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01-07-2020 | Original Paper

Impact of recruitment and retention on all-cause mortality in a large all-comers randomised controlled trial: insights from the GLOBAL LEADERS trial

Authors: Kuniaki Takahashi, Norihiro Kogame, Mariusz Tomaniak, Ply Chichareon, Chun-Chin Chang, Rodrigo Modolo, Edouard Benit, Christoph Liebetrau, Luc Janssens, Maurizio Ferrario, Aleksander Zurakowski, Robert Jan van Geuns, Marcello Dominici, Kurt Huber, Pawel Buszman, Leonardo Bolognese, Carlo Tumscitz, Krzysztof Żmudka, Adel Aminian, Mathias Vrolix, Ivo Petrov, Joanna J. Wykrzykowska, Robbert J. de Winter, Christian Hamm, Philippe Gabriel Steg, Yoshinobu Onuma, Marco Valgimigli, Stephan Windecker, Pascal Vranckx, Scot Garg, Patrick W. Serruys

Published in: Clinical Research in Cardiology | Issue 7/2020

Abstract

Objective

Recruitment and retention in trials may bias the results and subsequently complicate their interpretation and validity. The aim of this study is to evaluate the impact of recruitment and retention on all-cause mortality in a large all-comers trial.

Methods

The recruitment rate in each investigating center of the GLOBAL LEADERS trial was assessed and the 130 centers were subdivided into low and high recruiters according to the median, with all-cause mortality then compared between the two groups. Vital status was obtained from public records in patients with incomplete follow-up.

Results

The trial randomized 15,991 (7.86%) of 203,483 eligible patients with percutaneous coronary intervention during the recruitment period, of whom 15,267 (95.47%) completed follow-up, 23 (0.14%) patients withdrew consent and formally requested to be deleted from the database; 183 (1.14%) withdrew consent but only objected to future data collection; 303 (1.89%) discontinued the study; and 215 (1.34%) were lost to follow-up. Vital status was finally obtained in all but 31 patients (99.81%). Patients from low recruiters had a significantly lower all-cause mortality than high ones (2.26% vs. 3.24%; hazard ratio: 0.69; 95% confidence interval: 0.55–0.87; p = 0.002). There was a significant difference in all-cause mortality among the incomplete follow-up groups (log-rank p < 0.001) with a significantly higher mortality in the 183 patients who withdrew consent than those who completed follow-up (7.38% vs. 2.99%, p = 0.002).

Conclusions

Recruitment and retention significantly impacted all-cause mortality. Search for vital status through public domains is of paramount importance in the interpretation and validity of large clinical trials.

Graphic abstract

Available only for authorised users

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Title: Impact of recruitment and retention on all-cause mortality in a large all-comers randomised controlled trial: insights from the GLOBAL LEADERS trial
Authors: Kuniaki Takahashi
Norihiro Kogame
Mariusz Tomaniak
Ply Chichareon
Chun-Chin Chang
Rodrigo Modolo
Edouard Benit
Christoph Liebetrau
Luc Janssens
Maurizio Ferrario
Aleksander Zurakowski
Robert Jan van Geuns
Marcello Dominici
Kurt Huber
Pawel Buszman
Leonardo Bolognese
Carlo Tumscitz
Krzysztof Żmudka
Adel Aminian
Mathias Vrolix
Ivo Petrov
Joanna J. Wykrzykowska
Robbert J. de Winter
Christian Hamm
Philippe Gabriel Steg
Yoshinobu Onuma
Marco Valgimigli
Stephan Windecker
Pascal Vranckx
Scot Garg
Patrick W. Serruys
Publication date: 01-07-2020
Publisher: Springer Berlin Heidelberg
Published in: Clinical Research in Cardiology / Issue 7/2020
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-019-01585-w

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Springer Medicine

Impact of recruitment and retention on all-cause mortality in a large all-comers randomised controlled trial: insights from the GLOBAL LEADERS trial

Abstract

Objective

Methods

Results

Conclusions

Graphic abstract

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Conclusions

Graphic abstract

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