{
  "abstract": "Introduction To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE).Methods and analysis This protocol outlines the methodology for a scoping review, which will be conducted in two distinct sections: (1) identifying any existing guidelines, reviews or methodological studies describing environmental impacts of interventions and (2) identifying how environmental outcomes are reported in randomised trial protocols and trial results. A search specialist will search major medical databases, reference lists of trial publications and clinical trial registries to identify relevant publications. Data from the included studies will be extracted independently by two review authors. Based on the results, a preliminary list of items for the SPIRIT and CONSORT extensions will be developed.Ethics and dissemination This study does not include any human participants, and ethics approval is not required according to the Declaration of Helsinki. The findings from the scoping review will be published in international peer-reviewed journals, and the findings will be used to inform the design of a Delphi survey of relevant stakeholders.Open science Registered with Open Science 28 of February 2025.",
  "authors": [
    {
      "affiliations": [
        "Rigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Johanne Juul Petersen"
    },
    {
      "affiliations": [
        "Anaesthesia and Intensive Care, Lund University Department of Clinical Sciences Lund, Lund, Skåne County, Sweden",
        "Lund University, Lund, Sweden"
      ],
      "name": "Linn Hemberg"
    },
    {
      "affiliations": [
        "Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, New Zealand, Canada",
        "University of Johannesburg Faculty of Health Sciences, Johannesburg, GP, South Africa",
        "Biostatistics Unit, St Joseph’s Healthcare Hamilton, Hamilton, New Zealand, Canada"
      ],
      "name": "Lehana Thabane"
    },
    {
      "affiliations": [
        "Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Sally Hopewell"
    },
    {
      "affiliations": [
        "Department of Medicine, University of Toronto, Toronto, Ontario, Canada"
      ],
      "name": "An-Wen Chan"
    },
    {
      "affiliations": [
        "Open Patient data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark",
        "Cochrane Denmark and Centre for Evidence-Based Medicine Odense (CEBMO), University of Southern Denmark, Department of Clinical Research, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Asbjørn Hróbjartsson"
    },
    {
      "affiliations": [
        "Anaesthesiology, Zealand University Hospital Koge, Køge, Denmark",
        "Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Ole Mathiesen"
    },
    {
      "affiliations": [
        "McMaster University Department of Health Research Methods Evidence and Impact, Hamilton, New zealand, Canada"
      ],
      "name": "Sujane Kandasamy"
    },
    {
      "affiliations": [
        "Mental Health, Alcohol, Substance Use and Tobacco Research Unit, South African Medical Research Council, Cape Town, WC, South Africa"
      ],
      "name": "Nandi Siegfried"
    },
    {
      "affiliations": [
        "MRC-NIHR Trials Methodology Research Partnership, University of Liverpool Department of Health Data Science, Liverpool, England, UK"
      ],
      "name": "Paula R Williamson"
    },
    {
      "affiliations": [
        "Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK"
      ],
      "name": "Lisa Fox"
    },
    {
      "affiliations": [
        "Rigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Regional Health Research, University of Southern Denmark Faculty of Health Sciences, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Caroline Barkholt Kamp"
    },
    {
      "affiliations": [
        "Clinical Trials Center, University Hospital Zurich, Zürich, ZH, Switzerland"
      ],
      "name": "Jean-Marc Hoffmann"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery, Zealand University Hospital Koge, Koge, Denmark"
      ],
      "name": "Stig Brorson"
    },
    {
      "affiliations": [
        "Rigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Regional Health Research, University of Southern Denmark Faculty of Health Sciences, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Janus C Jakobsen"
    },
    {
      "affiliations": [
        "Lund University Department of Clinical Sciences Lund, Lund, Skåne County, Sweden",
        "Department of Intensive, Skåne University Hospital, Malmö, Sweden"
      ],
      "name": "Peter Bentzer"
    }
  ],
  "title": "Reporting of environmental outcomes in randomised clinical trials: a protocol for a scoping review",
  "uid": "f948ac8b-f5b6-5003-9930-189404581428"
}