Kuniaki Takahashi1, Norihiro Kogame1, Mariusz Tomaniak2,3, Ply Chichareon1,4, Chun-Chin Chang2, Rodrigo Modolo1,5, Edouard Benit6, Christoph Liebetrau7, Luc Janssens8, Maurizio Ferrario9, Aleksander Zurakowski10, Robert Jan van Geuns2, Marcello Dominici11, Kurt Huber12, Pawel Buszman10,13, Leonardo Bolognese14, Carlo Tumscitz15, Krzysztof Żmudka16, Adel Aminian17, Mathias Vrolix18, Ivo Petrov19, Joanna J Wykrzykowska1, Robbert J de Winter1, Christian Hamm20, Philippe Gabriel Steg21, Yoshinobu Onuma22, Marco Valgimigli23, Stephan Windecker23, Pascal Vranckx6, Scot Garg24, Patrick W Serruys25,26. 1. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. 2. Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. 3. First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland. 4. Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand. 5. Cardiology Division, Department of Internal Medicine, University of Campinas (UNICAMP), Campinas, Brazil. 6. Faculty of Medicine and Life Sciences, Jessa Ziekenhuis, Hasselt University, Hasselt, Belgium. 7. Kerckhoff Heart Center, Bad Nauheim, Germany. 8. Imelda Ziekenhuis, Bonheiden, Belgium. 9. UOC Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 10. American Heart of Poland, Ustroń, Poland. 11. Azienda Ospedaliera S. Maria, Terni, Italy. 12. 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Medical School, Wilhelminen Hospital, and Sigmund Freud University, Vienna, Austria. 13. Department of Epidemiology and Statistics, Medical University of Silesia, Katowice, Poland. 14. Ospedale S. Donato, Arezzo, Italy. 15. University Hospital of Ferrara, Ferrara, Italy. 16. Department of Interventional Cardiology, Faculty of Medicine, Jagiellonian University, Kraków, Poland. 17. Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium. 18. Ziekenhuis Oost-Limburg, Genk, Belgium. 19. City Clinic, Sofia, Bulgaria. 20. Kerckhoff Heartand, Thorax Center, University of Giessen, Bad Nauheim, Germany. 21. FACT (French Alliance for Cardiovascular Trials), Université Paris-Diderot, Paris, France. 22. Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland. 23. Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland. 24. Royal Blackburn Hospital, Blackburn, UK. 25. Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland. patrick.w.j.c.serruys@gmail.com. 26. Imperial College London, London, UK. patrick.w.j.c.serruys@gmail.com.
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.
RCT Entities:
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.
Authors: Masafumi Ono; Ply Chichareon; Mariusz Tomaniak; Hideyuki Kawashima; Kuniaki Takahashi; Norihiro Kogame; Rodrigo Modolo; Hironori Hara; Chao Gao; Rutao Wang; Simon Walsh; Harry Suryapranata; Pedro Canas da Silva; James Cotton; René Koning; Ibrahim Akin; Benno J W M Rensing; Scot Garg; Joanna J Wykrzykowska; Jan J Piek; Peter Jüni; Christian Hamm; Philippe Gabriel Steg; Marco Valgimigli; Stephan Windecker; Robert F Storey; Yoshinobu Onuma; Pascal Vranckx; Patrick W Serruys Journal: Clin Res Cardiol Date: 2020-01-31 Impact factor: 5.460