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      Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk

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          Abstract

          Introduction

          Lung cancer is the world’s leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.

          Methods and analysis

          Using a single-consent Zelen’s design, ever-smokers aged 55–80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCO M2012 (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.

          Ethics and dissemination

          The study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.

          Trial registration numbers

          ISRCTN42704678 and NCT03750110.

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          Most cited references54

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          Reduced lung-cancer mortality with low-dose computed tomographic screening.

          (2011)
          The aggressive and heterogeneous nature of lung cancer has thwarted efforts to reduce mortality from this cancer through the use of screening. The advent of low-dose helical computed tomography (CT) altered the landscape of lung-cancer screening, with studies indicating that low-dose CT detects many tumors at early stages. The National Lung Screening Trial (NLST) was conducted to determine whether screening with low-dose CT could reduce mortality from lung cancer. From August 2002 through April 2004, we enrolled 53,454 persons at high risk for lung cancer at 33 U.S. medical centers. Participants were randomly assigned to undergo three annual screenings with either low-dose CT (26,722 participants) or single-view posteroanterior chest radiography (26,732). Data were collected on cases of lung cancer and deaths from lung cancer that occurred through December 31, 2009. The rate of adherence to screening was more than 90%. The rate of positive screening tests was 24.2% with low-dose CT and 6.9% with radiography over all three rounds. A total of 96.4% of the positive screening results in the low-dose CT group and 94.5% in the radiography group were false positive results. The incidence of lung cancer was 645 cases per 100,000 person-years (1060 cancers) in the low-dose CT group, as compared with 572 cases per 100,000 person-years (941 cancers) in the radiography group (rate ratio, 1.13; 95% confidence interval [CI], 1.03 to 1.23). There were 247 deaths from lung cancer per 100,000 person-years in the low-dose CT group and 309 deaths per 100,000 person-years in the radiography group, representing a relative reduction in mortality from lung cancer with low-dose CT screening of 20.0% (95% CI, 6.8 to 26.7; P=0.004). The rate of death from any cause was reduced in the low-dose CT group, as compared with the radiography group, by 6.7% (95% CI, 1.2 to 13.6; P=0.02). Screening with the use of low-dose CT reduces mortality from lung cancer. (Funded by the National Cancer Institute; National Lung Screening Trial ClinicalTrials.gov number, NCT00047385.).
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            A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.

            Regression methods were used to select and score 12 items from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to reproduce the Physical Component Summary and Mental Component Summary scales in the general US population (n=2,333). The resulting 12-item short-form (SF-12) achieved multiple R squares of 0.911 and 0.918 in predictions of the SF-36 Physical Component Summary and SF-36 Mental Component Summary scores, respectively. Scoring algorithms from the general population used to score 12-item versions of the two components (Physical Components Summary and Mental Component Summary) achieved R squares of 0.905 with the SF-36 Physical Component Summary and 0.938 with SF-36 Mental Component Summary when cross-validated in the Medical Outcomes Study. Test-retest (2-week)correlations of 0.89 and 0.76 were observed for the 12-item Physical Component Summary and the 12-item Mental Component Summary, respectively, in the general US population (n=232). Twenty cross-sectional and longitudinal tests of empirical validity previously published for the 36-item short-form scales and summary measures were replicated for the 12-item Physical Component Summary and the 12-item Mental Component Summary, including comparisons between patient groups known to differ or to change in terms of the presence and seriousness of physical and mental conditions, acute symptoms, age and aging, self-reported 1-year changes in health, and recovery for depression. In 14 validity tests involving physical criteria, relative validity estimates for the 12-item Physical Component Summary ranged from 0.43 to 0.93 (median=0.67) in comparison with the best 36-item short-form scale. Relative validity estimates for the 12-item Mental Component Summary in 6 tests involving mental criteria ranged from 0.60 to 107 (median=0.97) in relation to the best 36-item short-form scale. Average scores for the 2 summary measures, and those for most scales in the 8-scale profile based on the 12-item short-form, closely mirrored those for the 36-item short-form, although standard errors were nearly always larger for the 12-item short-form.
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              EuroQol - a new facility for the measurement of health-related quality of life

              (1990)
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2020
                10 September 2020
                : 10
                : 9
                : e037075
                Affiliations
                [1 ]departmentDivision of Infection, Immunity and Respiratory Medicine , The University of Manchester , Manchester, UK
                [2 ]departmentCentre for Cancer Prevention, Wolfson Institute of Preventive Medicine , Queen Mary University of London , London, UK
                [3 ]Leeds Institute of Health Sciences, University of Leeds , Leeds, UK
                [4 ]Department of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust , Leeds, UK
                [5 ]departmentDepartment of Research and Innovation , Leeds Teaching Hospitals NHS Trust , Leeds, UK
                [6 ]departmentDepartment of Respiratory Medicine, City Campus , Nottingham University Hospitals , Nottingham, UK
                [7 ]departmentLung Cancer and Thoracic Surgery Directorate, Heart and Lung Division , Manchester University NHS Foundation Trust , Manchester, UK
                [8 ]departmentYork Trials Unit, Department of Health Sciences , University of York , York, UK
                [9 ]departmentDepartment of Radiology , Leeds Teaching Hospitals NHS Trust , Leeds, UK
                [10 ]departmentLeeds Cancer Centre , Leeds Teaching Hospitals NHS Trust , Leeds, UK
                [11 ]departmentCentre for Health Economics , University of York , York, UK
                [12 ]departmentDepartment of Respiratory Medicine , University College London , London, UK
                [13 ]departmentHull York Medical School , University of Hull , Hull, UK
                [14 ]departmentLeeds Centre for Personalised Medicine and Health , University of Leeds , Leeds, UK
                [15 ]departmentThames Cancer Registry , Kings College London , London, UK
                [16 ]departmentDivision of Epidemiology and Public Health, Faculty of Medicine , University of Nottingham , Nottingham, UK
                [17 ]departmentResearch Department of Epidemiology and Public Health , University College London , London, UK
                Author notes
                [Correspondence to ] Dr Matthew EJ Callister; matthew.callister@ 123456nhs.net
                Author information
                http://orcid.org/0000-0001-8941-4813
                http://orcid.org/0000-0001-8410-7160
                http://orcid.org/0000-0002-7117-4142
                http://orcid.org/0000-0001-5477-2557
                Article
                bmjopen-2020-037075
                10.1136/bmjopen-2020-037075
                7485242
                32912947
                1a7449ed-f5d1-45d8-a45f-958f17f5fca3
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/.

                History
                : 17 January 2020
                : 24 June 2020
                : 08 July 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100002653, Yorkshire Cancer Research;
                Award ID: L403 & L403B
                Categories
                Respiratory Medicine
                1506
                1731
                Protocol
                Custom metadata
                unlocked

                Medicine
                respiratory tract tumours,chest imaging
                Medicine
                respiratory tract tumours, chest imaging

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