Spirometry thresholds for clinical trial eligibility: time for urgent re-evaluation

Le résumé fourni par la source

A common eligibility criterion in respiratory clinical trials is a per cent-predicted forced expiratory volume in 1 second (ppFEV 1 ) 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 ppFEV 1 =90%, the changes in ppFEV 1 would lead to over 700 people becoming newly ineligible. Urgent review of fixed ppFEV 1 thresholds is required, with an initial recommendation to widen the range to 30–95% ppFEV 1 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 ppFEV 1 spirometry limits for trial eligibility.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.