Lenferink Anke, Brusse-Keizer Marjolein, van der Valk Paul Dlpm, Frith Peter A, Zwerink Marlies, Monninkhof Evelyn M, van der Palen Job, Effing Tanja W
Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, Netherlands.
Cochrane Database Syst Rev. 2017 Aug 4;8(8):CD011682. doi: 10.1002/14651858.CD011682.pub2.
Chronic Obstructive Pulmonary Disease (COPD) self-management interventions should be structured but personalised and often multi-component, with goals of motivating, engaging and supporting the patients to positively adapt their behaviour(s) and develop skills to better manage disease. Exacerbation action plans are considered to be a key component of COPD self-management interventions. Studies assessing these interventions show contradictory results. In this Cochrane Review, we compared the effectiveness of COPD self-management interventions that include action plans for acute exacerbations of COPD (AECOPD) with usual care.
To evaluate the efficacy of COPD-specific self-management interventions that include an action plan for exacerbations of COPD compared with usual care in terms of health-related quality of life, respiratory-related hospital admissions and other health outcomes.
We searched the Cochrane Airways Group Specialised Register of trials, trials registries, and the reference lists of included studies to May 2016.
We included randomised controlled trials evaluating a self-management intervention for people with COPD published since 1995. To be eligible for inclusion, the self-management intervention included a written action plan for AECOPD and an iterative process between participant and healthcare provider(s) in which feedback was provided. We excluded disease management programmes classified as pulmonary rehabilitation or exercise classes offered in a hospital, at a rehabilitation centre, or in a community-based setting to avoid overlap with pulmonary rehabilitation as much as possible.
Two review authors independently assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. Study authors were contacted to obtain additional information and missing outcome data where possible. When appropriate, study results were pooled using a random-effects modelling meta-analysis. The primary outcomes of the review were health-related quality of life (HRQoL) and number of respiratory-related hospital admissions.
We included 22 studies that involved 3,854 participants with COPD. The studies compared the effectiveness of COPD self-management interventions that included an action plan for AECOPD with usual care. The follow-up time ranged from two to 24 months and the content of the interventions was diverse.Over 12 months, there was a statistically significant beneficial effect of self-management interventions with action plans on HRQoL, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score, where a lower score represents better HRQoL. We found a mean difference from usual care of -2.69 points (95% CI -4.49 to -0.90; 1,582 participants; 10 studies; high-quality evidence). Intervention participants were at a statistically significant lower risk for at least one respiratory-related hospital admission compared with participants who received usual care (OR 0.69, 95% CI 0.51 to 0.94; 3,157 participants; 14 studies; moderate-quality evidence). The number needed to treat to prevent one respiratory-related hospital admission over one year was 12 (95% CI 7 to 69) for participants with high baseline risk and 17 (95% CI 11 to 93) for participants with low baseline risk (based on the seven studies with the highest and lowest baseline risk respectively).There was no statistically significant difference in the probability of at least one all-cause hospital admission in the self-management intervention group compared to the usual care group (OR 0.74, 95% CI 0.54 to 1.03; 2467 participants; 14 studies; moderate-quality evidence). Furthermore, we observed no statistically significant difference in the number of all-cause hospitalisation days, emergency department visits, General Practitioner visits, and dyspnoea scores as measured by the (modified) Medical Research Council questionnaire for self-management intervention participants compared to usual care participants. There was no statistically significant effect observed from self-management on the number of COPD exacerbations and no difference in all-cause mortality observed (RD 0.0019, 95% CI -0.0225 to 0.0263; 3296 participants; 16 studies; moderate-quality evidence). Exploratory analysis showed a very small, but significantly higher respiratory-related mortality rate in the self-management intervention group compared to the usual care group (RD 0.028, 95% CI 0.0049 to 0.0511; 1219 participants; 7 studies; very low-quality evidence).Subgroup analyses showed significant improvements in HRQoL in self-management interventions with a smoking cessation programme (MD -4.98, 95% CI -7.17 to -2.78) compared to studies without a smoking cessation programme (MD -1.33, 95% CI -2.94 to 0.27, test for subgroup differences: Chi² = 6.89, df = 1, P = 0.009, I² = 85.5%). The number of behavioural change techniques clusters integrated in the self-management intervention, the duration of the intervention and adaptation of maintenance medication as part of the action plan did not affect HRQoL. Subgroup analyses did not detect any potential variables to explain differences in respiratory-related hospital admissions among studies.
AUTHORS' CONCLUSIONS: Self-management interventions that include a COPD exacerbation action plan are associated with improvements in HRQoL, as measured with the SGRQ, and lower probability of respiratory-related hospital admissions. No excess all-cause mortality risk was observed, but exploratory analysis showed a small, but significantly higher respiratory-related mortality rate for self-management compared to usual care.For future studies, we would like to urge only using action plans together with self-management interventions that meet the requirements of the most recent COPD self-management intervention definition. To increase transparency, future study authors should provide more detailed information regarding interventions provided. This would help inform further subgroup analyses and increase the ability to provide stronger recommendations regarding effective self-management interventions that include action plans for AECOPD. For safety reasons, COPD self-management action plans should take into account comorbidities when used in the wider population of people with COPD who have comorbidities. Although we were unable to evaluate this strategy in this review, it can be expected to further increase the safety of self-management interventions. We also advise to involve Data and Safety Monitoring Boards for future COPD self-management studies.
慢性阻塞性肺疾病(COPD)自我管理干预措施应结构化但个性化,且通常包含多个组成部分,目标是激励、促使并支持患者积极改变其行为,并培养更好管理疾病的技能。急性加重期行动计划被认为是COPD自我管理干预措施的关键组成部分。评估这些干预措施的研究结果相互矛盾。在本Cochrane系统评价中,我们比较了包含COPD急性加重期(AECOPD)行动计划的COPD自我管理干预措施与常规治疗的效果。
评估与常规治疗相比,包含COPD加重期行动计划的特定COPD自我管理干预措施在健康相关生活质量、呼吸道相关住院率及其他健康结局方面的疗效。
我们检索了Cochrane气道组专业试验注册库、试验注册机构以及截至2016年5月纳入研究的参考文献列表。
我们纳入了自1995年以来发表的评估针对COPD患者自我管理干预措施的随机对照试验。要符合纳入条件,自我管理干预措施需包括一份针对AECOPD的书面行动计划,以及参与者与医疗服务提供者之间的迭代过程,在此过程中提供反馈。我们排除了归类为肺康复或在医院、康复中心或社区环境中提供的运动课程的疾病管理项目,以尽可能避免与肺康复重叠。
两位综述作者独立评估试验质量并提取数据。我们通过达成共识或邀请第三位综述作者解决分歧。尽可能联系研究作者以获取更多信息和缺失的结局数据。在适当情况下,使用随机效应模型荟萃分析汇总研究结果。本综述的主要结局为健康相关生活质量(HRQoL)和呼吸道相关住院次数。
我们纳入了22项研究,涉及3854例COPD患者。这些研究比较了包含AECOPD行动计划的COPD自我管理干预措施与常规治疗的效果。随访时间为2至24个月,干预措施的内容各不相同。在12个月期间,通过圣乔治呼吸问卷(SGRQ)总分衡量,包含行动计划的自我管理干预措施对HRQoL有统计学显著的有益效果,得分越低表明HRQoL越好。我们发现与常规治疗相比,平均差异为 -2.69分(95% CI -4.49至 -0.90;1582例参与者;10项研究;高质量证据)。与接受常规治疗的参与者相比,干预参与者发生至少一次呼吸道相关住院的风险在统计学上显著降低(OR 0.69,95% CI 0.51至0.94;3157例参与者;14项研究;中等质量证据)。对于基线风险高的参与者,预防一年中一次呼吸道相关住院所需治疗人数为12(95% CI 7至69),对于基线风险低的参与者为17(95% CI 11至93)(分别基于基线风险最高和最低的七项研究)。自我管理干预组与常规治疗组相比,至少一次全因住院的概率无统计学显著差异(OR 0.74,95% CI 0.54至1.03;2467例参与者;14项研究;中等质量证据)。此外,与常规治疗参与者相比,我们未观察到自我管理干预参与者在全因住院天数、急诊就诊次数、全科医生就诊次数以及通过(改良)医学研究委员会问卷测量的呼吸困难评分方面有统计学显著差异。自我管理对COPD加重次数无统计学显著影响,全因死亡率也无差异(RD 0.0019,95% CI -0.0225至0.0263;3296例参与者;16项研究;中等质量证据)。探索性分析显示,与常规治疗组相比,自我管理干预组的呼吸道相关死亡率非常低,但显著更高(RD 0.028,95% CI 0.0049至0.0511;1219例参与者;7项研究;极低质量证据)。亚组分析显示,与没有戒烟计划的研究相比,有戒烟计划的自我管理干预措施在HRQoL方面有显著改善(MD -4.98,95% CI -7.17至 -2.78)(无戒烟计划的研究:MD -1.33,95% CI -2.94至0.27,亚组差异检验:Chi² = 6.89,df = 1,P = 0.009,I² = 85.5%)。自我管理干预措施中整合的行为改变技术集群数量、干预持续时间以及作为行动计划一部分的维持药物调整均未影响HRQoL。亚组分析未发现任何潜在变量可解释各研究中呼吸道相关住院差异。
包含COPD加重期行动计划的自我管理干预措施与通过SGRQ测量的HRQoL改善以及呼吸道相关住院概率降低相关。未观察到全因死亡风险增加,但探索性分析显示,与常规治疗相比,自我管理的呼吸道相关死亡率虽低但显著更高。对于未来研究,我们敦促仅将行动计划与符合最新COPD自我管理干预定义要求的自我管理干预措施一起使用。为提高透明度,未来研究作者应提供有关所提供干预措施的更详细信息。这将有助于进行进一步的亚组分析,并增强就包含AECOPD行动计划的有效自我管理干预措施提供更强有力建议的能力。出于安全考虑,在更广泛的合并症COPD患者人群中使用COPD自我管理行动计划时应考虑合并症。尽管我们在本综述中无法评估该策略,但预计这将进一步提高自我管理干预措施的安全性。我们还建议未来的COPD自我管理研究纳入数据与安全监测委员会。