Complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): a feasibility, wait-list design randomised controlled trial.

IF 3.6 3区医学 Q1 RESPIRATORY SYSTEM

BMJ Open Respiratory Research Pub Date : 2025-03-22 DOI:10.1136/bmjresp-2024-002327

Michael George Crooks, Caroline Wright, Simon Hart, Victoria Allgar, Anne English, Flavia Swan, Judith Dyson, Gerry Richardson, Maureen Twiddy, Judith Cohen, Andrew Simpson, Chao Huang, Dominic L Sykes, Miriam Johnson

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引用次数: 0

Abstract

Introduction: Breathlessness is common and impairs the quality of life of people with idiopathic pulmonary fibrosis (IPF) and non-IPF fibrotic interstitial lung diseases (ILD). We report the findings of a multicentre, fast-track (wait-list), mixed-methods, randomised controlled, feasibility study of a complex breathlessness intervention in breathless IPF and non-IPF fibrotic ILD patients.

Methods: Breathless IPF and non-IPF fibrotic ILD patients were randomised to receive the intervention within 1 week (fast-track) or after 8 weeks (wait-list). The intervention comprised two face-to-face and one telephone appointment during a 3-week period covering breathing control, handheld fan-use, pacing and breathlessness management techniques, and techniques to manage anxiety. Feasibility and clinical outcomes were assessed to inform progression to, and optimal design for, a definitive trial. A qualitative substudy explored barriers and facilitators to trial and intervention delivery.

Results: 47 patients (M:F 38:9, mean (SD) age 73.9 (7.2)) were randomised with a recruitment rate of 2.5 participants per month across three sites. The adjusted mean differences (95% CI) for key clinical outcomes at 4 weeks post randomisation were as follows: Chronic Respiratory Questionnaire breathlessness mastery domain (0.45 (-0.07, 0.97)); and numerical rating scales for 'worst' (-0.93 (-1.95, 0.10)), 'best' (-0.19 (-1.38, 1.00)), 'distress caused by' (-1.84 (-3.29, -0.39)) and 'ability to cope with' (0.71 (-0.57, 1.99)) breathlessness within the past 24 hours. The qualitative substudy confirmed intervention acceptability and informed feasibility and acceptability of study outcome measures.

Conclusion: A definitive trial of a complex breathlessness intervention in patients with IPF and non-IPF fibrotic ILD is feasible with preliminary data supporting intervention effectiveness.

Trial registration number: ISRCTN13784514.

查看原文本刊更多论文

特发性肺纤维化的复杂呼吸困难干预（BREEZE-IPF）：一项可行性、等待名单设计的随机对照试验。

简介：憋气是特发性肺纤维化（IPF）和非 IPF 纤维化间质性肺病（ILD）患者的常见病，会影响他们的生活质量。我们报告了一项多中心、快速通道（候补名单）、混合方法、随机对照、可行性研究的结果，该研究针对憋气的 IPF 和非 IPF 纤维化 ILD 患者进行了复杂的憋气干预：呼吸困难的 IPF 和非 IPF 纤维化 ILD 患者被随机分配到 1 周内（快速通道）或 8 周后（候补名单）接受干预。干预措施包括在 3 周内进行两次面对面交流和一次电话预约，内容包括呼吸控制、手持风扇的使用、起搏和呼吸困难管理技巧以及焦虑管理技巧。对可行性和临床结果进行了评估，以便为最终试验的进展和优化设计提供依据。一项定性子研究探讨了进行试验和干预的障碍和促进因素：47 名患者（男女比例为 38:9，平均（标清）年龄为 73.9 (7.2)）被随机分配到三个地点，招募率为每月 2.5 人。随机化后 4 周的主要临床结果的调整后平均差异（95% CI）如下：过去 24 小时内 "最严重"（-0.93 (-1.95, 0.10)）、"最严重"（-0.19 (-1.38, 1.00)）、"造成的痛苦"（-1.84 (-3.29, -0.39)）和 "应对能力"（0.71 (-0.57, 1.99)）呼吸困难的数字评分量表。定性子研究证实了干预的可接受性，并告知了研究结果测量的可行性和可接受性：在 IPF 和非 IPF 纤维化 ILD 患者中进行复杂呼吸困难干预的最终试验是可行的，初步数据支持干预的有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BMJ Open Respiratory Research RESPIRATORY SYSTEM-

CiteScore

6.60

自引率

2.40%

发文量

审稿时长

12 weeks

期刊介绍： BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.