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Most patients with psoriasis not engaged in highly shared decision-making
TOPLINE:
METHODOLOGY:
- Researchers drew from the 2014-2017 and 2019 Medical Expenditure Panel Survey (MEPS) to identify 3,715,027 patients with psoriasis, to evaluate the association between SDM (a patient-centered approach to selecting treatment on the basis of a discussion between the clinician and patient) and satisfaction with care.
- SDM was determined by patient responses on a 4-point Likert scale to seven MEPS variables, including the question, “How often did doctors or other health providers listen carefully to you?”
- Patient satisfaction with care was measured with a MEPS variable that asked respondents to rate their health care providers on a scale of 1-10.
- Researchers used multiple logistic regression to assess the association between SDM and demographic and clinical characteristics in patients with psoriasis, and multiple linear regression analysis to assess the association between SDM and patient satisfaction with care.
TAKEAWAY:
- The average SDM score was 3.6 out of 4, and the average satisfaction with care score was 8.6 out of 10.
- However, only about 42% of the cohort reported a high SDM, defined as a score of 3.9 or greater.
- After adjusting for covariates, the researchers found that patients who had high SDM had, on average, 85% higher satisfaction with care (P < .001).
- Compared with men, women had about 27% higher satisfaction with care (P = .023), whereas non-Hispanic patients had lower satisfaction with care compared with Hispanic patients (P = .037).
IN PRACTICE:
“It is important to construct a framework for carrying out SDM with patients with psoriasis to enhance clinician-patient communication and improve patient outcomes,” the authors concluded.
SOURCE:
April W. Armstrong, MD, MPH, chief of dermatology at the University of California, Los Angeles, led the research. The study was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The ability to measure SDM in patients with psoriasis was limited by the seven items from MEPS. The diagnosis of psoriasis was based on self-report.
DISCLOSURES:
The study was funded by the National Psoriasis Foundation. Dr. Armstrong disclosed that she has served as a research investigator and/or scientific adviser to AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, EPI, Incyte, Leo, UCB, Janssen, Lilly, Nimbus, Novartis, Ortho Dermatologics, Sun, Dermavant, Dermira, Sanofi, Regeneron, Pfizer, and Modmed.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers drew from the 2014-2017 and 2019 Medical Expenditure Panel Survey (MEPS) to identify 3,715,027 patients with psoriasis, to evaluate the association between SDM (a patient-centered approach to selecting treatment on the basis of a discussion between the clinician and patient) and satisfaction with care.
- SDM was determined by patient responses on a 4-point Likert scale to seven MEPS variables, including the question, “How often did doctors or other health providers listen carefully to you?”
- Patient satisfaction with care was measured with a MEPS variable that asked respondents to rate their health care providers on a scale of 1-10.
- Researchers used multiple logistic regression to assess the association between SDM and demographic and clinical characteristics in patients with psoriasis, and multiple linear regression analysis to assess the association between SDM and patient satisfaction with care.
TAKEAWAY:
- The average SDM score was 3.6 out of 4, and the average satisfaction with care score was 8.6 out of 10.
- However, only about 42% of the cohort reported a high SDM, defined as a score of 3.9 or greater.
- After adjusting for covariates, the researchers found that patients who had high SDM had, on average, 85% higher satisfaction with care (P < .001).
- Compared with men, women had about 27% higher satisfaction with care (P = .023), whereas non-Hispanic patients had lower satisfaction with care compared with Hispanic patients (P = .037).
IN PRACTICE:
“It is important to construct a framework for carrying out SDM with patients with psoriasis to enhance clinician-patient communication and improve patient outcomes,” the authors concluded.
SOURCE:
April W. Armstrong, MD, MPH, chief of dermatology at the University of California, Los Angeles, led the research. The study was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The ability to measure SDM in patients with psoriasis was limited by the seven items from MEPS. The diagnosis of psoriasis was based on self-report.
DISCLOSURES:
The study was funded by the National Psoriasis Foundation. Dr. Armstrong disclosed that she has served as a research investigator and/or scientific adviser to AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, EPI, Incyte, Leo, UCB, Janssen, Lilly, Nimbus, Novartis, Ortho Dermatologics, Sun, Dermavant, Dermira, Sanofi, Regeneron, Pfizer, and Modmed.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers drew from the 2014-2017 and 2019 Medical Expenditure Panel Survey (MEPS) to identify 3,715,027 patients with psoriasis, to evaluate the association between SDM (a patient-centered approach to selecting treatment on the basis of a discussion between the clinician and patient) and satisfaction with care.
- SDM was determined by patient responses on a 4-point Likert scale to seven MEPS variables, including the question, “How often did doctors or other health providers listen carefully to you?”
- Patient satisfaction with care was measured with a MEPS variable that asked respondents to rate their health care providers on a scale of 1-10.
- Researchers used multiple logistic regression to assess the association between SDM and demographic and clinical characteristics in patients with psoriasis, and multiple linear regression analysis to assess the association between SDM and patient satisfaction with care.
TAKEAWAY:
- The average SDM score was 3.6 out of 4, and the average satisfaction with care score was 8.6 out of 10.
- However, only about 42% of the cohort reported a high SDM, defined as a score of 3.9 or greater.
- After adjusting for covariates, the researchers found that patients who had high SDM had, on average, 85% higher satisfaction with care (P < .001).
- Compared with men, women had about 27% higher satisfaction with care (P = .023), whereas non-Hispanic patients had lower satisfaction with care compared with Hispanic patients (P = .037).
IN PRACTICE:
“It is important to construct a framework for carrying out SDM with patients with psoriasis to enhance clinician-patient communication and improve patient outcomes,” the authors concluded.
SOURCE:
April W. Armstrong, MD, MPH, chief of dermatology at the University of California, Los Angeles, led the research. The study was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The ability to measure SDM in patients with psoriasis was limited by the seven items from MEPS. The diagnosis of psoriasis was based on self-report.
DISCLOSURES:
The study was funded by the National Psoriasis Foundation. Dr. Armstrong disclosed that she has served as a research investigator and/or scientific adviser to AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, EPI, Incyte, Leo, UCB, Janssen, Lilly, Nimbus, Novartis, Ortho Dermatologics, Sun, Dermavant, Dermira, Sanofi, Regeneron, Pfizer, and Modmed.
A version of this article first appeared on Medscape.com.
Dupilumab-associated lymphoid reactions require caution
, according to a study published in JAMA Dermatology
The potential for such reactions requires diagnosing AD carefully, monitoring patients on dupilumab for new and unusual symptoms, and thoroughly working up suspicious LRs, according to an accompanying editorial and experts interviewed for this article.
“Dupilumab has become such an important first-line systemic medication for our patients with moderate to severe atopic dermatitis. It’s important for us to understand everything we can about its use in the real world – both good and bad,”Raj Chovatiya, MD, PhD, MSCI, assistant professor of dermatology at Northwestern University, Chicago, said in an interview. He was uninvolved with either publication.
Robert Sidbury, MD, MPH, added that, although the affected patient group was small, studying lymphoid reactions associated with dupilumab is important because of the risk for diagnostic misadventure that these reactions carry. He is a professor of pediatrics and division head of dermatology at Seattle Children’s Hospital and the University of Washington, Seattle.
“AD and MF are easily confused for one another at baseline,” explained Dr. Sidbury, who was not involved with the study or editorial. “Dupilumab is known to make AD better and theoretically could help MF via its effect on interleukin (IL)–13, yet case reports of exacerbation and/or unmasking of MF are out there.”
For the study, researchers retrospectively examined records of 530 patients with AD treated with dupilumab at the University Medical Center Utrecht (the Netherlands). Reviewing pretreatment biopsies revealed that among 14 (2.6%) patients who developed clinical suspicion of cutaneous T-cell lymphoma (CTCL) while on treatment, three actually had preexisting MF.
All 14 patients with LR initially responded to dupilumab then developed worsening symptoms at a median of 4 months. Patients reported that the worsening lesions looked and felt different than did previous lesions, with symptoms including burning/pain and an appearance of generalized erythematous maculopapular plaques, sometimes with severe lichenification, on the lower trunk and upper thighs.
The 14 patients’ posttreatment biopsies showed an atypical lymphoid infiltrate with lichenoid or perivascular distribution and intraepithelial T-cell lymphocytes. Whereas patients with MF had hyperconvoluted cerebriform lymphocytes aligned in the epidermal basal layer at the dermoepidermal junction, the 11 with LR had similar-looking lesions dispersed throughout the upper epidermis.
Immunohistochemically, both groups had a dysregulated (mostly increased) CD4:CD8 ratio. CD30 overexpression, usually absent in early-stage MF, affected only patients with LR and one patient with advanced MF. In addition, patients with LR maintained pan–T-cell antigens (CD2, CD3, and CD5), whereas those with MF did not. The 11 patients with LR experienced biopsy-confirmed resolution once they discontinued dupilumab.
It is reassuring that the LRs resolved after dupilumab discontinuation, writes the author of the accompanying editorial, Joan Guitart, MD, chief of dermatopathology at Northwestern University. Nevertheless, he added, such patients deserve “a comprehensive workup including skin biopsy with T-cell receptor clonality assay, blood cell counts with flow cytometry analysis, serum lactate dehydrogenase, and documentation of possible adenopathy, followed with imaging studies and/or local biopsies in cases with abnormal results.”
The possibility that these LRs may represent a first step toward lymphoma requires dermatologists to remain vigilant in ruling out MF, Dr. Guitart wrote, particularly in atypical presentations such as adult-onset AD, cases lacking a history of AD, and cases involving erythrodermic and other uncharacteristic presentations such as plaques, nodules, or spared flexural sites.
For dermatopathologists, Dr. Guitart recommended a cautious approach that resists overdiagnosing MF and acknowledging that insufficient evidence exists to report such reactions as benign. The fact that one study patient had both MF and LR raises concerns that the LR may not always be reversible, Dr. Guitart added.
Clinicians and patients must consider the possibility of dupilumab-induced LR as part of the shared decision-making process and risk-benefit calculus, Dr. Sidbury said. In cases involving unexpected responses or atypical presentations, he added, clinicians must have a low threshold for stopping dupilumab.
For patients who must discontinue dupilumab because of LR, the list of treatment options is growing. “While more investigation is required to understand the role of newer IL-13–blocking biologics and JAK inhibitors among patients experiencing lymphoid reactions,” said Dr. Chovatiya, “traditional atopic dermatitis therapies like narrowband UVB phototherapy and the oral immunosuppressant methotrexate may be reassuring in this population.” Conversely, cyclosporine has been associated with progression of MF.
Also reassuring, said Dr. Sidbury and Dr. Chovatiya, is the rarity of LR overall. Dr. Sidbury said, “The numbers of patients in whom LR or onset/exacerbation of MF occurs is extraordinarily low when compared to those helped immeasurably by dupilumab.”
Dr. Sidbury added that the study and accompanying editorial also will alert clinicians to the potential for newer AD biologics that target solely IL-13 and not IL-4/13, as dupilumab does. “If the deregulated response leading to LR and potentially MF in the affected few is driven by IL-4 inhibition,” he said, “drugs such as tralokinumab (Adbry), lebrikizumab (once approved), and perhaps other newer options might calm AD without causing LRs.”
(Lebrikizumab is not yet approved. In an Oct. 2 press release, Eli Lilly and Company, developer of lebrikizumab, said that it would address issues the U.S. Food and Drug Administration had raised about a third-party manufacturing facility that arose during evaluation of the lebrikizumab biologic license application.)
Study limitations include the fact that most patients who experienced LR had already undergone skin biopsies before dupilumab treatment, which suggests that they had a more atypical AD presentation from the start. The authors add that their having treated all study patients in a tertiary referral hospital indicates a hard-to-treat AD subpopulation.
Study authors reported relationships with several biologic drug manufacturers including Sanofi and Regeneron (dupilumab), LEO Pharma (tralokinumab), and Eli Lilly (lebrikizumab). However, none of these companies provided support for the study.
Dr. Sidbury has been an investigator for Regeneron, Pfizer, and Galderma and a consultant for LEO Pharma and Eli Lilly. Dr. Chovatiya has served as an advisor, consultant, speaker, and investigator for Sanofi and Regeneron. Dr. Guitart reported no conflicts of interest.
A version of this article appeared on Medscape.com.
, according to a study published in JAMA Dermatology
The potential for such reactions requires diagnosing AD carefully, monitoring patients on dupilumab for new and unusual symptoms, and thoroughly working up suspicious LRs, according to an accompanying editorial and experts interviewed for this article.
“Dupilumab has become such an important first-line systemic medication for our patients with moderate to severe atopic dermatitis. It’s important for us to understand everything we can about its use in the real world – both good and bad,”Raj Chovatiya, MD, PhD, MSCI, assistant professor of dermatology at Northwestern University, Chicago, said in an interview. He was uninvolved with either publication.
Robert Sidbury, MD, MPH, added that, although the affected patient group was small, studying lymphoid reactions associated with dupilumab is important because of the risk for diagnostic misadventure that these reactions carry. He is a professor of pediatrics and division head of dermatology at Seattle Children’s Hospital and the University of Washington, Seattle.
“AD and MF are easily confused for one another at baseline,” explained Dr. Sidbury, who was not involved with the study or editorial. “Dupilumab is known to make AD better and theoretically could help MF via its effect on interleukin (IL)–13, yet case reports of exacerbation and/or unmasking of MF are out there.”
For the study, researchers retrospectively examined records of 530 patients with AD treated with dupilumab at the University Medical Center Utrecht (the Netherlands). Reviewing pretreatment biopsies revealed that among 14 (2.6%) patients who developed clinical suspicion of cutaneous T-cell lymphoma (CTCL) while on treatment, three actually had preexisting MF.
All 14 patients with LR initially responded to dupilumab then developed worsening symptoms at a median of 4 months. Patients reported that the worsening lesions looked and felt different than did previous lesions, with symptoms including burning/pain and an appearance of generalized erythematous maculopapular plaques, sometimes with severe lichenification, on the lower trunk and upper thighs.
The 14 patients’ posttreatment biopsies showed an atypical lymphoid infiltrate with lichenoid or perivascular distribution and intraepithelial T-cell lymphocytes. Whereas patients with MF had hyperconvoluted cerebriform lymphocytes aligned in the epidermal basal layer at the dermoepidermal junction, the 11 with LR had similar-looking lesions dispersed throughout the upper epidermis.
Immunohistochemically, both groups had a dysregulated (mostly increased) CD4:CD8 ratio. CD30 overexpression, usually absent in early-stage MF, affected only patients with LR and one patient with advanced MF. In addition, patients with LR maintained pan–T-cell antigens (CD2, CD3, and CD5), whereas those with MF did not. The 11 patients with LR experienced biopsy-confirmed resolution once they discontinued dupilumab.
It is reassuring that the LRs resolved after dupilumab discontinuation, writes the author of the accompanying editorial, Joan Guitart, MD, chief of dermatopathology at Northwestern University. Nevertheless, he added, such patients deserve “a comprehensive workup including skin biopsy with T-cell receptor clonality assay, blood cell counts with flow cytometry analysis, serum lactate dehydrogenase, and documentation of possible adenopathy, followed with imaging studies and/or local biopsies in cases with abnormal results.”
The possibility that these LRs may represent a first step toward lymphoma requires dermatologists to remain vigilant in ruling out MF, Dr. Guitart wrote, particularly in atypical presentations such as adult-onset AD, cases lacking a history of AD, and cases involving erythrodermic and other uncharacteristic presentations such as plaques, nodules, or spared flexural sites.
For dermatopathologists, Dr. Guitart recommended a cautious approach that resists overdiagnosing MF and acknowledging that insufficient evidence exists to report such reactions as benign. The fact that one study patient had both MF and LR raises concerns that the LR may not always be reversible, Dr. Guitart added.
Clinicians and patients must consider the possibility of dupilumab-induced LR as part of the shared decision-making process and risk-benefit calculus, Dr. Sidbury said. In cases involving unexpected responses or atypical presentations, he added, clinicians must have a low threshold for stopping dupilumab.
For patients who must discontinue dupilumab because of LR, the list of treatment options is growing. “While more investigation is required to understand the role of newer IL-13–blocking biologics and JAK inhibitors among patients experiencing lymphoid reactions,” said Dr. Chovatiya, “traditional atopic dermatitis therapies like narrowband UVB phototherapy and the oral immunosuppressant methotrexate may be reassuring in this population.” Conversely, cyclosporine has been associated with progression of MF.
Also reassuring, said Dr. Sidbury and Dr. Chovatiya, is the rarity of LR overall. Dr. Sidbury said, “The numbers of patients in whom LR or onset/exacerbation of MF occurs is extraordinarily low when compared to those helped immeasurably by dupilumab.”
Dr. Sidbury added that the study and accompanying editorial also will alert clinicians to the potential for newer AD biologics that target solely IL-13 and not IL-4/13, as dupilumab does. “If the deregulated response leading to LR and potentially MF in the affected few is driven by IL-4 inhibition,” he said, “drugs such as tralokinumab (Adbry), lebrikizumab (once approved), and perhaps other newer options might calm AD without causing LRs.”
(Lebrikizumab is not yet approved. In an Oct. 2 press release, Eli Lilly and Company, developer of lebrikizumab, said that it would address issues the U.S. Food and Drug Administration had raised about a third-party manufacturing facility that arose during evaluation of the lebrikizumab biologic license application.)
Study limitations include the fact that most patients who experienced LR had already undergone skin biopsies before dupilumab treatment, which suggests that they had a more atypical AD presentation from the start. The authors add that their having treated all study patients in a tertiary referral hospital indicates a hard-to-treat AD subpopulation.
Study authors reported relationships with several biologic drug manufacturers including Sanofi and Regeneron (dupilumab), LEO Pharma (tralokinumab), and Eli Lilly (lebrikizumab). However, none of these companies provided support for the study.
Dr. Sidbury has been an investigator for Regeneron, Pfizer, and Galderma and a consultant for LEO Pharma and Eli Lilly. Dr. Chovatiya has served as an advisor, consultant, speaker, and investigator for Sanofi and Regeneron. Dr. Guitart reported no conflicts of interest.
A version of this article appeared on Medscape.com.
, according to a study published in JAMA Dermatology
The potential for such reactions requires diagnosing AD carefully, monitoring patients on dupilumab for new and unusual symptoms, and thoroughly working up suspicious LRs, according to an accompanying editorial and experts interviewed for this article.
“Dupilumab has become such an important first-line systemic medication for our patients with moderate to severe atopic dermatitis. It’s important for us to understand everything we can about its use in the real world – both good and bad,”Raj Chovatiya, MD, PhD, MSCI, assistant professor of dermatology at Northwestern University, Chicago, said in an interview. He was uninvolved with either publication.
Robert Sidbury, MD, MPH, added that, although the affected patient group was small, studying lymphoid reactions associated with dupilumab is important because of the risk for diagnostic misadventure that these reactions carry. He is a professor of pediatrics and division head of dermatology at Seattle Children’s Hospital and the University of Washington, Seattle.
“AD and MF are easily confused for one another at baseline,” explained Dr. Sidbury, who was not involved with the study or editorial. “Dupilumab is known to make AD better and theoretically could help MF via its effect on interleukin (IL)–13, yet case reports of exacerbation and/or unmasking of MF are out there.”
For the study, researchers retrospectively examined records of 530 patients with AD treated with dupilumab at the University Medical Center Utrecht (the Netherlands). Reviewing pretreatment biopsies revealed that among 14 (2.6%) patients who developed clinical suspicion of cutaneous T-cell lymphoma (CTCL) while on treatment, three actually had preexisting MF.
All 14 patients with LR initially responded to dupilumab then developed worsening symptoms at a median of 4 months. Patients reported that the worsening lesions looked and felt different than did previous lesions, with symptoms including burning/pain and an appearance of generalized erythematous maculopapular plaques, sometimes with severe lichenification, on the lower trunk and upper thighs.
The 14 patients’ posttreatment biopsies showed an atypical lymphoid infiltrate with lichenoid or perivascular distribution and intraepithelial T-cell lymphocytes. Whereas patients with MF had hyperconvoluted cerebriform lymphocytes aligned in the epidermal basal layer at the dermoepidermal junction, the 11 with LR had similar-looking lesions dispersed throughout the upper epidermis.
Immunohistochemically, both groups had a dysregulated (mostly increased) CD4:CD8 ratio. CD30 overexpression, usually absent in early-stage MF, affected only patients with LR and one patient with advanced MF. In addition, patients with LR maintained pan–T-cell antigens (CD2, CD3, and CD5), whereas those with MF did not. The 11 patients with LR experienced biopsy-confirmed resolution once they discontinued dupilumab.
It is reassuring that the LRs resolved after dupilumab discontinuation, writes the author of the accompanying editorial, Joan Guitart, MD, chief of dermatopathology at Northwestern University. Nevertheless, he added, such patients deserve “a comprehensive workup including skin biopsy with T-cell receptor clonality assay, blood cell counts with flow cytometry analysis, serum lactate dehydrogenase, and documentation of possible adenopathy, followed with imaging studies and/or local biopsies in cases with abnormal results.”
The possibility that these LRs may represent a first step toward lymphoma requires dermatologists to remain vigilant in ruling out MF, Dr. Guitart wrote, particularly in atypical presentations such as adult-onset AD, cases lacking a history of AD, and cases involving erythrodermic and other uncharacteristic presentations such as plaques, nodules, or spared flexural sites.
For dermatopathologists, Dr. Guitart recommended a cautious approach that resists overdiagnosing MF and acknowledging that insufficient evidence exists to report such reactions as benign. The fact that one study patient had both MF and LR raises concerns that the LR may not always be reversible, Dr. Guitart added.
Clinicians and patients must consider the possibility of dupilumab-induced LR as part of the shared decision-making process and risk-benefit calculus, Dr. Sidbury said. In cases involving unexpected responses or atypical presentations, he added, clinicians must have a low threshold for stopping dupilumab.
For patients who must discontinue dupilumab because of LR, the list of treatment options is growing. “While more investigation is required to understand the role of newer IL-13–blocking biologics and JAK inhibitors among patients experiencing lymphoid reactions,” said Dr. Chovatiya, “traditional atopic dermatitis therapies like narrowband UVB phototherapy and the oral immunosuppressant methotrexate may be reassuring in this population.” Conversely, cyclosporine has been associated with progression of MF.
Also reassuring, said Dr. Sidbury and Dr. Chovatiya, is the rarity of LR overall. Dr. Sidbury said, “The numbers of patients in whom LR or onset/exacerbation of MF occurs is extraordinarily low when compared to those helped immeasurably by dupilumab.”
Dr. Sidbury added that the study and accompanying editorial also will alert clinicians to the potential for newer AD biologics that target solely IL-13 and not IL-4/13, as dupilumab does. “If the deregulated response leading to LR and potentially MF in the affected few is driven by IL-4 inhibition,” he said, “drugs such as tralokinumab (Adbry), lebrikizumab (once approved), and perhaps other newer options might calm AD without causing LRs.”
(Lebrikizumab is not yet approved. In an Oct. 2 press release, Eli Lilly and Company, developer of lebrikizumab, said that it would address issues the U.S. Food and Drug Administration had raised about a third-party manufacturing facility that arose during evaluation of the lebrikizumab biologic license application.)
Study limitations include the fact that most patients who experienced LR had already undergone skin biopsies before dupilumab treatment, which suggests that they had a more atypical AD presentation from the start. The authors add that their having treated all study patients in a tertiary referral hospital indicates a hard-to-treat AD subpopulation.
Study authors reported relationships with several biologic drug manufacturers including Sanofi and Regeneron (dupilumab), LEO Pharma (tralokinumab), and Eli Lilly (lebrikizumab). However, none of these companies provided support for the study.
Dr. Sidbury has been an investigator for Regeneron, Pfizer, and Galderma and a consultant for LEO Pharma and Eli Lilly. Dr. Chovatiya has served as an advisor, consultant, speaker, and investigator for Sanofi and Regeneron. Dr. Guitart reported no conflicts of interest.
A version of this article appeared on Medscape.com.
FROM JAMA DERMATOLOGY
Insulin appears less heat-sensitive than previously thought
The review included 17 studies in 22 published articles and additional unpublished information from major insulin manufacturers. The data suggest it is possible to store unopened short- and intermediate-acting human insulin vials, pens/cartridges or prefilled plastic syringes at temperatures up to 25 °C (77 °F) for a maximum of 6 months and up to 37 °C (98.6 °F) for a maximum of 2 months without a clinically relevant loss of insulin potency.
Two studies found small decrements in potency at higher temperatures and/or longer durations unrefrigerated, but the rest did not.
This contrasts with current guidance and labeling that advises storing unopened human insulin at temperatures between 2 °C (35.6 °F) and 8°C (46.4 °F), necessitating refrigeration. Once the vial or pen cartridge is opened, the guidance is to store at “room temperature” and use within about 4-6 weeks.
The recommendations vary, however, and there is no clear consensus on how human insulin should be stored in settings where reliable refrigeration can’t be guaranteed, such as low-income countries, those affected by extreme heat, or areas of conflict or natural disasters. Such areas are home to growing numbers of people with diabetes, according to the Cochrane Database of Systematic Reviews report, published online.
The review also found that oscillating temperatures between 25 °C (77 °F) and 37 °C (98.6 °F), typical of daytime and nighttime fluctuations in tropical countries, for up to 3 months do not result in clinically relevant loss of insulin activity for short-acting, intermediate-acting, or mixed human insulin.
“Our study opens up new possibilities for individuals living in challenging environments, where access to refrigeration is limited. By understanding the thermal stability of insulin and exploring innovative storage solutions, we can make a significant impact on the lives of those who depend on insulin for their well-being,” the study’s lead author, Bernd Richter, MD, of the Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Düsseldorf, Germany, said in a statement.
In addition, one small pilot clinical study showed that human insulin stored for 6 weeks in an unglazed clay pot with temperatures ranging between 25 °C (77 °F) and 27°C (80.6 °F) did not result in differences in plasma glucose–lowering in eight healthy volunteers, compared with refrigerator-stored insulin. “With the help of simple cooling devices for insulin storage such as clay pots, it is possible to effectively reduce high outside temperatures in many high-temperature regions of the world,” wrote Dr. Richter and colleagues Brenda Bongaerts, PhD, and Maria-Inti Metzendorf, also from Heinrich-Heine-University.
Asked to comment, Leonardo Scapozza, PhD, of the School of Pharmaceutical Sciences at the University of Geneva, Switzerland, said that these findings align with a study he published in 2021.
“Indeed ... we have done a small-scale study by analyzing the insulin coming back from the field and showing that insulin potency and stability was conserved. An extended clinical study where the insulin is submitted to varying controlled condition is not possible and ethically debatable. But an extended study where patients are given a log tag to monitor their real storage condition and the remaining samples are collected back and sent back for analysis in a specialized lab would be very good to further confirm the [conclusions],” said Dr. Scapozza, who was not part of Dr. Richter’s team on this review.
While the issue of insulin refrigeration is less urgent in higher-income countries, it does arise, as in situations where people accidentally leave their unopened insulin out of the refrigerator or when they carry backup insulin while traveling.
The Cochrane Review excluded studies of insulin analogs, used in most developed countries, but Dr. Scapozza’s study had included them. “We observed the same stability as the ones used in low-income countries.” He added that his data combined with those in the new report provide evidence that would make it “possible to better and optimally use the available insulin that is becoming more and more costly.”
Dr. Scapozza also told this news organization that after he presented his data to Médecins Sans Frontières (Doctors Without Borders), he heard from a collaborator with that group who has diabetes. “He always used his insulin for his own treatment when he was in the field working and his insulin pen was in his backpack or pocket and his treatment was working. After hearing the data, he was very happy because he got a scientific explanation why his treatment was working, whether he was in Switzerland or during his mission in the camps submitted to the same condition of storage as any other patient in low income countries.”
Dr. Richter and Dr. Scapozza report no relevant financial relationships.
A version of this article appeared on Medscape.com.
The review included 17 studies in 22 published articles and additional unpublished information from major insulin manufacturers. The data suggest it is possible to store unopened short- and intermediate-acting human insulin vials, pens/cartridges or prefilled plastic syringes at temperatures up to 25 °C (77 °F) for a maximum of 6 months and up to 37 °C (98.6 °F) for a maximum of 2 months without a clinically relevant loss of insulin potency.
Two studies found small decrements in potency at higher temperatures and/or longer durations unrefrigerated, but the rest did not.
This contrasts with current guidance and labeling that advises storing unopened human insulin at temperatures between 2 °C (35.6 °F) and 8°C (46.4 °F), necessitating refrigeration. Once the vial or pen cartridge is opened, the guidance is to store at “room temperature” and use within about 4-6 weeks.
The recommendations vary, however, and there is no clear consensus on how human insulin should be stored in settings where reliable refrigeration can’t be guaranteed, such as low-income countries, those affected by extreme heat, or areas of conflict or natural disasters. Such areas are home to growing numbers of people with diabetes, according to the Cochrane Database of Systematic Reviews report, published online.
The review also found that oscillating temperatures between 25 °C (77 °F) and 37 °C (98.6 °F), typical of daytime and nighttime fluctuations in tropical countries, for up to 3 months do not result in clinically relevant loss of insulin activity for short-acting, intermediate-acting, or mixed human insulin.
“Our study opens up new possibilities for individuals living in challenging environments, where access to refrigeration is limited. By understanding the thermal stability of insulin and exploring innovative storage solutions, we can make a significant impact on the lives of those who depend on insulin for their well-being,” the study’s lead author, Bernd Richter, MD, of the Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Düsseldorf, Germany, said in a statement.
In addition, one small pilot clinical study showed that human insulin stored for 6 weeks in an unglazed clay pot with temperatures ranging between 25 °C (77 °F) and 27°C (80.6 °F) did not result in differences in plasma glucose–lowering in eight healthy volunteers, compared with refrigerator-stored insulin. “With the help of simple cooling devices for insulin storage such as clay pots, it is possible to effectively reduce high outside temperatures in many high-temperature regions of the world,” wrote Dr. Richter and colleagues Brenda Bongaerts, PhD, and Maria-Inti Metzendorf, also from Heinrich-Heine-University.
Asked to comment, Leonardo Scapozza, PhD, of the School of Pharmaceutical Sciences at the University of Geneva, Switzerland, said that these findings align with a study he published in 2021.
“Indeed ... we have done a small-scale study by analyzing the insulin coming back from the field and showing that insulin potency and stability was conserved. An extended clinical study where the insulin is submitted to varying controlled condition is not possible and ethically debatable. But an extended study where patients are given a log tag to monitor their real storage condition and the remaining samples are collected back and sent back for analysis in a specialized lab would be very good to further confirm the [conclusions],” said Dr. Scapozza, who was not part of Dr. Richter’s team on this review.
While the issue of insulin refrigeration is less urgent in higher-income countries, it does arise, as in situations where people accidentally leave their unopened insulin out of the refrigerator or when they carry backup insulin while traveling.
The Cochrane Review excluded studies of insulin analogs, used in most developed countries, but Dr. Scapozza’s study had included them. “We observed the same stability as the ones used in low-income countries.” He added that his data combined with those in the new report provide evidence that would make it “possible to better and optimally use the available insulin that is becoming more and more costly.”
Dr. Scapozza also told this news organization that after he presented his data to Médecins Sans Frontières (Doctors Without Borders), he heard from a collaborator with that group who has diabetes. “He always used his insulin for his own treatment when he was in the field working and his insulin pen was in his backpack or pocket and his treatment was working. After hearing the data, he was very happy because he got a scientific explanation why his treatment was working, whether he was in Switzerland or during his mission in the camps submitted to the same condition of storage as any other patient in low income countries.”
Dr. Richter and Dr. Scapozza report no relevant financial relationships.
A version of this article appeared on Medscape.com.
The review included 17 studies in 22 published articles and additional unpublished information from major insulin manufacturers. The data suggest it is possible to store unopened short- and intermediate-acting human insulin vials, pens/cartridges or prefilled plastic syringes at temperatures up to 25 °C (77 °F) for a maximum of 6 months and up to 37 °C (98.6 °F) for a maximum of 2 months without a clinically relevant loss of insulin potency.
Two studies found small decrements in potency at higher temperatures and/or longer durations unrefrigerated, but the rest did not.
This contrasts with current guidance and labeling that advises storing unopened human insulin at temperatures between 2 °C (35.6 °F) and 8°C (46.4 °F), necessitating refrigeration. Once the vial or pen cartridge is opened, the guidance is to store at “room temperature” and use within about 4-6 weeks.
The recommendations vary, however, and there is no clear consensus on how human insulin should be stored in settings where reliable refrigeration can’t be guaranteed, such as low-income countries, those affected by extreme heat, or areas of conflict or natural disasters. Such areas are home to growing numbers of people with diabetes, according to the Cochrane Database of Systematic Reviews report, published online.
The review also found that oscillating temperatures between 25 °C (77 °F) and 37 °C (98.6 °F), typical of daytime and nighttime fluctuations in tropical countries, for up to 3 months do not result in clinically relevant loss of insulin activity for short-acting, intermediate-acting, or mixed human insulin.
“Our study opens up new possibilities for individuals living in challenging environments, where access to refrigeration is limited. By understanding the thermal stability of insulin and exploring innovative storage solutions, we can make a significant impact on the lives of those who depend on insulin for their well-being,” the study’s lead author, Bernd Richter, MD, of the Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Düsseldorf, Germany, said in a statement.
In addition, one small pilot clinical study showed that human insulin stored for 6 weeks in an unglazed clay pot with temperatures ranging between 25 °C (77 °F) and 27°C (80.6 °F) did not result in differences in plasma glucose–lowering in eight healthy volunteers, compared with refrigerator-stored insulin. “With the help of simple cooling devices for insulin storage such as clay pots, it is possible to effectively reduce high outside temperatures in many high-temperature regions of the world,” wrote Dr. Richter and colleagues Brenda Bongaerts, PhD, and Maria-Inti Metzendorf, also from Heinrich-Heine-University.
Asked to comment, Leonardo Scapozza, PhD, of the School of Pharmaceutical Sciences at the University of Geneva, Switzerland, said that these findings align with a study he published in 2021.
“Indeed ... we have done a small-scale study by analyzing the insulin coming back from the field and showing that insulin potency and stability was conserved. An extended clinical study where the insulin is submitted to varying controlled condition is not possible and ethically debatable. But an extended study where patients are given a log tag to monitor their real storage condition and the remaining samples are collected back and sent back for analysis in a specialized lab would be very good to further confirm the [conclusions],” said Dr. Scapozza, who was not part of Dr. Richter’s team on this review.
While the issue of insulin refrigeration is less urgent in higher-income countries, it does arise, as in situations where people accidentally leave their unopened insulin out of the refrigerator or when they carry backup insulin while traveling.
The Cochrane Review excluded studies of insulin analogs, used in most developed countries, but Dr. Scapozza’s study had included them. “We observed the same stability as the ones used in low-income countries.” He added that his data combined with those in the new report provide evidence that would make it “possible to better and optimally use the available insulin that is becoming more and more costly.”
Dr. Scapozza also told this news organization that after he presented his data to Médecins Sans Frontières (Doctors Without Borders), he heard from a collaborator with that group who has diabetes. “He always used his insulin for his own treatment when he was in the field working and his insulin pen was in his backpack or pocket and his treatment was working. After hearing the data, he was very happy because he got a scientific explanation why his treatment was working, whether he was in Switzerland or during his mission in the camps submitted to the same condition of storage as any other patient in low income countries.”
Dr. Richter and Dr. Scapozza report no relevant financial relationships.
A version of this article appeared on Medscape.com.
Be advised: Thyroid hormones may increase risk of cognitive disorders in older adults
published in JAMA Internal Medicine.
The study found that these patients with thyrotoxicosis had a higher likelihood of incident cognitive disorder (adjusted hazard ratio, 1.39; 95% confidence interval, 1.18-1.64; P < .001). Broken down between internal and external causes of thyrotoxicosis, exogenous thyrotoxicosis continued to be a significant risk factor (aHR, 1.34: 95% CI, 1.10-1.63; P = .003), while endogenous thyrotoxicosis did not show a statistically significant risk estimates (aHR, 1.38; 95% CI, 0.96-1.98; P = .08).
The study also found that women were more likely to have low levels of thyrotropin (thyroid-stimulating hormone/TSH) than men and were more likely to be overtreated.
Previous studies looking at the correlation between hyperthyroidism and cognitive disorders often did not include participants who were already taking thyroid hormones, according to Jennifer S. Mammen, MD, PhD, assistant professor of medicine at the Asthma and Allergy Center at John Hopkins University, Baltimore, and the senior author of the study.
“The fact that we see the signal both in people who are being overtreated with thyroid hormone and in people who have endogenous hyperthyroidism is one way that we think that this supports the fact that it’s not just confounding, it’s not just bias,” Dr. Mammen said. “There’s two different sources of hyperthyroidism, and they’re both showing the same relationship.”
In the study, Dr. Mammen and colleagues analyzed electronic health records for patients aged 65 years and older who received primary care in the Johns Hopkins Community Physicians Network over a 10-year period starting in 2014. Patients had to have a minimum of two visits 30 days apart. None had a history of low TSH levels or cognitive disorder diagnoses within 6 months of their first doctor visit.
More than 65,000 patients were included in the study. Slightly more than half (56%) were female, almost 70% were White, 19.3% were Black, 4.6% were Asian, and 0.4% were American Indian. Almost 25,000 low TSH measurements among 2,710 patients were recorded during the study period. The majority of low TSH measurements were exogenous (14,875), followed by origins of unknown cause (5,833), and endogenous (4,159).
During the follow-up period, 7.2% (4,779) patients received a new cognitive disorder diagnosis, which was dementia in 77% of cases.
Dr. Mammen said primary care physicians should carefully consider whether thyroid hormone therapy is necessary for older patients, and, if so, great care should be taken to avoid overtreatment.
“This is yet another reason for us to be vigilant about not overtreating people with thyroid hormone, especially in older adults,” Dr. Mammen said. “We already know that atrial fibrillation rates are increased in people who are hyperthyroid. We know that fracture and osteoporosis is affected by hyperthyroidism. And now we also have an association with higher rates of cognitive disorders.”
Taking a cautious approach to prescribing thyroid hormone therapy for older patients is paramount, according to Jean Chen, MD, partner at Texas Diabetes & Endocrinology, who was not affiliated with the study.
“All medical providers need to be aware that the 65 and older population does not need to be treated as aggressively with their thyroid hormone,” Dr. Chen said. “We are finding more and more complications from overtreatment rather than benefit in this population.”
Often, older patients may complain of symptoms such as constipation, feeling cold, or tiredness, which can be symptoms of hypothyroidism. But these symptoms could also be from anemia, vitamin deficiencies, depression, perimenopause, menopause, insulin resistance, and sleep apnea. If necessary, Dr. Chen recommended primary care physicians consult with an endocrinologist regarding a possible treatment plan and making a differential diagnosis.
In addition, Dr. Chen said other studies have shown that treating patients with thyroid hormone either did not resolve the condition or negatively impacted anxiety, muscle strength, and bone density, or it increased the risk for arrhythmia. Therefore, it’s important to weight the risks versus the benefits.
“There’s so much gray zone here,” Dr. Chen said.
The study was supported by the Richman Family Precision Medicine Center of Excellence in Alzheimer’s Disease, the Richman Family Foundation, the Rick Sharp Alzheimer’s Foundation, the Sharp Family Foundation, among others. The work was also supported by grants from the National Institutes of Health. One coauthor reported personal fees from Karuna, MapLight Therapeutics, Axsome Therapeutics, GIA, GW Research Limited, Merck, EXCIVA, Otsuka, IntraCellular Therapies, and Medesis Pharma for consulting for treatment development in Alzheimer’s disease outside the submitted work. No other disclosures were reported.
A version of this article appeared on Medscape.com.
published in JAMA Internal Medicine.
The study found that these patients with thyrotoxicosis had a higher likelihood of incident cognitive disorder (adjusted hazard ratio, 1.39; 95% confidence interval, 1.18-1.64; P < .001). Broken down between internal and external causes of thyrotoxicosis, exogenous thyrotoxicosis continued to be a significant risk factor (aHR, 1.34: 95% CI, 1.10-1.63; P = .003), while endogenous thyrotoxicosis did not show a statistically significant risk estimates (aHR, 1.38; 95% CI, 0.96-1.98; P = .08).
The study also found that women were more likely to have low levels of thyrotropin (thyroid-stimulating hormone/TSH) than men and were more likely to be overtreated.
Previous studies looking at the correlation between hyperthyroidism and cognitive disorders often did not include participants who were already taking thyroid hormones, according to Jennifer S. Mammen, MD, PhD, assistant professor of medicine at the Asthma and Allergy Center at John Hopkins University, Baltimore, and the senior author of the study.
“The fact that we see the signal both in people who are being overtreated with thyroid hormone and in people who have endogenous hyperthyroidism is one way that we think that this supports the fact that it’s not just confounding, it’s not just bias,” Dr. Mammen said. “There’s two different sources of hyperthyroidism, and they’re both showing the same relationship.”
In the study, Dr. Mammen and colleagues analyzed electronic health records for patients aged 65 years and older who received primary care in the Johns Hopkins Community Physicians Network over a 10-year period starting in 2014. Patients had to have a minimum of two visits 30 days apart. None had a history of low TSH levels or cognitive disorder diagnoses within 6 months of their first doctor visit.
More than 65,000 patients were included in the study. Slightly more than half (56%) were female, almost 70% were White, 19.3% were Black, 4.6% were Asian, and 0.4% were American Indian. Almost 25,000 low TSH measurements among 2,710 patients were recorded during the study period. The majority of low TSH measurements were exogenous (14,875), followed by origins of unknown cause (5,833), and endogenous (4,159).
During the follow-up period, 7.2% (4,779) patients received a new cognitive disorder diagnosis, which was dementia in 77% of cases.
Dr. Mammen said primary care physicians should carefully consider whether thyroid hormone therapy is necessary for older patients, and, if so, great care should be taken to avoid overtreatment.
“This is yet another reason for us to be vigilant about not overtreating people with thyroid hormone, especially in older adults,” Dr. Mammen said. “We already know that atrial fibrillation rates are increased in people who are hyperthyroid. We know that fracture and osteoporosis is affected by hyperthyroidism. And now we also have an association with higher rates of cognitive disorders.”
Taking a cautious approach to prescribing thyroid hormone therapy for older patients is paramount, according to Jean Chen, MD, partner at Texas Diabetes & Endocrinology, who was not affiliated with the study.
“All medical providers need to be aware that the 65 and older population does not need to be treated as aggressively with their thyroid hormone,” Dr. Chen said. “We are finding more and more complications from overtreatment rather than benefit in this population.”
Often, older patients may complain of symptoms such as constipation, feeling cold, or tiredness, which can be symptoms of hypothyroidism. But these symptoms could also be from anemia, vitamin deficiencies, depression, perimenopause, menopause, insulin resistance, and sleep apnea. If necessary, Dr. Chen recommended primary care physicians consult with an endocrinologist regarding a possible treatment plan and making a differential diagnosis.
In addition, Dr. Chen said other studies have shown that treating patients with thyroid hormone either did not resolve the condition or negatively impacted anxiety, muscle strength, and bone density, or it increased the risk for arrhythmia. Therefore, it’s important to weight the risks versus the benefits.
“There’s so much gray zone here,” Dr. Chen said.
The study was supported by the Richman Family Precision Medicine Center of Excellence in Alzheimer’s Disease, the Richman Family Foundation, the Rick Sharp Alzheimer’s Foundation, the Sharp Family Foundation, among others. The work was also supported by grants from the National Institutes of Health. One coauthor reported personal fees from Karuna, MapLight Therapeutics, Axsome Therapeutics, GIA, GW Research Limited, Merck, EXCIVA, Otsuka, IntraCellular Therapies, and Medesis Pharma for consulting for treatment development in Alzheimer’s disease outside the submitted work. No other disclosures were reported.
A version of this article appeared on Medscape.com.
published in JAMA Internal Medicine.
The study found that these patients with thyrotoxicosis had a higher likelihood of incident cognitive disorder (adjusted hazard ratio, 1.39; 95% confidence interval, 1.18-1.64; P < .001). Broken down between internal and external causes of thyrotoxicosis, exogenous thyrotoxicosis continued to be a significant risk factor (aHR, 1.34: 95% CI, 1.10-1.63; P = .003), while endogenous thyrotoxicosis did not show a statistically significant risk estimates (aHR, 1.38; 95% CI, 0.96-1.98; P = .08).
The study also found that women were more likely to have low levels of thyrotropin (thyroid-stimulating hormone/TSH) than men and were more likely to be overtreated.
Previous studies looking at the correlation between hyperthyroidism and cognitive disorders often did not include participants who were already taking thyroid hormones, according to Jennifer S. Mammen, MD, PhD, assistant professor of medicine at the Asthma and Allergy Center at John Hopkins University, Baltimore, and the senior author of the study.
“The fact that we see the signal both in people who are being overtreated with thyroid hormone and in people who have endogenous hyperthyroidism is one way that we think that this supports the fact that it’s not just confounding, it’s not just bias,” Dr. Mammen said. “There’s two different sources of hyperthyroidism, and they’re both showing the same relationship.”
In the study, Dr. Mammen and colleagues analyzed electronic health records for patients aged 65 years and older who received primary care in the Johns Hopkins Community Physicians Network over a 10-year period starting in 2014. Patients had to have a minimum of two visits 30 days apart. None had a history of low TSH levels or cognitive disorder diagnoses within 6 months of their first doctor visit.
More than 65,000 patients were included in the study. Slightly more than half (56%) were female, almost 70% were White, 19.3% were Black, 4.6% were Asian, and 0.4% were American Indian. Almost 25,000 low TSH measurements among 2,710 patients were recorded during the study period. The majority of low TSH measurements were exogenous (14,875), followed by origins of unknown cause (5,833), and endogenous (4,159).
During the follow-up period, 7.2% (4,779) patients received a new cognitive disorder diagnosis, which was dementia in 77% of cases.
Dr. Mammen said primary care physicians should carefully consider whether thyroid hormone therapy is necessary for older patients, and, if so, great care should be taken to avoid overtreatment.
“This is yet another reason for us to be vigilant about not overtreating people with thyroid hormone, especially in older adults,” Dr. Mammen said. “We already know that atrial fibrillation rates are increased in people who are hyperthyroid. We know that fracture and osteoporosis is affected by hyperthyroidism. And now we also have an association with higher rates of cognitive disorders.”
Taking a cautious approach to prescribing thyroid hormone therapy for older patients is paramount, according to Jean Chen, MD, partner at Texas Diabetes & Endocrinology, who was not affiliated with the study.
“All medical providers need to be aware that the 65 and older population does not need to be treated as aggressively with their thyroid hormone,” Dr. Chen said. “We are finding more and more complications from overtreatment rather than benefit in this population.”
Often, older patients may complain of symptoms such as constipation, feeling cold, or tiredness, which can be symptoms of hypothyroidism. But these symptoms could also be from anemia, vitamin deficiencies, depression, perimenopause, menopause, insulin resistance, and sleep apnea. If necessary, Dr. Chen recommended primary care physicians consult with an endocrinologist regarding a possible treatment plan and making a differential diagnosis.
In addition, Dr. Chen said other studies have shown that treating patients with thyroid hormone either did not resolve the condition or negatively impacted anxiety, muscle strength, and bone density, or it increased the risk for arrhythmia. Therefore, it’s important to weight the risks versus the benefits.
“There’s so much gray zone here,” Dr. Chen said.
The study was supported by the Richman Family Precision Medicine Center of Excellence in Alzheimer’s Disease, the Richman Family Foundation, the Rick Sharp Alzheimer’s Foundation, the Sharp Family Foundation, among others. The work was also supported by grants from the National Institutes of Health. One coauthor reported personal fees from Karuna, MapLight Therapeutics, Axsome Therapeutics, GIA, GW Research Limited, Merck, EXCIVA, Otsuka, IntraCellular Therapies, and Medesis Pharma for consulting for treatment development in Alzheimer’s disease outside the submitted work. No other disclosures were reported.
A version of this article appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE
Why aren’t doctors managing pain during gynecologic procedures?
During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None.
The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief.
But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.
By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.
As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated.
Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.
During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix.
“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
Lack of uniform protocols
The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience.
ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy.
For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain.
A clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%.
Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in.
“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said.
Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.
ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences.
The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.
“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
Making patients part of the discussion
Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.
“Part of it is just creating a really safe environment of trust as a medical provider,” she said.
A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure.
If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said.
Downplaying the experience
Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust.
When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”
Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand.
“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”
Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience.
“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
A version of this article first appeared on Medscape.com.
During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None.
The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief.
But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.
By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.
As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated.
Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.
During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix.
“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
Lack of uniform protocols
The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience.
ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy.
For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain.
A clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%.
Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in.
“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said.
Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.
ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences.
The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.
“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
Making patients part of the discussion
Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.
“Part of it is just creating a really safe environment of trust as a medical provider,” she said.
A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure.
If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said.
Downplaying the experience
Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust.
When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”
Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand.
“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”
Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience.
“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
A version of this article first appeared on Medscape.com.
During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None.
The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief.
But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.
By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.
As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated.
Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.
During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix.
“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
Lack of uniform protocols
The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience.
ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy.
For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain.
A clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%.
Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in.
“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said.
Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.
ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences.
The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.
“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
Making patients part of the discussion
Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.
“Part of it is just creating a really safe environment of trust as a medical provider,” she said.
A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure.
If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said.
Downplaying the experience
Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust.
When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”
Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand.
“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”
Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience.
“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
A version of this article first appeared on Medscape.com.
Five times greater suicide risk for trans, gender-diverse teens in ED
WASHINGTON – , according to a study presented at the annual meeting of the American Academy of Pediatrics.
“The take-home message here is this study emphasizes the importance of universal screening to identify gender-diverse youth at risk,” Amanda Burnside, PhD, assistant professor of psychiatry and behavioral sciences at Ann and Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, told attendees. “We really need to develop robust strategies and systems to link better mental health services.”
Suicide rates in transgender and gender-diverse youth are exceptionally high among youth in the U.S., Dr. Burnside said during her presentation. For example, the 2022 LGBTQ health survey from the Trevor Project found that much higher percentages of transgender and gender nonconforming youth had considered suicide in the past year compared with cisgender youth, even within the LGBTQ umbrella. Among nearly 34,000 LGBTQ youth aged 13-24, nearly half of trans females (48%) and more than half of trans males (59%) had considered suicide, compared with 28% of cisgender males and 37% of cisgender females. The rate among nonbinary/genderqueer individuals was 53%, and it was 48% for those questioning their gender.
Current methods of identifying trans and gender-diverse (TGD) youth in the hospital, however, may not actually be capturing the entire population.
“In health care settings, research involving TGD individuals has historically been limited to specialized clinic populations or youth with gender-specific diagnostic codes documented in the electronic medical record,” an approach that “likely significantly underestimates the prevalence of TGD youth in health care settings.” While at least one study has attempted to bridge this gap by searching the EMR for keywords, that study only tried to identify trans youth and not other youth on the gender diversity spectrum, such as nonbinary youth or those questioning their gender identity. Dr. Burnside and her colleagues therefore designed a study that used keywords to identify both trans youth and other gender-diverse youth who visited the ED so they could assess the rate of positive suicide screens in this population.
Underestimating the population at risk?
The researchers conducted a retrospective cross-sectional study of EMR data for all ED visits during which the patient underwent suicide screening. For the period of November 2019 to August 2022, they collected data on the screening results and the patient’s gender identity, age, race/ethnicity, insurance status, chief complaint in the ED and child opportunity index, which assess a youth’s access to resources based on geography. The suicide screener used was the Ask Suicide–Screening Questions (ASQ) tool.
The keywords they looked for in the EMR to identify trans and gender-diverse youth included transgender, pronouns, agender, gender dysphoria, male-to-female, female-to-male, nonbinary, preferred name, and they/them (captured as a complete term, not as “they” and “them” separately).
“If a keyword was present, the surrounding text was extracted and reviewed by two members of our team,” Dr. Burnside explained in her presentation. “We categorized keywords into either indicative of gender-diverse identity or not, and if it wasn’t clear based on the text extracted, we would conduct a manual chart review,” though that only occurred in about 3% of cases, she added.
Among 15,413 ED encounters with a suicide screen, the researchers identified 1,126 of these keywords in the EMR, among which 91.2% were classified as referring to a gender-diverse patient. Nearly all of the words were at least 90% effective in identify a gender-diverse youth, Dr. Burnside said, and all of the 197 instances of “they/them” were classified as gender diverse.
The accuracy was a little lower for the two keywords that appeared most frequently: For “pronouns,” 86.3% of 306 instances were classified as gender diverse, and for “transgender,” 83.1% of 207 instances were classified as gender diverse. Since some providers ask all patients their pronouns, the presence of “pronouns” in the EMR alone did not necessarily indicate the patient was gender diverse, Dr. Burnside said. A common reason the term “transgender” occurred in the EMR of non–gender diverse patients is that the department’s list of crisis resources includes transgender hotlines.
After identifying all the keywords, the researchers determined how many of these occurred in unique ED encounters and removed those with incomplete screening. Overall, they found 565 encounters by 399 gender-diverse individuals who had a suicide screening, representing 4.6% of total visits. This percentage is slightly lower than recent population-based estimates of gender-diverse youth, the researchers noted.
This population ranged from 8 to 23 years old, and 43% were publicly insured. The chief complaint for most of the patients (77.5%) was a mental health one. They were predominantly White (43%) or Hispanic (35%), with 10% Black youth, 4% Asian youth, and 8% youth who were “other” or two or more races. About half (52%) lived in a neighborhood with a “low” or “very low” child opportunity index.
Within this population, 81% of the patients screened positive on the suicide screening, compared with 23% positive screens across all ED visits. One in ten (10%) gender-diverse youth had active suicidal ideation, compared with 3.4% of the rest of the ED patient population. The researchers calculated that gender-diverse youth had 5.35 times greater odds of screening positive than cisgender youth in the ED (95% confidence interval [CI] 8.7-15.92). Further, a quarter (25%) of the trans and gender-diverse youth who screened positive for suicide risk had come to the ED for a primary complaint unrelated to mental health.
“We had a kid who came in because he broke his arm who had active suicidal ideation,” study coauthor Jennifer A. Hoffmann, MD, assistant professor of pediatrics at the Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, mentioned after the presentation. That particular patient even had a suicide plan, but was identified as actively suicidal only because of the screening. In other cases, she said, a youth may come in with self-inflicted injuries, and while those are the primary complaint, they are linked with suicidal ideation.
Among the study’s limitations are that gender identity is not necessarily being systematically assessed during visits, misspellings might have missed some youth, and their search strategy has not yet been externally validated, though they plan to seek that.
“Overall, however, this study did demonstrate that keyword searching is a promising technique to identify and prioritize gender-diverse youth in health services research,” Dr. Burnside said. In addition to showing the feasibility of using a keyword search strategy for identifying gender-diverse youth, Dr. Burnside noted that 31% of the encounters were identified by just one of the keywords they used, “highlighting the importance of using a comprehensive list of keywords to identify gender-diverse youth.”
Uncovering valuable information
Jason Rafferty, MD, MPH, EdM, clinical assistant professor of pediatrics and of psychiatry and human behavior at Brown University, Providence, R.I., who attended the presentation, noted that the study provides information on a population that’s often difficult to get through traditional EMR research methods.
“A lot of medical record systems don’t have uniform ways of capturing [gender diversity], but what we know as providers is that kids are really struggling and that it’s not a surprise that we’re seeing these disparities with suicidality,” Dr. Rafferty said.
The study also provides more discrete estimates by age than what most other current research measures, which tends to be lifetime suicidality as opposed to suicidal thoughts or attempts within the past year, Dr. Rafferty added.
”What this shows is, for adolescents, the risk of suicide is something we need to be paying attention to. Because it’s not that it’s something that only happens in adults, this really dispels a lot of the misquoting of the data that’s out there.” That kind of information is valuable for determining resource allocation, he said. “A disparity like this really underlies the importance of mental health resources in this field,” he said.
Dr. Burnside, Dr. Hoffmann, and Dr. Rafferty had no disclosures, and no external funding sources were noted.
WASHINGTON – , according to a study presented at the annual meeting of the American Academy of Pediatrics.
“The take-home message here is this study emphasizes the importance of universal screening to identify gender-diverse youth at risk,” Amanda Burnside, PhD, assistant professor of psychiatry and behavioral sciences at Ann and Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, told attendees. “We really need to develop robust strategies and systems to link better mental health services.”
Suicide rates in transgender and gender-diverse youth are exceptionally high among youth in the U.S., Dr. Burnside said during her presentation. For example, the 2022 LGBTQ health survey from the Trevor Project found that much higher percentages of transgender and gender nonconforming youth had considered suicide in the past year compared with cisgender youth, even within the LGBTQ umbrella. Among nearly 34,000 LGBTQ youth aged 13-24, nearly half of trans females (48%) and more than half of trans males (59%) had considered suicide, compared with 28% of cisgender males and 37% of cisgender females. The rate among nonbinary/genderqueer individuals was 53%, and it was 48% for those questioning their gender.
Current methods of identifying trans and gender-diverse (TGD) youth in the hospital, however, may not actually be capturing the entire population.
“In health care settings, research involving TGD individuals has historically been limited to specialized clinic populations or youth with gender-specific diagnostic codes documented in the electronic medical record,” an approach that “likely significantly underestimates the prevalence of TGD youth in health care settings.” While at least one study has attempted to bridge this gap by searching the EMR for keywords, that study only tried to identify trans youth and not other youth on the gender diversity spectrum, such as nonbinary youth or those questioning their gender identity. Dr. Burnside and her colleagues therefore designed a study that used keywords to identify both trans youth and other gender-diverse youth who visited the ED so they could assess the rate of positive suicide screens in this population.
Underestimating the population at risk?
The researchers conducted a retrospective cross-sectional study of EMR data for all ED visits during which the patient underwent suicide screening. For the period of November 2019 to August 2022, they collected data on the screening results and the patient’s gender identity, age, race/ethnicity, insurance status, chief complaint in the ED and child opportunity index, which assess a youth’s access to resources based on geography. The suicide screener used was the Ask Suicide–Screening Questions (ASQ) tool.
The keywords they looked for in the EMR to identify trans and gender-diverse youth included transgender, pronouns, agender, gender dysphoria, male-to-female, female-to-male, nonbinary, preferred name, and they/them (captured as a complete term, not as “they” and “them” separately).
“If a keyword was present, the surrounding text was extracted and reviewed by two members of our team,” Dr. Burnside explained in her presentation. “We categorized keywords into either indicative of gender-diverse identity or not, and if it wasn’t clear based on the text extracted, we would conduct a manual chart review,” though that only occurred in about 3% of cases, she added.
Among 15,413 ED encounters with a suicide screen, the researchers identified 1,126 of these keywords in the EMR, among which 91.2% were classified as referring to a gender-diverse patient. Nearly all of the words were at least 90% effective in identify a gender-diverse youth, Dr. Burnside said, and all of the 197 instances of “they/them” were classified as gender diverse.
The accuracy was a little lower for the two keywords that appeared most frequently: For “pronouns,” 86.3% of 306 instances were classified as gender diverse, and for “transgender,” 83.1% of 207 instances were classified as gender diverse. Since some providers ask all patients their pronouns, the presence of “pronouns” in the EMR alone did not necessarily indicate the patient was gender diverse, Dr. Burnside said. A common reason the term “transgender” occurred in the EMR of non–gender diverse patients is that the department’s list of crisis resources includes transgender hotlines.
After identifying all the keywords, the researchers determined how many of these occurred in unique ED encounters and removed those with incomplete screening. Overall, they found 565 encounters by 399 gender-diverse individuals who had a suicide screening, representing 4.6% of total visits. This percentage is slightly lower than recent population-based estimates of gender-diverse youth, the researchers noted.
This population ranged from 8 to 23 years old, and 43% were publicly insured. The chief complaint for most of the patients (77.5%) was a mental health one. They were predominantly White (43%) or Hispanic (35%), with 10% Black youth, 4% Asian youth, and 8% youth who were “other” or two or more races. About half (52%) lived in a neighborhood with a “low” or “very low” child opportunity index.
Within this population, 81% of the patients screened positive on the suicide screening, compared with 23% positive screens across all ED visits. One in ten (10%) gender-diverse youth had active suicidal ideation, compared with 3.4% of the rest of the ED patient population. The researchers calculated that gender-diverse youth had 5.35 times greater odds of screening positive than cisgender youth in the ED (95% confidence interval [CI] 8.7-15.92). Further, a quarter (25%) of the trans and gender-diverse youth who screened positive for suicide risk had come to the ED for a primary complaint unrelated to mental health.
“We had a kid who came in because he broke his arm who had active suicidal ideation,” study coauthor Jennifer A. Hoffmann, MD, assistant professor of pediatrics at the Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, mentioned after the presentation. That particular patient even had a suicide plan, but was identified as actively suicidal only because of the screening. In other cases, she said, a youth may come in with self-inflicted injuries, and while those are the primary complaint, they are linked with suicidal ideation.
Among the study’s limitations are that gender identity is not necessarily being systematically assessed during visits, misspellings might have missed some youth, and their search strategy has not yet been externally validated, though they plan to seek that.
“Overall, however, this study did demonstrate that keyword searching is a promising technique to identify and prioritize gender-diverse youth in health services research,” Dr. Burnside said. In addition to showing the feasibility of using a keyword search strategy for identifying gender-diverse youth, Dr. Burnside noted that 31% of the encounters were identified by just one of the keywords they used, “highlighting the importance of using a comprehensive list of keywords to identify gender-diverse youth.”
Uncovering valuable information
Jason Rafferty, MD, MPH, EdM, clinical assistant professor of pediatrics and of psychiatry and human behavior at Brown University, Providence, R.I., who attended the presentation, noted that the study provides information on a population that’s often difficult to get through traditional EMR research methods.
“A lot of medical record systems don’t have uniform ways of capturing [gender diversity], but what we know as providers is that kids are really struggling and that it’s not a surprise that we’re seeing these disparities with suicidality,” Dr. Rafferty said.
The study also provides more discrete estimates by age than what most other current research measures, which tends to be lifetime suicidality as opposed to suicidal thoughts or attempts within the past year, Dr. Rafferty added.
”What this shows is, for adolescents, the risk of suicide is something we need to be paying attention to. Because it’s not that it’s something that only happens in adults, this really dispels a lot of the misquoting of the data that’s out there.” That kind of information is valuable for determining resource allocation, he said. “A disparity like this really underlies the importance of mental health resources in this field,” he said.
Dr. Burnside, Dr. Hoffmann, and Dr. Rafferty had no disclosures, and no external funding sources were noted.
WASHINGTON – , according to a study presented at the annual meeting of the American Academy of Pediatrics.
“The take-home message here is this study emphasizes the importance of universal screening to identify gender-diverse youth at risk,” Amanda Burnside, PhD, assistant professor of psychiatry and behavioral sciences at Ann and Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, told attendees. “We really need to develop robust strategies and systems to link better mental health services.”
Suicide rates in transgender and gender-diverse youth are exceptionally high among youth in the U.S., Dr. Burnside said during her presentation. For example, the 2022 LGBTQ health survey from the Trevor Project found that much higher percentages of transgender and gender nonconforming youth had considered suicide in the past year compared with cisgender youth, even within the LGBTQ umbrella. Among nearly 34,000 LGBTQ youth aged 13-24, nearly half of trans females (48%) and more than half of trans males (59%) had considered suicide, compared with 28% of cisgender males and 37% of cisgender females. The rate among nonbinary/genderqueer individuals was 53%, and it was 48% for those questioning their gender.
Current methods of identifying trans and gender-diverse (TGD) youth in the hospital, however, may not actually be capturing the entire population.
“In health care settings, research involving TGD individuals has historically been limited to specialized clinic populations or youth with gender-specific diagnostic codes documented in the electronic medical record,” an approach that “likely significantly underestimates the prevalence of TGD youth in health care settings.” While at least one study has attempted to bridge this gap by searching the EMR for keywords, that study only tried to identify trans youth and not other youth on the gender diversity spectrum, such as nonbinary youth or those questioning their gender identity. Dr. Burnside and her colleagues therefore designed a study that used keywords to identify both trans youth and other gender-diverse youth who visited the ED so they could assess the rate of positive suicide screens in this population.
Underestimating the population at risk?
The researchers conducted a retrospective cross-sectional study of EMR data for all ED visits during which the patient underwent suicide screening. For the period of November 2019 to August 2022, they collected data on the screening results and the patient’s gender identity, age, race/ethnicity, insurance status, chief complaint in the ED and child opportunity index, which assess a youth’s access to resources based on geography. The suicide screener used was the Ask Suicide–Screening Questions (ASQ) tool.
The keywords they looked for in the EMR to identify trans and gender-diverse youth included transgender, pronouns, agender, gender dysphoria, male-to-female, female-to-male, nonbinary, preferred name, and they/them (captured as a complete term, not as “they” and “them” separately).
“If a keyword was present, the surrounding text was extracted and reviewed by two members of our team,” Dr. Burnside explained in her presentation. “We categorized keywords into either indicative of gender-diverse identity or not, and if it wasn’t clear based on the text extracted, we would conduct a manual chart review,” though that only occurred in about 3% of cases, she added.
Among 15,413 ED encounters with a suicide screen, the researchers identified 1,126 of these keywords in the EMR, among which 91.2% were classified as referring to a gender-diverse patient. Nearly all of the words were at least 90% effective in identify a gender-diverse youth, Dr. Burnside said, and all of the 197 instances of “they/them” were classified as gender diverse.
The accuracy was a little lower for the two keywords that appeared most frequently: For “pronouns,” 86.3% of 306 instances were classified as gender diverse, and for “transgender,” 83.1% of 207 instances were classified as gender diverse. Since some providers ask all patients their pronouns, the presence of “pronouns” in the EMR alone did not necessarily indicate the patient was gender diverse, Dr. Burnside said. A common reason the term “transgender” occurred in the EMR of non–gender diverse patients is that the department’s list of crisis resources includes transgender hotlines.
After identifying all the keywords, the researchers determined how many of these occurred in unique ED encounters and removed those with incomplete screening. Overall, they found 565 encounters by 399 gender-diverse individuals who had a suicide screening, representing 4.6% of total visits. This percentage is slightly lower than recent population-based estimates of gender-diverse youth, the researchers noted.
This population ranged from 8 to 23 years old, and 43% were publicly insured. The chief complaint for most of the patients (77.5%) was a mental health one. They were predominantly White (43%) or Hispanic (35%), with 10% Black youth, 4% Asian youth, and 8% youth who were “other” or two or more races. About half (52%) lived in a neighborhood with a “low” or “very low” child opportunity index.
Within this population, 81% of the patients screened positive on the suicide screening, compared with 23% positive screens across all ED visits. One in ten (10%) gender-diverse youth had active suicidal ideation, compared with 3.4% of the rest of the ED patient population. The researchers calculated that gender-diverse youth had 5.35 times greater odds of screening positive than cisgender youth in the ED (95% confidence interval [CI] 8.7-15.92). Further, a quarter (25%) of the trans and gender-diverse youth who screened positive for suicide risk had come to the ED for a primary complaint unrelated to mental health.
“We had a kid who came in because he broke his arm who had active suicidal ideation,” study coauthor Jennifer A. Hoffmann, MD, assistant professor of pediatrics at the Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, mentioned after the presentation. That particular patient even had a suicide plan, but was identified as actively suicidal only because of the screening. In other cases, she said, a youth may come in with self-inflicted injuries, and while those are the primary complaint, they are linked with suicidal ideation.
Among the study’s limitations are that gender identity is not necessarily being systematically assessed during visits, misspellings might have missed some youth, and their search strategy has not yet been externally validated, though they plan to seek that.
“Overall, however, this study did demonstrate that keyword searching is a promising technique to identify and prioritize gender-diverse youth in health services research,” Dr. Burnside said. In addition to showing the feasibility of using a keyword search strategy for identifying gender-diverse youth, Dr. Burnside noted that 31% of the encounters were identified by just one of the keywords they used, “highlighting the importance of using a comprehensive list of keywords to identify gender-diverse youth.”
Uncovering valuable information
Jason Rafferty, MD, MPH, EdM, clinical assistant professor of pediatrics and of psychiatry and human behavior at Brown University, Providence, R.I., who attended the presentation, noted that the study provides information on a population that’s often difficult to get through traditional EMR research methods.
“A lot of medical record systems don’t have uniform ways of capturing [gender diversity], but what we know as providers is that kids are really struggling and that it’s not a surprise that we’re seeing these disparities with suicidality,” Dr. Rafferty said.
The study also provides more discrete estimates by age than what most other current research measures, which tends to be lifetime suicidality as opposed to suicidal thoughts or attempts within the past year, Dr. Rafferty added.
”What this shows is, for adolescents, the risk of suicide is something we need to be paying attention to. Because it’s not that it’s something that only happens in adults, this really dispels a lot of the misquoting of the data that’s out there.” That kind of information is valuable for determining resource allocation, he said. “A disparity like this really underlies the importance of mental health resources in this field,” he said.
Dr. Burnside, Dr. Hoffmann, and Dr. Rafferty had no disclosures, and no external funding sources were noted.
AT AAP 2023
ADC with radiotherapy for brain mets ups risk of necrosis
TOPLINE:
, a new retrospective study suggests.
METHODOLOGY:
- Stereotactic radiotherapy is a key treatment for patients with brain metastases, but some develop radiation necrosis. Because ADCs can help shrink brain metastases as well, the researchers wanted to see whether adding an ADC to stereotactic radiotherapy increased patients’ risk of symptomatic radiation necrosis.
- The study included 98 patients (84% women; median age, 55 years) with brain metastases who received at least one course of stereotactic radiotherapy for intact brain metastases and at least one dose of trastuzumab emtansine, trastuzumab deruxtecan, or sacituzumab govitecan.
- Stereotactic radiotherapy was considered concurrent with ADC therapy if delivered within 7 days before the ADC or within 21 days after the ADC. The control cohort included patients with brain metastases treated sequentially with stereotactic radiotherapy and an ADC.
- Symptomatic radiation necrosis was the primary outcome, and the researchers used competing risks regression models to analyze the impact of concurrent therapy.
TAKEAWAY:
- For the entire cohort, the 24-month cumulative incidence of symptomatic radiation necrosis was 8.5%. ADC therapy given concurrently with stereotactic radiotherapy was associated with higher risk for symptomatic radiation necrosis in univariable analysis (subdistribution hazard ratio, 4.01) and multivariable analysis (SHR, 4.31) that controlled for prior radiotherapy and volume of brain metastases.
- The risk of symptomatic radiation necrosis with concurrent ADC was modest for patients with small brain metastases who received a first course of stereotactic radiotherapy but was substantial for those with larger and reirradiated lesions treated with concurrent ADC.
- For previously radiated lesions, the 24-month risk of necrosis was 42% with concurrent ADC versus 9.4% without concurrent ADC.
- Grade 4-5 symptomatic radiation necrosis following stereotactic radiotherapy was observed in 7.1% of brain metastases treated with concurrent ADC versus 0.7% treated without concurrent ADC. There was no difference in risk between different ADC agents.
IN PRACTICE:
On the basis of current findings, the researchers concluded that “clinicians should be cognizant of the [symptomatic radiation necrosis] risk and monitor patients closely when treating concurrently with ADCs.”
SOURCE:
The study, with first author Emily S. Lebow, MD, of Memorial Sloan Kettering Cancer Center in New York, was published online in JAMA Oncology.
LIMITATIONS:
Limitations include the retrospective study design as well as uncertainty in discriminating between radiation necrosis and local treatment failure.
DISCLOSURES:
The study had no specific funding. Four of the six authors reported various relationships with industry.
A version of this article first appeared on Medscape.com.
TOPLINE:
, a new retrospective study suggests.
METHODOLOGY:
- Stereotactic radiotherapy is a key treatment for patients with brain metastases, but some develop radiation necrosis. Because ADCs can help shrink brain metastases as well, the researchers wanted to see whether adding an ADC to stereotactic radiotherapy increased patients’ risk of symptomatic radiation necrosis.
- The study included 98 patients (84% women; median age, 55 years) with brain metastases who received at least one course of stereotactic radiotherapy for intact brain metastases and at least one dose of trastuzumab emtansine, trastuzumab deruxtecan, or sacituzumab govitecan.
- Stereotactic radiotherapy was considered concurrent with ADC therapy if delivered within 7 days before the ADC or within 21 days after the ADC. The control cohort included patients with brain metastases treated sequentially with stereotactic radiotherapy and an ADC.
- Symptomatic radiation necrosis was the primary outcome, and the researchers used competing risks regression models to analyze the impact of concurrent therapy.
TAKEAWAY:
- For the entire cohort, the 24-month cumulative incidence of symptomatic radiation necrosis was 8.5%. ADC therapy given concurrently with stereotactic radiotherapy was associated with higher risk for symptomatic radiation necrosis in univariable analysis (subdistribution hazard ratio, 4.01) and multivariable analysis (SHR, 4.31) that controlled for prior radiotherapy and volume of brain metastases.
- The risk of symptomatic radiation necrosis with concurrent ADC was modest for patients with small brain metastases who received a first course of stereotactic radiotherapy but was substantial for those with larger and reirradiated lesions treated with concurrent ADC.
- For previously radiated lesions, the 24-month risk of necrosis was 42% with concurrent ADC versus 9.4% without concurrent ADC.
- Grade 4-5 symptomatic radiation necrosis following stereotactic radiotherapy was observed in 7.1% of brain metastases treated with concurrent ADC versus 0.7% treated without concurrent ADC. There was no difference in risk between different ADC agents.
IN PRACTICE:
On the basis of current findings, the researchers concluded that “clinicians should be cognizant of the [symptomatic radiation necrosis] risk and monitor patients closely when treating concurrently with ADCs.”
SOURCE:
The study, with first author Emily S. Lebow, MD, of Memorial Sloan Kettering Cancer Center in New York, was published online in JAMA Oncology.
LIMITATIONS:
Limitations include the retrospective study design as well as uncertainty in discriminating between radiation necrosis and local treatment failure.
DISCLOSURES:
The study had no specific funding. Four of the six authors reported various relationships with industry.
A version of this article first appeared on Medscape.com.
TOPLINE:
, a new retrospective study suggests.
METHODOLOGY:
- Stereotactic radiotherapy is a key treatment for patients with brain metastases, but some develop radiation necrosis. Because ADCs can help shrink brain metastases as well, the researchers wanted to see whether adding an ADC to stereotactic radiotherapy increased patients’ risk of symptomatic radiation necrosis.
- The study included 98 patients (84% women; median age, 55 years) with brain metastases who received at least one course of stereotactic radiotherapy for intact brain metastases and at least one dose of trastuzumab emtansine, trastuzumab deruxtecan, or sacituzumab govitecan.
- Stereotactic radiotherapy was considered concurrent with ADC therapy if delivered within 7 days before the ADC or within 21 days after the ADC. The control cohort included patients with brain metastases treated sequentially with stereotactic radiotherapy and an ADC.
- Symptomatic radiation necrosis was the primary outcome, and the researchers used competing risks regression models to analyze the impact of concurrent therapy.
TAKEAWAY:
- For the entire cohort, the 24-month cumulative incidence of symptomatic radiation necrosis was 8.5%. ADC therapy given concurrently with stereotactic radiotherapy was associated with higher risk for symptomatic radiation necrosis in univariable analysis (subdistribution hazard ratio, 4.01) and multivariable analysis (SHR, 4.31) that controlled for prior radiotherapy and volume of brain metastases.
- The risk of symptomatic radiation necrosis with concurrent ADC was modest for patients with small brain metastases who received a first course of stereotactic radiotherapy but was substantial for those with larger and reirradiated lesions treated with concurrent ADC.
- For previously radiated lesions, the 24-month risk of necrosis was 42% with concurrent ADC versus 9.4% without concurrent ADC.
- Grade 4-5 symptomatic radiation necrosis following stereotactic radiotherapy was observed in 7.1% of brain metastases treated with concurrent ADC versus 0.7% treated without concurrent ADC. There was no difference in risk between different ADC agents.
IN PRACTICE:
On the basis of current findings, the researchers concluded that “clinicians should be cognizant of the [symptomatic radiation necrosis] risk and monitor patients closely when treating concurrently with ADCs.”
SOURCE:
The study, with first author Emily S. Lebow, MD, of Memorial Sloan Kettering Cancer Center in New York, was published online in JAMA Oncology.
LIMITATIONS:
Limitations include the retrospective study design as well as uncertainty in discriminating between radiation necrosis and local treatment failure.
DISCLOSURES:
The study had no specific funding. Four of the six authors reported various relationships with industry.
A version of this article first appeared on Medscape.com.
AI app can do biomechanical analysis in minutes
Stanford (Calif.) University’s human performance lab sits next to its physical therapy clinic, so orthopedic surgeons often stop by to request biomechanical analyses for their patients, such as athletes with repeat injuries.
“It would take us days to analyze the data, so we would only do it a handful of times per year,” said Scott Uhlrich, PhD, director of research at the lab.
Now an app can do the job in less than 10 minutes.
The motion-capture app, created by Dr. Uhlrich and fellow bioengineers at Stanford, could help clinicians design better interventions to ward off mobility problems and speed recovery. It could also help researchers fill huge knowledge gaps about human mobility.
It’s currently available free for research and educational use. Model Health, a startup affiliated with the Stanford researchers, provides licenses for commercial use and clinical practice.
Here’s how it works. Footage of human movement, recorded by two smartphones, gets uploaded to the cloud, where an algorithm identifies a set of points on the body. The app relies on computer vision algorithms, a form of AI that trains computers to “understand” visual data – in this case, a person’s pose.
Next, the app quantifies how the body is moving through three-dimensional space. Musculoskeletal system models reveal insights into that movement, such as the angle of a joint, the stretch in a tendon, or the force being transferred through the joints.
“These are the quantities that relate to injuries and disease,” said Dr. Uhlrich, co-author of a study introducing the app. “We need to get to those quantities to be able to inform medical research and eventually clinical practice.”
The conventional approach to getting this kind of analysis requires special expertise and costs $150,000. By contrast, the app is free and easy to use.
It “democratizes” human movement analysis, said senior study author Scott Delp, PhD, professor of bioengineering and mechanical engineering at Stanford. The researchers hope this will “improve outcomes for patients across the world.”
‘Endless opportunities’
A lot about human mobility remains mysterious.
In aging adults, researchers can’t say when balance starts to degrade or by how much every year. They’re also still unraveling how sports injuries occur and how degenerative joint diseases like arthritis progress.
“We don’t really understand the onset of a lot of things, because we’ve just never measured it,” Dr. Uhlrich said.
OpenCap could help change that in a big way. Although biomechanics studies tend to be small – just 14 participants, on average – the app could allow for much larger studies, thanks to its lower cost and ease of use. In the study, the app collected movement data on 100 participants in less than 10 hours and computed results in 31 hours – an effort that would otherwise have taken a year.
“Studies of hundreds will be common, and thousands will be feasible, especially if assessments are integrated into clinic visits,” Dr. Uhlrich said.
About 2,600 researchers around the world are already using the app, according to Dr. Uhlrich. Many had never created a dynamic simulation before.
“The opportunities here are endless,” said Eni Halilaj, PhD, an assistant professor of mechanical engineering at Carnegie Mellon, Pittsburgh, who was not involved in creating the app. That’s especially true for “highly heterogeneous conditions that we have not been able to fully characterize through traditional studies with limited patients.”
In one case, researcher Reed Gurchiek, a former Stanford postdoc and current professor at Clemson (S.C.) University, used the app to study hamstring strain injuries during sprinting and found that these muscles lengthen faster during acceleration, compared with running at a constant speed.
“This aligns with the higher observed injury rates when athletes are accelerating,” Dr. Uhlrich explained. “Varied-speed sprinting studies are not possible in the lab, so this was really enabled by OpenCap’s portability.”
Movement as a biomarker
The researchers are already using the app to build new tools, including metrics to identify risk for anterior cruciate ligament injury in young athletes and to measure balance.
Someday, the technology could augment annual physicals, establishing movement as a biomarker. By having patients perform a few movements, like walking or standing up, clinicians could assess their disease risk and progression or their risk of falling.
Excessive loading in the knee joint puts patients at higher risk of developing osteoarthritis, for instance, but clinicians can’t easily access this information. The disease is typically diagnosed after symptoms appear, even though intervention could happen much earlier.
“Prevention is still not as embraced as it should be,” said Pamela Toto, PhD, professor of occupational therapy at the University of Pittsburgh, who also was not involved in making the app. “If we could tie the technology to intervention down the road, that could be valuable.”
A version of this article first appeared on Medscape.com.
Stanford (Calif.) University’s human performance lab sits next to its physical therapy clinic, so orthopedic surgeons often stop by to request biomechanical analyses for their patients, such as athletes with repeat injuries.
“It would take us days to analyze the data, so we would only do it a handful of times per year,” said Scott Uhlrich, PhD, director of research at the lab.
Now an app can do the job in less than 10 minutes.
The motion-capture app, created by Dr. Uhlrich and fellow bioengineers at Stanford, could help clinicians design better interventions to ward off mobility problems and speed recovery. It could also help researchers fill huge knowledge gaps about human mobility.
It’s currently available free for research and educational use. Model Health, a startup affiliated with the Stanford researchers, provides licenses for commercial use and clinical practice.
Here’s how it works. Footage of human movement, recorded by two smartphones, gets uploaded to the cloud, where an algorithm identifies a set of points on the body. The app relies on computer vision algorithms, a form of AI that trains computers to “understand” visual data – in this case, a person’s pose.
Next, the app quantifies how the body is moving through three-dimensional space. Musculoskeletal system models reveal insights into that movement, such as the angle of a joint, the stretch in a tendon, or the force being transferred through the joints.
“These are the quantities that relate to injuries and disease,” said Dr. Uhlrich, co-author of a study introducing the app. “We need to get to those quantities to be able to inform medical research and eventually clinical practice.”
The conventional approach to getting this kind of analysis requires special expertise and costs $150,000. By contrast, the app is free and easy to use.
It “democratizes” human movement analysis, said senior study author Scott Delp, PhD, professor of bioengineering and mechanical engineering at Stanford. The researchers hope this will “improve outcomes for patients across the world.”
‘Endless opportunities’
A lot about human mobility remains mysterious.
In aging adults, researchers can’t say when balance starts to degrade or by how much every year. They’re also still unraveling how sports injuries occur and how degenerative joint diseases like arthritis progress.
“We don’t really understand the onset of a lot of things, because we’ve just never measured it,” Dr. Uhlrich said.
OpenCap could help change that in a big way. Although biomechanics studies tend to be small – just 14 participants, on average – the app could allow for much larger studies, thanks to its lower cost and ease of use. In the study, the app collected movement data on 100 participants in less than 10 hours and computed results in 31 hours – an effort that would otherwise have taken a year.
“Studies of hundreds will be common, and thousands will be feasible, especially if assessments are integrated into clinic visits,” Dr. Uhlrich said.
About 2,600 researchers around the world are already using the app, according to Dr. Uhlrich. Many had never created a dynamic simulation before.
“The opportunities here are endless,” said Eni Halilaj, PhD, an assistant professor of mechanical engineering at Carnegie Mellon, Pittsburgh, who was not involved in creating the app. That’s especially true for “highly heterogeneous conditions that we have not been able to fully characterize through traditional studies with limited patients.”
In one case, researcher Reed Gurchiek, a former Stanford postdoc and current professor at Clemson (S.C.) University, used the app to study hamstring strain injuries during sprinting and found that these muscles lengthen faster during acceleration, compared with running at a constant speed.
“This aligns with the higher observed injury rates when athletes are accelerating,” Dr. Uhlrich explained. “Varied-speed sprinting studies are not possible in the lab, so this was really enabled by OpenCap’s portability.”
Movement as a biomarker
The researchers are already using the app to build new tools, including metrics to identify risk for anterior cruciate ligament injury in young athletes and to measure balance.
Someday, the technology could augment annual physicals, establishing movement as a biomarker. By having patients perform a few movements, like walking or standing up, clinicians could assess their disease risk and progression or their risk of falling.
Excessive loading in the knee joint puts patients at higher risk of developing osteoarthritis, for instance, but clinicians can’t easily access this information. The disease is typically diagnosed after symptoms appear, even though intervention could happen much earlier.
“Prevention is still not as embraced as it should be,” said Pamela Toto, PhD, professor of occupational therapy at the University of Pittsburgh, who also was not involved in making the app. “If we could tie the technology to intervention down the road, that could be valuable.”
A version of this article first appeared on Medscape.com.
Stanford (Calif.) University’s human performance lab sits next to its physical therapy clinic, so orthopedic surgeons often stop by to request biomechanical analyses for their patients, such as athletes with repeat injuries.
“It would take us days to analyze the data, so we would only do it a handful of times per year,” said Scott Uhlrich, PhD, director of research at the lab.
Now an app can do the job in less than 10 minutes.
The motion-capture app, created by Dr. Uhlrich and fellow bioengineers at Stanford, could help clinicians design better interventions to ward off mobility problems and speed recovery. It could also help researchers fill huge knowledge gaps about human mobility.
It’s currently available free for research and educational use. Model Health, a startup affiliated with the Stanford researchers, provides licenses for commercial use and clinical practice.
Here’s how it works. Footage of human movement, recorded by two smartphones, gets uploaded to the cloud, where an algorithm identifies a set of points on the body. The app relies on computer vision algorithms, a form of AI that trains computers to “understand” visual data – in this case, a person’s pose.
Next, the app quantifies how the body is moving through three-dimensional space. Musculoskeletal system models reveal insights into that movement, such as the angle of a joint, the stretch in a tendon, or the force being transferred through the joints.
“These are the quantities that relate to injuries and disease,” said Dr. Uhlrich, co-author of a study introducing the app. “We need to get to those quantities to be able to inform medical research and eventually clinical practice.”
The conventional approach to getting this kind of analysis requires special expertise and costs $150,000. By contrast, the app is free and easy to use.
It “democratizes” human movement analysis, said senior study author Scott Delp, PhD, professor of bioengineering and mechanical engineering at Stanford. The researchers hope this will “improve outcomes for patients across the world.”
‘Endless opportunities’
A lot about human mobility remains mysterious.
In aging adults, researchers can’t say when balance starts to degrade or by how much every year. They’re also still unraveling how sports injuries occur and how degenerative joint diseases like arthritis progress.
“We don’t really understand the onset of a lot of things, because we’ve just never measured it,” Dr. Uhlrich said.
OpenCap could help change that in a big way. Although biomechanics studies tend to be small – just 14 participants, on average – the app could allow for much larger studies, thanks to its lower cost and ease of use. In the study, the app collected movement data on 100 participants in less than 10 hours and computed results in 31 hours – an effort that would otherwise have taken a year.
“Studies of hundreds will be common, and thousands will be feasible, especially if assessments are integrated into clinic visits,” Dr. Uhlrich said.
About 2,600 researchers around the world are already using the app, according to Dr. Uhlrich. Many had never created a dynamic simulation before.
“The opportunities here are endless,” said Eni Halilaj, PhD, an assistant professor of mechanical engineering at Carnegie Mellon, Pittsburgh, who was not involved in creating the app. That’s especially true for “highly heterogeneous conditions that we have not been able to fully characterize through traditional studies with limited patients.”
In one case, researcher Reed Gurchiek, a former Stanford postdoc and current professor at Clemson (S.C.) University, used the app to study hamstring strain injuries during sprinting and found that these muscles lengthen faster during acceleration, compared with running at a constant speed.
“This aligns with the higher observed injury rates when athletes are accelerating,” Dr. Uhlrich explained. “Varied-speed sprinting studies are not possible in the lab, so this was really enabled by OpenCap’s portability.”
Movement as a biomarker
The researchers are already using the app to build new tools, including metrics to identify risk for anterior cruciate ligament injury in young athletes and to measure balance.
Someday, the technology could augment annual physicals, establishing movement as a biomarker. By having patients perform a few movements, like walking or standing up, clinicians could assess their disease risk and progression or their risk of falling.
Excessive loading in the knee joint puts patients at higher risk of developing osteoarthritis, for instance, but clinicians can’t easily access this information. The disease is typically diagnosed after symptoms appear, even though intervention could happen much earlier.
“Prevention is still not as embraced as it should be,” said Pamela Toto, PhD, professor of occupational therapy at the University of Pittsburgh, who also was not involved in making the app. “If we could tie the technology to intervention down the road, that could be valuable.”
A version of this article first appeared on Medscape.com.
Strength training promotes knee health, lowers OA risk
TOPLINE:
Strength training at any point in life is associated with a lower risk of knee pain and osteoarthritis, contrary to persistent assumptions of adverse effects.
METHODOLOGY:
- Researchers reviewed data on strength training and knee pain from 2,607 adults. They used the Historical Physical Activity Survey Instrument to assess the impact of strength training during four periods (ages 12-18 years, 19-34 years, 35-49 years, and 50 years and older).
- The participants were enrolled in the Osteoarthritis Initiative, a multicenter, prospective, longitudinal study; 44% were male, the average age was 64.3 years, and the mean body mass index was 28.5 kg/m2.
- Strength training was defined as those exposed and not exposed, as well as divided into low, medium, and high tertiles for those exposed. A total of 818 individuals were exposed to strength training, and 1,789 were not exposed to strength training.
- The primary outcomes were frequent knee pain, radiographic OA (ROA), and symptomatic radiographic OA (SOA).
TAKEAWAY:
- The study is the first to examine the effect of strength training on knee health in a community population sample not selected for a history of elite weight lifting.
- Overall, strength training at any point in life was associated with lower incidence of frequent knee pain, ROA, and SOA, compared with no strength training (odds ratios, 0.82, 0.83, and 0.77, respectively).
- When separated by tertiles, only the high-exposure group had significantly reduced odds of frequent knee pain, ROA, and SOA, with odds ratios of 0.74, 0.70, and 0.69, respectively. A dose-response relationship appeared for all three conditions, with the lowest odds ratios in the highest strength training exposure groups.
- Findings were similar for different age ranges, but the association between strength training and less frequent knee pain, less ROA, and less SOA was strongest in the older age groups.
IN PRACTICE:
“Our findings support the idea that the medical community should proactively encourage more people to participate in strength training to help reduce their risk of osteoarthritis and other chronic conditions,” the researchers write.
SOURCE:
The study, with first author Grace H. Lo, MD, of Baylor College of Medicine, Houston, and colleagues, was published in Arthritis and Rheumatology.
LIMITATIONS:
The observational design and self-selected study population of strength training participants might bias the results, including participants’ recall of their activity level levels and changes in exercise trends over time. More research is needed to explore associations between strength training and knee OA among those who started strength training at a younger age.
DISCLOSURES:
The study was funded in part by the VA Health Services Research and Development Center for Innovations in Quality, Effectiveness, and Safety at the Michael E. DeBakey VA Medical Center, Houston, and by donations to the Tupper Research Fund at Tufts Medical Center. The Osteoarthritis Initiative is supported by the National Institutes of Health; private funding partners include Merck Research Laboratories, Novartis, GlaxoSmithKline, and Pfizer. Three authors report having financial relationships with multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
Strength training at any point in life is associated with a lower risk of knee pain and osteoarthritis, contrary to persistent assumptions of adverse effects.
METHODOLOGY:
- Researchers reviewed data on strength training and knee pain from 2,607 adults. They used the Historical Physical Activity Survey Instrument to assess the impact of strength training during four periods (ages 12-18 years, 19-34 years, 35-49 years, and 50 years and older).
- The participants were enrolled in the Osteoarthritis Initiative, a multicenter, prospective, longitudinal study; 44% were male, the average age was 64.3 years, and the mean body mass index was 28.5 kg/m2.
- Strength training was defined as those exposed and not exposed, as well as divided into low, medium, and high tertiles for those exposed. A total of 818 individuals were exposed to strength training, and 1,789 were not exposed to strength training.
- The primary outcomes were frequent knee pain, radiographic OA (ROA), and symptomatic radiographic OA (SOA).
TAKEAWAY:
- The study is the first to examine the effect of strength training on knee health in a community population sample not selected for a history of elite weight lifting.
- Overall, strength training at any point in life was associated with lower incidence of frequent knee pain, ROA, and SOA, compared with no strength training (odds ratios, 0.82, 0.83, and 0.77, respectively).
- When separated by tertiles, only the high-exposure group had significantly reduced odds of frequent knee pain, ROA, and SOA, with odds ratios of 0.74, 0.70, and 0.69, respectively. A dose-response relationship appeared for all three conditions, with the lowest odds ratios in the highest strength training exposure groups.
- Findings were similar for different age ranges, but the association between strength training and less frequent knee pain, less ROA, and less SOA was strongest in the older age groups.
IN PRACTICE:
“Our findings support the idea that the medical community should proactively encourage more people to participate in strength training to help reduce their risk of osteoarthritis and other chronic conditions,” the researchers write.
SOURCE:
The study, with first author Grace H. Lo, MD, of Baylor College of Medicine, Houston, and colleagues, was published in Arthritis and Rheumatology.
LIMITATIONS:
The observational design and self-selected study population of strength training participants might bias the results, including participants’ recall of their activity level levels and changes in exercise trends over time. More research is needed to explore associations between strength training and knee OA among those who started strength training at a younger age.
DISCLOSURES:
The study was funded in part by the VA Health Services Research and Development Center for Innovations in Quality, Effectiveness, and Safety at the Michael E. DeBakey VA Medical Center, Houston, and by donations to the Tupper Research Fund at Tufts Medical Center. The Osteoarthritis Initiative is supported by the National Institutes of Health; private funding partners include Merck Research Laboratories, Novartis, GlaxoSmithKline, and Pfizer. Three authors report having financial relationships with multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
Strength training at any point in life is associated with a lower risk of knee pain and osteoarthritis, contrary to persistent assumptions of adverse effects.
METHODOLOGY:
- Researchers reviewed data on strength training and knee pain from 2,607 adults. They used the Historical Physical Activity Survey Instrument to assess the impact of strength training during four periods (ages 12-18 years, 19-34 years, 35-49 years, and 50 years and older).
- The participants were enrolled in the Osteoarthritis Initiative, a multicenter, prospective, longitudinal study; 44% were male, the average age was 64.3 years, and the mean body mass index was 28.5 kg/m2.
- Strength training was defined as those exposed and not exposed, as well as divided into low, medium, and high tertiles for those exposed. A total of 818 individuals were exposed to strength training, and 1,789 were not exposed to strength training.
- The primary outcomes were frequent knee pain, radiographic OA (ROA), and symptomatic radiographic OA (SOA).
TAKEAWAY:
- The study is the first to examine the effect of strength training on knee health in a community population sample not selected for a history of elite weight lifting.
- Overall, strength training at any point in life was associated with lower incidence of frequent knee pain, ROA, and SOA, compared with no strength training (odds ratios, 0.82, 0.83, and 0.77, respectively).
- When separated by tertiles, only the high-exposure group had significantly reduced odds of frequent knee pain, ROA, and SOA, with odds ratios of 0.74, 0.70, and 0.69, respectively. A dose-response relationship appeared for all three conditions, with the lowest odds ratios in the highest strength training exposure groups.
- Findings were similar for different age ranges, but the association between strength training and less frequent knee pain, less ROA, and less SOA was strongest in the older age groups.
IN PRACTICE:
“Our findings support the idea that the medical community should proactively encourage more people to participate in strength training to help reduce their risk of osteoarthritis and other chronic conditions,” the researchers write.
SOURCE:
The study, with first author Grace H. Lo, MD, of Baylor College of Medicine, Houston, and colleagues, was published in Arthritis and Rheumatology.
LIMITATIONS:
The observational design and self-selected study population of strength training participants might bias the results, including participants’ recall of their activity level levels and changes in exercise trends over time. More research is needed to explore associations between strength training and knee OA among those who started strength training at a younger age.
DISCLOSURES:
The study was funded in part by the VA Health Services Research and Development Center for Innovations in Quality, Effectiveness, and Safety at the Michael E. DeBakey VA Medical Center, Houston, and by donations to the Tupper Research Fund at Tufts Medical Center. The Osteoarthritis Initiative is supported by the National Institutes of Health; private funding partners include Merck Research Laboratories, Novartis, GlaxoSmithKline, and Pfizer. Three authors report having financial relationships with multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
Higher prevalence of ADHD in episodic migraine
Key clinical point: Attention-deficit hyperactivity disorder (ADHD) symptoms and impulsive personality traits appeared to be more prevalent in patients with episodic migraine than in control individuals.
Major finding: Patients with episodic migraine vs control individuals had higher mean scores for inattention (5.0 vs 2.7; P < .00001), hyperactivity (4.0 vs 2.5; P = .000621), and impulsivity (2.0 vs 1.1; P = .000407) on the ADHD scale. A higher percentage of patients vs control participants (35.5% vs 8.6%) scored ‘often’ or ‘very often’ in ≥1 items of the impulsivity subscale (P < .05).
Study details: This observational cohort study included 100 patients with episodic migraine and 150 control participants without migraine.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Gonzalez-Hernandez A et al. Attention deficit hyperactivity disorder in adults with migraine. J Atten Disord. 2023 (Sep 27). doi: 10.1177/10870547231199256
Key clinical point: Attention-deficit hyperactivity disorder (ADHD) symptoms and impulsive personality traits appeared to be more prevalent in patients with episodic migraine than in control individuals.
Major finding: Patients with episodic migraine vs control individuals had higher mean scores for inattention (5.0 vs 2.7; P < .00001), hyperactivity (4.0 vs 2.5; P = .000621), and impulsivity (2.0 vs 1.1; P = .000407) on the ADHD scale. A higher percentage of patients vs control participants (35.5% vs 8.6%) scored ‘often’ or ‘very often’ in ≥1 items of the impulsivity subscale (P < .05).
Study details: This observational cohort study included 100 patients with episodic migraine and 150 control participants without migraine.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Gonzalez-Hernandez A et al. Attention deficit hyperactivity disorder in adults with migraine. J Atten Disord. 2023 (Sep 27). doi: 10.1177/10870547231199256
Key clinical point: Attention-deficit hyperactivity disorder (ADHD) symptoms and impulsive personality traits appeared to be more prevalent in patients with episodic migraine than in control individuals.
Major finding: Patients with episodic migraine vs control individuals had higher mean scores for inattention (5.0 vs 2.7; P < .00001), hyperactivity (4.0 vs 2.5; P = .000621), and impulsivity (2.0 vs 1.1; P = .000407) on the ADHD scale. A higher percentage of patients vs control participants (35.5% vs 8.6%) scored ‘often’ or ‘very often’ in ≥1 items of the impulsivity subscale (P < .05).
Study details: This observational cohort study included 100 patients with episodic migraine and 150 control participants without migraine.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Gonzalez-Hernandez A et al. Attention deficit hyperactivity disorder in adults with migraine. J Atten Disord. 2023 (Sep 27). doi: 10.1177/10870547231199256