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

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

doi:10.1016/j.euros.2021.09.014

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

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

Health Sciences

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Abstract

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.

Original language	English
Pages (from-to)	27-32
Number of pages	6
Journal	European Urology Open Science
Volume	34
DOIs	https://doi.org/10.1016/j.euros.2021.09.014
Publication status	Published - Dec 2021
Publication type	A1 Journal article-refereed

Funding

Funding/Support and role of the sponsor: ERSPC was supported by Hybritech Inc. Grants have also been received from Institut National du Cancer (Convention 12-2008, grant number 07/3D1616/SPC-111-13/NG-NC); Ligue Nationale Contre le Cancer (grant numbers PRE08/AV–CONV. DRC 2009/119, EPDCD14646–DRC no. 2014/620, PRE2014.LNCC/AV); and Pedro Cifuentes of the Foundation for Research in Urology of the Spanish Urological Association. Rebecka Arnsrud Godtman’s work on this article was supported by the Swedish state under an agreement between the Swedish government and the county councils (the ALF agreement). The sponsors had no access to data, and no influence on data analysis or drafting of the manuscript.

Keywords

Cause of death
Complications
Prostate cancer
Prostate-specific antigen
Screening
Treatment

Publication forum classification

Publication forum level 1

ASJC Scopus subject areas

Urology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.euros.2021.09.014Licence: CC BY-NC-ND

1-s2.0-S2666168321016955-mainFinal published version, 271 KBLicence: CC BY-NC-ND

https://urn.fi/URN:NBN:fi:tuni-202201251590Licence: CC BY-NC-ND

Cite this

Godtman, R. A., 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, M. J. (2021). Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer. European Urology Open Science, 34, 27-32. https://doi.org/10.1016/j.euros.2021.09.014

@article{c9159f721886468280b5e548f1b9b87a,

title = "Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer",

abstract = "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.",

keywords = "Cause of death, Complications, Prostate cancer, Prostate-specific antigen, Screening, Treatment",

author = "Godtman, {Rebecka Arnsrud} and Sebastiaan Remmers and Gunnar Aus and Vera Nelen and {van Eycken}, Liesbet and Arnauld Villers and Xavier Rebillard and Maciej Kwiatkowski and Stephen Wyler and Donella Puliti and Giuseppe Gorini and Alvaro Paez and Marcos Lujan and Teuvo Tammela and Chris Bangma and Anssi Auvinen and Roobol, {Monique J.}",

note = "Funding Information: Funding/Support and role of the sponsor: ERSPC was supported by Hybritech Inc. Grants have also been received from Institut National du Cancer (Convention 12-2008, grant number 07/3D1616/SPC-111-13/NG-NC); Ligue Nationale Contre le Cancer (grant numbers PRE08/AV–CONV. DRC 2009/119, EPDCD14646–DRC no. 2014/620, PRE2014.LNCC/AV); and Pedro Cifuentes of the Foundation for Research in Urology of the Spanish Urological Association. Rebecka Arnsrud Godtman{\textquoteright}s work on this article was supported by the Swedish state under an agreement between the Swedish government and the county councils (the ALF agreement). The sponsors had no access to data, and no influence on data analysis or drafting of the manuscript. ",

year = "2021",

month = dec,

doi = "10.1016/j.euros.2021.09.014",

language = "English",

volume = "34",

pages = "27--32",

}

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 2021, 'Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer', European Urology Open Science, vol. 34, pp. 27-32. https://doi.org/10.1016/j.euros.2021.09.014

TY - JOUR

T1 - Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer

AU - Godtman, Rebecka Arnsrud

AU - Remmers, Sebastiaan

AU - Aus, Gunnar

AU - Nelen, Vera

AU - van Eycken, Liesbet

AU - Villers, Arnauld

AU - Rebillard, Xavier

AU - Kwiatkowski, Maciej

AU - Wyler, Stephen

AU - Puliti, Donella

AU - Gorini, Giuseppe

AU - Paez, Alvaro

AU - Lujan, Marcos

AU - Tammela, Teuvo

AU - Bangma, Chris

AU - Auvinen, Anssi

AU - Roobol, Monique J.

N1 - Funding Information: Funding/Support and role of the sponsor: ERSPC was supported by Hybritech Inc. Grants have also been received from Institut National du Cancer (Convention 12-2008, grant number 07/3D1616/SPC-111-13/NG-NC); Ligue Nationale Contre le Cancer (grant numbers PRE08/AV–CONV. DRC 2009/119, EPDCD14646–DRC no. 2014/620, PRE2014.LNCC/AV); and Pedro Cifuentes of the Foundation for Research in Urology of the Spanish Urological Association. Rebecka Arnsrud Godtman’s work on this article was supported by the Swedish state under an agreement between the Swedish government and the county councils (the ALF agreement). The sponsors had no access to data, and no influence on data analysis or drafting of the manuscript.

PY - 2021/12

Y1 - 2021/12

N2 - 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.

AB - 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.

KW - Cause of death

KW - Complications

KW - Prostate cancer

KW - Prostate-specific antigen

KW - Screening

KW - Treatment

U2 - 10.1016/j.euros.2021.09.014

DO - 10.1016/j.euros.2021.09.014

M3 - Article

AN - SCOPUS:85122685114

SN - 2666-1691

VL - 34

SP - 27

EP - 32

JO - European Urology Open Science

JF - European Urology Open Science

ER -

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

Abstract

Funding

Keywords

Publication forum classification

ASJC Scopus subject areas

UN SDGs

Access to Document

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