Patient-centred composite scores as tools for assessment of response to biological therapy for paediatric and adult severe asthma.
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Khaleva Ekaterina, Brightling Chris, Eiwegger Thomas, Altraja Alan, Bégin Philippe, Blumchen Katharina, Bossios Apostolos, Bourdin Arnaud, Ten Brinke Anneke, Brusselle Guy, Bumbacea Roxana Silvia, Bush Andrew, Casale Thomas B, Clarke Graham W, Chaudhuri Rekha, Chung Kian Fan, Coleman Courtney, Corren Jonathan, Dahlén Sven-Erik, Deschildre Antoine, Djukanovic Ratko, Eger Katrien, Exley Andrew, Fleming Louise, Fowler Stephen J, Gaillard Erol A, Gappa Monika, Gupta Atul, Haitchi Hans Michael, Hashimoto Simone, Heaney Liam G, Hedlin Gunilla, Henderson Markaya, Hua Wen, Jackson David J, Karadag Bülent, Katelaris Constance Helen, Koh Mariko S, Kopp Matthias Volkmar, Koppelman Gerard H, Kull Inger, Kurukulaaratchy Ramesh J, Lee Ji-Hyang, Mahler Vera, Mäkelä Mika, Masoli Matthew, Mathioudakis Alexander G, Mazon Angel, Melén Erik, Milger Katrin, Moeller Alexander, Murray Clare S, Nagakumar Prasad, Nair Parameswaran, Negus Jenny, Nieto Antonio, Papadopoulos Nikolaos G, Paton James, Pijnenburg Mariëlle W, Pike Katharine C, Porsbjerg Celeste, Rattu Anna, Rupani Hitasha, Rusconi Franca, Rutjes Niels W, Saglani Sejal, Seddon Paul, Siddiqui Salman, Singer Florian, Tajiri Tomoko, Turner Steve, Upham John W, Vijverberg Susanne J H, Wark Peter A B, Wechsler Michael E, Yasinska Valentyna, Roberts Graham, 3TR Asthma Definition of Response Working Group
Аннотация
METHODS: International expert healthcare professionals and patients with severe asthma were invited to 1) develop consensus levels of clinically relevant changes for each outcome measure within COMSA, 2) use multicriteria decision analysis to develop the CONFiRM scores and 3) assess their internal validity. A separate group of healthcare professionals evaluated CONFiRM's external validity.
RESULTS: Five levels of change for each COMSA outcome were agreed. Severe exacerbations and maintenance oral corticosteroid use were rated as the most important in determining both paediatric and adult CONFiRM scores. There was strong agreement between healthcare professionals and patients, although patients assigned greater importance to quality of life. The CONFiRM score quantified response to a biologic from -31 (deterioration) to 69 (best possible response). Paediatric and adult CONFiRMs had good discriminative ability for a sufficient (area under the curve ≥0.92) and a substantial (area under the curve ≥0.95) response to biologics. Both CONFiRMs demonstrated excellent external validity (Spearman correlation coefficients 0.9 and 0.8 for paediatric and adult, respectively; p<0.0001).
CONCLUSIONS: We have developed novel patient-centred paediatric and adult CONFiRMs that include quality of life measures. CONFiRMs should allow a more holistic understanding of response for the patient and a standardised assessment of the effectiveness of biologics between studies. Further research is needed to prospectively validate CONFiRM scores.