{
  "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.\n\nMethods 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.\n\nEthics 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.\n\nTrial registration number: ISRCTN40090372.",
  "abstract_shown": true,
  "affiliations": [
    "School of Health & Social Care, Edinburgh Napier University, Edinburgh, UK",
    "Charite—Universitatsmedizin Berlin, Berlin, Germany",
    "Newcastle University, Newcastle upon Tyne, UK",
    "Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK",
    "Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK",
    "Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK",
    "Department of Health and Community Sciences, University of Exeter Medical School, Exeter, UK",
    "University of Newcastle upon Tyne, Newcastle upon Tyne, Tyne and Wear, UK",
    "Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK",
    "Department of Medical Microbiology, Royal Victoria Hospital, Belfast, UK",
    "The University of Edinburgh, Edinburgh, UK",
    "Intensive Care Unit, University of Manchester, Salford, Greater Manchester, UK",
    "Institute of Cellular Medicine, Medical School, Newcastle University Institute of Cellular Medicine, Newcastle upon Tyne, UK",
    "KCL, London, UK",
    "Faculty of Social Sciences, University of Stirling, Stirling, UK",
    "Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK",
    "Division of Research Methodology, Wrocław Medical University, Wrocław, Poland"
  ],
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  "arxiv": null,
  "author_total": 18,
  "authors": [
    {
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        0,
        1
      ],
      "name": "Jamie Smith",
      "orcid": "0000-0003-0097-6102"
    },
    {
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        2
      ],
      "name": "Helen Mossop"
    },
    {
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        3
      ],
      "name": "Zoe Walmsley"
    },
    {
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        4
      ],
      "name": "Phil Mawson",
      "orcid": "0000-0002-2056-5047"
    },
    {
      "affs": [
        5
      ],
      "name": "Miranda Morton",
      "orcid": "0000-0002-3362-9302"
    },
    {
      "affs": [
        4
      ],
      "name": "Cristina Fernandez-Garcia"
    },
    {
      "affs": [
        6
      ],
      "name": "Lydia M Emerson"
    },
    {
      "affs": [
        5
      ],
      "name": "Helen C Hancock",
      "orcid": "0000-0002-1494-8551"
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    {
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        7
      ],
      "name": "Dawn Teare"
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    {
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        8
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      "name": "Laura Ternent"
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    {
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        9
      ],
      "name": "Ronan McMullan"
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    {
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        10
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      "name": "Timothy S Walsh"
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    {
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        11
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      "name": "Paul Dark"
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    {
      "affs": [
        12
      ],
      "name": "John Simpson"
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    {
      "affs": [
        13
      ],
      "name": "Rashmi Kumar"
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    {
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        14
      ],
      "name": "Margaret Ogden"
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    {
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        15
      ],
      "name": "Thomas P Hellyer",
      "orcid": "0000-0001-5346-7411"
    },
    {
      "affs": [
        0,
        16
      ],
      "name": "Gosha Colquhoun (formerly Wojcik)",
      "orcid": "0000-0003-3857-2090"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/d16yhy7sz7wy8.bib",
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  "doi": "10.1136/bmjopen-2026-119173",
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  "pmcid": "PMC13735336",
  "pmid": "42971635",
  "published": "2026-11-02",
  "publisher": "BMJ",
  "ris": "https://research.draconitic.com/paper/d16yhy7sz7wy8.ris",
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  "subjects": [
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      "field": "medicine",
      "origin": "journal-openalex:F27",
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  "title": "Randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis (SHORTER trial): protocol for a mixed-methods process evaluation",
  "title_text": "Randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis (SHORTER trial): protocol for a mixed-methods process evaluation",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T12:21:02Z",
  "url": "https://research.draconitic.com/paper/d16yhy7sz7wy8",
  "venue": "BMJ Open",
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}