6-month Intervals Research Articles

Identification of health trajectories of patients with persistent spinal pain syndrome type 2 using latent class trajectory methods.

Persistent spinal pain syndrome Type 2 (PSPS-T2) is a long-lasting condition that consists of persistent pain following spinal surgery. Although this condition has long-term effects, it is currently studied at a given time point or over a limited period of time, which does not reflect the true impact of pain patients. To bridge this gap, we used latent class trajectory models to extract clusters with different trajectories of patients with PSPS-T2. Data from the PREDIBACK study, an observational, multicentric, and longitudinal investigation carried out prospectively, were used. This study focuses on patients with PSPS-T2, tracking their outcomes at 3-month intervals over a one-year period. Health status was evaluated using a novel multidimensional clinical response index (MCRI). The trajectories of patients' health status were extracted using mixture of mixed effect models. Two hundred (200) PSPS-T2 patients were included. Two clusters were identified, including 'persistent low health' trajectories (63.1%) and 'improving health' trajectories (36.9%). Regarding the factors associated with these trajectories, our results showed that lower age, lower body mass index, lower pain intensity, lower functional disability, lower anxiety and less extended pain surface were associated with improving health status. Clustering methods provide an opportunity to identify two distinct clusters of pain-related health trajectories of PSPS-T2 patients. Persistence of the symptoms was not observed in one third of the PSPS-T2 study patients, who belong to the improving pain-related health cluster, while the other two thirds did not achieve improved health over a 1-year follow-up. Our study findings suggest that the use of trajectory-based methods could improve patient evaluation and pain management as it allows for obtaining a global view of patients during their care pathway compared to conventional methods, which only focus on specific visits. Our study also advocates for multidimensional assessment and management of pain by targeting not only pain intensity but also the psychological distress, functional capacity and pain surface at an early stage of pain onset after spine surgery.

P40 Suboptimal clinical and quality of life outcomes in psoriasis patients: an evaluation of treatment patterns among the conventional systemic cohort of the British Association of Dermatologists Biologic and Immunomodulators Register

Abstract Moderate-to-severe psoriasis can be managed with conventional systemic (CS), targeted synthetic and biologic therapies. A stepwise treatment ladder paradigm is the standard of care, with CS typically prescribed first. CS exposure may be prolonged without formal guidance on treatment failure within a defined follow-up period, contrasting with specific guidance for biologics. A 2018–2019 global survey found non-switchers primarily on oral CS persisted >9 months despite greater disease severity and lower quality of life (QoL) post-initiation (Thai S, Barlow S, Lucas J, et al. Suboptimal clinical and quality of life outcomes in patients with psoriasis undertreated with oral therapies. Dermatol Ther 2023;13:1289–303); suboptimal treatment of psoriasis patients is not greatly understood. Using the UK and Ireland’s BADBIR CS cohort 2008–2022 (Amgen-sponsored), we retrospectively assessed treatment patterns and effects (PASI, PGA and DLQI) over time in routine clinical practice. Persistence was evaluated overall and at 6- and 12-month intervals. Effects were assessed at baseline, 6- and 12-months post-initiation among patients with non-missing data. 5662 patients enrolled in the BADBIR CS cohort. Most patients commenced methotrexate (n = 2822, 49.8%), ciclosporin (n = 1517, 26.8%) and acitretin (n = 1244, 22.0). Among completed therapy cycles, the mean overall length of persistence regardless of treatment was 15.9 (SD = 18.7) months. Proportions of patients that persisted at each of these intervals post-initiation were: 99.7% (n = 5646) at 6 months, 83.7% (n = 4739) at 12 months, 72.2% (n = 4088) at 24 months, 54.7% (n = 3096) at 36 months, 42.2% (n = 2387) at 48 months, 33.6% (n = 1900) at 60 months, and 27.6% (n = 1560) >60 months. At baseline (n = 4725), 85.0% of patients had severe disease (PASI > 10) and 10.6% had moderate (PASI 5–10). At 6 months (n = 3465), 25.8 and 25.6% had severe and moderate disease, respectively. At 12 months (n = 2926), 21.1 and 27.3% had severe and moderate disease, respectively. At baseline (n = 4228), 88.7% of patients reported very-to-extreme impact on QoL (DLQI ≥ 11) and 6.3% reported moderate impact (DLQI 6–10). At 6 months (n = 2959), 33.0 and 19.6% reported very-to-extreme and moderate impact on QoL, respectively. At 12 months (n = 2613), 28.6 and 19.6% reported very-to-extreme and moderate impact on QoL, respectively. Findings suggest that despite suboptimal clinical and QoL outcomes after 6 months, most patients persisted on CS beyond 12 months, with a quarter persisting >5 years. Long-term exposure to some CS may also increase the risk of toxicity. Defining treatment failure within a specific follow-up period for CS may result in earlier switches to targeted systemic therapies. Stringent guidance earlier in the treatment paradigm would greatly benefit patients with moderate-to-severe psoriasis and their treatment journey.

Users of chronic prescription opioids decrease in the first 12 months following bariatric surgery.

Obesity is an independent risk factor for chronic pain frequently treated with opioids. Our study investigated the effect of Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG) on chronic opioid prescription use. Using the IBM MarketScan database (2010-2017), we analyzed adult chronic opioid users who underwent bariatric surgery. Opioid use was measured in morphine milligram equivalents (MME) for 6-month periods before and after surgery. Changes in MME for each 6-month interval were compared to preoperative exposure and across the different types of bariatric surgery. Of the 2197 patients identified, 29% discontinued opioids 6 months post surgery, further decreasing to 23.4% at 12 months. Discontinuation rates were similar for VSG and RYGB. Preoperative opioid exposure did not predict postsurgery discontinuation, but patients with multiple opioid prescription types were less likely to stop. Among those continuing opioid use, average MME increased at 6 months post surgery compared with 6 months pre surgery in both groups (mean [SD], RYGB: 49.4 [347.3]; VSG: 74.9 [533.4]). Although bariatric surgery reduced the number of chronic opioid users by nearly 25%, persistent users showed increased average opioid exposure after surgery. Further research to track long-term opioid use should be conducted, and providers should inform patients of these risks and attempt opioid dose reductions before surgery.

Longitudinal Changes of Visual Sensitivity With Geographic Atrophy Progression Assessed by Defect-Mapping Microperimetry.

To determine the relationship between structural and functional changes over time in the progression of geographic atrophy (GA) as assessed by defect-mapping microperimetry, an approach optimized to characterize the spatial extent of deep visual sensitivity losses. A total of 57 eyes from 50 participants underwent defect-mapping microperimetry testing of the central 8° radius (with a 10-dB stimuli presented once each at 208 locations) over a median of five visits, scheduled at 3-monthly intervals. GA lesion(s) on fundus autofluorescence in the corresponding region tested on microperimetry at each visit were manually annotated. At a global level, change of GA extent in the central 8° radius explained a large proportion of the variance in the change in the proportion of locations missed (nonresponse) on defect-mapping microperimetry (R2 = 0.52). Locally, test locations that were entirely outside or within GA lesion(s) had a 0.3% (P = 0.305) and 2.3% (P < 0.001) probability of worsening between the two visits, respectively. In contrast, test locations with a 0% to 25%, 25% to 50%, 50% to 75%, or 75% to 100% change in the extent of GA overlapping between visits had a 4.1%, 12.0%, 17.5%, and 37.9% probability of worsening, respectively (all P < 0.001). This study confirms that longitudinal changes in GA extent are associated with functional changes on defect-mapping microperimetry, both on a global and local level. These findings highlight the expected functional relevance of GA progression, and demonstrates the potential effectiveness of this microperimetry testing strategy for capturing visual function decline associated with GA progression.

The impact of the COVID-19 pandemic on hospital admissions in a psychiatric ward in a general hospital in Greece.

The negative consequences of the COVID-19 pandemic and the subsequent restrictive measures on the mental health and well-being of the population and psychiatric patients have been widely recognized. Patients' treatment attendance and engagement with mental health services had been negatively affected by the pandemic, whereas patients were less likely to receive timely outpatient care. The pandemic also impacted the use of inpatient services. The aim of the present study was to explore the variability of attendance and admissions to a general hospital psychiatric ward over a 12-month interval after the onset of the pandemic (March 2020), compared to the respective 12-month pre-pandemic interval. A retrospective, observational pre/post study was performed, involving a general hospital psychiatric ward in Corfu, Northwest Greece, which serves an insular catchment area of approximately 100,000 inhabitants. For data analysis, c- and u-charts of statistical process control charts were employed, using monthly data (March 2019 to February 2021). Overall, a significant decline in attendance rates was observed, mostly accounted for by a 26.5% reduction in voluntary attendance rates (1516 patients prior vs. 1114 patients after the onset of the pandemic). The involuntary commitment of patients did not differ between the two periods (106 prior vs. 100 after the onset of the pandemic). Admission rates did not change significantly between the two periods. Diagnoses that exhibited significant variance in examinations between the two study periods were mood disorders and personality disorders, whereas there was no significant variation in the number of admissions across different diagnoses. Length of hospital stay increased significantly by 13.2% over the first year of the pandemic, from 25.57 days (Md= 13, IQR= 22) during the pre-COVID-19 period to 28.95 days (Md= 22, IQR= 28) during the COVID-19 period. Patients with schizophrenia and related disorders (Mean= 34.25 days, SD= 43.19) and mood disorders (Mean= 26.26, SD= 33.48) had prolonged hospital stays compared to other diagnoses. These findings highlight significant shifts in psychiatric care delivery during the pandemic and underscore the need for targeted interventions to address the evolving demands on mental health services during public health crises.

The relationship between cognitive and affective control and symptoms of depression and anxiety across the lifespan: A 3-wave longitudinal study

IntroductionThe association between cognitive functioning and mental health symptoms across the lifespan remains poorly understood. Understanding the directional associations between mental health and cognition is important as most gold-standard psychological therapies, such as cognitive-behaviour therapy, are cognitively demanding. Here, we examined the directionality of the association between cognitive and affective control with symptoms of depression and anxiety across the lifespan. Methods1002 participants (87.2 % female, age range: 11–89 years) completed self-report measures of depressive and anxiety symptoms and an affective backward digit span task thrice at 3-month intervals. Cross-lagged panel models (CLPMs) were used to model the longitudinal relationships between affective and cognitive control with depressive and anxiety symptoms. Multiple-group CLPMs were applied to test the model invariance between adolescents and adults. ResultsThe results supported a unidirectional relationship, where symptoms of depression and anxiety predicted impaired affective control across time points, over and above cognitive control. There was no evidence for affective or cognitive control capacity predicting emotional disorder symptomatology. In addition, multiple-group analysis revealed that depressive symptoms also predicted impaired cognitive control among adolescents only. There were no age-related differences in the associations between cognitive and affective control with anxiety symptoms. ConclusionsOur findings support depression and anxiety as antecedents, but not consequences, of impaired affective control, suggesting that timely management of emotional disorders, in particular for adolescents, is essential to prevent deterioration in cognitive functioning. The results further signal that practitioners should consider impaired affective control capacity in therapeutic contexts.

A Randomized Controlled Trial Evaluating the Clinical Performance of Bioactive Restorative Material and Resin-modified Glass Ionomer Cement in Carious Primary Molar Restorations.

To evaluate the clinical performance (marginal discoloration, surface texture, and retention) of bioactive restorative material (ACTIVA) and resin-modified glass ionomer cement (RMGIC) in carious primary molar restorations at 6 and 12-month intervals. The split-mouth randomized controlled trial comprised 31 children aged 5-8 years having contralateral matched pair of carious primary molars with an International Caries Detection and Assessment System (ICDAS) II score 5. Sixty-two teeth were randomly allocated into two groups: group I-ACTIVA (n = 31) and group II-RMGIC (n = 31). After caries excavation, the teeth were restored with the respective materials and evaluated the marginal discoloration, surface texture, and retention after 6 and 12 months using modified USPHS (United States Public Health Service) criteria under the dental operating microscope. Mann-Whitney "U" test was used for intragroup comparison and the Wilcoxon signed-rank test for intergroup comparison. A statistically significant difference was found in the surface texture of ACTIVA and RMGIC restorations at both 6-month (p = 0.002) and 12-month (p = 0.001) intervals, whereas the difference in the marginal discoloration and retention were not significant at both 6-month (p = 0.267 and 0.161, respectively) and 12-month intervals (p = 0.339 and 0.064, respectively). The surface texture of ACTIVA is found to be superior to RMGIC, whereas marginal discoloration and retention are similar to RMGIC at both 6 and 12-month intervals. ACTIVA bioactive restorative material and RMGIC both enhance tooth remineralization with improved adhesion and fluoride release properties, making them valuable choices in various clinical scenarios. Bhavana K, Uloopi K, Vinay C, et al. A Randomized Controlled Trial Evaluating the Clinical Performance of Bioactive Restorative Material and Resin-modified Glass Ionomer Cement in Carious Primary Molar Restorations. Int J Clin Pediatr Dent 2024;17(10):1109-1113.

Factors Influencing Post-Traumatic Growth in Surviving Students of the Sewol Ferry Disaster: A Long-Term Follow-Up Study.

Disaster survivors often experience negative impacts on their mental health, but some may also exhibit posttraumatic growth, overcoming adversity, and finding positive outcomes. This study aimed to identify psychological factors influencing posttraumatic growth (PTG) among students who survived the Sewol ferry disaster. The study used a longitudinal design. Data were collected at 6-month intervals between high school graduation and 6 years after the ferry disaster. Data were obtained from 48 adolescents who completed self-report measures of rumination, meaning in life, coping, PTG, family adaptability and cohesion. Generalized estimating equation models were fitted to 11 waves of follow-up data. Intrusive rumination (coefficient [coef]=0.165; p<0.001; 95% confidence interval [CI] 0.081-0.250) and deliberate rumination (coef=0.554; p<0.001; 95% CI 0.376-0.732) were significantly associated with PTG. Concerning meaning in life, the presence of meaning (coef=0.312; p<0.001; 95% CI 0.189-0.435) and the search for meaning (coef=0.216; p=0.001; 95% CI 0.093-0.340) were also significantly associated with PTG. Finally, the problem-focused (coef=0.682; p=0.011; 95% CI 0.153-1.210) and emotion-focused (coef=0.736; p=0.009; 95% CI 0.186-1.285) coping strategies both showed significant associations with PTG. The results of this study indicate that rumination, meaning in life, and adaptive coping (including cognitive and emotional coping) were protective factors for mental health problems among adolescents who survived the Sewol ferry disaster. These psychological factors may promote PTG over time.

Cumulative Interpersonal Risk, Non-Suicidal Self-Injury, and Suicide Attempts in Early Adolescence: Between-Person Differences and within-Person Effects.

Poor interpersonal relationships are one of the risk factors for non-suicidal self-injury (NSSI) and suicidal behaviors among adolescents. Previous studies have mostly focused on a single interpersonal perspective, and it remains uncertain how the cumulative interpersonal risk across time and domains interacts with NSSI and suicide. The current study employed cross-lagged panel models (CLPM) and random intercept cross-lagged panel models (RI-CLPM) to investigate the interaction among cumulative interpersonal risk, NSSI, and suicide attempts at both the between-person and within-person levels, while examining sex differences in these relationships. A total of 1038 Chinese adolescents (47.0% girls; baseline Mage = 12.35 years, SD = 0.52) participated in a four-wave longitudinal survey with 6-months intervals. The results showed that at the between-person level, there were reciprocal predictive relationships between cumulative interpersonal risk, NSSI and suicide attempts. At the within-person level, changes in NSSI affected changes in cumulative interpersonal risk, and suicide attempts exhibited a reciprocal relationship with cumulative interpersonal risk and NSSI, with significant sex differences observed. These findings underscore the stable and trait-like associations between cumulative interpersonal risk, NSSI and suicide attempts. Given these findings, to reduce the occurrence of suicide among adolescents, it is essential to target interventions aimed tat enhancing their interpersonal adaptability.

Early life, environmental, and demographic factors associated with change in toddlers’ objectively measured sedentary behaviour between 18 and 36 months of age

ABSTRACT This study examined individual variation in change over time in sedentary behaviour and factors associated with higher or lower sedentary behaviour and change in sedentary behaviour in 110 toddlers from 18 to 36 months of age. Mother/child dyads were recruited into the study when children were 6 months of age. Mothers completed surveys, and children were measured at 6-month intervals to 36 months. Children wore accelerometers for one week at each time point, and height and weight were measured. Growth curve modelling examined relationships between demographic, early life, and environmental factors and sedentary behaviour from 18 to 36 months. Fifty-one percent of the children were boys. The trajectory of sedentary behaviour increased from 18 to 24 months then declined. Children with higher sedentary behaviour were less likely to be enrolled in daycare (p < 0.05), and they engaged in higher TV/electronic media use (p < 0.05). Children with lower sedentary behaviour were more likely to have been breastfed (p < 0.05). Children with higher locomotion scores at 6 months were less sedentary at 18 months (p < 0.05), but this difference diminished over time. Mothers should be encouraged to breastfeed, limit their child’s TV/electronic media use, and provide opportunities for their young children to be physically active.

Impact of Social Determinants of Health on Melanoma Nodal Surveillance in a Multi-institutional Cohort.

Nodal surveillance (NS) has overtaken completion lymphadenectomy as the preferred management for sentinel node-positive (SLN+) melanoma, but requires frequent exams and nodal ultrasound (US). Social determinants of health (SDoH) may affect US adherence in real-world populations, and evaluation of these potential impacts is needed. Adults with SLN+ melanoma diagnosed from July 2017 to December 2019 who received NS at nine cancer centers were identified retrospectively. Exposures included insurance status, travel distance, and Centers for Disease Control and Prevention (CDC) Social Vulnerability Index (SVI), a validated measure of area-level SDoH, indicated as 0 (low) to 1 (high) vulnerability. The primary outcome was US adherence (≥ 1 study per 6-month follow-up interval). The secondary outcomes were combined-modality adherence [US, computed tomography (CT), or positron emission tomography (PET)] and loss to follow-up (LTFU). Bivariate analyses and mixed-effects multivariable logistic regression were performed. Most of the 519 patients were male (57%), non-Hispanic white (94.4%), and insured privately (45.3%) or by Medicare (43.5%). The median travel distance was 63.3 miles (interquartile range [IQR], 31.2-111.0 miles), and the median SVI was 0.426 (IQR, 0.253-0.610). The surveillance adherence rates were 41.6% for US and 75.1% for combined modalities. No significant differences in US adherence were observed based on sociodemographic covariates in regression analysis. Medicaid (odds ratio [OR], 3.12; p = 0.02) and uninsured (OR 4.48; p = 0.01) patients had increased likelihood of LTFU. Less than half of the patients in this multicenter cohort achieved US adherence, although the rates improved with combined modalities. Medicaid or non-insurance were social risk factors for LTFU. Optimizing surveillance practices for socially vulnerable groups will be crucial for the ongoing real-world implementation of NS.

ACROPath Oligometastases: The American College of Radiation Oncology Clinical Pathway.

Radiation oncology is among the most data-driven specialties in medicine. Recently, a wealth of peer-reviewed data has been published supporting the treatment of oligometastatic malignancies, demonstrating improved survival with metastasis-directed therapy, such as stereotactic body radiation therapy (SBRT), when combined with appropriate patient selection and treatment. However, there are currently few, if any, established guidelines that synthesize the abundance of data specific to radiotherapy into a single, easily accessed resource for clinicians. ACROPath®is a major initiative of the American College of Radiation Oncology (ACRO) that aims to present aggregated clinical pathway data in a highly usable format that is readily accessible to clinicians at the point of care in real time. The oligometastases pathway is the first published algorithm in this collection, with additional pathways anticipated in future publications.Clinical radiation oncologists with expertise in the treatment and management of oligometastatic disease were recruited from across ACRO's diverse membership, including both academic and private practice physicians, to ensure a broad-based experience and insight. Individual participants were assigned subsections of the pathway for guideline development, and then, each subsection was presented to the full group for evaluation and consensus development based on published data. Rather than presenting an unstructured set of treatment options, as is common in other treatment guidelines, this initiative aimed to categorize appropriate treatments based on published clinical evidence in a hierarchy further ranked by efficacy, toxicity, and cost. Based on these strata, treatment recommendations were collated and grouped into three rank categories (gold, silver, or bronze) to denote the degree of applicability.The team assembled an interactive document that will eventually be available online, and it is summarized in detail here. Recommendations are grouped both by the anatomic site of metastasis and by the primary tumor type, recognizing that original histology might impact the treatment differently in different anatomic locations. After a review of available published clinical evidence, the committee reached a consensus on all recommendations presented, categorizing each option as gold, silver, or bronze to guide clinicians appropriately. This first iteration of ACROPath®Oligometastases represents one of the few comprehensive clinical decision support tools available for managing patients with limited metastatic disease. It presents available data in a highly accessible, easily used reference, which will be formally reviewed and updated by the committee as frequently as emerging data requires, likely at six- to 12-month intervals.

Survival Analysis of Prefabricated Zirconia Crowns with and Without Pulpotomy in Primary Teeth: A Retrospective Cohort Study.

Prefabricated Zirconia Crowns (PZCs) are increasingly preferred for restoring primary teeth due to their esthetic appeal and retention. However, their rigid, unmodifiable design requires precise tooth preparation, often leading to aggressive reduction and potential pulp exposure. Pulpotomy, a standard treatment for reversible pulpitis and mechanical pulp exposure, is sometimes employed before PZCs. While pulpotomy is not routinely performed, its use raises important considerations about the interplay between restorative procedures and pulp therapy in pediatric dentistry, particularly regarding the long-term restoration outcomes of PZCs. This study aimed to investigate the impact of pulpotomy on the success rate of PZCs. We examined 81 anterior upper primary teeth treated with PZCs in children aged 2-5 years over a two-year period. Cases were divided into groups with and without pulpotomy. Follow-ups occurred at 6-month intervals, assessing clinical and radiographic outcomes. Analyses were performed using SPSS 25.0 software. The statistical significance was p < 0.05. A total of 81 anterior primary teeth were included. Chi-square analysis showed no association between pulp therapy and PZC success (χ2 = 0.051, p = 0.822). The Kaplan-Meier survival analysis revealed comparable survival curves and the log-rank test showed no statistically significant difference in survival time between pulpotomy-treated and untreated groups (χ2 = 0.051, p = 0.821). Pulpotomy did not significantly affect the success rate of PZCs within 2 years.

The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial.

Type 2 diabetes (T2D) contributes to significant morbidity and mortality for Chinese immigrants in the United States, exacerbated by social determinants of health (SDOH) barriers such as language barriers, limited access to healthy foods, and low health literacy. The goal of the Integrating Cultural Aspects into Diabetes Education (INCLUDE) study is to test a social media-based intervention adapting the Diabetes Prevention Program (DPP) for Chinese immigrants alongside a culturally adapted, community-supported agriculture program. Here, we report the protocol for the INCLUDE study. INCLUDE is a 3-year randomized controlled trial (n=150). Participants with prediabetes or at risk for T2D are enrolled and randomized into either the control or intervention group (n=75 each). Participants from the intervention group receive 2-3 culturally tailored, in-language DPP videos weekly for 12 weeks, as well as biweekly phone calls from bilingual study staff to review video content, support goal setting, and assess and address SDOH-related barriers such as food insecurity. Intervention participants will also be given produce for 10 weeks as part of the community-supported agriculture program. Weight (primary outcome), self-efficacy, diet, physical activity, and food insecurity (secondary outcomes) are measured at baseline, 3-month, and 6-month intervals. Splined linear mixed models will be used to examine group differences in longitudinal weight and other secondary outcomes. The INCLUDE study was approved by the Institutional Review Board at the NYU Grossman School of Medicine. Recruitment started in May 2023, with the first cohort of 75 participants enrolled and randomized into 2 groups in July 2023. The 3-month and 6-month assessment of the first-year cohort has been completed. We have recruited 75 participants for the second cohort as of July 2024. The INCLUDE study will serve as an innovative model for culturally adapted, multilevel interventions for underserved communities previously unable to access evidence-based diabetes prevention initiatives. Aligning with several national calls for multilevel interventions, the INCLUDE intervention will provide critical data that will inform how researchers and public health professionals address SDOH barriers faced by underserved populations and prevent diabetes. ClinicalTrials.gov NCT05492916; https://clinicaltrials.gov/study/NCT05492916. DERR1-10.2196/65455.

Impact of Therapeutic Inertia on Patient-Reported Outcomes in Moderate-to-Severe Atopic Dermatitis: A 12-Month Longitudinal Study from the TARGET-DERM AD Registry

Background: Therapeutic inertia, the delay or reluctance to modify treatment when goals are unmet, is a significant challenge in managing chronic diseases, including atopic dermatitis (AD). This inertia can lead to suboptimal disease control and affect patient outcomes. Objectives: This study evaluates the effect of therapeutic inertia on patient-reported outcomes (PROs) in moderate-to-severe AD patients undergoing systemic treatment over 3 to 12 months. Methods: We analyzed longitudinal data from the TARGET-DERM AD registry, which includes 3,457 patients with moderate-to-severe AD from 39 centers across the U.S. and Canada. Eligible patients had documented patient-reported outcomes (PROs) at the initiation of systemic therapy and at subsequent 3-month intervals up to 12 months of follow-up. We assessed the proportion of patients not meeting treatment targets based on expert consensus. Patients had a validated Investigator Global Assessment (vIGA-AD) score of 3 or more at initiation of either an advanced systemic therapy (AST) such as biologics or JAK inhibitors or a conventional systemic therapy (CST) such as cyclosporine, methotrexate, or prednisone. PROs were evaluated at 3-month intervals up to 12 months, assessing achievement against the predefined treatment targets. PRO measures included Worst-Itch (PROMIS Itch-Severity), POEM, PO-SCORAD, NRS-sleep, and NRS-pain with specific moderate and optimal target levels established for each. Itch-Severity (range: 0–10; moderate target: ≥4-point reduction, optimal target: score ≤1), POEM (range: 0-28; moderate target: ≥4-point reduction, optimal target: score ≤2), PO-SCORAD (range: 0-103; moderate target: score ≤24; optimal target: score ≤10), NRS-sleep and NRS-pain (range: 0-10; moderate target: reduction ≥3-points; optimal target: score ≤1). Results: Out of 2107 patients with moderate-to-severe AD, 445 qualifying participants were included (63.8% adult, 62.0% female, 45.4% Non-Hispanic White, mean age of 31 years). Most patients (88.8%) initiated AST, with dupilumab being the most common (86.5%). At 6 months, significant proportions of AST-treated patients failed to reach moderate and optimal targets for itch (67% and 79%, respectively), POEM (46% and 69%), and NRS-sleep (59% and 47%). By 12 months, these figures were similar, with 66% and 88% failing to meet itch targets, 53% and 73% failing to meet POEM targets, and 62% and 45% failing to meet NRS-sleep targets, respectively. A similar pattern was observed for other PROs. CST-treated patients exhibited similar trends. Conclusions: The study highlights the profound impact of therapeutic inertia on the quality of life of patients with moderate-to-severe AD. Despite systemic therapy, a considerable proportion failed to meet treatment targets over a 12-month period, underscoring the need for more proactive and responsive treatment strategies in AD management.

Slowing myopia progression with cylindrical annular refractive elements (CARE) spectacle lenses-Year 1 results from a 2-year prospective, multi-centre trial.

To evaluate the effectiveness of 12 months of spectacle lens wear incorporating cylindrical annular refractive elements (CARE) in slowing myopia progression compared to single vision (SV) spectacle wear. In an ongoing 2-year prospective, double-masked, multi-centre clinical trial, 240 Chinese children aged 6-13 years, spherical equivalent refractive error (SE) -0.75 D to -5.00 D were randomised to one of three groups of 80 participants each to wear: SV spectacle lens (N = 80), CARE spectacles (7 mm central clear zone surrounded by treatment zone incorporating CARE with mean surface power of +4.6 D) and CARE S (9 mm central clear zone surrounded by treatment zone comprising CARE with mean surface power of +3.8 D). Cycloplegic SE and axial length (AL) were measured at 6-month intervals. Compared to baseline, changes in SE and AL were significantly different between the groups at both 6 and 12 months (p < 0.001, linear mixed model). Adjusting for site, group, parental myopia and age, at 12 months, the estimated change in SE and AL with 95% CI with SV was -0.65 D (CI: -0.56 to -0.74 D)/0.32 mm (CI: 0.29-0.36 mm). In comparison, the estimated change in SE/AL at 12 months with CARE was -0.35 D (-0.26 to -0.44 D)/0.19 mm (0.15-0.22 mm) and with CARE S was -0.36 D (-0.27 to -0.46 D)/0.21 mm (0.18-0.25 mm) at 12 months. Progression was slower with CARE and CARE S compared to SV (p < 0.05) but did not differ from each other (p = 0.793 and 0.336 for SE and AL, respectively). In children with myopia, after 12 months of lens wear, both CARE and CARE S spectacle lenses significantly slowed myopia progression compared to SV lenses.

Variability in forced expiratory volume in 1 s in children with symptomatically well-controlled asthma

AimsSpirometry is used by many clinicians to monitor asthma in children but relatively little is understood about its variability over time. The aim of this study was to determine the...

Validation of a Set of Clinical Criteria for the Diagnosis of Secondary Progressive Multiple Sclerosis.

Background/Objectives: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by progressive impairment of neuronal transmission due to focal demyelination. The most common form is RRMS (relapsing-remitting multiple sclerosis), which, under the influence of certain factors, can progress to SPMS (secondary progressive multiple sclerosis). Our study aimed to validate the criteria proposed by a working group of the Romanian Society of Neurology versus the criteria proposed by a group of experts from Spain, Karolinska, and Croatia concerning the progression from RRMS to SPMS. Methods: This was done by gathering epidemiological data (age, gender) and by applying clinical tests such as the 9HPT (9-hole peg test), 25FWT (25-foot walk test), and EDSS (expanded disability status scale) tests and the SDMT test (symbol digit modalities test). The present research is a cohort study that included a number of 120 patients diagnosed with MS according to the McDonald Diagnostic Criteria 2017. The study was carried out between January 2023 and April 2024, including patients hospitalized in the Neurology Clinic of the Clinical Rehabilitation Hospital from Iasi, Romania. The data were collected at baseline (T0) and at a 12-month interval (T1). Results: The statistical analysis was conducted using Kaiser-Meyer-Olkin analysis, which indicated a value of 0.683, thus validating the clinical tests used. The correlation matrix and the linear regression for all the tests showed highly significant statistical results. Furthermore, the ROC curve analysis of the criteria suggested by the working group of the Romanian Society of Neurology demonstrated that the EDSS, 9HPT, and 25FWT are highly sensitive in diagnosing SPMS, an opinion that is shared with the Spanish experts, but not with the Karolinska expert panel. Using the criteria given by the Croatian expert group in the ROC curve analysis showed that only the EDSS was strongly significant for the progression to the SPMS phase. Conclusions: In conclusion, all clinical methods used demonstrated that they are valid and can contribute to identifying patients with an increased risk of progression. The model proposed by the Romanian Society of Neurology working group is similar to other countries' expert opinions and can be used to detect the risk of disease progression and establish a more tailored therapeutic management of SPMS.

BS SO04 - Intragastric Balloons - are they for the long term?

Abstract Background Intragastric balloons are a bridging therapy to bariatric metabolic surgery. When sufficient weight loss to facilitate surgery is not achieved, a second balloon may be considered. Traditionally, balloons were used for 6 months prior to removal. The COVID-19 pandemic limited patient interactions and treatment duration was doubled. We assessed outcomes (weight loss trends and safety) in patients with severe obesity undergoing sequential balloon treatment. The study period accounts for changes in balloon protocol instigated during the pandemic, addressing a current literature gap. Method Consecutive patients who underwent balloon treatment between May 2014 and February 2023 were identified. Only patients deemed fit enough for potential adjuvant bariatric surgery at presentation were included in the study. Outcomes recorded included: weight and BMI at 3-monthly intervals until balloon removal, progression to surgery and morbidity. Results 45 patients were identified. Median BMI on balloon insertion was 62kg/m2. Median weight loss with the first balloon was 15.2kg (8.8% weight loss). 11 patients (24.4%) had a second balloon, with median weight loss of 3.3kg (1.9%). 22 patients (48.8%) met criteria for surgery, only one had multiple balloons. Weight loss was observed during the first three quartiles of balloon treatment, however median 2kg was gained during months 9-12. 16 (35.6%) first balloon patients had complications. 2 (18.2%) second balloon patients had complications. Median time from insertion to complication was 14 days. Conclusion The present study concludes that, although not associated with increased complication risk, sequential IGB use as a bridging treatment to definitive bariatric surgery does not significantly contribute to weight loss in super obese patients. Optimal treatment is achieved with a single IGB, although weight loss is not uniform across a 12 month treatment period and weight gain can result after 9 months.

Level 4 seizure monitoring unit admissions are associated with reduced long-term health care costs.

This study was undertaken to determine whether admission to dedicated seizure monitoring units (SMUs) result in reduced health care use (HCU). This was a retrospective open cohort study covering the years 2010-2018 of patients residing in Alberta, Canada, who were referred to the Calgary Comprehensive Epilepsy Program and admitted to a level 4 SMU. Patients were required to have ≥3 years pre- and postadmission follow-up. The outcome was the change in trajectory of composite HCU (primary care, specialist outpatient visits, emergency department visits, and hospitalizations) for the 3 years prior to and 3 years following SMU admission using the point of admission as the "index date." Secondary outcomes were HCU limited to specific settings. We excluded the first 30 days following the point of admission to mitigate the confounding admission would have on the postadmission HCU trajectory. We used adjusted restricted maximum likelihood linear and nonlinear effects models to determine trajectories expressed as Canadian dollars. A total of 315 of 600 (53%) patients met eligibility criteria. Mean age was 40 years (SD = 17.4), 176 (56%) were female, 220 (70%) had focal epilepsy, and 60 (19%) had functional seizures or physiologic seizure mimics without epilepsy as adjudicated by the attending physician at the point of discharge. Mean per person health care costs increased by CAD$341.28 (95% confidence interval [CI] = -25.17 to 707.74) for each successive 6-month interval prior to SMU admission (p = .07). Following admission, mean per person costs decreased by CAD$802.34 (95% CI = 699.62-905.06, p < .001) for each successive 6-month interval up to 3 years postdischarge. Similar trends were noted for primary and specialist care, emergency department, admitted care, and when nonlinear models were applied. Admission to an SMU is associated with significant and enduring declines in HCU. Each 6-months following discharge overall HCU declined by a mean of CAD$802.34 and acute inpatient, emergency department, and outpatient physician interactions declined by 25%, 26%, and 18% respectively. Comprehensive epilepsy care not only reduces morbidity and mortality but also reduces cost.