The Bronchiectasis Exacerbation Diary: a novel patient-reported outcome for non-cystic fibrosis bronchiectasis

Abstract

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.

Cough in Non-Cystic Fibrosis Bronchiectasis

“…Objective cough frequency was significantly associated with the number of bronchiectasis exacerbations [90]. Cough has been incorporated into the recently developed patient-reported outcome instrument, the Bronchiectasis Exacerbation Diary [91].…”

Exacerbations of bronchiectasis

“…The bronchiectasis exacerbation diary (BED) and the bronchiectasis exacerbation and symptom tool (BEST) are both designed to monitor exacerbations and daily symptoms as reported by patients themselves (patient-reported outcome). However, they were developed with different focuses and methodologies [ 26 , 27 ]. The BED is an eight-item tracking system that aims to capture the variability of symptoms and the impact of exacerbations more qualitatively, whereas the BEST provides a structured approach for symptom monitoring with a scoring system, offering a more quantitative measure of exacerbation severity.…”

The BED-Pro Tool: facilitating the detection of bronchiectasis exacerbations

“…In this issue of ERJ Open Research , S hih et al [ 11 ] sought to improve the precision of detecting bronchiectasis exacerbations by developing a patient-centred, content-valid, Food and Drug Administration-compliant patient-reported outcome (PRO) instrument to monitor the key symptoms on a daily basis and during exacerbations. This study was conducted as the first phase of the multiphase BED-Pro study to develop a novel instrument for standardising the PRO assessment of exacerbations in bronchiectasis.…”