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Mindfulness-based stress reduction program benefits MS patients
DENVER – The use of according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Two studies assessed the effects of two mindfulness-based stress reduction (MBSR) programs, one primarily in person until the pandemic forced a move to online participation, and the other exclusively online. The in-person course also found, in a subset of the participants, that blood inflammation markers matched the patients’ reported reduction in stress and loneliness.
Putting mindfulness to the test
Previous research has found that life stressors are linked to clinical MS flares, Chris Hemond, MD, an assistant professor of neurology at the University of Massachusetts, Worcester, told attendees. He also noted previous research exploring possible explanations for how MBSR programs might improve clinical symptoms of MS. One hypothesis involves an effect on the “forebrain limbic areas responsible for the neurobiological stress response.” Part of this study therefore involved looking for possible MRI changes before and after the MBSR program to test this hypothesis.
The study involved 23 patients, all women with relapsing remitting MS with an median age of 45, and 57% of whom were taking B cell–depleting agents. The patients’ average Expanded Disability Status Scale score was 2, and none experienced any new clinical or MRI disease activity during a 12-week observation period.
Patients volunteered to participate in the free 8-week MBSR program. Half attended MBSR classes in person while the other half had to attend virtual classes due to the pandemic. The program involved eight weekly 2.5-hour classes with daily homework assignments. The program, developed by Jon Kabat-Zinn at the University of Massachusetts, is intended to be “mental training for nonjudgmental awareness of moment-to-moment experience” that aims to “improve accuracy of perception, acceptance of intractable health-related changes, realistic sense of control, and appreciation of available life experiences,” Dr. Hemond said.
Among the 91% of participants who completed the course, 57% underwent both pre- and postcourse structural MRI scans, and 83% completed both the pre- and postcourse questionnaires. A subset of patients (53%) also provided blood samples for analysis of inflammatory gene expression markers.
“The conserved transcriptional response to adversity (CTRA) score was determined using well-established methods from 53 prespecified blood gene expression markers representing a composite of inflammation, interferon response, and immunoglobulin expression,” Dr. Hemond explained.
Participants’ average scores both pre- and post questionnaires revealed statistically significant improvements in stress, anxiety, depression, fatigue, loneliness, well-being, and interoceptive awareness (P < .01 for all).
Although precise values were not provided in the presentation, patients’ scores significantly decreased on the Brief Inventory of Perceived Stress (BIPS) for “lack of control,” “pushed,” and “conflict” (P < .03). Average scores also improved (decreased) on the Modified Fatigue Inventory Scale, the UCLA Loneliness Scale, and all three subscales of the Depression Anxiety Stress Scales assessment (P <.01). Participants’ scores increased on the Mental Health Continuum “hedonic” and “eudaimonic well-being” scales (P < .05).
Improvements on the Multidimensional Assessment of Interoceptive Awareness included self-regulation, attention regulation, “noticing” (P = .02), “not worrying” (P < .01), “emotional awareness” (P < .01), “body listening” (P < .01), and “trusting” (P < .01).
After adjustment for age, race, body mass index, medical therapy and time, the researchers found changes in inflammatory gene expression in the 12 participants who provided blood samples, and these changes correlated inversely with changes in their reported loneliness (P =.002), pain (P <.001), several interoception aspects (P < .01), and stress (P < .0001), particularly regarding feeling a lack of control.
Although no structural MRI changes were observed in the amygdala or prefrontal cortex, the researchers did see a 1% volume increase on the right-side hippocampus. Though the increase was significant (P < .01) and right hippocampal enlargement has been linked with MBSR in past studies, Dr. Hemond acknowledged the study’s small sample size and urged caution in interpreting that finding.
Dr. Hemond also reported that interaction between higher CTRA and the MSBR training attenuated the right hippocampal volume increase that was seen with MBSR, a finding which raises more questions than it answers.
The primary finding, however, was that “mindfulness-based stress reduction was associated with substantial improvement in multiple patient-reported outcomes of the debilitating ‘silent symptoms’ of MS,” Dr. Hemond told attendees. Though the study is limited by its small sample size, observational biases, and missing data, the findings suggest the possibility that MBSR is also associated with structural limbic brain changes, especially in the right hippocampus.
Another tool for managing MS
Ellen Mowry, MD, MCR, a professor of neurology and epidemiology at Johns Hopkins University, Baltimore, who attended the presentation, said she was very enthusiastic about this research.
“People with MS often are seeking ways that they can have self-efficacy and managing the symptoms of their disease, and we know that the disease-modifying therapies make a big difference, but we need additional therapies that can help people feel better and live better with MS,” Dr. Mowry commented.
She also acknowledged the challenges, however, in developing a mindfulness program that is accessible by a broad range of MS patients. This particular program involved several hours of work per day.
“People with MS often are either on the younger side, and they’re working and raising their family and doing all the same stuff that everybody else is doing, or they might be quite disabled and have more fatigue and other things that might make it really challenging to persist through that long of an intervention,” Dr. Mowry said.
The ideal program would be one that’s financially accessible, either through insurance, society more broadly, or another source, and which is logistically feasible for a wide range of patients. Finding a “sweet spot” with a program that doesn’t “require such a lengthy amount of time in order to see a success would be really great,” Dr. Mowry said. “You have to start somewhere, though, and you have to start with a program that’s already been tried and true and work from there.”
An online-only mindfulness program
One possible way to find that sweet spot is through an all-online program that patients access from home, similar to the 8-week MBSR program offered by Concord (N.H.) Hospital featured in the second study. The program was conducted via Zoom during once weekly synchronous meetings throughout 2021 and 2022 for eight cohorts of 5-15 participants each. The time of day the program was offered alternated between evening and daytime courses each quarter and was free for patients because of a hospital grant, according to Nicole Delcourt, BSN, RN, MSCN, of Concord Hospital Neurology, who facilitated patient sign-ups for the program.
Before and after each 8-week course, participants completed the PHQ-9, the PROMIS Cognitive Function, the PROMIS Fatigue–MS, and the Wasson Health Confidence assessments. Among the total 77 participating adults with MS, the completion rate was 81%, with 73% completing the preprogram assessments and 53% completed the postprogram assessments.
The assessments revealed a statistically significant increase in cognitive function and health confidence and decrease in depressive symptoms and fatigue following the program. Participants’ average PROMIS Cognitive Function scores increased from 16.7 before the program to 22.4 after, and their average Wasson Health Confidence score increased from 13.6 to 15.3 (P < .01 for both). Meanwhile, improvement in depressive symptoms was seen in participants’ decrease in Patient Health Questionnaire–9 scores from an average 6.9 to 4.6 (P = .01), and their average PROMIS Fatigue scores fell slightly but significantly from 59.3 to 55.3 (P < .05).
The participants “really felt like they were more in touch with their own feelings and emotions, and it helped them self-regulate,” Ms. Delcourt sad, “so it was really exciting.”
Patients also expressed satisfaction more subjectively in their feedback surveys. “I feel more aware of my body’s reactions to food and movement, and things that make me feel better physically,” one participant said. Another said that the class’s “lasting value ... will be to remember my own needs and how to become one with them.” Another participant praised the relevance of the printed and course materials, the speed of feedback on homework, and the quality of the video conference.
Dr. Hemond owns stock in VIVIO health. No other authors of either study reported other disclosures. Dr. Mowry has received grant funding from Biogen and Genentech. Ms. Delcourt had no disclosures. The in-person program study was funded by CMSC. Funding information for the Concord online program was unavailable.
DENVER – The use of according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Two studies assessed the effects of two mindfulness-based stress reduction (MBSR) programs, one primarily in person until the pandemic forced a move to online participation, and the other exclusively online. The in-person course also found, in a subset of the participants, that blood inflammation markers matched the patients’ reported reduction in stress and loneliness.
Putting mindfulness to the test
Previous research has found that life stressors are linked to clinical MS flares, Chris Hemond, MD, an assistant professor of neurology at the University of Massachusetts, Worcester, told attendees. He also noted previous research exploring possible explanations for how MBSR programs might improve clinical symptoms of MS. One hypothesis involves an effect on the “forebrain limbic areas responsible for the neurobiological stress response.” Part of this study therefore involved looking for possible MRI changes before and after the MBSR program to test this hypothesis.
The study involved 23 patients, all women with relapsing remitting MS with an median age of 45, and 57% of whom were taking B cell–depleting agents. The patients’ average Expanded Disability Status Scale score was 2, and none experienced any new clinical or MRI disease activity during a 12-week observation period.
Patients volunteered to participate in the free 8-week MBSR program. Half attended MBSR classes in person while the other half had to attend virtual classes due to the pandemic. The program involved eight weekly 2.5-hour classes with daily homework assignments. The program, developed by Jon Kabat-Zinn at the University of Massachusetts, is intended to be “mental training for nonjudgmental awareness of moment-to-moment experience” that aims to “improve accuracy of perception, acceptance of intractable health-related changes, realistic sense of control, and appreciation of available life experiences,” Dr. Hemond said.
Among the 91% of participants who completed the course, 57% underwent both pre- and postcourse structural MRI scans, and 83% completed both the pre- and postcourse questionnaires. A subset of patients (53%) also provided blood samples for analysis of inflammatory gene expression markers.
“The conserved transcriptional response to adversity (CTRA) score was determined using well-established methods from 53 prespecified blood gene expression markers representing a composite of inflammation, interferon response, and immunoglobulin expression,” Dr. Hemond explained.
Participants’ average scores both pre- and post questionnaires revealed statistically significant improvements in stress, anxiety, depression, fatigue, loneliness, well-being, and interoceptive awareness (P < .01 for all).
Although precise values were not provided in the presentation, patients’ scores significantly decreased on the Brief Inventory of Perceived Stress (BIPS) for “lack of control,” “pushed,” and “conflict” (P < .03). Average scores also improved (decreased) on the Modified Fatigue Inventory Scale, the UCLA Loneliness Scale, and all three subscales of the Depression Anxiety Stress Scales assessment (P <.01). Participants’ scores increased on the Mental Health Continuum “hedonic” and “eudaimonic well-being” scales (P < .05).
Improvements on the Multidimensional Assessment of Interoceptive Awareness included self-regulation, attention regulation, “noticing” (P = .02), “not worrying” (P < .01), “emotional awareness” (P < .01), “body listening” (P < .01), and “trusting” (P < .01).
After adjustment for age, race, body mass index, medical therapy and time, the researchers found changes in inflammatory gene expression in the 12 participants who provided blood samples, and these changes correlated inversely with changes in their reported loneliness (P =.002), pain (P <.001), several interoception aspects (P < .01), and stress (P < .0001), particularly regarding feeling a lack of control.
Although no structural MRI changes were observed in the amygdala or prefrontal cortex, the researchers did see a 1% volume increase on the right-side hippocampus. Though the increase was significant (P < .01) and right hippocampal enlargement has been linked with MBSR in past studies, Dr. Hemond acknowledged the study’s small sample size and urged caution in interpreting that finding.
Dr. Hemond also reported that interaction between higher CTRA and the MSBR training attenuated the right hippocampal volume increase that was seen with MBSR, a finding which raises more questions than it answers.
The primary finding, however, was that “mindfulness-based stress reduction was associated with substantial improvement in multiple patient-reported outcomes of the debilitating ‘silent symptoms’ of MS,” Dr. Hemond told attendees. Though the study is limited by its small sample size, observational biases, and missing data, the findings suggest the possibility that MBSR is also associated with structural limbic brain changes, especially in the right hippocampus.
Another tool for managing MS
Ellen Mowry, MD, MCR, a professor of neurology and epidemiology at Johns Hopkins University, Baltimore, who attended the presentation, said she was very enthusiastic about this research.
“People with MS often are seeking ways that they can have self-efficacy and managing the symptoms of their disease, and we know that the disease-modifying therapies make a big difference, but we need additional therapies that can help people feel better and live better with MS,” Dr. Mowry commented.
She also acknowledged the challenges, however, in developing a mindfulness program that is accessible by a broad range of MS patients. This particular program involved several hours of work per day.
“People with MS often are either on the younger side, and they’re working and raising their family and doing all the same stuff that everybody else is doing, or they might be quite disabled and have more fatigue and other things that might make it really challenging to persist through that long of an intervention,” Dr. Mowry said.
The ideal program would be one that’s financially accessible, either through insurance, society more broadly, or another source, and which is logistically feasible for a wide range of patients. Finding a “sweet spot” with a program that doesn’t “require such a lengthy amount of time in order to see a success would be really great,” Dr. Mowry said. “You have to start somewhere, though, and you have to start with a program that’s already been tried and true and work from there.”
An online-only mindfulness program
One possible way to find that sweet spot is through an all-online program that patients access from home, similar to the 8-week MBSR program offered by Concord (N.H.) Hospital featured in the second study. The program was conducted via Zoom during once weekly synchronous meetings throughout 2021 and 2022 for eight cohorts of 5-15 participants each. The time of day the program was offered alternated between evening and daytime courses each quarter and was free for patients because of a hospital grant, according to Nicole Delcourt, BSN, RN, MSCN, of Concord Hospital Neurology, who facilitated patient sign-ups for the program.
Before and after each 8-week course, participants completed the PHQ-9, the PROMIS Cognitive Function, the PROMIS Fatigue–MS, and the Wasson Health Confidence assessments. Among the total 77 participating adults with MS, the completion rate was 81%, with 73% completing the preprogram assessments and 53% completed the postprogram assessments.
The assessments revealed a statistically significant increase in cognitive function and health confidence and decrease in depressive symptoms and fatigue following the program. Participants’ average PROMIS Cognitive Function scores increased from 16.7 before the program to 22.4 after, and their average Wasson Health Confidence score increased from 13.6 to 15.3 (P < .01 for both). Meanwhile, improvement in depressive symptoms was seen in participants’ decrease in Patient Health Questionnaire–9 scores from an average 6.9 to 4.6 (P = .01), and their average PROMIS Fatigue scores fell slightly but significantly from 59.3 to 55.3 (P < .05).
The participants “really felt like they were more in touch with their own feelings and emotions, and it helped them self-regulate,” Ms. Delcourt sad, “so it was really exciting.”
Patients also expressed satisfaction more subjectively in their feedback surveys. “I feel more aware of my body’s reactions to food and movement, and things that make me feel better physically,” one participant said. Another said that the class’s “lasting value ... will be to remember my own needs and how to become one with them.” Another participant praised the relevance of the printed and course materials, the speed of feedback on homework, and the quality of the video conference.
Dr. Hemond owns stock in VIVIO health. No other authors of either study reported other disclosures. Dr. Mowry has received grant funding from Biogen and Genentech. Ms. Delcourt had no disclosures. The in-person program study was funded by CMSC. Funding information for the Concord online program was unavailable.
DENVER – The use of according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Two studies assessed the effects of two mindfulness-based stress reduction (MBSR) programs, one primarily in person until the pandemic forced a move to online participation, and the other exclusively online. The in-person course also found, in a subset of the participants, that blood inflammation markers matched the patients’ reported reduction in stress and loneliness.
Putting mindfulness to the test
Previous research has found that life stressors are linked to clinical MS flares, Chris Hemond, MD, an assistant professor of neurology at the University of Massachusetts, Worcester, told attendees. He also noted previous research exploring possible explanations for how MBSR programs might improve clinical symptoms of MS. One hypothesis involves an effect on the “forebrain limbic areas responsible for the neurobiological stress response.” Part of this study therefore involved looking for possible MRI changes before and after the MBSR program to test this hypothesis.
The study involved 23 patients, all women with relapsing remitting MS with an median age of 45, and 57% of whom were taking B cell–depleting agents. The patients’ average Expanded Disability Status Scale score was 2, and none experienced any new clinical or MRI disease activity during a 12-week observation period.
Patients volunteered to participate in the free 8-week MBSR program. Half attended MBSR classes in person while the other half had to attend virtual classes due to the pandemic. The program involved eight weekly 2.5-hour classes with daily homework assignments. The program, developed by Jon Kabat-Zinn at the University of Massachusetts, is intended to be “mental training for nonjudgmental awareness of moment-to-moment experience” that aims to “improve accuracy of perception, acceptance of intractable health-related changes, realistic sense of control, and appreciation of available life experiences,” Dr. Hemond said.
Among the 91% of participants who completed the course, 57% underwent both pre- and postcourse structural MRI scans, and 83% completed both the pre- and postcourse questionnaires. A subset of patients (53%) also provided blood samples for analysis of inflammatory gene expression markers.
“The conserved transcriptional response to adversity (CTRA) score was determined using well-established methods from 53 prespecified blood gene expression markers representing a composite of inflammation, interferon response, and immunoglobulin expression,” Dr. Hemond explained.
Participants’ average scores both pre- and post questionnaires revealed statistically significant improvements in stress, anxiety, depression, fatigue, loneliness, well-being, and interoceptive awareness (P < .01 for all).
Although precise values were not provided in the presentation, patients’ scores significantly decreased on the Brief Inventory of Perceived Stress (BIPS) for “lack of control,” “pushed,” and “conflict” (P < .03). Average scores also improved (decreased) on the Modified Fatigue Inventory Scale, the UCLA Loneliness Scale, and all three subscales of the Depression Anxiety Stress Scales assessment (P <.01). Participants’ scores increased on the Mental Health Continuum “hedonic” and “eudaimonic well-being” scales (P < .05).
Improvements on the Multidimensional Assessment of Interoceptive Awareness included self-regulation, attention regulation, “noticing” (P = .02), “not worrying” (P < .01), “emotional awareness” (P < .01), “body listening” (P < .01), and “trusting” (P < .01).
After adjustment for age, race, body mass index, medical therapy and time, the researchers found changes in inflammatory gene expression in the 12 participants who provided blood samples, and these changes correlated inversely with changes in their reported loneliness (P =.002), pain (P <.001), several interoception aspects (P < .01), and stress (P < .0001), particularly regarding feeling a lack of control.
Although no structural MRI changes were observed in the amygdala or prefrontal cortex, the researchers did see a 1% volume increase on the right-side hippocampus. Though the increase was significant (P < .01) and right hippocampal enlargement has been linked with MBSR in past studies, Dr. Hemond acknowledged the study’s small sample size and urged caution in interpreting that finding.
Dr. Hemond also reported that interaction between higher CTRA and the MSBR training attenuated the right hippocampal volume increase that was seen with MBSR, a finding which raises more questions than it answers.
The primary finding, however, was that “mindfulness-based stress reduction was associated with substantial improvement in multiple patient-reported outcomes of the debilitating ‘silent symptoms’ of MS,” Dr. Hemond told attendees. Though the study is limited by its small sample size, observational biases, and missing data, the findings suggest the possibility that MBSR is also associated with structural limbic brain changes, especially in the right hippocampus.
Another tool for managing MS
Ellen Mowry, MD, MCR, a professor of neurology and epidemiology at Johns Hopkins University, Baltimore, who attended the presentation, said she was very enthusiastic about this research.
“People with MS often are seeking ways that they can have self-efficacy and managing the symptoms of their disease, and we know that the disease-modifying therapies make a big difference, but we need additional therapies that can help people feel better and live better with MS,” Dr. Mowry commented.
She also acknowledged the challenges, however, in developing a mindfulness program that is accessible by a broad range of MS patients. This particular program involved several hours of work per day.
“People with MS often are either on the younger side, and they’re working and raising their family and doing all the same stuff that everybody else is doing, or they might be quite disabled and have more fatigue and other things that might make it really challenging to persist through that long of an intervention,” Dr. Mowry said.
The ideal program would be one that’s financially accessible, either through insurance, society more broadly, or another source, and which is logistically feasible for a wide range of patients. Finding a “sweet spot” with a program that doesn’t “require such a lengthy amount of time in order to see a success would be really great,” Dr. Mowry said. “You have to start somewhere, though, and you have to start with a program that’s already been tried and true and work from there.”
An online-only mindfulness program
One possible way to find that sweet spot is through an all-online program that patients access from home, similar to the 8-week MBSR program offered by Concord (N.H.) Hospital featured in the second study. The program was conducted via Zoom during once weekly synchronous meetings throughout 2021 and 2022 for eight cohorts of 5-15 participants each. The time of day the program was offered alternated between evening and daytime courses each quarter and was free for patients because of a hospital grant, according to Nicole Delcourt, BSN, RN, MSCN, of Concord Hospital Neurology, who facilitated patient sign-ups for the program.
Before and after each 8-week course, participants completed the PHQ-9, the PROMIS Cognitive Function, the PROMIS Fatigue–MS, and the Wasson Health Confidence assessments. Among the total 77 participating adults with MS, the completion rate was 81%, with 73% completing the preprogram assessments and 53% completed the postprogram assessments.
The assessments revealed a statistically significant increase in cognitive function and health confidence and decrease in depressive symptoms and fatigue following the program. Participants’ average PROMIS Cognitive Function scores increased from 16.7 before the program to 22.4 after, and their average Wasson Health Confidence score increased from 13.6 to 15.3 (P < .01 for both). Meanwhile, improvement in depressive symptoms was seen in participants’ decrease in Patient Health Questionnaire–9 scores from an average 6.9 to 4.6 (P = .01), and their average PROMIS Fatigue scores fell slightly but significantly from 59.3 to 55.3 (P < .05).
The participants “really felt like they were more in touch with their own feelings and emotions, and it helped them self-regulate,” Ms. Delcourt sad, “so it was really exciting.”
Patients also expressed satisfaction more subjectively in their feedback surveys. “I feel more aware of my body’s reactions to food and movement, and things that make me feel better physically,” one participant said. Another said that the class’s “lasting value ... will be to remember my own needs and how to become one with them.” Another participant praised the relevance of the printed and course materials, the speed of feedback on homework, and the quality of the video conference.
Dr. Hemond owns stock in VIVIO health. No other authors of either study reported other disclosures. Dr. Mowry has received grant funding from Biogen and Genentech. Ms. Delcourt had no disclosures. The in-person program study was funded by CMSC. Funding information for the Concord online program was unavailable.
AT CMSC 2023
Abortion restrictions linked to less evidence-based care for miscarriages
BALTIMORE – , according to a cross-sectional study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists and published in Obstetrics & Gynecology.
The results revealed that “abortion restrictions have far-reaching effects on early pregnancy loss care and on resident education,” the researchers concluded.
“Abortion restrictions don’t just affect people seeking abortions; they affect people also suffering from early pregnancy loss,” Aurora Phillips, MD, an ob.gyn. resident at Albany (N.Y.) Medical Center, said in an interview. “It’s harder to make that diagnosis and to be able to offer interventions, and these institutions that had restrictions also were less likely to have mifepristone or office based human aspiration, which are the most efficient and cost-effective interventions that we have.”
For example, less than half the programs surveyed offered mifepristone to help manage a miscarriage, “with availability varying inversely with abortion restrictions,” they found. After considering all characteristics of residency programs, “institutional abortion restrictions and bans were more important than state policies or religious affiliation in determining whether evidence-based early pregnancy loss treatments were available,” the researchers found, though their findings predated the Supreme Court’s Dobbs ruling that overturned Roe v. Wade. “Training institutions with a commitment to evidence-based family planning care and education are able to ensure access to the most evidence-based, cost-effective, and timely treatments for pregnancy loss even in the face of state abortion restrictions, thereby preserving patient safety, physician competency, and health care system sustainability,” they wrote.
Reduced access leads to higher risk interventions
An estimated 10%-20% of pregnancies result in early miscarriage, totaling more than one million cases in the U.S. each year. But since treatments for miscarriage often overlap with those for abortion, the researchers wondered whether differences existed in how providers managed miscarriages in states or institutions with strict abortion restrictions versus management in hospitals without restrictions.
They also looked at how closely the management strategies adhered to ACOG’s recommendations, which advise that providers consider both ultrasound imaging and other factors, including clinical reasoning and patient preferences, before diagnosing early pregnancy loss and considering possible interventions.
For imaging guidelines, ACOG endorses the criteria established for ultrasound diagnosis of first trimester pregnancy loss from the Society of Radiologists in 2012. But, the authors note, these guidelines are very conservative, exceeding previous measurements that had a 99%-100% predictive value for pregnancy loss, in the interest of “[prioritizing preservation of] fetal potential over facilitating expeditious care.” Hence the reason ACOG advises providers to include clinical judgment and patient preferences in their approach to care.
”In places where abortion is heavily regulated, clinicians managing miscarriages may cautiously rely on the strictest criteria to differentiate early pregnancy loss from potentially viable pregnancy and may not offer certain treatments commonly associated with abortion,” the authors noted. ACOG recommends surgical aspiration and medical treatment with both mifepristone and misoprostol as the safest and most effective options in managing miscarriages.
“Treating early pregnancy loss without the use of mifepristone is more likely to fail, is more likely to require an unscheduled procedure, and people who choose medication management for their miscarriages are usually trying to avoid a procedure, so that is the downside of not using mifepristone,” coauthor Rachel M. Flink-Bochacki, MD, an associate professor at Albany (N.Y.) Medical Center, said in an interview.
“Office-based uterine aspiration has the same safety profile as uterine aspiration in the operating room minus the risks of anesthesia and also helps patients get in faster because they don’t need to wait for OR time,” Dr. Flink-Bochacki explained. “So again, for a patient who wants an aspiration and does not want to pass the pregnancy at home, not having access to office-based aspiration could lead them to miscarry at home, which has higher risks and is not what they wanted.”
Reduced access to miscarriage care options in ‘hostile’ states
Among all 296 U.S. ob.gyn. residency programs that were contacted between November 2021 and January 2022, half (50.3%) responded to the researchers’ survey about their institutional practices around miscarriage, including location of diagnosis, use of ultrasound diagnostic guidelines, treatment options offered by their institution, and institutional restrictions on abortions based on indication.
The survey also collected characteristics of each program, including its state, setting, religious affiliation, and affiliation with the Ryan Training Program in Abortion and Family Planning. The responding sample had similar geographic distribution and state abortion policies as those who did not respond, but the responding programs were slightly more likely to be academic programs and to be affiliated with the Ryan program.
At the time of the study, prior to the Dobbs ruling, more than half the U.S. states had legislation restricting abortion care, and 57% of national teaching hospitals had internal restrictions that limited care based on gestational age and indication, particularly if the indication was elective, the authors reported. The researchers relied on designations from the Guttmacher Institute in December 2020 to categorize states as “hostile” to abortion (very hostile, hostile, and leans hostile) or non-hostile (neutral, leans supportive, supportive, and very supportive).
Most of the programs (80%) had no religious affiliation, but 11% had a Catholic affiliation and 5% had a different Christian affiliation. Institutional policies either had no restrictions on abortion care (38%), had restrictions (39%) based on certain maternal or fetal indications, or completely banned abortion services unless the mother’s life was threatened (23%). Among the Christian-affiliated programs, 60% had bans and 40% had restrictions.
Half (49.7%) of the responding programs relied rigidly on ultrasound criteria before offering any intervention for suspected early pregnancy loss, regardless of patient preferences. The other half (50.3%) incorporated ultrasound criteria and other factors, including clinical judgment and patient preferences, into a holistic determination of what options to present to the patient.
Before accounting for other factors, the researchers found that only a third (33%) of programs in states with severe abortion restrictions considered additional factors besides imaging when offering patients options for miscarriage management. In states without such abortion restrictions, 79% of programs considered both imaging and other factors (P < .001).
In states with “hostile abortion legislation,” only 32% of the programs used mifepristone for miscarriage management, compared with 75% of the programs in states without onerous abortion restrictions (P < .001). The results were similar for use of office-based suction aspiration: Just under half the programs (48%) in states with severe abortion restrictions included this technique as part of standard miscarriage management, compared with 68% of programs in states without such restrictions (P = .014).
Those findings match up with the experience of Cara Heuser, MD, a maternal-fetal medicine specialist from Salt Lake City, who was not involved in this study.
“We had a lot of restrictions even before Roe fell,” including heavy regulation of mifepristone, Dr. Heuser said in an interview. “In non-restricted states, it’s pretty easy to get, but even before Roe in our state, it was very, very difficult to get institutions and individual doctor’s offices to carry mifepristone to treat miscarriages. They were still treating miscarriages in a way that was known to be less effective.” Adding mifepristone to misoprostol reduces the risk of needing an evacuation surgery procedure, she explained, “so adding the mifepristone makes it safer.”
Institutional policies had the strongest impact
Before accounting for the state a hospital was in, 27% of institutions with restrictive abortion policies looked at more than imaging in determining how to proceed, compared with 88% of institutions without abortion restrictions that included clinical judgment and patient preferences in their management.
After controlling for state policies and affiliation with a family planning training program or a religious entity, the odds of an institution relying solely on imaging guidelines were over 12 times greater for institutions with abortion restrictions or bans (odds ratio, 12.3; 95% confidence interval, 3.2-47.9). Specifically, the odds were 9 times greater for institutions with restrictions and 27 times greater for institutions with bans.
Only 12% of the institutions without restrictions relied solely on ultrasound criteria, compared with 67% of the institutions with restrictions and 82% of the institutions that banned all abortions except to save the life of the pregnant individual (P < .001).
Only one in four (25%) of the programs with institutional abortion restrictions used mifepristone, compared with 86% of unrestricted programs (P < .001), and 40% of programs with institutional abortion restrictions used office-based aspiration, compared with 81% of unrestricted programs (P < .001).
Without access to all evidence-based treatments, doctors are often forced to choose expectant management for miscarriages. “So you’re kind of forced to have them to pass the pregnancy at home, which can be traumatic for patients” if that’s not what they wanted, Dr. Phillips said.
Dr. Flink-Bochacki further noted that this patient population is already particularly vulnerable.
“Especially for patients with early pregnancy loss, it’s such a feeling of powerlessness already, so the mental state that many of these patients are in is already quite fraught,” Dr. Flink-Bochacki said. “Then to not even have power to choose the interventions that you want or to be able to access interventions in a timely fashion because you’re being held to some arbitrary guideline further takes away the power and further exacerbates the trauma of the experience.”
The biggest factor likely driving the reduced access to those interventions is the fear that the care could be confused with providing an abortion instead of simply managing a miscarriage, Dr. Flink-Bochacki said. “I think that’s why a lot of these programs don’t have mifepristone and don’t offer outpatient uterine aspiration,” she said. “Because those are so widely used in abortion and the connotation is with abortion, they’re just kind of steering clear of it, but meanwhile, patients with pregnancy loss are suffering because they’re being unnecessarily restrictive.”
The research did not use any external funding, and the authors and Dr. Heuser had no disclosures.
BALTIMORE – , according to a cross-sectional study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists and published in Obstetrics & Gynecology.
The results revealed that “abortion restrictions have far-reaching effects on early pregnancy loss care and on resident education,” the researchers concluded.
“Abortion restrictions don’t just affect people seeking abortions; they affect people also suffering from early pregnancy loss,” Aurora Phillips, MD, an ob.gyn. resident at Albany (N.Y.) Medical Center, said in an interview. “It’s harder to make that diagnosis and to be able to offer interventions, and these institutions that had restrictions also were less likely to have mifepristone or office based human aspiration, which are the most efficient and cost-effective interventions that we have.”
For example, less than half the programs surveyed offered mifepristone to help manage a miscarriage, “with availability varying inversely with abortion restrictions,” they found. After considering all characteristics of residency programs, “institutional abortion restrictions and bans were more important than state policies or religious affiliation in determining whether evidence-based early pregnancy loss treatments were available,” the researchers found, though their findings predated the Supreme Court’s Dobbs ruling that overturned Roe v. Wade. “Training institutions with a commitment to evidence-based family planning care and education are able to ensure access to the most evidence-based, cost-effective, and timely treatments for pregnancy loss even in the face of state abortion restrictions, thereby preserving patient safety, physician competency, and health care system sustainability,” they wrote.
Reduced access leads to higher risk interventions
An estimated 10%-20% of pregnancies result in early miscarriage, totaling more than one million cases in the U.S. each year. But since treatments for miscarriage often overlap with those for abortion, the researchers wondered whether differences existed in how providers managed miscarriages in states or institutions with strict abortion restrictions versus management in hospitals without restrictions.
They also looked at how closely the management strategies adhered to ACOG’s recommendations, which advise that providers consider both ultrasound imaging and other factors, including clinical reasoning and patient preferences, before diagnosing early pregnancy loss and considering possible interventions.
For imaging guidelines, ACOG endorses the criteria established for ultrasound diagnosis of first trimester pregnancy loss from the Society of Radiologists in 2012. But, the authors note, these guidelines are very conservative, exceeding previous measurements that had a 99%-100% predictive value for pregnancy loss, in the interest of “[prioritizing preservation of] fetal potential over facilitating expeditious care.” Hence the reason ACOG advises providers to include clinical judgment and patient preferences in their approach to care.
”In places where abortion is heavily regulated, clinicians managing miscarriages may cautiously rely on the strictest criteria to differentiate early pregnancy loss from potentially viable pregnancy and may not offer certain treatments commonly associated with abortion,” the authors noted. ACOG recommends surgical aspiration and medical treatment with both mifepristone and misoprostol as the safest and most effective options in managing miscarriages.
“Treating early pregnancy loss without the use of mifepristone is more likely to fail, is more likely to require an unscheduled procedure, and people who choose medication management for their miscarriages are usually trying to avoid a procedure, so that is the downside of not using mifepristone,” coauthor Rachel M. Flink-Bochacki, MD, an associate professor at Albany (N.Y.) Medical Center, said in an interview.
“Office-based uterine aspiration has the same safety profile as uterine aspiration in the operating room minus the risks of anesthesia and also helps patients get in faster because they don’t need to wait for OR time,” Dr. Flink-Bochacki explained. “So again, for a patient who wants an aspiration and does not want to pass the pregnancy at home, not having access to office-based aspiration could lead them to miscarry at home, which has higher risks and is not what they wanted.”
Reduced access to miscarriage care options in ‘hostile’ states
Among all 296 U.S. ob.gyn. residency programs that were contacted between November 2021 and January 2022, half (50.3%) responded to the researchers’ survey about their institutional practices around miscarriage, including location of diagnosis, use of ultrasound diagnostic guidelines, treatment options offered by their institution, and institutional restrictions on abortions based on indication.
The survey also collected characteristics of each program, including its state, setting, religious affiliation, and affiliation with the Ryan Training Program in Abortion and Family Planning. The responding sample had similar geographic distribution and state abortion policies as those who did not respond, but the responding programs were slightly more likely to be academic programs and to be affiliated with the Ryan program.
At the time of the study, prior to the Dobbs ruling, more than half the U.S. states had legislation restricting abortion care, and 57% of national teaching hospitals had internal restrictions that limited care based on gestational age and indication, particularly if the indication was elective, the authors reported. The researchers relied on designations from the Guttmacher Institute in December 2020 to categorize states as “hostile” to abortion (very hostile, hostile, and leans hostile) or non-hostile (neutral, leans supportive, supportive, and very supportive).
Most of the programs (80%) had no religious affiliation, but 11% had a Catholic affiliation and 5% had a different Christian affiliation. Institutional policies either had no restrictions on abortion care (38%), had restrictions (39%) based on certain maternal or fetal indications, or completely banned abortion services unless the mother’s life was threatened (23%). Among the Christian-affiliated programs, 60% had bans and 40% had restrictions.
Half (49.7%) of the responding programs relied rigidly on ultrasound criteria before offering any intervention for suspected early pregnancy loss, regardless of patient preferences. The other half (50.3%) incorporated ultrasound criteria and other factors, including clinical judgment and patient preferences, into a holistic determination of what options to present to the patient.
Before accounting for other factors, the researchers found that only a third (33%) of programs in states with severe abortion restrictions considered additional factors besides imaging when offering patients options for miscarriage management. In states without such abortion restrictions, 79% of programs considered both imaging and other factors (P < .001).
In states with “hostile abortion legislation,” only 32% of the programs used mifepristone for miscarriage management, compared with 75% of the programs in states without onerous abortion restrictions (P < .001). The results were similar for use of office-based suction aspiration: Just under half the programs (48%) in states with severe abortion restrictions included this technique as part of standard miscarriage management, compared with 68% of programs in states without such restrictions (P = .014).
Those findings match up with the experience of Cara Heuser, MD, a maternal-fetal medicine specialist from Salt Lake City, who was not involved in this study.
“We had a lot of restrictions even before Roe fell,” including heavy regulation of mifepristone, Dr. Heuser said in an interview. “In non-restricted states, it’s pretty easy to get, but even before Roe in our state, it was very, very difficult to get institutions and individual doctor’s offices to carry mifepristone to treat miscarriages. They were still treating miscarriages in a way that was known to be less effective.” Adding mifepristone to misoprostol reduces the risk of needing an evacuation surgery procedure, she explained, “so adding the mifepristone makes it safer.”
Institutional policies had the strongest impact
Before accounting for the state a hospital was in, 27% of institutions with restrictive abortion policies looked at more than imaging in determining how to proceed, compared with 88% of institutions without abortion restrictions that included clinical judgment and patient preferences in their management.
After controlling for state policies and affiliation with a family planning training program or a religious entity, the odds of an institution relying solely on imaging guidelines were over 12 times greater for institutions with abortion restrictions or bans (odds ratio, 12.3; 95% confidence interval, 3.2-47.9). Specifically, the odds were 9 times greater for institutions with restrictions and 27 times greater for institutions with bans.
Only 12% of the institutions without restrictions relied solely on ultrasound criteria, compared with 67% of the institutions with restrictions and 82% of the institutions that banned all abortions except to save the life of the pregnant individual (P < .001).
Only one in four (25%) of the programs with institutional abortion restrictions used mifepristone, compared with 86% of unrestricted programs (P < .001), and 40% of programs with institutional abortion restrictions used office-based aspiration, compared with 81% of unrestricted programs (P < .001).
Without access to all evidence-based treatments, doctors are often forced to choose expectant management for miscarriages. “So you’re kind of forced to have them to pass the pregnancy at home, which can be traumatic for patients” if that’s not what they wanted, Dr. Phillips said.
Dr. Flink-Bochacki further noted that this patient population is already particularly vulnerable.
“Especially for patients with early pregnancy loss, it’s such a feeling of powerlessness already, so the mental state that many of these patients are in is already quite fraught,” Dr. Flink-Bochacki said. “Then to not even have power to choose the interventions that you want or to be able to access interventions in a timely fashion because you’re being held to some arbitrary guideline further takes away the power and further exacerbates the trauma of the experience.”
The biggest factor likely driving the reduced access to those interventions is the fear that the care could be confused with providing an abortion instead of simply managing a miscarriage, Dr. Flink-Bochacki said. “I think that’s why a lot of these programs don’t have mifepristone and don’t offer outpatient uterine aspiration,” she said. “Because those are so widely used in abortion and the connotation is with abortion, they’re just kind of steering clear of it, but meanwhile, patients with pregnancy loss are suffering because they’re being unnecessarily restrictive.”
The research did not use any external funding, and the authors and Dr. Heuser had no disclosures.
BALTIMORE – , according to a cross-sectional study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists and published in Obstetrics & Gynecology.
The results revealed that “abortion restrictions have far-reaching effects on early pregnancy loss care and on resident education,” the researchers concluded.
“Abortion restrictions don’t just affect people seeking abortions; they affect people also suffering from early pregnancy loss,” Aurora Phillips, MD, an ob.gyn. resident at Albany (N.Y.) Medical Center, said in an interview. “It’s harder to make that diagnosis and to be able to offer interventions, and these institutions that had restrictions also were less likely to have mifepristone or office based human aspiration, which are the most efficient and cost-effective interventions that we have.”
For example, less than half the programs surveyed offered mifepristone to help manage a miscarriage, “with availability varying inversely with abortion restrictions,” they found. After considering all characteristics of residency programs, “institutional abortion restrictions and bans were more important than state policies or religious affiliation in determining whether evidence-based early pregnancy loss treatments were available,” the researchers found, though their findings predated the Supreme Court’s Dobbs ruling that overturned Roe v. Wade. “Training institutions with a commitment to evidence-based family planning care and education are able to ensure access to the most evidence-based, cost-effective, and timely treatments for pregnancy loss even in the face of state abortion restrictions, thereby preserving patient safety, physician competency, and health care system sustainability,” they wrote.
Reduced access leads to higher risk interventions
An estimated 10%-20% of pregnancies result in early miscarriage, totaling more than one million cases in the U.S. each year. But since treatments for miscarriage often overlap with those for abortion, the researchers wondered whether differences existed in how providers managed miscarriages in states or institutions with strict abortion restrictions versus management in hospitals without restrictions.
They also looked at how closely the management strategies adhered to ACOG’s recommendations, which advise that providers consider both ultrasound imaging and other factors, including clinical reasoning and patient preferences, before diagnosing early pregnancy loss and considering possible interventions.
For imaging guidelines, ACOG endorses the criteria established for ultrasound diagnosis of first trimester pregnancy loss from the Society of Radiologists in 2012. But, the authors note, these guidelines are very conservative, exceeding previous measurements that had a 99%-100% predictive value for pregnancy loss, in the interest of “[prioritizing preservation of] fetal potential over facilitating expeditious care.” Hence the reason ACOG advises providers to include clinical judgment and patient preferences in their approach to care.
”In places where abortion is heavily regulated, clinicians managing miscarriages may cautiously rely on the strictest criteria to differentiate early pregnancy loss from potentially viable pregnancy and may not offer certain treatments commonly associated with abortion,” the authors noted. ACOG recommends surgical aspiration and medical treatment with both mifepristone and misoprostol as the safest and most effective options in managing miscarriages.
“Treating early pregnancy loss without the use of mifepristone is more likely to fail, is more likely to require an unscheduled procedure, and people who choose medication management for their miscarriages are usually trying to avoid a procedure, so that is the downside of not using mifepristone,” coauthor Rachel M. Flink-Bochacki, MD, an associate professor at Albany (N.Y.) Medical Center, said in an interview.
“Office-based uterine aspiration has the same safety profile as uterine aspiration in the operating room minus the risks of anesthesia and also helps patients get in faster because they don’t need to wait for OR time,” Dr. Flink-Bochacki explained. “So again, for a patient who wants an aspiration and does not want to pass the pregnancy at home, not having access to office-based aspiration could lead them to miscarry at home, which has higher risks and is not what they wanted.”
Reduced access to miscarriage care options in ‘hostile’ states
Among all 296 U.S. ob.gyn. residency programs that were contacted between November 2021 and January 2022, half (50.3%) responded to the researchers’ survey about their institutional practices around miscarriage, including location of diagnosis, use of ultrasound diagnostic guidelines, treatment options offered by their institution, and institutional restrictions on abortions based on indication.
The survey also collected characteristics of each program, including its state, setting, religious affiliation, and affiliation with the Ryan Training Program in Abortion and Family Planning. The responding sample had similar geographic distribution and state abortion policies as those who did not respond, but the responding programs were slightly more likely to be academic programs and to be affiliated with the Ryan program.
At the time of the study, prior to the Dobbs ruling, more than half the U.S. states had legislation restricting abortion care, and 57% of national teaching hospitals had internal restrictions that limited care based on gestational age and indication, particularly if the indication was elective, the authors reported. The researchers relied on designations from the Guttmacher Institute in December 2020 to categorize states as “hostile” to abortion (very hostile, hostile, and leans hostile) or non-hostile (neutral, leans supportive, supportive, and very supportive).
Most of the programs (80%) had no religious affiliation, but 11% had a Catholic affiliation and 5% had a different Christian affiliation. Institutional policies either had no restrictions on abortion care (38%), had restrictions (39%) based on certain maternal or fetal indications, or completely banned abortion services unless the mother’s life was threatened (23%). Among the Christian-affiliated programs, 60% had bans and 40% had restrictions.
Half (49.7%) of the responding programs relied rigidly on ultrasound criteria before offering any intervention for suspected early pregnancy loss, regardless of patient preferences. The other half (50.3%) incorporated ultrasound criteria and other factors, including clinical judgment and patient preferences, into a holistic determination of what options to present to the patient.
Before accounting for other factors, the researchers found that only a third (33%) of programs in states with severe abortion restrictions considered additional factors besides imaging when offering patients options for miscarriage management. In states without such abortion restrictions, 79% of programs considered both imaging and other factors (P < .001).
In states with “hostile abortion legislation,” only 32% of the programs used mifepristone for miscarriage management, compared with 75% of the programs in states without onerous abortion restrictions (P < .001). The results were similar for use of office-based suction aspiration: Just under half the programs (48%) in states with severe abortion restrictions included this technique as part of standard miscarriage management, compared with 68% of programs in states without such restrictions (P = .014).
Those findings match up with the experience of Cara Heuser, MD, a maternal-fetal medicine specialist from Salt Lake City, who was not involved in this study.
“We had a lot of restrictions even before Roe fell,” including heavy regulation of mifepristone, Dr. Heuser said in an interview. “In non-restricted states, it’s pretty easy to get, but even before Roe in our state, it was very, very difficult to get institutions and individual doctor’s offices to carry mifepristone to treat miscarriages. They were still treating miscarriages in a way that was known to be less effective.” Adding mifepristone to misoprostol reduces the risk of needing an evacuation surgery procedure, she explained, “so adding the mifepristone makes it safer.”
Institutional policies had the strongest impact
Before accounting for the state a hospital was in, 27% of institutions with restrictive abortion policies looked at more than imaging in determining how to proceed, compared with 88% of institutions without abortion restrictions that included clinical judgment and patient preferences in their management.
After controlling for state policies and affiliation with a family planning training program or a religious entity, the odds of an institution relying solely on imaging guidelines were over 12 times greater for institutions with abortion restrictions or bans (odds ratio, 12.3; 95% confidence interval, 3.2-47.9). Specifically, the odds were 9 times greater for institutions with restrictions and 27 times greater for institutions with bans.
Only 12% of the institutions without restrictions relied solely on ultrasound criteria, compared with 67% of the institutions with restrictions and 82% of the institutions that banned all abortions except to save the life of the pregnant individual (P < .001).
Only one in four (25%) of the programs with institutional abortion restrictions used mifepristone, compared with 86% of unrestricted programs (P < .001), and 40% of programs with institutional abortion restrictions used office-based aspiration, compared with 81% of unrestricted programs (P < .001).
Without access to all evidence-based treatments, doctors are often forced to choose expectant management for miscarriages. “So you’re kind of forced to have them to pass the pregnancy at home, which can be traumatic for patients” if that’s not what they wanted, Dr. Phillips said.
Dr. Flink-Bochacki further noted that this patient population is already particularly vulnerable.
“Especially for patients with early pregnancy loss, it’s such a feeling of powerlessness already, so the mental state that many of these patients are in is already quite fraught,” Dr. Flink-Bochacki said. “Then to not even have power to choose the interventions that you want or to be able to access interventions in a timely fashion because you’re being held to some arbitrary guideline further takes away the power and further exacerbates the trauma of the experience.”
The biggest factor likely driving the reduced access to those interventions is the fear that the care could be confused with providing an abortion instead of simply managing a miscarriage, Dr. Flink-Bochacki said. “I think that’s why a lot of these programs don’t have mifepristone and don’t offer outpatient uterine aspiration,” she said. “Because those are so widely used in abortion and the connotation is with abortion, they’re just kind of steering clear of it, but meanwhile, patients with pregnancy loss are suffering because they’re being unnecessarily restrictive.”
The research did not use any external funding, and the authors and Dr. Heuser had no disclosures.
AT ACOG 2023
Youth-led sexual health program improves teen knowledge, autonomy
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
While the small pilot study focused primarily on assessing feasibility and effectiveness, the results suggest potential for scaling the program up to reach a larger audience and assessing the knowledge disseminated from direct youth participants.
“The good thing about this subject is that not a lot of it has to be context-specific,” Saumya Sao, a clinical researcher in gynecology and obstetrics at the Johns Hopkins University, Baltimore, and the study’s lead author, said in an interview. “A lot of it is just baseline information that everybody needs and doesn’t get.”
Jaime Friedman, MD, a pediatrician and director of marketing at Children’s Primary Care Medical Group in San Diego, was not involved in the study but was impressed with the program’s objectives and results so far.
“While education is massively important, teens don’t always want to hear it from their parents or other adults,” Dr. Friedman said in an interview. “Learning from their peers is one way to overcome this hurdle.”
Given the high rate of sexually transmitted infections and unintended pregnancies in youth, paired with low sexual and reproductive health literacy in this population, the researchers sought to learn whether a program focused on peer-to-peer health education on these topics was feasible. The goal was to increase youth sexual and reproductive health knowledge, self-efficacy, and autonomy using a youth-led intervention.
The researchers hosted nine monthly, interactive, youth-led sessions that lasted 2 hours over Zoom or in person. Incorporated into the meetings were principles from Youth Participatory Action Research (YPAR) and Positive Youth Development (PYD).
The major topics included the following: Use of social media, values and goal-setting, anatomy and menstrual health, risk factors of sexual activities , STI and HIV prevention, contraceptive methods, healthy relationships and consent, practice responding to unhealthy behavior, gender and sexuality, and social media and body image.
The 24 participants were provided with transportation to the study site at the researchers’ institution and received financial compensation for their participation. They were an average 15.8 years old, lived in the greater Baltimore area, and mostly self-identified as female. Eight percent identified as non-binary and half (50%) identified as LGBTQIA+. Just over half the participants (52%) were Black/African American, 28% were Asian/Asian American, 12% were White, and 8% were Hispanic. The participants attended an average 88% of the sessions throughout the full intervention.
For each of the nine sessions, more than 50% of participants reported that they “learned a lot,” and only one participant reported for one session (session 5) that they “didn’t learn” anything. The researchers assessed participants’ knowledge, self-efficacy, and sense of autonomy at baseline and after completion of the intervention. Significant improvements occurred across all areas.
The average score improved by 31% in sexual and reproductive health knowledge (P < .001), 33% in sexual and reproductive health services awareness (P = .002), 46% in advocacy and empowerment (P < .001), 16% in general perceived efficacy (P = .002), and 22% personal sexuality empowerment (P = .006).
Ms. Sao said she was very pleased to see that the improvements were significant in every domain they measured, which she attributed largely to the incorporation of YPAR and PYD into the program.
“We approached it using these two frameworks that really do focus on involving youth in the teaching themselves, so I think that’s what increased their general perceived efficacy and advocacy empowerment without us necessarily having to emphasize, ‘You are advocates,’” Ms. Sao said. “Those frameworks ask the youth for their opinions and then give the youth an opportunity in every single session to be teachers themselves, and I think that lends itself well to all of the domains.”
Ms. Sao was also pleasantly surprised at the high level of retention across the 9 months.
“Every single session was slotted for 2 hours, but they would want to stay for 3 hours. Eventually, we actually started meeting with them twice a month, just adding an extra session,” she said. “As they gained confidence, they were so excited to be peer educators and realized, ‘I can really do this. I can teach my peers. We’re not getting this from anywhere else.’ ”
Ms. Sao and another study author, Maclaine Barré-Quick, an undergraduate research assistant at Johns Hopkins University, said the participants quickly discovered how easy it was to have a non-stigmatizing conversation about many of the topics once a subject was brought up.
“They’re actively looking for that opportunity,” Ms. Barré-Quick said in an interview.
Dr. Friedman agreed that this type of program provides what many adolescents need in a way that they may welcome more than through other methods.
“Adolescents’ bodies are approaching adulthood and function like adults, but their brains are still developing. They don’t have the worldly experience and education of adults, but they think they know everything,” Dr. Friedman said. “They are a population known for their high risk behavior due to their natural impulsivity. This can be a scary combination, especially when it comes to sexual health.”
But if teens don’t want to hear some of the information they need from adults, they may be more open to hearing it from other teens, Dr. Friedman said.
“Using an evidence-based approach ensures the desired outcome of healthier habits, decreased STIs and decreased teen pregnancy,” Dr. Friedman said. “It also adds weight to the argument against abstinence-only education. Teens deserve accurate and evidence-based education about their own bodies.”
Ms. Sao said the next steps will be exploring ways to scale the program up, such as putting the curriculum resources into a bundle available to other educators. They’re also looking at ways to put it into an online platform that’s self-paced, though that requires solving the challenge of having synchronous meetings for youth-led discussion.
“There are certain kinks that we have to work out because there were some activities where I think the students really benefited from having those open discussions with each other, so [we need to determine] how to replicate that in an online format,” Ms. Sao said.
Dr. Friedman agreed that scalability appears to be the biggest challenge, along with funding programs. But if those obstacles can be overcome, such programs would complement and expand on the education she does currently with families.
“I don’t have time for a full sex ed course at each visit,” Dr. Friedman said. “I would like to be able to direct them to a program that I know works and would be easy for them to complete. Even better, this would be an amazing program to ‘sell’ to practices interested in hosting these sessions themselves.”
Ms. Sao said they also hope to assess the impact of the intervention on the participants’ peers to see how well the knowledge and self-efficacy spread through the youths’ teaching.
No external funding was noted. One author reported research support from Hologic and Merck. Dr. Friedman had no disclosures.
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
While the small pilot study focused primarily on assessing feasibility and effectiveness, the results suggest potential for scaling the program up to reach a larger audience and assessing the knowledge disseminated from direct youth participants.
“The good thing about this subject is that not a lot of it has to be context-specific,” Saumya Sao, a clinical researcher in gynecology and obstetrics at the Johns Hopkins University, Baltimore, and the study’s lead author, said in an interview. “A lot of it is just baseline information that everybody needs and doesn’t get.”
Jaime Friedman, MD, a pediatrician and director of marketing at Children’s Primary Care Medical Group in San Diego, was not involved in the study but was impressed with the program’s objectives and results so far.
“While education is massively important, teens don’t always want to hear it from their parents or other adults,” Dr. Friedman said in an interview. “Learning from their peers is one way to overcome this hurdle.”
Given the high rate of sexually transmitted infections and unintended pregnancies in youth, paired with low sexual and reproductive health literacy in this population, the researchers sought to learn whether a program focused on peer-to-peer health education on these topics was feasible. The goal was to increase youth sexual and reproductive health knowledge, self-efficacy, and autonomy using a youth-led intervention.
The researchers hosted nine monthly, interactive, youth-led sessions that lasted 2 hours over Zoom or in person. Incorporated into the meetings were principles from Youth Participatory Action Research (YPAR) and Positive Youth Development (PYD).
The major topics included the following: Use of social media, values and goal-setting, anatomy and menstrual health, risk factors of sexual activities , STI and HIV prevention, contraceptive methods, healthy relationships and consent, practice responding to unhealthy behavior, gender and sexuality, and social media and body image.
The 24 participants were provided with transportation to the study site at the researchers’ institution and received financial compensation for their participation. They were an average 15.8 years old, lived in the greater Baltimore area, and mostly self-identified as female. Eight percent identified as non-binary and half (50%) identified as LGBTQIA+. Just over half the participants (52%) were Black/African American, 28% were Asian/Asian American, 12% were White, and 8% were Hispanic. The participants attended an average 88% of the sessions throughout the full intervention.
For each of the nine sessions, more than 50% of participants reported that they “learned a lot,” and only one participant reported for one session (session 5) that they “didn’t learn” anything. The researchers assessed participants’ knowledge, self-efficacy, and sense of autonomy at baseline and after completion of the intervention. Significant improvements occurred across all areas.
The average score improved by 31% in sexual and reproductive health knowledge (P < .001), 33% in sexual and reproductive health services awareness (P = .002), 46% in advocacy and empowerment (P < .001), 16% in general perceived efficacy (P = .002), and 22% personal sexuality empowerment (P = .006).
Ms. Sao said she was very pleased to see that the improvements were significant in every domain they measured, which she attributed largely to the incorporation of YPAR and PYD into the program.
“We approached it using these two frameworks that really do focus on involving youth in the teaching themselves, so I think that’s what increased their general perceived efficacy and advocacy empowerment without us necessarily having to emphasize, ‘You are advocates,’” Ms. Sao said. “Those frameworks ask the youth for their opinions and then give the youth an opportunity in every single session to be teachers themselves, and I think that lends itself well to all of the domains.”
Ms. Sao was also pleasantly surprised at the high level of retention across the 9 months.
“Every single session was slotted for 2 hours, but they would want to stay for 3 hours. Eventually, we actually started meeting with them twice a month, just adding an extra session,” she said. “As they gained confidence, they were so excited to be peer educators and realized, ‘I can really do this. I can teach my peers. We’re not getting this from anywhere else.’ ”
Ms. Sao and another study author, Maclaine Barré-Quick, an undergraduate research assistant at Johns Hopkins University, said the participants quickly discovered how easy it was to have a non-stigmatizing conversation about many of the topics once a subject was brought up.
“They’re actively looking for that opportunity,” Ms. Barré-Quick said in an interview.
Dr. Friedman agreed that this type of program provides what many adolescents need in a way that they may welcome more than through other methods.
“Adolescents’ bodies are approaching adulthood and function like adults, but their brains are still developing. They don’t have the worldly experience and education of adults, but they think they know everything,” Dr. Friedman said. “They are a population known for their high risk behavior due to their natural impulsivity. This can be a scary combination, especially when it comes to sexual health.”
But if teens don’t want to hear some of the information they need from adults, they may be more open to hearing it from other teens, Dr. Friedman said.
“Using an evidence-based approach ensures the desired outcome of healthier habits, decreased STIs and decreased teen pregnancy,” Dr. Friedman said. “It also adds weight to the argument against abstinence-only education. Teens deserve accurate and evidence-based education about their own bodies.”
Ms. Sao said the next steps will be exploring ways to scale the program up, such as putting the curriculum resources into a bundle available to other educators. They’re also looking at ways to put it into an online platform that’s self-paced, though that requires solving the challenge of having synchronous meetings for youth-led discussion.
“There are certain kinks that we have to work out because there were some activities where I think the students really benefited from having those open discussions with each other, so [we need to determine] how to replicate that in an online format,” Ms. Sao said.
Dr. Friedman agreed that scalability appears to be the biggest challenge, along with funding programs. But if those obstacles can be overcome, such programs would complement and expand on the education she does currently with families.
“I don’t have time for a full sex ed course at each visit,” Dr. Friedman said. “I would like to be able to direct them to a program that I know works and would be easy for them to complete. Even better, this would be an amazing program to ‘sell’ to practices interested in hosting these sessions themselves.”
Ms. Sao said they also hope to assess the impact of the intervention on the participants’ peers to see how well the knowledge and self-efficacy spread through the youths’ teaching.
No external funding was noted. One author reported research support from Hologic and Merck. Dr. Friedman had no disclosures.
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
While the small pilot study focused primarily on assessing feasibility and effectiveness, the results suggest potential for scaling the program up to reach a larger audience and assessing the knowledge disseminated from direct youth participants.
“The good thing about this subject is that not a lot of it has to be context-specific,” Saumya Sao, a clinical researcher in gynecology and obstetrics at the Johns Hopkins University, Baltimore, and the study’s lead author, said in an interview. “A lot of it is just baseline information that everybody needs and doesn’t get.”
Jaime Friedman, MD, a pediatrician and director of marketing at Children’s Primary Care Medical Group in San Diego, was not involved in the study but was impressed with the program’s objectives and results so far.
“While education is massively important, teens don’t always want to hear it from their parents or other adults,” Dr. Friedman said in an interview. “Learning from their peers is one way to overcome this hurdle.”
Given the high rate of sexually transmitted infections and unintended pregnancies in youth, paired with low sexual and reproductive health literacy in this population, the researchers sought to learn whether a program focused on peer-to-peer health education on these topics was feasible. The goal was to increase youth sexual and reproductive health knowledge, self-efficacy, and autonomy using a youth-led intervention.
The researchers hosted nine monthly, interactive, youth-led sessions that lasted 2 hours over Zoom or in person. Incorporated into the meetings were principles from Youth Participatory Action Research (YPAR) and Positive Youth Development (PYD).
The major topics included the following: Use of social media, values and goal-setting, anatomy and menstrual health, risk factors of sexual activities , STI and HIV prevention, contraceptive methods, healthy relationships and consent, practice responding to unhealthy behavior, gender and sexuality, and social media and body image.
The 24 participants were provided with transportation to the study site at the researchers’ institution and received financial compensation for their participation. They were an average 15.8 years old, lived in the greater Baltimore area, and mostly self-identified as female. Eight percent identified as non-binary and half (50%) identified as LGBTQIA+. Just over half the participants (52%) were Black/African American, 28% were Asian/Asian American, 12% were White, and 8% were Hispanic. The participants attended an average 88% of the sessions throughout the full intervention.
For each of the nine sessions, more than 50% of participants reported that they “learned a lot,” and only one participant reported for one session (session 5) that they “didn’t learn” anything. The researchers assessed participants’ knowledge, self-efficacy, and sense of autonomy at baseline and after completion of the intervention. Significant improvements occurred across all areas.
The average score improved by 31% in sexual and reproductive health knowledge (P < .001), 33% in sexual and reproductive health services awareness (P = .002), 46% in advocacy and empowerment (P < .001), 16% in general perceived efficacy (P = .002), and 22% personal sexuality empowerment (P = .006).
Ms. Sao said she was very pleased to see that the improvements were significant in every domain they measured, which she attributed largely to the incorporation of YPAR and PYD into the program.
“We approached it using these two frameworks that really do focus on involving youth in the teaching themselves, so I think that’s what increased their general perceived efficacy and advocacy empowerment without us necessarily having to emphasize, ‘You are advocates,’” Ms. Sao said. “Those frameworks ask the youth for their opinions and then give the youth an opportunity in every single session to be teachers themselves, and I think that lends itself well to all of the domains.”
Ms. Sao was also pleasantly surprised at the high level of retention across the 9 months.
“Every single session was slotted for 2 hours, but they would want to stay for 3 hours. Eventually, we actually started meeting with them twice a month, just adding an extra session,” she said. “As they gained confidence, they were so excited to be peer educators and realized, ‘I can really do this. I can teach my peers. We’re not getting this from anywhere else.’ ”
Ms. Sao and another study author, Maclaine Barré-Quick, an undergraduate research assistant at Johns Hopkins University, said the participants quickly discovered how easy it was to have a non-stigmatizing conversation about many of the topics once a subject was brought up.
“They’re actively looking for that opportunity,” Ms. Barré-Quick said in an interview.
Dr. Friedman agreed that this type of program provides what many adolescents need in a way that they may welcome more than through other methods.
“Adolescents’ bodies are approaching adulthood and function like adults, but their brains are still developing. They don’t have the worldly experience and education of adults, but they think they know everything,” Dr. Friedman said. “They are a population known for their high risk behavior due to their natural impulsivity. This can be a scary combination, especially when it comes to sexual health.”
But if teens don’t want to hear some of the information they need from adults, they may be more open to hearing it from other teens, Dr. Friedman said.
“Using an evidence-based approach ensures the desired outcome of healthier habits, decreased STIs and decreased teen pregnancy,” Dr. Friedman said. “It also adds weight to the argument against abstinence-only education. Teens deserve accurate and evidence-based education about their own bodies.”
Ms. Sao said the next steps will be exploring ways to scale the program up, such as putting the curriculum resources into a bundle available to other educators. They’re also looking at ways to put it into an online platform that’s self-paced, though that requires solving the challenge of having synchronous meetings for youth-led discussion.
“There are certain kinks that we have to work out because there were some activities where I think the students really benefited from having those open discussions with each other, so [we need to determine] how to replicate that in an online format,” Ms. Sao said.
Dr. Friedman agreed that scalability appears to be the biggest challenge, along with funding programs. But if those obstacles can be overcome, such programs would complement and expand on the education she does currently with families.
“I don’t have time for a full sex ed course at each visit,” Dr. Friedman said. “I would like to be able to direct them to a program that I know works and would be easy for them to complete. Even better, this would be an amazing program to ‘sell’ to practices interested in hosting these sessions themselves.”
Ms. Sao said they also hope to assess the impact of the intervention on the participants’ peers to see how well the knowledge and self-efficacy spread through the youths’ teaching.
No external funding was noted. One author reported research support from Hologic and Merck. Dr. Friedman had no disclosures.
AT ACOG 2023
Safety remains top parent concern for HPV vaccine
, according to a study published online in Pediatrics.
“Although HPV vaccination rates in the United States have steadily improved over the past decade, a sizable subset of parents remains highly hesitant about administering the vaccine to their adolescent children,” wrote Eric Adjei Boakye, PhD, of the departments of public health sciences and otolaryngology–head and neck surgery at the Henry Ford Health System, Detroit, and associates. But a silver lining in the study is the downward trend in parents not vaccinating their children against HPV because the child’s provider did not recommend it.
“Provider recommendation has been shown to be the single best predictor of HPV vaccine uptake and vaccine acceptability,” the authors wrote. They noted one previous study finding that provider recommendations for the vaccine had increased from 27% in 2012 to 49.3% in 2018.
Safety concerns increased while other concerns decreased
The findings were not surprising to Robert A. Bednarczyk, PhD, associate professor of global health at Emory University Rollins School of Public Health, Atlanta, who specializes in HPV vaccine research.
“We have seen over the years that vaccine safety concerns have been on the increase, notably recently in the context of the COVID-19 pandemic and vaccination program, but HPV vaccine safety, though well established, continues to be a major concern for parents,” Dr. Bednarczyk said in an interview. But he found it striking that parents’ other reasons for turning down the vaccine had declined. “This shows that the outreach around the need for HPV vaccination and efforts to improve provider recommendation strategies is likely having positive impacts on HPV vaccine attitudes.”
Top five reasons for not vaccinating
The researchers analyzed data from the National Immunization Survey–Teen for the years 2010 through 2020 to track the annual changes in the top five reasons cited for not planning to get the HPV vaccine. The data covered 119,695 teens aged 13-17.
The researchers identified parents’ five most commonly cited reasons for not planning to vaccinate their children against HPV: “not necessary,” “safety concerns,” “lack of recommendation,” “lack of knowledge,” and “not sexually active.”
Parents’ HPV vaccine hesitancy decreased by 5.5% each year from 2010 to 2012, but then it stagnated for the remaining years through 2020. Across most of that time, from 2010 to 2018, parents’ concerns about the vaccine’s safety and side effects increased by 15.6%. A major reason for this increase, the authors suggested, may include the widespread distribution of online misinformation, particularly given the 7.8 million increase in antivaccine social media accounts since 2019.
“Fear tactics are often used by antivaccine campaigners to dissuade parents from vaccinating their children. There have been several myths propagated about vaccines causing adverse reactions,” the authors wrote. “Although these myths have been scientifically debunked, they continue to circulate.”
In contrast to parents’ concerns, a study in 2021 found a downward trend in reports of nonserious adverse effects and no change in reports of serious adverse effects from the HPV vaccine between 2015 and 2018. Further, more than 95% of the adverse effect reports to the Vaccine Adverse Event Reporting System after HPV vaccination were nonserious.
Reducing perceived barriers
Meanwhile, however, parents’ other reasons for avoiding the vaccine became less prevalent throughout most of the study period. For each year between 2013 and 2020, the proportion of parents saying they didn’t intend to get their children the HPV vaccine because it was “not recommended” decreased by 6.8%.
Similarly, avoiding the vaccine due to “lack of knowledge” declined 9.9%, and avoidance because the child was “not sexually active” declined 5.9% each year from 2013 to 2020. No difference occurred during that time period regarding how frequently parents cited that the vaccine was “not necessary.”
“Decreases in the percentage of parents/guardians citing lack of provider recommendation, lack of knowledge, and child ‘not sexually active’ as the main reason for HPV vaccine hesitancy ... are encouraging and suggest that interventions have been successful in reducing perceived barriers to HPV vaccination,” the authors wrote.
Dr. Bednarczyk agreed that these findings were encouraging, underscoring that outreach and support for health care providers to give strong recommendations for the vaccine need to continue.
“But additionally, we need to find better ways to communicate about vaccine safety,” Dr. Bednarczyk said. “Seeing that the number of parents citing safety concerns as the primary barrier has not changed much between 2016 and 2020, but that the percent of parents having those concerns increased, likely means there is a stable part of the population with these safety concerns, and as more adolescents are getting vaccinated against HPV, the relative contribution of safety concerns is increasing.” A key way to address those concerns includes “engaging with our trusted community partners and giving them the tools to discuss the safety of HPV vaccination with members of the community,” he said.
Debunking misinformation
Like the authors, Dr. Bednarczyk pointed out several conditions that parents erroneously worry could be caused by the HPV vaccine, but he emphasized that simply telling parents those misconceptions are untrue is insufficient to allay fears.
“It’s important for both clinicians and community partners to recognize we cannot just present a list of facts and figures and statistics to parents to reassure them and hope that this works,” Dr. Bednarczyk said. “Effective communication, strong narratives to illustrate this knowledge, and engagement with not just clinicians but community partners and other trusted sources is needed.” Dr. Bednarczyk continues to support the evidence-based model of presumptive recommendations, which does not remove parental autonomy but simplifies vaccine messaging about what’s recommended, “but clinicians need to be prepared with both the data and effective ways to communicate it to address questions if they come up after the presumptive recommendation is given,” he added.
The researchers pointed out that their study data were collected before the pandemic, so “it is reasonable to expect that HPV vaccine–related safety concerns may continue to rise because of the plethora of misinformation surrounding coronavirus disease 2019 vaccination.”
Dr. Bednarczyk said it will be important to see in future research whether shifts in beliefs about the HPV vaccine have occurred in the midst of the pandemic and afterward.
“As the authors stated, it’s important to remember that HPV vaccination has consistently been shown to be safe and effective,” Dr. Bednarczyk said. “But those research findings are not seeming to resonate with parents, highlighting how we need to improve our outreach and communication work.”
The research did not receive external funding. A coauthor is a scientific adviser to Navigating Cancer. The other authors and Dr. Bednarczyk had no disclosures.
, according to a study published online in Pediatrics.
“Although HPV vaccination rates in the United States have steadily improved over the past decade, a sizable subset of parents remains highly hesitant about administering the vaccine to their adolescent children,” wrote Eric Adjei Boakye, PhD, of the departments of public health sciences and otolaryngology–head and neck surgery at the Henry Ford Health System, Detroit, and associates. But a silver lining in the study is the downward trend in parents not vaccinating their children against HPV because the child’s provider did not recommend it.
“Provider recommendation has been shown to be the single best predictor of HPV vaccine uptake and vaccine acceptability,” the authors wrote. They noted one previous study finding that provider recommendations for the vaccine had increased from 27% in 2012 to 49.3% in 2018.
Safety concerns increased while other concerns decreased
The findings were not surprising to Robert A. Bednarczyk, PhD, associate professor of global health at Emory University Rollins School of Public Health, Atlanta, who specializes in HPV vaccine research.
“We have seen over the years that vaccine safety concerns have been on the increase, notably recently in the context of the COVID-19 pandemic and vaccination program, but HPV vaccine safety, though well established, continues to be a major concern for parents,” Dr. Bednarczyk said in an interview. But he found it striking that parents’ other reasons for turning down the vaccine had declined. “This shows that the outreach around the need for HPV vaccination and efforts to improve provider recommendation strategies is likely having positive impacts on HPV vaccine attitudes.”
Top five reasons for not vaccinating
The researchers analyzed data from the National Immunization Survey–Teen for the years 2010 through 2020 to track the annual changes in the top five reasons cited for not planning to get the HPV vaccine. The data covered 119,695 teens aged 13-17.
The researchers identified parents’ five most commonly cited reasons for not planning to vaccinate their children against HPV: “not necessary,” “safety concerns,” “lack of recommendation,” “lack of knowledge,” and “not sexually active.”
Parents’ HPV vaccine hesitancy decreased by 5.5% each year from 2010 to 2012, but then it stagnated for the remaining years through 2020. Across most of that time, from 2010 to 2018, parents’ concerns about the vaccine’s safety and side effects increased by 15.6%. A major reason for this increase, the authors suggested, may include the widespread distribution of online misinformation, particularly given the 7.8 million increase in antivaccine social media accounts since 2019.
“Fear tactics are often used by antivaccine campaigners to dissuade parents from vaccinating their children. There have been several myths propagated about vaccines causing adverse reactions,” the authors wrote. “Although these myths have been scientifically debunked, they continue to circulate.”
In contrast to parents’ concerns, a study in 2021 found a downward trend in reports of nonserious adverse effects and no change in reports of serious adverse effects from the HPV vaccine between 2015 and 2018. Further, more than 95% of the adverse effect reports to the Vaccine Adverse Event Reporting System after HPV vaccination were nonserious.
Reducing perceived barriers
Meanwhile, however, parents’ other reasons for avoiding the vaccine became less prevalent throughout most of the study period. For each year between 2013 and 2020, the proportion of parents saying they didn’t intend to get their children the HPV vaccine because it was “not recommended” decreased by 6.8%.
Similarly, avoiding the vaccine due to “lack of knowledge” declined 9.9%, and avoidance because the child was “not sexually active” declined 5.9% each year from 2013 to 2020. No difference occurred during that time period regarding how frequently parents cited that the vaccine was “not necessary.”
“Decreases in the percentage of parents/guardians citing lack of provider recommendation, lack of knowledge, and child ‘not sexually active’ as the main reason for HPV vaccine hesitancy ... are encouraging and suggest that interventions have been successful in reducing perceived barriers to HPV vaccination,” the authors wrote.
Dr. Bednarczyk agreed that these findings were encouraging, underscoring that outreach and support for health care providers to give strong recommendations for the vaccine need to continue.
“But additionally, we need to find better ways to communicate about vaccine safety,” Dr. Bednarczyk said. “Seeing that the number of parents citing safety concerns as the primary barrier has not changed much between 2016 and 2020, but that the percent of parents having those concerns increased, likely means there is a stable part of the population with these safety concerns, and as more adolescents are getting vaccinated against HPV, the relative contribution of safety concerns is increasing.” A key way to address those concerns includes “engaging with our trusted community partners and giving them the tools to discuss the safety of HPV vaccination with members of the community,” he said.
Debunking misinformation
Like the authors, Dr. Bednarczyk pointed out several conditions that parents erroneously worry could be caused by the HPV vaccine, but he emphasized that simply telling parents those misconceptions are untrue is insufficient to allay fears.
“It’s important for both clinicians and community partners to recognize we cannot just present a list of facts and figures and statistics to parents to reassure them and hope that this works,” Dr. Bednarczyk said. “Effective communication, strong narratives to illustrate this knowledge, and engagement with not just clinicians but community partners and other trusted sources is needed.” Dr. Bednarczyk continues to support the evidence-based model of presumptive recommendations, which does not remove parental autonomy but simplifies vaccine messaging about what’s recommended, “but clinicians need to be prepared with both the data and effective ways to communicate it to address questions if they come up after the presumptive recommendation is given,” he added.
The researchers pointed out that their study data were collected before the pandemic, so “it is reasonable to expect that HPV vaccine–related safety concerns may continue to rise because of the plethora of misinformation surrounding coronavirus disease 2019 vaccination.”
Dr. Bednarczyk said it will be important to see in future research whether shifts in beliefs about the HPV vaccine have occurred in the midst of the pandemic and afterward.
“As the authors stated, it’s important to remember that HPV vaccination has consistently been shown to be safe and effective,” Dr. Bednarczyk said. “But those research findings are not seeming to resonate with parents, highlighting how we need to improve our outreach and communication work.”
The research did not receive external funding. A coauthor is a scientific adviser to Navigating Cancer. The other authors and Dr. Bednarczyk had no disclosures.
, according to a study published online in Pediatrics.
“Although HPV vaccination rates in the United States have steadily improved over the past decade, a sizable subset of parents remains highly hesitant about administering the vaccine to their adolescent children,” wrote Eric Adjei Boakye, PhD, of the departments of public health sciences and otolaryngology–head and neck surgery at the Henry Ford Health System, Detroit, and associates. But a silver lining in the study is the downward trend in parents not vaccinating their children against HPV because the child’s provider did not recommend it.
“Provider recommendation has been shown to be the single best predictor of HPV vaccine uptake and vaccine acceptability,” the authors wrote. They noted one previous study finding that provider recommendations for the vaccine had increased from 27% in 2012 to 49.3% in 2018.
Safety concerns increased while other concerns decreased
The findings were not surprising to Robert A. Bednarczyk, PhD, associate professor of global health at Emory University Rollins School of Public Health, Atlanta, who specializes in HPV vaccine research.
“We have seen over the years that vaccine safety concerns have been on the increase, notably recently in the context of the COVID-19 pandemic and vaccination program, but HPV vaccine safety, though well established, continues to be a major concern for parents,” Dr. Bednarczyk said in an interview. But he found it striking that parents’ other reasons for turning down the vaccine had declined. “This shows that the outreach around the need for HPV vaccination and efforts to improve provider recommendation strategies is likely having positive impacts on HPV vaccine attitudes.”
Top five reasons for not vaccinating
The researchers analyzed data from the National Immunization Survey–Teen for the years 2010 through 2020 to track the annual changes in the top five reasons cited for not planning to get the HPV vaccine. The data covered 119,695 teens aged 13-17.
The researchers identified parents’ five most commonly cited reasons for not planning to vaccinate their children against HPV: “not necessary,” “safety concerns,” “lack of recommendation,” “lack of knowledge,” and “not sexually active.”
Parents’ HPV vaccine hesitancy decreased by 5.5% each year from 2010 to 2012, but then it stagnated for the remaining years through 2020. Across most of that time, from 2010 to 2018, parents’ concerns about the vaccine’s safety and side effects increased by 15.6%. A major reason for this increase, the authors suggested, may include the widespread distribution of online misinformation, particularly given the 7.8 million increase in antivaccine social media accounts since 2019.
“Fear tactics are often used by antivaccine campaigners to dissuade parents from vaccinating their children. There have been several myths propagated about vaccines causing adverse reactions,” the authors wrote. “Although these myths have been scientifically debunked, they continue to circulate.”
In contrast to parents’ concerns, a study in 2021 found a downward trend in reports of nonserious adverse effects and no change in reports of serious adverse effects from the HPV vaccine between 2015 and 2018. Further, more than 95% of the adverse effect reports to the Vaccine Adverse Event Reporting System after HPV vaccination were nonserious.
Reducing perceived barriers
Meanwhile, however, parents’ other reasons for avoiding the vaccine became less prevalent throughout most of the study period. For each year between 2013 and 2020, the proportion of parents saying they didn’t intend to get their children the HPV vaccine because it was “not recommended” decreased by 6.8%.
Similarly, avoiding the vaccine due to “lack of knowledge” declined 9.9%, and avoidance because the child was “not sexually active” declined 5.9% each year from 2013 to 2020. No difference occurred during that time period regarding how frequently parents cited that the vaccine was “not necessary.”
“Decreases in the percentage of parents/guardians citing lack of provider recommendation, lack of knowledge, and child ‘not sexually active’ as the main reason for HPV vaccine hesitancy ... are encouraging and suggest that interventions have been successful in reducing perceived barriers to HPV vaccination,” the authors wrote.
Dr. Bednarczyk agreed that these findings were encouraging, underscoring that outreach and support for health care providers to give strong recommendations for the vaccine need to continue.
“But additionally, we need to find better ways to communicate about vaccine safety,” Dr. Bednarczyk said. “Seeing that the number of parents citing safety concerns as the primary barrier has not changed much between 2016 and 2020, but that the percent of parents having those concerns increased, likely means there is a stable part of the population with these safety concerns, and as more adolescents are getting vaccinated against HPV, the relative contribution of safety concerns is increasing.” A key way to address those concerns includes “engaging with our trusted community partners and giving them the tools to discuss the safety of HPV vaccination with members of the community,” he said.
Debunking misinformation
Like the authors, Dr. Bednarczyk pointed out several conditions that parents erroneously worry could be caused by the HPV vaccine, but he emphasized that simply telling parents those misconceptions are untrue is insufficient to allay fears.
“It’s important for both clinicians and community partners to recognize we cannot just present a list of facts and figures and statistics to parents to reassure them and hope that this works,” Dr. Bednarczyk said. “Effective communication, strong narratives to illustrate this knowledge, and engagement with not just clinicians but community partners and other trusted sources is needed.” Dr. Bednarczyk continues to support the evidence-based model of presumptive recommendations, which does not remove parental autonomy but simplifies vaccine messaging about what’s recommended, “but clinicians need to be prepared with both the data and effective ways to communicate it to address questions if they come up after the presumptive recommendation is given,” he added.
The researchers pointed out that their study data were collected before the pandemic, so “it is reasonable to expect that HPV vaccine–related safety concerns may continue to rise because of the plethora of misinformation surrounding coronavirus disease 2019 vaccination.”
Dr. Bednarczyk said it will be important to see in future research whether shifts in beliefs about the HPV vaccine have occurred in the midst of the pandemic and afterward.
“As the authors stated, it’s important to remember that HPV vaccination has consistently been shown to be safe and effective,” Dr. Bednarczyk said. “But those research findings are not seeming to resonate with parents, highlighting how we need to improve our outreach and communication work.”
The research did not receive external funding. A coauthor is a scientific adviser to Navigating Cancer. The other authors and Dr. Bednarczyk had no disclosures.
FROM PEDIATRICS
Once-daily nifedipine sufficient for hypertension in pregnancy
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*
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
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*
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
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*
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
AT ACOG 2023
Over half of pregnant patients not properly screened for thyroid disease
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.
FROM ACOG 2023
New AI tool may help predict best treatments for colorectal cancer
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.
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.
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.
FROM NATURE COMMUNICATIONS
Metformin linked to reduced osteoarthritis risk
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.
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.
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.
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.
FROM JAMA NETWORK OPEN AND OARSI 2023
Answers sought for mental health challenges in pediatric rheumatology patients
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.
“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.
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.
“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.
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.
“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.
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.
AT PRSYM 2023
Spinal cord stimulation may help diabetic neuropathy
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.
“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.
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.
“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.
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.
“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.
FROM AAN 2023