TY - JOUR
T1 - Impact of recruitment and retention on all-cause mortality in a large all-comers randomised controlled trial: insights from the GLOBAL LEADERS trial
AU - Takahashi, Kuniaki
AU - Kogame, Norihiro
AU - Tomaniak, Mariusz
AU - Chichareon, Ply
AU - Chang, Chun-Chin
AU - Modolo, Rodrigo
AU - Benit, Edouard
AU - Liebetrau, Christoph
AU - Janssens, Luc
AU - Ferrario, Maurizio
AU - Zurakowski, Aleksander
AU - van Geuns, Robert Jan
AU - Dominici, Marcello
AU - Huber, Kurt
AU - Buszman, Pawel
AU - Bolognese, Leonardo
AU - Tumscitz, Carlo
AU - Żmudka, Krzysztof
AU - Aminian, Adel
AU - Vrolix, Mathias
AU - Petrov, Ivo
AU - Wykrzykowska, Joanna J.
AU - de Winter, Robbert J.
AU - Hamm, Christian
AU - Steg, Philippe Gabriel
AU - Onuma, Yoshinobu
AU - Valgimigli, Marco
AU - Windecker, Stephan
AU - Vranckx, Pascal
AU - Garg, Scot
AU - Serruys, Patrick W.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - 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: [Figure not available: see fulltext.].
AB - 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: [Figure not available: see fulltext.].
KW - All-cause mortality
KW - All-comers
KW - Randomised controlled trial
KW - Recruitment
KW - Retention
UR - http://www.scopus.com/inward/record.url?scp=85076377230&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00392-019-01585-w
DO - https://doi.org/10.1007/s00392-019-01585-w
M3 - Article
C2 - 31828504
SN - 1861-0684
VL - 109
SP - 918
EP - 929
JO - Clinical research in cardiology
JF - Clinical research in cardiology
IS - 7
ER -