Evidence map›Paper›PMID 31828504›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2020

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

Kuniaki Takahashi, Norihiro Kogame, Mariusz Tomaniak, Ply Chichareon, Chun-Chin Chang, Rodrigo Modolo, Edouard Benit, Christoph Liebetrau, Luc Janssens, Maurizio Ferrario and 21 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Kuniaki TakahashiDepartment of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Norihiro KogameDepartment of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Mariusz TomaniakDepartment of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Ply ChichareonDepartment of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Chun-Chin ChangDepartment of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Rodrigo ModoloDepartment of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Edouard BenitFaculty of Medicine and Life Sciences, Jessa Ziekenhuis, Hasselt University, Hasselt, Belgium.
Christoph LiebetrauKerckhoff Heart Center, Bad Nauheim, Germany.
Luc JanssensImelda Ziekenhuis, Bonheiden, Belgium.
Maurizio FerrarioUOC Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Aleksander ZurakowskiAmerican Heart of Poland, Ustroń, Poland.
Robert Jan van GeunsDepartment of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Marcello DominiciAzienda Ospedaliera S. Maria, Terni, Italy.
Kurt Huber3rd Department of Medicine, Cardiology and Intensive Care Medicine, Medical School, Wilhelminen Hospital, and Sigmund Freud University, Vienna, Austria.
Pawel BuszmanAmerican Heart of Poland, Ustroń, Poland.
Leonardo BologneseOspedale S. Donato, Arezzo, Italy.
Carlo TumscitzUniversity Hospital of Ferrara, Ferrara, Italy.
Krzysztof ŻmudkaDepartment of Interventional Cardiology, Faculty of Medicine, Jagiellonian University, Kraków, Poland.
Adel AminianCentre Hospitalier Universitaire Charleroi, Charleroi, Belgium.
Mathias VrolixZiekenhuis Oost-Limburg, Genk, Belgium.
Ivo PetrovCity Clinic, Sofia, Bulgaria.
Joanna J WykrzykowskaDepartment of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Robbert J de WinterDepartment of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Christian HammKerckhoff Heartand, Thorax Center, University of Giessen, Bad Nauheim, Germany.
Philippe Gabriel StegFACT (French Alliance for Cardiovascular Trials), Université Paris-Diderot, Paris, France.
Yoshinobu OnumaDepartment of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland.
Marco ValgimigliDepartment of Cardiology, University of Bern, Inselspital, Bern, Switzerland.
Stephan WindeckerDepartment of Cardiology, University of Bern, Inselspital, Bern, Switzerland.
Pascal VranckxFaculty of Medicine and Life Sciences, Jessa Ziekenhuis, Hasselt University, Hasselt, Belgium.
Scot GargRoyal Blackburn Hospital, Blackburn, UK.
Patrick W SerruysDepartment of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland. patrick.w.j.c.serruys@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveRecruitment 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.

methodsThe 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.

resultsThe 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).

conclusionsRecruitment 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.

Indexed as

Patient DropoutsPatient SelectionAgedBiomedical ResearchCoronary Artery DiseaseDual Anti-Platelet TherapyFemaleHumansMaleMiddle AgedPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsStentsTicagrelorPlatelet Aggregation InhibitorsTicagrelorAll-cause mortalityAll-comersRandomised controlled trialRecruitmentRetention

Identifiers

PMID31828504

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.