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

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; Żmudka, Krzysztof; Aminian, Adel; Vrolix, Mathias; ... (2020). Impact of recruitment and retention on all-cause mortality in a large all-comers randomised controlled trial: insights from the GLOBAL LEADERS trial. Clinical research in cardiology, 109(7), pp. 918-929. Springer-Verlag 10.1007/s00392-019-01585-w

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Valgimigli, Marco and Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1861-0684

Publisher:

Springer-Verlag

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

07 Feb 2020 13:10

Last Modified:

25 Jun 2020 01:31

Publisher DOI:

10.1007/s00392-019-01585-w

PubMed ID:

31828504

Uncontrolled Keywords:

All-cause mortality All-comers Randomised controlled trial Recruitment Retention

BORIS DOI:

10.7892/boris.139037

URI:

https://boris.unibe.ch/id/eprint/139037

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