening test and, if selected, would result in less protection against developing CRC or dying from CRC than other screening tests. But models suggest that this test will perform better than no screening. Therefore, it is reasonable to offer the test to individuals who decline any other form of screening.
Dr. May: I will do what I’ve always done — after the FDA approval, I wait for the US Preventive Services Task Force (USPSTF) to endorse it. If it does, then I feel it’s my responsibility to tell my patients about all the options they have and stay up to date on how the tests perform, what the pros and cons are, and what reliable information will help patients make the best decision.
Dr. Venook: No, but I could potentially see us moving it into surveillance mode, where CRC survivors or patients undergoing therapy could take it, which might give us a unique second bite of the apple. The test could potentially be of value in identifying early relapse or recurrence, which might give us a heads-up or jump start on follow-up.
Are you concerned that patients won’t return for a colonoscopy after a positive result?
Dr. Golden: This concern is relevant for all tests, including fecal immunochemical test (FIT), but I’ve found that if the patient is willing to do the initial test and it comes back positive, most are willing to do the follow-up. Of course, some folks have issues with this, but now we’ll have a marker in their medical records and can re-engage them through outreach.
Dr. Lieberman: I am concerned that a patient who previously declined to have a colonoscopy may not follow up an abnormal blood test with a colonoscopy. If this occurs, it will render a blood test program ineffective for those patients. Patients should be told upfront that if the test is abnormal, a colonoscopy would be recommended.
Dr. May: This is a big concern that I have. We already have two-step screening processes with FIT, Cologuard, and CT colonography, and strong data show there is attrition. All doctors and companies will need to make it clear that if patients have an abnormal test result, they must undergo a colonoscopy. We must have activated and involved systems of patient follow-up and navigation.
Dr. Lin: I already have some concerns, given that some patients with positive FIT tests don’t get timely follow-up. I see it in my own practice where we call patients to get a colonoscopy, but they don’t take it seriously or their initial counseling wasn’t clear about the possibility of needing a follow-up colonoscopy. If people aren’t being screened for whatever reason in the first place and they get a positive result on the Shield blood test, they might be even less likely to get the necessary follow-up testing afterward.
What might this mean for insurance coverage and costs for patients?
Dr. May: This is an important question because if we don’t have equal access, we create or widen disparities. For insurers to cover Shield, it’ll need to be endorsed by major medical societies, including USPSTF. But what will happen in the beginning is that wealthy patients who can pay out of pocket will use it, while lower-income individuals won’t have access until insurers cover it.
Dr. Golden: I could do 70 (or more) FIT tests for the cost of this one blood test. A FIT test should be offered first. We’re advising the Medicaid program that physicians should be required to explain why a patient doesn’t want a FIT test, prior to covering this blood test.
Dr. Venook: It’s too early to say. Although it’s approved, we now have to look at the monetization factor. At the end of the day, we still need a colonoscopy. The science is impressive, but it doesn’t mean we need to spend $900 doing a blood test.
Dr. Lin: I could see the coverage trajectory being similar to that for Cologuard, which had little coverage when it came out 10 years ago, but eventually, Medicare and commercial coverage happened. With Shield, initially, there will be some coverage gaps, especially with commercial insurance, and I can see insurance companies having concerns, especially because the test is expensive compared with other tests and the return isn’t well known. It could also be a waste of money if people with positive tests don’t receive follow-up colonoscopies.
What else would you like to share that people may not have considered?
Dr. Marshall: These tests could pick up other genes from other cancers. My worry is that people could have another cancer detected but not find it on a colonoscopy and think the blood test must be wrong. Or they’ll do a scan, which could lead to more scans and tests.
Dr. Golden: This test has received a lot of attention and coverage that didn’t discuss other screening options, limitations, or nuances. Let’s face it — we’ll see lots of TV ads about it, but once we start dealing with the total cost of care and alternate payment models, it’s going to be hard for this test to find a niche.
Dr. Venook: This test has only been validated in a population of ages 45 years or older, which is the conventional screening population. We desperately need something that can work in younger people, where CRC rates are increasing. I’d like to see the research move in that direction.
Dr. Lin: I thought it was unique that the FDA Advisory Panel clearly stated this was better than nothing but also should be used as second-line screening. The agency took pains to say this is not a colonoscopy or even equivalent to the fecal tests in use. But they appropriately did approve it because a lot of people aren’t getting anything at all, which is the biggest problem with CRC screening.
A version of this article first appeared on Medscape.com.
In July, the US Food and Drug Administration (FDA) approved the first blood-based test to screen for colorectal cancer (CRC).
The FDA’s approval of Shield (Guardant Health) marks a notable achievement, as individuals at average risk now have the option to receive a simple blood test for CRC screening, starting at age 45.
“No one has an excuse anymore not to be screened,” said John Marshall, MD, director of The Ruesch Center for the Cure of Gastrointestinal Cancers and chief medical officer of the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center in Washington, DC.
The approval was based on findings from the ECLIPSE study, which reported that Shield had 83% sensitivity for CRC and 90% specificity for advanced neoplasia, though only 13% sensitivity for advanced precancerous lesions.
While an exciting option, the test has its pros and cons.
The bad news, however, is that it does a poor job of detecting precancerous lesions. This could snowball if patients decide to replace a colonoscopy — which helps both detect and prevent CRC — with the blood test.
This news organization spoke to experts across three core specialties involved in the screening and treatment of CRC — primary care, gastroenterology, and oncology — to better understand both the potential value and potential pitfalls of this new option.
The interview responses have been condensed and edited for clarity.
What does this FDA approval mean for CRC screening?
David Lieberman, MD, gastroenterologist and professor emeritus at Oregon Health & Science University: Detecting circulating-free DNA associated with CRC in blood is a major scientific breakthrough. The ease of blood testing will appeal to patients and providers.
Folasade May, MD, director of the gastroenterology quality improvement program at the University of California, Los Angeles: The FDA approval means that we continue to broaden the scope of available tools to help reduce the impact of this largely preventable disease.
Dr. Marshall: Colonoscopy is still the gold standard, but we have to recognize that not everyone does it. And that not everyone wants to send their poop in the mail (with a stool-based test). Now there are no more excuses.
Alan Venook, MD, gastrointestinal medical oncologist at the University of California, San Francisco: Although it’s good to have a blood test that’s approved for CRC screening, I don’t think it moves the bar much in terms of screening. I worry about it overpromising and under-delivering. If it could find polyps or premalignant lesions, that would make a big difference; however, at 13%, that doesn’t really register, so this doesn’t really change anything.
Kenny Lin, MD, a family physician at Penn Medicine Lancaster General Health: I see this test as a good option for the 30% people of CRC screening age who are either not being screened or out of date for screening. I’m a little concerned about the people who are already getting recommended screening and may try to switch to this option.
William Golden, MD, internist and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, Arkansas: On a scale of 1-10, I give it a 2. It’s expensive ($900 per test without insurance). It’s also not sensitive for early cancers, which would be its main value. Frankly, there are better strategies to get patients engaged.
What do you see as the pros and cons of this test?
Dr. Lin: The pros are that it’s very convenient for patients, and it’s especially easy for physicians if they have a lab in their office and can avoid a referral where patients may never get the test. However, the data I saw were disappointing, with sensitivity and specificity falling short of the stool-based Cologuard test, which is also not invasive and less likely to miss early cancers, precancerous lesions, and polyps.
Dr. Lieberman: A major con is the detection rate of only 13% for advanced precancerous lesions, which means that this test is not likely to result in much cancer prevention. There is good evidence that if advanced precancerous lesions are detected and removed, many — if not most — CRCs can be prevented.
Dr. Marshall: Another issue is the potential for a false-positive result (which occurs for 1 in every 10 tests). With this result, you would do a scope but can’t find what’s going on. This is a big deal. It’s the first of the blood tests that will be used for cancer screening, and it could be scary for a patient to receive a positive result but not be able to figure out where it’s coming from.
Will you be recommending this test or relying on its results?
Dr. Lieberman: Patients need to understand that the blood test is inferior to every other screening test and, if selected, would result in less protection against developing CRC or dying from CRC than other screening tests. But models suggest that this test will perform better than no screening. Therefore, it is reasonable to offer the test to individuals who decline any other form of screening.
Dr. May: I will do what I’ve always done — after the FDA approval, I wait for the US Preventive Services Task Force (USPSTF) to endorse it. If it does, then I feel it’s my responsibility to tell my patients about all the options they have and stay up to date on how the tests perform, what the pros and cons are, and what reliable information will help patients make the best decision.
Dr. Venook: No, but I could potentially see us moving it into surveillance mode, where CRC survivors or patients undergoing therapy could take it, which might give us a unique second bite of the apple. The test could potentially be of value in identifying early relapse or recurrence, which might give us a heads-up or jump start on follow-up.
Are you concerned that patients won’t return for a colonoscopy after a positive result?
Dr. Golden: This concern is relevant for all tests, including fecal immunochemical test (FIT), but I’ve found that if the patient is willing to do the initial test and it comes back positive, most are willing to do the follow-up. Of course, some folks have issues with this, but now we’ll have a marker in their medical records and can re-engage them through outreach.
Dr. Lieberman: I am concerned that a patient who previously declined to have a colonoscopy may not follow up an abnormal blood test with a colonoscopy. If this occurs, it will render a blood test program ineffective for those patients. Patients should be told upfront that if the test is abnormal, a colonoscopy would be recommended.
Dr. May: This is a big concern that I have. We already have two-step screening processes with FIT, Cologuard, and CT colonography, and strong data show there is attrition. All doctors and companies will need to make it clear that if patients have an abnormal test result, they must undergo a colonoscopy. We must have activated and involved systems of patient follow-up and navigation.
Dr. Lin: I already have some concerns, given that some patients with positive FIT tests don’t get timely follow-up. I see it in my own practice where we call patients to get a colonoscopy, but they don’t take it seriously or their initial counseling wasn’t clear about the possibility of needing a follow-up colonoscopy. If people aren’t being screened for whatever reason in the first place and they get a positive result on the Shield blood test, they might be even less likely to get the necessary follow-up testing afterward.
What might this mean for insurance coverage and costs for patients?
Dr. May: This is an important question because if we don’t have equal access, we create or widen disparities. For insurers to cover Shield, it’ll need to be endorsed by major medical societies, including USPSTF. But what will happen in the beginning is that wealthy patients who can pay out of pocket will use it, while lower-income individuals won’t have access until insurers cover it.
Dr. Golden: I could do 70 (or more) FIT tests for the cost of this one blood test. A FIT test should be offered first. We’re advising the Medicaid program that physicians should be required to explain why a patient doesn’t want a FIT test, prior to covering this blood test.
Dr. Venook: It’s too early to say. Although it’s approved, we now have to look at the monetization factor. At the end of the day, we still need a colonoscopy. The science is impressive, but it doesn’t mean we need to spend $900 doing a blood test.
Dr. Lin: I could see the coverage trajectory being similar to that for Cologuard, which had little coverage when it came out 10 years ago, but eventually, Medicare and commercial coverage happened. With Shield, initially, there will be some coverage gaps, especially with commercial insurance, and I can see insurance companies having concerns, especially because the test is expensive compared with other tests and the return isn’t well known. It could also be a waste of money if people with positive tests don’t receive follow-up colonoscopies.
What else would you like to share that people may not have considered?
Dr. Marshall: These tests could pick up other genes from other cancers. My worry is that people could have another cancer detected but not find it on a colonoscopy and think the blood test must be wrong. Or they’ll do a scan, which could lead to more scans and tests.
Dr. Golden: This test has received a lot of attention and coverage that didn’t discuss other screening options, limitations, or nuances. Let’s face it — we’ll see lots of TV ads about it, but once we start dealing with the total cost of care and alternate payment models, it’s going to be hard for this test to find a niche.
Dr. Venook: This test has only been validated in a population of ages 45 years or older, which is the conventional screening population. We desperately need something that can work in younger people, where CRC rates are increasing. I’d like to see the research move in that direction.
Dr. Lin: I thought it was unique that the FDA Advisory Panel clearly stated this was better than nothing but also should be used as second-line screening. The agency took pains to say this is not a colonoscopy or even equivalent to the fecal tests in use. But they appropriately did approve it because a lot of people aren’t getting anything at all, which is the biggest problem with CRC screening.
A version of this article first appeared on Medscape.com.
Five Steps to Improved Colonoscopy Performance
According to several experts who spoke at the American Gastroenterological Association’s Postgraduate Course this spring, which was offered at Digestive Disease Week (DDW), gastroenterologists can take these five steps to improve their performance: Addressing poor bowel prep, improving polyp detection, following the best intervals for polyp surveillance, reducing the environmental impact of gastrointestinal (GI) practice, and implementing artificial intelligence (AI) tools for efficiency and quality.
Addressing Poor Prep
To improve bowel preparation rates, clinicians may consider identifying those at high risk for inadequate prep, which could include known risk factors such as age, body mass index, inpatient status, constipation, tobacco use, and hypertension. However, other variables tend to serve as bigger predictors of inadequate prep, such as the patient’s status regarding cirrhosis, Parkinson’s disease, dementia, diabetes, opioid use, gastroparesis, tricyclics, and colorectal surgery.
Although several prediction models are based on some of these factors — looking at comorbidities, antidepressant use, constipation, and prior abdominal or pelvic surgery — the data don’t indicate whether knowing about or addressing these risks actually leads to better bowel prep, said Brian Jacobson, MD, associate professor of medicine at Harvard Medical School, Boston, and director of program development for gastroenterology at Massachusetts General Hospital in Boston.
Instead, the biggest return-on-investment option is to maximize prep for all patients, he said, especially since every patient has at least some risk of poor prep, either due to the required diet changes, medication considerations, or purgative solution and timing.
To create a state-of-the-art bowel prep process, Dr. Jacobson recommended numerous tactics for all patients: Verbal and written instructions for all components of prep, patient navigation with phone or virtual messaging to guide patients through the process, a low-fiber or all-liquid diet on the day before colonoscopy, and a split-dose 2-L prep regimen. Patients should begin the second half of the split-dose regimen 4-6 hours before colonoscopy and complete it at least 2 hours before the procedure starts, and clinicians should use an irrigation pump during colonoscopy to improve visibility.
Beyond that, Dr. Jacobson noted, higher risk patients can take a split-dose 4-L prep regimen with bisacodyl, a low-fiber diet 2-3 days before colonoscopy, and a clear liquid diet the day before colonoscopy. Using simethicone as an adjunct solution can also reduce bubbles in the colon.
Future tech developments may help clinicians as well, he said, such as using AI to identify patients at high risk and modifying their prep process, creating a personalized prep on a digital platform with videos that guide patients through the process, and using a phone checklist tool to indicate when they’re ready for colonoscopy.
Improving Polyp Detection
Adenoma detection rates (ADR) can be highly variable due to different techniques, technical skills, pattern recognition, interpretation, and experience. New adjunct and AI-based tools can help improve ADR, especially if clinicians want to improve, receive training, and use best-practice techniques.
“In colonoscopy, it’s tricky because it’s not just a blood test or an x-ray. There’s really a lot of technique involved, both cognitive awareness and pattern recognition, as well as our technical skills,” said Tonya Kaltenbach, MD, professor of clinical medicine at the University of California San Francisco and director of advanced endoscopy at the San Francisco VA Health Care System in San Francisco.
For instance, multiple tools and techniques may be needed in real time to interpret a lesion, such as washing, retroflexing, and using better lighting, while paying attention to alerts and noting areas for further inspection and resection.
“This is not innate. It’s a learned skill,” she said. “It’s something we need to intentionally make efforts on and get feedback to improve.”
Improvement starts with using the right mindset for lesion detection, Dr. Kaltenbach said, by having a “reflexive recognition of deconstructed patterns of normal” — following the lines, vessels, and folds and looking for interruptions, abnormal thickness, and mucus caps. On top of that, adjunctive tools such as caps/cuffs and dye chromoendoscopy can help with proper ergonomics, irrigation, and mucosa exposure.
In the past 3 years, real-world studies using AI and computer-assisted detection have shown mixed results, with some demonstrating significant increases in ADR, while others haven’t, she said. However, being willing to try AI and other tools, such as the Endocuff cap, may help improve ADR, standardize interpretation, improve efficiency, and increase reproducibility.
“We’re always better with intentional feedback and deliberate practice,” she said. “Remember that if you improve, you’re protecting the patient from death and reducing interval cancer.”
Following Polyp Surveillance Intervals
The US Multi-Society Task Force on Colorectal Cancer’s recommendations for follow-up after colonoscopy and polypectomy provide valuable information and rationale for how to determine surveillance intervals for patients. However, clinicians still may be unsure what to recommend for some patients — or tell them to come back too soon, leading to unnecessary colonoscopy.
For instance, a 47-year-old woman who presents for her initial screening and has a single 6-mm polyp, which pathology returns as a single adenoma may be considered to be at average risk and suggested to return in 7-10 years. The guidelines seem more obvious for patients with one or two adenomas under 10 mm removed en bloc.
However, once the case details shift into gray areas and include three or four adenomas between 10 and 20 mm, or piecemeal removal, clinicians may differ on their recommendations, said Rajesh N. Keswani, MD, associate professor of medicine at the Northwestern University Feinberg School of Medicine and director of endoscopy for Northwestern Medicine in Chicago. At DDW 2024, Dr. Keswani presented several case examples, often finding various audience opinions.
In addition, he noted, recent studies have found that clinicians may estimate imprecise polyp measurements, struggle to identify sessile serrated polyposis syndrome, and often don’t follow evidence-based guidelines.
“Why do we ignore the guidelines? There’s this perception that a patient has risk factors that aren’t addressed by the guidelines, with regards to family history or a distant history of a large polyp that we don’t want to leave to the usual intervals,” he said. “We feel uncomfortable, even with our meticulous colonoscopy, telling people to come back in 10 years.”
To improve guideline adherence, Dr. Keswani suggested providing additional education, implementing an automated surveillance calculator, and using guidelines at the point of care. At Northwestern, for instance, clinicians use a hyperlink with an interpreted version of the guidelines with prior colonoscopy considerations. Overall though, practitioners should feel comfortable leaning toward longer surveillance intervals, he noted.
“More effort should be spent on getting unscreened patients in for colonoscopy than bringing back low-risk patients too early,” he said.
Reducing Environmental Effects
In recent waste audits of endoscopy rooms, providers generate 1-3 kg of waste per procedure, which would fill 117 soccer fields to a depth of 1 m, based on 18 million procedures in the United States per year. This waste comes from procedure-related equipment, administration, medications, travel of patients and staff, and infrastructure with systems such as air conditioning. Taking steps toward a green practice can reduce waste and the carbon footprint of healthcare.
“When we think about improving colonoscopy performance, the goal is to prevent colon cancer death, but when we expand that, we have to apply sustainable practices as a domain of quality,” said Heiko Pohl, MD, professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, and a gastroenterologist at White River Junction VA Medical Center in White River Junction, Vermont.
The GI Multisociety Strategic Plan on Environmental Sustainability suggests a 5-year initiative to improve sustainability and reduce waste across seven domains — clinical setting, education, research, society efforts, intersociety efforts, industry, and advocacy.
For instance, clinicians can take the biggest step toward sustainability by avoiding unneeded colonoscopies, Dr. Pohl said, noting that between 20% and 30% aren’t appropriate or indicated. Instead, practitioners can implement longer surveillance intervals, adhere to guidelines, and consider alternative tests, such as the fecal immunochemical test, fecal DNA, blood-based tests, and CT colonography, where relevant.
Clinicians can also rethink their approach to resection, such as using a snare first instead of forceps to reduce single-instrument use, using clip closure only when it’s truly indicated, and implementing AI-assisted optical diagnosis to help with leaving rectosigmoid polyps in place.
In terms of physical waste, practices may also reconsider how they sort bins and biohazards, looking at new ways to dispose of regulated medical waste, sharps, recyclables, and typical trash. Waste audits can help find ways to reduce paper, combine procedures, and create more efficient use of endoscopy rooms.
“We are really in a very precarious situation,” Dr. Pohl said. “It’s our generation that has a responsibility to change the course for our children’s and grandchildren’s sake.”
AI for Quality And Efficiency
Moving forward, AI tools will likely become more popular in various parts of GI practice, by assisting with documentation, spotting polyps, tracking mucosal surfaces, providing optical histopathology, and supervising performance through high-quality feedback.
“Endoscopy has reached the limits of human visual capacity, where seeing more pixels won’t necessarily improve clinical diagnosis. What’s next for elevating the care of patients really is AI,” said Jason B. Samarasena, MD, professor of medicine and program director of the interventional endoscopy training program at the University of California Irvine in Irvine, California.
As practices adopt AI-based systems, however, clinicians should be cautious about a false sense of comfort or “alarm fatigue” if bounding boxes become distracting. Instead, new tools need to be adopted as a “physician-AI hybrid,” with the endoscopist in mind, particularly if helpful for performing a better exam by watching withdrawal time or endoscope slippage.
“In real-world practice, this is being implemented without attention to endoscopist inclination and behavior,” he said. “Having a better understanding of physician attitudes could yield more optimal results.”
Notably, AI-assisted tools should be viewed akin to spell-check, which signals to the endoscopist when to pay attention and double-check an area — but primarily relies on the expert to do a high-quality exam, said Aasma Shaukat, MD, professor of medicine and director of GI outcomes research at the NYU Grossman School of Medicine, New York City.
“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”
Future tools show promise in terms of tracking additional data related to prep quality, cecal landmarks, polyp size, mucosa exposure, histology prediction, and complete resection. These automated reports could also link to real-time dashboards, hospital or national registries, and reimbursement systems, Dr. Shaukat noted.
“At the end of the day, our interests are aligned,” she said. “Everybody cares about quality, patient satisfaction, and reimbursement, and with that goal in mind, I think some of the tools can be applied to show how we can achieve those principles together.”
Dr. Jacobson, Dr. Kaltenbach, Dr. Keswani, Dr. Pohl, Dr. Samarasena, and Dr. Shaukat reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
According to several experts who spoke at the American Gastroenterological Association’s Postgraduate Course this spring, which was offered at Digestive Disease Week (DDW), gastroenterologists can take these five steps to improve their performance: Addressing poor bowel prep, improving polyp detection, following the best intervals for polyp surveillance, reducing the environmental impact of gastrointestinal (GI) practice, and implementing artificial intelligence (AI) tools for efficiency and quality.
Addressing Poor Prep
To improve bowel preparation rates, clinicians may consider identifying those at high risk for inadequate prep, which could include known risk factors such as age, body mass index, inpatient status, constipation, tobacco use, and hypertension. However, other variables tend to serve as bigger predictors of inadequate prep, such as the patient’s status regarding cirrhosis, Parkinson’s disease, dementia, diabetes, opioid use, gastroparesis, tricyclics, and colorectal surgery.
Although several prediction models are based on some of these factors — looking at comorbidities, antidepressant use, constipation, and prior abdominal or pelvic surgery — the data don’t indicate whether knowing about or addressing these risks actually leads to better bowel prep, said Brian Jacobson, MD, associate professor of medicine at Harvard Medical School, Boston, and director of program development for gastroenterology at Massachusetts General Hospital in Boston.
Instead, the biggest return-on-investment option is to maximize prep for all patients, he said, especially since every patient has at least some risk of poor prep, either due to the required diet changes, medication considerations, or purgative solution and timing.
To create a state-of-the-art bowel prep process, Dr. Jacobson recommended numerous tactics for all patients: Verbal and written instructions for all components of prep, patient navigation with phone or virtual messaging to guide patients through the process, a low-fiber or all-liquid diet on the day before colonoscopy, and a split-dose 2-L prep regimen. Patients should begin the second half of the split-dose regimen 4-6 hours before colonoscopy and complete it at least 2 hours before the procedure starts, and clinicians should use an irrigation pump during colonoscopy to improve visibility.
Beyond that, Dr. Jacobson noted, higher risk patients can take a split-dose 4-L prep regimen with bisacodyl, a low-fiber diet 2-3 days before colonoscopy, and a clear liquid diet the day before colonoscopy. Using simethicone as an adjunct solution can also reduce bubbles in the colon.
Future tech developments may help clinicians as well, he said, such as using AI to identify patients at high risk and modifying their prep process, creating a personalized prep on a digital platform with videos that guide patients through the process, and using a phone checklist tool to indicate when they’re ready for colonoscopy.
Improving Polyp Detection
Adenoma detection rates (ADR) can be highly variable due to different techniques, technical skills, pattern recognition, interpretation, and experience. New adjunct and AI-based tools can help improve ADR, especially if clinicians want to improve, receive training, and use best-practice techniques.
“In colonoscopy, it’s tricky because it’s not just a blood test or an x-ray. There’s really a lot of technique involved, both cognitive awareness and pattern recognition, as well as our technical skills,” said Tonya Kaltenbach, MD, professor of clinical medicine at the University of California San Francisco and director of advanced endoscopy at the San Francisco VA Health Care System in San Francisco.
For instance, multiple tools and techniques may be needed in real time to interpret a lesion, such as washing, retroflexing, and using better lighting, while paying attention to alerts and noting areas for further inspection and resection.
“This is not innate. It’s a learned skill,” she said. “It’s something we need to intentionally make efforts on and get feedback to improve.”
Improvement starts with using the right mindset for lesion detection, Dr. Kaltenbach said, by having a “reflexive recognition of deconstructed patterns of normal” — following the lines, vessels, and folds and looking for interruptions, abnormal thickness, and mucus caps. On top of that, adjunctive tools such as caps/cuffs and dye chromoendoscopy can help with proper ergonomics, irrigation, and mucosa exposure.
In the past 3 years, real-world studies using AI and computer-assisted detection have shown mixed results, with some demonstrating significant increases in ADR, while others haven’t, she said. However, being willing to try AI and other tools, such as the Endocuff cap, may help improve ADR, standardize interpretation, improve efficiency, and increase reproducibility.
“We’re always better with intentional feedback and deliberate practice,” she said. “Remember that if you improve, you’re protecting the patient from death and reducing interval cancer.”
Following Polyp Surveillance Intervals
The US Multi-Society Task Force on Colorectal Cancer’s recommendations for follow-up after colonoscopy and polypectomy provide valuable information and rationale for how to determine surveillance intervals for patients. However, clinicians still may be unsure what to recommend for some patients — or tell them to come back too soon, leading to unnecessary colonoscopy.
For instance, a 47-year-old woman who presents for her initial screening and has a single 6-mm polyp, which pathology returns as a single adenoma may be considered to be at average risk and suggested to return in 7-10 years. The guidelines seem more obvious for patients with one or two adenomas under 10 mm removed en bloc.
However, once the case details shift into gray areas and include three or four adenomas between 10 and 20 mm, or piecemeal removal, clinicians may differ on their recommendations, said Rajesh N. Keswani, MD, associate professor of medicine at the Northwestern University Feinberg School of Medicine and director of endoscopy for Northwestern Medicine in Chicago. At DDW 2024, Dr. Keswani presented several case examples, often finding various audience opinions.
In addition, he noted, recent studies have found that clinicians may estimate imprecise polyp measurements, struggle to identify sessile serrated polyposis syndrome, and often don’t follow evidence-based guidelines.
“Why do we ignore the guidelines? There’s this perception that a patient has risk factors that aren’t addressed by the guidelines, with regards to family history or a distant history of a large polyp that we don’t want to leave to the usual intervals,” he said. “We feel uncomfortable, even with our meticulous colonoscopy, telling people to come back in 10 years.”
To improve guideline adherence, Dr. Keswani suggested providing additional education, implementing an automated surveillance calculator, and using guidelines at the point of care. At Northwestern, for instance, clinicians use a hyperlink with an interpreted version of the guidelines with prior colonoscopy considerations. Overall though, practitioners should feel comfortable leaning toward longer surveillance intervals, he noted.
“More effort should be spent on getting unscreened patients in for colonoscopy than bringing back low-risk patients too early,” he said.
Reducing Environmental Effects
In recent waste audits of endoscopy rooms, providers generate 1-3 kg of waste per procedure, which would fill 117 soccer fields to a depth of 1 m, based on 18 million procedures in the United States per year. This waste comes from procedure-related equipment, administration, medications, travel of patients and staff, and infrastructure with systems such as air conditioning. Taking steps toward a green practice can reduce waste and the carbon footprint of healthcare.
“When we think about improving colonoscopy performance, the goal is to prevent colon cancer death, but when we expand that, we have to apply sustainable practices as a domain of quality,” said Heiko Pohl, MD, professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, and a gastroenterologist at White River Junction VA Medical Center in White River Junction, Vermont.
The GI Multisociety Strategic Plan on Environmental Sustainability suggests a 5-year initiative to improve sustainability and reduce waste across seven domains — clinical setting, education, research, society efforts, intersociety efforts, industry, and advocacy.
For instance, clinicians can take the biggest step toward sustainability by avoiding unneeded colonoscopies, Dr. Pohl said, noting that between 20% and 30% aren’t appropriate or indicated. Instead, practitioners can implement longer surveillance intervals, adhere to guidelines, and consider alternative tests, such as the fecal immunochemical test, fecal DNA, blood-based tests, and CT colonography, where relevant.
Clinicians can also rethink their approach to resection, such as using a snare first instead of forceps to reduce single-instrument use, using clip closure only when it’s truly indicated, and implementing AI-assisted optical diagnosis to help with leaving rectosigmoid polyps in place.
In terms of physical waste, practices may also reconsider how they sort bins and biohazards, looking at new ways to dispose of regulated medical waste, sharps, recyclables, and typical trash. Waste audits can help find ways to reduce paper, combine procedures, and create more efficient use of endoscopy rooms.
“We are really in a very precarious situation,” Dr. Pohl said. “It’s our generation that has a responsibility to change the course for our children’s and grandchildren’s sake.”
AI for Quality And Efficiency
Moving forward, AI tools will likely become more popular in various parts of GI practice, by assisting with documentation, spotting polyps, tracking mucosal surfaces, providing optical histopathology, and supervising performance through high-quality feedback.
“Endoscopy has reached the limits of human visual capacity, where seeing more pixels won’t necessarily improve clinical diagnosis. What’s next for elevating the care of patients really is AI,” said Jason B. Samarasena, MD, professor of medicine and program director of the interventional endoscopy training program at the University of California Irvine in Irvine, California.
As practices adopt AI-based systems, however, clinicians should be cautious about a false sense of comfort or “alarm fatigue” if bounding boxes become distracting. Instead, new tools need to be adopted as a “physician-AI hybrid,” with the endoscopist in mind, particularly if helpful for performing a better exam by watching withdrawal time or endoscope slippage.
“In real-world practice, this is being implemented without attention to endoscopist inclination and behavior,” he said. “Having a better understanding of physician attitudes could yield more optimal results.”
Notably, AI-assisted tools should be viewed akin to spell-check, which signals to the endoscopist when to pay attention and double-check an area — but primarily relies on the expert to do a high-quality exam, said Aasma Shaukat, MD, professor of medicine and director of GI outcomes research at the NYU Grossman School of Medicine, New York City.
“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”
Future tools show promise in terms of tracking additional data related to prep quality, cecal landmarks, polyp size, mucosa exposure, histology prediction, and complete resection. These automated reports could also link to real-time dashboards, hospital or national registries, and reimbursement systems, Dr. Shaukat noted.
“At the end of the day, our interests are aligned,” she said. “Everybody cares about quality, patient satisfaction, and reimbursement, and with that goal in mind, I think some of the tools can be applied to show how we can achieve those principles together.”
Dr. Jacobson, Dr. Kaltenbach, Dr. Keswani, Dr. Pohl, Dr. Samarasena, and Dr. Shaukat reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
According to several experts who spoke at the American Gastroenterological Association’s Postgraduate Course this spring, which was offered at Digestive Disease Week (DDW), gastroenterologists can take these five steps to improve their performance: Addressing poor bowel prep, improving polyp detection, following the best intervals for polyp surveillance, reducing the environmental impact of gastrointestinal (GI) practice, and implementing artificial intelligence (AI) tools for efficiency and quality.
Addressing Poor Prep
To improve bowel preparation rates, clinicians may consider identifying those at high risk for inadequate prep, which could include known risk factors such as age, body mass index, inpatient status, constipation, tobacco use, and hypertension. However, other variables tend to serve as bigger predictors of inadequate prep, such as the patient’s status regarding cirrhosis, Parkinson’s disease, dementia, diabetes, opioid use, gastroparesis, tricyclics, and colorectal surgery.
Although several prediction models are based on some of these factors — looking at comorbidities, antidepressant use, constipation, and prior abdominal or pelvic surgery — the data don’t indicate whether knowing about or addressing these risks actually leads to better bowel prep, said Brian Jacobson, MD, associate professor of medicine at Harvard Medical School, Boston, and director of program development for gastroenterology at Massachusetts General Hospital in Boston.
Instead, the biggest return-on-investment option is to maximize prep for all patients, he said, especially since every patient has at least some risk of poor prep, either due to the required diet changes, medication considerations, or purgative solution and timing.
To create a state-of-the-art bowel prep process, Dr. Jacobson recommended numerous tactics for all patients: Verbal and written instructions for all components of prep, patient navigation with phone or virtual messaging to guide patients through the process, a low-fiber or all-liquid diet on the day before colonoscopy, and a split-dose 2-L prep regimen. Patients should begin the second half of the split-dose regimen 4-6 hours before colonoscopy and complete it at least 2 hours before the procedure starts, and clinicians should use an irrigation pump during colonoscopy to improve visibility.
Beyond that, Dr. Jacobson noted, higher risk patients can take a split-dose 4-L prep regimen with bisacodyl, a low-fiber diet 2-3 days before colonoscopy, and a clear liquid diet the day before colonoscopy. Using simethicone as an adjunct solution can also reduce bubbles in the colon.
Future tech developments may help clinicians as well, he said, such as using AI to identify patients at high risk and modifying their prep process, creating a personalized prep on a digital platform with videos that guide patients through the process, and using a phone checklist tool to indicate when they’re ready for colonoscopy.
Improving Polyp Detection
Adenoma detection rates (ADR) can be highly variable due to different techniques, technical skills, pattern recognition, interpretation, and experience. New adjunct and AI-based tools can help improve ADR, especially if clinicians want to improve, receive training, and use best-practice techniques.
“In colonoscopy, it’s tricky because it’s not just a blood test or an x-ray. There’s really a lot of technique involved, both cognitive awareness and pattern recognition, as well as our technical skills,” said Tonya Kaltenbach, MD, professor of clinical medicine at the University of California San Francisco and director of advanced endoscopy at the San Francisco VA Health Care System in San Francisco.
For instance, multiple tools and techniques may be needed in real time to interpret a lesion, such as washing, retroflexing, and using better lighting, while paying attention to alerts and noting areas for further inspection and resection.
“This is not innate. It’s a learned skill,” she said. “It’s something we need to intentionally make efforts on and get feedback to improve.”
Improvement starts with using the right mindset for lesion detection, Dr. Kaltenbach said, by having a “reflexive recognition of deconstructed patterns of normal” — following the lines, vessels, and folds and looking for interruptions, abnormal thickness, and mucus caps. On top of that, adjunctive tools such as caps/cuffs and dye chromoendoscopy can help with proper ergonomics, irrigation, and mucosa exposure.
In the past 3 years, real-world studies using AI and computer-assisted detection have shown mixed results, with some demonstrating significant increases in ADR, while others haven’t, she said. However, being willing to try AI and other tools, such as the Endocuff cap, may help improve ADR, standardize interpretation, improve efficiency, and increase reproducibility.
“We’re always better with intentional feedback and deliberate practice,” she said. “Remember that if you improve, you’re protecting the patient from death and reducing interval cancer.”
Following Polyp Surveillance Intervals
The US Multi-Society Task Force on Colorectal Cancer’s recommendations for follow-up after colonoscopy and polypectomy provide valuable information and rationale for how to determine surveillance intervals for patients. However, clinicians still may be unsure what to recommend for some patients — or tell them to come back too soon, leading to unnecessary colonoscopy.
For instance, a 47-year-old woman who presents for her initial screening and has a single 6-mm polyp, which pathology returns as a single adenoma may be considered to be at average risk and suggested to return in 7-10 years. The guidelines seem more obvious for patients with one or two adenomas under 10 mm removed en bloc.
However, once the case details shift into gray areas and include three or four adenomas between 10 and 20 mm, or piecemeal removal, clinicians may differ on their recommendations, said Rajesh N. Keswani, MD, associate professor of medicine at the Northwestern University Feinberg School of Medicine and director of endoscopy for Northwestern Medicine in Chicago. At DDW 2024, Dr. Keswani presented several case examples, often finding various audience opinions.
In addition, he noted, recent studies have found that clinicians may estimate imprecise polyp measurements, struggle to identify sessile serrated polyposis syndrome, and often don’t follow evidence-based guidelines.
“Why do we ignore the guidelines? There’s this perception that a patient has risk factors that aren’t addressed by the guidelines, with regards to family history or a distant history of a large polyp that we don’t want to leave to the usual intervals,” he said. “We feel uncomfortable, even with our meticulous colonoscopy, telling people to come back in 10 years.”
To improve guideline adherence, Dr. Keswani suggested providing additional education, implementing an automated surveillance calculator, and using guidelines at the point of care. At Northwestern, for instance, clinicians use a hyperlink with an interpreted version of the guidelines with prior colonoscopy considerations. Overall though, practitioners should feel comfortable leaning toward longer surveillance intervals, he noted.
“More effort should be spent on getting unscreened patients in for colonoscopy than bringing back low-risk patients too early,” he said.
Reducing Environmental Effects
In recent waste audits of endoscopy rooms, providers generate 1-3 kg of waste per procedure, which would fill 117 soccer fields to a depth of 1 m, based on 18 million procedures in the United States per year. This waste comes from procedure-related equipment, administration, medications, travel of patients and staff, and infrastructure with systems such as air conditioning. Taking steps toward a green practice can reduce waste and the carbon footprint of healthcare.
“When we think about improving colonoscopy performance, the goal is to prevent colon cancer death, but when we expand that, we have to apply sustainable practices as a domain of quality,” said Heiko Pohl, MD, professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, and a gastroenterologist at White River Junction VA Medical Center in White River Junction, Vermont.
The GI Multisociety Strategic Plan on Environmental Sustainability suggests a 5-year initiative to improve sustainability and reduce waste across seven domains — clinical setting, education, research, society efforts, intersociety efforts, industry, and advocacy.
For instance, clinicians can take the biggest step toward sustainability by avoiding unneeded colonoscopies, Dr. Pohl said, noting that between 20% and 30% aren’t appropriate or indicated. Instead, practitioners can implement longer surveillance intervals, adhere to guidelines, and consider alternative tests, such as the fecal immunochemical test, fecal DNA, blood-based tests, and CT colonography, where relevant.
Clinicians can also rethink their approach to resection, such as using a snare first instead of forceps to reduce single-instrument use, using clip closure only when it’s truly indicated, and implementing AI-assisted optical diagnosis to help with leaving rectosigmoid polyps in place.
In terms of physical waste, practices may also reconsider how they sort bins and biohazards, looking at new ways to dispose of regulated medical waste, sharps, recyclables, and typical trash. Waste audits can help find ways to reduce paper, combine procedures, and create more efficient use of endoscopy rooms.
“We are really in a very precarious situation,” Dr. Pohl said. “It’s our generation that has a responsibility to change the course for our children’s and grandchildren’s sake.”
AI for Quality And Efficiency
Moving forward, AI tools will likely become more popular in various parts of GI practice, by assisting with documentation, spotting polyps, tracking mucosal surfaces, providing optical histopathology, and supervising performance through high-quality feedback.
“Endoscopy has reached the limits of human visual capacity, where seeing more pixels won’t necessarily improve clinical diagnosis. What’s next for elevating the care of patients really is AI,” said Jason B. Samarasena, MD, professor of medicine and program director of the interventional endoscopy training program at the University of California Irvine in Irvine, California.
As practices adopt AI-based systems, however, clinicians should be cautious about a false sense of comfort or “alarm fatigue” if bounding boxes become distracting. Instead, new tools need to be adopted as a “physician-AI hybrid,” with the endoscopist in mind, particularly if helpful for performing a better exam by watching withdrawal time or endoscope slippage.
“In real-world practice, this is being implemented without attention to endoscopist inclination and behavior,” he said. “Having a better understanding of physician attitudes could yield more optimal results.”
Notably, AI-assisted tools should be viewed akin to spell-check, which signals to the endoscopist when to pay attention and double-check an area — but primarily relies on the expert to do a high-quality exam, said Aasma Shaukat, MD, professor of medicine and director of GI outcomes research at the NYU Grossman School of Medicine, New York City.
“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”
Future tools show promise in terms of tracking additional data related to prep quality, cecal landmarks, polyp size, mucosa exposure, histology prediction, and complete resection. These automated reports could also link to real-time dashboards, hospital or national registries, and reimbursement systems, Dr. Shaukat noted.
“At the end of the day, our interests are aligned,” she said. “Everybody cares about quality, patient satisfaction, and reimbursement, and with that goal in mind, I think some of the tools can be applied to show how we can achieve those principles together.”
Dr. Jacobson, Dr. Kaltenbach, Dr. Keswani, Dr. Pohl, Dr. Samarasena, and Dr. Shaukat reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Rheumatology Clinic Interventions for Smoking, Blood Pressure ‘Make a Big Difference’
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
First Combined Face and Eye Transplant Performed
In a groundbreaking procedure, a team of surgeons from New York University Langone Health successfully performed the first combined face and eye transplant on a patient with extensive craniofacial tissue loss after an electrical accident.
The highly complex surgery lasted for 21 hours and involved more than 140 surgeons, nurses, and other healthcare professionals under the leadership of Eduardo D. Rodriguez. MD. It not only restored the patient’s facial features, but also integrated a functional eyeball, potentially setting a new standard for future treatments in similar cases.
The transplant took place in May 2023, and the case report was published on September 5 this year in JAMA.
The 46-year-old man lost a large part of his craniofacial tissue and his left eyeball. The approach was highly specialized. Advanced microsurgical techniques such as anastomoses of microscopic vessels and delicate suturing techniques were crucial for the transplant’s success.
Moreover, customized surgical devices, specific implants, and tissue manipulation tools were developed specifically for this case, thus ensuring the viability of the transplant and adequate perfusion of the transplanted ocular tissue.
The initial results are encouraging. Retinal arterial perfusion has been maintained, and retinal architecture has been preserved, as demonstrated by optical coherence tomography. Electroretinography confirmed retinal responses to light, suggesting that the transplanted eye may eventually contribute to the patient’s visual perception. These results are comparable to those of previous facial tissue transplants, but with the significant addition of ocular functionality, which is a notable advance.
“The successful revascularization of the transplanted eye achieved in this study may serve as a step toward the goal of globe transplant for restoration of vision,” wrote the authors.
The complexity of the combined transplant required a deep understanding of facial and ocular anatomy, as well as tissue preservation techniques. The surgical team reported significant challenges, including the need to align delicate anatomical structures and ensure immunological compatibility between the donor and recipient. Meticulous planning from donor selection to postoperative follow-up was considered essential to maximize the likelihood of success and minimize the risk for allograft rejection.
The patient will now be continuously monitored and receive treatment with immunosuppressants such as tacrolimus and prednisone, adjusted according to his response to the transplant. According to the researchers, further studies will be needed to assess the long-term functionality of the transplanted eye and its integration with the central nervous system.
Despite being the fifth facial transplant surgery performed under Dr. Rodriguez’s leadership, this is the first record of a whole-eye transplant. “The mere fact that we have successfully performed the first whole-eye transplant along with a face transplant is a tremendous achievement that many believed to be impossible,” the doctor said in a statement. “We have taken a giant step forward and paved the way for the next chapter in vision restoration.”
This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
In a groundbreaking procedure, a team of surgeons from New York University Langone Health successfully performed the first combined face and eye transplant on a patient with extensive craniofacial tissue loss after an electrical accident.
The highly complex surgery lasted for 21 hours and involved more than 140 surgeons, nurses, and other healthcare professionals under the leadership of Eduardo D. Rodriguez. MD. It not only restored the patient’s facial features, but also integrated a functional eyeball, potentially setting a new standard for future treatments in similar cases.
The transplant took place in May 2023, and the case report was published on September 5 this year in JAMA.
The 46-year-old man lost a large part of his craniofacial tissue and his left eyeball. The approach was highly specialized. Advanced microsurgical techniques such as anastomoses of microscopic vessels and delicate suturing techniques were crucial for the transplant’s success.
Moreover, customized surgical devices, specific implants, and tissue manipulation tools were developed specifically for this case, thus ensuring the viability of the transplant and adequate perfusion of the transplanted ocular tissue.
The initial results are encouraging. Retinal arterial perfusion has been maintained, and retinal architecture has been preserved, as demonstrated by optical coherence tomography. Electroretinography confirmed retinal responses to light, suggesting that the transplanted eye may eventually contribute to the patient’s visual perception. These results are comparable to those of previous facial tissue transplants, but with the significant addition of ocular functionality, which is a notable advance.
“The successful revascularization of the transplanted eye achieved in this study may serve as a step toward the goal of globe transplant for restoration of vision,” wrote the authors.
The complexity of the combined transplant required a deep understanding of facial and ocular anatomy, as well as tissue preservation techniques. The surgical team reported significant challenges, including the need to align delicate anatomical structures and ensure immunological compatibility between the donor and recipient. Meticulous planning from donor selection to postoperative follow-up was considered essential to maximize the likelihood of success and minimize the risk for allograft rejection.
The patient will now be continuously monitored and receive treatment with immunosuppressants such as tacrolimus and prednisone, adjusted according to his response to the transplant. According to the researchers, further studies will be needed to assess the long-term functionality of the transplanted eye and its integration with the central nervous system.
Despite being the fifth facial transplant surgery performed under Dr. Rodriguez’s leadership, this is the first record of a whole-eye transplant. “The mere fact that we have successfully performed the first whole-eye transplant along with a face transplant is a tremendous achievement that many believed to be impossible,” the doctor said in a statement. “We have taken a giant step forward and paved the way for the next chapter in vision restoration.”
This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
In a groundbreaking procedure, a team of surgeons from New York University Langone Health successfully performed the first combined face and eye transplant on a patient with extensive craniofacial tissue loss after an electrical accident.
The highly complex surgery lasted for 21 hours and involved more than 140 surgeons, nurses, and other healthcare professionals under the leadership of Eduardo D. Rodriguez. MD. It not only restored the patient’s facial features, but also integrated a functional eyeball, potentially setting a new standard for future treatments in similar cases.
The transplant took place in May 2023, and the case report was published on September 5 this year in JAMA.
The 46-year-old man lost a large part of his craniofacial tissue and his left eyeball. The approach was highly specialized. Advanced microsurgical techniques such as anastomoses of microscopic vessels and delicate suturing techniques were crucial for the transplant’s success.
Moreover, customized surgical devices, specific implants, and tissue manipulation tools were developed specifically for this case, thus ensuring the viability of the transplant and adequate perfusion of the transplanted ocular tissue.
The initial results are encouraging. Retinal arterial perfusion has been maintained, and retinal architecture has been preserved, as demonstrated by optical coherence tomography. Electroretinography confirmed retinal responses to light, suggesting that the transplanted eye may eventually contribute to the patient’s visual perception. These results are comparable to those of previous facial tissue transplants, but with the significant addition of ocular functionality, which is a notable advance.
“The successful revascularization of the transplanted eye achieved in this study may serve as a step toward the goal of globe transplant for restoration of vision,” wrote the authors.
The complexity of the combined transplant required a deep understanding of facial and ocular anatomy, as well as tissue preservation techniques. The surgical team reported significant challenges, including the need to align delicate anatomical structures and ensure immunological compatibility between the donor and recipient. Meticulous planning from donor selection to postoperative follow-up was considered essential to maximize the likelihood of success and minimize the risk for allograft rejection.
The patient will now be continuously monitored and receive treatment with immunosuppressants such as tacrolimus and prednisone, adjusted according to his response to the transplant. According to the researchers, further studies will be needed to assess the long-term functionality of the transplanted eye and its integration with the central nervous system.
Despite being the fifth facial transplant surgery performed under Dr. Rodriguez’s leadership, this is the first record of a whole-eye transplant. “The mere fact that we have successfully performed the first whole-eye transplant along with a face transplant is a tremendous achievement that many believed to be impossible,” the doctor said in a statement. “We have taken a giant step forward and paved the way for the next chapter in vision restoration.”
This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
FDA OKs Subcutaneous Atezolizumab Formulation for Multiple Cancer Indications
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Is It Time for Universal Suicide Screening?
US suicide rates have reached alarming levels, with data from Centers for Disease Control and Prevention (CDC) showing a 37% increase from 2000 to 2022. Nearly 49,000 people died by suicide in 2022 alone, translating to one death every 11 minutes.
The increase in suicide rates has prompted calls for expansion of universal suicide screening, in which all individuals in medical or mental health care settings are screened for suicide risk, regardless of the purpose for their visit. But the psychiatric field is split on the issue, with some experts citing false positives and a lack of mental health care resources for those deemed at risk.
In 2022, when the US Preventative Services Task Force released its recommendations on suicide prevention, first in children and adolescents, and then in adults, the authors said there was insufficient evidence to support universal suicide screening.
Proponents of the practice pushed back on that finding, arguing that universal suicide screening could help identify those at high risk who might otherwise go undiagnosed, leading to earlier, potentially lifesaving, intervention.
So, what is the case for — and against — universal screening?
Sounding an Alert
The introduction of universal screening was driven by a confluence of factors that began with a 1999 report by then-US Surgeon General David Satcher, MD. This was followed by a report in 2016 from the Joint Commission on Detecting and Treating Suicidal Ideation that called for healthcare organizations to improve detection and treatment of suicidal ideation in all healthcare care settings.
Data from the alert showed that a significant number of people who died by suicide had a healthcare visit before their death. Half had seen a clinician a month before their death; nearly 30% had a medical visit just the week before — all with no detection of increased suicide risk.
It was that sort of finding that led Parkland Health and Hospital System in Dallas to become the first US hospital to implement universal suicide screening. Since the program launched in 2015, the system has screened more than 4.3 million patients in its emergency department, inpatient units, and 20 primary care clinics.
“Since the program began, we’ve completed between 40,000 to 50,000 screenings per month,” said Kimberly Roaten, PhD, associate chief quality and safety officer for behavioral health at Parkland Health.
Clinicians at Parkland use the five-item Ask Suicide-Screening Questions to assess suicidal intent, a commonly used tool that was originally developed for use in pediatric emergency rooms (ERs). The tool, which takes about 20 seconds to administer, has since been validated in both children and adults.
Based on a patient’s response, a clinical decision support system integrated into the electronic health record classifies suicide risk as none, moderate, or high.
Patients identified as moderate risk are offered a more in-depth assessment with a mental health clinician, though participation is not mandatory, said Dr. Roaten. Those at high risk receive a more thorough evaluation.
The proportion of ER patients at Parkland who screen positive for any suicidal intent has consistently remained at about 7%, and at 2% in the primary care clinics, she said.
To better understand what the program may have had on suicide prevention, Dr. Roaten is leading a National Institute of Mental Health–funded study to link a decade of mortality data from the state of Texas to patient data from Parkland Health. Investigators will analyze information about patients identified at risk for suicide, those patients’ characteristics, and who dies by suicide.
Universal Screening Expands
Other health systems have adopted universal suicide screening including the Indian Health Service and the US Veterans Health Administration. Universal suicide screening is also in place in a growing number of primary care practices and hospitals throughout the United States and will be mandatory for patients aged 12 years and older in all acute care hospitals in California beginning in 2025.
There is also a push for universal screening to be coordinated through local, state, and federal government, nonprofit, and private sectors. The National Action Alliance for Suicide Prevention is charged with advancing the White House’s 2024 National Strategy for Suicide Prevention, a 10-year plan to address gaps in suicide prevention in the United States.
Sarah Brummett, JD, director of the National Action Alliance for Suicide Prevention’s executive committee, said that universal suicide screening is part of the 2024 strategy. “We know there are barriers to universal screening, and so it’s important to recognize what they are so we can address them,” said Ms. Brummett.
Barriers may include adequate staffing, or a system in place to triage patients who screen positive.
At Parkland, cost and workload have been minimal, Dr. Roaten said. “We built a model that only dedicates our highest-value resources to the most at-risk patients.”
She also noted that relief may be on the horizon for health systems where cost is an obstacle to universal screening and subsequent intervention. “There are efforts at the federal level to increase funding for suicide assessment and crisis response,” she said.
Pushback on Universal Screening
Universal suicide screening has its detractors, including critics who say expansion is unlikely to reduce suicide rates.
“The issue with suicidal ideation is that it is very dynamic. Suicidal ideation changes very quickly — sometimes within hours,” said Craig Bryan, PsyD, professor of psychiatry and behavioral health at Ohio State University in Columbus, Ohio.
Universal screening can also lead to false positives, where a patient who screens positive for suicidal ideation has no actual intention of attempting suicide, potentially creating unnecessary concern and burden on health care resources, Dr. Bryan noted.
“What do you do with everyone who screens positive?” Dr. Bryan said. “I’ve spoken with leaders of many health systems in the United States, and there is pushback against universal screening because they don’t have enough mental health resources to handle all of the referrals.”
Suicide screening also doesn’t predict who will die by suicide, Dr. Bryan added. It only identifies those willing to disclose suicidal thoughts. There is a significant number of people without mental illness who may never seek medical care, so “the warning signs we’re teaching people to recognize — depression, anxiety, and substance abuse — might not be evident in these individuals,” he said.
“Life sideswipes them suddenly, and they go from 0 to 60 ... and they may have access to a highly lethal method [of suicide] which weaponizes that moment of despair,” said Dr. Bryan. No amount of screening could possibly predict those types of suicides, he added.
Paul Nestadt, MD, associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, agrees with Dr. Bryan and noted there isn’t a strong correlation between suicidal ideation and death by suicide.
“Suicidal thoughts are very common, but suicide is a rare event,” he said.
He cited a study that showed that two thirds of individuals who died by suicide had denied experiencing suicidal thoughts when asked, and half of them died within 2 days of this denial. Other research suggests that as many as 98% of people who express suicidal ideation do not die by suicide, Dr. Nestadt said.
A Public Health Issue
If universal screening is not the answer to predicting and preventing suicide, what is? One way would be to approach suicide as a public health issue, Dr. Nestadt said.
“How did we reduce the rate of motor vehicle deaths? We didn’t test each driver’s reaction time behind the wheel,” he said. “Instead, we passed seatbelt and airbag legislation, implemented federal speed limits, and as a result, the number of motor vehicle fatalities decreased.”
Dr. Nestadt is an advocate for stronger gun safety legislation, which has proven effective in reducing suicide rates. A study published this year showed that states with child access prevention laws, negligent storage laws, and mandatory waiting periods for gun purchases reported fewer suicide deaths than those without that legislation.
Other measures might be applied in cases of extreme individual suicide risk, including extreme risk protection orders, also known as “red flag” laws, he added. This type of legislation provides a pathway for law enforcement to temporarily remove firearms from individuals who pose a risk to themselves or others.
“These have been shown to be very effective in saving lives,” Dr. Nestadt said.
Dr. Nestadt and others are also using machine learning models to predict suicide risk. Those identified as high-risk may be flagged on their electronic medical record. Ideally, when the algorithm becomes more accurate at predicting suicide, anyone treating this patient can then decide if action is needed, said Dr. Nestadt.
In his work with suicidal military personnel, Dr. Bryan and his colleagues established a brief form of cognitive behavioral therapy (BCBT) to help participants challenge cognitive distortions and build coping strategies to deal with feel with intense feelings of distress. Data show that BCBT reduced suicide attempts among active-duty soldiers by 60% compared with standard mental health treatment. It has since been shown to work in civilians as well.
Dr. Bryan is also researching fluctuations in the wish to live versus the wish to die relative to one another and mapping the trajectory of risk states along the way.
The goal is that these and other suicide prevention strategies currently under study by his team and others will help stem the rise in suicide deaths.
“Overall, we need to train mental health providers to implement suicide prevention therapies and establish suicide risk programs,” Dr. Bryan said. “But until we build one of these suicide prevention interventions to scale, we’re putting the cart before the horse.”
Dr. Roaten, Ms. Brummett, Dr. Bryan, and Dr. Nestadt reported no relevant disclosures.
A version of this article appeared on Medscape.com.
US suicide rates have reached alarming levels, with data from Centers for Disease Control and Prevention (CDC) showing a 37% increase from 2000 to 2022. Nearly 49,000 people died by suicide in 2022 alone, translating to one death every 11 minutes.
The increase in suicide rates has prompted calls for expansion of universal suicide screening, in which all individuals in medical or mental health care settings are screened for suicide risk, regardless of the purpose for their visit. But the psychiatric field is split on the issue, with some experts citing false positives and a lack of mental health care resources for those deemed at risk.
In 2022, when the US Preventative Services Task Force released its recommendations on suicide prevention, first in children and adolescents, and then in adults, the authors said there was insufficient evidence to support universal suicide screening.
Proponents of the practice pushed back on that finding, arguing that universal suicide screening could help identify those at high risk who might otherwise go undiagnosed, leading to earlier, potentially lifesaving, intervention.
So, what is the case for — and against — universal screening?
Sounding an Alert
The introduction of universal screening was driven by a confluence of factors that began with a 1999 report by then-US Surgeon General David Satcher, MD. This was followed by a report in 2016 from the Joint Commission on Detecting and Treating Suicidal Ideation that called for healthcare organizations to improve detection and treatment of suicidal ideation in all healthcare care settings.
Data from the alert showed that a significant number of people who died by suicide had a healthcare visit before their death. Half had seen a clinician a month before their death; nearly 30% had a medical visit just the week before — all with no detection of increased suicide risk.
It was that sort of finding that led Parkland Health and Hospital System in Dallas to become the first US hospital to implement universal suicide screening. Since the program launched in 2015, the system has screened more than 4.3 million patients in its emergency department, inpatient units, and 20 primary care clinics.
“Since the program began, we’ve completed between 40,000 to 50,000 screenings per month,” said Kimberly Roaten, PhD, associate chief quality and safety officer for behavioral health at Parkland Health.
Clinicians at Parkland use the five-item Ask Suicide-Screening Questions to assess suicidal intent, a commonly used tool that was originally developed for use in pediatric emergency rooms (ERs). The tool, which takes about 20 seconds to administer, has since been validated in both children and adults.
Based on a patient’s response, a clinical decision support system integrated into the electronic health record classifies suicide risk as none, moderate, or high.
Patients identified as moderate risk are offered a more in-depth assessment with a mental health clinician, though participation is not mandatory, said Dr. Roaten. Those at high risk receive a more thorough evaluation.
The proportion of ER patients at Parkland who screen positive for any suicidal intent has consistently remained at about 7%, and at 2% in the primary care clinics, she said.
To better understand what the program may have had on suicide prevention, Dr. Roaten is leading a National Institute of Mental Health–funded study to link a decade of mortality data from the state of Texas to patient data from Parkland Health. Investigators will analyze information about patients identified at risk for suicide, those patients’ characteristics, and who dies by suicide.
Universal Screening Expands
Other health systems have adopted universal suicide screening including the Indian Health Service and the US Veterans Health Administration. Universal suicide screening is also in place in a growing number of primary care practices and hospitals throughout the United States and will be mandatory for patients aged 12 years and older in all acute care hospitals in California beginning in 2025.
There is also a push for universal screening to be coordinated through local, state, and federal government, nonprofit, and private sectors. The National Action Alliance for Suicide Prevention is charged with advancing the White House’s 2024 National Strategy for Suicide Prevention, a 10-year plan to address gaps in suicide prevention in the United States.
Sarah Brummett, JD, director of the National Action Alliance for Suicide Prevention’s executive committee, said that universal suicide screening is part of the 2024 strategy. “We know there are barriers to universal screening, and so it’s important to recognize what they are so we can address them,” said Ms. Brummett.
Barriers may include adequate staffing, or a system in place to triage patients who screen positive.
At Parkland, cost and workload have been minimal, Dr. Roaten said. “We built a model that only dedicates our highest-value resources to the most at-risk patients.”
She also noted that relief may be on the horizon for health systems where cost is an obstacle to universal screening and subsequent intervention. “There are efforts at the federal level to increase funding for suicide assessment and crisis response,” she said.
Pushback on Universal Screening
Universal suicide screening has its detractors, including critics who say expansion is unlikely to reduce suicide rates.
“The issue with suicidal ideation is that it is very dynamic. Suicidal ideation changes very quickly — sometimes within hours,” said Craig Bryan, PsyD, professor of psychiatry and behavioral health at Ohio State University in Columbus, Ohio.
Universal screening can also lead to false positives, where a patient who screens positive for suicidal ideation has no actual intention of attempting suicide, potentially creating unnecessary concern and burden on health care resources, Dr. Bryan noted.
“What do you do with everyone who screens positive?” Dr. Bryan said. “I’ve spoken with leaders of many health systems in the United States, and there is pushback against universal screening because they don’t have enough mental health resources to handle all of the referrals.”
Suicide screening also doesn’t predict who will die by suicide, Dr. Bryan added. It only identifies those willing to disclose suicidal thoughts. There is a significant number of people without mental illness who may never seek medical care, so “the warning signs we’re teaching people to recognize — depression, anxiety, and substance abuse — might not be evident in these individuals,” he said.
“Life sideswipes them suddenly, and they go from 0 to 60 ... and they may have access to a highly lethal method [of suicide] which weaponizes that moment of despair,” said Dr. Bryan. No amount of screening could possibly predict those types of suicides, he added.
Paul Nestadt, MD, associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, agrees with Dr. Bryan and noted there isn’t a strong correlation between suicidal ideation and death by suicide.
“Suicidal thoughts are very common, but suicide is a rare event,” he said.
He cited a study that showed that two thirds of individuals who died by suicide had denied experiencing suicidal thoughts when asked, and half of them died within 2 days of this denial. Other research suggests that as many as 98% of people who express suicidal ideation do not die by suicide, Dr. Nestadt said.
A Public Health Issue
If universal screening is not the answer to predicting and preventing suicide, what is? One way would be to approach suicide as a public health issue, Dr. Nestadt said.
“How did we reduce the rate of motor vehicle deaths? We didn’t test each driver’s reaction time behind the wheel,” he said. “Instead, we passed seatbelt and airbag legislation, implemented federal speed limits, and as a result, the number of motor vehicle fatalities decreased.”
Dr. Nestadt is an advocate for stronger gun safety legislation, which has proven effective in reducing suicide rates. A study published this year showed that states with child access prevention laws, negligent storage laws, and mandatory waiting periods for gun purchases reported fewer suicide deaths than those without that legislation.
Other measures might be applied in cases of extreme individual suicide risk, including extreme risk protection orders, also known as “red flag” laws, he added. This type of legislation provides a pathway for law enforcement to temporarily remove firearms from individuals who pose a risk to themselves or others.
“These have been shown to be very effective in saving lives,” Dr. Nestadt said.
Dr. Nestadt and others are also using machine learning models to predict suicide risk. Those identified as high-risk may be flagged on their electronic medical record. Ideally, when the algorithm becomes more accurate at predicting suicide, anyone treating this patient can then decide if action is needed, said Dr. Nestadt.
In his work with suicidal military personnel, Dr. Bryan and his colleagues established a brief form of cognitive behavioral therapy (BCBT) to help participants challenge cognitive distortions and build coping strategies to deal with feel with intense feelings of distress. Data show that BCBT reduced suicide attempts among active-duty soldiers by 60% compared with standard mental health treatment. It has since been shown to work in civilians as well.
Dr. Bryan is also researching fluctuations in the wish to live versus the wish to die relative to one another and mapping the trajectory of risk states along the way.
The goal is that these and other suicide prevention strategies currently under study by his team and others will help stem the rise in suicide deaths.
“Overall, we need to train mental health providers to implement suicide prevention therapies and establish suicide risk programs,” Dr. Bryan said. “But until we build one of these suicide prevention interventions to scale, we’re putting the cart before the horse.”
Dr. Roaten, Ms. Brummett, Dr. Bryan, and Dr. Nestadt reported no relevant disclosures.
A version of this article appeared on Medscape.com.
US suicide rates have reached alarming levels, with data from Centers for Disease Control and Prevention (CDC) showing a 37% increase from 2000 to 2022. Nearly 49,000 people died by suicide in 2022 alone, translating to one death every 11 minutes.
The increase in suicide rates has prompted calls for expansion of universal suicide screening, in which all individuals in medical or mental health care settings are screened for suicide risk, regardless of the purpose for their visit. But the psychiatric field is split on the issue, with some experts citing false positives and a lack of mental health care resources for those deemed at risk.
In 2022, when the US Preventative Services Task Force released its recommendations on suicide prevention, first in children and adolescents, and then in adults, the authors said there was insufficient evidence to support universal suicide screening.
Proponents of the practice pushed back on that finding, arguing that universal suicide screening could help identify those at high risk who might otherwise go undiagnosed, leading to earlier, potentially lifesaving, intervention.
So, what is the case for — and against — universal screening?
Sounding an Alert
The introduction of universal screening was driven by a confluence of factors that began with a 1999 report by then-US Surgeon General David Satcher, MD. This was followed by a report in 2016 from the Joint Commission on Detecting and Treating Suicidal Ideation that called for healthcare organizations to improve detection and treatment of suicidal ideation in all healthcare care settings.
Data from the alert showed that a significant number of people who died by suicide had a healthcare visit before their death. Half had seen a clinician a month before their death; nearly 30% had a medical visit just the week before — all with no detection of increased suicide risk.
It was that sort of finding that led Parkland Health and Hospital System in Dallas to become the first US hospital to implement universal suicide screening. Since the program launched in 2015, the system has screened more than 4.3 million patients in its emergency department, inpatient units, and 20 primary care clinics.
“Since the program began, we’ve completed between 40,000 to 50,000 screenings per month,” said Kimberly Roaten, PhD, associate chief quality and safety officer for behavioral health at Parkland Health.
Clinicians at Parkland use the five-item Ask Suicide-Screening Questions to assess suicidal intent, a commonly used tool that was originally developed for use in pediatric emergency rooms (ERs). The tool, which takes about 20 seconds to administer, has since been validated in both children and adults.
Based on a patient’s response, a clinical decision support system integrated into the electronic health record classifies suicide risk as none, moderate, or high.
Patients identified as moderate risk are offered a more in-depth assessment with a mental health clinician, though participation is not mandatory, said Dr. Roaten. Those at high risk receive a more thorough evaluation.
The proportion of ER patients at Parkland who screen positive for any suicidal intent has consistently remained at about 7%, and at 2% in the primary care clinics, she said.
To better understand what the program may have had on suicide prevention, Dr. Roaten is leading a National Institute of Mental Health–funded study to link a decade of mortality data from the state of Texas to patient data from Parkland Health. Investigators will analyze information about patients identified at risk for suicide, those patients’ characteristics, and who dies by suicide.
Universal Screening Expands
Other health systems have adopted universal suicide screening including the Indian Health Service and the US Veterans Health Administration. Universal suicide screening is also in place in a growing number of primary care practices and hospitals throughout the United States and will be mandatory for patients aged 12 years and older in all acute care hospitals in California beginning in 2025.
There is also a push for universal screening to be coordinated through local, state, and federal government, nonprofit, and private sectors. The National Action Alliance for Suicide Prevention is charged with advancing the White House’s 2024 National Strategy for Suicide Prevention, a 10-year plan to address gaps in suicide prevention in the United States.
Sarah Brummett, JD, director of the National Action Alliance for Suicide Prevention’s executive committee, said that universal suicide screening is part of the 2024 strategy. “We know there are barriers to universal screening, and so it’s important to recognize what they are so we can address them,” said Ms. Brummett.
Barriers may include adequate staffing, or a system in place to triage patients who screen positive.
At Parkland, cost and workload have been minimal, Dr. Roaten said. “We built a model that only dedicates our highest-value resources to the most at-risk patients.”
She also noted that relief may be on the horizon for health systems where cost is an obstacle to universal screening and subsequent intervention. “There are efforts at the federal level to increase funding for suicide assessment and crisis response,” she said.
Pushback on Universal Screening
Universal suicide screening has its detractors, including critics who say expansion is unlikely to reduce suicide rates.
“The issue with suicidal ideation is that it is very dynamic. Suicidal ideation changes very quickly — sometimes within hours,” said Craig Bryan, PsyD, professor of psychiatry and behavioral health at Ohio State University in Columbus, Ohio.
Universal screening can also lead to false positives, where a patient who screens positive for suicidal ideation has no actual intention of attempting suicide, potentially creating unnecessary concern and burden on health care resources, Dr. Bryan noted.
“What do you do with everyone who screens positive?” Dr. Bryan said. “I’ve spoken with leaders of many health systems in the United States, and there is pushback against universal screening because they don’t have enough mental health resources to handle all of the referrals.”
Suicide screening also doesn’t predict who will die by suicide, Dr. Bryan added. It only identifies those willing to disclose suicidal thoughts. There is a significant number of people without mental illness who may never seek medical care, so “the warning signs we’re teaching people to recognize — depression, anxiety, and substance abuse — might not be evident in these individuals,” he said.
“Life sideswipes them suddenly, and they go from 0 to 60 ... and they may have access to a highly lethal method [of suicide] which weaponizes that moment of despair,” said Dr. Bryan. No amount of screening could possibly predict those types of suicides, he added.
Paul Nestadt, MD, associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, agrees with Dr. Bryan and noted there isn’t a strong correlation between suicidal ideation and death by suicide.
“Suicidal thoughts are very common, but suicide is a rare event,” he said.
He cited a study that showed that two thirds of individuals who died by suicide had denied experiencing suicidal thoughts when asked, and half of them died within 2 days of this denial. Other research suggests that as many as 98% of people who express suicidal ideation do not die by suicide, Dr. Nestadt said.
A Public Health Issue
If universal screening is not the answer to predicting and preventing suicide, what is? One way would be to approach suicide as a public health issue, Dr. Nestadt said.
“How did we reduce the rate of motor vehicle deaths? We didn’t test each driver’s reaction time behind the wheel,” he said. “Instead, we passed seatbelt and airbag legislation, implemented federal speed limits, and as a result, the number of motor vehicle fatalities decreased.”
Dr. Nestadt is an advocate for stronger gun safety legislation, which has proven effective in reducing suicide rates. A study published this year showed that states with child access prevention laws, negligent storage laws, and mandatory waiting periods for gun purchases reported fewer suicide deaths than those without that legislation.
Other measures might be applied in cases of extreme individual suicide risk, including extreme risk protection orders, also known as “red flag” laws, he added. This type of legislation provides a pathway for law enforcement to temporarily remove firearms from individuals who pose a risk to themselves or others.
“These have been shown to be very effective in saving lives,” Dr. Nestadt said.
Dr. Nestadt and others are also using machine learning models to predict suicide risk. Those identified as high-risk may be flagged on their electronic medical record. Ideally, when the algorithm becomes more accurate at predicting suicide, anyone treating this patient can then decide if action is needed, said Dr. Nestadt.
In his work with suicidal military personnel, Dr. Bryan and his colleagues established a brief form of cognitive behavioral therapy (BCBT) to help participants challenge cognitive distortions and build coping strategies to deal with feel with intense feelings of distress. Data show that BCBT reduced suicide attempts among active-duty soldiers by 60% compared with standard mental health treatment. It has since been shown to work in civilians as well.
Dr. Bryan is also researching fluctuations in the wish to live versus the wish to die relative to one another and mapping the trajectory of risk states along the way.
The goal is that these and other suicide prevention strategies currently under study by his team and others will help stem the rise in suicide deaths.
“Overall, we need to train mental health providers to implement suicide prevention therapies and establish suicide risk programs,” Dr. Bryan said. “But until we build one of these suicide prevention interventions to scale, we’re putting the cart before the horse.”
Dr. Roaten, Ms. Brummett, Dr. Bryan, and Dr. Nestadt reported no relevant disclosures.
A version of this article appeared on Medscape.com.
Montana Hospital to Pay $10.8M to Settle False Claims Oncology Suit
As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.
On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”
“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.
On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
When It Began
The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims.
“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.
At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job.
Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.
Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.
Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause.
John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
$10.8 Million: ‘It’s a Big Number’
At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million.
The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020.
According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims.
The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.
“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.”
“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.”
The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement
Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020.
“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.
In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”
Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”
The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.”
The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.
The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025.
A Community’s Support
Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.
Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well.
Like other residents, she has strong opinions about the settlement.
“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”
Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members.
Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters.
“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.
A version of this article first appeared on Medscape.com.
As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.
On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”
“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.
On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
When It Began
The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims.
“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.
At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job.
Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.
Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.
Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause.
John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
$10.8 Million: ‘It’s a Big Number’
At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million.
The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020.
According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims.
The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.
“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.”
“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.”
The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement
Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020.
“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.
In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”
Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”
The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.”
The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.
The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025.
A Community’s Support
Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.
Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well.
Like other residents, she has strong opinions about the settlement.
“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”
Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members.
Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters.
“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.
A version of this article first appeared on Medscape.com.
As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.
On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”
“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.
On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
When It Began
The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims.
“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.
At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job.
Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.
Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.
Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause.
John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
$10.8 Million: ‘It’s a Big Number’
At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million.
The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020.
According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims.
The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.
“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.”
“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.”
The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement
Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020.
“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.
In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”
Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”
The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.”
The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.
The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025.
A Community’s Support
Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.
Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well.
Like other residents, she has strong opinions about the settlement.
“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”
Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members.
Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters.
“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.
A version of this article first appeared on Medscape.com.
Could a Virus Reverse Antibiotic Resistance?
Peering through his microscope in 1910, Franco-Canadian microbiologist Félix d’Hérelle noticed some “clear spots” in his bacterial cultures, an anomaly that turned out to be viruses preying on the bacteria. Years later, Mr. d’Hérelle would come to use these viruses, which he called bacteriophages, to treat patients plagued with dysentery after World War I.
But now, with bacteria evolving resistance to more and more antibiotics, phage therapy is drawing a second look from researchers — sometimes with a novel twist. Instead of simply using the phages to kill bacteria directly, the new strategy aims to catch the bacteria in an evolutionary dilemma — one in which they cannot evade phages and antibiotics simultaneously.
This plan, which uses something called “phage steering,” has shown promising results in initial tests, but the scope of its usefulness remains to be proven.
There’s certainly need to find new ways to respond to bacterial infections. More than 70% of hospital-acquired bacterial infections in the United States are resistant to at least one type of antibiotic. And some pathogens, such as Acinetobacter, Pseudomonas, Escherichia coli, and Klebsiella — classified by the World Health Organization as some of the biggest threats to human health — are resistant to multiple antibiotics. In 2019, antibacterial resistance was linked to 4.95 million deaths globally, heightening the call for more effective treatment options.
One of the ways that bacteria can evolve resistance to antibiotics is by using structures in their membranes that are designed to move unwanted molecules out of the cell. By modifying these “efflux pumps” to recognize the antibiotic, bacteria can eliminate the drug before it poisons them.
As it turns out, some phages appear to use these same efflux pumps to invade the bacterial cell. The phage presumably attaches its tail to the outer portion of the pump protein, like a key slipping into a lock, and then injects its genetic material into the cell. This lucky coincidence led Paul Turner, PhD, an evolutionary biologist at Yale University, New Haven, Connecticut, to suggest that treating a patient with phages and antibiotics simultaneously could trap bacteria in a no-win situation: If they evolve to modify their efflux pumps so the phage can’t bind, the pumps will no longer expel antibiotics, and the bacteria will lose their resistance. But if they retain their antibiotic resistance, the phages will kill them, as Dr. Turner and colleagues explained in the 2023 Annual Review of Virology.
The result, in other words, is a two-pronged attack, said Michael Hochberg, PhD, an evolutionary biologist at the French National Centre for Scientific Research who studies how to prevent the evolution of bacterial resistance. “It’s kind of like a crisscross effect.” The same principle can target other bacterial molecules that play a dual role in resistance to viruses and antibiotics.
Turner tested this hypothesis on multidrug-resistant Pseudomonas aeruginosa, which causes dangerous infections, especially in healthcare settings. This bacterium has four efflux pumps involved in antibiotic resistance, and Dr. Turner predicted that if he could find a phage that used one of the pumps as a way into the cell, the bacterium would be forced to slam the door on the phage by mutating the receptor — thereby impeding its ability to pump out antibiotics.
Sampling from the environment, Dr. Turner’s team collected 42 phage strains that infect P aeruginosa. Out of all the phages, one, OMKO1, bound to an efflux pump, making it the perfect candidate for the experiment.
The researchers then cultured antibiotic-resistant P aeruginosa together with OMKO1, hoping this would force the bacterium to modify its efflux pump to resist the phage. They exposed these phage-resistant bacteria, as well as their normal, phage-sensitive counterparts, to four antibiotics the bacteria had been resistant to: tetracycline, erythromycin, ciprofloxacin, and ceftazidime.
As the theory predicted, the bacteria that had evolved resistance to the phage were more sensitive to the antibiotics than those that had not been exposed to the phage. This suggests that the bacteria had, indeed, been forced to lose their antibiotic resistance through their need to fight off the phage.
Other researchers have also shown that phage steering can resensitize bacteria to common antibiotics they’d become resistant to. One study, by an international research team, showed that a phage called Phab24 can be used to restore sensitivity to the antibiotic colistin in Acinetobacter baumannii, which causes life-threatening diseases.
In a second study, researchers at Monash University in Australia sampled infectious bacteria from patients. They found that several phages, including strains known as phi-FG02 and phi-CO01, were already present in some of the samples, and that A baumannii bacteria exposed to the phages had inactivated a gene that helps create the microbe’s important outer layer, or capsule. This layer serves as the entry point for the phages, but it also helps the bacterium to form biofilms that keep out antibiotics — so removing the layer rendered A baumannii susceptible to several antibiotics that it was previously resistant to.
In a third study, researchers from the University of Liverpool discovered that, when a P aeruginosa strain that was resistant to all antibiotics was exposed to phages, the bacterium became sensitive to two antibiotics that were otherwise considered ineffective against P aeruginosa.
Dr. Turner’s team has used phage steering in dozens of cases of personalized therapy in clinical settings, said Benjamin Chan, PhD, a microbiologist at Yale University who works with Dr. Turner. The results, many still unpublished, have been promising so far. Nonrespiratory infections are relatively easy to clear off, and lung infections, which the phage steering approach wouldn’t be expected to eradicate completely, often show some improvement.
“I would say that we have been quite successful in using phage steering to treat difficult-to-manage infections, reducing antimicrobial resistance in many cases,” he said. But he notes that it is sometimes difficult to determine whether phage steering really was responsible for the cures.
Devil in the details
Phage therapy may not work for all antibiotic-resistant bacteria, said molecular biologist Graham Hatfull, PhD, of the University of Pittsburgh in Pennsylvania. That’s because phages are very host specific, and for most phages, no one knows what target they bind to on the bacterial cell surface. For phage steering to work against antibiotic resistance, the phage has to bind to a molecule that’s involved in that resistance — and it’s not clear how often that fortuitous coincidence occurs.
Jason Gill, PhD, who studies bacteriophage biology at Texas A&M University, College Station, said that it is not easy to predict if a phage will induce antibiotic sensitivity. So you always have to hunt for the right virus each time.
Dr. Gill knows from experience how complicated the approach can get. He was part of a team of researchers and doctors who used phages to treat a patient with a multidrug-resistant A baumannii infection. Less than 4 days after the team administered phages intravenously and through the skin, the patient woke up from a coma and became responsive to the previously ineffective antibiotic minocycline — a striking success.
But when Dr. Gill tried a similar experiment in cell cultures, he got a different result. The A baumannii developed resistance to the phages, but they also maintained their resistance to minocycline. “There’s not a complete mechanistic understanding,” said Dr. Gill. “The linkage between phage resistance and antibiotic sensitivity probably varies by bacterial strain, phage and antibiotic.” That means phage steering may not always work.
Dr. Turner, for his part, pointed out another potential problem: That phages could work too well. If phage therapy kills large amounts of bacteria and deposits their remains in the bloodstream quickly, for example, this could trigger septic shock in patients. Scientists do not yet know how to address this problem.
Another concern is that doctors have less precise control over phages than antibiotics. “Phages can mutate, they can adapt, they have a genome,” said Dr. Hochberg. Safety concerns, he notes, are one factor inhibiting the routine use of phage therapy in countries like the United States, restricting it to case-by-case applications such as Dr. Turner and Dr. Chan’s.
Phage therapy may have been too high-tech for the 1940s, and even today, scientists grapple with how to use it. What we need now, said Dr. Turner, are rigorous experiments that will teach us how to make it work.
This article originally appeared in Knowable Magazine on September 09, 2024. Knowable Magazine is an independent journalistic endeavor from Annual Reviews, a nonprofit publisher dedicated to synthesizing and integrating knowledge for the progress of science and the benefit of society. Sign up for Knowable Magazine’s newsletter. A version of this article appeared on Medscape.com.
Peering through his microscope in 1910, Franco-Canadian microbiologist Félix d’Hérelle noticed some “clear spots” in his bacterial cultures, an anomaly that turned out to be viruses preying on the bacteria. Years later, Mr. d’Hérelle would come to use these viruses, which he called bacteriophages, to treat patients plagued with dysentery after World War I.
But now, with bacteria evolving resistance to more and more antibiotics, phage therapy is drawing a second look from researchers — sometimes with a novel twist. Instead of simply using the phages to kill bacteria directly, the new strategy aims to catch the bacteria in an evolutionary dilemma — one in which they cannot evade phages and antibiotics simultaneously.
This plan, which uses something called “phage steering,” has shown promising results in initial tests, but the scope of its usefulness remains to be proven.
There’s certainly need to find new ways to respond to bacterial infections. More than 70% of hospital-acquired bacterial infections in the United States are resistant to at least one type of antibiotic. And some pathogens, such as Acinetobacter, Pseudomonas, Escherichia coli, and Klebsiella — classified by the World Health Organization as some of the biggest threats to human health — are resistant to multiple antibiotics. In 2019, antibacterial resistance was linked to 4.95 million deaths globally, heightening the call for more effective treatment options.
One of the ways that bacteria can evolve resistance to antibiotics is by using structures in their membranes that are designed to move unwanted molecules out of the cell. By modifying these “efflux pumps” to recognize the antibiotic, bacteria can eliminate the drug before it poisons them.
As it turns out, some phages appear to use these same efflux pumps to invade the bacterial cell. The phage presumably attaches its tail to the outer portion of the pump protein, like a key slipping into a lock, and then injects its genetic material into the cell. This lucky coincidence led Paul Turner, PhD, an evolutionary biologist at Yale University, New Haven, Connecticut, to suggest that treating a patient with phages and antibiotics simultaneously could trap bacteria in a no-win situation: If they evolve to modify their efflux pumps so the phage can’t bind, the pumps will no longer expel antibiotics, and the bacteria will lose their resistance. But if they retain their antibiotic resistance, the phages will kill them, as Dr. Turner and colleagues explained in the 2023 Annual Review of Virology.
The result, in other words, is a two-pronged attack, said Michael Hochberg, PhD, an evolutionary biologist at the French National Centre for Scientific Research who studies how to prevent the evolution of bacterial resistance. “It’s kind of like a crisscross effect.” The same principle can target other bacterial molecules that play a dual role in resistance to viruses and antibiotics.
Turner tested this hypothesis on multidrug-resistant Pseudomonas aeruginosa, which causes dangerous infections, especially in healthcare settings. This bacterium has four efflux pumps involved in antibiotic resistance, and Dr. Turner predicted that if he could find a phage that used one of the pumps as a way into the cell, the bacterium would be forced to slam the door on the phage by mutating the receptor — thereby impeding its ability to pump out antibiotics.
Sampling from the environment, Dr. Turner’s team collected 42 phage strains that infect P aeruginosa. Out of all the phages, one, OMKO1, bound to an efflux pump, making it the perfect candidate for the experiment.
The researchers then cultured antibiotic-resistant P aeruginosa together with OMKO1, hoping this would force the bacterium to modify its efflux pump to resist the phage. They exposed these phage-resistant bacteria, as well as their normal, phage-sensitive counterparts, to four antibiotics the bacteria had been resistant to: tetracycline, erythromycin, ciprofloxacin, and ceftazidime.
As the theory predicted, the bacteria that had evolved resistance to the phage were more sensitive to the antibiotics than those that had not been exposed to the phage. This suggests that the bacteria had, indeed, been forced to lose their antibiotic resistance through their need to fight off the phage.
Other researchers have also shown that phage steering can resensitize bacteria to common antibiotics they’d become resistant to. One study, by an international research team, showed that a phage called Phab24 can be used to restore sensitivity to the antibiotic colistin in Acinetobacter baumannii, which causes life-threatening diseases.
In a second study, researchers at Monash University in Australia sampled infectious bacteria from patients. They found that several phages, including strains known as phi-FG02 and phi-CO01, were already present in some of the samples, and that A baumannii bacteria exposed to the phages had inactivated a gene that helps create the microbe’s important outer layer, or capsule. This layer serves as the entry point for the phages, but it also helps the bacterium to form biofilms that keep out antibiotics — so removing the layer rendered A baumannii susceptible to several antibiotics that it was previously resistant to.
In a third study, researchers from the University of Liverpool discovered that, when a P aeruginosa strain that was resistant to all antibiotics was exposed to phages, the bacterium became sensitive to two antibiotics that were otherwise considered ineffective against P aeruginosa.
Dr. Turner’s team has used phage steering in dozens of cases of personalized therapy in clinical settings, said Benjamin Chan, PhD, a microbiologist at Yale University who works with Dr. Turner. The results, many still unpublished, have been promising so far. Nonrespiratory infections are relatively easy to clear off, and lung infections, which the phage steering approach wouldn’t be expected to eradicate completely, often show some improvement.
“I would say that we have been quite successful in using phage steering to treat difficult-to-manage infections, reducing antimicrobial resistance in many cases,” he said. But he notes that it is sometimes difficult to determine whether phage steering really was responsible for the cures.
Devil in the details
Phage therapy may not work for all antibiotic-resistant bacteria, said molecular biologist Graham Hatfull, PhD, of the University of Pittsburgh in Pennsylvania. That’s because phages are very host specific, and for most phages, no one knows what target they bind to on the bacterial cell surface. For phage steering to work against antibiotic resistance, the phage has to bind to a molecule that’s involved in that resistance — and it’s not clear how often that fortuitous coincidence occurs.
Jason Gill, PhD, who studies bacteriophage biology at Texas A&M University, College Station, said that it is not easy to predict if a phage will induce antibiotic sensitivity. So you always have to hunt for the right virus each time.
Dr. Gill knows from experience how complicated the approach can get. He was part of a team of researchers and doctors who used phages to treat a patient with a multidrug-resistant A baumannii infection. Less than 4 days after the team administered phages intravenously and through the skin, the patient woke up from a coma and became responsive to the previously ineffective antibiotic minocycline — a striking success.
But when Dr. Gill tried a similar experiment in cell cultures, he got a different result. The A baumannii developed resistance to the phages, but they also maintained their resistance to minocycline. “There’s not a complete mechanistic understanding,” said Dr. Gill. “The linkage between phage resistance and antibiotic sensitivity probably varies by bacterial strain, phage and antibiotic.” That means phage steering may not always work.
Dr. Turner, for his part, pointed out another potential problem: That phages could work too well. If phage therapy kills large amounts of bacteria and deposits their remains in the bloodstream quickly, for example, this could trigger septic shock in patients. Scientists do not yet know how to address this problem.
Another concern is that doctors have less precise control over phages than antibiotics. “Phages can mutate, they can adapt, they have a genome,” said Dr. Hochberg. Safety concerns, he notes, are one factor inhibiting the routine use of phage therapy in countries like the United States, restricting it to case-by-case applications such as Dr. Turner and Dr. Chan’s.
Phage therapy may have been too high-tech for the 1940s, and even today, scientists grapple with how to use it. What we need now, said Dr. Turner, are rigorous experiments that will teach us how to make it work.
This article originally appeared in Knowable Magazine on September 09, 2024. Knowable Magazine is an independent journalistic endeavor from Annual Reviews, a nonprofit publisher dedicated to synthesizing and integrating knowledge for the progress of science and the benefit of society. Sign up for Knowable Magazine’s newsletter. A version of this article appeared on Medscape.com.
Peering through his microscope in 1910, Franco-Canadian microbiologist Félix d’Hérelle noticed some “clear spots” in his bacterial cultures, an anomaly that turned out to be viruses preying on the bacteria. Years later, Mr. d’Hérelle would come to use these viruses, which he called bacteriophages, to treat patients plagued with dysentery after World War I.
But now, with bacteria evolving resistance to more and more antibiotics, phage therapy is drawing a second look from researchers — sometimes with a novel twist. Instead of simply using the phages to kill bacteria directly, the new strategy aims to catch the bacteria in an evolutionary dilemma — one in which they cannot evade phages and antibiotics simultaneously.
This plan, which uses something called “phage steering,” has shown promising results in initial tests, but the scope of its usefulness remains to be proven.
There’s certainly need to find new ways to respond to bacterial infections. More than 70% of hospital-acquired bacterial infections in the United States are resistant to at least one type of antibiotic. And some pathogens, such as Acinetobacter, Pseudomonas, Escherichia coli, and Klebsiella — classified by the World Health Organization as some of the biggest threats to human health — are resistant to multiple antibiotics. In 2019, antibacterial resistance was linked to 4.95 million deaths globally, heightening the call for more effective treatment options.
One of the ways that bacteria can evolve resistance to antibiotics is by using structures in their membranes that are designed to move unwanted molecules out of the cell. By modifying these “efflux pumps” to recognize the antibiotic, bacteria can eliminate the drug before it poisons them.
As it turns out, some phages appear to use these same efflux pumps to invade the bacterial cell. The phage presumably attaches its tail to the outer portion of the pump protein, like a key slipping into a lock, and then injects its genetic material into the cell. This lucky coincidence led Paul Turner, PhD, an evolutionary biologist at Yale University, New Haven, Connecticut, to suggest that treating a patient with phages and antibiotics simultaneously could trap bacteria in a no-win situation: If they evolve to modify their efflux pumps so the phage can’t bind, the pumps will no longer expel antibiotics, and the bacteria will lose their resistance. But if they retain their antibiotic resistance, the phages will kill them, as Dr. Turner and colleagues explained in the 2023 Annual Review of Virology.
The result, in other words, is a two-pronged attack, said Michael Hochberg, PhD, an evolutionary biologist at the French National Centre for Scientific Research who studies how to prevent the evolution of bacterial resistance. “It’s kind of like a crisscross effect.” The same principle can target other bacterial molecules that play a dual role in resistance to viruses and antibiotics.
Turner tested this hypothesis on multidrug-resistant Pseudomonas aeruginosa, which causes dangerous infections, especially in healthcare settings. This bacterium has four efflux pumps involved in antibiotic resistance, and Dr. Turner predicted that if he could find a phage that used one of the pumps as a way into the cell, the bacterium would be forced to slam the door on the phage by mutating the receptor — thereby impeding its ability to pump out antibiotics.
Sampling from the environment, Dr. Turner’s team collected 42 phage strains that infect P aeruginosa. Out of all the phages, one, OMKO1, bound to an efflux pump, making it the perfect candidate for the experiment.
The researchers then cultured antibiotic-resistant P aeruginosa together with OMKO1, hoping this would force the bacterium to modify its efflux pump to resist the phage. They exposed these phage-resistant bacteria, as well as their normal, phage-sensitive counterparts, to four antibiotics the bacteria had been resistant to: tetracycline, erythromycin, ciprofloxacin, and ceftazidime.
As the theory predicted, the bacteria that had evolved resistance to the phage were more sensitive to the antibiotics than those that had not been exposed to the phage. This suggests that the bacteria had, indeed, been forced to lose their antibiotic resistance through their need to fight off the phage.
Other researchers have also shown that phage steering can resensitize bacteria to common antibiotics they’d become resistant to. One study, by an international research team, showed that a phage called Phab24 can be used to restore sensitivity to the antibiotic colistin in Acinetobacter baumannii, which causes life-threatening diseases.
In a second study, researchers at Monash University in Australia sampled infectious bacteria from patients. They found that several phages, including strains known as phi-FG02 and phi-CO01, were already present in some of the samples, and that A baumannii bacteria exposed to the phages had inactivated a gene that helps create the microbe’s important outer layer, or capsule. This layer serves as the entry point for the phages, but it also helps the bacterium to form biofilms that keep out antibiotics — so removing the layer rendered A baumannii susceptible to several antibiotics that it was previously resistant to.
In a third study, researchers from the University of Liverpool discovered that, when a P aeruginosa strain that was resistant to all antibiotics was exposed to phages, the bacterium became sensitive to two antibiotics that were otherwise considered ineffective against P aeruginosa.
Dr. Turner’s team has used phage steering in dozens of cases of personalized therapy in clinical settings, said Benjamin Chan, PhD, a microbiologist at Yale University who works with Dr. Turner. The results, many still unpublished, have been promising so far. Nonrespiratory infections are relatively easy to clear off, and lung infections, which the phage steering approach wouldn’t be expected to eradicate completely, often show some improvement.
“I would say that we have been quite successful in using phage steering to treat difficult-to-manage infections, reducing antimicrobial resistance in many cases,” he said. But he notes that it is sometimes difficult to determine whether phage steering really was responsible for the cures.
Devil in the details
Phage therapy may not work for all antibiotic-resistant bacteria, said molecular biologist Graham Hatfull, PhD, of the University of Pittsburgh in Pennsylvania. That’s because phages are very host specific, and for most phages, no one knows what target they bind to on the bacterial cell surface. For phage steering to work against antibiotic resistance, the phage has to bind to a molecule that’s involved in that resistance — and it’s not clear how often that fortuitous coincidence occurs.
Jason Gill, PhD, who studies bacteriophage biology at Texas A&M University, College Station, said that it is not easy to predict if a phage will induce antibiotic sensitivity. So you always have to hunt for the right virus each time.
Dr. Gill knows from experience how complicated the approach can get. He was part of a team of researchers and doctors who used phages to treat a patient with a multidrug-resistant A baumannii infection. Less than 4 days after the team administered phages intravenously and through the skin, the patient woke up from a coma and became responsive to the previously ineffective antibiotic minocycline — a striking success.
But when Dr. Gill tried a similar experiment in cell cultures, he got a different result. The A baumannii developed resistance to the phages, but they also maintained their resistance to minocycline. “There’s not a complete mechanistic understanding,” said Dr. Gill. “The linkage between phage resistance and antibiotic sensitivity probably varies by bacterial strain, phage and antibiotic.” That means phage steering may not always work.
Dr. Turner, for his part, pointed out another potential problem: That phages could work too well. If phage therapy kills large amounts of bacteria and deposits their remains in the bloodstream quickly, for example, this could trigger septic shock in patients. Scientists do not yet know how to address this problem.
Another concern is that doctors have less precise control over phages than antibiotics. “Phages can mutate, they can adapt, they have a genome,” said Dr. Hochberg. Safety concerns, he notes, are one factor inhibiting the routine use of phage therapy in countries like the United States, restricting it to case-by-case applications such as Dr. Turner and Dr. Chan’s.
Phage therapy may have been too high-tech for the 1940s, and even today, scientists grapple with how to use it. What we need now, said Dr. Turner, are rigorous experiments that will teach us how to make it work.
This article originally appeared in Knowable Magazine on September 09, 2024. Knowable Magazine is an independent journalistic endeavor from Annual Reviews, a nonprofit publisher dedicated to synthesizing and integrating knowledge for the progress of science and the benefit of society. Sign up for Knowable Magazine’s newsletter. A version of this article appeared on Medscape.com.
Genitourinary Symptoms in Men: Canaries in the Coal Mine for Underlying Chronic Disease
At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.
While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.
Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.
“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.
That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.
In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.
In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.
This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.
As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
Ask Early, Ask Often
Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.
It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.
Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:
- Are you having trouble with erections or having sex?
- Are you getting up at night to pass urine more than once?
“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”
Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”
Addressing the Issue
Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.
Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”
“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.
Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.
Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
A version of this article appeared on Medscape.com.
At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.
While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.
Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.
“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.
That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.
In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.
In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.
This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.
As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
Ask Early, Ask Often
Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.
It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.
Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:
- Are you having trouble with erections or having sex?
- Are you getting up at night to pass urine more than once?
“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”
Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”
Addressing the Issue
Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.
Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”
“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.
Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.
Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
A version of this article appeared on Medscape.com.
At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.
While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.
Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.
“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.
That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.
In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.
In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.
This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.
As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
Ask Early, Ask Often
Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.
It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.
Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:
- Are you having trouble with erections or having sex?
- Are you getting up at night to pass urine more than once?
“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”
Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”
Addressing the Issue
Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.
Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”
“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.
Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.
Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
A version of this article appeared on Medscape.com.