title: UK Lung Screen (UKLS) nodule management protocol: modelling of a single screen randomised controlled trial of low-dose CT screening for lung cancer.
abstract: The UK Lung Screen (UKLS) is a randomised controlled trial of the use of low-dose multidetector CT for lung cancer screening. It completed the Health Technology Appraisal (HTA)-funded feasibility stage in October 2009 and the pilot UKLS will be initiated in early 2011. The pilot will randomise 4000 subjects to either low-dose CT screening or no screening. The full study, due to start in September 2012, if progression criteria are met, will randomise a further 28,000 subjects from seven centres in the UK. Subjects will be selected if they have sufficient risk of developing lung cancer according to the Liverpool Lung Project risk model. The UKLS employs the 'Wald Single Screen Design', which was modelled in the UKLS feasibility study. This paper describes the modelling of nodule management in UKLS by using volumetric analysis with a single initial screen design and follow-up period of 10 years. This modelling has resulted in the development and adoption of the UKLS care pathway, which will be implemented in the planned CT screening trial in the UK.
authors.affiliation: Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, City Campus, Hucknall Road, Nottingham NG5 1PB, UK. david.baldwin@nuh.nhs.uk
authors.forename: D R
authors.initials: DR
authors.lastname: Baldwin
authors.forename: S W
authors.initials: SW
authors.lastname: Duffy
authors.forename: N J
authors.initials: NJ
authors.lastname: Wald
authors.forename: R
authors.initials: R
authors.lastname: Page
authors.forename: D M
authors.initials: DM
authors.lastname: Hansell
authors.forename: J K
authors.initials: JK
authors.lastname: Field
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D019091:Critical Pathways / Q000458:organization & administration; D018450:Disease Progression; D055088:Early Detection of Cancer / Q000379:methods; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000379:methods; D010348:Patient Care Team; D018579:Patient Selection; D011829:Radiation Dosage; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D013997:Time Factors; D014057:Tomography, X-Ray Computed / Q000379:methods