Evidence map›Paper›PMID 39731129›Full record

ArticleTrials2024

Enrolment patterns in a randomized controlled trial of probiotics in critically ill patients: a retrospective analysis of the PROSPECT trial.

Alyson Takaoka, Jennie Johnstone, François Lauzier, Diane Heels-Ansdell, Megan Davis, Nicole Zytaruk, Erick Duan, Joanna Dionne, Lois Saunders, Yaseen M Arabi and 13 more

Registry-linked trialAbstract read
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In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02462590 (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT02462590 phase4completednot on this map

Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT)

TypeinterventionalSponsorMcMaster UniversityRan2015 to 2020Enrolled2,650ConditionsVentilator Associated Pneumonia, Infections, C-Difficile, Antibiotic-associated DiarrheaArmsL. rhamnosus GG - Probiotic, Placebo - Microcrystalline Cellulose
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

23 authors.

Alyson TakaokaQueen's University, Kingston, Canada.
Jennie JohnstoneUniversity of Toronto, Toronto, Canada.
François LauzierUniversité Laval, Québec City, Canada.
Diane Heels-AnsdellMcMaster University, Hamilton, Canada.
Megan DavisMcMaster University, Hamilton, Canada.
Nicole ZytarukMcMaster University, Hamilton, Canada.
Erick DuanMcMaster University, Hamilton, ON, Canada.
Joanna DionneMcMaster University, Hamilton, ON, Canada.
Lois SaundersMcMaster University, Hamilton, Canada.
Yaseen M ArabiKing Saud bin Abdulaziz University Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
John MarshallUniversity of Toronto, Toronto, Canada.
Lehana ThabaneMcMaster University, Hamilton, Canada.
France ClarkeMcMaster University, Hamilton, Canada.
Lori HandMcMaster University, Hamilton, Canada.
Marie-Helene MasseUniversité de Sherbrooke, Sherbrooke, Canada.
Bram RochwergMcMaster University, Hamilton, Canada.
Lauralyn McIntyreUniversity of Ottawa, Ottawa, Canada.
Martin GirardUniversité de Montréal, Montréal, Canada.
Andreas FreitagMcMaster University, Hamilton, Canada.
Tim KarachiMcMaster University, Hamilton, Canada.
Deborah J CookMcMaster University, Hamilton, Canada. debcook@mcmaster.ca.ORCID http://orcid.org/0000-0002-4087-543X
PROSPECT Investigators
Canadian Critical Care Trials Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUnderstanding site-related factors that influence enrolment within multicenter randomized controlled trials (RCT) may help reduce trial delays and cost over-runs and prevent early trial discontinuation. In this analysis of PROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial), we describe patient enrolment patterns and examine factors influencing site-based monthly enrolment.

designRetrospective analysis of a multicenter RCT.

methodsThe PROSPECT multicenter RCT enrolled patients in the main trial from July 2015 to March 2019. We documented site characteristics and trial metrics including data from the methods center tracking documents, site-level data at trial initiation, screening logs submitted by research coordinators, and prospectively collected case report forms. In this retrospective analysis of trial data, we analyzed enrolment patterns across sites using negative binomial regression to explore the association between monthly enrolment rate accounting for number of ICU beds, site characteristics, and trial metrics.

resultsOverall, 41 sites enrolling 2365 patients in the PROSPECT main trial were analyzed. After accounting for number of beds in each ICU, site launch early in the trial was associated with higher monthly enrolment rates, but time to first enrolment and research coordinator experience was not. We observed considerable variability in the number of active screening months and enrolment rates across sites.

conclusionThese findings highlight the complexity of recruitment dynamics in critical care RCTs and emphasize the need for tailored approaches to trial planning and execution.

trial registrationPROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial): NCT02462590 (registered June 2, 2015).

Indexed as

Critical IllnessPatient SelectionProbioticsHumansIntensive Care UnitsMulticenter Studies as TopicRandomized Controlled Trials as TopicRetrospective StudiesTime FactorsTreatment OutcomeCritical illnessEnrolmentRandomized trialScreening

Identifiers

PMID39731129
PMCPMC11673600

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Registered trials

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.