TY - JOUR T1 - The Bronchiectasis Exacerbation Diary: A Novel PRO for Non-Cystic Fibrosis Bronchiectasis JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00712-2022 SP - 00712-2022 AU - Vivian H. Shih AU - Maria Jison AU - Erik Bark AU - Meredith Venerus AU - Oren Meyers AU - James D. Chalmers Y1 - 2023/01/01 UR - http://openres.ersjournals.com/content/early/2023/01/05/23120541.00712-2022.abstract N2 - Bronchiectasis is a chronic, progressive lung disease believed to result from a vicious cycle of infection and inflammation, with symptoms of chronic cough with sputum production, chronic fatigue, rhinosinusitis, chest pain, breathlessness, and haemoptysis. There are currently no established instruments to monitor daily symptoms and exacerbations for use in clinical trials. Following a literature review and three expert clinician interviews, we conducted concept elicitation interviews with 20 patients with bronchiectasis to understand their personal disease experience. Findings from literature and clinician feedback were used to develop a draft version of the Bronchiectasis Exacerbation Diary (BED), which was designed to monitor key symptoms on a daily basis and during exacerbations. Patients were eligible to be interviewed if they were US residents aged ≥18 years, had a computed tomography scan–confirmed diagnosis of bronchiectasis with ≥2 exacerbations in the previous two years, and had no other uncontrolled respiratory conditions. Four waves of five patient interviews each were conducted. Patients (N=20) had a mean (standard deviation) age of 53.9 (12.8) years, and most were female (85%) and white (85%). Thirty-three symptoms and 23 impacts arose from the patient concept elicitation interviews. The BED was revised and finalised based upon patient feedback. The final BED is a novel, eight-item patient-reported outcome (PRO) instrument for monitoring key exacerbation symptoms on a daily basis with content validity established through comprehensive qualitative research and direct patient insight. The BED PRO development framework will be completed following psychometric evaluations of the data from a phase 3 bronchiectasis clinical trial.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflicts of interest: Vivian H. Shih, Maria Jison, and Erik Bark are employees of AstraZeneca and may own stock. Meredith Venerus and Oren Meyers are employees of IQVIA, which received funding from AstraZeneca to conduct this study.Conflicts of interest: James D. Chalmers has received research grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Gilead Sciences, Novartis, and Insmed, as well as consultancy or speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Insmed, Janssen, and Zambon. ER -