Background:

Patient self-management plans (PSMP) are advised for bronchiectasis but their efficacy is not established. We aimed to determine whether, in people with bronchiectasis, the use of our bronchiectasis PSMP – Bronchiectasis Empowerment Tool (BET), compared to standard care, would improve self-efficacy.

Methods:

In a multi-centre mixed-methods randomised controlled parallel study, 220 patients with bronchiectasis were randomised to receive standard care with or without the addition of our BET plus education sessions explaining its use. BET comprised an action plan, indicating when to seek medical help based on pictorial represented indications for antibiotic therapy, and four educational support sections. At baseline and after 12 months, patients completed the Self-Efficacy to Manage Chronic Disease Scale (SEMCD), St George’s Respiratory Questionnaire (SGRQ), EQ-5D-3 L (to calculate Quality Adjusted Life Years (QALYs) and cost questionnaires. Qualitative data were obtained by focus groups.

Results:

The recruitment to the study was high (63% of eligible patients agreeing to participate) however completion rate was low (57%). BET had no effect on SEMCD (mean difference (0.14 (95% confidence interval (95%CI) −0.37 to 0.64), p = 0.59) or SGRQ, exacerbation rates, overall cost to the NHS or QALYs. Most had developed their own techniques for monitoring their condition and they did not find BET useful as it was difficult to complete. Participant knowledge was good in both groups.

Conclusion:

The demand for patient support in bronchiectasis was high suggesting a clinical need. However, the BET did not improve self-efficacy, health related quality of life, costs or clinically relevant outcome measures. BET needs to be modified to be less onerous for users and implemented within a wider package of care. Further studies, particularly those evaluating people newly diagnosed with bronchiectasis, are required and should allow for 50% withdrawal rate or utilise less burdensome outcome measures.

Clinical trials registration:

ISRCTN ISRCTN 18400127. Registered 24 June 2015. Retrospectively Registered

中文翻译：

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支气管扩张自我管理干预的效果，费用和可接受性的随机对照试验

背景：

建议患者进行支气管扩张自我管理计划（PSMP），但尚未确定其疗效。我们旨在确定与标准护理相比，在支气管扩张患者中使用支气管扩张PSMP –支气管扩张赋能工具（BET）是否会提高自我效能。

方法：

在一项多中心混合方法随机对照平行研究中，将220例支气管扩张患者随机接受标准护理，无论是否添加我们的BET以及对其用法进行解释的培训。BET包括一个行动计划，该计划根据图示的抗生素治疗适应症指示何时寻求医疗帮助，并设有四个教育支持部门。在基线和12个月后，患者完成了自我管理慢性病量表（SEMCD），圣乔治呼吸问卷（SGRQ），EQ-5D-3 L（以计算质量调整生命年（QALYs）和费用调查表。定性数据是通过焦点小组获得的。

结果：

该研究的招募率很高（63％的合格患者同意参加），但完成率很低（57％）。BET对SEMCD（均值差异（0.14（95％置信区间（95％CI）-0.37至0.64），p = 0.59）或SGRQ），恶化率，NHS或QALY的总体成本没有影响。大多数人都自行开发监测他们的病情的技术，他们认为BET很难完成，因此没有用，两组的参与者知识都很好。

结论：

支气管扩张对患者支持的需求很高，表明存在临床需求。但是，BET并没有改善自我效能，与健康相关的生活质量，成本或临床相关的结局指标。BET需要进行修改，以减轻用户负担，并在更广泛的护理方案中实施。需要进一步的研究，尤其是那些评估刚被诊断为支气管扩张的人的研究，这些研究应允许50％的戒断率或采用负担较小的预后措施。

临床试验注册：

ISRCTN ISRCTN18400127。2015年6月24日注册。追溯注册