Background: In the 3TR consortium we have previously developed Core Outcome Measures sets for Severe Asthma (COMSA). There are no patient-centred tools to quantify response to biologics for severe asthma. We aimed to develop adult CompOsite iNdex For Response in asthMa (CONFiRM) incorporating clinical parameters and quality of life (QoL).

Methods: Internationally recruited expert healthcare professionals (HCPs) and patients with severe asthma were invited to: 1) establish the overall magnitude of response for patient profiles; 2) develop consensus levels of clinically relevant changes for each outcome measure in the COMSA; 3) use multicriteria decision analysis to develop CONFiRM; and 4) assess CONFiRM?s initial validity.

Results: Fifty patient profiles were developed from 1430 cases on biologics. 79 participants (45 (57.0%) HCPs and 34 (43.0%) severe asthma patients) rated the overall magnitude of response for each profile. Five levels of change for each outcome measure in the COMSA were agreed. Highest relative importance in the CONFiRM was assigned to severe asthma attacks and maintenance oral corticosteroids. There was strong agreement between HCPs and patients, but patients assigned greater importance to QoL. The CONFiRM demonstrated good initial validity, excellent discriminative ability for substantial (AUC?0.95) and sufficient (AUC?0.92) response to biologics.

Conclusions: We have developed novel patient-centred adult CONFiRM which include QoL measure. CONFiRM should allow a more holistic understanding of response for the patient and a standardised assessment of the effectiveness of biologics. Further research is needed to prospectively validate CONFiRM.