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

Supported self-management for patients with moderate to severe chronic obstructive pulmonary disease (COPD): an evidence synthesis and economic analysis
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DOI:
10.3310/hta19360
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发表时间:
2015-05-01
影响因子:
3.6
通讯作者:
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中科院分区:
医学2区
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背景:慢性阻塞性肺疾病(COPD)患者的自我管理(SM)支持在其覆盖面、内容、方法和时间上是不同的。没有足够的证据表明SM干预是最有效和最具成本效益的。目的:(1)对出院后6周内开始的SM干预对COPD恶化的有效性的证据进行系统综述(综述1);(2)对有关患者满意度、接受度和SM干预障碍的定性证据进行系统综述(综述2);(3)对出院6周内SM支持干预对COPD恶化的成本效果进行系统综述(综述3);(4)病情加重后SM支持与常规护理(UC)的成本-效果分析和经济模型(经济模型);以及(5)对SM支持有效性的证据进行更广泛的系统审查,包括包含SM重要组成部分的干预措施(如肺康复),以确定哪些组成部分在减少病情恶化、住院/再入院和改善生活质量方面最重要(综述4)。方法:从最初到2012年5月检索以下电子数据库:Medline、MEDLINE in-Process和其他非索引引文、EMbase、Cochrane中央对照试验登记(CENTAL)和科学引文索引[ISI]。还搜索了特定于受试者的数据库:Pedro物理治疗证据数据库、QicINFO和Cochrane Airways Group注册试验。正在进行的研究通过当前对照试验MetaRegister、国际标准随机对照试验号码数据库、世界卫生组织国际临床试验注册平台门户和ClinicalTrials.gov获取。专家摘要和会议记录通过ISI的会议论文集引文索引和大英图书馆的电子目录(ZETEC)获得。还通过欧洲呼吸学会、美国胸科学会和英国胸科学会2010年至2012年的会议记录进行了手工搜索,并对选定的网站进行了检查。潜在相关研究的标题、摘要和全文由两名独立的审查员扫描。如果大约90%的人患有COPD,大多数至少是中度严重的,并报告了任何包括SM成分或包的干预措施,则包括初步研究。接受的研究设计和结果在两次综述中都有所不同。使用Cochrane工具评估随机对照试验(RCT)的偏倚风险。在适当的情况下,使用随机效应荟萃分析来结合研究。马尔可夫模型以30年为时间跨度,将因急性加重入院后立即进行SM干预的患者与UC进行比较。结果:13355篇文献中,纳入综述1的随机对照试验10篇,综述2和综述3各1篇,综述4的随机对照试验174篇。Meta分析没有发现出院后SM支持对入院[危险比(HR)0.78,95%可信区间(CI)0.52至1.17]、死亡率(HR 1.07,95%CI 0.74至1.54)和大多数其他健康结果的益处的证据。健康相关的生活质量(HRQOL)有了适度的改善,但这可能是有偏见的,因为随访率很高。由于对重新接纳的影响的不确定性,经济模型是投机性的。与UC相比,出院后SM支持(出院后6周内交付)成本更高,结果更好(683磅成本差异和0.0831的QALY收益)。评估单个成分的影响的研究很少,但只有锻炼显著改善了HRQL(3个月圣乔治呼吸问卷4.87,95%可信区间3.96至5.79)。与UC相比,多因素干预改善了患者的HRQL(3个月时的平均差值为6.50,95%可信区间为3.62~9.39)。结果与潜在的入院人数减少相一致。在1年的随访中,来自医疗保健专业人员的更多加强护理的干预措施改善了HRQOL并减少了入院人数。干预措施包括有监督或无监督的有组织的锻炼,在长达6个月的时间里,HRQL得到了显著的和临床上重要的改善。限制:这项综述是基于一项全面的搜索策略,该策略本应确定大多数相关研究。主要的局限性是现有研究的异质性及其设计和报告中普遍存在的问题。结论:尽管观察到的效果与HRQL的可能改善和住院人数的减少相一致,但几乎没有证据表明出院后为患者提供SM支持有好处。尽管包含运动的干预措施似乎是最有效的,但要梳理出SM支持方案中最有效的部分并不容易。未来的工作应该包括定性研究,以探索SM后恶化的障碍和促进者,以及根据个人和他们的情况量身定做的影响行为变化的新方法。任何新的试验都应该适当地设计和进行,并特别注意减少后续的损失。个体参与者数据的荟萃分析可能有助于确定SM干预的最有效组成部分。
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 approximate to 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 pound 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.