Follow-up Visit Research Articles

Real-World Effectiveness of Upadacitinib in Moderate‑to‑Severe Atopic Dermatitis (AD): Results From Longitudinal Analyses of the CorEvitas AD Registry

Introduction: Clinical trials demonstrated that upadacitinib is efficacious in treating atopic dermatitis (AD). Its real-world effectiveness is less understood. In this study, we investigated the longitudinal real-world outcomes of upadacitinib-treated adults in the CorEvitas AD Registry. Methods: The CorEvitas AD Registry is a prospective, non-interventional registry of adults diagnosed with AD in the United States and Canada. We evaluated participants enrolled through April 30, 2024 with data available prior to upadacitinib exposure (baseline) and at the six-month follow-up visit, and were receiving upadacitinib at the follow-up visit. Outcomes evaluated include the achievement of: Validated Investigators Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) of “clear” or “almost clear” among participants rated “mild” or worse at baseline (vIGA-AD 0/1); Eczema Area and Severity Index improvement of ≥75%/≥90%/100% from baseline (EASI 75/90/100); Peak Pruritus Numeric Rating Scale (PP-NRS) improvement ≥4 among participants with a score ≥4 at baseline (∆PP-NRS≥4); PP-NRS score of 0 or 1 among participants with a score >1 at baseline (PP-NRS 0/1); Dermatology Life Quality Index (DLQI) score improvement ≥4 among participants with a score ≥4 at baseline (∆DLQI≥4); and DLQI score of 0 or 1 among participants with a score >1 at baseline (DLQI 0/1). Simultaneous achievement of both EASI 90 & PP-NRS 0/1 was also assessed. Data were analyzed as observed with no imputation. Safety events were not assessed in this analysis. Results: The longitudinal analysis included 192 participants (mean age 46.2 years; 57.8% female; 69.8% White; 43.8% prior exposure to dupilumab or tralokinumab; 64.4% receiving 15 mg dose at follow-up visit; mean upadacitinib treatment duration of 6.0 months). More than half achieved clear/almost clear skin (66.1% vIGA-AD 0/1), EASI 75 (69.3%), and EASI 90 (59.2%); 45.3% achieved complete skin clearance (EASI 100). More than 40% reported little-to-no itch (44.4% PP-NRS 0/1) and no impact of AD on quality of life (43.3% DLQI 0/1), and more than half reported meaningful improvements in itch (58.6% ∆PP-NRS≥4) and quality of life (76.0% ∆DLQI≥4). Simultaneous attainment of both EASI 90 & PP-NRS 0/1 was achieved in 46.6% of participants at 6 months. Conclusions: In the real-world setting, the majority of adults treated and remained on upadacitinib achieved clinically meaningful outcomes in skin lesions, itch, and quality of life, with many achieving complete skin clearance, little-to-no itch, and experiencing no impact of AD on their quality of life. These findings underscore upadacitinib's potential to offer multidimensional relief to patients with AD in everyday clinical practice.

Myocardial deformation in children post cardiac surgery, a cross-sectional prospective study

Abstract Background Myocardial deformation by speckle tracking echocardiography provides valuable information on the left ventricular function. The study aims to assess myocardial deformation in terms of left ventricular strain as an indicator of myocardial function in children after cardiac surgery at outpatient follow-up visits. Methods The study design was a prospective observational cross-sectional study that included pediatric patients after biventricular cardiac surgery during the postoperative follow-up visits in the outpatient department. In addition to conventional echocardiographic examination, two-dimensional speckle tracking echocardiography was done to evaluate myocardial deformation in terms of left ventricular strain. Echocardiographic measurements were done offline and were compared to published reference normal values for age. Study subjects were divided according to age at follow-up into four groups (1 month–1 year, 1–2 years, 2–5 years, and 5–11 years). Results Over ten months, 100 patients (64 males and 36 females) were included in the study. The median age was 30.8 months (IQR 12.8–65.3 months), the median weight was 11.7 kg (IQR 8–17 kg) and the median duration after surgery was 7.3 months (IQR 3.2–30.8 months). Longitudinal strain values were significantly (p < 0.001) lower than reference values for different age groups. Global circumferential strain showed no significant difference from the reference values. The duration after surgery had a statistically significant effect on longitudinal strain values, with improvement of the strain values with increasing intervals after surgery. Conclusion Using myocardial deformation method to evaluate cardiac function may detect underlying cardiac function abnormalities even with normal traditional functional parameters, which could have implications for patient management and follow-up.

Predictors of the efficacy of CO2 laser therapy for female stress urinary incontinence

Background: Predictors of the efficacy of a single-session of CO2 laser therapy for female stress urinary incontinence are important for pretreatment consultation. Thus, the objective of this study was to evaluate these predictors. Methods: All consecutive women who underwent vaginal CO2 laser therapy for stress urinary incontinence were prospectively enrolled. Results: The median duration of subjective improvement (defined as ≥1 on the global response assessment) was 18.3 months (95% confidence interval (CI): 12.1 to 18.3 months, n = 75). Multivariable analysis revealed that low voided volume (dL, hazard ratio [HR] = 0.707; area under the curve [AUC] = 0.66, cutoff value of voided volume ≤4.0 dL), high postvoid residual volume (dL, HR = 2.714; AUC = 0.60, cutoff value of postvoid residual volume ≥1.0 dL), and low functional profile length (HR = 0.956; AUC = 0.58, cutoff value of functional profile length ≤2.8 cm) were predictors of subjective failure. A logit(p) = 1.0 - 0.5 x (voided volume) + 0.9 x (postvoid residual volume) can be used to predict failure (HR = 1.775; AUC = 0.71, cutoff value of logit(p) ≥0.0). Pad weights decreased at 3 and 6-month follow-up visits. At 6 months, 8 women (21%) were cured (<1 g pad weight), and 16 women (42%) showed improvement (>50% decrease in pad weight). Overactive bladder symptoms improved at 3 and 6 months. However, there was no change in female sexual function from baseline. Conclusion: A low voided volume and high postvoid residual volume can be used to predict subjective failure after one session of transvaginal CO2 laser therapy. However, the subjective therapeutic effect may diminish within a median duration of 18 months.

Correlation between blepharospasm and psychological diseases: the anxiety, depression and sleep disorder study

AIM: To investigate the relationship between benign essential blepharospasm (BEB) symptoms and depression/anxiety/sleep disorder in a prospective manner and to determine whether treatment the BEB with botulinum toxin type A (BoNT/A) can impact psychological symptoms. METHODS: This prospective interventional case series recruited 61 adults with evidence of BEB. Patients were administered the Jankovic Rating Scale (JRS), the Blepharospasm Disability Index (BSDI), Personal Health Questionnaire Depression Scale (PHQ-8), Generalized Anxiety Disorder 7-item scale (GAD-7) and the Athens insomnia scale (AIS) to evaluate the severity of BEB symptoms, depression, anxiety and sleep disorder before and 1wk, 1, 3mo after the BoNTA treatment. Statistical analysis was performed to assess the relationships between changes in the survey scores. RESULTS: The mean score for JRS, BSDI, PHQ-8, and GAD-7 improved significantly (P<0.0001), respectively, compared to the initial visit at follow-up. At baseline, worse BSDI scores were correlated with worse GAD-7 and PHQ-8, but not with worse AIS. At 1mo follow-up visit, there was no correlation between change in BSDI and PHQ-8/AIS, the change in GAD-7 showed a mild association with change in BSDI. The change in BSDI was correlated with the change in both PHQ-8 and GAD-7 in the subgroup of patients without a prior diagnosis of depression or anxiety. Patient satisfaction with BoNT/A treatment reached the highest at 1mo of follow-up (83.6%, 51/61). CONCLUSION: BEB may lead to psychological diseases. BoNT/A can significantly improve motor and non-motor symptoms of BEB, which emphasize the effectiveness of BoNT/A and therefore pave the way for its use in the field of psychiatry. However, further research is needed to confirm these findings and understand the underlying mechanisms.

Partial Cardiac Denervation to Prevent Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: The pCAD-POAF Randomized Clinical Trial.

Efficient approaches to prevent postoperative atrial fibrillation (POAF) after coronary artery bypass grafting (CABG) are still needed. To investigate whether partial cardiac denervation, achieved by cutting off the ligament of Marshall (LOM) and resecting the fat pad along the Waterston groove, can reduce the risk of POAF following CABG. This single-center, randomized clinical trial enrolled adult patients scheduled for isolated CABG in China. Enrollment was from August 15, 2022, to December 13, 2023; follow-up visits were 30 days after discharge. Participants were randomized into the intervention group (CABG plus partial cardiac denervation) and the control group (CABG only) in a 1:1 pattern. All participants were continuously monitored for the incidence of POAF until day 6 after the operation. The primary end point was the incidence of POAF in 6 days, defined as a supraventricular arrhythmia lasting for more than 30 seconds. The trial enrolled 430 patients (79 [18.4%] female; mean [SD] age, 61.9 [7.8] years). Compared with the control group, the 6-day incidence of POAF was significantly lower in the intervention group (18.1% vs 31.6%; P = .001; risk ratio, 0.57 [95% CI, 0.41-0.81]). To further support these results, a sensitivity analysis performed with Kaplan-Meier survival curves also showed a significant reduction in the occurrence of POAF in the intervention group (hazard ratio, 0.53 [95% CI, 0.36-0.79]; P = .002). Safety assessments showed no difference between the 2 groups, while postoperative medical cost was reduced in the intervention group. This randomized clinical trial found that partial cardiac denervation was an effective procedure to reduce the occurrence of POAF after isolated CABG without additional postoperative complications. These results suggest that partial cardiac denervation may be a good option for cardiac surgeons to consider for preventing POAF after CABG. ClinicalTrials.gov Identifier: NCT05009914.

Endoscopic revision surgery for ossicular chain reconstruction: intraoperative findings and functional outcomes.

To report the intraoperative observations and hearing outcomes in patients undergoing endoscopic revision ossiculoplasty. A retrospective cohort of patients who had undergone revision ossiculoplasty were enrolled in this study. Intraoperative findings were documented. Follow-up visits were scheduled from 3 to 12 months post-surgery to assess hearing levels and record any potential complications. Between April 2020 and May 2023, a total of 26 cases were enrolled, with 11 male patients represented. The mean age of the patients was 40.5 ± 9.4 years, ranging from 18 to 66 years. During the revision surgeries, various intraoperative findings were noted, including adhesive tissues affecting the activity of ossicular chain (observed in 37.0% of cases), tympanosclerosis of the ossicular chain (also in 37.0% of cases), dislocation of ossicular prosthesis (33.3%), erosion of the ossicular chain (33.3%), and identified cholesteatoma (11.1%). In terms of hearing outcomes, a significant improvement was observed. Overall, only 37.0% of patients achieved an air-bone gap of 20 dB or less, indicating the inferior outcome in revision ossiculoplasty. This study highlight the role of inflammatory responses (adhesion, tympanosclerosis), stapes erosion, and prosthesis dislocation, as contributing factors to the failure of primary tympanoplasty. Endoscopic revision ossiculoplasty emerges as a reliable and effective approach.

Life Course Stressors, Latent Coping Strategies, Alcohol Use, and Latent Coping Strategies Among People with HIV.

People with HIV (PWH) have often experienced chronic stressors across their lifespan, including adverse childhood experiences (ACES), lifetime economic hardship (LEH), and concurrent stressors associated with living in urban areas (urban stress). Prolonged exposure to stressors might result in differential coping patterns among PWH that can impact care trajectories. We utilized a life course-informed approach to examine chronic stressors as antecedents of latent coping strategies among PWH in care. High-risk alcohol use and non-adherence to anti-retroviral therapy (ART) were examined as consequences of latent coping strategies. Data were utilized from the baseline and interim follow-up visit of the New Orleans Alcohol Use in HIV (NOAH) study. Three latent classes of coping strategies were identified: avoidance coping (31%), low-frequency coping (43%), and problem-solving coping (25%). Exposure to ACES was associated with greater use of avoidance versus low-frequency coping class at wave II. Urban stress was associated with greater use of avoidance coping compared to problem-solving or low-frequency coping classes at wave II. LEH was associated with greater use of low-frequency coping at wave II. Those utilizing low-frequency coping had a two-fold increase in ART non-adherence compared to problem-solving coping. PWH utilizing avoidance and low-frequency coping had a nearly two-fold increase in high-risk alcohol use versus problem-solving coping. These findings reveal important coping classifications that are linked to stressors across the life course of PWH. An understanding of coping styles and stressors may aid in improving the continuum of care among PWH by reducing alcohol use and improving medication adherence.

Esophageal food bolus impaction in children: A 15-year experience and a review.

We aimed to analyze the episodes of esophageal food bolus impaction (EFI) occurred over a time of 15 years in children admitted to a large pediatric emergency department (PED), documenting their clinical presentation, underlying pathology, management, biopsy rate, and follow-up visits. Additionally, to combine our institutional experience with the existing literature, a comprehensive review was conducted. We reviewed the medical records of all children presenting to our PED with EFI from 2010 to 2024. The comprehensive review was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement for systematic reviews. Electronic databases including PubMed/Medline and EMBASE were screened. The data obtained was synthesized to map out the actual status and current literature on pediatric EFI. We identified 54 cases of EFI. Overall, 22 patients (41%) had underlying pathology. Previous episodes were reported in 14 cases (26%). Urgent endoscopy was performed in 31 cases (57%). The presence of underlying pathology was associated with the need for endoscopic removal (p = 0.013), as well as the history of previous episodes (p = 0.016). Biopsies were performed in 14 cases (26%). Pediatric gastroenterologists showed a higher rate of performed biopsies compared to surgeons, as well as higher rate of follow-up visits. An underlying disease was found during later clinical follow-up in 5 out of 54 cases of EFI (9%). A comprehensive review of 16 studies revealed high rates of underlying pathology and low rates of biopsies and follow-up visits among children with EFI. Increased vigilance in identifying underlying pathologies in children with EFI is crucial. The importance of performing biopsies, regardless of prior anatomical conditions, and the need for ongoing follow-up to ensure timely and accurate diagnoses should be addressed through shared protocols.

Long-Term Disease-Free Survival and Health-Related Quality of Life Results of High-Dose-Rate Brachytherapy as Monotherapy for Low and Intermediate-Risk Prostate Cancer Treated in a Community Cancer Centre

To determine the long-term disease-free survival, long-term toxicity, and effect on health-related quality of life of a two-fraction regimen of high-dose-rate (HDR) prostate brachytherapy. Patients with low- or intermediate-risk prostate cancer were treated with CT-planned HDR brachytherapy as monotherapy in two implants of 13.5 Gy in one community cancer center. Prostate-specific antigen (PSA), International Prostate Symptom Score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires were evaluated at each follow-up visit. Biochemical recurrence (Phoenix definition) was evaluated to determine disease-free survival at 5 and 7 years. Proportion of patients in each IPSS category (mild = 0-7, moderate = 8-18, severe = 19+) was evaluated at each follow-up interval. Thirty patients were accrued to the study between 2014 and 2016. Median prostate-specific antigen was 8,7 (range 4.1-17.5). T stages were T1c = 65%, T2a = 21%, and T2b = 14%. Twenty-seven percent of patients had a Gleason score of 6 and 73% had a Gleason score of 7. 13% were in low risk category and 87% in intermediate risk category. Median follow-up was 84 months. There were no deaths at 84 months after brachytherapy. Disease-free survival was 90% at 5 years and 86% at 7 years. Two patients experienced late Grade 3 GU toxicity (6.6%). This study serves as proof of concept that HDR monotherapy can be performed successfully with excellent long-term outcomes in a community cancer center with adequate training and experience. The long-term disease-free survival rate and the health-related quality of life seem acceptable as compared to other treatment modalities. Further study is ongoing with regard to the optimal dosing regimen for HDR monotherapy.

Addressing unmet social needs of children with obesity: a pilot randomized controlled trial.

Childhood obesity is an ongoing public health crisis, and recent clinical practice guidelines identify addressing the role of social inequities in the disparity of health among children with obesity as an area to address. This study aimed to assess the feasibility of a community navigation intervention in a pediatric weight management clinic. A single-center pilot randomized controlled trial (RCT) recruiting families from a tertiary hospital pediatric weight management program to evaluate the feasibility of a community navigation intervention. The primary feasibility outcomes were recruitment rates (goal to recruit 80% of the sample in 6months), uptake of the intervention (goal > 80% of participants in the intervention group to have a visit with the navigator), and acceptability (goal > 90% of families in the intervention group complete all follow-up). Eighty participants completed the social needs screening, and 42 (52.5%) participants screened positive for an unmet social need. In the first 6months of recruitment, 18 participants were recruited out of a goal of 40 participants (the recruitment rate was 45% vs. the goal of 80% in 6months), and complete recruitment was achieved in 12months. Of the 21 participants randomized to the intervention arm, 20 completed the intervention (uptake of intervention was 95% vs. goal 80%). Ten participants in the intervention arm completed all four planned follow-up study visits (the acceptability of follow-up was 48% vs. the goal of 90%). We completed a pilot RCT of implementing a community navigator program in a pediatric weight management program. We found feasibility in the intervention's uptake but limited feasibility in recruiting participants and the acceptability of the follow-up. Clinicaltrials.gov, NCT04711707, https://clinicaltrials.gov/ct2/show/NCT04711707.

Patient-Reported Outcomes in RLBP1 Retinal Dystrophy: Longitudinal Assessment in a Prospective Natural History Study.

To evaluate the performance of two non-disease-specific patient-reported outcome (PRO) instruments, the National Eye Institute Visual Function Questionnaire-25 (VFQ-25) and the Low Luminance Questionnaire (LLQ), in patients with retinaldehyde-binding protein 1 retinal dystrophy (RLBP1 RD). PROs were assessed using the VFQ-25 and LLQ. Rasch analysis was conducted to estimate person and item measures of the VFQ-25 and LLQ questionnaires to determine the association between the two PROs. In addition, the association between these two instruments and their correlations to weighted measures of visual function and disease progression were analyzed in this three-year PRO-focused sub-study of a five-year prospective natural history study. Forty-two patients participated, with most of them having completed at least two PRO follow-up visits at least one year apart. The mean VFQ-25 scores were lowest for distance activities (39.2-49.0) and peripheral vision (37.5-52.4), with mean LLQ subscale scores generally low (<41), except for the emotional distress subscale. Using Rasch analysis, calibrated item and person measures along with their standard errors were estimated for both ePROs. This indicated that the distribution of the VFQ-25 and LLQ item measures well covered the distribution of person function in this group. This suggests that the item difficulties well cover the person-level performance in this population. As well, the two PROs showed a strong and significant correlation at all assessed time points as assessed with Pearson correlation coefficient (0.81, 0.91, 0.81 and 0.87 at baseline, 1/1.5, 2/2.5 (P < 0.001) and 3/3.5 years (P = 0.002)). The composite scores of both PRO questionnaires strongly correlated with clinical measures of visual function. At 2 to 2.5 years of follow-up, meaningful statistically significant declines in peripheral vision (both VFQ-25 and LLQ), distance vision (VFQ-25), and extreme lighting in dark and bright light (LLQ) subscales were noted. This study demonstrated a strong association between VFQ-25 and LLQ scores and their association with clinical measures of visual function. PRO instruments can provide insights into the specific disabilities of this unique patient population and help to guide appropriate outcome measures for future clinical trials.

α-Synuclein Oligomers in Skin Biopsies Predict the Worsening of Cognitive Functions in Parkinson’s Disease: A Single-Center Longitudinal Cohort Study

α-synuclein oligomers within synaptic terminals of autonomic fibers of the skin reliably discriminate Parkinson’s disease (PD) patients from healthy controls. Nonetheless, the prognostic role of oligomers for disease progression is unknown. We explored whether α-synuclein oligomers evaluated as proximity ligation assay (PLA) score may predict the worsening of cognitive functions in patients with Parkinson’s disease. Thirty-four patients with PD and thirty-four healthy controls (HC), matched 1:1 for age and sex, were enrolled. Patients with PD underwent baseline skin biopsy and an assessment of cognitive domains including Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Clock Drawing Test, and Frontal Assessment Battery. At the last follow-up visit available, patients were either cognitively stable (PD-CS) or cognitively deteriorated (PD-CD). α-synuclein oligomers were quantified as PLA scores. Differences between groups were assessed, controlling for potential confounders. The relationship between skin biopsy measures and cognitive changes was explored using correlation and multivariable regression analyses. The discrimination power of the PLA score was assessed via ROC curve. To elucidate the relationship between skin biopsy and longitudinal cognitive measures, we conducted multivariable regression analyses using delta scores of cognitive tests (Δ) as dependent variables. We found that PD-CD had higher baseline PLA scores than PD-CS (p = 0.0003), and they were correctly identified in the ROC curve analysis (AUC = 0.872, p = 0.0003). Furthermore, ANCOVA analysis with Bonferroni correction, considering all groups (PD-CS, PD-CD, and HC), showed significant differences between PD-CS and PD-CD (p = 0.003), PD-CS and HC (p = 0.002), and PD-CD and HC (p &lt; 0.001). In the regression model using ΔMMSE as the dependent variable, the PLA score was found to be a significant predictor (β = −0.441, p = 0.016). Similar results were observed when evaluating the model with ΔMoCA (β = −0.378, p = 0.042). In conclusion, patients with Parkinson’s disease with higher α-synuclein burden in the peripheral nervous system may be more susceptible to cognitive decline.

The Efficacy of Botulinum Toxin A Injection in Pelvic Floor Muscles in Chronic Pelvic Pain Patients: A Double-Blinded Randomised Controlled Trial.

To evaluate and compare the efficacy and safety of Botulinum Toxin A (BTA) injections versus placebo injections, combined with pelvic floor muscle therapy (PFMT), in women with chronic pelvic pain (CPP). Randomised, double-blinded clinical trial (January 2020-April 2023). This multicentre study was conducted at four hospitals in the Netherlands. Ninety-four women with CPP and increased pelvic floor muscle tone despite previous PFMT, were enrolled. Participants received either BTA injections (100 units) or placebo injections into the pelvic floor muscle, followed by four PFMT sessions. Primary outcomes included the number of women with at least a 33% reduction in pain and those reporting (very) much improvement of their pain. Secondary outcomes covered quality of life and pelvic floor function. Follow-up visits were scheduled at 4, 8, 12, and 26 weeks post-treatment. Mixed models for repeated measurements were used for analysis. A 33% reduction or more in average pain score was reported by 15 participants (33%) after BTA treatment and 9 participants (20%) after placebo treatment (odd ratio placebo/BTA 1.88; 95% CI 0.72-4.90, p = 0.19). In both groups, 8 women (17%) reported their improvement as (very) much better (odd ratio placebo/BTA 0.947; 95% CI 0.32-2.80, p = 0.92). Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo (p = 0.001). The results from this study do not support the use of BTA injections in the management of CPP in women.

Does adjunctive phototherapy have better outcomes than adjunctive antibiotic therapy for the management of peri-implantitis?

Elsevier's Scopus, Web of Science and Pubmed through Medline identified 431 articles, which were reduced to 206 when duplicates were removed. 8 articles were screened, and 1 excluded after reading the full-text, leaving 7 studies. 6 of these were randomised controlled trials, and 1 a non-randomised controlled clinical trial. Studies selected were either blinded, double-blinded, split-mouth clinical studies, comparative or controlled clinical studies, or randomised controlled trials in humans. There were no limitations on year of publication or language of studies. Most studies had a control of mechanical debridement (MD) with adjuvant antibiotics; 1 was surgical therapy. The test group was MD with adjuvant phototherapy. Exclusions were in vitro reports, animal studies, treatment with sole laser therapy, treatment with no additional antimicrobial therapy alongside MD. Pre-prints, reviews, abstracts, opinion articles, editorials, case reports and case series were also excluded. Data were extracted electronically by a single author and a senior librarian from the 3 databases. Titles and abstracts of articles were screened by the author if they contained Medical Subject Headings either in free terms or with Boolean operators. Full text studies that met the inclusion criteria were included. Data were also searched manually in 6 journals. For missing or conflicting information, the author of the article was contacted for clarification. Data extracted were country of origin of article, study design, sample size, research groups, diagnostic criteria, frequency of intervention, follow-up visits, and outcome of parameters which included clinically: plaque index (PI), probing depth (PD), bleeding on probing (BOP) and radiographically: crestal bone loss (CBL). Additional data on lasers were also collected, although not all studies had complete data on this. RevMan was used for statistical analysis. Inconsistencies were evaluated using I2 value > 50% and Cochrane's Q test, with a P value < 0.05 considered. Standard Mean Differences (SMD) were calculated and Confidence Interval was set at 95%. A random effects model was used for each meta-analysis. PI had no statistical difference, with high heterogeneity. PD had no statistical difference, with no heterogeneity. BOP had a statistically significant difference and a high level of heterogeneity, favouring adjunctive phototherapy. MBL had statistically non-significant differences between control and test groups, and no heterogeneity. The findings from the systematic review differed from the meta-analysis, suggesting that application of adjuvant phototherapy was equally as effective as adjunctive antibiotic therapy in outcomes such as PI, PD, BOP and MBL. The meta-analysis found that implants treated with adjuvant phototherapy had superior outcomes in relation to BOP only.

Cost analysis of adding hypertension and diabetes management into routine HIV care in Mbarara and Ibanda districts, Uganda.

In 2016, Uganda introduced services for hypertension and diabetes in selected HIV clinics. We evaluated the costs associated with scaling up these services in HIV clinics in Mbarara and Ibanda districts, Uganda. We estimated the annual costs of providing hypertension and diabetes services using an activity-based costing approach from the health system perspective in ten randomly selected HIV clinics in Mbarara and Ibanda districts. Cost inputs included 2023 data on costs of medications, health provider time, salaries, training costs, and monitoring costs. We determined the average annual cost and medication costs for hypertension and diabetes treatment per enrolled adult patient, stratified by type of health facility. The total annual cost of hypertension and diabetes management services in ten selected HIV clinics was estimated to be $413,850 (range: $8,386 - 186,973). The annual average clinic-level cost per enrolled patient was estimated at $14 (range: $7 - 31). Of the total annual cost, the cost of provider time for initial and follow-up visits represented the largest cost component in 5/10 clinics (mean: 37%, range [13-58%]). In 4/10 clinics, the major cost components were the costs of medication, diagnostic tests, and related supplies (mean: 37%, range [10-75%]). The average cost per enrolled adult patient was $11 at public facilities and $21 in private not-for-profit facilities. The average medication cost per patient for hypertension was $24 (range: $7 - 97) annually; $13 at public facilities and $50 at private not-for-profit facilities. For diabetes treatment, the average annual medication cost per patient was estimated at $14 (range: $6 - 35); $11 at public facilities and $22 at private not-for-profit facilities. Adding hypertension and diabetes management to routine HIV care might be feasible based on the estimated annual cost per patient. Hypertension and diabetes treatment was more costly in private not-for-profit facility-based clinics than at public facilities. This variation was primarily driven by higher medication procurement prices at private facilities, revealing a potential area for optimizing costs through improved procurement practices.

Decentralization Matters: Association of Adherence to Treatment and Distance for the Management of Non-Communicable Diseases in Rural Tanzania

Since March 2019, a non-communicable diseases program has been established at hospital level, with enrollment and clinical reassessment every 6 months. Since July 2023, monthly enrollment and visits have also been conducted at health center level. This study aimed at assessing the adherence to scheduled follow-up visits following the decentralization of the integrated NCDs program from Hospital to Health Center level and investigate factors influencing follow-up adherence. The study was performed in a rural district in Iringa Region, Tanzania. Adherence was measured at both levels. Multivariate regression analysis was conducted to describe socio-demographic and clinical factors influencing attendance at the 6-month hospital-level visit. Among 2198 patients enrolled at the hospital level, weighted adherence over 42 months was 40.8% (95% CI 39.0–42.6%) at the 6-month visit. Multivariate analysis revealed that as the distance from the hospital increased, the probability of attendance decreased (OR 0.17; 95% CI: 0.08–0.39). Among 571 patients enrolled at the residence level, adherence over the first 10 months of program implementation was 91.6% (90.4–92.8%). The findings showed that distance was by far the most important barrier to follow-up adherence and suggested that decentralizing the program from the hospital to peripheral health centers may ensure high follow-up rates.

Clinical effect of indirect moxibustion with Taiyi moxa stick in treatment of back myofascitis: a randomized controlled trial

To observe the impact of indirect moxibustion with Taiyi moxa stick on pain severity and the quality of life in the patients with back myofascitis, and evaluate its clinical effect and safety. Seventy-two patients with back myofascitis were randomly divided into an observation group (36 cases, 1 cases dropped out) and a control group (36 cases, 3 cases dropped out). Three to six ashi points were selected using acupoint diagnosis methods. In the observation group, the indirect moxibustion with Taiyi moxa stick was operated at the ashi points, once every other day, three times a week. In the control group, the topical treatment with diclofenac sodium gel was given at ashi points, three times daily. The treatment was delivered consecutively for 2 weeks in the two groups. The scores of visual analogue scale (VAS) and the short-form McGill pain questionnaire (SF-MPQ) were recorded before treatment, after 1 and 2 weeks of treatment, and after 4 weeks of treatment completion (follow-up visit) in the two groups separately. The difference value between VAS score after 2 weeks of treatment and that before treatment was taken as the primary outcome. The SF-36 score was observed before treatment, after 2 weeks of treatment and during the follow-up visit, and the safety was evaluated in the two groups. The difference value of VAS scores was (-4.57±1.50) points and (-2.40±1.31) points in the observation group and the control group, respectively, the reduction of the score in the observation treatment was larger than that of the control group (P<0.001). After 1 and 2 weeks of treatment and during the follow-up visit, VAS and SF-MPQ scores were reduced when compared with those before treatment (P<0.05) in the two groups, and VAS and SF-MPQ scores in the observation group were lower than those in the control group (P<0.05). In the follow-up visit, VAS and SF-MPQ scores in the observation group were dropped in comparison with those after 1 week of treatment (P<0.05), and these scores in the control group were elevated compared with those after 2 weeks of treatment (P < 0.05). After 2 weeks of treatment and during the follow-up visit, the score of each dimension and total score of SF-36 scale were increased in comparison with those before treatment in the observation group (P<0.05); and the scores of the dimensions except that of mental health of SF-36 scale were elevated in the control group (P<0.05). During the follow-up visit, in the control group, the scores of physical functioning, bodily pain, general health and role emotional were elevated when compared with those before treatment (P<0.05). After 2 weeks of treatment and during the follow-up visit, the score of every dimension and total score of SF-36 scale in the observation group were higher than those in the control group (P<0.05). During the follow-up visit, the score of bodily pain was increased when compared with that after 2 weeks of treatment in the observation group (P<0.05), while the scores of bodily pain and vitality were dropped in the control group (P<0.05). No adverse event happened in the two groups. The indirect moxibustion with Taiyi moxa stick effectively reduces pain severity and improves the quality of life in the patients with back myofascitis. This therapy presents the superior and persistent effect compared with topical application of diclofenac sodium gel.

Abstract 4136869: Time Course and Predictors of PVC Recurrence After Acutely Successful Catheter Ablation

Introduction: In prior studies, predictors of long-term success following acutely successful radiofrequency (RF) ablation have included female-sex, single-PVC morphology and EGM-QRS &gt; 24ms. Time course and predictors of PVC recurrence following acutely successful ablation has been less well documented. Use of extended ambulatory monitoring in the immediate post-procedural period can help to identify those with early recurrence. Goals: To define time to recurrence and predictors of recurrence of PVCs after RF ablation following acutely successful ablation. Methods: Consecutive patients from January 1 st , 2016 through December 31 st , 2023 undergoing PVC ablation with available post-ablation extended ambulatory monitoring (Zio, iRhythm, San Francisco, CA) were retrospectively analyzed. Recurrence was defined as an increase in PVC burden to &gt;5% during monitoring after acute success or failure to have sustained reduction in PVC burden of &gt;80%. Acute success was defined as elimination of the targeted PVC after the last ablation lesion. Long-term succes was defined as absence of targeted PVC's during all follow-up visits and PVC-burden &lt; 5% on follow-up monitoring. Results: Among 121 patients who underwent successful PVC ablation, 101 (83.4%) had long-term success and 20 (17%) had recurrence. Patients with recurrence were older (62.4 ± 12 vs 55 ± 13., p = 0.019), had a higher incidence of CAD (13 (13%) vs 9 (45%), p = 0.001) and CHF (40 (40%) vs 15 (75%), p = 0.004). At time of ablation, the recurrence group was also more likely to have &gt;1 PVC morphology (6 (6%) vs 8 (40%), p = &lt;0.001). Location and earliest activation time of the predominant PVC were not assocated with likelihood of recurrence. Within the recurrence group, 13 (65%) had recurrence in the immediate 2 week post-procedural period with an average time to recurrence of 3.9 days. Conclusion: Recurrence occured in slightly less than 20% of cases with a relatively high proportion of those occuring within the immediate 2 week post-procedural period during extended ambulatory monitoring. The presence of greater than 1 PVC morphology at time of ablation is a risk factor for recurrence suggesting a higher likelihood of acute suppression without durable resolution in those instances.

Abstract 4145819: Reducing the Burden of the Opioid Epidemic by Adopting a Novel Pain Control Strategy Utilizing Pectoral Nerve Block in Adults Undergoing Transvenous Cardiac Device Implants

Introduction: Despite early mitigation efforts, the opioid pandemic in the United States has persisted and affected many Americans. A public health emergency was declared urging all prescribers to use caution in prescribing opioids. Alternative approaches to postoperative pain management during transvenous cardiac device implants (TCDI) in adults have not been described. Methods: We report a single-center retrospective analysis of 612 consecutive patients that underwent TCDI between January 2021 and January 2024 with ultrasound guided pectoral nerve block (PNB) using liposomal bupivacaine prior to implant for postoperative pain management. Pain scores (0-10) were recorded systematically in the postoperative period, at discharge, and at wound check follow-up. Any need for opioid use in the postoperative period was recorded as well. Results: A total of 612 patients were evaluated, 50% female with a mean age of 71.2 years. All patients received PNB successfully with no device site infection or hematomas. The mean Visualized Analog Scale (VAS) pain scores at 1, 3, and 5 hours after the procedure, at discharge, and at the follow-up visit were 1.93, 1.22, 1.10, 1.05, and 0.13 respectively. During follow-up, no patients required opioids for pain control throughout the entire postoperative period of 14 days. Conclusion: Pectoral nerve block with liposomal bupivacaine can be performed safely preoperatively during TCDI and provides adequate pain control without need for opioid use postoperatively. Further research is needed to assess broad scale implications of this approach to larger patient populations.

Abstract 4138593: Sex-, Age-and Racial- specific disparities, echocardiographic myocardial mechanics and biomarkers, and 1-year survival among patients with heart failure.

Background: Heart failure with reduced ejection fraction (HFrEF) is a global health burden affecting millions worldwide, particularly among resource constrained communities. Information is limited regarding addative prognostic relations of sex -, age- and racial- differences, myocardial mechanics and biomarkers, in HFrEF. Aim: Assess prognostic implications of sex-, age- and racial- related disparity in HFrEF; and additive prognostic implications of these parameters to other markers including echocardiography (myocardial mechanics). Methodology: The HFrEF patients’ data were prospectively evaluated during the initial assessment and those hospitalized, and subseguently followed for at least 12months. Patients' KCCQ and EQ-5D-5L Questionnaires were assessed during the initial evaluation and follow-up. Sex, age and racial/ethnic disparities, in-hospital management, follow-ups, health status and 1year mortality were assessed. These parameters were further assessed in addition to biomakers and echocardiographic parameters including LV and RV systolic and distolic strain. Multivariable Cox regression models were fitted to investigate additive prognostic differences. Results: The study population consisted mainly of blacks and major factors were hypertension, diabetes, mitral valve disease, and older age (p&lt;0.0001). Of the initial 2642 screened, only 1883 completed the 1year follow-up visit (mean LVEF 38%). Women were likely to have hypertension, atrial fibrillation and diabetes (p&lt;.001). Rheumatic or valvular heart diseases were more commonly identified among younger, black ethnicity, and males patients. No demonstrated sex differences in functional class and biomarkers including NT-proBNP levels. Men demonstrated significant risk for one-year mortality than women, as was black ethnicity and older age. Impaired strain parameters (RV&gt;LV systolic) were independent risk factors for poor survival, more so when added to sex, racial ethnicity, age and biomarkers i.e. the NT-proBNP levels. Conclusion: The prevalence of HFrEF was higher than anticipated. Men, black ethnicity and older age were associated with a high one-year mortality. Impaired strain (RV&gt;LV systolic) parameters were independent risk factors for poor survival, with additive prognostic implications to sex, racial ethnicity, age and traditional biomarkers. These parameters should be assessed routunely to risk stratify HFrEF patients earlier during their disease course.