{
  "abstract": "Randomised controlled trials that use cohorts or health-and-care systems data, often known as routinely collected data—such as electronic health records, registries, or administrative claims—are becoming increasingly common. These trials have the potential to streamline recruitment, intervention delivery, follow-up (within trial and long term), and to lower costs. The lack of clear information governance pathways, heterogeneous data quality, delays in data recording and acquisition, and regulatory or ethical complexities undermine reproducibility and bias assessment when routinely collected data are used in trials. We introduce the SPIRIT-ROUTINE extension to the SPIRIT 2025 guideline: a checklist and explanation designed to improve the reporting of trial protocols that rely on cohorts or routinely collected data sources. Investigators, funders, ethics committees, journal editors, and peer reviewers can use the SPIRIT-ROUTINE extension to enhance completeness, transparency, and usability of such protocols to support better research, healthcare decisions, and patient outcomes.",
  "authors": [
    {
      "affiliations": [
        "School of Public Health, University College Cork, Cork T12 XF62, Ireland"
      ],
      "name": "Patricia M Kearney"
    },
    {
      "affiliations": [
        "School of Public Health, University College Cork, Cork T12 XF62, Ireland"
      ],
      "name": "Megan McCarthy"
    },
    {
      "affiliations": [
        "School of Public Health, University College Cork, Cork T12 XF62, Ireland"
      ],
      "name": "Sandhya Rengarajan"
    },
    {
      "affiliations": [
        "School of Public Health, University College Cork, Cork T12 XF62, Ireland"
      ],
      "name": "Linda M O’Keeffe"
    },
    {
      "affiliations": [
        "NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol UK"
      ],
      "name": "Kerry Avery"
    },
    {
      "affiliations": [
        "Department of Medicine, Women’s College Research Institute, University of Toronto, Toronto, ON, Canada"
      ],
      "name": "An-Wen Chan"
    },
    {
      "affiliations": [
        "School of Nursing and Midwifery, University of Galway, Galway, Ireland",
        "Health Research Board-Trials Methodology Research Network, University of Galway, Galway, Ireland"
      ],
      "name": "Declan Devane"
    },
    {
      "affiliations": [
        "UCL Great Ormond Street Institute of Child Health, University College London, London, UK",
        "Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK"
      ],
      "name": "Gwyneth Davies"
    },
    {
      "affiliations": [
        "Neonatal Medicine, School of Public Health, Imperial College London, Chelsea and Westminster Hospital campus, London, UK",
        "Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London",
        "Centre for Paediatrics and Child Health, Imperial College London, London"
      ],
      "name": "Chris Gale"
    },
    {
      "affiliations": [
        "Department of Clinical Research, University of Bern, Bern, Switzerland",
        "Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland",
        "Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA"
      ],
      "name": "Lars G Hemkens"
    },
    {
      "affiliations": [
        "Nottingham Clinical Trials Unit, Applied Health Research Building, School of Medicine, University of Nottingham, University Park, Nottingham, UK"
      ],
      "name": "Edmund Juszczak"
    },
    {
      "affiliations": [
        "Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands"
      ],
      "name": "Linda Kwakkenbos"
    },
    {
      "affiliations": [
        "Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK",
        "Guy’s and St Thomas’ NHS Foundation Trust, London, UK",
        "Health Data Research, London, UK"
      ],
      "name": "Sinéad M Langan"
    },
    {
      "affiliations": [
        "Centre for Trials Research, Cardiff University, Cardiff, UK"
      ],
      "name": "Fiona Lugg-Widger"
    },
    {
      "affiliations": [
        "Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada"
      ],
      "name": "David Moher"
    },
    {
      "affiliations": [
        "Department of Cardiology, Gødstrup Regional Hospital, Denmark",
        "Department of Clinical Medicine, Aarhus University, Aarhus, Denmark"
      ],
      "name": "Morten Schmidt"
    },
    {
      "affiliations": [
        "Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada",
        "St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada"
      ],
      "name": "Lehana Thabane"
    },
    {
      "affiliations": [
        "Lady Davis Institute for Medical Research of the Jewish General Hospital, Montréal, Québec, Canada",
        "Department of Psychiatry, McGill University, Montréal, Québec, Canada"
      ],
      "name": "Brett D Thombs"
    },
    {
      "affiliations": [
        "MRC-NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool, UK"
      ],
      "name": "Alice-Maria Toader"
    },
    {
      "affiliations": [
        "Faculty of Medicine, Health & Life Sciences, Swansea University, Swansea, UK"
      ],
      "name": "Alan Watkins"
    },
    {
      "affiliations": [
        "Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK"
      ],
      "name": "Amanda J Farrin"
    },
    {
      "affiliations": [
        "Centre for Studies in Family Medicine, Departments of Family Medicine and of Epidemiology/Biostatistics, Schulich School of Medicine and Dentistry, London, ON, Canada",
        "ICES, Toronto, ON, Canada"
      ],
      "name": "Merrick Zwarenstein"
    },
    {
      "affiliations": [
        "MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, UCL, London, UK",
        "Data for R&D, Transformation Directorate, NHS England, London, UK"
      ],
      "name": "Matthew R Sydes"
    },
    {
      "affiliations": [
        "MRC-NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool, UK"
      ],
      "name": "Paula R Williamson"
    },
    {
      "affiliations": [
        "Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, UK"
      ],
      "name": "Sarah Markham"
    }
  ],
  "title": "Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration",
  "uid": "1891eba4-3fa7-5b64-88d3-d05c310e7826"
}