Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Leiden, Netherlands.
Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.
BACKGROUND: People with chronic obstructive pulmonary disease (COPD) show considerable variation in symptoms, limitations, and well-being; this often complicates medical care. A multi-disciplinary and multi-component programme that addresses different elements of care could improve quality of life (QoL) and exercise tolerance, while reducing the number of exacerbations. OBJECTIVES: To compare the effectiveness of integrated disease management (IDM) programmes versus usual care for people with chronic obstructive pulmonary disease (COPD) in terms of health-related quality of life (QoL), exercise tolerance, and exacerbation-related outcomes. SEARCH METHODS: We searched the Cochrane Airways Group Register of Trials, CENTRAL, MEDLINE, Embase, and CINAHL for potentially eligible studies. Searches were current as of September 2020. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared IDM programmes for COPD versus usual care were included. Interventions consisted of multi-disciplinary (two or more healthcare providers) and multi-treatment (two or more components) IDM programmes of at least three months' duration. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. If required, we contacted study authors to request additional data. We performed meta-analyses using random-effects modelling. We carried out sensitivity analyses for the quality of included studies and performed subgroup analyses based on setting, study design, dominant intervention components, and region. MAIN RESULTS: Along with 26 studies included in the 2013 Cochrane Review, we added 26 studies for this update, resulting in 52 studies involving 21,086 participants for inclusion in the meta-analysis. Follow-up periods ranged between 3 and 48 months and were classified as short-term (up to 6 months), medium-term (6 to 15 months), and long-term (longer than 15 months) follow-up. Studies were conducted in 19 different countries. The mean age of included participants was 67 years, and 66% were male. Participants were treated in all types of healthcare settings, including primary (n =15), secondary (n = 22), and tertiary care (n = 5), and combined primary and secondary care (n = 10). Overall, the level of certainty of evidence was moderate to high. We found that IDM probably improves health-related QoL as measured by St. George's Respiratory Questionnaire (SGRQ) total score at medium-term follow-up (mean difference (MD) -3.89, 95% confidence interval (CI) -6.16 to -1.63; 18 RCTs, 4321 participants; moderate-certainty evidence). A comparable effect was observed at short-term follow-up (MD -3.78, 95% CI -6.29 to -1.28; 16 RCTs, 1788 participants). However, the common effect did not exceed the minimum clinically important difference (MCID) of 4 points. There was no significant difference between IDM and control for long-term follow-up and for generic QoL. IDM probably also leads to a large improvement in maximum and functional exercise capacity, as measured by six-minute walking distance (6MWD), at medium-term follow-up (MD 44.69, 95% CI 24.01 to 65.37; 13 studies, 2071 participants; moderate-certainty evidence). The effect exceeded the MCID of 35 metres and was even greater at short-term (MD 52.26, 95% CI 32.39 to 72.74; 17 RCTs, 1390 participants) and long-term (MD 48.83, 95% CI 16.37 to 80.49; 6 RCTs, 7288 participants) follow-up. The number of participants with respiratory-related admissions was reduced from 324 per 1000 participants in the control group to 235 per 1000 participants in the IDM group (odds ratio (OR) 0.64, 95% CI 0.50 to 0.81; 15 RCTs, median follow-up 12 months, 4207 participants; high-certainty evidence). Likewise, IDM probably results in a reduction in emergency department (ED) visits (OR 0.69, 95%CI 0.50 to 0.93; 9 RCTs, median follow-up 12 months, 8791 participants; moderate-certainty evidence), a slight reduction in all-cause hospital admissions (OR 0.75, 95%CI 0.57 to 0.98; 10 RCTs, median follow-up 12 months, 9030 participants; moderate-certainty evidence), and fewer hospital days per person admitted (MD -2.27, 95% CI -3.98 to -0.56; 14 RCTs, median follow-up 12 months, 3563 participants; moderate-certainty evidence). Statistically significant improvement was noted on the Medical Research Council (MRC) Dyspnoea Scale at short- and medium-term follow-up but not at long-term follow-up. No differences between groups were reported for mortality, courses of antibiotics/prednisolone, dyspnoea, and depression and anxiety scores. Subgroup analysis of dominant intervention components and regions of study suggested context- and intervention-specific effects. However, some subgroup analyses were marked by considerable heterogeneity or included few studies. These results should therefore be interpreted with caution. AUTHORS' CONCLUSIONS: This review shows that IDM probably results in improvement in disease-specific QoL, exercise capacity, hospital admissions, and hospital days per person. Future research should evaluate which combination of IDM components and which intervention duration are most effective for IDM programmes, and should consider contextual determinants of implementation and treatment effect, including process-related outcomes, long-term follow-up, and cost-effectiveness analyses.
背景:患有慢性阻塞性肺疾病(COPD)的患者在症状、受限和幸福感方面存在显著差异;这常常使医疗护理复杂化。针对不同护理要素的多学科和多组分方案可以提高生活质量(QoL)和运动耐量,同时减少恶化的次数。
目的:比较综合疾病管理(IDM)方案与 COPD 患者的常规护理相比,在健康相关生活质量(QoL)、运动耐量和恶化相关结局方面的效果。
检索方法:我们检索了 Cochrane 气道组试验注册库、CENTRAL、MEDLINE、Embase 和 CINAHL,以确定可能符合条件的研究。检索截至 2020 年 9 月。
入选标准:纳入了将 COPD 的 IDM 方案与常规护理进行比较的随机对照试验(RCT)。干预措施包括至少 3 个月的多学科(两个或更多医疗保健提供者)和多治疗(两个或更多治疗成分)IDM 方案。
数据收集和分析:两名综述作者独立评估了试验质量并提取了数据。如果需要,我们联系了研究作者以请求额外的数据。我们使用随机效应模型进行了荟萃分析。我们对纳入研究的质量进行了敏感性分析,并基于研究地点、研究设计、主要干预成分和地区进行了亚组分析。
主要结果:除了 2013 年 Cochrane 综述中包含的 26 项研究外,我们还增加了 26 项研究,共有 52 项研究纳入了 21086 名参与者进行荟萃分析。随访时间从 3 到 48 个月不等,分为短期(6 个月内)、中期(6 至 15 个月)和长期(15 个月以上)随访。研究在 19 个不同的国家进行。纳入参与者的平均年龄为 67 岁,66%为男性。参与者在各种医疗保健环境中接受治疗,包括初级(n=15)、二级(n=22)和三级保健(n=5)以及初级和二级保健相结合的环境(n=10)。总体而言,证据的确定性水平为中等到高度。我们发现,IDM 可能会改善中期随访时的健康相关 QoL,表现在圣乔治呼吸问卷(SGRQ)总分上(平均差(MD)-3.89,95%置信区间(CI)-6.16 至-1.63;18 项 RCT,4321 名参与者;中高度确定性证据)。在短期随访时也观察到类似的效果(MD-3.78,95%CI-6.29 至-1.28;16 项 RCT,1788 名参与者)。然而,常见的影响没有超过 4 分的最小临床重要差异(MCID)。IDM 与对照组在长期随访和一般 QoL 方面没有差异。IDM 可能还会导致 6 分钟步行距离(6MWD)的最大和功能性运动能力有较大的改善,表现在中期随访时(MD44.69,95%CI24.01 至 65.37;13 项研究,2071 名参与者;中高度确定性证据)。这种效果超过了 35 米的 MCID,在短期(MD52.26,95%CI32.39 至 72.74;17 项 RCT,1390 名参与者)和长期(MD48.83,95%CI16.37 至 80.49;6 项 RCT,7288 名参与者)随访中更大。对照组中每 1000 名参与者中因呼吸相关原因入院的人数从 324 人减少到 IDM 组的 235 人(比值比(OR)0.64,95%CI0.50 至 0.81;15 项 RCT,中位数随访 12 个月,4207 名参与者;高确定性证据)。同样,IDM 可能会减少急诊部(ED)就诊(OR0.69,95%CI0.50 至 0.93;9 项 RCT,中位数随访 12 个月,8791 名参与者;中高度确定性证据),略微减少所有原因的住院(OR0.75,95%CI0.57 至 0.98;10 项 RCT,中位数随访 12 个月,9030 名参与者;中高度确定性证据),并减少每人住院天数(MD-2.27,95%CI-3.98 至-0.56;14 项 RCT,中位数随访 12 个月,3563 名参与者;中高度确定性证据)。在短期和中期随访时,在医学研究委员会(MRC)呼吸困难量表上观察到了统计学意义上的改善,但在长期随访时没有。在死亡率、抗生素/泼尼松龙疗程、呼吸困难和抑郁焦虑评分方面,两组之间没有差异。主要干预成分和研究地点的亚组分析表明,存在与背景和干预措施相关的影响。然而,一些亚组分析存在很大的异质性或纳入的研究很少。因此,这些结果应谨慎解释。
结论:本综述表明,IDM 可能会改善疾病特异性 QoL、运动能力、住院次数和每人住院天数。未来的研究应评估 IDM 方案的哪些组合和干预持续时间对 IDM 方案最有效,并应考虑实施和治疗效果的背景决定因素,包括过程相关结果、长期随访和成本效益分析。
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