抽象的
介绍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.
方法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.
结果包括173名患者。八《婚姻保护法》ins (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.
结论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.
抽象的
这项研究验证了支气管扩张患者的新型患者报告结果。支气管扩张撞击度量(BIM)是可重复的,内容有效且对变化有效的,并且可能是测试新疗法的有用结果指标。https://bit.ly/3pean44
脚注
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利益冲突:M.L。克里顿(Crichton)在提交的工作之外报告了阿斯利康(Astrazeneca)的个人费用。
Conflict of interest: E.K. Dudgeon has nothing to disclose.
利益冲突:A。Shoemark没有什么可披露的。
Conflict of interest: J.D. Chalmers reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Insmed, personal fees from Chiesi, Novartis and Zambon, grants from Gilead Sciences, outside the submitted work.
支持声明:这项工作是由欧洲呼吸社会通过EMBARC2财团资助的。188bet官网地址Embarc2得到了Project Partners Chiesi,Grifols,Insmed,Novartis和Zambon的支持。这项工作得到了欧盟委员会资助项目IABC(赠款115721)的创新药品计划(IMI)和EFPIA公司的支持。本文的资金信息已存入Crossref Funder Registry.
- 已收到2020年8月15日。
- Accepted2020年11月5日。
- 复制right ©ERS 2021