title: Design-corrected variation by centre in mortality reduction in the ERSPC randomised prostate cancer screening trial.
abstract: Objectives To calculate design-corrected estimates of the effect of screening on prostate cancer mortality by centre in the European Randomised Study of Screening for Prostate Cancer (ERSPC). Setting The ERSPC has shown a 21% reduction in prostate cancer mortality in men invited to screening with follow-up truncated at 13 years. Centres either used pre-consent randomisation (effectiveness design) or post-consent randomisation (efficacy design). Methods In six centres (three effectiveness design, three efficacy design) with follow-up until the end of 2010, or maximum 13 years, the effect of screening was estimated as both effectiveness (mortality reduction in the target population) and efficacy (reduction in those actually screened). Results The overall crude prostate cancer mortality risk ratio in the intervention arm vs control arm for the six centres was 0.79 ranging from a 14% increase to a 38% reduction. The risk ratio was 0.85 in centres with effectiveness design and 0.73 in those with efficacy design. After correcting for design, overall efficacy was 27%, 24% in pre-consent and 29% in post-consent centres, ranging between a 12% increase and a 52% reduction. Conclusion The estimated overall effect of screening in attenders (efficacy) was a 27% reduction in prostate cancer mortality at 13 years' follow-up. The variation in efficacy between centres was greater than the range in risk ratio without correction for design. The centre-specific variation in the mortality reduction could not be accounted for by the randomisation method.
authors: 1 Finnish Cancer Registry, Helsinki, Finland.
authors: Matti
authors: M
authors: Hakama
authors: 2 Centre for Cancer Prevention, Queen Mary University of London, London, UK.
authors: Sue M
authors: SM
authors: Moss
authors: 3 Department of Clinical Chemistry, Helsinki University and HUSLAB, Helsinki, Finland.
authors: Ulf-Hakan
authors: UH
authors: Stenman
authors: 4 Department of Urology Erasmus University Medical Center, Rotterdam, The Netherlands.
authors: Monique J
authors: MJ
authors: Roobol
authors: 5 Unit of Clinical and Descriptive Epidemiology, ISPO, Florence, Italy.
authors: Marco
authors: M
authors: Zappa
authors: 6 Department of Urology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.|7 Department of Surgery (Urology), Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors: Sigrid
authors: S
authors: Carlsson
authors: 8 Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.|9 Department of Urology, University Hospital Zürich and University of Zürich, Switzerland.
authors: Marco
authors: M
authors: Randazzo
authors: 10 Provincial Instituut voor Hygiene, Antwerp, Belgium.
authors: Vera
authors: V
authors: Nelen
authors: 6 Department of Urology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.
authors: Jonas
authors: J
authors: Hugosson
mesh_terms: D000368:Aged; D000465:Algorithms; D055088:Early Detection of Cancer / Q000379:methods*; D005006:Ethnicity; D005060:Europe; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D016017:Odds Ratio; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000378:metabolism; D012107:Research Design
chemical_list: D017430:Prostate-Specific Antigen
keywords: Prostate cancer; prostate specific antigen; screening; study design