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Little Less Talk and a Lot More Action

Article Type
Changed
Fri, 05/17/2024 - 13:50

No matter where one looks for the statistics, no matter what words one chooses to describe it, this country has a child and adolescent mental health crisis. Almost 20% of young people in the 3-17 age bracket have a mental, emotional, developmental, or behavioral disorder. COVID-19 has certainly exacerbated the problem, but the downward trend in the mental health of this nation has been going on for decades.

The voices calling for more services to address the problem are getting more numerous and louder. But, what exactly should those services look like and who should be delivering them?

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff


When considered together, two recent research papers suggest that we should be venturing well beyond the usual mental health strategies if we are going to be successful in addressing the current crisis.

The first paper is an analysis by two psychologists who contend that our efforts to raise the awareness of mental issues may be contributing to the increase in reported mental health problems. The authors agree that more attention paid to mental health conditions can result in “more accurate reporting of previous under-recognized symptoms” and would seem to be a positive. However, the investigators also observe that when exposed to this flood of information, some individuals who are only experiencing minor distress may report their symptoms as mental problems. The authors of the paper have coined the term for this phenomenon as “prevalence inflation.” Their preliminary investigation suggests it may be much more common than once believed and they present numerous situations in which prevalence inflation seems to have occurred.

A New York Times article about this hypothesis reports on a British study in which nearly 30,000 teenagers were instructed by their teachers to “direct their attentions to the present moment” and utilize other mindfulness strategies. The educators had hoped that after 8 years of this indoctrination, the students’ mental health would have improved. The bottom line was that this mindfulness-based program was of no help and may have actually made things worse for a subgroup of students who were at greatest risk for mental health challenges.

Dr. Jack Andrews, one of the authors, feels that mindfulness training may encourage what he calls “co-rumination,” which he describes as “the kind of long, unresolved group discussion that churns up problems without finding solutions.” One has to wonder if “prevalence inflation” and “co-rumination,” if they do exist, may be playing a role in the hotly debated phenomenon some have termed “late-onset gender dysphoria.”

Never having been a fan of mindfulness training as an effective strategy, I am relieved to learn that serious investigators are finding evidence that supports my gut reaction.

If raising awareness, “education,” and group discussion aren’t working, and in some cases are actually contributing to the crisis, or at least making the data difficult to interpret, what should we be doing to turn this foundering ship around?

A second paper, coming from Taiwan, may provide an answer. Huey-Ling Chiang and fellow investigators have reported on a study of nearly two million children and adolescents in which they found improved performance in a variety of physical fitness challenges “was linked with a lower risk of mental health disorder.” The dose-dependent effect resulted in less anxiety and depressive disorders as well as less attention-deficit/hyperactivity disorder when cardio-respiratory, muscle endurance, and power indices improved.

There have been other observers who have suggested a link between physical fitness and improved mental health, but this Taiwanese study is by far one of the largest. And, the discovery of a dose-dependent effect makes it particularly convincing.

As I reviewed these two papers, I became increasingly frustrated because this is another example in which one of the answers is staring us in the face and we continue to do nothing more than talk about it.

We already know that physically active people are healthier both physically and mentally, but we do little more than talk. It may be helpful for some people to become a bit more self-aware. However, it is becoming increasingly clear that you can’t talk yourself into being mentally healthy without a concurrent effort to actually do the things that can improve your overall health, such as being physically active and adopting healthy sleep habits. A political advisor once said, “It’s the economy, stupid.” As a community interested in the health of our children and the adults they will become, we need to remind ourselves again, “It’s the old Mind-Body Thing, Stupid.” Our children need a little less talk and a lot more action.

 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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No matter where one looks for the statistics, no matter what words one chooses to describe it, this country has a child and adolescent mental health crisis. Almost 20% of young people in the 3-17 age bracket have a mental, emotional, developmental, or behavioral disorder. COVID-19 has certainly exacerbated the problem, but the downward trend in the mental health of this nation has been going on for decades.

The voices calling for more services to address the problem are getting more numerous and louder. But, what exactly should those services look like and who should be delivering them?

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff


When considered together, two recent research papers suggest that we should be venturing well beyond the usual mental health strategies if we are going to be successful in addressing the current crisis.

The first paper is an analysis by two psychologists who contend that our efforts to raise the awareness of mental issues may be contributing to the increase in reported mental health problems. The authors agree that more attention paid to mental health conditions can result in “more accurate reporting of previous under-recognized symptoms” and would seem to be a positive. However, the investigators also observe that when exposed to this flood of information, some individuals who are only experiencing minor distress may report their symptoms as mental problems. The authors of the paper have coined the term for this phenomenon as “prevalence inflation.” Their preliminary investigation suggests it may be much more common than once believed and they present numerous situations in which prevalence inflation seems to have occurred.

A New York Times article about this hypothesis reports on a British study in which nearly 30,000 teenagers were instructed by their teachers to “direct their attentions to the present moment” and utilize other mindfulness strategies. The educators had hoped that after 8 years of this indoctrination, the students’ mental health would have improved. The bottom line was that this mindfulness-based program was of no help and may have actually made things worse for a subgroup of students who were at greatest risk for mental health challenges.

Dr. Jack Andrews, one of the authors, feels that mindfulness training may encourage what he calls “co-rumination,” which he describes as “the kind of long, unresolved group discussion that churns up problems without finding solutions.” One has to wonder if “prevalence inflation” and “co-rumination,” if they do exist, may be playing a role in the hotly debated phenomenon some have termed “late-onset gender dysphoria.”

Never having been a fan of mindfulness training as an effective strategy, I am relieved to learn that serious investigators are finding evidence that supports my gut reaction.

If raising awareness, “education,” and group discussion aren’t working, and in some cases are actually contributing to the crisis, or at least making the data difficult to interpret, what should we be doing to turn this foundering ship around?

A second paper, coming from Taiwan, may provide an answer. Huey-Ling Chiang and fellow investigators have reported on a study of nearly two million children and adolescents in which they found improved performance in a variety of physical fitness challenges “was linked with a lower risk of mental health disorder.” The dose-dependent effect resulted in less anxiety and depressive disorders as well as less attention-deficit/hyperactivity disorder when cardio-respiratory, muscle endurance, and power indices improved.

There have been other observers who have suggested a link between physical fitness and improved mental health, but this Taiwanese study is by far one of the largest. And, the discovery of a dose-dependent effect makes it particularly convincing.

As I reviewed these two papers, I became increasingly frustrated because this is another example in which one of the answers is staring us in the face and we continue to do nothing more than talk about it.

We already know that physically active people are healthier both physically and mentally, but we do little more than talk. It may be helpful for some people to become a bit more self-aware. However, it is becoming increasingly clear that you can’t talk yourself into being mentally healthy without a concurrent effort to actually do the things that can improve your overall health, such as being physically active and adopting healthy sleep habits. A political advisor once said, “It’s the economy, stupid.” As a community interested in the health of our children and the adults they will become, we need to remind ourselves again, “It’s the old Mind-Body Thing, Stupid.” Our children need a little less talk and a lot more action.

 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

No matter where one looks for the statistics, no matter what words one chooses to describe it, this country has a child and adolescent mental health crisis. Almost 20% of young people in the 3-17 age bracket have a mental, emotional, developmental, or behavioral disorder. COVID-19 has certainly exacerbated the problem, but the downward trend in the mental health of this nation has been going on for decades.

The voices calling for more services to address the problem are getting more numerous and louder. But, what exactly should those services look like and who should be delivering them?

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff


When considered together, two recent research papers suggest that we should be venturing well beyond the usual mental health strategies if we are going to be successful in addressing the current crisis.

The first paper is an analysis by two psychologists who contend that our efforts to raise the awareness of mental issues may be contributing to the increase in reported mental health problems. The authors agree that more attention paid to mental health conditions can result in “more accurate reporting of previous under-recognized symptoms” and would seem to be a positive. However, the investigators also observe that when exposed to this flood of information, some individuals who are only experiencing minor distress may report their symptoms as mental problems. The authors of the paper have coined the term for this phenomenon as “prevalence inflation.” Their preliminary investigation suggests it may be much more common than once believed and they present numerous situations in which prevalence inflation seems to have occurred.

A New York Times article about this hypothesis reports on a British study in which nearly 30,000 teenagers were instructed by their teachers to “direct their attentions to the present moment” and utilize other mindfulness strategies. The educators had hoped that after 8 years of this indoctrination, the students’ mental health would have improved. The bottom line was that this mindfulness-based program was of no help and may have actually made things worse for a subgroup of students who were at greatest risk for mental health challenges.

Dr. Jack Andrews, one of the authors, feels that mindfulness training may encourage what he calls “co-rumination,” which he describes as “the kind of long, unresolved group discussion that churns up problems without finding solutions.” One has to wonder if “prevalence inflation” and “co-rumination,” if they do exist, may be playing a role in the hotly debated phenomenon some have termed “late-onset gender dysphoria.”

Never having been a fan of mindfulness training as an effective strategy, I am relieved to learn that serious investigators are finding evidence that supports my gut reaction.

If raising awareness, “education,” and group discussion aren’t working, and in some cases are actually contributing to the crisis, or at least making the data difficult to interpret, what should we be doing to turn this foundering ship around?

A second paper, coming from Taiwan, may provide an answer. Huey-Ling Chiang and fellow investigators have reported on a study of nearly two million children and adolescents in which they found improved performance in a variety of physical fitness challenges “was linked with a lower risk of mental health disorder.” The dose-dependent effect resulted in less anxiety and depressive disorders as well as less attention-deficit/hyperactivity disorder when cardio-respiratory, muscle endurance, and power indices improved.

There have been other observers who have suggested a link between physical fitness and improved mental health, but this Taiwanese study is by far one of the largest. And, the discovery of a dose-dependent effect makes it particularly convincing.

As I reviewed these two papers, I became increasingly frustrated because this is another example in which one of the answers is staring us in the face and we continue to do nothing more than talk about it.

We already know that physically active people are healthier both physically and mentally, but we do little more than talk. It may be helpful for some people to become a bit more self-aware. However, it is becoming increasingly clear that you can’t talk yourself into being mentally healthy without a concurrent effort to actually do the things that can improve your overall health, such as being physically active and adopting healthy sleep habits. A political advisor once said, “It’s the economy, stupid.” As a community interested in the health of our children and the adults they will become, we need to remind ourselves again, “It’s the old Mind-Body Thing, Stupid.” Our children need a little less talk and a lot more action.

 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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Specialists Are ‘Underwater’ With Some Insurance-Preferred Biosimilars

Article Type
Changed
Thu, 05/16/2024 - 16:02

 

Editor’s note: This article is adapted from an explanatory statement that Dr. Feldman wrote for the Coalition of State Rheumatology Organizations (CSRO).

According to the Guinness Book of World records, the longest time someone has held their breath underwater voluntarily is 24 minutes and 37.36 seconds. While certainly an amazing feat, UnitedHealthcare, many of the Blues, and other national “payers” are expecting rheumatologists and other specialists to live “underwater” in order to take care of their patients. In other words, these insurance companies are mandating that specialists use certain provider-administered biosimilars whose acquisition cost is higher than what the insurance company is willing to reimburse them. Essentially, the insurance companies expect the rheumatologists to pay them to take care of their patients. Because of the substantial and destabilizing financial losses incurred, many practices and free-standing infusion centers have been forced to cease offering these biosimilars. Most rheumatologists will provide patients with appropriate alternatives when available and permitted by the insurer; otherwise, they must refer patients to hospital-based infusion centers. That results in delayed care and increased costs for patients and the system, because hospital-based infusion typically costs more than twice what office-based infusion costs.

Quantifying the Problem

To help quantify the magnitude of this issue, the Coalition of State Rheumatology Organizations (CSRO) recently conducted a survey of its membership. A shocking 97% of respondents reported that their practice had been affected by reimbursement rates for some biosimilars being lower than acquisition costs, with 91% of respondents stating that this issue is more pronounced for certain biosimilars than others. Across the board, respondents most frequently identified Inflectra (infliximab-dyyb) and Avsola (infliximab-axxq) as being especially affected: Over 88% and over 85% of respondents identified these two products, respectively, as being underwater. These results support the ongoing anecdotal reports CSRO continues to receive from rheumatology practices.

Dr. Madelaine A. Feldman

However, the survey results indicated that this issue is by no means confined to those two biosimilars. Truxima (rituximab-abbs) — a biosimilar for Rituxan — was frequently mentioned as well. Notably, respondents almost uniformly identified biosimilars in the infliximab and rituximab families, which illustrates that this issue is no longer confined to one or two early-to-market biosimilars but has almost become a hallmark of this particular biosimilars market. Remarkably, one respondent commented that the brand products are now cheaper to acquire than the biosimilars. Furthermore, the survey included respondents from across the country, indicating that this issue is not confined to a particular region.
 

How Did This Happen?

Biosimilars held promise for increasing availability and decreasing biologic costs for patients but, thus far, no patients have seen their cost go down. It appears that the only biosimilars that have made it to “preferred” status on the formulary are the ones that have made more money for the middlemen in the drug supply chain, particularly those that construct formularies. Now, we have provider-administered biosimilars whose acquisition cost exceeds the reimbursement for these drugs. This disparity was ultimately created by biosimilar manufacturers “over-rebating” their drugs to health insurance companies to gain “fail-first” status on the formulary.

For example, the manufacturer of Inflectra offered substantial rebates to health insurers for preferred formulary placement. These rebates are factored into the sales price of the medication, which then results in a rapidly declining average sales price (ASP) for the biosimilar. Unfortunately, the acquisition cost for the drug does not experience commensurate reductions, resulting in physicians being reimbursed far less for the drug than it costs to acquire. The financial losses for physicians put them underwater as a result of the acquisition costs for the preferred drugs far surpassing the reimbursement from the health insurance company that constructed the formulary.

While various factors affect ASPs and acquisition costs, this particular consequence of formulary placement based on price concessions is a major driver of the underwater situation in which physicians have found themselves with many biosimilars. Not only does that lead to a lower uptake of biosimilars, but it also results in patients being referred to the hospital outpatient infusion sites to receive this care, as freestanding infusion centers cannot treat these patients either. Hospitals incur higher costs because of facility fees and elevated rates, and this makes private rheumatology in-office infusion centers a much lower-cost option. Similarly, home infusion services, while convenient, are marginally more expensive than private practices and, in cases of biologic infusions, it is important to note that physicians’ offices have a greater safety profile than home infusion of biologics. The overall result of these “fail-first underwater drugs” is delayed and more costly care for the patient and the “system,” particularly self-insured employers.
 

What Is Being Done to Correct This?

Since ASPs are updated quarterly, it is possible that acquisition costs and reimbursements might stabilize over time, making the drugs affordable again to practices. However, that does not appear to be happening in the near future, so that possibility does not offer immediate relief to struggling practices. It doesn’t promise a favorable outlook for future biosimilar entries of provider-administered medications if formularies continue to prefer the highest-rebated medication.

This dynamic between ASP and acquisition cost does not happen on the pharmacy side because the price concessions on specific drug rebates and fees are proprietary. There appears to be no equivalent to a publicly known ASP on the pharmacy side, which has led to myriad pricing definitions and manipulation on the pharmacy benefit side of medications. In any event, the savings from rebates and other manufacturer price concessions on pharmacy drugs do not influence ASPs of medical benefit drugs.

The Inflation Reduction Act provided a temporary increase in the add-on payment for biosimilars from ASP+6% to ASP+8%, but as long as the biosimilar’s ASP is lower than the reference brand’s ASP, that temporary increase does not appear to make up for the large differential between ASP and acquisition cost. It should be noted that any federal attempt to artificially lower the ASP of a provider-administered drug without a pathway assuring that the acquisition cost for the provider is less than the reimbursement is going to result in loss of access for patients to those medications and/or higher hospital site of care costs.
 

 

 

A Few Partial Fixes, But Most Complaints Go Ignored

Considering the higher costs of hospital-based infusion, insurers should be motivated to keep patients within private practices. Perhaps through insurers’ recognition of that fact, some practices have successfully negotiated exceptions for specific patients by discussing this situation with insurers. From the feedback that CSRO has received from rheumatology practices, it appears that most insurers have been ignoring the complaints from physicians. The few who have responded have resulted in only partial fixes, with some of the biosimilars still left underwater.

Ultimate Solution?

This issue is a direct result of the “rebate game,” whereby price concessions from drug manufacturers drive formulary placement. For provider-administered medications, this results in an artificially lowered ASP, not as a consequence of free-market incentives that benefit the patient, but as a result of misaligned incentives created by Safe Harbor–protected “kickbacks,” distorting the free market and paradoxically reducing access to these medications, delaying care, and increasing prices for patients and the healthcare system.

While federal and state governments are not likely to address this particular situation in the biosimilars market, CSRO is highlighting this issue as a prime example of why the current formulary construction system urgently requires federal reform. At this time, the biosimilars most affected are Inflectra and Avsola, but if nothing changes, more and more biosimilars will fall victim to the short-sighted pricing strategy of aggressive rebating to gain formulary position, with physician purchasers and patients left to navigate the aftermath. The existing system, which necessitates drug companies purchasing formulary access from pharmacy benefit managers, has led to delayed and even denied patient access to certain provider-administered drugs. Moreover, it now appears to be hindering the adoption of biosimilars.

To address this, a multifaceted approach is required. It not only involves reevaluating the rebate system and its impact on formulary construction and ASP, but also ensuring that acquisition costs for providers are aligned with reimbursement rates. Insurers must recognize the economic and clinical value of maintaining infusions within private practices and immediately update their policies to ensure that physician in-office infusion is financially feasible for these “fail-first” biosimilars.

Ultimately, the goal should be to create a sustainable model that promotes the use of affordable biosimilars, enhances patient access to affordable care, and supports the financial viability of medical practices. Concerted efforts to reform the current formulary construction system are required to achieve a healthcare environment that is both cost effective and patient centric.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

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Editor’s note: This article is adapted from an explanatory statement that Dr. Feldman wrote for the Coalition of State Rheumatology Organizations (CSRO).

According to the Guinness Book of World records, the longest time someone has held their breath underwater voluntarily is 24 minutes and 37.36 seconds. While certainly an amazing feat, UnitedHealthcare, many of the Blues, and other national “payers” are expecting rheumatologists and other specialists to live “underwater” in order to take care of their patients. In other words, these insurance companies are mandating that specialists use certain provider-administered biosimilars whose acquisition cost is higher than what the insurance company is willing to reimburse them. Essentially, the insurance companies expect the rheumatologists to pay them to take care of their patients. Because of the substantial and destabilizing financial losses incurred, many practices and free-standing infusion centers have been forced to cease offering these biosimilars. Most rheumatologists will provide patients with appropriate alternatives when available and permitted by the insurer; otherwise, they must refer patients to hospital-based infusion centers. That results in delayed care and increased costs for patients and the system, because hospital-based infusion typically costs more than twice what office-based infusion costs.

Quantifying the Problem

To help quantify the magnitude of this issue, the Coalition of State Rheumatology Organizations (CSRO) recently conducted a survey of its membership. A shocking 97% of respondents reported that their practice had been affected by reimbursement rates for some biosimilars being lower than acquisition costs, with 91% of respondents stating that this issue is more pronounced for certain biosimilars than others. Across the board, respondents most frequently identified Inflectra (infliximab-dyyb) and Avsola (infliximab-axxq) as being especially affected: Over 88% and over 85% of respondents identified these two products, respectively, as being underwater. These results support the ongoing anecdotal reports CSRO continues to receive from rheumatology practices.

Dr. Madelaine A. Feldman

However, the survey results indicated that this issue is by no means confined to those two biosimilars. Truxima (rituximab-abbs) — a biosimilar for Rituxan — was frequently mentioned as well. Notably, respondents almost uniformly identified biosimilars in the infliximab and rituximab families, which illustrates that this issue is no longer confined to one or two early-to-market biosimilars but has almost become a hallmark of this particular biosimilars market. Remarkably, one respondent commented that the brand products are now cheaper to acquire than the biosimilars. Furthermore, the survey included respondents from across the country, indicating that this issue is not confined to a particular region.
 

How Did This Happen?

Biosimilars held promise for increasing availability and decreasing biologic costs for patients but, thus far, no patients have seen their cost go down. It appears that the only biosimilars that have made it to “preferred” status on the formulary are the ones that have made more money for the middlemen in the drug supply chain, particularly those that construct formularies. Now, we have provider-administered biosimilars whose acquisition cost exceeds the reimbursement for these drugs. This disparity was ultimately created by biosimilar manufacturers “over-rebating” their drugs to health insurance companies to gain “fail-first” status on the formulary.

For example, the manufacturer of Inflectra offered substantial rebates to health insurers for preferred formulary placement. These rebates are factored into the sales price of the medication, which then results in a rapidly declining average sales price (ASP) for the biosimilar. Unfortunately, the acquisition cost for the drug does not experience commensurate reductions, resulting in physicians being reimbursed far less for the drug than it costs to acquire. The financial losses for physicians put them underwater as a result of the acquisition costs for the preferred drugs far surpassing the reimbursement from the health insurance company that constructed the formulary.

While various factors affect ASPs and acquisition costs, this particular consequence of formulary placement based on price concessions is a major driver of the underwater situation in which physicians have found themselves with many biosimilars. Not only does that lead to a lower uptake of biosimilars, but it also results in patients being referred to the hospital outpatient infusion sites to receive this care, as freestanding infusion centers cannot treat these patients either. Hospitals incur higher costs because of facility fees and elevated rates, and this makes private rheumatology in-office infusion centers a much lower-cost option. Similarly, home infusion services, while convenient, are marginally more expensive than private practices and, in cases of biologic infusions, it is important to note that physicians’ offices have a greater safety profile than home infusion of biologics. The overall result of these “fail-first underwater drugs” is delayed and more costly care for the patient and the “system,” particularly self-insured employers.
 

What Is Being Done to Correct This?

Since ASPs are updated quarterly, it is possible that acquisition costs and reimbursements might stabilize over time, making the drugs affordable again to practices. However, that does not appear to be happening in the near future, so that possibility does not offer immediate relief to struggling practices. It doesn’t promise a favorable outlook for future biosimilar entries of provider-administered medications if formularies continue to prefer the highest-rebated medication.

This dynamic between ASP and acquisition cost does not happen on the pharmacy side because the price concessions on specific drug rebates and fees are proprietary. There appears to be no equivalent to a publicly known ASP on the pharmacy side, which has led to myriad pricing definitions and manipulation on the pharmacy benefit side of medications. In any event, the savings from rebates and other manufacturer price concessions on pharmacy drugs do not influence ASPs of medical benefit drugs.

The Inflation Reduction Act provided a temporary increase in the add-on payment for biosimilars from ASP+6% to ASP+8%, but as long as the biosimilar’s ASP is lower than the reference brand’s ASP, that temporary increase does not appear to make up for the large differential between ASP and acquisition cost. It should be noted that any federal attempt to artificially lower the ASP of a provider-administered drug without a pathway assuring that the acquisition cost for the provider is less than the reimbursement is going to result in loss of access for patients to those medications and/or higher hospital site of care costs.
 

 

 

A Few Partial Fixes, But Most Complaints Go Ignored

Considering the higher costs of hospital-based infusion, insurers should be motivated to keep patients within private practices. Perhaps through insurers’ recognition of that fact, some practices have successfully negotiated exceptions for specific patients by discussing this situation with insurers. From the feedback that CSRO has received from rheumatology practices, it appears that most insurers have been ignoring the complaints from physicians. The few who have responded have resulted in only partial fixes, with some of the biosimilars still left underwater.

Ultimate Solution?

This issue is a direct result of the “rebate game,” whereby price concessions from drug manufacturers drive formulary placement. For provider-administered medications, this results in an artificially lowered ASP, not as a consequence of free-market incentives that benefit the patient, but as a result of misaligned incentives created by Safe Harbor–protected “kickbacks,” distorting the free market and paradoxically reducing access to these medications, delaying care, and increasing prices for patients and the healthcare system.

While federal and state governments are not likely to address this particular situation in the biosimilars market, CSRO is highlighting this issue as a prime example of why the current formulary construction system urgently requires federal reform. At this time, the biosimilars most affected are Inflectra and Avsola, but if nothing changes, more and more biosimilars will fall victim to the short-sighted pricing strategy of aggressive rebating to gain formulary position, with physician purchasers and patients left to navigate the aftermath. The existing system, which necessitates drug companies purchasing formulary access from pharmacy benefit managers, has led to delayed and even denied patient access to certain provider-administered drugs. Moreover, it now appears to be hindering the adoption of biosimilars.

To address this, a multifaceted approach is required. It not only involves reevaluating the rebate system and its impact on formulary construction and ASP, but also ensuring that acquisition costs for providers are aligned with reimbursement rates. Insurers must recognize the economic and clinical value of maintaining infusions within private practices and immediately update their policies to ensure that physician in-office infusion is financially feasible for these “fail-first” biosimilars.

Ultimately, the goal should be to create a sustainable model that promotes the use of affordable biosimilars, enhances patient access to affordable care, and supports the financial viability of medical practices. Concerted efforts to reform the current formulary construction system are required to achieve a healthcare environment that is both cost effective and patient centric.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

 

Editor’s note: This article is adapted from an explanatory statement that Dr. Feldman wrote for the Coalition of State Rheumatology Organizations (CSRO).

According to the Guinness Book of World records, the longest time someone has held their breath underwater voluntarily is 24 minutes and 37.36 seconds. While certainly an amazing feat, UnitedHealthcare, many of the Blues, and other national “payers” are expecting rheumatologists and other specialists to live “underwater” in order to take care of their patients. In other words, these insurance companies are mandating that specialists use certain provider-administered biosimilars whose acquisition cost is higher than what the insurance company is willing to reimburse them. Essentially, the insurance companies expect the rheumatologists to pay them to take care of their patients. Because of the substantial and destabilizing financial losses incurred, many practices and free-standing infusion centers have been forced to cease offering these biosimilars. Most rheumatologists will provide patients with appropriate alternatives when available and permitted by the insurer; otherwise, they must refer patients to hospital-based infusion centers. That results in delayed care and increased costs for patients and the system, because hospital-based infusion typically costs more than twice what office-based infusion costs.

Quantifying the Problem

To help quantify the magnitude of this issue, the Coalition of State Rheumatology Organizations (CSRO) recently conducted a survey of its membership. A shocking 97% of respondents reported that their practice had been affected by reimbursement rates for some biosimilars being lower than acquisition costs, with 91% of respondents stating that this issue is more pronounced for certain biosimilars than others. Across the board, respondents most frequently identified Inflectra (infliximab-dyyb) and Avsola (infliximab-axxq) as being especially affected: Over 88% and over 85% of respondents identified these two products, respectively, as being underwater. These results support the ongoing anecdotal reports CSRO continues to receive from rheumatology practices.

Dr. Madelaine A. Feldman

However, the survey results indicated that this issue is by no means confined to those two biosimilars. Truxima (rituximab-abbs) — a biosimilar for Rituxan — was frequently mentioned as well. Notably, respondents almost uniformly identified biosimilars in the infliximab and rituximab families, which illustrates that this issue is no longer confined to one or two early-to-market biosimilars but has almost become a hallmark of this particular biosimilars market. Remarkably, one respondent commented that the brand products are now cheaper to acquire than the biosimilars. Furthermore, the survey included respondents from across the country, indicating that this issue is not confined to a particular region.
 

How Did This Happen?

Biosimilars held promise for increasing availability and decreasing biologic costs for patients but, thus far, no patients have seen their cost go down. It appears that the only biosimilars that have made it to “preferred” status on the formulary are the ones that have made more money for the middlemen in the drug supply chain, particularly those that construct formularies. Now, we have provider-administered biosimilars whose acquisition cost exceeds the reimbursement for these drugs. This disparity was ultimately created by biosimilar manufacturers “over-rebating” their drugs to health insurance companies to gain “fail-first” status on the formulary.

For example, the manufacturer of Inflectra offered substantial rebates to health insurers for preferred formulary placement. These rebates are factored into the sales price of the medication, which then results in a rapidly declining average sales price (ASP) for the biosimilar. Unfortunately, the acquisition cost for the drug does not experience commensurate reductions, resulting in physicians being reimbursed far less for the drug than it costs to acquire. The financial losses for physicians put them underwater as a result of the acquisition costs for the preferred drugs far surpassing the reimbursement from the health insurance company that constructed the formulary.

While various factors affect ASPs and acquisition costs, this particular consequence of formulary placement based on price concessions is a major driver of the underwater situation in which physicians have found themselves with many biosimilars. Not only does that lead to a lower uptake of biosimilars, but it also results in patients being referred to the hospital outpatient infusion sites to receive this care, as freestanding infusion centers cannot treat these patients either. Hospitals incur higher costs because of facility fees and elevated rates, and this makes private rheumatology in-office infusion centers a much lower-cost option. Similarly, home infusion services, while convenient, are marginally more expensive than private practices and, in cases of biologic infusions, it is important to note that physicians’ offices have a greater safety profile than home infusion of biologics. The overall result of these “fail-first underwater drugs” is delayed and more costly care for the patient and the “system,” particularly self-insured employers.
 

What Is Being Done to Correct This?

Since ASPs are updated quarterly, it is possible that acquisition costs and reimbursements might stabilize over time, making the drugs affordable again to practices. However, that does not appear to be happening in the near future, so that possibility does not offer immediate relief to struggling practices. It doesn’t promise a favorable outlook for future biosimilar entries of provider-administered medications if formularies continue to prefer the highest-rebated medication.

This dynamic between ASP and acquisition cost does not happen on the pharmacy side because the price concessions on specific drug rebates and fees are proprietary. There appears to be no equivalent to a publicly known ASP on the pharmacy side, which has led to myriad pricing definitions and manipulation on the pharmacy benefit side of medications. In any event, the savings from rebates and other manufacturer price concessions on pharmacy drugs do not influence ASPs of medical benefit drugs.

The Inflation Reduction Act provided a temporary increase in the add-on payment for biosimilars from ASP+6% to ASP+8%, but as long as the biosimilar’s ASP is lower than the reference brand’s ASP, that temporary increase does not appear to make up for the large differential between ASP and acquisition cost. It should be noted that any federal attempt to artificially lower the ASP of a provider-administered drug without a pathway assuring that the acquisition cost for the provider is less than the reimbursement is going to result in loss of access for patients to those medications and/or higher hospital site of care costs.
 

 

 

A Few Partial Fixes, But Most Complaints Go Ignored

Considering the higher costs of hospital-based infusion, insurers should be motivated to keep patients within private practices. Perhaps through insurers’ recognition of that fact, some practices have successfully negotiated exceptions for specific patients by discussing this situation with insurers. From the feedback that CSRO has received from rheumatology practices, it appears that most insurers have been ignoring the complaints from physicians. The few who have responded have resulted in only partial fixes, with some of the biosimilars still left underwater.

Ultimate Solution?

This issue is a direct result of the “rebate game,” whereby price concessions from drug manufacturers drive formulary placement. For provider-administered medications, this results in an artificially lowered ASP, not as a consequence of free-market incentives that benefit the patient, but as a result of misaligned incentives created by Safe Harbor–protected “kickbacks,” distorting the free market and paradoxically reducing access to these medications, delaying care, and increasing prices for patients and the healthcare system.

While federal and state governments are not likely to address this particular situation in the biosimilars market, CSRO is highlighting this issue as a prime example of why the current formulary construction system urgently requires federal reform. At this time, the biosimilars most affected are Inflectra and Avsola, but if nothing changes, more and more biosimilars will fall victim to the short-sighted pricing strategy of aggressive rebating to gain formulary position, with physician purchasers and patients left to navigate the aftermath. The existing system, which necessitates drug companies purchasing formulary access from pharmacy benefit managers, has led to delayed and even denied patient access to certain provider-administered drugs. Moreover, it now appears to be hindering the adoption of biosimilars.

To address this, a multifaceted approach is required. It not only involves reevaluating the rebate system and its impact on formulary construction and ASP, but also ensuring that acquisition costs for providers are aligned with reimbursement rates. Insurers must recognize the economic and clinical value of maintaining infusions within private practices and immediately update their policies to ensure that physician in-office infusion is financially feasible for these “fail-first” biosimilars.

Ultimately, the goal should be to create a sustainable model that promotes the use of affordable biosimilars, enhances patient access to affordable care, and supports the financial viability of medical practices. Concerted efforts to reform the current formulary construction system are required to achieve a healthcare environment that is both cost effective and patient centric.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

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Pediatric Dermatologists Beat ChatGPT on Board Questions

Article Type
Changed
Thu, 05/16/2024 - 12:15

In an experiment that pitted the wits of pediatric dermatologists against ChatGPT versions 3.5 and 4.0 to answer board examination–type questions, pediatric dermatologists outperformed both iterations of the artificial intelligence (AI)–based tool, results from a small single-center study showed.

“We were relieved to find that the pediatric dermatologists in our study performed better than ChatGPT on both multiple choice and case-based questions; however, the latest iteration of ChatGPT (4.0) was very close,” one of the study’s first authors Charles Huang, a fourth-year medical student at Thomas Jefferson University, Philadelphia, said in an interview. “Something else that was interesting in our data was that the pediatric dermatologists performed much better than ChatGPT on questions related to procedural dermatology/surgical techniques, perhaps indicating that knowledge/reasoning gained through practical experience isn’t easily replicated in AI tools such as ChatGPT.”

Charles Huang
Mr. Charles Huang

For the study, which was published on May 9 in Pediatric Dermatology, Mr. Huang, and co-first author Esther Zhang, BS, a medical student at the University of Pennsylvania, Philadelphia, and coauthors from the Department of Dermatology, Children’s Hospital of Philadelphia, asked five pediatric dermatologists to answer 24 text-based questions including 16 single-answer, multiple-choice questions and two multiple answer questions drawn from the American Board of Dermatology 2021 Certification Sample Test and six free-response case-based questions drawn from the “Photoquiz” section of Pediatric Dermatology between July 2022 and July 2023. The researchers then processed the same set of questions through ChatGPT versions 3.5 and 4.0 and used statistical analysis to compare responses between the pediatric dermatologists and ChatGPT. A 5-point scale adapted from current AI tools was used to score replies to case-based questions.

On average, study participants had 5.6 years of clinical experience. Pediatric dermatologists performed significantly better than ChatGPT version 3.5 on multiple-choice and multiple answer questions (91.4% vs 76.2%, respectively; P = .021) but not significantly better than ChatGPT version 4.0 (90.5%; P = .44). As for replies to case-based questions, the average performance based on the 5-point scale was 3.81 for pediatric dermatologists and 3.53 for ChatGPT overall. The mean scores were significantly greater for pediatric dermatologists than for ChatGPT version 3.5 (P = .039) but not ChatGPT version 4.0 (P = .43).



The researchers acknowledged certain limitations of the analysis, including the evolving nature of AI tools, which may affect the reproducibility of results with subsequent model updates. And, while participating pediatric dermatologists said they were unfamiliar with the questions and cases used in the study, “there is potential for prior exposure through other dermatology board examination review processes,” they wrote.

“AI tools such as ChatGPT and similar large language models can be a valuable tool in your clinical practice, but be aware of potential pitfalls such as patient privacy, medical inaccuracies, [and] intrinsic biases in the tools,” Mr. Huang told this news organization. “As these technologies continue to advance, it is essential for all of us as medical clinicians to gain familiarity and stay abreast of new developments, just as we adapted to electronic health records and the use of the Internet.”

Maria Buethe, MD, PhD, a pediatric dermatology fellow at Rady Children’s Hospital–San Diego, who was asked to comment on the study, said she found it “interesting” that ChatGPT’s version 4.0 started to produce comparable results to clinician responses in some of the tested scenarios.

Dr. Buethe
Dr. Maria Buethe

“The authors propose a set of best practices for pediatric dermatology clinicians using ChatGPT and other AI tools,” said Dr. Buethe, who was senior author of a recent literature review on AI and its application to pediatric dermatology. It was published in SKIN The Journal of Cutaneous Medicine. “One interesting recommended use for AI tools is to utilize it to generate differential diagnosis, which can broaden the list of pathologies previously considered.”

Asked to comment on the study, Erum Ilyas, MD, who practices dermatology in King of Prussia, Pennsylvania, and is a member of the Society for Pediatric Dermatology, said she was not surprised that ChatGPT “can perform fairly well on multiple-choice questions as we find available in testing circumstances,” as presented in the study. “Just as board questions only support testing a base of medical knowledge and facts for clinicians to master, they do not necessarily provide real-life circumstances that apply to caring for patients, which is inherently nuanced.”

Dr. Ilyas
Dr. Erum Ilyas


In addition, the study “highlights that ChatGPT can be an aid to support thinking through differentials based on data entered by a clinician who understands how to phrase queries, especially if provided with enough data while respecting patient privacy, in the context of fact checking responses,” Dr. Ilyas said. “This underscores the fact that AI tools can be helpful to clinicians in assimilating various data points entered. However, ultimately, the tool is only able to support an output based on the information it has access to.” She added, “ChatGPT cannot be relied on to provide a single diagnosis with the clinician still responsible for making a final diagnosis. The tool is not definitive and cannot assimilate data that is not entered correctly.”

The study was not funded, and the study authors reported having no disclosures. Dr. Buethe and Dr. Ilyas, who were not involved with the study, had no disclosures.

A version of this article appeared on Medscape.com .

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In an experiment that pitted the wits of pediatric dermatologists against ChatGPT versions 3.5 and 4.0 to answer board examination–type questions, pediatric dermatologists outperformed both iterations of the artificial intelligence (AI)–based tool, results from a small single-center study showed.

“We were relieved to find that the pediatric dermatologists in our study performed better than ChatGPT on both multiple choice and case-based questions; however, the latest iteration of ChatGPT (4.0) was very close,” one of the study’s first authors Charles Huang, a fourth-year medical student at Thomas Jefferson University, Philadelphia, said in an interview. “Something else that was interesting in our data was that the pediatric dermatologists performed much better than ChatGPT on questions related to procedural dermatology/surgical techniques, perhaps indicating that knowledge/reasoning gained through practical experience isn’t easily replicated in AI tools such as ChatGPT.”

Charles Huang
Mr. Charles Huang

For the study, which was published on May 9 in Pediatric Dermatology, Mr. Huang, and co-first author Esther Zhang, BS, a medical student at the University of Pennsylvania, Philadelphia, and coauthors from the Department of Dermatology, Children’s Hospital of Philadelphia, asked five pediatric dermatologists to answer 24 text-based questions including 16 single-answer, multiple-choice questions and two multiple answer questions drawn from the American Board of Dermatology 2021 Certification Sample Test and six free-response case-based questions drawn from the “Photoquiz” section of Pediatric Dermatology between July 2022 and July 2023. The researchers then processed the same set of questions through ChatGPT versions 3.5 and 4.0 and used statistical analysis to compare responses between the pediatric dermatologists and ChatGPT. A 5-point scale adapted from current AI tools was used to score replies to case-based questions.

On average, study participants had 5.6 years of clinical experience. Pediatric dermatologists performed significantly better than ChatGPT version 3.5 on multiple-choice and multiple answer questions (91.4% vs 76.2%, respectively; P = .021) but not significantly better than ChatGPT version 4.0 (90.5%; P = .44). As for replies to case-based questions, the average performance based on the 5-point scale was 3.81 for pediatric dermatologists and 3.53 for ChatGPT overall. The mean scores were significantly greater for pediatric dermatologists than for ChatGPT version 3.5 (P = .039) but not ChatGPT version 4.0 (P = .43).



The researchers acknowledged certain limitations of the analysis, including the evolving nature of AI tools, which may affect the reproducibility of results with subsequent model updates. And, while participating pediatric dermatologists said they were unfamiliar with the questions and cases used in the study, “there is potential for prior exposure through other dermatology board examination review processes,” they wrote.

“AI tools such as ChatGPT and similar large language models can be a valuable tool in your clinical practice, but be aware of potential pitfalls such as patient privacy, medical inaccuracies, [and] intrinsic biases in the tools,” Mr. Huang told this news organization. “As these technologies continue to advance, it is essential for all of us as medical clinicians to gain familiarity and stay abreast of new developments, just as we adapted to electronic health records and the use of the Internet.”

Maria Buethe, MD, PhD, a pediatric dermatology fellow at Rady Children’s Hospital–San Diego, who was asked to comment on the study, said she found it “interesting” that ChatGPT’s version 4.0 started to produce comparable results to clinician responses in some of the tested scenarios.

Dr. Buethe
Dr. Maria Buethe

“The authors propose a set of best practices for pediatric dermatology clinicians using ChatGPT and other AI tools,” said Dr. Buethe, who was senior author of a recent literature review on AI and its application to pediatric dermatology. It was published in SKIN The Journal of Cutaneous Medicine. “One interesting recommended use for AI tools is to utilize it to generate differential diagnosis, which can broaden the list of pathologies previously considered.”

Asked to comment on the study, Erum Ilyas, MD, who practices dermatology in King of Prussia, Pennsylvania, and is a member of the Society for Pediatric Dermatology, said she was not surprised that ChatGPT “can perform fairly well on multiple-choice questions as we find available in testing circumstances,” as presented in the study. “Just as board questions only support testing a base of medical knowledge and facts for clinicians to master, they do not necessarily provide real-life circumstances that apply to caring for patients, which is inherently nuanced.”

Dr. Ilyas
Dr. Erum Ilyas


In addition, the study “highlights that ChatGPT can be an aid to support thinking through differentials based on data entered by a clinician who understands how to phrase queries, especially if provided with enough data while respecting patient privacy, in the context of fact checking responses,” Dr. Ilyas said. “This underscores the fact that AI tools can be helpful to clinicians in assimilating various data points entered. However, ultimately, the tool is only able to support an output based on the information it has access to.” She added, “ChatGPT cannot be relied on to provide a single diagnosis with the clinician still responsible for making a final diagnosis. The tool is not definitive and cannot assimilate data that is not entered correctly.”

The study was not funded, and the study authors reported having no disclosures. Dr. Buethe and Dr. Ilyas, who were not involved with the study, had no disclosures.

A version of this article appeared on Medscape.com .

In an experiment that pitted the wits of pediatric dermatologists against ChatGPT versions 3.5 and 4.0 to answer board examination–type questions, pediatric dermatologists outperformed both iterations of the artificial intelligence (AI)–based tool, results from a small single-center study showed.

“We were relieved to find that the pediatric dermatologists in our study performed better than ChatGPT on both multiple choice and case-based questions; however, the latest iteration of ChatGPT (4.0) was very close,” one of the study’s first authors Charles Huang, a fourth-year medical student at Thomas Jefferson University, Philadelphia, said in an interview. “Something else that was interesting in our data was that the pediatric dermatologists performed much better than ChatGPT on questions related to procedural dermatology/surgical techniques, perhaps indicating that knowledge/reasoning gained through practical experience isn’t easily replicated in AI tools such as ChatGPT.”

Charles Huang
Mr. Charles Huang

For the study, which was published on May 9 in Pediatric Dermatology, Mr. Huang, and co-first author Esther Zhang, BS, a medical student at the University of Pennsylvania, Philadelphia, and coauthors from the Department of Dermatology, Children’s Hospital of Philadelphia, asked five pediatric dermatologists to answer 24 text-based questions including 16 single-answer, multiple-choice questions and two multiple answer questions drawn from the American Board of Dermatology 2021 Certification Sample Test and six free-response case-based questions drawn from the “Photoquiz” section of Pediatric Dermatology between July 2022 and July 2023. The researchers then processed the same set of questions through ChatGPT versions 3.5 and 4.0 and used statistical analysis to compare responses between the pediatric dermatologists and ChatGPT. A 5-point scale adapted from current AI tools was used to score replies to case-based questions.

On average, study participants had 5.6 years of clinical experience. Pediatric dermatologists performed significantly better than ChatGPT version 3.5 on multiple-choice and multiple answer questions (91.4% vs 76.2%, respectively; P = .021) but not significantly better than ChatGPT version 4.0 (90.5%; P = .44). As for replies to case-based questions, the average performance based on the 5-point scale was 3.81 for pediatric dermatologists and 3.53 for ChatGPT overall. The mean scores were significantly greater for pediatric dermatologists than for ChatGPT version 3.5 (P = .039) but not ChatGPT version 4.0 (P = .43).



The researchers acknowledged certain limitations of the analysis, including the evolving nature of AI tools, which may affect the reproducibility of results with subsequent model updates. And, while participating pediatric dermatologists said they were unfamiliar with the questions and cases used in the study, “there is potential for prior exposure through other dermatology board examination review processes,” they wrote.

“AI tools such as ChatGPT and similar large language models can be a valuable tool in your clinical practice, but be aware of potential pitfalls such as patient privacy, medical inaccuracies, [and] intrinsic biases in the tools,” Mr. Huang told this news organization. “As these technologies continue to advance, it is essential for all of us as medical clinicians to gain familiarity and stay abreast of new developments, just as we adapted to electronic health records and the use of the Internet.”

Maria Buethe, MD, PhD, a pediatric dermatology fellow at Rady Children’s Hospital–San Diego, who was asked to comment on the study, said she found it “interesting” that ChatGPT’s version 4.0 started to produce comparable results to clinician responses in some of the tested scenarios.

Dr. Buethe
Dr. Maria Buethe

“The authors propose a set of best practices for pediatric dermatology clinicians using ChatGPT and other AI tools,” said Dr. Buethe, who was senior author of a recent literature review on AI and its application to pediatric dermatology. It was published in SKIN The Journal of Cutaneous Medicine. “One interesting recommended use for AI tools is to utilize it to generate differential diagnosis, which can broaden the list of pathologies previously considered.”

Asked to comment on the study, Erum Ilyas, MD, who practices dermatology in King of Prussia, Pennsylvania, and is a member of the Society for Pediatric Dermatology, said she was not surprised that ChatGPT “can perform fairly well on multiple-choice questions as we find available in testing circumstances,” as presented in the study. “Just as board questions only support testing a base of medical knowledge and facts for clinicians to master, they do not necessarily provide real-life circumstances that apply to caring for patients, which is inherently nuanced.”

Dr. Ilyas
Dr. Erum Ilyas


In addition, the study “highlights that ChatGPT can be an aid to support thinking through differentials based on data entered by a clinician who understands how to phrase queries, especially if provided with enough data while respecting patient privacy, in the context of fact checking responses,” Dr. Ilyas said. “This underscores the fact that AI tools can be helpful to clinicians in assimilating various data points entered. However, ultimately, the tool is only able to support an output based on the information it has access to.” She added, “ChatGPT cannot be relied on to provide a single diagnosis with the clinician still responsible for making a final diagnosis. The tool is not definitive and cannot assimilate data that is not entered correctly.”

The study was not funded, and the study authors reported having no disclosures. Dr. Buethe and Dr. Ilyas, who were not involved with the study, had no disclosures.

A version of this article appeared on Medscape.com .

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Global Analysis Identifies Drugs Associated With SJS-TEN in Children

Article Type
Changed
Thu, 05/16/2024 - 11:28

 

TOPLINE:

Antiepileptic and anti-infectious agents were the most common drugs associated with Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) in children in an analysis of a World Health Organization (WHO) database.

METHODOLOGY:

  • SJS and TEN are rare, life-threatening mucocutaneous reactions mainly associated with medications, but large pharmacovigilance studies of drugs associated with SJS-TEN in the pediatric population are still lacking.
  • Using the WHO’s pharmacovigilance database (VigiBase) containing individual case safety reports from January 1967 to July 2022, researchers identified 7342 adverse drug reaction reports of SJS-TEN in children (younger than 18 years; median age, 9 years) in all six continents. Median onset was 5 days, and 3.2% were fatal.
  • They analyzed drugs reported as suspected treatments, and for each molecule, they performed a case–non-case study to assess a potential pharmacovigilance signal by computing the information component (IC).
  • A positive IC value suggested more frequent reporting of a specific drug-adverse reaction pair. A positive IC025, a traditional threshold for statistical signal detection, is suggestive of a potential pharmacovigilance signal.

TAKEAWAY:

  • Overall, 165 drugs were associated with a diagnosis of SJS-TEN; antiepileptic and anti-infectious drugs were the most common drug classes represented.
  • The five most frequently reported drugs were carbamazepine (11.7%), lamotrigine (10.6%), sulfamethoxazole-trimethoprim (9%), acetaminophen (8.4%), and phenytoin (6.6%). The five drugs with the highest IC025 were lamotrigine, carbamazepine, phenobarbital, phenytoin, and nimesulide.
  • All antiepileptics, many antibiotic families, dapsone, antiretroviral drugs, some antifungal drugs, and nonsteroidal anti-inflammatory drugs were identified in reports, with penicillins the most frequently reported antibiotic family and sulfonamides having the strongest pharmacovigilance signal.
  • Vaccines were not associated with significant signals.

IN PRACTICE:

The study provides an update on “the spectrum of drugs potentially associated with SJS-TEN in the pediatric population,” the authors concluded, and “underlines the importance of reporting to pharmacovigilance the suspicion of this severe side effect of drugs with the most precise and detailed clinical description possible.”

SOURCE:

The study, led by Pauline Bataille, MD, of the Department of Pediatric Dermatology, Hôpital Necker-Enfants Malades, Paris City University, France, was published online in the Journal of the European Academy of Dermatology and Venereology.

LIMITATIONS:

Limitations include the possibility that some cases could have had an infectious or idiopathic cause not related to a drug and the lack of detailed clinical data in the database.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflict of interest.

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

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TOPLINE:

Antiepileptic and anti-infectious agents were the most common drugs associated with Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) in children in an analysis of a World Health Organization (WHO) database.

METHODOLOGY:

  • SJS and TEN are rare, life-threatening mucocutaneous reactions mainly associated with medications, but large pharmacovigilance studies of drugs associated with SJS-TEN in the pediatric population are still lacking.
  • Using the WHO’s pharmacovigilance database (VigiBase) containing individual case safety reports from January 1967 to July 2022, researchers identified 7342 adverse drug reaction reports of SJS-TEN in children (younger than 18 years; median age, 9 years) in all six continents. Median onset was 5 days, and 3.2% were fatal.
  • They analyzed drugs reported as suspected treatments, and for each molecule, they performed a case–non-case study to assess a potential pharmacovigilance signal by computing the information component (IC).
  • A positive IC value suggested more frequent reporting of a specific drug-adverse reaction pair. A positive IC025, a traditional threshold for statistical signal detection, is suggestive of a potential pharmacovigilance signal.

TAKEAWAY:

  • Overall, 165 drugs were associated with a diagnosis of SJS-TEN; antiepileptic and anti-infectious drugs were the most common drug classes represented.
  • The five most frequently reported drugs were carbamazepine (11.7%), lamotrigine (10.6%), sulfamethoxazole-trimethoprim (9%), acetaminophen (8.4%), and phenytoin (6.6%). The five drugs with the highest IC025 were lamotrigine, carbamazepine, phenobarbital, phenytoin, and nimesulide.
  • All antiepileptics, many antibiotic families, dapsone, antiretroviral drugs, some antifungal drugs, and nonsteroidal anti-inflammatory drugs were identified in reports, with penicillins the most frequently reported antibiotic family and sulfonamides having the strongest pharmacovigilance signal.
  • Vaccines were not associated with significant signals.

IN PRACTICE:

The study provides an update on “the spectrum of drugs potentially associated with SJS-TEN in the pediatric population,” the authors concluded, and “underlines the importance of reporting to pharmacovigilance the suspicion of this severe side effect of drugs with the most precise and detailed clinical description possible.”

SOURCE:

The study, led by Pauline Bataille, MD, of the Department of Pediatric Dermatology, Hôpital Necker-Enfants Malades, Paris City University, France, was published online in the Journal of the European Academy of Dermatology and Venereology.

LIMITATIONS:

Limitations include the possibility that some cases could have had an infectious or idiopathic cause not related to a drug and the lack of detailed clinical data in the database.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflict of interest.

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

 

TOPLINE:

Antiepileptic and anti-infectious agents were the most common drugs associated with Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) in children in an analysis of a World Health Organization (WHO) database.

METHODOLOGY:

  • SJS and TEN are rare, life-threatening mucocutaneous reactions mainly associated with medications, but large pharmacovigilance studies of drugs associated with SJS-TEN in the pediatric population are still lacking.
  • Using the WHO’s pharmacovigilance database (VigiBase) containing individual case safety reports from January 1967 to July 2022, researchers identified 7342 adverse drug reaction reports of SJS-TEN in children (younger than 18 years; median age, 9 years) in all six continents. Median onset was 5 days, and 3.2% were fatal.
  • They analyzed drugs reported as suspected treatments, and for each molecule, they performed a case–non-case study to assess a potential pharmacovigilance signal by computing the information component (IC).
  • A positive IC value suggested more frequent reporting of a specific drug-adverse reaction pair. A positive IC025, a traditional threshold for statistical signal detection, is suggestive of a potential pharmacovigilance signal.

TAKEAWAY:

  • Overall, 165 drugs were associated with a diagnosis of SJS-TEN; antiepileptic and anti-infectious drugs were the most common drug classes represented.
  • The five most frequently reported drugs were carbamazepine (11.7%), lamotrigine (10.6%), sulfamethoxazole-trimethoprim (9%), acetaminophen (8.4%), and phenytoin (6.6%). The five drugs with the highest IC025 were lamotrigine, carbamazepine, phenobarbital, phenytoin, and nimesulide.
  • All antiepileptics, many antibiotic families, dapsone, antiretroviral drugs, some antifungal drugs, and nonsteroidal anti-inflammatory drugs were identified in reports, with penicillins the most frequently reported antibiotic family and sulfonamides having the strongest pharmacovigilance signal.
  • Vaccines were not associated with significant signals.

IN PRACTICE:

The study provides an update on “the spectrum of drugs potentially associated with SJS-TEN in the pediatric population,” the authors concluded, and “underlines the importance of reporting to pharmacovigilance the suspicion of this severe side effect of drugs with the most precise and detailed clinical description possible.”

SOURCE:

The study, led by Pauline Bataille, MD, of the Department of Pediatric Dermatology, Hôpital Necker-Enfants Malades, Paris City University, France, was published online in the Journal of the European Academy of Dermatology and Venereology.

LIMITATIONS:

Limitations include the possibility that some cases could have had an infectious or idiopathic cause not related to a drug and the lack of detailed clinical data in the database.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflict of interest.

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

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Aquagenic Wrinkling Among Skin-Related Signs of Cystic Fibrosis

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Fri, 05/17/2024 - 15:39

 

TOPLINE:

Cutaneous manifestations of cystic fibrosis (CF) include palmar wrinkling, nutrient deficiency dermatitis, vascular disorders, and reactions to CF treatments.

METHODOLOGY:

  • Patients with CF, caused by a mutation in the CF Transmembrane Conductance Regulator (CFTR) gene, can develop diverse dermatologic manifestations.
  • Researchers reviewed the literature and provided their own clinical experience regarding dermatologic manifestations of CF.
  • They also reviewed the cutaneous side effects of CFTR modulators and antibiotics used to treat CF.

TAKEAWAY:

  • Aquagenic wrinkling of the palm is common in individuals with CF, affecting up to 80% of patients (and 25% of CF gene carriers), and can be an early manifestation of CF. Treatments include topical medications (such as aluminum chloride, corticosteroids, and salicylic acid), botulinum toxin injections, and recently, CFTR-modulating treatments.
  • CF nutrient deficiency dermatitis, often in a diaper distribution, usually appears in infancy and, before newborn screening was available, was sometimes the first sign of CF in some cases. It usually resolves with an adequate diet, pancreatic enzymes, and/or nutritional supplements. Zinc and essential fatty acid deficiencies can lead to acrodermatitis enteropathica–like symptoms and psoriasiform rashes, respectively.
  • CF is also associated with vascular disorders, including cutaneous and, rarely, systemic vasculitis. Treatment includes topical and oral steroids and immune-modulating therapies.
  • CFTR modulators, now the most common and highly effective treatment for CF, are associated with several skin reactions, which can be managed with treatments that include topical steroids and oral antihistamines. Frequent antibiotic treatment can also trigger skin reactions.

IN PRACTICE:

“Recognition and familiarity with dermatologic clinical manifestations of CF are important for multidisciplinary care” for patients with CF, the authors wrote, adding that “dermatology providers may play a significant role in the diagnosis and management of CF cutaneous comorbidities.”

SOURCE:

Aaron D. Smith, BS, from the University of Virginia (UVA) School of Medicine, Charlottesville, and coauthors were from the departments of dermatology and pulmonology/critical care medicine at UVA. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The authors did not make a comment about the limitations of their review.

DISCLOSURES:

No funding was received for the review. The authors had no disclosures.

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

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TOPLINE:

Cutaneous manifestations of cystic fibrosis (CF) include palmar wrinkling, nutrient deficiency dermatitis, vascular disorders, and reactions to CF treatments.

METHODOLOGY:

  • Patients with CF, caused by a mutation in the CF Transmembrane Conductance Regulator (CFTR) gene, can develop diverse dermatologic manifestations.
  • Researchers reviewed the literature and provided their own clinical experience regarding dermatologic manifestations of CF.
  • They also reviewed the cutaneous side effects of CFTR modulators and antibiotics used to treat CF.

TAKEAWAY:

  • Aquagenic wrinkling of the palm is common in individuals with CF, affecting up to 80% of patients (and 25% of CF gene carriers), and can be an early manifestation of CF. Treatments include topical medications (such as aluminum chloride, corticosteroids, and salicylic acid), botulinum toxin injections, and recently, CFTR-modulating treatments.
  • CF nutrient deficiency dermatitis, often in a diaper distribution, usually appears in infancy and, before newborn screening was available, was sometimes the first sign of CF in some cases. It usually resolves with an adequate diet, pancreatic enzymes, and/or nutritional supplements. Zinc and essential fatty acid deficiencies can lead to acrodermatitis enteropathica–like symptoms and psoriasiform rashes, respectively.
  • CF is also associated with vascular disorders, including cutaneous and, rarely, systemic vasculitis. Treatment includes topical and oral steroids and immune-modulating therapies.
  • CFTR modulators, now the most common and highly effective treatment for CF, are associated with several skin reactions, which can be managed with treatments that include topical steroids and oral antihistamines. Frequent antibiotic treatment can also trigger skin reactions.

IN PRACTICE:

“Recognition and familiarity with dermatologic clinical manifestations of CF are important for multidisciplinary care” for patients with CF, the authors wrote, adding that “dermatology providers may play a significant role in the diagnosis and management of CF cutaneous comorbidities.”

SOURCE:

Aaron D. Smith, BS, from the University of Virginia (UVA) School of Medicine, Charlottesville, and coauthors were from the departments of dermatology and pulmonology/critical care medicine at UVA. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The authors did not make a comment about the limitations of their review.

DISCLOSURES:

No funding was received for the review. The authors had no disclosures.

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

 

TOPLINE:

Cutaneous manifestations of cystic fibrosis (CF) include palmar wrinkling, nutrient deficiency dermatitis, vascular disorders, and reactions to CF treatments.

METHODOLOGY:

  • Patients with CF, caused by a mutation in the CF Transmembrane Conductance Regulator (CFTR) gene, can develop diverse dermatologic manifestations.
  • Researchers reviewed the literature and provided their own clinical experience regarding dermatologic manifestations of CF.
  • They also reviewed the cutaneous side effects of CFTR modulators and antibiotics used to treat CF.

TAKEAWAY:

  • Aquagenic wrinkling of the palm is common in individuals with CF, affecting up to 80% of patients (and 25% of CF gene carriers), and can be an early manifestation of CF. Treatments include topical medications (such as aluminum chloride, corticosteroids, and salicylic acid), botulinum toxin injections, and recently, CFTR-modulating treatments.
  • CF nutrient deficiency dermatitis, often in a diaper distribution, usually appears in infancy and, before newborn screening was available, was sometimes the first sign of CF in some cases. It usually resolves with an adequate diet, pancreatic enzymes, and/or nutritional supplements. Zinc and essential fatty acid deficiencies can lead to acrodermatitis enteropathica–like symptoms and psoriasiform rashes, respectively.
  • CF is also associated with vascular disorders, including cutaneous and, rarely, systemic vasculitis. Treatment includes topical and oral steroids and immune-modulating therapies.
  • CFTR modulators, now the most common and highly effective treatment for CF, are associated with several skin reactions, which can be managed with treatments that include topical steroids and oral antihistamines. Frequent antibiotic treatment can also trigger skin reactions.

IN PRACTICE:

“Recognition and familiarity with dermatologic clinical manifestations of CF are important for multidisciplinary care” for patients with CF, the authors wrote, adding that “dermatology providers may play a significant role in the diagnosis and management of CF cutaneous comorbidities.”

SOURCE:

Aaron D. Smith, BS, from the University of Virginia (UVA) School of Medicine, Charlottesville, and coauthors were from the departments of dermatology and pulmonology/critical care medicine at UVA. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The authors did not make a comment about the limitations of their review.

DISCLOSURES:

No funding was received for the review. The authors had no disclosures.

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

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PCP Compensation, Part 4

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Changed
Thu, 05/16/2024 - 09:10

I have already shared with you that healthcare systems value panel size and productivity when they are considering primary care physician compensation. Your employers also know that the market won’t bear a substantial price increase for the procedure-poor practice style typical of primary care. You know that the relative value unit (RVU) system for calculating complexity of service is time consuming and discourages the inclusion of customer-friendly short visits that could allow an efficient provider to see more patients. Unfortunately, there is little hope that RVUs will become more PCP-friendly in the near future.

However, before leaving the topic of value and moving on to a consideration of quality, I can’t resist sharing some thoughts about efficiency and time management.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff


First, it must be said that the inexpert development and the clumsy rollout of electronic medical records (EMRs) have struck the biggest blow to the compensation potential and mental health of even the most efficient PCPs. Until that chasm is filled, there will be little progress in improving the efficiency and, consequently, the fair compensation of PCPs.

However, there is a myth that there is a direct correlation between the time spent with the patient and the quality of care. Eighty-five percent of PCPs report they would like to spend more time to get to know their patients. On the other hand, in my experience, really getting to know a patient is a process best done over multiple visits — some long, many of them short. It is unrealistic and inefficient to gain an in-depth understanding of the patient in a single visit.

Yes, one often hears a patient complain “they only spent 5 minutes with me.” While the patient may be technically correct, I contend that the provider’s manner has a major influence on the patient’s perception of the time spent in the exam room.

Was the provider reasonably prompt? In other words did they value my time? Did they appear rushed? Were they aware of my relevant history and prepared to deal with the current situation? In other words, did they do their homework? Did they engage me visually and seem to know what they were talking about? But, most importantly, did they exude sympathy and seem to care? Was I treated in the same manner that they would like to have been treated? If the answer is YES to those questions, then likely the patient could care less about the time spent.

It may seem counterintuitive to some of you, but there is a simple strategy that a provider can employ that will give them more time with the patient and at the same time allow them to claim to the boss that they are lowering the overhead costs. Management consultants often lean heavily on delegation as a more efficient use of resources. However, when the provider takes the patient’s vital signs and gives the injections, this multitasking provides an excellent hands-on opportunity to take the history and get to know the patient better. And, by giving the immunizations the provider is making the clearest statement possible that these vaccines are so important that they administer them personally.

You may have been wondering why I haven’t included the quality of PCP care in a discussion of compensation. It is because I don’t believe anyone has figured out how to do it in a manner that makes sense and is fair. PCPs don’t do procedures on which their success rate can be measured. A PCP’s patient panel almost by definition is going to be a mix of ages with a broad variety of complaints. Do they see enough diabetics to use their panel’s hemoglobin A1cs as a metric, or enough asthmatics to use emergency department visits as a quality-of-care measurement? In pediatrics, the closest we can come to a valid measure may be the provider’s vaccine acceptance rate.

But, then how does one factor in the general health of the community? If I open a practice in an underserved community, can you measure the quality of my care based on how quickly I can improve the metrics when I have no control over the poverty and educational system?

Since we aren’t surgeons, outcomes can’t be used to judge our quality. I’m afraid the only way we can assure quality is to demand evidence of our efforts to keep abreast of the current knowledge in our field and hope that at some level CME credits accumulated translate to the care we provide. A recent study has demonstrated an association between board certification exam board scores and newly trained internists and the care they provide. The patients of the physicians with the top scores had a lower risk of being readmitted to the hospital and were less likely to die in the first seven days of hospitalization.

We now may have come full circle. The fact is that, like it or not, our value to the folks that pay us lies in the number of patients we can bring into the system. To keep our overhead down, we will always be encouraged to see as many patients as we can, or at least be efficient. Even if there were a way to quantify the quality of our care using outcome metrics, the patients will continue to select their providers based on availability, and the professional and consumer-friendly behavior of those providers. The patients’ perception of how good we are at making them feel better may be our strongest argument for better compensation.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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I have already shared with you that healthcare systems value panel size and productivity when they are considering primary care physician compensation. Your employers also know that the market won’t bear a substantial price increase for the procedure-poor practice style typical of primary care. You know that the relative value unit (RVU) system for calculating complexity of service is time consuming and discourages the inclusion of customer-friendly short visits that could allow an efficient provider to see more patients. Unfortunately, there is little hope that RVUs will become more PCP-friendly in the near future.

However, before leaving the topic of value and moving on to a consideration of quality, I can’t resist sharing some thoughts about efficiency and time management.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff


First, it must be said that the inexpert development and the clumsy rollout of electronic medical records (EMRs) have struck the biggest blow to the compensation potential and mental health of even the most efficient PCPs. Until that chasm is filled, there will be little progress in improving the efficiency and, consequently, the fair compensation of PCPs.

However, there is a myth that there is a direct correlation between the time spent with the patient and the quality of care. Eighty-five percent of PCPs report they would like to spend more time to get to know their patients. On the other hand, in my experience, really getting to know a patient is a process best done over multiple visits — some long, many of them short. It is unrealistic and inefficient to gain an in-depth understanding of the patient in a single visit.

Yes, one often hears a patient complain “they only spent 5 minutes with me.” While the patient may be technically correct, I contend that the provider’s manner has a major influence on the patient’s perception of the time spent in the exam room.

Was the provider reasonably prompt? In other words did they value my time? Did they appear rushed? Were they aware of my relevant history and prepared to deal with the current situation? In other words, did they do their homework? Did they engage me visually and seem to know what they were talking about? But, most importantly, did they exude sympathy and seem to care? Was I treated in the same manner that they would like to have been treated? If the answer is YES to those questions, then likely the patient could care less about the time spent.

It may seem counterintuitive to some of you, but there is a simple strategy that a provider can employ that will give them more time with the patient and at the same time allow them to claim to the boss that they are lowering the overhead costs. Management consultants often lean heavily on delegation as a more efficient use of resources. However, when the provider takes the patient’s vital signs and gives the injections, this multitasking provides an excellent hands-on opportunity to take the history and get to know the patient better. And, by giving the immunizations the provider is making the clearest statement possible that these vaccines are so important that they administer them personally.

You may have been wondering why I haven’t included the quality of PCP care in a discussion of compensation. It is because I don’t believe anyone has figured out how to do it in a manner that makes sense and is fair. PCPs don’t do procedures on which their success rate can be measured. A PCP’s patient panel almost by definition is going to be a mix of ages with a broad variety of complaints. Do they see enough diabetics to use their panel’s hemoglobin A1cs as a metric, or enough asthmatics to use emergency department visits as a quality-of-care measurement? In pediatrics, the closest we can come to a valid measure may be the provider’s vaccine acceptance rate.

But, then how does one factor in the general health of the community? If I open a practice in an underserved community, can you measure the quality of my care based on how quickly I can improve the metrics when I have no control over the poverty and educational system?

Since we aren’t surgeons, outcomes can’t be used to judge our quality. I’m afraid the only way we can assure quality is to demand evidence of our efforts to keep abreast of the current knowledge in our field and hope that at some level CME credits accumulated translate to the care we provide. A recent study has demonstrated an association between board certification exam board scores and newly trained internists and the care they provide. The patients of the physicians with the top scores had a lower risk of being readmitted to the hospital and were less likely to die in the first seven days of hospitalization.

We now may have come full circle. The fact is that, like it or not, our value to the folks that pay us lies in the number of patients we can bring into the system. To keep our overhead down, we will always be encouraged to see as many patients as we can, or at least be efficient. Even if there were a way to quantify the quality of our care using outcome metrics, the patients will continue to select their providers based on availability, and the professional and consumer-friendly behavior of those providers. The patients’ perception of how good we are at making them feel better may be our strongest argument for better compensation.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I have already shared with you that healthcare systems value panel size and productivity when they are considering primary care physician compensation. Your employers also know that the market won’t bear a substantial price increase for the procedure-poor practice style typical of primary care. You know that the relative value unit (RVU) system for calculating complexity of service is time consuming and discourages the inclusion of customer-friendly short visits that could allow an efficient provider to see more patients. Unfortunately, there is little hope that RVUs will become more PCP-friendly in the near future.

However, before leaving the topic of value and moving on to a consideration of quality, I can’t resist sharing some thoughts about efficiency and time management.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff


First, it must be said that the inexpert development and the clumsy rollout of electronic medical records (EMRs) have struck the biggest blow to the compensation potential and mental health of even the most efficient PCPs. Until that chasm is filled, there will be little progress in improving the efficiency and, consequently, the fair compensation of PCPs.

However, there is a myth that there is a direct correlation between the time spent with the patient and the quality of care. Eighty-five percent of PCPs report they would like to spend more time to get to know their patients. On the other hand, in my experience, really getting to know a patient is a process best done over multiple visits — some long, many of them short. It is unrealistic and inefficient to gain an in-depth understanding of the patient in a single visit.

Yes, one often hears a patient complain “they only spent 5 minutes with me.” While the patient may be technically correct, I contend that the provider’s manner has a major influence on the patient’s perception of the time spent in the exam room.

Was the provider reasonably prompt? In other words did they value my time? Did they appear rushed? Were they aware of my relevant history and prepared to deal with the current situation? In other words, did they do their homework? Did they engage me visually and seem to know what they were talking about? But, most importantly, did they exude sympathy and seem to care? Was I treated in the same manner that they would like to have been treated? If the answer is YES to those questions, then likely the patient could care less about the time spent.

It may seem counterintuitive to some of you, but there is a simple strategy that a provider can employ that will give them more time with the patient and at the same time allow them to claim to the boss that they are lowering the overhead costs. Management consultants often lean heavily on delegation as a more efficient use of resources. However, when the provider takes the patient’s vital signs and gives the injections, this multitasking provides an excellent hands-on opportunity to take the history and get to know the patient better. And, by giving the immunizations the provider is making the clearest statement possible that these vaccines are so important that they administer them personally.

You may have been wondering why I haven’t included the quality of PCP care in a discussion of compensation. It is because I don’t believe anyone has figured out how to do it in a manner that makes sense and is fair. PCPs don’t do procedures on which their success rate can be measured. A PCP’s patient panel almost by definition is going to be a mix of ages with a broad variety of complaints. Do they see enough diabetics to use their panel’s hemoglobin A1cs as a metric, or enough asthmatics to use emergency department visits as a quality-of-care measurement? In pediatrics, the closest we can come to a valid measure may be the provider’s vaccine acceptance rate.

But, then how does one factor in the general health of the community? If I open a practice in an underserved community, can you measure the quality of my care based on how quickly I can improve the metrics when I have no control over the poverty and educational system?

Since we aren’t surgeons, outcomes can’t be used to judge our quality. I’m afraid the only way we can assure quality is to demand evidence of our efforts to keep abreast of the current knowledge in our field and hope that at some level CME credits accumulated translate to the care we provide. A recent study has demonstrated an association between board certification exam board scores and newly trained internists and the care they provide. The patients of the physicians with the top scores had a lower risk of being readmitted to the hospital and were less likely to die in the first seven days of hospitalization.

We now may have come full circle. The fact is that, like it or not, our value to the folks that pay us lies in the number of patients we can bring into the system. To keep our overhead down, we will always be encouraged to see as many patients as we can, or at least be efficient. Even if there were a way to quantify the quality of our care using outcome metrics, the patients will continue to select their providers based on availability, and the professional and consumer-friendly behavior of those providers. The patients’ perception of how good we are at making them feel better may be our strongest argument for better compensation.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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Smart Use of Smartphones

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Wed, 05/15/2024 - 16:39

Amid the declarations about the current mental health crisis among youth, it has become increasingly common to link rising rates of anxiety and depression among youth to screen time, and more specifically to hours spent on social media. But in truth, this matter is far from settled. The evidence linking mood and anxiety disorders to social media use is inconsistent. And where the evidence is stronger, causality has not been established. Does screen time precipitate an episode of depression or does a preteen at risk for depression, in the midst of a divorce or burdened by learning problems, use screen time excessively as a solution to these problems? There is also substantial variation across age groups, genders, and other factors that suggests that time spent on smartphone apps may not be the primary factor creating risk. Indeed, there is growing uncertainty about whether the climbing rates of anxiety and mood disorders among youth reflect yet to be identified factors increasing the burden of mental illness or the altered screening and tracking landscape in the United States after COVID and the Affordable Care Act. This uncertainty does not mean that we cannot make recommendations about how to guide patients and their families. Smartphones (and watches, glasses, etc) are here to stay. We can help young people and their families to be smart users of their smartphones and social media as we learn more detail about risk and vulnerability.

Start by asking your patients how much time they spend on screens of all sorts and on social media in particular. Find out if there are rules at school or at home limiting screen time or social media. Are there disagreements about screen time? Are patients frustrated with their parents’ use of screens? What are their favorite apps to use? How much time do they think they spend on them? If they don’t know, point out how they can track it on their phone directly. Is it painful to be separated from their phone? Do they have interests or hobbies that are not screen-based? What would they do if the power or Wi-Fi was out for a week? These questions can be the start of an ongoing project for screen time and social media literacy.

Dr. Susan D. Swick

 

Recognize That Apps Are Designed to Be Addictive

Smartphones are useful tools designed to help people stay connected, manage their bank accounts, keep up with current events, access entertainment, and much more. It is easy to spend more time than one intended on them. The applications developed for smartphones promise, and often deliver, efficiency and ease, including staying connected to friends and families. But social media applications have been developed to make their parent companies profit from ad revenue or selling user data. They are designed to encourage more and more use, and for some may become addictive. Start the literacy course with a clear statement of this fact. Remind teenagers that they are often the target audience for the corporations making money from these apps. They are especially sensitive to the likes and followers that can be the currency of social media. For every minute they spend on the apps, a corporation is profiting. It can be helpful to remind teenagers to bring their healthy skepticism of authority to their use of these corporate products.

Dr. Michael S. Jellinek

Develop Awareness of Their Time, Energy, and Mood

Time is our most precious commodity, and most teenagers are stressed by not having enough of it. Ask your patients about the variety of things they need to do and want to do each day. Do they have enough time to do the things they want beyond their smartphones? Is the time on their smartphones more or less than they want? How do they feel when they finish with different activities? Energized? Engaged? Exhilarated? Drained? Irritable? Sad? Do they feel connected? Lonely? Loved? Left out? Suggest that they pay attention to how they feel after engaging in all kinds of activities (including homework, sports, hobbies, and time with friends), as these are the types of choices they will make throughout their adult lives. Some tasks are simply required (homework), some are relaxing (leaving us feeling calm and even sleepy), and some are recharging (leaving us feeling focused and energized). If an activity consistently leaves them drained and irritable, sad, and lonely or discouraged and insecure, they need to step back and ask themselves why they are making this choice and if that is the choice they want to make. Support their developing self-awareness, activating their sense of agency and independence in making choices that will serve them.

Develop Awareness of Their Sense of Connection to Others

As your patients are paying attention to their mood, focus, interest, and energy, they can also pay attention to these components of their social life. How do they feel with individual friends? With different groups? In different settings? How does this compare with how they feel when engaged with social media? In general, when technology is supporting strong connections with friends, it can enhance their health and well-being. When it helps youth isolated by interests or identity to become connected to supportive youth who are physically far away, it can be a social lifeline. But sometimes, social media exploits youth sensitivity to peer opinions and social comparison to keep their attention without the payoff of deepened or new relationships. Do they know the youth they are chatting with or following? Could they spend 2 hours with them offline? How do they feel after spending 2 hours “with” them online? Once again, the goal is to develop teens’ awareness of the quality of their relationships and of their control over how to manage this.

Acknowledge Their Own Vulnerabilities

Does your patient have attention-deficit/hyperactivity disorder (ADHD)? Are they being treated for depression? An anxiety disorder? An eating disorder? While we cannot say whether excessive use of social media can cause these problems, we know that it can be counterproductive to their treatment. Youth with ADHD have great difficulty switching their cognitive focus away from something rewarding, so are particularly prone to spending excessive time in addictive apps. Those with depression often have low energy and initiative alongside feelings of worthlessness that can make engaging in physical, in-person activities challenging. Those with anxiety disorders are prone to rumination and avoidance. The possibility of escaping into virtual social activities or distractions can be very hard to resist and counter-therapeutic for these youth (and adults). Those with eating disorders are vulnerable to comparing themselves with idealized (airbrushed) images online, which can intensify the body image distortion and competitiveness that are common in eating disorders. While there may be helpful information about diagnoses, treatment, and support, there is also troubling information about self-injury, restrictive eating, and even suicide that can increase the risk for these behaviors in vulnerable youth. You can help your patients cultivate awareness of how to take good care of themselves.

 

 

Create Habits That Support Sleep, Exercise, and Relationships

Talk with your patients and their parents about strategies to set habits that will make it easier for them to be smart users of their smartphones. Can they explore new apps or games together? Can they talk together about how each of them relaxes and recharges? Then they can work together on how this tool (and toy) can fit into a healthy life. The task is to prioritize sleep, exercise, and live, in-person social time, so virtual activities don’t take over the time needed for them. This can be as simple as consistent bed and waking times and ensuring that smartphones are not at the dining table or in bedrooms at night. Having dinner together as a family most nights (an especially positive habit), going for walks, runs, or hikes together, or doing activities that everyone enjoys (playing music or board games, making cookies or art, gardening) are beneficial for every family member’s physical and mental health and ensure that screen time is not at the expense of real connection. Invite your patients to tell you how they practice putting their smartphones away, getting their homework done, or making time for activities that matter to them. And find out how they relax and recharge beyond using their smartphones. Healthy habits evolve over a lifetime, and there will surely be new technologies that require new limits in the coming years. Helping your patients to make good choices will serve them well as they enter adulthood and throughout their lives.

Dr. Swick is physician in chief at Ohana Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (California) Peninsula. Dr. Michael S. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

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Amid the declarations about the current mental health crisis among youth, it has become increasingly common to link rising rates of anxiety and depression among youth to screen time, and more specifically to hours spent on social media. But in truth, this matter is far from settled. The evidence linking mood and anxiety disorders to social media use is inconsistent. And where the evidence is stronger, causality has not been established. Does screen time precipitate an episode of depression or does a preteen at risk for depression, in the midst of a divorce or burdened by learning problems, use screen time excessively as a solution to these problems? There is also substantial variation across age groups, genders, and other factors that suggests that time spent on smartphone apps may not be the primary factor creating risk. Indeed, there is growing uncertainty about whether the climbing rates of anxiety and mood disorders among youth reflect yet to be identified factors increasing the burden of mental illness or the altered screening and tracking landscape in the United States after COVID and the Affordable Care Act. This uncertainty does not mean that we cannot make recommendations about how to guide patients and their families. Smartphones (and watches, glasses, etc) are here to stay. We can help young people and their families to be smart users of their smartphones and social media as we learn more detail about risk and vulnerability.

Start by asking your patients how much time they spend on screens of all sorts and on social media in particular. Find out if there are rules at school or at home limiting screen time or social media. Are there disagreements about screen time? Are patients frustrated with their parents’ use of screens? What are their favorite apps to use? How much time do they think they spend on them? If they don’t know, point out how they can track it on their phone directly. Is it painful to be separated from their phone? Do they have interests or hobbies that are not screen-based? What would they do if the power or Wi-Fi was out for a week? These questions can be the start of an ongoing project for screen time and social media literacy.

Dr. Susan D. Swick

 

Recognize That Apps Are Designed to Be Addictive

Smartphones are useful tools designed to help people stay connected, manage their bank accounts, keep up with current events, access entertainment, and much more. It is easy to spend more time than one intended on them. The applications developed for smartphones promise, and often deliver, efficiency and ease, including staying connected to friends and families. But social media applications have been developed to make their parent companies profit from ad revenue or selling user data. They are designed to encourage more and more use, and for some may become addictive. Start the literacy course with a clear statement of this fact. Remind teenagers that they are often the target audience for the corporations making money from these apps. They are especially sensitive to the likes and followers that can be the currency of social media. For every minute they spend on the apps, a corporation is profiting. It can be helpful to remind teenagers to bring their healthy skepticism of authority to their use of these corporate products.

Dr. Michael S. Jellinek

Develop Awareness of Their Time, Energy, and Mood

Time is our most precious commodity, and most teenagers are stressed by not having enough of it. Ask your patients about the variety of things they need to do and want to do each day. Do they have enough time to do the things they want beyond their smartphones? Is the time on their smartphones more or less than they want? How do they feel when they finish with different activities? Energized? Engaged? Exhilarated? Drained? Irritable? Sad? Do they feel connected? Lonely? Loved? Left out? Suggest that they pay attention to how they feel after engaging in all kinds of activities (including homework, sports, hobbies, and time with friends), as these are the types of choices they will make throughout their adult lives. Some tasks are simply required (homework), some are relaxing (leaving us feeling calm and even sleepy), and some are recharging (leaving us feeling focused and energized). If an activity consistently leaves them drained and irritable, sad, and lonely or discouraged and insecure, they need to step back and ask themselves why they are making this choice and if that is the choice they want to make. Support their developing self-awareness, activating their sense of agency and independence in making choices that will serve them.

Develop Awareness of Their Sense of Connection to Others

As your patients are paying attention to their mood, focus, interest, and energy, they can also pay attention to these components of their social life. How do they feel with individual friends? With different groups? In different settings? How does this compare with how they feel when engaged with social media? In general, when technology is supporting strong connections with friends, it can enhance their health and well-being. When it helps youth isolated by interests or identity to become connected to supportive youth who are physically far away, it can be a social lifeline. But sometimes, social media exploits youth sensitivity to peer opinions and social comparison to keep their attention without the payoff of deepened or new relationships. Do they know the youth they are chatting with or following? Could they spend 2 hours with them offline? How do they feel after spending 2 hours “with” them online? Once again, the goal is to develop teens’ awareness of the quality of their relationships and of their control over how to manage this.

Acknowledge Their Own Vulnerabilities

Does your patient have attention-deficit/hyperactivity disorder (ADHD)? Are they being treated for depression? An anxiety disorder? An eating disorder? While we cannot say whether excessive use of social media can cause these problems, we know that it can be counterproductive to their treatment. Youth with ADHD have great difficulty switching their cognitive focus away from something rewarding, so are particularly prone to spending excessive time in addictive apps. Those with depression often have low energy and initiative alongside feelings of worthlessness that can make engaging in physical, in-person activities challenging. Those with anxiety disorders are prone to rumination and avoidance. The possibility of escaping into virtual social activities or distractions can be very hard to resist and counter-therapeutic for these youth (and adults). Those with eating disorders are vulnerable to comparing themselves with idealized (airbrushed) images online, which can intensify the body image distortion and competitiveness that are common in eating disorders. While there may be helpful information about diagnoses, treatment, and support, there is also troubling information about self-injury, restrictive eating, and even suicide that can increase the risk for these behaviors in vulnerable youth. You can help your patients cultivate awareness of how to take good care of themselves.

 

 

Create Habits That Support Sleep, Exercise, and Relationships

Talk with your patients and their parents about strategies to set habits that will make it easier for them to be smart users of their smartphones. Can they explore new apps or games together? Can they talk together about how each of them relaxes and recharges? Then they can work together on how this tool (and toy) can fit into a healthy life. The task is to prioritize sleep, exercise, and live, in-person social time, so virtual activities don’t take over the time needed for them. This can be as simple as consistent bed and waking times and ensuring that smartphones are not at the dining table or in bedrooms at night. Having dinner together as a family most nights (an especially positive habit), going for walks, runs, or hikes together, or doing activities that everyone enjoys (playing music or board games, making cookies or art, gardening) are beneficial for every family member’s physical and mental health and ensure that screen time is not at the expense of real connection. Invite your patients to tell you how they practice putting their smartphones away, getting their homework done, or making time for activities that matter to them. And find out how they relax and recharge beyond using their smartphones. Healthy habits evolve over a lifetime, and there will surely be new technologies that require new limits in the coming years. Helping your patients to make good choices will serve them well as they enter adulthood and throughout their lives.

Dr. Swick is physician in chief at Ohana Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (California) Peninsula. Dr. Michael S. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

Amid the declarations about the current mental health crisis among youth, it has become increasingly common to link rising rates of anxiety and depression among youth to screen time, and more specifically to hours spent on social media. But in truth, this matter is far from settled. The evidence linking mood and anxiety disorders to social media use is inconsistent. And where the evidence is stronger, causality has not been established. Does screen time precipitate an episode of depression or does a preteen at risk for depression, in the midst of a divorce or burdened by learning problems, use screen time excessively as a solution to these problems? There is also substantial variation across age groups, genders, and other factors that suggests that time spent on smartphone apps may not be the primary factor creating risk. Indeed, there is growing uncertainty about whether the climbing rates of anxiety and mood disorders among youth reflect yet to be identified factors increasing the burden of mental illness or the altered screening and tracking landscape in the United States after COVID and the Affordable Care Act. This uncertainty does not mean that we cannot make recommendations about how to guide patients and their families. Smartphones (and watches, glasses, etc) are here to stay. We can help young people and their families to be smart users of their smartphones and social media as we learn more detail about risk and vulnerability.

Start by asking your patients how much time they spend on screens of all sorts and on social media in particular. Find out if there are rules at school or at home limiting screen time or social media. Are there disagreements about screen time? Are patients frustrated with their parents’ use of screens? What are their favorite apps to use? How much time do they think they spend on them? If they don’t know, point out how they can track it on their phone directly. Is it painful to be separated from their phone? Do they have interests or hobbies that are not screen-based? What would they do if the power or Wi-Fi was out for a week? These questions can be the start of an ongoing project for screen time and social media literacy.

Dr. Susan D. Swick

 

Recognize That Apps Are Designed to Be Addictive

Smartphones are useful tools designed to help people stay connected, manage their bank accounts, keep up with current events, access entertainment, and much more. It is easy to spend more time than one intended on them. The applications developed for smartphones promise, and often deliver, efficiency and ease, including staying connected to friends and families. But social media applications have been developed to make their parent companies profit from ad revenue or selling user data. They are designed to encourage more and more use, and for some may become addictive. Start the literacy course with a clear statement of this fact. Remind teenagers that they are often the target audience for the corporations making money from these apps. They are especially sensitive to the likes and followers that can be the currency of social media. For every minute they spend on the apps, a corporation is profiting. It can be helpful to remind teenagers to bring their healthy skepticism of authority to their use of these corporate products.

Dr. Michael S. Jellinek

Develop Awareness of Their Time, Energy, and Mood

Time is our most precious commodity, and most teenagers are stressed by not having enough of it. Ask your patients about the variety of things they need to do and want to do each day. Do they have enough time to do the things they want beyond their smartphones? Is the time on their smartphones more or less than they want? How do they feel when they finish with different activities? Energized? Engaged? Exhilarated? Drained? Irritable? Sad? Do they feel connected? Lonely? Loved? Left out? Suggest that they pay attention to how they feel after engaging in all kinds of activities (including homework, sports, hobbies, and time with friends), as these are the types of choices they will make throughout their adult lives. Some tasks are simply required (homework), some are relaxing (leaving us feeling calm and even sleepy), and some are recharging (leaving us feeling focused and energized). If an activity consistently leaves them drained and irritable, sad, and lonely or discouraged and insecure, they need to step back and ask themselves why they are making this choice and if that is the choice they want to make. Support their developing self-awareness, activating their sense of agency and independence in making choices that will serve them.

Develop Awareness of Their Sense of Connection to Others

As your patients are paying attention to their mood, focus, interest, and energy, they can also pay attention to these components of their social life. How do they feel with individual friends? With different groups? In different settings? How does this compare with how they feel when engaged with social media? In general, when technology is supporting strong connections with friends, it can enhance their health and well-being. When it helps youth isolated by interests or identity to become connected to supportive youth who are physically far away, it can be a social lifeline. But sometimes, social media exploits youth sensitivity to peer opinions and social comparison to keep their attention without the payoff of deepened or new relationships. Do they know the youth they are chatting with or following? Could they spend 2 hours with them offline? How do they feel after spending 2 hours “with” them online? Once again, the goal is to develop teens’ awareness of the quality of their relationships and of their control over how to manage this.

Acknowledge Their Own Vulnerabilities

Does your patient have attention-deficit/hyperactivity disorder (ADHD)? Are they being treated for depression? An anxiety disorder? An eating disorder? While we cannot say whether excessive use of social media can cause these problems, we know that it can be counterproductive to their treatment. Youth with ADHD have great difficulty switching their cognitive focus away from something rewarding, so are particularly prone to spending excessive time in addictive apps. Those with depression often have low energy and initiative alongside feelings of worthlessness that can make engaging in physical, in-person activities challenging. Those with anxiety disorders are prone to rumination and avoidance. The possibility of escaping into virtual social activities or distractions can be very hard to resist and counter-therapeutic for these youth (and adults). Those with eating disorders are vulnerable to comparing themselves with idealized (airbrushed) images online, which can intensify the body image distortion and competitiveness that are common in eating disorders. While there may be helpful information about diagnoses, treatment, and support, there is also troubling information about self-injury, restrictive eating, and even suicide that can increase the risk for these behaviors in vulnerable youth. You can help your patients cultivate awareness of how to take good care of themselves.

 

 

Create Habits That Support Sleep, Exercise, and Relationships

Talk with your patients and their parents about strategies to set habits that will make it easier for them to be smart users of their smartphones. Can they explore new apps or games together? Can they talk together about how each of them relaxes and recharges? Then they can work together on how this tool (and toy) can fit into a healthy life. The task is to prioritize sleep, exercise, and live, in-person social time, so virtual activities don’t take over the time needed for them. This can be as simple as consistent bed and waking times and ensuring that smartphones are not at the dining table or in bedrooms at night. Having dinner together as a family most nights (an especially positive habit), going for walks, runs, or hikes together, or doing activities that everyone enjoys (playing music or board games, making cookies or art, gardening) are beneficial for every family member’s physical and mental health and ensure that screen time is not at the expense of real connection. Invite your patients to tell you how they practice putting their smartphones away, getting their homework done, or making time for activities that matter to them. And find out how they relax and recharge beyond using their smartphones. Healthy habits evolve over a lifetime, and there will surely be new technologies that require new limits in the coming years. Helping your patients to make good choices will serve them well as they enter adulthood and throughout their lives.

Dr. Swick is physician in chief at Ohana Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (California) Peninsula. Dr. Michael S. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

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Pediatricians Face Competing Goals in Well Visits for LGBTQ+ Adolescents

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Wed, 05/15/2024 - 11:05

In the course of a well visit, the way in which clinicians elicit an adolescent’s sexual orientation and gender identity (SOGI) matters, and there are different preferences for those with a gender identity different from their birth assignment or non-heterosexuals relative to those in neither of these categories.

In a study that surveyed more than 60,000 adolescents, one of the messages was that there is a “balancing act” that involves affirming the child’s self-identity while recognizing the substantial vulnerability at this step in development, reported Scott Jelinek, MD, a third-year pediatrics resident in the Children’s Hospital of Philadelphia, University of Pennsylvania.

Based on his work, there are two aims.

“The first is to determine the comfort level of the adolescent in discussing sensitive health information,” said Dr. Jelinek, referring to the discussion of SOGI irrespective of how the adolescent responds. “To understand this is crucial because this first encounter with healthcare can be formative.”

Yet, for those who identify as lesbian, gay, bisexual, transsexual, queer, or with another sexual or gender orientation (LBGTQ+), the encounter can be more delicate, according to Dr. Jelinek. One reason is that there is greater uncertainty about acceptance of these identities from peers, parents, and others, Dr. Jelinek said.

This was reinforced by results of a cross-sectional study of 62,695 adolescents in 31 pediatric clinics in the Philadelphia area. Of these, 10,381 (16.6%) identified as LGBTQ+. The adolescents aged in range from 13 to 21 years with a mean age of 15.3.

These data were presented at the Pediatric Academic Societies annual meeting. Dr. Jelinek received this year’s Society of Pediatric Research Richard D. Rowe Award for clinical research by a fellow.
 

Revealing Sensitive Information

With the intention of comparing responses from LBGTQ+ youth to those of cisgender heterosexuals, the first of two primary questions elicited information about comfort level discussing SOGI in the presence of parents or caregivers during a primary care visit. The second asked for a preference regarding electronic or oral capture of the information. “Almost half [49.4%] of the LGBTQ+ adolescents expressed discomfort discussing this information with the caregiver present,” reported Dr. Jelinek. This proportion, which was close to double the 25.5% rate among the cisgender heterosexual respondents, reached significance (P < .01). After adjustment for covariates, there was a 60% greater odds ratio (OR) among LBGTQ+ adolescents for expressing reluctance to share this information in front of a caregiver (adjusted odds ratio [aOR] 0.37; 95% CI: 0.35-0.39).

The greater preference among LBGTQ+ adolescents for electronic capture of SOGI-relevant information also reached statistical significance. Even though the proportional difference was modest (74.2% vs 72.7%; P < .01), it corresponded to about a 10% greater preference for electronic data collection after adjustment (aOR 1.08; 95% CI: 1.03-1.14), Dr. Jelinek reported.

These results were generally consistent across clinics, which were located in urban, suburban, and rural areas. Responses among Black adolescents, which represented 29.7% of the study population, were similar to those provided by White adolescents, which represented 46.1%, and Hispanics, which represented about 10% of the sample.

The results are not entirely surprising in the context of the potential for LBGTQ+ stigma, but Dr. Jelinek emphasized the need for being aware that this discussion is delicate and might have ramifications after the visit for children trying to accept and affirm their self-identification.

“Let us remember that the healthcare system has the potential to be a powerful ally in the lives of LBGTQ+ youth and to meet their unique needs,” he said.

The interaction is also delicate because parents might not yet be aware of their child’s sexual orientation. Indeed, Dr. Jelinek said that completion of the Attitudes Toward Homosexuality Questionnaire (AHQ) might be the first time that these individuals have revealed this aspect of their identity to anyone.

For confirming a non-heterosexual orientation, “pediatricians are on the front line and often the first point of contact for adolescents seeking health support and affirmation,” he said.

For this reason, it is also essential to maintain confidentiality to the degree that the patient specifies. Dr. Jelinek recognizes tension when balancing visibility and affirmation against the need for privacy, but he said both are important. Even if pediatricians should provide a positive experience for adolescents revealing their sexual orientation, there might be personal, family, and social adjustments to navigate over time.

As a result, Dr. Jelinek warned that there are issues for protecting information that an adolescent is not ready to reveal.

In this regard. “there is an urgent need for innovative solutions to balance visibility with privacy in primary care,” he said, reporting that electronic medical records (EMR) do not necessarily guarantee confidentiality, particularly from family members.

When adolescents arrive at the office to complete an AHQ, front desk staff at Dr. Jelinek’s center are instructed to hand the tablet to the child, not the caregiver. However, he recognizes that this does not prevent the caregiver from reviewing the answers or in some cases taking the tablet to complete the answers.

“If I enter the exam room and see the tablet in a parent’s lap, I am going to want to have a conversation with the patient to verify the answers,” he said.
 

 

 

Protecting Patients

The data from this study provoke important questions about how to achieve the goals that Dr. Jelinek described, according to Ashley M. Lekach, MSN, RN, a family nurse practitioner working in pediatric endocrinology at NewYork-Presbyterian’s Methodist Hospital in Brooklyn, New York. Ms. Lekach was not involved with the study.

“My concern is that once we are given this sensitive information, how do we make sure we are going to protect the patient from unwanted disclosure?” Ms. Lekach said. She agreed that there is a risk that EMRs can be accessed by individuals to which the patient would not want SOGI information revealed.

“It is a vote of confidence for the patient to reveal this information to me, and it is clearly our job to make sure the patient feels safe,” she said.

She also expressed concern that adolescents who reveal this information might need resources to cope with issues raised by non-heterosexual identification. She agreed that discussing sexual orientation and gender identity in the clinical setting is often a major step for adolescents, particularly young adolescents, but she believes follow-up and next steps are in the interest of the patient.

Although the need for affirmation and confidentiality are not new ideas, Ms. Lekach said that the talk provided some useful context for thinking about these issues.

Dr. Jelinek and Ms. Lekach report no potential conflicts of interest.

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In the course of a well visit, the way in which clinicians elicit an adolescent’s sexual orientation and gender identity (SOGI) matters, and there are different preferences for those with a gender identity different from their birth assignment or non-heterosexuals relative to those in neither of these categories.

In a study that surveyed more than 60,000 adolescents, one of the messages was that there is a “balancing act” that involves affirming the child’s self-identity while recognizing the substantial vulnerability at this step in development, reported Scott Jelinek, MD, a third-year pediatrics resident in the Children’s Hospital of Philadelphia, University of Pennsylvania.

Based on his work, there are two aims.

“The first is to determine the comfort level of the adolescent in discussing sensitive health information,” said Dr. Jelinek, referring to the discussion of SOGI irrespective of how the adolescent responds. “To understand this is crucial because this first encounter with healthcare can be formative.”

Yet, for those who identify as lesbian, gay, bisexual, transsexual, queer, or with another sexual or gender orientation (LBGTQ+), the encounter can be more delicate, according to Dr. Jelinek. One reason is that there is greater uncertainty about acceptance of these identities from peers, parents, and others, Dr. Jelinek said.

This was reinforced by results of a cross-sectional study of 62,695 adolescents in 31 pediatric clinics in the Philadelphia area. Of these, 10,381 (16.6%) identified as LGBTQ+. The adolescents aged in range from 13 to 21 years with a mean age of 15.3.

These data were presented at the Pediatric Academic Societies annual meeting. Dr. Jelinek received this year’s Society of Pediatric Research Richard D. Rowe Award for clinical research by a fellow.
 

Revealing Sensitive Information

With the intention of comparing responses from LBGTQ+ youth to those of cisgender heterosexuals, the first of two primary questions elicited information about comfort level discussing SOGI in the presence of parents or caregivers during a primary care visit. The second asked for a preference regarding electronic or oral capture of the information. “Almost half [49.4%] of the LGBTQ+ adolescents expressed discomfort discussing this information with the caregiver present,” reported Dr. Jelinek. This proportion, which was close to double the 25.5% rate among the cisgender heterosexual respondents, reached significance (P < .01). After adjustment for covariates, there was a 60% greater odds ratio (OR) among LBGTQ+ adolescents for expressing reluctance to share this information in front of a caregiver (adjusted odds ratio [aOR] 0.37; 95% CI: 0.35-0.39).

The greater preference among LBGTQ+ adolescents for electronic capture of SOGI-relevant information also reached statistical significance. Even though the proportional difference was modest (74.2% vs 72.7%; P < .01), it corresponded to about a 10% greater preference for electronic data collection after adjustment (aOR 1.08; 95% CI: 1.03-1.14), Dr. Jelinek reported.

These results were generally consistent across clinics, which were located in urban, suburban, and rural areas. Responses among Black adolescents, which represented 29.7% of the study population, were similar to those provided by White adolescents, which represented 46.1%, and Hispanics, which represented about 10% of the sample.

The results are not entirely surprising in the context of the potential for LBGTQ+ stigma, but Dr. Jelinek emphasized the need for being aware that this discussion is delicate and might have ramifications after the visit for children trying to accept and affirm their self-identification.

“Let us remember that the healthcare system has the potential to be a powerful ally in the lives of LBGTQ+ youth and to meet their unique needs,” he said.

The interaction is also delicate because parents might not yet be aware of their child’s sexual orientation. Indeed, Dr. Jelinek said that completion of the Attitudes Toward Homosexuality Questionnaire (AHQ) might be the first time that these individuals have revealed this aspect of their identity to anyone.

For confirming a non-heterosexual orientation, “pediatricians are on the front line and often the first point of contact for adolescents seeking health support and affirmation,” he said.

For this reason, it is also essential to maintain confidentiality to the degree that the patient specifies. Dr. Jelinek recognizes tension when balancing visibility and affirmation against the need for privacy, but he said both are important. Even if pediatricians should provide a positive experience for adolescents revealing their sexual orientation, there might be personal, family, and social adjustments to navigate over time.

As a result, Dr. Jelinek warned that there are issues for protecting information that an adolescent is not ready to reveal.

In this regard. “there is an urgent need for innovative solutions to balance visibility with privacy in primary care,” he said, reporting that electronic medical records (EMR) do not necessarily guarantee confidentiality, particularly from family members.

When adolescents arrive at the office to complete an AHQ, front desk staff at Dr. Jelinek’s center are instructed to hand the tablet to the child, not the caregiver. However, he recognizes that this does not prevent the caregiver from reviewing the answers or in some cases taking the tablet to complete the answers.

“If I enter the exam room and see the tablet in a parent’s lap, I am going to want to have a conversation with the patient to verify the answers,” he said.
 

 

 

Protecting Patients

The data from this study provoke important questions about how to achieve the goals that Dr. Jelinek described, according to Ashley M. Lekach, MSN, RN, a family nurse practitioner working in pediatric endocrinology at NewYork-Presbyterian’s Methodist Hospital in Brooklyn, New York. Ms. Lekach was not involved with the study.

“My concern is that once we are given this sensitive information, how do we make sure we are going to protect the patient from unwanted disclosure?” Ms. Lekach said. She agreed that there is a risk that EMRs can be accessed by individuals to which the patient would not want SOGI information revealed.

“It is a vote of confidence for the patient to reveal this information to me, and it is clearly our job to make sure the patient feels safe,” she said.

She also expressed concern that adolescents who reveal this information might need resources to cope with issues raised by non-heterosexual identification. She agreed that discussing sexual orientation and gender identity in the clinical setting is often a major step for adolescents, particularly young adolescents, but she believes follow-up and next steps are in the interest of the patient.

Although the need for affirmation and confidentiality are not new ideas, Ms. Lekach said that the talk provided some useful context for thinking about these issues.

Dr. Jelinek and Ms. Lekach report no potential conflicts of interest.

In the course of a well visit, the way in which clinicians elicit an adolescent’s sexual orientation and gender identity (SOGI) matters, and there are different preferences for those with a gender identity different from their birth assignment or non-heterosexuals relative to those in neither of these categories.

In a study that surveyed more than 60,000 adolescents, one of the messages was that there is a “balancing act” that involves affirming the child’s self-identity while recognizing the substantial vulnerability at this step in development, reported Scott Jelinek, MD, a third-year pediatrics resident in the Children’s Hospital of Philadelphia, University of Pennsylvania.

Based on his work, there are two aims.

“The first is to determine the comfort level of the adolescent in discussing sensitive health information,” said Dr. Jelinek, referring to the discussion of SOGI irrespective of how the adolescent responds. “To understand this is crucial because this first encounter with healthcare can be formative.”

Yet, for those who identify as lesbian, gay, bisexual, transsexual, queer, or with another sexual or gender orientation (LBGTQ+), the encounter can be more delicate, according to Dr. Jelinek. One reason is that there is greater uncertainty about acceptance of these identities from peers, parents, and others, Dr. Jelinek said.

This was reinforced by results of a cross-sectional study of 62,695 adolescents in 31 pediatric clinics in the Philadelphia area. Of these, 10,381 (16.6%) identified as LGBTQ+. The adolescents aged in range from 13 to 21 years with a mean age of 15.3.

These data were presented at the Pediatric Academic Societies annual meeting. Dr. Jelinek received this year’s Society of Pediatric Research Richard D. Rowe Award for clinical research by a fellow.
 

Revealing Sensitive Information

With the intention of comparing responses from LBGTQ+ youth to those of cisgender heterosexuals, the first of two primary questions elicited information about comfort level discussing SOGI in the presence of parents or caregivers during a primary care visit. The second asked for a preference regarding electronic or oral capture of the information. “Almost half [49.4%] of the LGBTQ+ adolescents expressed discomfort discussing this information with the caregiver present,” reported Dr. Jelinek. This proportion, which was close to double the 25.5% rate among the cisgender heterosexual respondents, reached significance (P < .01). After adjustment for covariates, there was a 60% greater odds ratio (OR) among LBGTQ+ adolescents for expressing reluctance to share this information in front of a caregiver (adjusted odds ratio [aOR] 0.37; 95% CI: 0.35-0.39).

The greater preference among LBGTQ+ adolescents for electronic capture of SOGI-relevant information also reached statistical significance. Even though the proportional difference was modest (74.2% vs 72.7%; P < .01), it corresponded to about a 10% greater preference for electronic data collection after adjustment (aOR 1.08; 95% CI: 1.03-1.14), Dr. Jelinek reported.

These results were generally consistent across clinics, which were located in urban, suburban, and rural areas. Responses among Black adolescents, which represented 29.7% of the study population, were similar to those provided by White adolescents, which represented 46.1%, and Hispanics, which represented about 10% of the sample.

The results are not entirely surprising in the context of the potential for LBGTQ+ stigma, but Dr. Jelinek emphasized the need for being aware that this discussion is delicate and might have ramifications after the visit for children trying to accept and affirm their self-identification.

“Let us remember that the healthcare system has the potential to be a powerful ally in the lives of LBGTQ+ youth and to meet their unique needs,” he said.

The interaction is also delicate because parents might not yet be aware of their child’s sexual orientation. Indeed, Dr. Jelinek said that completion of the Attitudes Toward Homosexuality Questionnaire (AHQ) might be the first time that these individuals have revealed this aspect of their identity to anyone.

For confirming a non-heterosexual orientation, “pediatricians are on the front line and often the first point of contact for adolescents seeking health support and affirmation,” he said.

For this reason, it is also essential to maintain confidentiality to the degree that the patient specifies. Dr. Jelinek recognizes tension when balancing visibility and affirmation against the need for privacy, but he said both are important. Even if pediatricians should provide a positive experience for adolescents revealing their sexual orientation, there might be personal, family, and social adjustments to navigate over time.

As a result, Dr. Jelinek warned that there are issues for protecting information that an adolescent is not ready to reveal.

In this regard. “there is an urgent need for innovative solutions to balance visibility with privacy in primary care,” he said, reporting that electronic medical records (EMR) do not necessarily guarantee confidentiality, particularly from family members.

When adolescents arrive at the office to complete an AHQ, front desk staff at Dr. Jelinek’s center are instructed to hand the tablet to the child, not the caregiver. However, he recognizes that this does not prevent the caregiver from reviewing the answers or in some cases taking the tablet to complete the answers.

“If I enter the exam room and see the tablet in a parent’s lap, I am going to want to have a conversation with the patient to verify the answers,” he said.
 

 

 

Protecting Patients

The data from this study provoke important questions about how to achieve the goals that Dr. Jelinek described, according to Ashley M. Lekach, MSN, RN, a family nurse practitioner working in pediatric endocrinology at NewYork-Presbyterian’s Methodist Hospital in Brooklyn, New York. Ms. Lekach was not involved with the study.

“My concern is that once we are given this sensitive information, how do we make sure we are going to protect the patient from unwanted disclosure?” Ms. Lekach said. She agreed that there is a risk that EMRs can be accessed by individuals to which the patient would not want SOGI information revealed.

“It is a vote of confidence for the patient to reveal this information to me, and it is clearly our job to make sure the patient feels safe,” she said.

She also expressed concern that adolescents who reveal this information might need resources to cope with issues raised by non-heterosexual identification. She agreed that discussing sexual orientation and gender identity in the clinical setting is often a major step for adolescents, particularly young adolescents, but she believes follow-up and next steps are in the interest of the patient.

Although the need for affirmation and confidentiality are not new ideas, Ms. Lekach said that the talk provided some useful context for thinking about these issues.

Dr. Jelinek and Ms. Lekach report no potential conflicts of interest.

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More Rapid Confirmation of an Autism Diagnosis Is Coming to Primary Care

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TORONTO — Driven by evidence that early access to autism services improves long-term outcomes, an evolution is rapidly unfolding to accelerate the diagnosis, often with the direct participation of pediatricians, according to a series of studies presented at the Pediatric Academic Societies annual meeting.

Accelerated Diagnosis

In one study, 80% of the evaluations were conducted within 6 weeks of patient enrollment, according to Corinna Rea, MD, a clinician in the primary care center at Boston Children’s Hospital as well as an assistant professor at Harvard Medical School, Boston, Massachusetts.

This outcome was drawn from a pilot study with 179 children suspected of autism spectrum disorder (ASD) by clinicians in a pediatric clinic. All were under the age of 3 years. In the first step, families completed the Bayley-4 Social-Emotional and Adaptive Behavior Scale.

The next step was a virtual assessment by a trained clinician using the TELE-ADS-PEDs (TAP) tool developed by Vanderbilt University, Nashville, Tennessee. Patients and families participated from their homes. The diagnosis of ASD was made by a psychologist using the patient’s history and data provided by the two assessment tools.

Through this approach, the median time to diagnosis was 30 days, according to Dr. Rea. Relative to a median time of 168 days to diagnosis among patients considered likely to have ASD at Dr. Rea’s center in the year prior to this pilot study, the time was reduced significantly (P < .001).

All patients in the study were subsequently evaluated by traditional methods. One hundred percent of the ASD diagnoses were confirmed with traditional assessment.

On the basis of these data, the accelerated approach “seems efficient and quite accurate,” Dr. Rea reported. When family members were surveyed at the end of the pilot study, 60% were satisfied and 28% were moderately satisfied. Although 59% reported that they would have preferred an in-person assessment, approximately 90% agreed the child’s development was mostly or completely captured in the accelerated assessment.

Dr. Rea pointed out that the psychologists participating in this study offered the opinion that home-based assessments are in their experience better than in-person evaluations due to the more natural behavior of the child in their own environment. However, she said that the diagnostic approach in the pilot study is still being modified, and one of the goals is to make virtual assessment more acceptable to the families.
 

A Commercialized Diagnostic Approach

A similar approach has been commercialized by a firm called As You Are, according to Steven D. Hicks, MD, PhD, who is an associate professor of pediatrics at Pennsylvania State University College of Medicine, Hershey, Pennsylvania. Dr. Hicks is a principal in the enterprise, which is also assessing ASD virtually.

Trained pediatricians are evaluating patients with multiple tools in addition to TAP, including the Childhood Autism Rating Scale (CARS) and the Diagnostic and Statistical Manual (DSM-V) checklist for ASD. The company, which began offering this diagnostic service in 2022, now employs more than 30 pediatricians who participated in a 1-month training program.

At the 2024 PAS meeting, quality assurance data were presented on 215 (2.2%) of the 9632 children evaluated between February 2023 and March 2024. The diagnostic assessments of these randomly selected children were reviewed by one of three randomly assigned experts (a developmental pediatrician, a child psychologist, or a pediatrician with 7 years’ diagnostic experience) blinded to the initial scoring.

The diagnostic agreement was 94%, according to the data presented, providing a specificity of 90% and a sensitivity of 90% for ASD. The commercialized diagnostic approach is providing a diagnosis in a mean time of 29 days from initial contact, compared with delays that typically exceed 1 year for many children with suspected ASD, according to Dr. Hicks.

 

 

Additional Studies Aim at Streamlining Diagnosis

Two additional studies also evaluated strategies to streamline the diagnosis of ASD. Both were positive. In one, the accuracy and time to diagnosis among pediatricians trained in TAP and CARS were compared with those of ASD specialists in a dedicated autism clinic. Both were located at Nemours Children’s Health Center, Wilmington, Delaware.

In this study, presented by Meghan Harrison, DO, an attending pediatrician at Nemours Children’s Health, time to diagnosis among the 39 patients evaluated by pediatricians relative to the 349 patients evaluated at the dedicated ASD center (2.0 vs 5.1 months; P = .001) was significantly shorter. The age at diagnosis in the pediatrician-assessed population (27.5 vs 36.5 months; P < .001) was also significantly younger.

In another study, led by Ashely L. Early, MSW, a clinical social worker at the Medical University of South Carolina, Charleston, South Carolina, switching to a screening tool called the Rapid Interactive Screening Test for Autism in Toddlers (RITA-1) reduced the wait time to evaluation by approximately 5 months relative to previous practice with a more cumbersome screening method.
 

An ‘Urgent Need’ to Accelerate Diagnosis

In most places in the United States, children suspected of ASD are referred to specialists for confirmation of the diagnosis, which is needed to quality for ASD services, according to Katherine Zuckerman, MD, a professor of pediatrics the Oregon Health and Science University, Portland, Oregon. Dr. Zuckerman, who was moderator of the session in which all four of these abstracts were presented, explained that there is an urgent need to accelerate the time to diagnosis, which involves long delays for many if not most children with ASD. This is important because treatment and supportive services for ASD are almost always dependent on a diagnosis.

“There are tons of data to show that earlier access to ASD services has important patient benefits, including higher IQs,” she said. Other benefits she listed include a better quality of life for the child and the family.

“It can provide a huge reduction in family stress,” she added, suggesting that early interventions favorably modify the trajectory of the disability over time with accruing benefits.

“The lifetime costs of ASD exceed cancer and most other disease, so there are major implications for the cumulative cost of ASD management,” Dr. Zuckerman said. She suggested that the studies presented at the meeting reflect a likely evolution in who evaluates children for ASD and how quickly the evaluation is performed.

Dr. Rea, Dr. Harrison, Dr. Zuckerman, and Ms. Early reported no potential conflicts of interest. In addition to his executive role in As You Are, Dr. Hicks has financial relationships with Quadrant Biosciences and Spectrum Solutions.

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TORONTO — Driven by evidence that early access to autism services improves long-term outcomes, an evolution is rapidly unfolding to accelerate the diagnosis, often with the direct participation of pediatricians, according to a series of studies presented at the Pediatric Academic Societies annual meeting.

Accelerated Diagnosis

In one study, 80% of the evaluations were conducted within 6 weeks of patient enrollment, according to Corinna Rea, MD, a clinician in the primary care center at Boston Children’s Hospital as well as an assistant professor at Harvard Medical School, Boston, Massachusetts.

This outcome was drawn from a pilot study with 179 children suspected of autism spectrum disorder (ASD) by clinicians in a pediatric clinic. All were under the age of 3 years. In the first step, families completed the Bayley-4 Social-Emotional and Adaptive Behavior Scale.

The next step was a virtual assessment by a trained clinician using the TELE-ADS-PEDs (TAP) tool developed by Vanderbilt University, Nashville, Tennessee. Patients and families participated from their homes. The diagnosis of ASD was made by a psychologist using the patient’s history and data provided by the two assessment tools.

Through this approach, the median time to diagnosis was 30 days, according to Dr. Rea. Relative to a median time of 168 days to diagnosis among patients considered likely to have ASD at Dr. Rea’s center in the year prior to this pilot study, the time was reduced significantly (P < .001).

All patients in the study were subsequently evaluated by traditional methods. One hundred percent of the ASD diagnoses were confirmed with traditional assessment.

On the basis of these data, the accelerated approach “seems efficient and quite accurate,” Dr. Rea reported. When family members were surveyed at the end of the pilot study, 60% were satisfied and 28% were moderately satisfied. Although 59% reported that they would have preferred an in-person assessment, approximately 90% agreed the child’s development was mostly or completely captured in the accelerated assessment.

Dr. Rea pointed out that the psychologists participating in this study offered the opinion that home-based assessments are in their experience better than in-person evaluations due to the more natural behavior of the child in their own environment. However, she said that the diagnostic approach in the pilot study is still being modified, and one of the goals is to make virtual assessment more acceptable to the families.
 

A Commercialized Diagnostic Approach

A similar approach has been commercialized by a firm called As You Are, according to Steven D. Hicks, MD, PhD, who is an associate professor of pediatrics at Pennsylvania State University College of Medicine, Hershey, Pennsylvania. Dr. Hicks is a principal in the enterprise, which is also assessing ASD virtually.

Trained pediatricians are evaluating patients with multiple tools in addition to TAP, including the Childhood Autism Rating Scale (CARS) and the Diagnostic and Statistical Manual (DSM-V) checklist for ASD. The company, which began offering this diagnostic service in 2022, now employs more than 30 pediatricians who participated in a 1-month training program.

At the 2024 PAS meeting, quality assurance data were presented on 215 (2.2%) of the 9632 children evaluated between February 2023 and March 2024. The diagnostic assessments of these randomly selected children were reviewed by one of three randomly assigned experts (a developmental pediatrician, a child psychologist, or a pediatrician with 7 years’ diagnostic experience) blinded to the initial scoring.

The diagnostic agreement was 94%, according to the data presented, providing a specificity of 90% and a sensitivity of 90% for ASD. The commercialized diagnostic approach is providing a diagnosis in a mean time of 29 days from initial contact, compared with delays that typically exceed 1 year for many children with suspected ASD, according to Dr. Hicks.

 

 

Additional Studies Aim at Streamlining Diagnosis

Two additional studies also evaluated strategies to streamline the diagnosis of ASD. Both were positive. In one, the accuracy and time to diagnosis among pediatricians trained in TAP and CARS were compared with those of ASD specialists in a dedicated autism clinic. Both were located at Nemours Children’s Health Center, Wilmington, Delaware.

In this study, presented by Meghan Harrison, DO, an attending pediatrician at Nemours Children’s Health, time to diagnosis among the 39 patients evaluated by pediatricians relative to the 349 patients evaluated at the dedicated ASD center (2.0 vs 5.1 months; P = .001) was significantly shorter. The age at diagnosis in the pediatrician-assessed population (27.5 vs 36.5 months; P < .001) was also significantly younger.

In another study, led by Ashely L. Early, MSW, a clinical social worker at the Medical University of South Carolina, Charleston, South Carolina, switching to a screening tool called the Rapid Interactive Screening Test for Autism in Toddlers (RITA-1) reduced the wait time to evaluation by approximately 5 months relative to previous practice with a more cumbersome screening method.
 

An ‘Urgent Need’ to Accelerate Diagnosis

In most places in the United States, children suspected of ASD are referred to specialists for confirmation of the diagnosis, which is needed to quality for ASD services, according to Katherine Zuckerman, MD, a professor of pediatrics the Oregon Health and Science University, Portland, Oregon. Dr. Zuckerman, who was moderator of the session in which all four of these abstracts were presented, explained that there is an urgent need to accelerate the time to diagnosis, which involves long delays for many if not most children with ASD. This is important because treatment and supportive services for ASD are almost always dependent on a diagnosis.

“There are tons of data to show that earlier access to ASD services has important patient benefits, including higher IQs,” she said. Other benefits she listed include a better quality of life for the child and the family.

“It can provide a huge reduction in family stress,” she added, suggesting that early interventions favorably modify the trajectory of the disability over time with accruing benefits.

“The lifetime costs of ASD exceed cancer and most other disease, so there are major implications for the cumulative cost of ASD management,” Dr. Zuckerman said. She suggested that the studies presented at the meeting reflect a likely evolution in who evaluates children for ASD and how quickly the evaluation is performed.

Dr. Rea, Dr. Harrison, Dr. Zuckerman, and Ms. Early reported no potential conflicts of interest. In addition to his executive role in As You Are, Dr. Hicks has financial relationships with Quadrant Biosciences and Spectrum Solutions.

TORONTO — Driven by evidence that early access to autism services improves long-term outcomes, an evolution is rapidly unfolding to accelerate the diagnosis, often with the direct participation of pediatricians, according to a series of studies presented at the Pediatric Academic Societies annual meeting.

Accelerated Diagnosis

In one study, 80% of the evaluations were conducted within 6 weeks of patient enrollment, according to Corinna Rea, MD, a clinician in the primary care center at Boston Children’s Hospital as well as an assistant professor at Harvard Medical School, Boston, Massachusetts.

This outcome was drawn from a pilot study with 179 children suspected of autism spectrum disorder (ASD) by clinicians in a pediatric clinic. All were under the age of 3 years. In the first step, families completed the Bayley-4 Social-Emotional and Adaptive Behavior Scale.

The next step was a virtual assessment by a trained clinician using the TELE-ADS-PEDs (TAP) tool developed by Vanderbilt University, Nashville, Tennessee. Patients and families participated from their homes. The diagnosis of ASD was made by a psychologist using the patient’s history and data provided by the two assessment tools.

Through this approach, the median time to diagnosis was 30 days, according to Dr. Rea. Relative to a median time of 168 days to diagnosis among patients considered likely to have ASD at Dr. Rea’s center in the year prior to this pilot study, the time was reduced significantly (P < .001).

All patients in the study were subsequently evaluated by traditional methods. One hundred percent of the ASD diagnoses were confirmed with traditional assessment.

On the basis of these data, the accelerated approach “seems efficient and quite accurate,” Dr. Rea reported. When family members were surveyed at the end of the pilot study, 60% were satisfied and 28% were moderately satisfied. Although 59% reported that they would have preferred an in-person assessment, approximately 90% agreed the child’s development was mostly or completely captured in the accelerated assessment.

Dr. Rea pointed out that the psychologists participating in this study offered the opinion that home-based assessments are in their experience better than in-person evaluations due to the more natural behavior of the child in their own environment. However, she said that the diagnostic approach in the pilot study is still being modified, and one of the goals is to make virtual assessment more acceptable to the families.
 

A Commercialized Diagnostic Approach

A similar approach has been commercialized by a firm called As You Are, according to Steven D. Hicks, MD, PhD, who is an associate professor of pediatrics at Pennsylvania State University College of Medicine, Hershey, Pennsylvania. Dr. Hicks is a principal in the enterprise, which is also assessing ASD virtually.

Trained pediatricians are evaluating patients with multiple tools in addition to TAP, including the Childhood Autism Rating Scale (CARS) and the Diagnostic and Statistical Manual (DSM-V) checklist for ASD. The company, which began offering this diagnostic service in 2022, now employs more than 30 pediatricians who participated in a 1-month training program.

At the 2024 PAS meeting, quality assurance data were presented on 215 (2.2%) of the 9632 children evaluated between February 2023 and March 2024. The diagnostic assessments of these randomly selected children were reviewed by one of three randomly assigned experts (a developmental pediatrician, a child psychologist, or a pediatrician with 7 years’ diagnostic experience) blinded to the initial scoring.

The diagnostic agreement was 94%, according to the data presented, providing a specificity of 90% and a sensitivity of 90% for ASD. The commercialized diagnostic approach is providing a diagnosis in a mean time of 29 days from initial contact, compared with delays that typically exceed 1 year for many children with suspected ASD, according to Dr. Hicks.

 

 

Additional Studies Aim at Streamlining Diagnosis

Two additional studies also evaluated strategies to streamline the diagnosis of ASD. Both were positive. In one, the accuracy and time to diagnosis among pediatricians trained in TAP and CARS were compared with those of ASD specialists in a dedicated autism clinic. Both were located at Nemours Children’s Health Center, Wilmington, Delaware.

In this study, presented by Meghan Harrison, DO, an attending pediatrician at Nemours Children’s Health, time to diagnosis among the 39 patients evaluated by pediatricians relative to the 349 patients evaluated at the dedicated ASD center (2.0 vs 5.1 months; P = .001) was significantly shorter. The age at diagnosis in the pediatrician-assessed population (27.5 vs 36.5 months; P < .001) was also significantly younger.

In another study, led by Ashely L. Early, MSW, a clinical social worker at the Medical University of South Carolina, Charleston, South Carolina, switching to a screening tool called the Rapid Interactive Screening Test for Autism in Toddlers (RITA-1) reduced the wait time to evaluation by approximately 5 months relative to previous practice with a more cumbersome screening method.
 

An ‘Urgent Need’ to Accelerate Diagnosis

In most places in the United States, children suspected of ASD are referred to specialists for confirmation of the diagnosis, which is needed to quality for ASD services, according to Katherine Zuckerman, MD, a professor of pediatrics the Oregon Health and Science University, Portland, Oregon. Dr. Zuckerman, who was moderator of the session in which all four of these abstracts were presented, explained that there is an urgent need to accelerate the time to diagnosis, which involves long delays for many if not most children with ASD. This is important because treatment and supportive services for ASD are almost always dependent on a diagnosis.

“There are tons of data to show that earlier access to ASD services has important patient benefits, including higher IQs,” she said. Other benefits she listed include a better quality of life for the child and the family.

“It can provide a huge reduction in family stress,” she added, suggesting that early interventions favorably modify the trajectory of the disability over time with accruing benefits.

“The lifetime costs of ASD exceed cancer and most other disease, so there are major implications for the cumulative cost of ASD management,” Dr. Zuckerman said. She suggested that the studies presented at the meeting reflect a likely evolution in who evaluates children for ASD and how quickly the evaluation is performed.

Dr. Rea, Dr. Harrison, Dr. Zuckerman, and Ms. Early reported no potential conflicts of interest. In addition to his executive role in As You Are, Dr. Hicks has financial relationships with Quadrant Biosciences and Spectrum Solutions.

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High-Potency Cannabis Tied to Impaired Brain Development, Psychosis, Cannabis-Use Disorder

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Tue, 05/14/2024 - 13:08

It’s becoming clear that the adolescent brain is particularly vulnerable to cannabis, especially today’s higher-potency products, which put teens at risk for impaired brain development; mental health issues, including psychosis; and cannabis-use disorder (CUD). 

That was the message delivered by Yasmin Hurd, PhD, director of the Addiction Institute at Mount Sinai in New York, during a press briefing at the American Psychiatric Association (APA) 2024 annual meeting

“We’re actually in historic times in that we now have highly concentrated, highly potent cannabis products that are administered in various routes,” Dr. Hurd told reporters. 

Tetrahydrocannabinol (THC) concentrations in cannabis products have increased over the years, from around 2%-4% to 15%-24% now, Dr. Hurd noted.

The impact of high-potency cannabis products and increased risk for CUD and mental health problems, particularly in adolescents, “must be taken seriously, especially in light of the current mental health crisis,” Dr. Hurd and colleagues wrote in a commentary on the developmental trajectory of CUD published simultaneously in the American Journal of Psychiatry
 

Dramatic Increase in Teen Cannabis Use

A recent study from Oregon Health & Science University showed that adolescent cannabis abuse in the United States has increased dramatically, by about 245%, since 2000. 

“Drug abuse is often driven by what is in front of you,” Nora Volkow, MD, director of the National Institute on Drug Abuse, noted in an interview. 

“Right now, cannabis is widely available. So, guess what? Cannabis becomes the drug that people take. Nicotine is much harder to get. It is regulated to a much greater extent than cannabis, so fewer teenagers are consuming nicotine than are consuming cannabis,” Dr. Volkow said. 

Cannabis exposure during neurodevelopment has the potential to alter the endocannabinoid system, which in turn, can affect the development of neural pathways that mediate reward; emotional regulation; and multiple cognitive domains including executive functioning and decision-making, learning, abstraction, and attention — all processes central to substance use disorder and other psychiatric disorders, Dr. Hurd said at the briefing.

Dr. Volkow said that cannabis use in adolescence and young adulthood is “very concerning because that’s also the age of risk for psychosis, particularly schizophrenia, with one study showing that use of cannabis in high doses can trigger psychotic episodes, particularly among young males.”

Dr. Hurd noted that not all young people who use cannabis develop CUD, “but a significant number do,” and large-scale studies have consistently reported two main factors associated with CUD risk.

The first is age, both for the onset and frequency of use at younger age. Those who start using cannabis before age 16 years are at the highest risk for CUD. The risk for CUD also increases significantly among youth who use cannabis at least weekly, with the highest prevalence among youth who use cannabis daily. One large study linked increased frequency of use with up to a 17-fold increased risk for CUD.

The second factor consistently associated with the risk for CUD is biologic sex, with CUD rates typically higher in male individuals.
 

Treatment Challenges

For young people who develop CUD, access to and uptake of treatment can be challenging.

“Given that the increased potency of cannabis and cannabinoid products is expected to increase CUD risk, it is disturbing that less than 10% of youth who meet the criteria for a substance use disorder, including CUD, receive treatment,” Dr. Hurd and colleagues point out in their commentary. 

Another challenge is that treatment strategies for CUD are currently limited and consist mainly of motivational enhancement and cognitive-behavioral therapies. 

“Clearly new treatment strategies are needed to address the mounting challenge of CUD risk in teens and young adults,” Dr. Hurd and colleagues wrote. 

Summing up, Dr. Hurd told reporters, “We now know that most psychiatric disorders have a developmental origin, and the adolescent time period is a critical window for cannabis use disorder risk.”

Yet, on a positive note, the “plasticity of the developing brain that makes it vulnerable to cannabis use disorder and psychiatric comorbidities also provides an opportunity for prevention and early intervention to change that trajectory,” Dr. Hurd said. 

The changing legal landscape of cannabis — the US Drug Enforcement Agency is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act — makes addressing these risks all the timelier. 

“As states vie to leverage tax dollars from the growing cannabis industry, a significant portion of such funds must be used for early intervention/prevention strategies to reduce the impact of cannabis on the developing brain,” Dr. Hurd and colleagues wrote. 

This research was supported in part by the National Institute on Drug Abuse and the National Institutes of Health. Dr. Hurd and Dr. Volkow have no relevant disclosures. 

A version of this article appeared on Medscape.com.

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It’s becoming clear that the adolescent brain is particularly vulnerable to cannabis, especially today’s higher-potency products, which put teens at risk for impaired brain development; mental health issues, including psychosis; and cannabis-use disorder (CUD). 

That was the message delivered by Yasmin Hurd, PhD, director of the Addiction Institute at Mount Sinai in New York, during a press briefing at the American Psychiatric Association (APA) 2024 annual meeting

“We’re actually in historic times in that we now have highly concentrated, highly potent cannabis products that are administered in various routes,” Dr. Hurd told reporters. 

Tetrahydrocannabinol (THC) concentrations in cannabis products have increased over the years, from around 2%-4% to 15%-24% now, Dr. Hurd noted.

The impact of high-potency cannabis products and increased risk for CUD and mental health problems, particularly in adolescents, “must be taken seriously, especially in light of the current mental health crisis,” Dr. Hurd and colleagues wrote in a commentary on the developmental trajectory of CUD published simultaneously in the American Journal of Psychiatry
 

Dramatic Increase in Teen Cannabis Use

A recent study from Oregon Health & Science University showed that adolescent cannabis abuse in the United States has increased dramatically, by about 245%, since 2000. 

“Drug abuse is often driven by what is in front of you,” Nora Volkow, MD, director of the National Institute on Drug Abuse, noted in an interview. 

“Right now, cannabis is widely available. So, guess what? Cannabis becomes the drug that people take. Nicotine is much harder to get. It is regulated to a much greater extent than cannabis, so fewer teenagers are consuming nicotine than are consuming cannabis,” Dr. Volkow said. 

Cannabis exposure during neurodevelopment has the potential to alter the endocannabinoid system, which in turn, can affect the development of neural pathways that mediate reward; emotional regulation; and multiple cognitive domains including executive functioning and decision-making, learning, abstraction, and attention — all processes central to substance use disorder and other psychiatric disorders, Dr. Hurd said at the briefing.

Dr. Volkow said that cannabis use in adolescence and young adulthood is “very concerning because that’s also the age of risk for psychosis, particularly schizophrenia, with one study showing that use of cannabis in high doses can trigger psychotic episodes, particularly among young males.”

Dr. Hurd noted that not all young people who use cannabis develop CUD, “but a significant number do,” and large-scale studies have consistently reported two main factors associated with CUD risk.

The first is age, both for the onset and frequency of use at younger age. Those who start using cannabis before age 16 years are at the highest risk for CUD. The risk for CUD also increases significantly among youth who use cannabis at least weekly, with the highest prevalence among youth who use cannabis daily. One large study linked increased frequency of use with up to a 17-fold increased risk for CUD.

The second factor consistently associated with the risk for CUD is biologic sex, with CUD rates typically higher in male individuals.
 

Treatment Challenges

For young people who develop CUD, access to and uptake of treatment can be challenging.

“Given that the increased potency of cannabis and cannabinoid products is expected to increase CUD risk, it is disturbing that less than 10% of youth who meet the criteria for a substance use disorder, including CUD, receive treatment,” Dr. Hurd and colleagues point out in their commentary. 

Another challenge is that treatment strategies for CUD are currently limited and consist mainly of motivational enhancement and cognitive-behavioral therapies. 

“Clearly new treatment strategies are needed to address the mounting challenge of CUD risk in teens and young adults,” Dr. Hurd and colleagues wrote. 

Summing up, Dr. Hurd told reporters, “We now know that most psychiatric disorders have a developmental origin, and the adolescent time period is a critical window for cannabis use disorder risk.”

Yet, on a positive note, the “plasticity of the developing brain that makes it vulnerable to cannabis use disorder and psychiatric comorbidities also provides an opportunity for prevention and early intervention to change that trajectory,” Dr. Hurd said. 

The changing legal landscape of cannabis — the US Drug Enforcement Agency is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act — makes addressing these risks all the timelier. 

“As states vie to leverage tax dollars from the growing cannabis industry, a significant portion of such funds must be used for early intervention/prevention strategies to reduce the impact of cannabis on the developing brain,” Dr. Hurd and colleagues wrote. 

This research was supported in part by the National Institute on Drug Abuse and the National Institutes of Health. Dr. Hurd and Dr. Volkow have no relevant disclosures. 

A version of this article appeared on Medscape.com.

It’s becoming clear that the adolescent brain is particularly vulnerable to cannabis, especially today’s higher-potency products, which put teens at risk for impaired brain development; mental health issues, including psychosis; and cannabis-use disorder (CUD). 

That was the message delivered by Yasmin Hurd, PhD, director of the Addiction Institute at Mount Sinai in New York, during a press briefing at the American Psychiatric Association (APA) 2024 annual meeting

“We’re actually in historic times in that we now have highly concentrated, highly potent cannabis products that are administered in various routes,” Dr. Hurd told reporters. 

Tetrahydrocannabinol (THC) concentrations in cannabis products have increased over the years, from around 2%-4% to 15%-24% now, Dr. Hurd noted.

The impact of high-potency cannabis products and increased risk for CUD and mental health problems, particularly in adolescents, “must be taken seriously, especially in light of the current mental health crisis,” Dr. Hurd and colleagues wrote in a commentary on the developmental trajectory of CUD published simultaneously in the American Journal of Psychiatry
 

Dramatic Increase in Teen Cannabis Use

A recent study from Oregon Health & Science University showed that adolescent cannabis abuse in the United States has increased dramatically, by about 245%, since 2000. 

“Drug abuse is often driven by what is in front of you,” Nora Volkow, MD, director of the National Institute on Drug Abuse, noted in an interview. 

“Right now, cannabis is widely available. So, guess what? Cannabis becomes the drug that people take. Nicotine is much harder to get. It is regulated to a much greater extent than cannabis, so fewer teenagers are consuming nicotine than are consuming cannabis,” Dr. Volkow said. 

Cannabis exposure during neurodevelopment has the potential to alter the endocannabinoid system, which in turn, can affect the development of neural pathways that mediate reward; emotional regulation; and multiple cognitive domains including executive functioning and decision-making, learning, abstraction, and attention — all processes central to substance use disorder and other psychiatric disorders, Dr. Hurd said at the briefing.

Dr. Volkow said that cannabis use in adolescence and young adulthood is “very concerning because that’s also the age of risk for psychosis, particularly schizophrenia, with one study showing that use of cannabis in high doses can trigger psychotic episodes, particularly among young males.”

Dr. Hurd noted that not all young people who use cannabis develop CUD, “but a significant number do,” and large-scale studies have consistently reported two main factors associated with CUD risk.

The first is age, both for the onset and frequency of use at younger age. Those who start using cannabis before age 16 years are at the highest risk for CUD. The risk for CUD also increases significantly among youth who use cannabis at least weekly, with the highest prevalence among youth who use cannabis daily. One large study linked increased frequency of use with up to a 17-fold increased risk for CUD.

The second factor consistently associated with the risk for CUD is biologic sex, with CUD rates typically higher in male individuals.
 

Treatment Challenges

For young people who develop CUD, access to and uptake of treatment can be challenging.

“Given that the increased potency of cannabis and cannabinoid products is expected to increase CUD risk, it is disturbing that less than 10% of youth who meet the criteria for a substance use disorder, including CUD, receive treatment,” Dr. Hurd and colleagues point out in their commentary. 

Another challenge is that treatment strategies for CUD are currently limited and consist mainly of motivational enhancement and cognitive-behavioral therapies. 

“Clearly new treatment strategies are needed to address the mounting challenge of CUD risk in teens and young adults,” Dr. Hurd and colleagues wrote. 

Summing up, Dr. Hurd told reporters, “We now know that most psychiatric disorders have a developmental origin, and the adolescent time period is a critical window for cannabis use disorder risk.”

Yet, on a positive note, the “plasticity of the developing brain that makes it vulnerable to cannabis use disorder and psychiatric comorbidities also provides an opportunity for prevention and early intervention to change that trajectory,” Dr. Hurd said. 

The changing legal landscape of cannabis — the US Drug Enforcement Agency is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act — makes addressing these risks all the timelier. 

“As states vie to leverage tax dollars from the growing cannabis industry, a significant portion of such funds must be used for early intervention/prevention strategies to reduce the impact of cannabis on the developing brain,” Dr. Hurd and colleagues wrote. 

This research was supported in part by the National Institute on Drug Abuse and the National Institutes of Health. Dr. Hurd and Dr. Volkow have no relevant disclosures. 

A version of this article appeared on Medscape.com.

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