OBJECTIVE: To assess the impact of different study designs on outcome data within the European Randomized Study of Screening for Prostate Cancer (ERSPC). METHODS: Observed data from the Gothenburg centre (effectiveness trial with upfront randomization before informed consent) and the Rotterdam centre (efficacy trial with randomization after informed consent) were compared with expected data, which were retrieved from national cancer registries and life tables. Endpoints were 11-year cumulative prostate cancer (PC) incidence, overall mortality and PC-specific mortality. RESULTS: In Gothenburg, the 11-year PC incidence was higher than predicted (5.8%) in both the intervention (12.4%) and control arms (7.3%). The observed overall mortality was higher than predicted (15.9%) in both the intervention (17.8%) and control arms (18.5%). The observed PC-specific mortality in the intervention arm was 0.56% versus 0.83% in the control arm, while the expected mortality was 0.83%. In Rotterdam, the observed PC incidence in the intervention arm (10.4%) was higher than expected (4.4%). The incidence in the control arm was 4.6%. The observed overall mortality was lower than expected: 13.6% in the intervention arm and 14.0% in the control arm versus an expected mortality of 16.1%. The observed PC-specific mortality was lower than expected (0.65%) in both the intervention (0.27%) and control arms (0.41%). CONCLUSIONS: Our results suggest that an efficacy trial with informed consent prior to randomization may have introduced a 'healthy screenee bias'. Therefore, an effectiveness trial with consent after randomization may more accurately estimate the PC-specific mortality reduction if population-based screening is introduced.
RCT Entities:
OBJECTIVE: To assess the impact of different study designs on outcome data within the European Randomized Study of Screening for Prostate Cancer (ERSPC). METHODS: Observed data from the Gothenburg centre (effectiveness trial with upfront randomization before informed consent) and the Rotterdam centre (efficacy trial with randomization after informed consent) were compared with expected data, which were retrieved from national cancer registries and life tables. Endpoints were 11-year cumulative prostate cancer (PC) incidence, overall mortality and PC-specific mortality. RESULTS: In Gothenburg, the 11-year PC incidence was higher than predicted (5.8%) in both the intervention (12.4%) and control arms (7.3%). The observed overall mortality was higher than predicted (15.9%) in both the intervention (17.8%) and control arms (18.5%). The observed PC-specific mortality in the intervention arm was 0.56% versus 0.83% in the control arm, while the expected mortality was 0.83%. In Rotterdam, the observed PC incidence in the intervention arm (10.4%) was higher than expected (4.4%). The incidence in the control arm was 4.6%. The observed overall mortality was lower than expected: 13.6% in the intervention arm and 14.0% in the control arm versus an expected mortality of 16.1%. The observed PC-specific mortality was lower than expected (0.65%) in both the intervention (0.27%) and control arms (0.41%). CONCLUSIONS: Our results suggest that an efficacy trial with informed consent prior to randomization may have introduced a 'healthy screenee bias'. Therefore, an effectiveness trial with consent after randomization may more accurately estimate the PC-specific mortality reduction if population-based screening is introduced.
Authors: R G H M Cremers; H E Karim-Kos; S Houterman; R H A Verhoeven; F H Schröder; T H van der Kwast; P J M Kil; J W W Coebergh; L A L M Kiemeney Journal: Eur J Cancer Date: 2010-05-12 Impact factor: 9.162
Authors: Suzie J Otto; Ingrid W van der Cruijsen; Michael K Liem; Ida J Korfage; Jan J Lous; Fritz H Schröder; Harry J de Koning Journal: Int J Cancer Date: 2003-06-20 Impact factor: 7.396
Authors: Fritz H Schröder; Jonas Hugosson; Monique J Roobol; Teuvo L J Tammela; Stefano Ciatto; Vera Nelen; Maciej Kwiatkowski; Marcos Lujan; Hans Lilja; Marco Zappa; Louis J Denis; Franz Recker; Alvaro Páez; Liisa Määttänen; Chris H Bangma; Gunnar Aus; Sigrid Carlsson; Arnauld Villers; Xavier Rebillard; Theodorus van der Kwast; Paula M Kujala; Bert G Blijenberg; Ulf-Hakan Stenman; Andreas Huber; Kimmo Taari; Matti Hakama; Sue M Moss; Harry J de Koning; Anssi Auvinen Journal: N Engl J Med Date: 2012-03-15 Impact factor: 91.245
Authors: Pim J van Leeuwen; Monique J Roobol; Ries Kranse; Marco Zappa; Sigrid Carlsson; Meelan Bul; Xiaoye Zhu; Chris H Bangma; Fritz H Schröder; Jonas Hugosson Journal: Eur Urol Date: 2011-08-10 Impact factor: 20.096
Authors: Stijn Roemeling; Monique J Roobol; Suzie J Otto; Dik F Habbema; Claartje Gosselaar; Jan J Lous; Jack Cuzick; Fritz H Schröder Journal: Prostate Date: 2007-07-01 Impact factor: 4.104
Authors: Matti Hakama; Sue M Moss; Ulf-Hakan Stenman; Monique J Roobol; Marco Zappa; Sigrid Carlsson; Marco Randazzo; Vera Nelen; Jonas Hugosson Journal: J Med Screen Date: 2016-08-09 Impact factor: 2.136