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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: | Takahashi, Kuniaki Kogame, Norihiro Tomaniak, Mariusz Chichareon, Ply Chang, Chun-Chin Modolo, Rodrigo BENIT, Edouard Liebetrau, Christoph Janssens, Luc Ferrario, Maurizio Zurakowski, Aleksander van Geuns, Robert Jan Dominici, Marcello Huber, Kurt Buszman, Pawel Bolognese, Leonardo Tumscitz, Carlo Zmudka, Krzysztof Aminian, Adel VROLIX, Mathias Petrov, Ivo Wykrzykowska, Joanna J. de Winter, Robbert J. Hamm, Christian Steg, Philippe Gabriel Onuma, Yoshinobu Valgimigli, Marco Windecker, Stephan VRANCKX, Pascal Garg, Scot Serruys, Patrick W. |
Issue Date: | 2020 | Publisher: | SPRINGER HEIDELBERG | Source: | CLINICAL RESEARCH IN CARDIOLOGY, 109 (7) , p. 918 -929 | 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-rankp < 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 | Notes: | Serruys, PW (corresponding author), Natl Univ Ireland, Dept Cardiol, Galway NUIG, Univ Rd, Galway H91 TK33, Ireland.; Serruys, PW (corresponding author), Imperial Coll London, London, England. patrick.w.j.c.serruys@gmail.com |
Other: | Serruys, PW (corresponding author), Natl Univ Ireland, Dept Cardiol, Galway NUIG, Univ Rd, Galway H91 TK33, Ireland; Imperial Coll London, London, England. patrick.w.j.c.serruys@gmail.com | Keywords: | All-cause mortality;All-comers;Recruitment;Retention;Randomised controlled trial | Document URI: | http://hdl.handle.net/1942/32475 | ISSN: | 1861-0684 | e-ISSN: | 1861-0692 | DOI: | 10.1007/s00392-019-01585-w | ISI #: | WOS:000541925600002 | Rights: | © Springer-Verlag GmbH Germany, part of Springer Nature 2019. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2021 |
Appears in Collections: | Research publications |
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kuniaki.pdf Restricted Access | Published version | 1.76 MB | Adobe PDF | View/Open Request a copy |
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