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

Authors :
Godtman RA
Remmers S
Aus G
Nelen V
van Eycken L
Villers A
Rebillard X
Kwiatkowski M
Wyler S
Puliti D
Gorini G
Paez A
Lujan M
Tammela T
Bangma C
Auvinen A
Roobol MJ
Source :
European urology open science [Eur Urol Open Sci] 2021 Oct 28; Vol. 34, pp. 27-32. Date of Electronic Publication: 2021 Oct 28 (Print Publication: 2021).
Publication Year :
2021

Abstract

Background: Identification of intervention-related deaths is important for an accurate assessment of the ratio of benefit to harm in screening trials.<br />Objective: To investigate intervention-related deaths by study arm in the European Randomized Study of Prostate Cancer Screening (ERSPC).<br />Design Setting and Participants: 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.<br />Outcome Measurements and Statistical Analysis: 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.<br />Results and Limitations: 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.<br />Conclusions: Intervention-related deaths were rare in ERSPC. Monitoring of intervention-related deaths in screening trials is important for assessment of harms.<br />Patient Summary: We investigated deaths due to screening or treatment to assess harm in a trial of prostate cancer screening. Few such deaths were identified.<br /> (© 2021 The Author(s).)

Details

Language :
English
ISSN :
2666-1683
Volume :
34
Database :
MEDLINE
Journal :
European urology open science
Publication Type :
Academic Journal
Accession number :
34934964
Full Text :
https://doi.org/10.1016/j.euros.2021.09.014