Your patients come in wanting a script for the latest medication they saw on a television commercial (Ozempic anyone?), a request for a medical marijuana card for their shoulder ache, or any number of pleas for drugs, procedures, or tests that are medically inappropriate.

One of the toughest parts of the job as a physician is balancing patient requests with patient satisfaction. In the age of Healthgrades, Yelp reviews, and patients sharing their visit high points on multiple social media platforms, how can you keep patients happy and satisfied when you have to say no?

Turns out, you can likely reroute those patient-driven requests if you can get to the heart of the issue the patient is looking to resolve, suggested Peter Lee, MD, a plastic surgeon at Wave Plastic Surgery in Los Angeles.

“The conversation between physicians and patients hinges less on the answer ‘no’ than it does on being a careful listener,” he said. “This includes focusing on the different available treatment options and then deciding which of these is most suitable to the particular situation facing that patient.”

Here are a few failsafe ways to say no — and why physicians think these approaches can make the difference between a contentious appointment and a positive one.
 

Hear Patients Out

When patients book an appointment with a physician to discuss a noncritical issue, they likely have a sense from Google of what they might need, which is why Dara Kass, MD, an emergency medicine physician in Hartford, Connecticut, always asks patients “why did you come in” and “what test do you think you need.”

“For example, they may say, ‘I came for a CT scan of my head because I’ve had a headache for 2 years, and it’s frustrating trying to find a neurologist,’” she said. “Maybe they don’t need a CT scan after all, but it’s up to me to figure that out, and letting them share what they think they need frames out a feeling that we’re making joint decisions.”
 

Help Patients Rethink Requests

The ubiquity of online searching is just one reason patients may tend to arrive at your office armed with “information.” This is especially true for patients seeking plastic surgery, said Dr. Lee. “A plastic surgeon’s reaction to such a request may be less about saying ‘no’ than taking the patient a few steps back in the decision-making process,” he said. “The goal should be to educate the patient, in the case of plastic surgery, about what is actually causing the appearance he or she is trying to correct.”

For something like a marijuana card for a slight ache, explaining that it may not be appropriate and “here’s what we can do instead” goes a long way in getting the patient to rethink and understand that their request may not be legitimate.
 

Use Safety Concerns as an Out

Often, a patient just isn’t a good candidate for a procedure, said Samuel Lin, MD, a plastic surgeon in Boston and an associate professor of surgery at Harvard Medical School, Boston. “They may think they need to have a procedure, but it might not be a safe thing for them to have it,” he said.

“I would lean heavily on the fact that it may not be medically safe for this patient to have this procedure due to elements of their medical history or the fact that they have had prior surgeries. Then, if you pivot to the more conservative things you can do, this can help you say no when a patient is seeking a certain procedure.”

Likewise, explaining that a weight loss drug may have more risks than benefits and isn’t appropriate for that 15 pounds they’re struggling with couched as a safety concern can ease the disappointment of a no.
 

Remind Patients That Tests Can Be Costly

It’s one thing for a patient to request certain tests, say an MRI or a CT scan, but those same patients may grumble when they get the bill for the tests. That said, it’s always a good idea to remind them of the costs of these tests, said Dr. Kass. Patients will get bills in the mail after their visit for those extra tests and scans. “They may not realize this until after they asked for it, and if they, for example, have $1000 in coinsurance, that bill may be a very upsetting surprise.”
 

You Can’t Always Prevent a Negative Patient Review

No matter how hard you try, a patient may still be unhappy that you’ve declined their request, and this may show up in the form of a negative review for all to see. However, it’s always best to keep these reviews in perspective. “The ‘no’ that might result in a bad review can happen for everything from waiting 15 minutes to see the doctor to not getting a discount at checkout and everything in between including being told they don’t need the drug, test, or procedure they requested.”

“I feel like people who write bad reviews want money back, or they have an alternative agenda. That’s why, I educate patients and empower them to make the right decisions,” said Jody A. Levine, MD, director of dermatology at Plastic Surgery & Dermatology of New York City.

Dr. Lee told this news organization that the fundamental pledge to “do no harm” is as good as any other credo when saying no to patients. “If we don’t believe there is a likely probability that a surgery will be safe to perform on a patient and leave the patient satisfied with the result, then it is our duty to decline to perform that surgery.”

Ultimately, being transparent leads to a happy doctor-patient relationship. “As long as you are clear and honest in explaining to a patient why you are declining to perform a procedure, most patients, rather than being angry with you, will thank you for your candor,” he said. “They’ll leave your office a little bit wiser, too.”

A version of this article appeared on Medscape.com.

Your patients come in wanting a script for the latest medication they saw on a television commercial (Ozempic anyone?), a request for a medical marijuana card for their shoulder ache, or any number of pleas for drugs, procedures, or tests that are medically inappropriate.

One of the toughest parts of the job as a physician is balancing patient requests with patient satisfaction. In the age of Healthgrades, Yelp reviews, and patients sharing their visit high points on multiple social media platforms, how can you keep patients happy and satisfied when you have to say no?

Turns out, you can likely reroute those patient-driven requests if you can get to the heart of the issue the patient is looking to resolve, suggested Peter Lee, MD, a plastic surgeon at Wave Plastic Surgery in Los Angeles.

“The conversation between physicians and patients hinges less on the answer ‘no’ than it does on being a careful listener,” he said. “This includes focusing on the different available treatment options and then deciding which of these is most suitable to the particular situation facing that patient.”

Here are a few failsafe ways to say no — and why physicians think these approaches can make the difference between a contentious appointment and a positive one.
 

Hear Patients Out

When patients book an appointment with a physician to discuss a noncritical issue, they likely have a sense from Google of what they might need, which is why Dara Kass, MD, an emergency medicine physician in Hartford, Connecticut, always asks patients “why did you come in” and “what test do you think you need.”

“For example, they may say, ‘I came for a CT scan of my head because I’ve had a headache for 2 years, and it’s frustrating trying to find a neurologist,’” she said. “Maybe they don’t need a CT scan after all, but it’s up to me to figure that out, and letting them share what they think they need frames out a feeling that we’re making joint decisions.”
 

Help Patients Rethink Requests

The ubiquity of online searching is just one reason patients may tend to arrive at your office armed with “information.” This is especially true for patients seeking plastic surgery, said Dr. Lee. “A plastic surgeon’s reaction to such a request may be less about saying ‘no’ than taking the patient a few steps back in the decision-making process,” he said. “The goal should be to educate the patient, in the case of plastic surgery, about what is actually causing the appearance he or she is trying to correct.”

For something like a marijuana card for a slight ache, explaining that it may not be appropriate and “here’s what we can do instead” goes a long way in getting the patient to rethink and understand that their request may not be legitimate.
 

Use Safety Concerns as an Out

Often, a patient just isn’t a good candidate for a procedure, said Samuel Lin, MD, a plastic surgeon in Boston and an associate professor of surgery at Harvard Medical School, Boston. “They may think they need to have a procedure, but it might not be a safe thing for them to have it,” he said.

“I would lean heavily on the fact that it may not be medically safe for this patient to have this procedure due to elements of their medical history or the fact that they have had prior surgeries. Then, if you pivot to the more conservative things you can do, this can help you say no when a patient is seeking a certain procedure.”

Likewise, explaining that a weight loss drug may have more risks than benefits and isn’t appropriate for that 15 pounds they’re struggling with couched as a safety concern can ease the disappointment of a no.
 

Remind Patients That Tests Can Be Costly

It’s one thing for a patient to request certain tests, say an MRI or a CT scan, but those same patients may grumble when they get the bill for the tests. That said, it’s always a good idea to remind them of the costs of these tests, said Dr. Kass. Patients will get bills in the mail after their visit for those extra tests and scans. “They may not realize this until after they asked for it, and if they, for example, have $1000 in coinsurance, that bill may be a very upsetting surprise.”
 

You Can’t Always Prevent a Negative Patient Review

No matter how hard you try, a patient may still be unhappy that you’ve declined their request, and this may show up in the form of a negative review for all to see. However, it’s always best to keep these reviews in perspective. “The ‘no’ that might result in a bad review can happen for everything from waiting 15 minutes to see the doctor to not getting a discount at checkout and everything in between including being told they don’t need the drug, test, or procedure they requested.”

“I feel like people who write bad reviews want money back, or they have an alternative agenda. That’s why, I educate patients and empower them to make the right decisions,” said Jody A. Levine, MD, director of dermatology at Plastic Surgery & Dermatology of New York City.

Dr. Lee told this news organization that the fundamental pledge to “do no harm” is as good as any other credo when saying no to patients. “If we don’t believe there is a likely probability that a surgery will be safe to perform on a patient and leave the patient satisfied with the result, then it is our duty to decline to perform that surgery.”

Ultimately, being transparent leads to a happy doctor-patient relationship. “As long as you are clear and honest in explaining to a patient why you are declining to perform a procedure, most patients, rather than being angry with you, will thank you for your candor,” he said. “They’ll leave your office a little bit wiser, too.”

A version of this article appeared on Medscape.com.

Your patients come in wanting a script for the latest medication they saw on a television commercial (Ozempic anyone?), a request for a medical marijuana card for their shoulder ache, or any number of pleas for drugs, procedures, or tests that are medically inappropriate.

One of the toughest parts of the job as a physician is balancing patient requests with patient satisfaction. In the age of Healthgrades, Yelp reviews, and patients sharing their visit high points on multiple social media platforms, how can you keep patients happy and satisfied when you have to say no?

Turns out, you can likely reroute those patient-driven requests if you can get to the heart of the issue the patient is looking to resolve, suggested Peter Lee, MD, a plastic surgeon at Wave Plastic Surgery in Los Angeles.

“The conversation between physicians and patients hinges less on the answer ‘no’ than it does on being a careful listener,” he said. “This includes focusing on the different available treatment options and then deciding which of these is most suitable to the particular situation facing that patient.”

Here are a few failsafe ways to say no — and why physicians think these approaches can make the difference between a contentious appointment and a positive one.
 

Hear Patients Out

When patients book an appointment with a physician to discuss a noncritical issue, they likely have a sense from Google of what they might need, which is why Dara Kass, MD, an emergency medicine physician in Hartford, Connecticut, always asks patients “why did you come in” and “what test do you think you need.”

“For example, they may say, ‘I came for a CT scan of my head because I’ve had a headache for 2 years, and it’s frustrating trying to find a neurologist,’” she said. “Maybe they don’t need a CT scan after all, but it’s up to me to figure that out, and letting them share what they think they need frames out a feeling that we’re making joint decisions.”
 

Help Patients Rethink Requests

The ubiquity of online searching is just one reason patients may tend to arrive at your office armed with “information.” This is especially true for patients seeking plastic surgery, said Dr. Lee. “A plastic surgeon’s reaction to such a request may be less about saying ‘no’ than taking the patient a few steps back in the decision-making process,” he said. “The goal should be to educate the patient, in the case of plastic surgery, about what is actually causing the appearance he or she is trying to correct.”

For something like a marijuana card for a slight ache, explaining that it may not be appropriate and “here’s what we can do instead” goes a long way in getting the patient to rethink and understand that their request may not be legitimate.
 

Use Safety Concerns as an Out

Often, a patient just isn’t a good candidate for a procedure, said Samuel Lin, MD, a plastic surgeon in Boston and an associate professor of surgery at Harvard Medical School, Boston. “They may think they need to have a procedure, but it might not be a safe thing for them to have it,” he said.

“I would lean heavily on the fact that it may not be medically safe for this patient to have this procedure due to elements of their medical history or the fact that they have had prior surgeries. Then, if you pivot to the more conservative things you can do, this can help you say no when a patient is seeking a certain procedure.”

Likewise, explaining that a weight loss drug may have more risks than benefits and isn’t appropriate for that 15 pounds they’re struggling with couched as a safety concern can ease the disappointment of a no.
 

Remind Patients That Tests Can Be Costly

It’s one thing for a patient to request certain tests, say an MRI or a CT scan, but those same patients may grumble when they get the bill for the tests. That said, it’s always a good idea to remind them of the costs of these tests, said Dr. Kass. Patients will get bills in the mail after their visit for those extra tests and scans. “They may not realize this until after they asked for it, and if they, for example, have $1000 in coinsurance, that bill may be a very upsetting surprise.”
 

You Can’t Always Prevent a Negative Patient Review

No matter how hard you try, a patient may still be unhappy that you’ve declined their request, and this may show up in the form of a negative review for all to see. However, it’s always best to keep these reviews in perspective. “The ‘no’ that might result in a bad review can happen for everything from waiting 15 minutes to see the doctor to not getting a discount at checkout and everything in between including being told they don’t need the drug, test, or procedure they requested.”

“I feel like people who write bad reviews want money back, or they have an alternative agenda. That’s why, I educate patients and empower them to make the right decisions,” said Jody A. Levine, MD, director of dermatology at Plastic Surgery & Dermatology of New York City.

Dr. Lee told this news organization that the fundamental pledge to “do no harm” is as good as any other credo when saying no to patients. “If we don’t believe there is a likely probability that a surgery will be safe to perform on a patient and leave the patient satisfied with the result, then it is our duty to decline to perform that surgery.”

Ultimately, being transparent leads to a happy doctor-patient relationship. “As long as you are clear and honest in explaining to a patient why you are declining to perform a procedure, most patients, rather than being angry with you, will thank you for your candor,” he said. “They’ll leave your office a little bit wiser, too.”

A version of this article appeared on Medscape.com.

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

• According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
• This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
• In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
• The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
• The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

• Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
• Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
• The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
• On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

• According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
• This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
• In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
• The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
• The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

• Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
• Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
• The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
• On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

• According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
• This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
• In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
• The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
• The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

• Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
• Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
• The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
• On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Three out of five sudden unexpected infant deaths (SUID) happen when the baby is sharing a sleep space with at least one other infant, child, or adult, according to new data published online in Pediatrics.

SUID occur in infants less than 1 year old. The deaths happen without an obvious cause before investigation and account for 3,400 deaths per year in the United States.

Alexa B. Erck Lambert, MPH, Maternal and Infant Health Branch of the Centers for Disease Control and Prevention (CDC), led the study that examined 7,595 such deaths in 23 US jurisdictions from 2011 to 2020, using data from the CDC’s SUID Case Registry.

The researchers reported that the prevalence of surface sharing ranges from 34% to 64% among living infants and about 50% among SUID.
 

Common Factors

They found common factors when infants share sleep space compared with infants who did not. Those who shared space, for example, were often 0-3 months old; publicly insured; non-Hispanic Black; found in an adult bed, couch, or chair; exposed to maternal cigarette smoking prenatally; and supervised by a parent when they died or had a supervisor who was impaired by drugs or alcohol at the time of death.

Having a supervisor who was impaired by drugs or alcohol was much more common among sharing (16.3%) than nonsharing infants (4.7%).

The American Academy of Pediatrics (AAP) guidance says a safe sleep environment for infants includes a place to sleep on a nonshared sleep surface (in a crib or bassinet) without soft bedding, and lying on the back facing up.
 

Most Who Died had Multiple Unsafe Sleep Factors

At least 76% of all SUID had multiple unsafe sleep factors present, regardless of whether the infants shared sleep space. Unsafe sleep factors include an inclined or soft sleep surface, sleeping on the side or stomach, sleeping with soft or loose bedding or objects, not breastfeeding, prenatal or environmental exposure to cigarette smoke, and overheating.

Sharing sleep space combined with parents’ smoking and maternal alcohol or drug use greatly increases risk of sudden infant death, the authors noted.
 

Sharing More Common With Multiples

Among SUID, surface sharing was more common among multiples than singletons and more common in an adult bed than in the same crib. The authors noted that parents often cite financial reasons for such arrangements.

However, AAP recommends multiples sleep on separate surfaces. The authors say pediatricians and other healthcare providers should be aware of free crib distribution programs. A study by Hauck et al. found “crib distribution and safe sleep education positively influence knowledge and practices about safe sleep.”

Robin Haynes, PhD, who studies causes underlying the pathology of SIDS at Boston Children’s Hospital, pointed to the Cribs for Kids website as a place for parents and clinicians to start for help with providing separate sleeping surfaces.

Dr. Haynes said the large number of infants included is a strength of the study. The findings help confirm the risk of sharing a sleep surface, she said, but the details on characteristics of sleep-sharing environments provide “novel insight into this problem,” she said.

“For basic researchers,” Dr. Haynes said, “it reiterates that most cases of sudden and unexpected infant deaths are exposed to multiple risk factors. It also highlights the role that young infant age and maternal smoking have as risk factors that contribute to biological vulnerabilities in infants.”

The results also give clinicians more information on characteristics of bedsharing families and some of the factors related to bedsharing, including socioeconomic and behavioral factors, she said. She highlighted the higher risk of SUID when drug or alcohol impairment is involved while bedsharing.

“All of this information is really important and helps clinicians shape the safe sleep messages to families,” she said.

The study authors and Dr. Haynes report no relevant financial relationships.

Three out of five sudden unexpected infant deaths (SUID) happen when the baby is sharing a sleep space with at least one other infant, child, or adult, according to new data published online in Pediatrics.

SUID occur in infants less than 1 year old. The deaths happen without an obvious cause before investigation and account for 3,400 deaths per year in the United States.

Alexa B. Erck Lambert, MPH, Maternal and Infant Health Branch of the Centers for Disease Control and Prevention (CDC), led the study that examined 7,595 such deaths in 23 US jurisdictions from 2011 to 2020, using data from the CDC’s SUID Case Registry.

The researchers reported that the prevalence of surface sharing ranges from 34% to 64% among living infants and about 50% among SUID.
 

Common Factors

They found common factors when infants share sleep space compared with infants who did not. Those who shared space, for example, were often 0-3 months old; publicly insured; non-Hispanic Black; found in an adult bed, couch, or chair; exposed to maternal cigarette smoking prenatally; and supervised by a parent when they died or had a supervisor who was impaired by drugs or alcohol at the time of death.

Having a supervisor who was impaired by drugs or alcohol was much more common among sharing (16.3%) than nonsharing infants (4.7%).

The American Academy of Pediatrics (AAP) guidance says a safe sleep environment for infants includes a place to sleep on a nonshared sleep surface (in a crib or bassinet) without soft bedding, and lying on the back facing up.
 

Most Who Died had Multiple Unsafe Sleep Factors

At least 76% of all SUID had multiple unsafe sleep factors present, regardless of whether the infants shared sleep space. Unsafe sleep factors include an inclined or soft sleep surface, sleeping on the side or stomach, sleeping with soft or loose bedding or objects, not breastfeeding, prenatal or environmental exposure to cigarette smoke, and overheating.

Sharing sleep space combined with parents’ smoking and maternal alcohol or drug use greatly increases risk of sudden infant death, the authors noted.
 

Sharing More Common With Multiples

Among SUID, surface sharing was more common among multiples than singletons and more common in an adult bed than in the same crib. The authors noted that parents often cite financial reasons for such arrangements.

However, AAP recommends multiples sleep on separate surfaces. The authors say pediatricians and other healthcare providers should be aware of free crib distribution programs. A study by Hauck et al. found “crib distribution and safe sleep education positively influence knowledge and practices about safe sleep.”

Robin Haynes, PhD, who studies causes underlying the pathology of SIDS at Boston Children’s Hospital, pointed to the Cribs for Kids website as a place for parents and clinicians to start for help with providing separate sleeping surfaces.

Dr. Haynes said the large number of infants included is a strength of the study. The findings help confirm the risk of sharing a sleep surface, she said, but the details on characteristics of sleep-sharing environments provide “novel insight into this problem,” she said.

“For basic researchers,” Dr. Haynes said, “it reiterates that most cases of sudden and unexpected infant deaths are exposed to multiple risk factors. It also highlights the role that young infant age and maternal smoking have as risk factors that contribute to biological vulnerabilities in infants.”

The results also give clinicians more information on characteristics of bedsharing families and some of the factors related to bedsharing, including socioeconomic and behavioral factors, she said. She highlighted the higher risk of SUID when drug or alcohol impairment is involved while bedsharing.

“All of this information is really important and helps clinicians shape the safe sleep messages to families,” she said.

The study authors and Dr. Haynes report no relevant financial relationships.

Three out of five sudden unexpected infant deaths (SUID) happen when the baby is sharing a sleep space with at least one other infant, child, or adult, according to new data published online in Pediatrics.

SUID occur in infants less than 1 year old. The deaths happen without an obvious cause before investigation and account for 3,400 deaths per year in the United States.

Alexa B. Erck Lambert, MPH, Maternal and Infant Health Branch of the Centers for Disease Control and Prevention (CDC), led the study that examined 7,595 such deaths in 23 US jurisdictions from 2011 to 2020, using data from the CDC’s SUID Case Registry.

The researchers reported that the prevalence of surface sharing ranges from 34% to 64% among living infants and about 50% among SUID.
 

Common Factors

They found common factors when infants share sleep space compared with infants who did not. Those who shared space, for example, were often 0-3 months old; publicly insured; non-Hispanic Black; found in an adult bed, couch, or chair; exposed to maternal cigarette smoking prenatally; and supervised by a parent when they died or had a supervisor who was impaired by drugs or alcohol at the time of death.

Having a supervisor who was impaired by drugs or alcohol was much more common among sharing (16.3%) than nonsharing infants (4.7%).

The American Academy of Pediatrics (AAP) guidance says a safe sleep environment for infants includes a place to sleep on a nonshared sleep surface (in a crib or bassinet) without soft bedding, and lying on the back facing up.
 

Most Who Died had Multiple Unsafe Sleep Factors

At least 76% of all SUID had multiple unsafe sleep factors present, regardless of whether the infants shared sleep space. Unsafe sleep factors include an inclined or soft sleep surface, sleeping on the side or stomach, sleeping with soft or loose bedding or objects, not breastfeeding, prenatal or environmental exposure to cigarette smoke, and overheating.

Sharing sleep space combined with parents’ smoking and maternal alcohol or drug use greatly increases risk of sudden infant death, the authors noted.
 

Sharing More Common With Multiples

Among SUID, surface sharing was more common among multiples than singletons and more common in an adult bed than in the same crib. The authors noted that parents often cite financial reasons for such arrangements.

However, AAP recommends multiples sleep on separate surfaces. The authors say pediatricians and other healthcare providers should be aware of free crib distribution programs. A study by Hauck et al. found “crib distribution and safe sleep education positively influence knowledge and practices about safe sleep.”

Robin Haynes, PhD, who studies causes underlying the pathology of SIDS at Boston Children’s Hospital, pointed to the Cribs for Kids website as a place for parents and clinicians to start for help with providing separate sleeping surfaces.

Dr. Haynes said the large number of infants included is a strength of the study. The findings help confirm the risk of sharing a sleep surface, she said, but the details on characteristics of sleep-sharing environments provide “novel insight into this problem,” she said.

“For basic researchers,” Dr. Haynes said, “it reiterates that most cases of sudden and unexpected infant deaths are exposed to multiple risk factors. It also highlights the role that young infant age and maternal smoking have as risk factors that contribute to biological vulnerabilities in infants.”

The results also give clinicians more information on characteristics of bedsharing families and some of the factors related to bedsharing, including socioeconomic and behavioral factors, she said. She highlighted the higher risk of SUID when drug or alcohol impairment is involved while bedsharing.

“All of this information is really important and helps clinicians shape the safe sleep messages to families,” she said.

The study authors and Dr. Haynes report no relevant financial relationships.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

• The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
• Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
• Referring patients for diabetes self-management education and support
• Navigating available therapeutic options and explaining complex regimens to patients
• Minimizing therapeutic and clinical inertia
• Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
• Discussing strategies to minimize hypoglycemia when relevant
• Using telehealth when appropriate
• Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

• The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
• Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
• Referring patients for diabetes self-management education and support
• Navigating available therapeutic options and explaining complex regimens to patients
• Minimizing therapeutic and clinical inertia
• Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
• Discussing strategies to minimize hypoglycemia when relevant
• Using telehealth when appropriate
• Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

• The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
• Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
• Referring patients for diabetes self-management education and support
• Navigating available therapeutic options and explaining complex regimens to patients
• Minimizing therapeutic and clinical inertia
• Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
• Discussing strategies to minimize hypoglycemia when relevant
• Using telehealth when appropriate
• Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Upon reviewing repeated prostate cancer screenings, researchers observed the absence of suspicious MRI findings in over 86% of men who had prostate-specific antigen (PSA) levels of 3 ng/mL or higher during their second screening.

METHODOLOGY:

• New initiatives are focusing on organizing prostate cancer screening using MRI to reduce overdiagnosis, as current evidence does not support the effectiveness of a single PSA test, with guidelines now recommending repeated testing every 1-4 years.
• In the STHLM3-MRI trial, men, aged 50-74 years, living in Stockholm County, Sweden, were invited to participate in prostate cancer screening and randomly assigned to traditional screening with systematic  or an MRI-based strategy.
• Blood samples were analyzed for PSA levels and Stockholm3 risk score; men with elevated risk underwent targeted MRI and biopsy procedures.
• In this follow-up analysis, 2,078 men with PSA levels of 1.5 ng/mL or higher and a Stockholm3 risk score less than 0.11 were re-invited for screening 2-3 years after their initial screening.
• The primary outcome was clinically significant prostate cancer (Gleason score of 3 + 4 or greater). A Gleason score of 6 was detected in 0.7% of patients, and a score of 4 + 3 or greater was detected in 19 (1.3%) men.

TAKEAWAY:

• Of 1,500 men (median age of 67 years) who underwent a blood test, the median PSA level was 2.8 ng/mL and 26.0% changed risk classification groups (PSA levels < 3 vs 3 ng/mL).
• Out of 667 men with PSA levels of 3 ng/mL or higher, 617 (92.5%) had an MRI. Of the 617, 51 (7.6%) had equivocal lesions (a Prostate Imaging-Reporting and Data System score of 3) and 33 (4.9%) had suspicious lesions.
• Of the 1,500 rescreened men, clinically significant prostate cancer was detected in 48 men (3.2%); this corresponds to 59.2% of the biopsied men.
• Out of 383 men who had previously received a negative MRI result, only 10 (2.6%) exhibited a lesion with a Prostate Imaging-Reporting and Data System score of 4 or higher.

IN PRACTICE:

In an accompanying editorial, Ola Bratt, MD, PhD, noted that the “most important finding was the very high proportion of nonsuspicious repeat MRI scans,” but also emphasizes the necessity of observing a decrease in overall prostate cancer incidence before asserting that the current cancer diagnostics effectively reduce overdiagnosis.

SOURCE:

This study, led by Tobias Nordström, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published on February 7, 2024, in JAMA Network Open.

LIMITATIONS:

Long-term outcomes like prostate cancer mortality were not evaluated. Information on cancer detection in men with a negative MRI result at rescreening was not available. Authors noted that a subset of individuals may still be at risk despite lower PSA levels.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare, Karolinska Institute, Prostatacancerförbundet, Region Stockholm, and Åke Wibergs Stiftelse. The authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Upon reviewing repeated prostate cancer screenings, researchers observed the absence of suspicious MRI findings in over 86% of men who had prostate-specific antigen (PSA) levels of 3 ng/mL or higher during their second screening.

METHODOLOGY:

• New initiatives are focusing on organizing prostate cancer screening using MRI to reduce overdiagnosis, as current evidence does not support the effectiveness of a single PSA test, with guidelines now recommending repeated testing every 1-4 years.
• In the STHLM3-MRI trial, men, aged 50-74 years, living in Stockholm County, Sweden, were invited to participate in prostate cancer screening and randomly assigned to traditional screening with systematic  or an MRI-based strategy.
• Blood samples were analyzed for PSA levels and Stockholm3 risk score; men with elevated risk underwent targeted MRI and biopsy procedures.
• In this follow-up analysis, 2,078 men with PSA levels of 1.5 ng/mL or higher and a Stockholm3 risk score less than 0.11 were re-invited for screening 2-3 years after their initial screening.
• The primary outcome was clinically significant prostate cancer (Gleason score of 3 + 4 or greater). A Gleason score of 6 was detected in 0.7% of patients, and a score of 4 + 3 or greater was detected in 19 (1.3%) men.

TAKEAWAY:

• Of 1,500 men (median age of 67 years) who underwent a blood test, the median PSA level was 2.8 ng/mL and 26.0% changed risk classification groups (PSA levels < 3 vs 3 ng/mL).
• Out of 667 men with PSA levels of 3 ng/mL or higher, 617 (92.5%) had an MRI. Of the 617, 51 (7.6%) had equivocal lesions (a Prostate Imaging-Reporting and Data System score of 3) and 33 (4.9%) had suspicious lesions.
• Of the 1,500 rescreened men, clinically significant prostate cancer was detected in 48 men (3.2%); this corresponds to 59.2% of the biopsied men.
• Out of 383 men who had previously received a negative MRI result, only 10 (2.6%) exhibited a lesion with a Prostate Imaging-Reporting and Data System score of 4 or higher.

IN PRACTICE:

In an accompanying editorial, Ola Bratt, MD, PhD, noted that the “most important finding was the very high proportion of nonsuspicious repeat MRI scans,” but also emphasizes the necessity of observing a decrease in overall prostate cancer incidence before asserting that the current cancer diagnostics effectively reduce overdiagnosis.

SOURCE:

This study, led by Tobias Nordström, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published on February 7, 2024, in JAMA Network Open.

LIMITATIONS:

Long-term outcomes like prostate cancer mortality were not evaluated. Information on cancer detection in men with a negative MRI result at rescreening was not available. Authors noted that a subset of individuals may still be at risk despite lower PSA levels.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare, Karolinska Institute, Prostatacancerförbundet, Region Stockholm, and Åke Wibergs Stiftelse. The authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Upon reviewing repeated prostate cancer screenings, researchers observed the absence of suspicious MRI findings in over 86% of men who had prostate-specific antigen (PSA) levels of 3 ng/mL or higher during their second screening.

METHODOLOGY:

• New initiatives are focusing on organizing prostate cancer screening using MRI to reduce overdiagnosis, as current evidence does not support the effectiveness of a single PSA test, with guidelines now recommending repeated testing every 1-4 years.
• In the STHLM3-MRI trial, men, aged 50-74 years, living in Stockholm County, Sweden, were invited to participate in prostate cancer screening and randomly assigned to traditional screening with systematic  or an MRI-based strategy.
• Blood samples were analyzed for PSA levels and Stockholm3 risk score; men with elevated risk underwent targeted MRI and biopsy procedures.
• In this follow-up analysis, 2,078 men with PSA levels of 1.5 ng/mL or higher and a Stockholm3 risk score less than 0.11 were re-invited for screening 2-3 years after their initial screening.
• The primary outcome was clinically significant prostate cancer (Gleason score of 3 + 4 or greater). A Gleason score of 6 was detected in 0.7% of patients, and a score of 4 + 3 or greater was detected in 19 (1.3%) men.

TAKEAWAY:

• Of 1,500 men (median age of 67 years) who underwent a blood test, the median PSA level was 2.8 ng/mL and 26.0% changed risk classification groups (PSA levels < 3 vs 3 ng/mL).
• Out of 667 men with PSA levels of 3 ng/mL or higher, 617 (92.5%) had an MRI. Of the 617, 51 (7.6%) had equivocal lesions (a Prostate Imaging-Reporting and Data System score of 3) and 33 (4.9%) had suspicious lesions.
• Of the 1,500 rescreened men, clinically significant prostate cancer was detected in 48 men (3.2%); this corresponds to 59.2% of the biopsied men.
• Out of 383 men who had previously received a negative MRI result, only 10 (2.6%) exhibited a lesion with a Prostate Imaging-Reporting and Data System score of 4 or higher.

IN PRACTICE:

In an accompanying editorial, Ola Bratt, MD, PhD, noted that the “most important finding was the very high proportion of nonsuspicious repeat MRI scans,” but also emphasizes the necessity of observing a decrease in overall prostate cancer incidence before asserting that the current cancer diagnostics effectively reduce overdiagnosis.

SOURCE:

This study, led by Tobias Nordström, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published on February 7, 2024, in JAMA Network Open.

LIMITATIONS:

Long-term outcomes like prostate cancer mortality were not evaluated. Information on cancer detection in men with a negative MRI result at rescreening was not available. Authors noted that a subset of individuals may still be at risk despite lower PSA levels.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare, Karolinska Institute, Prostatacancerförbundet, Region Stockholm, and Åke Wibergs Stiftelse. The authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Skin conditions burden many children with inflammatory bowel disease (IBD), according to the authors of a single-center study.

METHODOLOGY:

• Little is known about the prevalence of IBD-associated skin lesions and their association with IBD severity in children ages 18 and younger.Researchers retrospectively reviewed the medical charts of 425 children and adolescents with  (CD) or ulcerative  (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
• Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
• They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.
• Researchers retrospectively reviewed the medical charts of 425 children and adolescents with Crohn’s disease (CD) or ulcerative colitis (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
• Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
• They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.

TAKEAWAY:

• The most common noninfectious dermatologic condition among the 425 children and adolescents was  (30.8%), followed by eczema (15.8%) and perianal skin tags (14.6%).
• Angular cheilitis was more common among those with CD than those with UC (7.2% vs 2%, respectively; P = .024) as was keratosis pilaris (6.9% vs 0.7%; P = .003), and perianal skin complications such as skin tags (20.3% vs 4%), fistulas (13.4% vs 2.7%), and abscesses (13.4% vs 2%; P < .001 for all associations).
• Fungal skin infections were more frequently diagnosed in children with UC than those with CD (15.4% vs 8%; P = .017).
• The researchers observed that the severity of IBD correlated with a higher prevalence of perianal fistula (P = .003), perianal region abscess (P = .041), psoriasis (P < .001), and pyoderma gangrenosum (P = .003).

IN PRACTICE:

“Early identification of common dermatologic conditions in children and adolescents with IBD and recognizing their characteristic associations may alter management and improve skin-related outcomes in this patient population,” the authors wrote.

SOURCE:

Corresponding author Megha M. Tollefson, MD, of the Department of Dermatology at Mayo Clinic, Rochester, Minnesota, and colleagues conducted the research, which was published in Pediatric Dermatology.

LIMITATIONS:

The single-center design and the fact that database studies are subject to extraction error. There was no age- and sex-matched cohort to determine whether the prevalence of cutaneous infections, acne, eczema, and other inflammatory disorders was truly increased in IBD.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Skin conditions burden many children with inflammatory bowel disease (IBD), according to the authors of a single-center study.

METHODOLOGY:

• Little is known about the prevalence of IBD-associated skin lesions and their association with IBD severity in children ages 18 and younger.Researchers retrospectively reviewed the medical charts of 425 children and adolescents with  (CD) or ulcerative  (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
• Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
• They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.
• Researchers retrospectively reviewed the medical charts of 425 children and adolescents with Crohn’s disease (CD) or ulcerative colitis (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
• Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
• They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.

TAKEAWAY:

• The most common noninfectious dermatologic condition among the 425 children and adolescents was  (30.8%), followed by eczema (15.8%) and perianal skin tags (14.6%).
• Angular cheilitis was more common among those with CD than those with UC (7.2% vs 2%, respectively; P = .024) as was keratosis pilaris (6.9% vs 0.7%; P = .003), and perianal skin complications such as skin tags (20.3% vs 4%), fistulas (13.4% vs 2.7%), and abscesses (13.4% vs 2%; P < .001 for all associations).
• Fungal skin infections were more frequently diagnosed in children with UC than those with CD (15.4% vs 8%; P = .017).
• The researchers observed that the severity of IBD correlated with a higher prevalence of perianal fistula (P = .003), perianal region abscess (P = .041), psoriasis (P < .001), and pyoderma gangrenosum (P = .003).

IN PRACTICE:

“Early identification of common dermatologic conditions in children and adolescents with IBD and recognizing their characteristic associations may alter management and improve skin-related outcomes in this patient population,” the authors wrote.

SOURCE:

Corresponding author Megha M. Tollefson, MD, of the Department of Dermatology at Mayo Clinic, Rochester, Minnesota, and colleagues conducted the research, which was published in Pediatric Dermatology.

LIMITATIONS:

The single-center design and the fact that database studies are subject to extraction error. There was no age- and sex-matched cohort to determine whether the prevalence of cutaneous infections, acne, eczema, and other inflammatory disorders was truly increased in IBD.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Skin conditions burden many children with inflammatory bowel disease (IBD), according to the authors of a single-center study.

METHODOLOGY:

• Little is known about the prevalence of IBD-associated skin lesions and their association with IBD severity in children ages 18 and younger.Researchers retrospectively reviewed the medical charts of 425 children and adolescents with  (CD) or ulcerative  (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
• Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
• They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.
• Researchers retrospectively reviewed the medical charts of 425 children and adolescents with Crohn’s disease (CD) or ulcerative colitis (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
• Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
• They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.

TAKEAWAY:

• The most common noninfectious dermatologic condition among the 425 children and adolescents was  (30.8%), followed by eczema (15.8%) and perianal skin tags (14.6%).
• Angular cheilitis was more common among those with CD than those with UC (7.2% vs 2%, respectively; P = .024) as was keratosis pilaris (6.9% vs 0.7%; P = .003), and perianal skin complications such as skin tags (20.3% vs 4%), fistulas (13.4% vs 2.7%), and abscesses (13.4% vs 2%; P < .001 for all associations).
• Fungal skin infections were more frequently diagnosed in children with UC than those with CD (15.4% vs 8%; P = .017).
• The researchers observed that the severity of IBD correlated with a higher prevalence of perianal fistula (P = .003), perianal region abscess (P = .041), psoriasis (P < .001), and pyoderma gangrenosum (P = .003).

IN PRACTICE:

“Early identification of common dermatologic conditions in children and adolescents with IBD and recognizing their characteristic associations may alter management and improve skin-related outcomes in this patient population,” the authors wrote.

SOURCE:

Corresponding author Megha M. Tollefson, MD, of the Department of Dermatology at Mayo Clinic, Rochester, Minnesota, and colleagues conducted the research, which was published in Pediatric Dermatology.

LIMITATIONS:

The single-center design and the fact that database studies are subject to extraction error. There was no age- and sex-matched cohort to determine whether the prevalence of cutaneous infections, acne, eczema, and other inflammatory disorders was truly increased in IBD.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

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

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

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

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

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

PHOENIX — Black women who develop high blood pressure before age 35 have a threefold increased risk of having a midlife stroke, new observational data suggest. The Black Women’s Health Study, which has followed 59,000 participants in the United States since 1990s, also showed that those who develop hypertension before age 45 have twice the risk of suffering a stroke.

“The really concerning thing about this data is the high proportion of young Black women who had high blood pressure and are suffering strokes relatively early in life,” said the study’s lead author, Hugo J. Aparicio, MD, associate professor of neurology at Boston University Chobanian & Avedisian School of Medicine, Boston. “This can lead to a burden of disability in relatively young women who may be at the prime of their life, pursuing careers, and looking after family.”

Dr. Aparicio presented the data at the International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.

He explained that while there has been good progress in reducing stroke rates in older people over the past decades, there is a concerning observation from multiple datasets showing that stroke rates in midlife have been plateauing or even increasing in recent years.

“For Black women specifically, there is a concern, as we know this group has higher rates of raised blood pressure and stroke overall,” said Dr. Aparicio. “We were interested in looking at whether the onset of hypertension at an earlier age in this group is one of the reasons for the increased stroke risk in midlife.”
 

A Large Study Cohort

The researchers analyzed data from the Black Women’s Health Study; the baseline year for this analysis, which included 46,754 stroke-free participants younger than age 65 (mean age, 42 years), was the 1999 questionnaire.

Both history of hypertension — defined as physician-diagnosed hypertension with the use of an antihypertensive medication — and stroke occurrence were determined by self-report. It has been shown in previous studies that these self-reported data on incidence of hypertension in this dataset are highly reliable, Dr. Aparicio noted.

At baseline, 10.5% of participants aged 45-64 years had hypertension. Stroke occurred in 3.2% of individuals over a mean follow-up of 17 years.

Black women with hypertension before age 45 had a higher risk for midlife stroke (hazard ratio [HR], 2.23; 95% confidence interval [CI], 1.79-2.78), after adjustment for age, neighborhood socioeconomic status, residence in the Stroke Belt, smoking, body mass index, and diabetes than women with no history of hypertension.

The risk was also increased with hypertension at midlife ages 45-64 years (HR, 1.69; 95% CI, 1.47-1.95) and was highest among those with hypertension at ages 24-34 years (HR, 3.15; 95% CI, 1.92-5.16).

“Our results show that among young Black women, those with hypertension have a much higher stroke risk than those without hypertension, even if they are taking antihypertensive medication,” Dr. Aparicio said. “This underscores how potent hypertension is as a risk factor for stroke.”

He concluded that both individuals and doctors need to realize that hypertension and stroke are not problems of the elderly exclusively.

“These are conditions that need to be addressed very early in life. This is even more important for Black women, as they are a high-risk group. They need to pay attention to blood pressure numbers early in life — ideally from adolescence — to catch levels before they become too elevated,” Dr. Aparicio said.

“We also need to address lifestyle changes including diet, physical activity, sleep habits, and address other cardiovascular risk factors such as cholesterol and body mass index, so we can prevent strokes from occurring,” he added. “At the policy level, we need to advocate, provide and fund primary prevention measures, and enable earlier screening and better treatment.”
 

The Role of Psychosocial Stressors

Commenting on the study, the American Heart Association immediate past president, Michelle A. Albert, MD, professor of medicine at the University of California, San Francisco, emphasized the importance of regular primary care appointments to screen for high blood pressure and other cardiovascular risk factors.

She pointed out that one of the contributing factors that may increase the risk for Black women is their disproportionate experience of psychosocial stressors and chronic cumulative stress.

This could include stress related to financial issues, racism and other forms of bias, the neighborhood environment, and having to take care of multiple generations of family with limited resources.

“These are some of the things that are less talked about as going into the heightened risk for many cardiovascular risk factors, including hypertension, very early in life for Black women that we need to bring to the forefront of conversations,” Dr. Albert said.

“These stressors not only impact hypertension onset but also they impact one’s ability to be able to seek help, and once the help is sought, to be able to sustain the therapies recommended and the interventions recommended,” she added.

The authors reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

PHOENIX — Black women who develop high blood pressure before age 35 have a threefold increased risk of having a midlife stroke, new observational data suggest. The Black Women’s Health Study, which has followed 59,000 participants in the United States since 1990s, also showed that those who develop hypertension before age 45 have twice the risk of suffering a stroke.

“The really concerning thing about this data is the high proportion of young Black women who had high blood pressure and are suffering strokes relatively early in life,” said the study’s lead author, Hugo J. Aparicio, MD, associate professor of neurology at Boston University Chobanian & Avedisian School of Medicine, Boston. “This can lead to a burden of disability in relatively young women who may be at the prime of their life, pursuing careers, and looking after family.”

Dr. Aparicio presented the data at the International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.

He explained that while there has been good progress in reducing stroke rates in older people over the past decades, there is a concerning observation from multiple datasets showing that stroke rates in midlife have been plateauing or even increasing in recent years.

“For Black women specifically, there is a concern, as we know this group has higher rates of raised blood pressure and stroke overall,” said Dr. Aparicio. “We were interested in looking at whether the onset of hypertension at an earlier age in this group is one of the reasons for the increased stroke risk in midlife.”
 

A Large Study Cohort

The researchers analyzed data from the Black Women’s Health Study; the baseline year for this analysis, which included 46,754 stroke-free participants younger than age 65 (mean age, 42 years), was the 1999 questionnaire.

Both history of hypertension — defined as physician-diagnosed hypertension with the use of an antihypertensive medication — and stroke occurrence were determined by self-report. It has been shown in previous studies that these self-reported data on incidence of hypertension in this dataset are highly reliable, Dr. Aparicio noted.

At baseline, 10.5% of participants aged 45-64 years had hypertension. Stroke occurred in 3.2% of individuals over a mean follow-up of 17 years.

Black women with hypertension before age 45 had a higher risk for midlife stroke (hazard ratio [HR], 2.23; 95% confidence interval [CI], 1.79-2.78), after adjustment for age, neighborhood socioeconomic status, residence in the Stroke Belt, smoking, body mass index, and diabetes than women with no history of hypertension.

The risk was also increased with hypertension at midlife ages 45-64 years (HR, 1.69; 95% CI, 1.47-1.95) and was highest among those with hypertension at ages 24-34 years (HR, 3.15; 95% CI, 1.92-5.16).

“Our results show that among young Black women, those with hypertension have a much higher stroke risk than those without hypertension, even if they are taking antihypertensive medication,” Dr. Aparicio said. “This underscores how potent hypertension is as a risk factor for stroke.”

He concluded that both individuals and doctors need to realize that hypertension and stroke are not problems of the elderly exclusively.

“These are conditions that need to be addressed very early in life. This is even more important for Black women, as they are a high-risk group. They need to pay attention to blood pressure numbers early in life — ideally from adolescence — to catch levels before they become too elevated,” Dr. Aparicio said.

“We also need to address lifestyle changes including diet, physical activity, sleep habits, and address other cardiovascular risk factors such as cholesterol and body mass index, so we can prevent strokes from occurring,” he added. “At the policy level, we need to advocate, provide and fund primary prevention measures, and enable earlier screening and better treatment.”
 

The Role of Psychosocial Stressors

Commenting on the study, the American Heart Association immediate past president, Michelle A. Albert, MD, professor of medicine at the University of California, San Francisco, emphasized the importance of regular primary care appointments to screen for high blood pressure and other cardiovascular risk factors.

She pointed out that one of the contributing factors that may increase the risk for Black women is their disproportionate experience of psychosocial stressors and chronic cumulative stress.

This could include stress related to financial issues, racism and other forms of bias, the neighborhood environment, and having to take care of multiple generations of family with limited resources.

“These are some of the things that are less talked about as going into the heightened risk for many cardiovascular risk factors, including hypertension, very early in life for Black women that we need to bring to the forefront of conversations,” Dr. Albert said.

“These stressors not only impact hypertension onset but also they impact one’s ability to be able to seek help, and once the help is sought, to be able to sustain the therapies recommended and the interventions recommended,” she added.

The authors reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

PHOENIX — Black women who develop high blood pressure before age 35 have a threefold increased risk of having a midlife stroke, new observational data suggest. The Black Women’s Health Study, which has followed 59,000 participants in the United States since 1990s, also showed that those who develop hypertension before age 45 have twice the risk of suffering a stroke.

“The really concerning thing about this data is the high proportion of young Black women who had high blood pressure and are suffering strokes relatively early in life,” said the study’s lead author, Hugo J. Aparicio, MD, associate professor of neurology at Boston University Chobanian & Avedisian School of Medicine, Boston. “This can lead to a burden of disability in relatively young women who may be at the prime of their life, pursuing careers, and looking after family.”

Dr. Aparicio presented the data at the International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.

He explained that while there has been good progress in reducing stroke rates in older people over the past decades, there is a concerning observation from multiple datasets showing that stroke rates in midlife have been plateauing or even increasing in recent years.

“For Black women specifically, there is a concern, as we know this group has higher rates of raised blood pressure and stroke overall,” said Dr. Aparicio. “We were interested in looking at whether the onset of hypertension at an earlier age in this group is one of the reasons for the increased stroke risk in midlife.”
 

A Large Study Cohort

The researchers analyzed data from the Black Women’s Health Study; the baseline year for this analysis, which included 46,754 stroke-free participants younger than age 65 (mean age, 42 years), was the 1999 questionnaire.

Both history of hypertension — defined as physician-diagnosed hypertension with the use of an antihypertensive medication — and stroke occurrence were determined by self-report. It has been shown in previous studies that these self-reported data on incidence of hypertension in this dataset are highly reliable, Dr. Aparicio noted.

At baseline, 10.5% of participants aged 45-64 years had hypertension. Stroke occurred in 3.2% of individuals over a mean follow-up of 17 years.

Black women with hypertension before age 45 had a higher risk for midlife stroke (hazard ratio [HR], 2.23; 95% confidence interval [CI], 1.79-2.78), after adjustment for age, neighborhood socioeconomic status, residence in the Stroke Belt, smoking, body mass index, and diabetes than women with no history of hypertension.

The risk was also increased with hypertension at midlife ages 45-64 years (HR, 1.69; 95% CI, 1.47-1.95) and was highest among those with hypertension at ages 24-34 years (HR, 3.15; 95% CI, 1.92-5.16).

“Our results show that among young Black women, those with hypertension have a much higher stroke risk than those without hypertension, even if they are taking antihypertensive medication,” Dr. Aparicio said. “This underscores how potent hypertension is as a risk factor for stroke.”

He concluded that both individuals and doctors need to realize that hypertension and stroke are not problems of the elderly exclusively.

“These are conditions that need to be addressed very early in life. This is even more important for Black women, as they are a high-risk group. They need to pay attention to blood pressure numbers early in life — ideally from adolescence — to catch levels before they become too elevated,” Dr. Aparicio said.

“We also need to address lifestyle changes including diet, physical activity, sleep habits, and address other cardiovascular risk factors such as cholesterol and body mass index, so we can prevent strokes from occurring,” he added. “At the policy level, we need to advocate, provide and fund primary prevention measures, and enable earlier screening and better treatment.”
 

The Role of Psychosocial Stressors

Commenting on the study, the American Heart Association immediate past president, Michelle A. Albert, MD, professor of medicine at the University of California, San Francisco, emphasized the importance of regular primary care appointments to screen for high blood pressure and other cardiovascular risk factors.

She pointed out that one of the contributing factors that may increase the risk for Black women is their disproportionate experience of psychosocial stressors and chronic cumulative stress.

This could include stress related to financial issues, racism and other forms of bias, the neighborhood environment, and having to take care of multiple generations of family with limited resources.

“These are some of the things that are less talked about as going into the heightened risk for many cardiovascular risk factors, including hypertension, very early in life for Black women that we need to bring to the forefront of conversations,” Dr. Albert said.

“These stressors not only impact hypertension onset but also they impact one’s ability to be able to seek help, and once the help is sought, to be able to sustain the therapies recommended and the interventions recommended,” she added.

The authors reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

In 2013, a prostate-specific antigen (PSA) blood test revealed that Richard LaFrate’s levels had jumped. 

Previously in a normal range, his PSA was now above 6 ng/mL, indicating an elevated likelihood for prostate cancer. The jazz guitarist from Leesburg, Florida, then 70 years old, underwent a biopsy, which found two Gleason 6 lesions. 

Mr. LaFrate had low-risk prostate cancer.

Guidelines now recommend active surveillance for patients like Mr. LaFrate, who have low-risk disease. This strategy would mean monitoring the cancer until LaFrate required treatment, with the upside being he might never need therapy.

Mr. LaFrate’s urologist, however, was pushing whole gland surgery — an invasive and unnecessary procedure given his diagnosis and age. 

Mr. LaFrate decided to look for another doctor. He filled out a form online that pointed him to a new urologist who offered him one option: An investigational procedure known as high-intensity focused ultrasound.

At the time, high-intensity focused ultrasound — a form of focal therapy — was being studied in the United States to treat men with low or intermediate-risk prostate cancer, but it was still relatively early days.

Mr. LaFrate’s urologist asked him to pay $25,000 out of pocket to undergo the focal procedure at a clinic in the Bahamas. He refused and, ultimately, landed on active surveillance as the best strategy to manage for his low-risk disease.

That urologist was “a shyster in my opinion,” Mr. LaFrate said. 

Over the past 10 years, the popularity of focal therapy has grown among men with intermediate-risk prostate cancer — Gleason 3+4 (grade group 2) tumors — as an alternative to invasive surgery and active surveillance. Prestigious medical centers, such as Cleveland Clinic, Mayo Clinic, Memorial Sloan Kettering, UCLA, and the University of Chicago, routinely offer focal therapy. 

But use of the techniques remains controversial and costly.

As the Cleveland Clinic’s website acknowledges, although “the use of focal therapy for localized prostate cancer appears to be a promising development in a number of ways, it is still considered investigational and not yet part of standard therapy.” Major caveats to focal therapy include unknown long-term effectiveness, the possibility of leaving behind untreated cancer, and higher overall costs. 

No major national guidelines endorse the use of focal therapy, unless offered in a research or clinical trial setting. Insurance companies, such as Aetna, Blue Cross Blue Shield, and United, also consider focal therapy for prostate cancer investigational and don’t cover it.

Without a stamp of approval from guideline bodies and insurance companies, patients, like Mr. LaFrate, remain vulnerable to the high out-of-pocket costs for these focal techniques. 

“Almost every place charges $15,000-$30,000 in cash,” said Daniel Spratt, MD, radiation oncology chair at University Hospitals Seidman Cancer Center and Case Western Reserve University in Cleveland. 

Dr. Spratt has seen hundreds of patients after focal therapy, some from prominent centers, who have emptied their bank accounts to undergo treatment with the promise of great results and ultimately felt misled when the cancer has recurred.

“It pains me that there are doctors willing to ignore the Hippocratic oath of ‘Do No Harm’ simply to jump on this fad to bring in revenue,” Dr. Spratt said. 
 

Evidence-Based or Oversold?

Focal therapy gained a foothold in the United Kingdom well before the United States.

Hashim Ahmed, FRCS, urology chair at Imperial College London, has used focal therapy for 15 years, treated over 1000 patients, and taught dozens of surgeons how to use the leading focal therapies — focal cryoablation, in which surgeons use a needle-thin probe to target, freeze, and kill prostate tumors, as well as high-intensity focused ultrasound, which uses sound wave energy to superheat and kill tumors.

“Certainly, in the United Kingdom, focal therapy has been prime time in a number of centers for a number of years,” Dr. Ahmed said. 

In the United States, focal therapy has become an attractive option for men with prostate cancer who want to avoid radiation or radical prostatectomy but don’t feel comfortable simply monitoring their disease with active surveillance. Experts from specialized focal therapy centers touting the promise of this “innovative technique” predict its routine use in the next few years.

But the excitement surrounding the use of focal therapy in prostate cancer has outpaced broader acceptance.

In 2015, the FDA approved high-intensity focused ultrasound to treat prostatic disease, but not prostate cancer specifically. Although the approval language “means that companies cannot advertise that their devices can be used for prostate cancer,” physicians can still determine how to use the technology, which includes treating prostate cancer, Dr. Ahmed said. 

The evidence is starting to catch up to the demand. The latest research suggests that the partial-gland techniques may stand up well to radical prostatectomy.

A 2022 prospective database study comparing radical prostatectomies to focal therapy — mostly high-intensity focused ultrasound — in more than 800 men found similar rates of failure-free survival in the two groups at the 8-year follow-up. A 2019 registry study found that failure-free survival at 3 years was just over 90% in high and intermediate-risk patients receiving focal cryotherapy, with the rate rising to about 93% for the intermediate-risk group. And a 2018 prospective study of 625 patients with intermediate or high-risk prostate cancer who underwent high-intensity focused ultrasound had 5-year metastasis-free survival of 98% and overall survival rates of 100%.

One of the biggest draws of focal therapy vs more aggressive treatments is the “massive differences in side-effect profiles,” said Dr. Ahmed.

In a 2021 meta-analysis, researchers found that 6 months after high-intensity focused ultrasound, 98% of patients remained continent and 80% retained erectile function, while erectile dysfunction can occur in 30% to as many as 85% of patients following prostatectomy or radiotherapy and urinary incontinence can occur in as many as 40% of patients.

Despite these potential advantages of focal therapy, the long-term efficacy of the techniques remains uncertain.

A recent study from a team at MSK, for instance, reported that 40% of men with intermediate (grade 2) or high-risk (grade 3) disease had residual cancer following MRI-guided focused ultrasound. A 2020 prospective registry study found that almost 20% of patients undergoing high-intensity focal ultrasound required a second round following a recurrence. 

Dr. Spratt worries that patients who recur after focal therapy may go on to receive a second round — often offered at half price — and will still ultimately need surgery or radiation therapy later. By that point, however, patients may have spent as much as $45,000 — ie, $30,000 on the initial and another $15,000 on the follow-up procedure.

When patients see Dr. Spratt after a recurrence, he informs them that their side effects will be worse if he gives them radiation or surgery now vs if he had given them curative therapy upfront. “But this is what we’re left with,” he tells them.

Another big concern in the field is “the quality of data for focal therapy is overwhelmingly poor,” said Jonathan Shoag, MD, a urologic oncologist at University Hospitals and an associate professor of urology at Case Western Reserve University School of Medicine in Cleveland. “Essentially, the bulk of the data is from single-institution retrospective series without defined follow-up protocols or endpoints.”

The American Urological Association (AUA) has even cautioned experts and patients about the lack of high-quality data comparing focal therapy techniques to radiation therapy, surgery, and active surveillance. According to the AUA, focal options should only be considered in intermediate-risk prostate cancer in a clinical trial setting.

“The lack of randomized clinical trials poses a major stumbling block for the field,” said Dr. Ahmed.

Although randomized trials would be ideal, the results would take many years to mature, and growing patient demand for these less invasive focal procedures has made randomized trials difficult to complete, explained Arvin George, MD, associate professor at Johns Hopkins School of Medicine in Baltimore. Several randomized trials attempted in Norway and the United Kingdom, for instance, fell apart when patients refused to be randomized between focal and radical therapy, Dr. George said.

Focal therapy is now in the same position that active surveillance was a few years ago, according to Dr. George.

“We are hearing the same concerns about focal therapy now as we did about active surveillance,” he said. The initial evidence supporting active surveillance largely came from real-world experience and retrospective studies. The randomized data came later, and skeptics of active surveillance “were proven wrong,” he added.

But Dr. Shoag has a different take on the trajectory of focal therapy research and care in the United States. 

“I think there’s this emerging kind of tragedy happening in our field now, where you have even academic institutions offering focal therapy to patients off-trial with essentially no data to suggest it is oncologically effective,” Dr. Shoag said.

William Catalona, MD, Northwestern University Feinberg School of Medicine, Chicago, agreed, noting that too many low-risk patients are undergoing focal treatment who should be on active surveillance. “Many men are attracted to focal because they just are uncomfortable having a cancer in their body that’s not treated,” Dr. Catalona said. But “giving these patients focal therapy is really overtreatment.”

Patients with higher-risk disease who want to avoid aggressive treatment are also being lured into focal without guidelines or clear evidence to back up that option, Dr. Catalona explained.

Although it’s not clear how many men in the United States are receiving focal therapy who shouldn’t, even proponents of focal therapy, like George, have expressed concern.

Dr. George agreed that focal therapy marketing geared towards patients is drawing in some men who are not good candidates for these techniques, and feels there’s not enough objective material from medical societies or academic centers giving patients a realistic picture of focal therapy. 

“There is concern that patients may be receiving biased information,” Dr. George said, adding that it’s ultimately up to the physician to reconcile the best available evidence, understand the outcomes, and discuss these options with the patient to guide them to what’s best.

At the end of the day, Dr. Spratt said, physicians giving focal therapy off a clinical trial need to pause and ask themselves “why are they giving a treatment that remains investigational by payers, not recommended by any major guideline, and that lacks any randomized evidence?” 

Mr. LaFrate does not regret his decision to forgo focal therapy in 2013. He has been on active surveillance for about a decade now.

Following an MRI in 2022, Mr. LaFrate’s radiology report found that “clinically significant cancer is very unlikely to be present.”

Still, his PSA has risen two points in the past year to 14. His current urologist feels that the PSA is going up because there’s cancer present and is suggesting focal therapy for Mr. LaFrate.

Mr. LaFrate, who has prostate enlargement issues, remains skeptical of focal therapy and is still resisting the sales pitch.

“My doctor is not aggressively pushing it. He’s just giving me that as one of my options,” he said. “I just have a hunch I don’t need it at this point.”

A version of this article appeared on Medscape.com.

In 2013, a prostate-specific antigen (PSA) blood test revealed that Richard LaFrate’s levels had jumped. 

Previously in a normal range, his PSA was now above 6 ng/mL, indicating an elevated likelihood for prostate cancer. The jazz guitarist from Leesburg, Florida, then 70 years old, underwent a biopsy, which found two Gleason 6 lesions. 

Mr. LaFrate had low-risk prostate cancer.

Guidelines now recommend active surveillance for patients like Mr. LaFrate, who have low-risk disease. This strategy would mean monitoring the cancer until LaFrate required treatment, with the upside being he might never need therapy.

Mr. LaFrate’s urologist, however, was pushing whole gland surgery — an invasive and unnecessary procedure given his diagnosis and age. 

Mr. LaFrate decided to look for another doctor. He filled out a form online that pointed him to a new urologist who offered him one option: An investigational procedure known as high-intensity focused ultrasound.

At the time, high-intensity focused ultrasound — a form of focal therapy — was being studied in the United States to treat men with low or intermediate-risk prostate cancer, but it was still relatively early days.

Mr. LaFrate’s urologist asked him to pay $25,000 out of pocket to undergo the focal procedure at a clinic in the Bahamas. He refused and, ultimately, landed on active surveillance as the best strategy to manage for his low-risk disease.

That urologist was “a shyster in my opinion,” Mr. LaFrate said. 

Over the past 10 years, the popularity of focal therapy has grown among men with intermediate-risk prostate cancer — Gleason 3+4 (grade group 2) tumors — as an alternative to invasive surgery and active surveillance. Prestigious medical centers, such as Cleveland Clinic, Mayo Clinic, Memorial Sloan Kettering, UCLA, and the University of Chicago, routinely offer focal therapy. 

But use of the techniques remains controversial and costly.

As the Cleveland Clinic’s website acknowledges, although “the use of focal therapy for localized prostate cancer appears to be a promising development in a number of ways, it is still considered investigational and not yet part of standard therapy.” Major caveats to focal therapy include unknown long-term effectiveness, the possibility of leaving behind untreated cancer, and higher overall costs. 

No major national guidelines endorse the use of focal therapy, unless offered in a research or clinical trial setting. Insurance companies, such as Aetna, Blue Cross Blue Shield, and United, also consider focal therapy for prostate cancer investigational and don’t cover it.

Without a stamp of approval from guideline bodies and insurance companies, patients, like Mr. LaFrate, remain vulnerable to the high out-of-pocket costs for these focal techniques. 

“Almost every place charges $15,000-$30,000 in cash,” said Daniel Spratt, MD, radiation oncology chair at University Hospitals Seidman Cancer Center and Case Western Reserve University in Cleveland. 

Dr. Spratt has seen hundreds of patients after focal therapy, some from prominent centers, who have emptied their bank accounts to undergo treatment with the promise of great results and ultimately felt misled when the cancer has recurred.

“It pains me that there are doctors willing to ignore the Hippocratic oath of ‘Do No Harm’ simply to jump on this fad to bring in revenue,” Dr. Spratt said. 
 

Evidence-Based or Oversold?

Focal therapy gained a foothold in the United Kingdom well before the United States.

Hashim Ahmed, FRCS, urology chair at Imperial College London, has used focal therapy for 15 years, treated over 1000 patients, and taught dozens of surgeons how to use the leading focal therapies — focal cryoablation, in which surgeons use a needle-thin probe to target, freeze, and kill prostate tumors, as well as high-intensity focused ultrasound, which uses sound wave energy to superheat and kill tumors.

“Certainly, in the United Kingdom, focal therapy has been prime time in a number of centers for a number of years,” Dr. Ahmed said. 

In the United States, focal therapy has become an attractive option for men with prostate cancer who want to avoid radiation or radical prostatectomy but don’t feel comfortable simply monitoring their disease with active surveillance. Experts from specialized focal therapy centers touting the promise of this “innovative technique” predict its routine use in the next few years.

But the excitement surrounding the use of focal therapy in prostate cancer has outpaced broader acceptance.

In 2015, the FDA approved high-intensity focused ultrasound to treat prostatic disease, but not prostate cancer specifically. Although the approval language “means that companies cannot advertise that their devices can be used for prostate cancer,” physicians can still determine how to use the technology, which includes treating prostate cancer, Dr. Ahmed said. 

The evidence is starting to catch up to the demand. The latest research suggests that the partial-gland techniques may stand up well to radical prostatectomy.

A 2022 prospective database study comparing radical prostatectomies to focal therapy — mostly high-intensity focused ultrasound — in more than 800 men found similar rates of failure-free survival in the two groups at the 8-year follow-up. A 2019 registry study found that failure-free survival at 3 years was just over 90% in high and intermediate-risk patients receiving focal cryotherapy, with the rate rising to about 93% for the intermediate-risk group. And a 2018 prospective study of 625 patients with intermediate or high-risk prostate cancer who underwent high-intensity focused ultrasound had 5-year metastasis-free survival of 98% and overall survival rates of 100%.

One of the biggest draws of focal therapy vs more aggressive treatments is the “massive differences in side-effect profiles,” said Dr. Ahmed.

In a 2021 meta-analysis, researchers found that 6 months after high-intensity focused ultrasound, 98% of patients remained continent and 80% retained erectile function, while erectile dysfunction can occur in 30% to as many as 85% of patients following prostatectomy or radiotherapy and urinary incontinence can occur in as many as 40% of patients.

Despite these potential advantages of focal therapy, the long-term efficacy of the techniques remains uncertain.

A recent study from a team at MSK, for instance, reported that 40% of men with intermediate (grade 2) or high-risk (grade 3) disease had residual cancer following MRI-guided focused ultrasound. A 2020 prospective registry study found that almost 20% of patients undergoing high-intensity focal ultrasound required a second round following a recurrence. 

Dr. Spratt worries that patients who recur after focal therapy may go on to receive a second round — often offered at half price — and will still ultimately need surgery or radiation therapy later. By that point, however, patients may have spent as much as $45,000 — ie, $30,000 on the initial and another $15,000 on the follow-up procedure.

When patients see Dr. Spratt after a recurrence, he informs them that their side effects will be worse if he gives them radiation or surgery now vs if he had given them curative therapy upfront. “But this is what we’re left with,” he tells them.

Another big concern in the field is “the quality of data for focal therapy is overwhelmingly poor,” said Jonathan Shoag, MD, a urologic oncologist at University Hospitals and an associate professor of urology at Case Western Reserve University School of Medicine in Cleveland. “Essentially, the bulk of the data is from single-institution retrospective series without defined follow-up protocols or endpoints.”

The American Urological Association (AUA) has even cautioned experts and patients about the lack of high-quality data comparing focal therapy techniques to radiation therapy, surgery, and active surveillance. According to the AUA, focal options should only be considered in intermediate-risk prostate cancer in a clinical trial setting.

“The lack of randomized clinical trials poses a major stumbling block for the field,” said Dr. Ahmed.

Although randomized trials would be ideal, the results would take many years to mature, and growing patient demand for these less invasive focal procedures has made randomized trials difficult to complete, explained Arvin George, MD, associate professor at Johns Hopkins School of Medicine in Baltimore. Several randomized trials attempted in Norway and the United Kingdom, for instance, fell apart when patients refused to be randomized between focal and radical therapy, Dr. George said.

Focal therapy is now in the same position that active surveillance was a few years ago, according to Dr. George.

“We are hearing the same concerns about focal therapy now as we did about active surveillance,” he said. The initial evidence supporting active surveillance largely came from real-world experience and retrospective studies. The randomized data came later, and skeptics of active surveillance “were proven wrong,” he added.

But Dr. Shoag has a different take on the trajectory of focal therapy research and care in the United States. 

“I think there’s this emerging kind of tragedy happening in our field now, where you have even academic institutions offering focal therapy to patients off-trial with essentially no data to suggest it is oncologically effective,” Dr. Shoag said.

William Catalona, MD, Northwestern University Feinberg School of Medicine, Chicago, agreed, noting that too many low-risk patients are undergoing focal treatment who should be on active surveillance. “Many men are attracted to focal because they just are uncomfortable having a cancer in their body that’s not treated,” Dr. Catalona said. But “giving these patients focal therapy is really overtreatment.”

Patients with higher-risk disease who want to avoid aggressive treatment are also being lured into focal without guidelines or clear evidence to back up that option, Dr. Catalona explained.

Although it’s not clear how many men in the United States are receiving focal therapy who shouldn’t, even proponents of focal therapy, like George, have expressed concern.

Dr. George agreed that focal therapy marketing geared towards patients is drawing in some men who are not good candidates for these techniques, and feels there’s not enough objective material from medical societies or academic centers giving patients a realistic picture of focal therapy. 

“There is concern that patients may be receiving biased information,” Dr. George said, adding that it’s ultimately up to the physician to reconcile the best available evidence, understand the outcomes, and discuss these options with the patient to guide them to what’s best.

At the end of the day, Dr. Spratt said, physicians giving focal therapy off a clinical trial need to pause and ask themselves “why are they giving a treatment that remains investigational by payers, not recommended by any major guideline, and that lacks any randomized evidence?” 

Mr. LaFrate does not regret his decision to forgo focal therapy in 2013. He has been on active surveillance for about a decade now.

Following an MRI in 2022, Mr. LaFrate’s radiology report found that “clinically significant cancer is very unlikely to be present.”

Still, his PSA has risen two points in the past year to 14. His current urologist feels that the PSA is going up because there’s cancer present and is suggesting focal therapy for Mr. LaFrate.

Mr. LaFrate, who has prostate enlargement issues, remains skeptical of focal therapy and is still resisting the sales pitch.

“My doctor is not aggressively pushing it. He’s just giving me that as one of my options,” he said. “I just have a hunch I don’t need it at this point.”

A version of this article appeared on Medscape.com.

In 2013, a prostate-specific antigen (PSA) blood test revealed that Richard LaFrate’s levels had jumped. 

Previously in a normal range, his PSA was now above 6 ng/mL, indicating an elevated likelihood for prostate cancer. The jazz guitarist from Leesburg, Florida, then 70 years old, underwent a biopsy, which found two Gleason 6 lesions. 

Mr. LaFrate had low-risk prostate cancer.

Guidelines now recommend active surveillance for patients like Mr. LaFrate, who have low-risk disease. This strategy would mean monitoring the cancer until LaFrate required treatment, with the upside being he might never need therapy.

Mr. LaFrate’s urologist, however, was pushing whole gland surgery — an invasive and unnecessary procedure given his diagnosis and age. 

Mr. LaFrate decided to look for another doctor. He filled out a form online that pointed him to a new urologist who offered him one option: An investigational procedure known as high-intensity focused ultrasound.

At the time, high-intensity focused ultrasound — a form of focal therapy — was being studied in the United States to treat men with low or intermediate-risk prostate cancer, but it was still relatively early days.

Mr. LaFrate’s urologist asked him to pay $25,000 out of pocket to undergo the focal procedure at a clinic in the Bahamas. He refused and, ultimately, landed on active surveillance as the best strategy to manage for his low-risk disease.

That urologist was “a shyster in my opinion,” Mr. LaFrate said. 

Over the past 10 years, the popularity of focal therapy has grown among men with intermediate-risk prostate cancer — Gleason 3+4 (grade group 2) tumors — as an alternative to invasive surgery and active surveillance. Prestigious medical centers, such as Cleveland Clinic, Mayo Clinic, Memorial Sloan Kettering, UCLA, and the University of Chicago, routinely offer focal therapy. 

But use of the techniques remains controversial and costly.

As the Cleveland Clinic’s website acknowledges, although “the use of focal therapy for localized prostate cancer appears to be a promising development in a number of ways, it is still considered investigational and not yet part of standard therapy.” Major caveats to focal therapy include unknown long-term effectiveness, the possibility of leaving behind untreated cancer, and higher overall costs. 

No major national guidelines endorse the use of focal therapy, unless offered in a research or clinical trial setting. Insurance companies, such as Aetna, Blue Cross Blue Shield, and United, also consider focal therapy for prostate cancer investigational and don’t cover it.

Without a stamp of approval from guideline bodies and insurance companies, patients, like Mr. LaFrate, remain vulnerable to the high out-of-pocket costs for these focal techniques. 

“Almost every place charges $15,000-$30,000 in cash,” said Daniel Spratt, MD, radiation oncology chair at University Hospitals Seidman Cancer Center and Case Western Reserve University in Cleveland. 

Dr. Spratt has seen hundreds of patients after focal therapy, some from prominent centers, who have emptied their bank accounts to undergo treatment with the promise of great results and ultimately felt misled when the cancer has recurred.

“It pains me that there are doctors willing to ignore the Hippocratic oath of ‘Do No Harm’ simply to jump on this fad to bring in revenue,” Dr. Spratt said. 
 

Evidence-Based or Oversold?

Focal therapy gained a foothold in the United Kingdom well before the United States.

Hashim Ahmed, FRCS, urology chair at Imperial College London, has used focal therapy for 15 years, treated over 1000 patients, and taught dozens of surgeons how to use the leading focal therapies — focal cryoablation, in which surgeons use a needle-thin probe to target, freeze, and kill prostate tumors, as well as high-intensity focused ultrasound, which uses sound wave energy to superheat and kill tumors.

“Certainly, in the United Kingdom, focal therapy has been prime time in a number of centers for a number of years,” Dr. Ahmed said. 

In the United States, focal therapy has become an attractive option for men with prostate cancer who want to avoid radiation or radical prostatectomy but don’t feel comfortable simply monitoring their disease with active surveillance. Experts from specialized focal therapy centers touting the promise of this “innovative technique” predict its routine use in the next few years.

But the excitement surrounding the use of focal therapy in prostate cancer has outpaced broader acceptance.

In 2015, the FDA approved high-intensity focused ultrasound to treat prostatic disease, but not prostate cancer specifically. Although the approval language “means that companies cannot advertise that their devices can be used for prostate cancer,” physicians can still determine how to use the technology, which includes treating prostate cancer, Dr. Ahmed said. 

The evidence is starting to catch up to the demand. The latest research suggests that the partial-gland techniques may stand up well to radical prostatectomy.

A 2022 prospective database study comparing radical prostatectomies to focal therapy — mostly high-intensity focused ultrasound — in more than 800 men found similar rates of failure-free survival in the two groups at the 8-year follow-up. A 2019 registry study found that failure-free survival at 3 years was just over 90% in high and intermediate-risk patients receiving focal cryotherapy, with the rate rising to about 93% for the intermediate-risk group. And a 2018 prospective study of 625 patients with intermediate or high-risk prostate cancer who underwent high-intensity focused ultrasound had 5-year metastasis-free survival of 98% and overall survival rates of 100%.

One of the biggest draws of focal therapy vs more aggressive treatments is the “massive differences in side-effect profiles,” said Dr. Ahmed.

In a 2021 meta-analysis, researchers found that 6 months after high-intensity focused ultrasound, 98% of patients remained continent and 80% retained erectile function, while erectile dysfunction can occur in 30% to as many as 85% of patients following prostatectomy or radiotherapy and urinary incontinence can occur in as many as 40% of patients.

Despite these potential advantages of focal therapy, the long-term efficacy of the techniques remains uncertain.

A recent study from a team at MSK, for instance, reported that 40% of men with intermediate (grade 2) or high-risk (grade 3) disease had residual cancer following MRI-guided focused ultrasound. A 2020 prospective registry study found that almost 20% of patients undergoing high-intensity focal ultrasound required a second round following a recurrence. 

Dr. Spratt worries that patients who recur after focal therapy may go on to receive a second round — often offered at half price — and will still ultimately need surgery or radiation therapy later. By that point, however, patients may have spent as much as $45,000 — ie, $30,000 on the initial and another $15,000 on the follow-up procedure.

When patients see Dr. Spratt after a recurrence, he informs them that their side effects will be worse if he gives them radiation or surgery now vs if he had given them curative therapy upfront. “But this is what we’re left with,” he tells them.

Another big concern in the field is “the quality of data for focal therapy is overwhelmingly poor,” said Jonathan Shoag, MD, a urologic oncologist at University Hospitals and an associate professor of urology at Case Western Reserve University School of Medicine in Cleveland. “Essentially, the bulk of the data is from single-institution retrospective series without defined follow-up protocols or endpoints.”

The American Urological Association (AUA) has even cautioned experts and patients about the lack of high-quality data comparing focal therapy techniques to radiation therapy, surgery, and active surveillance. According to the AUA, focal options should only be considered in intermediate-risk prostate cancer in a clinical trial setting.

“The lack of randomized clinical trials poses a major stumbling block for the field,” said Dr. Ahmed.

Although randomized trials would be ideal, the results would take many years to mature, and growing patient demand for these less invasive focal procedures has made randomized trials difficult to complete, explained Arvin George, MD, associate professor at Johns Hopkins School of Medicine in Baltimore. Several randomized trials attempted in Norway and the United Kingdom, for instance, fell apart when patients refused to be randomized between focal and radical therapy, Dr. George said.

Focal therapy is now in the same position that active surveillance was a few years ago, according to Dr. George.

“We are hearing the same concerns about focal therapy now as we did about active surveillance,” he said. The initial evidence supporting active surveillance largely came from real-world experience and retrospective studies. The randomized data came later, and skeptics of active surveillance “were proven wrong,” he added.

But Dr. Shoag has a different take on the trajectory of focal therapy research and care in the United States. 

“I think there’s this emerging kind of tragedy happening in our field now, where you have even academic institutions offering focal therapy to patients off-trial with essentially no data to suggest it is oncologically effective,” Dr. Shoag said.

William Catalona, MD, Northwestern University Feinberg School of Medicine, Chicago, agreed, noting that too many low-risk patients are undergoing focal treatment who should be on active surveillance. “Many men are attracted to focal because they just are uncomfortable having a cancer in their body that’s not treated,” Dr. Catalona said. But “giving these patients focal therapy is really overtreatment.”

Patients with higher-risk disease who want to avoid aggressive treatment are also being lured into focal without guidelines or clear evidence to back up that option, Dr. Catalona explained.

Although it’s not clear how many men in the United States are receiving focal therapy who shouldn’t, even proponents of focal therapy, like George, have expressed concern.

Dr. George agreed that focal therapy marketing geared towards patients is drawing in some men who are not good candidates for these techniques, and feels there’s not enough objective material from medical societies or academic centers giving patients a realistic picture of focal therapy. 

“There is concern that patients may be receiving biased information,” Dr. George said, adding that it’s ultimately up to the physician to reconcile the best available evidence, understand the outcomes, and discuss these options with the patient to guide them to what’s best.

At the end of the day, Dr. Spratt said, physicians giving focal therapy off a clinical trial need to pause and ask themselves “why are they giving a treatment that remains investigational by payers, not recommended by any major guideline, and that lacks any randomized evidence?” 

Mr. LaFrate does not regret his decision to forgo focal therapy in 2013. He has been on active surveillance for about a decade now.

Following an MRI in 2022, Mr. LaFrate’s radiology report found that “clinically significant cancer is very unlikely to be present.”

Still, his PSA has risen two points in the past year to 14. His current urologist feels that the PSA is going up because there’s cancer present and is suggesting focal therapy for Mr. LaFrate.

Mr. LaFrate, who has prostate enlargement issues, remains skeptical of focal therapy and is still resisting the sales pitch.

“My doctor is not aggressively pushing it. He’s just giving me that as one of my options,” he said. “I just have a hunch I don’t need it at this point.”

A version of this article appeared on Medscape.com.