{
  "abstract": "A common eligibility criterion in respiratory clinical trials is a per cent-predicted forced expiratory volume in 1 second (ppFEV1) between 40% and 90%, using the ethnicity-dependent Global Lung Function Initiative (GLI)-2012 spirometry reference equations. International societies now endorse the newer ‘race-neutral’ GLI-Global equations. We quantify the impact on trial eligibility of switching from GLI-2012 to GLI-Global for the UK Cystic Fibrosis Registry (n=8182). In a future trial with a maximum eligibility threshold of ppFEV1=90%, the changes in ppFEV1 would lead to over 700 people becoming newly ineligible. Urgent review of fixed ppFEV1 thresholds is required, with an initial recommendation to widen the range to 30–95% ppFEV1 when GLI-Global is implemented to ensure equitable access for people of all ethnicities. There is also a wider need to review the use of fixed ppFEV1 spirometry limits for trial eligibility.",
  "authors": [
    {
      "affiliations": [
        "National Heart and Lung Institute, Imperial College London, London, UK",
        "Clinical Trials Accelerator Platform, London, UK",
        "Royal Brompton & Harefield NHS Foundation Trust, London, UK"
      ],
      "name": "Idan Bokobza"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "King’s College Hospital NHS Foundation Trust, London, UK"
      ],
      "name": "Melanie Le Sayec"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "King’s College Hospital NHS Foundation Trust, London, UK"
      ],
      "name": "Cara Bossley"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK"
      ],
      "name": "Rossa Brugha"
    },
    {
      "affiliations": [
        "National Heart and Lung Institute, Imperial College London, London, UK",
        "Clinical Trials Accelerator Platform, London, UK",
        "Royal Brompton & Harefield NHS Foundation Trust, London, UK"
      ],
      "name": "Jane Carolyn Davies"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK"
      ],
      "name": "Charlotte Dawson"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK"
      ],
      "name": "Lucy Holt"
    },
    {
      "affiliations": [
        "National Heart and Lung Institute, Imperial College London, London, UK",
        "Clinical Trials Accelerator Platform, London, UK",
        "Royal Brompton & Harefield NHS Foundation Trust, London, UK"
      ],
      "name": "Dominic A Hughes"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Royal Brompton & Harefield NHS Foundation Trust, London, UK"
      ],
      "name": "Yasmine Needham"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Barts Health NHS Trust, London, UK"
      ],
      "name": "Caroline Pao"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "King’s College Hospital NHS Foundation Trust, London, UK"
      ],
      "name": "Gary Ruiz"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Barts Health NHS Trust, London, UK"
      ],
      "name": "Shahideh Safavi"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Royal Brompton & Harefield NHS Foundation Trust, London, UK"
      ],
      "name": "Clare Saunders"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Barts Health NHS Trust, London, UK"
      ],
      "name": "Nadia Shafi"
    },
    {
      "affiliations": [
        "National Heart and Lung Institute, Imperial College London, London, UK",
        "Clinical Trials Accelerator Platform, London, UK",
        "Royal Brompton & Harefield NHS Foundation Trust, London, UK"
      ],
      "name": "Nicholas J Simmonds"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "King’s College Hospital NHS Foundation Trust, London, UK",
        "King’s College London, London, UK"
      ],
      "name": "Michael D Waller"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Barts Health NHS Trust, London, UK"
      ],
      "name": "Danie Watson"
    },
    {
      "affiliations": [
        "Clinical Trials Accelerator Platform, London, UK",
        "Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK",
        "UCL Great Ormond Street Institute of Child Health, University College London, London, UK"
      ],
      "name": "Gwyneth Davies"
    }
  ],
  "title": "Spirometry thresholds for clinical trial eligibility: time for urgent re-evaluation",
  "uid": "94f33065-f44d-57df-8fd5-d1914c144140"
}