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Benefits of group sequential design and sample size re-estimation for randomised controlled trials evaluating the prevention of ventilator-associated pneumonia: a simulation study informed by real world data

Crossref DOI link: https://doi.org/10.1186/s12874-025-02681-4

Published Online: 2025-11-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Jackson, Holly

Sauser, Julien

van Werkhoven, C. H.

Harbarth, Stephan

de Kraker, Marlieke E.A.
Funding

Funding for this research was provided by:

University of Geneva
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Text and Data Mining valid from 2025-11-12

Version of Record valid from 2025-11-12
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Article History

Received: 6 January 2025

Accepted: 16 September 2025

First Online: 12 November 2025

Declarations

:

: This simulation study was informed by data from the prospective observational Hospital Network Study – Preparation for a Randomised Evaluation of anti-Pneumonia Strategies (HONEST-PREPS) study (ClinicalTrials.gov ID: NCT05060718). Approval for HONEST-PREPS came from the Institutional Boards or local Ethics Committees prior to its site initiation, listed below. Routine clinical and microbiological data were only collected for eligible participants, who themselves, or their legal representative, signed informed consent. All clinical research during HONEST-PREPS was conducted according to the principles of the Declaration of Helsinki, GCP and local legislations. No study related diagnostic procedures or interventions were performed. Authors of the current study are part of the original HONEST-PREPS study team, and this work was part of the original HONEST-PREPS objectives. The 12 local Ethics Committees which approved this trial are:

: Not applicable.

: The authors declare no competing interests.

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