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The DEA Plans to Reschedule Marijuana: What Happens Next?
The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week.
First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.
How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry?
Why Reschedule? Why Now?
The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III.
Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.
Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports.
Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.
“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization.
How Does Rescheduling Work? What’s the Timeline?
The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear.
Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.
“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”
A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.
How Will Rescheduling Affect Medical Marijuana?
For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said.
“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.
Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use.
“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.
But what about patients living in states that have not legalized medical cannabis?
“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.”
The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.
What Does It Mean for Medical Marijuana Dispensaries?
Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.
“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said.
“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.
However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.
“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said.
Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said.
“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.
Will Rescheduling Make It Easier to Conduct Cannabis-Related Research?
Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.
“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said.
The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition.
In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds.
It’s unclear whether those guidelines would be updated if the rescheduling moves forward.
Does Rescheduling Marijuana Pose Any Risk?
In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”
That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said.
“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”
Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia.
“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”
Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness.
“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”
Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures.
A version of this article appeared on Medscape.com.
The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week.
First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.
How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry?
Why Reschedule? Why Now?
The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III.
Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.
Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports.
Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.
“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization.
How Does Rescheduling Work? What’s the Timeline?
The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear.
Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.
“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”
A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.
How Will Rescheduling Affect Medical Marijuana?
For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said.
“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.
Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use.
“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.
But what about patients living in states that have not legalized medical cannabis?
“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.”
The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.
What Does It Mean for Medical Marijuana Dispensaries?
Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.
“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said.
“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.
However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.
“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said.
Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said.
“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.
Will Rescheduling Make It Easier to Conduct Cannabis-Related Research?
Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.
“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said.
The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition.
In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds.
It’s unclear whether those guidelines would be updated if the rescheduling moves forward.
Does Rescheduling Marijuana Pose Any Risk?
In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”
That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said.
“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”
Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia.
“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”
Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness.
“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”
Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures.
A version of this article appeared on Medscape.com.
The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week.
First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.
How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry?
Why Reschedule? Why Now?
The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III.
Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.
Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports.
Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.
“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization.
How Does Rescheduling Work? What’s the Timeline?
The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear.
Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.
“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”
A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.
How Will Rescheduling Affect Medical Marijuana?
For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said.
“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.
Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use.
“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.
But what about patients living in states that have not legalized medical cannabis?
“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.”
The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.
What Does It Mean for Medical Marijuana Dispensaries?
Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.
“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said.
“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.
However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.
“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said.
Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said.
“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.
Will Rescheduling Make It Easier to Conduct Cannabis-Related Research?
Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.
“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said.
The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition.
In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds.
It’s unclear whether those guidelines would be updated if the rescheduling moves forward.
Does Rescheduling Marijuana Pose Any Risk?
In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”
That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said.
“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”
Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia.
“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”
Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness.
“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”
Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures.
A version of this article appeared on Medscape.com.
Risk of Knee OA From Weight-Bearing Exercise Seen Only With Low Muscle Mass
Weight-bearing recreational activity was associated with a 22% increased odds of developing knee osteoarthritis (OA) in a large prospective cohort study in the Netherlands, but notably, the increased risk was seen only in those with low levels of lower-limb muscle mass.
The findings point toward the value of “tailored advice” for physical activity, and suggest that “caution is needed when engaging in weight-bearing activity, especially for individuals with low levels of lower-limb muscle mass,” Yahong Wu, MD, and coinvestigators, of the Erasmus Medical Center in Rotterdam, the Netherlands, wrote in JAMA Network Open.
Investigators used data from sequential cohorts of the longitudinal Rotterdam Study, which enrolled people aged 45 and older starting in 1990. The 5003 participants in this new analysis of physical activity and knee OA had complete records of baseline recreational physical activity, baseline knee pain, and knee radiographs from both baseline and at least one follow-up exam. Those with radiographically defined knee OA at baseline were excluded.
The incident rate of radiographically defined (x-ray) knee OA among all participants was 8.4%, with a mean follow-up time of 6.33 years. Among 3492 individuals without baseline knee pain, the researchers found no increased odds of incident radiographic OA with non–weight-bearing activity (odds ratio [OR], 1.04; 95% CI, 0.95-1.15; P = .37) but a significant association of weight-bearing activity with OA incidence (OR, 1.22; 95% CI, 1.10-1.35; P < .001).
A stratification analysis of a subset of participants whose lower-limb mass had been measured by dual-energy x-ray absorptiometry (DXA) showed, however, that the association of weight-bearing activity with incident OA was limited to patients in the lowest third of lower-limb muscle mass index (LMI), who had a 53% increased likelihood of developing knee OA (OR, 1.53; 95% CI, 1.15-2.04; P = .003).
For patients in the middle and upper tertiles, there was no significant association between weight-bearing activity and the odds of incident OA (OR, 0.93; P = .73, and OR, 1.15; P = .40, respectively).
The findings are reassuring overall, said Kelli D. Allen, PhD, research professor of medicine and exercise physiologist at the University of North Carolina at Chapel Hill, who was asked to comment on the study. “The study corroborates prior research showing that for most people, weight-bearing recreational activity does not increase the risk of knee osteoarthritis. This should be encouraging for people who want to increase their physical activity,” she said.
The study also suggests that “for people with low lower-limb muscle mass, there may be some considerations to make regarding the best type of physical activity to prevent future knee osteoarthritis,” she said in an e-mail. “The best approach may include non–weight-bearing activities, which could include biking, swimming, or other water exercises, along with strengthening exercises that help to increase muscle mass.”
Other studies, Dr. Allen said, have shown that low muscle mass itself is a risk factor for knee OA.
Physical Activity Types, Other Analyses
The researchers assessed total, weight-bearing, and non–weight-bearing physical activity using two validated questionnaires (an adapted version of the Zutphen Physical Activity Questionnaire and the Longitudinal Aging Study Amsterdam physical activity questionnaire) that asked participants about the frequency and duration of various types of physical activity. Activity was quantified as metabolic equivalent of task (MET) hours per week, and weight-bearing activities were defined as those in which the knee joint bears the body’s weight.
Walking, gardening, golf, dancing, and ball sports were among the activities qualifying as weight-bearing activities. Non–weight-bearing activities included cycling, rowing, and swimming.
Sex, body mass index, and follow-up time were among the covariates adjusted for in the primary analysis. Similar results were found when adjustments were also made for educational level, alcohol intake, lipid levels, and diabetes.
While incident radiographic knee OA (measured using the Kellgren & Lawrence grading system) was the primary outcome, the researchers also looked at symptomatic knee OA, as defined by x-ray and a knee pain questionnaire, and found no significant association of its incidence with any of the exercise categories (total, weight-bearing, or non-weight-bearing).
Coauthor Joyce B. J. van Meurs, PhD, of the departments of internal medicine and orthopedics & sports medicine at Erasmus Medical Center, told this news organization that “pain as a subjective, recurrent symptom is more difficult to study … [and] a larger sample size or more precise measurements [of pain] in future studies would help to better understand the true association” of symptomatic knee OA and physical activity.
Similarly, analyses of the 1511 patients (out of 5003) who had knee pain at baseline found no significant association of weight-bearing or non–weight-bearing physical activity with incident radiographic knee OA. The trends were similar to those found in the population without knee pain, however, which suggests the analysis was underpowered, the researchers wrote, noting too that patients with baseline pain had lower activity levels than those without pain. (Low case numbers precluded a stratification analysis on LMI for incident symptomatic OA.)
Thigh Circumference as an Indicator of Muscle Mass
The findings build upon an international meta-analysis published in 2021 that found no association between total physical activity and knee OA and align with other studies suggesting a link between greater mechanical stress/strain and greater OA risk, the researchers wrote. (The meta-analysis couldn’t investigate different types of activity.)
“Although we cannot establish a causal relationship … we hypothesize that the mechanical loading on joints and cartilage could explain the association of weight-bearing activity with osteoarthritis in the low LMI tertile group,” they said.
It is possible that thigh muscle-specific strength or mass may temper the risk of knee OA, they wrote, but the lack of thigh strength data in the Rotterdam Study precluded such evaluation. Still, in everyday practice, the researchers noted, lower limb muscle function could be assessed using thigh circumference.
Dr. Allen agreed. “ ‘Gold standard’ assessment of muscle mass is not common in routine practice, but clinicians can evaluate muscle mass in other ways, such as thigh circumference,” she told this news organization, noting that measurement should align with procedures described by the National Health and Nutrition Examination Survey in its anthropometry procedures manual.
“If low lower-limb muscle mass is suspected, a referral to a physical therapist can be helpful for more formally assessing muscle mass and muscle strength,” she added, “and for instructions for a safe and appropriate exercise program for building muscle and protecting joints.”
Among other limitations of the study, according to the researchers, are an ethnically nondiverse population, the unavailability of knee injury data, and the assessment of physical activity only at baseline.
Moving forward, Dr. van Meurs told this news organization, “the main question regarding physical activity and OA is still, if people already have pain or early OA complaints, what kinds of sports they can do without hurting their joints?” This “should be tested,” she said, “in a real-life, ideally trial-like intervention study.”
The study was funded by the Erasmus Medical Center and Erasmus University as well as through various government grants. Dr. Wu also had study support from the China Scholarship Council. Two of the authors reported relationships with arthritis-related organizations. Dr. Allen reported having no disclosures relevant to her comments.
Weight-bearing recreational activity was associated with a 22% increased odds of developing knee osteoarthritis (OA) in a large prospective cohort study in the Netherlands, but notably, the increased risk was seen only in those with low levels of lower-limb muscle mass.
The findings point toward the value of “tailored advice” for physical activity, and suggest that “caution is needed when engaging in weight-bearing activity, especially for individuals with low levels of lower-limb muscle mass,” Yahong Wu, MD, and coinvestigators, of the Erasmus Medical Center in Rotterdam, the Netherlands, wrote in JAMA Network Open.
Investigators used data from sequential cohorts of the longitudinal Rotterdam Study, which enrolled people aged 45 and older starting in 1990. The 5003 participants in this new analysis of physical activity and knee OA had complete records of baseline recreational physical activity, baseline knee pain, and knee radiographs from both baseline and at least one follow-up exam. Those with radiographically defined knee OA at baseline were excluded.
The incident rate of radiographically defined (x-ray) knee OA among all participants was 8.4%, with a mean follow-up time of 6.33 years. Among 3492 individuals without baseline knee pain, the researchers found no increased odds of incident radiographic OA with non–weight-bearing activity (odds ratio [OR], 1.04; 95% CI, 0.95-1.15; P = .37) but a significant association of weight-bearing activity with OA incidence (OR, 1.22; 95% CI, 1.10-1.35; P < .001).
A stratification analysis of a subset of participants whose lower-limb mass had been measured by dual-energy x-ray absorptiometry (DXA) showed, however, that the association of weight-bearing activity with incident OA was limited to patients in the lowest third of lower-limb muscle mass index (LMI), who had a 53% increased likelihood of developing knee OA (OR, 1.53; 95% CI, 1.15-2.04; P = .003).
For patients in the middle and upper tertiles, there was no significant association between weight-bearing activity and the odds of incident OA (OR, 0.93; P = .73, and OR, 1.15; P = .40, respectively).
The findings are reassuring overall, said Kelli D. Allen, PhD, research professor of medicine and exercise physiologist at the University of North Carolina at Chapel Hill, who was asked to comment on the study. “The study corroborates prior research showing that for most people, weight-bearing recreational activity does not increase the risk of knee osteoarthritis. This should be encouraging for people who want to increase their physical activity,” she said.
The study also suggests that “for people with low lower-limb muscle mass, there may be some considerations to make regarding the best type of physical activity to prevent future knee osteoarthritis,” she said in an e-mail. “The best approach may include non–weight-bearing activities, which could include biking, swimming, or other water exercises, along with strengthening exercises that help to increase muscle mass.”
Other studies, Dr. Allen said, have shown that low muscle mass itself is a risk factor for knee OA.
Physical Activity Types, Other Analyses
The researchers assessed total, weight-bearing, and non–weight-bearing physical activity using two validated questionnaires (an adapted version of the Zutphen Physical Activity Questionnaire and the Longitudinal Aging Study Amsterdam physical activity questionnaire) that asked participants about the frequency and duration of various types of physical activity. Activity was quantified as metabolic equivalent of task (MET) hours per week, and weight-bearing activities were defined as those in which the knee joint bears the body’s weight.
Walking, gardening, golf, dancing, and ball sports were among the activities qualifying as weight-bearing activities. Non–weight-bearing activities included cycling, rowing, and swimming.
Sex, body mass index, and follow-up time were among the covariates adjusted for in the primary analysis. Similar results were found when adjustments were also made for educational level, alcohol intake, lipid levels, and diabetes.
While incident radiographic knee OA (measured using the Kellgren & Lawrence grading system) was the primary outcome, the researchers also looked at symptomatic knee OA, as defined by x-ray and a knee pain questionnaire, and found no significant association of its incidence with any of the exercise categories (total, weight-bearing, or non-weight-bearing).
Coauthor Joyce B. J. van Meurs, PhD, of the departments of internal medicine and orthopedics & sports medicine at Erasmus Medical Center, told this news organization that “pain as a subjective, recurrent symptom is more difficult to study … [and] a larger sample size or more precise measurements [of pain] in future studies would help to better understand the true association” of symptomatic knee OA and physical activity.
Similarly, analyses of the 1511 patients (out of 5003) who had knee pain at baseline found no significant association of weight-bearing or non–weight-bearing physical activity with incident radiographic knee OA. The trends were similar to those found in the population without knee pain, however, which suggests the analysis was underpowered, the researchers wrote, noting too that patients with baseline pain had lower activity levels than those without pain. (Low case numbers precluded a stratification analysis on LMI for incident symptomatic OA.)
Thigh Circumference as an Indicator of Muscle Mass
The findings build upon an international meta-analysis published in 2021 that found no association between total physical activity and knee OA and align with other studies suggesting a link between greater mechanical stress/strain and greater OA risk, the researchers wrote. (The meta-analysis couldn’t investigate different types of activity.)
“Although we cannot establish a causal relationship … we hypothesize that the mechanical loading on joints and cartilage could explain the association of weight-bearing activity with osteoarthritis in the low LMI tertile group,” they said.
It is possible that thigh muscle-specific strength or mass may temper the risk of knee OA, they wrote, but the lack of thigh strength data in the Rotterdam Study precluded such evaluation. Still, in everyday practice, the researchers noted, lower limb muscle function could be assessed using thigh circumference.
Dr. Allen agreed. “ ‘Gold standard’ assessment of muscle mass is not common in routine practice, but clinicians can evaluate muscle mass in other ways, such as thigh circumference,” she told this news organization, noting that measurement should align with procedures described by the National Health and Nutrition Examination Survey in its anthropometry procedures manual.
“If low lower-limb muscle mass is suspected, a referral to a physical therapist can be helpful for more formally assessing muscle mass and muscle strength,” she added, “and for instructions for a safe and appropriate exercise program for building muscle and protecting joints.”
Among other limitations of the study, according to the researchers, are an ethnically nondiverse population, the unavailability of knee injury data, and the assessment of physical activity only at baseline.
Moving forward, Dr. van Meurs told this news organization, “the main question regarding physical activity and OA is still, if people already have pain or early OA complaints, what kinds of sports they can do without hurting their joints?” This “should be tested,” she said, “in a real-life, ideally trial-like intervention study.”
The study was funded by the Erasmus Medical Center and Erasmus University as well as through various government grants. Dr. Wu also had study support from the China Scholarship Council. Two of the authors reported relationships with arthritis-related organizations. Dr. Allen reported having no disclosures relevant to her comments.
Weight-bearing recreational activity was associated with a 22% increased odds of developing knee osteoarthritis (OA) in a large prospective cohort study in the Netherlands, but notably, the increased risk was seen only in those with low levels of lower-limb muscle mass.
The findings point toward the value of “tailored advice” for physical activity, and suggest that “caution is needed when engaging in weight-bearing activity, especially for individuals with low levels of lower-limb muscle mass,” Yahong Wu, MD, and coinvestigators, of the Erasmus Medical Center in Rotterdam, the Netherlands, wrote in JAMA Network Open.
Investigators used data from sequential cohorts of the longitudinal Rotterdam Study, which enrolled people aged 45 and older starting in 1990. The 5003 participants in this new analysis of physical activity and knee OA had complete records of baseline recreational physical activity, baseline knee pain, and knee radiographs from both baseline and at least one follow-up exam. Those with radiographically defined knee OA at baseline were excluded.
The incident rate of radiographically defined (x-ray) knee OA among all participants was 8.4%, with a mean follow-up time of 6.33 years. Among 3492 individuals without baseline knee pain, the researchers found no increased odds of incident radiographic OA with non–weight-bearing activity (odds ratio [OR], 1.04; 95% CI, 0.95-1.15; P = .37) but a significant association of weight-bearing activity with OA incidence (OR, 1.22; 95% CI, 1.10-1.35; P < .001).
A stratification analysis of a subset of participants whose lower-limb mass had been measured by dual-energy x-ray absorptiometry (DXA) showed, however, that the association of weight-bearing activity with incident OA was limited to patients in the lowest third of lower-limb muscle mass index (LMI), who had a 53% increased likelihood of developing knee OA (OR, 1.53; 95% CI, 1.15-2.04; P = .003).
For patients in the middle and upper tertiles, there was no significant association between weight-bearing activity and the odds of incident OA (OR, 0.93; P = .73, and OR, 1.15; P = .40, respectively).
The findings are reassuring overall, said Kelli D. Allen, PhD, research professor of medicine and exercise physiologist at the University of North Carolina at Chapel Hill, who was asked to comment on the study. “The study corroborates prior research showing that for most people, weight-bearing recreational activity does not increase the risk of knee osteoarthritis. This should be encouraging for people who want to increase their physical activity,” she said.
The study also suggests that “for people with low lower-limb muscle mass, there may be some considerations to make regarding the best type of physical activity to prevent future knee osteoarthritis,” she said in an e-mail. “The best approach may include non–weight-bearing activities, which could include biking, swimming, or other water exercises, along with strengthening exercises that help to increase muscle mass.”
Other studies, Dr. Allen said, have shown that low muscle mass itself is a risk factor for knee OA.
Physical Activity Types, Other Analyses
The researchers assessed total, weight-bearing, and non–weight-bearing physical activity using two validated questionnaires (an adapted version of the Zutphen Physical Activity Questionnaire and the Longitudinal Aging Study Amsterdam physical activity questionnaire) that asked participants about the frequency and duration of various types of physical activity. Activity was quantified as metabolic equivalent of task (MET) hours per week, and weight-bearing activities were defined as those in which the knee joint bears the body’s weight.
Walking, gardening, golf, dancing, and ball sports were among the activities qualifying as weight-bearing activities. Non–weight-bearing activities included cycling, rowing, and swimming.
Sex, body mass index, and follow-up time were among the covariates adjusted for in the primary analysis. Similar results were found when adjustments were also made for educational level, alcohol intake, lipid levels, and diabetes.
While incident radiographic knee OA (measured using the Kellgren & Lawrence grading system) was the primary outcome, the researchers also looked at symptomatic knee OA, as defined by x-ray and a knee pain questionnaire, and found no significant association of its incidence with any of the exercise categories (total, weight-bearing, or non-weight-bearing).
Coauthor Joyce B. J. van Meurs, PhD, of the departments of internal medicine and orthopedics & sports medicine at Erasmus Medical Center, told this news organization that “pain as a subjective, recurrent symptom is more difficult to study … [and] a larger sample size or more precise measurements [of pain] in future studies would help to better understand the true association” of symptomatic knee OA and physical activity.
Similarly, analyses of the 1511 patients (out of 5003) who had knee pain at baseline found no significant association of weight-bearing or non–weight-bearing physical activity with incident radiographic knee OA. The trends were similar to those found in the population without knee pain, however, which suggests the analysis was underpowered, the researchers wrote, noting too that patients with baseline pain had lower activity levels than those without pain. (Low case numbers precluded a stratification analysis on LMI for incident symptomatic OA.)
Thigh Circumference as an Indicator of Muscle Mass
The findings build upon an international meta-analysis published in 2021 that found no association between total physical activity and knee OA and align with other studies suggesting a link between greater mechanical stress/strain and greater OA risk, the researchers wrote. (The meta-analysis couldn’t investigate different types of activity.)
“Although we cannot establish a causal relationship … we hypothesize that the mechanical loading on joints and cartilage could explain the association of weight-bearing activity with osteoarthritis in the low LMI tertile group,” they said.
It is possible that thigh muscle-specific strength or mass may temper the risk of knee OA, they wrote, but the lack of thigh strength data in the Rotterdam Study precluded such evaluation. Still, in everyday practice, the researchers noted, lower limb muscle function could be assessed using thigh circumference.
Dr. Allen agreed. “ ‘Gold standard’ assessment of muscle mass is not common in routine practice, but clinicians can evaluate muscle mass in other ways, such as thigh circumference,” she told this news organization, noting that measurement should align with procedures described by the National Health and Nutrition Examination Survey in its anthropometry procedures manual.
“If low lower-limb muscle mass is suspected, a referral to a physical therapist can be helpful for more formally assessing muscle mass and muscle strength,” she added, “and for instructions for a safe and appropriate exercise program for building muscle and protecting joints.”
Among other limitations of the study, according to the researchers, are an ethnically nondiverse population, the unavailability of knee injury data, and the assessment of physical activity only at baseline.
Moving forward, Dr. van Meurs told this news organization, “the main question regarding physical activity and OA is still, if people already have pain or early OA complaints, what kinds of sports they can do without hurting their joints?” This “should be tested,” she said, “in a real-life, ideally trial-like intervention study.”
The study was funded by the Erasmus Medical Center and Erasmus University as well as through various government grants. Dr. Wu also had study support from the China Scholarship Council. Two of the authors reported relationships with arthritis-related organizations. Dr. Allen reported having no disclosures relevant to her comments.
FROM JAMA NETWORK OPEN
Updated Sjögren Disease Guideline Advises Doing ‘the Little Things Well’
LIVERPOOL, ENGLAND — An updated guideline from the British Society for Rheumatology (BSR) on the management of Sjögren disease asks rheumatologists and other clinicians caring for patients with the condition to “do the little things well” rather than overly focusing on rheumatologic treatments. The guideline’s new format provides recommendations for specific clinical questions and now also includes recommendations for managing the disease in children and adolescents.
“The original guideline was published in 2017, and things move on very rapidly,” consultant rheumatologist Elizabeth Price, MBBCh, PhD, said ahead of her presentation of the updated guideline at the annual meeting of the British Society for Rheumatology.
“We approached the update in a slightly different way,” said Dr. Price, who works at Great Western Hospital NHS Foundation Trust in Swindon, England. She was the chair of the new guideline’s working group and convenes the BSR’s Special Interest Group for Sjögren disease.
Previously, the approach was to look at the management of Sjögren disease affecting the eyes, mouth, salivary glands, and, in turn, systemic disease. “This time we posed questions that we felt needed to be asked, interrogated the literature, and then used that to come up with our recommendations,” Dr. Price said.
The answers to those questions were used to form the 19 recommendations that now make up the guideline. These cover four key areas on the management of Sjögren disease: confirming the diagnosis, treating the symptoms, managing systemic disease, and considering special situations such as planned pregnancy and comorbidities. There is also lifestyle advice and information about where to get good patient education.
What’s in a Name?
The BSR guideline on the management of adult and juvenile onset Sjögren disease is published in Rheumatology and is available via the BSR website, where it is accompanied by a short summary sheet.
The most notable change perhaps is the name the guideline now uses, Dr. Price said at BSR 2024. “We have been bold and called it Sjögren disease.” Previously, the guideline used the term primary Sjögren’s syndrome, but there has been a “move away from using eponymous syndromes and dropping s’s and apostrophes,” she explained.
Another significant change is that advice on managing Sjögren disease in children and adolescents is now included where appropriate, meaning that the British guideline is now the first to cover Sjögren disease “across the ages,” Dr. Price said.
A pediatric/adolescent rheumatologist joined the guideline working group, which already consisted of several adult rheumatologists, ophthalmologists, and a dentistry consultant. The group now comprises 22 members total, including a general practitioner, an oncologist, a renal physician, an occupational therapist, two patients with Sjögren disease, and a librarian.
Confirming the Diagnosis
The first questions asked to help form the new recommendations were around confirming a diagnosis of Sjögren disease, such as what is the diagnostic accuracy of antinuclear antibodies (ANAs), extractable nuclear antigens (ENAs), and other novel antigens in Sjögren disease? And what is the diagnostic accuracy of salivary gland ultrasound, imaging in general, and salivary gland or lacrimal gland biopsies?
The resulting recommendations advised not to measure ANAs in the absence of clinical indicators of Sjögren disease or any other connective tissue disease but to use it to screen if there was a clinical suspicion. And ENAs should be measured even if the ANAs were negative and there is a high index of suspicion.
In terms of imaging, ultrasound of the salivary glands was thought to be useful, but other imaging was not recommended for routine practice at the current time. Minor lip but not lacrimal gland biopsies were recommended if clinical and serologic features were not enough to make a diagnosis.
Lymphoma Worries
The 2017 version of the guideline did not include information about lymphoma, but this is the thing that most patients with Sjögren disease will worry about, Dr. Price said. “They all look it up on YouTube, they all come back and tell me that they are really worried they’ll develop it.”
The question that was therefore posed was whether there were any measurable biomarkers that could predict the development of lymphoma in adults and children. Seven predictors were found, the strongest being a low level of complement C4 alone or together with low levels of C3. Other predictors were salivary gland enlargement, lymphadenopathy, anti-Ro/La and rheumatoid factor autoantibodies, cryoglobulinemia, monoclonal gammopathy, and a high focus score.
All of these predictors put someone in a higher risk category for lymphoma. If two or fewer of those features are present, the lifetime risk is “probably below 2%,” Dr. Price said. However, if all seven are present, the lifetime risk is “approaching 100%.”
The recommendation made on the basis of these findings is that people with Sjögren disease need to be offered early further investigation if they present with any new salivary gland swelling or other symptoms that might suggest the development of lymphoma. In this regard, a labial salivary gland biopsy might provide additional prognostic information.
‘Do the Little Things Well’
“You have to do the little things well,” Dr. Price said. “Many of the patients [who] come to see me for a second opinion have not been prescribed the right eye drops, have not been given advice on dental care,” with their management taking “too much on the rheumatological treatments.”
Rheumatologists are of course not trained or expected to be experts in ophthalmology or dentistry, but “you need to look at their mouth and you do need to examine their eyes, and you do need to give them some advice,” Dr. Price advised.
Thankfully, that is where the updated guidelines should help, with a recommendation that people with Sjögren disease should use preservative-free eye drops every 2-3 hours.
“It’s vital you avoid preservatives, because preservatives flatten the corneal surface and reduce the surface area and can cause inflammation in their own right,” Dr. Price cautioned, adding that there are plenty of suitable eye drop formulations available.
In regard to helping with dry mouth symptoms, the recommendation is to use a saliva substitute for symptomatic relief. For vaginal dryness, the recommendation is to consider advising topical nonhormonal vaginal moisturizers plus estrogen creams or pessaries in peri- or postmenopausal women with significant vaginal dryness.
“Very important, however, is to maintain a neutral pH, an alkaline environment in the mouth because acid damages dental enamel,” Dr. Price said. Conversely, an acidic vaginal moisturizer is needed to treat vaginal dryness.
Dental hygiene is important. Regular brushing with a fluoride-based toothpaste is advised. The use of xylitol-containing products has been shown to reduce bacteria known to increase the risk for dental decay. Telling patients not to eat between meals is also simple but important advice.
“We do recommend that patients are assessed holistically,” Dr. Price said, noting that they should be offered access to cognitive-behavioral therapy and exercise therapies to help with the symptoms of fatigue and joint pain.
Watch Out for Comorbidities
Sjögren disease is associated with many comorbidities, some of which might be predicted from the age and demographics of the people who are normally affected.
“This is on the whole an older, female population, so you see a lot of osteoarthritis, gastroesophageal reflux, and hypertension,” Dr. Price said. “However, you may not be aware that 1 in 5 of these patients develop thyroid disease,” and there is a higher rate of celiac disease and primary biliary cholangitis than is seen in the general background population.
The recommendation, therefore, is to “be aware of and consider screening for commonly associated conditions, as guided by age and/or clinical presentation.” As such, it’s recommended that baseline and repeated investigations that look for signs of comorbidity are performed, such as thyroid function assessment and liver function tests, to name two.
Treatment Recommendations
As in the original guideline, the treatment of systemic disease is discussed, but the advice has been overhauled with the availability of new data.
The updated guidance notes that a trial of hydroxychloroquine for 6-12 months is the recommended treatment approach for people with fatigue and systemic symptoms.
Systemic steroids may be used in the short-term for specific indications but should not be offered routinely.
Conventional immunosuppressive or biologic drugs and immunoglobulins are not currently recommended outside of managing specific systemic complications.
In juvenile cases, the treatment of recurrent swollen parotid glands that are not due to infection or stone disease should include a short course of a nonsteroidal anti-inflammatory drug or a short course of oral steroids. This should be combined with massage followed by washouts with saline or steroids. In refractory cases, escalation to anti–B-cell–targeted therapies may be considered in select situations.
View on Updates
Patient advocate Bridget Crampton, who leads the helpline team at Sjögren’s UK (formerly the British Sjögren’s Syndrome Association), commented on the importance of the guidelines during a roundtable held by the BSR.
“I think it will help [patients] make better use of their own appointments. So, they’ll know what treatments might be offered. They’ll know what they want to talk about at their appointments,” she said.
Ms. Crampton, who has lived with Sjögren disease herself for the past 20 years, added: “I think it’s important for patients that we have guidelines like this. It means that all clinicians can easily access information. My hope is that it might standardize care across the UK a little bit more.”
No specific funding was received to create the guidelines, be that from any bodies in the public, commercial, or not-for-profit sectors. No conflicts of interests were expressed by any of the experts quoted in this article.
A version of this article appeared on Medscape.com.
LIVERPOOL, ENGLAND — An updated guideline from the British Society for Rheumatology (BSR) on the management of Sjögren disease asks rheumatologists and other clinicians caring for patients with the condition to “do the little things well” rather than overly focusing on rheumatologic treatments. The guideline’s new format provides recommendations for specific clinical questions and now also includes recommendations for managing the disease in children and adolescents.
“The original guideline was published in 2017, and things move on very rapidly,” consultant rheumatologist Elizabeth Price, MBBCh, PhD, said ahead of her presentation of the updated guideline at the annual meeting of the British Society for Rheumatology.
“We approached the update in a slightly different way,” said Dr. Price, who works at Great Western Hospital NHS Foundation Trust in Swindon, England. She was the chair of the new guideline’s working group and convenes the BSR’s Special Interest Group for Sjögren disease.
Previously, the approach was to look at the management of Sjögren disease affecting the eyes, mouth, salivary glands, and, in turn, systemic disease. “This time we posed questions that we felt needed to be asked, interrogated the literature, and then used that to come up with our recommendations,” Dr. Price said.
The answers to those questions were used to form the 19 recommendations that now make up the guideline. These cover four key areas on the management of Sjögren disease: confirming the diagnosis, treating the symptoms, managing systemic disease, and considering special situations such as planned pregnancy and comorbidities. There is also lifestyle advice and information about where to get good patient education.
What’s in a Name?
The BSR guideline on the management of adult and juvenile onset Sjögren disease is published in Rheumatology and is available via the BSR website, where it is accompanied by a short summary sheet.
The most notable change perhaps is the name the guideline now uses, Dr. Price said at BSR 2024. “We have been bold and called it Sjögren disease.” Previously, the guideline used the term primary Sjögren’s syndrome, but there has been a “move away from using eponymous syndromes and dropping s’s and apostrophes,” she explained.
Another significant change is that advice on managing Sjögren disease in children and adolescents is now included where appropriate, meaning that the British guideline is now the first to cover Sjögren disease “across the ages,” Dr. Price said.
A pediatric/adolescent rheumatologist joined the guideline working group, which already consisted of several adult rheumatologists, ophthalmologists, and a dentistry consultant. The group now comprises 22 members total, including a general practitioner, an oncologist, a renal physician, an occupational therapist, two patients with Sjögren disease, and a librarian.
Confirming the Diagnosis
The first questions asked to help form the new recommendations were around confirming a diagnosis of Sjögren disease, such as what is the diagnostic accuracy of antinuclear antibodies (ANAs), extractable nuclear antigens (ENAs), and other novel antigens in Sjögren disease? And what is the diagnostic accuracy of salivary gland ultrasound, imaging in general, and salivary gland or lacrimal gland biopsies?
The resulting recommendations advised not to measure ANAs in the absence of clinical indicators of Sjögren disease or any other connective tissue disease but to use it to screen if there was a clinical suspicion. And ENAs should be measured even if the ANAs were negative and there is a high index of suspicion.
In terms of imaging, ultrasound of the salivary glands was thought to be useful, but other imaging was not recommended for routine practice at the current time. Minor lip but not lacrimal gland biopsies were recommended if clinical and serologic features were not enough to make a diagnosis.
Lymphoma Worries
The 2017 version of the guideline did not include information about lymphoma, but this is the thing that most patients with Sjögren disease will worry about, Dr. Price said. “They all look it up on YouTube, they all come back and tell me that they are really worried they’ll develop it.”
The question that was therefore posed was whether there were any measurable biomarkers that could predict the development of lymphoma in adults and children. Seven predictors were found, the strongest being a low level of complement C4 alone or together with low levels of C3. Other predictors were salivary gland enlargement, lymphadenopathy, anti-Ro/La and rheumatoid factor autoantibodies, cryoglobulinemia, monoclonal gammopathy, and a high focus score.
All of these predictors put someone in a higher risk category for lymphoma. If two or fewer of those features are present, the lifetime risk is “probably below 2%,” Dr. Price said. However, if all seven are present, the lifetime risk is “approaching 100%.”
The recommendation made on the basis of these findings is that people with Sjögren disease need to be offered early further investigation if they present with any new salivary gland swelling or other symptoms that might suggest the development of lymphoma. In this regard, a labial salivary gland biopsy might provide additional prognostic information.
‘Do the Little Things Well’
“You have to do the little things well,” Dr. Price said. “Many of the patients [who] come to see me for a second opinion have not been prescribed the right eye drops, have not been given advice on dental care,” with their management taking “too much on the rheumatological treatments.”
Rheumatologists are of course not trained or expected to be experts in ophthalmology or dentistry, but “you need to look at their mouth and you do need to examine their eyes, and you do need to give them some advice,” Dr. Price advised.
Thankfully, that is where the updated guidelines should help, with a recommendation that people with Sjögren disease should use preservative-free eye drops every 2-3 hours.
“It’s vital you avoid preservatives, because preservatives flatten the corneal surface and reduce the surface area and can cause inflammation in their own right,” Dr. Price cautioned, adding that there are plenty of suitable eye drop formulations available.
In regard to helping with dry mouth symptoms, the recommendation is to use a saliva substitute for symptomatic relief. For vaginal dryness, the recommendation is to consider advising topical nonhormonal vaginal moisturizers plus estrogen creams or pessaries in peri- or postmenopausal women with significant vaginal dryness.
“Very important, however, is to maintain a neutral pH, an alkaline environment in the mouth because acid damages dental enamel,” Dr. Price said. Conversely, an acidic vaginal moisturizer is needed to treat vaginal dryness.
Dental hygiene is important. Regular brushing with a fluoride-based toothpaste is advised. The use of xylitol-containing products has been shown to reduce bacteria known to increase the risk for dental decay. Telling patients not to eat between meals is also simple but important advice.
“We do recommend that patients are assessed holistically,” Dr. Price said, noting that they should be offered access to cognitive-behavioral therapy and exercise therapies to help with the symptoms of fatigue and joint pain.
Watch Out for Comorbidities
Sjögren disease is associated with many comorbidities, some of which might be predicted from the age and demographics of the people who are normally affected.
“This is on the whole an older, female population, so you see a lot of osteoarthritis, gastroesophageal reflux, and hypertension,” Dr. Price said. “However, you may not be aware that 1 in 5 of these patients develop thyroid disease,” and there is a higher rate of celiac disease and primary biliary cholangitis than is seen in the general background population.
The recommendation, therefore, is to “be aware of and consider screening for commonly associated conditions, as guided by age and/or clinical presentation.” As such, it’s recommended that baseline and repeated investigations that look for signs of comorbidity are performed, such as thyroid function assessment and liver function tests, to name two.
Treatment Recommendations
As in the original guideline, the treatment of systemic disease is discussed, but the advice has been overhauled with the availability of new data.
The updated guidance notes that a trial of hydroxychloroquine for 6-12 months is the recommended treatment approach for people with fatigue and systemic symptoms.
Systemic steroids may be used in the short-term for specific indications but should not be offered routinely.
Conventional immunosuppressive or biologic drugs and immunoglobulins are not currently recommended outside of managing specific systemic complications.
In juvenile cases, the treatment of recurrent swollen parotid glands that are not due to infection or stone disease should include a short course of a nonsteroidal anti-inflammatory drug or a short course of oral steroids. This should be combined with massage followed by washouts with saline or steroids. In refractory cases, escalation to anti–B-cell–targeted therapies may be considered in select situations.
View on Updates
Patient advocate Bridget Crampton, who leads the helpline team at Sjögren’s UK (formerly the British Sjögren’s Syndrome Association), commented on the importance of the guidelines during a roundtable held by the BSR.
“I think it will help [patients] make better use of their own appointments. So, they’ll know what treatments might be offered. They’ll know what they want to talk about at their appointments,” she said.
Ms. Crampton, who has lived with Sjögren disease herself for the past 20 years, added: “I think it’s important for patients that we have guidelines like this. It means that all clinicians can easily access information. My hope is that it might standardize care across the UK a little bit more.”
No specific funding was received to create the guidelines, be that from any bodies in the public, commercial, or not-for-profit sectors. No conflicts of interests were expressed by any of the experts quoted in this article.
A version of this article appeared on Medscape.com.
LIVERPOOL, ENGLAND — An updated guideline from the British Society for Rheumatology (BSR) on the management of Sjögren disease asks rheumatologists and other clinicians caring for patients with the condition to “do the little things well” rather than overly focusing on rheumatologic treatments. The guideline’s new format provides recommendations for specific clinical questions and now also includes recommendations for managing the disease in children and adolescents.
“The original guideline was published in 2017, and things move on very rapidly,” consultant rheumatologist Elizabeth Price, MBBCh, PhD, said ahead of her presentation of the updated guideline at the annual meeting of the British Society for Rheumatology.
“We approached the update in a slightly different way,” said Dr. Price, who works at Great Western Hospital NHS Foundation Trust in Swindon, England. She was the chair of the new guideline’s working group and convenes the BSR’s Special Interest Group for Sjögren disease.
Previously, the approach was to look at the management of Sjögren disease affecting the eyes, mouth, salivary glands, and, in turn, systemic disease. “This time we posed questions that we felt needed to be asked, interrogated the literature, and then used that to come up with our recommendations,” Dr. Price said.
The answers to those questions were used to form the 19 recommendations that now make up the guideline. These cover four key areas on the management of Sjögren disease: confirming the diagnosis, treating the symptoms, managing systemic disease, and considering special situations such as planned pregnancy and comorbidities. There is also lifestyle advice and information about where to get good patient education.
What’s in a Name?
The BSR guideline on the management of adult and juvenile onset Sjögren disease is published in Rheumatology and is available via the BSR website, where it is accompanied by a short summary sheet.
The most notable change perhaps is the name the guideline now uses, Dr. Price said at BSR 2024. “We have been bold and called it Sjögren disease.” Previously, the guideline used the term primary Sjögren’s syndrome, but there has been a “move away from using eponymous syndromes and dropping s’s and apostrophes,” she explained.
Another significant change is that advice on managing Sjögren disease in children and adolescents is now included where appropriate, meaning that the British guideline is now the first to cover Sjögren disease “across the ages,” Dr. Price said.
A pediatric/adolescent rheumatologist joined the guideline working group, which already consisted of several adult rheumatologists, ophthalmologists, and a dentistry consultant. The group now comprises 22 members total, including a general practitioner, an oncologist, a renal physician, an occupational therapist, two patients with Sjögren disease, and a librarian.
Confirming the Diagnosis
The first questions asked to help form the new recommendations were around confirming a diagnosis of Sjögren disease, such as what is the diagnostic accuracy of antinuclear antibodies (ANAs), extractable nuclear antigens (ENAs), and other novel antigens in Sjögren disease? And what is the diagnostic accuracy of salivary gland ultrasound, imaging in general, and salivary gland or lacrimal gland biopsies?
The resulting recommendations advised not to measure ANAs in the absence of clinical indicators of Sjögren disease or any other connective tissue disease but to use it to screen if there was a clinical suspicion. And ENAs should be measured even if the ANAs were negative and there is a high index of suspicion.
In terms of imaging, ultrasound of the salivary glands was thought to be useful, but other imaging was not recommended for routine practice at the current time. Minor lip but not lacrimal gland biopsies were recommended if clinical and serologic features were not enough to make a diagnosis.
Lymphoma Worries
The 2017 version of the guideline did not include information about lymphoma, but this is the thing that most patients with Sjögren disease will worry about, Dr. Price said. “They all look it up on YouTube, they all come back and tell me that they are really worried they’ll develop it.”
The question that was therefore posed was whether there were any measurable biomarkers that could predict the development of lymphoma in adults and children. Seven predictors were found, the strongest being a low level of complement C4 alone or together with low levels of C3. Other predictors were salivary gland enlargement, lymphadenopathy, anti-Ro/La and rheumatoid factor autoantibodies, cryoglobulinemia, monoclonal gammopathy, and a high focus score.
All of these predictors put someone in a higher risk category for lymphoma. If two or fewer of those features are present, the lifetime risk is “probably below 2%,” Dr. Price said. However, if all seven are present, the lifetime risk is “approaching 100%.”
The recommendation made on the basis of these findings is that people with Sjögren disease need to be offered early further investigation if they present with any new salivary gland swelling or other symptoms that might suggest the development of lymphoma. In this regard, a labial salivary gland biopsy might provide additional prognostic information.
‘Do the Little Things Well’
“You have to do the little things well,” Dr. Price said. “Many of the patients [who] come to see me for a second opinion have not been prescribed the right eye drops, have not been given advice on dental care,” with their management taking “too much on the rheumatological treatments.”
Rheumatologists are of course not trained or expected to be experts in ophthalmology or dentistry, but “you need to look at their mouth and you do need to examine their eyes, and you do need to give them some advice,” Dr. Price advised.
Thankfully, that is where the updated guidelines should help, with a recommendation that people with Sjögren disease should use preservative-free eye drops every 2-3 hours.
“It’s vital you avoid preservatives, because preservatives flatten the corneal surface and reduce the surface area and can cause inflammation in their own right,” Dr. Price cautioned, adding that there are plenty of suitable eye drop formulations available.
In regard to helping with dry mouth symptoms, the recommendation is to use a saliva substitute for symptomatic relief. For vaginal dryness, the recommendation is to consider advising topical nonhormonal vaginal moisturizers plus estrogen creams or pessaries in peri- or postmenopausal women with significant vaginal dryness.
“Very important, however, is to maintain a neutral pH, an alkaline environment in the mouth because acid damages dental enamel,” Dr. Price said. Conversely, an acidic vaginal moisturizer is needed to treat vaginal dryness.
Dental hygiene is important. Regular brushing with a fluoride-based toothpaste is advised. The use of xylitol-containing products has been shown to reduce bacteria known to increase the risk for dental decay. Telling patients not to eat between meals is also simple but important advice.
“We do recommend that patients are assessed holistically,” Dr. Price said, noting that they should be offered access to cognitive-behavioral therapy and exercise therapies to help with the symptoms of fatigue and joint pain.
Watch Out for Comorbidities
Sjögren disease is associated with many comorbidities, some of which might be predicted from the age and demographics of the people who are normally affected.
“This is on the whole an older, female population, so you see a lot of osteoarthritis, gastroesophageal reflux, and hypertension,” Dr. Price said. “However, you may not be aware that 1 in 5 of these patients develop thyroid disease,” and there is a higher rate of celiac disease and primary biliary cholangitis than is seen in the general background population.
The recommendation, therefore, is to “be aware of and consider screening for commonly associated conditions, as guided by age and/or clinical presentation.” As such, it’s recommended that baseline and repeated investigations that look for signs of comorbidity are performed, such as thyroid function assessment and liver function tests, to name two.
Treatment Recommendations
As in the original guideline, the treatment of systemic disease is discussed, but the advice has been overhauled with the availability of new data.
The updated guidance notes that a trial of hydroxychloroquine for 6-12 months is the recommended treatment approach for people with fatigue and systemic symptoms.
Systemic steroids may be used in the short-term for specific indications but should not be offered routinely.
Conventional immunosuppressive or biologic drugs and immunoglobulins are not currently recommended outside of managing specific systemic complications.
In juvenile cases, the treatment of recurrent swollen parotid glands that are not due to infection or stone disease should include a short course of a nonsteroidal anti-inflammatory drug or a short course of oral steroids. This should be combined with massage followed by washouts with saline or steroids. In refractory cases, escalation to anti–B-cell–targeted therapies may be considered in select situations.
View on Updates
Patient advocate Bridget Crampton, who leads the helpline team at Sjögren’s UK (formerly the British Sjögren’s Syndrome Association), commented on the importance of the guidelines during a roundtable held by the BSR.
“I think it will help [patients] make better use of their own appointments. So, they’ll know what treatments might be offered. They’ll know what they want to talk about at their appointments,” she said.
Ms. Crampton, who has lived with Sjögren disease herself for the past 20 years, added: “I think it’s important for patients that we have guidelines like this. It means that all clinicians can easily access information. My hope is that it might standardize care across the UK a little bit more.”
No specific funding was received to create the guidelines, be that from any bodies in the public, commercial, or not-for-profit sectors. No conflicts of interests were expressed by any of the experts quoted in this article.
A version of this article appeared on Medscape.com.
FROM BSR 2024
Prospect of Better Hours, Less Burnout Fuels Locum Tenens
Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.
In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.
The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).
“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.
“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”
These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:
- Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
- Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
- Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
- The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.
Trying Locum Tenens Early in Career
According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.
In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.
Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).
“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”
A version of this article appeared on Medscape.com.
Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.
In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.
The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).
“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.
“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”
These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:
- Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
- Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
- Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
- The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.
Trying Locum Tenens Early in Career
According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.
In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.
Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).
“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”
A version of this article appeared on Medscape.com.
Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.
In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.
The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).
“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.
“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”
These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:
- Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
- Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
- Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
- The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.
Trying Locum Tenens Early in Career
According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.
In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.
Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).
“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”
A version of this article appeared on Medscape.com.
This Tech Will Change Your Practice Sooner Than You Think
Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.
1. Artificial Intelligence (AI) Medical Scribes
You may already be using this or, at the very least, have heard about it.
Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.
“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.
Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”
Several companies are already selling these AI devices, including Ambience Healthcare, Augmedix, Nuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.
“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”
Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”
2. Three-Dimensional (3D) Printing
Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.
“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”
Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.
“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.
The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.
3. Drones
For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.
Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.
Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.
“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.
According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.
4. Portable Ultrasound
Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.
AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.
“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.
More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.
5. Virtual Reality (VR)
When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.
“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.
Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.
“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”
Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.
Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.
A version of this article appeared on Medscape.com.
Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.
1. Artificial Intelligence (AI) Medical Scribes
You may already be using this or, at the very least, have heard about it.
Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.
“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.
Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”
Several companies are already selling these AI devices, including Ambience Healthcare, Augmedix, Nuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.
“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”
Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”
2. Three-Dimensional (3D) Printing
Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.
“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”
Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.
“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.
The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.
3. Drones
For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.
Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.
Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.
“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.
According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.
4. Portable Ultrasound
Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.
AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.
“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.
More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.
5. Virtual Reality (VR)
When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.
“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.
Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.
“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”
Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.
Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.
A version of this article appeared on Medscape.com.
Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.
1. Artificial Intelligence (AI) Medical Scribes
You may already be using this or, at the very least, have heard about it.
Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.
“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.
Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”
Several companies are already selling these AI devices, including Ambience Healthcare, Augmedix, Nuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.
“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”
Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”
2. Three-Dimensional (3D) Printing
Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.
“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”
Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.
“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.
The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.
3. Drones
For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.
Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.
Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.
“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.
According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.
4. Portable Ultrasound
Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.
AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.
“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.
More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.
5. Virtual Reality (VR)
When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.
“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.
Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.
“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”
Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.
Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.
A version of this article appeared on Medscape.com.
Excess Thrombotic Risk in RA Has No Clear Driving Factor
LIVERPOOL, ENGLAND — People with rheumatoid arthritis (RA) have a consistently higher risk for venous thromboembolism (VTE) than the general population, but the reasons for this remain unclear, research presented at the annual meeting of the British Society for Rheumatology (BSR) reaffirmed.
Regardless of age, sex, body mass index (BMI), duration of disease, use of estrogen-based oral contraceptives, or hormone replacement therapy (HRT), people with RA are more likely to experience a pulmonary embolism or deep vein thrombosis than those without RA.
However, “these are rare events,” James Galloway, MBChB, PhD, professor of rheumatology and deputy head of the Centre for Rheumatic Diseases at King’s College London in England, said at the meeting.
In one analysis of data from 117,050 individuals living in England and Wales that are held within a large primary care practice database, Dr. Galloway and colleagues found that the unadjusted incidence of VTE in people diagnosed with RA (n = 23,410) was 0.44% vs 0.26% for matched controls within the general population (n = 93,640).
RA and VTE Risk
The overall risk for VTE was 46% higher among people with RA than among those without, although the absolute difference was small, Dr. Galloway reported.
“RA is associated with an increased risk of VTE; that’s been well described over the years,” Dr. Galloway told this news organization. Past research into why there is an elevated risk for VTE in patients with RA has often focused on the role of disease activity and inflammation.
“In the last few years, a new class of drugs, the JAK [Janus kinase] inhibitors, have emerged in which we have seen a signal of increased VTE risk from a number of studies. And I think that puts a spotlight on our understanding of VTE risk,” Dr. Galloway said.
He added “JAK inhibitors are very powerful at controlling inflammation, but if you take away inflammation, there is still an excess risk. What else could be driving that?”
To examine the excess risk for VTE seen in people with RA, Dr. Galloway and colleagues performed three separate analyses using data collected between January 1999 and December 2018 by the Royal College of General Practitioners Research and Surveillance Center.
One analysis looked at VTE risk according to age, sex, and BMI; another looked at the effect of the duration of RA; and a third analysis focused on the use of estrogen-based oral contraceptives or HRT.
For all three analyses, those with RA were matched in a 4:1 ratio to people from the general population without RA on the basis of current age, sex, calendar time, and years since registration at the primary care practice.
Observational Data Challenged
“These are observational data, so it’s important to weigh up the strengths and limitations,” Dr. Galloway acknowledged. Strengths are the large sample size and long follow-up provided by the database, which assesses and monitors more than 2000 primary care practices in England and Wales.
Confounding is still possible, despite adjusting for multiple factors that included sociodemographic factors; clinical features; and VTE risk factors such as smoking status, alcohol use, thrombophilia, reduced mobility, lower limb fracture, and a family history of VTE if data had been available. There wasn’t information on disease activity, for example, and disease duration was used as a surrogate marker for this.
Sitting in the audience, Marwan Bukhari, MBBS, PhD, challenged the population-matching process.
“Do you think maybe it was the matching that was the problem?” asked Dr. Bukhari, who is consultant rheumatologist at University Hospitals of Morecambe Bay NHS Foundation Trust and an honorary senior lecturer at the University of Manchester, both in England.
“They’re not entirely matched completely, correctly. Even if it is 4:1, there’s a difference between the populations,” he said.
Age, Sex, and Bodyweight
Over an average of 8.2 years’ follow-up, the adjusted hazard ratios (aHRs) comparing VTE risk in women and men with and without RA were a respective 1.62 and 1.52. The corresponding aHRs for VTE according to different age groups were 2.13 for age 18-49 years, 1.57 for age 50-69 years, and 1.34 for age 70 years and older.
“The highest excess risk was in the youngest age group,” Dr. Galloway pointed out, “but all age groups showing a significant increased risk of venous thromboembolism.”
Similar findings were seen across different BMI categories, with the highest risk occurring in those in the lowest BMI group. The aHRs were 1.66, 1.60, and 1.41 for the BMI categories of less than 25 kg/m2, 25-30 kg/m2, and more than 30 kg/m2, respectively.
Duration of RA
As for disease duration, nearly two thirds (63.9%) of the 23,410 adults with RA included in this analysis were included at or within 2 years of a diagnosis of RA, 7.8% within 2-5 years of diagnosis, 9.8% within 5-10 years of diagnosis, and 18.5% at 10 or more years after diagnosis.
The aHR for an increased relative risk for VTE in people with RA vs the control group ranged from 1.49 for 0-2 years of diagnosis up to 1.63 for more than 10 years since diagnosis.
“We could see no evidence that the VTE excess risk in rheumatoid arthritis was with a specific time since diagnosis,” Dr. Galloway said in the interview. “It appears that the risk is increased in people with established RA, whether you’ve had the disease for 2 years or 10 years.”
Similar findings were also seen when they looked at aHRs for pulmonary embolism (1.46-2.02) and deep vein thrombosis (1.43-1.89) separately.
Oral Contraceptives and HRT
Data on the use of estrogen-based oral contraceptives or HRT were detailed in a virtual poster presentation. In this analysis, there were 16,664 women with and 65,448 without RA, and the average follow-up was 8.3 years.
“The number of people available for this analysis was small, and bigger studies are needed,” Dr. Galloway said in the interview. Indeed, in the RA group, just 3.3% had used an estrogen-based oral contraceptive and 4.5% had used HRT compared with 3.9% and 3.8% in the control group, respectively.
The overall VTE risk was 52% higher in women with RA than in those without RA.
Risk for VTE was higher among women with RA regardless of the use of estrogen-based oral contraceptives or not (aHRs, 1.43 and 1.52, respectively) and regardless of the use of HRT or not (aHRs, 2.32 and 1.51).
Assess and Monitor
Together these data increase understanding of how age, gender, obesity, duration of disease, and estrogen-based contraception and HRT may make a difference to someone’s VTE risk.
“In all people with RA, we observe an increased risk of venous thromboembolism, and that is both relevant in a contemporary era when we think about prescribing and the different risks of drugs we use for therapeutic strategies,” Dr. Galloway said.
The overall take-home message, he said, is that VTE risk should be considered in everyone with RA and assessed and monitored accordingly. This includes those who may have traditionally been thought of as having a lower risk than others, such as men vs women, younger vs older individuals, and those who may have had RA for a few years.
The research was funded by Pfizer. Dr. Galloway reported receiving honoraria from Pfizer, AbbVie, Biovitrum, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Janssen, Lilly, Novartis, Roche, Sanofi, Sobi, and UCB. Two coauthors of the work were employees of Pfizer. Dr. Bukhari had no conflicts of interest and was not involved in the research.
A version of this article appeared on Medscape.com.
LIVERPOOL, ENGLAND — People with rheumatoid arthritis (RA) have a consistently higher risk for venous thromboembolism (VTE) than the general population, but the reasons for this remain unclear, research presented at the annual meeting of the British Society for Rheumatology (BSR) reaffirmed.
Regardless of age, sex, body mass index (BMI), duration of disease, use of estrogen-based oral contraceptives, or hormone replacement therapy (HRT), people with RA are more likely to experience a pulmonary embolism or deep vein thrombosis than those without RA.
However, “these are rare events,” James Galloway, MBChB, PhD, professor of rheumatology and deputy head of the Centre for Rheumatic Diseases at King’s College London in England, said at the meeting.
In one analysis of data from 117,050 individuals living in England and Wales that are held within a large primary care practice database, Dr. Galloway and colleagues found that the unadjusted incidence of VTE in people diagnosed with RA (n = 23,410) was 0.44% vs 0.26% for matched controls within the general population (n = 93,640).
RA and VTE Risk
The overall risk for VTE was 46% higher among people with RA than among those without, although the absolute difference was small, Dr. Galloway reported.
“RA is associated with an increased risk of VTE; that’s been well described over the years,” Dr. Galloway told this news organization. Past research into why there is an elevated risk for VTE in patients with RA has often focused on the role of disease activity and inflammation.
“In the last few years, a new class of drugs, the JAK [Janus kinase] inhibitors, have emerged in which we have seen a signal of increased VTE risk from a number of studies. And I think that puts a spotlight on our understanding of VTE risk,” Dr. Galloway said.
He added “JAK inhibitors are very powerful at controlling inflammation, but if you take away inflammation, there is still an excess risk. What else could be driving that?”
To examine the excess risk for VTE seen in people with RA, Dr. Galloway and colleagues performed three separate analyses using data collected between January 1999 and December 2018 by the Royal College of General Practitioners Research and Surveillance Center.
One analysis looked at VTE risk according to age, sex, and BMI; another looked at the effect of the duration of RA; and a third analysis focused on the use of estrogen-based oral contraceptives or HRT.
For all three analyses, those with RA were matched in a 4:1 ratio to people from the general population without RA on the basis of current age, sex, calendar time, and years since registration at the primary care practice.
Observational Data Challenged
“These are observational data, so it’s important to weigh up the strengths and limitations,” Dr. Galloway acknowledged. Strengths are the large sample size and long follow-up provided by the database, which assesses and monitors more than 2000 primary care practices in England and Wales.
Confounding is still possible, despite adjusting for multiple factors that included sociodemographic factors; clinical features; and VTE risk factors such as smoking status, alcohol use, thrombophilia, reduced mobility, lower limb fracture, and a family history of VTE if data had been available. There wasn’t information on disease activity, for example, and disease duration was used as a surrogate marker for this.
Sitting in the audience, Marwan Bukhari, MBBS, PhD, challenged the population-matching process.
“Do you think maybe it was the matching that was the problem?” asked Dr. Bukhari, who is consultant rheumatologist at University Hospitals of Morecambe Bay NHS Foundation Trust and an honorary senior lecturer at the University of Manchester, both in England.
“They’re not entirely matched completely, correctly. Even if it is 4:1, there’s a difference between the populations,” he said.
Age, Sex, and Bodyweight
Over an average of 8.2 years’ follow-up, the adjusted hazard ratios (aHRs) comparing VTE risk in women and men with and without RA were a respective 1.62 and 1.52. The corresponding aHRs for VTE according to different age groups were 2.13 for age 18-49 years, 1.57 for age 50-69 years, and 1.34 for age 70 years and older.
“The highest excess risk was in the youngest age group,” Dr. Galloway pointed out, “but all age groups showing a significant increased risk of venous thromboembolism.”
Similar findings were seen across different BMI categories, with the highest risk occurring in those in the lowest BMI group. The aHRs were 1.66, 1.60, and 1.41 for the BMI categories of less than 25 kg/m2, 25-30 kg/m2, and more than 30 kg/m2, respectively.
Duration of RA
As for disease duration, nearly two thirds (63.9%) of the 23,410 adults with RA included in this analysis were included at or within 2 years of a diagnosis of RA, 7.8% within 2-5 years of diagnosis, 9.8% within 5-10 years of diagnosis, and 18.5% at 10 or more years after diagnosis.
The aHR for an increased relative risk for VTE in people with RA vs the control group ranged from 1.49 for 0-2 years of diagnosis up to 1.63 for more than 10 years since diagnosis.
“We could see no evidence that the VTE excess risk in rheumatoid arthritis was with a specific time since diagnosis,” Dr. Galloway said in the interview. “It appears that the risk is increased in people with established RA, whether you’ve had the disease for 2 years or 10 years.”
Similar findings were also seen when they looked at aHRs for pulmonary embolism (1.46-2.02) and deep vein thrombosis (1.43-1.89) separately.
Oral Contraceptives and HRT
Data on the use of estrogen-based oral contraceptives or HRT were detailed in a virtual poster presentation. In this analysis, there were 16,664 women with and 65,448 without RA, and the average follow-up was 8.3 years.
“The number of people available for this analysis was small, and bigger studies are needed,” Dr. Galloway said in the interview. Indeed, in the RA group, just 3.3% had used an estrogen-based oral contraceptive and 4.5% had used HRT compared with 3.9% and 3.8% in the control group, respectively.
The overall VTE risk was 52% higher in women with RA than in those without RA.
Risk for VTE was higher among women with RA regardless of the use of estrogen-based oral contraceptives or not (aHRs, 1.43 and 1.52, respectively) and regardless of the use of HRT or not (aHRs, 2.32 and 1.51).
Assess and Monitor
Together these data increase understanding of how age, gender, obesity, duration of disease, and estrogen-based contraception and HRT may make a difference to someone’s VTE risk.
“In all people with RA, we observe an increased risk of venous thromboembolism, and that is both relevant in a contemporary era when we think about prescribing and the different risks of drugs we use for therapeutic strategies,” Dr. Galloway said.
The overall take-home message, he said, is that VTE risk should be considered in everyone with RA and assessed and monitored accordingly. This includes those who may have traditionally been thought of as having a lower risk than others, such as men vs women, younger vs older individuals, and those who may have had RA for a few years.
The research was funded by Pfizer. Dr. Galloway reported receiving honoraria from Pfizer, AbbVie, Biovitrum, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Janssen, Lilly, Novartis, Roche, Sanofi, Sobi, and UCB. Two coauthors of the work were employees of Pfizer. Dr. Bukhari had no conflicts of interest and was not involved in the research.
A version of this article appeared on Medscape.com.
LIVERPOOL, ENGLAND — People with rheumatoid arthritis (RA) have a consistently higher risk for venous thromboembolism (VTE) than the general population, but the reasons for this remain unclear, research presented at the annual meeting of the British Society for Rheumatology (BSR) reaffirmed.
Regardless of age, sex, body mass index (BMI), duration of disease, use of estrogen-based oral contraceptives, or hormone replacement therapy (HRT), people with RA are more likely to experience a pulmonary embolism or deep vein thrombosis than those without RA.
However, “these are rare events,” James Galloway, MBChB, PhD, professor of rheumatology and deputy head of the Centre for Rheumatic Diseases at King’s College London in England, said at the meeting.
In one analysis of data from 117,050 individuals living in England and Wales that are held within a large primary care practice database, Dr. Galloway and colleagues found that the unadjusted incidence of VTE in people diagnosed with RA (n = 23,410) was 0.44% vs 0.26% for matched controls within the general population (n = 93,640).
RA and VTE Risk
The overall risk for VTE was 46% higher among people with RA than among those without, although the absolute difference was small, Dr. Galloway reported.
“RA is associated with an increased risk of VTE; that’s been well described over the years,” Dr. Galloway told this news organization. Past research into why there is an elevated risk for VTE in patients with RA has often focused on the role of disease activity and inflammation.
“In the last few years, a new class of drugs, the JAK [Janus kinase] inhibitors, have emerged in which we have seen a signal of increased VTE risk from a number of studies. And I think that puts a spotlight on our understanding of VTE risk,” Dr. Galloway said.
He added “JAK inhibitors are very powerful at controlling inflammation, but if you take away inflammation, there is still an excess risk. What else could be driving that?”
To examine the excess risk for VTE seen in people with RA, Dr. Galloway and colleagues performed three separate analyses using data collected between January 1999 and December 2018 by the Royal College of General Practitioners Research and Surveillance Center.
One analysis looked at VTE risk according to age, sex, and BMI; another looked at the effect of the duration of RA; and a third analysis focused on the use of estrogen-based oral contraceptives or HRT.
For all three analyses, those with RA were matched in a 4:1 ratio to people from the general population without RA on the basis of current age, sex, calendar time, and years since registration at the primary care practice.
Observational Data Challenged
“These are observational data, so it’s important to weigh up the strengths and limitations,” Dr. Galloway acknowledged. Strengths are the large sample size and long follow-up provided by the database, which assesses and monitors more than 2000 primary care practices in England and Wales.
Confounding is still possible, despite adjusting for multiple factors that included sociodemographic factors; clinical features; and VTE risk factors such as smoking status, alcohol use, thrombophilia, reduced mobility, lower limb fracture, and a family history of VTE if data had been available. There wasn’t information on disease activity, for example, and disease duration was used as a surrogate marker for this.
Sitting in the audience, Marwan Bukhari, MBBS, PhD, challenged the population-matching process.
“Do you think maybe it was the matching that was the problem?” asked Dr. Bukhari, who is consultant rheumatologist at University Hospitals of Morecambe Bay NHS Foundation Trust and an honorary senior lecturer at the University of Manchester, both in England.
“They’re not entirely matched completely, correctly. Even if it is 4:1, there’s a difference between the populations,” he said.
Age, Sex, and Bodyweight
Over an average of 8.2 years’ follow-up, the adjusted hazard ratios (aHRs) comparing VTE risk in women and men with and without RA were a respective 1.62 and 1.52. The corresponding aHRs for VTE according to different age groups were 2.13 for age 18-49 years, 1.57 for age 50-69 years, and 1.34 for age 70 years and older.
“The highest excess risk was in the youngest age group,” Dr. Galloway pointed out, “but all age groups showing a significant increased risk of venous thromboembolism.”
Similar findings were seen across different BMI categories, with the highest risk occurring in those in the lowest BMI group. The aHRs were 1.66, 1.60, and 1.41 for the BMI categories of less than 25 kg/m2, 25-30 kg/m2, and more than 30 kg/m2, respectively.
Duration of RA
As for disease duration, nearly two thirds (63.9%) of the 23,410 adults with RA included in this analysis were included at or within 2 years of a diagnosis of RA, 7.8% within 2-5 years of diagnosis, 9.8% within 5-10 years of diagnosis, and 18.5% at 10 or more years after diagnosis.
The aHR for an increased relative risk for VTE in people with RA vs the control group ranged from 1.49 for 0-2 years of diagnosis up to 1.63 for more than 10 years since diagnosis.
“We could see no evidence that the VTE excess risk in rheumatoid arthritis was with a specific time since diagnosis,” Dr. Galloway said in the interview. “It appears that the risk is increased in people with established RA, whether you’ve had the disease for 2 years or 10 years.”
Similar findings were also seen when they looked at aHRs for pulmonary embolism (1.46-2.02) and deep vein thrombosis (1.43-1.89) separately.
Oral Contraceptives and HRT
Data on the use of estrogen-based oral contraceptives or HRT were detailed in a virtual poster presentation. In this analysis, there were 16,664 women with and 65,448 without RA, and the average follow-up was 8.3 years.
“The number of people available for this analysis was small, and bigger studies are needed,” Dr. Galloway said in the interview. Indeed, in the RA group, just 3.3% had used an estrogen-based oral contraceptive and 4.5% had used HRT compared with 3.9% and 3.8% in the control group, respectively.
The overall VTE risk was 52% higher in women with RA than in those without RA.
Risk for VTE was higher among women with RA regardless of the use of estrogen-based oral contraceptives or not (aHRs, 1.43 and 1.52, respectively) and regardless of the use of HRT or not (aHRs, 2.32 and 1.51).
Assess and Monitor
Together these data increase understanding of how age, gender, obesity, duration of disease, and estrogen-based contraception and HRT may make a difference to someone’s VTE risk.
“In all people with RA, we observe an increased risk of venous thromboembolism, and that is both relevant in a contemporary era when we think about prescribing and the different risks of drugs we use for therapeutic strategies,” Dr. Galloway said.
The overall take-home message, he said, is that VTE risk should be considered in everyone with RA and assessed and monitored accordingly. This includes those who may have traditionally been thought of as having a lower risk than others, such as men vs women, younger vs older individuals, and those who may have had RA for a few years.
The research was funded by Pfizer. Dr. Galloway reported receiving honoraria from Pfizer, AbbVie, Biovitrum, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Janssen, Lilly, Novartis, Roche, Sanofi, Sobi, and UCB. Two coauthors of the work were employees of Pfizer. Dr. Bukhari had no conflicts of interest and was not involved in the research.
A version of this article appeared on Medscape.com.
FROM BSR 2024
Optimized Hospital Care for Gout Improves Uptake of Urate-Lowering Therapy
LIVERPOOL, ENGLAND — Optimizing how people experiencing a gout flare are managed in hospital and then followed-up afterwards can substantially increase the uptake of guideline-recommended urate-lowering therapy (ULT), researchers reported at the annual meeting of the British Society for Rheumatology (BSR).
In a prospective study, 92% of 97 people admitted to hospital for gout flares were using ULT within 6 months of discharge after a multifaceted intervention was introduced. By comparison, 49% of 94 people admitted for gout flares before the introduction of the intervention were taking ULT within the same postdischarge time frame.
Moreover, a higher proportion of individuals had urate blood tests done at least once within the 6-month postdischarge period after the intervention’s introduction (58% vs 32%) and fewer (9% vs 15%) needed repeated hospital treatment.
“Gout is the most common inflammatory arthritis affecting one in 30 adults in the United Kingdom, yet it’s one of the most poorly managed,” study investigator Mark D. Russell, MB, BChir, pointed out during a poster presentation.
“There are very effective treatments,” added Dr. Russell, a rheumatology registrar and postdoctoral research fellow at King’s College London in London, England. “Urate-lowering therapies such as allopurinol, which when taken at the correct dose, in the long term, effectively cures patients of their symptoms and prevents complications.”
Dr. Russell said in an interview that there was still work to be done as the rate of people achieving urate levels below the recommended threshold of 360 micromol/L (6 mg/dL) within 6 months was still low, at 27%, even it if was still better than the 11% seen before the intervention was introduced.
Improving the In- and Post-Hospital Pathway
“We developed and implemented an in-hospital management pathway which encouraged urate-lowering therapy initiation prior to discharge, followed by a post-discharge nurse-led review,” Dr. Russell explained.
The in-hospital pathway was based upon BSR, European Alliance of Associations for Rheumatology, and American College of Rheumatology guidelines and involved diagnosing and managing the gout flare appropriately. This may have been via early joint aspiration, medication, or both, as directed by the rheumatology team. Affected individuals also received education and were directed where to obtain further information on the use of ULT. Outpatient follow-up was considered if an individual had severe or tophaceous gout, recurrent episodes, or contraindications or intolerances to ULT. Otherwise, a rheumatology nurse telephoned the individual 2 weeks later to review symptoms and discuss next steps.
The researchers recorded improvements in in-hospital outcomes. The frequency of in-hospital serum urate level measurements rose from 66% in the 12-month preimplementation period to 93% in the 12-month period after the intervention’s introduction. Almost two thirds (62%) of patients were discharged on ULT compared with 18% preimplementation. And gout-specific recommendations were given 86% of the time compared with 59% before the intervention.
Related Work on Gout Incidence
Separately, Dr. Russell also presented data from a nationwide, population-level cohort study that used data from OpenSAFELY, the secure data analytics platform used by the National Health Service in England.
“We did an analysis previously using the CPRD [Clinical Research Practice Datalink], which is another good primary care database, showing that only a third of people with gout in the UK get urate-lowering drugs, when really it should be the vast majority,” he said in the interview.
“And then we wanted to look at, on top of that, what was the impact of the [COVID-19] pandemic,” Russell added. Specifically, the aim was to look at how the pandemic had affected the incidence, management, and prevalence of gout.
Between March 2015 and February 2023, 246,695 new cases of gout were identified among 17.9 million adults, seen in primary and secondary care.
COVID-19 Pandemic Affected Cases
“The number of new cases of gout dropped by about one third in the first year of the pandemic,” Dr. Russell said. Incidence declined from 1.78 to 1.23 per 1000 adults. “Whether that was through people not feeling comfortable going to their GP [general practitioner] or not being able to get an appointment, we don’t know.”
While there was a subsequent increase in new cases of gout since this time, the rates still haven’t reached what they were before the pandemic. This implies that there could be a substantial number of people who may be undiagnosed because of the pandemic, Dr. Russell suggested.
Moreover, he reported that in 2022-2023, the prevalence of gout was 3.21%, up slightly from the 3.07% recorded 7 years earlier in 2015-2016.
ULT Treatment Rates Low
“If you did see a GP, however, so as long as you saw someone, the treatment wasn’t any worse,” Dr. Russell said. Just under 30% of people with incident gout for whom follow-up data were available had initiated ULT within 6 months of their diagnosis. And, of these new starters, around a quarter had a serum urate level below a target of 360 micromol/L.
“This doesn’t detract from the fact that this is pretty low. Despite guidelines, we’re still not getting the majority of people on these very effective urate-lowering drugs,” Dr. Russell said.
There is perhaps too much reliance on modifying diet and lifestyle, he added, which are important for many reasons but will not do much to lower blood urate levels.
As a final word, Dr. Russell said, “It’s not just a case of preventing a bit of joint pain. People get lots of complications when they’re undertreated — erosive joint damage, work disability, impaired quality of life — and yet we’ve got very cheap, well-tolerated drugs.”
The work was independently funded. Dr. Russell acknowledged grant or research support from Eli Lilly, Janssen, Pfizer, and UCB and receipt of honoraria from AbbVie, Biogen, Eli Lilly, Galapagos, and Menarini.
A version of this article appeared on Medscape.com.
LIVERPOOL, ENGLAND — Optimizing how people experiencing a gout flare are managed in hospital and then followed-up afterwards can substantially increase the uptake of guideline-recommended urate-lowering therapy (ULT), researchers reported at the annual meeting of the British Society for Rheumatology (BSR).
In a prospective study, 92% of 97 people admitted to hospital for gout flares were using ULT within 6 months of discharge after a multifaceted intervention was introduced. By comparison, 49% of 94 people admitted for gout flares before the introduction of the intervention were taking ULT within the same postdischarge time frame.
Moreover, a higher proportion of individuals had urate blood tests done at least once within the 6-month postdischarge period after the intervention’s introduction (58% vs 32%) and fewer (9% vs 15%) needed repeated hospital treatment.
“Gout is the most common inflammatory arthritis affecting one in 30 adults in the United Kingdom, yet it’s one of the most poorly managed,” study investigator Mark D. Russell, MB, BChir, pointed out during a poster presentation.
“There are very effective treatments,” added Dr. Russell, a rheumatology registrar and postdoctoral research fellow at King’s College London in London, England. “Urate-lowering therapies such as allopurinol, which when taken at the correct dose, in the long term, effectively cures patients of their symptoms and prevents complications.”
Dr. Russell said in an interview that there was still work to be done as the rate of people achieving urate levels below the recommended threshold of 360 micromol/L (6 mg/dL) within 6 months was still low, at 27%, even it if was still better than the 11% seen before the intervention was introduced.
Improving the In- and Post-Hospital Pathway
“We developed and implemented an in-hospital management pathway which encouraged urate-lowering therapy initiation prior to discharge, followed by a post-discharge nurse-led review,” Dr. Russell explained.
The in-hospital pathway was based upon BSR, European Alliance of Associations for Rheumatology, and American College of Rheumatology guidelines and involved diagnosing and managing the gout flare appropriately. This may have been via early joint aspiration, medication, or both, as directed by the rheumatology team. Affected individuals also received education and were directed where to obtain further information on the use of ULT. Outpatient follow-up was considered if an individual had severe or tophaceous gout, recurrent episodes, or contraindications or intolerances to ULT. Otherwise, a rheumatology nurse telephoned the individual 2 weeks later to review symptoms and discuss next steps.
The researchers recorded improvements in in-hospital outcomes. The frequency of in-hospital serum urate level measurements rose from 66% in the 12-month preimplementation period to 93% in the 12-month period after the intervention’s introduction. Almost two thirds (62%) of patients were discharged on ULT compared with 18% preimplementation. And gout-specific recommendations were given 86% of the time compared with 59% before the intervention.
Related Work on Gout Incidence
Separately, Dr. Russell also presented data from a nationwide, population-level cohort study that used data from OpenSAFELY, the secure data analytics platform used by the National Health Service in England.
“We did an analysis previously using the CPRD [Clinical Research Practice Datalink], which is another good primary care database, showing that only a third of people with gout in the UK get urate-lowering drugs, when really it should be the vast majority,” he said in the interview.
“And then we wanted to look at, on top of that, what was the impact of the [COVID-19] pandemic,” Russell added. Specifically, the aim was to look at how the pandemic had affected the incidence, management, and prevalence of gout.
Between March 2015 and February 2023, 246,695 new cases of gout were identified among 17.9 million adults, seen in primary and secondary care.
COVID-19 Pandemic Affected Cases
“The number of new cases of gout dropped by about one third in the first year of the pandemic,” Dr. Russell said. Incidence declined from 1.78 to 1.23 per 1000 adults. “Whether that was through people not feeling comfortable going to their GP [general practitioner] or not being able to get an appointment, we don’t know.”
While there was a subsequent increase in new cases of gout since this time, the rates still haven’t reached what they were before the pandemic. This implies that there could be a substantial number of people who may be undiagnosed because of the pandemic, Dr. Russell suggested.
Moreover, he reported that in 2022-2023, the prevalence of gout was 3.21%, up slightly from the 3.07% recorded 7 years earlier in 2015-2016.
ULT Treatment Rates Low
“If you did see a GP, however, so as long as you saw someone, the treatment wasn’t any worse,” Dr. Russell said. Just under 30% of people with incident gout for whom follow-up data were available had initiated ULT within 6 months of their diagnosis. And, of these new starters, around a quarter had a serum urate level below a target of 360 micromol/L.
“This doesn’t detract from the fact that this is pretty low. Despite guidelines, we’re still not getting the majority of people on these very effective urate-lowering drugs,” Dr. Russell said.
There is perhaps too much reliance on modifying diet and lifestyle, he added, which are important for many reasons but will not do much to lower blood urate levels.
As a final word, Dr. Russell said, “It’s not just a case of preventing a bit of joint pain. People get lots of complications when they’re undertreated — erosive joint damage, work disability, impaired quality of life — and yet we’ve got very cheap, well-tolerated drugs.”
The work was independently funded. Dr. Russell acknowledged grant or research support from Eli Lilly, Janssen, Pfizer, and UCB and receipt of honoraria from AbbVie, Biogen, Eli Lilly, Galapagos, and Menarini.
A version of this article appeared on Medscape.com.
LIVERPOOL, ENGLAND — Optimizing how people experiencing a gout flare are managed in hospital and then followed-up afterwards can substantially increase the uptake of guideline-recommended urate-lowering therapy (ULT), researchers reported at the annual meeting of the British Society for Rheumatology (BSR).
In a prospective study, 92% of 97 people admitted to hospital for gout flares were using ULT within 6 months of discharge after a multifaceted intervention was introduced. By comparison, 49% of 94 people admitted for gout flares before the introduction of the intervention were taking ULT within the same postdischarge time frame.
Moreover, a higher proportion of individuals had urate blood tests done at least once within the 6-month postdischarge period after the intervention’s introduction (58% vs 32%) and fewer (9% vs 15%) needed repeated hospital treatment.
“Gout is the most common inflammatory arthritis affecting one in 30 adults in the United Kingdom, yet it’s one of the most poorly managed,” study investigator Mark D. Russell, MB, BChir, pointed out during a poster presentation.
“There are very effective treatments,” added Dr. Russell, a rheumatology registrar and postdoctoral research fellow at King’s College London in London, England. “Urate-lowering therapies such as allopurinol, which when taken at the correct dose, in the long term, effectively cures patients of their symptoms and prevents complications.”
Dr. Russell said in an interview that there was still work to be done as the rate of people achieving urate levels below the recommended threshold of 360 micromol/L (6 mg/dL) within 6 months was still low, at 27%, even it if was still better than the 11% seen before the intervention was introduced.
Improving the In- and Post-Hospital Pathway
“We developed and implemented an in-hospital management pathway which encouraged urate-lowering therapy initiation prior to discharge, followed by a post-discharge nurse-led review,” Dr. Russell explained.
The in-hospital pathway was based upon BSR, European Alliance of Associations for Rheumatology, and American College of Rheumatology guidelines and involved diagnosing and managing the gout flare appropriately. This may have been via early joint aspiration, medication, or both, as directed by the rheumatology team. Affected individuals also received education and were directed where to obtain further information on the use of ULT. Outpatient follow-up was considered if an individual had severe or tophaceous gout, recurrent episodes, or contraindications or intolerances to ULT. Otherwise, a rheumatology nurse telephoned the individual 2 weeks later to review symptoms and discuss next steps.
The researchers recorded improvements in in-hospital outcomes. The frequency of in-hospital serum urate level measurements rose from 66% in the 12-month preimplementation period to 93% in the 12-month period after the intervention’s introduction. Almost two thirds (62%) of patients were discharged on ULT compared with 18% preimplementation. And gout-specific recommendations were given 86% of the time compared with 59% before the intervention.
Related Work on Gout Incidence
Separately, Dr. Russell also presented data from a nationwide, population-level cohort study that used data from OpenSAFELY, the secure data analytics platform used by the National Health Service in England.
“We did an analysis previously using the CPRD [Clinical Research Practice Datalink], which is another good primary care database, showing that only a third of people with gout in the UK get urate-lowering drugs, when really it should be the vast majority,” he said in the interview.
“And then we wanted to look at, on top of that, what was the impact of the [COVID-19] pandemic,” Russell added. Specifically, the aim was to look at how the pandemic had affected the incidence, management, and prevalence of gout.
Between March 2015 and February 2023, 246,695 new cases of gout were identified among 17.9 million adults, seen in primary and secondary care.
COVID-19 Pandemic Affected Cases
“The number of new cases of gout dropped by about one third in the first year of the pandemic,” Dr. Russell said. Incidence declined from 1.78 to 1.23 per 1000 adults. “Whether that was through people not feeling comfortable going to their GP [general practitioner] or not being able to get an appointment, we don’t know.”
While there was a subsequent increase in new cases of gout since this time, the rates still haven’t reached what they were before the pandemic. This implies that there could be a substantial number of people who may be undiagnosed because of the pandemic, Dr. Russell suggested.
Moreover, he reported that in 2022-2023, the prevalence of gout was 3.21%, up slightly from the 3.07% recorded 7 years earlier in 2015-2016.
ULT Treatment Rates Low
“If you did see a GP, however, so as long as you saw someone, the treatment wasn’t any worse,” Dr. Russell said. Just under 30% of people with incident gout for whom follow-up data were available had initiated ULT within 6 months of their diagnosis. And, of these new starters, around a quarter had a serum urate level below a target of 360 micromol/L.
“This doesn’t detract from the fact that this is pretty low. Despite guidelines, we’re still not getting the majority of people on these very effective urate-lowering drugs,” Dr. Russell said.
There is perhaps too much reliance on modifying diet and lifestyle, he added, which are important for many reasons but will not do much to lower blood urate levels.
As a final word, Dr. Russell said, “It’s not just a case of preventing a bit of joint pain. People get lots of complications when they’re undertreated — erosive joint damage, work disability, impaired quality of life — and yet we’ve got very cheap, well-tolerated drugs.”
The work was independently funded. Dr. Russell acknowledged grant or research support from Eli Lilly, Janssen, Pfizer, and UCB and receipt of honoraria from AbbVie, Biogen, Eli Lilly, Galapagos, and Menarini.
A version of this article appeared on Medscape.com.
FROM BSR 2024
Blood Biomarkers Predict Knee Osteoarthritis Years in Advance
A small number of blood biomarkers can identify patients who will develop knee osteoarthritis (OA) up to 8 years before signs of the disease are detectable via X-ray, according to new research.
The study “provides more evidence for a pre-radiographic phase of disease,” wrote Virginia Byers Dr. Kraus, MD, PhD, a professor of medicine, pathology, and orthopedic surgery at Duke University School of Medicine in Durham, North Carolina, and colleagues. The results also “provide valuable information for understanding the molecular events of early disease that could inform strategies to develop disease-modifying drugs for preclinical OA,” they continued.
In the study, published in Science Advances, researchers analyzed blood samples from a population-based, longitudinal study of women in London that assessed participants annually for osteoporosis and OA. They selected individuals at low risk for radiographic knee OA, who did not have traditional risk factors for knee OA such as a history of major knee injury, knee surgery, or OA of the hand or opposite knee.
The researchers analyzed serum of 100 women who went on to develop radiographic knee OA and 100 controls who were matched by age and body mass index (BMI). Participants were, on average, aged 54 years with a BMI of 26 and all were White. They analyzed serum peptides via mass spectrometry and used machine learning to select which out of the 115 identified peptides were most predictive of OA.
Ultimately, the team zeroed in on six peptides, corresponding to six proteins, that could most accurately distinguish women who went on to develop radiographic signs of OA from controls (area under the receiver operating characteristic curve, 0.77) up to 8 years before x-rays detected these changes.
“The value of our study is a panel that, in the absence of clinical factors indicative of high-risk knee OA, has the potential to discriminate individuals at risk for incident radiographic knee OA from those not at risk,” the authors wrote.
In earlier work, a similar group of biomarkers could accurately diagnose knee OA as well as predict the progression of the disease. More than half (58%) of biomarkers that predicted incident OA also predicted OA progression.
“Even for the ones that didn’t overlap with OA progression, they all pointed to the same sort of disease process, which is an unresolved acute phase response type of biological process,” Dr. Kraus told this news organization.
Commenting on the study, Andrew Grose, MD, an orthopedic trauma surgeon at the Hospital for Special Surgery in New York City, noted that the methods and conclusions seemed sound but cautioned that the study only looked for radiographic evidence of OA, and not symptomatic OA.
“Clinically relevant OA is correlated with what you see on an x-ray, but the x-ray is definitely not the whole story,” he said in an interview with this news organization.
To be clinically relevant, patients must also have symptoms, such as pain and stiffness, and interfere with daily life. But what shows up on an x-ray is not necessarily indicative of what patients are experiencing, he said. Solely focusing on radiographic findings could lead to overdiagnosis and overtreatment of OA, he said.
The study population was also small, and only included White women, he added, so further validation is necessary. Dr. Kraus and colleagues also acknowledged these limitations.
“Further validation will be needed in independent and larger cohorts, preferability prospectively collected and including male participants and the combination of incident radiographic and symptomatic OA,” they wrote. They noted that while this current study included only women, the biomarkers were not associated with sex in previous studies that used larger and mixed-sex cohorts.
“If they did more studies showing that this [test] was able to predict clinically relevant OA, then I think you could have a meaningful conversation with a patient in a primary care doctor’s office,” Dr. Grose added. “Until that time, just the fact that it predicts an x-ray finding is a little bit of a red herring.”
This work was supported by grants from the National Institutes of Health. Dr. Kraus is an inventor on a patent related to OA progression biomarkers. Dr. Grose had no relevant disclosures.
A version of this article appeared on Medscape.com.
A small number of blood biomarkers can identify patients who will develop knee osteoarthritis (OA) up to 8 years before signs of the disease are detectable via X-ray, according to new research.
The study “provides more evidence for a pre-radiographic phase of disease,” wrote Virginia Byers Dr. Kraus, MD, PhD, a professor of medicine, pathology, and orthopedic surgery at Duke University School of Medicine in Durham, North Carolina, and colleagues. The results also “provide valuable information for understanding the molecular events of early disease that could inform strategies to develop disease-modifying drugs for preclinical OA,” they continued.
In the study, published in Science Advances, researchers analyzed blood samples from a population-based, longitudinal study of women in London that assessed participants annually for osteoporosis and OA. They selected individuals at low risk for radiographic knee OA, who did not have traditional risk factors for knee OA such as a history of major knee injury, knee surgery, or OA of the hand or opposite knee.
The researchers analyzed serum of 100 women who went on to develop radiographic knee OA and 100 controls who were matched by age and body mass index (BMI). Participants were, on average, aged 54 years with a BMI of 26 and all were White. They analyzed serum peptides via mass spectrometry and used machine learning to select which out of the 115 identified peptides were most predictive of OA.
Ultimately, the team zeroed in on six peptides, corresponding to six proteins, that could most accurately distinguish women who went on to develop radiographic signs of OA from controls (area under the receiver operating characteristic curve, 0.77) up to 8 years before x-rays detected these changes.
“The value of our study is a panel that, in the absence of clinical factors indicative of high-risk knee OA, has the potential to discriminate individuals at risk for incident radiographic knee OA from those not at risk,” the authors wrote.
In earlier work, a similar group of biomarkers could accurately diagnose knee OA as well as predict the progression of the disease. More than half (58%) of biomarkers that predicted incident OA also predicted OA progression.
“Even for the ones that didn’t overlap with OA progression, they all pointed to the same sort of disease process, which is an unresolved acute phase response type of biological process,” Dr. Kraus told this news organization.
Commenting on the study, Andrew Grose, MD, an orthopedic trauma surgeon at the Hospital for Special Surgery in New York City, noted that the methods and conclusions seemed sound but cautioned that the study only looked for radiographic evidence of OA, and not symptomatic OA.
“Clinically relevant OA is correlated with what you see on an x-ray, but the x-ray is definitely not the whole story,” he said in an interview with this news organization.
To be clinically relevant, patients must also have symptoms, such as pain and stiffness, and interfere with daily life. But what shows up on an x-ray is not necessarily indicative of what patients are experiencing, he said. Solely focusing on radiographic findings could lead to overdiagnosis and overtreatment of OA, he said.
The study population was also small, and only included White women, he added, so further validation is necessary. Dr. Kraus and colleagues also acknowledged these limitations.
“Further validation will be needed in independent and larger cohorts, preferability prospectively collected and including male participants and the combination of incident radiographic and symptomatic OA,” they wrote. They noted that while this current study included only women, the biomarkers were not associated with sex in previous studies that used larger and mixed-sex cohorts.
“If they did more studies showing that this [test] was able to predict clinically relevant OA, then I think you could have a meaningful conversation with a patient in a primary care doctor’s office,” Dr. Grose added. “Until that time, just the fact that it predicts an x-ray finding is a little bit of a red herring.”
This work was supported by grants from the National Institutes of Health. Dr. Kraus is an inventor on a patent related to OA progression biomarkers. Dr. Grose had no relevant disclosures.
A version of this article appeared on Medscape.com.
A small number of blood biomarkers can identify patients who will develop knee osteoarthritis (OA) up to 8 years before signs of the disease are detectable via X-ray, according to new research.
The study “provides more evidence for a pre-radiographic phase of disease,” wrote Virginia Byers Dr. Kraus, MD, PhD, a professor of medicine, pathology, and orthopedic surgery at Duke University School of Medicine in Durham, North Carolina, and colleagues. The results also “provide valuable information for understanding the molecular events of early disease that could inform strategies to develop disease-modifying drugs for preclinical OA,” they continued.
In the study, published in Science Advances, researchers analyzed blood samples from a population-based, longitudinal study of women in London that assessed participants annually for osteoporosis and OA. They selected individuals at low risk for radiographic knee OA, who did not have traditional risk factors for knee OA such as a history of major knee injury, knee surgery, or OA of the hand or opposite knee.
The researchers analyzed serum of 100 women who went on to develop radiographic knee OA and 100 controls who were matched by age and body mass index (BMI). Participants were, on average, aged 54 years with a BMI of 26 and all were White. They analyzed serum peptides via mass spectrometry and used machine learning to select which out of the 115 identified peptides were most predictive of OA.
Ultimately, the team zeroed in on six peptides, corresponding to six proteins, that could most accurately distinguish women who went on to develop radiographic signs of OA from controls (area under the receiver operating characteristic curve, 0.77) up to 8 years before x-rays detected these changes.
“The value of our study is a panel that, in the absence of clinical factors indicative of high-risk knee OA, has the potential to discriminate individuals at risk for incident radiographic knee OA from those not at risk,” the authors wrote.
In earlier work, a similar group of biomarkers could accurately diagnose knee OA as well as predict the progression of the disease. More than half (58%) of biomarkers that predicted incident OA also predicted OA progression.
“Even for the ones that didn’t overlap with OA progression, they all pointed to the same sort of disease process, which is an unresolved acute phase response type of biological process,” Dr. Kraus told this news organization.
Commenting on the study, Andrew Grose, MD, an orthopedic trauma surgeon at the Hospital for Special Surgery in New York City, noted that the methods and conclusions seemed sound but cautioned that the study only looked for radiographic evidence of OA, and not symptomatic OA.
“Clinically relevant OA is correlated with what you see on an x-ray, but the x-ray is definitely not the whole story,” he said in an interview with this news organization.
To be clinically relevant, patients must also have symptoms, such as pain and stiffness, and interfere with daily life. But what shows up on an x-ray is not necessarily indicative of what patients are experiencing, he said. Solely focusing on radiographic findings could lead to overdiagnosis and overtreatment of OA, he said.
The study population was also small, and only included White women, he added, so further validation is necessary. Dr. Kraus and colleagues also acknowledged these limitations.
“Further validation will be needed in independent and larger cohorts, preferability prospectively collected and including male participants and the combination of incident radiographic and symptomatic OA,” they wrote. They noted that while this current study included only women, the biomarkers were not associated with sex in previous studies that used larger and mixed-sex cohorts.
“If they did more studies showing that this [test] was able to predict clinically relevant OA, then I think you could have a meaningful conversation with a patient in a primary care doctor’s office,” Dr. Grose added. “Until that time, just the fact that it predicts an x-ray finding is a little bit of a red herring.”
This work was supported by grants from the National Institutes of Health. Dr. Kraus is an inventor on a patent related to OA progression biomarkers. Dr. Grose had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM SCIENCE ADVANCES
New British Behçet’s Disease Guidelines Emphasize Multidisciplinary Management
LIVERPOOL, ENGLAND — The British Society for Rheumatology (BSR) and the British Association of Dermatologists (BAD) have joined forces for the first time to develop the first British guidelines for the management of people living with Behçet’s disease.
The guidelines will also be the first “living guidelines” produced by either society, which means they will be regularly revised and updated when new evidence emerges that warrants inclusion.
With more than 90 recommendations being made, the new guidelines promise to be the most comprehensive and most up-to-date yet for what is regarded as a rare disease. Robert Moots, MBBS, PhD, provided a “sneak peek” of the guidelines at the annual meeting of the British Society for Rheumatology.
Dr. Moots, professor of rheumatology at the University of Liverpool and a consultant rheumatologist for Liverpool University Hospitals NHS Foundation Trust in England, noted that while the European Alliance of Associations for Rheumatology has produced a guideline for Behçet’s disease, this was last updated in 2018 and is not specific for the population for patients that is seen in the United Kingdom.
The British recommendations will cover all possible manifestations of Behçet’s disease and give practical advice on how to manage everything from the most common presentations such as skin lesions, mouth ulcers, and genital ulcers, as well as the potentially more serious eye, neurological, and vascular involvement.
Importance of Raising Awareness
“Joint and musculoskeletal problems are actually one of the least complained of symptoms in people with Behçet’s, and they often can’t understand why a rheumatologist is seeing them,” Dr. Moot said. “But of course, people do get joint problems, they can get enthesitis and arthralgia.”
Dr. Moots has been leading one of the three National Health Service (NHS) Centres of Excellence for Behçet’s Syndrome in England for more than a decade and told this news organization that diagnosing patients could be challenging. It can take up to 10 years from the first symptoms appearing to getting a diagnosis, so part of the job of the NHS Centres of Excellence is to raise awareness among both the healthcare profession and the general public.
“It’s a condition that people learn about at medical school. Most doctors will have come across it, but because it was thought to be really rare in the UK, nobody perhaps really expects to see it,” Dr. Moot said.
“But we all have these patients,” he added. “In Liverpool, we’re commissioned to be looking after an anticipated 150 people with Behçet’s — we’ve got 700. With more awareness, there’s more diagnoses being made, and people are being looked after better.”
Patient Perspective
Tony Thornburn, OBE, chair of the patient advocacy group Behçet’s UK, agreed in a separate interview that raising awareness of the syndrome was key to improving its management.
“Patients have said that it is a bit like having arthritis, lupus, MS [multiple sclerosis], and Crohn’s [disease] all at once,” Mr. Thorburn said. “So what we need is a guideline to ensure that people know what they’re looking at.”
Mr. Thorburn added, “Guidelines are important for raising awareness but also providing the detailed information that clinicians and GPs [general practitioners] need to have to treat a patient when they come in with this multifaceted condition.”
Multifaceted Means Multidisciplinary Management
Because there can be so many different aspects to managing someone with Behçet’s disease, a multispecialty team that was convened to develop the guidelines agreed that multidisciplinary management should be an overarching theme.
“The guideline development group consisted of all the specialties that you would need for a complex multisystem disease like Behçet’s,” Dr. Moot said. He highlighted that working alongside the consultants in adult and pediatric rheumatology were specialists in dermatology, gastroenterology, neurology, ophthalmology, obstetrics and gynecology, and psychology.
“We’re actually looking at psychological interactions and their impact for the first time,” Dr. Moot said, noting that clinicians needed to “take it seriously, and ask about it.”
Management of Manifestations
One of the general principles of the guidelines is to assess the involvement of each organ system and target treatment accordingly.
“One of the problems is that the evidence base to tell us what to do is pretty low,” Dr. Moots acknowledged. There have been few good quality randomized trials, so “treatment tends to be eminence-based rather than evidence-based.”
The recommendation wording bears this in mind, stating whether a treatment should or should not be offered, or just considered if there is no strong evidence to back up its use.
With regard to musculoskeletal manifestations, the recommendations say that colchicine should be offered, perhaps as a first-line option, or an intraarticular steroid injection in the case of monoarthritis. An intramuscular depot steroid may also be appropriate to offer, and there was good evidence to offer azathioprine or, as an alternative in refractory cases, a tumor necrosis factor (TNF) inhibitor. Nonsteroidal anti-inflammatory drugs, methotrexate, apremilast, secukinumab, and referral to a physiotherapist could only be considered, however, based on weaker levels of evidence for their use.
To treat mucocutaneous disease, the guidelines advise offering topical steroids in the form of ointment for genital ulcers or mouthwash or ointment for oral ulcers. For skin lesions, it is recommended to offer colchicine, azathioprine, mycophenolate mofetil, or TNF inhibitor and to consider the use of apremilast, secukinumab, or dapsone.
Future Work and Revision
“One of the key things we would like to see developing is a national registry,” Dr. Moots said. This would include biobanking samples for future research and possible genomic and phenotyping studies.
More work needs to be done in conducting clinical trials in children and young people with Behçet’s disease, studies to find prognostic factors for neurological disease, and clinical trials of potential new drug approaches such as Janus kinase inhibitors. Importantly, an auditing process needs to be set up to see what effect, if any, the guidelines will actually have onpatient management.
“It’s taken 5 years to today” to develop the guidelines, Dr. Moot said. What form the process of updating them will take still has to be decided, he said in the interview. It is likely that the necessary literature searches will be performed every 6 months or so, but it will be a compromise between the ideal situation and having the staffing time to do it.
“It’s a big ask,” Dr. Moot acknowledged, adding that even if updates were only once a year, it would still be much faster than the 5- or 6-year cycle that it traditionally takes for most guidelines to be updated.
The BSR and BAD’s processes for developing guidelines are accredited by the National Institute for Health and Care Excellence in England. Dr. Moots is the chief investigator for the Secukinumab in Behçet’s trial, which is sponsored by the Liverpool University Hospitals NHS Foundation Trust via grant funding from Novartis.
A version of this article appeared on Medscape.com.
LIVERPOOL, ENGLAND — The British Society for Rheumatology (BSR) and the British Association of Dermatologists (BAD) have joined forces for the first time to develop the first British guidelines for the management of people living with Behçet’s disease.
The guidelines will also be the first “living guidelines” produced by either society, which means they will be regularly revised and updated when new evidence emerges that warrants inclusion.
With more than 90 recommendations being made, the new guidelines promise to be the most comprehensive and most up-to-date yet for what is regarded as a rare disease. Robert Moots, MBBS, PhD, provided a “sneak peek” of the guidelines at the annual meeting of the British Society for Rheumatology.
Dr. Moots, professor of rheumatology at the University of Liverpool and a consultant rheumatologist for Liverpool University Hospitals NHS Foundation Trust in England, noted that while the European Alliance of Associations for Rheumatology has produced a guideline for Behçet’s disease, this was last updated in 2018 and is not specific for the population for patients that is seen in the United Kingdom.
The British recommendations will cover all possible manifestations of Behçet’s disease and give practical advice on how to manage everything from the most common presentations such as skin lesions, mouth ulcers, and genital ulcers, as well as the potentially more serious eye, neurological, and vascular involvement.
Importance of Raising Awareness
“Joint and musculoskeletal problems are actually one of the least complained of symptoms in people with Behçet’s, and they often can’t understand why a rheumatologist is seeing them,” Dr. Moot said. “But of course, people do get joint problems, they can get enthesitis and arthralgia.”
Dr. Moots has been leading one of the three National Health Service (NHS) Centres of Excellence for Behçet’s Syndrome in England for more than a decade and told this news organization that diagnosing patients could be challenging. It can take up to 10 years from the first symptoms appearing to getting a diagnosis, so part of the job of the NHS Centres of Excellence is to raise awareness among both the healthcare profession and the general public.
“It’s a condition that people learn about at medical school. Most doctors will have come across it, but because it was thought to be really rare in the UK, nobody perhaps really expects to see it,” Dr. Moot said.
“But we all have these patients,” he added. “In Liverpool, we’re commissioned to be looking after an anticipated 150 people with Behçet’s — we’ve got 700. With more awareness, there’s more diagnoses being made, and people are being looked after better.”
Patient Perspective
Tony Thornburn, OBE, chair of the patient advocacy group Behçet’s UK, agreed in a separate interview that raising awareness of the syndrome was key to improving its management.
“Patients have said that it is a bit like having arthritis, lupus, MS [multiple sclerosis], and Crohn’s [disease] all at once,” Mr. Thorburn said. “So what we need is a guideline to ensure that people know what they’re looking at.”
Mr. Thorburn added, “Guidelines are important for raising awareness but also providing the detailed information that clinicians and GPs [general practitioners] need to have to treat a patient when they come in with this multifaceted condition.”
Multifaceted Means Multidisciplinary Management
Because there can be so many different aspects to managing someone with Behçet’s disease, a multispecialty team that was convened to develop the guidelines agreed that multidisciplinary management should be an overarching theme.
“The guideline development group consisted of all the specialties that you would need for a complex multisystem disease like Behçet’s,” Dr. Moot said. He highlighted that working alongside the consultants in adult and pediatric rheumatology were specialists in dermatology, gastroenterology, neurology, ophthalmology, obstetrics and gynecology, and psychology.
“We’re actually looking at psychological interactions and their impact for the first time,” Dr. Moot said, noting that clinicians needed to “take it seriously, and ask about it.”
Management of Manifestations
One of the general principles of the guidelines is to assess the involvement of each organ system and target treatment accordingly.
“One of the problems is that the evidence base to tell us what to do is pretty low,” Dr. Moots acknowledged. There have been few good quality randomized trials, so “treatment tends to be eminence-based rather than evidence-based.”
The recommendation wording bears this in mind, stating whether a treatment should or should not be offered, or just considered if there is no strong evidence to back up its use.
With regard to musculoskeletal manifestations, the recommendations say that colchicine should be offered, perhaps as a first-line option, or an intraarticular steroid injection in the case of monoarthritis. An intramuscular depot steroid may also be appropriate to offer, and there was good evidence to offer azathioprine or, as an alternative in refractory cases, a tumor necrosis factor (TNF) inhibitor. Nonsteroidal anti-inflammatory drugs, methotrexate, apremilast, secukinumab, and referral to a physiotherapist could only be considered, however, based on weaker levels of evidence for their use.
To treat mucocutaneous disease, the guidelines advise offering topical steroids in the form of ointment for genital ulcers or mouthwash or ointment for oral ulcers. For skin lesions, it is recommended to offer colchicine, azathioprine, mycophenolate mofetil, or TNF inhibitor and to consider the use of apremilast, secukinumab, or dapsone.
Future Work and Revision
“One of the key things we would like to see developing is a national registry,” Dr. Moots said. This would include biobanking samples for future research and possible genomic and phenotyping studies.
More work needs to be done in conducting clinical trials in children and young people with Behçet’s disease, studies to find prognostic factors for neurological disease, and clinical trials of potential new drug approaches such as Janus kinase inhibitors. Importantly, an auditing process needs to be set up to see what effect, if any, the guidelines will actually have onpatient management.
“It’s taken 5 years to today” to develop the guidelines, Dr. Moot said. What form the process of updating them will take still has to be decided, he said in the interview. It is likely that the necessary literature searches will be performed every 6 months or so, but it will be a compromise between the ideal situation and having the staffing time to do it.
“It’s a big ask,” Dr. Moot acknowledged, adding that even if updates were only once a year, it would still be much faster than the 5- or 6-year cycle that it traditionally takes for most guidelines to be updated.
The BSR and BAD’s processes for developing guidelines are accredited by the National Institute for Health and Care Excellence in England. Dr. Moots is the chief investigator for the Secukinumab in Behçet’s trial, which is sponsored by the Liverpool University Hospitals NHS Foundation Trust via grant funding from Novartis.
A version of this article appeared on Medscape.com.
LIVERPOOL, ENGLAND — The British Society for Rheumatology (BSR) and the British Association of Dermatologists (BAD) have joined forces for the first time to develop the first British guidelines for the management of people living with Behçet’s disease.
The guidelines will also be the first “living guidelines” produced by either society, which means they will be regularly revised and updated when new evidence emerges that warrants inclusion.
With more than 90 recommendations being made, the new guidelines promise to be the most comprehensive and most up-to-date yet for what is regarded as a rare disease. Robert Moots, MBBS, PhD, provided a “sneak peek” of the guidelines at the annual meeting of the British Society for Rheumatology.
Dr. Moots, professor of rheumatology at the University of Liverpool and a consultant rheumatologist for Liverpool University Hospitals NHS Foundation Trust in England, noted that while the European Alliance of Associations for Rheumatology has produced a guideline for Behçet’s disease, this was last updated in 2018 and is not specific for the population for patients that is seen in the United Kingdom.
The British recommendations will cover all possible manifestations of Behçet’s disease and give practical advice on how to manage everything from the most common presentations such as skin lesions, mouth ulcers, and genital ulcers, as well as the potentially more serious eye, neurological, and vascular involvement.
Importance of Raising Awareness
“Joint and musculoskeletal problems are actually one of the least complained of symptoms in people with Behçet’s, and they often can’t understand why a rheumatologist is seeing them,” Dr. Moot said. “But of course, people do get joint problems, they can get enthesitis and arthralgia.”
Dr. Moots has been leading one of the three National Health Service (NHS) Centres of Excellence for Behçet’s Syndrome in England for more than a decade and told this news organization that diagnosing patients could be challenging. It can take up to 10 years from the first symptoms appearing to getting a diagnosis, so part of the job of the NHS Centres of Excellence is to raise awareness among both the healthcare profession and the general public.
“It’s a condition that people learn about at medical school. Most doctors will have come across it, but because it was thought to be really rare in the UK, nobody perhaps really expects to see it,” Dr. Moot said.
“But we all have these patients,” he added. “In Liverpool, we’re commissioned to be looking after an anticipated 150 people with Behçet’s — we’ve got 700. With more awareness, there’s more diagnoses being made, and people are being looked after better.”
Patient Perspective
Tony Thornburn, OBE, chair of the patient advocacy group Behçet’s UK, agreed in a separate interview that raising awareness of the syndrome was key to improving its management.
“Patients have said that it is a bit like having arthritis, lupus, MS [multiple sclerosis], and Crohn’s [disease] all at once,” Mr. Thorburn said. “So what we need is a guideline to ensure that people know what they’re looking at.”
Mr. Thorburn added, “Guidelines are important for raising awareness but also providing the detailed information that clinicians and GPs [general practitioners] need to have to treat a patient when they come in with this multifaceted condition.”
Multifaceted Means Multidisciplinary Management
Because there can be so many different aspects to managing someone with Behçet’s disease, a multispecialty team that was convened to develop the guidelines agreed that multidisciplinary management should be an overarching theme.
“The guideline development group consisted of all the specialties that you would need for a complex multisystem disease like Behçet’s,” Dr. Moot said. He highlighted that working alongside the consultants in adult and pediatric rheumatology were specialists in dermatology, gastroenterology, neurology, ophthalmology, obstetrics and gynecology, and psychology.
“We’re actually looking at psychological interactions and their impact for the first time,” Dr. Moot said, noting that clinicians needed to “take it seriously, and ask about it.”
Management of Manifestations
One of the general principles of the guidelines is to assess the involvement of each organ system and target treatment accordingly.
“One of the problems is that the evidence base to tell us what to do is pretty low,” Dr. Moots acknowledged. There have been few good quality randomized trials, so “treatment tends to be eminence-based rather than evidence-based.”
The recommendation wording bears this in mind, stating whether a treatment should or should not be offered, or just considered if there is no strong evidence to back up its use.
With regard to musculoskeletal manifestations, the recommendations say that colchicine should be offered, perhaps as a first-line option, or an intraarticular steroid injection in the case of monoarthritis. An intramuscular depot steroid may also be appropriate to offer, and there was good evidence to offer azathioprine or, as an alternative in refractory cases, a tumor necrosis factor (TNF) inhibitor. Nonsteroidal anti-inflammatory drugs, methotrexate, apremilast, secukinumab, and referral to a physiotherapist could only be considered, however, based on weaker levels of evidence for their use.
To treat mucocutaneous disease, the guidelines advise offering topical steroids in the form of ointment for genital ulcers or mouthwash or ointment for oral ulcers. For skin lesions, it is recommended to offer colchicine, azathioprine, mycophenolate mofetil, or TNF inhibitor and to consider the use of apremilast, secukinumab, or dapsone.
Future Work and Revision
“One of the key things we would like to see developing is a national registry,” Dr. Moots said. This would include biobanking samples for future research and possible genomic and phenotyping studies.
More work needs to be done in conducting clinical trials in children and young people with Behçet’s disease, studies to find prognostic factors for neurological disease, and clinical trials of potential new drug approaches such as Janus kinase inhibitors. Importantly, an auditing process needs to be set up to see what effect, if any, the guidelines will actually have onpatient management.
“It’s taken 5 years to today” to develop the guidelines, Dr. Moot said. What form the process of updating them will take still has to be decided, he said in the interview. It is likely that the necessary literature searches will be performed every 6 months or so, but it will be a compromise between the ideal situation and having the staffing time to do it.
“It’s a big ask,” Dr. Moot acknowledged, adding that even if updates were only once a year, it would still be much faster than the 5- or 6-year cycle that it traditionally takes for most guidelines to be updated.
The BSR and BAD’s processes for developing guidelines are accredited by the National Institute for Health and Care Excellence in England. Dr. Moots is the chief investigator for the Secukinumab in Behçet’s trial, which is sponsored by the Liverpool University Hospitals NHS Foundation Trust via grant funding from Novartis.
A version of this article appeared on Medscape.com.
FROM BSR 2024
Poor Use of ICD-10 Rheumatology Codes Suggests New Approach Needed for ICD-11 Adoption
Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.
Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.
“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”
The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.
ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.
To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.
The findings were published in a research letter in JAMA Network Open on April 18.
For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.
The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.
“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.
Moving to ICD-11 Brings Challenges as Well as Opportunities
Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.
“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.
Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.
And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.
“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored invited commentary.
This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)
This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.
Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.
The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.
But if the United States takes a different, innovative approach, the opposite could be true.
“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.
“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”
No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.
A version of this article appeared on Medscape.com.
Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.
Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.
“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”
The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.
ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.
To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.
The findings were published in a research letter in JAMA Network Open on April 18.
For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.
The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.
“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.
Moving to ICD-11 Brings Challenges as Well as Opportunities
Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.
“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.
Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.
And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.
“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored invited commentary.
This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)
This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.
Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.
The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.
But if the United States takes a different, innovative approach, the opposite could be true.
“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.
“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”
No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.
A version of this article appeared on Medscape.com.
Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.
Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.
“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”
The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.
ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.
To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.
The findings were published in a research letter in JAMA Network Open on April 18.
For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.
The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.
“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.
Moving to ICD-11 Brings Challenges as Well as Opportunities
Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.
“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.
Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.
And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.
“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored invited commentary.
This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)
This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.
Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.
The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.
But if the United States takes a different, innovative approach, the opposite could be true.
“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.
“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”
No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.
A version of this article appeared on Medscape.com.
FROM JAMA NETWORK OPEN