Cochrane Airways, Population Health Research Institute, St George's, University of London, London, UK.
School of Health and Social Care, Teesside University, Middlesbrough, UK.
Cochrane Database Syst Rev. 2021 Jul 26;7(7):CD013384. doi: 10.1002/14651858.CD013384.pub2.
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory condition characterised by shortness of breath, cough and recurrent exacerbations. People with COPD often live with one or more co-existing long-term health conditions (comorbidities). People with more severe COPD often have a higher number of comorbidities, putting them at greater risk of morbidity and mortality.
To assess the effectiveness of any single intervention for COPD adapted or tailored to their comorbidity(s) compared to any other intervention for people with COPD and one or more common comorbidities (quantitative data, RCTs) in terms of the following outcomes: Quality of life, exacerbations, functional status, all-cause and respiratory-related hospital admissions, mortality, pain, and depression and anxiety. To assess the effectiveness of an adapted or tailored single COPD intervention (simple or complex) that is aimed at changing the management of people with COPD and one or more common comorbidities (quantitative data, RCTs) compared to usual care in terms of the following outcomes: Quality of life, exacerbations, functional status, all-cause and respiratory-related hospital admissions, mortality, pain, and depression and anxiety. To identify emerging themes that describe the views and experiences of patients, carers and healthcare professionals when receiving or providing care to manage multimorbidities (qualitative data).
We searched multiple databases including the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, and CINAHL, to identify relevant randomised and qualitative studies. We also searched trial registries and conducted citation searches. The latest search was conducted in January 2021.
Eligible randomised controlled trials (RCTs) compared a) any single intervention for COPD adapted or tailored to their comorbidity(s) compared to any other intervention, or b) any adapted or tailored single COPD intervention (simple or complex) that is aimed at changing the management of people with COPD and one or more comorbidities, compared to usual care. We included qualitative studies or mixed-methods studies to identify themes.
We used standard Cochrane methods for analysis of the RCTs. We used Cochrane's risk of bias tool for the RCTs and the CASP checklist for the qualitative studies. We planned to use the Mixed Methods Appraisal tool (MMAT) to assess the risk of bias in mixed-methods studies, but we found none. We used GRADE and CERQual to assess the quality of the quantitative and qualitative evidence respectively. The primary outcome measures for this review were quality of life and exacerbations.
Quantitative studies We included seven studies (1197 participants) in the quantitative analyses, with interventions including telemonitoring, pulmonary rehabilitation, treatment optimisation, water-based exercise training and case management. Interventions were either compared with usual care or with an active comparator (such as land-based exercise training). Duration of trials ranged from 4 to 52 weeks. Mean age of participants ranged from 64 to 72 years and COPD severity ranged from mild to very severe. Trials included either people with COPD and a specific comorbidity (including cardiovascular disease, metabolic syndrome, lung cancer, head or neck cancer, and musculoskeletal conditions), or with one or more comorbidities of any type. Overall, we judged the evidence presented to be of moderate to very low certainty (GRADE), mainly due to the methodological quality of included trials and imprecision of effect estimates. Intervention versus usual care Quality of life as measured by the St George's Respiratory Questionnaire (SGRQ) total score may improve with tailored pulmonary rehabilitation compared to usual care at 52 weeks (mean difference (MD) -10.85, 95% confidence interval (CI) -12.66 to -9.04; 1 study, 70 participants; low-certainty evidence). Tailored pulmonary rehabilitation is likely to improve COPD assessment test (CAT) scores compared with usual care at 52 weeks (MD -8.02, 95% CI -9.44 to -6.60; 1 study, 70 participants, moderate-certainty evidence) and with a multicomponent telehealth intervention at 52 weeks (MD -6.90, 95% CI -9.56 to -4.24; moderate-certainty evidence). Evidence is uncertain about effects of pharmacotherapy optimisation or telemonitoring interventions on CAT improvement compared with usual care. There may be little to no difference in the number of people experiencing exacerbations, or mean exacerbations with case management compared with usual care (OR 1.09, 95% CI 0.75 to 1.57; 1 study, 470 participants; very low-certainty evidence). For secondary outcomes, six-minute walk distance (6MWD) may improve with pulmonary rehabilitation, water-based exercise or multicomponent interventions at 38 to 52 weeks (low-certainty evidence). A multicomponent intervention may result in fewer people being admitted to hospital at 17 weeks, although there may be little to no difference in a telemonitoring intervention. There may be little to no difference between intervention and usual care for mortality. Intervention versus active comparator We included one study comparing water-based and land-based exercise (30 participants). We found no evidence for quality of life or exacerbations. There may be little to no difference between water- and land-based exercise for 6MWD (MD 5 metres, 95% CI -22 to 32; 38 participants; very low-certainty evidence). Qualitative studies One nested qualitative study (21 participants) explored perceptions and experiences of people with COPD and long-term conditions, and of researchers and health professionals who were involved in an RCT of telemonitoring equipment. Several themes were identified, including health status, beliefs and concerns, reliability of equipment, self-efficacy, perceived ease of use, factors affecting usefulness and perceived usefulness, attitudes and intention, self-management and changes in healthcare use. We judged the qualitative evidence presented as of very low certainty overall.
AUTHORS' CONCLUSIONS: Owing to a paucity of eligible trials, as well as diversity in the intervention type, comorbidities and the outcome measures reported, we were unable to provide a robust synthesis of data. Pulmonary rehabilitation or multicomponent interventions may improve quality of life and functional status (6MWD), but the evidence is too limited to draw a robust conclusion. The key take-home message from this review is the lack of data from RCTs on treatments for people living with COPD and comorbidities. Given the variation in number and type of comorbidity(s) an individual may have, and severity of COPD, larger studies reporting individual patient data are required to determine these effects.
慢性阻塞性肺疾病(COPD)是一种以呼吸困难、咳嗽和反复恶化为特征的慢性呼吸系统疾病。COPD 患者通常同时患有一种或多种长期健康状况(合并症)。病情更严重的 COPD 患者往往合并症更多,因此面临更高的发病和死亡风险。
评估针对 COPD 患者合并症的单一干预措施(适应性或针对性干预)与针对 COPD 患者和一种或多种常见合并症的任何其他干预措施(定量数据,RCT)相比,在以下结局方面的有效性:生活质量、恶化、功能状态、全因和呼吸相关住院、死亡率、疼痛、抑郁和焦虑。评估针对 COPD 患者和一种或多种常见合并症(定量数据,RCT)的适应性或针对性单一 COPD 干预措施(简单或复杂)与常规护理相比在以下结局方面的有效性:生活质量、恶化、功能状态、全因和呼吸相关住院、死亡率、疼痛、抑郁和焦虑。确定描述患者、护理人员和医疗保健专业人员在接受或提供管理多种合并症的护理时的观点和经验的新兴主题(定性数据)。
我们检索了多个数据库,包括 Cochrane 气道试验注册库、CENTRAL、MEDLINE、Embase 和 CINAHL,以确定相关的随机对照试验(RCT)和定性研究。我们还检索了试验注册库并进行了引文搜索。最新搜索于 2021 年 1 月进行。
合格的 RCT 比较了 a)针对 COPD 患者合并症的任何单一干预措施(适应性或针对性干预)与任何其他干预措施,或 b)针对 COPD 患者和一种或多种合并症的任何适应性或针对性单一 COPD 干预措施(简单或复杂)与常规护理。我们纳入了定性研究或混合方法研究以确定主题。
我们使用标准的 Cochrane 方法对 RCT 进行分析。我们使用 Cochrane 的偏倚风险工具对 RCT 进行评估,使用 CASP 清单对定性研究进行评估。我们计划使用混合方法评估工具(MMAT)评估混合方法研究的偏倚风险,但我们没有找到。我们使用 GRADE 和 CERQual 分别评估定量和定性证据的质量。本综述的主要结局测量指标是生活质量和恶化。
定量研究我们纳入了 7 项研究(1197 名参与者)进行定量分析,干预措施包括远程监测、肺康复、治疗优化、水基运动训练和病例管理。干预措施要么与常规护理相比,要么与活性对照(如陆地运动训练)相比。试验的持续时间从 4 周到 52 周不等。参与者的平均年龄从 64 岁到 72 岁不等,COPD 严重程度从轻度到非常严重不等。试验包括同时患有 COPD 和特定合并症(包括心血管疾病、代谢综合征、肺癌、头颈部癌症和肌肉骨骼疾病)或同时患有任何类型的一种或多种合并症的患者。总体而言,我们认为呈现的证据是中度至非常低确定性的(GRADE),主要是由于纳入试验的方法学质量和效应估计的不精确性。干预措施与常规护理相比,在 52 周时,针对 COPD 患者合并症的适应性肺康复治疗可能会改善生活质量(圣乔治呼吸问卷(SGRQ)总分)(平均差异(MD)-10.85,95%置信区间(CI)-12.66 至-9.04;1 项研究,70 名参与者;低确定性证据)。在 52 周时,针对 COPD 患者合并症的适应性肺康复治疗可能会改善 COPD 评估测试(CAT)评分,与常规护理相比(MD-8.02,95%CI-9.44 至-6.60;1 项研究,70 名参与者,中等确定性证据)和与多成分远程健康干预相比(MD-6.90,95%CI-9.56 至-4.24;中等确定性证据)。证据不确定适应性或针对性的药物治疗优化或远程监测干预措施与常规护理相比是否能改善 CAT 改善。与常规护理相比,病例管理可能对减少恶化或平均恶化没有影响(或有影响)(比值比(OR)1.09,95%CI 0.75 至 1.57;1 项研究,470 名参与者;非常低确定性证据)。对于次要结局,在 38 至 52 周时,肺康复、水基运动或多成分干预可能会改善 6 分钟步行距离(6MWD)(低确定性证据)。多成分干预可能会导致在 17 周时住院人数减少,尽管远程监测干预可能没有差异。干预措施与常规护理相比,死亡率可能没有差异。干预措施与活性对照相比我们纳入了一项比较水上和陆地运动的研究(30 名参与者)。我们没有发现生活质量或恶化的证据。水上和陆地运动在 6MWD 方面可能没有差异(MD 5 米,95%CI-22 至 32;38 名参与者;非常低确定性证据)。定性研究一项嵌套的定性研究(21 名参与者)探讨了患有 COPD 和长期疾病的患者、参与远程监测设备 RCT 的研究人员和医疗保健专业人员的感知和体验。确定了几个主题,包括健康状况、信念和担忧、设备的可靠性、自我效能、感知易用性、影响有用性和感知有用性的因素、态度和意图、自我管理和医疗保健使用的变化。我们认为整体定性证据的确定性非常低。
由于合格试验数量有限,以及干预类型、合并症和报告的结局测量指标的多样性,我们无法对数据进行稳健的综合分析。肺康复或多成分干预可能会改善生活质量和功能状态(6MWD),但证据还不足以得出可靠的结论。本综述的主要结论是缺乏针对患有 COPD 和合并症的患者的治疗方法的 RCT 数据。鉴于个体可能患有多种合并症(和合并症的数量)以及 COPD 的严重程度,需要更大规模的报告个体患者数据的研究来确定这些影响。