{
  "abstract": "Introduction Increased risks and concerns regarding patient safety in early-phase studies exist because knowledge about the new intervention is still accumulating. This means that narrow eligibility criteria are needed. However, if early-phase studies are narrow in their inclusion, for example, by not including diverse populations, there is a potential risk that new therapies have insufficient relevant efficacy and safety data. Existing research has explored equity, diversity and inclusion (EDI) factors in early-phase pharmaceutical studies, but it has not been possible to find studies that have systematically examined whether EDI factors have been considered in surgical studies reporting innovative procedures. We aim to examine how EDI factors are considered in early-phase surgical studies and surgical innovation reports to explore how this may impact on later-phase evaluation and inclusive intervention implementation.Methods and analysis A scoping review following the JBI (Joanna Briggs Institute) and Arksey and O’Malley’s five-step process is being conducted. We will search Scopus, PubMed and Web of Science for surgical early-phase studies. A two-step screening process for eligibility is being used. Independent double screening will take place for 20% of the papers. Eligible articles will report early evaluation of an innovative surgical/invasive procedure. Excluded will be comparative and later-phase studies and early evaluations of pharmaceutical products even in a surgical setting. Data on article details, patient eligibility and whether protected characteristics are reported and considered will be extracted. Information about EDI considerations reported in the introduction or discussion of the papers will also be extracted. Findings will be discussed with a patient advisory group. A content synthesis approach will be undertaken and descriptive summaries presented.Ethics and dissemination This study does not require ethical approval being a secondary analysis. The findings will be disseminated through academic journal publications and oral presentations.",
  "authors": [
    {
      "affiliations": [
        "Bristol Centre for Surgical Research, Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, UK",
        "NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK"
      ],
      "name": "Manal Etemadi"
    },
    {
      "affiliations": [
        "Bristol Centre for Surgical Research, Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, UK",
        "NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK"
      ],
      "name": "Rhiannon Macefield"
    },
    {
      "affiliations": [
        "Bristol Centre for Surgical Research, Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, UK",
        "NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK"
      ],
      "name": "Kerry Avery"
    },
    {
      "affiliations": [
        "Bristol Centre for Surgical Research, Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, UK",
        "NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK"
      ],
      "name": "Daisy Elliott"
    },
    {
      "affiliations": [
        "School of Medicine and Population Health, The University of Sheffield, Sheffield, UK"
      ],
      "name": "Shoba Dawson"
    },
    {
      "affiliations": [
        "Bristol Centre for Surgical Research, Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, UK",
        "NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK"
      ],
      "name": "Natalie S Blencowe"
    },
    {
      "affiliations": [
        "Bristol Centre for Surgical Research, Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, UK",
        "NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK"
      ],
      "name": "Maeve Coyle"
    },
    {
      "affiliations": [
        "Bristol Centre for Surgical Research, Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, UK",
        "NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK"
      ],
      "name": "Hollie Sarah Richards"
    },
    {
      "affiliations": [
        "Warwick Medical School, University of Warwick, Coventry, UK"
      ],
      "name": "Benjamin Graham"
    },
    {
      "affiliations": [
        "Warwick Medical School, University of Warwick, Coventry, UK"
      ],
      "name": "Eddie Jones"
    },
    {
      "affiliations": [
        "Bristol Medical School, University of Bristol, Bristol, UK"
      ],
      "name": "Amber Torkington"
    },
    {
      "affiliations": [
        "Warwick Medical School, University of Warwick, Coventry, UK"
      ],
      "name": "Katie Chatfield"
    },
    {
      "affiliations": [
        "Bristol Medical School, University of Bristol, Bristol, UK"
      ],
      "name": "Hussein Malik"
    },
    {
      "affiliations": [
        "Bristol Medical School, University of Bristol, Bristol, UK"
      ],
      "name": "Mackenzie Garlick"
    },
    {
      "affiliations": [
        "Bristol Centre for Surgical Research, Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, UK",
        "NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK"
      ],
      "name": "Jane Blazeby"
    }
  ],
  "title": "Are equity, diversity and inclusion considered in early-phase studies evaluating innovative and developing surgical procedures? Protocol for a scoping review",
  "uid": "c4fd59e4-253b-5249-bcb2-73eaf26bdfb3"
}