| Autor: |
Rebecka Arnsrud Godtman, Sebastiaan Remmers, Gunnar Aus, Vera Nelen, Liesbet van Eycken, Arnauld Villers, Xavier Rebillard, Maciej Kwiatkowski, Stephen Wyler, Donella Puliti, Giuseppe Gorini, Alvaro Paez, Marcos Lujan, Teuvo Tammela, Chris Bangma, Anssi Auvinen, Monique J. Roobol |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
European Urology Open Science, Vol 34, Iss , Pp 27-32 (2021) |
| Druh dokumentu: |
article |
| ISSN: |
2666-1683 |
| DOI: |
10.1016/j.euros.2021.09.014 |
| Popis: |
Background: Identification of intervention-related deaths is important for an accurate assessment of the ratio of benefit to harm in screening trials. Objective: To investigate intervention-related deaths by study arm in the European Randomized Study of Prostate Cancer Screening (ERSPC). 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. 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. 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. Conclusions: Intervention-related deaths were rare in ERSPC. Monitoring of intervention-related deaths in screening trials is important for assessment of harms. 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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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