WS10.02 Mind the gap! Impact of GLI Global and GLI 2012 spirometry reference equations on clinical trial eligibility: the London experience
No Thumbnail Available
Authors
Bokobza,I.
Le Sayec,M.
Pereira,S.
Bossley,C.
Brugha,R. E.
Davies,J. C.
Dawson,C.
Holt,L.
Hughes,D. A.
Needham,Y.
Contact
Check for full-text access
Issue Date
2024
Type
Conference Proceedings
Language
Keywords
Alternative Title
Abstract
Objectives Percent predicted forced expiratory volume in 1 second (ppFEV1) is a common eligibility criterion in Cystic Fibrosis (CF) trials. Spirometry reference equations may impact participation if eligibility criteria include absolute ppFEV1 cut-offs. We compared ppFEV1 values between GLI2012 (ERJ 2012;40:1324) and new 'race-neutral' GLI global equations (AJRCCM 2023;207:768) to understand potential impact on clinical trial eligibility. Methods People with a 2022 annual review spirometry recorded on the UK CF Registry at 3 adult and 4 paediatric centres in London (n = 1456 individuals) were included. A registry data query was applied at sites for FEV1 (L), sex, height, age and ethnicity. ppFEV1 values were calculated for GLI2012 and GLI global using ERS GLI calculator (https://gli-calculator. ersnet.org/). These were analysed according to hypothetical trial inclusion criteria: minimum ppFEV1 40, 60, or maximum ppFEV1 90. Results Significant differences in ppFEV1 were observed between equations, associated with ethnicity. For GLIglobal, people with White ethnicity had significantly higher ppFEV1. Max ppFEV1 90 criteria decreased the eligible population in this group (e.g. 163/220 (74%) eligible GLI2012 vs 137/220 (62%) GLIglobal at one adult clinic) and increased numbers meeting eligibility at lower ppFEV1 thresholds. Less impact was observed if ethnicity = 'Other' in GLI2012 (e.g. Mixed and Asian: Indian and Pakistani). Significantly lower ppFEV1 were seen for people with Black ethnicity with GLIglobal than GLI2012 (p were seen for people with Black ethnicity with GLIglobal than GLI2012 (p 1 90 criteria becomes eligible with GLIglobal (ppFEV1 95% vs 82%). Conclusion To promote equity of access to trials and better understand implications of absolute ppFEV1 as an eligibility criterion, the consequences of applying spirometry reference equations requires further consideration by the CF community and trial sponsors.
Description
Citation
Publisher
License
Journal
Journal of Cystic Fibrosis