Predictors of Visual Acuity Outcomes after Anti–Vascular Endothelial Growth Factor Treatment for Macular Edema Secondary to Central Retinal Vein Occlusion

Purpose: To evaluate whether baseline demographic, clinical, and OCT characteristics predict visual acuity (VA) outcomes in patients receiving anti–vascular endothelial growth factor (VEGF) therapy for macular edema (ME) due to central retinal vein occlusion (CRVO). Design: Post hoc analysis of the randomized noninferiority trial (Lucentis, Eylea, Avastin in CRVO) LEAVO Study from December 12, 2014, to December 16, 2016, carried out across 44 UK National Health Service ophthalmology departments. Participants: Data on 267 participants with a baseline best-corrected mean visual acuity (BCVA) range of 19 to 78 Early Treatment Diabetic Retinopathy Study letter score (approximate Snellen equivalent, 20/32 to 20/320) who had central subfield thickness (CST) ≥ 320 μm on Spectralis OCT (Heidelberg Engineering) were analyzed. Methods: Study participants were randomized to receive repeated intravitreal injections of ranibizumab (0.5 mg/50 μl), aflibercept (2.0 mg/50 μl), or bevacizumab (1.25 mg/50 μl), and a protocol-driven pro re nata re-treatment regimen at 4 to 8 weekly visits was followed up to week 100 after 4 mandated 4-weekly loading injections. Main Outcome Measures: Change in BCVA and percentage of patients gaining ≥ 10 letters and achieving BCVA letter score > 70 letters at 52 and 100 weeks. Results: The analysis was adjusted for treatment effects and confirmed by sensitivity analysis. Age ≥ 75 years is a poor predictor for all 3 visual outcomes. Lower baseline BCVA predicted 10-letter gainers and higher gains in BCVA, although it is a poor predictor of achieving > 70 Early Treatment Diabetic Retinopathy Study letters. None of the baseline OCT morphologic characteristics except ellipsoid zone (EZ) integrity influenced any visual outcomes. Both baseline CST and total macular volume showed a nonlinear relation to 10-letter gainers, with CST > 900 μm being a poor prognostic indicator. Baseline CST and macular volume did not predict mean change in BCVA or BCVA > 70 letters at 52 and 100 weeks. The sensitivity analysis conclusions after removing iCRVO were similar. Conclusions: At presentation, younger age, higher baseline BCVA, and a definitely intact subfoveal EZ are predictors of BCVA score > 70 letters at 100 weeks

Clinical efficacy and safety of a light mask for prevention of dark adaptation in treating and preventing progression of early diabetic macular oedema at 24 months (CLEOPATRA): a multicentre, phase 3, randomised controlled trial

Background: We aimed to assess 24-month outcomes of wearing an organic light-emitting sleep mask as an intervention to treat and prevent progression of non-central diabetic macular oedema. Methods: CLEOPATRA was a phase 3, single-blind, parallel-group, randomised controlled trial undertaken at 15 ophthalmic centres in the UK. Adults with non-centre-involving diabetic macular oedema were randomly assigned (1:1) to wearing either a light mask during sleep (Noctura 400 Sleep Mask, PolyPhotonix Medical, Sedgefield, UK) or a sham (non-light) mask, for 24 months. Randomisation was by minimisation generated by a central web-based computer system. Outcome assessors were masked technicians and optometrists. The primary outcome was the change in maximum retinal thickness on optical coherence tomography (OCT) at 24 months, analysed using a linear mixed-effects model incorporating 4-monthly measurements and baseline adjustment. Analysis was done using the intention-to-treat principle in all randomised patients with OCT data. Safety was assessed in all patients. This trial is registered with Controlled-Trials.com, number ISRCTN85596558. Findings: Between April 10, 2014, and June 15, 2015, 308 patients were randomly assigned to wearing the light mask (n=155) or a sham mask (n=153). 277 patients (144 assigned the light mask and 133 the sham mask) contributed to the mixed-effects model over time, including 246 patients with OCT data at 24 months. The change in maximum retinal thickness at 24 months did not differ between treatment groups (mean change −9·2 μm [SE 2·5] for the light mask vs −12·9 μm [SE 2·9] for the sham mask; adjusted mean difference −0·65 μm, 95% CI −6·90 to 5·59; p=0·84). Median compliance with wearing the light mask at 24 months was 19·5% (IQR 1·9–51·6). No serious adverse events were related to either mask. The most frequent adverse events related to the assigned treatment were discomfort on the eyes (14 with the light mask vs seven with the sham mask), painful, sticky, or watery eyes (14 vs six), and sleep disturbance (seven vs one). Interpretation: The light mask as used in this study did not confer long-term therapeutic benefit on non-centre-involving diabetic macular oedema and the study does not support its use for this indication. Funding: The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership

Development and validation of a screening tool for feeding/swallowing difficulties and undernutrition in children with cerebral palsy

To develop and validate a screening tool for feeding/swallowing difficulties and/or undernutrition in children with cerebral palsy (CP).This cross-sectional, observational study included 89 children with CP (63 males, 26 females; median age 6y 0mo; interquartile range 4y 0mo-8y 11mo), across all Gross Motor Function Classification System levels. Children with feeding tubes were excluded. Children were classified as well-nourished or moderately to severely undernourished, using the paediatric Subjective Global Nutrition Assessment. Eating and drinking abilities were classified using the Eating and Drinking Ability Classification System (EDACS) from mealtime observation and videofluoroscopic swallow studies when indicated. Parents/caregivers answered 33 screening questions regarding their child's feeding/swallowing abilities and nutritional status. The diagnostic ability of each question for identifying children with feeding/swallowing difficulties and undernutrition was calculated and the combination of questions with the highest sensitivity and specificity identified.Feeding difficulties impacted on swallow safety in 26 children (29%) and 26 children (29%) were moderately or severely undernourished. The 4-item final tool had high sensitivity and specificity for identifying children with feeding/swallowing difficulties (81% and 79% respectively) and undernutrition (72% and 75% respectively). The tool successfully identified 100 per cent of children with severe undernutrition and 100 per cent of those classified as EDACS level IV or V.Screening for feeding/swallowing difficulties and undernutrition will enable early identification, assessment, and management for those children in need.A screening tool with high sensitivities and specificities for identifying children with feeding/swallowing difficulties and undernutrition. The tool identified 100 per cent of children with severe undernutrition. The tool identified 100 per cent of children in Eating and Drinking Ability Classification System levels IV or V

The pediatric subjective global nutrition assessment classifies more children with cerebral palsy as malnourished compared with anthropometry

BackgroundNutrition assessment is multidimensional; however, much of the literature examining the nutritional status of children with cerebral palsy (CP) focuses on a single dimension.ObjectiveThe aim of the study was to evaluate nutritional status in children and adolescents with CP by comparing results from the Pediatric Subjective Global Nutrition Assessment (SGNA) with results from traditional anthropometric measures.DesignThis study was a cross-sectional observational study.Participants/settingThis study was conducted in a tertiary hospital outpatient setting in Brisbane, Australia, from February 2017 to March 2018. A total of 89 children (63 boys) with CP aged between 2 and 18 years of age were included. All Gross Motor Function Classification System levels were observed. The majority of children were in Gross Motor Function Classification System I and II (57, 64%) compared with Gross Motor Function Classification System III to V (32, 36%). Children with feeding tubes and those acutely unwell or hospitalized were excluded.Main outcome measuresChildren were classified as well nourished, moderately malnourished, or severely malnourished by dietitians using the SGNA. Weight, height, body mass index (BMI), triceps skinfold thickness, subscapular skinfold thickness, and mid upper arm circumference were measured and converted to z scores to account for age and sex differences. Moderate malnutrition was defined by z scores\ua0−2.00 to\ua0−2.99 and severe malnutrition as ≤−3.00 z scores.Statistical analysis performedMultinomial logistic analyses were used to compare results from the SGNA and each single measurement. Continuous outcomes were transformed into z scores. Agreement was assessed with 2 categories: not malnourished and malnourished. Comparison statistics included percent agreement, sensitivity, and specificity.ResultsMore children were classified as moderately or severely malnourished by SGNA than any of the anthropometric z score cutoffs. The majority of children were well nourished (n\ua0= 63) with 20 (22%) moderately malnourished and 6 (7%) severely malnourished by SGNA. The SGNA classified 11 children as malnourished that were not classified as malnourished by BMI. Children with moderate or severe malnutrition by SGNA had lower weight (P < .001, P < .001), BMI (P < .001, P < .001), mid upper arm circumference (P < .001, P < .001), triceps skinfold thickness (P\ua0= .01, P\ua0= .007), and subscapular skinfold thickness (P\ua0= .005, P\ua0= .02) z scores than well-nourished children.ConclusionThe SGNA identified more potentially malnourished children including children classified as well nourished by the single measurements such as BMI, height, and weight. The SGNA provided a clinically useful multidimensional approach to nutrition assessment for children with CP

Predictors of physical and mental health-related quality of life outcomes among myocardial infarction patients

Background: Health-related quality of life (HRQoL) is an important outcome for patients diagnosed with coronary heart disease. This report describes predictors of physical and mental HRQoL at six months post-hospitalisation for myocardial infarction

Characteristics and outcomes of an international cohort of 600 000 hospitalized patients with COVID-19

Background: We describe demographic features, treatments and clinical outcomes in the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) COVID-19 cohort, one of the world’s largest international, standardized data sets concerning hospitalized patients. Methods: The data set analysed includes COVID-19 patients hospitalized between January 2020 and January 2022 in 52 countries. We investigated how symptoms on admission, co-morbidities, risk factors and treatments varied by age, sex and other characteristics. We used Cox regression models to investigate associations between demographics, symptoms, co-morbidities and other factors with risk of death, admission to an intensive care unit (ICU) and invasive mechanical ventilation (IMV). Results: Data were available for 689 572 patients with laboratory-confirmed (91.1%) or clinically diagnosed (8.9%) SARS-CoV-2 infection from 52 countries. Age [adjusted hazard ratio per 10 years 1.49 (95% CI 1.48, 1.49)] and male sex [1.23 (1.21, 1.24)] were associated with a higher risk of death. Rates of admission to an ICU and use of IMV increased with age up to age 60 years then dropped. Symptoms, co-morbidities and treatments varied by age and had varied associations with clinical outcomes. The case-fatality ratio varied by country partly due to differences in the clinical characteristics of recruited patients and was on average 21.5%. Conclusions: Age was the strongest determinant of risk of death, with a ~30-fold difference between the oldest and youngest groups; each of the co-morbidities included was associated with up to an almost 2-fold increase in risk. Smoking and obesity were also associated with a higher risk of death. The size of our international database and the standardized data collection method make this study a comprehensive international description of COVID-19 clinical features. Our findings may inform strategies that involve prioritization of patients hospitalized with COVID-19 who have a higher risk of death