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
GSD and SSR are effective adaptive designs, preferable to fixed RCTs in a superiority trial comparing the effectiveness of an investigational intervention with a standard of care in preventing VAP among critically ill, ventilated patients. They can reduce the expected sample size between 9% and 12% and should be considered at the trial design stage.
Authors
- Julien Sauser
- Cornelis H. van Werkhoven (ORCID: https://orcid.org/0000-0002-0626-4635)
- Holly Jackson (ORCID: https://orcid.org/0000-0003-0646-6437)
- Stephan Harbarth (ORCID: https://orcid.org/0000-0002-3551-1025)
- Marlieke E.A. de Kraker (ORCID: https://orcid.org/0000-0003-0903-8614)
Institutions
- Utrecht University (NL)
- University Medical Center Utrecht (NL)
- World Health Organization (CH)
- Geneva College (US)
- University of Lausanne (CH)
Publication Details
- Journal
- BMC Medical Research Methodology
- Published
- 2025-11-12
- DOI
- https://doi.org/10.1186/s12874-025-02681-4
- Primary Topic
- Nosocomial Infections in ICU
- Type
- article
- Field-Weighted Citation Impact
- 0.00