6-month Intervals Research Articles

Human Papillomavirus, Human Immunodeficiency Virus, and Oral Microbiota Interplay in Nigerian Youth (HOMINY): A Prospective Cohort Study Protocol

IntroductionPersistent oral infections with high-risk human papillomavirus (HR-HPV) are a potential cause of most oropharyngeal cancers (OPCs). Oral HR-HPV infection and persistence are significantly higher in people living with HIV...

Two-year outcomes of male alcohol-dependence patients treated in hospitals for uniformed forces

ABSTRACT Background: Alcohol use disorder (AUD) is a highly prevalent disorder with a large treatment gap. Treatment of AUD is a challenging task for mental health practitioners, as there is no decisive marker for recovery, and abstinence rates are equivocal with and without treatment. A paucity of Indian studies determining the prognosis of AUD in armed forces led to the initiation of this study. Aim: To study the outcome of alcohol-dependence patients two years after treatment in uniformed forces. Materials and Methods: The study included 100 consecutive male inpatients with alcohol dependence admitted to the psychiatry ward of two hospitals for uniformed forces personnel. Relevant investigations were requisitioned for them, and records were maintained to facilitate easy follow-up at 6-month intervals over 2 years. Results: The majority of patients had begun consumption voluntarily to seek pleasure. The average daily intake was 71.36 g of alcohol. Most of them consumed alone. Ninety-three percent showed features of withdrawal after admission. The most common physical comorbidities were injuries and gastrointestinal disorders, while the most common psychiatric comorbid disorders were substance use disorders and depression. Upon follow-up, 42% maintained abstinence, which was either partial or absolute, 5% were rendered unfit to serve further, 42 were lost to follow-up, and 17% had eventually retired. Conclusion: Contrary to prevailing belief, the results of the present study indicate that 42% of patients with AUD improved with treatment.

Clinical Outcomes Among Adolescents Diagnosed With Anorexia Nervosa During the COVID-19 Pandemic.

The COVID-19 pandemic was associated with a significant rise in the incidence of anorexia nervosa (AN) and atypical anorexia nervosa (AAN), longer wait times and reduced opportunities for in-person medical services. How these changes affected clinical outcomes among adolescents newly diagnosed with AN/AAN remains largely unknown. We performed a retrospective analysis of standardized intake and follow-up data from a pediatric eating disorder program to compare clinical outcomes among adolescents newly diagnosed with AN/AAN during pre-pandemic (July/2017-December/2018) and pandemic (July/2020-December/2021) periods. Clinical data were collected at the time of diagnosis and at 1-, 3-, 6-, and 12-month intervals. The primary outcomes were unscheduled AN/AAN-related emergency department visits and need for medical hospitalization. Overall, 253 patients were included (pre-pandemic = 77; pandemic = 176). By 12-months following diagnosis, 18.8% (95% CI 13.3%-25.3%) of patients diagnosed during the pandemic had unscheduled AN/AAN-related emergency department visits, compared to 7.8% (95% CI 2.9%-16.2%, p = 0.03) of those diagnosed pre-pandemic. Medical hospitalization was required more frequently in the pandemic group (35.8%; 95% CI 28.7%-43.4%) compared to pre-pandemic (15.6%; 95% CI 8.3%-25.6%, p = 0.001). Mean weight gain at 12-months did not differ between groups (8.1 kg pre-pandemic vs. 8.8 kg pandemic; p = 0.35) however the mean time to target weight was longer in the pandemic group (2.7 vs. 4.4 months; p = 0.002). Patients newly diagnosed with AN/AAN during the pandemic had significantly more AN/AAN-related emergency department visits and hospitalizations and took longer to achieve target weight than those diagnosed pre-pandemic. These findings suggest a more complicated treatment course among adolescents diagnosed with AN/AAN during the pandemic.

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

The association between cognitive functioning and mental health symptoms across the lifespan remains poorly understood. Understanding the directionality of the association 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. 1002 participants (87.2% female, age range: 11-89years) 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. The 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. Our findings support depression and anxiety as antecedents, but not consequences, of impaired affective control. This suggests 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.

Impact of neoadjuvant radiation therapy modalities on post-surgical lymphopenia in operable pancreatic cancer.

710 Background: Recent advances in therapeutic vaccines show promise for KRAS -mutated pancreatic cancer (PC), with ongoing clinical trials exploring their potential further. Lymphocytes are essential in generating vaccine-induced immune response. Patients who develop lymphopenia following neoadjuvant radiation therapy (RT) are frequently excluded from these vaccine trials. We aimed to assess how different modalities of neoadjuvant RT impact the severity and incidence of lymphopenia. Methods: We identified patients with PC who received neoadjuvant therapy including RT followed by surgery at our institution between March 2009 and June 2024. Patients were stratified by the type of RT they received: conventional long-course chemo-RT (LCRT) with 50.4 Gy over 28 fractions (Fr), short-course chemo-RT (SCRT) with 36 Gy over 15 Fr, and stereotactic body RT (SBRT) with 30 Gy over 5 Fr. The absolute lymphocyte count (ALC, 10 3 cells/µL) was compared at various timepoints: baseline, during RT, 6-weeks after surgery (post-op), and every 3-month interval up to 1 year post-op. Moderate lymphopenia was defined as ALC <1.0 and severe lymphopenia as ALC <0.5. Results: Among the 627 patients included in the study, 522 had baseline pre-RT ALC data available for analysis. There was no difference in baseline ALC among the different RT groups (Table). During RT, patients receiving LCRT experienced a higher incidence of severe lymphopenia (86.1%; median ALC (mALC) nadir 0.28) compared to SCRT (41.9%; mALC nadir 0.50) or SBRT (20.0%; mALC nadir 0.72, p<0001). No difference in the mALC or rates of lymphopenia was observed beyond 6 weeks post-op. Notably, 53% of the patients experienced lymphopenia for as long as 1 year after surgery. Conclusions: LCRT resulted in more severe lymphopenia compared to SCRT or SBRT during RT, but this difference in severity diminished 6 weeks after surgery. Alternatives in treatment sequencing for operable pancreatic cancer can have profound effects on patterns of disease recurrence. When applying multiple treatments in series, toxicities such as lymphopenia may impact receipt of therapy. Techniques to mitigate such toxicities, while maximizing response, will be important to consider. Absolute lymphocyte count (ALC, 10 3 cells/µL) at different time point. Patients with baseline ALC LCRT (n=454) SCRT (n=34) SBRT (n=34) P-value Baseline ALC, median (IQR) 1.48 (0.74) 1.27 (0.94) 1.51 (0.74) 0.74 6-week lymphopenia, n (%) No Moderate Severe 173 (37)219 (46)79 (17) 13/27 (48)11/27 (41)3/27 (11) 18/35 (51)16/35 (46)1/35 (3) 0.10 1-year lymphopenia, n (%) No Moderate Severe 101/217 (47)90/217 (41)26/217 (12) 3/8 (37)5/8 (63)0/8 (0) 9/13 (69)1/13 (8)3/13 (23) 0.054

Survival and quality of life in patients with lower risk myelodysplastic syndromes exposed to erythropoiesis-stimulating agents: an observational cohort study.

In our previous study on erythropoiesis-stimulating agent (ESA) treatment in lower risk myelodysplastic syndromes from the European MDS (EUMDS) Registry, we showed that patients treated with ESAs had longer survival compared with patients who receive red blood cell transfusion (RBCT). In this study, with a longer follow up time and more patients included, we aimed to assess long-term effects on survival and health-related quality of life (HRQoL) of exposure to ESAs with or without RBCT in patients with lower risk myelodysplastic syndromes. The EUMDS Registry is a non-interventional, longitudinal, real-world registry prospectively enrolling newly diagnosed patients older than 18 years with lower risk (International Prognostic Scoring System low or intermediate-1) myelodysplastic syndromes from 16 European countries and Israel. The analysis was restricted to patients with haemoglobin concentrations less than 100 g/L enrolled between Jan 1, 2008, and July 1, 2019, with last censoring of data on Dec 31, 2021. Patient management was recorded every 6 months, including treatment, transfusions, and HRQoL. ESA treatment followed local guidelines. The patients were separated into four groups at each study visit: no ESA or RBCT, ESA only, ESA plus RBCT, and RBCT only. The data were analysed longitudinally over time according to ESA and RBCT status during each 6-month interval, using propensity score matching. The main outcomes were median overall survival and leukaemia-free survival, and HRQoL. This study is registered with ClinicalTrials.gov, NCT00600860, as is ongoing. 2448 patients (the ESA-unexposed group [n=1265] and ESA-exposed group [n=1183]) were diagnosed before July 1, 2019; 1520 (62·1%) were male and 928 (37·9%) were female. Median follow-up time was 3·9 years (IQR 1·6-6·5). After applying eligibility criteria and propensity matching, there were 426 patients in the ESA-unexposed group and 744 patients in the ESA-exposed group. Median overall survival in the ESA exposed group was 44·9 months (95% CI 40·2-50·5) compared with 34·8 months (28·6-39·2) in the ESA unexposed group; the absolute difference was 10·1 months (95% CI 2·2-18·0; hazard ratio [HR] 0·70 [95% CI 0·59-0·83]; p<0·0001). Patients without RBCT in the presence or absence of ESA exposure maintained significantly better HRQoL than those with RBCT, irrespective of ESA exposure (linear mixed effect model of EQ-5d-3L index score, RBCT coefficient -0·04 [95% CI -0·06 to 0·03], p<0·0001; linear mixed effect model of VAS, -4·57 [-6·02 to -3·13], p<0·0001). ESA treatment in patients with lower risk myelodysplastic syndromes significantly improves overall survival when started before or early after the onset of regular transfusion therapy. Avoiding RBCT is associated with significantly better HRQoL. H2020 European Research Council, Novartis Pharmacy B V Oncology Europe, Amgen, BMS/Celgene International, Janssen Pharmaceutica, Takeda Pharmaceuticals International, and Gilead Sciences.

Impact of cartoon-animated video, caregiver-supervised training, and pamphlet on plaque control, oral hygiene status, and oral hygiene knowledge, attitude, and practices in orphaned adolescents: A randomized controlled trial.

To evaluate the effectiveness of cartoon animated video, caregiver-supervised training, and pamphlet-based oral health education on plaque control, oral hygiene status, and oral health knowledge, attitude, and practice (KAP) among orphaned adolescents with plaque-induced gingivitis. A total of ninety adolescents were randomly selected and allocated into three different groups. Group A received the pamphlet (n=30), Group B received the cartoon animated video (n=30), and Group C received the caregiver-supervised training (n=30). A two-stage random sampling methodology was employed to select orphanages and the study population in Puducherry, India. Clinical examinations were conducted using the plaque index and simplified Oral Hygiene Index (OHI-S), and a pre-validated questionnaire was administered to assess oral hygiene KAP, which were recorded at baseline, 3-month, and 6-month intervals. All three groups experienced statistically significant reductions in plaque scores (from 3.7±0.8 to 0.9±0.2 in the pamphlet group, 3.9±0.8 to 0.4±0.2 in the animated video group, and 3.6±0.8 to 0.7±0.1 in the caregiver group) and OHI-S scores (from 3.9±0.6 to 1.3±0.3, 3.7±0.5 to 1.0±0.2, and 3.9±0.7 to 0.5±0.1, respectively). Notably, the caregiver-based training and animated video methods demonstrated superior outcomes in reducing dental plaque and improving oral hygiene, while also an increase in the KAP scores compared to the pamphlet method. Both caregiver-supervised training and cartoon animated video methods proved to be more effective than the pamphlet method on plaque control and improvement of oral hygiene status, oral health knowledge, attitude, and its application in oral hygiene maintenance.

Patterns of immune checkpoint inhibitor utilization and PD-L1 testing in advanced gastroesophageal cancers using real-world data.

370 Background: Globally, gastroesophageal cancer (GEC) is a leading cause of morbidity and mortality, with poor 5-year overall survival (OS). The addition of immune checkpoint inhibitors (ICIs) such as nivolumab and pembrolizumab to chemotherapy has resulted in significant improvement in OS of those patients (pts) with metastatic GEC (mGEC), most notably in those with tumors exhibiting high PD-L1 CPS scores. However, the pattern of ICI utilization in associated PD-L1 testing since the adoption of this treatment (tx) has yet to be elucidated. We evaluated the patterns of ICI utilization and PD-L1/CPS testing in the first-line tx of mGEC pre and post FDA approval of ICI use in this setting. Methods: Pts ≥ 18 years of age, with recurrent/metastatic squamous or adenocarcinoma GEC diagnosed after 2011 were included from the de-identified nationwide Flatiron Health, electronic health record-derived database. We presented the proportion of pts receiving ICI therapy, stratified by line of tx, as well as the proportion of patients who received PD-L1 testing at 6-month intervals. Pts demographics and clinical characteristics, including age, gender, race, ECOG score, documented insurance, and stage at diagnosis (dx) were described and compared using T or Wilcoxon rank-sum tests for continuous variables, and chi-square or Fisher’s exact tests for categorical data. We compared tx rates and PDL-1 testing across four time points: time 1: Jan-June 2020, prior to ASCO data presentation; time 2: July-Dec 2020, ASCO data presentation; time 3: Jan- June 2021, FDA label change; time 4: July 2021 to 6 m after FDA label change using Chi-square test. Results: A total of 9,573 pts were included with 1,593 (16.6%) receiving ICI-based tx. Among these, 62.3% were White, 7% Black. Descriptive statistics indicated that pts with ICI- tx tend to be younger (median age 65y vs. 66.7; (p &lt;0.001). Within the total cohort, 74% pt were dx before FDA approval of ICI tx, while 26% pts were dx after FDA approval. PD-L1 testing was conducted in 4,065 (42.5%) pts. A total of 1,268 (13%) pts received first-line ICI-based tx. Of these, 154 pts (12.1%) were treated before FDA approval, while 1,114 pts (87.9%) received tx following FDA approval. The rate of first-line ICI tx significantly increased at each subsequent time point Time 2: 11.2% (p &lt;0.0001), Time 3: 32.9% (p &lt;0.0001), Time 4: 37.4% (p &lt;0.0001). PD-L1 testing rates also increased over time, particularly after FDA label change. Testing rates at Time 1 was 68%. Comparatively, testing rates at subsequent time points were: Time 2 (67.2%; p 0.88), Time 3 (71.5%; p 0.324) and Time 4 (77.4%; p=0.004). Conclusions: The approval of ICIs for first-line tx of mGEC led to a significant increase in both ICI utilization and PD-L1/CPS testing rates. Despite these advancements, ongoing disparities in tx access and testing highlight the need for further research and efforts to ensure equitable care.

Non-contrast MRI as a surveillance tool for recurrent hepatocellular carcinoma after curative treatment: A prospective multicenter intra-individual comparison trial.

530 Background: Hepatocellular carcinoma (HCC) often recurs following curative treatment, significantly impacting long-term survival. Contrast-enhanced multiphasic computed tomography (CECT) is widely utilized for HCC recurrence surveillance but carries risks such as radiation exposure and adverse reactions to contrast agents. This prospective multicenter trial aimed to compare the accuracy of non-contrast abbreviated magnetic resonance imaging (NC-MRI) with CECT in detecting late recurrent HCC. Methods: This prospective multicenter intra-individual head-to-head comparison trial (study identifier: NCT05690451, KCT0006395) enrolled participants who had undergone curative treatment for HCC and remained recurrence-free for over two years. Participants underwent three rounds of surveillance at 2–6-month intervals using both CECT and NC-MRI. The primary outcome was the detection accuracy of each modality, compared using the McNemar test. Secondary outcomes included detection sensitivity and specificity. Results: A total of 203 participants underwent 528 rounds of paired CECT and NC-MRI, detecting recurrent HCC in 22 participants (10.8%). Among these cases, 21 showed intrahepatic recurrent HCC with a median tumor size of 1.3 cm, and one exhibited aortocaval lymph node metastasis. NC-MRI demonstrated a detection accuracy of 96.6% (196/203), significantly higher than CECT's 91.6% (186/203) (P=0.006). NC-MRI also exhibited significantly higher sensitivity in detecting recurrent HCC compared to CECT (77.3% [17/22] vs. 36.4% [8/22]; P=0.012), while specificity did not differ significantly between NC-MRI and CECT (98.9% [179/181] vs. 98.3% [178/181]; P=0.999). Conclusions: NC-MRI showed significantly higher sensitivity and accuracy in detecting recurrent HCC among patients who had been disease-free for more than two years after curative treatment, establishing it as the preferred surveillance modality for late recurrence. Clinical trial information: NCT05690451 . Contrast enhanced CT Non-contrast MRI Difference, % (95% CI) P-value Estimates, % (n/N) 95% CI, % Estimates, % (n/N) 95% CI, % Accuracy 91.6% (186/203) 87.8-95.5 96.6% (196/203) 94.0-99.1 4.9 (1.7, 8.2) 0.006 Sensitivity 36.4% (8/22) 14.5-58.2 77.3% (17/22) 58.3-96.3 40.9 (16.8, 65.0) 0.012 Specificity 98.3% (178/181) 96.5-100 98.9% (179/181) 97.4-100 0.6 (-0.5, 1.6) 0.999

3D printed endocrowns versus prefabricated zirconia crowns for pulpotomized primary molars: A randomized controlled trial.

This study aims to compare the clinical performance of 3D printed endocrowns (ECs) and prefabricated zirconia crowns (PZRCs) in restoring pulpotomized primary molars, over 3, 6, and 12 months. Thirty pulpotomized mandibular primary molars in 16 children aged 4-8 years were randomized with a 1:1 allocation ratio into two groups: group (A), PZRCs, and group (B), 3D-printed ECs. All restorations were evaluated for esthetic, functional, and biological properties using FDI criteria at 3-, 6-, and 12-month intervals. Restorations requiring repair or replacement (a total restoration score of 4 or 5, respectively) were recorded as failures. For each outcome variable, the Mann-Whitney U test was used for intergroup comparisons, while Friedman's test was used for intragroup comparisons, followed by the Nemenyi post hoc test. The significance level was set at p ≤ 0.05. No statistically significant difference in survival times between PZRCs and ECs was found (12 and 11.36 months, respectively). Both restoration types showed a clinical success rate of 64.3 %. No statistically significant difference was found between the esthetic success of PZRCs and ECs (92.9 % and 71.4 %, respectively), matching their functional success rates. Similarly, no statistically significant difference was observed in the biological success of ECs and PZRCs (78.6 % and 64.3 %, respectively). 3D-printed ECs can be a promising and convenient alternative to full-coverage restorations in pulpotomized primary molars for up to one year. Restoration of pulpotomized primary molars using 3D-printed ECs offers a more conservative and esthetic option with minimal trauma to gingival tissues and reduced chair time, which is crucial for pediatric patients. NCT04909827.

AGA Clinical Practice Guideline on the Prevention and Treatment of Hepatitis B Virus Reactivation in At-Risk Individuals.

Hepatitis B reactivation (HBVr) can occur due to a variety of immune-modulating exposures, including multiple drug classes and disease states. Antiviral prophylaxis can be effective in mitigating the risk of HBVr. In select cases, clinical monitoring without antiviral prophylaxis is sufficient for managing the risk of HBVr. This clinical practice guideline update aims to inform frontline health care practitioners by providing evidence-based practice recommendation for the management of HBVr in at-risk individuals. The Grading of Recommendations Assessment, Development and Evaluation framework was used to assess evidence and make recommendations. The panel conducted a systematic evidence review to identify new studies since publication of the first version of this clinical practice guideline in 2014. The Evidence to Decision framework was used to develop recommendations regarding the role of antiviral prophylaxis and monitoring without antiviral prophylaxis for management of HBVr. Clinical recommendations were based on the balance between desirable and undesirable effects, patient values, costs, and health equity considerations. The panel agreed on 4 recommendations. Based on evidence and baseline risk assessment, the panel made a strong recommendation in favor of antiviral prophylaxis for individuals at high risk of HBVr. For individuals at moderate risk of HBVr, a conditional recommendation was made in favor of antiviral prophylaxis. For individuals at low risk of HBVr, a conditional recommendation was made in favor of monitoring alone without antiviral prophylaxis. Monitoring should be performed at 1- to 3-month intervals, and must include assessment of hepatitis B viral load in addition to assessment of alanine aminotransferase. For individuals deemed to be at-risk of HBVr, the panel agreed on a strong recommendation in favor of testing for HBV; given universal Centers for Disease Control and Prevention screening guidance for hepatitis B for all adults 18 years and older by testing for HBV surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody, stratifying screening practices by magnitude of HBVr risk is no longer needed. This document provides updated guidance for the management of HBVr in at-risk individuals. Limitations and gaps in the evidence are highlighted. This guideline is expected to require updating in 5 years from publication.

The Bidirectional Relations Between Parental Autonomy Support, Gratitude and Academic Engagement in Chinese Adolescents.

Abundant evidence highlights the benefits of self-determined motivation (e.g., parental autonomy support as internalized extrinsic motivation, gratitude as intrinsic motivation) on academic engagement during adolescence, yet the potential mutual relations remain relatively unexplored. This study investigated the bidirectional relations and potential mechanisms among parental autonomy support, gratitude, and academic engagement using a traditional cross-lag-panel model (CLPM) and a within-person CLPM with random intercept (RI-CLPM) in a sample of Chinese youth (N = 1214; Mage = 15.46, SDage = 0.71; 39.30% girls) across three time points with 6-month intervals. The results indicated that the bidirectional relation between parental autonomy support and academic engagement was present in CLPM but not in RI-CLPM. However, the bidirectional relations between gratitude and academic engagement, and between gratitude and parental autonomy support, existed at both levels. Furthermore, in CLPM, parental autonomy support influenced academic engagement through gratitude, and gratitude, in turn, affected academic engagement through parental autonomy support. Academic engagement impacted gratitude via parental autonomy support, and simultaneously, academic engagement influenced parental autonomy support through gratitude. Academic engagement served as a mediator between parental autonomy support and gratitude, as well as between gratitude and parental autonomy support. Five self-enhancing loops were identified in CLPM. These findings reveal a virtuous cycle of mutual influence between parental autonomy support, gratitude, and adolescent academic engagement, highlighting the important role of academic engagement in strengthening autonomous motivation.

Spinal cord demyelination predicts neurological deterioration in patients with mild degenerative cervical myelopathy

BackgroundDegenerative cervical myelopathy (DCM) is the most common form of atraumatic spinal cord injury globally. Clinical guidelines regarding surgery for patients with mild DCM and minimal symptoms remain uncertain. This...

An education program modified with e-learning brought equivalent outcomes in healthcare students' communication support for people with amyotrophic lateral sclerosis

Introduction: Patients with amyotrophic lateral sclerosis (ALS) often require augmentative and alternative communication (AAC) to support impaired communication. We evaluated the effectiveness of an e-learning program for healthcare students on communication support for patients with ALS, which was adapted from a previous face-to-face program. Methods: The program included an 85-min preparatory session, 165-min AAC practice session, and 40-min review session. Fifty-five healthcare students completed the program with pre-/post-tests, AAC practices using a transparent communication board (Flick), Kuchimoji, the communication device, subjective burden based on the visual analog scale (VAS), and free-response comments. The participants completed the practice twice over a 6-month interval. Data were analyzed using the Wilcoxon signed-rank sum and chi-square tests. Results: The program was effective in improving knowledge and AAC skills, similar to the face-to-face version. The pre-/post-test scores significantly increased for beginners (from 70 to 80, P&lt;.001) and experienced participants (from 75 to 80, P&lt;.001). However, after 6 months, a significant decrease in the pre-/post-test scores was observed (from 80 to 75, P=.017). In AAC practice, the number of letters transmitted in 5 min significantly increased for Flick (beginner: 27, experienced: 30, P&lt;.001) and Kuchimoji (beginner: 21, experienced: 24, P&lt;.001), with a reduction in subjective burden according to the VAS ratio. Text mining revealed a high frequency of positive sentences in participants’ feedback regarding communication devices. Conclusions: The e-learning program effectively improved ALS communication support knowledge and skills, with a lower perceived burden than face-to-face training.

P-1963. Changes in COVID-19 Sentiment and Behavior among Healthcare Professionals Over Time in a Rural State

Abstract Background We assessed attitudes towards COVID-19 and use of COVID-19 infection prevention practices during the pandemic among employees at an academic health center in a rural state.Figure 1:Reported Level of Worry about Spreading SARS- CoV-2 Methods We invited all employees aged &amp;gt;18 years reporting prior COVID-19 on a screening survey to participate and randomly selected other participants (Ps) from among those not reporting prior COVID-19 to create a study cohort of 302 participants. Ps completed surveys at 3-month intervals (T0, T3, T6, T9). We used the Chi-squared test to assess changes in Ps’ responses between individual time points.Figure 2:Reported Willingness to Go into Public Places Results At T0 most Ps thought their risk of acquiring COVID-19 either in the hospital or the community was low (&amp;lt; 3%) and &amp;lt; 20% worried that they or their household members would “catch COVID-19.” However, 45% of Ps were worried about spreading SARS-CoV-2 asymptomatically. Ps’ perceived likelihood of getting COVID-19 at the hospital and in the community did not change. The percent of Ps who were very worried about getting COVID-19 was significantly lower at T1 (1.7%), T2 (2.6%), and T3 (5.7%) than at T0 (11.3%; P &amp;lt; .05 for all). The percent of Ps who were very worried that household members would get COVID-19 decreased from T0 (16.6%) to T1 (8.0%; P = .03). After vaccines were introduced, Ps tended to report being less worried about spreading COVID-19, more willing to go to public places and less likely to wear face masks in the public. Shortly after the Delta variant emerged, these sentiments changed direction but did not return to their baseline cautiousness level. Shortly before the Omicron variant emerged, the sentiments of those who were seropositive at any time and those who remained seronegative during the study period diverged, with the latter being more worried about asymptomatic spread, less willing to go to public places and more willing to mask in the community than those who seroconverted. Consistent with these changes, 21 of 26 (80.8%) seroconversions occurred during the Omicron surge.Figure 3:Changes in Reported Use of Face Coverings in Public Conclusion Some attitudes and behaviors changed over time possibly related to vaccine availability and the predominant SARS-Co-V2 variant. Ps who remained seronegative tended to be more concerned about getting COVID-19 and were more likely to continue using COVID-19 infection prevention practices. Disclosures Daniel Diekema, MD, MS, D(ABMM), Affinity Biosensors: Grant/Research Support|bioMerieux, Inc: Grant/Research Support Loreen Herwaldt, MD, 3M: Grant/Research Support|PDI: Grant/Research Support

P-2035. Pharmacokinetics (PK) and Serum Virus Neutralizing Antibody (sVNA) Titers Following the 2nd dose of Pemivibart in the Phase 3 CANOPY Trial

Abstract Background Pemivibart (PEM) is a half-life extended recombinant human monoclonal IgG1 antibody that targets the SARS-CoV-2 spike protein receptor binding domain. PEM has been granted emergency use authorization (EUA) for the pre-exposure prophylaxis of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise, with dosing recommended every 3 months. Methods CANOPY (NCT06039449) is a Phase 3 study investigating PEM 4500 mg for the prevention of COVID-19 that enrolled adult (≥18 years) participants (ppts) with immune compromise (Cohort A, single arm, open label) and those at risk of exposure to SARS-CoV-2 (Cohort B, randomized 2:1 to PEM or placebo). Ppts received an initial dose of study drug administered via intravenous (IV) infusion on Day 1 followed by a second dose approximately 3 months later (i.e., month 3). Serum samples were collected for PK analysis at the month 3 visit prior to and after receipt of the second PEM dose and at month 6 and month 12. Here we describe calculated sVNA titers for ppts in Cohort A following a second dose of PEM and further estimates from a population PK (PPK) model constructed with available data from a Phase 1 first-in-human study and the Phase 3 CANOPY study. Results At the completion of the second (i.e., month 3) dose of PEM, the calculated sVNA geometric mean titer (GMT) to the SARS-CoV-2 Omicron JN.1 variant in Cohort A ppts was 17% higher than the corresponding value following the initial PEM dose. This is consistent with the estimated accumulation ratio based on the PPK model. Based on this model, the median calculated GMT is predicted to remain above the predefined protection titer threshold of 3514 for at least 90 days following dosing at month 3 (Figure 1). The steady-state AUC over the entire 3-month dosing interval is estimated to be approximately 30% higher than the AUC observed following the initial dose. Conclusion A second dose of PEM 4500 mg IV given at month 3 boosted calculated sVNA titers and is anticipated to provide continued protection above predefined protection titer thresholds in immune compromised participants through 90 days post-dose for JN.1. The overall risk-benefit of PEM supports use in certain adults and adolescents with moderate-to-severe immune compromise for the prevention of COVID-19 per the EUA. Disclosures Anna Holmes, PhD, Invivyd, Inc.: employee|Invivyd, Inc.: Stocks/Bonds (Private Company) Yong Li, PhD, Invivyd, Inc.: Employee|Invivyd, Inc.: Stocks/Bonds (Public Company) Deepali Gupta, BSc, Invivyd, Inc.: Employee|Invivyd, Inc.: Stocks/Bonds (Public Company) Chloe Katz, PMP, Invivyd, Inc.: Employee|Invivyd, Inc.: Stocks/Bonds (Public Company) Mike Gavazzi, B.S., Invivyd, Inc.: Employee|Invivyd, Inc.: Stocks/Bonds (Public Company) Pamela Hawn, Pharm.D., Invivyd, Inc.: Employee|Invivyd, Inc.: Stocks/Bonds (Public Company) Kathryn Mahoney, PharmD, Invivyd, Inc.: Employee|Invivyd, Inc.: Stocks/Bonds (Public Company) Myra Popejoy, Pharm.D., Invivyd, Inc.: employee|Invivyd, Inc.: Stocks/Bonds (Public Company)

Non-enhanced abbreviated MRI as a periodic surveillance protocol for colorectal liver metastases compared with contrast-enhanced CT: a prospective observational study.

Adopting appropriate noninvasive radiological method is crucial for periodic surveillance of liver metastases in colorectal cancer (CRC) patients after surgery, which is closely related to clinical management and prognosis. This study aimed to prospectively enroll stage II-III CRC patients for the surveillance of liver metastases, and compare the diagnostic performance of contrast-enhanced CT (CE-CT) and non-enhanced abbreviated MRI (NE-AMRI) during this process. 587 CRC patients undergoing radical resection of the primary tumor were evaluated by 1 to 3 rounds of surveillance tests, consisting of abdominal CE-CT and contrast-enhanced MRI (CE-MRI) within 7days at 6-month intervals. Subsequently, images of NE-AMRI were extracted from the CE-MRI examination, paired CE-CT and NE-AMRI analysis were performed. The lesion-based detection rates between two protocols were compared and a subgroup analysis was performed in lesions with the size of ≤ 10mm. The patient-based sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and the areas under the curves (AUCs) of CE-CT and NE-AMRI in each round were evaluated. Finally, the relationship between the diagnostic accuracy of two protocols and characteristics of patients was explored. The lesion-based detection rates of NE-AMRI in three rounds were all significantly higher than that of CE-CT (p < 0.001, p < 0.001, p=0.003, respectively). In the subgroup analysis of lesions ≤ 10mm, NE-AMRI also performed better than CE-CT (p < 0.001, p=0.002, p=0.005, respectively). The patient-based sensitivities, specificities, NPVs, PPVs of NE-AMRI were higher than those of CE-CT in three rounds of surveillance. The AUCs for NE-AMRI were all significantly better than that for CE-CT in each round (p=0.015, p=0.045, p=0.009, respectively). Furthermore, patient BMI and fatty liver disease had impacts on the diagnostic accuracy of CE-CT protocol, but not on NE-AMRI protocol. NE-AMRI may be a promising periodic surveillance tool for CRC patients after surgery to increase diagnostic accuracy of liver metastases, developing personalized clinical management and improving prognosis, simultaneously avoiding side-effects associated with ionizing radiation and contrast agents.

Behavioural Changes of Late Talkers During the Covid-19 Pandemic, One Year Follow-Up From a Community Sample.

Global threats to child health and well-being, compounded by the COVID-19 pandemic, have put child development at grave risk. This study aimed to observe the behavioural changes of children with isolated language delays from a paediatric outpatient clinic as a community sample during the pandemic with a 1-year follow-up. Patients admitted to the paediatrics outpatient clinic due to isolated language delays were included in the study. The Ages and Stages Questionnaire and Child Behaviour Checklist-1½-5 were implemented at baseline and 1 year later. All families were provided with information on developmental supportive strategies and called at 3-month intervals for follow-up. Eighty-three children were initially included in this prospective study and completed with a 66.3% retention rate after 1 year. The mean initial age of the children was 30 ± 5.1 months. Internalising behaviour problems were high enough for concern at the baseline and all behavioural problem scores decreased after 1 year (p < 0.001). The initial proportion of children with borderline or clinical internalising problems also decreased from 69.1% to 5.5% after 1 year, and most children had normal language development. Late talkers experienced some behavioural problems during the pandemic, and the language and behaviour outcomes of these children who attended the paediatric clinic were better after the 1-year follow-up, even during the COVID-19 pandemic. The management of language delays in young children in crisis should include providing families with developmental support strategies consistently through the paediatric healthcare system to optimise child developmental and behavioural functioning.

Evaluation of Tele-Education in Malawi for Detection of Macular Features Using Optical Coherence Tomography.

The study aimed to assess the reliability of tele-education in training a Malawian ophthalmology resident to interpret optical coherence tomography (OCT) images of patients with macular conditions. This was a retrospective analysis of 1000 macula-centered OCT image series from 1000 eyes of 1000 consecutive patients from Malawi, which involved initial interpretation by a German retina specialist (observer 1) (T0). Observer 1 then trained a Malawian resident (observer 2) via email, and observer 2 independently interpreted images at T1, followed by face-to-face training in Malawi and reinterpretation at T2 and T3 (3-month intervals). The observers had to recognize, on OCT imaging, the normal macular structure, vitreofoveal traction (VFT), absent fovea depression (FD), epiretinal membrane (ERM), lamellar macular hole (LMH), full-thickness macular hole (FTMH), foveoschisis, intraretinal pseudocyst (IPC), intraretinal hyperreflective foci (IHF), subretinal fluid (SRF), pigment epithelial detachment (PED), and drusen. Cohen's Kappa statistic measured inter-observer agreement. At T1 post-tele-education, almost perfect agreement (κ = 0.86; 99.6% agreement) was observed for FTMH. Agreement remained high at T2 post-face-to-face training (κ = 0.9; 99.7%) and decreased substantially at T3 (κ = 0.77; 99.4%). Following tele-education (T1), substantial agreement (κ range: 0.77 - 0.86) was found for IPC, PED, IHF, and FD, while ERM showed fair agreement (κ = 0.33; 81%). Face-to-face training notably improved agreement for SRF (T1 κ = 0.6, T2 κ = 0.63), LMH (T1 κ = 0.6, T2 κ = 0.67), and normal macular structure (T1 κ = 0.6, T2 κ = 0.62). There was good agreement in the detection of the majority of the OCT features seen in most of the macular pathologies following training through tele-education and the results did not change significantly following face-to-face teaching. Tele-education could reliably complement training in vitreoretinal diagnostic skills in resource-limited settings.

Mobile Health App as an Auxiliary Tool in Management of Atopic Dermatitis in Children: Randomized Controlled Trial.

Mobile health apps can boost treatment adherence and support disease management at home. The Atopic App and web-based Atopic School patient education program offer a chance to enhance adherence to atopic dermatitis (AD) management. We aim to evaluate the feasibility, acceptability, and preliminary efficacy of the Atopic App mobile health intervention in the managing of AD in children. A randomized controlled study in children with AD divided participants into 3 groups: a control group (no app), an observational group with the app, and an interventional group with investigator supervision. Patients were examined at screening and follow-up visits 1 and 2 at 3-month intervals. Outcome measures included SCORAD (Scoring Atopic Dermatitis) for objective severity and Patient-Oriented Eczema Measure (POEM) for subjective effectiveness. Statistical analysis used paired t tests (2-tailed), the Mann-Whitney U test, and multiple regression. Fifty-eight participants entered this study (38 boys and 20 girls): group 1 (control) comprised 17 patients, while experimental groups 2 and 3 consisted of 20 and 21 patients, respectively. The rates of missed appointments were similar and statistically insignificant across the groups. All groups showed a significant decrease in SCORAD and POEM scores (P<.05). Usage of the app for ≥8 days showed a more significant decrease in severity scores compared to those who used it for ≤7 days, or did not use it at all. Participants who used the app for ≥8 days had a median SCORAD of 6.25 (95% CI 4.6-14.1; IQR 4-16.3) at visit 1, significantly lower than nonusers (17.9, 95% CI 13.9-24.0; IQR 13.9-24; P=.03) and those using it ≤7 days (13, 95% CI 9.35-27; IQR 7.2-27; P=.04). Their median POEM of 2 (95% CI 1.0-4.5; IQR 1-5.3) was also significantly lower than those using the app ≤7 days (9, 95% CI 2-12; IQR 2-12; P=.04) and lower, though not significantly, than nonusers (7, 95% CI 1-9; IQR 1-9; P=.14). Additionally, using the Atopic App for ≥8 days after the screening visit strongly predicted a decrease in both SCORAD and POEM scores (P=.01 and P=.04, respectively). The time since the screening visit significantly predicted increased outcome scores, while prescriptions of topical calcineurin inhibitors, oral antihistamines, and oral antibiotics were weak and insignificant predictors of score changes. Our findings indicate that the Atopic App is helpful tool in managing AD in children, and they underscore the potential of mobile health interventions in the disease management.