Background Surgery is the main modality of cure for solid cancers and was prioritised to continue during COVID-19 outbreaks. This study aimed to identify immediate areas for system strengthening by comparing the delivery of elective cancer surgery during the COVID-19 pandemic in periods of lockdown versus light restriction. Methods This international, prospective, cohort study enrolled 20 006 adult (≥18 years) patients from 466 hospitals in 61 countries with 15 cancer types, who had a decision for curative surgery during the COVID-19 pandemic and were followed up until the point of surgery or cessation of follow-up (Aug 31, 2020). Average national Oxford COVID-19 Stringency Index scores were calculated to define the government response to COVID-19 for each patient for the period they awaited surgery, and classified into light restrictions (index <20), moderate lockdowns (20–60), and full lockdowns (>60). The primary outcome was the non-operation rate (defined as the proportion of patients who did not undergo planned surgery). Cox proportional-hazards regression models were used to explore the associations between lockdowns and non-operation. Intervals from diagnosis to surgery were compared across COVID-19 government response index groups. This study was registered at ClinicalTrials.gov , NCT04384926 . Findings Of eligible patients awaiting surgery, 2003 (10·0%) of 20 006 did not receive surgery after a median follow-up of 23 weeks (IQR 16–30), all of whom had a COVID-19-related reason given for non-operation. Light restrictions were associated with a 0·6% non-operation rate (26 of 4521), moderate lockdowns with a 5·5% rate (201 of 3646; adjusted hazard ratio [HR] 0·81, 95% CI 0·77–0·84; p<0·0001), and full lockdowns with a 15·0% rate (1775 of 11 827; HR 0·51, 0·50–0·53; p<0·0001). In sensitivity analyses, including adjustment for SARS-CoV-2 case notification rates, moderate lockdowns (HR 0·84, 95% CI 0·80–0·88; p<0·001), and full lockdowns (0·57, 0·54–0·60; p<0·001), remained independently associated with non-operation. Surgery beyond 12 weeks from diagnosis in patients without neoadjuvant therapy increased during lockdowns (374 [9·1%] of 4521 in light restrictions, 317 [10·4%] of 3646 in moderate lockdowns, 2001 [23·8%] of 11 827 in full lockdowns), although there were no differences in resectability rates observed with longer delays. Interpretation Cancer surgery systems worldwide were fragile to lockdowns, with one in seven patients who were in regions with full lockdowns not undergoing planned surgery and experiencing longer preoperative delays. Although short-term oncological outcomes were not compromised in those selected for surgery, delays and non-operations might lead to long-term reductions in survival. During current and future periods of societal restriction, the resilience of elective surgery systems requires strengthening, which might include...
Objective: Sensory deficits are important risk factors for delirium but have been investigated in single-center studies and single clinical settings. This multicenter study aims to evaluate the association between hearing and visual impairment or bi-sensory impairment (visual and hearing impairment) and delirium. Design: Cross-sectional study nested in the 2017 "Delirium Day" project. Setting and Participants: Patients 65 years and older admitted to acute hospital medical wards, emergency departments, rehabilitation wards, nursing homes, and hospices in Italy. Methods: Delirium was assessed with the 4AT (a short tool for delirium assessment) and sensory deficits with a clinical evaluation. We assessed the association between delirium, hearing and visual impairment in multivariable logistic regression models, adjusting for: Model 1, we included predisposing factors for delirium (ie, dementia, weight loss and autonomy in the activities of daily living); Model 2, we added to Model 1 variables, which could be considered precipitating factors for delirium (ie, psychoactive drugs and urinary catheters). Results: A total of 3038 patients were included; delirium prevalence was 25%. Patients with delirium had a higher prevalence of hearing impairment (30.5% vs 18%; P < .001), visual impairment (24.2% vs 15.7%; P < .01) and bi-sensory impairment (16.2% vs 7.5%) compared with those without delirium. In the multivariable logistic regression analysis, the presence of bi-sensory impairment was associated with delirium in Model 1 [odds ratio (OR) 1.5, confidence interval (CI) 1.2e2.1; P ¼ .00] and in Model 2 (OR 1.4; CI 1.1e1.9; P ¼ .02), whereas the presence of visual and hearing impairment alone was not associated with delirium either in Model 1 (OR 0.8; CI 0.6e1.2, P ¼ .36; OR 1.1; CI 0.8e1.4; P ¼ .42) or in Model 2 (OR 0.8, CI 0.6e1.2, P ¼ .27; OR 1.1, CI 0.8e1.4, P ¼ .63).
Background Early learning and childcare centers (ELCCs) can offer young children critical opportunities for quality outdoor play. There are multiple actual and perceived barriers to outdoor play at ELCCs, ranging from safety fears and lack of familiarity with supporting play outdoors to challenges around diverse perspectives on outdoor play among early childhood educators (ECEs), administrators, licensing officers, and parents. Objective Our study objective is to develop and evaluate a web-based intervention that influences ECEs’ and ELCC administrators’ perceptions and practices in support of children’s outdoor play at ELCCs. Methods The development of the fully automated, open-access, web-based intervention was guided by the intervention mapping process. We first completed a needs assessment through focus groups of ECEs, ELCC administrators, and licensing officers. We identified key issues, needs, and challenges; opportunities to influence behavior change; and intervention outcomes and objectives. This enabled us to develop design objectives and identify features of the OutsidePlay web-based intervention that are central to addressing the issues, needs, and challenges of ECEs and ELCC administrators. We used social cognitive theory and behavior change techniques to select methods, applications, and technology to deliver the intervention. We will use a two-parallel-group randomized controlled trial (RCT) design to evaluate the efficacy of the intervention. We will recruit 324 ECEs and ELCC administrators through a variety of web-based means, including Facebook advertisements and mass emails through our partner networks. The RCT study will be a purely web-based trial where outcomes will be self-assessed through questionnaires. The RCT participants will be randomized into the intervention group or the control group. The control group participants will read the Position Statement on Active Outdoor Play. Results The primary outcome is increased tolerance of risk in children’s play, as measured by the Teacher Tolerance of Risk in Play Scale. The secondary outcome is self-reported attainment of a self-developed behavior change goal. We will use mixed effects models to test the hypothesis that there will be a difference between the intervention and control groups with respect to tolerance of risk in children’s play. Differences in goal attainment will be tested using logistic regression analysis. Conclusions The OutsidePlay web-based intervention guides users through a personalized journey that is split into 3 chapters. An effective intervention that addresses the barriers to outdoor play in ELCC settings has the potential to improve children’s access to outdoor play and support high-quality early childhood education. Trial Registration ClinicalTrials.gov NCT04624932; https://clinicaltrials.gov/ct2/show/NCT04624932 International Registered Report Identifier (IRRID) DERR1-10.2196/31041
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