Using artificial intelligence to analyze large amounts of information from social media platforms generated some novel insights into public perceptions about statins, results of a new study show.

The study, which used AI to analyze discussions about statins on the social media platform Reddit, corroborated previously documented reasons for statin hesitancy, including adverse effect profiles and general disenfranchisement with health care.

But it also found novel points of discourse, including linking statins to COVID-19 outcomes and the role of cholesterol, statins, and the ketogenic diet.

“We used AI to tell us what is being discussed about statins on social media and to quantify the information in topics that people think are important,” senior study author Fatima Rodriguez, MD, MPH, Stanford (Calif.) University School of Medicine, said in an interview.

“Some of the themes were surprising to us. While we expected discussion on side effects, we were surprised to see so much discussion refuting the idea that increased levels of LDL were detrimental. There were also a large amount of posts on statin use being correlated to COVID outcomes. Our findings show how widespread this misinformation is,” she said.

“As a preventative cardiologist, I spend a lot of my time trying to get patients to take statins, but patients often rely on social media for information, and this can contain a lot of misinformation. People tend to be more honest on online forums than they are in the doctor’s office, so they are probably asking the questions and having discussions on subjects they really care about. So, understanding what is being discussed on social media is very valuable information for us as clinicians.”

The study was published online in JAMA Network Open.

The researchers analyzed all statin-related discussions on Reddit that were dated between Jan. 1, 2009, and July 12, 2022. Statin- and cholesterol-focused communities were identified to create a list of statin-related discussions. An AI pipeline was developed to cluster these discussions into specific topics and overarching thematic groups.

A total of 10,233 unique statin-related discussions and 5,188 unique authors were identified. A total of 100 discussion topics were identified and classified into six overarching thematic groups: (1) ketogenic diets, diabetes, supplements, and statins; (2) statin adverse effects; (3) statin hesitancy; (4) clinical trial appraisals; (5) pharmaceutical industry bias and statins; and (6) red yeast rice and statins.

Several examples of statin-related misinformation were identified, including distrust of the hypothesis that LDL-C has a causal association with heart disease. Discussions included quotes such as, “I think LDL is pretty much irrelevant. Your HDL and triglycerides are far more important.”

Other topics suggested that certain natural supplements would be an acceptable alternative to statins. Quotes included: “Red yeast rice is a statin basically, by the way,” and “statins are basically mycotoxins and deplete you of fat-soluble nutrients, like coQ10, vit D, K, A and E, and in all likelihood through these depletions worsen cardiovascular health.”

The researchers also looked at temporal trends and found that these sorts of discussions have increased over time.

One of the common themes identified was using the ketogenic diet phenomenon as an argument against increased cholesterol levels being bad for health.

Dr. Rodriguez elaborated: “People think the ketogenic diet is healthy as they lose weight on it. And as it can be associated with a small increase in LDL cholesterol, there was a lot of opinion that this meant increasing LDL was a good thing.”

The researchers also conducted a sentiment analysis, which designated topics as positive, negative, or neutral with regard to statins.  

“We found that almost no topic was positive. Everything was either neutral or negative. This is pretty consistent with what we are seeing around hesitancy in clinical practice, but you would think that maybe a few people may have a positive view on statins,” Dr. Rodriguez commented.

“One of the problems with statins and lowering cholesterol is that it takes a long time to see a benefit, but this misinformation will result in some people not taking their medication,” she added.

Dr. Rodriguez noted that in this study AI is augmenting, not replacing, what clinicians and researchers do. “But it is a valuable tool to scan a large volume of information, and we have shown here it can generate new insights that we may not have thought of. It’s important to know what’s out there so we can try and combat it.” 

She pointed out that patients don’t read the medical literature showing the benefits of statins but rather rely on social media for their information. 

“We need to understand all sorts of patient engagement and use the same tools to combat this misinformation. We have a responsibility to try and stop dangerous and false information from being propagated,” she commented.

“These drugs are clearly not dangerous when used in line with clinical guidelines, and they have been proven to have multiple benefits again and again, but we don’t see those kinds of discussions in the community at all. We as clinicians need to use social media and AI to give out the right information. This could start to combat all the misinformation out there.”

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

Using artificial intelligence to analyze large amounts of information from social media platforms generated some novel insights into public perceptions about statins, results of a new study show.

The study, which used AI to analyze discussions about statins on the social media platform Reddit, corroborated previously documented reasons for statin hesitancy, including adverse effect profiles and general disenfranchisement with health care.

But it also found novel points of discourse, including linking statins to COVID-19 outcomes and the role of cholesterol, statins, and the ketogenic diet.

“We used AI to tell us what is being discussed about statins on social media and to quantify the information in topics that people think are important,” senior study author Fatima Rodriguez, MD, MPH, Stanford (Calif.) University School of Medicine, said in an interview.

“Some of the themes were surprising to us. While we expected discussion on side effects, we were surprised to see so much discussion refuting the idea that increased levels of LDL were detrimental. There were also a large amount of posts on statin use being correlated to COVID outcomes. Our findings show how widespread this misinformation is,” she said.

“As a preventative cardiologist, I spend a lot of my time trying to get patients to take statins, but patients often rely on social media for information, and this can contain a lot of misinformation. People tend to be more honest on online forums than they are in the doctor’s office, so they are probably asking the questions and having discussions on subjects they really care about. So, understanding what is being discussed on social media is very valuable information for us as clinicians.”

The study was published online in JAMA Network Open.

The researchers analyzed all statin-related discussions on Reddit that were dated between Jan. 1, 2009, and July 12, 2022. Statin- and cholesterol-focused communities were identified to create a list of statin-related discussions. An AI pipeline was developed to cluster these discussions into specific topics and overarching thematic groups.

A total of 10,233 unique statin-related discussions and 5,188 unique authors were identified. A total of 100 discussion topics were identified and classified into six overarching thematic groups: (1) ketogenic diets, diabetes, supplements, and statins; (2) statin adverse effects; (3) statin hesitancy; (4) clinical trial appraisals; (5) pharmaceutical industry bias and statins; and (6) red yeast rice and statins.

Several examples of statin-related misinformation were identified, including distrust of the hypothesis that LDL-C has a causal association with heart disease. Discussions included quotes such as, “I think LDL is pretty much irrelevant. Your HDL and triglycerides are far more important.”

Other topics suggested that certain natural supplements would be an acceptable alternative to statins. Quotes included: “Red yeast rice is a statin basically, by the way,” and “statins are basically mycotoxins and deplete you of fat-soluble nutrients, like coQ10, vit D, K, A and E, and in all likelihood through these depletions worsen cardiovascular health.”

The researchers also looked at temporal trends and found that these sorts of discussions have increased over time.

One of the common themes identified was using the ketogenic diet phenomenon as an argument against increased cholesterol levels being bad for health.

Dr. Rodriguez elaborated: “People think the ketogenic diet is healthy as they lose weight on it. And as it can be associated with a small increase in LDL cholesterol, there was a lot of opinion that this meant increasing LDL was a good thing.”

The researchers also conducted a sentiment analysis, which designated topics as positive, negative, or neutral with regard to statins.  

“We found that almost no topic was positive. Everything was either neutral or negative. This is pretty consistent with what we are seeing around hesitancy in clinical practice, but you would think that maybe a few people may have a positive view on statins,” Dr. Rodriguez commented.

“One of the problems with statins and lowering cholesterol is that it takes a long time to see a benefit, but this misinformation will result in some people not taking their medication,” she added.

Dr. Rodriguez noted that in this study AI is augmenting, not replacing, what clinicians and researchers do. “But it is a valuable tool to scan a large volume of information, and we have shown here it can generate new insights that we may not have thought of. It’s important to know what’s out there so we can try and combat it.” 

She pointed out that patients don’t read the medical literature showing the benefits of statins but rather rely on social media for their information. 

“We need to understand all sorts of patient engagement and use the same tools to combat this misinformation. We have a responsibility to try and stop dangerous and false information from being propagated,” she commented.

“These drugs are clearly not dangerous when used in line with clinical guidelines, and they have been proven to have multiple benefits again and again, but we don’t see those kinds of discussions in the community at all. We as clinicians need to use social media and AI to give out the right information. This could start to combat all the misinformation out there.”

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

Using artificial intelligence to analyze large amounts of information from social media platforms generated some novel insights into public perceptions about statins, results of a new study show.

The study, which used AI to analyze discussions about statins on the social media platform Reddit, corroborated previously documented reasons for statin hesitancy, including adverse effect profiles and general disenfranchisement with health care.

But it also found novel points of discourse, including linking statins to COVID-19 outcomes and the role of cholesterol, statins, and the ketogenic diet.

“We used AI to tell us what is being discussed about statins on social media and to quantify the information in topics that people think are important,” senior study author Fatima Rodriguez, MD, MPH, Stanford (Calif.) University School of Medicine, said in an interview.

“Some of the themes were surprising to us. While we expected discussion on side effects, we were surprised to see so much discussion refuting the idea that increased levels of LDL were detrimental. There were also a large amount of posts on statin use being correlated to COVID outcomes. Our findings show how widespread this misinformation is,” she said.

“As a preventative cardiologist, I spend a lot of my time trying to get patients to take statins, but patients often rely on social media for information, and this can contain a lot of misinformation. People tend to be more honest on online forums than they are in the doctor’s office, so they are probably asking the questions and having discussions on subjects they really care about. So, understanding what is being discussed on social media is very valuable information for us as clinicians.”

The study was published online in JAMA Network Open.

The researchers analyzed all statin-related discussions on Reddit that were dated between Jan. 1, 2009, and July 12, 2022. Statin- and cholesterol-focused communities were identified to create a list of statin-related discussions. An AI pipeline was developed to cluster these discussions into specific topics and overarching thematic groups.

A total of 10,233 unique statin-related discussions and 5,188 unique authors were identified. A total of 100 discussion topics were identified and classified into six overarching thematic groups: (1) ketogenic diets, diabetes, supplements, and statins; (2) statin adverse effects; (3) statin hesitancy; (4) clinical trial appraisals; (5) pharmaceutical industry bias and statins; and (6) red yeast rice and statins.

Several examples of statin-related misinformation were identified, including distrust of the hypothesis that LDL-C has a causal association with heart disease. Discussions included quotes such as, “I think LDL is pretty much irrelevant. Your HDL and triglycerides are far more important.”

Other topics suggested that certain natural supplements would be an acceptable alternative to statins. Quotes included: “Red yeast rice is a statin basically, by the way,” and “statins are basically mycotoxins and deplete you of fat-soluble nutrients, like coQ10, vit D, K, A and E, and in all likelihood through these depletions worsen cardiovascular health.”

The researchers also looked at temporal trends and found that these sorts of discussions have increased over time.

One of the common themes identified was using the ketogenic diet phenomenon as an argument against increased cholesterol levels being bad for health.

Dr. Rodriguez elaborated: “People think the ketogenic diet is healthy as they lose weight on it. And as it can be associated with a small increase in LDL cholesterol, there was a lot of opinion that this meant increasing LDL was a good thing.”

The researchers also conducted a sentiment analysis, which designated topics as positive, negative, or neutral with regard to statins.  

“We found that almost no topic was positive. Everything was either neutral or negative. This is pretty consistent with what we are seeing around hesitancy in clinical practice, but you would think that maybe a few people may have a positive view on statins,” Dr. Rodriguez commented.

“One of the problems with statins and lowering cholesterol is that it takes a long time to see a benefit, but this misinformation will result in some people not taking their medication,” she added.

Dr. Rodriguez noted that in this study AI is augmenting, not replacing, what clinicians and researchers do. “But it is a valuable tool to scan a large volume of information, and we have shown here it can generate new insights that we may not have thought of. It’s important to know what’s out there so we can try and combat it.” 

She pointed out that patients don’t read the medical literature showing the benefits of statins but rather rely on social media for their information. 

“We need to understand all sorts of patient engagement and use the same tools to combat this misinformation. We have a responsibility to try and stop dangerous and false information from being propagated,” she commented.

“These drugs are clearly not dangerous when used in line with clinical guidelines, and they have been proven to have multiple benefits again and again, but we don’t see those kinds of discussions in the community at all. We as clinicians need to use social media and AI to give out the right information. This could start to combat all the misinformation out there.”

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

The effects of maribavir (Levtencity) for the treatment of resistant or refractory post-transplant cytomegalovirus (CMV) infection persisted at 52-week follow-up in hematopoietic stem cell and solid organ transplant patients from the pivotal phase 3 SOLSTICE trial.

Overall mortality in the 109 patients from these subcohorts from SOLSTICE was lower, compared with mortality reported for similar populations treated with conventional therapies used to treat relapsed or refractory (R/R) CMV, according to findings presented in April at the annual meeting of the European Society for Bone and Marrow Transplantation.

“These results, in addition to the superior efficacy in CMV clearance observed for maribavir in SOLSTICE provide supportive evidence of the potential for the long-term benefit of maribavir treatment for post-transplant CMV infection,” Ishan Hirji, of Takeda Development Center Americas, and colleagues reported during a poster session at the meeting.

A retrospective chart review of the 41 hematopoietic stem cell transplant (HSCT) patients and 68 solid organ transplant (SOT) patients randomized to receive maribavir showed an overall mortality rate of 15.6% at 52 weeks after initiation of treatment with the antiviral agent. Among the HSCT patients, 14 deaths occurred (34.1%), with 8 occurring during the study periods and 6 occurring during follow-up. Among the SOT patients, three deaths occurred (4.4%), all during follow-up chart review.

Causes of death included underlying disease relapse in four patients, infection other than CMV in six patients, and one case each of CMV-related factors, transplant-related factors, acute lymphoblastic leukemia, and septic shock. Causes of death in the SOT patients included one case each of CMV-related factors, anemia, and renal failure.

“No patients had new graft loss or retransplantation during the chart review period,” the investigators noted.

The findings are notable as CMV infection occurs in 30%-70% of HSCT recipients and 16%-56% of SOT recipients and can lead to complications, including transplant failure and death. Reported 1-year mortality rates following standard therapies for CMV range from 31% to 50%, they explained.

Patients in the SOLSTICE trial received 8 weeks of treatment and were followed for 12 additional weeks. CMV clearance at the end of treatment was 55.7% in the maribavir treatment arm versus 23.9% in a control group of patients treated with investigator choice of therapy. As reported by this news organization, the findings formed the basis for U.S. Food and Drug Administration approval of maribavir in November 2021.

The current analysis included a chart review period that started 1 day after the SOLSTICE trial period and continued for 32 additional weeks.

These long-term follow-up data confirm the benefits of maribavir for the treatment of post-transplant CMV, according to the investigators, and findings from a separate study reported at the ESBMT meeting underscore the importance of the durable benefits observed with maribavir treatment.

For that retrospective study, Maria Laura Fox, of Vall d’Hebron Institute of Oncology, Barcelona, and colleagues pooled de-identified data from 250 adult HSCT recipients with R/R CMV who were treated with agents other than maribavir at transplant centers in the United States or Europe. They aimed to “generate real-world evidence on the burden of CMV infection/disease in HSCT recipients who had refractory/resistant CMV or were intolerant to current treatments.”

Nearly 92% of patients received two or more therapies to treat CMV, and 92.2% discontinued treatment or had one or more therapy dose changes or discontinuation, and 42 patients failed to achieve clearance of the CMV index episode.

CMV recurred in 35.2% of patients, and graft failure occurred in 4% of patients, the investigators reported.

All-cause mortality was 56.0%, and mortality at 1 year after identification of R/R disease or treatment intolerance was 45.2%, they noted, adding that the study results “highlight the real-world complexities and high burden of CMV infection for HSCT recipients.”

“With available anti-CMV agents [excluding maribavir], a notable proportion of patients failed to achieve viremia clearance once developing RRI [resistant, refractory, or intolerant] CMV and/or experienced recurrence, and were at risk of adverse outcomes, including myelosuppression and mortality. There is a need for therapies that achieve and maintain CMV clearance with improved safety profiles,” they concluded.

Both studies were funded by Takeda Development Center Americas, the maker of Levtencity. Ms. Hirji is an employee of Takeda and reported stock ownership. Ms. Fox reported relationships with Sierra Oncology, GlaxoSmithKline, Bristol Myers Squibb, Novartis, and AbbVie.

The effects of maribavir (Levtencity) for the treatment of resistant or refractory post-transplant cytomegalovirus (CMV) infection persisted at 52-week follow-up in hematopoietic stem cell and solid organ transplant patients from the pivotal phase 3 SOLSTICE trial.

Overall mortality in the 109 patients from these subcohorts from SOLSTICE was lower, compared with mortality reported for similar populations treated with conventional therapies used to treat relapsed or refractory (R/R) CMV, according to findings presented in April at the annual meeting of the European Society for Bone and Marrow Transplantation.

“These results, in addition to the superior efficacy in CMV clearance observed for maribavir in SOLSTICE provide supportive evidence of the potential for the long-term benefit of maribavir treatment for post-transplant CMV infection,” Ishan Hirji, of Takeda Development Center Americas, and colleagues reported during a poster session at the meeting.

A retrospective chart review of the 41 hematopoietic stem cell transplant (HSCT) patients and 68 solid organ transplant (SOT) patients randomized to receive maribavir showed an overall mortality rate of 15.6% at 52 weeks after initiation of treatment with the antiviral agent. Among the HSCT patients, 14 deaths occurred (34.1%), with 8 occurring during the study periods and 6 occurring during follow-up. Among the SOT patients, three deaths occurred (4.4%), all during follow-up chart review.

Causes of death included underlying disease relapse in four patients, infection other than CMV in six patients, and one case each of CMV-related factors, transplant-related factors, acute lymphoblastic leukemia, and septic shock. Causes of death in the SOT patients included one case each of CMV-related factors, anemia, and renal failure.

“No patients had new graft loss or retransplantation during the chart review period,” the investigators noted.

The findings are notable as CMV infection occurs in 30%-70% of HSCT recipients and 16%-56% of SOT recipients and can lead to complications, including transplant failure and death. Reported 1-year mortality rates following standard therapies for CMV range from 31% to 50%, they explained.

Patients in the SOLSTICE trial received 8 weeks of treatment and were followed for 12 additional weeks. CMV clearance at the end of treatment was 55.7% in the maribavir treatment arm versus 23.9% in a control group of patients treated with investigator choice of therapy. As reported by this news organization, the findings formed the basis for U.S. Food and Drug Administration approval of maribavir in November 2021.

The current analysis included a chart review period that started 1 day after the SOLSTICE trial period and continued for 32 additional weeks.

These long-term follow-up data confirm the benefits of maribavir for the treatment of post-transplant CMV, according to the investigators, and findings from a separate study reported at the ESBMT meeting underscore the importance of the durable benefits observed with maribavir treatment.

For that retrospective study, Maria Laura Fox, of Vall d’Hebron Institute of Oncology, Barcelona, and colleagues pooled de-identified data from 250 adult HSCT recipients with R/R CMV who were treated with agents other than maribavir at transplant centers in the United States or Europe. They aimed to “generate real-world evidence on the burden of CMV infection/disease in HSCT recipients who had refractory/resistant CMV or were intolerant to current treatments.”

Nearly 92% of patients received two or more therapies to treat CMV, and 92.2% discontinued treatment or had one or more therapy dose changes or discontinuation, and 42 patients failed to achieve clearance of the CMV index episode.

CMV recurred in 35.2% of patients, and graft failure occurred in 4% of patients, the investigators reported.

All-cause mortality was 56.0%, and mortality at 1 year after identification of R/R disease or treatment intolerance was 45.2%, they noted, adding that the study results “highlight the real-world complexities and high burden of CMV infection for HSCT recipients.”

“With available anti-CMV agents [excluding maribavir], a notable proportion of patients failed to achieve viremia clearance once developing RRI [resistant, refractory, or intolerant] CMV and/or experienced recurrence, and were at risk of adverse outcomes, including myelosuppression and mortality. There is a need for therapies that achieve and maintain CMV clearance with improved safety profiles,” they concluded.

Both studies were funded by Takeda Development Center Americas, the maker of Levtencity. Ms. Hirji is an employee of Takeda and reported stock ownership. Ms. Fox reported relationships with Sierra Oncology, GlaxoSmithKline, Bristol Myers Squibb, Novartis, and AbbVie.

The effects of maribavir (Levtencity) for the treatment of resistant or refractory post-transplant cytomegalovirus (CMV) infection persisted at 52-week follow-up in hematopoietic stem cell and solid organ transplant patients from the pivotal phase 3 SOLSTICE trial.

Overall mortality in the 109 patients from these subcohorts from SOLSTICE was lower, compared with mortality reported for similar populations treated with conventional therapies used to treat relapsed or refractory (R/R) CMV, according to findings presented in April at the annual meeting of the European Society for Bone and Marrow Transplantation.

“These results, in addition to the superior efficacy in CMV clearance observed for maribavir in SOLSTICE provide supportive evidence of the potential for the long-term benefit of maribavir treatment for post-transplant CMV infection,” Ishan Hirji, of Takeda Development Center Americas, and colleagues reported during a poster session at the meeting.

A retrospective chart review of the 41 hematopoietic stem cell transplant (HSCT) patients and 68 solid organ transplant (SOT) patients randomized to receive maribavir showed an overall mortality rate of 15.6% at 52 weeks after initiation of treatment with the antiviral agent. Among the HSCT patients, 14 deaths occurred (34.1%), with 8 occurring during the study periods and 6 occurring during follow-up. Among the SOT patients, three deaths occurred (4.4%), all during follow-up chart review.

Causes of death included underlying disease relapse in four patients, infection other than CMV in six patients, and one case each of CMV-related factors, transplant-related factors, acute lymphoblastic leukemia, and septic shock. Causes of death in the SOT patients included one case each of CMV-related factors, anemia, and renal failure.

“No patients had new graft loss or retransplantation during the chart review period,” the investigators noted.

The findings are notable as CMV infection occurs in 30%-70% of HSCT recipients and 16%-56% of SOT recipients and can lead to complications, including transplant failure and death. Reported 1-year mortality rates following standard therapies for CMV range from 31% to 50%, they explained.

Patients in the SOLSTICE trial received 8 weeks of treatment and were followed for 12 additional weeks. CMV clearance at the end of treatment was 55.7% in the maribavir treatment arm versus 23.9% in a control group of patients treated with investigator choice of therapy. As reported by this news organization, the findings formed the basis for U.S. Food and Drug Administration approval of maribavir in November 2021.

The current analysis included a chart review period that started 1 day after the SOLSTICE trial period and continued for 32 additional weeks.

These long-term follow-up data confirm the benefits of maribavir for the treatment of post-transplant CMV, according to the investigators, and findings from a separate study reported at the ESBMT meeting underscore the importance of the durable benefits observed with maribavir treatment.

For that retrospective study, Maria Laura Fox, of Vall d’Hebron Institute of Oncology, Barcelona, and colleagues pooled de-identified data from 250 adult HSCT recipients with R/R CMV who were treated with agents other than maribavir at transplant centers in the United States or Europe. They aimed to “generate real-world evidence on the burden of CMV infection/disease in HSCT recipients who had refractory/resistant CMV or were intolerant to current treatments.”

Nearly 92% of patients received two or more therapies to treat CMV, and 92.2% discontinued treatment or had one or more therapy dose changes or discontinuation, and 42 patients failed to achieve clearance of the CMV index episode.

CMV recurred in 35.2% of patients, and graft failure occurred in 4% of patients, the investigators reported.

All-cause mortality was 56.0%, and mortality at 1 year after identification of R/R disease or treatment intolerance was 45.2%, they noted, adding that the study results “highlight the real-world complexities and high burden of CMV infection for HSCT recipients.”

“With available anti-CMV agents [excluding maribavir], a notable proportion of patients failed to achieve viremia clearance once developing RRI [resistant, refractory, or intolerant] CMV and/or experienced recurrence, and were at risk of adverse outcomes, including myelosuppression and mortality. There is a need for therapies that achieve and maintain CMV clearance with improved safety profiles,” they concluded.

Both studies were funded by Takeda Development Center Americas, the maker of Levtencity. Ms. Hirji is an employee of Takeda and reported stock ownership. Ms. Fox reported relationships with Sierra Oncology, GlaxoSmithKline, Bristol Myers Squibb, Novartis, and AbbVie.

The American Board of Internal Medicine’s (ABIM) Longitudinal Knowledge Assessment (LKA®) has entered its second year of availability, and was launched in January 2023 for the disciplines of pulmonary disease and critical care medicine, as well as infectious disease. Tens of thousands of physicians nationwide are taking advantage of this option for a flexible assessment that also incorporates more learning opportunities. If you are due for an ABIM assessment in 2023 in pulmonary disease or critical care medicine, the deadline to enroll in LKA is June 30, 2023.

Many diplomates—including myself—are taking advantage of the flexibility offered by the LKA to maintain certification in one or more specialties. Others are using it to regain certifications that they allowed to lapse. Both scenarios offer a lower-stakes and less time-intensive route to maintaining or recertifying that also promotes relevant and timely learning in a given discipline. Remember that you can still choose to take the traditional 10-year Maintenance of Certification (MOC) exam in any discipline if you feel that works better for you than the LKA.

CHEST

Detailed information about the LKA and how it works, as well as a walkthrough video and FAQs, are available on ABIM’s website. Following are some suggestions based on the experience of physicians who are currently enrolled in the LKA.
 

Take it one day at a time

With 30 questions released each quarter, the LKA is designed to be manageable and work with your schedule. You could take one question a day or every few days over the course of the quarter or you can choose to do all 30 in one sitting—whatever works for you. Each correct answer also earns you 0.2 MOC points, meaning that over time, you could potentially achieve all of your required MOC points through the LKA alone.

Don’t forget your time bank

Every question has a 4-minute time limit, but if you need more time to think through a question or look up a resource, you can draw from a 30-minute extra time bank that renews each year. On average, physicians answer most questions in less than 2 minutes.

Use resources

The LKA is essentially “open book,” meaning you can use any resource to help with a question except for another physician. Some physicians cite online sites or hard copy medical references as reliable resources, and CHEST offers additional resources that can be helpful, as well.

Set up your work area for success

Many physicians report using two screens or two devices while taking the LKA—one with the LKA platform open to answer questions and one for looking up resources. Questions involving viewing of media will prompt you when a larger screen may be helpful.

Consider the cost savings

The LKA is included in your annual MOC fee for each certificate you maintain at no additional cost. If you use the LKA to meet your MOC assessment requirement, you don’t need to take the traditional 10-year MOC exam or pay an additional exam fee.

Gauge areas of strength and weakness

Most questions on the LKA will give you rationale and feedback after you’ve answered, allowing you to brush up on knowledge gaps. In addition, you’ll receive interim quarterly score reports starting after your fifth quarter of participation showing your current score relative to the passing standard, including areas where you might need to focus more study.

Regain lapsed certification

The LKA is a simple and lower-stakes way to regain certification in a specialty that has lapsed, though it should be noted that you must complete your 5-year LKA cycle and achieve a passing score for the certificate to become active again. In the meantime, you can use the LKA to refresh your knowledge of current information in that specialty.

Ask about disability accommodations

ABIM offers some accommodations for the LKA in compliance with Title III of the Americans with Disabilities Act (ADA) for individuals with documented disabilities who demonstrate a need for accommodation. Physicians requesting special testing accommodations under the ADA can submit a request on ABIM’s website.

If you’re due for an assessment in 2023, and you haven’t looked into the LKA yet, now is the time: the second quarter closes on June 30, 2023, and you will not be able to enroll after that date. Sign in to your ABIM Physician Portal to see if you are eligible and visit ABIM.org/LKA to learn more.

The American Board of Internal Medicine’s (ABIM) Longitudinal Knowledge Assessment (LKA®) has entered its second year of availability, and was launched in January 2023 for the disciplines of pulmonary disease and critical care medicine, as well as infectious disease. Tens of thousands of physicians nationwide are taking advantage of this option for a flexible assessment that also incorporates more learning opportunities. If you are due for an ABIM assessment in 2023 in pulmonary disease or critical care medicine, the deadline to enroll in LKA is June 30, 2023.

Many diplomates—including myself—are taking advantage of the flexibility offered by the LKA to maintain certification in one or more specialties. Others are using it to regain certifications that they allowed to lapse. Both scenarios offer a lower-stakes and less time-intensive route to maintaining or recertifying that also promotes relevant and timely learning in a given discipline. Remember that you can still choose to take the traditional 10-year Maintenance of Certification (MOC) exam in any discipline if you feel that works better for you than the LKA.

CHEST

Detailed information about the LKA and how it works, as well as a walkthrough video and FAQs, are available on ABIM’s website. Following are some suggestions based on the experience of physicians who are currently enrolled in the LKA.
 

Take it one day at a time

With 30 questions released each quarter, the LKA is designed to be manageable and work with your schedule. You could take one question a day or every few days over the course of the quarter or you can choose to do all 30 in one sitting—whatever works for you. Each correct answer also earns you 0.2 MOC points, meaning that over time, you could potentially achieve all of your required MOC points through the LKA alone.

Don’t forget your time bank

Every question has a 4-minute time limit, but if you need more time to think through a question or look up a resource, you can draw from a 30-minute extra time bank that renews each year. On average, physicians answer most questions in less than 2 minutes.

Use resources

The LKA is essentially “open book,” meaning you can use any resource to help with a question except for another physician. Some physicians cite online sites or hard copy medical references as reliable resources, and CHEST offers additional resources that can be helpful, as well.

Set up your work area for success

Many physicians report using two screens or two devices while taking the LKA—one with the LKA platform open to answer questions and one for looking up resources. Questions involving viewing of media will prompt you when a larger screen may be helpful.

Consider the cost savings

The LKA is included in your annual MOC fee for each certificate you maintain at no additional cost. If you use the LKA to meet your MOC assessment requirement, you don’t need to take the traditional 10-year MOC exam or pay an additional exam fee.

Gauge areas of strength and weakness

Most questions on the LKA will give you rationale and feedback after you’ve answered, allowing you to brush up on knowledge gaps. In addition, you’ll receive interim quarterly score reports starting after your fifth quarter of participation showing your current score relative to the passing standard, including areas where you might need to focus more study.

Regain lapsed certification

The LKA is a simple and lower-stakes way to regain certification in a specialty that has lapsed, though it should be noted that you must complete your 5-year LKA cycle and achieve a passing score for the certificate to become active again. In the meantime, you can use the LKA to refresh your knowledge of current information in that specialty.

Ask about disability accommodations

ABIM offers some accommodations for the LKA in compliance with Title III of the Americans with Disabilities Act (ADA) for individuals with documented disabilities who demonstrate a need for accommodation. Physicians requesting special testing accommodations under the ADA can submit a request on ABIM’s website.

If you’re due for an assessment in 2023, and you haven’t looked into the LKA yet, now is the time: the second quarter closes on June 30, 2023, and you will not be able to enroll after that date. Sign in to your ABIM Physician Portal to see if you are eligible and visit ABIM.org/LKA to learn more.

The American Board of Internal Medicine’s (ABIM) Longitudinal Knowledge Assessment (LKA®) has entered its second year of availability, and was launched in January 2023 for the disciplines of pulmonary disease and critical care medicine, as well as infectious disease. Tens of thousands of physicians nationwide are taking advantage of this option for a flexible assessment that also incorporates more learning opportunities. If you are due for an ABIM assessment in 2023 in pulmonary disease or critical care medicine, the deadline to enroll in LKA is June 30, 2023.

Many diplomates—including myself—are taking advantage of the flexibility offered by the LKA to maintain certification in one or more specialties. Others are using it to regain certifications that they allowed to lapse. Both scenarios offer a lower-stakes and less time-intensive route to maintaining or recertifying that also promotes relevant and timely learning in a given discipline. Remember that you can still choose to take the traditional 10-year Maintenance of Certification (MOC) exam in any discipline if you feel that works better for you than the LKA.

CHEST

Detailed information about the LKA and how it works, as well as a walkthrough video and FAQs, are available on ABIM’s website. Following are some suggestions based on the experience of physicians who are currently enrolled in the LKA.
 

Take it one day at a time

With 30 questions released each quarter, the LKA is designed to be manageable and work with your schedule. You could take one question a day or every few days over the course of the quarter or you can choose to do all 30 in one sitting—whatever works for you. Each correct answer also earns you 0.2 MOC points, meaning that over time, you could potentially achieve all of your required MOC points through the LKA alone.

Don’t forget your time bank

Every question has a 4-minute time limit, but if you need more time to think through a question or look up a resource, you can draw from a 30-minute extra time bank that renews each year. On average, physicians answer most questions in less than 2 minutes.

Use resources

The LKA is essentially “open book,” meaning you can use any resource to help with a question except for another physician. Some physicians cite online sites or hard copy medical references as reliable resources, and CHEST offers additional resources that can be helpful, as well.

Set up your work area for success

Many physicians report using two screens or two devices while taking the LKA—one with the LKA platform open to answer questions and one for looking up resources. Questions involving viewing of media will prompt you when a larger screen may be helpful.

Consider the cost savings

The LKA is included in your annual MOC fee for each certificate you maintain at no additional cost. If you use the LKA to meet your MOC assessment requirement, you don’t need to take the traditional 10-year MOC exam or pay an additional exam fee.

Gauge areas of strength and weakness

Most questions on the LKA will give you rationale and feedback after you’ve answered, allowing you to brush up on knowledge gaps. In addition, you’ll receive interim quarterly score reports starting after your fifth quarter of participation showing your current score relative to the passing standard, including areas where you might need to focus more study.

Regain lapsed certification

The LKA is a simple and lower-stakes way to regain certification in a specialty that has lapsed, though it should be noted that you must complete your 5-year LKA cycle and achieve a passing score for the certificate to become active again. In the meantime, you can use the LKA to refresh your knowledge of current information in that specialty.

Ask about disability accommodations

ABIM offers some accommodations for the LKA in compliance with Title III of the Americans with Disabilities Act (ADA) for individuals with documented disabilities who demonstrate a need for accommodation. Physicians requesting special testing accommodations under the ADA can submit a request on ABIM’s website.

If you’re due for an assessment in 2023, and you haven’t looked into the LKA yet, now is the time: the second quarter closes on June 30, 2023, and you will not be able to enroll after that date. Sign in to your ABIM Physician Portal to see if you are eligible and visit ABIM.org/LKA to learn more.

The threshold for abandoning supportive measures and initiating invasive mechanical ventilation (IMV) in patients with respiratory failure is unclear. Noninvasive respiratory support (RS) devices, such as high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NIV), are tools used to support patients in distress prior to failure and the need for IMV. However, prolonged RS in patients who ultimately require IMV can be harmful.

As the COVID-19 pandemic evolved, ICUs around the world were overrun by patients with varying degrees of respiratory failure. With this novel pathogen came novel approaches to management. Here we will review data available prior to the pandemic and relate them to emerging evidence on prolonged RS in patients with COVID-19. We believe it is time to acknowledge that prolonged RS in patients who ultimately require IMV is likely deleterious. Increased awareness and care to avoid this situation (often meaning earlier intubation) should be implemented in clinical practice.

CHEST

Excessive tidal volume delivered during IMV can lead to lung injury. Though this principle is widely accepted, the recognition that the same physiology holds in a spontaneously breathing patient receiving RS has been slow to take hold. In the presence of a high respiratory drive injury from overdistension and large transpulmonary pressure, swings can occur with or without IMV. An excellent review summarizing the existing evidence of this risk was published years before the COVID-19 pandemic (Brochard L, et al. AJRCCM. 2017;195[4]:438).

A number of pre-COVID-19 publications focused on examining this topic in clinical practice deserve specific mention. A study of respiratory mechanics in patients on NIV found it was nearly impossible to meet traditional targets for lung protective tidal volumes. Those patients who progressed to IMV had higher expired tidal volumes (Carteaux G, et al. Crit Care Med. 2016;44[2]:282). A large systematic review and metanalysis including more than 11,000 immunocompromised patients found delayed intubation led to increased mortality (Dumas G, et al. AJRCCM. 2021;204[2]:187). This study did not specifically implicate RS days and patient self-induced lung injury as factors driving the excess mortality; another smaller propensity-matched retrospective analysis of patients in the ICU supported with HFNC noted a 65% reduction in mortality among patients intubated after less than vs greater than 48 hours on HFNC who ultimately required IMV (Kang B, et al. Intensive Care Med. 2015;41[4]:623).

Despite this and other existing evidence regarding the hazards of prolonged RS prior to IMV, COVID-19’s burden on the health care system dramatically changed the way hypoxemic respiratory failure is managed in the ICU. Anecdotally, during the height of the pandemic, it was commonplace to encounter patients with severe COVID-19 supported with very high RS settings for days or often weeks. Occasionally, RS may have stabilized breathing mechanics. However, it was often our experience that among those patients supported with RS for extended periods prior to IMV lung compliance was poor, lung recovery did not occur, and prognosis was dismal. Various factors, including early reports of high mortality among patients with COVID-19 supported with IMV, resulted in reliance on RS as a means for delaying or avoiding IMV. Interestingly, a propensity-matched study of more than 2,700 patients found that prolonged RS was associated with significantly higher in-hospital mortality but despite this finding, the practice increased over the course of the pandemic (Riera J, et al. Eur Respir J. 2023;61[3]:2201426). Further, a prospective study comparing outcomes between patients intubated within 48 hours for COVID-19-related respiratory failure to those intubated later found a greater risk of in-hospital mortality and worse long-term outpatient lung function testing (in survivors) in the latter group.

CHEST

It has previously been postulated that longer duration of IMV prior to the initiation of extracorporeal membrane oxygenation (ECMO) support in patients with hypoxemic respiratory failure may contribute to worse overall ECMO-related outcomes. This supposition is based on the principle that ECMO protects the lung by reducing ventilatory drive, tidal volume, and transpulmonary pressure swings. Several studies have documented an increase in mortality in patients supported with ECMO for COVID-19-related respiratory failure over the course of the pandemic. These investigators have noted that time to cannulation, but not IMV days (possibly reflecting duration of RS), correlates with worse ECMO outcomes (Ahmad Q, et al. ASAIO J. 2022;68[2]:171; Barbaro R, et al. Lancet. 2021;398[10307]:1230). We wonder if this reflects greater attention to low tidal volume ventilation during IMV but lack of awareness of or the inability to prevent injurious ventilation during prolonged RS. We view this as an important area for future research that may aid in patient selection in the ongoing effort to improve COVID-19-related ECMO outcomes.

The COVID-19 pandemic remains a significant burden on the health care system. Changes in care necessitated by the crisis produced innovations with the potential to rapidly improve outcomes. Notably though, it also has resulted in negative changes in response to a new pathogen that are hard to reconcile with physiologic principles. Evidence before and since the emergence of COVID-19 suggests prolonged RS prior to IMV is potentially harmful. It is critical for clinicians to recognize this principle and take steps to mitigate this problem in patients where a positive response to RS is not demonstrated in a timely manner.



Drs. Wilson and Chandel are with the Department of Pulmonary and Critical Care, Walter Reed National Military Medical Center, Washington, DC.

The threshold for abandoning supportive measures and initiating invasive mechanical ventilation (IMV) in patients with respiratory failure is unclear. Noninvasive respiratory support (RS) devices, such as high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NIV), are tools used to support patients in distress prior to failure and the need for IMV. However, prolonged RS in patients who ultimately require IMV can be harmful.

As the COVID-19 pandemic evolved, ICUs around the world were overrun by patients with varying degrees of respiratory failure. With this novel pathogen came novel approaches to management. Here we will review data available prior to the pandemic and relate them to emerging evidence on prolonged RS in patients with COVID-19. We believe it is time to acknowledge that prolonged RS in patients who ultimately require IMV is likely deleterious. Increased awareness and care to avoid this situation (often meaning earlier intubation) should be implemented in clinical practice.

CHEST

Excessive tidal volume delivered during IMV can lead to lung injury. Though this principle is widely accepted, the recognition that the same physiology holds in a spontaneously breathing patient receiving RS has been slow to take hold. In the presence of a high respiratory drive injury from overdistension and large transpulmonary pressure, swings can occur with or without IMV. An excellent review summarizing the existing evidence of this risk was published years before the COVID-19 pandemic (Brochard L, et al. AJRCCM. 2017;195[4]:438).

A number of pre-COVID-19 publications focused on examining this topic in clinical practice deserve specific mention. A study of respiratory mechanics in patients on NIV found it was nearly impossible to meet traditional targets for lung protective tidal volumes. Those patients who progressed to IMV had higher expired tidal volumes (Carteaux G, et al. Crit Care Med. 2016;44[2]:282). A large systematic review and metanalysis including more than 11,000 immunocompromised patients found delayed intubation led to increased mortality (Dumas G, et al. AJRCCM. 2021;204[2]:187). This study did not specifically implicate RS days and patient self-induced lung injury as factors driving the excess mortality; another smaller propensity-matched retrospective analysis of patients in the ICU supported with HFNC noted a 65% reduction in mortality among patients intubated after less than vs greater than 48 hours on HFNC who ultimately required IMV (Kang B, et al. Intensive Care Med. 2015;41[4]:623).

Despite this and other existing evidence regarding the hazards of prolonged RS prior to IMV, COVID-19’s burden on the health care system dramatically changed the way hypoxemic respiratory failure is managed in the ICU. Anecdotally, during the height of the pandemic, it was commonplace to encounter patients with severe COVID-19 supported with very high RS settings for days or often weeks. Occasionally, RS may have stabilized breathing mechanics. However, it was often our experience that among those patients supported with RS for extended periods prior to IMV lung compliance was poor, lung recovery did not occur, and prognosis was dismal. Various factors, including early reports of high mortality among patients with COVID-19 supported with IMV, resulted in reliance on RS as a means for delaying or avoiding IMV. Interestingly, a propensity-matched study of more than 2,700 patients found that prolonged RS was associated with significantly higher in-hospital mortality but despite this finding, the practice increased over the course of the pandemic (Riera J, et al. Eur Respir J. 2023;61[3]:2201426). Further, a prospective study comparing outcomes between patients intubated within 48 hours for COVID-19-related respiratory failure to those intubated later found a greater risk of in-hospital mortality and worse long-term outpatient lung function testing (in survivors) in the latter group.

CHEST

It has previously been postulated that longer duration of IMV prior to the initiation of extracorporeal membrane oxygenation (ECMO) support in patients with hypoxemic respiratory failure may contribute to worse overall ECMO-related outcomes. This supposition is based on the principle that ECMO protects the lung by reducing ventilatory drive, tidal volume, and transpulmonary pressure swings. Several studies have documented an increase in mortality in patients supported with ECMO for COVID-19-related respiratory failure over the course of the pandemic. These investigators have noted that time to cannulation, but not IMV days (possibly reflecting duration of RS), correlates with worse ECMO outcomes (Ahmad Q, et al. ASAIO J. 2022;68[2]:171; Barbaro R, et al. Lancet. 2021;398[10307]:1230). We wonder if this reflects greater attention to low tidal volume ventilation during IMV but lack of awareness of or the inability to prevent injurious ventilation during prolonged RS. We view this as an important area for future research that may aid in patient selection in the ongoing effort to improve COVID-19-related ECMO outcomes.

The COVID-19 pandemic remains a significant burden on the health care system. Changes in care necessitated by the crisis produced innovations with the potential to rapidly improve outcomes. Notably though, it also has resulted in negative changes in response to a new pathogen that are hard to reconcile with physiologic principles. Evidence before and since the emergence of COVID-19 suggests prolonged RS prior to IMV is potentially harmful. It is critical for clinicians to recognize this principle and take steps to mitigate this problem in patients where a positive response to RS is not demonstrated in a timely manner.



Drs. Wilson and Chandel are with the Department of Pulmonary and Critical Care, Walter Reed National Military Medical Center, Washington, DC.

The threshold for abandoning supportive measures and initiating invasive mechanical ventilation (IMV) in patients with respiratory failure is unclear. Noninvasive respiratory support (RS) devices, such as high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NIV), are tools used to support patients in distress prior to failure and the need for IMV. However, prolonged RS in patients who ultimately require IMV can be harmful.

As the COVID-19 pandemic evolved, ICUs around the world were overrun by patients with varying degrees of respiratory failure. With this novel pathogen came novel approaches to management. Here we will review data available prior to the pandemic and relate them to emerging evidence on prolonged RS in patients with COVID-19. We believe it is time to acknowledge that prolonged RS in patients who ultimately require IMV is likely deleterious. Increased awareness and care to avoid this situation (often meaning earlier intubation) should be implemented in clinical practice.

CHEST

Excessive tidal volume delivered during IMV can lead to lung injury. Though this principle is widely accepted, the recognition that the same physiology holds in a spontaneously breathing patient receiving RS has been slow to take hold. In the presence of a high respiratory drive injury from overdistension and large transpulmonary pressure, swings can occur with or without IMV. An excellent review summarizing the existing evidence of this risk was published years before the COVID-19 pandemic (Brochard L, et al. AJRCCM. 2017;195[4]:438).

A number of pre-COVID-19 publications focused on examining this topic in clinical practice deserve specific mention. A study of respiratory mechanics in patients on NIV found it was nearly impossible to meet traditional targets for lung protective tidal volumes. Those patients who progressed to IMV had higher expired tidal volumes (Carteaux G, et al. Crit Care Med. 2016;44[2]:282). A large systematic review and metanalysis including more than 11,000 immunocompromised patients found delayed intubation led to increased mortality (Dumas G, et al. AJRCCM. 2021;204[2]:187). This study did not specifically implicate RS days and patient self-induced lung injury as factors driving the excess mortality; another smaller propensity-matched retrospective analysis of patients in the ICU supported with HFNC noted a 65% reduction in mortality among patients intubated after less than vs greater than 48 hours on HFNC who ultimately required IMV (Kang B, et al. Intensive Care Med. 2015;41[4]:623).

Despite this and other existing evidence regarding the hazards of prolonged RS prior to IMV, COVID-19’s burden on the health care system dramatically changed the way hypoxemic respiratory failure is managed in the ICU. Anecdotally, during the height of the pandemic, it was commonplace to encounter patients with severe COVID-19 supported with very high RS settings for days or often weeks. Occasionally, RS may have stabilized breathing mechanics. However, it was often our experience that among those patients supported with RS for extended periods prior to IMV lung compliance was poor, lung recovery did not occur, and prognosis was dismal. Various factors, including early reports of high mortality among patients with COVID-19 supported with IMV, resulted in reliance on RS as a means for delaying or avoiding IMV. Interestingly, a propensity-matched study of more than 2,700 patients found that prolonged RS was associated with significantly higher in-hospital mortality but despite this finding, the practice increased over the course of the pandemic (Riera J, et al. Eur Respir J. 2023;61[3]:2201426). Further, a prospective study comparing outcomes between patients intubated within 48 hours for COVID-19-related respiratory failure to those intubated later found a greater risk of in-hospital mortality and worse long-term outpatient lung function testing (in survivors) in the latter group.

CHEST

It has previously been postulated that longer duration of IMV prior to the initiation of extracorporeal membrane oxygenation (ECMO) support in patients with hypoxemic respiratory failure may contribute to worse overall ECMO-related outcomes. This supposition is based on the principle that ECMO protects the lung by reducing ventilatory drive, tidal volume, and transpulmonary pressure swings. Several studies have documented an increase in mortality in patients supported with ECMO for COVID-19-related respiratory failure over the course of the pandemic. These investigators have noted that time to cannulation, but not IMV days (possibly reflecting duration of RS), correlates with worse ECMO outcomes (Ahmad Q, et al. ASAIO J. 2022;68[2]:171; Barbaro R, et al. Lancet. 2021;398[10307]:1230). We wonder if this reflects greater attention to low tidal volume ventilation during IMV but lack of awareness of or the inability to prevent injurious ventilation during prolonged RS. We view this as an important area for future research that may aid in patient selection in the ongoing effort to improve COVID-19-related ECMO outcomes.

The COVID-19 pandemic remains a significant burden on the health care system. Changes in care necessitated by the crisis produced innovations with the potential to rapidly improve outcomes. Notably though, it also has resulted in negative changes in response to a new pathogen that are hard to reconcile with physiologic principles. Evidence before and since the emergence of COVID-19 suggests prolonged RS prior to IMV is potentially harmful. It is critical for clinicians to recognize this principle and take steps to mitigate this problem in patients where a positive response to RS is not demonstrated in a timely manner.



Drs. Wilson and Chandel are with the Department of Pulmonary and Critical Care, Walter Reed National Military Medical Center, Washington, DC.

BOSTON – In emergency department stroke consultations, the National Institute of Health Stroke Scale (NIHSS) alone does not appear to be a reliable guide for ordering diagnostic tests for a large vessel occlusion (LVO), according to large body of data presented at the 2023 annual meeting of the American Academy of Neurology.

If the goal is not to miss any LVOs, there is no NIHSS score below which these do not occur, according to Theresa Sevilis, DO, regional medical director, TeleSpecialists, Fort Myers, Fla.

For example, her evaluation of a large and nationally representative dataset shows that more than 10% of the LVOs eventually identified and accepted for intervention would be missed with a cutoff of NIHSS score of 6 or higher. Moving the cutoff NIHSS score to 4 or greater, 6% of LVOs among the 23,166 strokes evaluated would have gone undetected.

“The current guidelines do not address low NIHSS score largely due to a paucity of data,” according to Dr. Sevilis, who showed data indicating that there is great variation among institutions in regard to ordering computed tomography angiography (CTA). She indicated that CTA is the current imaging standard for detecting LVO.
 

Large prospective dataset

The data for this study were derived from the TeleCare database, which captures acute stroke consultations in the emergency departments in 227 facilities in 27 states. Stroke consultations over a 6-month period from July through December 2021 were evaluated. The prospectively collected data were subjected to a multivariate analysis to determine the odds ratio for a CTA performed and LVO found at each NIHSS score of 0 to 5. Scores 6 or above served as the reference.

“Only consults performed within 24 hours [of presentation] were included,” Dr. Sevilis said.

After excluding cases in which no NIHSS score was captured, which represented less than 1% of cases, more than 10,500 cases underwent CTA, providing a rate of 45.5%. The rate of CTA for the whole dataset was 45.5%. Of the study population, 24.6% had a NIHSS score of 6 or above.

“When you are discussing when to perform CTA in patients with a low NIHSS score, you are discussing the majority of patients,” Dr. Sevilis said.

Of those with a NIHSS stroke of 6 or below, 28.2% had a score of 0. Not surprisingly, these were the least likely to have a CTA performed on the basis of an odds ratio of 0.14 and the least likely to have a LVO detected (OR, 0.1). With the exception of a NIHSS stroke score of 1, the likelihood of CTA and LVO climbed incrementally with higher stroke scores. These odds ratios were, respectively, 0.16 and 0.09 for a score of 1; 0.27 and 0.16 for a score of 2; 0.33 and 0.14 for a score of 3; 0.49 and 0.24 for a score of 4; and 0.71 and 0.27 for a score of 5.

In the group with NIHSS score of 6 or above, 24.1% were found to have an LVO. Of these, the proportion accepted for a mechanical thrombectomy was less than half. The intervention acceptance rate for mechanical intervention among LVOs in patients with lower NIHSS scores again fell incrementally by score. The acceptance rate was about 35% among LVO patients with a NIHSS score of 3 or 4 and 25% for those with a score of 0-2.

The interpretation of these data “depends on goals,” Dr. Sevilis said. “If the goal is to not miss a single LVO, then it is important to consider the balance between benefits and risks.”
 

No consistent cutoff

In participating facilities, the protocol for considering CTA to detect and treat LVOs ranges from neurologist choice to cutoffs of NIHSS scores of 2, 4, and 6, according to Dr. Sevilis. Where the data suggest that a cutoff of 4 or above might be reasonable, she said that NIHSS scoring is not a useful tool for those “who do not want to miss any LVOs.”

These data are based on emergency room stroke consultations and not on confirmed strokes,” Dr. Sevilis emphasized. Indeed, she noted that the final discharge diagnosis was not available. Recognizing that the analysis was not performed on a population with confirmed strokes is particularly important for understanding the limited rate of CTAs performed even in those with relatively high NIHSS scores. She noted this could be explained by many different reasons, including suspicion of hemorrhage or clinical features that took the workup in a different direction.
 

Reconsidering protocols

Based on the large sample size, Dr. Sevilis contended that it is likely that these data are representative, but she considers this study a first step toward considering protocols and developing guidelines for addressing stroke alerts in the emergency department.

A more important step will be ongoing trials designed specifically to generate data to answer this question. Pascal Jabbour, MD, chief of the division of neurovascular and endovascular neurosurgery, Thomas Jefferson University Hospitals, Philadelphia, is participating in one of these trials. He agreed with the premise that better evidence-based criteria are needed when evaluating acute stroke patients with a potential LVO.

The trial in which he is a coinvestigator, called ENDOLOW, is testing the hypothesis that outcomes will be better if acute stroke patients with a LVO and a low baseline NIHSS score (< 5) are treated with immediate thrombectomy rather than medical management. If this hypothesis is confirmed in the randomized ENDOLOW, it will provide an evidence basis for an approach already being practiced at some centers.

“There should be a very low threshold for CTA,” said Dr. Jabbour in an interview. This imaging “takes less than 2 minutes and it can provide the basis for a life-saving endovascular thrombectomy if a LVO is found.”

It is already well known that LVO is not restricted only to patients with an elevated NIHSS score, he said.

For determining whether to order a CTA, “I do not agree with NIHSS score of 6 or above. There is no absolute number below which risk of missing a LVO is eliminated,” Dr. Jabbour said. He also argued against relying on NIHSS score without considering other clinical features, particularly cortical signs, which should raise suspicion of a LVO regardless of NIHSS score.

One problem is that NIHSS scores are not static. Decompensation can be rapid with the NIHSS score quickly climbing. When this happens, the delay in treatment might lead to a preventable adverse outcome.

“There is a change in the paradigm now that we have more evidence of a benefit from aggressive treatment in the right candidates,” according to Dr. Jabbour, referring to the recently published SELECT2 trial. In that trial, on which Dr. Jabbour served as a coauthor, patients with LVO and large territory infarct were randomized to thrombectomy or medical care within 24 hours of a stroke. It was stopped early for efficacy because of the increased functional independence (20% vs. 7%) in the surgical intervention group.

If the ongoing trials establish better criteria for ruling in or out the presence of LVO in patients with acute stroke, Dr. Jabbour predicted that guidelines will be written to standardize practice.

Dr. Sevilis reports no potential conflicts of interest. Dr. Jabbour has financial relationships with Cerenovus, Medtronic, and Microvention.
 

BOSTON – In emergency department stroke consultations, the National Institute of Health Stroke Scale (NIHSS) alone does not appear to be a reliable guide for ordering diagnostic tests for a large vessel occlusion (LVO), according to large body of data presented at the 2023 annual meeting of the American Academy of Neurology.

If the goal is not to miss any LVOs, there is no NIHSS score below which these do not occur, according to Theresa Sevilis, DO, regional medical director, TeleSpecialists, Fort Myers, Fla.

For example, her evaluation of a large and nationally representative dataset shows that more than 10% of the LVOs eventually identified and accepted for intervention would be missed with a cutoff of NIHSS score of 6 or higher. Moving the cutoff NIHSS score to 4 or greater, 6% of LVOs among the 23,166 strokes evaluated would have gone undetected.

“The current guidelines do not address low NIHSS score largely due to a paucity of data,” according to Dr. Sevilis, who showed data indicating that there is great variation among institutions in regard to ordering computed tomography angiography (CTA). She indicated that CTA is the current imaging standard for detecting LVO.
 

Large prospective dataset

The data for this study were derived from the TeleCare database, which captures acute stroke consultations in the emergency departments in 227 facilities in 27 states. Stroke consultations over a 6-month period from July through December 2021 were evaluated. The prospectively collected data were subjected to a multivariate analysis to determine the odds ratio for a CTA performed and LVO found at each NIHSS score of 0 to 5. Scores 6 or above served as the reference.

“Only consults performed within 24 hours [of presentation] were included,” Dr. Sevilis said.

After excluding cases in which no NIHSS score was captured, which represented less than 1% of cases, more than 10,500 cases underwent CTA, providing a rate of 45.5%. The rate of CTA for the whole dataset was 45.5%. Of the study population, 24.6% had a NIHSS score of 6 or above.

“When you are discussing when to perform CTA in patients with a low NIHSS score, you are discussing the majority of patients,” Dr. Sevilis said.

Of those with a NIHSS stroke of 6 or below, 28.2% had a score of 0. Not surprisingly, these were the least likely to have a CTA performed on the basis of an odds ratio of 0.14 and the least likely to have a LVO detected (OR, 0.1). With the exception of a NIHSS stroke score of 1, the likelihood of CTA and LVO climbed incrementally with higher stroke scores. These odds ratios were, respectively, 0.16 and 0.09 for a score of 1; 0.27 and 0.16 for a score of 2; 0.33 and 0.14 for a score of 3; 0.49 and 0.24 for a score of 4; and 0.71 and 0.27 for a score of 5.

In the group with NIHSS score of 6 or above, 24.1% were found to have an LVO. Of these, the proportion accepted for a mechanical thrombectomy was less than half. The intervention acceptance rate for mechanical intervention among LVOs in patients with lower NIHSS scores again fell incrementally by score. The acceptance rate was about 35% among LVO patients with a NIHSS score of 3 or 4 and 25% for those with a score of 0-2.

The interpretation of these data “depends on goals,” Dr. Sevilis said. “If the goal is to not miss a single LVO, then it is important to consider the balance between benefits and risks.”
 

No consistent cutoff

In participating facilities, the protocol for considering CTA to detect and treat LVOs ranges from neurologist choice to cutoffs of NIHSS scores of 2, 4, and 6, according to Dr. Sevilis. Where the data suggest that a cutoff of 4 or above might be reasonable, she said that NIHSS scoring is not a useful tool for those “who do not want to miss any LVOs.”

These data are based on emergency room stroke consultations and not on confirmed strokes,” Dr. Sevilis emphasized. Indeed, she noted that the final discharge diagnosis was not available. Recognizing that the analysis was not performed on a population with confirmed strokes is particularly important for understanding the limited rate of CTAs performed even in those with relatively high NIHSS scores. She noted this could be explained by many different reasons, including suspicion of hemorrhage or clinical features that took the workup in a different direction.
 

Reconsidering protocols

Based on the large sample size, Dr. Sevilis contended that it is likely that these data are representative, but she considers this study a first step toward considering protocols and developing guidelines for addressing stroke alerts in the emergency department.

A more important step will be ongoing trials designed specifically to generate data to answer this question. Pascal Jabbour, MD, chief of the division of neurovascular and endovascular neurosurgery, Thomas Jefferson University Hospitals, Philadelphia, is participating in one of these trials. He agreed with the premise that better evidence-based criteria are needed when evaluating acute stroke patients with a potential LVO.

The trial in which he is a coinvestigator, called ENDOLOW, is testing the hypothesis that outcomes will be better if acute stroke patients with a LVO and a low baseline NIHSS score (< 5) are treated with immediate thrombectomy rather than medical management. If this hypothesis is confirmed in the randomized ENDOLOW, it will provide an evidence basis for an approach already being practiced at some centers.

“There should be a very low threshold for CTA,” said Dr. Jabbour in an interview. This imaging “takes less than 2 minutes and it can provide the basis for a life-saving endovascular thrombectomy if a LVO is found.”

It is already well known that LVO is not restricted only to patients with an elevated NIHSS score, he said.

For determining whether to order a CTA, “I do not agree with NIHSS score of 6 or above. There is no absolute number below which risk of missing a LVO is eliminated,” Dr. Jabbour said. He also argued against relying on NIHSS score without considering other clinical features, particularly cortical signs, which should raise suspicion of a LVO regardless of NIHSS score.

One problem is that NIHSS scores are not static. Decompensation can be rapid with the NIHSS score quickly climbing. When this happens, the delay in treatment might lead to a preventable adverse outcome.

“There is a change in the paradigm now that we have more evidence of a benefit from aggressive treatment in the right candidates,” according to Dr. Jabbour, referring to the recently published SELECT2 trial. In that trial, on which Dr. Jabbour served as a coauthor, patients with LVO and large territory infarct were randomized to thrombectomy or medical care within 24 hours of a stroke. It was stopped early for efficacy because of the increased functional independence (20% vs. 7%) in the surgical intervention group.

If the ongoing trials establish better criteria for ruling in or out the presence of LVO in patients with acute stroke, Dr. Jabbour predicted that guidelines will be written to standardize practice.

Dr. Sevilis reports no potential conflicts of interest. Dr. Jabbour has financial relationships with Cerenovus, Medtronic, and Microvention.
 

BOSTON – In emergency department stroke consultations, the National Institute of Health Stroke Scale (NIHSS) alone does not appear to be a reliable guide for ordering diagnostic tests for a large vessel occlusion (LVO), according to large body of data presented at the 2023 annual meeting of the American Academy of Neurology.

If the goal is not to miss any LVOs, there is no NIHSS score below which these do not occur, according to Theresa Sevilis, DO, regional medical director, TeleSpecialists, Fort Myers, Fla.

For example, her evaluation of a large and nationally representative dataset shows that more than 10% of the LVOs eventually identified and accepted for intervention would be missed with a cutoff of NIHSS score of 6 or higher. Moving the cutoff NIHSS score to 4 or greater, 6% of LVOs among the 23,166 strokes evaluated would have gone undetected.

“The current guidelines do not address low NIHSS score largely due to a paucity of data,” according to Dr. Sevilis, who showed data indicating that there is great variation among institutions in regard to ordering computed tomography angiography (CTA). She indicated that CTA is the current imaging standard for detecting LVO.
 

Large prospective dataset

The data for this study were derived from the TeleCare database, which captures acute stroke consultations in the emergency departments in 227 facilities in 27 states. Stroke consultations over a 6-month period from July through December 2021 were evaluated. The prospectively collected data were subjected to a multivariate analysis to determine the odds ratio for a CTA performed and LVO found at each NIHSS score of 0 to 5. Scores 6 or above served as the reference.

“Only consults performed within 24 hours [of presentation] were included,” Dr. Sevilis said.

After excluding cases in which no NIHSS score was captured, which represented less than 1% of cases, more than 10,500 cases underwent CTA, providing a rate of 45.5%. The rate of CTA for the whole dataset was 45.5%. Of the study population, 24.6% had a NIHSS score of 6 or above.

“When you are discussing when to perform CTA in patients with a low NIHSS score, you are discussing the majority of patients,” Dr. Sevilis said.

Of those with a NIHSS stroke of 6 or below, 28.2% had a score of 0. Not surprisingly, these were the least likely to have a CTA performed on the basis of an odds ratio of 0.14 and the least likely to have a LVO detected (OR, 0.1). With the exception of a NIHSS stroke score of 1, the likelihood of CTA and LVO climbed incrementally with higher stroke scores. These odds ratios were, respectively, 0.16 and 0.09 for a score of 1; 0.27 and 0.16 for a score of 2; 0.33 and 0.14 for a score of 3; 0.49 and 0.24 for a score of 4; and 0.71 and 0.27 for a score of 5.

In the group with NIHSS score of 6 or above, 24.1% were found to have an LVO. Of these, the proportion accepted for a mechanical thrombectomy was less than half. The intervention acceptance rate for mechanical intervention among LVOs in patients with lower NIHSS scores again fell incrementally by score. The acceptance rate was about 35% among LVO patients with a NIHSS score of 3 or 4 and 25% for those with a score of 0-2.

The interpretation of these data “depends on goals,” Dr. Sevilis said. “If the goal is to not miss a single LVO, then it is important to consider the balance between benefits and risks.”
 

No consistent cutoff

In participating facilities, the protocol for considering CTA to detect and treat LVOs ranges from neurologist choice to cutoffs of NIHSS scores of 2, 4, and 6, according to Dr. Sevilis. Where the data suggest that a cutoff of 4 or above might be reasonable, she said that NIHSS scoring is not a useful tool for those “who do not want to miss any LVOs.”

These data are based on emergency room stroke consultations and not on confirmed strokes,” Dr. Sevilis emphasized. Indeed, she noted that the final discharge diagnosis was not available. Recognizing that the analysis was not performed on a population with confirmed strokes is particularly important for understanding the limited rate of CTAs performed even in those with relatively high NIHSS scores. She noted this could be explained by many different reasons, including suspicion of hemorrhage or clinical features that took the workup in a different direction.
 

Reconsidering protocols

Based on the large sample size, Dr. Sevilis contended that it is likely that these data are representative, but she considers this study a first step toward considering protocols and developing guidelines for addressing stroke alerts in the emergency department.

A more important step will be ongoing trials designed specifically to generate data to answer this question. Pascal Jabbour, MD, chief of the division of neurovascular and endovascular neurosurgery, Thomas Jefferson University Hospitals, Philadelphia, is participating in one of these trials. He agreed with the premise that better evidence-based criteria are needed when evaluating acute stroke patients with a potential LVO.

The trial in which he is a coinvestigator, called ENDOLOW, is testing the hypothesis that outcomes will be better if acute stroke patients with a LVO and a low baseline NIHSS score (< 5) are treated with immediate thrombectomy rather than medical management. If this hypothesis is confirmed in the randomized ENDOLOW, it will provide an evidence basis for an approach already being practiced at some centers.

“There should be a very low threshold for CTA,” said Dr. Jabbour in an interview. This imaging “takes less than 2 minutes and it can provide the basis for a life-saving endovascular thrombectomy if a LVO is found.”

It is already well known that LVO is not restricted only to patients with an elevated NIHSS score, he said.

For determining whether to order a CTA, “I do not agree with NIHSS score of 6 or above. There is no absolute number below which risk of missing a LVO is eliminated,” Dr. Jabbour said. He also argued against relying on NIHSS score without considering other clinical features, particularly cortical signs, which should raise suspicion of a LVO regardless of NIHSS score.

One problem is that NIHSS scores are not static. Decompensation can be rapid with the NIHSS score quickly climbing. When this happens, the delay in treatment might lead to a preventable adverse outcome.

“There is a change in the paradigm now that we have more evidence of a benefit from aggressive treatment in the right candidates,” according to Dr. Jabbour, referring to the recently published SELECT2 trial. In that trial, on which Dr. Jabbour served as a coauthor, patients with LVO and large territory infarct were randomized to thrombectomy or medical care within 24 hours of a stroke. It was stopped early for efficacy because of the increased functional independence (20% vs. 7%) in the surgical intervention group.

If the ongoing trials establish better criteria for ruling in or out the presence of LVO in patients with acute stroke, Dr. Jabbour predicted that guidelines will be written to standardize practice.

Dr. Sevilis reports no potential conflicts of interest. Dr. Jabbour has financial relationships with Cerenovus, Medtronic, and Microvention.
 

As many as 40% of lumpectomies leave positive margins that necessitate a second surgery, but a novel fluorescent imaging agent used along with a direct visualization system may improve complete resection rates, new phase 3 findings show.

Pegulicianine (Lumisight), an investigational and activatable fluorescent imaging agent used with a novel direct visualization system, helped identify residual tumor or circumvent second surgeries in about 10% of patients in the trial.

Use of the agent and direct visualization system – both from Lumicell and currently under review by the Food and Drug Administration – could provide more complete resection for patients with early breast cancer and avert the need for reexcisions, the investigators write.

The findings were published online in NEJM Evidence and were subsequently presented at the annual meeting of the American Society of Breast Surgeons.

Local recurrence following lumpectomy increases the risk of dying from breast cancer, and the risk of local recurrence is directly linked to inadequate tumor removal during lumpectomy. In about 20%-40% of lumpectomies, positive margins are identified after surgery.

To improve patient outcomes, investigators assessed whether a novel fluorescence-guided surgery system helped surgeons perform more complete resections during lumpectomy.

In the Novel Surgical Imaging for Tumor Excision (INSITE) trial, 392 patients were randomly assigned to undergo pegulicianine fluorescence-guided surgery (n = 357) or standard lumpectomy (n = 35).

To prevent surgeons from performing a smaller than standard lumpectomy in anticipation of using the pegulicianine fluorescence-guided system, patients were randomly assigned to the pegulicianine fluorescence-guided surgery group or the control group. The groups were revealed only after the surgeon completed the standard lumpectomy.

“Randomization was not designed to provide a control group for analysis of device performance,” The authors explain. “In this study design, each patient undergoing pegulicianine fluorescence-guided surgery served as her own control,” they write. The investigators compared final margin pathology after standard lumpectomy and after guided surgery. Those in the control group were included in the safety analysis.

Study participants were women aged 18 years or older who were undergoing lumpectomy for stage I–III breast cancer and/or ductal carcinoma in situ. All patients received pegulicianine 1.0 mg/kg via a 3-minute intravenous infusion 2-6 hours before surgery.

The agent produces a signal at sites of residual tumor, and a handheld probe illuminates the cavity during surgery. A tumor detection algorithm then analyzes and displays the images to the surgeon in real time – an overall process that adds about 7 minutes to the operative procedure, the authors say.

Investigators identified invasive cancers in 316 patients and in situ cancers in 76 patients. Among the 357 patients in the treatment group, 27 (7.6%) were found to have residual tumor after standard lumpectomy. For 22 patients, cavity orientations were deemed negative on standard margin evaluations, the authors report.

With use of pegulicianine fluorescence-guided surgery, positive margins were converted to negative margins for 9 of 62 patients (14.5%), potentially averting a second surgery in those patients.

Overall, the authors say that pegulicianine fluorescence-guided surgery removed residual tumor (27 of 357) or avoided second surgeries (9 of 357) in 10% of patients in the trial.

The current trial findings confirm results regarding the safety and efficacy of pegulicianine fluorescence-guided surgery and the direct visualization system that were reported in a prior multicenter feasibility study, the authors say.

Pegulicianine fluorescence-guided surgery met prespecified thresholds for removal of residual tumor and specificity, at 85.2%, but did not meet the prespecified threshold for sensitivity, which was only 49.3%.

The rate of serious adverse events with pegulicianine was 0.5% (two patients), similar to that of other contrast agents. Administration of the agent was stopped because of adverse events for six patients, the investigators write.

Serious adverse events included grade 3 hypersensitivity in one patient and an anaphylactic reaction in another. The other four adverse events included an allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation. All adverse events resolved, and patients proceeded to standard lumpectomy.

Overall, the trial findings “suggest that a more complete breast cancer resection may be achieved” with pegulicianine fluorescence-guided surgery and the direct visualization system, lead investigator Barbara Smith, MD, PhD, director of the breast program at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston, said in a press release. “Given the low complication rate, minimal added operative time and, most importantly, the discovery of additional cancer left behind after a lumpectomy, the Lumicell [system] has the potential to be a critical adjunct to enhance standard practice for breast cancer patients.”

The system also has the potential to reduce “the patient burden of additional surgery” and decrease “costs associated with a return to the operating room,” the authors conclude.

The INSITE trial was funded by Lumicell and the National Institutes of Health. Dr. Smith reported unpaid research collaboration with Lumicell.

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

As many as 40% of lumpectomies leave positive margins that necessitate a second surgery, but a novel fluorescent imaging agent used along with a direct visualization system may improve complete resection rates, new phase 3 findings show.

Pegulicianine (Lumisight), an investigational and activatable fluorescent imaging agent used with a novel direct visualization system, helped identify residual tumor or circumvent second surgeries in about 10% of patients in the trial.

Use of the agent and direct visualization system – both from Lumicell and currently under review by the Food and Drug Administration – could provide more complete resection for patients with early breast cancer and avert the need for reexcisions, the investigators write.

The findings were published online in NEJM Evidence and were subsequently presented at the annual meeting of the American Society of Breast Surgeons.

Local recurrence following lumpectomy increases the risk of dying from breast cancer, and the risk of local recurrence is directly linked to inadequate tumor removal during lumpectomy. In about 20%-40% of lumpectomies, positive margins are identified after surgery.

To improve patient outcomes, investigators assessed whether a novel fluorescence-guided surgery system helped surgeons perform more complete resections during lumpectomy.

In the Novel Surgical Imaging for Tumor Excision (INSITE) trial, 392 patients were randomly assigned to undergo pegulicianine fluorescence-guided surgery (n = 357) or standard lumpectomy (n = 35).

To prevent surgeons from performing a smaller than standard lumpectomy in anticipation of using the pegulicianine fluorescence-guided system, patients were randomly assigned to the pegulicianine fluorescence-guided surgery group or the control group. The groups were revealed only after the surgeon completed the standard lumpectomy.

“Randomization was not designed to provide a control group for analysis of device performance,” The authors explain. “In this study design, each patient undergoing pegulicianine fluorescence-guided surgery served as her own control,” they write. The investigators compared final margin pathology after standard lumpectomy and after guided surgery. Those in the control group were included in the safety analysis.

Study participants were women aged 18 years or older who were undergoing lumpectomy for stage I–III breast cancer and/or ductal carcinoma in situ. All patients received pegulicianine 1.0 mg/kg via a 3-minute intravenous infusion 2-6 hours before surgery.

The agent produces a signal at sites of residual tumor, and a handheld probe illuminates the cavity during surgery. A tumor detection algorithm then analyzes and displays the images to the surgeon in real time – an overall process that adds about 7 minutes to the operative procedure, the authors say.

Investigators identified invasive cancers in 316 patients and in situ cancers in 76 patients. Among the 357 patients in the treatment group, 27 (7.6%) were found to have residual tumor after standard lumpectomy. For 22 patients, cavity orientations were deemed negative on standard margin evaluations, the authors report.

With use of pegulicianine fluorescence-guided surgery, positive margins were converted to negative margins for 9 of 62 patients (14.5%), potentially averting a second surgery in those patients.

Overall, the authors say that pegulicianine fluorescence-guided surgery removed residual tumor (27 of 357) or avoided second surgeries (9 of 357) in 10% of patients in the trial.

The current trial findings confirm results regarding the safety and efficacy of pegulicianine fluorescence-guided surgery and the direct visualization system that were reported in a prior multicenter feasibility study, the authors say.

Pegulicianine fluorescence-guided surgery met prespecified thresholds for removal of residual tumor and specificity, at 85.2%, but did not meet the prespecified threshold for sensitivity, which was only 49.3%.

The rate of serious adverse events with pegulicianine was 0.5% (two patients), similar to that of other contrast agents. Administration of the agent was stopped because of adverse events for six patients, the investigators write.

Serious adverse events included grade 3 hypersensitivity in one patient and an anaphylactic reaction in another. The other four adverse events included an allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation. All adverse events resolved, and patients proceeded to standard lumpectomy.

Overall, the trial findings “suggest that a more complete breast cancer resection may be achieved” with pegulicianine fluorescence-guided surgery and the direct visualization system, lead investigator Barbara Smith, MD, PhD, director of the breast program at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston, said in a press release. “Given the low complication rate, minimal added operative time and, most importantly, the discovery of additional cancer left behind after a lumpectomy, the Lumicell [system] has the potential to be a critical adjunct to enhance standard practice for breast cancer patients.”

The system also has the potential to reduce “the patient burden of additional surgery” and decrease “costs associated with a return to the operating room,” the authors conclude.

The INSITE trial was funded by Lumicell and the National Institutes of Health. Dr. Smith reported unpaid research collaboration with Lumicell.

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

As many as 40% of lumpectomies leave positive margins that necessitate a second surgery, but a novel fluorescent imaging agent used along with a direct visualization system may improve complete resection rates, new phase 3 findings show.

Pegulicianine (Lumisight), an investigational and activatable fluorescent imaging agent used with a novel direct visualization system, helped identify residual tumor or circumvent second surgeries in about 10% of patients in the trial.

Use of the agent and direct visualization system – both from Lumicell and currently under review by the Food and Drug Administration – could provide more complete resection for patients with early breast cancer and avert the need for reexcisions, the investigators write.

The findings were published online in NEJM Evidence and were subsequently presented at the annual meeting of the American Society of Breast Surgeons.

Local recurrence following lumpectomy increases the risk of dying from breast cancer, and the risk of local recurrence is directly linked to inadequate tumor removal during lumpectomy. In about 20%-40% of lumpectomies, positive margins are identified after surgery.

To improve patient outcomes, investigators assessed whether a novel fluorescence-guided surgery system helped surgeons perform more complete resections during lumpectomy.

In the Novel Surgical Imaging for Tumor Excision (INSITE) trial, 392 patients were randomly assigned to undergo pegulicianine fluorescence-guided surgery (n = 357) or standard lumpectomy (n = 35).

To prevent surgeons from performing a smaller than standard lumpectomy in anticipation of using the pegulicianine fluorescence-guided system, patients were randomly assigned to the pegulicianine fluorescence-guided surgery group or the control group. The groups were revealed only after the surgeon completed the standard lumpectomy.

“Randomization was not designed to provide a control group for analysis of device performance,” The authors explain. “In this study design, each patient undergoing pegulicianine fluorescence-guided surgery served as her own control,” they write. The investigators compared final margin pathology after standard lumpectomy and after guided surgery. Those in the control group were included in the safety analysis.

Study participants were women aged 18 years or older who were undergoing lumpectomy for stage I–III breast cancer and/or ductal carcinoma in situ. All patients received pegulicianine 1.0 mg/kg via a 3-minute intravenous infusion 2-6 hours before surgery.

The agent produces a signal at sites of residual tumor, and a handheld probe illuminates the cavity during surgery. A tumor detection algorithm then analyzes and displays the images to the surgeon in real time – an overall process that adds about 7 minutes to the operative procedure, the authors say.

Investigators identified invasive cancers in 316 patients and in situ cancers in 76 patients. Among the 357 patients in the treatment group, 27 (7.6%) were found to have residual tumor after standard lumpectomy. For 22 patients, cavity orientations were deemed negative on standard margin evaluations, the authors report.

With use of pegulicianine fluorescence-guided surgery, positive margins were converted to negative margins for 9 of 62 patients (14.5%), potentially averting a second surgery in those patients.

Overall, the authors say that pegulicianine fluorescence-guided surgery removed residual tumor (27 of 357) or avoided second surgeries (9 of 357) in 10% of patients in the trial.

The current trial findings confirm results regarding the safety and efficacy of pegulicianine fluorescence-guided surgery and the direct visualization system that were reported in a prior multicenter feasibility study, the authors say.

Pegulicianine fluorescence-guided surgery met prespecified thresholds for removal of residual tumor and specificity, at 85.2%, but did not meet the prespecified threshold for sensitivity, which was only 49.3%.

The rate of serious adverse events with pegulicianine was 0.5% (two patients), similar to that of other contrast agents. Administration of the agent was stopped because of adverse events for six patients, the investigators write.

Serious adverse events included grade 3 hypersensitivity in one patient and an anaphylactic reaction in another. The other four adverse events included an allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation. All adverse events resolved, and patients proceeded to standard lumpectomy.

Overall, the trial findings “suggest that a more complete breast cancer resection may be achieved” with pegulicianine fluorescence-guided surgery and the direct visualization system, lead investigator Barbara Smith, MD, PhD, director of the breast program at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston, said in a press release. “Given the low complication rate, minimal added operative time and, most importantly, the discovery of additional cancer left behind after a lumpectomy, the Lumicell [system] has the potential to be a critical adjunct to enhance standard practice for breast cancer patients.”

The system also has the potential to reduce “the patient burden of additional surgery” and decrease “costs associated with a return to the operating room,” the authors conclude.

The INSITE trial was funded by Lumicell and the National Institutes of Health. Dr. Smith reported unpaid research collaboration with Lumicell.

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

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Many years ago, at the conclusion of a talk I gave on bone health in teens with anorexia nervosa, I was approached by a colleague, Ann Neumeyer, MD, medical director of the Lurie Center for Autism at Massachusetts General Hospital, Boston, who asked about bone health in children with autism spectrum disorder (ASD).

When I explained that there was little information about bone health in this patient population, she suggested that we learn and investigate together. Ann explained that she had observed that some of her patients with ASD had suffered fractures with minimal trauma, raising her concern about their bone health.

This was the beginning of a partnership that led us down the path of many grant submissions, some of which were funded and others that were not, to explore and investigate bone outcomes in children with ASD.

Over the years it has become very clear that these patients are at high risk for low bone density at multiple sites. This applies to prepubertal children as well as older children and adolescents. One study showed that 28% and 33% of children with ASD 8-14 years old had very low bone density (z scores of ≤ –2) at the spine and hip, respectively, compared with 0% of typically developing controls.

Studies that have used sophisticated imaging techniques to determine bone strength have shown that it is lower at the forearm and lower leg in children with ASD versus neurotypical children.

These findings are of particular concern during the childhood and teenage years when bone is typically accrued at a rapid rate. A normal rate of bone accrual at this time of life is essential for optimal bone health in later life. While children with ASD gain bone mass at a similar rate as neurotypical controls, they start at a deficit and seem unable to “catch up.”

Further, people with ASD are more prone to certain kinds of fracture than those without the condition. For example, both children and adults with ASD have a high risk for hip fracture, while adult women with ASD have a higher risk for forearm and spine fractures. There is some protection against forearm fractures in children and adult men, probably because of markedly lower levels of physical activity, which would reduce fall risk.

Many of Ann’s patients with ASD had unusual or restricted diets, low levels of physical activity, and were on multiple medications. We have since learned that some factors that contribute to low bone density in ASD include lower levels of weight-bearing physical activity; lower muscle mass; low muscle tone; suboptimal dietary calcium and vitamin D intake; lower vitamin D levels; higher levels of the hormone cortisol, which has deleterious effects on bone; and use of medications that can lower bone density.

In order to mitigate the risk for low bone density and fractures, it is important to optimize physical activity while considering the child’s ability to safely engage in weight-bearing sports.

High-impact sports like gymnastics and jumping, or cross-impact sports like soccer, basketball, field hockey, and lacrosse, are particularly useful in this context, but many patients with ASD are not able to easily engage in typical team sports.

For such children, a prescribed amount of time spent walking, as well as weight and resistance training, could be helpful. The latter would also help increase muscle mass, a key modulator of bone health.

Other strategies include ensuring sufficient intake of calcium and vitamin D through diet and supplements. This can be a particular challenge for children with ASD on specialized diets, such as a gluten-free or dairy-free diet, which are deficient in calcium and vitamin D. Health care providers should check for intake of dairy and dairy products, as well as serum vitamin D levels, and prescribe supplements as needed.

All children should get at least 600 IUs of vitamin D and 1,000-1,300 mg of elemental calcium daily. That said, many with ASD need much higher quantities of vitamin D (1,000-4,000 IUs or more) to maintain levels in the normal range. This is particularly true for dark-skinned children and children with obesity, as well as those who have medical disorders that cause malabsorption.

Higher cortisol levels in the ASD patient population are harder to manage. Efforts to ease anxiety and depression may help reduce cortisol levels. Medications such as protein pump inhibitors and glucocorticosteroids can compromise bone health.

In addition, certain antipsychotics can cause marked elevations in prolactin which, in turn, can lower levels of estrogen and testosterone, which are very important for bone health. In such cases, the clinician should consider switching patients to a different, less detrimental medication or adjust the current medication so that patients receive the lowest possible effective dose.

Obesity is associated with increased fracture risk and with suboptimal bone accrual during childhood, so ensuring a healthy diet is important. This includes avoiding sugary beverages and reducing intake of processed food and juice.

Sometimes, particularly when a child has low bone density and a history of several low-trauma fractures, medications such as bisphosphonates should be considered to increase bone density.

Above all, as physicians who manage ASD, it is essential that we raise awareness about bone health among our colleagues, patients, and their families to help mitigate fracture risk.

Madhusmita Misra, MD, MPH, is chief of the Division of Pediatric Endocrinology at Mass General for Children, Boston.

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

Many years ago, at the conclusion of a talk I gave on bone health in teens with anorexia nervosa, I was approached by a colleague, Ann Neumeyer, MD, medical director of the Lurie Center for Autism at Massachusetts General Hospital, Boston, who asked about bone health in children with autism spectrum disorder (ASD).

When I explained that there was little information about bone health in this patient population, she suggested that we learn and investigate together. Ann explained that she had observed that some of her patients with ASD had suffered fractures with minimal trauma, raising her concern about their bone health.

This was the beginning of a partnership that led us down the path of many grant submissions, some of which were funded and others that were not, to explore and investigate bone outcomes in children with ASD.

Over the years it has become very clear that these patients are at high risk for low bone density at multiple sites. This applies to prepubertal children as well as older children and adolescents. One study showed that 28% and 33% of children with ASD 8-14 years old had very low bone density (z scores of ≤ –2) at the spine and hip, respectively, compared with 0% of typically developing controls.

Studies that have used sophisticated imaging techniques to determine bone strength have shown that it is lower at the forearm and lower leg in children with ASD versus neurotypical children.

These findings are of particular concern during the childhood and teenage years when bone is typically accrued at a rapid rate. A normal rate of bone accrual at this time of life is essential for optimal bone health in later life. While children with ASD gain bone mass at a similar rate as neurotypical controls, they start at a deficit and seem unable to “catch up.”

Further, people with ASD are more prone to certain kinds of fracture than those without the condition. For example, both children and adults with ASD have a high risk for hip fracture, while adult women with ASD have a higher risk for forearm and spine fractures. There is some protection against forearm fractures in children and adult men, probably because of markedly lower levels of physical activity, which would reduce fall risk.

Many of Ann’s patients with ASD had unusual or restricted diets, low levels of physical activity, and were on multiple medications. We have since learned that some factors that contribute to low bone density in ASD include lower levels of weight-bearing physical activity; lower muscle mass; low muscle tone; suboptimal dietary calcium and vitamin D intake; lower vitamin D levels; higher levels of the hormone cortisol, which has deleterious effects on bone; and use of medications that can lower bone density.

In order to mitigate the risk for low bone density and fractures, it is important to optimize physical activity while considering the child’s ability to safely engage in weight-bearing sports.

High-impact sports like gymnastics and jumping, or cross-impact sports like soccer, basketball, field hockey, and lacrosse, are particularly useful in this context, but many patients with ASD are not able to easily engage in typical team sports.

For such children, a prescribed amount of time spent walking, as well as weight and resistance training, could be helpful. The latter would also help increase muscle mass, a key modulator of bone health.

Other strategies include ensuring sufficient intake of calcium and vitamin D through diet and supplements. This can be a particular challenge for children with ASD on specialized diets, such as a gluten-free or dairy-free diet, which are deficient in calcium and vitamin D. Health care providers should check for intake of dairy and dairy products, as well as serum vitamin D levels, and prescribe supplements as needed.

All children should get at least 600 IUs of vitamin D and 1,000-1,300 mg of elemental calcium daily. That said, many with ASD need much higher quantities of vitamin D (1,000-4,000 IUs or more) to maintain levels in the normal range. This is particularly true for dark-skinned children and children with obesity, as well as those who have medical disorders that cause malabsorption.

Higher cortisol levels in the ASD patient population are harder to manage. Efforts to ease anxiety and depression may help reduce cortisol levels. Medications such as protein pump inhibitors and glucocorticosteroids can compromise bone health.

In addition, certain antipsychotics can cause marked elevations in prolactin which, in turn, can lower levels of estrogen and testosterone, which are very important for bone health. In such cases, the clinician should consider switching patients to a different, less detrimental medication or adjust the current medication so that patients receive the lowest possible effective dose.

Obesity is associated with increased fracture risk and with suboptimal bone accrual during childhood, so ensuring a healthy diet is important. This includes avoiding sugary beverages and reducing intake of processed food and juice.

Sometimes, particularly when a child has low bone density and a history of several low-trauma fractures, medications such as bisphosphonates should be considered to increase bone density.

Above all, as physicians who manage ASD, it is essential that we raise awareness about bone health among our colleagues, patients, and their families to help mitigate fracture risk.

Madhusmita Misra, MD, MPH, is chief of the Division of Pediatric Endocrinology at Mass General for Children, Boston.

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

Many years ago, at the conclusion of a talk I gave on bone health in teens with anorexia nervosa, I was approached by a colleague, Ann Neumeyer, MD, medical director of the Lurie Center for Autism at Massachusetts General Hospital, Boston, who asked about bone health in children with autism spectrum disorder (ASD).

When I explained that there was little information about bone health in this patient population, she suggested that we learn and investigate together. Ann explained that she had observed that some of her patients with ASD had suffered fractures with minimal trauma, raising her concern about their bone health.

This was the beginning of a partnership that led us down the path of many grant submissions, some of which were funded and others that were not, to explore and investigate bone outcomes in children with ASD.

Over the years it has become very clear that these patients are at high risk for low bone density at multiple sites. This applies to prepubertal children as well as older children and adolescents. One study showed that 28% and 33% of children with ASD 8-14 years old had very low bone density (z scores of ≤ –2) at the spine and hip, respectively, compared with 0% of typically developing controls.

Studies that have used sophisticated imaging techniques to determine bone strength have shown that it is lower at the forearm and lower leg in children with ASD versus neurotypical children.

These findings are of particular concern during the childhood and teenage years when bone is typically accrued at a rapid rate. A normal rate of bone accrual at this time of life is essential for optimal bone health in later life. While children with ASD gain bone mass at a similar rate as neurotypical controls, they start at a deficit and seem unable to “catch up.”

Further, people with ASD are more prone to certain kinds of fracture than those without the condition. For example, both children and adults with ASD have a high risk for hip fracture, while adult women with ASD have a higher risk for forearm and spine fractures. There is some protection against forearm fractures in children and adult men, probably because of markedly lower levels of physical activity, which would reduce fall risk.

Many of Ann’s patients with ASD had unusual or restricted diets, low levels of physical activity, and were on multiple medications. We have since learned that some factors that contribute to low bone density in ASD include lower levels of weight-bearing physical activity; lower muscle mass; low muscle tone; suboptimal dietary calcium and vitamin D intake; lower vitamin D levels; higher levels of the hormone cortisol, which has deleterious effects on bone; and use of medications that can lower bone density.

In order to mitigate the risk for low bone density and fractures, it is important to optimize physical activity while considering the child’s ability to safely engage in weight-bearing sports.

High-impact sports like gymnastics and jumping, or cross-impact sports like soccer, basketball, field hockey, and lacrosse, are particularly useful in this context, but many patients with ASD are not able to easily engage in typical team sports.

For such children, a prescribed amount of time spent walking, as well as weight and resistance training, could be helpful. The latter would also help increase muscle mass, a key modulator of bone health.

Other strategies include ensuring sufficient intake of calcium and vitamin D through diet and supplements. This can be a particular challenge for children with ASD on specialized diets, such as a gluten-free or dairy-free diet, which are deficient in calcium and vitamin D. Health care providers should check for intake of dairy and dairy products, as well as serum vitamin D levels, and prescribe supplements as needed.

All children should get at least 600 IUs of vitamin D and 1,000-1,300 mg of elemental calcium daily. That said, many with ASD need much higher quantities of vitamin D (1,000-4,000 IUs or more) to maintain levels in the normal range. This is particularly true for dark-skinned children and children with obesity, as well as those who have medical disorders that cause malabsorption.

Higher cortisol levels in the ASD patient population are harder to manage. Efforts to ease anxiety and depression may help reduce cortisol levels. Medications such as protein pump inhibitors and glucocorticosteroids can compromise bone health.

In addition, certain antipsychotics can cause marked elevations in prolactin which, in turn, can lower levels of estrogen and testosterone, which are very important for bone health. In such cases, the clinician should consider switching patients to a different, less detrimental medication or adjust the current medication so that patients receive the lowest possible effective dose.

Obesity is associated with increased fracture risk and with suboptimal bone accrual during childhood, so ensuring a healthy diet is important. This includes avoiding sugary beverages and reducing intake of processed food and juice.

Sometimes, particularly when a child has low bone density and a history of several low-trauma fractures, medications such as bisphosphonates should be considered to increase bone density.

Above all, as physicians who manage ASD, it is essential that we raise awareness about bone health among our colleagues, patients, and their families to help mitigate fracture risk.

Madhusmita Misra, MD, MPH, is chief of the Division of Pediatric Endocrinology at Mass General for Children, Boston.

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

The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
 

Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.

The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.

Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.

Roughly 1.9 million veterans every year receive government-paid health care from private doctors.

The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”

The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.

The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.

The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”

Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.

If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.

The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:

• Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
• Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
• Establish a comprehensive data-sharing agreement with the VHA.
• Establish an internal process (such as system edits) to address duplicate payments.

“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.

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

The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
 

Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.

The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.

Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.

Roughly 1.9 million veterans every year receive government-paid health care from private doctors.

The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”

The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.

The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.

The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”

Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.

If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.

The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:

• Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
• Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
• Establish a comprehensive data-sharing agreement with the VHA.
• Establish an internal process (such as system edits) to address duplicate payments.

“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.

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

The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
 

Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.

The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.

Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.

Roughly 1.9 million veterans every year receive government-paid health care from private doctors.

The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”

The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.

The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.

The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”

Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.

If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.

The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:

• Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
• Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
• Establish a comprehensive data-sharing agreement with the VHA.
• Establish an internal process (such as system edits) to address duplicate payments.

“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.

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

SAN DIEGO – Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

SAN DIEGO – Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

SAN DIEGO – Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.