Cargando…

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

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, SET...

Descripción completa

Detalles Bibliográficos
Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655382/
https://www.ncbi.nlm.nih.gov/pubmed/34934964
http://dx.doi.org/10.1016/j.euros.2021.09.014
_version_ 1784612060900884480
author 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.
author_facet 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.
author_sort Godtman, Rebecka Arnsrud
collection PubMed
description 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.
format Online
Article
Text
id pubmed-8655382
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Elsevier
record_format MEDLINE/PubMed
spelling pubmed-86553822021-12-20 Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer 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. Eur Urol Open Sci Prostate Cancer 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. Elsevier 2021-10-28 /pmc/articles/PMC8655382/ /pubmed/34934964 http://dx.doi.org/10.1016/j.euros.2021.09.014 Text en © 2021 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Prostate Cancer
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.
Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer
title Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer
title_full Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer
title_fullStr Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer
title_full_unstemmed Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer
title_short Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer
title_sort intervention-related deaths in the european randomized study of screening for prostate cancer
topic Prostate Cancer
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655382/
https://www.ncbi.nlm.nih.gov/pubmed/34934964
http://dx.doi.org/10.1016/j.euros.2021.09.014
work_keys_str_mv AT godtmanrebeckaarnsrud interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT remmerssebastiaan interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT ausgunnar interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT nelenvera interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT vaneyckenliesbet interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT villersarnauld interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT rebillardxavier interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT kwiatkowskimaciej interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT wylerstephen interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT pulitidonella interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT gorinigiuseppe interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT paezalvaro interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT lujanmarcos interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT tammelateuvo interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT bangmachris interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT auvinenanssi interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer
AT roobolmoniquej interventionrelateddeathsintheeuropeanrandomizedstudyofscreeningforprostatecancer