Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer

• Published in: European urology open science (Online) 2021-12, Vol.34, p.27-32
• Main Authors: Godtman, Rebecka Arnsrud, Remmers, Sebastiaan, Aus, Gunnar, Nelen, Vera, van Eycken, Liesbet, Villers, Arnauld, Rebillard, Xavier, Kwiatkowski, Maciej, Wyler, Stephen, Puliti, Donella, Gorini, Giuseppe, Paez, Alvaro, Lujan, Marcos, Tammela, Teuvo, Bangma, Chris, Auvinen, Anssi, Roobol, Monique J.
• Format: Article
• Language: English
• Subjects: Cause of death; Complications; Life Sciences; Prostate Cancer; Prostate-specific antigen; Screening; Treatment
• ISSN: 2666-1683; 2666-1691; 2666-1683
• DOI: 10.1016/j.euros.2021.09.014

Intervention-related deaths were rare in the ERSPC trial, but relatively large differences in the number of intervention-related deaths were observed among centers. Standardized cause-of-death reviews are important in identifying intervention-related deaths and should be used in screening trials. Identification of intervention-related deaths is important for an accurate assessment of the ratio of benefit to harm in screening trials. To investigate intervention-related deaths by study arm in the European Randomized Study of Prostate Cancer Screening (ERSPC). ERSPC is a multicenter trial initiated in the 1990s to investigate whether screening on the basis of prostate-specific antigen (PSA) can decrease prostate cancer mortality. The present study included men in the core age group (55–69 yr: screening group n = 112 553, control group n = 128 681) with 16-yr follow-up. Causes of death among men with prostate cancer in ERSPC were predominantly evaluated by independent national committees via review of medical records according to a predefined algorithm. Intervention-related deaths were defined as deaths caused by complications during the screening procedure, treatment, or follow-up. Descriptive statistics were used for the results. In total, 34 deaths were determined to be intervention-related, of which 21 were in the screening arm and 13 in the control arm. The overall risk of intervention-related death was 1.41 (95% confidence interval 0.99–1.99) per 10 000 randomized men for both arms combined and varied among centers from 0 to 7.0 per 10 000 randomized men. A limitation of this study is that differences in procedures among centers decreased the comparability of the results. Intervention-related deaths were rare in ERSPC. Monitoring of intervention-related deaths in screening trials is important for assessment of harms. We investigated deaths due to screening or treatment to assess harm in a trial of prostate cancer screening. Few such deaths were identified.