Randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis (SHORTER trial): protocol for a mixed-methods process evaluation
17 affiliations
- 1School of Health & Social Care, Edinburgh Napier University, Edinburgh, UK
- 2Charite—Universitatsmedizin Berlin, Berlin, Germany
- 3Newcastle University, Newcastle upon Tyne, UK
- 4Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
- 5Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK
- 6Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
- 7Department of Health and Community Sciences, University of Exeter Medical School, Exeter, UK
- 8University of Newcastle upon Tyne, Newcastle upon Tyne, Tyne and Wear, UK
- 9Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK
- 10Department of Medical Microbiology, Royal Victoria Hospital, Belfast, UK
- 11The University of Edinburgh, Edinburgh, UK
- 12Intensive Care Unit, University of Manchester, Salford, Greater Manchester, UK
- 13Institute of Cellular Medicine, Medical School, Newcastle University Institute of Cellular Medicine, Newcastle upon Tyne, UK
- 14KCL, London, UK
- 15Faculty of Social Sciences, University of Stirling, Stirling, UK
- 16Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK
- 17Division of Research Methodology, Wrocław Medical University, Wrocław, Poland
Abstract
Introduction: The randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis (SHORTER trial) (ISRCTN40090372) is a multicentre, pragmatic, randomised controlled trial evaluating whether a fixed 5-day course of antibiotics for sepsis in critical care is non-inferior to usual care in terms of mortality, while reducing antibiotic exposure. An embedded process evaluation will examine how organisational, team-based and individual factors shape whether the 5-day protocol is followed as intended (fidelity), whether antibiotic duration actually differs between trial arms (separation) and what drives variation in delivery across approximately 50 UK sites over time.
Methods and analysis: We will undertake a longitudinal mixed-methods process evaluation combining surveys, interviews, observations and routine trial data. Three complementary frameworks guide the analysis at different levels: the Theory of Planned Behaviour (individual clinician decisions), Normalisation Process Theory (team-level embedding of the protocol; assessed using the NoMAD-23 instrument) and the Consolidated Framework for Implementation Research (organisational and system-level conditions). Quantitative components include baseline site profiling, NoMAD-23 survey responses and monthly trial metrics (fidelity, separation, recruitment) across all participating sites. Qualitative components include semistructured interviews and non-participant observations at 10 purposively selected sites. Integration will use site-level case summaries, cross-site typologies and joint displays.
Ethics and dissemination: Favourable ethical opinions were received from Wales REC 4 (REC reference 23/WA/0197) and Scotland A Research Ethics Committee (REC reference 24/SS/0013); Health Research Authority approval is recorded under Integrated Research Application System (IRAS ID) 317788. Findings will be disseminated through peer-reviewed publications, conference presentations, site feedback and accessible summaries for patient/public audiences.
Trial registration number: ISRCTN40090372.
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BibTeX
@article{smith2026randomised,
title = {{Randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis (SHORTER trial): protocol for a mixed-methods process evaluation}},
author = {Jamie Smith and Helen Mossop and Zoe Walmsley and Phil Mawson and Miranda Morton and Cristina Fernandez-Garcia and Lydia M Emerson and Helen C Hancock and Dawn Teare and Laura Ternent and Ronan McMullan and Timothy S Walsh and Paul Dark and John Simpson and Rashmi Kumar and Margaret Ogden and Thomas P Hellyer and Gosha Colquhoun (formerly Wojcik)},
journal = {BMJ Open},
year = {2026},
month = nov,
doi = {10.1136/bmjopen-2026-119173},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-119173},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis (SHORTER trial): protocol for a mixed-methods process evaluation
AU - Jamie Smith
AU - Helen Mossop
AU - Zoe Walmsley
AU - Phil Mawson
AU - Miranda Morton
AU - Cristina Fernandez-Garcia
AU - Lydia M Emerson
AU - Helen C Hancock
AU - Dawn Teare
AU - Laura Ternent
AU - Ronan McMullan
AU - Timothy S Walsh
AU - Paul Dark
AU - John Simpson
AU - Rashmi Kumar
AU - Margaret Ogden
AU - Thomas P Hellyer
AU - Gosha Colquhoun (formerly Wojcik)
PY - 2026
DA - 2026/11/02
JO - BMJ Open
DO - 10.1136/bmjopen-2026-119173
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-119173
AB - Introduction: The randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis (SHORTER trial) (ISRCTN40090372) is a multicentre, pragmatic, randomised controlled trial evaluating whether a fixed 5-day course of antibiotics for sepsis in critical care is non-inferior to usual care in terms of mortality, while reducing antibiotic exposure. An embedded process evaluation will examine how organisational, team-based and individual factors shape whether the 5-day protocol is followed as intended (fidelity), whether antibiotic duration actually differs between trial arms (separation) and what drives variation in delivery across approximately 50 UK sites over time. Methods and analysis: We will undertake a longitudinal mixed-methods process evaluation combining surveys, interviews, observations and routine trial data. Three complementary frameworks guide the analysis at different levels: the Theory of Planned Behaviour (individual clinician decisions), Normalisation Process Theory (team-level embedding of the protocol; assessed using the NoMAD-23 instrument) and the Consolidated Framework for Implementation Research (organisational and system-level conditions). Quantitative components include baseline site profiling, NoMAD-23 survey responses and monthly trial metrics (fidelity, separation, recruitment) across all participating sites. Qualitative components include semistructured interviews and non-participant observations at 10 purposively selected sites. Integration will use site-level case summaries, cross-site typologies and joint displays. Ethics and dissemination: Favourable ethical opinions were received from Wales REC 4 (REC reference 23/WA/0197) and Scotland A Research Ethics Committee (REC reference 24/SS/0013); Health Research Authority approval is recorded under Integrated Research Application System (IRAS ID) 317788. Findings will be disseminated through peer-reviewed publications, conference presentations, site feedback and accessible summaries for patient/public audiences. Trial registration number: ISRCTN40090372.
SN - 2044-6055
SN - 2044-6055
ER -