Moderate Baseline Research Articles

Mitral and aortic valve regurgitation following surgical and transcatheter perimembranous ventricular septal defect closure in children and adolescents: midterm outcomes

BackgroundClosure of perimembranous ventricular septal defects (pmVSD), either surgical or percutaneous, might improve or cause new-onset mitral regurgitation (MR) and aortic regurgitation (AR). We aimed to evaluate the changes in MR and AR after pmVSD closure by these two methods.Material and methodWe performed a comparative retrospective data review of all pediatric patients with pmVSDs treated at our institution with surgical or antegrade percutaneous methods from 2014 to 2019 and 146 consecutive patients under 18 years were enrolled. We closely looked at the mitral and aortic valve function after repair. Included patients had no or lower than moderate aortic valve prolapse and baseline normal mitral or aortic valve function or less than moderate MR or AR.ResultsOut of 146 patients, 83 (57%) pmVSDs were closed percutaneously, and 63 (43%) pmVSDs were closed surgically. 80 and 62 patients were included for MR evaluation, and 81 and 62 patients for AR evaluation in percutaneous and surgical groups. The mean follow-up time was 40.48 ± 21.59 months in the surgery group and 20.44 ± 18.66 months in the transcatheter group. Mild to moderate degrees of MR and AR did not change or decreased in most patients. In detail, MR of 70% and AR of 50% of the valves were resolved or decreased in both groups. 13% of patients with no MR developed trivial to mild MR, and 10% of patients with no AR showed mild to moderate AR after pmVSD closure in both methods. There was no significant difference between the two methods regarding emerging new regurgitation or change in the severity of the previous regurgitation.ConclusionpmVSD closure usually improves mild to moderate MR and AR to a nearly similar extent in both percutaneous and surgical methods among children and adolescents. It might lead to the onset of new MR or AR in cases with no regurgitation.

A gender-sensitive analysis of the feasibility and benefit of a psychological intervention for patients with advanced cancer

Background: The role of gender in psychotherapy has been widely recognized but infrequently investigated in psychotherapy trials. We conducted a secondary analysis of data from a randomized controlled trial of Managing Cancer and Living Meaningfully (CALM), a supportive-expressive intervention for individuals with advanced cancer, to examine gender effects in the feasibility, acceptability, perceived benefit, and effectiveness of CALM. Methods: Trial participants, outpatients with advanced cancer (N = 305, 40% men and 60% women), completed measures at baseline, 3 months (t1), and 6 months (t2). We investigated gender differences in participation rates, attrition rates, number of CALM sessions received, and perceived benefit of CALM. Separate subgroup analyses of data and gender × treatment group moderator analyses from men and women were compared in examining treatment effects on depressive symptoms, end-of-life preparation, and death anxiety at each follow-up period. Results: No gender differences were observed in participation or attrition rates, number of CALM sessions received, or perceived benefit of CALM. In subgroup analyses at t2, men in CALM reported significantly lower depressive symptoms than men in usual care (UC; P = .017), women in CALM with moderate baseline death anxiety reported lower death anxiety than women in UC (P = .009), and both men (P = .022) and women (P = .016) in CALM reported greater end-of-life preparation than those in UC. There were no significant gender × treatment group interaction effects on any outcome. Conclusions: CALM therapy is feasible, acceptable, and beneficial on different outcomes for men and women. Further clinical trials with comprehensive measures of gender identity are needed to evaluate gender effects in psychotherapeutic interventions for patients with advanced disease.

An assessment of short- and long-term efficacy of local corticosteroid injection in patients with lateral epicondylitis

Aim of the study: An assessment of short- and long-term efficacy of local corticosteroid injection in patients with lateral epicondylitis (tennis elbow) based on The Disabilities of the Aim, Shoulder and Hand (DASH) questionnaire and Visual Analogue Scale (VAS), as well as an assessment of long-term treatment efficacy depending on baseline ultrasound disease activity. Materials and methods: A total of 32 patients presenting with tennis elbow and increased blood flow on ultrasound who were treated with local corticosteroid injection were included in the study. Baseline increase in blood flow, pain severity, upper limb function and the subjective response to treatment at 2 weeks (short-term outcomes) and 6 months (long-term outcomes) were assessed. Results: Short-term improvement was achieved in all patients. Long-term improvement was observed in 24 (75%) patients with lower baseline DASH and VAS. Long-term improvement was achieved in 15 (94%) patients in the group with low to moderate baseline disease activity on power Doppler ultrasound (16 patients) and in only 9 (54%) patients in the group with high baseline Doppler disease activity (16 patients). Conclusions: Local corticosteroid injection in patients with tennis elbow who present with increased baseline vascularity on ultrasound seems show short-term efficacy. Negative long-term prognostic factors seem to include significantly increased baseline vascularisation and high baseline DASH and VAS scores. Therefore, it seems reasonable to evaluate these factors before treatment onset, and if abnormalities are found, intensification of treatment or switch to another therapeutic option should be considered.

Association of time-varying changes in physical activity with cardiac death and all-cause mortality after ICD or CRT-D implantation.

OBJECTIVETo evaluate the association of longitudinal changes in physical activity (PA) with long-term outcomes after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implantation.METHODSPatients with ICD/CRT-D implantation from SUMMIT registry were retrospectively analyzed. Accelerometer-derived PA changes over 12 months post implantation were obtained from the archived home monitoring data. The primary endpoints were cardiac death and all-cause mortality. The secondary endpoints were the first ventricular arrthymia (VA) and first appropriate ICD shock.RESULTSIn 705 patients, 446 (63.3%) patients showed improved PA over 12 months after implantation. During a mean 61.5-month follow-up duration, 99 cardiac deaths (14.0%) and 153 all-cause deaths (21.7%) occurred. Compared to reduced/unchanged PA, improved PA over 12 months could result in significantly reduced risks of cardiac death (improved PA ≤ 30 min: hazard ratio (HR) = 0.494, 95% CI: 0.288−0.848; > 30 min: HR = 0.390, 95% CI: 0.235−0.648) and all-cause mortality (improved PA ≤ 30 min: HR = 0.467, 95%CI: 0.299−0.728; > 30 min: HR = 0.451, 95% CI: 0.304−0.669). No differences in the VAs or ICD shocks were observed across different groups of PA changes. PA changes can predict the risks of cardiac death only in the low baseline PA group, but improved PA was associated with 56.7%, 57.4%, and 62.3% reduced risks of all-cause mortality in the low, moderate, and high baseline PA groups, respectively, than reduced/unchanged PA.CONCLUSIONSImproved PA could protect aganist cardiac death and all-cause mortality, probably reflecting better clinical efficacy after ICD/CRT-D implantation. Low-intensity exercise training might be encouraged among patients with different baseline PA levels.

Upregulation of PSMA Expression by Enzalutamide in Patients with Advanced mCRPC.

Simple SummaryThe prostate-specific membrane antigen (PSMA) which shows overexpression on the cell surface of prostate cancer cells, provides a specific target for molecular imaging and radioligand therapy. In this study, we investigated PSMA upregulation by enzalutamide, an established androgen axis drug, in a cohort (n = 30) of patients with advanced, metastatic, castration-resistant prostate cancer (mCRPC). Our results show that short-term enzalutamide medication significantly increases PSMA expression in patients with mCRPC. Therefore, enzalutamide may provide a potential enhancer medication for PSMA-targeted radioligand therapy.In this study, we investigated upregulation of prostate-specific membrane antigen (PSMA) by enzalutamide in a cohort (n = 30) of patients with advanced metastatic castration-resistant prostate cancer (mCRPC). Patients were examined by [68Ga]Ga-PSMA-11 PET/CT pre- and post-enzalutamide medication (mean 13 ± 7 days). Imaging results were compared based on quantification of whole-body PSMA tumor burden: total lesion PSMA (TLP) and normalized TLP values to liver (TLP-LR) and to parotid gland (TLP-PR). In addition, lesion-based analyses were performed. The median (mean) increases in TLP, TLP-LR and TLP-PR after enzalutamide medication were 10.1% (20.2%), 29.5% (34.8%) and 27.6% (24.4%), respectively. These increases were statistically significant (p = 0.002, p < 0.001, and p < 0.001), while prostate-specific antigen (PSA) serum values did not change significantly (p = 0.483). The increase was independent of prior patient exposure to enzalutamide. SUVmax increased substantially (>10%) in 49.6% of target lesions. The relative change was significantly higher in the subgroup of lesions with SUVmax < 10 (p < 0.001). In conclusion, short-term enzalutamide medication significantly increases PSMA expression in patients with mCRPC, irrespective of prior enzalutamide exposure. The relative PSMA upregulation effect seems to be more pronounced in lesions with only moderate baseline PSMA expression. Enzalutamide may provide a potential enhancer medication for PSMA-targeted radioligand therapy.

Nociception level index variations in patients with complex regional pain syndrome: a pilot study.

The nociception level index (NOL) is a multi-parameter index that incorporates changes in autonomic parameters to evaluate nociception, with more painful stimuli causing more pronounced index variations. How this nociception monitor relates to the pain experience is uncertain, and patients with chronic pain may respond differently to acute pain due to alterations in pain processing. The goal of this pilot study was to evaluate NOL index variations after a painful physiotherapy exercise in patients with upper limb complex regional pain syndrome. Baseline NOL indexes were recorded using a finger probe (PMD-200™Monitor, Medasense, Israel) and patient reported baseline pain scores using an 11-point numeric rating scale (NRS). Patients then performed a painful physiotherapy exercise and NOL index and pain scores were again recorded. The same procedure and recordings were repeated after a stellate ganglion block. Data were analyzed using a paired Student T test and a P value < 0.05 was considered statistically significant. Twenty patients (12/20 female, 10/20 right-sided) were included in this study. Patients reported moderate baseline pain (4.0 ± 2.7) despite having a low baseline NOL index (7.66 ± 5.76 out of 100). NRS and NOL index scores increased significantly during exercise, both before and after the block. The NOL index increased significantly when patients reported increased pain, indicating that it could eventually be useful in the objective assessment of acute pain in the chronic pain patients. However, NOL index was not able to reflect pain levels at rest, before the painful stimulation, in this chronic pain population. Further studies are needed to better assess NOL index utility at rest and to confirm these findings in this specific chronic pain population.

Vitamin D Supplementation for the Treatment of Depressive Symptoms in Women with Type 2 Diabetes: A Randomized Clinical Trial.

Aim To determine the efficacy and safety of vitamin D3 supplementation in reducing depressive symptoms in women with type 2 diabetes (T2D), depression, and low vitamin D. Methods In this double-blind randomized active comparator-controlled trial, women with significant depressive symptoms as assessed by the Center for Epidemiologic Studies Depression (CES-D) scale received weekly oral vitamin D3 supplementation (50,000 IU) or an active comparator (5,000 IU) for 6 months. Assessments of vitamin D, 25-hydroxyvitamin D [25 (OH) D], and depression were measured at baseline, 3 months, and 6 months. Results A total of 129 women were randomized, from which 119 completed the study (57 in lower dose and 62 in higher dose). Participants had an average 25 (OH) D and HbA1c of 20.8 ng/mL and 7.8%, respectively, at baseline. They were diverse (48% Black) and had a mean age of 50 and T2D for about 8 years. Upon completion of vitamin D3 supplementation, serum 25 (OH) D levels increased with 50,000 IU (+34 ng/mL) and 5,000 IU (+10 ng/mL). There was no difference in CES-D scores by treatment dose. Overall, depressive symptoms significantly improved over time with an average CES-D decline of 12.98 points (95% CI: −15.04 to −10.93; p < 0.001). Among women with moderate baseline depressive symptoms, those receiving the lower dose had nominally lower depression scores at follow-up than those in the higher dose cohort. Among women with severe baseline depressive symptoms, the improvement in follow-up depression scores was the same regardless of dose. Conclusions There was no difference in the dosing effect of vitamin D3 supplementation for the treatment of depressive symptoms in women with T2D who present with significant symptoms and low vitamin D. Regardless of the dose, participants' mood improved over time. Further study of vitamin D to target depressive symptoms in comorbid populations is needed.

Performance of the Modified Adult Spinal Deformity Frailty Index in Preoperative Risk Assessment.

Retrospective single-center, consecutively enrolled database of adult spinal deformity (ASD) patients. The aim of this study was to assess the performance of the mASD-FI in predicting clinical and patient-reported outcomes after ASD-corrective surgery. The recently described modified Adult Spinal Deformity frailty index (mASD-FI) quantifies frailty of ASD patients, but the utility of this clinical prediction tool as a means of prognosticating postoperative outcomes has not been investigated. ASD patients with available mASD-FI scores and HRQL data at presentation and 2-years postop were included.Patients were stratified by mASD-FI score using published cutoffs: not frail (NF <7), frail (F, 7-12), severely frail (SF, >12). Analysis of vaiance assessed differences in patient factors across frailty groups. Linear regression assessed the relationship of mASD-FI with length of stay (LOS) and HRQLs. Multivariable logistic regression revealed how frailty category predicted odds of complications, infections and reoperation. A total of 509 patients included (59 years, 79%F, 27.7 kg/m 2 ). The cohort presented with moderate baseline deformity: sagittal vertical axis (83.7 mm ± 71), PT (12.7° ± 10.8°), PI-LL (43.1° ± 21.1°). Mean preoperative mASD-FI score was 7.2, frailty category: NF (50.3%), F (34.0%), SF (15.7%).Age, BMI, and Charlson Comorbidity Index increased with frailty categories (all P < 0.001); however, fusion length ( P = 0.247) and osteotomy rate ( P = 0.731) did not. At baseline, increasing frailty was associated with inferior Oswestry Disability Index (ODI), EuroQol 5-Dimension Questionnaire (EQ-5D), SRS-22r, Pain Catastrophizing Scale, and NRS Back and Leg (all P < 0.001). Greater frailty was associated with increased LOS and reduced postoperative HRQL. Controlling for complication incidence, baseline mASD-FI predicted 2 year postop scores for year ODI (b = 0.7, 0.58-0.8, P < 0.001) SRS (b = -0.023, -0.03 to -0.02, P < 0.001), EQ-5D (b = -0.003, -0.004 to -0.002, P < 0.001). F and SF were associated with greater odds of unplanned revision surgery and complications. Higher preoperative mASD-FI score was associated with significantly greater complications, higher rate of unplanned reoperations and lower postoperative HRQL in this investigation. The mASD-FI provides similar prognostic utility while reducing burden for surgeons and patients.

Free Papers Compiled

Background:Antidepressant treatment response can be estimated by tracking the course of symptom change over a series of treatment sessions. However, many prognostic factors can influence response trajectories, and patients with depressive and anxiety symptoms may respond differently to the same antidepressant treatment.Methods:Repeated measurements of Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) scores were used to track the symptoms and severity of depression and anxiety in patients for 12 weeks after initiating an antidepressant treatment. Group-based trajectory modeling was used to generate trajectories that cluster patients with similar trends in symptom progression. Finally, multinomial logistic regression was used to explore associations of various baseline patient characteristics with the different trajectories.Results:Of the 577 participants, 373 (64.64%) were female, and the mean age was 39.34 (SD: 12.87) years. Six depression trajectory subgroups were identified, which included three subgroups that responded to antidepressant treatment and three other subgroups that showed nonresponse. In particular, for three responded subgroups: one group with severe baseline depression showed a steady, yet substantial improvement in symptoms (n=49, 8.49%). Two groups with moderate baseline depression showed more rapid response (n=93, 16.12%) and remission (n=106, 18.37%). For three nonresponse subgroups: one group had severe baseline symptoms (n=62, 10.75%), and two groups had moderate baseline symptoms (n=137, 23.74% and n=130, 22.53%). Similar patterns were also observed in anxiety trajectories, which included six trajectory subgroups. In particular, three subgroups demonstrated response to antidepressant treatment: two groups with severe baseline anxiety showed a rapid response (n=100, 17.33%) and remission (n=66, 11.44%), and one group with moderate baseline anxiety also achieved remission (n=93, 16.12%). The three nonresponse subgroups included one group with severe baseline anxiety (n=106, 18.37%) and two groups with moderate baseline anxiety (n=97, 16.81% and n=115, 19.93%). Anxiety nonresponse was typically associated with higher pre-treatment depression severity, poorer sleep quality, healthier lifestyle, lower pre-treatment anxiety severity, and non-white race.Discussion:The observed trajectory patterns demonstrate one example of the various paths to improvement or maintenance in depression and anxiety. This analysis sheds light on the often overlooked heterogeneity between depression and anxiety and illustrates that treatments suitable for one condition alone may be insufficient for addressing symptoms of the other.

Subkilometer scale ionospheric studies at the SKA-Low site, using MWA extended baselines

The ambitious scientific goals of SKA require a matching capability for calibration of instrumental and atmospheric propagation contributions as functions of time, frequency and position. The development of novel calibration algorithms to meet these requirements is an active field of research. In this work {we aim to characterize} these, focusing on the spatial and temporal structure scales of the ionospheric effects; ultimately, these provide the guidelines for designing the optimum calibration strategy. We used empirical ionospheric measurements at the site where the SKA-Low will be built, using MWA Phase-2 Extended baseline observations and the station-based Low-frequency Excision of Atmosphere in Parallel (LEAP) calibration algorithm. We have done this via direct regression analysis of the ionospheric screens and by forming the full and detrended structure functions. We found that 50% of the screens show significant non-linear structures at scales >0.6km that dominate at >2km, and 1% show significant sub-minute temporal changes, providing that there is sufficient sensitivity. Even at the moderate sensitivity and baseline lengths of MWA, non-linear corrections are required at 88 MHz during moderate-weather and at 154 MHz during poor weather, or for high SNR measurements. Therefore we predict that improvements will come from correcting for higher-order defocusing effects in observations with MWA Phase-2, and further with new developments in MWA Phase-3. Because of the giant leap in sensitivity, the correction for complex ionospheric structures will be mandatory on SKA-Low, for both imaging and tied-array beam formation.

Improvement in Disease Severity and Pruritus Outcomes With Crisaborole Ointment, 2%, by Baseline Atopic Dermatitis Severity in Children and Adolescents With Mild-to-Moderate Atopic Dermatitis

To assess improvement of mild-to-moderate atopic dermatitis (AD) disease severity and pruritus with the use of crisaborole ointment 2%.In the study, the researchers included pediatric patients aged ≥2 years with mild-to-moderate AD from 2 phase 3 studies. The severity of AD was determined by Investigator’s Static Global Assessment (ISGA) score.Patients were randomly assigned 2:1 to receive either crisaborole or vehicle twice daily applied to affected areas (excluding the scalp) for 28 days in 2 identically designed, multicenter, double-blinded, vehicle-controlled phase 3 study. The ISGA outcomes included the number of patients and time to reaching an ISGA score of clear (0) or almost clear (1) with ≥2-grade improvement from the baseline. Moreover, on study days 8, 15, 22, and 29, investigators evaluated the share of patients achieving ISGA clear or almost clear and/or ≥1-grade improvement in ISGA. The Severity of Pruritus Scale (SPS) outcomes included the number of patients who reach SPS success. SPS success was defined as SPS score ≤ 1with ≥ 1-grade improvement from baseline and the time to reach that success. Furthermore, at weeks 1, 2, 3, and 4, the proportion of patients attaining a ≥1-grade improvement in SPS score from the baseline were stratified. An electronic diary was used by patients or caregivers to evaluate SPS twice daily through day 29. If there were <2 SPS assessment entries on day 1 for a patient, they were excluded from the data set.Of the 1016 patients enrolled, 874 (86%) were pediatric ages 2 to 17 years and included in this post hoc subanalysis. Demographics and baseline disease characteristics were similar between both study arms. Irrespective of the baseline disease severity, a significantly greater proportion of crisaborole-treated patients reached ISGA success on day 8, when compared with vehicle-treated patients. This significant difference continued to be true for those patients with moderate baseline ISGA until day 29. However, after day 8, those with a mild baseline ISGA did not have a significant ISGA difference until day 22. Throughout the study, a significantly larger number of the crisaborole-treated arm reached ISGA clear or almost clear compared with the vehicle-treated arm in both baseline disease severity subgroups. Similarly, in both disease severity groups, crisaborole-treated patients achieved a ≥1-grade improvement in ISGA, compared with that of vehicle-treated patients. SPS outcomes also revealed significant improvement in the crisaborole-treated arm, compared with that of the vehicle-treated arm, on day 8. These SPS outcomes persisted again for the moderate baseline ISGA subgroups through the end of the study. Furthermore, crisaborole-treated patients of both subgroups achieved a ≥1-point SPS score improvement in a significantly shorter median time than vehicle-treated patients did.Pediatric patients with mild-to-moderate baseline AD saw an improvement in ISGA and SPS outcomes with the use of crisaborole.With this study, the authors continue to prove crisaborole as a suitable choice as a nonsteroid management option for mild-to-moderate AD. Naturally, independent studies in which researchers comparing crisaborole to corticosteroid standard of care options as well as time to reoccurrence of flares would be of value.

Abstract 10648: The Presence of Iatrogenic Atrial Septal Defect Does Not Affect the Right Ventricular Strain Function in Patients with More Than Moderate Tricuspid Regurgitation

Background/Introduction: More than moderate tricuspid regurgitation (TR) at baseline is associated with worse outcome in MitraClip patients. The presence of iatrogenic ASD (iASD) may cause right-sided volume overload and lead to adverse events. However, the real effects of iASD are not well-investigated in these patients who are vulnerable to right-sided volume overload. Methods: Patients with more than moderate TR who underwent a successful MitraClip procedure in the period from June 2014 to September 2020 were identified from the Mayo institutional NCDR database. Follow-up transthoracic echocardiography (TTE) at about 1 year after the procedure was used to determine the presence of iASD, and speckle-tracking strain analysis was done. Patients were grouped according to the presence of iASD (iASD+ group vs. iASD- group) for statistical analysis. Results: A total of 141 consecutive patients were included for the final analysis (iASD+ group n=44 and iASD- group n=97). The mean age was 79.3 ± 8.8 years, and 72.3% were male. Follow-up echocardiography and speckle-tracking strain data did not show a significant difference in either left or right ventricular function in conventional echocardiographic parameters and strain. LA reservoir strain (13.7 ± 6.9 vs 11.5±7.5, P=0.0418) was the only parameter with significant difference among the two groups. Details are summarized in Table 1 . Conclusion: The presence of iASD can decompress the left atrium, but does not affect left or right ventricular strain function in MitraClip patients with more than moderate baseline TR.

The impact of substrate and trigger ablation for reduction of functional mitral regurgitation in patients with persistent atrial fibrillation

Abstract Background Functional mitral regurgitation (FMR) is not uncommon in atrial fibrillation (AF) patients. Left atrial (LA) substrate remodeling and corresponding mitral valve annulus dilation has been reported as the most possible cause of FMR. Percutaneous catheter ablation (CA) is an effective treatment for AF. Although significant FMR could be improved by sinus restoration, patients with mitral regurgitation were more likely to experience recurrent AF post ablation, especially those with significant mitral regurgitation. There is no information available on the efficacy of CA for persistent AF in patients with FMR. Purpose The purpose of this study is to investigate the predictors of FMR improvement by CA and to determine the efficacy of substrate and trigger CA for persistent AF in patients with FMR. Methods We prospectively studied 512 consecutive patients admitted for persistent AF ablation from the EARNEST-PVI (Prospective Multicenter Randomized Study of Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation) trial. On admission, enrolled patients were randomly assigned in a 1:1 ratio to pulmonary vein isolation (PVI) or PVI-plus additional ablation (linear ablation or/and CFAE ablation). Of the 512 patients, we studied 94 patients with preoperative echocardiography showing moderate or greater baseline FMR. FMR grades were classified into 5 grades (0/1/2/3/4). The FMR improvement group (FMRI(+)) was defined as a case in which the FMR was improved by two or more grades compared the preoperative echocardiography and the one year follow-up examination. Results Of the 94 patients, 42 were in the PVI group and 52 were in the PVI-plus additional ablation group. There were 30 cases in the FMRI(+) group and 64 cases in the FMRI(−) group. There were no significant baseline differences in age, sinus rhythm maintenance, plasma B-type natriuretic peptide (BNP) level, left ventricular diastolic dimension, or left atrium dimension between the FMRI(+) and FMRI(−) groups. AF duration was significantly shorter in the FMRI(+) group than FMRI(−) groups (5.8±9.4 months vs 12.4±15.4 months, p&amp;lt;0.0001). In addition, significantly more additional ablation cases were observed in the FMRI(+) group than in the FMRI(−) group (73.3% vs 46.8%, p=0.016). In multivariate analyses, only additional ablation was an independent predictor of FMRI (odds ratio 0.226 95% CI 0.081–0.626; p=0.004). Conclusions Catheter ablation is a valid option for the treatment of AF in patients with functional MR and additional substrate and trigger ablation were the only independent predictor of FMR improvement. Funding Acknowledgement Type of funding sources: None.

Probiotics for the prevention of antibiotic-associated diarrhoea: a systematic review and meta-analysis

ObjectiveTo evaluate existing evidence for the use of probiotics in preventing antibiotic-associated diarrhoea (AAD) in adults.DesignSystematic review and meta-analysis of randomised controlled trials (RCTs).Data sourcesWe performed a literature search of...

A prognostic model for failure and worsening after lumbar microdiscectomy: a multicenter study from the Norwegian Registry for Spine Surgery

ObjectiveTo develop a prognostic model for failure and worsening 1 year after surgery for lumbar disc herniation.MethodsThis multicenter cohort study included 11,081 patients operated with lumbar microdiscectomy, registered at the Norwegian Registry for Spine Surgery. Follow-up was 1 year. Uni- and multivariate logistic regression analyses were used to assess potential prognostic factors for previously defined cut-offs for failure and worsening on the Oswestry Disability Index scores 12 months after surgery. Since the cut-offs for failure and worsening are different for patients with low, moderate, and high baseline ODI scores, the multivariate analyses were run separately for these subgroups. Data were split into a training (70%) and a validation set (30%). The model was developed in the training set and tested in the validation set. A prediction (%) of an outcome was calculated for each patient in a risk matrix.ResultsThe prognostic model produced six risk matrices based on three baseline ODI ranges (low, medium, and high) and two outcomes (failure and worsening), each containing 7 to 11 prognostic factors. Model discrimination and calibration were acceptable. The estimated preoperative probabilities ranged from 3 to 94% for failure and from 1 to 72% for worsening in our validation cohort.ConclusionWe developed a prognostic model for failure and worsening 12 months after surgery for lumbar disc herniation. The model showed acceptable calibration and discrimination, and could be useful in assisting physicians and patients in clinical decision-making process prior to surgery.

Hybrid dual stream blender for wide baseline view synthesis

Free navigation of a scene requires warping some reference views to some desired target viewpoint and blending them to synthesize a virtual view. Convolutional Neural Networks (ConvNets) based methods can learn both the warping and blending tasks jointly. Such methods are often designed for moderate inter-camera baseline distance and larger kernels are required for warping if the baseline distance increases. Algorithmic methods can in principle deal with large baselines, however the synthesized view suffers from artifacts near disoccluded pixels. We present a hybrid approach where first, reference views are algorithmically warped to the target position and then are blended via a ConvNet. Preliminary view warping allows reducing the size of the convolutional kernels and thus the learnable parameters count. We propose a residual encoder–decoder for image blending with a Siamese encoder to further keep the parameters count low. We also contribute a hole inpainting algorithm to fill the disocclusions in the warped views. Our view synthesis experiments on real multiview sequences show better objective image quality than state-of-the-art methods due to fewer artifacts in the synthesized images.

Trajectories of Change in an Open-access Internet-Based Cognitive Behavior Program for Childhood and Adolescent Anxiety: Open Trial.

BackgroundAlthough evidence bolstering the efficacy of internet-based cognitive behavioral therapy (iCBT) for treating childhood anxiety has been growing continuously, there is scant empirical research investigating the timing of benefits made in iCBT programs (eg, early or delayed).ObjectiveThis study aims to examine the patterns of symptom trajectories (changes in anxiety) across an iCBT program for anxiety (BRAVE Self-Help).MethodsThis study’s participants included 10,366 Australian youth aged 7 to 17 years (4140 children aged 7-12 years; 6226 adolescents aged 12-17 years) with elevated anxiety who registered for the BRAVE Self-Help program. Participants self-reported their anxiety symptoms at baseline or session 1 and then at the commencement of each subsequent session.ResultsThe results show that young people completing the BRAVE Self-Help program tend to fall into two trajectory classes that can be reliably identified in terms of high versus moderate baseline levels of anxiety and subsequent reduction in symptoms. Both high and moderate anxiety severity trajectory classes showed significant reductions in anxiety, with the greatest level of change being achieved within the first six sessions for both classes. However, those in the moderate anxiety severity class tended to show reductions in anxiety symptoms to levels below the elevated range, whereas those in the high symptom group tended to remain in the elevated range despite improvements.ConclusionsThese findings suggest that those in the high severity group who do not respond well to iCBT on a self-help basis may benefit from the additional support provided alongside the program or a stepped-care approach where progress is monitored and support can be provided as necessary.

Racial and ethnic disparities among patients with breast cancer and COVID-19.

6500 Background: Racial/ethnic minorities have disproportionately increased risk of contracting COVID-19 and experiencing severe illness; they also have worse breast cancer (BC) outcomes. COVID-19 outcomes among racial/ethnic minorities with BC are currently unknown. We sought to compare clinicopathologic characteristics and COVID-19 outcomes stratified by race/ethnicity. Methods: The COVID-19 and Cancer Consortium registry (NCT04354701) was used to identify patients with invasive BC and laboratory-confirmed SARS-CoV-2 diagnosed in the U.S. between 2020-03-06 and 2021-02-04. The primary analysis was restricted to women who self-identified as non-Hispanic White (NHW), non-Hispanic Black (NHB), or Hispanic (H). Demographic, cancer characteristics, and COVID-19 outcomes were evaluated. COVID-19 outcomes included: hospital admission, intensive care unit (ICU) admission, mechanical ventilation, death within 30 days of COVID-19 diagnosis and death from any cause during follow-up. Descriptive statistics were used to compare clinicopathologic characteristics and Fisher exact tests were used to compare COVID-19 outcomes across the 3 racial/ethnic groups. Results: A total of 1133 patients were identified of which 1111 (98%) were women; of which 575 (52%) NHW, 243 (22%) NHB, 183 (16%) H, and 110 (10%) other/unknown. Baseline characteristics differed among racial/ethnic groups. H were younger (median age: NHW 63y; NHB 62y; H 54y) and more likely to be never smokers (NHW 62%; NHB 62%; H 78%). NHB had higher rates of obesity (NHW 40%; NHB 54%; H 46%), diabetes (NHW 16 %; NHB 32%; H 20%) and combined moderate and severe baseline COVID-19 at presentation (NHW 28%; NHB 42%; H 28%). Cancer characteristics are as shown (Table). Significant differences were observed in outcomes across racial/ethnic groups including higher rates of hospital admission (NHW 34%; NHB 49%; H 34%; P &lt;0.001), mechanical ventilation (NHW 3%; NHB 9%; H 5%; P=0.002), 30-day mortality (NHW 6%; NHB 9%; H 4%; P=0.043) and total mortality (NHW 8%; NHB 12%; H 5%; P=0.05) among NHB compared to NHW and H. Conclusions: This is the largest study to show significant differences in COVID-19 outcomes by racial/ethnic groups of women with BC. The adverse outcomes in NHB could be due to higher moderate to severe COVID-19 at presentation and preexisting co-morbidities. H did not have worse outcomes despite having more active disease and recent anti-cancer therapy, including with cytotoxic chemotherapy – potentially due to younger age and nonsmoking status.[Table: see text]

Investigating the Use of Electronic Well-being Diaries Completed Within a Psychoeducation Program for University Students: Longitudinal Text Analysis Study.

BackgroundPsychoeducation has the potential to support students experiencing distress and help meet the demand for support; however, there is a need to understand how these programs are experienced. Web-based diaries are a useful activity for psychoeducation because of their therapeutic benefits, ability to capture naturalistic data relevant to well-being, and appropriateness for text analysis methods.ObjectiveThis study aims to examine how university students use electronic diaries within a psychoeducation program designed to enhance mental well-being.MethodsThe Science of Happiness course was administered to 154 undergraduate students in a university setting (the United Kingdom). Diaries were collected from the students for 9 weeks. Baseline well-being data were collected using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). The percentage of negative and positive emotion words used in diaries (emotional tone) and use of words from five life domains (social, work, money, health, and leisure) were calculated using the Linguistic Inquiry and Word Count 2015 software. Random effects (generalized least squares) regression models were estimated to examine whether time, diary characteristics, demographics, and baseline well-being predict the emotional tone of diaries.ResultsA total of 149 students participated in the diary study, producing 1124 individual diary entries. Compliance with the diary task peaked in week 1 (n=1041, 92.62%) and was at its lowest in week 3 (n=807, 71.81%). Compared with week 1, diaries were significantly more positive in their emotional tone during week 5 (mean difference 23.90, 95% CI 16.89-30.90) and week 6 (mean difference 26.62, 95% CI 19.35-33.88) when students were tasked with writing about gratitude and their strengths. Across weeks, moderate and high baseline SWEMWBS scores were associated with a higher percentage of positive emotion words used in diaries (increases compared with students scoring low in SWEMWBS were 5.03, 95% CI 0.08-9.98 and 7.48, 95% CI 1.84-13.12, respectively). At week 1, the diaries of students with the highest levels of baseline well-being (82.92, 95% CI 73.08-92.76) were more emotionally positive on average than the diaries of students with the lowest levels of baseline well-being (59.38, 95% CI 51.02-67.73). Diaries largely focused on the use of social words. The emotional tone of diary entries was positively related to the use of leisure (3.56, 95% CI 2.28-4.85) and social words (0.74, 95% CI 0.21-1.27), and inversely related to the use of health words (−1.96, 95% CI −3.70 to −0.22).ConclusionsWe found evidence for short-term task-specific spikes in the emotional positivity of web-based diary entries and recommend future studies examine the possibility of long-term impacts on the writing and well-being of students. With student well-being strategies in mind, universities should value and encourage leisure and social activities.

Impact of gender, depression severity and type of depressive episode on efficacy and safety of escitalopram: an observational study on major depressive disorder patients in southern India

BackgroundAntidepressant response is a complex trait influenced by clinical, demographic and genetic factors.ObjectivesTo explore the influences of baseline depression severity, gender and type of depressive episode on efficacy and safety of escitalopram (10–20 mg/day) in South Indian patients with major depressive disorder (MDD).MethodsThe study was conducted on 18–65-year-old patients (n = 151) suffering from a first or recurrent episode of MDD with a 17-item Hamilton Depression Rating Scale (HDRS-17) score of ≥ 18 at baseline. Efficacy assessments were done using HDRS-17, Montgomery-Asberg Depression Rating Scale (MADRS), and Clinical Global Impression (CGI) at baseline and weeks 4, 8 and 12. Patients were monitored for adverse drug reactions (ADRs). Clinical outcomes were compared among various groups based on gender, type of depressive episode (first or recurrent episode) and baseline HDRS-17 scores (moderate depression—score between 17 and 23; severe depression—score ≥ 24).ResultsAmong the 148 subjects who completed the 12-week study, 43.9% and 42.6% achieved response and remission, respectively. The decline in HDRS-17 and MADRS scores from baseline was significant (p value < 0.05) at all follow-up visits and a similar pattern was seen with CGI. Efficacy outcomes were better in the moderate baseline depression group compared with severe depression. There were no associations of efficacy with gender and type of depressive episode. A total of 247 adverse drug reactions (ADR) were reported and 119 (80.41%) subjects experienced at least one ADR during the study period. No serious ADR was reported. Male patients experienced more ADRs compared with females. The safety profile of escitalopram was similar across various groups based on baseline depression severity and type of depressive episode.ConclusionThe study revealed that escitalopram is efficacious in south Indian MDD patients with a favourable safety profile. The efficacy was influenced by baseline depression severity whereas more ADRs were reported by male patients.