Tara Haelle

BALTIMORE – A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*

Isabelle Band

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose – the most common adjustment – and 20.7% needed both an increase in nifedipine and an additional medication.

The researchers observed no statistically significant differences in the proportion of patients who required a dose increase or an additional antihypertensive in the group taking the twice-daily dose (33.8%) or those receiving the once-daily dose (35.7%). This finding remained statistically insignificant after controlling for gestational diabetes, delivery mode, administration of Lasix, and receipt of emergency antihypertensive treatment (P = .71). The time that passed before patients needed a dose increase was also statistically similar between the groups: 24.3 hours in the twice-daily group and 24 hours in the once-daily group (P = .49).

There were no statistically significant differences in the need for a dose increase or an additional hypertensive agent based on race, ethnicity, body mass index, or history of preeclampsia as well. However, 24.5% of those taking the once-daily dosage had a history of preeclampsia, compared with 7.2% of those taking the twice-daily dosage (P < .001). Further, the median number of prior pregnancies was two in the twice-daily group versus three in the once-daily group (P = .002).

The authors found no significant difference between the two dosing groups in the need for emergency hypertensive treatment after reaching the study dose or in readmission for blood pressure control. In the twice-daily group, 21.6% of patients needed emergency antihypertensive treatment, compared with 14.3% in the once-daily group (P = .19). Readmission was necessary for 7.2% of the twice-daily group and 6.1% of the once-daily group (P > .99).

A subgroup analysis compared those who started nifedipine antepartum and those who started it post partum, but again, no significant difference in the dosing regimens existed.

Michael Ruma, MD, a maternal-fetal medicine specialist at Perinatal Associates of New Mexico in Albuquerque, was not involved in the study and said he welcomed the results.

“We have too many choices in medicine, so we need to just simplify the plan of attack,” reducing the number of things that clinicians need to think about, Dr. Ruma said in an interview. “A singular dose is always easiest for the patient, always easier for nursing staff, and usually, if you can optimize the dosing, that’s the best approach.”

Annabeth Brewton, MD, a resident at University of Tennessee, Knoxville, agreed, adding that new parents already have a lot going on immediately post partum.

“They’re going to be breastfeeding, they’re not sleeping, they’re going to forget to take that [second] dose,” Dr. Brewton said.

Ms. Band and Dr. Brewton had no disclosures. Dr. Ruma reported consulting and speaking for Hologic and consulting for Philips Ultrasound.

Correction, 5/24/23: An earlier version of this article misstated the daily doses of nifedipine. The study compared a single 60-mg daily dose with a 30-mg dose taken twice daily.  

BALTIMORE – A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*

Isabelle Band

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose – the most common adjustment – and 20.7% needed both an increase in nifedipine and an additional medication.

The researchers observed no statistically significant differences in the proportion of patients who required a dose increase or an additional antihypertensive in the group taking the twice-daily dose (33.8%) or those receiving the once-daily dose (35.7%). This finding remained statistically insignificant after controlling for gestational diabetes, delivery mode, administration of Lasix, and receipt of emergency antihypertensive treatment (P = .71). The time that passed before patients needed a dose increase was also statistically similar between the groups: 24.3 hours in the twice-daily group and 24 hours in the once-daily group (P = .49).

There were no statistically significant differences in the need for a dose increase or an additional hypertensive agent based on race, ethnicity, body mass index, or history of preeclampsia as well. However, 24.5% of those taking the once-daily dosage had a history of preeclampsia, compared with 7.2% of those taking the twice-daily dosage (P < .001). Further, the median number of prior pregnancies was two in the twice-daily group versus three in the once-daily group (P = .002).

The authors found no significant difference between the two dosing groups in the need for emergency hypertensive treatment after reaching the study dose or in readmission for blood pressure control. In the twice-daily group, 21.6% of patients needed emergency antihypertensive treatment, compared with 14.3% in the once-daily group (P = .19). Readmission was necessary for 7.2% of the twice-daily group and 6.1% of the once-daily group (P > .99).

A subgroup analysis compared those who started nifedipine antepartum and those who started it post partum, but again, no significant difference in the dosing regimens existed.

Michael Ruma, MD, a maternal-fetal medicine specialist at Perinatal Associates of New Mexico in Albuquerque, was not involved in the study and said he welcomed the results.

“We have too many choices in medicine, so we need to just simplify the plan of attack,” reducing the number of things that clinicians need to think about, Dr. Ruma said in an interview. “A singular dose is always easiest for the patient, always easier for nursing staff, and usually, if you can optimize the dosing, that’s the best approach.”

Annabeth Brewton, MD, a resident at University of Tennessee, Knoxville, agreed, adding that new parents already have a lot going on immediately post partum.

“They’re going to be breastfeeding, they’re not sleeping, they’re going to forget to take that [second] dose,” Dr. Brewton said.

Ms. Band and Dr. Brewton had no disclosures. Dr. Ruma reported consulting and speaking for Hologic and consulting for Philips Ultrasound.

Correction, 5/24/23: An earlier version of this article misstated the daily doses of nifedipine. The study compared a single 60-mg daily dose with a 30-mg dose taken twice daily.  

BALTIMORE – A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*

Isabelle Band

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose – the most common adjustment – and 20.7% needed both an increase in nifedipine and an additional medication.

The researchers observed no statistically significant differences in the proportion of patients who required a dose increase or an additional antihypertensive in the group taking the twice-daily dose (33.8%) or those receiving the once-daily dose (35.7%). This finding remained statistically insignificant after controlling for gestational diabetes, delivery mode, administration of Lasix, and receipt of emergency antihypertensive treatment (P = .71). The time that passed before patients needed a dose increase was also statistically similar between the groups: 24.3 hours in the twice-daily group and 24 hours in the once-daily group (P = .49).

There were no statistically significant differences in the need for a dose increase or an additional hypertensive agent based on race, ethnicity, body mass index, or history of preeclampsia as well. However, 24.5% of those taking the once-daily dosage had a history of preeclampsia, compared with 7.2% of those taking the twice-daily dosage (P < .001). Further, the median number of prior pregnancies was two in the twice-daily group versus three in the once-daily group (P = .002).

The authors found no significant difference between the two dosing groups in the need for emergency hypertensive treatment after reaching the study dose or in readmission for blood pressure control. In the twice-daily group, 21.6% of patients needed emergency antihypertensive treatment, compared with 14.3% in the once-daily group (P = .19). Readmission was necessary for 7.2% of the twice-daily group and 6.1% of the once-daily group (P > .99).

A subgroup analysis compared those who started nifedipine antepartum and those who started it post partum, but again, no significant difference in the dosing regimens existed.

Michael Ruma, MD, a maternal-fetal medicine specialist at Perinatal Associates of New Mexico in Albuquerque, was not involved in the study and said he welcomed the results.

“We have too many choices in medicine, so we need to just simplify the plan of attack,” reducing the number of things that clinicians need to think about, Dr. Ruma said in an interview. “A singular dose is always easiest for the patient, always easier for nursing staff, and usually, if you can optimize the dosing, that’s the best approach.”

Annabeth Brewton, MD, a resident at University of Tennessee, Knoxville, agreed, adding that new parents already have a lot going on immediately post partum.

“They’re going to be breastfeeding, they’re not sleeping, they’re going to forget to take that [second] dose,” Dr. Brewton said.

Ms. Band and Dr. Brewton had no disclosures. Dr. Ruma reported consulting and speaking for Hologic and consulting for Philips Ultrasound.

Correction, 5/24/23: An earlier version of this article misstated the daily doses of nifedipine. The study compared a single 60-mg daily dose with a 30-mg dose taken twice daily.  

BALTIMORE – Less than half of the pregnant patients who met the criteria for thyroid screening were actually screened by their clinician, according to a retrospective cohort study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists in Baltimore. Those who met criteria and did receive screening had higher live birth rates and lower miscarriage rates than those who met the criteria but did not undergo screening, the study found.

“These results suggest that improving thyroid screening adherence may lead to improved pregnancy outcomes,” lead author Allan Dong, MD, of Advocate Lutheran General Hospital in Des Plaines, Ill., told attendees. “However, following targeted screening guidelines can be difficult for clinicians. In practice, universal screening for diabetes and pregnancy may provide more comprehensive screening coverage and potentially lead to improved outcomes.”

Instead of universal screening for thyroid disease, ACOG and the American Thyroid Association recommend targeted screening of high-risk patients, though ATA’s criteria are substantially broader than ACOG’s. But, Dr. Dong told attendees, “guidelines are only beneficial if they are followed appropriately,” and Ob.Gyns. have limited time to screen for risk factors in the midst of other clinical priorities. So he aimed to learn whether Ob.Gyns. were following the guidelines of either organization in screening people at higher risk for thyroid disease.

Dr. Dong and his coauthor, Melisa Lott, DO, reviewed the charts of all 1,025 patients who presented at their institution for new obstetrical visits in 2020 to determine which ones had risk factors that would qualify them for screening under ATA or ACOG guidelines. ACOG’s screening criteria included having a personal or family history of thyroid disease or type 1 diabetes, or there being clinical suspicion for thyroid disease. ATA’s screening criteria included the following:

• Personal or family history of thyroid disease.
• History of head or neck radiation.
• History of a prior thyroid surgery.
• Over age 30.
• Any autoimmune disease.
• A body mass index greater than 40 kg/m².
• History of pregnancy loss, preterm delivery, or infertility.
• Recently used amiodarone lithium or iodine-based contrast.
• Lived in an area of known iodine deficiency.
• Clinical suspicion of thyroid disease.

ATA screening criteria identified four times as many patients requiring screening than did ACOG criteria, Dr. Dong noted. Of the 198 patients who met ACOG’s criteria, 43.9% were screened with thyroid function testing. Meanwhile, 826 patients – including all those who met ACOG’s criteria – met ATA’s criteria for screening, but only 13.1% of them underwent thyroid function testing.

Live birth rates were significantly higher among patients who met ATA criteria and were screened (92.6%) than among patients who met ATA criteria but were not screened (83.3%, P = .006). Similarly, the miscarriage rate was 4.6% in patients who met ATA criteria and were screened, compared to 12.4% in patients who met the criteria but did not undergo thyroid function testing (P = .009).

“A similar difference, although not statistically significant, was noted when comparing patients who were screened appropriately per ACOG criteria with those who met criteria for screening but were not screened,” Dr. Dong told attendees. “However, our study was underpowered to detect this difference due to the lower number of patients who meet criteria for screening under ACOG guidelines.”

The researchers did not find any significant difference in preterm delivery rates.

Anna Whelan, MD, of Women & Infants Hospital of Brown University, Providence, R.I., was not involved in the study but viewed the poster and pointed out that many of the patients, if seen by a primary care provider prior to pregnancy, would likely have been screened by their PCP. The rate of underscreening therefore suggests that patients “are not getting good, consistent primary care because there’s a lack of primary care physicians,” Dr. Whelan said in an interview.

In addition, she added, “maybe not all obstetricians and those providing care, such as midwives and other providers, are aware of the [ATA] guidelines on who should be screened.” She added that additional education about thyroid screening guidelines might be helpful for providers.

Dr. Dong reported being a stock shareholder in 3M, AbbVie, General Electric, Johnson & Johnson, Medtronic, Pfizer, and Viking Therapeutics. Dr. Whelan had no disclosures.
 

BALTIMORE – Less than half of the pregnant patients who met the criteria for thyroid screening were actually screened by their clinician, according to a retrospective cohort study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists in Baltimore. Those who met criteria and did receive screening had higher live birth rates and lower miscarriage rates than those who met the criteria but did not undergo screening, the study found.

“These results suggest that improving thyroid screening adherence may lead to improved pregnancy outcomes,” lead author Allan Dong, MD, of Advocate Lutheran General Hospital in Des Plaines, Ill., told attendees. “However, following targeted screening guidelines can be difficult for clinicians. In practice, universal screening for diabetes and pregnancy may provide more comprehensive screening coverage and potentially lead to improved outcomes.”

Instead of universal screening for thyroid disease, ACOG and the American Thyroid Association recommend targeted screening of high-risk patients, though ATA’s criteria are substantially broader than ACOG’s. But, Dr. Dong told attendees, “guidelines are only beneficial if they are followed appropriately,” and Ob.Gyns. have limited time to screen for risk factors in the midst of other clinical priorities. So he aimed to learn whether Ob.Gyns. were following the guidelines of either organization in screening people at higher risk for thyroid disease.

Dr. Dong and his coauthor, Melisa Lott, DO, reviewed the charts of all 1,025 patients who presented at their institution for new obstetrical visits in 2020 to determine which ones had risk factors that would qualify them for screening under ATA or ACOG guidelines. ACOG’s screening criteria included having a personal or family history of thyroid disease or type 1 diabetes, or there being clinical suspicion for thyroid disease. ATA’s screening criteria included the following:

• Personal or family history of thyroid disease.
• History of head or neck radiation.
• History of a prior thyroid surgery.
• Over age 30.
• Any autoimmune disease.
• A body mass index greater than 40 kg/m².
• History of pregnancy loss, preterm delivery, or infertility.
• Recently used amiodarone lithium or iodine-based contrast.
• Lived in an area of known iodine deficiency.
• Clinical suspicion of thyroid disease.

ATA screening criteria identified four times as many patients requiring screening than did ACOG criteria, Dr. Dong noted. Of the 198 patients who met ACOG’s criteria, 43.9% were screened with thyroid function testing. Meanwhile, 826 patients – including all those who met ACOG’s criteria – met ATA’s criteria for screening, but only 13.1% of them underwent thyroid function testing.

Live birth rates were significantly higher among patients who met ATA criteria and were screened (92.6%) than among patients who met ATA criteria but were not screened (83.3%, P = .006). Similarly, the miscarriage rate was 4.6% in patients who met ATA criteria and were screened, compared to 12.4% in patients who met the criteria but did not undergo thyroid function testing (P = .009).

“A similar difference, although not statistically significant, was noted when comparing patients who were screened appropriately per ACOG criteria with those who met criteria for screening but were not screened,” Dr. Dong told attendees. “However, our study was underpowered to detect this difference due to the lower number of patients who meet criteria for screening under ACOG guidelines.”

The researchers did not find any significant difference in preterm delivery rates.

Anna Whelan, MD, of Women & Infants Hospital of Brown University, Providence, R.I., was not involved in the study but viewed the poster and pointed out that many of the patients, if seen by a primary care provider prior to pregnancy, would likely have been screened by their PCP. The rate of underscreening therefore suggests that patients “are not getting good, consistent primary care because there’s a lack of primary care physicians,” Dr. Whelan said in an interview.

In addition, she added, “maybe not all obstetricians and those providing care, such as midwives and other providers, are aware of the [ATA] guidelines on who should be screened.” She added that additional education about thyroid screening guidelines might be helpful for providers.

Dr. Dong reported being a stock shareholder in 3M, AbbVie, General Electric, Johnson & Johnson, Medtronic, Pfizer, and Viking Therapeutics. Dr. Whelan had no disclosures.
 

BALTIMORE – Less than half of the pregnant patients who met the criteria for thyroid screening were actually screened by their clinician, according to a retrospective cohort study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists in Baltimore. Those who met criteria and did receive screening had higher live birth rates and lower miscarriage rates than those who met the criteria but did not undergo screening, the study found.

“These results suggest that improving thyroid screening adherence may lead to improved pregnancy outcomes,” lead author Allan Dong, MD, of Advocate Lutheran General Hospital in Des Plaines, Ill., told attendees. “However, following targeted screening guidelines can be difficult for clinicians. In practice, universal screening for diabetes and pregnancy may provide more comprehensive screening coverage and potentially lead to improved outcomes.”

Instead of universal screening for thyroid disease, ACOG and the American Thyroid Association recommend targeted screening of high-risk patients, though ATA’s criteria are substantially broader than ACOG’s. But, Dr. Dong told attendees, “guidelines are only beneficial if they are followed appropriately,” and Ob.Gyns. have limited time to screen for risk factors in the midst of other clinical priorities. So he aimed to learn whether Ob.Gyns. were following the guidelines of either organization in screening people at higher risk for thyroid disease.

Dr. Dong and his coauthor, Melisa Lott, DO, reviewed the charts of all 1,025 patients who presented at their institution for new obstetrical visits in 2020 to determine which ones had risk factors that would qualify them for screening under ATA or ACOG guidelines. ACOG’s screening criteria included having a personal or family history of thyroid disease or type 1 diabetes, or there being clinical suspicion for thyroid disease. ATA’s screening criteria included the following:

• Personal or family history of thyroid disease.
• History of head or neck radiation.
• History of a prior thyroid surgery.
• Over age 30.
• Any autoimmune disease.
• A body mass index greater than 40 kg/m².
• History of pregnancy loss, preterm delivery, or infertility.
• Recently used amiodarone lithium or iodine-based contrast.
• Lived in an area of known iodine deficiency.
• Clinical suspicion of thyroid disease.

ATA screening criteria identified four times as many patients requiring screening than did ACOG criteria, Dr. Dong noted. Of the 198 patients who met ACOG’s criteria, 43.9% were screened with thyroid function testing. Meanwhile, 826 patients – including all those who met ACOG’s criteria – met ATA’s criteria for screening, but only 13.1% of them underwent thyroid function testing.

Live birth rates were significantly higher among patients who met ATA criteria and were screened (92.6%) than among patients who met ATA criteria but were not screened (83.3%, P = .006). Similarly, the miscarriage rate was 4.6% in patients who met ATA criteria and were screened, compared to 12.4% in patients who met the criteria but did not undergo thyroid function testing (P = .009).

“A similar difference, although not statistically significant, was noted when comparing patients who were screened appropriately per ACOG criteria with those who met criteria for screening but were not screened,” Dr. Dong told attendees. “However, our study was underpowered to detect this difference due to the lower number of patients who meet criteria for screening under ACOG guidelines.”

The researchers did not find any significant difference in preterm delivery rates.

Anna Whelan, MD, of Women & Infants Hospital of Brown University, Providence, R.I., was not involved in the study but viewed the poster and pointed out that many of the patients, if seen by a primary care provider prior to pregnancy, would likely have been screened by their PCP. The rate of underscreening therefore suggests that patients “are not getting good, consistent primary care because there’s a lack of primary care physicians,” Dr. Whelan said in an interview.

In addition, she added, “maybe not all obstetricians and those providing care, such as midwives and other providers, are aware of the [ATA] guidelines on who should be screened.” She added that additional education about thyroid screening guidelines might be helpful for providers.

Dr. Dong reported being a stock shareholder in 3M, AbbVie, General Electric, Johnson & Johnson, Medtronic, Pfizer, and Viking Therapeutics. Dr. Whelan had no disclosures.
 

Researchers have developed an artificial intelligence (AI) machine-learning platform that can predict the prognosis and likely treatment response of patients with colorectal cancer (CRC) using histopathology images, according to a new study published in Nature Communications.
 

Specifically, the tool can aid doctors in identifying a “molecular diagnosis” based on a patient’s tumor and cancer characteristics, Kun-Hsing Yu, MD, PhD, the study’s senior author and an assistant professor of biomedical informatics at Harvard Medical School, Boston, said in an interview.

The Multi-omics Multi-cohort Assessment (MOMA) “successfully identified indicators of how aggressive a tumor was and how likely it was to behave in response to a particular treatment,” as well as patients’ overall and disease-free survival, noted Harvard Medical School in a press release. “Based on an image alone, the model also pinpointed characteristics associated with the presence or absence of specific genetic mutations – something that typically requires genomic sequencing of the tumor.”

The researchers designed the tool to offer “transparent reasoning,” so that if a clinician asks it why it made a certain prediction, it would be able to explain its reasoning and the variables it used, the press release noted.

“We first allow AI to explore any correlation, and then we try to explain those correlations using existing pathology terms that experts will be able to understand,” Dr. Yu said in an interview.

Although the tool is freely available to clinicians and researchers, it’s not yet ready for clinical use. When it is, the tool has the potential to provide timely, accurate decision support based on tumor imaging.

Colorectal cancer is the second most common cause of death from cancer in the United States, with more than 53,000 deaths each year, and the patient population has been gradually skewing younger over the past 2 decades.

Although clinicians already use histopathology and genetic analysis to guide treatment, the process can take several days or weeks in some areas, and these services may not be available in all parts of the world.

“Currently, a clinician has to send a [tissue] sample from the tumor specimen to genomic sequencing labs and wait for a week, sometimes up to 3 or more weeks, to get genomic sequencing results,” Dr. Yu said. That means a patient’s anxiety grows as they wait to find out which treatments might benefit them or how they might respond to a particular treatment.

Additionally, current knowledge for predicting patient survival, beyond considering the patient’s cancer stage, age, and general health status, is limited, Dr. Yu said.
 

Predictive ability

The MOMA platform was trained on information from 1,888 patients with colorectal cancer from three national cohorts: 628 patients from The Cancer Genome Atlas (TCGA) program, 927 patients from the Nurses’ Health Study with Health Professionals Follow-Up Study (NHS-HPFS), and 333 patients from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

During the training, they fed the model information about the patients’ age, sex, cancer stage, and outcomes, as well as their tumors’ “multi-omic” information: the cancers’ genomic, epigenetic, protein, and metabolic profiles. Researchers showed the AI model digital, whole-slide histopathology images of tumor samples and asked it to look for visual markers related to tumor types, genetic mutations, epigenetic alterations, disease progression, and patient survival with the goal of enabling the platform to detect patterns that are indiscernible to the human eye.

They then tested the MOMA platform’s ability to interpret images by feeding it new tumor sample images from different patients and asking it to predict their survival and progression-free survival.

The researchers found that the tool successfully identified overall survival outcomes in patients with stage I or II cancer in the TCGA cohort, which they further validated with the NHS-HPFS and PLCO cohorts. The platform revealed that “dense clusters of adenocarcinoma cells are highly indicative of worse overall survival outcomes” and that the interaction of cancer cells with smooth muscle cells in cancerous areas predicted poorer overall survival.

MOMA was slightly more effective in predicting progression-free survival for stage I and stage II colorectal cancer across all three cohorts.

“Compared with the overall survival prediction, our progression-free survival model puts more emphasis on infiltrating lymphocytes and regions associated with extracellular mucin in its prediction,” the authors noted.

Prediction of overall survival and progression-free survival for stage III colorectal cancer showed similar levels of accuracy, they noted.

The tool also successfully assessed patients’ likely response to immunotherapy using predictions of microsatellite instability, since high MSI indicates a better response to immune checkpoint inhibitors.

MOMA outperformed a different machine-learning algorithm in predicting the copy number alterations and other features related to cancer development, and it predicted the likelihood of a BRAF mutation, which is linked to poorer prognosis.
 

Pushing the envelope?

MOMA presents an “intriguing new avenue of adding to how we think about and assess someone who has cancer,” Stacey Cohen, MD, an associate professor in the clinical research division of Fred Hutchinson Cancer Center at the University of Washington Medicine, Seattle, said in an interview.

However, the tool as it’s currently described appears primarily to duplicate what clinicians already are doing, which is considering a wide range of factors – including pathologic features, patient features and demographics, and the patient’s other medical illnesses – to develop a treatment plan within the context of current guidelines, noted Dr. Cohen, who was not involved in the project.

“I’m looking for these types of models to not just prognosticate an outcome but to really predict how someone should be treated, and to do that better than [using] standard clinical features,” Dr. Cohen said. “To some degree, they’re taking this AI model and trying to catch up to what we’re currently doing. Clearly, if they could do that, they can then push the envelope.”

Dr. Cohen acknowledged that a strength of using an AI platform is the speed at which it can provide its predictions in areas with few medical resources and few health care professionals – as long as the necessary imaging is available and physicians have a way to use the platform.

“On the one hand, I do see this as an opportunity to share the wealth of knowledge in a more rapid fashion, but I don’t think anybody is going to let a computer program dictate their treatment without a human medical oncologist being able to interpret that information,” Dr. Cohen said. “It still will require a lot of education by the users and not just by the people who are designing the study.”

Although the MOMA platform looked at multiple pathologic features in multiple cohorts, the results remain limited by the fact that the patients in those cohorts were treated decades ago, before many current treatments may have been available, Dr. Cohen said.

She also added that the cohorts did not have much ethnic diversity. In the NHS-HPFS, the largest cohort, 57% of the patients were White, and researchers lacked data on race for 42% of patients, so only about 1% of participants were of a known non-White race. Similarly, 47% of the TCGA patients were White and 41% had no data on race, leaving only 12% of patients from known, non-White racial backgrounds, including 10% Black or African American.

Additional studies that focus on specific patient populations are needed to evaluate the model’s applicability in clinical settings, the investigators note. More research is required to “identify the optimal prognostic prediction methods and enable personalized treatments and advance care planning,” they added.

These are the early days for this type of technology, Dr. Cohen noted.

“I’m very excited to see how this technology develops and how it could be potentially additive or improve upon our current treatment planning for patients,” she said.

Dr. Yu developed the invention “Quantitative Pathology Analysis and Diagnosis using Neural Networks,” whose patent is held by Harvard University, and has consulted for Curatio. One coauthor is a stakeholder and employee of Vertex Pharmaceuticals. The study’s funding sources included the National Institute of General Medical Sciences, the Google Research Scholar Award, the Blavatnik Center for Computational Biomedicine Award, the National Science and Technology Council Taiwan, and the National Center for High-performance Computing Taiwan. Dr. Cohen has advised or consulted for Natera.

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

Researchers have developed an artificial intelligence (AI) machine-learning platform that can predict the prognosis and likely treatment response of patients with colorectal cancer (CRC) using histopathology images, according to a new study published in Nature Communications.
 

Specifically, the tool can aid doctors in identifying a “molecular diagnosis” based on a patient’s tumor and cancer characteristics, Kun-Hsing Yu, MD, PhD, the study’s senior author and an assistant professor of biomedical informatics at Harvard Medical School, Boston, said in an interview.

The Multi-omics Multi-cohort Assessment (MOMA) “successfully identified indicators of how aggressive a tumor was and how likely it was to behave in response to a particular treatment,” as well as patients’ overall and disease-free survival, noted Harvard Medical School in a press release. “Based on an image alone, the model also pinpointed characteristics associated with the presence or absence of specific genetic mutations – something that typically requires genomic sequencing of the tumor.”

The researchers designed the tool to offer “transparent reasoning,” so that if a clinician asks it why it made a certain prediction, it would be able to explain its reasoning and the variables it used, the press release noted.

“We first allow AI to explore any correlation, and then we try to explain those correlations using existing pathology terms that experts will be able to understand,” Dr. Yu said in an interview.

Although the tool is freely available to clinicians and researchers, it’s not yet ready for clinical use. When it is, the tool has the potential to provide timely, accurate decision support based on tumor imaging.

Colorectal cancer is the second most common cause of death from cancer in the United States, with more than 53,000 deaths each year, and the patient population has been gradually skewing younger over the past 2 decades.

Although clinicians already use histopathology and genetic analysis to guide treatment, the process can take several days or weeks in some areas, and these services may not be available in all parts of the world.

“Currently, a clinician has to send a [tissue] sample from the tumor specimen to genomic sequencing labs and wait for a week, sometimes up to 3 or more weeks, to get genomic sequencing results,” Dr. Yu said. That means a patient’s anxiety grows as they wait to find out which treatments might benefit them or how they might respond to a particular treatment.

Additionally, current knowledge for predicting patient survival, beyond considering the patient’s cancer stage, age, and general health status, is limited, Dr. Yu said.
 

Predictive ability

The MOMA platform was trained on information from 1,888 patients with colorectal cancer from three national cohorts: 628 patients from The Cancer Genome Atlas (TCGA) program, 927 patients from the Nurses’ Health Study with Health Professionals Follow-Up Study (NHS-HPFS), and 333 patients from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

During the training, they fed the model information about the patients’ age, sex, cancer stage, and outcomes, as well as their tumors’ “multi-omic” information: the cancers’ genomic, epigenetic, protein, and metabolic profiles. Researchers showed the AI model digital, whole-slide histopathology images of tumor samples and asked it to look for visual markers related to tumor types, genetic mutations, epigenetic alterations, disease progression, and patient survival with the goal of enabling the platform to detect patterns that are indiscernible to the human eye.

They then tested the MOMA platform’s ability to interpret images by feeding it new tumor sample images from different patients and asking it to predict their survival and progression-free survival.

The researchers found that the tool successfully identified overall survival outcomes in patients with stage I or II cancer in the TCGA cohort, which they further validated with the NHS-HPFS and PLCO cohorts. The platform revealed that “dense clusters of adenocarcinoma cells are highly indicative of worse overall survival outcomes” and that the interaction of cancer cells with smooth muscle cells in cancerous areas predicted poorer overall survival.

MOMA was slightly more effective in predicting progression-free survival for stage I and stage II colorectal cancer across all three cohorts.

“Compared with the overall survival prediction, our progression-free survival model puts more emphasis on infiltrating lymphocytes and regions associated with extracellular mucin in its prediction,” the authors noted.

Prediction of overall survival and progression-free survival for stage III colorectal cancer showed similar levels of accuracy, they noted.

The tool also successfully assessed patients’ likely response to immunotherapy using predictions of microsatellite instability, since high MSI indicates a better response to immune checkpoint inhibitors.

MOMA outperformed a different machine-learning algorithm in predicting the copy number alterations and other features related to cancer development, and it predicted the likelihood of a BRAF mutation, which is linked to poorer prognosis.
 

Pushing the envelope?

MOMA presents an “intriguing new avenue of adding to how we think about and assess someone who has cancer,” Stacey Cohen, MD, an associate professor in the clinical research division of Fred Hutchinson Cancer Center at the University of Washington Medicine, Seattle, said in an interview.

However, the tool as it’s currently described appears primarily to duplicate what clinicians already are doing, which is considering a wide range of factors – including pathologic features, patient features and demographics, and the patient’s other medical illnesses – to develop a treatment plan within the context of current guidelines, noted Dr. Cohen, who was not involved in the project.

“I’m looking for these types of models to not just prognosticate an outcome but to really predict how someone should be treated, and to do that better than [using] standard clinical features,” Dr. Cohen said. “To some degree, they’re taking this AI model and trying to catch up to what we’re currently doing. Clearly, if they could do that, they can then push the envelope.”

Dr. Cohen acknowledged that a strength of using an AI platform is the speed at which it can provide its predictions in areas with few medical resources and few health care professionals – as long as the necessary imaging is available and physicians have a way to use the platform.

“On the one hand, I do see this as an opportunity to share the wealth of knowledge in a more rapid fashion, but I don’t think anybody is going to let a computer program dictate their treatment without a human medical oncologist being able to interpret that information,” Dr. Cohen said. “It still will require a lot of education by the users and not just by the people who are designing the study.”

Although the MOMA platform looked at multiple pathologic features in multiple cohorts, the results remain limited by the fact that the patients in those cohorts were treated decades ago, before many current treatments may have been available, Dr. Cohen said.

She also added that the cohorts did not have much ethnic diversity. In the NHS-HPFS, the largest cohort, 57% of the patients were White, and researchers lacked data on race for 42% of patients, so only about 1% of participants were of a known non-White race. Similarly, 47% of the TCGA patients were White and 41% had no data on race, leaving only 12% of patients from known, non-White racial backgrounds, including 10% Black or African American.

Additional studies that focus on specific patient populations are needed to evaluate the model’s applicability in clinical settings, the investigators note. More research is required to “identify the optimal prognostic prediction methods and enable personalized treatments and advance care planning,” they added.

These are the early days for this type of technology, Dr. Cohen noted.

“I’m very excited to see how this technology develops and how it could be potentially additive or improve upon our current treatment planning for patients,” she said.

Dr. Yu developed the invention “Quantitative Pathology Analysis and Diagnosis using Neural Networks,” whose patent is held by Harvard University, and has consulted for Curatio. One coauthor is a stakeholder and employee of Vertex Pharmaceuticals. The study’s funding sources included the National Institute of General Medical Sciences, the Google Research Scholar Award, the Blavatnik Center for Computational Biomedicine Award, the National Science and Technology Council Taiwan, and the National Center for High-performance Computing Taiwan. Dr. Cohen has advised or consulted for Natera.

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

Researchers have developed an artificial intelligence (AI) machine-learning platform that can predict the prognosis and likely treatment response of patients with colorectal cancer (CRC) using histopathology images, according to a new study published in Nature Communications.
 

Specifically, the tool can aid doctors in identifying a “molecular diagnosis” based on a patient’s tumor and cancer characteristics, Kun-Hsing Yu, MD, PhD, the study’s senior author and an assistant professor of biomedical informatics at Harvard Medical School, Boston, said in an interview.

The Multi-omics Multi-cohort Assessment (MOMA) “successfully identified indicators of how aggressive a tumor was and how likely it was to behave in response to a particular treatment,” as well as patients’ overall and disease-free survival, noted Harvard Medical School in a press release. “Based on an image alone, the model also pinpointed characteristics associated with the presence or absence of specific genetic mutations – something that typically requires genomic sequencing of the tumor.”

The researchers designed the tool to offer “transparent reasoning,” so that if a clinician asks it why it made a certain prediction, it would be able to explain its reasoning and the variables it used, the press release noted.

“We first allow AI to explore any correlation, and then we try to explain those correlations using existing pathology terms that experts will be able to understand,” Dr. Yu said in an interview.

Although the tool is freely available to clinicians and researchers, it’s not yet ready for clinical use. When it is, the tool has the potential to provide timely, accurate decision support based on tumor imaging.

Colorectal cancer is the second most common cause of death from cancer in the United States, with more than 53,000 deaths each year, and the patient population has been gradually skewing younger over the past 2 decades.

Although clinicians already use histopathology and genetic analysis to guide treatment, the process can take several days or weeks in some areas, and these services may not be available in all parts of the world.

“Currently, a clinician has to send a [tissue] sample from the tumor specimen to genomic sequencing labs and wait for a week, sometimes up to 3 or more weeks, to get genomic sequencing results,” Dr. Yu said. That means a patient’s anxiety grows as they wait to find out which treatments might benefit them or how they might respond to a particular treatment.

Additionally, current knowledge for predicting patient survival, beyond considering the patient’s cancer stage, age, and general health status, is limited, Dr. Yu said.
 

Predictive ability

The MOMA platform was trained on information from 1,888 patients with colorectal cancer from three national cohorts: 628 patients from The Cancer Genome Atlas (TCGA) program, 927 patients from the Nurses’ Health Study with Health Professionals Follow-Up Study (NHS-HPFS), and 333 patients from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

During the training, they fed the model information about the patients’ age, sex, cancer stage, and outcomes, as well as their tumors’ “multi-omic” information: the cancers’ genomic, epigenetic, protein, and metabolic profiles. Researchers showed the AI model digital, whole-slide histopathology images of tumor samples and asked it to look for visual markers related to tumor types, genetic mutations, epigenetic alterations, disease progression, and patient survival with the goal of enabling the platform to detect patterns that are indiscernible to the human eye.

They then tested the MOMA platform’s ability to interpret images by feeding it new tumor sample images from different patients and asking it to predict their survival and progression-free survival.

The researchers found that the tool successfully identified overall survival outcomes in patients with stage I or II cancer in the TCGA cohort, which they further validated with the NHS-HPFS and PLCO cohorts. The platform revealed that “dense clusters of adenocarcinoma cells are highly indicative of worse overall survival outcomes” and that the interaction of cancer cells with smooth muscle cells in cancerous areas predicted poorer overall survival.

MOMA was slightly more effective in predicting progression-free survival for stage I and stage II colorectal cancer across all three cohorts.

“Compared with the overall survival prediction, our progression-free survival model puts more emphasis on infiltrating lymphocytes and regions associated with extracellular mucin in its prediction,” the authors noted.

Prediction of overall survival and progression-free survival for stage III colorectal cancer showed similar levels of accuracy, they noted.

The tool also successfully assessed patients’ likely response to immunotherapy using predictions of microsatellite instability, since high MSI indicates a better response to immune checkpoint inhibitors.

MOMA outperformed a different machine-learning algorithm in predicting the copy number alterations and other features related to cancer development, and it predicted the likelihood of a BRAF mutation, which is linked to poorer prognosis.
 

Pushing the envelope?

MOMA presents an “intriguing new avenue of adding to how we think about and assess someone who has cancer,” Stacey Cohen, MD, an associate professor in the clinical research division of Fred Hutchinson Cancer Center at the University of Washington Medicine, Seattle, said in an interview.

However, the tool as it’s currently described appears primarily to duplicate what clinicians already are doing, which is considering a wide range of factors – including pathologic features, patient features and demographics, and the patient’s other medical illnesses – to develop a treatment plan within the context of current guidelines, noted Dr. Cohen, who was not involved in the project.

“I’m looking for these types of models to not just prognosticate an outcome but to really predict how someone should be treated, and to do that better than [using] standard clinical features,” Dr. Cohen said. “To some degree, they’re taking this AI model and trying to catch up to what we’re currently doing. Clearly, if they could do that, they can then push the envelope.”

Dr. Cohen acknowledged that a strength of using an AI platform is the speed at which it can provide its predictions in areas with few medical resources and few health care professionals – as long as the necessary imaging is available and physicians have a way to use the platform.

“On the one hand, I do see this as an opportunity to share the wealth of knowledge in a more rapid fashion, but I don’t think anybody is going to let a computer program dictate their treatment without a human medical oncologist being able to interpret that information,” Dr. Cohen said. “It still will require a lot of education by the users and not just by the people who are designing the study.”

Although the MOMA platform looked at multiple pathologic features in multiple cohorts, the results remain limited by the fact that the patients in those cohorts were treated decades ago, before many current treatments may have been available, Dr. Cohen said.

She also added that the cohorts did not have much ethnic diversity. In the NHS-HPFS, the largest cohort, 57% of the patients were White, and researchers lacked data on race for 42% of patients, so only about 1% of participants were of a known non-White race. Similarly, 47% of the TCGA patients were White and 41% had no data on race, leaving only 12% of patients from known, non-White racial backgrounds, including 10% Black or African American.

Additional studies that focus on specific patient populations are needed to evaluate the model’s applicability in clinical settings, the investigators note. More research is required to “identify the optimal prognostic prediction methods and enable personalized treatments and advance care planning,” they added.

These are the early days for this type of technology, Dr. Cohen noted.

“I’m very excited to see how this technology develops and how it could be potentially additive or improve upon our current treatment planning for patients,” she said.

Dr. Yu developed the invention “Quantitative Pathology Analysis and Diagnosis using Neural Networks,” whose patent is held by Harvard University, and has consulted for Curatio. One coauthor is a stakeholder and employee of Vertex Pharmaceuticals. The study’s funding sources included the National Institute of General Medical Sciences, the Google Research Scholar Award, the Blavatnik Center for Computational Biomedicine Award, the National Science and Technology Council Taiwan, and the National Center for High-performance Computing Taiwan. Dr. Cohen has advised or consulted for Natera.

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

Patients taking metformin for type 2 diabetes had a lower risk of developing osteoarthritis than did patients taking a sulfonylurea, according to a cohort study published in JAMA Network Open. The findings jibe with those seen in a 2022 systematic review of preclinical and observational human studies finding potentially protective effects of metformin on osteoarthritis.

“Our study provides further, robust epidemiological evidence that metformin may be associated with protection in the development and progression of osteoarthritis in individuals with type 2 diabetes,” wrote Matthew C. Baker, MD, MS, an assistant professor of medicine in immunology and rheumatology at Stanford (Calif.) University, and his colleagues.

Thinglass/iStock Editorial/Getty Images

The findings also fit with the results of a poster presented at the Osteoarthritis Research Society International 2023 World Congress, although that abstract’s findings did not reach statistical significance.

In the published study, the researchers analyzed deidentified claims data from Optum’s Clinformatics Data Mart Database between December 2003 and December 2019. The database includes more than 15 million people with private insurance or Medicare Advantage Part D but does not include people with Medicaid, thereby excluding people from lower socioeconomic groups.

The researchers included all patients who were at least 40 years old, had type 2 diabetes, were taking metformin, and had been enrolled in the database for at least 1 uninterrupted year. They excluded anyone with type 1 diabetes or a prior diagnosis of osteoarthritis, inflammatory arthritis, or joint replacement. The authors then compared the incidence of osteoarthritis and joint replacement in these 20,937 participants to 20,937 control participants who were taking a sulfonylurea, matched to those taking metformin on the basis of age, sex, race, a comorbidity score, and duration of treatment. More than half the overall population (58%) was male with an average age of 62.

Patients needed to be on either drug for at least 3 months, but those who were initially treated with metformin before later taking a sulfonylurea could also be included and contribute to both groups. Those who first took a sulfonylurea and later switched to metformin were included only for the sulfonylurea group and censored after their switch to ensure the sulfonylurea group had enough participants. The comparison was further adjusted for age, sex, race, ethnicity, geographic region, education, comorbidities, and outpatient visit frequency.

The results revealed that those who were taking metformin were 24% less likely to develop osteoarthritis at least 3 months after starting the medication than were those taking a sulfonylurea (P < .001). The rate of joint replacements was not significantly different between those taking metformin and those taking a sulfonylurea. These two results did not change in a sensitivity analysis that compared patients who only ever took metformin or a sulfonylurea (as opposed to those who took one drug before switching to the other).

“When stratified by prior exposure to metformin within the sulfonylurea group, the observed benefit associated with metformin ... was attenuated in the people treated with a sulfonylurea with prior exposure to metformin, compared with those treated with a sulfonylurea with no prior exposure to metformin,” the authors further reported. A possible reason for this finding is that those taking a sulfonylurea after having previously taken metformin gained some protection from the earlier metformin exposure, the authors hypothesized.

This observational study could not show a causative effect from the metformin, but the researchers speculated on potential mechanisms if a causative effect were present, based on past research.

”Several preclinical studies have suggested a protective association of metformin in osteoarthritis through activating AMP-activated protein kinase signaling, decreasing the level of matrix metalloproteinase, increasing autophagy and reducing chondrocyte apoptosis, and augmenting chondroprotective and anti-inflammatory properties of mesenchymal stem cells,” the authors wrote.

Among this study’s limitations, however, was the lack of data on body mass index, which is associated with osteoarthritis in the literature and may differ between patients taking metformin versus a sulfonylurea. The researchers also did not have data on physical activity or a history of trauma to the joints, though there’s no reason to think these rates might differ between those taking one or the other medication.

Another substantial limitation is that all patients had type 2 diabetes, making it impossible to determine whether a similar protective effect from metformin might exist in people without diabetes.

Nonsignificant lower risk for posttraumatic knee osteoarthritis

Similar to the published study, the OARSI poster compared 5-year odds of incident osteoarthritis or total knee replacement surgery between patients taking metformin and those taking sulfonylureas, but it focused on younger patients, aged 18-40 years, who underwent anterior cruciate ligament or meniscus surgery.

Using data from MarketScan commercial insurance claims databases between 2006 and 2020, the authors identified 2,376 participants who were taking metformin or a sulfonylurea when they underwent their surgery or began taking it in the 6 months after their surgery. More than half the participants were female (57%) with an average age of 35.

Within 5 years, 10.8% of those taking metformin developed osteoarthritis, compared with 17.9% of those taking a sulfonylurea. In addition, 3% of those taking metformin underwent a total knee replacement, compared with 5.3% of those taking a sulfonylurea. After adjustment for age, sex, obesity, and a history of chronic kidney disease, liver disease, and depression, however, both risk difference and odds ratios were not statistically significant.

Risk of osteoarthritis was 17% lower in patients taking metformin (95% confidence interval, –0.18 to 0.09), whose odds of osteoarthritis were approximately half the odds of those taking a sulfonylurea (OR, 0.5; 95% CI, 0.21-1.67). Risk of a total knee replacement was 10% lower in metformin users (95% CI, –0.28 to 0.08) with a similar reduction in odds, compared with those taking a sulfonylurea (OR, 0.53; 95% CI, 0.2-1.44).

In this study, the researchers did not specifically determine whether the participants were diagnosed with diabetes, but they assumed all, or at least most, were, according to S. Reza Jafarzadeh, PhD, DVM, an assistant professor of medicine at Boston University.

“The goal was not to only focus on the diabetes population, but on people who received that exposure [of metformin or sulfonylureas],” Dr. Jafarzadeh said in an interview. Dr. Jafarzadeh noted that a larger randomized controlled trial is underway to look at whether metformin reduces the risk of osteoarthritis independent of whether a patient has diabetes.

The published study was funded by grants from the National Institutes of Health, the Department of Veterans Affairs, and Stanford University, and the authors reported no disclosures. The poster at OARSI was funded by NIH and the Arthritis Foundation, and the authors reported no disclosures.

Patients taking metformin for type 2 diabetes had a lower risk of developing osteoarthritis than did patients taking a sulfonylurea, according to a cohort study published in JAMA Network Open. The findings jibe with those seen in a 2022 systematic review of preclinical and observational human studies finding potentially protective effects of metformin on osteoarthritis.

“Our study provides further, robust epidemiological evidence that metformin may be associated with protection in the development and progression of osteoarthritis in individuals with type 2 diabetes,” wrote Matthew C. Baker, MD, MS, an assistant professor of medicine in immunology and rheumatology at Stanford (Calif.) University, and his colleagues.

Thinglass/iStock Editorial/Getty Images

The findings also fit with the results of a poster presented at the Osteoarthritis Research Society International 2023 World Congress, although that abstract’s findings did not reach statistical significance.

In the published study, the researchers analyzed deidentified claims data from Optum’s Clinformatics Data Mart Database between December 2003 and December 2019. The database includes more than 15 million people with private insurance or Medicare Advantage Part D but does not include people with Medicaid, thereby excluding people from lower socioeconomic groups.

The researchers included all patients who were at least 40 years old, had type 2 diabetes, were taking metformin, and had been enrolled in the database for at least 1 uninterrupted year. They excluded anyone with type 1 diabetes or a prior diagnosis of osteoarthritis, inflammatory arthritis, or joint replacement. The authors then compared the incidence of osteoarthritis and joint replacement in these 20,937 participants to 20,937 control participants who were taking a sulfonylurea, matched to those taking metformin on the basis of age, sex, race, a comorbidity score, and duration of treatment. More than half the overall population (58%) was male with an average age of 62.

Patients needed to be on either drug for at least 3 months, but those who were initially treated with metformin before later taking a sulfonylurea could also be included and contribute to both groups. Those who first took a sulfonylurea and later switched to metformin were included only for the sulfonylurea group and censored after their switch to ensure the sulfonylurea group had enough participants. The comparison was further adjusted for age, sex, race, ethnicity, geographic region, education, comorbidities, and outpatient visit frequency.

The results revealed that those who were taking metformin were 24% less likely to develop osteoarthritis at least 3 months after starting the medication than were those taking a sulfonylurea (P < .001). The rate of joint replacements was not significantly different between those taking metformin and those taking a sulfonylurea. These two results did not change in a sensitivity analysis that compared patients who only ever took metformin or a sulfonylurea (as opposed to those who took one drug before switching to the other).

“When stratified by prior exposure to metformin within the sulfonylurea group, the observed benefit associated with metformin ... was attenuated in the people treated with a sulfonylurea with prior exposure to metformin, compared with those treated with a sulfonylurea with no prior exposure to metformin,” the authors further reported. A possible reason for this finding is that those taking a sulfonylurea after having previously taken metformin gained some protection from the earlier metformin exposure, the authors hypothesized.

This observational study could not show a causative effect from the metformin, but the researchers speculated on potential mechanisms if a causative effect were present, based on past research.

”Several preclinical studies have suggested a protective association of metformin in osteoarthritis through activating AMP-activated protein kinase signaling, decreasing the level of matrix metalloproteinase, increasing autophagy and reducing chondrocyte apoptosis, and augmenting chondroprotective and anti-inflammatory properties of mesenchymal stem cells,” the authors wrote.

Among this study’s limitations, however, was the lack of data on body mass index, which is associated with osteoarthritis in the literature and may differ between patients taking metformin versus a sulfonylurea. The researchers also did not have data on physical activity or a history of trauma to the joints, though there’s no reason to think these rates might differ between those taking one or the other medication.

Another substantial limitation is that all patients had type 2 diabetes, making it impossible to determine whether a similar protective effect from metformin might exist in people without diabetes.

Nonsignificant lower risk for posttraumatic knee osteoarthritis

Similar to the published study, the OARSI poster compared 5-year odds of incident osteoarthritis or total knee replacement surgery between patients taking metformin and those taking sulfonylureas, but it focused on younger patients, aged 18-40 years, who underwent anterior cruciate ligament or meniscus surgery.

Using data from MarketScan commercial insurance claims databases between 2006 and 2020, the authors identified 2,376 participants who were taking metformin or a sulfonylurea when they underwent their surgery or began taking it in the 6 months after their surgery. More than half the participants were female (57%) with an average age of 35.

Within 5 years, 10.8% of those taking metformin developed osteoarthritis, compared with 17.9% of those taking a sulfonylurea. In addition, 3% of those taking metformin underwent a total knee replacement, compared with 5.3% of those taking a sulfonylurea. After adjustment for age, sex, obesity, and a history of chronic kidney disease, liver disease, and depression, however, both risk difference and odds ratios were not statistically significant.

Risk of osteoarthritis was 17% lower in patients taking metformin (95% confidence interval, –0.18 to 0.09), whose odds of osteoarthritis were approximately half the odds of those taking a sulfonylurea (OR, 0.5; 95% CI, 0.21-1.67). Risk of a total knee replacement was 10% lower in metformin users (95% CI, –0.28 to 0.08) with a similar reduction in odds, compared with those taking a sulfonylurea (OR, 0.53; 95% CI, 0.2-1.44).

In this study, the researchers did not specifically determine whether the participants were diagnosed with diabetes, but they assumed all, or at least most, were, according to S. Reza Jafarzadeh, PhD, DVM, an assistant professor of medicine at Boston University.

“The goal was not to only focus on the diabetes population, but on people who received that exposure [of metformin or sulfonylureas],” Dr. Jafarzadeh said in an interview. Dr. Jafarzadeh noted that a larger randomized controlled trial is underway to look at whether metformin reduces the risk of osteoarthritis independent of whether a patient has diabetes.

The published study was funded by grants from the National Institutes of Health, the Department of Veterans Affairs, and Stanford University, and the authors reported no disclosures. The poster at OARSI was funded by NIH and the Arthritis Foundation, and the authors reported no disclosures.

Patients taking metformin for type 2 diabetes had a lower risk of developing osteoarthritis than did patients taking a sulfonylurea, according to a cohort study published in JAMA Network Open. The findings jibe with those seen in a 2022 systematic review of preclinical and observational human studies finding potentially protective effects of metformin on osteoarthritis.

“Our study provides further, robust epidemiological evidence that metformin may be associated with protection in the development and progression of osteoarthritis in individuals with type 2 diabetes,” wrote Matthew C. Baker, MD, MS, an assistant professor of medicine in immunology and rheumatology at Stanford (Calif.) University, and his colleagues.

Thinglass/iStock Editorial/Getty Images

The findings also fit with the results of a poster presented at the Osteoarthritis Research Society International 2023 World Congress, although that abstract’s findings did not reach statistical significance.

In the published study, the researchers analyzed deidentified claims data from Optum’s Clinformatics Data Mart Database between December 2003 and December 2019. The database includes more than 15 million people with private insurance or Medicare Advantage Part D but does not include people with Medicaid, thereby excluding people from lower socioeconomic groups.

The researchers included all patients who were at least 40 years old, had type 2 diabetes, were taking metformin, and had been enrolled in the database for at least 1 uninterrupted year. They excluded anyone with type 1 diabetes or a prior diagnosis of osteoarthritis, inflammatory arthritis, or joint replacement. The authors then compared the incidence of osteoarthritis and joint replacement in these 20,937 participants to 20,937 control participants who were taking a sulfonylurea, matched to those taking metformin on the basis of age, sex, race, a comorbidity score, and duration of treatment. More than half the overall population (58%) was male with an average age of 62.

Patients needed to be on either drug for at least 3 months, but those who were initially treated with metformin before later taking a sulfonylurea could also be included and contribute to both groups. Those who first took a sulfonylurea and later switched to metformin were included only for the sulfonylurea group and censored after their switch to ensure the sulfonylurea group had enough participants. The comparison was further adjusted for age, sex, race, ethnicity, geographic region, education, comorbidities, and outpatient visit frequency.

The results revealed that those who were taking metformin were 24% less likely to develop osteoarthritis at least 3 months after starting the medication than were those taking a sulfonylurea (P < .001). The rate of joint replacements was not significantly different between those taking metformin and those taking a sulfonylurea. These two results did not change in a sensitivity analysis that compared patients who only ever took metformin or a sulfonylurea (as opposed to those who took one drug before switching to the other).

“When stratified by prior exposure to metformin within the sulfonylurea group, the observed benefit associated with metformin ... was attenuated in the people treated with a sulfonylurea with prior exposure to metformin, compared with those treated with a sulfonylurea with no prior exposure to metformin,” the authors further reported. A possible reason for this finding is that those taking a sulfonylurea after having previously taken metformin gained some protection from the earlier metformin exposure, the authors hypothesized.

This observational study could not show a causative effect from the metformin, but the researchers speculated on potential mechanisms if a causative effect were present, based on past research.

”Several preclinical studies have suggested a protective association of metformin in osteoarthritis through activating AMP-activated protein kinase signaling, decreasing the level of matrix metalloproteinase, increasing autophagy and reducing chondrocyte apoptosis, and augmenting chondroprotective and anti-inflammatory properties of mesenchymal stem cells,” the authors wrote.

Among this study’s limitations, however, was the lack of data on body mass index, which is associated with osteoarthritis in the literature and may differ between patients taking metformin versus a sulfonylurea. The researchers also did not have data on physical activity or a history of trauma to the joints, though there’s no reason to think these rates might differ between those taking one or the other medication.

Another substantial limitation is that all patients had type 2 diabetes, making it impossible to determine whether a similar protective effect from metformin might exist in people without diabetes.

Nonsignificant lower risk for posttraumatic knee osteoarthritis

Similar to the published study, the OARSI poster compared 5-year odds of incident osteoarthritis or total knee replacement surgery between patients taking metformin and those taking sulfonylureas, but it focused on younger patients, aged 18-40 years, who underwent anterior cruciate ligament or meniscus surgery.

Using data from MarketScan commercial insurance claims databases between 2006 and 2020, the authors identified 2,376 participants who were taking metformin or a sulfonylurea when they underwent their surgery or began taking it in the 6 months after their surgery. More than half the participants were female (57%) with an average age of 35.

Within 5 years, 10.8% of those taking metformin developed osteoarthritis, compared with 17.9% of those taking a sulfonylurea. In addition, 3% of those taking metformin underwent a total knee replacement, compared with 5.3% of those taking a sulfonylurea. After adjustment for age, sex, obesity, and a history of chronic kidney disease, liver disease, and depression, however, both risk difference and odds ratios were not statistically significant.

Risk of osteoarthritis was 17% lower in patients taking metformin (95% confidence interval, –0.18 to 0.09), whose odds of osteoarthritis were approximately half the odds of those taking a sulfonylurea (OR, 0.5; 95% CI, 0.21-1.67). Risk of a total knee replacement was 10% lower in metformin users (95% CI, –0.28 to 0.08) with a similar reduction in odds, compared with those taking a sulfonylurea (OR, 0.53; 95% CI, 0.2-1.44).

In this study, the researchers did not specifically determine whether the participants were diagnosed with diabetes, but they assumed all, or at least most, were, according to S. Reza Jafarzadeh, PhD, DVM, an assistant professor of medicine at Boston University.

“The goal was not to only focus on the diabetes population, but on people who received that exposure [of metformin or sulfonylureas],” Dr. Jafarzadeh said in an interview. Dr. Jafarzadeh noted that a larger randomized controlled trial is underway to look at whether metformin reduces the risk of osteoarthritis independent of whether a patient has diabetes.

The published study was funded by grants from the National Institutes of Health, the Department of Veterans Affairs, and Stanford University, and the authors reported no disclosures. The poster at OARSI was funded by NIH and the Arthritis Foundation, and the authors reported no disclosures.

NEW ORLEANS – Pediatric patients with rheumatologic diseases experience a particularly high prevalence of psychological distress and depression and anxiety symptoms, according to research presented at the Pediatric Rheumatology Symposium. Although this finding is not necessarily surprising, the extent to which depression and psychological distress impacts these young patients’ quality of life has led to greater research and innovation in seeking ways to identify, address, and treat depression and anxiety in children and adolescents with diseases such as juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE).

Accordingly, other studies presented at the conference examined more efficient ways to screen adolescent patients for depression and assessed programs designed to improve symptoms. In fact, the American College of Rheumatology award for the top Quality, Health Services, and Education Research abstract at this year’s symposium went to Lauren Harper, MD, a pediatric rheumatology fellow at Nationwide Children’s Hospital, Columbus, whose research examined the effects of automating depression screening during check-in for adolescent patients with SLE. Her findings revealed that automation of screening increased detection of depression and suicidality, thereby increasing interventions and ultimately resulting in a reduction in depression prevalence.

Tara Haelle/MDedge News

“The key clinical takeaway is that mental health screening is really important – it affects our patients in so many different ways – and it’s very doable in your rheumatology clinic,” Dr. Harper said in an interview. “It’s also important because they’re coming to us very frequently, but they don’t see their PCP [primary care provider] very often, so we can’t leave screening to the PCPs.”

Two other studies assessed the effectiveness of a 6-week cognitive-behavioral intervention for youth called Treatment and Education Approach for Childhood-Onset Lupus (TEACH). One study found that remote delivery of TEACH resulted in improved mood symptoms and reduced fatigue, and another found the program particularly effective in improving mood for patients deemed “high risk” because of greater depression and fatigue symptoms.

The impact of growing mental health problems has been enormous both in the pediatric rheumatology population and society at large, Daria Sosna, MSc, a research coordinator at the University of Calgary (Alta.), said in an interview as she visited the research posters related to psychological stress and depression.

“We need to do something,” said Ms. Sosna, whose department is currently applying for funding to develop a research project to improve mental health outcomes in adolescents with lupus. “This population, specifically, has higher numbers than anyone else does because they have chronic illness” – and those issues need to be addressed.
 

High psychological stress levels

The study looking at psychological stress in pediatric rheumatology patients, led by Natalie Rosenwasser, MD, of Seattle Children’s Hospital, relied on cross-sectional data from patients enrolled in two Childhood Arthritis and Rheumatology Research Alliance sites, one in Utah and one in Seattle. The average age of the 71 patients who completed the surveys was 13, and the researchers reported the findings in two separate age groups: those aged 13-17, who completed the surveys themselves, and those aged 8-12, whose parents completed the surveys. Nearly all the patients (94.4%) had JIA, but one had lupus and three had juvenile dermatomyositis.

E+/Getty Images

The participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS) for psychological stress, physical stress, and depressive symptoms. They also filled out the National Institutes of Health–Toolbox Perceived Stress survey, the 9-item Patient Health Questionnaire (PHQ-9), the Screen for Child Anxiety Related Disorders (SCARED), a visual analog scale for COVID-related distress, and a questionnaire asking about how receptive they were to mental health screening. The researchers determined that a score 1 standard deviation above the mean on the PROMIS and NIH-Toolbox assessments qualified as a high level of psychological stress.

“There are data that suggest that psychological stress can be a precursor to depression and anxiety, which raises the concern that not every patient who’s experiencing mental health symptoms is going to be picked up on traditional measures that meet that clinical threshold, but they may really need interventions to protect their mental health,” presenter Erin Treemarcki, DO, an assistant professor of pediatric rheumatology at the University of Utah, Salt Lake City, said in an interview. “Not every patient may necessarily need referral to a mental health specialist, but there are still potential interventions that we can do in the clinical setting to address mental health, which in turn can improve outcomes, including medication compliance and knowing how patients are feeling.”

More than one-third of the patients (39%) reported a high level of psychological stress, and 43% had elevated physical stress. Broken down by age, 26% of the teens and 15% of the younger patients reported high levels of perceived stress. The PROMIS only identified increased depressive symptoms in 26% of the participants, whereas more than half (54%) had a positive PHQ-9 depression screen. Furthermore, half the patients had SCARED scores (50%) that likely indicated anxiety disorder. Only 6% of patients reported severe stress specifically related to the pandemic, but most reported mild distress from the pandemic.

“Psychological stress was highly correlated with physical stress, perceived stress, depressive symptoms [PROMIS and PHQ-9], and anxiety,” the authors reported (P < .05). The authors next plan to expand their assessment to a third CARRA site and then explore the interaction between psychological distress and sociodemographic factors.

“There’s such an increase in mental health disorders right now, and we’re overwhelmed in general,” Ms. Sosna said in an interview. “There have to be interventions that approach this. We can use pharmacological approaches, we can use CBT, we can use a lot of these things that are very well established, and they’re absolutely fantastic, but we don’t necessarily have the resources or capabilities to do that all the time.”
 

Benefits of automated depression screening

To reduce the likelihood of depression screenings falling through the cracks during visits, Dr. Harper’s study assessed the impact of automating screens in an adolescent population. In her presentation, she noted previous research finding that nearly half of youth with lupus (47%) had depression, compared with 24% of adults with lupus. Pediatric patients have nearly three times the odds of depression and more than five times the odds of suicidal ideation, she told attendees. These mood disorders are correlated with greater physical disability, higher cardiovascular risk, more disease activity, higher risk of premature death, and decreased educational attainment, medication compliance, and quality of life.

Despite recommendations for depression screening from the U.S. Preventive Services Task Force and the American Academy of Pediatrics, only 2% of pediatric rheumatology patients are routinely screened for depression with a validated instrument, and only 7% of those with depressive symptoms are screened, according to a 2016 study that Dr. Harper cited. Yet the same study found that nearly all pediatric rheumatologists (95%) supported routine depression screening every 6-12 months. Hence her team’s decision to test whether automating screening improved their screening rates.

Their population included lupus patients aged 12 and older seen at Nationwide Children’s Hospital between 2014 and 2022. Initially, patients completed the PHQ-9 on paper, which was then transcribed into the electronic health record. The process became automated and administered on an iPad at every visit in 2022. Positive screens – those endorsing suicidality or with a score of at least 10 – caused an alert to pop up for clinicians during their workflow so that they would talk to the mental health team about the patient’s needs.

A total of 149 patients completed 529 screenings during the study’s 8 years. Only 1 patient completed a PHQ-9 in 2014, which increased to just 17 patients in 2017. Automation resulted in 225 screens (P < .01). Subsequently, positive screens increased from 0% in 2014 to 25%-30% in 2018-2021, but then fell to 12% in 2022 (P < .01). The median PHQ-9 score was 3; overall scores decreased as screening increased.

The overall incidence of positive screens during the study period was 20% and prevalence was 38%, the authors reported. Of the 10 automated alerts triggered by positive screens, 90% resulted in a meeting with a psychologist or social worker, and 90% completed a suicide risk assessment. The intrusive alert for clinicians requires them to acknowledge the alert, agreeing to initiate a risk assessment, before they can enter data into the patient’s chart.

The study findings reveal “that you can successfully screen a high-risk population using an automated, seamless process, and you can alert providers without too much disruption to their typical clinic flow,” Dr. Harper told attendees. “And all of these processes have led to sustainability for routine depression screening in our lupus clinic.”

Dr. Harper’s team next plans to expand the automated screenings to populations with other diseases, to add an automated screening for anxiety, and to explore how PHQ-9 scores correlate with disease activity.
 

Treating patients’ mental health

Another two other abstracts at the symposium looked at another option, the 6-week cognitive-behavioral TEACH program. Deborah Levy, MD, MS, an associate professor of pediatrics at the University of Toronto and the clinical director of rheumatology at The Hospital for Sick Children, and colleagues assessed the program’s success when delivered remotely to adolescent patients with lupus. Pilot testing with TEACH had already shown improvements in fatigue and mood, Dr. Levy told attendees, but barriers to in-person delivery limited its utility even before the pandemic, so this study aimed to determine a remote version’s feasibility and effects, compared with treatment as usual.

The randomized, controlled trial, led by Natoshia Cunningham, PhD, from Michigan State University, Grand Rapids, included 57 participants, aged 12-22, from seven U.S. and Canadian rheumatology sites. All had been diagnosed with childhood-onset SLE by age 18 and had elevated symptoms in fatigue, pain, or depression. A PROMIS Fatigue T score of 60 or greater indicated elevated fatigue scores, whereas a high pain score was at least a 3/10 on a visual analog scale, and a high depression T score was at least a 60 but not higher than 80 on the Children’s Depression Inventory–2 or the Beck Depression Inventory–II (depending on the patient’s age).

Patients with other chronic medical conditions, developmental delays, or untreated major psychiatric illness were excluded from the study, as were patients who were receiving overlapping treatment, such as cognitive-behavioral therapy for pain or mood. Thirty patients were randomly assigned to receive treatment as usual while 27 patients were assigned to participate in the remote TEACH program.

Nearly all the patients (94%) were female, but they were racially diverse, with 42% White, 28% Asian, 19% Black, 19% Hispanic, and 4% multiracial. The patients were an average 16 years old and had been diagnosed for a median 5 years. Three of the intervention’s six modules involved the caregivers or, for older patients, their partners if desired. The communication strategies taught in the program were also tailored to patients’ ages.

“All of these strategies are educational, cognitive, behavioral, mindfulness strategies that target fatigue [and] pain, and they also developed web content for participants to use on their own,” Dr. Levy told attendees.

The researchers had complete postassessment data from 88% of participants, but they also reported some of the statements made during qualitative interviews about the program’s feasibility.

“I think it makes people more aware of themselves to become a better version of themselves, whether that’s in their normal life or in handling a lupus kind of life,” one participant said about the program’s benefits. Another appreciated the “alternative ways of thinking,” including “being more mindful of my thoughts and how those kind of aggravate my stress.”

The quantitative findings revealed a statistically significant reduction in depressive symptoms and fatigue for TEACH participants, compared with treatment as usual. Mood scores fell by an average 13.7 points in the TEACH group, compared with a drop of 2.4 points in the treatment as usual group (P < .001). Scores for fatigue fell 9.16 points in the TEACH group and 2.93 in the control group (P = .003). No statistically significant difference showed up in pain scores between the groups, although pain, medication adherence, and disease activity did improve slightly more in the TEACH group.

In addition to the significant improvements in mood and fatigue, therefore, “completion of TEACH may be associated with improved medication adherence and disease activity versus treatment as usual,” Dr. Levy said.

A much smaller study authored by some of the same researchers also assessed TEACH’s impact not in remote form but in terms of its value specifically for adolescent patients with SLE and elevated depression and fatigue scores. Comparison of 6 high-risk patients with 10 low-risk patients who underwent TEACH suggested that the program was especially effective for improving depression in high-risk patients since these patients had a statistically significantly greater improvement in mood. Fatigue, pain, anxiety, quality of life, and disease activity scores did not statistically differ between the groups.

Authors of the automated depression screening study reported no disclosures or outside funding. The study assessing psychological distress was funded by a CARRA–Arthritis Foundation grant, and the authors reported no disclosures. The remote TEACH study was funded by a CARRA–Arthritis Foundation grant, and all but one author reported no disclosures. One author had disclosures with Janssen, Roche, and Sobi. The high-risk TEACH study was also funded by a CARRA grant, and the authors had no disclosures.

NEW ORLEANS – Pediatric patients with rheumatologic diseases experience a particularly high prevalence of psychological distress and depression and anxiety symptoms, according to research presented at the Pediatric Rheumatology Symposium. Although this finding is not necessarily surprising, the extent to which depression and psychological distress impacts these young patients’ quality of life has led to greater research and innovation in seeking ways to identify, address, and treat depression and anxiety in children and adolescents with diseases such as juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE).

Accordingly, other studies presented at the conference examined more efficient ways to screen adolescent patients for depression and assessed programs designed to improve symptoms. In fact, the American College of Rheumatology award for the top Quality, Health Services, and Education Research abstract at this year’s symposium went to Lauren Harper, MD, a pediatric rheumatology fellow at Nationwide Children’s Hospital, Columbus, whose research examined the effects of automating depression screening during check-in for adolescent patients with SLE. Her findings revealed that automation of screening increased detection of depression and suicidality, thereby increasing interventions and ultimately resulting in a reduction in depression prevalence.

Tara Haelle/MDedge News

“The key clinical takeaway is that mental health screening is really important – it affects our patients in so many different ways – and it’s very doable in your rheumatology clinic,” Dr. Harper said in an interview. “It’s also important because they’re coming to us very frequently, but they don’t see their PCP [primary care provider] very often, so we can’t leave screening to the PCPs.”

Two other studies assessed the effectiveness of a 6-week cognitive-behavioral intervention for youth called Treatment and Education Approach for Childhood-Onset Lupus (TEACH). One study found that remote delivery of TEACH resulted in improved mood symptoms and reduced fatigue, and another found the program particularly effective in improving mood for patients deemed “high risk” because of greater depression and fatigue symptoms.

The impact of growing mental health problems has been enormous both in the pediatric rheumatology population and society at large, Daria Sosna, MSc, a research coordinator at the University of Calgary (Alta.), said in an interview as she visited the research posters related to psychological stress and depression.

“We need to do something,” said Ms. Sosna, whose department is currently applying for funding to develop a research project to improve mental health outcomes in adolescents with lupus. “This population, specifically, has higher numbers than anyone else does because they have chronic illness” – and those issues need to be addressed.
 

High psychological stress levels

The study looking at psychological stress in pediatric rheumatology patients, led by Natalie Rosenwasser, MD, of Seattle Children’s Hospital, relied on cross-sectional data from patients enrolled in two Childhood Arthritis and Rheumatology Research Alliance sites, one in Utah and one in Seattle. The average age of the 71 patients who completed the surveys was 13, and the researchers reported the findings in two separate age groups: those aged 13-17, who completed the surveys themselves, and those aged 8-12, whose parents completed the surveys. Nearly all the patients (94.4%) had JIA, but one had lupus and three had juvenile dermatomyositis.

E+/Getty Images

The participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS) for psychological stress, physical stress, and depressive symptoms. They also filled out the National Institutes of Health–Toolbox Perceived Stress survey, the 9-item Patient Health Questionnaire (PHQ-9), the Screen for Child Anxiety Related Disorders (SCARED), a visual analog scale for COVID-related distress, and a questionnaire asking about how receptive they were to mental health screening. The researchers determined that a score 1 standard deviation above the mean on the PROMIS and NIH-Toolbox assessments qualified as a high level of psychological stress.

“There are data that suggest that psychological stress can be a precursor to depression and anxiety, which raises the concern that not every patient who’s experiencing mental health symptoms is going to be picked up on traditional measures that meet that clinical threshold, but they may really need interventions to protect their mental health,” presenter Erin Treemarcki, DO, an assistant professor of pediatric rheumatology at the University of Utah, Salt Lake City, said in an interview. “Not every patient may necessarily need referral to a mental health specialist, but there are still potential interventions that we can do in the clinical setting to address mental health, which in turn can improve outcomes, including medication compliance and knowing how patients are feeling.”

More than one-third of the patients (39%) reported a high level of psychological stress, and 43% had elevated physical stress. Broken down by age, 26% of the teens and 15% of the younger patients reported high levels of perceived stress. The PROMIS only identified increased depressive symptoms in 26% of the participants, whereas more than half (54%) had a positive PHQ-9 depression screen. Furthermore, half the patients had SCARED scores (50%) that likely indicated anxiety disorder. Only 6% of patients reported severe stress specifically related to the pandemic, but most reported mild distress from the pandemic.

“Psychological stress was highly correlated with physical stress, perceived stress, depressive symptoms [PROMIS and PHQ-9], and anxiety,” the authors reported (P < .05). The authors next plan to expand their assessment to a third CARRA site and then explore the interaction between psychological distress and sociodemographic factors.

“There’s such an increase in mental health disorders right now, and we’re overwhelmed in general,” Ms. Sosna said in an interview. “There have to be interventions that approach this. We can use pharmacological approaches, we can use CBT, we can use a lot of these things that are very well established, and they’re absolutely fantastic, but we don’t necessarily have the resources or capabilities to do that all the time.”
 

Benefits of automated depression screening

To reduce the likelihood of depression screenings falling through the cracks during visits, Dr. Harper’s study assessed the impact of automating screens in an adolescent population. In her presentation, she noted previous research finding that nearly half of youth with lupus (47%) had depression, compared with 24% of adults with lupus. Pediatric patients have nearly three times the odds of depression and more than five times the odds of suicidal ideation, she told attendees. These mood disorders are correlated with greater physical disability, higher cardiovascular risk, more disease activity, higher risk of premature death, and decreased educational attainment, medication compliance, and quality of life.

Despite recommendations for depression screening from the U.S. Preventive Services Task Force and the American Academy of Pediatrics, only 2% of pediatric rheumatology patients are routinely screened for depression with a validated instrument, and only 7% of those with depressive symptoms are screened, according to a 2016 study that Dr. Harper cited. Yet the same study found that nearly all pediatric rheumatologists (95%) supported routine depression screening every 6-12 months. Hence her team’s decision to test whether automating screening improved their screening rates.

Their population included lupus patients aged 12 and older seen at Nationwide Children’s Hospital between 2014 and 2022. Initially, patients completed the PHQ-9 on paper, which was then transcribed into the electronic health record. The process became automated and administered on an iPad at every visit in 2022. Positive screens – those endorsing suicidality or with a score of at least 10 – caused an alert to pop up for clinicians during their workflow so that they would talk to the mental health team about the patient’s needs.

A total of 149 patients completed 529 screenings during the study’s 8 years. Only 1 patient completed a PHQ-9 in 2014, which increased to just 17 patients in 2017. Automation resulted in 225 screens (P < .01). Subsequently, positive screens increased from 0% in 2014 to 25%-30% in 2018-2021, but then fell to 12% in 2022 (P < .01). The median PHQ-9 score was 3; overall scores decreased as screening increased.

The overall incidence of positive screens during the study period was 20% and prevalence was 38%, the authors reported. Of the 10 automated alerts triggered by positive screens, 90% resulted in a meeting with a psychologist or social worker, and 90% completed a suicide risk assessment. The intrusive alert for clinicians requires them to acknowledge the alert, agreeing to initiate a risk assessment, before they can enter data into the patient’s chart.

The study findings reveal “that you can successfully screen a high-risk population using an automated, seamless process, and you can alert providers without too much disruption to their typical clinic flow,” Dr. Harper told attendees. “And all of these processes have led to sustainability for routine depression screening in our lupus clinic.”

Dr. Harper’s team next plans to expand the automated screenings to populations with other diseases, to add an automated screening for anxiety, and to explore how PHQ-9 scores correlate with disease activity.
 

Treating patients’ mental health

Another two other abstracts at the symposium looked at another option, the 6-week cognitive-behavioral TEACH program. Deborah Levy, MD, MS, an associate professor of pediatrics at the University of Toronto and the clinical director of rheumatology at The Hospital for Sick Children, and colleagues assessed the program’s success when delivered remotely to adolescent patients with lupus. Pilot testing with TEACH had already shown improvements in fatigue and mood, Dr. Levy told attendees, but barriers to in-person delivery limited its utility even before the pandemic, so this study aimed to determine a remote version’s feasibility and effects, compared with treatment as usual.

The randomized, controlled trial, led by Natoshia Cunningham, PhD, from Michigan State University, Grand Rapids, included 57 participants, aged 12-22, from seven U.S. and Canadian rheumatology sites. All had been diagnosed with childhood-onset SLE by age 18 and had elevated symptoms in fatigue, pain, or depression. A PROMIS Fatigue T score of 60 or greater indicated elevated fatigue scores, whereas a high pain score was at least a 3/10 on a visual analog scale, and a high depression T score was at least a 60 but not higher than 80 on the Children’s Depression Inventory–2 or the Beck Depression Inventory–II (depending on the patient’s age).

Patients with other chronic medical conditions, developmental delays, or untreated major psychiatric illness were excluded from the study, as were patients who were receiving overlapping treatment, such as cognitive-behavioral therapy for pain or mood. Thirty patients were randomly assigned to receive treatment as usual while 27 patients were assigned to participate in the remote TEACH program.

Nearly all the patients (94%) were female, but they were racially diverse, with 42% White, 28% Asian, 19% Black, 19% Hispanic, and 4% multiracial. The patients were an average 16 years old and had been diagnosed for a median 5 years. Three of the intervention’s six modules involved the caregivers or, for older patients, their partners if desired. The communication strategies taught in the program were also tailored to patients’ ages.

“All of these strategies are educational, cognitive, behavioral, mindfulness strategies that target fatigue [and] pain, and they also developed web content for participants to use on their own,” Dr. Levy told attendees.

The researchers had complete postassessment data from 88% of participants, but they also reported some of the statements made during qualitative interviews about the program’s feasibility.

“I think it makes people more aware of themselves to become a better version of themselves, whether that’s in their normal life or in handling a lupus kind of life,” one participant said about the program’s benefits. Another appreciated the “alternative ways of thinking,” including “being more mindful of my thoughts and how those kind of aggravate my stress.”

The quantitative findings revealed a statistically significant reduction in depressive symptoms and fatigue for TEACH participants, compared with treatment as usual. Mood scores fell by an average 13.7 points in the TEACH group, compared with a drop of 2.4 points in the treatment as usual group (P < .001). Scores for fatigue fell 9.16 points in the TEACH group and 2.93 in the control group (P = .003). No statistically significant difference showed up in pain scores between the groups, although pain, medication adherence, and disease activity did improve slightly more in the TEACH group.

In addition to the significant improvements in mood and fatigue, therefore, “completion of TEACH may be associated with improved medication adherence and disease activity versus treatment as usual,” Dr. Levy said.

A much smaller study authored by some of the same researchers also assessed TEACH’s impact not in remote form but in terms of its value specifically for adolescent patients with SLE and elevated depression and fatigue scores. Comparison of 6 high-risk patients with 10 low-risk patients who underwent TEACH suggested that the program was especially effective for improving depression in high-risk patients since these patients had a statistically significantly greater improvement in mood. Fatigue, pain, anxiety, quality of life, and disease activity scores did not statistically differ between the groups.

Authors of the automated depression screening study reported no disclosures or outside funding. The study assessing psychological distress was funded by a CARRA–Arthritis Foundation grant, and the authors reported no disclosures. The remote TEACH study was funded by a CARRA–Arthritis Foundation grant, and all but one author reported no disclosures. One author had disclosures with Janssen, Roche, and Sobi. The high-risk TEACH study was also funded by a CARRA grant, and the authors had no disclosures.

NEW ORLEANS – Pediatric patients with rheumatologic diseases experience a particularly high prevalence of psychological distress and depression and anxiety symptoms, according to research presented at the Pediatric Rheumatology Symposium. Although this finding is not necessarily surprising, the extent to which depression and psychological distress impacts these young patients’ quality of life has led to greater research and innovation in seeking ways to identify, address, and treat depression and anxiety in children and adolescents with diseases such as juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE).

Accordingly, other studies presented at the conference examined more efficient ways to screen adolescent patients for depression and assessed programs designed to improve symptoms. In fact, the American College of Rheumatology award for the top Quality, Health Services, and Education Research abstract at this year’s symposium went to Lauren Harper, MD, a pediatric rheumatology fellow at Nationwide Children’s Hospital, Columbus, whose research examined the effects of automating depression screening during check-in for adolescent patients with SLE. Her findings revealed that automation of screening increased detection of depression and suicidality, thereby increasing interventions and ultimately resulting in a reduction in depression prevalence.

Tara Haelle/MDedge News

“The key clinical takeaway is that mental health screening is really important – it affects our patients in so many different ways – and it’s very doable in your rheumatology clinic,” Dr. Harper said in an interview. “It’s also important because they’re coming to us very frequently, but they don’t see their PCP [primary care provider] very often, so we can’t leave screening to the PCPs.”

Two other studies assessed the effectiveness of a 6-week cognitive-behavioral intervention for youth called Treatment and Education Approach for Childhood-Onset Lupus (TEACH). One study found that remote delivery of TEACH resulted in improved mood symptoms and reduced fatigue, and another found the program particularly effective in improving mood for patients deemed “high risk” because of greater depression and fatigue symptoms.

The impact of growing mental health problems has been enormous both in the pediatric rheumatology population and society at large, Daria Sosna, MSc, a research coordinator at the University of Calgary (Alta.), said in an interview as she visited the research posters related to psychological stress and depression.

“We need to do something,” said Ms. Sosna, whose department is currently applying for funding to develop a research project to improve mental health outcomes in adolescents with lupus. “This population, specifically, has higher numbers than anyone else does because they have chronic illness” – and those issues need to be addressed.
 

High psychological stress levels

The study looking at psychological stress in pediatric rheumatology patients, led by Natalie Rosenwasser, MD, of Seattle Children’s Hospital, relied on cross-sectional data from patients enrolled in two Childhood Arthritis and Rheumatology Research Alliance sites, one in Utah and one in Seattle. The average age of the 71 patients who completed the surveys was 13, and the researchers reported the findings in two separate age groups: those aged 13-17, who completed the surveys themselves, and those aged 8-12, whose parents completed the surveys. Nearly all the patients (94.4%) had JIA, but one had lupus and three had juvenile dermatomyositis.

E+/Getty Images

The participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS) for psychological stress, physical stress, and depressive symptoms. They also filled out the National Institutes of Health–Toolbox Perceived Stress survey, the 9-item Patient Health Questionnaire (PHQ-9), the Screen for Child Anxiety Related Disorders (SCARED), a visual analog scale for COVID-related distress, and a questionnaire asking about how receptive they were to mental health screening. The researchers determined that a score 1 standard deviation above the mean on the PROMIS and NIH-Toolbox assessments qualified as a high level of psychological stress.

“There are data that suggest that psychological stress can be a precursor to depression and anxiety, which raises the concern that not every patient who’s experiencing mental health symptoms is going to be picked up on traditional measures that meet that clinical threshold, but they may really need interventions to protect their mental health,” presenter Erin Treemarcki, DO, an assistant professor of pediatric rheumatology at the University of Utah, Salt Lake City, said in an interview. “Not every patient may necessarily need referral to a mental health specialist, but there are still potential interventions that we can do in the clinical setting to address mental health, which in turn can improve outcomes, including medication compliance and knowing how patients are feeling.”

More than one-third of the patients (39%) reported a high level of psychological stress, and 43% had elevated physical stress. Broken down by age, 26% of the teens and 15% of the younger patients reported high levels of perceived stress. The PROMIS only identified increased depressive symptoms in 26% of the participants, whereas more than half (54%) had a positive PHQ-9 depression screen. Furthermore, half the patients had SCARED scores (50%) that likely indicated anxiety disorder. Only 6% of patients reported severe stress specifically related to the pandemic, but most reported mild distress from the pandemic.

“Psychological stress was highly correlated with physical stress, perceived stress, depressive symptoms [PROMIS and PHQ-9], and anxiety,” the authors reported (P < .05). The authors next plan to expand their assessment to a third CARRA site and then explore the interaction between psychological distress and sociodemographic factors.

“There’s such an increase in mental health disorders right now, and we’re overwhelmed in general,” Ms. Sosna said in an interview. “There have to be interventions that approach this. We can use pharmacological approaches, we can use CBT, we can use a lot of these things that are very well established, and they’re absolutely fantastic, but we don’t necessarily have the resources or capabilities to do that all the time.”
 

Benefits of automated depression screening

To reduce the likelihood of depression screenings falling through the cracks during visits, Dr. Harper’s study assessed the impact of automating screens in an adolescent population. In her presentation, she noted previous research finding that nearly half of youth with lupus (47%) had depression, compared with 24% of adults with lupus. Pediatric patients have nearly three times the odds of depression and more than five times the odds of suicidal ideation, she told attendees. These mood disorders are correlated with greater physical disability, higher cardiovascular risk, more disease activity, higher risk of premature death, and decreased educational attainment, medication compliance, and quality of life.

Despite recommendations for depression screening from the U.S. Preventive Services Task Force and the American Academy of Pediatrics, only 2% of pediatric rheumatology patients are routinely screened for depression with a validated instrument, and only 7% of those with depressive symptoms are screened, according to a 2016 study that Dr. Harper cited. Yet the same study found that nearly all pediatric rheumatologists (95%) supported routine depression screening every 6-12 months. Hence her team’s decision to test whether automating screening improved their screening rates.

Their population included lupus patients aged 12 and older seen at Nationwide Children’s Hospital between 2014 and 2022. Initially, patients completed the PHQ-9 on paper, which was then transcribed into the electronic health record. The process became automated and administered on an iPad at every visit in 2022. Positive screens – those endorsing suicidality or with a score of at least 10 – caused an alert to pop up for clinicians during their workflow so that they would talk to the mental health team about the patient’s needs.

A total of 149 patients completed 529 screenings during the study’s 8 years. Only 1 patient completed a PHQ-9 in 2014, which increased to just 17 patients in 2017. Automation resulted in 225 screens (P < .01). Subsequently, positive screens increased from 0% in 2014 to 25%-30% in 2018-2021, but then fell to 12% in 2022 (P < .01). The median PHQ-9 score was 3; overall scores decreased as screening increased.

The overall incidence of positive screens during the study period was 20% and prevalence was 38%, the authors reported. Of the 10 automated alerts triggered by positive screens, 90% resulted in a meeting with a psychologist or social worker, and 90% completed a suicide risk assessment. The intrusive alert for clinicians requires them to acknowledge the alert, agreeing to initiate a risk assessment, before they can enter data into the patient’s chart.

The study findings reveal “that you can successfully screen a high-risk population using an automated, seamless process, and you can alert providers without too much disruption to their typical clinic flow,” Dr. Harper told attendees. “And all of these processes have led to sustainability for routine depression screening in our lupus clinic.”

Dr. Harper’s team next plans to expand the automated screenings to populations with other diseases, to add an automated screening for anxiety, and to explore how PHQ-9 scores correlate with disease activity.
 

Treating patients’ mental health

Another two other abstracts at the symposium looked at another option, the 6-week cognitive-behavioral TEACH program. Deborah Levy, MD, MS, an associate professor of pediatrics at the University of Toronto and the clinical director of rheumatology at The Hospital for Sick Children, and colleagues assessed the program’s success when delivered remotely to adolescent patients with lupus. Pilot testing with TEACH had already shown improvements in fatigue and mood, Dr. Levy told attendees, but barriers to in-person delivery limited its utility even before the pandemic, so this study aimed to determine a remote version’s feasibility and effects, compared with treatment as usual.

The randomized, controlled trial, led by Natoshia Cunningham, PhD, from Michigan State University, Grand Rapids, included 57 participants, aged 12-22, from seven U.S. and Canadian rheumatology sites. All had been diagnosed with childhood-onset SLE by age 18 and had elevated symptoms in fatigue, pain, or depression. A PROMIS Fatigue T score of 60 or greater indicated elevated fatigue scores, whereas a high pain score was at least a 3/10 on a visual analog scale, and a high depression T score was at least a 60 but not higher than 80 on the Children’s Depression Inventory–2 or the Beck Depression Inventory–II (depending on the patient’s age).

Patients with other chronic medical conditions, developmental delays, or untreated major psychiatric illness were excluded from the study, as were patients who were receiving overlapping treatment, such as cognitive-behavioral therapy for pain or mood. Thirty patients were randomly assigned to receive treatment as usual while 27 patients were assigned to participate in the remote TEACH program.

Nearly all the patients (94%) were female, but they were racially diverse, with 42% White, 28% Asian, 19% Black, 19% Hispanic, and 4% multiracial. The patients were an average 16 years old and had been diagnosed for a median 5 years. Three of the intervention’s six modules involved the caregivers or, for older patients, their partners if desired. The communication strategies taught in the program were also tailored to patients’ ages.

“All of these strategies are educational, cognitive, behavioral, mindfulness strategies that target fatigue [and] pain, and they also developed web content for participants to use on their own,” Dr. Levy told attendees.

The researchers had complete postassessment data from 88% of participants, but they also reported some of the statements made during qualitative interviews about the program’s feasibility.

“I think it makes people more aware of themselves to become a better version of themselves, whether that’s in their normal life or in handling a lupus kind of life,” one participant said about the program’s benefits. Another appreciated the “alternative ways of thinking,” including “being more mindful of my thoughts and how those kind of aggravate my stress.”

The quantitative findings revealed a statistically significant reduction in depressive symptoms and fatigue for TEACH participants, compared with treatment as usual. Mood scores fell by an average 13.7 points in the TEACH group, compared with a drop of 2.4 points in the treatment as usual group (P < .001). Scores for fatigue fell 9.16 points in the TEACH group and 2.93 in the control group (P = .003). No statistically significant difference showed up in pain scores between the groups, although pain, medication adherence, and disease activity did improve slightly more in the TEACH group.

In addition to the significant improvements in mood and fatigue, therefore, “completion of TEACH may be associated with improved medication adherence and disease activity versus treatment as usual,” Dr. Levy said.

A much smaller study authored by some of the same researchers also assessed TEACH’s impact not in remote form but in terms of its value specifically for adolescent patients with SLE and elevated depression and fatigue scores. Comparison of 6 high-risk patients with 10 low-risk patients who underwent TEACH suggested that the program was especially effective for improving depression in high-risk patients since these patients had a statistically significantly greater improvement in mood. Fatigue, pain, anxiety, quality of life, and disease activity scores did not statistically differ between the groups.

Authors of the automated depression screening study reported no disclosures or outside funding. The study assessing psychological distress was funded by a CARRA–Arthritis Foundation grant, and the authors reported no disclosures. The remote TEACH study was funded by a CARRA–Arthritis Foundation grant, and all but one author reported no disclosures. One author had disclosures with Janssen, Roche, and Sobi. The high-risk TEACH study was also funded by a CARRA grant, and the authors had no disclosures.

Both pain relief and neurological improvements persisted in patients with diabetic neuropathy 2 years after they began receiving treatment with 10 kHz of spinal cord stimulation, according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.

The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.

University of Arkansas

“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
 

Encouraging preliminary findings

The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”

An underused treatment

Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.

“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”

At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
 

Testing high-frequency stimulation

The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.

For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.

Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.

At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.

Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.

“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
 

Surgical considerations

Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.

An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.

“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”

Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
 

Improvement in symptom severity and quality of life

After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.

“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”

The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.

“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”

The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.

Both pain relief and neurological improvements persisted in patients with diabetic neuropathy 2 years after they began receiving treatment with 10 kHz of spinal cord stimulation, according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.

The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.

University of Arkansas

“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
 

Encouraging preliminary findings

The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”

An underused treatment

Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.

“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”

At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
 

Testing high-frequency stimulation

The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.

For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.

Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.

At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.

Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.

“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
 

Surgical considerations

Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.

An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.

“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”

Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
 

Improvement in symptom severity and quality of life

After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.

“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”

The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.

“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”

The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.

Both pain relief and neurological improvements persisted in patients with diabetic neuropathy 2 years after they began receiving treatment with 10 kHz of spinal cord stimulation, according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.

The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.

University of Arkansas

“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
 

Encouraging preliminary findings

The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”

An underused treatment

Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.

“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”

At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
 

Testing high-frequency stimulation

The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.

For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.

Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.

At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.

Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.

“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
 

Surgical considerations

Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.

An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.

“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”

Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
 

Improvement in symptom severity and quality of life

After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.

“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”

The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.

“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”

The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.

NEW ORLEANS – Parents’ concerns about vaccinating their children against COVID-19 remain a substantial barrier to immunizing children against the disease, whether those children have chronic rheumatologic conditions or a history of multisystem inflammatory syndrome in children (MIS-C), according to two studies presented at the Pediatric Rheumatology Symposium.

Parents of children who developed MIS-C after a SARS-CoV-2 infection were particularly hesitant to vaccinate, despite strong encouragement from health care professionals at Baylor College of Medicine, Houston, said the presenter of one of the studies.

“Unfortunately, it remains unclear who is susceptible and what the mechanisms are” when it comes to MIS-C, Mariana Sanchez Villa, MS, a research coordinator at Baylor, told attendees. “Because of this, there is much hesitancy to vaccinate children with a history of MIS-C against COVID-19 out of a fear that hyperinflammation may occur.”

Ms. Sanchez Villa reported findings on the vaccination rate among patients who had been hospitalized with MIS-C. The researchers included all 295 patients who presented at the hospital with MIS-C between May 2020 and October 2022. Overall, 5% of these patients had been vaccinated against COVID-19 before they were diagnosed with MIS-C. When all these patients and their families came to outpatient follow-up appointments after discharge, the subspecialist clinicians recommended the children receive the COVID-19 vaccine 3 months after discharge. The researchers then reviewed the patients’ charts to see who did and did not receive the vaccine, which they confirmed through the state’s immunization registry.

Among the 295 patients with MIS-C, 1 died, and 99 (34%) received at least one COVID-19 vaccine dose after their diagnosis, including 7 of the 15 who had also been vaccinated prior to their MIS-C diagnosis. Just over half of the vaccinated patients (58%) were male. They received their vaccine an average 8.8 months after their hospitalization, when they were an average 10 years old, and all but one of the vaccine doses they received were the Pfizer/BioNTech mRNA vaccine.

Only 9 of the 99 vaccinated patients are fully vaccinated, defined as receiving the primary series plus the recommended boosters. Of the other patients, 13 received only one dose of the vaccine, 60 received two doses, and 17 received at least three doses of the primary series doses but no bivalent boosters. Over a subsequent average 11 months of follow-up, none of the vaccinated patients returned to the hospital with a recurrence of MIS-C or any other hyperinflammatory condition. The seven patients who had been vaccinated both before and after their MIS-C diagnosis have also not had any recurrence of a hyperinflammatory condition.

“SARS-CoV-2 vaccination is well-tolerated by children with a history of MIS-C,” the researchers concluded. Ms. Sanchez Villa referenced two other studies, in The Pediatric Infectious Disease Journal and in JAMA Network Open, with similar findings on the safety of COVID-19 vaccination in patients who have had MIS-C. “This is reassuring as SARS-CoV-2 becomes endemic and annual vaccination against SARS-CoV-2 is considered.”

Dilan Dissanayake, MD, PhD, a rheumatologist at The Hospital for Sick Children in Toronto, who attended the presentation, told this news organization that data increasingly show a “synergistic protective effect” from COVID-19 infection and vaccination. That is, “having COVID or having MIS-C once doesn’t necessarily preclude you from having it again,” thereby supporting the importance of vaccination after an MIS-C diagnosis. In talking to parents about vaccinating, he has found it most helpful for them to hear about rheumatologists’ experience regarding COVID-19 vaccination.

“Particularly as the pandemic went on, being able to comfortably say that we have this large patient group, as well as collaborators across the world who have been monitoring for any safety issues, and that all the data has been reassuring” has been most useful for parents to hear, Dr. Dissanayake said.

The other study, led by Beth Rutstein, MD, MSCE, an attending rheumatologist at Children’s Hospital of Philadelphia, focused on the population of pediatric rheumatology patients by surveying pediatric rheumatologists who were members of the Childhood Arthritis and Rheumatology Research Alliance. The survey, conducted from March to May 2022, included questions about the rheumatologists’ COVID-19 vaccination practices as well as perceptions of the vaccine by the parents of their patients.

The 219 respondents included 74% pediatric rheumatologists and 21% fellows. Nearly all the respondents (98%) believed that any disease flares after COVID-19 vaccination would be mild and/or rare, and nearly all (98%) recommend their patients be vaccinated against COVID-19.

The primary finding from the study was that “we [rheumatologists] have different concerns from the families,” coauthor and presenter Vidya Sivaraman, MD, a pediatric rheumatologist at Nationwide Children’s Hospital and the Ohio State University in Columbus, told this news organization. “We’re more worried about the efficacy of the vaccine on immunosuppressive medications,” such as rituximab, which depletes B cells, Dr. Sivaraman said, but concerns about the vaccine’s immunogenicity or efficacy were very low among parents.

Just over half the clinicians surveyed (59%) were concerned about how effective the vaccine would be for their patients, especially those receiving immunosuppressive therapy. Health care professionals were most concerned about patients on rituximab – all clinicians reported concerns about the vaccine’s effectiveness in these patients – followed by patients taking systemic corticosteroids (86%), mycophenolate mofetil (59%), and Janus kinase inhibitors (46%).

Most clinicians (88%) reported that they had temporarily modified a patient’s immunosuppressive therapy to allow for vaccination, following guidelines by the American College of Rheumatology. Aside from a small proportion of health care professionals who checked patients’ post-vaccination serology primarily for research purposes, most clinicians (82%) did not collect this serology.

In regard to adverse events, the concern cited most often by respondents was myocarditis (76%), followed by development of new autoimmune conditions (29%) and thrombosis (22%), but the clinicians ranked these adverse events as low risk.

Meanwhile, the top three concerns about vaccination among parents, as reported to physicians, were worries about side effects, lack of long-term safety data on the vaccine, and misinformation they had heard, such as anxiety about changes to their child’s genetics or vaccination causing a COVID-19 infection. “They’re seeing things on social media from other parents [saying that COVID-19 vaccines are] going to affect their fertility, so they don’t want their daughters to get it,” Dr. Sivaraman said as another example of commonly cited misinformation.

Nearly half of the respondents (47%) said more than half of their families had concerns about side effects and the lack of data on long-term outcomes after vaccination. Only 8.5% of physicians said that fewer than 10% of their families were anxious about side effects. In addition, 39% of physicians said more than half of their families had concerns about misinformation they had heard, and only 16% of physicians had heard about misinformation concerns from fewer than 10% of their patients.

Other concerns cited by parents included their child’s disease flaring; lack of data on how well the vaccine would stimulate their child’s immune system; their child having already had COVID-19; and not believing COVID-19 was a major health risk to their child. Nearly every respondent (98%) said they had parents who turned down COVID-19 vaccination, and a majority (75%) reported that more than 10% of their patients had parents who were hesitant about COVID-19 vaccination.

No external funding was noted for either study. Ms. Sanchez Villa had no relevant financial relationships, but two abstract coauthors reported financial relationships with Pfizer and Moderna, and one reported a financial relationship with Novartis. Dr. Rutstein, Dr. Sivaraman, and Dr. Dissanayake had no relevant financial relationships.

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

NEW ORLEANS – Parents’ concerns about vaccinating their children against COVID-19 remain a substantial barrier to immunizing children against the disease, whether those children have chronic rheumatologic conditions or a history of multisystem inflammatory syndrome in children (MIS-C), according to two studies presented at the Pediatric Rheumatology Symposium.

Parents of children who developed MIS-C after a SARS-CoV-2 infection were particularly hesitant to vaccinate, despite strong encouragement from health care professionals at Baylor College of Medicine, Houston, said the presenter of one of the studies.

“Unfortunately, it remains unclear who is susceptible and what the mechanisms are” when it comes to MIS-C, Mariana Sanchez Villa, MS, a research coordinator at Baylor, told attendees. “Because of this, there is much hesitancy to vaccinate children with a history of MIS-C against COVID-19 out of a fear that hyperinflammation may occur.”

Ms. Sanchez Villa reported findings on the vaccination rate among patients who had been hospitalized with MIS-C. The researchers included all 295 patients who presented at the hospital with MIS-C between May 2020 and October 2022. Overall, 5% of these patients had been vaccinated against COVID-19 before they were diagnosed with MIS-C. When all these patients and their families came to outpatient follow-up appointments after discharge, the subspecialist clinicians recommended the children receive the COVID-19 vaccine 3 months after discharge. The researchers then reviewed the patients’ charts to see who did and did not receive the vaccine, which they confirmed through the state’s immunization registry.

Among the 295 patients with MIS-C, 1 died, and 99 (34%) received at least one COVID-19 vaccine dose after their diagnosis, including 7 of the 15 who had also been vaccinated prior to their MIS-C diagnosis. Just over half of the vaccinated patients (58%) were male. They received their vaccine an average 8.8 months after their hospitalization, when they were an average 10 years old, and all but one of the vaccine doses they received were the Pfizer/BioNTech mRNA vaccine.

Only 9 of the 99 vaccinated patients are fully vaccinated, defined as receiving the primary series plus the recommended boosters. Of the other patients, 13 received only one dose of the vaccine, 60 received two doses, and 17 received at least three doses of the primary series doses but no bivalent boosters. Over a subsequent average 11 months of follow-up, none of the vaccinated patients returned to the hospital with a recurrence of MIS-C or any other hyperinflammatory condition. The seven patients who had been vaccinated both before and after their MIS-C diagnosis have also not had any recurrence of a hyperinflammatory condition.

“SARS-CoV-2 vaccination is well-tolerated by children with a history of MIS-C,” the researchers concluded. Ms. Sanchez Villa referenced two other studies, in The Pediatric Infectious Disease Journal and in JAMA Network Open, with similar findings on the safety of COVID-19 vaccination in patients who have had MIS-C. “This is reassuring as SARS-CoV-2 becomes endemic and annual vaccination against SARS-CoV-2 is considered.”

Dilan Dissanayake, MD, PhD, a rheumatologist at The Hospital for Sick Children in Toronto, who attended the presentation, told this news organization that data increasingly show a “synergistic protective effect” from COVID-19 infection and vaccination. That is, “having COVID or having MIS-C once doesn’t necessarily preclude you from having it again,” thereby supporting the importance of vaccination after an MIS-C diagnosis. In talking to parents about vaccinating, he has found it most helpful for them to hear about rheumatologists’ experience regarding COVID-19 vaccination.

“Particularly as the pandemic went on, being able to comfortably say that we have this large patient group, as well as collaborators across the world who have been monitoring for any safety issues, and that all the data has been reassuring” has been most useful for parents to hear, Dr. Dissanayake said.

The other study, led by Beth Rutstein, MD, MSCE, an attending rheumatologist at Children’s Hospital of Philadelphia, focused on the population of pediatric rheumatology patients by surveying pediatric rheumatologists who were members of the Childhood Arthritis and Rheumatology Research Alliance. The survey, conducted from March to May 2022, included questions about the rheumatologists’ COVID-19 vaccination practices as well as perceptions of the vaccine by the parents of their patients.

The 219 respondents included 74% pediatric rheumatologists and 21% fellows. Nearly all the respondents (98%) believed that any disease flares after COVID-19 vaccination would be mild and/or rare, and nearly all (98%) recommend their patients be vaccinated against COVID-19.

The primary finding from the study was that “we [rheumatologists] have different concerns from the families,” coauthor and presenter Vidya Sivaraman, MD, a pediatric rheumatologist at Nationwide Children’s Hospital and the Ohio State University in Columbus, told this news organization. “We’re more worried about the efficacy of the vaccine on immunosuppressive medications,” such as rituximab, which depletes B cells, Dr. Sivaraman said, but concerns about the vaccine’s immunogenicity or efficacy were very low among parents.

Just over half the clinicians surveyed (59%) were concerned about how effective the vaccine would be for their patients, especially those receiving immunosuppressive therapy. Health care professionals were most concerned about patients on rituximab – all clinicians reported concerns about the vaccine’s effectiveness in these patients – followed by patients taking systemic corticosteroids (86%), mycophenolate mofetil (59%), and Janus kinase inhibitors (46%).

Most clinicians (88%) reported that they had temporarily modified a patient’s immunosuppressive therapy to allow for vaccination, following guidelines by the American College of Rheumatology. Aside from a small proportion of health care professionals who checked patients’ post-vaccination serology primarily for research purposes, most clinicians (82%) did not collect this serology.

In regard to adverse events, the concern cited most often by respondents was myocarditis (76%), followed by development of new autoimmune conditions (29%) and thrombosis (22%), but the clinicians ranked these adverse events as low risk.

Meanwhile, the top three concerns about vaccination among parents, as reported to physicians, were worries about side effects, lack of long-term safety data on the vaccine, and misinformation they had heard, such as anxiety about changes to their child’s genetics or vaccination causing a COVID-19 infection. “They’re seeing things on social media from other parents [saying that COVID-19 vaccines are] going to affect their fertility, so they don’t want their daughters to get it,” Dr. Sivaraman said as another example of commonly cited misinformation.

Nearly half of the respondents (47%) said more than half of their families had concerns about side effects and the lack of data on long-term outcomes after vaccination. Only 8.5% of physicians said that fewer than 10% of their families were anxious about side effects. In addition, 39% of physicians said more than half of their families had concerns about misinformation they had heard, and only 16% of physicians had heard about misinformation concerns from fewer than 10% of their patients.

Other concerns cited by parents included their child’s disease flaring; lack of data on how well the vaccine would stimulate their child’s immune system; their child having already had COVID-19; and not believing COVID-19 was a major health risk to their child. Nearly every respondent (98%) said they had parents who turned down COVID-19 vaccination, and a majority (75%) reported that more than 10% of their patients had parents who were hesitant about COVID-19 vaccination.

No external funding was noted for either study. Ms. Sanchez Villa had no relevant financial relationships, but two abstract coauthors reported financial relationships with Pfizer and Moderna, and one reported a financial relationship with Novartis. Dr. Rutstein, Dr. Sivaraman, and Dr. Dissanayake had no relevant financial relationships.

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

NEW ORLEANS – Parents’ concerns about vaccinating their children against COVID-19 remain a substantial barrier to immunizing children against the disease, whether those children have chronic rheumatologic conditions or a history of multisystem inflammatory syndrome in children (MIS-C), according to two studies presented at the Pediatric Rheumatology Symposium.

Parents of children who developed MIS-C after a SARS-CoV-2 infection were particularly hesitant to vaccinate, despite strong encouragement from health care professionals at Baylor College of Medicine, Houston, said the presenter of one of the studies.

“Unfortunately, it remains unclear who is susceptible and what the mechanisms are” when it comes to MIS-C, Mariana Sanchez Villa, MS, a research coordinator at Baylor, told attendees. “Because of this, there is much hesitancy to vaccinate children with a history of MIS-C against COVID-19 out of a fear that hyperinflammation may occur.”

Ms. Sanchez Villa reported findings on the vaccination rate among patients who had been hospitalized with MIS-C. The researchers included all 295 patients who presented at the hospital with MIS-C between May 2020 and October 2022. Overall, 5% of these patients had been vaccinated against COVID-19 before they were diagnosed with MIS-C. When all these patients and their families came to outpatient follow-up appointments after discharge, the subspecialist clinicians recommended the children receive the COVID-19 vaccine 3 months after discharge. The researchers then reviewed the patients’ charts to see who did and did not receive the vaccine, which they confirmed through the state’s immunization registry.

Among the 295 patients with MIS-C, 1 died, and 99 (34%) received at least one COVID-19 vaccine dose after their diagnosis, including 7 of the 15 who had also been vaccinated prior to their MIS-C diagnosis. Just over half of the vaccinated patients (58%) were male. They received their vaccine an average 8.8 months after their hospitalization, when they were an average 10 years old, and all but one of the vaccine doses they received were the Pfizer/BioNTech mRNA vaccine.

Only 9 of the 99 vaccinated patients are fully vaccinated, defined as receiving the primary series plus the recommended boosters. Of the other patients, 13 received only one dose of the vaccine, 60 received two doses, and 17 received at least three doses of the primary series doses but no bivalent boosters. Over a subsequent average 11 months of follow-up, none of the vaccinated patients returned to the hospital with a recurrence of MIS-C or any other hyperinflammatory condition. The seven patients who had been vaccinated both before and after their MIS-C diagnosis have also not had any recurrence of a hyperinflammatory condition.

“SARS-CoV-2 vaccination is well-tolerated by children with a history of MIS-C,” the researchers concluded. Ms. Sanchez Villa referenced two other studies, in The Pediatric Infectious Disease Journal and in JAMA Network Open, with similar findings on the safety of COVID-19 vaccination in patients who have had MIS-C. “This is reassuring as SARS-CoV-2 becomes endemic and annual vaccination against SARS-CoV-2 is considered.”

Dilan Dissanayake, MD, PhD, a rheumatologist at The Hospital for Sick Children in Toronto, who attended the presentation, told this news organization that data increasingly show a “synergistic protective effect” from COVID-19 infection and vaccination. That is, “having COVID or having MIS-C once doesn’t necessarily preclude you from having it again,” thereby supporting the importance of vaccination after an MIS-C diagnosis. In talking to parents about vaccinating, he has found it most helpful for them to hear about rheumatologists’ experience regarding COVID-19 vaccination.

“Particularly as the pandemic went on, being able to comfortably say that we have this large patient group, as well as collaborators across the world who have been monitoring for any safety issues, and that all the data has been reassuring” has been most useful for parents to hear, Dr. Dissanayake said.

The other study, led by Beth Rutstein, MD, MSCE, an attending rheumatologist at Children’s Hospital of Philadelphia, focused on the population of pediatric rheumatology patients by surveying pediatric rheumatologists who were members of the Childhood Arthritis and Rheumatology Research Alliance. The survey, conducted from March to May 2022, included questions about the rheumatologists’ COVID-19 vaccination practices as well as perceptions of the vaccine by the parents of their patients.

The 219 respondents included 74% pediatric rheumatologists and 21% fellows. Nearly all the respondents (98%) believed that any disease flares after COVID-19 vaccination would be mild and/or rare, and nearly all (98%) recommend their patients be vaccinated against COVID-19.

The primary finding from the study was that “we [rheumatologists] have different concerns from the families,” coauthor and presenter Vidya Sivaraman, MD, a pediatric rheumatologist at Nationwide Children’s Hospital and the Ohio State University in Columbus, told this news organization. “We’re more worried about the efficacy of the vaccine on immunosuppressive medications,” such as rituximab, which depletes B cells, Dr. Sivaraman said, but concerns about the vaccine’s immunogenicity or efficacy were very low among parents.

Just over half the clinicians surveyed (59%) were concerned about how effective the vaccine would be for their patients, especially those receiving immunosuppressive therapy. Health care professionals were most concerned about patients on rituximab – all clinicians reported concerns about the vaccine’s effectiveness in these patients – followed by patients taking systemic corticosteroids (86%), mycophenolate mofetil (59%), and Janus kinase inhibitors (46%).

Most clinicians (88%) reported that they had temporarily modified a patient’s immunosuppressive therapy to allow for vaccination, following guidelines by the American College of Rheumatology. Aside from a small proportion of health care professionals who checked patients’ post-vaccination serology primarily for research purposes, most clinicians (82%) did not collect this serology.

In regard to adverse events, the concern cited most often by respondents was myocarditis (76%), followed by development of new autoimmune conditions (29%) and thrombosis (22%), but the clinicians ranked these adverse events as low risk.

Meanwhile, the top three concerns about vaccination among parents, as reported to physicians, were worries about side effects, lack of long-term safety data on the vaccine, and misinformation they had heard, such as anxiety about changes to their child’s genetics or vaccination causing a COVID-19 infection. “They’re seeing things on social media from other parents [saying that COVID-19 vaccines are] going to affect their fertility, so they don’t want their daughters to get it,” Dr. Sivaraman said as another example of commonly cited misinformation.

Nearly half of the respondents (47%) said more than half of their families had concerns about side effects and the lack of data on long-term outcomes after vaccination. Only 8.5% of physicians said that fewer than 10% of their families were anxious about side effects. In addition, 39% of physicians said more than half of their families had concerns about misinformation they had heard, and only 16% of physicians had heard about misinformation concerns from fewer than 10% of their patients.

Other concerns cited by parents included their child’s disease flaring; lack of data on how well the vaccine would stimulate their child’s immune system; their child having already had COVID-19; and not believing COVID-19 was a major health risk to their child. Nearly every respondent (98%) said they had parents who turned down COVID-19 vaccination, and a majority (75%) reported that more than 10% of their patients had parents who were hesitant about COVID-19 vaccination.

No external funding was noted for either study. Ms. Sanchez Villa had no relevant financial relationships, but two abstract coauthors reported financial relationships with Pfizer and Moderna, and one reported a financial relationship with Novartis. Dr. Rutstein, Dr. Sivaraman, and Dr. Dissanayake had no relevant financial relationships.

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

NEW ORLEANS – Implementing a pediatric transition program in which a patient meets with both their pediatric and soon-to-be adult rheumatologist during a visit before formal transition resulted in less time setting up the first adult visit, according to research presented at the Pediatric Rheumatology Symposium.

The presentation was one of two that focused on ways to improve the transition from pediatric to adult care for rheumatology patients. The other, a poster from researchers at Baylor College of Medicine, Houston, took the first steps toward learning what factors can help predict a successful transition.

Tara Haelle

“This period of transitioning from pediatric to adult care, both rheumatology specific and otherwise, is a high-risk time,” John M. Bridges, MD, a fourth-year pediatric rheumatology fellow at the University of Alabama at Birmingham, told attendees. “There are changes in insurance coverage, employment, geographic mobility, and shifting responsibilities between parents and children in the setting of a still-developing frontal lobe that contribute to the risk of this period. Risks include disease flare, and then organ damage, as well as issues with decreasing medication and therapy, adherence, unscheduled care utilization, and increasing loss to follow-up.”

Dr. Bridges developed a structured transition program called the Bridge to Adult Care from Childhood for Young Adults with Rheumatic Disease (BACC YARD) aimed at improving the pediatric transition period. The analysis he presented focused specifically on reducing loss to follow-up by introducing a pretransfer visit with both rheumatologists. The patient first meets with their pediatric rheumatologist.

During that visit, the adult rheumatologist attends and discusses the patient’s history and current therapy with the pediatric rheumatologist before entering the patient’s room and having “a brief introductory conversation, a sort of verbal handoff and handshake, in front of the patient,” Dr. Bridges explained. “Then I assume responsibility for this patient and their next visit is to see me, both proverbially and literally down the street at the adulthood rheumatology clinic, where this patient becomes a part of my continuity cohort.”

Bridges entered patients from this BACC YARD cohort into an observational registry that included their dual provider pretransfer visit and a posttransfer visit, occurring between July 2020 and May 2022. He compared these patients with a historical control cohort of 45 patients from March 2018 to March 2020, who had at least two pediatric rheumatology visits prior to their transfer to adult care and no documentation of outside rheumatology visits during the study period. Specifically, he examined at the requested and actual interval between patients’ final pediatric rheumatology visit and their first adult rheumatology visit.

The intervention cohort included 86 patients, mostly female (73%), with a median age of 20. About two-thirds were White (65%) and one-third (34%) were Black. One patient was Asian, and 7% were Hispanic. Just over half the patients had juvenile idiopathic arthritis (58%), and 30% had lupus and related connective tissue diseases. The other patients had vasculitis, uveitis, inflammatory myopathy, relapsing polychondritis, morphea, or syndrome of undifferentiated recurrent fever.

A total of 8% of these patients had previously been lost to follow-up at Children’s of Alabama before they re-established rheumatology care at UAB, and 3.5% came from a pediatric rheumatologist from somewhere other than Children’s of Alabama but established adult care at UAB through the BACC YARD program. Among the remaining patients, 65% (n = 56) had both a dual provider pretransfer visit and a posttransfer visit.

The BACC YARD patients requested their next rheumatology visit (the first adult one) a median 119 days after their last pediatric visit, and the actual time until that visit was a median 141 days (P < .05). By comparison, the 45 patients in the historical control group had a median 261 days between their last pediatric visit and their first adult visit (P < .001). The median days between visits was shorter for those with JIA (129 days) and lupus (119 days) than for patients with other conditions (149 days).

Bridges acknowledged that the study was limited by the small size of the cohort and potential contextual factors related to individual patients’ circumstances.

“We’re continuing to make iterative changes to this process to try to continue to improve the transition and its outcomes in this cohort,” Dr. Bridges said.

Aimee Hersh, MD, an associate professor of pediatric rheumatology and division chief of pediatric rheumatology at the University of Utah and Primary Children’s Hospital, both in Salt Lake City, attended the presentation and noted that the University of Utah has a very similar transfer program.

“I think one of the challenges of that model, and our model, is that you have to have a very specific type of physician who is both [medical-pediatrics] trained and has a specific interest in transition,” Dr. Hersh said in an interview. She noted that the adult rheumatologist at her institution didn’t train in pediatric rheumatology but did complete a meds-peds residency. “So if you can find an adult rheumatologist who can do something similar, can see older adolescent patients and serve as that transition bridge, then I think it is feasible.”

For practices that don’t have the resources for this kind of program, Dr. Hersh recommended the Got Transition program, which provides transition guidance that can be applied to any adolescent population with chronic illness.

The other study, led by Kristiana Nasto, BS, a third-year medical student at Baylor College of Medicine, reported on the findings from one aspect of a program also developed to improve the transition from pediatric to adult care for rheumatology patients. It included periodic self-reported evaluation using the validated Adolescent Assessment of Preparation for Transition (ADAPT) survey. As the first step to better understanding the factors that can predict successful transition, the researchers surveyed returning patients with any rheumatologic diagnosis, aged 14 years and older, between July 2021 and November 2022.

Since the survey was automated through the electronic medical record, patients and their caregivers could respond during in-person or virtual visit check-in. The researchers calculated three composite scores out of 100 for self-management, prescription management, and transfer planning, using responses from the ADAPT survey. Among 462 patients who returned 670 surveys, 87% provided surveys that could be scored for at least one composite score. Most respondents were female (75%), White (69%), non-Hispanic (64%), English speaking (90%), and aged 14-17 years (83%).

The overall average score for self-management from 401 respondents was 35. For prescription management, the average score was 59 from 288 respondents, and the average transfer planning score was 17 from 367 respondents. Self-management and transfer planning scores both improved with age (P = .0001). Self-management scores rose from an average of 20 at age 14 to an average of 64 at age 18 and older. Transfer planning scores increased from an average of 1 at age 14 to an average of 49 at age 18 and older. Prescription management scores remained high across all ages, from an average of 59 at age 14 to an average score of 66 at age 18 and older (P = .044). Although the scores did not statistically vary by age or race, Hispanic patients did score higher in self-management with an average of 44.5, compared with 31 among other patients (P = .0001).

Only 21% of patients completed two surveys, and 8.4% completed all three surveys. The average time between the first and second surveys was 4 months, during which there was no statistically significant change in self-management or prescription management scores, but transfer planning scores did increase from 14 to 21 (P = .008) among the 90 patients who completed those surveys.

The researchers concluded from their analysis that “participation in the transition pathway can rapidly improve transfer planning scores, [but] opportunities remain to improve readiness in all domains.” The researchers are in the process of developing Spanish-language surveys.

No external funding was noted for either study. Dr. Bridges, Dr. Hersh, and Ms. Nasto reported no relevant financial relationships.

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

NEW ORLEANS – Implementing a pediatric transition program in which a patient meets with both their pediatric and soon-to-be adult rheumatologist during a visit before formal transition resulted in less time setting up the first adult visit, according to research presented at the Pediatric Rheumatology Symposium.

The presentation was one of two that focused on ways to improve the transition from pediatric to adult care for rheumatology patients. The other, a poster from researchers at Baylor College of Medicine, Houston, took the first steps toward learning what factors can help predict a successful transition.

Tara Haelle

“This period of transitioning from pediatric to adult care, both rheumatology specific and otherwise, is a high-risk time,” John M. Bridges, MD, a fourth-year pediatric rheumatology fellow at the University of Alabama at Birmingham, told attendees. “There are changes in insurance coverage, employment, geographic mobility, and shifting responsibilities between parents and children in the setting of a still-developing frontal lobe that contribute to the risk of this period. Risks include disease flare, and then organ damage, as well as issues with decreasing medication and therapy, adherence, unscheduled care utilization, and increasing loss to follow-up.”

Dr. Bridges developed a structured transition program called the Bridge to Adult Care from Childhood for Young Adults with Rheumatic Disease (BACC YARD) aimed at improving the pediatric transition period. The analysis he presented focused specifically on reducing loss to follow-up by introducing a pretransfer visit with both rheumatologists. The patient first meets with their pediatric rheumatologist.

During that visit, the adult rheumatologist attends and discusses the patient’s history and current therapy with the pediatric rheumatologist before entering the patient’s room and having “a brief introductory conversation, a sort of verbal handoff and handshake, in front of the patient,” Dr. Bridges explained. “Then I assume responsibility for this patient and their next visit is to see me, both proverbially and literally down the street at the adulthood rheumatology clinic, where this patient becomes a part of my continuity cohort.”

Bridges entered patients from this BACC YARD cohort into an observational registry that included their dual provider pretransfer visit and a posttransfer visit, occurring between July 2020 and May 2022. He compared these patients with a historical control cohort of 45 patients from March 2018 to March 2020, who had at least two pediatric rheumatology visits prior to their transfer to adult care and no documentation of outside rheumatology visits during the study period. Specifically, he examined at the requested and actual interval between patients’ final pediatric rheumatology visit and their first adult rheumatology visit.

The intervention cohort included 86 patients, mostly female (73%), with a median age of 20. About two-thirds were White (65%) and one-third (34%) were Black. One patient was Asian, and 7% were Hispanic. Just over half the patients had juvenile idiopathic arthritis (58%), and 30% had lupus and related connective tissue diseases. The other patients had vasculitis, uveitis, inflammatory myopathy, relapsing polychondritis, morphea, or syndrome of undifferentiated recurrent fever.

A total of 8% of these patients had previously been lost to follow-up at Children’s of Alabama before they re-established rheumatology care at UAB, and 3.5% came from a pediatric rheumatologist from somewhere other than Children’s of Alabama but established adult care at UAB through the BACC YARD program. Among the remaining patients, 65% (n = 56) had both a dual provider pretransfer visit and a posttransfer visit.

The BACC YARD patients requested their next rheumatology visit (the first adult one) a median 119 days after their last pediatric visit, and the actual time until that visit was a median 141 days (P < .05). By comparison, the 45 patients in the historical control group had a median 261 days between their last pediatric visit and their first adult visit (P < .001). The median days between visits was shorter for those with JIA (129 days) and lupus (119 days) than for patients with other conditions (149 days).

Bridges acknowledged that the study was limited by the small size of the cohort and potential contextual factors related to individual patients’ circumstances.

“We’re continuing to make iterative changes to this process to try to continue to improve the transition and its outcomes in this cohort,” Dr. Bridges said.

Aimee Hersh, MD, an associate professor of pediatric rheumatology and division chief of pediatric rheumatology at the University of Utah and Primary Children’s Hospital, both in Salt Lake City, attended the presentation and noted that the University of Utah has a very similar transfer program.

“I think one of the challenges of that model, and our model, is that you have to have a very specific type of physician who is both [medical-pediatrics] trained and has a specific interest in transition,” Dr. Hersh said in an interview. She noted that the adult rheumatologist at her institution didn’t train in pediatric rheumatology but did complete a meds-peds residency. “So if you can find an adult rheumatologist who can do something similar, can see older adolescent patients and serve as that transition bridge, then I think it is feasible.”

For practices that don’t have the resources for this kind of program, Dr. Hersh recommended the Got Transition program, which provides transition guidance that can be applied to any adolescent population with chronic illness.

The other study, led by Kristiana Nasto, BS, a third-year medical student at Baylor College of Medicine, reported on the findings from one aspect of a program also developed to improve the transition from pediatric to adult care for rheumatology patients. It included periodic self-reported evaluation using the validated Adolescent Assessment of Preparation for Transition (ADAPT) survey. As the first step to better understanding the factors that can predict successful transition, the researchers surveyed returning patients with any rheumatologic diagnosis, aged 14 years and older, between July 2021 and November 2022.

Since the survey was automated through the electronic medical record, patients and their caregivers could respond during in-person or virtual visit check-in. The researchers calculated three composite scores out of 100 for self-management, prescription management, and transfer planning, using responses from the ADAPT survey. Among 462 patients who returned 670 surveys, 87% provided surveys that could be scored for at least one composite score. Most respondents were female (75%), White (69%), non-Hispanic (64%), English speaking (90%), and aged 14-17 years (83%).

The overall average score for self-management from 401 respondents was 35. For prescription management, the average score was 59 from 288 respondents, and the average transfer planning score was 17 from 367 respondents. Self-management and transfer planning scores both improved with age (P = .0001). Self-management scores rose from an average of 20 at age 14 to an average of 64 at age 18 and older. Transfer planning scores increased from an average of 1 at age 14 to an average of 49 at age 18 and older. Prescription management scores remained high across all ages, from an average of 59 at age 14 to an average score of 66 at age 18 and older (P = .044). Although the scores did not statistically vary by age or race, Hispanic patients did score higher in self-management with an average of 44.5, compared with 31 among other patients (P = .0001).

Only 21% of patients completed two surveys, and 8.4% completed all three surveys. The average time between the first and second surveys was 4 months, during which there was no statistically significant change in self-management or prescription management scores, but transfer planning scores did increase from 14 to 21 (P = .008) among the 90 patients who completed those surveys.

The researchers concluded from their analysis that “participation in the transition pathway can rapidly improve transfer planning scores, [but] opportunities remain to improve readiness in all domains.” The researchers are in the process of developing Spanish-language surveys.

No external funding was noted for either study. Dr. Bridges, Dr. Hersh, and Ms. Nasto reported no relevant financial relationships.

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

NEW ORLEANS – Implementing a pediatric transition program in which a patient meets with both their pediatric and soon-to-be adult rheumatologist during a visit before formal transition resulted in less time setting up the first adult visit, according to research presented at the Pediatric Rheumatology Symposium.

The presentation was one of two that focused on ways to improve the transition from pediatric to adult care for rheumatology patients. The other, a poster from researchers at Baylor College of Medicine, Houston, took the first steps toward learning what factors can help predict a successful transition.

Tara Haelle

“This period of transitioning from pediatric to adult care, both rheumatology specific and otherwise, is a high-risk time,” John M. Bridges, MD, a fourth-year pediatric rheumatology fellow at the University of Alabama at Birmingham, told attendees. “There are changes in insurance coverage, employment, geographic mobility, and shifting responsibilities between parents and children in the setting of a still-developing frontal lobe that contribute to the risk of this period. Risks include disease flare, and then organ damage, as well as issues with decreasing medication and therapy, adherence, unscheduled care utilization, and increasing loss to follow-up.”

Dr. Bridges developed a structured transition program called the Bridge to Adult Care from Childhood for Young Adults with Rheumatic Disease (BACC YARD) aimed at improving the pediatric transition period. The analysis he presented focused specifically on reducing loss to follow-up by introducing a pretransfer visit with both rheumatologists. The patient first meets with their pediatric rheumatologist.

During that visit, the adult rheumatologist attends and discusses the patient’s history and current therapy with the pediatric rheumatologist before entering the patient’s room and having “a brief introductory conversation, a sort of verbal handoff and handshake, in front of the patient,” Dr. Bridges explained. “Then I assume responsibility for this patient and their next visit is to see me, both proverbially and literally down the street at the adulthood rheumatology clinic, where this patient becomes a part of my continuity cohort.”

Bridges entered patients from this BACC YARD cohort into an observational registry that included their dual provider pretransfer visit and a posttransfer visit, occurring between July 2020 and May 2022. He compared these patients with a historical control cohort of 45 patients from March 2018 to March 2020, who had at least two pediatric rheumatology visits prior to their transfer to adult care and no documentation of outside rheumatology visits during the study period. Specifically, he examined at the requested and actual interval between patients’ final pediatric rheumatology visit and their first adult rheumatology visit.

The intervention cohort included 86 patients, mostly female (73%), with a median age of 20. About two-thirds were White (65%) and one-third (34%) were Black. One patient was Asian, and 7% were Hispanic. Just over half the patients had juvenile idiopathic arthritis (58%), and 30% had lupus and related connective tissue diseases. The other patients had vasculitis, uveitis, inflammatory myopathy, relapsing polychondritis, morphea, or syndrome of undifferentiated recurrent fever.

A total of 8% of these patients had previously been lost to follow-up at Children’s of Alabama before they re-established rheumatology care at UAB, and 3.5% came from a pediatric rheumatologist from somewhere other than Children’s of Alabama but established adult care at UAB through the BACC YARD program. Among the remaining patients, 65% (n = 56) had both a dual provider pretransfer visit and a posttransfer visit.

The BACC YARD patients requested their next rheumatology visit (the first adult one) a median 119 days after their last pediatric visit, and the actual time until that visit was a median 141 days (P < .05). By comparison, the 45 patients in the historical control group had a median 261 days between their last pediatric visit and their first adult visit (P < .001). The median days between visits was shorter for those with JIA (129 days) and lupus (119 days) than for patients with other conditions (149 days).

Bridges acknowledged that the study was limited by the small size of the cohort and potential contextual factors related to individual patients’ circumstances.

“We’re continuing to make iterative changes to this process to try to continue to improve the transition and its outcomes in this cohort,” Dr. Bridges said.

Aimee Hersh, MD, an associate professor of pediatric rheumatology and division chief of pediatric rheumatology at the University of Utah and Primary Children’s Hospital, both in Salt Lake City, attended the presentation and noted that the University of Utah has a very similar transfer program.

“I think one of the challenges of that model, and our model, is that you have to have a very specific type of physician who is both [medical-pediatrics] trained and has a specific interest in transition,” Dr. Hersh said in an interview. She noted that the adult rheumatologist at her institution didn’t train in pediatric rheumatology but did complete a meds-peds residency. “So if you can find an adult rheumatologist who can do something similar, can see older adolescent patients and serve as that transition bridge, then I think it is feasible.”

For practices that don’t have the resources for this kind of program, Dr. Hersh recommended the Got Transition program, which provides transition guidance that can be applied to any adolescent population with chronic illness.

The other study, led by Kristiana Nasto, BS, a third-year medical student at Baylor College of Medicine, reported on the findings from one aspect of a program also developed to improve the transition from pediatric to adult care for rheumatology patients. It included periodic self-reported evaluation using the validated Adolescent Assessment of Preparation for Transition (ADAPT) survey. As the first step to better understanding the factors that can predict successful transition, the researchers surveyed returning patients with any rheumatologic diagnosis, aged 14 years and older, between July 2021 and November 2022.

Since the survey was automated through the electronic medical record, patients and their caregivers could respond during in-person or virtual visit check-in. The researchers calculated three composite scores out of 100 for self-management, prescription management, and transfer planning, using responses from the ADAPT survey. Among 462 patients who returned 670 surveys, 87% provided surveys that could be scored for at least one composite score. Most respondents were female (75%), White (69%), non-Hispanic (64%), English speaking (90%), and aged 14-17 years (83%).

The overall average score for self-management from 401 respondents was 35. For prescription management, the average score was 59 from 288 respondents, and the average transfer planning score was 17 from 367 respondents. Self-management and transfer planning scores both improved with age (P = .0001). Self-management scores rose from an average of 20 at age 14 to an average of 64 at age 18 and older. Transfer planning scores increased from an average of 1 at age 14 to an average of 49 at age 18 and older. Prescription management scores remained high across all ages, from an average of 59 at age 14 to an average score of 66 at age 18 and older (P = .044). Although the scores did not statistically vary by age or race, Hispanic patients did score higher in self-management with an average of 44.5, compared with 31 among other patients (P = .0001).

Only 21% of patients completed two surveys, and 8.4% completed all three surveys. The average time between the first and second surveys was 4 months, during which there was no statistically significant change in self-management or prescription management scores, but transfer planning scores did increase from 14 to 21 (P = .008) among the 90 patients who completed those surveys.

The researchers concluded from their analysis that “participation in the transition pathway can rapidly improve transfer planning scores, [but] opportunities remain to improve readiness in all domains.” The researchers are in the process of developing Spanish-language surveys.

No external funding was noted for either study. Dr. Bridges, Dr. Hersh, and Ms. Nasto reported no relevant financial relationships.

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

NEW ORLEANS – The sociodemographic characteristics of Black and Hispanic children with systemic lupus erythematosus (SLE) appear to play a strong role in influencing the severity of disease in these patients, according to two studies presented at the Pediatric Rheumatology Symposium.

One study showed an association between multiple determinants of health and disease severity among children seen in a large Texas city, and a separate descriptive cross-sectional cohort study of predominantly Black children at two centers in Mississippi and Alabama reinforced the finding of greater severity of disease and social hardships among this racial group.

The findings from both studies supplement existing evidence that the prevalence of childhood-onset SLE is greater among Black and Hispanic children.

“Several demographic and social determinants of health parameters influenced disease severity at levels that reached statistical significance, including insurance status, race/ethnicity, referral source, PCP [primary care provider] availability, primary language, and transportation needs,” Emily Beil, MD, a pediatric rheumatologist at Texas Children’s Hospital in Houston, told attendees at the conference, which was sponsored by the American College of Rheumatology. Her team’s goal, she said, was to “better understand our patient population and social disparities that contribute to disease severity.”

Dr. Beil and her colleagues conducted a retrospective review of 136 children who had been diagnosed with childhood-onset SLE between January 2018 and May 2022 at Texas Children’s Hospital. Only children who were younger than 18 years at the time of diagnosis at Texas Children’s were included. The analysis considered demographics, clinical characteristics, insurance status, social work consultation, access to a primary care provider, transportation needs, primary language, and other parameters related to social determinants of health.

The average age of the patients was 13 years, and most were girls (82%). Just over half were Hispanic (53%), and just over a quarter were Black (26%). Half had Medicaid or participated in the Children’s Health Insurance Program (CHIP), and 1 in 10 were uninsured (10%). Half the diagnoses were made during an inpatient admission; 36% were made on the floor, and 14% were made in the intensive care unit (ICU).

The average Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score was 12.5, and 48.5% of patients had severe disease, indicated by a score of at least 12. Only two in three children were documented as having a primary care physician (66%), and 32% preferred a language other than English. Most of the children (80%) had a social work consult.

Black and biracial children had higher SLEDAI scores at presentation. Non-Hispanic White children were less likely to have a social work consult, compared with other racial/ethnic groups (P = .01 for both). Central nervous system involvement was most prevalent among Black patients (P = .004). Cyclophosphamide was used most often for Black and biracial patients.

Uninsured patients were most likely to be diagnosed on an inpatient floor. The highest proportion of ICU admissions was among patients insured by Medicaid (P = .034). Average SLEDAI scores were highest among uninsured patients, followed by Medicaid patients. More than half of the patients who did not have insurance lacked access to a regular primary care provider, compared with 12% of Medicaid patients and 7% of privately insured patients (P = .001). All the uninsured patients had transportation needs, which was a significantly higher rate than among those with Medicaid (13%) or private insurance (15%) (P = .001). The highest percentage of social work consults was among patients who were insured by Medicaid or were without insurance (P = .001).
 

Salient demographics and clinical features

In the second presentation, Anita Dhanrajani, MD, assistant professor of pediatrics at the University of Mississippi Medical Center in Jackson, began by noting that Alabama and Mississippi are ranked in the top 10 states for the highest poverty rate: Mississippi is No. 1, and Alabama is No. 7. Further, 40% of children in Mississippi and 29% of children in Alabama are of African American ancestry, she said.

“So, we know that this population that we’re dealing with has several high-risk factors that can lead them to have poor outcomes, and yet, we haven’t really ever characterized their clinical features or their social demographic features,” Dr. Dhanrajani told attendees. “My hope is that with this very miniscule first step, we’re able to move towards solutions to decrease health care disparities in this population.”

She presented findings regarding the first of three aims in the study, which was to describe the baseline clinical, demographic, and socioeconomic profiles of childhood lupus patients at the two centers. The two other aims were to examine genetic factors potentially linked to poor outcomes in the cohort and to assess the mental health status of the population.

The study relied on a retrospective chart review for the 17 patients at the University of Mississippi Medical Center and on Childhood Arthritis and Rheumatology Research Alliance registry data for the 19 patients at the University of Alabama at Birmingham. Most of the patients (86%) were female, Black (78%), and insured by Medicaid (64%). The average age at diagnosis was 13 years. Most (83%) also lived in a ZIP code that met the criteria for a medium-high or high Social Vulnerability Index. The children had to travel an average 75 miles to see a rheumatologist, compared with the national average of 43 miles.

At diagnosis, their average Systemic Lupus International Collaborating Clinics (SLICC) score was 8.8, their average American College of Rheumatology score was 5.2, and their average SLEDAI score was 12.1 – the latter was substantially higher than the average 3.1 score in a multiethnic Canadian cohort (the 1000 Canadian Faces of Lupus Study) with 10% Black children (P < .00001). The SLEDAI score dropped to 6.8 at 6 months and to 4 at 1 year. Nearly half (47%) had a SLICC Damage Index (SDI) greater than 0, and one-third had an SDI of 2 or greater, compared with 16% and 7%, respectively, reported in other recent studies (P < .0001 for both).

“These disparities are very difficult to investigate in terms of causal relationships and [are] likely to be very modifiable,” Coziana Ciurtin, MD, PhD, associate professor of rheumatology at University College London, told this news organization. “I think the socioeconomic status, the level of education, poverty, [type of] medical insurance, and probably genetic variants are all underpinning the presentation, damage, or disease activity being very high, and also organ involvement,” such as the greater CNS involvement seen in non-White patients.

Being mindful of these risk profiles can help doctors in asking about patients’ support at home and their families’ education, beliefs, and cultural practices, Dr. Ciurtin added. “Helping them to engage and be involved in decision-making is probably the most important” aspect of learning this information about families, she said.

Collecting this information should not be the sole responsibility of the physician, added Eve Smith, PhD, MBCHB, an academic clinical lecturer at the University of Liverpool, England, who attended the presentations. Dr. Smith noted a discussion in a work group during the previous day of the conference concerning questionnaires for screening patients regarding the need for social services and for identifying areas in which patients and their families were having difficulties.

“Obviously, if you’re going to do that, you have to have access to someone who can actually help to deal with that. Some hospitals have patient navigators that can help, for example, with a food security issue to highlight resources within the community, so it’s not all on the doctor,” Dr. Smith said. “To really make a difference in this area, it can’t just be down to the doctor. There needs to be social care, there needs to be community-based interventions and things to do about it. Doctors can help identify these patients, or maybe somebody in the [medical] team can help with that, but there needs to be an intervention. Otherwise, you’re left with this problem without a solution that you can’t do anything about.”

The researchers did not note any external funding for either study. Dr. Beil, Dr. Dhanrajani, Dr. Smith, and Dr. Ciurtin reported no relevant financial relationships.

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

NEW ORLEANS – The sociodemographic characteristics of Black and Hispanic children with systemic lupus erythematosus (SLE) appear to play a strong role in influencing the severity of disease in these patients, according to two studies presented at the Pediatric Rheumatology Symposium.

One study showed an association between multiple determinants of health and disease severity among children seen in a large Texas city, and a separate descriptive cross-sectional cohort study of predominantly Black children at two centers in Mississippi and Alabama reinforced the finding of greater severity of disease and social hardships among this racial group.

The findings from both studies supplement existing evidence that the prevalence of childhood-onset SLE is greater among Black and Hispanic children.

“Several demographic and social determinants of health parameters influenced disease severity at levels that reached statistical significance, including insurance status, race/ethnicity, referral source, PCP [primary care provider] availability, primary language, and transportation needs,” Emily Beil, MD, a pediatric rheumatologist at Texas Children’s Hospital in Houston, told attendees at the conference, which was sponsored by the American College of Rheumatology. Her team’s goal, she said, was to “better understand our patient population and social disparities that contribute to disease severity.”

Dr. Beil and her colleagues conducted a retrospective review of 136 children who had been diagnosed with childhood-onset SLE between January 2018 and May 2022 at Texas Children’s Hospital. Only children who were younger than 18 years at the time of diagnosis at Texas Children’s were included. The analysis considered demographics, clinical characteristics, insurance status, social work consultation, access to a primary care provider, transportation needs, primary language, and other parameters related to social determinants of health.

The average age of the patients was 13 years, and most were girls (82%). Just over half were Hispanic (53%), and just over a quarter were Black (26%). Half had Medicaid or participated in the Children’s Health Insurance Program (CHIP), and 1 in 10 were uninsured (10%). Half the diagnoses were made during an inpatient admission; 36% were made on the floor, and 14% were made in the intensive care unit (ICU).

The average Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score was 12.5, and 48.5% of patients had severe disease, indicated by a score of at least 12. Only two in three children were documented as having a primary care physician (66%), and 32% preferred a language other than English. Most of the children (80%) had a social work consult.

Black and biracial children had higher SLEDAI scores at presentation. Non-Hispanic White children were less likely to have a social work consult, compared with other racial/ethnic groups (P = .01 for both). Central nervous system involvement was most prevalent among Black patients (P = .004). Cyclophosphamide was used most often for Black and biracial patients.

Uninsured patients were most likely to be diagnosed on an inpatient floor. The highest proportion of ICU admissions was among patients insured by Medicaid (P = .034). Average SLEDAI scores were highest among uninsured patients, followed by Medicaid patients. More than half of the patients who did not have insurance lacked access to a regular primary care provider, compared with 12% of Medicaid patients and 7% of privately insured patients (P = .001). All the uninsured patients had transportation needs, which was a significantly higher rate than among those with Medicaid (13%) or private insurance (15%) (P = .001). The highest percentage of social work consults was among patients who were insured by Medicaid or were without insurance (P = .001).
 

Salient demographics and clinical features

In the second presentation, Anita Dhanrajani, MD, assistant professor of pediatrics at the University of Mississippi Medical Center in Jackson, began by noting that Alabama and Mississippi are ranked in the top 10 states for the highest poverty rate: Mississippi is No. 1, and Alabama is No. 7. Further, 40% of children in Mississippi and 29% of children in Alabama are of African American ancestry, she said.

“So, we know that this population that we’re dealing with has several high-risk factors that can lead them to have poor outcomes, and yet, we haven’t really ever characterized their clinical features or their social demographic features,” Dr. Dhanrajani told attendees. “My hope is that with this very miniscule first step, we’re able to move towards solutions to decrease health care disparities in this population.”

She presented findings regarding the first of three aims in the study, which was to describe the baseline clinical, demographic, and socioeconomic profiles of childhood lupus patients at the two centers. The two other aims were to examine genetic factors potentially linked to poor outcomes in the cohort and to assess the mental health status of the population.

The study relied on a retrospective chart review for the 17 patients at the University of Mississippi Medical Center and on Childhood Arthritis and Rheumatology Research Alliance registry data for the 19 patients at the University of Alabama at Birmingham. Most of the patients (86%) were female, Black (78%), and insured by Medicaid (64%). The average age at diagnosis was 13 years. Most (83%) also lived in a ZIP code that met the criteria for a medium-high or high Social Vulnerability Index. The children had to travel an average 75 miles to see a rheumatologist, compared with the national average of 43 miles.

At diagnosis, their average Systemic Lupus International Collaborating Clinics (SLICC) score was 8.8, their average American College of Rheumatology score was 5.2, and their average SLEDAI score was 12.1 – the latter was substantially higher than the average 3.1 score in a multiethnic Canadian cohort (the 1000 Canadian Faces of Lupus Study) with 10% Black children (P < .00001). The SLEDAI score dropped to 6.8 at 6 months and to 4 at 1 year. Nearly half (47%) had a SLICC Damage Index (SDI) greater than 0, and one-third had an SDI of 2 or greater, compared with 16% and 7%, respectively, reported in other recent studies (P < .0001 for both).

“These disparities are very difficult to investigate in terms of causal relationships and [are] likely to be very modifiable,” Coziana Ciurtin, MD, PhD, associate professor of rheumatology at University College London, told this news organization. “I think the socioeconomic status, the level of education, poverty, [type of] medical insurance, and probably genetic variants are all underpinning the presentation, damage, or disease activity being very high, and also organ involvement,” such as the greater CNS involvement seen in non-White patients.

Being mindful of these risk profiles can help doctors in asking about patients’ support at home and their families’ education, beliefs, and cultural practices, Dr. Ciurtin added. “Helping them to engage and be involved in decision-making is probably the most important” aspect of learning this information about families, she said.

Collecting this information should not be the sole responsibility of the physician, added Eve Smith, PhD, MBCHB, an academic clinical lecturer at the University of Liverpool, England, who attended the presentations. Dr. Smith noted a discussion in a work group during the previous day of the conference concerning questionnaires for screening patients regarding the need for social services and for identifying areas in which patients and their families were having difficulties.

“Obviously, if you’re going to do that, you have to have access to someone who can actually help to deal with that. Some hospitals have patient navigators that can help, for example, with a food security issue to highlight resources within the community, so it’s not all on the doctor,” Dr. Smith said. “To really make a difference in this area, it can’t just be down to the doctor. There needs to be social care, there needs to be community-based interventions and things to do about it. Doctors can help identify these patients, or maybe somebody in the [medical] team can help with that, but there needs to be an intervention. Otherwise, you’re left with this problem without a solution that you can’t do anything about.”

The researchers did not note any external funding for either study. Dr. Beil, Dr. Dhanrajani, Dr. Smith, and Dr. Ciurtin reported no relevant financial relationships.

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

NEW ORLEANS – The sociodemographic characteristics of Black and Hispanic children with systemic lupus erythematosus (SLE) appear to play a strong role in influencing the severity of disease in these patients, according to two studies presented at the Pediatric Rheumatology Symposium.

One study showed an association between multiple determinants of health and disease severity among children seen in a large Texas city, and a separate descriptive cross-sectional cohort study of predominantly Black children at two centers in Mississippi and Alabama reinforced the finding of greater severity of disease and social hardships among this racial group.

The findings from both studies supplement existing evidence that the prevalence of childhood-onset SLE is greater among Black and Hispanic children.

“Several demographic and social determinants of health parameters influenced disease severity at levels that reached statistical significance, including insurance status, race/ethnicity, referral source, PCP [primary care provider] availability, primary language, and transportation needs,” Emily Beil, MD, a pediatric rheumatologist at Texas Children’s Hospital in Houston, told attendees at the conference, which was sponsored by the American College of Rheumatology. Her team’s goal, she said, was to “better understand our patient population and social disparities that contribute to disease severity.”

Dr. Beil and her colleagues conducted a retrospective review of 136 children who had been diagnosed with childhood-onset SLE between January 2018 and May 2022 at Texas Children’s Hospital. Only children who were younger than 18 years at the time of diagnosis at Texas Children’s were included. The analysis considered demographics, clinical characteristics, insurance status, social work consultation, access to a primary care provider, transportation needs, primary language, and other parameters related to social determinants of health.

The average age of the patients was 13 years, and most were girls (82%). Just over half were Hispanic (53%), and just over a quarter were Black (26%). Half had Medicaid or participated in the Children’s Health Insurance Program (CHIP), and 1 in 10 were uninsured (10%). Half the diagnoses were made during an inpatient admission; 36% were made on the floor, and 14% were made in the intensive care unit (ICU).

The average Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score was 12.5, and 48.5% of patients had severe disease, indicated by a score of at least 12. Only two in three children were documented as having a primary care physician (66%), and 32% preferred a language other than English. Most of the children (80%) had a social work consult.

Black and biracial children had higher SLEDAI scores at presentation. Non-Hispanic White children were less likely to have a social work consult, compared with other racial/ethnic groups (P = .01 for both). Central nervous system involvement was most prevalent among Black patients (P = .004). Cyclophosphamide was used most often for Black and biracial patients.

Uninsured patients were most likely to be diagnosed on an inpatient floor. The highest proportion of ICU admissions was among patients insured by Medicaid (P = .034). Average SLEDAI scores were highest among uninsured patients, followed by Medicaid patients. More than half of the patients who did not have insurance lacked access to a regular primary care provider, compared with 12% of Medicaid patients and 7% of privately insured patients (P = .001). All the uninsured patients had transportation needs, which was a significantly higher rate than among those with Medicaid (13%) or private insurance (15%) (P = .001). The highest percentage of social work consults was among patients who were insured by Medicaid or were without insurance (P = .001).
 

Salient demographics and clinical features

In the second presentation, Anita Dhanrajani, MD, assistant professor of pediatrics at the University of Mississippi Medical Center in Jackson, began by noting that Alabama and Mississippi are ranked in the top 10 states for the highest poverty rate: Mississippi is No. 1, and Alabama is No. 7. Further, 40% of children in Mississippi and 29% of children in Alabama are of African American ancestry, she said.

“So, we know that this population that we’re dealing with has several high-risk factors that can lead them to have poor outcomes, and yet, we haven’t really ever characterized their clinical features or their social demographic features,” Dr. Dhanrajani told attendees. “My hope is that with this very miniscule first step, we’re able to move towards solutions to decrease health care disparities in this population.”

She presented findings regarding the first of three aims in the study, which was to describe the baseline clinical, demographic, and socioeconomic profiles of childhood lupus patients at the two centers. The two other aims were to examine genetic factors potentially linked to poor outcomes in the cohort and to assess the mental health status of the population.

The study relied on a retrospective chart review for the 17 patients at the University of Mississippi Medical Center and on Childhood Arthritis and Rheumatology Research Alliance registry data for the 19 patients at the University of Alabama at Birmingham. Most of the patients (86%) were female, Black (78%), and insured by Medicaid (64%). The average age at diagnosis was 13 years. Most (83%) also lived in a ZIP code that met the criteria for a medium-high or high Social Vulnerability Index. The children had to travel an average 75 miles to see a rheumatologist, compared with the national average of 43 miles.

At diagnosis, their average Systemic Lupus International Collaborating Clinics (SLICC) score was 8.8, their average American College of Rheumatology score was 5.2, and their average SLEDAI score was 12.1 – the latter was substantially higher than the average 3.1 score in a multiethnic Canadian cohort (the 1000 Canadian Faces of Lupus Study) with 10% Black children (P < .00001). The SLEDAI score dropped to 6.8 at 6 months and to 4 at 1 year. Nearly half (47%) had a SLICC Damage Index (SDI) greater than 0, and one-third had an SDI of 2 or greater, compared with 16% and 7%, respectively, reported in other recent studies (P < .0001 for both).

“These disparities are very difficult to investigate in terms of causal relationships and [are] likely to be very modifiable,” Coziana Ciurtin, MD, PhD, associate professor of rheumatology at University College London, told this news organization. “I think the socioeconomic status, the level of education, poverty, [type of] medical insurance, and probably genetic variants are all underpinning the presentation, damage, or disease activity being very high, and also organ involvement,” such as the greater CNS involvement seen in non-White patients.

Being mindful of these risk profiles can help doctors in asking about patients’ support at home and their families’ education, beliefs, and cultural practices, Dr. Ciurtin added. “Helping them to engage and be involved in decision-making is probably the most important” aspect of learning this information about families, she said.

Collecting this information should not be the sole responsibility of the physician, added Eve Smith, PhD, MBCHB, an academic clinical lecturer at the University of Liverpool, England, who attended the presentations. Dr. Smith noted a discussion in a work group during the previous day of the conference concerning questionnaires for screening patients regarding the need for social services and for identifying areas in which patients and their families were having difficulties.

“Obviously, if you’re going to do that, you have to have access to someone who can actually help to deal with that. Some hospitals have patient navigators that can help, for example, with a food security issue to highlight resources within the community, so it’s not all on the doctor,” Dr. Smith said. “To really make a difference in this area, it can’t just be down to the doctor. There needs to be social care, there needs to be community-based interventions and things to do about it. Doctors can help identify these patients, or maybe somebody in the [medical] team can help with that, but there needs to be an intervention. Otherwise, you’re left with this problem without a solution that you can’t do anything about.”

The researchers did not note any external funding for either study. Dr. Beil, Dr. Dhanrajani, Dr. Smith, and Dr. Ciurtin reported no relevant financial relationships.

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

NEW ORLEANS – More than one-third of pediatric residency programs do not have a pediatric rheumatologist on faculty, a situation that has changed little since 2004, according to a poster presented at the Pediatric Rheumatology Symposium 2023 conference.

“This shortage has significant downstream effects,” according to author Miriah Gillispie-Taylor, MD, an assistant professor of pediatric rheumatology at Baylor College of Medicine and Texas Children’s Hospital in Houston. Without adequate education, it’s unreasonable to expect that a pediatrician will recognize the great diversity of presentations among rheumatic diseases, for example. “Without recognition, patients are not referred in a timely manner, and earlier identification and treatment of rheumatic diseases leads to improved outcomes,” Dr. Gillispie-Taylor said.

Currently, eight U.S. states do not have a board-certified pediatric rheumatologist, including Alaska. Dr. Gillispie-Taylor cited a 2006 study that found that one-third of medical schools (33%) and 40% of U.S. pediatric residency programs did not have an on-site pediatric rheumatologist in 2004.

As the long-standing workforce shortage in pediatric rheumatology continues, Dr. Gillispie-Taylor and her colleagues investigated whether increasing awareness of this problem has influenced the number of United States and Puerto Rico residency training programs with pediatric rheumatology faculty from 2004 to present.

The researchers identified 212 pediatric residency programs accredited by the Accreditation Council for Graduate Medical Education for 2022-2023 and reviewed their program website to see which ones had affiliated pediatric rheumatology faculty. After determining the faculty from the website for 85% of the programs, the researchers emailed the other programs to find out whether a pediatric rheumatologist was on faculty, filling out another 6% of the programs. Most of the remaining uncategorized programs (7%) were categorized at a meeting of the Childhood Arthritis and Rheumatology Research Alliance medical education workgroup. Only 2% of programs could not be ultimately categorized.

The region with the greatest proportion of pediatric residency programs that had a pediatric rheumatologist was the Southeast, where 95% (36 of 38 programs) of programs had one on faculty. The Southwest, comprising Texas, Oklahoma, New Mexico, and Arizona, had the lowest proportion: 43% (9 of 21 programs). For the other regions, 69% of the West/Pacific Northwest (18 of 26), 62% of the Midwest (28 of 45), and 61% of the Northeast (39 of 64) programs had a pediatric rheumatologist on faculty. Three of Puerto Rico’s four programs had one as well.

Overall, 63% of programs had a pediatric rheumatologist on faculty, and 36% did not; the state of three programs was unknown.

The large proportion of programs without a pediatric rheumatologist “limits exposure to rheumatologic conditions and learning opportunities during residency and contribute to declining fellow match rates,” the authors concluded. They noted that only 62.8% of pediatric rheumatology fellowship positions were filled in 2022, down slightly from the 69.2% filled in 2021, according to report data from the National Matching Resident Program.

The researchers acknowledged that their results could be skewed if website information was outdated for any programs, and it’s difficult to determine which programs might lack resources on the basis of only publicly available information. Though programs without pediatric rheumatologists might benefit from visiting professorships, it can be difficult to identify which ones, they added.

The authors recommend two next steps: one, establishing areas of essential knowledge in pediatric rheumatology to enable the creation of learning objectives so programs can focus their educational efforts; and two, continuing efforts to understand residents’ motivation to pursue fellowships in pediatric rheumatology for the purpose of improving recruitment.

Two medical students at Dr. Gillispie-Taylor’s institution spoke with this news organization about their thoughts on the findings and how they were approaching their own career goals in medicine in light of these findings.

Kyla Fergason, a second-year medical student at Baylor College of Medicine, said that she thinks she wants to pursue pediatrics or meds-peds. Though she’s not sure whether she specifically wants to pursue pediatric rheumatology, she is very interested in the area and said that she has learned much from the Pediatric Rheumatology Symposium conference. She found the dearth of pediatric rheumatology faculty at residency programs worrisome, particularly in states like Alaska and Hawaii because they aren’t contiguous with the rest of the United States. Only three pediatric rheumatologists are practicing in Hawaii.

“It’s really concerning that sometimes there is not any rheumatologist there to see the patient,” Ms. Fergason told this news organization. “These are diseases that affect people chronically throughout their entire lives, so it’s definitely concerning to think that, at a time when they could be helped and there could be interventions made, none are made because there’s just no one available.”

Kristiana Nasto, a third-year medical student at Baylor College of Medicine, is similarly interested in pediatrics but leaning more toward meds-peds and has an interest in rheumatology as well. She was surprised at how many programs had no pediatric rheumatologist on faculty because Baylor has a robust program.

“I was not aware of the fact that other states or other parts of Texas do not have the luxury of the great rheumatologists that we have at Baylor College of Medicine,” Ms. Nasto said. “That can definitely impact care for many patients because some of these rheumatologic diseases are so unique and challenging to treat that they require specialized care, so it makes me a bit sad that this is the case.”

Dr. Gillispie-Taylor has received an educational grant from Pfizer. Ms. Fergason and Ms. Nasto had no disclosures. No external funding was noted for the study.

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

NEW ORLEANS – More than one-third of pediatric residency programs do not have a pediatric rheumatologist on faculty, a situation that has changed little since 2004, according to a poster presented at the Pediatric Rheumatology Symposium 2023 conference.

“This shortage has significant downstream effects,” according to author Miriah Gillispie-Taylor, MD, an assistant professor of pediatric rheumatology at Baylor College of Medicine and Texas Children’s Hospital in Houston. Without adequate education, it’s unreasonable to expect that a pediatrician will recognize the great diversity of presentations among rheumatic diseases, for example. “Without recognition, patients are not referred in a timely manner, and earlier identification and treatment of rheumatic diseases leads to improved outcomes,” Dr. Gillispie-Taylor said.

Currently, eight U.S. states do not have a board-certified pediatric rheumatologist, including Alaska. Dr. Gillispie-Taylor cited a 2006 study that found that one-third of medical schools (33%) and 40% of U.S. pediatric residency programs did not have an on-site pediatric rheumatologist in 2004.

As the long-standing workforce shortage in pediatric rheumatology continues, Dr. Gillispie-Taylor and her colleagues investigated whether increasing awareness of this problem has influenced the number of United States and Puerto Rico residency training programs with pediatric rheumatology faculty from 2004 to present.

The researchers identified 212 pediatric residency programs accredited by the Accreditation Council for Graduate Medical Education for 2022-2023 and reviewed their program website to see which ones had affiliated pediatric rheumatology faculty. After determining the faculty from the website for 85% of the programs, the researchers emailed the other programs to find out whether a pediatric rheumatologist was on faculty, filling out another 6% of the programs. Most of the remaining uncategorized programs (7%) were categorized at a meeting of the Childhood Arthritis and Rheumatology Research Alliance medical education workgroup. Only 2% of programs could not be ultimately categorized.

The region with the greatest proportion of pediatric residency programs that had a pediatric rheumatologist was the Southeast, where 95% (36 of 38 programs) of programs had one on faculty. The Southwest, comprising Texas, Oklahoma, New Mexico, and Arizona, had the lowest proportion: 43% (9 of 21 programs). For the other regions, 69% of the West/Pacific Northwest (18 of 26), 62% of the Midwest (28 of 45), and 61% of the Northeast (39 of 64) programs had a pediatric rheumatologist on faculty. Three of Puerto Rico’s four programs had one as well.

Overall, 63% of programs had a pediatric rheumatologist on faculty, and 36% did not; the state of three programs was unknown.

The large proportion of programs without a pediatric rheumatologist “limits exposure to rheumatologic conditions and learning opportunities during residency and contribute to declining fellow match rates,” the authors concluded. They noted that only 62.8% of pediatric rheumatology fellowship positions were filled in 2022, down slightly from the 69.2% filled in 2021, according to report data from the National Matching Resident Program.

The researchers acknowledged that their results could be skewed if website information was outdated for any programs, and it’s difficult to determine which programs might lack resources on the basis of only publicly available information. Though programs without pediatric rheumatologists might benefit from visiting professorships, it can be difficult to identify which ones, they added.

The authors recommend two next steps: one, establishing areas of essential knowledge in pediatric rheumatology to enable the creation of learning objectives so programs can focus their educational efforts; and two, continuing efforts to understand residents’ motivation to pursue fellowships in pediatric rheumatology for the purpose of improving recruitment.

Two medical students at Dr. Gillispie-Taylor’s institution spoke with this news organization about their thoughts on the findings and how they were approaching their own career goals in medicine in light of these findings.

Kyla Fergason, a second-year medical student at Baylor College of Medicine, said that she thinks she wants to pursue pediatrics or meds-peds. Though she’s not sure whether she specifically wants to pursue pediatric rheumatology, she is very interested in the area and said that she has learned much from the Pediatric Rheumatology Symposium conference. She found the dearth of pediatric rheumatology faculty at residency programs worrisome, particularly in states like Alaska and Hawaii because they aren’t contiguous with the rest of the United States. Only three pediatric rheumatologists are practicing in Hawaii.

“It’s really concerning that sometimes there is not any rheumatologist there to see the patient,” Ms. Fergason told this news organization. “These are diseases that affect people chronically throughout their entire lives, so it’s definitely concerning to think that, at a time when they could be helped and there could be interventions made, none are made because there’s just no one available.”

Kristiana Nasto, a third-year medical student at Baylor College of Medicine, is similarly interested in pediatrics but leaning more toward meds-peds and has an interest in rheumatology as well. She was surprised at how many programs had no pediatric rheumatologist on faculty because Baylor has a robust program.

“I was not aware of the fact that other states or other parts of Texas do not have the luxury of the great rheumatologists that we have at Baylor College of Medicine,” Ms. Nasto said. “That can definitely impact care for many patients because some of these rheumatologic diseases are so unique and challenging to treat that they require specialized care, so it makes me a bit sad that this is the case.”

Dr. Gillispie-Taylor has received an educational grant from Pfizer. Ms. Fergason and Ms. Nasto had no disclosures. No external funding was noted for the study.

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

NEW ORLEANS – More than one-third of pediatric residency programs do not have a pediatric rheumatologist on faculty, a situation that has changed little since 2004, according to a poster presented at the Pediatric Rheumatology Symposium 2023 conference.

“This shortage has significant downstream effects,” according to author Miriah Gillispie-Taylor, MD, an assistant professor of pediatric rheumatology at Baylor College of Medicine and Texas Children’s Hospital in Houston. Without adequate education, it’s unreasonable to expect that a pediatrician will recognize the great diversity of presentations among rheumatic diseases, for example. “Without recognition, patients are not referred in a timely manner, and earlier identification and treatment of rheumatic diseases leads to improved outcomes,” Dr. Gillispie-Taylor said.

Currently, eight U.S. states do not have a board-certified pediatric rheumatologist, including Alaska. Dr. Gillispie-Taylor cited a 2006 study that found that one-third of medical schools (33%) and 40% of U.S. pediatric residency programs did not have an on-site pediatric rheumatologist in 2004.

As the long-standing workforce shortage in pediatric rheumatology continues, Dr. Gillispie-Taylor and her colleagues investigated whether increasing awareness of this problem has influenced the number of United States and Puerto Rico residency training programs with pediatric rheumatology faculty from 2004 to present.

The researchers identified 212 pediatric residency programs accredited by the Accreditation Council for Graduate Medical Education for 2022-2023 and reviewed their program website to see which ones had affiliated pediatric rheumatology faculty. After determining the faculty from the website for 85% of the programs, the researchers emailed the other programs to find out whether a pediatric rheumatologist was on faculty, filling out another 6% of the programs. Most of the remaining uncategorized programs (7%) were categorized at a meeting of the Childhood Arthritis and Rheumatology Research Alliance medical education workgroup. Only 2% of programs could not be ultimately categorized.

The region with the greatest proportion of pediatric residency programs that had a pediatric rheumatologist was the Southeast, where 95% (36 of 38 programs) of programs had one on faculty. The Southwest, comprising Texas, Oklahoma, New Mexico, and Arizona, had the lowest proportion: 43% (9 of 21 programs). For the other regions, 69% of the West/Pacific Northwest (18 of 26), 62% of the Midwest (28 of 45), and 61% of the Northeast (39 of 64) programs had a pediatric rheumatologist on faculty. Three of Puerto Rico’s four programs had one as well.

Overall, 63% of programs had a pediatric rheumatologist on faculty, and 36% did not; the state of three programs was unknown.

The large proportion of programs without a pediatric rheumatologist “limits exposure to rheumatologic conditions and learning opportunities during residency and contribute to declining fellow match rates,” the authors concluded. They noted that only 62.8% of pediatric rheumatology fellowship positions were filled in 2022, down slightly from the 69.2% filled in 2021, according to report data from the National Matching Resident Program.

The researchers acknowledged that their results could be skewed if website information was outdated for any programs, and it’s difficult to determine which programs might lack resources on the basis of only publicly available information. Though programs without pediatric rheumatologists might benefit from visiting professorships, it can be difficult to identify which ones, they added.

The authors recommend two next steps: one, establishing areas of essential knowledge in pediatric rheumatology to enable the creation of learning objectives so programs can focus their educational efforts; and two, continuing efforts to understand residents’ motivation to pursue fellowships in pediatric rheumatology for the purpose of improving recruitment.

Two medical students at Dr. Gillispie-Taylor’s institution spoke with this news organization about their thoughts on the findings and how they were approaching their own career goals in medicine in light of these findings.

Kyla Fergason, a second-year medical student at Baylor College of Medicine, said that she thinks she wants to pursue pediatrics or meds-peds. Though she’s not sure whether she specifically wants to pursue pediatric rheumatology, she is very interested in the area and said that she has learned much from the Pediatric Rheumatology Symposium conference. She found the dearth of pediatric rheumatology faculty at residency programs worrisome, particularly in states like Alaska and Hawaii because they aren’t contiguous with the rest of the United States. Only three pediatric rheumatologists are practicing in Hawaii.

“It’s really concerning that sometimes there is not any rheumatologist there to see the patient,” Ms. Fergason told this news organization. “These are diseases that affect people chronically throughout their entire lives, so it’s definitely concerning to think that, at a time when they could be helped and there could be interventions made, none are made because there’s just no one available.”

Kristiana Nasto, a third-year medical student at Baylor College of Medicine, is similarly interested in pediatrics but leaning more toward meds-peds and has an interest in rheumatology as well. She was surprised at how many programs had no pediatric rheumatologist on faculty because Baylor has a robust program.

“I was not aware of the fact that other states or other parts of Texas do not have the luxury of the great rheumatologists that we have at Baylor College of Medicine,” Ms. Nasto said. “That can definitely impact care for many patients because some of these rheumatologic diseases are so unique and challenging to treat that they require specialized care, so it makes me a bit sad that this is the case.”

Dr. Gillispie-Taylor has received an educational grant from Pfizer. Ms. Fergason and Ms. Nasto had no disclosures. No external funding was noted for the study.

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