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基于家庭的结构化康复方案与常规监督下的肺康复的比较:一项随机非劣效试验。

Comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation: a randomised non-inferiority trial.

机构信息

Faculty of Health and Life Sciences, Coventry University, Coventry, UK.

Centre for Exercise and Rehabilitation Science, University Hospitals Leicester NHS Trust, Leicester, UK.

出版信息

Thorax. 2018 Jan;73(1):29-36. doi: 10.1136/thoraxjnl-2016-208506. Epub 2017 Jul 29.


DOI:10.1136/thoraxjnl-2016-208506
PMID:28756402
Abstract

BACKGROUND: Standardised home-based pulmonary rehabilitation (PR) programmes offer an alternative model to centre-based supervised PR for which uptake is currently poor. We determined if a structured home-based unsupervised PR programme was non-inferior to supervised centre-based PR for participants with COPD. METHODS: A total of 287 participants with COPD who were referred to PR (187 male, mean (SD) age 68 (8.86) years, FEV% predicted 48.34 (17.92)) were recruited. They were randomised to either centre-based PR or a structured unsupervised home-based PR programme including a hospital visit with a healthcare professional trained in motivational interviewing, a self-management manual and two telephone calls. Fifty-eight (20%) withdrew from the centre-based group and 51 (18%) from the home group. The primary outcome was dyspnoea domain in the chronic respiratory disease questionnaire (Chronic Respiratory Questionnaire Self-Report; CRQ-SR) at 7 weeks. Measures were taken blinded. We undertook a modified intention-to-treat (mITT) complete case analysis, comparing groups according to original random allocation and with complete data at follow-up. The non-inferiority margin was 0.5 units. RESULTS: There was evidence of significant gains in CRQ-dyspnoea at 7 weeks in both home and centre-based groups. There was inconclusive evidence that home-based PR was non-inferior to PR in dyspnoea (mean group difference, mITT: -0.24, 95% CI -0.61 to 0.12, p=0.18), favouring the centre group at 7 weeks. CONCLUSIONS: The standardised home-based programme provides benefits in dyspnoea. Further evidence is needed to definitively determine if the health benefits of the standardised home-based programme are non-inferior or equivalent to supervised centre-based rehabilitation. TRIAL REGISTRATION NUMBER: ISRCTN81189044.

摘要

背景:标准化的家庭为基础的肺康复(PR)计划为中心为基础的监督 PR 提供了一种替代模式,目前后者的参与度很低。我们确定了结构化的家庭为基础的非监督 PR 计划是否与监督的中心为基础的 PR 一样适用于 COPD 患者。

方法:共招募了 287 名被转介到 PR 的 COPD 患者(187 名男性,平均(SD)年龄 68(8.86)岁,FEV%预测值 48.34(17.92))。他们被随机分配到中心为基础的 PR 或结构化的非监督家庭为基础的 PR 计划,包括与接受动机访谈培训的医疗保健专业人员的医院就诊、自我管理手册和两次电话。58(20%)名患者从中心组退出,51(18%)名患者从家庭组退出。主要结局是 7 周时慢性呼吸道疾病问卷(慢性呼吸道问卷自我报告;CRQ-SR)的呼吸困难域。测量是盲法进行的。我们进行了修改后的意向治疗(mITT)完全案例分析,根据原始随机分配和随访时完整数据比较组间差异。非劣效性边界为 0.5 个单位。

结果:在家庭和中心组中,7 周时 CRQ 呼吸困难都有明显的改善。有不确定的证据表明,家庭为基础的 PR 在呼吸困难方面不劣于 PR(平均组间差异,mITT:-0.24,95%置信区间-0.61 至 0.12,p=0.18),7 周时有利于中心组。

结论:标准化的家庭计划在呼吸困难方面提供了益处。需要进一步的证据来确定标准化的家庭计划的健康益处是否不劣于或等同于监督的中心为基础的康复。

试验注册号:ISRCTN81189044。

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Comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation: a randomised non-inferiority trial.

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[10]
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BMJ Open. 2025-1-7

[2]
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Chron Respir Dis. 2024

[3]
Clinically important changes and adverse events with centre-based or home-based pulmonary rehabilitation in chronic respiratory disease: A systematic review and meta-analysis.

Chron Respir Dis. 2024

[4]
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[5]
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[6]
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[7]
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Chron Respir Dis. 2024

[8]
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[9]
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[10]
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