School of Medicine, University of Dundee, Dundee, UK.
School of Medicine, University of Dundee, Dundee, UK
Eur Respir J. 2021 May 27;57(5). doi: 10.1183/13993003.03156-2020. Print 2021 May.
Existing quality-of-life and symptom tools used in bronchiectasis trials are either not disease specific or are complex and have not been consistently responsive. We developed a simple patient-reported visual analogue outcome measure, the Bronchiectasis Impact Measure (BIM), for use in clinical research, including clinical trials.
Patients with bronchiectasis attending a tertiary referral clinic in the east of Scotland were invited to complete the BIM questionnaire and the quality-of-life bronchiectasis questionnaire at baseline with repeat questionnaires after 2 weeks and 6 months. We assessed internal consistency, test-retest reliability, construct validity and responsiveness by evaluating change during an acute exacerbation.
173 patients were included. The eight domains (cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) showed excellent internal consistency (Cronbach's α 0.93). The intraclass correlation coefficient demonstrated excellent reliability over a 2-week period: cough (0.79, 95% CI 0.70-0.85), sputum (0.86, 95% CI 0.80-0.90), dyspnoea (0.82, 95% CI 0.74-0.87), tiredness (0.88, 95% CI 0.82-0.91), activity (0.84, 95% CI 0.77-0.89), general health (0.81, 95% CI 0.74-0.87), control (0.83, 95% CI 0.75-0.88) and exacerbation (0.71, 95% CI 0.60-0.79). Domains correlated strongly with bronchiectasis severity and exacerbation history. Both distribution and patient-based methods estimated the minimal clinically important difference for each domain as 1.5 points on a 10-point scale. Statistically significant changes in all BIM domains were observed during an acute exacerbation.
The BIM is a simple patient-reported outcome. This study validates the internal consistency, reliability, construct validity and response of the tool at acute exacerbation. Further validation of the tool is now required.
现有的支气管扩张临床试验中使用的生活质量和症状工具要么不是针对特定疾病的，要么过于复杂，而且一直没有得到一致的响应。我们开发了一种简单的患者报告视觉模拟量表，即支气管扩张影响量表（BIM），用于临床研究，包括临床试验。
苏格兰东部的一家三级转诊诊所邀请支气管扩张患者在基线时完成 BIM 问卷和生活质量支气管扩张问卷，并在 2 周和 6 个月后重复问卷。我们通过评估急性加重期间的变化来评估内部一致性、测试-重测可靠性、结构有效性和响应能力。
共纳入 173 例患者。八个领域（咳嗽、痰、呼吸困难、疲劳、活动、一般健康、控制、加重）显示出极好的内部一致性（Cronbach's α 0.93）。在为期 2 周的时间内，组内相关系数显示出极好的可靠性：咳嗽（0.79，95%置信区间 0.70-0.85）、痰（0.86，95%置信区间 0.80-0.90）、呼吸困难（0.82，95%置信区间 0.74-0.87）、疲劳（0.88，95%置信区间 0.82-0.91）、活动（0.84，95%置信区间 0.77-0.89）、一般健康（0.81，95%置信区间 0.74-0.87）、控制（0.83，95%置信区间 0.75-0.88）和加重（0.71，95%置信区间 0.60-0.79）。各领域与支气管扩张严重程度和加重史密切相关。分布和基于患者的方法均估计各领域的最小临床重要差异为 10 分制上的 1.5 分。在急性加重期间，BIM 所有领域的变化均具有统计学意义。
BIM 是一种简单的患者报告结果。本研究验证了工具在急性加重时的内部一致性、可靠性、结构有效性和响应能力。现在需要进一步验证该工具。
