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一项社区与医院肺康复的随机 2 x 2 试验,随后进行电话或常规随访。

A randomised 2 x 2 trial of community versus hospital pulmonary rehabilitation, followed by telephone or conventional follow-up.

机构信息

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.

出版信息

Health Technol Assess. 2010 Feb;14(6):i-v, vii-xi, 1-140. doi: 10.3310/hta14060.

Abstract

OBJECTIVES

To determine whether pulmonary rehabilitation carried out in a community setting is more effective than that carried out in a standard hospital setting and which is more cost-effective; also whether telephone follow-up is both cost-effective and useful in prolonging the beneficial effects of a pulmonary rehabilitation programme.

DESIGN

A randomised trial. Participants were randomised in 2 x 2 factorial fashion to hospital or community rehabilitation and telephone or standard follow-up with review.

SETTING

Hospitals or community sites in Sheffield. The community venues were selected to be close to public transport routes and have good parking and level access. The two hospital venues were the physiotherapy gym and a staff gym within the grounds of the hospital.

PARTICIPANTS

Patients with chronic obstructive pulmonary disease diagnosed by respiratory physicians according to Global Initiative for Chronic Obstructive Lung Disease guidelines.

INTERVENTIONS

Participants were randomised to one of four groups: hospital rehabilitation with no telephone follow-up; hospital rehabilitation with telephone follow-up; community rehabilitation with no telephone follow-up; or community rehabilitation with telephone follow-up. All were blinded to the telephone intervention arm until 1 month post rehabilitation, when only the assessment team and research participants were unblinded.

MAIN OUTCOME MEASURES

The primary outcome measure was the difference in improvement in endurance shuttle walking test (ESWT) between hospital and community pulmonary rehabilitation groups post rehabilitation, and the difference in ESWT during 18 months' follow-up between those receiving telephone encouragement and those receiving standard care. A secondary measure was health-related quality of life.

RESULTS

A total of 240 participants had evaluable data. Of these, 129 were randomised to hospital rehabilitation (64 with telephone follow-up and 65 with no telephone follow-up) and 111 to community rehabilitation (55 with telephone follow-up and 56 with no telephone follow-up). For the primary outcome measure, there were 162 patients with data for analysis: hospital rehabilitation with no telephone follow-up (n = 38); hospital rehabilitation with telephone follow-up (n = 48); community rehabilitation with no telephone follow-up (n = 43); and community rehabilitation with telephone follow-up (n = 33). For the acute phase post-rehabilitation outcomes, before patients had the opportunity for telephone follow-up, we compared outcomes between the 76 patients in the community rehabilitation group and the 86 patients in the hospital rehabilitation group. Patients in the hospital rehabilitation group increased the distance they could walk at the post-rehabilitation follow-up by 283 m (SD 360 m), an increase relative to baseline of 109% (SD 137%). Patients in the community rehabilitation group increased the distance they could walk at the post-rehabilitation follow-up by 216 m (SD 340 m), an increase relative to baseline of 91% (SD 133%). There was no statistically significant difference between the groups [17.8% (95% CI -24.3 to 59.9, p = 0.405)]. For longer term outcomes at 6, 12 and 18 months post rehabilitation there was no evidence of a rehabilitation group effect. After allowing for the initial post-rehabilitation baseline distance walked, time (follow-up visit) and the factorial design (telephone follow-up group), the average difference in the post-rehabilitation follow-up distance walked on the ESWT between the hospital and community rehabilitation groups was 1.5 m (95% CI -82.1 to 97.2, p = 0.971), and between the telephone and no-telephone groups it was 56.9 m (95% CI -25.2 to 139, p = 0.174). There was no difference between hospital or community groups in terms of acute effect or persistence of effect. Health economic analysis favoured neither hospital nor community settings, nor did it clearly favour telephone follow-up or routine care.

CONCLUSIONS

Pulmonary rehabilitation delivered in a community setting has similar efficacy to that produced in a more traditional hospital-based setting, both settings producing significant improvements in terms of exercise capacity and quality of life acutely and after long-term follow-up. Health economic analysis showed that neither hospital nor community programmes were greatly favoured. The choice of model will depend on local factors of convenience, existing availability of resources and incremental costs. Staff characteristics may be important in gaining optimal outcome, and care should be taken in staff recruitment and training.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN86821773.

摘要

目的

确定在社区环境中进行的肺康复是否比在标准医院环境中更有效,以及哪种方法更具成本效益;还确定电话随访是否既具有成本效益,又能延长肺康复计划的有益效果。

设计

随机试验。参与者以 2 x 2 析因设计的方式随机分配到医院或社区康复以及电话或标准随访加复查。

地点

谢菲尔德的医院或社区场所。社区场地选择靠近公共交通路线,并有良好的停车和无障碍通道。两个医院场地是物理治疗健身房和医院内的员工健身房。

参与者

根据全球慢性阻塞性肺疾病倡议的指南,由呼吸内科医生诊断为慢性阻塞性肺疾病的患者。

干预措施

参与者随机分配到以下四组之一:无电话随访的医院康复;有电话随访的医院康复;无电话随访的社区康复;有电话随访的社区康复。所有参与者在康复后 1 个月时对电话干预组保持盲法,只有评估小组和研究参与者不盲。

主要观察指标

主要观察指标是康复后医院和社区肺康复组在耐力穿梭步行测试(ESWT)方面的改善差异,以及接受电话鼓励和接受标准护理的两组在 18 个月随访期间 ESWT 的差异。次要观察指标是健康相关生活质量。

结果

共有 240 名参与者有可评估的数据。其中,129 名被随机分配到医院康复(64 名接受电话随访,65 名不接受电话随访),111 名被随机分配到社区康复(55 名接受电话随访,56 名不接受电话随访)。对于主要观察指标,有 162 名患者有数据分析:无电话随访的医院康复(n = 38);有电话随访的医院康复(n = 48);无电话随访的社区康复(n = 43);有电话随访的社区康复(n = 33)。对于康复后的急性期结果,在患者有机会接受电话随访之前,我们比较了社区康复组的 76 名患者和医院康复组的 86 名患者的结果。医院康复组患者在康复后的随访中行走距离增加了 283 米(SD 360 米),相对于基线增加了 109%(SD 137%)。社区康复组患者在康复后的随访中行走距离增加了 216 米(SD 340 米),相对于基线增加了 91%(SD 133%)。两组之间没有统计学差异[17.8%(95%CI-24.3 至 59.9,p = 0.405)]。在康复后 6、12 和 18 个月的长期结果中,没有证据表明康复组有效果。在考虑到康复后随访中行走的初始基线距离、时间(随访访问)和析因设计(电话随访组)后,医院和社区康复组之间 ESWT 康复后随访中行走距离的平均差异为 1.5 米(95%CI-82.1 至 97.2,p = 0.971),电话和无电话组之间的差异为 56.9 米(95%CI-25.2 至 139,p = 0.174)。在急性效应或效应持续时间方面,医院或社区组之间没有差异。健康经济学分析既不支持医院也不支持社区环境,也不明显支持电话随访或常规护理。

结论

在社区环境中进行的肺康复与更传统的基于医院的环境产生的效果相似,两种环境都能显著提高运动能力和生活质量,无论是在急性期还是长期随访中。健康经济学分析表明,医院和社区方案都没有明显的优势。模型的选择将取决于方便、现有资源可用性和增量成本等当地因素。工作人员的特点可能对获得最佳结果很重要,因此在人员招聘和培训方面应加以注意。

试验注册

当前对照试验 ISRCTN86821773。

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