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中重度慢性阻塞性肺疾病(COPD)患者的支持性自我管理:证据综合与经济分析

Supported self-management for patients with moderate to severe chronic obstructive pulmonary disease (COPD): an evidence synthesis and economic analysis.

作者信息

Jordan Rachel E, Majothi Saimma, Heneghan Nicola R, Blissett Deirdre B, Riley Richard D, Sitch Alice J, Price Malcolm J, Bates Elizabeth J, Turner Alice M, Bayliss Susan, Moore David, Singh Sally, Adab Peymane, Fitzmaurice David A, Jowett Susan, Jolly Kate

机构信息

Public Health, Epidemiology and Biostatistics, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, UK.

School of Sport, Exercise & Rehabilitation Science, University of Birmingham, Edgbaston, Birmingham, UK.

出版信息

Health Technol Assess. 2015 May;19(36):1-516. doi: 10.3310/hta19360.

DOI:10.3310/hta19360
PMID:25980984
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4781645/
Abstract

BACKGROUND

Self-management (SM) support for patients with chronic obstructive pulmonary disease (COPD) is variable in its coverage, content, method and timing of delivery. There is insufficient evidence for which SM interventions are the most effective and cost-effective.

OBJECTIVES

To undertake (1) a systematic review of the evidence for the effectiveness of SM interventions commencing within 6 weeks of hospital discharge for an exacerbation for COPD (review 1); (2) a systematic review of the qualitative evidence about patient satisfaction, acceptance and barriers to SM interventions (review 2); (3) a systematic review of the cost-effectiveness of SM support interventions within 6 weeks of hospital discharge for an exacerbation of COPD (review 3); (4) a cost-effectiveness analysis and economic model of post-exacerbation SM support compared with usual care (UC) (economic model); and (5) a wider systematic review of the evidence of the effectiveness of SM support, including interventions (such as pulmonary rehabilitation) in which there are significant components of SM, to identify which components are the most important in reducing exacerbations, hospital admissions/readmissions and improving quality of life (review 4).

METHODS

The following electronic databases were searched from inception to May 2012: MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and Science Citation Index [Institute of Scientific Information (ISI)]. Subject-specific databases were also searched: PEDro physiotherapy evidence database, PsycINFO and the Cochrane Airways Group Register of Trials. Ongoing studies were sourced through the metaRegister of Current Controlled Trials, International Standard Randomised Controlled Trial Number database, World Health Organization International Clinical Trials Registry Platform Portal and ClinicalTrials.gov. Specialist abstract and conference proceedings were sourced through ISI's Conference Proceedings Citation Index and British Library's Electronic Table of Contents (Zetoc). Hand-searching through European Respiratory Society, the American Thoracic Society and British Thoracic Society conference proceedings from 2010 to 2012 was also undertaken, and selected websites were also examined. Title, abstracts and full texts of potentially relevant studies were scanned by two independent reviewers. Primary studies were included if ≈90% of the population had COPD, the majority were of at least moderate severity and reported on any intervention that included a SM component or package. Accepted study designs and outcomes differed between the reviews. Risk of bias for randomised controlled trials (RCTs) was assessed using the Cochrane tool. Random-effects meta-analysis was used to combine studies where appropriate. A Markov model, taking a 30-year time horizon, compared a SM intervention immediately following a hospital admission for an acute exacerbation with UC. Incremental costs and quality-adjusted life-years were calculated, with sensitivity analyses.

RESULTS

From 13,355 abstracts, 10 RCTs were included for review 1, one study each for reviews 2 and 3, and 174 RCTs for review 4. Available studies were heterogeneous and many were of poor quality. Meta-analysis identified no evidence of benefit of post-discharge SM support on admissions [hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.52 to 1.17], mortality (HR 1.07, 95% CI 0.74 to 1.54) and most other health outcomes. A modest improvement in health-related quality of life (HRQoL) was identified but this was possibly biased due to high loss to follow-up. The economic model was speculative due to uncertainty in impact on readmissions. Compared with UC, post-discharge SM support (delivered within 6 weeks of discharge) was more costly and resulted in better outcomes (£683 cost difference and 0.0831 QALY gain). Studies assessing the effect of individual components were few but only exercise significantly improved HRQoL (3-month St George's Respiratory Questionnaire 4.87, 95% CI 3.96 to 5.79). Multicomponent interventions produced an improved HRQoL compared with UC (mean difference 6.50, 95% CI 3.62 to 9.39, at 3 months). Results were consistent with a potential reduction in admissions. Interventions with more enhanced care from health-care professionals improved HRQoL and reduced admissions at 1-year follow-up. Interventions that included supervised or unsupervised structured exercise resulted in significant and clinically important improvements in HRQoL up to 6 months.

LIMITATIONS

This review was based on a comprehensive search strategy that should have identified most of the relevant studies. The main limitations result from the heterogeneity of studies available and widespread problems with their design and reporting.

CONCLUSIONS

There was little evidence of benefit of providing SM support to patients shortly after discharge from hospital, although effects observed were consistent with possible improvement in HRQoL and reduction in hospital admissions. It was not easy to tease out the most effective components of SM support packages, although interventions containing exercise seemed the most effective. Future work should include qualitative studies to explore barriers and facilitators to SM post exacerbation and novel approaches to affect behaviour change, tailored to the individual and their circumstances. Any new trials should be properly designed and conducted, with special attention to reducing loss to follow-up. Individual participant data meta-analysis may help to identify the most effective components of SM interventions.

STUDY REGISTRATION

This study is registered as PROSPERO CRD42011001588.

FUNDING

The National Institute for Health Research Health Technology Assessment programme.

摘要

背景

针对慢性阻塞性肺疾病(COPD)患者的自我管理(SM)支持在覆盖范围、内容、方法和提供时机方面存在差异。关于哪些SM干预措施最有效和最具成本效益,证据不足。

目的

进行(1)对因COPD急性加重而在出院后6周内开始的SM干预措施有效性证据的系统评价(评价1);(2)对关于患者对SM干预措施的满意度、接受度和障碍的定性证据的系统评价(评价2);(3)对因COPD急性加重而在出院后6周内的SM支持干预措施成本效益的系统评价(评价3);(4)与常规护理(UC)相比,对急性加重后SM支持的成本效益分析和经济模型(经济模型);以及(5)对SM支持有效性证据的更广泛系统评价,包括其中有显著SM成分的干预措施(如肺康复),以确定哪些成分在减少急性加重、住院/再入院以及改善生活质量方面最为重要(评价4)。

方法

从数据库建立至2012年5月检索了以下电子数据库:MEDLINE、MEDLINE在研及其他未索引引文、EMBASE、Cochrane对照试验中心注册库(CENTRAL)和科学引文索引[科学信息研究所(ISI)]。还检索了特定主题数据库:PEDro物理治疗证据数据库、PsycINFO和Cochrane气道组试验注册库。通过当前对照试验的元注册库、国际标准随机对照试验编号数据库、世界卫生组织国际临床试验注册平台门户和ClinicalTrials.gov获取正在进行的研究。通过ISI的会议论文引文索引和大英图书馆的电子目录(Zetoc)获取专业摘要和会议论文集。还对2010年至2012年欧洲呼吸学会、美国胸科学会和英国胸科学会的会议论文集进行了手工检索,并检查了选定的网站。两名独立评审员对潜在相关研究的标题、摘要和全文进行了筛选。如果约90%的研究对象患有COPD,大多数至少为中度严重程度,并报告了任何包含SM成分或方案的干预措施,则纳入主要研究。不同评价中的纳入研究设计和结局各不相同。使用Cochrane工具评估随机对照试验(RCT)的偏倚风险。在适当情况下,使用随机效应荟萃分析合并研究。采用马尔可夫模型,以30年为时间跨度,比较急性加重住院后立即进行的SM干预措施与UC。计算了增量成本和质量调整生命年,并进行了敏感性分析。

结果

从13355篇摘要中,评价1纳入了10项RCT,评价2和评价3各纳入1项研究,评价4纳入174项RCT。现有研究具有异质性,许多质量较差。荟萃分析未发现出院后SM支持对入院(风险比[HR]0.78,95%置信区间[CI]0.52至1.17)、死亡率(HR1.07,95%CI0.74至1.54)和大多数其他健康结局有获益证据。发现健康相关生活质量(HRQoL)有适度改善,但由于随访失访率高,这可能存在偏倚。由于对再入院影响存在不确定性,经济模型具有推测性。与UC相比,出院后SM支持(出院后6周内提供)成本更高,但结局更好(成本差异683英镑,质量调整生命年增加0.0831)。评估各个成分效果的研究较少,但只有运动显著改善了HRQoL(3个月时圣乔治呼吸问卷评分为4.87,95%CI3.9至5.79)。与UC相比,多成分干预措施改善了HRQoL(3个月时平均差异为6.50,95%CI3.62至9.39)。结果与入院可能减少一致。来自医疗保健专业人员的强化护理更多的干预措施在1年随访时改善了HRQoL并减少了入院。包括有监督或无监督结构化运动的干预措施在长达6个月的时间里使HRQoL有显著且具有临床意义的改善。

局限性

本评价基于全面的检索策略,该策略应已识别出大多数相关研究。主要局限性源于现有研究的异质性及其设计和报告方面存在普遍问题。

结论

几乎没有证据表明出院后不久为患者提供SM支持有获益,尽管观察到的效果与HRQoL可能改善和住院次数减少一致。梳理出SM支持方案中最有效的成分并不容易,尽管包含运动的干预措施似乎最有效。未来的工作应包括定性研究,以探索急性加重后SM的障碍和促进因素,以及针对个体及其情况影响行为改变的新方法。任何新的试验都应进行适当设计和实施,特别注意减少随访失访。个体参与者数据荟萃分析可能有助于确定SM干预措施中最有效的成分。

研究注册

本研究注册为PROSPERO CRD42011001588。

资助

国家卫生研究院卫生技术评估计划。