ABSTRACT
Background: People presenting with early-stage LPCa have several treatment options. There is therapeutic equipoise with lack of randomised evidence for superiority of radiotherapy or surgery. PACE-A aimed to determine if there is improved quality of life (QoL) following SBRT compared to surgery. Method(s): PACE (NCT01584258) is a phase 3 open-label multiple-cohort RCT. In PACE-A, people with LPCa, T1-T2, Gleason<=3+4, PSA<=20ng/mL & suitable for surgery were randomised (1:1) to SBRT or surgery. SBRT dose was 36.25Gy/5 fractions in 1-2 weeks;surgery was laparoscopic or robotically assisted prostatectomy. Androgen deprivation was not permitted. Co-primary endpoints were patient reported outcomes (PROs) of Expanded Prostate Index Composite (EPIC-26) questionnaire number of absorbent pads per day & EPIC bowel subdomain score at 2 years. Target sample size was 234 participants (pts) to detect 9% difference in urinary incontinence (80% power, 5% 2-sided alpha) & 5-point difference in mean bowel subdomain score (90% power, 5% 2-sided alpha) with higher EPIC score (range 0-100) indicating better QoL. Secondary endpoints included clinician reported toxicity and additional PROs (1% significance level). Analysis is by treatment received. Result(s): From Aug 2012 to Feb 2022, 123 men from 10 UK centres were randomised. The IDMC advised stopping recruitment after a 2-year gap in during COVID. Pts had median age 66years (IQR: 61, 69), median PSA 8ng/ml (6, 11) with 52% tumours >=T2b and 79% Gleason 3+4;93% pts were of white race. 58/63 pts received SBRT as allocated (2 received surgery, 2 unknown, 1 withdrawn);48/60 received surgery as allocated (1 received SBRT, 3 received CRT, 2 unknown, 6 withdrawn). 8 laparoscopic and 42 robotic assisted operations were performed. Median follow-up is 50 months (IQR 41, 74). At 2 years, fewer SBRT pts reported use of urinary pads: 2/43 (4.5%) vs 15/32 (46.9%), p<0.001. SBRT pts had significantly worse bowel subdomain score (mean (SD) 88.4 (12.7) vs 97.3 (5.5), p<0.001). 7/45 (15.6%) SBRT and 0/31 (0%) surgery pts reported moderate/big problem with bowel symptoms (p=0.04). SBRT pts reported less EPIC sexual subdomain score (58.0 (31.9) vs 29.3 (20.5), p<0.001);there was no evidence of a difference in urinary subdomain score (85.5 (19.8) vs 80.5 (20.8), p=0.29). At 2 years, CTCAE genitourinary grade 2 or higher(G2+) toxicity was seen in 5/54 (9.3%) SBRT vs 4/42 (9.5%) surgery pts (p=0.97);there was no G2+ gastrointestinal (GI) events seen in either group. Conclusion(s): PACE-A contributes the first randomised data to the comparison of SBRT with surgery in LPCa providing PRO data relevant to informed decision making. Compared to surgery, pts receiving SBRT had better urinary continence & sexual bother score;clinician reported GI toxicity was low but SBRT pts reported more bowel bother at 2 years.
ABSTRACT
This editorial sets the scene for this special issue by unpacking the concept of ‘lockdown leisure' as closely linked with the Coronavirus disease 2019 (COVID-19) pandemic which spread globally in early 2020 and throughout 2021 and 2022. It provides a snapshot of the parameters of lockdown leisure, outlines the separate articles in this special issue, and considers the medium-to-long term implications of the pandemic for leisure studies. By incorporating perspectives from a plethora of academic disciplines, the special issue advances our understanding of the social, spatial and cultural impacts of the various lockdowns on leisure and our lives more broadly. © 2023 Informa UK Limited, trading as Taylor & Francis Group.
ABSTRACT
Background The National Health and Nutrition Examination Survey (NHANES) produces national estimates that are representative of the total noninstitutionalized civilian U.S. population. The NHANES sample is selected using a complex, four-stage sample design. NHANES sample weights are used by analysts to produce estimates of the health statistics that would have been obtained if the entire sampling frame (the noninstitutionalized civilian U.S. population) had been surveyed. Sampling errors should be calculated for all survey estimates to assess their statistical reliability. Variance approximation procedures are required to provide reasonable, approximately unbiased, and design-consistent variance estimates for complex sample surveys like NHANES. The 2017–March 2020 files represent a unique public-use data release from NHANES. The coronavirus disease 2019 (COVID-19) pandemic required suspension of data collection in March 2020. As a result, the partially completed NHANES 2019–2020 cycle was not nationally representative. Therefore, the 2019–March 2020 data were combined with the data from the 2017–2018 cycle to create the nationally representative 2017–March 2020 prepandemic data files. Objective This report describes the creation of the NHANES 2017–March 2020 prepandemic data files, including the selection of the appropriate NHANES sample design (2015–2018) to create sample weights and variance units for public-use data files. Additionally, the development of a factor applied to the primary sampling units to adjust the 2017–March 2020 data to fit the NHANES 2015–2018 sample design is described. Analyses to assess representativeness of the target population were performed, and a simulation to replicate the impact of interrupted data collection using earlier NHANES cycles was undertaken. Analytic guidance specific to use for prepandemic data files is also included. © 2022, National Center for Health Statistics. All rights reserved.
ABSTRACT
The COVID-19 pandemic has had a profound impact on the lives of young people, transforming and disrupting education provision, employment opportunities, social practices, mobilities, and experiences of health and well-being. In the UK context, the pandemic can be understood as both a unique event and as a further addition to the intersecting crises—including austerity and Brexit—that are increasingly shaping and constraining youth experiences and aspirations and exacerbating precarity and inequality. In this article, seven undergraduate students from Manchester, UK, with two academic co-authors, employ a co-productive approach to reflect on our experiences of the pandemic. Our autoethnographic accounts draw attention to the situated effects of the pandemic, and its intersection with existing challenges and pressures, including the gig economy, mental and physical ill health, and transnational family networks. At the same time, our narratives capture a sense of precarious hope: hopefulness that is both a product of precarity and itself precarious, opening up new possibilities for collectively imagining and pursuing viable and meaningful futures in uncertain times. Supporting our endeavours requires the inclusion of youth voices in research, policy, and practice;work we begin here. © 2021, The Author(s).
ABSTRACT
Objective - This report calculates the prevalence of selected conditions by race and Hispanic origin among U.S. adults (aged 20 and over) during 2015-2018. Methods - Interview, physical examination, and laboratory data were used from the National Health and Nutrition Examination Survey. Conditions included asthma, chronic obstructive pulmonary disease, and heart disease based on self-report;and obesity, severe obesity, diabetes, chronic kidney disease, smoking, and hypertension based on physical measurements. Estimates accounted for survey design. Results - Seventy-six percent of adults and 86.4% (95% CI: 83.5-89.0) of non-Hispanic black adults had at least one condition. Obesity and diabetes were highest among non-Hispanic black (47.9% CI: 45.0-50.8;19.2% CI: 16.7-21.8, respectively) and Hispanic adults (45.7% CI: 42.9-48.6;21.3% CI: 19.0-23.7, respectively). Conclusions - Non-Hispanic black and Hispanic adults had a disproportionate burden of some conditions, including obesity and diabetes. Understanding populations at highest risk for severe coronavirus disease 2019-related illness could help inform prevention strategies.