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To investigate refractive error development in preterm children with severe retinopathy of prematurity (ROP) treated with anti-vascular endothelial growth factor (anti-VEGF) agents and laser photocoagulation. Selection criteria were comparative studies that compared the refractive errors in children, birthweights ≤1500 grams and gestational ages ≤30 weeks, and treatments for Type I ROP with intravitreal bevacizumab (IVB) versus laser photocoagulation. Studies were identified using PubMed, Google Scholar, and published reviews. Meta-analyses were performed on the post-treatment outcomes of spherical equivalent (SEQ), cylindrical power, and prevalence of high myopia. Longitudinal development of refractive error in IVB, or in laser-treated children, or in normal full-term children was visually summarized. Two randomized controlled trials and 5 non-randomized studies, including a total of 272 eyes treated by IVB and 247 eyes treated by laser, were included in this study. Compared with laser-treated children, IVB-treated children have less myopic refractive error (P<0.001), lower prevalence of high myopia (P<0.05), and less astigmatism (P = 0.02). Treatment with IVB is associated with less myopia and astigmatism than laser treatment for infants with severe ROP. Given the complexity of ROP and the variability of dosing, our review supports close monitoring of refractive error outcomes in children treated with IVB.

The safe in-field operation of autonomous agricultural vehicles requires detecting all objects that pose a risk of collision. Current vision-based algorithms for object detection and classification are unable to detect unknown classes of objects. In this paper, the problem is posed as anomaly detection instead, where convolutional autoencoders are applied to identify any objects deviating from the normal pattern. Training an autoencoder network to reconstruct normal patterns in agricultural fields makes it possible to detect unknown objects by high reconstruction error. Basic autoencoder (AE), vector-quantized variational autoencoder (VQ-VAE), denoising autoencoder (DAE) and semisupervised autoencoder (SSAE) with a max-margin-inspired loss function are investigated and compared with a baseline object detector based on YOLOv5. Results indicate that SSAE with an area under the curve for precision/recall (PR AUC) of 0.9353 outperforms other autoencoder models and is comparable to an object detector with a PR AUC of 0.9794. Qualitative results show that SSAE is capable of detecting unknown objects, whereas the object detector is unable to do so and fails to identify known classes of objects in specific cases.

Vision-based object detection is essential for safe and efficient field operation for autonomous agricultural vehicles. However, one of the challenges in transferring state-of-the-art object detectors to the agricultural domain is the limited availability of labeled datasets. This paper seeks to address this challenge by utilizing two object detection models based on YOLOv5, one pre-trained on a large-scale dataset for detecting general classes of objects and one trained to detect a smaller number of agriculture-specific classes. To combine the detections of the models at inference, we propose an ensemble module based on a hierarchical structure of classes. Results show that applying the proposed ensemble module increases mAP@.5 from 0.575 to 0.65 on the test dataset and reduces the misclassification of similar classes detected by different models. Furthermore, by translating detections from base classes to a higher level in the class hierarchy, we can increase the overall mAP@.5 to 0.701 at the cost of reducing class granularity.

Hyperglucagonemia contributes to hyperglycemia in patients with type 1 diabetes (T1D); however, novel therapeutics that block glucagon action could improve glycemic control. This phase 2 study evaluated the safety and efficacy of volagidemab, an antagonistic monoclonal glucagon receptor (GCGR) antibody, as an adjunct to insulin therapy in adults with T1D. The primary endpoint was change in daily insulin use at week 12. Secondary endpoints included changes in hemoglobin A1c (HbA1c) at week 13, in average daily blood glucose concentration and time within target range as assessed by continuous blood glucose monitoring (CGM) and seven-point glucose profile at week 12, incidence of hypoglycemic events, the proportion of subjects who achieve HbA1c reduction of ≥0.4%, volagidemab drug concentrations and incidence of anti-drug antibodies. Eligible participants ( n  = 79) were randomized to receive weekly subcutaneous injections of placebo, 35 mg volagidemab or 70 mg volagidemab. Volagidemab produced a reduction in total daily insulin use at week 12 (35 mg volagidemab: −7.59 units (U) (95% confidence interval (CI) −11.79, −3.39; P  = 0.040 versus placebo); 70 mg volagidemab: −6.64 U (95% CI −10.99, −2.29; P  = 0.084 versus placebo); placebo: −1.27 U (95% CI −5.4, 2.9)) without meeting the prespecified significance level ( P  < 0.025). At week 13, the placebo-corrected reduction in HbA1c percentage was −0.53 (95% CI −0.89 to −0.17, nominal P  = 0.004) in the 35 mg volagidemab group and −0.49 (95% CI −0.85 to −0.12, nominal P  = 0.010) in the 70 mg volagidemab group. No increase in hypoglycemia was observed with volagidemab therapy; however, increases in serum transaminases, low-density lipoprotein (LDL)-cholesterol and blood pressure were observed. Although the primary endpoint did not meet the prespecified significance level, we believe that the observed reduction in HbA1c and tolerable safety profile provide a rationale for further randomized studies to define the long-term efficacy and safety of volagidemab in patients with T1D. See clinicaltrials.gov registration no. NCT03117998 . A phase 2 study testing glucagon receptor antagonist volagidemab as an adjunct to insulin therapy in patients was found to be safe and tolerable. Although the primary endpoint of reduction in daily insulin usage was not met, volagidemab therapy was associated with improved glycaemic control compared to placebo.

A conditionally replication-defective human cytomegalovirus (CMV) vaccine (V160) derived from AD169 and genetically engineered to express CMV pentameric complex (gH/gL/pUL128/pUL130/pUL131) was developed and evaluated for phase 1 vaccine safety and immunogenicity in CMV-seronegative and CMV-seropositive adults. Subjects received 3 doses of V160 or placebo on day 1, month 1, and month 6. Four vaccine dose levels, formulated with or without aluminum phosphate adjuvant, were evaluated. Injection-site and systemic adverse events (AEs) and vaccine viral shedding were monitored. CMV-specific cellular and humoral responses were measured by interferon-gamma ELISPOT and virus neutralization assay up to 12 months after last dose. V160 was generally well-tolerated, with no serious AEs observed. Transient, mild-to-moderate injection-site and systemic AEs were reported more frequently in vaccinated subjects than placebo. Vaccine viral shedding was not detected in any subject, confirming the nonreplicating feature of V160. Robust neutralizing antibody titers were elicited and maintained through 12 months postvaccination. Cellular responses to structural and nonstructural viral proteins were observed, indicating de novo expression of viral genes postvaccination. V160 displayed an acceptable safety profile. Levels of neutralizing antibodies and T-cell responses in CMV-seronegative subjects were within ranges observed following natural CMV infection. . NCT01986010.

Background: Overeating and obesity are frequently attributed to an addiction to food. However, there is currently a lack of evidence to support the idea that certain foods contain any specific addictive substance. An alternative approach is to focus on dimensions of observable behaviour, which may underpin a behavioural addiction to eating. To facilitate this, it is necessary to develop a tool to quantify addiction-like eating behaviour, which is not based on the clinical criteria for substance dependence. The current study provides initial validation of the Addiction-like Eating Behaviour Scale (AEBS). Methods: English speaking male and female participants ( N =511) from a community sample completed the AEBS, alongside a range of other health- and eating-related questionnaires including the Yale Food Addiction Scale (YFAS) and Binge Eating Scale (BES). Participants also provided their height and weight to enable calculation of body mass index (BMI). Finally, to assess test–retest reliability, an additional 70 participants completed the AEBS twice, 2 weeks apart. Results: Principle components analysis revealed that a two-factor structure best accounted for the data. Factor 1 consisted of items that referred to appetitive drive, whereas factor two consisted of items that referred to dietary control practices. Both subscales demonstrated good internal reliability and test–retest reliability, and a confirmatory factor analysis confirmed the two-factor scale structure. AEBS scores correlated positively with body mass index (BMI) ( P <0.001) and other self-report measures of overeating. Importantly, the AEBS significantly predicted variance in BMI above that accounted for by both the YFAS and BES ( P =0.027). Conclusions: The AEBS provides a valid and reliable tool to quantify the behavioural features of a potential ‘eating addiction’. In doing so, the AEBS overcomes many limitations associated with applying substance-dependence criteria to eating.

Obesity and systemic inflammation are associated with breast cancer (BC) outcomes. Systemic inflammation is increased in obesity. We examined the association between C-reactive protein (CRP) and disease-free survival (DFS) and overall survival (OS) overall, and according to body mass index (BMI). We assembled a cohort of women with BC (stage I–III) seen at Aarhus University Hospital between 2010 and 2020 who donated blood at BC diagnosis (N = 2673). CRP levels were measured and divided into quartiles. We followed patients from surgery to recurrence, contralateral BC, other malignancy, death, emigration, or end-of-follow-up. We used Cox regression to estimate hazard ratios (HRs) with 95% confidence intervals (95% CIs) to compare outcomes across CRP quartiles, overall and stratified by BMI (normal-weight (18.5 ≤ BMI < 25 kg/m 2 ), overweight (25 ≤ BMI < 30 kg/m 2 ), and obesity (BMI ≥ 30 kg/m 2 )). During follow-up, 368 events (212 recurrences, 38 contralateral BCs, and 118 deaths) occurred (median follow-up 5.55 years). For DFS, high CRP (CRP ≥ 3.19 mg/L) was associated with an increased risk of events (HR adj :1.62 [95% CI = 1.14–2.28]). In BMI-stratified analyses, high CRP was associated with elevated risk of events in normal-weight and overweight (HR adj :1.70 [95% CI = 1.09–2.66]; HR adj :1.75 [95% CI = 1.08–2.86]), but in obesity, the estimate was less precise (HR adj :1.73 [95% CI = 0.78–3.83]). For OS, high CRP was associated with increased risk of death (HR adj :2.47 [95% CI = 1.62–3.76]). The association was strong in normal-weight and overweight (HR adj :3.66 [95% CI = 1.95–6.87]; HR adj :1.92 [95% CI = 1.06–3.46]), but less clear in obesity (HR adj :1.40 [95% CI = 0.64–3.09]). To sum up, high CRP levels at BC diagnosis were associated with inferior prognosis in early BC irrespective of BMI, although less clear in patients with obesity.

Introduction Behaviour change interventions delivered in dental settings could be useful in reducing oral health inequalities. Pragmatic randomised controlled trials testing interventions, however, are vulnerable to problems with internal and external validity. Intervention fidelity strategies are helpful to address methodological problems and to provide scientific assurances about trial results. This paper sets out the intervention fidelity assessment of the RETURN intervention which was delivered in dental settings to promote planned dental visits. Methods The assessment was guided by the National Institutes of Health Behaviour Change Consortium intervention fidelity framework domains of training and delivery. A mixed-methods design was selected, using quantitative data collected during intervention delivery training, together with qualitative observations ( n  = 58), interviews ( n  = 13) and audio-recordings of intervention delivery sessions ( n  = 472). Data were analysed separately using descriptive statistics and multiple logistic regression for the quantitative data and reflexive thematic analysis for the qualitative data. Data were integrated to provide a comprehensive fidelity assessment. Results Dental nurses were successfully trained to deliver the RETURN intervention; training was successfully standardised, and skills drift minimised. Training presented challenges, and not all nurses achieved competency sign-off to deliver the intervention independently. Nurse characteristics such as dental nursing experience, wider trial procedures and confidence were all found to impact training success. The RETURN intervention was judged to have been delivered with high levels of fidelity, despite few interventions reaching the pre-determined fidelity threshold. Fidelity levels of between 75% and 85% were achieved across intervention domains. Interventionist, intervention dose and intervention topic (dental visiting barrier) were all found to have a relationship with fidelity levels. Conclusions Dental nurses can be trained to deliver a brief behaviour change intervention alongside their usual clinical roles, and this can be delivered with a high degree of intervention fidelity. The results from this fidelity assessment provide assurances about the scientific validity of the RETURN trial results. Recommendations about the suitability of dental nurse interventionists within future dental trials are discussed. Trial registration ISRCTN 84666712. Registered on 12/04/2021.

Background To date, few assessment instruments have been developed to quantitatively measure the mental health status of migrant populations specifically. This paper describes the development and preliminary assessment of the ‘Good Life in the Community Scale’ (GLiCS). GLiCS is a wellbeing measure for migrant women in high-income settings that was coproduced with experts by experience across two phases. Methods The study used a mixed-methods approach and was composed of two phases. Phase I: 88 initial items generated using qualitative data collected in a previous study were reduced to 42 through consultation with expert advisory panels, based on whether each item was considered understandable and relevant Phase II: these 42 items were piloted with a sample of migrant women ( N  = 109). A preliminary exploratory factor analysis was conducted using Oblique rotation. Internal consistency was measured using McDonald’s ω. Convergent validity was tested by correlating the GLiCS with the Oxford Capabilities Questionnaire Mental Health (OxCAP-MH), WHO-5 wellbeing index and Objective Social Outcomes Index (SIX). Incremental validity was tested using hierarchical regression analysis to ascertain the effect on the WHO-5 wellbeing index of: age, migration status, SIX, OxCAP-MH and GLiCS. Known groups validity, the ability a measure has to discriminate between groups likely to differ on the variables of interest, was tested between the different migrant categories using a simple between subjects ANOVA. Results Exploratory factor analysis confirmed a 17-item (three-factor: (i) access to resources, (ii) belonging and contributing, (iii) independence) scale with high internal consistency (McDonald’s ω = 0.91). Convergent and incremental validity were also evidenced. Conclusion The GLiCS has demonstrable good internal consistency and construct validity, and it presents a promising wellbeing measure for better understanding the experience of migrant women.