[BioSAT: Development and conceptual validation of a satisfaction questionnaire regarding biologic therapies for severe asthma through a structured patient-professional co-creation process].

Introduction: The benefits of biologic therapies in severe uncontrolled asthma (SUA) have primarily focused on clinical and lung function variables. However, other patient-relevant dimensions, such as confidence in treatment, comfort, or emotional impact, have been scarcely explored. The objective of this study was to develop a specific Patient-Reported Outcomes (PRO) questionnaire and conduct its conceptual and content validation to assess patient satisfaction. Material and methods: A sequential qualitative study following ISPOR recommendations for the development of PRO instruments. A multidisciplinary committee comprising 5 pulmonologists and 5 patients with SSEA defined the priority domains. Following iterative and structured development, the preliminary version underwent conceptual, content, and linguistic validation through cognitive interviews with 10 adult patients with SSEA treated with biologics. A qualitative analysis was performed. Results: The final questionnaire (BioSAT) consists of 10 Likert-scale items (1-5) that explore time to benefit, convenience of administration, ease of use, symptom control, adverse effects, improvement in physical activity, benefit in social relationships, emotional well-being, therapeutic trust, and experience with systemic corticosteroids. The interviews revealed adequate understanding of the questionnaire, as well as high relevance and acceptability. Conclusions: BioSAT is the first Spanish questionnaire designed to measure patient satisfaction among patients with NCSA undergoing biologic therapy. Its brevity, clinical focus, and methodological alignment with international standards position it as a useful tool in clinical practice.