Wide variance described in lab monitoring of conventional synthetic DMARDs

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Rheumatologists tend to order the same types of tests to monitor their patients’ responses to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but they vary widely in how often they order tests and how they respond to abnormal results, responses to a survey suggest.

“The study found that, although guidelines exist, people didn’t follow them consistently. They also responded to abnormal test results in wildly different ways,” senior study author Philip C. Robinson, MBChB, PhD, of the University of Queensland, Herston, Australia, said in an interview.

Dr. Philip C. Robinson

“The take-home message of this study is that everyone is doing something different, which means that the system likely has a lot of low-value activity and that money is being wasted,” he added. “However, we don’t have the evidence to guide people to make better choices.”

The literature on laboratory monitoring of people taking csDMARDs for rheumatic disease is scant, the authors wrote in BMC Rheumatology, and current guidelines on csDMARD monitoring vary, likely because of the lack of high-quality evidence for specific monitoring regimens.

“An enormous amount of money is spent on DMARD monitoring with little evidence to support current practices,” Dr. Robinson said. So he and his colleagues asked rheumatologists and rheumatology trainees about their attitudes and practices related to laboratory monitoring of csDMARDs in an online questionnaire.

They used the Australian Rheumatology Association newsletter to invite around 530 Australian rheumatologists and trainees, around 4,500 of Dr. Robinson’s Twitter followers, and 25 Australian and overseas email contacts, to respond to questions about csDMARDs they prescribed, frequency and patterns of monitoring, influences of additional factors and combination therapy, responses to abnormal tests, and attitudes toward monitoring frequency.

The researchers based their questions on csDMARD monitoring guidelines published by the American College of Rheumatology (which recommends monitoring every 2-4 weeks from initiation to 3 months, every 8-12 weeks during months 3-6, and every 12 weeks from 6 months onward), and from the British Society for Rheumatology (whose guidance is similar but bases monitoring frequency on how long DMARD doses remain stable).

The 221 valid responses they collected included 53 from Australia and 39 from the United States. Overall, 53% of respondents were in public practice, 56% were women, and 56% had practiced rheumatology for 11 or more years.

Respondents reported more frequent monitoring of patients with multiple comorbidities and those taking csDMARD combinations, including methotrexate and leflunomide. Responses to abnormal monitoring results varied widely, and 40% of respondents reported that monitoring tests are performed too often. Compared with females, males reported greater tolerance of significant test abnormalities before acting. They also were more likely to report that guidelines recommend, and doctors perform, tests too frequently.
 

Testing, monitoring patterns can differ from current guidelines

Rheumatologists who were asked to comment on the survey welcomed its results.

Dr. Daniel E. Furst

They came as no surprise to Daniel E. Furst, MD, professor emeritus of medicine at the University of California, Los Angeles.

“Most guidelines point out in the introduction that they are recommendations and need to be modified by specific patient and environmental needs,” he noted in an interview.

Stephen Myers, MD, assistant professor of clinical medicine in the division of rheumatology at the University of Southern California, Los Angeles, said: “The findings seem generally consistent with my observed practices and those of my peers, with the exception of sulfasalazine, which we tend to monitor every 3 months, similar to the way we monitor other csDMARDs.”

Caoilfhionn Connolly, MD, MSc, postdoctoral fellow in rheumatology at Johns Hopkins University, Baltimore, called “the variability in monitoring somewhat surprising given that both the American College of Rheumatology and the British Society for Rheumatology provide guidance statements on optimal monitoring.

Dr. Caoilfhionn Connolly

“As the authors highlight,” she added, “the variability in monitoring and response to lab abnormalities is likely driven by the lack of a high-quality evidence base, which should ideally be derived from clinical trials.”

Medication monitoring is critical to ensuring patient safety in rheumatology and other specialties, said Puja Khanna, MD, MPH, a rheumatologist and clinical associate professor of medicine at the University of Michigan, Ann Arbor.

Dr. Khanna described how in 2018, the Michigan Medicine health care system revisited its processes and protocols for medication monitoring.

Previously, “we were reliant on society guidelines that were not used consistently across the academic and community rheumatology practices,” she said. “Using lean thinking methodology, we found that we lacked familiarity with laboratory monitoring protocols amongst the interdisciplinary teams involved in the process and that we had a clear need for consensus.

Dr. Puja Khanna

“A consistent departmental protocol was created to help streamline the workflow for ancillary support staff, to close identified operational gaps, and to reduce delays in monitoring that impacted safe practice patterns,” Dr. Khanna added.

“We developed standardized medication- and disease-based monitoring protocols for eight medical specialties, where the person who writes a prescription that requires monitoring can utilize standard work flows to enroll the patient in the medication monitoring program and have dedicated ancillary support staff follow the results periodically and alert clinicians in a timely manner,” she explained. “Almost 15,000 patients are currently monitored in this collaborative program involving clinicians, nurses, pharmacists, and IT and administrative teams.”
 

 

 

Guidelines may not capture clinical realities of csDMARD monitoring

Dr. Myers and colleagues may monitor testing more intensively if, for example, a patient becomes ill, has side effects, or has taken medication incorrectly. But they’ll less intensively monitor a patient who’s been stable on a csDMARD.

Dr. Stephen Myers

“In my current academic practice, deciding lab monitoring frequency is left up to physicians. In my previous private practice experience, lab monitoring seemed to be more frequent than the current guidelines for many patients, compared to public or academic practice,” he said. “It would be interesting to compare monitoring practices in private, public, and academic settings.

“The clinical reality is that frequent monitoring depends on the regular follow-up, which for some patients is difficult, due to socioeconomic factors including lack of childcare and public transport,” Dr. Myers added.

Dr. Khanna mentioned that “guidelines tend to provide details of extant practice patterns, usually taken from evidence-based data. With monitoring, however, that is tough to achieve, unless substantial data can be found in large national registries of patients on immunosuppressive medications.”

Experience and comfort with using immunosuppressive medications, and medicolegal liability considerations, especially because many immunomodulatory agents confer adverse effects, can contribute to clinicians’ behaviors varying from guidelines, she added.
 

A good scoping review, and further research needed

“This article did what it was supposed to do: Define the various approaches to monitoring,” Dr. Furst said. “It is the next steps that will make a difference in practice.

“Next steps ... may require delving into large observational data sets such as registries to ascertain the consequences of different monitoring strategies for various patient groups and disparate drugs and drug combinations,” added Dr. Furst, who coauthored a 2017 review summarizing guidelines for laboratory monitoring in patients with rheumatoid arthritis.

“A significant oversight is the lack of consideration regarding monitoring for corticosteroids, which are well known to have very consequential adverse events and require careful monitoring,” Dr. Furst observed.

“The difference between men’s and women’s monitoring strategies is of some interest,” he added, “but will only be important if it leads to an understanding of and change in monitoring recommendations.”

Dr. Connolly also noted the differences in strategies between male and female respondents.



“Of interest, male respondents were more likely to feel that monitoring was performed too frequently and were also more tolerant of significant abnormalities,” she said. “This begs the question of whether rheumatologist gender differentially impacts other areas of clinical practice.”

Despite the small sample size that limits generalizability, the results provide preliminary insight into the varied practices among rheumatologists worldwide, Dr. Connolly added.

“Given the frequency of csDMARD prescription, the study highlights the clinical unmet need for a more robust evidence base to guide clinical practice,” she said. “The study also adds to important efforts to provide high-value care to patients with rheumatic diseases and may form the basis for larger studies to facilitate the pragmatic utilization of lab monitoring and ultimately optimize both the quality and value of rheumatological care globally.”

Dr. Robinson and coauthors urged further research. “We need more studies of higher quality to help inform the best strategy for protecting our patients from harm from our commonly used rheumatic medicines,” he said.

Dr. Robinson and two coauthors reported relationships with pharmaceutical companies. The remaining authors and all uninvolved sources, who commented by email, reported no relevant relationships. The study received no funding.

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Rheumatologists tend to order the same types of tests to monitor their patients’ responses to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but they vary widely in how often they order tests and how they respond to abnormal results, responses to a survey suggest.

“The study found that, although guidelines exist, people didn’t follow them consistently. They also responded to abnormal test results in wildly different ways,” senior study author Philip C. Robinson, MBChB, PhD, of the University of Queensland, Herston, Australia, said in an interview.

Dr. Philip C. Robinson

“The take-home message of this study is that everyone is doing something different, which means that the system likely has a lot of low-value activity and that money is being wasted,” he added. “However, we don’t have the evidence to guide people to make better choices.”

The literature on laboratory monitoring of people taking csDMARDs for rheumatic disease is scant, the authors wrote in BMC Rheumatology, and current guidelines on csDMARD monitoring vary, likely because of the lack of high-quality evidence for specific monitoring regimens.

“An enormous amount of money is spent on DMARD monitoring with little evidence to support current practices,” Dr. Robinson said. So he and his colleagues asked rheumatologists and rheumatology trainees about their attitudes and practices related to laboratory monitoring of csDMARDs in an online questionnaire.

They used the Australian Rheumatology Association newsletter to invite around 530 Australian rheumatologists and trainees, around 4,500 of Dr. Robinson’s Twitter followers, and 25 Australian and overseas email contacts, to respond to questions about csDMARDs they prescribed, frequency and patterns of monitoring, influences of additional factors and combination therapy, responses to abnormal tests, and attitudes toward monitoring frequency.

The researchers based their questions on csDMARD monitoring guidelines published by the American College of Rheumatology (which recommends monitoring every 2-4 weeks from initiation to 3 months, every 8-12 weeks during months 3-6, and every 12 weeks from 6 months onward), and from the British Society for Rheumatology (whose guidance is similar but bases monitoring frequency on how long DMARD doses remain stable).

The 221 valid responses they collected included 53 from Australia and 39 from the United States. Overall, 53% of respondents were in public practice, 56% were women, and 56% had practiced rheumatology for 11 or more years.

Respondents reported more frequent monitoring of patients with multiple comorbidities and those taking csDMARD combinations, including methotrexate and leflunomide. Responses to abnormal monitoring results varied widely, and 40% of respondents reported that monitoring tests are performed too often. Compared with females, males reported greater tolerance of significant test abnormalities before acting. They also were more likely to report that guidelines recommend, and doctors perform, tests too frequently.
 

Testing, monitoring patterns can differ from current guidelines

Rheumatologists who were asked to comment on the survey welcomed its results.

Dr. Daniel E. Furst

They came as no surprise to Daniel E. Furst, MD, professor emeritus of medicine at the University of California, Los Angeles.

“Most guidelines point out in the introduction that they are recommendations and need to be modified by specific patient and environmental needs,” he noted in an interview.

Stephen Myers, MD, assistant professor of clinical medicine in the division of rheumatology at the University of Southern California, Los Angeles, said: “The findings seem generally consistent with my observed practices and those of my peers, with the exception of sulfasalazine, which we tend to monitor every 3 months, similar to the way we monitor other csDMARDs.”

Caoilfhionn Connolly, MD, MSc, postdoctoral fellow in rheumatology at Johns Hopkins University, Baltimore, called “the variability in monitoring somewhat surprising given that both the American College of Rheumatology and the British Society for Rheumatology provide guidance statements on optimal monitoring.

Dr. Caoilfhionn Connolly

“As the authors highlight,” she added, “the variability in monitoring and response to lab abnormalities is likely driven by the lack of a high-quality evidence base, which should ideally be derived from clinical trials.”

Medication monitoring is critical to ensuring patient safety in rheumatology and other specialties, said Puja Khanna, MD, MPH, a rheumatologist and clinical associate professor of medicine at the University of Michigan, Ann Arbor.

Dr. Khanna described how in 2018, the Michigan Medicine health care system revisited its processes and protocols for medication monitoring.

Previously, “we were reliant on society guidelines that were not used consistently across the academic and community rheumatology practices,” she said. “Using lean thinking methodology, we found that we lacked familiarity with laboratory monitoring protocols amongst the interdisciplinary teams involved in the process and that we had a clear need for consensus.

Dr. Puja Khanna

“A consistent departmental protocol was created to help streamline the workflow for ancillary support staff, to close identified operational gaps, and to reduce delays in monitoring that impacted safe practice patterns,” Dr. Khanna added.

“We developed standardized medication- and disease-based monitoring protocols for eight medical specialties, where the person who writes a prescription that requires monitoring can utilize standard work flows to enroll the patient in the medication monitoring program and have dedicated ancillary support staff follow the results periodically and alert clinicians in a timely manner,” she explained. “Almost 15,000 patients are currently monitored in this collaborative program involving clinicians, nurses, pharmacists, and IT and administrative teams.”
 

 

 

Guidelines may not capture clinical realities of csDMARD monitoring

Dr. Myers and colleagues may monitor testing more intensively if, for example, a patient becomes ill, has side effects, or has taken medication incorrectly. But they’ll less intensively monitor a patient who’s been stable on a csDMARD.

Dr. Stephen Myers

“In my current academic practice, deciding lab monitoring frequency is left up to physicians. In my previous private practice experience, lab monitoring seemed to be more frequent than the current guidelines for many patients, compared to public or academic practice,” he said. “It would be interesting to compare monitoring practices in private, public, and academic settings.

“The clinical reality is that frequent monitoring depends on the regular follow-up, which for some patients is difficult, due to socioeconomic factors including lack of childcare and public transport,” Dr. Myers added.

Dr. Khanna mentioned that “guidelines tend to provide details of extant practice patterns, usually taken from evidence-based data. With monitoring, however, that is tough to achieve, unless substantial data can be found in large national registries of patients on immunosuppressive medications.”

Experience and comfort with using immunosuppressive medications, and medicolegal liability considerations, especially because many immunomodulatory agents confer adverse effects, can contribute to clinicians’ behaviors varying from guidelines, she added.
 

A good scoping review, and further research needed

“This article did what it was supposed to do: Define the various approaches to monitoring,” Dr. Furst said. “It is the next steps that will make a difference in practice.

“Next steps ... may require delving into large observational data sets such as registries to ascertain the consequences of different monitoring strategies for various patient groups and disparate drugs and drug combinations,” added Dr. Furst, who coauthored a 2017 review summarizing guidelines for laboratory monitoring in patients with rheumatoid arthritis.

“A significant oversight is the lack of consideration regarding monitoring for corticosteroids, which are well known to have very consequential adverse events and require careful monitoring,” Dr. Furst observed.

“The difference between men’s and women’s monitoring strategies is of some interest,” he added, “but will only be important if it leads to an understanding of and change in monitoring recommendations.”

Dr. Connolly also noted the differences in strategies between male and female respondents.



“Of interest, male respondents were more likely to feel that monitoring was performed too frequently and were also more tolerant of significant abnormalities,” she said. “This begs the question of whether rheumatologist gender differentially impacts other areas of clinical practice.”

Despite the small sample size that limits generalizability, the results provide preliminary insight into the varied practices among rheumatologists worldwide, Dr. Connolly added.

“Given the frequency of csDMARD prescription, the study highlights the clinical unmet need for a more robust evidence base to guide clinical practice,” she said. “The study also adds to important efforts to provide high-value care to patients with rheumatic diseases and may form the basis for larger studies to facilitate the pragmatic utilization of lab monitoring and ultimately optimize both the quality and value of rheumatological care globally.”

Dr. Robinson and coauthors urged further research. “We need more studies of higher quality to help inform the best strategy for protecting our patients from harm from our commonly used rheumatic medicines,” he said.

Dr. Robinson and two coauthors reported relationships with pharmaceutical companies. The remaining authors and all uninvolved sources, who commented by email, reported no relevant relationships. The study received no funding.

Rheumatologists tend to order the same types of tests to monitor their patients’ responses to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but they vary widely in how often they order tests and how they respond to abnormal results, responses to a survey suggest.

“The study found that, although guidelines exist, people didn’t follow them consistently. They also responded to abnormal test results in wildly different ways,” senior study author Philip C. Robinson, MBChB, PhD, of the University of Queensland, Herston, Australia, said in an interview.

Dr. Philip C. Robinson

“The take-home message of this study is that everyone is doing something different, which means that the system likely has a lot of low-value activity and that money is being wasted,” he added. “However, we don’t have the evidence to guide people to make better choices.”

The literature on laboratory monitoring of people taking csDMARDs for rheumatic disease is scant, the authors wrote in BMC Rheumatology, and current guidelines on csDMARD monitoring vary, likely because of the lack of high-quality evidence for specific monitoring regimens.

“An enormous amount of money is spent on DMARD monitoring with little evidence to support current practices,” Dr. Robinson said. So he and his colleagues asked rheumatologists and rheumatology trainees about their attitudes and practices related to laboratory monitoring of csDMARDs in an online questionnaire.

They used the Australian Rheumatology Association newsletter to invite around 530 Australian rheumatologists and trainees, around 4,500 of Dr. Robinson’s Twitter followers, and 25 Australian and overseas email contacts, to respond to questions about csDMARDs they prescribed, frequency and patterns of monitoring, influences of additional factors and combination therapy, responses to abnormal tests, and attitudes toward monitoring frequency.

The researchers based their questions on csDMARD monitoring guidelines published by the American College of Rheumatology (which recommends monitoring every 2-4 weeks from initiation to 3 months, every 8-12 weeks during months 3-6, and every 12 weeks from 6 months onward), and from the British Society for Rheumatology (whose guidance is similar but bases monitoring frequency on how long DMARD doses remain stable).

The 221 valid responses they collected included 53 from Australia and 39 from the United States. Overall, 53% of respondents were in public practice, 56% were women, and 56% had practiced rheumatology for 11 or more years.

Respondents reported more frequent monitoring of patients with multiple comorbidities and those taking csDMARD combinations, including methotrexate and leflunomide. Responses to abnormal monitoring results varied widely, and 40% of respondents reported that monitoring tests are performed too often. Compared with females, males reported greater tolerance of significant test abnormalities before acting. They also were more likely to report that guidelines recommend, and doctors perform, tests too frequently.
 

Testing, monitoring patterns can differ from current guidelines

Rheumatologists who were asked to comment on the survey welcomed its results.

Dr. Daniel E. Furst

They came as no surprise to Daniel E. Furst, MD, professor emeritus of medicine at the University of California, Los Angeles.

“Most guidelines point out in the introduction that they are recommendations and need to be modified by specific patient and environmental needs,” he noted in an interview.

Stephen Myers, MD, assistant professor of clinical medicine in the division of rheumatology at the University of Southern California, Los Angeles, said: “The findings seem generally consistent with my observed practices and those of my peers, with the exception of sulfasalazine, which we tend to monitor every 3 months, similar to the way we monitor other csDMARDs.”

Caoilfhionn Connolly, MD, MSc, postdoctoral fellow in rheumatology at Johns Hopkins University, Baltimore, called “the variability in monitoring somewhat surprising given that both the American College of Rheumatology and the British Society for Rheumatology provide guidance statements on optimal monitoring.

Dr. Caoilfhionn Connolly

“As the authors highlight,” she added, “the variability in monitoring and response to lab abnormalities is likely driven by the lack of a high-quality evidence base, which should ideally be derived from clinical trials.”

Medication monitoring is critical to ensuring patient safety in rheumatology and other specialties, said Puja Khanna, MD, MPH, a rheumatologist and clinical associate professor of medicine at the University of Michigan, Ann Arbor.

Dr. Khanna described how in 2018, the Michigan Medicine health care system revisited its processes and protocols for medication monitoring.

Previously, “we were reliant on society guidelines that were not used consistently across the academic and community rheumatology practices,” she said. “Using lean thinking methodology, we found that we lacked familiarity with laboratory monitoring protocols amongst the interdisciplinary teams involved in the process and that we had a clear need for consensus.

Dr. Puja Khanna

“A consistent departmental protocol was created to help streamline the workflow for ancillary support staff, to close identified operational gaps, and to reduce delays in monitoring that impacted safe practice patterns,” Dr. Khanna added.

“We developed standardized medication- and disease-based monitoring protocols for eight medical specialties, where the person who writes a prescription that requires monitoring can utilize standard work flows to enroll the patient in the medication monitoring program and have dedicated ancillary support staff follow the results periodically and alert clinicians in a timely manner,” she explained. “Almost 15,000 patients are currently monitored in this collaborative program involving clinicians, nurses, pharmacists, and IT and administrative teams.”
 

 

 

Guidelines may not capture clinical realities of csDMARD monitoring

Dr. Myers and colleagues may monitor testing more intensively if, for example, a patient becomes ill, has side effects, or has taken medication incorrectly. But they’ll less intensively monitor a patient who’s been stable on a csDMARD.

Dr. Stephen Myers

“In my current academic practice, deciding lab monitoring frequency is left up to physicians. In my previous private practice experience, lab monitoring seemed to be more frequent than the current guidelines for many patients, compared to public or academic practice,” he said. “It would be interesting to compare monitoring practices in private, public, and academic settings.

“The clinical reality is that frequent monitoring depends on the regular follow-up, which for some patients is difficult, due to socioeconomic factors including lack of childcare and public transport,” Dr. Myers added.

Dr. Khanna mentioned that “guidelines tend to provide details of extant practice patterns, usually taken from evidence-based data. With monitoring, however, that is tough to achieve, unless substantial data can be found in large national registries of patients on immunosuppressive medications.”

Experience and comfort with using immunosuppressive medications, and medicolegal liability considerations, especially because many immunomodulatory agents confer adverse effects, can contribute to clinicians’ behaviors varying from guidelines, she added.
 

A good scoping review, and further research needed

“This article did what it was supposed to do: Define the various approaches to monitoring,” Dr. Furst said. “It is the next steps that will make a difference in practice.

“Next steps ... may require delving into large observational data sets such as registries to ascertain the consequences of different monitoring strategies for various patient groups and disparate drugs and drug combinations,” added Dr. Furst, who coauthored a 2017 review summarizing guidelines for laboratory monitoring in patients with rheumatoid arthritis.

“A significant oversight is the lack of consideration regarding monitoring for corticosteroids, which are well known to have very consequential adverse events and require careful monitoring,” Dr. Furst observed.

“The difference between men’s and women’s monitoring strategies is of some interest,” he added, “but will only be important if it leads to an understanding of and change in monitoring recommendations.”

Dr. Connolly also noted the differences in strategies between male and female respondents.



“Of interest, male respondents were more likely to feel that monitoring was performed too frequently and were also more tolerant of significant abnormalities,” she said. “This begs the question of whether rheumatologist gender differentially impacts other areas of clinical practice.”

Despite the small sample size that limits generalizability, the results provide preliminary insight into the varied practices among rheumatologists worldwide, Dr. Connolly added.

“Given the frequency of csDMARD prescription, the study highlights the clinical unmet need for a more robust evidence base to guide clinical practice,” she said. “The study also adds to important efforts to provide high-value care to patients with rheumatic diseases and may form the basis for larger studies to facilitate the pragmatic utilization of lab monitoring and ultimately optimize both the quality and value of rheumatological care globally.”

Dr. Robinson and coauthors urged further research. “We need more studies of higher quality to help inform the best strategy for protecting our patients from harm from our commonly used rheumatic medicines,” he said.

Dr. Robinson and two coauthors reported relationships with pharmaceutical companies. The remaining authors and all uninvolved sources, who commented by email, reported no relevant relationships. The study received no funding.

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Without guidelines, docs make their own long-COVID protocols

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Diagnosing long COVID is something of an art for doctors who, without any formal criteria, say they know it when they see it. Treating the condition requires equal combinations of skill, experience, and intuition, and doctors waiting for guidelines have started cobbling together treatment plans designed to ease the worst symptoms.

Their work is urgent. In the United States alone, as many as 29 million people have long COVID, according to estimates from the American Academy of Physical Medicine and Rehabilitation.

“Patients with long COVID have on average at least 14 different symptoms involving nine or more different organ systems, so a holistic approach to treatment is essential,” said Janna Friedly, MD, executive director of the Post-COVID Rehabilitation and Recovery Clinic at the University of Washington in Seattle. 

For acute COVID cases, the National Institutes of Health has treatment guidelines that are taking a lot of the guesswork out of managing patients’ complex mix of symptoms. This has made it easier for primary care providers to manage people with milder cases and for specialists to come up with effective treatment plans for those with severe illness. But no such guidelines exist for long COVID, and this is making it harder for many doctors – particularly in primary care – to determine the best treatment. 

While there isn’t a single treatment that is effective for all long-COVID symptoms – and nothing is approved by the Food and Drug Administration specifically for this syndrome – doctors do have tools, Dr. Friedly said. 

“We always start with the basics – making sure we help patients get enough restorative sleep, optimizing their nutrition, ensuring proper hydration, reducing stress, breathing exercises, and restorative exercise – because all of these are critically important to helping people’s immune system stay as healthy as possible,” she said. “In addition, we help people manage the anxiety and depression that may be exacerbating their symptoms.”

Fatigue is an obvious target. Widely available screening tools, including assessments that have been used in cancer patients and people with chronic fatigue syndrome, can pinpoint how bad symptoms are in long-COVID patients. 

“Fatigue is generally the No. 1 symptom,” said Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the COVID-19 Recovery Clinic at the University of Texas Health Science Center in San Antonio. “If a patient has this, then their therapy program has to look very different, because they actually do better with pacing themselves.”

This was the first symptom tackled in a series of long-COVID treatment guidelines issued by the medical society representing many of the providers on the front lines with these patients every day – the American Academy of Physical Medicine and Rehabilitation. These fatigue guidelines stress the importance of rest, energy conservation, and proper hydration. 

For patients with only mild fatigue who can still keep up with essential activities like work and school, activity programs may begin with a gradual return to daily routines such as housework or going out with friends. As long as they have no setbacks, patients can also start with light aerobic exercise and make it more intense and frequent over time. As long as they have no setbacks in symptoms, they can ramp up exercise by about 10% every 10 days. 

But with severe fatigue, this is too much, too soon. Activity plans are more apt to start with only light stretching and progress to light muscle strengthening before any aerobic exercise enters the picture. 

“Traditional exercise programs may be harmful to some patients with long COVID,” said Dr. Verduzco-Gutierrez. “Many cannot tolerate graded exercise [where exertion slowly ramps up], and it actually can make them worse.” 

There’s less consensus on other options for treating fatigue, like prescription medications, dietary supplements, and acupuncture. Some doctors have tried prescription drugs like the antiviral and movement disorder medication amantadine, the narcolepsy drug modafinil, and the stimulant methylphenidate, which have been studied for managing fatigue in patients with other conditions like cancer, multiple sclerosis, traumatic brain injuries, and Parkinson’s disease. But there isn’t yet clear evidence from clinical trials about how well these options work for long COVID. 

Similarly, interventions to tackle neurological symptoms and cognitive problems borrow a page from treatments used for other conditions like stroke and dementia – but require changes to meet the needs of those with long COVID. Four in five long-COVID patients with neurological and cognitive issues have brain fog, while more than two-thirds have headaches, and more than half have numbness and tingling in their extremities, loss of taste, loss of smell, and muscle pain, one study suggests.

Patients with deficits in areas like memory, attention, executive function, and visual and spatial planning may get speech therapy or occupational therapy, for example – both approaches that are common in people with cognitive decline caused by other medical conditions. 

Doctors also promote good sleep practices and treating any mood disorders – both of which can contribute to cognitive problems. But they often have to skip one of the best interventions for improving brain function – exercise – because so many long-COVID patients struggle with fatigue and exertion or have cardiovascular issues that limit their exercise. 

The lack of formal guidelines is especially a problem because there aren’t nearly enough specialists to manage the surge of patients who need treatment for issues like fatigue and brain fog. And without guidelines, primary care providers lack a reliable road map to guide referrals that many patients may need. 

“Given the complexity of long COVID and the wide range of symptoms and medical issues associated with long COVID, most physicians, regardless of specialty, will need to evaluate and treat long-COVID symptoms,” said Dr. Friedly. “And yet, most do not have the knowledge or experience to effectively manage long-COVID symptoms, so having guidelines that can be updated as more research is conducted is critical.”

One barrier to developing guidelines for long COVID is the lack of research into the biological causes of fatigue and autonomic dysfunction – nervous system damage that can impact critical things like blood pressure, digestion, and body temperature – that affect so many long-COVID patients, said Alba Miranda Azola, MD, codirector of the Post-Acute COVID-19 Team at Johns Hopkins University in Baltimore. 

Research is also progressing much more slowly for long COVID than it did for those hospitalized with severe acute infections. The logistics of running rigorous studies to prove which treatments work best for specific symptoms – information needed to create definitive treatment guidelines – are much more complicated for people with long COVID who live at home and may be too exhausted or too preoccupied with their daily lives to take part in research. 

The vast number of symptoms, surfacing in different ways for each patient, also make it hard to isolate specific ways to manage specific long-COVID symptoms. Even when two patients have fatigue and brain fog, they may still need different treatments based on the complex mix of other symptoms they have. 

“All long-COVID patients are not equal, and it is critical that research focuses on establishing specific descriptions of the disease,” Dr. Azola said. 

The National Institutes of Health is working on this through its long-COVID Recover Initiative. It’s unclear how long it will take for this research to yield enough definitive information to inform long-COVID treatment guidelines similar to what the agency produced for acute coronavirus infections, and it didn’t respond to questions about the timeline. 

But over the next few months, the National Institutes of Health expects to begin several clinical trials focused on some of the symptoms that doctors are seeing most often in their clinics, like fatigue, brain fog, exercise intolerance, sleep disturbances, and changes in the nervous system’s ability to regulate key functions like heart rate and body temperature. 

One trial starting in January will examine whether the COVID-19 drug Paxlovid can help. A recent preprint Department of Veterans Affairs study showed patients treated with Paxlovid were less likely to get long COVID in the first place.

Some professionals aren’t waiting for the agency. The LongCovid Research Consortium links researchers from Harvard and Stanford universities; the University of California, San Francisco; the J. Craig Venter Institute; Johns Hopkins University; the University of Pennsylvania; Mount Sinai; Cardiff; and Yale who are studying, for instance, whether tiny blood clots contribute to long COVID and whether drugs can reduce or eliminate them.

“Given the widespread and diverse impact the virus has on the human body, it is unlikely that there will be one cure, one treatment,” said Gary H. Gibbons, MD, director of the National Heart, Lung, and Blood Institute at the National Institutes of Health. “This is why there will be multiple clinical trials over the coming months that study a range of symptoms, underlying causes, risk factors, outcomes, and potential strategies for treatment and prevention, in people of all races, ethnicities, genders, and ages.”

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

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Diagnosing long COVID is something of an art for doctors who, without any formal criteria, say they know it when they see it. Treating the condition requires equal combinations of skill, experience, and intuition, and doctors waiting for guidelines have started cobbling together treatment plans designed to ease the worst symptoms.

Their work is urgent. In the United States alone, as many as 29 million people have long COVID, according to estimates from the American Academy of Physical Medicine and Rehabilitation.

“Patients with long COVID have on average at least 14 different symptoms involving nine or more different organ systems, so a holistic approach to treatment is essential,” said Janna Friedly, MD, executive director of the Post-COVID Rehabilitation and Recovery Clinic at the University of Washington in Seattle. 

For acute COVID cases, the National Institutes of Health has treatment guidelines that are taking a lot of the guesswork out of managing patients’ complex mix of symptoms. This has made it easier for primary care providers to manage people with milder cases and for specialists to come up with effective treatment plans for those with severe illness. But no such guidelines exist for long COVID, and this is making it harder for many doctors – particularly in primary care – to determine the best treatment. 

While there isn’t a single treatment that is effective for all long-COVID symptoms – and nothing is approved by the Food and Drug Administration specifically for this syndrome – doctors do have tools, Dr. Friedly said. 

“We always start with the basics – making sure we help patients get enough restorative sleep, optimizing their nutrition, ensuring proper hydration, reducing stress, breathing exercises, and restorative exercise – because all of these are critically important to helping people’s immune system stay as healthy as possible,” she said. “In addition, we help people manage the anxiety and depression that may be exacerbating their symptoms.”

Fatigue is an obvious target. Widely available screening tools, including assessments that have been used in cancer patients and people with chronic fatigue syndrome, can pinpoint how bad symptoms are in long-COVID patients. 

“Fatigue is generally the No. 1 symptom,” said Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the COVID-19 Recovery Clinic at the University of Texas Health Science Center in San Antonio. “If a patient has this, then their therapy program has to look very different, because they actually do better with pacing themselves.”

This was the first symptom tackled in a series of long-COVID treatment guidelines issued by the medical society representing many of the providers on the front lines with these patients every day – the American Academy of Physical Medicine and Rehabilitation. These fatigue guidelines stress the importance of rest, energy conservation, and proper hydration. 

For patients with only mild fatigue who can still keep up with essential activities like work and school, activity programs may begin with a gradual return to daily routines such as housework or going out with friends. As long as they have no setbacks, patients can also start with light aerobic exercise and make it more intense and frequent over time. As long as they have no setbacks in symptoms, they can ramp up exercise by about 10% every 10 days. 

But with severe fatigue, this is too much, too soon. Activity plans are more apt to start with only light stretching and progress to light muscle strengthening before any aerobic exercise enters the picture. 

“Traditional exercise programs may be harmful to some patients with long COVID,” said Dr. Verduzco-Gutierrez. “Many cannot tolerate graded exercise [where exertion slowly ramps up], and it actually can make them worse.” 

There’s less consensus on other options for treating fatigue, like prescription medications, dietary supplements, and acupuncture. Some doctors have tried prescription drugs like the antiviral and movement disorder medication amantadine, the narcolepsy drug modafinil, and the stimulant methylphenidate, which have been studied for managing fatigue in patients with other conditions like cancer, multiple sclerosis, traumatic brain injuries, and Parkinson’s disease. But there isn’t yet clear evidence from clinical trials about how well these options work for long COVID. 

Similarly, interventions to tackle neurological symptoms and cognitive problems borrow a page from treatments used for other conditions like stroke and dementia – but require changes to meet the needs of those with long COVID. Four in five long-COVID patients with neurological and cognitive issues have brain fog, while more than two-thirds have headaches, and more than half have numbness and tingling in their extremities, loss of taste, loss of smell, and muscle pain, one study suggests.

Patients with deficits in areas like memory, attention, executive function, and visual and spatial planning may get speech therapy or occupational therapy, for example – both approaches that are common in people with cognitive decline caused by other medical conditions. 

Doctors also promote good sleep practices and treating any mood disorders – both of which can contribute to cognitive problems. But they often have to skip one of the best interventions for improving brain function – exercise – because so many long-COVID patients struggle with fatigue and exertion or have cardiovascular issues that limit their exercise. 

The lack of formal guidelines is especially a problem because there aren’t nearly enough specialists to manage the surge of patients who need treatment for issues like fatigue and brain fog. And without guidelines, primary care providers lack a reliable road map to guide referrals that many patients may need. 

“Given the complexity of long COVID and the wide range of symptoms and medical issues associated with long COVID, most physicians, regardless of specialty, will need to evaluate and treat long-COVID symptoms,” said Dr. Friedly. “And yet, most do not have the knowledge or experience to effectively manage long-COVID symptoms, so having guidelines that can be updated as more research is conducted is critical.”

One barrier to developing guidelines for long COVID is the lack of research into the biological causes of fatigue and autonomic dysfunction – nervous system damage that can impact critical things like blood pressure, digestion, and body temperature – that affect so many long-COVID patients, said Alba Miranda Azola, MD, codirector of the Post-Acute COVID-19 Team at Johns Hopkins University in Baltimore. 

Research is also progressing much more slowly for long COVID than it did for those hospitalized with severe acute infections. The logistics of running rigorous studies to prove which treatments work best for specific symptoms – information needed to create definitive treatment guidelines – are much more complicated for people with long COVID who live at home and may be too exhausted or too preoccupied with their daily lives to take part in research. 

The vast number of symptoms, surfacing in different ways for each patient, also make it hard to isolate specific ways to manage specific long-COVID symptoms. Even when two patients have fatigue and brain fog, they may still need different treatments based on the complex mix of other symptoms they have. 

“All long-COVID patients are not equal, and it is critical that research focuses on establishing specific descriptions of the disease,” Dr. Azola said. 

The National Institutes of Health is working on this through its long-COVID Recover Initiative. It’s unclear how long it will take for this research to yield enough definitive information to inform long-COVID treatment guidelines similar to what the agency produced for acute coronavirus infections, and it didn’t respond to questions about the timeline. 

But over the next few months, the National Institutes of Health expects to begin several clinical trials focused on some of the symptoms that doctors are seeing most often in their clinics, like fatigue, brain fog, exercise intolerance, sleep disturbances, and changes in the nervous system’s ability to regulate key functions like heart rate and body temperature. 

One trial starting in January will examine whether the COVID-19 drug Paxlovid can help. A recent preprint Department of Veterans Affairs study showed patients treated with Paxlovid were less likely to get long COVID in the first place.

Some professionals aren’t waiting for the agency. The LongCovid Research Consortium links researchers from Harvard and Stanford universities; the University of California, San Francisco; the J. Craig Venter Institute; Johns Hopkins University; the University of Pennsylvania; Mount Sinai; Cardiff; and Yale who are studying, for instance, whether tiny blood clots contribute to long COVID and whether drugs can reduce or eliminate them.

“Given the widespread and diverse impact the virus has on the human body, it is unlikely that there will be one cure, one treatment,” said Gary H. Gibbons, MD, director of the National Heart, Lung, and Blood Institute at the National Institutes of Health. “This is why there will be multiple clinical trials over the coming months that study a range of symptoms, underlying causes, risk factors, outcomes, and potential strategies for treatment and prevention, in people of all races, ethnicities, genders, and ages.”

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

Diagnosing long COVID is something of an art for doctors who, without any formal criteria, say they know it when they see it. Treating the condition requires equal combinations of skill, experience, and intuition, and doctors waiting for guidelines have started cobbling together treatment plans designed to ease the worst symptoms.

Their work is urgent. In the United States alone, as many as 29 million people have long COVID, according to estimates from the American Academy of Physical Medicine and Rehabilitation.

“Patients with long COVID have on average at least 14 different symptoms involving nine or more different organ systems, so a holistic approach to treatment is essential,” said Janna Friedly, MD, executive director of the Post-COVID Rehabilitation and Recovery Clinic at the University of Washington in Seattle. 

For acute COVID cases, the National Institutes of Health has treatment guidelines that are taking a lot of the guesswork out of managing patients’ complex mix of symptoms. This has made it easier for primary care providers to manage people with milder cases and for specialists to come up with effective treatment plans for those with severe illness. But no such guidelines exist for long COVID, and this is making it harder for many doctors – particularly in primary care – to determine the best treatment. 

While there isn’t a single treatment that is effective for all long-COVID symptoms – and nothing is approved by the Food and Drug Administration specifically for this syndrome – doctors do have tools, Dr. Friedly said. 

“We always start with the basics – making sure we help patients get enough restorative sleep, optimizing their nutrition, ensuring proper hydration, reducing stress, breathing exercises, and restorative exercise – because all of these are critically important to helping people’s immune system stay as healthy as possible,” she said. “In addition, we help people manage the anxiety and depression that may be exacerbating their symptoms.”

Fatigue is an obvious target. Widely available screening tools, including assessments that have been used in cancer patients and people with chronic fatigue syndrome, can pinpoint how bad symptoms are in long-COVID patients. 

“Fatigue is generally the No. 1 symptom,” said Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the COVID-19 Recovery Clinic at the University of Texas Health Science Center in San Antonio. “If a patient has this, then their therapy program has to look very different, because they actually do better with pacing themselves.”

This was the first symptom tackled in a series of long-COVID treatment guidelines issued by the medical society representing many of the providers on the front lines with these patients every day – the American Academy of Physical Medicine and Rehabilitation. These fatigue guidelines stress the importance of rest, energy conservation, and proper hydration. 

For patients with only mild fatigue who can still keep up with essential activities like work and school, activity programs may begin with a gradual return to daily routines such as housework or going out with friends. As long as they have no setbacks, patients can also start with light aerobic exercise and make it more intense and frequent over time. As long as they have no setbacks in symptoms, they can ramp up exercise by about 10% every 10 days. 

But with severe fatigue, this is too much, too soon. Activity plans are more apt to start with only light stretching and progress to light muscle strengthening before any aerobic exercise enters the picture. 

“Traditional exercise programs may be harmful to some patients with long COVID,” said Dr. Verduzco-Gutierrez. “Many cannot tolerate graded exercise [where exertion slowly ramps up], and it actually can make them worse.” 

There’s less consensus on other options for treating fatigue, like prescription medications, dietary supplements, and acupuncture. Some doctors have tried prescription drugs like the antiviral and movement disorder medication amantadine, the narcolepsy drug modafinil, and the stimulant methylphenidate, which have been studied for managing fatigue in patients with other conditions like cancer, multiple sclerosis, traumatic brain injuries, and Parkinson’s disease. But there isn’t yet clear evidence from clinical trials about how well these options work for long COVID. 

Similarly, interventions to tackle neurological symptoms and cognitive problems borrow a page from treatments used for other conditions like stroke and dementia – but require changes to meet the needs of those with long COVID. Four in five long-COVID patients with neurological and cognitive issues have brain fog, while more than two-thirds have headaches, and more than half have numbness and tingling in their extremities, loss of taste, loss of smell, and muscle pain, one study suggests.

Patients with deficits in areas like memory, attention, executive function, and visual and spatial planning may get speech therapy or occupational therapy, for example – both approaches that are common in people with cognitive decline caused by other medical conditions. 

Doctors also promote good sleep practices and treating any mood disorders – both of which can contribute to cognitive problems. But they often have to skip one of the best interventions for improving brain function – exercise – because so many long-COVID patients struggle with fatigue and exertion or have cardiovascular issues that limit their exercise. 

The lack of formal guidelines is especially a problem because there aren’t nearly enough specialists to manage the surge of patients who need treatment for issues like fatigue and brain fog. And without guidelines, primary care providers lack a reliable road map to guide referrals that many patients may need. 

“Given the complexity of long COVID and the wide range of symptoms and medical issues associated with long COVID, most physicians, regardless of specialty, will need to evaluate and treat long-COVID symptoms,” said Dr. Friedly. “And yet, most do not have the knowledge or experience to effectively manage long-COVID symptoms, so having guidelines that can be updated as more research is conducted is critical.”

One barrier to developing guidelines for long COVID is the lack of research into the biological causes of fatigue and autonomic dysfunction – nervous system damage that can impact critical things like blood pressure, digestion, and body temperature – that affect so many long-COVID patients, said Alba Miranda Azola, MD, codirector of the Post-Acute COVID-19 Team at Johns Hopkins University in Baltimore. 

Research is also progressing much more slowly for long COVID than it did for those hospitalized with severe acute infections. The logistics of running rigorous studies to prove which treatments work best for specific symptoms – information needed to create definitive treatment guidelines – are much more complicated for people with long COVID who live at home and may be too exhausted or too preoccupied with their daily lives to take part in research. 

The vast number of symptoms, surfacing in different ways for each patient, also make it hard to isolate specific ways to manage specific long-COVID symptoms. Even when two patients have fatigue and brain fog, they may still need different treatments based on the complex mix of other symptoms they have. 

“All long-COVID patients are not equal, and it is critical that research focuses on establishing specific descriptions of the disease,” Dr. Azola said. 

The National Institutes of Health is working on this through its long-COVID Recover Initiative. It’s unclear how long it will take for this research to yield enough definitive information to inform long-COVID treatment guidelines similar to what the agency produced for acute coronavirus infections, and it didn’t respond to questions about the timeline. 

But over the next few months, the National Institutes of Health expects to begin several clinical trials focused on some of the symptoms that doctors are seeing most often in their clinics, like fatigue, brain fog, exercise intolerance, sleep disturbances, and changes in the nervous system’s ability to regulate key functions like heart rate and body temperature. 

One trial starting in January will examine whether the COVID-19 drug Paxlovid can help. A recent preprint Department of Veterans Affairs study showed patients treated with Paxlovid were less likely to get long COVID in the first place.

Some professionals aren’t waiting for the agency. The LongCovid Research Consortium links researchers from Harvard and Stanford universities; the University of California, San Francisco; the J. Craig Venter Institute; Johns Hopkins University; the University of Pennsylvania; Mount Sinai; Cardiff; and Yale who are studying, for instance, whether tiny blood clots contribute to long COVID and whether drugs can reduce or eliminate them.

“Given the widespread and diverse impact the virus has on the human body, it is unlikely that there will be one cure, one treatment,” said Gary H. Gibbons, MD, director of the National Heart, Lung, and Blood Institute at the National Institutes of Health. “This is why there will be multiple clinical trials over the coming months that study a range of symptoms, underlying causes, risk factors, outcomes, and potential strategies for treatment and prevention, in people of all races, ethnicities, genders, and ages.”

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

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Opt-out HIV testing in EDs can help identify undiagnosed cases

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Results of a new study indicate that opt-out HIV testing, in particular “notional consent testing” where a patient is not asked or counseled before conducting the test, is an effective tool for identifying undiagnosed HIV cases in populations with an HIV positivity rate greater than 0.2%.

On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.

“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.

The study was published online in HIV Medicine.

She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”

Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.

The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.

Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.

Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).

“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”

Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.

“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”

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

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Results of a new study indicate that opt-out HIV testing, in particular “notional consent testing” where a patient is not asked or counseled before conducting the test, is an effective tool for identifying undiagnosed HIV cases in populations with an HIV positivity rate greater than 0.2%.

On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.

“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.

The study was published online in HIV Medicine.

She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”

Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.

The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.

Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.

Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).

“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”

Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.

“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”

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

Results of a new study indicate that opt-out HIV testing, in particular “notional consent testing” where a patient is not asked or counseled before conducting the test, is an effective tool for identifying undiagnosed HIV cases in populations with an HIV positivity rate greater than 0.2%.

On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.

“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.

The study was published online in HIV Medicine.

She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”

Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.

The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.

Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.

Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).

“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”

Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.

“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”

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

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Could this computer help you beat cancer?

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The 1960s marked the arrival of computers in medicine. Expensive, cumbersome hunks of plastic and metal that could (maybe) get test results to a doctor faster. The 1980s saw the first real difference-making functions computers could offer – clinical, financial, administrative – and in 1991, the Institute of Medicine published the first manifesto on what electronic health records could (and would) be.

Since then, we’ve seen computer breakthroughs across all areas of medicine, with artificial intelligence (AI), virtual reality, and telemedicine brought to the fore. But something else is brewing that not a lot of people know about yet: Quantum computing, a completely new type of computing has already begun to advance everything from drug development and disease identification to the security of electronic records.

“Think of it as transitioning from getting light through fire and candles and now having electricity, and there’s a light bulb that is lighting it all,” said Lara Jehi, MD, Cleveland Clinic’s chief research information officer.
 

What is quantum computing?

Classical computers (aka binary computers), which are the foundation of today’s devices, including artificial intelligence and machine learning, work by using information known as bits. These appear as 0 or 1 (sometimes defined as off/on or false/true). 

Quantum computers, on the other hand, use quantum bits known as qubits. And yes, the definition of “quantum” – as in: very, very small – applies.

International Business Machines, more commonly known as IBM, is currently leading this new tech. A common misconception about quantum computers is that they are “a next evolution of computers that will get faster,” said Frederik Flöther, PhD, life sciences and health care lead with IBM Quantum Industry Consulting. Instead, he wants us to look at quantum computing as something completely new “because it is fundamentally a different hardware, a different software, not just an evolution of the same.”

How does it work differently from existing computers? Quantum computing deals in nature. Therefore, qubits have to be based on the natural world. What does that mean? Nobel Prize-winning physicist Richard Feynman was famously quoted as saying: “Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical, and by golly it’s a wonderful problem, because it doesn’t look so easy.” 

Nature, said Dr. Jehi, doesn’t work in black and white or fit into boxes. 

“We have to convert it to zeros and ones because that’s what computers speak,” she explained. But quantum computing uses the principles of quantum mechanics. “It’s exactly how nature works, because it is based on the fundamental unit of everything in nature, which is atomic structure.”

Very, very small indeed. And that’s why quantum computing could be game-changing tech in medicine. 

“Quantum computers can be used to represent a bunch of different solutions to a problem all at the same time, and then collapse down to the optimal solution, the one that actually works,” said Tony Uttley, president and chief operating officer with Quantinuum, a collaboration between Cambridge Quantum and Honeywell Quantum Solutions that is working to drive the future of quantum computing. “And the reason it does that is because of some fabulous properties of quantum physics.”
 

 

 

Establishing a quantum computing beachhead 

Scientists around the globe are studying quantum computers looking for ways to harness this technology to make big gains in medicine. 

IBM has created the IBM Quantum Network and is partnering with different organizations, from startups to Fortune 500 companies, to develop and test technology in various settings. One of these partnerships with the Cleveland Clinic is set to establish the “Discovery Accelerator,” focused on advancing health care through high-performance computing on the hybrid cloud, quantum computing technologies, and artificial intelligence. 

Many people around the country are now using this technology on existing computers by tapping into the cloud, but with limited qubit access. IBM has researchers in places like Germany and Japan working on quantum computers and will be installing the country’s first of IBM’s next-generation 1,000+ qubit quantum systems on the Cleveland Clinic campus, which they are planning to use to help further investigate quantum computing’s many predicted benefits.

But what are those benefits? 
 

Drug discovery and development 

Quantum chemistry is one main area quantum computing is poised to help. 

“The immediate application of that would be in drug discovery,” said Dr. Jehi. When scientists make drugs, they sit in a lab and develop different chemical formulas for what might constitute that drug. 

“But for us to really know if it’s going to work, we need to be able to imagine how that chemical composition will translate into a structure,” she said. 

Even in their most powerful form, today’s supercomputers are slow in their ability to change this chemical formula on paper to a simulation of what the chemical compound will look like. And in many cases, they can’t do this type of analysis. 

“So, we end up making the drugs without knowing exactly how they’re going to look, which is not really the optimal way of creating a drug you expect to work” explained Dr. Jehi. “It’s a waste of time creating compounds that aren’t going to have any effect.”

Quantum computers will allow researchers to create and see these molecular structures and know how they bind and interact with the human body. In effect, they’ll know if a potential drug will work before ever having to physically make it.

Because of its differences from classic computing, quantum computers are not limited in their ability to simulate how different compounds can appear. Being able to simulate the compounds that drugs are made of can lead to a faster discovery of medications to treat a wide range of conditions. 
 

Disease analysis 

Eventually, this technology could assist with disease analysis, working on a molecular level to allow computers/AI to contemplate, for example, cancer molecules and gain a deeper understanding of how they function. 

Dr. Jehi said quantum computing can also be used to study things like chronic illnesses. These are conditions that people must live with and manage, and how a person is feeling in this instance can vary day to day, based on things like what a person is eating, the weather, or medications they are taking. 

“There are so many different possibilities for what could change a patient’s trajectory in one way versus another,” said Dr. Jehi.

She stressed that, if one has a group of patients, and everything that’s happened to them along their disease journey has been captured, it’s very challenging to mimic what that group looks like, and then study the effects of these different interventions on it using traditional computing. 

“It just gets way too complicated, and the computers that we have can’t keep up with analyzing the effects of the different possibilities. It gets jumbled up,” Dr. Jehi said. 

But quantum computing can offer quantum machine learning, meaning you use this special quantum ability to handle different simulations and different possibilities. 

The Cleveland Clinic, for instance, is looking at how some patients who undergo general surgeries have heart complications after their procedures. 

“It would be transformative if we could identify ahead of time who is at highest risk of having a heart attack after surgery, as so we could take care of those people better,” she said. 

The clinic’s current data set includes records for 450,000 patients, and current AI/machine learning makes sifting through this very slow and complex. The clinic is using machine learning approaches to create a synthetic data set, a smaller group that is a replica of the much larger one. Quantum technology could improve and speed this analysis to produce models that better perform.
 

 

 

Disease detection 

“Imagine you go get a CT scan,” said Mr. Uttley. “There are already AI solutions that you can run that set of images through and ask: ‘Does this look like something that would be cancer?’ ” This existing technology works well on things that are typical and have been identified before, because that’s how machine learning works. If AI has seen something 100,000 times, it can often find something else that looks like it. 

But today’s classical computers aren’t equipped to identify something unfamiliar. “Those are places where quantum computers can be much better at thinking of images and being able to say: ‘I can detect rare cancers or rare conditions that you don’t have a huge library of things that look like that,’ ” Mr. Uttley said. 

This is also where researchers can use a quantum computer to be able to figure out what things could look like. 

“The beauty of quantum computing is that it is a bias formation in quantum physics, this more probabilistic design. And so you can take advantage of that probabilistic design to help them think about this,” Mr. Uttley said. 
 

How far out are we? 

Mr. Uttley said we’re in an emergent era of quantum computing. Quantum computers exist and that’s a big deal, but a lot of this technology is still in fairly early stages. 

“It’s a little bit like we’re at the beginning of the internet and saying, how are things going to play out,” he explained. 

Right now, companies like Quantinuum are striving to perform computations on both a quantum and classic computer, compare the results, and say: “We’re getting the same answer.” 

“So, this is the era where we’re able to build trust and say these quantum computers are actually working correctly,” Mr. Uttley explained.

In the future, he said, we can possibly imagine something like a quantum MRI that is able to understand your body in a way that transmits that data to a quantum computer to detect what’s wrong, and be able to tell the difference between cancerous and noncancerous. That will allow faster treatments and tailoring them to specific patient populations.

“What we’re doing today might seem slightly less sexy than that, but is maybe even equally important,” said Mr. Uttley. 

This is using quantum computers to make the best encryption keys that can be made. The medical community, which is already using quantum computing to execute this, is excited about this being a better means of keeping patient data as secure as possible. 

In June, Quantinuum launched InQuanto, which is quantum computing software that is allowing computational chemists, who, until now, only had classical computers at their fingertips. The move created an opportunity to start thinking about the problems that they worked on and what they would do with a quantum computer. As quantum computers become higher performing over the years, Mr. Uttley said the software will go from tasks like isolating one molecule to solving larger problems. 

“That will happen over this next decade, where I think we’ll see the first kind of real use cases come out in the next likely 2 to 3 years,” he said. For now, this technology will likely be used in tandem with classical computers.

Mr. Uttley said that progress in the quantum world and medicine will continue to grow at a slow and steady pace, and in years to come, we’ll likely see things start to click and then eventually take off “full force.”

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

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The 1960s marked the arrival of computers in medicine. Expensive, cumbersome hunks of plastic and metal that could (maybe) get test results to a doctor faster. The 1980s saw the first real difference-making functions computers could offer – clinical, financial, administrative – and in 1991, the Institute of Medicine published the first manifesto on what electronic health records could (and would) be.

Since then, we’ve seen computer breakthroughs across all areas of medicine, with artificial intelligence (AI), virtual reality, and telemedicine brought to the fore. But something else is brewing that not a lot of people know about yet: Quantum computing, a completely new type of computing has already begun to advance everything from drug development and disease identification to the security of electronic records.

“Think of it as transitioning from getting light through fire and candles and now having electricity, and there’s a light bulb that is lighting it all,” said Lara Jehi, MD, Cleveland Clinic’s chief research information officer.
 

What is quantum computing?

Classical computers (aka binary computers), which are the foundation of today’s devices, including artificial intelligence and machine learning, work by using information known as bits. These appear as 0 or 1 (sometimes defined as off/on or false/true). 

Quantum computers, on the other hand, use quantum bits known as qubits. And yes, the definition of “quantum” – as in: very, very small – applies.

International Business Machines, more commonly known as IBM, is currently leading this new tech. A common misconception about quantum computers is that they are “a next evolution of computers that will get faster,” said Frederik Flöther, PhD, life sciences and health care lead with IBM Quantum Industry Consulting. Instead, he wants us to look at quantum computing as something completely new “because it is fundamentally a different hardware, a different software, not just an evolution of the same.”

How does it work differently from existing computers? Quantum computing deals in nature. Therefore, qubits have to be based on the natural world. What does that mean? Nobel Prize-winning physicist Richard Feynman was famously quoted as saying: “Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical, and by golly it’s a wonderful problem, because it doesn’t look so easy.” 

Nature, said Dr. Jehi, doesn’t work in black and white or fit into boxes. 

“We have to convert it to zeros and ones because that’s what computers speak,” she explained. But quantum computing uses the principles of quantum mechanics. “It’s exactly how nature works, because it is based on the fundamental unit of everything in nature, which is atomic structure.”

Very, very small indeed. And that’s why quantum computing could be game-changing tech in medicine. 

“Quantum computers can be used to represent a bunch of different solutions to a problem all at the same time, and then collapse down to the optimal solution, the one that actually works,” said Tony Uttley, president and chief operating officer with Quantinuum, a collaboration between Cambridge Quantum and Honeywell Quantum Solutions that is working to drive the future of quantum computing. “And the reason it does that is because of some fabulous properties of quantum physics.”
 

 

 

Establishing a quantum computing beachhead 

Scientists around the globe are studying quantum computers looking for ways to harness this technology to make big gains in medicine. 

IBM has created the IBM Quantum Network and is partnering with different organizations, from startups to Fortune 500 companies, to develop and test technology in various settings. One of these partnerships with the Cleveland Clinic is set to establish the “Discovery Accelerator,” focused on advancing health care through high-performance computing on the hybrid cloud, quantum computing technologies, and artificial intelligence. 

Many people around the country are now using this technology on existing computers by tapping into the cloud, but with limited qubit access. IBM has researchers in places like Germany and Japan working on quantum computers and will be installing the country’s first of IBM’s next-generation 1,000+ qubit quantum systems on the Cleveland Clinic campus, which they are planning to use to help further investigate quantum computing’s many predicted benefits.

But what are those benefits? 
 

Drug discovery and development 

Quantum chemistry is one main area quantum computing is poised to help. 

“The immediate application of that would be in drug discovery,” said Dr. Jehi. When scientists make drugs, they sit in a lab and develop different chemical formulas for what might constitute that drug. 

“But for us to really know if it’s going to work, we need to be able to imagine how that chemical composition will translate into a structure,” she said. 

Even in their most powerful form, today’s supercomputers are slow in their ability to change this chemical formula on paper to a simulation of what the chemical compound will look like. And in many cases, they can’t do this type of analysis. 

“So, we end up making the drugs without knowing exactly how they’re going to look, which is not really the optimal way of creating a drug you expect to work” explained Dr. Jehi. “It’s a waste of time creating compounds that aren’t going to have any effect.”

Quantum computers will allow researchers to create and see these molecular structures and know how they bind and interact with the human body. In effect, they’ll know if a potential drug will work before ever having to physically make it.

Because of its differences from classic computing, quantum computers are not limited in their ability to simulate how different compounds can appear. Being able to simulate the compounds that drugs are made of can lead to a faster discovery of medications to treat a wide range of conditions. 
 

Disease analysis 

Eventually, this technology could assist with disease analysis, working on a molecular level to allow computers/AI to contemplate, for example, cancer molecules and gain a deeper understanding of how they function. 

Dr. Jehi said quantum computing can also be used to study things like chronic illnesses. These are conditions that people must live with and manage, and how a person is feeling in this instance can vary day to day, based on things like what a person is eating, the weather, or medications they are taking. 

“There are so many different possibilities for what could change a patient’s trajectory in one way versus another,” said Dr. Jehi.

She stressed that, if one has a group of patients, and everything that’s happened to them along their disease journey has been captured, it’s very challenging to mimic what that group looks like, and then study the effects of these different interventions on it using traditional computing. 

“It just gets way too complicated, and the computers that we have can’t keep up with analyzing the effects of the different possibilities. It gets jumbled up,” Dr. Jehi said. 

But quantum computing can offer quantum machine learning, meaning you use this special quantum ability to handle different simulations and different possibilities. 

The Cleveland Clinic, for instance, is looking at how some patients who undergo general surgeries have heart complications after their procedures. 

“It would be transformative if we could identify ahead of time who is at highest risk of having a heart attack after surgery, as so we could take care of those people better,” she said. 

The clinic’s current data set includes records for 450,000 patients, and current AI/machine learning makes sifting through this very slow and complex. The clinic is using machine learning approaches to create a synthetic data set, a smaller group that is a replica of the much larger one. Quantum technology could improve and speed this analysis to produce models that better perform.
 

 

 

Disease detection 

“Imagine you go get a CT scan,” said Mr. Uttley. “There are already AI solutions that you can run that set of images through and ask: ‘Does this look like something that would be cancer?’ ” This existing technology works well on things that are typical and have been identified before, because that’s how machine learning works. If AI has seen something 100,000 times, it can often find something else that looks like it. 

But today’s classical computers aren’t equipped to identify something unfamiliar. “Those are places where quantum computers can be much better at thinking of images and being able to say: ‘I can detect rare cancers or rare conditions that you don’t have a huge library of things that look like that,’ ” Mr. Uttley said. 

This is also where researchers can use a quantum computer to be able to figure out what things could look like. 

“The beauty of quantum computing is that it is a bias formation in quantum physics, this more probabilistic design. And so you can take advantage of that probabilistic design to help them think about this,” Mr. Uttley said. 
 

How far out are we? 

Mr. Uttley said we’re in an emergent era of quantum computing. Quantum computers exist and that’s a big deal, but a lot of this technology is still in fairly early stages. 

“It’s a little bit like we’re at the beginning of the internet and saying, how are things going to play out,” he explained. 

Right now, companies like Quantinuum are striving to perform computations on both a quantum and classic computer, compare the results, and say: “We’re getting the same answer.” 

“So, this is the era where we’re able to build trust and say these quantum computers are actually working correctly,” Mr. Uttley explained.

In the future, he said, we can possibly imagine something like a quantum MRI that is able to understand your body in a way that transmits that data to a quantum computer to detect what’s wrong, and be able to tell the difference between cancerous and noncancerous. That will allow faster treatments and tailoring them to specific patient populations.

“What we’re doing today might seem slightly less sexy than that, but is maybe even equally important,” said Mr. Uttley. 

This is using quantum computers to make the best encryption keys that can be made. The medical community, which is already using quantum computing to execute this, is excited about this being a better means of keeping patient data as secure as possible. 

In June, Quantinuum launched InQuanto, which is quantum computing software that is allowing computational chemists, who, until now, only had classical computers at their fingertips. The move created an opportunity to start thinking about the problems that they worked on and what they would do with a quantum computer. As quantum computers become higher performing over the years, Mr. Uttley said the software will go from tasks like isolating one molecule to solving larger problems. 

“That will happen over this next decade, where I think we’ll see the first kind of real use cases come out in the next likely 2 to 3 years,” he said. For now, this technology will likely be used in tandem with classical computers.

Mr. Uttley said that progress in the quantum world and medicine will continue to grow at a slow and steady pace, and in years to come, we’ll likely see things start to click and then eventually take off “full force.”

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

The 1960s marked the arrival of computers in medicine. Expensive, cumbersome hunks of plastic and metal that could (maybe) get test results to a doctor faster. The 1980s saw the first real difference-making functions computers could offer – clinical, financial, administrative – and in 1991, the Institute of Medicine published the first manifesto on what electronic health records could (and would) be.

Since then, we’ve seen computer breakthroughs across all areas of medicine, with artificial intelligence (AI), virtual reality, and telemedicine brought to the fore. But something else is brewing that not a lot of people know about yet: Quantum computing, a completely new type of computing has already begun to advance everything from drug development and disease identification to the security of electronic records.

“Think of it as transitioning from getting light through fire and candles and now having electricity, and there’s a light bulb that is lighting it all,” said Lara Jehi, MD, Cleveland Clinic’s chief research information officer.
 

What is quantum computing?

Classical computers (aka binary computers), which are the foundation of today’s devices, including artificial intelligence and machine learning, work by using information known as bits. These appear as 0 or 1 (sometimes defined as off/on or false/true). 

Quantum computers, on the other hand, use quantum bits known as qubits. And yes, the definition of “quantum” – as in: very, very small – applies.

International Business Machines, more commonly known as IBM, is currently leading this new tech. A common misconception about quantum computers is that they are “a next evolution of computers that will get faster,” said Frederik Flöther, PhD, life sciences and health care lead with IBM Quantum Industry Consulting. Instead, he wants us to look at quantum computing as something completely new “because it is fundamentally a different hardware, a different software, not just an evolution of the same.”

How does it work differently from existing computers? Quantum computing deals in nature. Therefore, qubits have to be based on the natural world. What does that mean? Nobel Prize-winning physicist Richard Feynman was famously quoted as saying: “Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical, and by golly it’s a wonderful problem, because it doesn’t look so easy.” 

Nature, said Dr. Jehi, doesn’t work in black and white or fit into boxes. 

“We have to convert it to zeros and ones because that’s what computers speak,” she explained. But quantum computing uses the principles of quantum mechanics. “It’s exactly how nature works, because it is based on the fundamental unit of everything in nature, which is atomic structure.”

Very, very small indeed. And that’s why quantum computing could be game-changing tech in medicine. 

“Quantum computers can be used to represent a bunch of different solutions to a problem all at the same time, and then collapse down to the optimal solution, the one that actually works,” said Tony Uttley, president and chief operating officer with Quantinuum, a collaboration between Cambridge Quantum and Honeywell Quantum Solutions that is working to drive the future of quantum computing. “And the reason it does that is because of some fabulous properties of quantum physics.”
 

 

 

Establishing a quantum computing beachhead 

Scientists around the globe are studying quantum computers looking for ways to harness this technology to make big gains in medicine. 

IBM has created the IBM Quantum Network and is partnering with different organizations, from startups to Fortune 500 companies, to develop and test technology in various settings. One of these partnerships with the Cleveland Clinic is set to establish the “Discovery Accelerator,” focused on advancing health care through high-performance computing on the hybrid cloud, quantum computing technologies, and artificial intelligence. 

Many people around the country are now using this technology on existing computers by tapping into the cloud, but with limited qubit access. IBM has researchers in places like Germany and Japan working on quantum computers and will be installing the country’s first of IBM’s next-generation 1,000+ qubit quantum systems on the Cleveland Clinic campus, which they are planning to use to help further investigate quantum computing’s many predicted benefits.

But what are those benefits? 
 

Drug discovery and development 

Quantum chemistry is one main area quantum computing is poised to help. 

“The immediate application of that would be in drug discovery,” said Dr. Jehi. When scientists make drugs, they sit in a lab and develop different chemical formulas for what might constitute that drug. 

“But for us to really know if it’s going to work, we need to be able to imagine how that chemical composition will translate into a structure,” she said. 

Even in their most powerful form, today’s supercomputers are slow in their ability to change this chemical formula on paper to a simulation of what the chemical compound will look like. And in many cases, they can’t do this type of analysis. 

“So, we end up making the drugs without knowing exactly how they’re going to look, which is not really the optimal way of creating a drug you expect to work” explained Dr. Jehi. “It’s a waste of time creating compounds that aren’t going to have any effect.”

Quantum computers will allow researchers to create and see these molecular structures and know how they bind and interact with the human body. In effect, they’ll know if a potential drug will work before ever having to physically make it.

Because of its differences from classic computing, quantum computers are not limited in their ability to simulate how different compounds can appear. Being able to simulate the compounds that drugs are made of can lead to a faster discovery of medications to treat a wide range of conditions. 
 

Disease analysis 

Eventually, this technology could assist with disease analysis, working on a molecular level to allow computers/AI to contemplate, for example, cancer molecules and gain a deeper understanding of how they function. 

Dr. Jehi said quantum computing can also be used to study things like chronic illnesses. These are conditions that people must live with and manage, and how a person is feeling in this instance can vary day to day, based on things like what a person is eating, the weather, or medications they are taking. 

“There are so many different possibilities for what could change a patient’s trajectory in one way versus another,” said Dr. Jehi.

She stressed that, if one has a group of patients, and everything that’s happened to them along their disease journey has been captured, it’s very challenging to mimic what that group looks like, and then study the effects of these different interventions on it using traditional computing. 

“It just gets way too complicated, and the computers that we have can’t keep up with analyzing the effects of the different possibilities. It gets jumbled up,” Dr. Jehi said. 

But quantum computing can offer quantum machine learning, meaning you use this special quantum ability to handle different simulations and different possibilities. 

The Cleveland Clinic, for instance, is looking at how some patients who undergo general surgeries have heart complications after their procedures. 

“It would be transformative if we could identify ahead of time who is at highest risk of having a heart attack after surgery, as so we could take care of those people better,” she said. 

The clinic’s current data set includes records for 450,000 patients, and current AI/machine learning makes sifting through this very slow and complex. The clinic is using machine learning approaches to create a synthetic data set, a smaller group that is a replica of the much larger one. Quantum technology could improve and speed this analysis to produce models that better perform.
 

 

 

Disease detection 

“Imagine you go get a CT scan,” said Mr. Uttley. “There are already AI solutions that you can run that set of images through and ask: ‘Does this look like something that would be cancer?’ ” This existing technology works well on things that are typical and have been identified before, because that’s how machine learning works. If AI has seen something 100,000 times, it can often find something else that looks like it. 

But today’s classical computers aren’t equipped to identify something unfamiliar. “Those are places where quantum computers can be much better at thinking of images and being able to say: ‘I can detect rare cancers or rare conditions that you don’t have a huge library of things that look like that,’ ” Mr. Uttley said. 

This is also where researchers can use a quantum computer to be able to figure out what things could look like. 

“The beauty of quantum computing is that it is a bias formation in quantum physics, this more probabilistic design. And so you can take advantage of that probabilistic design to help them think about this,” Mr. Uttley said. 
 

How far out are we? 

Mr. Uttley said we’re in an emergent era of quantum computing. Quantum computers exist and that’s a big deal, but a lot of this technology is still in fairly early stages. 

“It’s a little bit like we’re at the beginning of the internet and saying, how are things going to play out,” he explained. 

Right now, companies like Quantinuum are striving to perform computations on both a quantum and classic computer, compare the results, and say: “We’re getting the same answer.” 

“So, this is the era where we’re able to build trust and say these quantum computers are actually working correctly,” Mr. Uttley explained.

In the future, he said, we can possibly imagine something like a quantum MRI that is able to understand your body in a way that transmits that data to a quantum computer to detect what’s wrong, and be able to tell the difference between cancerous and noncancerous. That will allow faster treatments and tailoring them to specific patient populations.

“What we’re doing today might seem slightly less sexy than that, but is maybe even equally important,” said Mr. Uttley. 

This is using quantum computers to make the best encryption keys that can be made. The medical community, which is already using quantum computing to execute this, is excited about this being a better means of keeping patient data as secure as possible. 

In June, Quantinuum launched InQuanto, which is quantum computing software that is allowing computational chemists, who, until now, only had classical computers at their fingertips. The move created an opportunity to start thinking about the problems that they worked on and what they would do with a quantum computer. As quantum computers become higher performing over the years, Mr. Uttley said the software will go from tasks like isolating one molecule to solving larger problems. 

“That will happen over this next decade, where I think we’ll see the first kind of real use cases come out in the next likely 2 to 3 years,” he said. For now, this technology will likely be used in tandem with classical computers.

Mr. Uttley said that progress in the quantum world and medicine will continue to grow at a slow and steady pace, and in years to come, we’ll likely see things start to click and then eventually take off “full force.”

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

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Are nurses who pick up extra shifts at risk of harming themselves or others?

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To boost their pay, many nurses pick up extra shifts. But juggling extra work and racking up 50-plus hours a week can take a toll on a nurse’s physical and mental health. Plus, it can diminish quality of care and lead to patient errors.

Medscape’s RN/LPN Compensation Report 2022 found that more than half of RNs and LPNs don’t think they get paid enough. Even though many nurses saw pay increases over the past 2 years, many were still dissatisfied with their earnings. They blamed job stress, staffing shortages, and benefits that cut into their wages.
 

Why do nurses pick up extra shifts?

Most nurses work extra hours for the money. Incentives like getting paid time and a half or scoring a $200 bonus are hard to pass up.

“I’m a single mother with two kids,” said Cynthia West, a critical care nurse in Atlanta. “I want to be able to pay my bills and enjoy my life, too.” So, Ms. West picks up two to three extra shifts a month. She also works on-call for a sexual assault center, earning $350 per exam.

But money isn’t the only reason for some nurses. Trang Robinson travels from her home in Atlanta to Palo Alto, Calif., every other week for her job as a labor and delivery RN.

“If my unit needs extra help, I want to help,” she said. “It’s not about the extra money, although that helps my family; it’s that we’ve been so short-staffed. My colleagues are burned out. Staff members are burned out. When I’m there, I work as much as I can to help out my unit.”

Leslie Wysong, an Atlanta postanesthesia nurse, worked in intensive care during much of COVID. She said the chance to make level 3 pay was rewarding for many nurses, but most weren’t doing it for the money.

“We were doing it to alleviate the strain on our fellow nurses, to get closer to a 2:1 patient/nurse ratio rather than the 3:1 we were dealing with over the pandemic,” she said. “It was to help out our colleagues during a desperate situation.”
 

What are the risks?

The U.S. Occupational Safety and Health Administration states that a work shift that lasts more than 8 hours can disrupt the body’s sleep/wake cycle. It can also lead to physical and mental fatigue resulting in errors, injuries, and accidents.

And a study published in the American Association of Occupational Health Nurses found that extended shifts or shift work impacted nurses in many ways, including more medication errors, falling asleep during work hours, decreased productivity in the last 4 shift hours (of a 12-hour shift), increased risk of mistakes and near-errors associated with decreased vigilance, critical thinking impairment, and more needlestick injuries.

Another study, published in Rehabilitation Nursing Journal, found even more adverse effects, such as sleep disorders like insomnia and excessive sleepiness; cognitive impairment such as the reduced ability to concentrate, slower reactions times, and reduced ability to remember information; higher rates of injury while on the job; being more likely to engage in overeating and alcohol misuse; GI issues such as abdominal pain, constipation, and heartburn; higher rates of heart disease and high blood pressure; higher risk for breast and prostate cancers, and higher rates of depression and anxiety.

These are risks some nurses aren’t willing to take. For example, Caitlin Riley, a pediatric ED nurse in Ocala, Fla., only picks up extra shifts when she must, like when Hurricane Ian swept through Central Florida.

“I think working extra hours can compromise your quality of care,” she said. “You may make mistakes with things like math calculations or not catch something if you’re not totally ‘in’ it mentally. At the end of the day, it’s your nursing license. Sure, the money is great, but I won’t do anything to compromise losing my license or patient care.”
 

 

 

How can nurses boost pay without working extra shifts?

Instead, Ms. Riley returned to school and earned an MSN in health care leadership/management, knowing that an advanced degree could lead to higher-paying work. According to the Medscape report, RNs with master’s and doctoral degrees earned over $10,000 more than those with bachelor’s, associate’s, or RN diplomas.

The report also compiled the following earnings data. The data may help nurses find other ways to raise their salaries without taking on extra shifts.

  • Salaried RNs and LPNs made more than hourly paid nurses.
  • In-patient hospital RNs and skilled nursing facility LPNs got paid more than nurses in other settings.
  • Specialty certifications helped RNs earn more money than nurses without specialty certificates.
  • Union RNs and LPNs earned more than nonunion nurses.
  • RNs and LPNs who work in big cities or suburbs make more money than those in rural areas.

How to prevent burnout and exhaustion when you work extra shifts

While burnout can happen in any profession, an investigation published in JAMA Network Open suggests it’s prevalent among US nurses. The study found that nurses who worked over 40 hours a week were more likely to experience burnout. However, researchers say that adequate staffing and limiting shift hours may alleviate the problem. Here’s how the nurses in the survey dealt with battle burnout:

  • Change departments. Ms. Wysong stepped away from the ICU after COVID and switched to postanesthesia. “The move has made my work life much less stressful,” said Ms. Wysong. “They are all happy endings in postanesthesia.”
  • Leave work at work. Ms. Riley said she mentally clocks out as she leaves the hospital. “When I put my papers in my shredder at the end of my shift, I let it go. I walk away knowing I did the best for my patients. Once I’m home, it’s time for me to be with the people I love and to refuel my own sense of happiness with the people that mean the most to me.”
  • Take time off. “When I’m burned out, I just don’t come in,” said Ms. Robinson. “If I’m mentally or emotionally drained, I give myself a shift off to decompress, or I don’t pick up extra shifts.”
  • Engage in relaxing hobbies. Kris Coleman, an ED nurse in Hardeeville, S.C., typically works three 12-hours shifts and only picks up an extra 4-hour shift once a week. When he’s off, he takes advantage of his time away from work. He said: “Do the things that help you relax on your time off. For me, it’s golfing, fishing, and spending time with my family.”
  • Build a support system. “I have a group of friends at work,” said Ms. West. “We talk to each other and vent. Having a good support system, people that are in it with you who get what you’re going through is a helpful way to manage burnout.”

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

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To boost their pay, many nurses pick up extra shifts. But juggling extra work and racking up 50-plus hours a week can take a toll on a nurse’s physical and mental health. Plus, it can diminish quality of care and lead to patient errors.

Medscape’s RN/LPN Compensation Report 2022 found that more than half of RNs and LPNs don’t think they get paid enough. Even though many nurses saw pay increases over the past 2 years, many were still dissatisfied with their earnings. They blamed job stress, staffing shortages, and benefits that cut into their wages.
 

Why do nurses pick up extra shifts?

Most nurses work extra hours for the money. Incentives like getting paid time and a half or scoring a $200 bonus are hard to pass up.

“I’m a single mother with two kids,” said Cynthia West, a critical care nurse in Atlanta. “I want to be able to pay my bills and enjoy my life, too.” So, Ms. West picks up two to three extra shifts a month. She also works on-call for a sexual assault center, earning $350 per exam.

But money isn’t the only reason for some nurses. Trang Robinson travels from her home in Atlanta to Palo Alto, Calif., every other week for her job as a labor and delivery RN.

“If my unit needs extra help, I want to help,” she said. “It’s not about the extra money, although that helps my family; it’s that we’ve been so short-staffed. My colleagues are burned out. Staff members are burned out. When I’m there, I work as much as I can to help out my unit.”

Leslie Wysong, an Atlanta postanesthesia nurse, worked in intensive care during much of COVID. She said the chance to make level 3 pay was rewarding for many nurses, but most weren’t doing it for the money.

“We were doing it to alleviate the strain on our fellow nurses, to get closer to a 2:1 patient/nurse ratio rather than the 3:1 we were dealing with over the pandemic,” she said. “It was to help out our colleagues during a desperate situation.”
 

What are the risks?

The U.S. Occupational Safety and Health Administration states that a work shift that lasts more than 8 hours can disrupt the body’s sleep/wake cycle. It can also lead to physical and mental fatigue resulting in errors, injuries, and accidents.

And a study published in the American Association of Occupational Health Nurses found that extended shifts or shift work impacted nurses in many ways, including more medication errors, falling asleep during work hours, decreased productivity in the last 4 shift hours (of a 12-hour shift), increased risk of mistakes and near-errors associated with decreased vigilance, critical thinking impairment, and more needlestick injuries.

Another study, published in Rehabilitation Nursing Journal, found even more adverse effects, such as sleep disorders like insomnia and excessive sleepiness; cognitive impairment such as the reduced ability to concentrate, slower reactions times, and reduced ability to remember information; higher rates of injury while on the job; being more likely to engage in overeating and alcohol misuse; GI issues such as abdominal pain, constipation, and heartburn; higher rates of heart disease and high blood pressure; higher risk for breast and prostate cancers, and higher rates of depression and anxiety.

These are risks some nurses aren’t willing to take. For example, Caitlin Riley, a pediatric ED nurse in Ocala, Fla., only picks up extra shifts when she must, like when Hurricane Ian swept through Central Florida.

“I think working extra hours can compromise your quality of care,” she said. “You may make mistakes with things like math calculations or not catch something if you’re not totally ‘in’ it mentally. At the end of the day, it’s your nursing license. Sure, the money is great, but I won’t do anything to compromise losing my license or patient care.”
 

 

 

How can nurses boost pay without working extra shifts?

Instead, Ms. Riley returned to school and earned an MSN in health care leadership/management, knowing that an advanced degree could lead to higher-paying work. According to the Medscape report, RNs with master’s and doctoral degrees earned over $10,000 more than those with bachelor’s, associate’s, or RN diplomas.

The report also compiled the following earnings data. The data may help nurses find other ways to raise their salaries without taking on extra shifts.

  • Salaried RNs and LPNs made more than hourly paid nurses.
  • In-patient hospital RNs and skilled nursing facility LPNs got paid more than nurses in other settings.
  • Specialty certifications helped RNs earn more money than nurses without specialty certificates.
  • Union RNs and LPNs earned more than nonunion nurses.
  • RNs and LPNs who work in big cities or suburbs make more money than those in rural areas.

How to prevent burnout and exhaustion when you work extra shifts

While burnout can happen in any profession, an investigation published in JAMA Network Open suggests it’s prevalent among US nurses. The study found that nurses who worked over 40 hours a week were more likely to experience burnout. However, researchers say that adequate staffing and limiting shift hours may alleviate the problem. Here’s how the nurses in the survey dealt with battle burnout:

  • Change departments. Ms. Wysong stepped away from the ICU after COVID and switched to postanesthesia. “The move has made my work life much less stressful,” said Ms. Wysong. “They are all happy endings in postanesthesia.”
  • Leave work at work. Ms. Riley said she mentally clocks out as she leaves the hospital. “When I put my papers in my shredder at the end of my shift, I let it go. I walk away knowing I did the best for my patients. Once I’m home, it’s time for me to be with the people I love and to refuel my own sense of happiness with the people that mean the most to me.”
  • Take time off. “When I’m burned out, I just don’t come in,” said Ms. Robinson. “If I’m mentally or emotionally drained, I give myself a shift off to decompress, or I don’t pick up extra shifts.”
  • Engage in relaxing hobbies. Kris Coleman, an ED nurse in Hardeeville, S.C., typically works three 12-hours shifts and only picks up an extra 4-hour shift once a week. When he’s off, he takes advantage of his time away from work. He said: “Do the things that help you relax on your time off. For me, it’s golfing, fishing, and spending time with my family.”
  • Build a support system. “I have a group of friends at work,” said Ms. West. “We talk to each other and vent. Having a good support system, people that are in it with you who get what you’re going through is a helpful way to manage burnout.”

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

To boost their pay, many nurses pick up extra shifts. But juggling extra work and racking up 50-plus hours a week can take a toll on a nurse’s physical and mental health. Plus, it can diminish quality of care and lead to patient errors.

Medscape’s RN/LPN Compensation Report 2022 found that more than half of RNs and LPNs don’t think they get paid enough. Even though many nurses saw pay increases over the past 2 years, many were still dissatisfied with their earnings. They blamed job stress, staffing shortages, and benefits that cut into their wages.
 

Why do nurses pick up extra shifts?

Most nurses work extra hours for the money. Incentives like getting paid time and a half or scoring a $200 bonus are hard to pass up.

“I’m a single mother with two kids,” said Cynthia West, a critical care nurse in Atlanta. “I want to be able to pay my bills and enjoy my life, too.” So, Ms. West picks up two to three extra shifts a month. She also works on-call for a sexual assault center, earning $350 per exam.

But money isn’t the only reason for some nurses. Trang Robinson travels from her home in Atlanta to Palo Alto, Calif., every other week for her job as a labor and delivery RN.

“If my unit needs extra help, I want to help,” she said. “It’s not about the extra money, although that helps my family; it’s that we’ve been so short-staffed. My colleagues are burned out. Staff members are burned out. When I’m there, I work as much as I can to help out my unit.”

Leslie Wysong, an Atlanta postanesthesia nurse, worked in intensive care during much of COVID. She said the chance to make level 3 pay was rewarding for many nurses, but most weren’t doing it for the money.

“We were doing it to alleviate the strain on our fellow nurses, to get closer to a 2:1 patient/nurse ratio rather than the 3:1 we were dealing with over the pandemic,” she said. “It was to help out our colleagues during a desperate situation.”
 

What are the risks?

The U.S. Occupational Safety and Health Administration states that a work shift that lasts more than 8 hours can disrupt the body’s sleep/wake cycle. It can also lead to physical and mental fatigue resulting in errors, injuries, and accidents.

And a study published in the American Association of Occupational Health Nurses found that extended shifts or shift work impacted nurses in many ways, including more medication errors, falling asleep during work hours, decreased productivity in the last 4 shift hours (of a 12-hour shift), increased risk of mistakes and near-errors associated with decreased vigilance, critical thinking impairment, and more needlestick injuries.

Another study, published in Rehabilitation Nursing Journal, found even more adverse effects, such as sleep disorders like insomnia and excessive sleepiness; cognitive impairment such as the reduced ability to concentrate, slower reactions times, and reduced ability to remember information; higher rates of injury while on the job; being more likely to engage in overeating and alcohol misuse; GI issues such as abdominal pain, constipation, and heartburn; higher rates of heart disease and high blood pressure; higher risk for breast and prostate cancers, and higher rates of depression and anxiety.

These are risks some nurses aren’t willing to take. For example, Caitlin Riley, a pediatric ED nurse in Ocala, Fla., only picks up extra shifts when she must, like when Hurricane Ian swept through Central Florida.

“I think working extra hours can compromise your quality of care,” she said. “You may make mistakes with things like math calculations or not catch something if you’re not totally ‘in’ it mentally. At the end of the day, it’s your nursing license. Sure, the money is great, but I won’t do anything to compromise losing my license or patient care.”
 

 

 

How can nurses boost pay without working extra shifts?

Instead, Ms. Riley returned to school and earned an MSN in health care leadership/management, knowing that an advanced degree could lead to higher-paying work. According to the Medscape report, RNs with master’s and doctoral degrees earned over $10,000 more than those with bachelor’s, associate’s, or RN diplomas.

The report also compiled the following earnings data. The data may help nurses find other ways to raise their salaries without taking on extra shifts.

  • Salaried RNs and LPNs made more than hourly paid nurses.
  • In-patient hospital RNs and skilled nursing facility LPNs got paid more than nurses in other settings.
  • Specialty certifications helped RNs earn more money than nurses without specialty certificates.
  • Union RNs and LPNs earned more than nonunion nurses.
  • RNs and LPNs who work in big cities or suburbs make more money than those in rural areas.

How to prevent burnout and exhaustion when you work extra shifts

While burnout can happen in any profession, an investigation published in JAMA Network Open suggests it’s prevalent among US nurses. The study found that nurses who worked over 40 hours a week were more likely to experience burnout. However, researchers say that adequate staffing and limiting shift hours may alleviate the problem. Here’s how the nurses in the survey dealt with battle burnout:

  • Change departments. Ms. Wysong stepped away from the ICU after COVID and switched to postanesthesia. “The move has made my work life much less stressful,” said Ms. Wysong. “They are all happy endings in postanesthesia.”
  • Leave work at work. Ms. Riley said she mentally clocks out as she leaves the hospital. “When I put my papers in my shredder at the end of my shift, I let it go. I walk away knowing I did the best for my patients. Once I’m home, it’s time for me to be with the people I love and to refuel my own sense of happiness with the people that mean the most to me.”
  • Take time off. “When I’m burned out, I just don’t come in,” said Ms. Robinson. “If I’m mentally or emotionally drained, I give myself a shift off to decompress, or I don’t pick up extra shifts.”
  • Engage in relaxing hobbies. Kris Coleman, an ED nurse in Hardeeville, S.C., typically works three 12-hours shifts and only picks up an extra 4-hour shift once a week. When he’s off, he takes advantage of his time away from work. He said: “Do the things that help you relax on your time off. For me, it’s golfing, fishing, and spending time with my family.”
  • Build a support system. “I have a group of friends at work,” said Ms. West. “We talk to each other and vent. Having a good support system, people that are in it with you who get what you’re going through is a helpful way to manage burnout.”

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

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Patient safety in hospitals improved in past decade: Report

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The patient safety record of U.S. hospitals improved over the past decade, according to the 10th annual report from nonprofit the Leapfrog Group, a national nonprofit organization focused on health care safety and quality.

For five outcome measures, the safety improvements saved an estimated 16,000 lives during the 10-year period, the report said. These included two “never” events that both declined by approximately 25%: incidents of falls and trauma and incidents of objects unintentionally left in a body after surgery.

There were also decreases in three health care–associated infections, including methicillin-resistant Staphylococcus aureus (MRSA), which decreased by 22%; central line–associated bloodstream infection (CLABSI), which fell by 43%; and Clostridioides difficile infection (C. Diff), which declined by 8%.

The patient safety record of U.S. hospitals improved over the past decade, according to the report.

“Never in history have we seen across-the-board improvement in patient safety until this last decade, coinciding with the history of the [Leapfrog] Hospital Safety Grade,” said Leah Binder, president and CEO of the Leapfrog Group, in a news release. “We salute hospitals for this milestone and encourage them to accelerate their hard work saving patient lives.”

During the past decade, the report noted, hospitals have widely adopted technology and staffing strategies that can protect patients from preventable harm and death. Leapfrog cited a nearly sevenfold increase in the adoption of computerized provider order entry, which can reduce medication errors by more than 40%. 

However, federal health officials separately have reported that the pandemic may have eroded some of those gains.

The Leapfrog report also cited a recent study, published in JAMA, that found that the rates of preventable adverse events in hospitalized patients – including adverse drug events, hospital-acquired infections, postprocedure events, and hospital-acquired pressure ulcers and falls – significantly declined between 2010 and 2019.

That study pointed to specific decreases in the rates of adverse events for patients admitted for myocardial infarction, heart failure, pneumonia, and major surgical procedures. There were also significant drops in adverse events for all other conditions, the study found.

Quality improvement efforts targeting those four conditions might have partly accounted for the lower rates of adverse events in patients with the conditions, the study observed. But “similar interventions did not occur for most of the conditions represented in the ‘all other conditions’ group,” it said.

In a 2019 report by the U.S. Agency for Healthcare Research and Quality (AHRQ), the agency noted that from 2000 to 2017, there had been gains in nearly two-thirds of patient-safety measures in acute, post-acute, and ambulatory care. Hospital safety improved on nine metrics and was unchanged on three. For example, from 2014 to 2017, the number of some hospital-acquired conditions, including adverse drug events and C. Diff infections, dropped about 20%.

However, in an article this past February, officials of the Centers for Medicare & Medicaid Services (CMS) said they had observed deterioration on multiple patient-safety metrics since the start of the pandemic. For example, central line infections, which had dropped by 31% in the five years before the COVID-19 outbreak, jumped 28% in the second quarter of 2020, compared with the prior-year period.

Commenting on these developments, the CMS authors said “the fact that the pandemic degraded patient safety so quickly and severely suggests that our health care system lacks a sufficiently resilient safety culture and infrastructure.”

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

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The patient safety record of U.S. hospitals improved over the past decade, according to the 10th annual report from nonprofit the Leapfrog Group, a national nonprofit organization focused on health care safety and quality.

For five outcome measures, the safety improvements saved an estimated 16,000 lives during the 10-year period, the report said. These included two “never” events that both declined by approximately 25%: incidents of falls and trauma and incidents of objects unintentionally left in a body after surgery.

There were also decreases in three health care–associated infections, including methicillin-resistant Staphylococcus aureus (MRSA), which decreased by 22%; central line–associated bloodstream infection (CLABSI), which fell by 43%; and Clostridioides difficile infection (C. Diff), which declined by 8%.

The patient safety record of U.S. hospitals improved over the past decade, according to the report.

“Never in history have we seen across-the-board improvement in patient safety until this last decade, coinciding with the history of the [Leapfrog] Hospital Safety Grade,” said Leah Binder, president and CEO of the Leapfrog Group, in a news release. “We salute hospitals for this milestone and encourage them to accelerate their hard work saving patient lives.”

During the past decade, the report noted, hospitals have widely adopted technology and staffing strategies that can protect patients from preventable harm and death. Leapfrog cited a nearly sevenfold increase in the adoption of computerized provider order entry, which can reduce medication errors by more than 40%. 

However, federal health officials separately have reported that the pandemic may have eroded some of those gains.

The Leapfrog report also cited a recent study, published in JAMA, that found that the rates of preventable adverse events in hospitalized patients – including adverse drug events, hospital-acquired infections, postprocedure events, and hospital-acquired pressure ulcers and falls – significantly declined between 2010 and 2019.

That study pointed to specific decreases in the rates of adverse events for patients admitted for myocardial infarction, heart failure, pneumonia, and major surgical procedures. There were also significant drops in adverse events for all other conditions, the study found.

Quality improvement efforts targeting those four conditions might have partly accounted for the lower rates of adverse events in patients with the conditions, the study observed. But “similar interventions did not occur for most of the conditions represented in the ‘all other conditions’ group,” it said.

In a 2019 report by the U.S. Agency for Healthcare Research and Quality (AHRQ), the agency noted that from 2000 to 2017, there had been gains in nearly two-thirds of patient-safety measures in acute, post-acute, and ambulatory care. Hospital safety improved on nine metrics and was unchanged on three. For example, from 2014 to 2017, the number of some hospital-acquired conditions, including adverse drug events and C. Diff infections, dropped about 20%.

However, in an article this past February, officials of the Centers for Medicare & Medicaid Services (CMS) said they had observed deterioration on multiple patient-safety metrics since the start of the pandemic. For example, central line infections, which had dropped by 31% in the five years before the COVID-19 outbreak, jumped 28% in the second quarter of 2020, compared with the prior-year period.

Commenting on these developments, the CMS authors said “the fact that the pandemic degraded patient safety so quickly and severely suggests that our health care system lacks a sufficiently resilient safety culture and infrastructure.”

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

The patient safety record of U.S. hospitals improved over the past decade, according to the 10th annual report from nonprofit the Leapfrog Group, a national nonprofit organization focused on health care safety and quality.

For five outcome measures, the safety improvements saved an estimated 16,000 lives during the 10-year period, the report said. These included two “never” events that both declined by approximately 25%: incidents of falls and trauma and incidents of objects unintentionally left in a body after surgery.

There were also decreases in three health care–associated infections, including methicillin-resistant Staphylococcus aureus (MRSA), which decreased by 22%; central line–associated bloodstream infection (CLABSI), which fell by 43%; and Clostridioides difficile infection (C. Diff), which declined by 8%.

The patient safety record of U.S. hospitals improved over the past decade, according to the report.

“Never in history have we seen across-the-board improvement in patient safety until this last decade, coinciding with the history of the [Leapfrog] Hospital Safety Grade,” said Leah Binder, president and CEO of the Leapfrog Group, in a news release. “We salute hospitals for this milestone and encourage them to accelerate their hard work saving patient lives.”

During the past decade, the report noted, hospitals have widely adopted technology and staffing strategies that can protect patients from preventable harm and death. Leapfrog cited a nearly sevenfold increase in the adoption of computerized provider order entry, which can reduce medication errors by more than 40%. 

However, federal health officials separately have reported that the pandemic may have eroded some of those gains.

The Leapfrog report also cited a recent study, published in JAMA, that found that the rates of preventable adverse events in hospitalized patients – including adverse drug events, hospital-acquired infections, postprocedure events, and hospital-acquired pressure ulcers and falls – significantly declined between 2010 and 2019.

That study pointed to specific decreases in the rates of adverse events for patients admitted for myocardial infarction, heart failure, pneumonia, and major surgical procedures. There were also significant drops in adverse events for all other conditions, the study found.

Quality improvement efforts targeting those four conditions might have partly accounted for the lower rates of adverse events in patients with the conditions, the study observed. But “similar interventions did not occur for most of the conditions represented in the ‘all other conditions’ group,” it said.

In a 2019 report by the U.S. Agency for Healthcare Research and Quality (AHRQ), the agency noted that from 2000 to 2017, there had been gains in nearly two-thirds of patient-safety measures in acute, post-acute, and ambulatory care. Hospital safety improved on nine metrics and was unchanged on three. For example, from 2014 to 2017, the number of some hospital-acquired conditions, including adverse drug events and C. Diff infections, dropped about 20%.

However, in an article this past February, officials of the Centers for Medicare & Medicaid Services (CMS) said they had observed deterioration on multiple patient-safety metrics since the start of the pandemic. For example, central line infections, which had dropped by 31% in the five years before the COVID-19 outbreak, jumped 28% in the second quarter of 2020, compared with the prior-year period.

Commenting on these developments, the CMS authors said “the fact that the pandemic degraded patient safety so quickly and severely suggests that our health care system lacks a sufficiently resilient safety culture and infrastructure.”

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

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Will ICER review aid bid for Medicare to pay for obesity drugs?

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A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

 

 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

 

 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

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A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

 

 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

 

 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

 

 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

 

 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

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Nurse practitioner fined $20k for advertising herself as ‘Doctor Sarah’

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A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

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A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

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Patients trying to lose weight overestimate their diet quality

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There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m2.

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

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There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m2.

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m2.

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

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Intermittent fasting diet trend linked to disordered eating

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Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

 

 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

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Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

 

 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

 

 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

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