Effect of rehabilitation worker input on visual function outcomes in individuals with low vision: study protocol for a randomised controlled trial

BACKGROUND: Visual Rehabilitation Officers help people with a visual impairment maintain their independence. This intervention adopts a flexible, goal-centred approach, which may include training in mobility, use of optical and non-optical aids, and performance of activities of daily living. Although Visual Rehabilitation Officers are an integral part of the low vision service in the United Kingdom, evidence that they are effective is lacking. The purpose of this exploratory trial is to estimate the impact of a Visual Rehabilitation Officer on self-reported visual function, psychosocial and quality-of-life outcomes in individuals with low vision. METHODS/DESIGN: In this exploratory, assessor-masked, parallel group, randomised controlled trial, participants will be allocated either to receive home visits from a Visual Rehabilitation Officer (n = 30) or to a waiting list control group (n = 30) in a 1:1 ratio. Adult volunteers with a visual impairment, who have been identified as needing rehabilitation officer input by a social worker, will take part. Those with an urgent need for a Visual Rehabilitation Officer or who have a cognitive impairment will be excluded. The primary outcome measure will be self-reported visual function (48-item Veterans Affairs Low Vision Visual Functioning Questionnaire). Secondary outcome measures will include psychological and quality-of-life metrics: the Patient Health Questionnaire (PHQ-9), the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), the Adjustment to Age-related Visual Loss Scale (AVL-12), the Standardised Health-related Quality of Life Questionnaire (EQ-5D) and the UCLA Loneliness Scale. The interviewer collecting the outcomes will be masked to the group allocations. The analysis will be undertaken on a complete case and intention-to-treat basis. Analysis of covariance (ANCOVA) will be applied to follow-up questionnaire scores, with the baseline score as a covariate. DISCUSSION: This trial is expected to provide robust effect size estimates of the intervention effect. The data will be used to design a large-scale randomised controlled trial to evaluate fully the Visual Rehabilitation Officer intervention. A rigorous evaluation of Rehabilitation Officer input is vital to direct a future low vision rehabilitation strategy and to help direct government resources. TRIAL REGISTRATION: The trial was registered with ( ISRCTN44807874 ) on 9 March 2015

Investigation of hospital discharge cases and SARS-CoV-2 introduction into Lothian care homes

Background The first epidemic wave of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in Scotland resulted in high case numbers and mortality in care homes. In Lothian, over one-third of care homes reported an outbreak, while there was limited testing of hospital patients discharged to care homes. Aim To investigate patients discharged from hospitals as a source of SARS-CoV-2 introduction into care homes during the first epidemic wave. Methods A clinical review was performed for all patients discharges from hospitals to care homes from 1st March 2020 to 31st May 2020. Episodes were ruled out based on coronavirus disease 2019 (COVID-19) test history, clinical assessment at discharge, whole-genome sequencing (WGS) data and an infectious period of 14 days. Clinical samples were processed for WGS, and consensus genomes generated were used for analysis using Cluster Investigation and Virus Epidemiological Tool software. Patient timelines were obtained using electronic hospital records. Findings In total, 787 patients discharged from hospitals to care homes were identified. Of these, 776 (99%) were ruled out for subsequent introduction of SARS-CoV-2 into care homes. However, for 10 episodes, the results were inconclusive as there was low genomic diversity in consensus genomes or no sequencing data were available. Only one discharge episode had a genomic, time and location link to positive cases during hospital admission, leading to 10 positive cases in their care home. Conclusion The majority of patients discharged from hospitals were ruled out for introduction of SARS-CoV-2 into care homes, highlighting the importance of screening all new admissions when faced with a novel emerging virus and no available vaccine

SARS-CoV-2 Omicron is an immune escape variant with an altered cell entry pathway

Vaccines based on the spike protein of SARS-CoV-2 are a cornerstone of the public health response to COVID-19. The emergence of hypermutated, increasingly transmissible variants of concern (VOCs) threaten this strategy. Omicron (B.1.1.529), the fifth VOC to be described, harbours multiple amino acid mutations in spike, half of which lie within the receptor-binding domain. Here we demonstrate substantial evasion of neutralization by Omicron BA.1 and BA.2 variants in vitro using sera from individuals vaccinated with ChAdOx1, BNT162b2 and mRNA-1273. These data were mirrored by a substantial reduction in real-world vaccine effectiveness that was partially restored by booster vaccination. The Omicron variants BA.1 and BA.2 did not induce cell syncytia in vitro and favoured a TMPRSS2-independent endosomal entry pathway, these phenotypes mapping to distinct regions of the spike protein. Impaired cell fusion was determined by the receptor-binding domain, while endosomal entry mapped to the S2 domain. Such marked changes in antigenicity and replicative biology may underlie the rapid global spread and altered pathogenicity of the Omicron variant

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication

Evaluating Computer Capabilities in a Primary Care Practice-Based Research Network

PURPOSE We wanted to assess computer capabilities in a primary care practice-based research network and to understand how receptive the practices were to new ideas for automation of practice activities and research. METHOD This study was conducted among members of the Pediatric Practice Research Group (PPRG). A survey to assess computer capabilities was developed to explore hardware types, software programs, Internet connectivity and data transmission; views on privacy and security; and receptivity to future electronic data collection approaches. RESULTS Of the 40 PPRG practices participating in the study during the autumn of 2001, all used IBM-compatible systems. Of these, 45% used stand-alone desktops, 40% had networked desktops, and approximately 15% used laptops and minicomputers. A variety of software packages were used, with most practices (82%) having software for some aspect of patient care documentation, patient accounting (90%), business support (60%), and management reports and analysis (97%). The main obstacles to expanding use of computers in patient care were insufficient staff training (63%) and privacy concerns (82%). If provided with training and support, most practices indicated they were willing to consider an array of electronic data collection options for practice-based research activities. CONCLUSIONS There is wide variability in hardware and software use in the pediatric practice setting. Implementing electronic data collection in the PPRG would require a substantial start-up effort and ongoing training and support at the practice site

Early Origins of Child Obesity: Bridging Disciplines and Phases of Development - September 30–October 1, 2010

This report summarizes a conference: “Early Origins of Child Obesity: Bridging Disciplines and Phases of Development”, held in Chicago on September 30–October 1, 2010. The conference was funded in part by the National Institutes of Health and the Williams Heart Foundation, to achieve the conference objective: forging a next-step research agenda related to the early origins of childhood obesity. This research agenda was to include working with an array of factors (from genetic determinants to societal ones) along a continuum from prenatal life to age 7, with an emphasis on how the developing child deals with the challenges presented by his/her environment (prenatal, parental, nutritional, etc.). The conference offered a unique opportunity to facilitate communication and planning of future work among a variety of researchers whose work separately addresses different periods in early life. Over the span of two days, speakers addressed existing, critical research topics within each of the most-studied age ranges. On the final day, workshops fostered the discussion needed to identify the highest priority research topics related to linking varied early factor domains. These are presented for use in planning future research and research funding

Interpreting and Managing Blood Lead Levels of Less Than 10 µg/dL in Children and Reducing Childhood Exposure to Lead: Recommendations of the Centers for Disease Control and Prevention Advisory Committee on Childhood Lead Poisoning Prevention

Lead is a common environmental contaminant. Lead exposure is a preventable risk that exists in all areas of the United States. In children, lead is associated with impaired cognitive, motor, behavioral, and physical abilities. In 1991, the Centers for Disease Control and Prevention defined the blood lead level that should prompt public health actions as 10 µg/dL. Concurrently, the Centers for Disease Control and Prevention also recognized that a blood lead level of 10 µg/dL did not define a threshold for the harmful effects of lead. Research conducted since 1991 has strengthened the evidence that children’s physical and mental development can be affected at blood lead levels of \u3c10 µg/dL. In this report we provide information to help clinicians understand blood lead levels \u3c10 µg/dL, identify gaps in knowledge concerning lead levels in this range, and outline strategies to reduce childhood exposures to lead. We also summarize scientific data relevant to counseling, blood lead screening, and lead-exposure risk assessment. To aid in the interpretation of blood lead levels, clinicians should understand the laboratory error range for blood lead values and, if possible, select a laboratory that achieves routine performance within ±2 µg/dL. Clinicians should obtain an environmental history on all children they examine, provide families with lead-prevention counseling, and follow blood lead screening recommendations established for their areas. As circumstances permit, clinicians should consider referral to developmental programs for children at high risk for exposure to lead and more frequent rescreening of children with blood lead levels approaching 10 µg/dL. In addition, clinicians should direct parents to agencies and sources of information that will help them establish a lead-safe environment for their children. For these preventive strategies to succeed, partnerships between health care providers, families, and local public health and housing programs should be strengthened

Screening for elevated risk of liver disease in preschool children (aged 2–5 years) being seen for obesity management

Objectives: Elevated alanine aminotransferase can heighten concern for the presence of nonalcoholic fatty liver disease in obese children. Guidelines recommend alanine aminotransferase screening of obese children start at the age of 10 years. We examined alanine aminotransferase values routinely obtained for tertiary obesity care among preschool (2–5 years) and school-age children. Methods: Medical records of children attending a tertiary obesity clinic and with alanine aminotransferase measured within 6 months of the initial visit were reviewed. Children with known genetic abnormalities were excluded. Children were grouped by age to focus attention on groups not covered by screening guidelines. Associations with elevated alanine aminotransferase (>30 IU/L) were examined. Results: A total of 284 records were analyzed (73 preschool, 143 young school-age (6–9 years), 68 older school-age (10–11 years)). Children were primarily Hispanic and had body mass index ≥ 99th percentile (preschool children 92%, young school-age 73%, older school-age 59%). In all, 26% of preschool children had elevated alanine aminotransferase (young school-age 30%, older school-age 44%). Preschool children with elevated alanine aminotransferase had higher body mass index compared to preschool children with alanine aminotransferase ≤ 30 IU/L (median body mass index 27.8 kg/m 2 vs 24.0 kg/m 2 ; Mann–Whitney U test, p = 0.003), but there was no disparity for elevated alanine aminotransferase related to Hispanic ethnicity. For older children, Hispanic ethnicity, not body mass index, predicted elevated alanine aminotransferase. Conclusion: Alanine aminotransferase elevation was common in these preschool children. Screening severely obese children for elevated alanine aminotransferase should begin at the age of 2 years

Case Reports: Multifaceted Experiences Treating Youth with Severe Obesity

The management of youth with severe obesity is strongly impacted by social determinants of health and family dynamics. We present case studies of three patients seen in our tertiary care obesity treatment clinic as examples of the challenges faced by these patients and their families, as well as by the medical team. We discuss how these cases illustrate potential barriers to care, the role of child protective services, and we reflect upon lessons learned through the care of these patients. These cases highlight the need for comprehensive care in the management of youth with severe obesity, which can include: visits to multiple medical specialists, and mental and behavioral health providers; school accommodations; linkage to community resources; and, potentially, child protective services involvement. Through the care of these youth, our medical team gained more experience with using anti-obesity medications and meal replacements. The care of these youth also heightened our appreciation for the integral role of mental health services and community-based resources in the management of youth with severe obesity