Schrijver Jade, Lenferink Anke, Brusse-Keizer Marjolein, Zwerink Marlies, van der Valk Paul Dlpm, van der Palen Job, Effing Tanja W
Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, Netherlands.
Section Cognition, Data and Education, Faculty of Behavioural, Management and Social Sciences, University of Twente, Enschede, Netherlands.
Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD002990. doi: 10.1002/14651858.CD002990.pub4.
Self-management interventions help people with chronic obstructive pulmonary disease (COPD) to acquire and practise the skills they need to carry out disease-specific medical regimens, guide changes in health behaviour and provide emotional support to enable them to control their disease. Since the 2014 update of this review, several studies have been published.
Primary objectives To evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of health-related quality of life (HRQoL) and respiratory-related hospital admissions. To evaluate the safety of COPD self-management interventions compared to usual care in terms of respiratory-related mortality and all-cause mortality. Secondary objectives To evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of other health outcomes and healthcare utilisation. To evaluate effective characteristics of COPD self-management interventions.
We searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, EMBASE, trials registries and the reference lists of included studies up until January 2020.
Randomised controlled trials (RCTs) and cluster-randomised trials (CRTs) published since 1995. To be eligible for inclusion, self-management interventions had to include at least two intervention components and include an iterative process between participant and healthcare provider(s) in which goals were formulated and feedback was given on self-management actions by the participant.
Two review authors independently selected studies for inclusion, assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. We contacted study authors to obtain additional information and missing outcome data where possible. Primary outcomes were health-related quality of life (HRQoL), number of respiratory-related hospital admissions, respiratory-related mortality, and all-cause mortality. When appropriate, we pooled study results using random-effects modelling meta-analyses.
We included 27 studies involving 6008 participants with COPD. The follow-up time ranged from two-and-a-half to 24 months and the content of the interventions was diverse. Participants' mean age ranged from 57 to 74 years, and the proportion of male participants ranged from 33% to 98%. The post-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of participants ranged from 33.6% to 57.0%. The FEV1/FVC ratio is a measure used to diagnose COPD and to determine the severity of the disease. Studies were conducted on four different continents (Europe (n = 15), North America (n = 8), Asia (n = 1), and Oceania (n = 4); with one study conducted in both Europe and Oceania). Self-management interventions likely improve HRQoL, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score (lower score represents better HRQoL) with a mean difference (MD) from usual care of -2.86 points (95% confidence interval (CI) -4.87 to -0.85; 14 studies, 2778 participants; low-quality evidence). The pooled MD of -2.86 did not reach the SGRQ minimal clinically important difference (MCID) of four points. Self-management intervention participants were also at a slightly lower risk for at least one respiratory-related hospital admission (odds ratio (OR) 0.75, 95% CI 0.57 to 0.98; 15 studies, 3263 participants; very low-quality evidence). The number needed to treat to prevent one respiratory-related hospital admission over a mean of 9.75 months' follow-up was 15 (95% CI 8 to 399) for participants with high baseline risk and 26 (95% CI 15 to 677) for participants with low baseline risk. No differences were observed in respiratory-related mortality (risk difference (RD) 0.01, 95% CI -0.02 to 0.04; 8 studies, 1572 participants ; low-quality evidence) and all-cause mortality (RD -0.01, 95% CI -0.03 to 0.01; 24 studies, 5719 participants; low-quality evidence). We graded the evidence to be of 'moderate' to 'very low' quality according to GRADE. All studies had a substantial risk of bias, because of lack of blinding of participants and personnel to the interventions, which is inherently impossible in a self-management intervention. In addition, risk of bias was noticeably increased because of insufficient information regarding a) non-protocol interventions, and b) analyses to estimate the effect of adhering to interventions. Consequently, the highest GRADE evidence score that could be obtained by studies was 'moderate'.
AUTHORS' CONCLUSIONS: Self-management interventions for people with COPD are associated with improvements in HRQoL, as measured with the SGRQ, and a lower probability of respiratory-related hospital admissions. No excess respiratory-related and all-cause mortality risks were observed, which strengthens the view that COPD self-management interventions are unlikely to cause harm. By using stricter inclusion criteria, we decreased heterogeneity in studies, but also reduced the number of included studies and therefore our capacity to conduct subgroup analyses. Data were therefore still insufficient to reach clear conclusions about effective (intervention) characteristics of COPD self-management interventions. As tailoring of COPD self-management interventions to individuals is desirable, heterogeneity is and will likely remain present in self-management interventions. For future studies, we would urge using only COPD self-management interventions that include iterative interactions between participants and healthcare professionals who are competent using behavioural change techniques (BCTs) to elicit participants' motivation, confidence and competence to positively adapt their health behaviour(s) and develop skills to better manage their disease. In addition, to inform further subgroup and meta-regression analyses and to provide stronger conclusions regarding effective COPD self-management interventions, there is a need for more homogeneity in outcome measures. More attention should be paid to behavioural outcome measures and to providing more detailed, uniform and transparently reported data on self-management intervention components and BCTs. Assessment of outcomes over the long term is also recommended to capture changes in people's behaviour. Finally, information regarding non-protocol interventions as well as analyses to estimate the effect of adhering to interventions should be included to increase the quality of evidence.
自我管理干预措施有助于慢性阻塞性肺疾病(COPD)患者掌握并实践执行特定疾病医疗方案所需的技能,引导健康行为改变,并提供情感支持,使他们能够控制自身疾病。自本综述2014年更新以来,已发表了多项研究。
主要目的 评估与常规护理相比,COPD自我管理干预措施在健康相关生活质量(HRQoL)和呼吸系统相关住院方面的有效性。评估与常规护理相比,COPD自我管理干预措施在呼吸系统相关死亡率和全因死亡率方面的安全性。次要目的 评估与常规护理相比,COPD自我管理干预措施在其他健康结局和医疗保健利用方面的有效性。评估COPD自我管理干预措施的有效特征。
我们检索了Cochrane Airways试验注册库、CENTRAL、MEDLINE、EMBASE、试验注册库以及截至2020年1月纳入研究的参考文献列表。
1995年以来发表的随机对照试验(RCT)和整群随机试验(CRT)。要符合纳入条件,自我管理干预措施必须至少包括两个干预组成部分,并包括参与者与医疗保健提供者之间的迭代过程,在此过程中制定目标并就参与者的自我管理行动提供反馈。
两位综述作者独立选择纳入研究、评估试验质量并提取数据。我们通过达成共识或引入第三位综述作者来解决分歧。我们尽可能联系研究作者以获取更多信息和缺失的结局数据。主要结局为健康相关生活质量(HRQoL)、呼吸系统相关住院次数、呼吸系统相关死亡率和全因死亡率。在适当情况下,我们使用随机效应模型荟萃分析汇总研究结果。
我们纳入了27项研究,涉及6008名COPD患者。随访时间从2.5个月到24个月不等,干预措施的内容各不相同。参与者的平均年龄在57岁至74岁之间,男性参与者的比例在33%至98%之间。参与者支气管扩张剂后一秒用力呼气量(FEV1)与用力肺活量(FVC)的比值在33.6%至57.0%之间。FEV1/FVC比值是用于诊断COPD和确定疾病严重程度的一项指标。研究在四大洲进行(欧洲(n = 15)、北美洲(n = 8)、亚洲(n = 1)和大洋洲(n = 4);其中一项研究在欧洲和大洋洲均有开展)。自我管理干预措施可能会改善HRQoL,以圣乔治呼吸问卷(SGRQ)总分衡量(分数越低表示HRQoL越好),与常规护理相比平均差值(MD)为-2.86分(95%置信区间(CI)-4.87至-0.85;14项研究,2778名参与者;低质量证据)。汇总的MD为-2.86未达到SGRQ最小临床重要差异(MCID)的4分。自我管理干预措施的参与者至少发生一次呼吸系统相关住院的风险也略低(优势比(OR)0.75,95%CI 0.57至0.98;15项研究,3263名参与者;极低质量证据)。在平均9.75个月的随访期间,预防一次呼吸系统相关住院所需治疗的人数,基线风险高的参与者为15(95%CI 8至399),基线风险低的参与者为26(95%CI 15至677)。在呼吸系统相关死亡率(风险差值(RD)0.01,95%CI -0.02至0.04;8项研究,1572名参与者;低质量证据)和全因死亡率(RD -0.01,95%CI -0.03至0.01;24项研究,5719名参与者;低质量证据)方面未观察到差异。根据GRADE标准,我们将证据等级评定为“中等”至“极低”质量。所有研究都存在较大的偏倚风险,因为参与者和工作人员对干预措施缺乏盲法,这在自我管理干预中本质上是不可能的。此外,由于关于a)非方案干预和b)估计坚持干预措施效果的分析的信息不足,偏倚风险明显增加。因此,研究能够获得的最高GRADE证据评分是“中等”。
COPD患者的自我管理干预措施与使用SGRQ测量的HRQoL改善以及呼吸系统相关住院概率降低相关。未观察到呼吸系统相关和全因死亡率的额外风险,这强化了COPD自我管理干预措施不太可能造成伤害的观点。通过使用更严格的纳入标准,我们减少了研究中的异质性,但也减少了纳入研究的数量,因此我们进行亚组分析的能力也降低了。因此,数据仍然不足以就COPD自我管理干预措施的有效(干预)特征得出明确结论。由于需要针对个体定制COPD自我管理干预措施,自我管理干预措施中存在异质性,并且可能会一直存在。对于未来的研究,我们敦促仅使用包括参与者与具备使用行为改变技术(BCT)能力的医疗保健专业人员之间进行迭代互动的COPD自我管理干预措施,以激发参与者积极调整健康行为的动机、信心和能力,并培养更好管理疾病的技能。此外,为了为进一步的亚组分析和元回归分析提供信息,并就有效的COPD自我管理干预措施提供更有力的结论,需要在结局测量方面更加同质化。应更多关注行为结局测量,并提供关于自我管理干预组成部分和BCT的更详细、统一和透明报告的数据。还建议进行长期结局评估以捕捉人们行为的变化。最后,应纳入关于非方案干预以及估计坚持干预措施效果的分析的信息,以提高证据质量。