Key clinical point: Atopic dermatitis (AD) is significantly associated with a higher risk for headache disorders or migraine.

Major finding: Patients with AD had a significantly higher risk for headache disorder (odds ratio [OR] 1.46; 95% CI 1.36-1.56) or migraine (OR 1.32; 95% CI 1.18-1.47; both P < .001). This finding was consistent across the different subgroup analyses.

Study details: The data come from a meta-analysis of 10 observational studies that evaluated the risk for headache disorders in 12,717,747 patients with AD, of which six studies evaluated migraine risk in 11,090,412 patients with AD.

Disclosures: This study was supported by the project of training talent for Zhejiang province young and middle-aged clinical traditional Chinese medicine experts and Hangzhou Municipal Health and Family Planning Commission Science and Technology Project, China. The authors declared no conflicts of interest.

Source: Yang W, Dai H, Xu X-F, et al. Association of atopic dermatitis and headache disorder: A systematic review and meta-analyses. Front Neurol. 2024;15:1383832. doi: 10.3389/fneur.2024.1383832 Source

Key clinical point: Atopic dermatitis (AD) is significantly associated with a higher risk for headache disorders or migraine.

Major finding: Patients with AD had a significantly higher risk for headache disorder (odds ratio [OR] 1.46; 95% CI 1.36-1.56) or migraine (OR 1.32; 95% CI 1.18-1.47; both P < .001). This finding was consistent across the different subgroup analyses.

Study details: The data come from a meta-analysis of 10 observational studies that evaluated the risk for headache disorders in 12,717,747 patients with AD, of which six studies evaluated migraine risk in 11,090,412 patients with AD.

Disclosures: This study was supported by the project of training talent for Zhejiang province young and middle-aged clinical traditional Chinese medicine experts and Hangzhou Municipal Health and Family Planning Commission Science and Technology Project, China. The authors declared no conflicts of interest.

Source: Yang W, Dai H, Xu X-F, et al. Association of atopic dermatitis and headache disorder: A systematic review and meta-analyses. Front Neurol. 2024;15:1383832. doi: 10.3389/fneur.2024.1383832 Source

Key clinical point: Atopic dermatitis (AD) is significantly associated with a higher risk for headache disorders or migraine.

Major finding: Patients with AD had a significantly higher risk for headache disorder (odds ratio [OR] 1.46; 95% CI 1.36-1.56) or migraine (OR 1.32; 95% CI 1.18-1.47; both P < .001). This finding was consistent across the different subgroup analyses.

Study details: The data come from a meta-analysis of 10 observational studies that evaluated the risk for headache disorders in 12,717,747 patients with AD, of which six studies evaluated migraine risk in 11,090,412 patients with AD.

Disclosures: This study was supported by the project of training talent for Zhejiang province young and middle-aged clinical traditional Chinese medicine experts and Hangzhou Municipal Health and Family Planning Commission Science and Technology Project, China. The authors declared no conflicts of interest.

Source: Yang W, Dai H, Xu X-F, et al. Association of atopic dermatitis and headache disorder: A systematic review and meta-analyses. Front Neurol. 2024;15:1383832. doi: 10.3389/fneur.2024.1383832 Source

Key clinical point: Patients with chronic kidney disease (CKD), particularly older adults and women, had a modestly reduced risk of developing migraine over a 16-year follow-up period.

Major finding: During the 16-year follow-up, patients with vs without CKD had an 11% lower risk for migraine (adjusted hazard ratio [aHR] 0.89; P = .006), with the risk being prominently lower among older adults (age ≥ 70 years; aHR 0.69; P < .001) and women (aHR 0.84; P = .006).

Study details: This nationwide, 16-year longitudinal follow-up study included 15,443 participants with CKD, of whom 349 (2.26%) had migraine, and 61,772 participants without CKD, of whom 1901 (3.08%) had migraine.

Disclosures: This study was supported by Bracco Imaging Korea and the National Research Foundation of Korea. The authors declared no conflicts of interest.

Source: Kwon MJ, Kim J-K, Kim M-J, et al. Associations between chronic kidney disease and migraine incidence: Findings from a Korean longitudinal big data study. J Pers Med. 2024;14(4):356 (Mar 28).  doi: 10.3390/jpm14040356 Source

Key clinical point: Patients with chronic kidney disease (CKD), particularly older adults and women, had a modestly reduced risk of developing migraine over a 16-year follow-up period.

Major finding: During the 16-year follow-up, patients with vs without CKD had an 11% lower risk for migraine (adjusted hazard ratio [aHR] 0.89; P = .006), with the risk being prominently lower among older adults (age ≥ 70 years; aHR 0.69; P < .001) and women (aHR 0.84; P = .006).

Study details: This nationwide, 16-year longitudinal follow-up study included 15,443 participants with CKD, of whom 349 (2.26%) had migraine, and 61,772 participants without CKD, of whom 1901 (3.08%) had migraine.

Disclosures: This study was supported by Bracco Imaging Korea and the National Research Foundation of Korea. The authors declared no conflicts of interest.

Source: Kwon MJ, Kim J-K, Kim M-J, et al. Associations between chronic kidney disease and migraine incidence: Findings from a Korean longitudinal big data study. J Pers Med. 2024;14(4):356 (Mar 28).  doi: 10.3390/jpm14040356 Source

Key clinical point: Patients with chronic kidney disease (CKD), particularly older adults and women, had a modestly reduced risk of developing migraine over a 16-year follow-up period.

Major finding: During the 16-year follow-up, patients with vs without CKD had an 11% lower risk for migraine (adjusted hazard ratio [aHR] 0.89; P = .006), with the risk being prominently lower among older adults (age ≥ 70 years; aHR 0.69; P < .001) and women (aHR 0.84; P = .006).

Study details: This nationwide, 16-year longitudinal follow-up study included 15,443 participants with CKD, of whom 349 (2.26%) had migraine, and 61,772 participants without CKD, of whom 1901 (3.08%) had migraine.

Disclosures: This study was supported by Bracco Imaging Korea and the National Research Foundation of Korea. The authors declared no conflicts of interest.

Source: Kwon MJ, Kim J-K, Kim M-J, et al. Associations between chronic kidney disease and migraine incidence: Findings from a Korean longitudinal big data study. J Pers Med. 2024;14(4):356 (Mar 28).  doi: 10.3390/jpm14040356 Source

Key clinical point: In patients with migraine, any oral prophylactic therapy significantly improved sleep quality, but anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) had significantly better effects than other oral prophylactic therapies.

Major finding: The Pittsburgh Sleep Quality Index (PSQI) score significantly reduced from 6.84 at baseline to 5.581 at 3 months with any oral prophylactic therapy and from 8.913 at baseline to 6.491 at 3 months with anti-CGRP mAbs. Among oral therapies, calcium channel blockers (P = .042) and antidepressants (P = .049) showed higher efficacy in reducing PSQI scores.

Study details: This multicenter prospective study included 214 patients with migraine, with or without aura, who received any oral prophylactic therapy (n = 143) or anti-CGRP mAb (n = 71).

Disclosures: This study was partially supported by Fondazione Giorgini, Italy. Mauro Silvestrini declared receiving financial support from the Giorgini Foundation. The other authors declared no conflicts of interest.

Source: Viticchi G, Di Stefano V, Altamura C, et al. Effects of prophylactic drug therapies and anti-calcitonin peptide-related monoclonal antibodies on subjective sleep quality: An Italian multicenter study. Sleep Med. 2024;117:87-94 (Mar 17). doi: 10.1016/j.sleep.2024.03.026 Source

Key clinical point: In patients with migraine, any oral prophylactic therapy significantly improved sleep quality, but anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) had significantly better effects than other oral prophylactic therapies.

Major finding: The Pittsburgh Sleep Quality Index (PSQI) score significantly reduced from 6.84 at baseline to 5.581 at 3 months with any oral prophylactic therapy and from 8.913 at baseline to 6.491 at 3 months with anti-CGRP mAbs. Among oral therapies, calcium channel blockers (P = .042) and antidepressants (P = .049) showed higher efficacy in reducing PSQI scores.

Study details: This multicenter prospective study included 214 patients with migraine, with or without aura, who received any oral prophylactic therapy (n = 143) or anti-CGRP mAb (n = 71).

Disclosures: This study was partially supported by Fondazione Giorgini, Italy. Mauro Silvestrini declared receiving financial support from the Giorgini Foundation. The other authors declared no conflicts of interest.

Source: Viticchi G, Di Stefano V, Altamura C, et al. Effects of prophylactic drug therapies and anti-calcitonin peptide-related monoclonal antibodies on subjective sleep quality: An Italian multicenter study. Sleep Med. 2024;117:87-94 (Mar 17). doi: 10.1016/j.sleep.2024.03.026 Source

Key clinical point: In patients with migraine, any oral prophylactic therapy significantly improved sleep quality, but anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) had significantly better effects than other oral prophylactic therapies.

Major finding: The Pittsburgh Sleep Quality Index (PSQI) score significantly reduced from 6.84 at baseline to 5.581 at 3 months with any oral prophylactic therapy and from 8.913 at baseline to 6.491 at 3 months with anti-CGRP mAbs. Among oral therapies, calcium channel blockers (P = .042) and antidepressants (P = .049) showed higher efficacy in reducing PSQI scores.

Study details: This multicenter prospective study included 214 patients with migraine, with or without aura, who received any oral prophylactic therapy (n = 143) or anti-CGRP mAb (n = 71).

Disclosures: This study was partially supported by Fondazione Giorgini, Italy. Mauro Silvestrini declared receiving financial support from the Giorgini Foundation. The other authors declared no conflicts of interest.

Source: Viticchi G, Di Stefano V, Altamura C, et al. Effects of prophylactic drug therapies and anti-calcitonin peptide-related monoclonal antibodies on subjective sleep quality: An Italian multicenter study. Sleep Med. 2024;117:87-94 (Mar 17). doi: 10.1016/j.sleep.2024.03.026 Source

Key clinical point: Early initiation of erenumab demonstrated better long-term efficacy, tolerability, and patient adherence than non-specific oral migraine preventive medications (OMPM) in patients with episodic migraine (EM) and one or two previous preventive treatment failures.

Major finding: At month 12, significantly more patients in the erenumab vs OMPM group completed the initially assigned treatment and also achieved a ≥50% reduction in monthly migraine days (odds ratio 6.48; P < .001). A smaller proportion of patients in the erenumab group vs the OMPM group switched medications (2.2% vs 34.6%) and discontinued treatment due to adverse events (2.9% vs 23.3%).

Study details: Findings are from the APPRAISE trial that included 621 patients with EM (age ≥ 18 years) who had previously failed 1 or 2 preventive treatments and were randomly assigned to receive erenumab (n = 413) and OMPM (n = 208).

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Several authors declared themselves as employees of or holding stocks in Novartis, and the other authors declared ties with various sources, including Novartis.

Source: Pozo-Rosich P, Dolezil D, Paemeleire K, et al. Early use of erenumab vs nonspecific oral migraine preventives: The APPRAISE randomized clinical trial. JAMA Neurol. 2024 (Mar 25). doi: 10.1001/jamaneurol.2024.0368 Source

Key clinical point: Early initiation of erenumab demonstrated better long-term efficacy, tolerability, and patient adherence than non-specific oral migraine preventive medications (OMPM) in patients with episodic migraine (EM) and one or two previous preventive treatment failures.

Major finding: At month 12, significantly more patients in the erenumab vs OMPM group completed the initially assigned treatment and also achieved a ≥50% reduction in monthly migraine days (odds ratio 6.48; P < .001). A smaller proportion of patients in the erenumab group vs the OMPM group switched medications (2.2% vs 34.6%) and discontinued treatment due to adverse events (2.9% vs 23.3%).

Study details: Findings are from the APPRAISE trial that included 621 patients with EM (age ≥ 18 years) who had previously failed 1 or 2 preventive treatments and were randomly assigned to receive erenumab (n = 413) and OMPM (n = 208).

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Several authors declared themselves as employees of or holding stocks in Novartis, and the other authors declared ties with various sources, including Novartis.

Source: Pozo-Rosich P, Dolezil D, Paemeleire K, et al. Early use of erenumab vs nonspecific oral migraine preventives: The APPRAISE randomized clinical trial. JAMA Neurol. 2024 (Mar 25). doi: 10.1001/jamaneurol.2024.0368 Source

Key clinical point: Early initiation of erenumab demonstrated better long-term efficacy, tolerability, and patient adherence than non-specific oral migraine preventive medications (OMPM) in patients with episodic migraine (EM) and one or two previous preventive treatment failures.

Major finding: At month 12, significantly more patients in the erenumab vs OMPM group completed the initially assigned treatment and also achieved a ≥50% reduction in monthly migraine days (odds ratio 6.48; P < .001). A smaller proportion of patients in the erenumab group vs the OMPM group switched medications (2.2% vs 34.6%) and discontinued treatment due to adverse events (2.9% vs 23.3%).

Study details: Findings are from the APPRAISE trial that included 621 patients with EM (age ≥ 18 years) who had previously failed 1 or 2 preventive treatments and were randomly assigned to receive erenumab (n = 413) and OMPM (n = 208).

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Several authors declared themselves as employees of or holding stocks in Novartis, and the other authors declared ties with various sources, including Novartis.

Source: Pozo-Rosich P, Dolezil D, Paemeleire K, et al. Early use of erenumab vs nonspecific oral migraine preventives: The APPRAISE randomized clinical trial. JAMA Neurol. 2024 (Mar 25). doi: 10.1001/jamaneurol.2024.0368 Source

Key clinical point: High-dose eicosapentaenoic acid (EPA) monotherapy for 12 weeks showed superior efficacy, safety, and tolerability in patients with episodic migraine (EM), emphasizing its potential as a promising prophylactic option for managing EM.

Major finding: At 12 weeks, EPA vs placebo significantly improved monthly migraine frequency (P = .001), frequency of acute headache medication usage (P = .035), and headache severity (P = .030). No serious adverse events (AE) were reported, and no patients discontinued treatment due to intolerable AE.

Study details: This 12-week randomized, double-blind, placebo-controlled clinical trial included 70 patients with EM who were randomly assigned to receive high-dose EPA (1800 mg/day; n = 70) or placebo (n = 70).

Disclosures: This study was supported by grants from Kuang Tien General Hospital, the Ministry of Science and Technology, the National Science and Technology Council (NSTC) in Taiwan, and others. The authors declared no conflicts of interest.

Source: Wang H-F, Liu W-C, Zailani H, et al. A 12-week randomized, double-blind clinical trial of eicosapentaenoic acid intervention in episodic migraine. Brain Behav Immun. 2024;18:459-467 (Mar 16). doi: 10.1016/j.bbi.2024.03.019 Source

Key clinical point: High-dose eicosapentaenoic acid (EPA) monotherapy for 12 weeks showed superior efficacy, safety, and tolerability in patients with episodic migraine (EM), emphasizing its potential as a promising prophylactic option for managing EM.

Major finding: At 12 weeks, EPA vs placebo significantly improved monthly migraine frequency (P = .001), frequency of acute headache medication usage (P = .035), and headache severity (P = .030). No serious adverse events (AE) were reported, and no patients discontinued treatment due to intolerable AE.

Study details: This 12-week randomized, double-blind, placebo-controlled clinical trial included 70 patients with EM who were randomly assigned to receive high-dose EPA (1800 mg/day; n = 70) or placebo (n = 70).

Disclosures: This study was supported by grants from Kuang Tien General Hospital, the Ministry of Science and Technology, the National Science and Technology Council (NSTC) in Taiwan, and others. The authors declared no conflicts of interest.

Source: Wang H-F, Liu W-C, Zailani H, et al. A 12-week randomized, double-blind clinical trial of eicosapentaenoic acid intervention in episodic migraine. Brain Behav Immun. 2024;18:459-467 (Mar 16). doi: 10.1016/j.bbi.2024.03.019 Source

Key clinical point: High-dose eicosapentaenoic acid (EPA) monotherapy for 12 weeks showed superior efficacy, safety, and tolerability in patients with episodic migraine (EM), emphasizing its potential as a promising prophylactic option for managing EM.

Major finding: At 12 weeks, EPA vs placebo significantly improved monthly migraine frequency (P = .001), frequency of acute headache medication usage (P = .035), and headache severity (P = .030). No serious adverse events (AE) were reported, and no patients discontinued treatment due to intolerable AE.

Study details: This 12-week randomized, double-blind, placebo-controlled clinical trial included 70 patients with EM who were randomly assigned to receive high-dose EPA (1800 mg/day; n = 70) or placebo (n = 70).

Disclosures: This study was supported by grants from Kuang Tien General Hospital, the Ministry of Science and Technology, the National Science and Technology Council (NSTC) in Taiwan, and others. The authors declared no conflicts of interest.

Source: Wang H-F, Liu W-C, Zailani H, et al. A 12-week randomized, double-blind clinical trial of eicosapentaenoic acid intervention in episodic migraine. Brain Behav Immun. 2024;18:459-467 (Mar 16). doi: 10.1016/j.bbi.2024.03.019 Source

A study conducted in the United States showed that many individuals undergo lung cancer screening despite having a higher likelihood of experiencing harm rather than benefit. Why does this happen? Could it also occur in Italy?

Reasons in Favor

The authors of the study, which was published in Annals of Family Medicine interviewed 40 former military personnel with a significant history of smoking. Though the patients presented with various comorbidities and had a limited life expectancy, the Veterans Health Administration had offered them lung cancer screening.

Of the 40 respondents, 26 had accepted the screening test. When asked why they had done so, they responded, “to take care of my health and achieve my life goals,” “because screening is an opportunity to identify potential issues,” “because it was recommended by a doctor I trust,” and “because I don’t want to regret not accepting it.” Strangely, when deciding about lung cancer screening, the respondents did not consider their poor health or life expectancy.
 

Potential Harms 

The screening was also welcomed because low-dose computed tomography (LDCT) is a noninvasive test. However, many participants were unaware that the screening needed to be repeated annually and that further imaging or other types of tests could follow LDCT, such as biopsies and bronchoscopies.

Many did not recall discussing with the doctor the potential harms of screening, including overdiagnosis, stress due to false positives, and complications and risks associated with investigations and treatments. Informed about this, several patients stated that they would not necessarily undergo further tests or antitumor treatments, especially if intensive or invasive.

The authors of the article emphasized the importance of shared decision-making with patients who have a marginal expected benefit from screening. But is it correct to offer screening under these conditions? Guidelines advise against screening individuals with limited life expectancy and multiple comorbidities because the risk-benefit ratio is not favorable.
 

Screening in Italy

Italy has no organized public program for lung screening. However, in 2022, the Rete Italiana Screening Polmonare (RISP) program for early lung cancer diagnosis was launched. Supported by European funds, it is coordinated by the National Cancer Institute (INT) in Milan and aims to recruit 10,000 high-risk candidates for free screening at 18 hospitals across Italy.

Optimizing participant selection is important in any screening, but in a program like RISP, it is essential, said Alessandro Pardolesi, MD, a thoracic surgeon at INT. “Subjects with multiple comorbidities would create a limit to the study, because there would be too many confounding factors. By maintaining correct inclusion criteria, we can build a reproducible model to demonstrate that screening has a clear social and economic impact. Only after proving its effectiveness can we consider extending it to patients with pre-existing issues or who are very elderly,” he said. The RISP project is limited to participants aged 55-75 years. Participants must be smokers or have quit smoking no more than 15 years ago, with an average consumption of 20 cigarettes per day for 30 years.

Participant selection for the RISP program is also dictated by the costs to be incurred. “If something emerges from the CT scan, whether oncologic or not, it needs to be investigated, triggering mechanisms that consume time, space, and resources,” said Dr. Pardolesi. The economic aspect is crucial for determining the effectiveness of screening. “We need to demonstrate that in addition to increasing the patient’s life expectancy, healthcare costs are reduced. By anticipating the diagnosis, the intervention is less expensive, the patient is discharged in three days, and there’s no need for therapy, so there’s a saving. This is important, given the increasingly evident economic problems of the Italian public health system,” said Dr. Pardolesi.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

A study conducted in the United States showed that many individuals undergo lung cancer screening despite having a higher likelihood of experiencing harm rather than benefit. Why does this happen? Could it also occur in Italy?

Reasons in Favor

The authors of the study, which was published in Annals of Family Medicine interviewed 40 former military personnel with a significant history of smoking. Though the patients presented with various comorbidities and had a limited life expectancy, the Veterans Health Administration had offered them lung cancer screening.

Of the 40 respondents, 26 had accepted the screening test. When asked why they had done so, they responded, “to take care of my health and achieve my life goals,” “because screening is an opportunity to identify potential issues,” “because it was recommended by a doctor I trust,” and “because I don’t want to regret not accepting it.” Strangely, when deciding about lung cancer screening, the respondents did not consider their poor health or life expectancy.
 

Potential Harms 

The screening was also welcomed because low-dose computed tomography (LDCT) is a noninvasive test. However, many participants were unaware that the screening needed to be repeated annually and that further imaging or other types of tests could follow LDCT, such as biopsies and bronchoscopies.

Many did not recall discussing with the doctor the potential harms of screening, including overdiagnosis, stress due to false positives, and complications and risks associated with investigations and treatments. Informed about this, several patients stated that they would not necessarily undergo further tests or antitumor treatments, especially if intensive or invasive.

The authors of the article emphasized the importance of shared decision-making with patients who have a marginal expected benefit from screening. But is it correct to offer screening under these conditions? Guidelines advise against screening individuals with limited life expectancy and multiple comorbidities because the risk-benefit ratio is not favorable.
 

Screening in Italy

Italy has no organized public program for lung screening. However, in 2022, the Rete Italiana Screening Polmonare (RISP) program for early lung cancer diagnosis was launched. Supported by European funds, it is coordinated by the National Cancer Institute (INT) in Milan and aims to recruit 10,000 high-risk candidates for free screening at 18 hospitals across Italy.

Optimizing participant selection is important in any screening, but in a program like RISP, it is essential, said Alessandro Pardolesi, MD, a thoracic surgeon at INT. “Subjects with multiple comorbidities would create a limit to the study, because there would be too many confounding factors. By maintaining correct inclusion criteria, we can build a reproducible model to demonstrate that screening has a clear social and economic impact. Only after proving its effectiveness can we consider extending it to patients with pre-existing issues or who are very elderly,” he said. The RISP project is limited to participants aged 55-75 years. Participants must be smokers or have quit smoking no more than 15 years ago, with an average consumption of 20 cigarettes per day for 30 years.

Participant selection for the RISP program is also dictated by the costs to be incurred. “If something emerges from the CT scan, whether oncologic or not, it needs to be investigated, triggering mechanisms that consume time, space, and resources,” said Dr. Pardolesi. The economic aspect is crucial for determining the effectiveness of screening. “We need to demonstrate that in addition to increasing the patient’s life expectancy, healthcare costs are reduced. By anticipating the diagnosis, the intervention is less expensive, the patient is discharged in three days, and there’s no need for therapy, so there’s a saving. This is important, given the increasingly evident economic problems of the Italian public health system,” said Dr. Pardolesi.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

A study conducted in the United States showed that many individuals undergo lung cancer screening despite having a higher likelihood of experiencing harm rather than benefit. Why does this happen? Could it also occur in Italy?

Reasons in Favor

The authors of the study, which was published in Annals of Family Medicine interviewed 40 former military personnel with a significant history of smoking. Though the patients presented with various comorbidities and had a limited life expectancy, the Veterans Health Administration had offered them lung cancer screening.

Of the 40 respondents, 26 had accepted the screening test. When asked why they had done so, they responded, “to take care of my health and achieve my life goals,” “because screening is an opportunity to identify potential issues,” “because it was recommended by a doctor I trust,” and “because I don’t want to regret not accepting it.” Strangely, when deciding about lung cancer screening, the respondents did not consider their poor health or life expectancy.
 

Potential Harms 

The screening was also welcomed because low-dose computed tomography (LDCT) is a noninvasive test. However, many participants were unaware that the screening needed to be repeated annually and that further imaging or other types of tests could follow LDCT, such as biopsies and bronchoscopies.

Many did not recall discussing with the doctor the potential harms of screening, including overdiagnosis, stress due to false positives, and complications and risks associated with investigations and treatments. Informed about this, several patients stated that they would not necessarily undergo further tests or antitumor treatments, especially if intensive or invasive.

The authors of the article emphasized the importance of shared decision-making with patients who have a marginal expected benefit from screening. But is it correct to offer screening under these conditions? Guidelines advise against screening individuals with limited life expectancy and multiple comorbidities because the risk-benefit ratio is not favorable.
 

Screening in Italy

Italy has no organized public program for lung screening. However, in 2022, the Rete Italiana Screening Polmonare (RISP) program for early lung cancer diagnosis was launched. Supported by European funds, it is coordinated by the National Cancer Institute (INT) in Milan and aims to recruit 10,000 high-risk candidates for free screening at 18 hospitals across Italy.

Optimizing participant selection is important in any screening, but in a program like RISP, it is essential, said Alessandro Pardolesi, MD, a thoracic surgeon at INT. “Subjects with multiple comorbidities would create a limit to the study, because there would be too many confounding factors. By maintaining correct inclusion criteria, we can build a reproducible model to demonstrate that screening has a clear social and economic impact. Only after proving its effectiveness can we consider extending it to patients with pre-existing issues or who are very elderly,” he said. The RISP project is limited to participants aged 55-75 years. Participants must be smokers or have quit smoking no more than 15 years ago, with an average consumption of 20 cigarettes per day for 30 years.

Participant selection for the RISP program is also dictated by the costs to be incurred. “If something emerges from the CT scan, whether oncologic or not, it needs to be investigated, triggering mechanisms that consume time, space, and resources,” said Dr. Pardolesi. The economic aspect is crucial for determining the effectiveness of screening. “We need to demonstrate that in addition to increasing the patient’s life expectancy, healthcare costs are reduced. By anticipating the diagnosis, the intervention is less expensive, the patient is discharged in three days, and there’s no need for therapy, so there’s a saving. This is important, given the increasingly evident economic problems of the Italian public health system,” said Dr. Pardolesi.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The Injury Prevention Program (TIPP), supported by pediatric residents and equipped with parent-focused tools, effectively reduced reported childhood injuries over the first 2 years of life.

METHODOLOGY:

• The American Academy of Pediatrics designed TIPP in 1983 to aid pediatricians in preventing unintentional injuries among children. TIPP’s effectiveness in reducing childhood injuries had not been formally evaluated in a randomized trial prior to this study.
• TIPP implementation included developmentally based safety counseling and distribution of age-appropriate safety materials to parents.
• A total of 781 parent-infant dyads participated, with the study population primarily consisting of low-income, Hispanic, and non-Hispanic Black families.
• Parent-reported injuries were tracked at each well-child check from 2 to 24 months, with the study adjusting for baseline child, parent, and household factors.

TAKEAWAY:

• TIPP led to a significant reduction in reported childhood injuries over 2 years with adjusted odds ratios of 0.77 (0.66-0.91), 0.60 (0.44-0.82), 0.32 (0.16-0.62), 0.26 (0.12-0.53), and 0.27 (0.14-0.52) at 4, 6, 12, 18, and 24 months, respectively.
• The study highlights the need for further research to explore TIPP’s impact on serious injuries and to identify optimal implementation strategies in busy clinical settings.
• IN PRACTICE:

“This program includes a developmentally based safety counseling schedule that guides what materials (safety sheets and an age-appropriate Framingham safety survey) to ask about risk behaviors. For the age group relevant here, there are pediatric patient handouts for parents of children who are aged 0 to 6 months, 6 to 12 months, and 1 to 2 years, and they review safety for falls, motor vehicles, firearms, drowning, poisoning, choking, and burns”, wrote the authors of the study.

SOURCE:

The study was led by Eliana M. Perrin, MD, MPH, Department of Pediatrics, Johns Hopkins University Schools of Medicine and Nursing, Baltimore, Maryland. It was published online in Pediatrics.

LIMITATIONS:

Further research is necessary to assess TIPP’s effect on serious injuries and to determine effective implementation strategies in various clinical settings.

DISCLOSURES:

The study was supported by grants from the Eunice Kennedy Shriver Institute of Child Health and Development, with supplemental funding from the Centers for Disease Control and Prevention, and the Office of Behavioral and Social Sciences Research.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The Injury Prevention Program (TIPP), supported by pediatric residents and equipped with parent-focused tools, effectively reduced reported childhood injuries over the first 2 years of life.

METHODOLOGY:

• The American Academy of Pediatrics designed TIPP in 1983 to aid pediatricians in preventing unintentional injuries among children. TIPP’s effectiveness in reducing childhood injuries had not been formally evaluated in a randomized trial prior to this study.
• TIPP implementation included developmentally based safety counseling and distribution of age-appropriate safety materials to parents.
• A total of 781 parent-infant dyads participated, with the study population primarily consisting of low-income, Hispanic, and non-Hispanic Black families.
• Parent-reported injuries were tracked at each well-child check from 2 to 24 months, with the study adjusting for baseline child, parent, and household factors.

TAKEAWAY:

• TIPP led to a significant reduction in reported childhood injuries over 2 years with adjusted odds ratios of 0.77 (0.66-0.91), 0.60 (0.44-0.82), 0.32 (0.16-0.62), 0.26 (0.12-0.53), and 0.27 (0.14-0.52) at 4, 6, 12, 18, and 24 months, respectively.
• The study highlights the need for further research to explore TIPP’s impact on serious injuries and to identify optimal implementation strategies in busy clinical settings.
• IN PRACTICE:

“This program includes a developmentally based safety counseling schedule that guides what materials (safety sheets and an age-appropriate Framingham safety survey) to ask about risk behaviors. For the age group relevant here, there are pediatric patient handouts for parents of children who are aged 0 to 6 months, 6 to 12 months, and 1 to 2 years, and they review safety for falls, motor vehicles, firearms, drowning, poisoning, choking, and burns”, wrote the authors of the study.

SOURCE:

The study was led by Eliana M. Perrin, MD, MPH, Department of Pediatrics, Johns Hopkins University Schools of Medicine and Nursing, Baltimore, Maryland. It was published online in Pediatrics.

LIMITATIONS:

Further research is necessary to assess TIPP’s effect on serious injuries and to determine effective implementation strategies in various clinical settings.

DISCLOSURES:

The study was supported by grants from the Eunice Kennedy Shriver Institute of Child Health and Development, with supplemental funding from the Centers for Disease Control and Prevention, and the Office of Behavioral and Social Sciences Research.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The Injury Prevention Program (TIPP), supported by pediatric residents and equipped with parent-focused tools, effectively reduced reported childhood injuries over the first 2 years of life.

METHODOLOGY:

• The American Academy of Pediatrics designed TIPP in 1983 to aid pediatricians in preventing unintentional injuries among children. TIPP’s effectiveness in reducing childhood injuries had not been formally evaluated in a randomized trial prior to this study.
• TIPP implementation included developmentally based safety counseling and distribution of age-appropriate safety materials to parents.
• A total of 781 parent-infant dyads participated, with the study population primarily consisting of low-income, Hispanic, and non-Hispanic Black families.
• Parent-reported injuries were tracked at each well-child check from 2 to 24 months, with the study adjusting for baseline child, parent, and household factors.

TAKEAWAY:

• TIPP led to a significant reduction in reported childhood injuries over 2 years with adjusted odds ratios of 0.77 (0.66-0.91), 0.60 (0.44-0.82), 0.32 (0.16-0.62), 0.26 (0.12-0.53), and 0.27 (0.14-0.52) at 4, 6, 12, 18, and 24 months, respectively.
• The study highlights the need for further research to explore TIPP’s impact on serious injuries and to identify optimal implementation strategies in busy clinical settings.
• IN PRACTICE:

“This program includes a developmentally based safety counseling schedule that guides what materials (safety sheets and an age-appropriate Framingham safety survey) to ask about risk behaviors. For the age group relevant here, there are pediatric patient handouts for parents of children who are aged 0 to 6 months, 6 to 12 months, and 1 to 2 years, and they review safety for falls, motor vehicles, firearms, drowning, poisoning, choking, and burns”, wrote the authors of the study.

SOURCE:

The study was led by Eliana M. Perrin, MD, MPH, Department of Pediatrics, Johns Hopkins University Schools of Medicine and Nursing, Baltimore, Maryland. It was published online in Pediatrics.

LIMITATIONS:

Further research is necessary to assess TIPP’s effect on serious injuries and to determine effective implementation strategies in various clinical settings.

DISCLOSURES:

The study was supported by grants from the Eunice Kennedy Shriver Institute of Child Health and Development, with supplemental funding from the Centers for Disease Control and Prevention, and the Office of Behavioral and Social Sciences Research.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

• Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
• The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
• Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
• The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

• Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
• Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
• Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
• Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

• Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
• The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
• Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
• The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

• Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
• Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
• Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
• Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

• Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
• The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
• Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
• The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

• Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
• Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
• Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
• Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

DENVER — Lidocaine injections into the greater occipital nerve relieve severe, refractory migraine attacks in children, results of a randomized controlled trial show. 

Investigators found children receiving bilateral occipital nerve blocks with 2% lidocaine had significantly greater pain relief than that of peers receiving saline injections. 

Cases series have shown a benefit of peripheral nerve blocks (PNBs) — injections of local anesthetics over branches of the occipital or trigeminal nerve — for severe, refractory headache in children.  

Although 80% of pediatric headache specialists use PNBs, there is “inconsistent insurance coverage” for this treatment, which had not been tested in a randomized controlled trial in children before now, lead investigator Christina Szperka, MD, with the Pediatric Headache Program, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, told delegates attending the 2024 annual meeting of the American Academy of Neurology. 
 

Significant Results

Investigators enrolled 58 children and adolescents with acute status migrainosus. The mean age was 16 years, and reported gender was female for 44 participants, male for 11 participants, and nonbinary or transgender in 3 participants. Participants had a migraine flare duration of 22 days and had not responded to other treatments. 

All participants had topical lidocaine cream applied for 30 minutes as a run-in step and could decline injections if they experienced sufficient benefit from cream alone. 

“We used a lidocaine cream lead-in for two reasons. One was to try to see if we could address the issue of high placebo response in pediatric trials in particular, and also to see if we could help with blinding to injection,” said Dr. Szperka. 

Topical lidocaine cream led to a small decrease in pain score overall (0.2 point on a 0-10 scale), and all participants proceeded to randomized blinded bilateral greater occipital nerve injection with 2% lidocaine or saline, she reported. 

On the primary endpoint — change in pain score at 30 minutes — lidocaine was significantly more effective than saline, achieving a 2.3-point decrease on average (on a 0-10 scale) vs a 1.1-point decrease with saline (P = .01).

A 2-point pain reduction was achieved in 69% of patients in the lidocaine group versus 34% in the saline group.

Three quarters (76%) of patients getting lidocaine reported at least partial relief in severity or location of pain compared with 48% of those getting saline (P = .03). Rates of pain freedom at 30 minutes were 17% and 7%, respectively, and at 24 hours were 14% and 0%, respectively.

The majority of adverse events were mild and fairly equal across groups and included anxiety, worsening headache, injection site pain, dizziness, and numbness (more so with lidocaine). There was one case of anaphylaxis after lidocaine injection.

Quite unexpectedly, said Dr. Szperka, patients rated the saline injection as more painful than the lidocaine injection. “This was not what I expected going in, and I think is relevant for future trials,” she said.
 

Encouraging Results 

Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, said that as a neurologist and pain physician, he sees firsthand the “devastating impact of status migrainosus on children.”

“These debilitating headaches can rob them of precious school days, hindering learning and social interaction,” said Dr. Lakhan. “The constant pain and fear of the next attack can also take a toll on their emotional well-being.”

The impact on families is significant as well, highlighting the need to find more effective treatments, Dr. Lakhan said. 

“Traditionally, we’ve relied on case studies to see the benefits of nerve blocks for migraine in younger patients. This is the first randomized controlled trial that shows lidocaine injections can be significantly more effective than a placebo for these unrelenting migraines,” he said.

“It’s important to note that this is a relatively small study, and not without safety concerns, including rare but potentially life-threatening anaphylaxis to lidocaine,” Dr. Lakhan added. “More research is needed, but these findings are encouraging. Lidocaine injections could become a valuable tool for managing treatment-resistant migraines in adolescents and young adults.”

The study was supported by a grant from the National Institute of Neurological Disorders and Stroke. Dr. Szperka is a consultant for AbbVie and Teva; serves on a Data Safety Monitoring Board for Eli Lilly and Upsher-Smith; and is a site principal investigator for AbbVie, Amgen, Biohaven/Pfizer, Teva, and Theranica. Dr. Lakhan had no disclosures.
 

A version of this article appeared on Medscape.com.

DENVER — Lidocaine injections into the greater occipital nerve relieve severe, refractory migraine attacks in children, results of a randomized controlled trial show. 

Investigators found children receiving bilateral occipital nerve blocks with 2% lidocaine had significantly greater pain relief than that of peers receiving saline injections. 

Cases series have shown a benefit of peripheral nerve blocks (PNBs) — injections of local anesthetics over branches of the occipital or trigeminal nerve — for severe, refractory headache in children.  

Although 80% of pediatric headache specialists use PNBs, there is “inconsistent insurance coverage” for this treatment, which had not been tested in a randomized controlled trial in children before now, lead investigator Christina Szperka, MD, with the Pediatric Headache Program, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, told delegates attending the 2024 annual meeting of the American Academy of Neurology. 
 

Significant Results

Investigators enrolled 58 children and adolescents with acute status migrainosus. The mean age was 16 years, and reported gender was female for 44 participants, male for 11 participants, and nonbinary or transgender in 3 participants. Participants had a migraine flare duration of 22 days and had not responded to other treatments. 

All participants had topical lidocaine cream applied for 30 minutes as a run-in step and could decline injections if they experienced sufficient benefit from cream alone. 

“We used a lidocaine cream lead-in for two reasons. One was to try to see if we could address the issue of high placebo response in pediatric trials in particular, and also to see if we could help with blinding to injection,” said Dr. Szperka. 

Topical lidocaine cream led to a small decrease in pain score overall (0.2 point on a 0-10 scale), and all participants proceeded to randomized blinded bilateral greater occipital nerve injection with 2% lidocaine or saline, she reported. 

On the primary endpoint — change in pain score at 30 minutes — lidocaine was significantly more effective than saline, achieving a 2.3-point decrease on average (on a 0-10 scale) vs a 1.1-point decrease with saline (P = .01).

A 2-point pain reduction was achieved in 69% of patients in the lidocaine group versus 34% in the saline group.

Three quarters (76%) of patients getting lidocaine reported at least partial relief in severity or location of pain compared with 48% of those getting saline (P = .03). Rates of pain freedom at 30 minutes were 17% and 7%, respectively, and at 24 hours were 14% and 0%, respectively.

The majority of adverse events were mild and fairly equal across groups and included anxiety, worsening headache, injection site pain, dizziness, and numbness (more so with lidocaine). There was one case of anaphylaxis after lidocaine injection.

Quite unexpectedly, said Dr. Szperka, patients rated the saline injection as more painful than the lidocaine injection. “This was not what I expected going in, and I think is relevant for future trials,” she said.
 

Encouraging Results 

Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, said that as a neurologist and pain physician, he sees firsthand the “devastating impact of status migrainosus on children.”

“These debilitating headaches can rob them of precious school days, hindering learning and social interaction,” said Dr. Lakhan. “The constant pain and fear of the next attack can also take a toll on their emotional well-being.”

The impact on families is significant as well, highlighting the need to find more effective treatments, Dr. Lakhan said. 

“Traditionally, we’ve relied on case studies to see the benefits of nerve blocks for migraine in younger patients. This is the first randomized controlled trial that shows lidocaine injections can be significantly more effective than a placebo for these unrelenting migraines,” he said.

“It’s important to note that this is a relatively small study, and not without safety concerns, including rare but potentially life-threatening anaphylaxis to lidocaine,” Dr. Lakhan added. “More research is needed, but these findings are encouraging. Lidocaine injections could become a valuable tool for managing treatment-resistant migraines in adolescents and young adults.”

The study was supported by a grant from the National Institute of Neurological Disorders and Stroke. Dr. Szperka is a consultant for AbbVie and Teva; serves on a Data Safety Monitoring Board for Eli Lilly and Upsher-Smith; and is a site principal investigator for AbbVie, Amgen, Biohaven/Pfizer, Teva, and Theranica. Dr. Lakhan had no disclosures.
 

A version of this article appeared on Medscape.com.

DENVER — Lidocaine injections into the greater occipital nerve relieve severe, refractory migraine attacks in children, results of a randomized controlled trial show. 

Investigators found children receiving bilateral occipital nerve blocks with 2% lidocaine had significantly greater pain relief than that of peers receiving saline injections. 

Cases series have shown a benefit of peripheral nerve blocks (PNBs) — injections of local anesthetics over branches of the occipital or trigeminal nerve — for severe, refractory headache in children.  

Although 80% of pediatric headache specialists use PNBs, there is “inconsistent insurance coverage” for this treatment, which had not been tested in a randomized controlled trial in children before now, lead investigator Christina Szperka, MD, with the Pediatric Headache Program, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, told delegates attending the 2024 annual meeting of the American Academy of Neurology. 
 

Significant Results

Investigators enrolled 58 children and adolescents with acute status migrainosus. The mean age was 16 years, and reported gender was female for 44 participants, male for 11 participants, and nonbinary or transgender in 3 participants. Participants had a migraine flare duration of 22 days and had not responded to other treatments. 

All participants had topical lidocaine cream applied for 30 minutes as a run-in step and could decline injections if they experienced sufficient benefit from cream alone. 

“We used a lidocaine cream lead-in for two reasons. One was to try to see if we could address the issue of high placebo response in pediatric trials in particular, and also to see if we could help with blinding to injection,” said Dr. Szperka. 

Topical lidocaine cream led to a small decrease in pain score overall (0.2 point on a 0-10 scale), and all participants proceeded to randomized blinded bilateral greater occipital nerve injection with 2% lidocaine or saline, she reported. 

On the primary endpoint — change in pain score at 30 minutes — lidocaine was significantly more effective than saline, achieving a 2.3-point decrease on average (on a 0-10 scale) vs a 1.1-point decrease with saline (P = .01).

A 2-point pain reduction was achieved in 69% of patients in the lidocaine group versus 34% in the saline group.

Three quarters (76%) of patients getting lidocaine reported at least partial relief in severity or location of pain compared with 48% of those getting saline (P = .03). Rates of pain freedom at 30 minutes were 17% and 7%, respectively, and at 24 hours were 14% and 0%, respectively.

The majority of adverse events were mild and fairly equal across groups and included anxiety, worsening headache, injection site pain, dizziness, and numbness (more so with lidocaine). There was one case of anaphylaxis after lidocaine injection.

Quite unexpectedly, said Dr. Szperka, patients rated the saline injection as more painful than the lidocaine injection. “This was not what I expected going in, and I think is relevant for future trials,” she said.
 

Encouraging Results 

Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, said that as a neurologist and pain physician, he sees firsthand the “devastating impact of status migrainosus on children.”

“These debilitating headaches can rob them of precious school days, hindering learning and social interaction,” said Dr. Lakhan. “The constant pain and fear of the next attack can also take a toll on their emotional well-being.”

The impact on families is significant as well, highlighting the need to find more effective treatments, Dr. Lakhan said. 

“Traditionally, we’ve relied on case studies to see the benefits of nerve blocks for migraine in younger patients. This is the first randomized controlled trial that shows lidocaine injections can be significantly more effective than a placebo for these unrelenting migraines,” he said.

“It’s important to note that this is a relatively small study, and not without safety concerns, including rare but potentially life-threatening anaphylaxis to lidocaine,” Dr. Lakhan added. “More research is needed, but these findings are encouraging. Lidocaine injections could become a valuable tool for managing treatment-resistant migraines in adolescents and young adults.”

The study was supported by a grant from the National Institute of Neurological Disorders and Stroke. Dr. Szperka is a consultant for AbbVie and Teva; serves on a Data Safety Monitoring Board for Eli Lilly and Upsher-Smith; and is a site principal investigator for AbbVie, Amgen, Biohaven/Pfizer, Teva, and Theranica. Dr. Lakhan had no disclosures.
 

A version of this article appeared on Medscape.com.

Rheumatologists and their staff have been dutifully recording disease activity and patient-reported outcomes for decades, and now, all that drudgery is beginning to pay off with the introduction of artificial intelligence (AI) and natural language processing systems that can mine electronic health records (EHRs) for nuggets of research gold and accurately predict short-term rheumatoid arthritis (RA) outcomes.

“I think we have learned from our very early experiments that longitudinal deep learning models can forecast rheumatoid arthritis [RA] outcomes with actually surprising efficiency, with fewer patients than we assumed would be needed,” said Jinoos Yazdany, MD, MPH, chief of rheumatology at Zuckerberg San Francisco General Hospital and Trauma Center, and codirector of the University of California San Francisco (UCSF) Quality and Informatics Lab.

At the 2024 Rheumatoid Arthritis Research Summit (RA Summit 2024), presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City, Dr. Yazdany discussed why rheumatologists are well positioned to take advantage of predictive analytics and how natural language processing systems can be used to extract previously hard-to-find data from EHRs, which can then be applied to RA prognostics and research.
 

Data Galore

EHR data can be particularly useful for RA research because of the large volume of information, clinical data such as notes and imaging, less selection bias compared with other data sources such as cohorts or randomized controlled trials, real-time access, and the fact that many records contain longitudinal data (follow-ups, etc.).

However, EHR data may have gaps or inaccurate coding, and data such as text and images may require significant data processing and scrubbing before it can be used to advance research. In addition, EHR data are subject to patient privacy and security concerns, can be plagued by incompatibility across different systems, and may not represent patients who have less access to care, Dr. Yazdany said.

She noted that most rheumatologists record some measure of RA disease activity and patient physical function, and that patient-reported outcomes have been routinely incorporated into clinical records, especially since the 1980 introduction of the Health Assessment Questionnaire.

“In rheumatology, by achieving consensus and building a national quality measurement program, we have a cohesive national RA outcome measure selection strategy. RA outcomes are available for a majority of patients seen by rheumatologists, and that’s a critical strength of EHR data,” she said.
 

Spinning Text Into Analytics

The challenge for investigators who want to use this treasure trove of RA data is that more than 80% of the data are in the form of text, which raises questions about how to best extract outcomes data and drug dosing information from the written record.

As described in an article published online in Arthritis Care & Research February 14, 2023, Dr. Yazdany and colleagues at UCSF and Stanford University developed a natural language processing “pipeline” designed to extract RA outcomes from clinical notes on all patients included in the American College of Rheumatology’s Rheumatology Informatics System for Effectiveness (RISE) registry.

The model used expert-curated terms and a text processing tool to identify patterns and numerical scores linked to outcome measures in the records.

“This was an enormously difficult and ambitious project because we had many, many sites, the data was very messy, we had very complicated [independent review board] procedures, and we actually had to go through de-identification procedures because we were using this data for research, so we learned a lot,” Dr. Yazdany said.

The model processed 34 million notes on 854,628 patients across 158 practices and 24 different EHR systems.

In internal validation studies, the models had 95% sensitivity, 87% positive predictive value (PPV), and an F1 score (a measure of predictive performance) of 91%. Applying the model to an EHR from a large, non-RISE health system for external validation, the natural language processing pipeline had a 92% sensitivity, 69% PPV, and an F1 score of 79%.

The investigators also looked at the use of OpenAI large language models, including GPT 3.5 and 4 to interpret complex prescription orders and found that after training with 100 examples, GPT 4 was able to correctly interpret 95.6% of orders. But this experiment came at a high computational and financial cost, with one experiment running north of $3000, Dr. Yazdany cautioned.
 

Predicting Outcomes

Experiments to see whether an AI system can forecast RA disease activity at the next clinic visit are in their early stages.

Dr. Yazdany and colleagues used EHR data from UCSF and Zuckerberg San Francisco General Hospital on patients with two RA diagnostic codes at 30 days apart, who had at least one disease-modifying antirheumatic drug prescription and two Clinical Disease Activity Index (CDAI) scores 30 days apart.

One model, designed to predict CDAI at the next visit by “playing the odds” based on clinical experience, showed that about 60% of patients at UCSF achieved treat-to-target goals, while the remaining 40% did not.

This model performed barely better than pure chance, with an area under the receiver operating characteristic curve (AUC) of 0.54.

A second model that included the patient’s last CDAI score also fared little better than a roll of the dice, with an AUC of 0.55.

However, a neural network or “deep learning” model designed to process data akin to the way that the human brain works performed much better at predicting outcomes at the second visit, with an AUC of 0.91.

Applying the UCSF-trained neural network model to the Zuckerberg San Francisco General Hospital population, with different patient characteristics from those of UCSF, the AUC was 0.74. Although this result was not as good as that seen when applied to UCSF patients, it demonstrated that the model retains some predictive capability across different hospital systems, Dr. Yazdany said.

The next steps, she said, are to build more robust models based on vast and varied patient data pools that will allow the predictive models to be generalized across various healthcare settings.
 

The Here and Now

In the Q & A following the presentation, an audience member said that the study was “very cool stuff.”

“Is there a way to sort of get ahead and think of the technology that we’re starting to pilot? Hospitals are already using AI scribes, for example, to collect the data that is going to make it much easier to feed it to the predictive analytics that we’re going to use,” she said.

Dr. Yazdany replied that “over the last couple of years, one of the projects that we’ve worked on is to interview rheumatologists who are participating in the RISE registry about the ways that they are collecting [patient-reported outcomes], and it has been fascinating: A vast majority of people are still using paper forms.”

“The challenge is that our patient populations are very diverse. Technology, and especially filling out forms via online platforms, doesn’t work for everybody, and in some ways, filling out the paper forms when you go to the doctor’s office is a great equalizer. So, I think that we have some real challenges, and the solutions have to be embedded in the real world,” she added.

Dr. Yazdany’s research was supported by grants from the Agency for Healthcare Research & Quality and the National Institutes of Health. She disclosed consulting fees and/or research support from AstraZeneca, Aurinia, Bristol Myers Squibb, Gilead, and Pfizer.

A version of this article appeared on Medscape.com.

Rheumatologists and their staff have been dutifully recording disease activity and patient-reported outcomes for decades, and now, all that drudgery is beginning to pay off with the introduction of artificial intelligence (AI) and natural language processing systems that can mine electronic health records (EHRs) for nuggets of research gold and accurately predict short-term rheumatoid arthritis (RA) outcomes.

“I think we have learned from our very early experiments that longitudinal deep learning models can forecast rheumatoid arthritis [RA] outcomes with actually surprising efficiency, with fewer patients than we assumed would be needed,” said Jinoos Yazdany, MD, MPH, chief of rheumatology at Zuckerberg San Francisco General Hospital and Trauma Center, and codirector of the University of California San Francisco (UCSF) Quality and Informatics Lab.

At the 2024 Rheumatoid Arthritis Research Summit (RA Summit 2024), presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City, Dr. Yazdany discussed why rheumatologists are well positioned to take advantage of predictive analytics and how natural language processing systems can be used to extract previously hard-to-find data from EHRs, which can then be applied to RA prognostics and research.
 

Data Galore

EHR data can be particularly useful for RA research because of the large volume of information, clinical data such as notes and imaging, less selection bias compared with other data sources such as cohorts or randomized controlled trials, real-time access, and the fact that many records contain longitudinal data (follow-ups, etc.).

However, EHR data may have gaps or inaccurate coding, and data such as text and images may require significant data processing and scrubbing before it can be used to advance research. In addition, EHR data are subject to patient privacy and security concerns, can be plagued by incompatibility across different systems, and may not represent patients who have less access to care, Dr. Yazdany said.

She noted that most rheumatologists record some measure of RA disease activity and patient physical function, and that patient-reported outcomes have been routinely incorporated into clinical records, especially since the 1980 introduction of the Health Assessment Questionnaire.

“In rheumatology, by achieving consensus and building a national quality measurement program, we have a cohesive national RA outcome measure selection strategy. RA outcomes are available for a majority of patients seen by rheumatologists, and that’s a critical strength of EHR data,” she said.
 

Spinning Text Into Analytics

The challenge for investigators who want to use this treasure trove of RA data is that more than 80% of the data are in the form of text, which raises questions about how to best extract outcomes data and drug dosing information from the written record.

As described in an article published online in Arthritis Care & Research February 14, 2023, Dr. Yazdany and colleagues at UCSF and Stanford University developed a natural language processing “pipeline” designed to extract RA outcomes from clinical notes on all patients included in the American College of Rheumatology’s Rheumatology Informatics System for Effectiveness (RISE) registry.

The model used expert-curated terms and a text processing tool to identify patterns and numerical scores linked to outcome measures in the records.

“This was an enormously difficult and ambitious project because we had many, many sites, the data was very messy, we had very complicated [independent review board] procedures, and we actually had to go through de-identification procedures because we were using this data for research, so we learned a lot,” Dr. Yazdany said.

The model processed 34 million notes on 854,628 patients across 158 practices and 24 different EHR systems.

In internal validation studies, the models had 95% sensitivity, 87% positive predictive value (PPV), and an F1 score (a measure of predictive performance) of 91%. Applying the model to an EHR from a large, non-RISE health system for external validation, the natural language processing pipeline had a 92% sensitivity, 69% PPV, and an F1 score of 79%.

The investigators also looked at the use of OpenAI large language models, including GPT 3.5 and 4 to interpret complex prescription orders and found that after training with 100 examples, GPT 4 was able to correctly interpret 95.6% of orders. But this experiment came at a high computational and financial cost, with one experiment running north of $3000, Dr. Yazdany cautioned.
 

Predicting Outcomes

Experiments to see whether an AI system can forecast RA disease activity at the next clinic visit are in their early stages.

Dr. Yazdany and colleagues used EHR data from UCSF and Zuckerberg San Francisco General Hospital on patients with two RA diagnostic codes at 30 days apart, who had at least one disease-modifying antirheumatic drug prescription and two Clinical Disease Activity Index (CDAI) scores 30 days apart.

One model, designed to predict CDAI at the next visit by “playing the odds” based on clinical experience, showed that about 60% of patients at UCSF achieved treat-to-target goals, while the remaining 40% did not.

This model performed barely better than pure chance, with an area under the receiver operating characteristic curve (AUC) of 0.54.

A second model that included the patient’s last CDAI score also fared little better than a roll of the dice, with an AUC of 0.55.

However, a neural network or “deep learning” model designed to process data akin to the way that the human brain works performed much better at predicting outcomes at the second visit, with an AUC of 0.91.

Applying the UCSF-trained neural network model to the Zuckerberg San Francisco General Hospital population, with different patient characteristics from those of UCSF, the AUC was 0.74. Although this result was not as good as that seen when applied to UCSF patients, it demonstrated that the model retains some predictive capability across different hospital systems, Dr. Yazdany said.

The next steps, she said, are to build more robust models based on vast and varied patient data pools that will allow the predictive models to be generalized across various healthcare settings.
 

The Here and Now

In the Q & A following the presentation, an audience member said that the study was “very cool stuff.”

“Is there a way to sort of get ahead and think of the technology that we’re starting to pilot? Hospitals are already using AI scribes, for example, to collect the data that is going to make it much easier to feed it to the predictive analytics that we’re going to use,” she said.

Dr. Yazdany replied that “over the last couple of years, one of the projects that we’ve worked on is to interview rheumatologists who are participating in the RISE registry about the ways that they are collecting [patient-reported outcomes], and it has been fascinating: A vast majority of people are still using paper forms.”

“The challenge is that our patient populations are very diverse. Technology, and especially filling out forms via online platforms, doesn’t work for everybody, and in some ways, filling out the paper forms when you go to the doctor’s office is a great equalizer. So, I think that we have some real challenges, and the solutions have to be embedded in the real world,” she added.

Dr. Yazdany’s research was supported by grants from the Agency for Healthcare Research & Quality and the National Institutes of Health. She disclosed consulting fees and/or research support from AstraZeneca, Aurinia, Bristol Myers Squibb, Gilead, and Pfizer.

A version of this article appeared on Medscape.com.

Rheumatologists and their staff have been dutifully recording disease activity and patient-reported outcomes for decades, and now, all that drudgery is beginning to pay off with the introduction of artificial intelligence (AI) and natural language processing systems that can mine electronic health records (EHRs) for nuggets of research gold and accurately predict short-term rheumatoid arthritis (RA) outcomes.

“I think we have learned from our very early experiments that longitudinal deep learning models can forecast rheumatoid arthritis [RA] outcomes with actually surprising efficiency, with fewer patients than we assumed would be needed,” said Jinoos Yazdany, MD, MPH, chief of rheumatology at Zuckerberg San Francisco General Hospital and Trauma Center, and codirector of the University of California San Francisco (UCSF) Quality and Informatics Lab.

At the 2024 Rheumatoid Arthritis Research Summit (RA Summit 2024), presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City, Dr. Yazdany discussed why rheumatologists are well positioned to take advantage of predictive analytics and how natural language processing systems can be used to extract previously hard-to-find data from EHRs, which can then be applied to RA prognostics and research.
 

Data Galore

EHR data can be particularly useful for RA research because of the large volume of information, clinical data such as notes and imaging, less selection bias compared with other data sources such as cohorts or randomized controlled trials, real-time access, and the fact that many records contain longitudinal data (follow-ups, etc.).

However, EHR data may have gaps or inaccurate coding, and data such as text and images may require significant data processing and scrubbing before it can be used to advance research. In addition, EHR data are subject to patient privacy and security concerns, can be plagued by incompatibility across different systems, and may not represent patients who have less access to care, Dr. Yazdany said.

She noted that most rheumatologists record some measure of RA disease activity and patient physical function, and that patient-reported outcomes have been routinely incorporated into clinical records, especially since the 1980 introduction of the Health Assessment Questionnaire.

“In rheumatology, by achieving consensus and building a national quality measurement program, we have a cohesive national RA outcome measure selection strategy. RA outcomes are available for a majority of patients seen by rheumatologists, and that’s a critical strength of EHR data,” she said.
 

Spinning Text Into Analytics

The challenge for investigators who want to use this treasure trove of RA data is that more than 80% of the data are in the form of text, which raises questions about how to best extract outcomes data and drug dosing information from the written record.

As described in an article published online in Arthritis Care & Research February 14, 2023, Dr. Yazdany and colleagues at UCSF and Stanford University developed a natural language processing “pipeline” designed to extract RA outcomes from clinical notes on all patients included in the American College of Rheumatology’s Rheumatology Informatics System for Effectiveness (RISE) registry.

The model used expert-curated terms and a text processing tool to identify patterns and numerical scores linked to outcome measures in the records.

“This was an enormously difficult and ambitious project because we had many, many sites, the data was very messy, we had very complicated [independent review board] procedures, and we actually had to go through de-identification procedures because we were using this data for research, so we learned a lot,” Dr. Yazdany said.

The model processed 34 million notes on 854,628 patients across 158 practices and 24 different EHR systems.

In internal validation studies, the models had 95% sensitivity, 87% positive predictive value (PPV), and an F1 score (a measure of predictive performance) of 91%. Applying the model to an EHR from a large, non-RISE health system for external validation, the natural language processing pipeline had a 92% sensitivity, 69% PPV, and an F1 score of 79%.

The investigators also looked at the use of OpenAI large language models, including GPT 3.5 and 4 to interpret complex prescription orders and found that after training with 100 examples, GPT 4 was able to correctly interpret 95.6% of orders. But this experiment came at a high computational and financial cost, with one experiment running north of $3000, Dr. Yazdany cautioned.
 

Predicting Outcomes

Experiments to see whether an AI system can forecast RA disease activity at the next clinic visit are in their early stages.

Dr. Yazdany and colleagues used EHR data from UCSF and Zuckerberg San Francisco General Hospital on patients with two RA diagnostic codes at 30 days apart, who had at least one disease-modifying antirheumatic drug prescription and two Clinical Disease Activity Index (CDAI) scores 30 days apart.

One model, designed to predict CDAI at the next visit by “playing the odds” based on clinical experience, showed that about 60% of patients at UCSF achieved treat-to-target goals, while the remaining 40% did not.

This model performed barely better than pure chance, with an area under the receiver operating characteristic curve (AUC) of 0.54.

A second model that included the patient’s last CDAI score also fared little better than a roll of the dice, with an AUC of 0.55.

However, a neural network or “deep learning” model designed to process data akin to the way that the human brain works performed much better at predicting outcomes at the second visit, with an AUC of 0.91.

Applying the UCSF-trained neural network model to the Zuckerberg San Francisco General Hospital population, with different patient characteristics from those of UCSF, the AUC was 0.74. Although this result was not as good as that seen when applied to UCSF patients, it demonstrated that the model retains some predictive capability across different hospital systems, Dr. Yazdany said.

The next steps, she said, are to build more robust models based on vast and varied patient data pools that will allow the predictive models to be generalized across various healthcare settings.
 

The Here and Now

In the Q & A following the presentation, an audience member said that the study was “very cool stuff.”

“Is there a way to sort of get ahead and think of the technology that we’re starting to pilot? Hospitals are already using AI scribes, for example, to collect the data that is going to make it much easier to feed it to the predictive analytics that we’re going to use,” she said.

Dr. Yazdany replied that “over the last couple of years, one of the projects that we’ve worked on is to interview rheumatologists who are participating in the RISE registry about the ways that they are collecting [patient-reported outcomes], and it has been fascinating: A vast majority of people are still using paper forms.”

“The challenge is that our patient populations are very diverse. Technology, and especially filling out forms via online platforms, doesn’t work for everybody, and in some ways, filling out the paper forms when you go to the doctor’s office is a great equalizer. So, I think that we have some real challenges, and the solutions have to be embedded in the real world,” she added.

Dr. Yazdany’s research was supported by grants from the Agency for Healthcare Research & Quality and the National Institutes of Health. She disclosed consulting fees and/or research support from AstraZeneca, Aurinia, Bristol Myers Squibb, Gilead, and Pfizer.

A version of this article appeared on Medscape.com.