Takeda Andrea, Martin Nicole, Taylor Rod S, Taylor Stephanie Jc
Institute of Health Informatics Research, University College London, London, UK.
Cochrane Database Syst Rev. 2019 Jan 8;1(1):CD002752. doi: 10.1002/14651858.CD002752.pub4.
Despite advances in treatment, the increasing and ageing population makes heart failure an important cause of morbidity and death worldwide. It is associated with high healthcare costs, partly driven by frequent hospital readmissions. Disease management interventions may help to manage people with heart failure in a more proactive, preventative way than drug therapy alone. This is the second update of a review published in 2005 and updated in 2012.
To compare the effects of different disease management interventions for heart failure (which are not purely educational in focus), with usual care, in terms of death, hospital readmissions, quality of life and cost-related outcomes.
We searched CENTRAL, MEDLINE, Embase and CINAHL for this review update on 9 January 2018 and two clinical trials registries on 4 July 2018. We applied no language restrictions.
We included randomised controlled trials (RCTs) with at least six months' follow-up, comparing disease management interventions to usual care for adults who had been admitted to hospital at least once with a diagnosis of heart failure. There were three main types of intervention: case management; clinic-based interventions; multidisciplinary interventions.
We used standard methodological procedures expected by Cochrane. Outcomes of interest were mortality due to heart failure, mortality due to any cause, hospital readmission for heart failure, hospital readmission for any cause, adverse effects, quality of life, costs and cost-effectiveness.
We found 22 new RCTs, so now include 47 RCTs (10,869 participants). Twenty-eight were case management interventions, seven were clinic-based models, nine were multidisciplinary interventions, and three could not be categorised as any of these. The included studies were predominantly in an older population, with most studies reporting a mean age of between 67 and 80 years. Seven RCTs were in upper-middle-income countries, the rest were in high-income countries.Only two multidisciplinary-intervention RCTs reported mortality due to heart failure. Pooled analysis gave a risk ratio (RR) of 0.46 (95% confidence interval (CI) 0.23 to 0.95), but the very low-quality evidence means we are uncertain of the effect on mortality due to heart failure. Based on this limited evidence, the number needed to treat for an additional beneficial outcome (NNTB) is 12 (95% CI 9 to 126).Twenty-six case management RCTs reported all-cause mortality, with low-quality evidence indicating that these may reduce all-cause mortality (RR 0.78, 95% CI 0.68 to 0.90; NNTB 25, 95% CI 17 to 54). We pooled all seven clinic-based studies, with low-quality evidence suggesting they may make little to no difference to all-cause mortality. Pooled analysis of eight multidisciplinary studies gave moderate-quality evidence that these probably reduce all-cause mortality (RR 0.67, 95% CI 0.54 to 0.83; NNTB 17, 95% CI 12 to 32).We pooled data on heart failure readmissions from 12 case management studies. Moderate-quality evidence suggests that they probably reduce heart failure readmissions (RR 0.64, 95% CI 0.53 to 0.78; NNTB 8, 95% CI 6 to 13). We were able to pool only two clinic-based studies, and the moderate-quality evidence suggested that there is probably little or no difference in heart failure readmissions between clinic-based interventions and usual care (RR 1.01, 95% CI 0.87 to 1.18). Pooled analysis of five multidisciplinary interventions gave low-quality evidence that these may reduce the risk of heart failure readmissions (RR 0.68, 95% CI 0.50 to 0.92; NNTB 11, 95% CI 7 to 44).Meta-analysis of 14 RCTs gave moderate-quality evidence that case management probably slightly reduces all-cause readmissions (RR 0.92, 95% CI 0.83 to 1.01); a decrease from 491 to 451 in 1000 people (95% CI 407 to 495). Pooling four clinic-based RCTs gave low-quality and somewhat heterogeneous evidence that these may result in little or no difference in all-cause readmissions (RR 0.90, 95% CI 0.72 to 1.12). Low-quality evidence from five RCTs indicated that multidisciplinary interventions may slightly reduce all-cause readmissions (RR 0.85, 95% CI 0.71 to 1.01); a decrease from 450 to 383 in 1000 people (95% CI 320 to 455).Neither case management nor clinic-based intervention RCTs reported adverse effects. Two multidisciplinary interventions reported that no adverse events occurred. GRADE assessment of moderate quality suggested that there may be little or no difference in adverse effects between multidisciplinary interventions and usual care.Quality of life was generally poorly reported, with high attrition. Low-quality evidence means we are uncertain about the effect of case management and multidisciplinary interventions on quality of life. Four clinic-based studies reported quality of life but we could not pool them due to differences in reporting. Low-quality evidence indicates that clinic-based interventions may result in little or no difference in quality of life.Four case management programmes had cost-effectiveness analyses, and seven reported cost data. Low-quality evidence indicates that these may reduce costs and may be cost-effective. Two clinic-based studies reported cost savings. Low-quality evidence indicates that clinic-based interventions may reduce costs slightly. Low-quality data from one multidisciplinary intervention suggested this may be cost-effective from a societal perspective but less so from a health-services perspective.
AUTHORS' CONCLUSIONS: We found limited evidence for the effect of disease management programmes on mortality due to heart failure, with few studies reporting this outcome. Case management may reduce all-cause mortality, and multidisciplinary interventions probably also reduce all-cause mortality, but clinic-based interventions had little or no effect on all-cause mortality. Readmissions due to heart failure or any cause were probably reduced by case-management interventions. Clinic-based interventions probably make little or no difference to heart failure readmissions and may result in little or no difference in readmissions for any cause. Multidisciplinary interventions may reduce the risk of readmission for heart failure or for any cause. There was a lack of evidence for adverse effects, and conclusions on quality of life remain uncertain due to poor-quality data. Variations in study location and time of occurrence hamper attempts to review costs and cost-effectiveness.The potential to improve quality of life is an important consideration but remains poorly reported. Improved reporting in future trials would strengthen the evidence for this patient-relevant outcome.
尽管治疗方法有所进步,但人口增长和老龄化使得心力衰竭成为全球发病和死亡的重要原因。它与高昂的医疗费用相关,部分原因是频繁的住院再入院。疾病管理干预措施可能有助于以比单纯药物治疗更积极、更具预防性的方式管理心力衰竭患者。这是对2005年发表并于2012年更新的一篇综述的第二次更新。
比较不同的心力衰竭疾病管理干预措施(并非单纯聚焦于教育)与常规护理在死亡、住院再入院、生活质量和成本相关结局方面的效果。
我们于2018年1月9日检索了Cochrane系统评价数据库(CENTRAL)、医学期刊数据库(MEDLINE)、荷兰医学文摘数据库(Embase)和护理学与健康领域数据库(CINAHL)以进行本次综述更新,并于2018年7月4日检索了两个临床试验注册库。我们未设置语言限制。
我们纳入了至少随访六个月的随机对照试验(RCT),比较疾病管理干预措施与常规护理对至少因心力衰竭入院一次的成年患者的效果。主要有三种干预类型:病例管理;基于诊所的干预措施;多学科干预措施。
我们采用了Cochrane期望的标准方法程序。感兴趣的结局包括心力衰竭导致的死亡率、任何原因导致的死亡率、因心力衰竭再次住院、因任何原因再次住院、不良反应、生活质量、成本和成本效益。
我们发现了22项新的RCT,因此现在共纳入47项RCT(10,869名参与者)。其中28项是病例管理干预措施,7项是基于诊所的模式,9项是多学科干预措施,3项无法归类为上述任何一种。纳入的研究主要针对老年人群,大多数研究报告的平均年龄在67至80岁之间。7项RCT来自中高收入国家,其余来自高收入国家。只有两项多学科干预RCT报告了心力衰竭导致的死亡率。汇总分析得出风险比(RR)为0.46(95%置信区间(CI)0.23至0.95),但证据质量极低,这意味着我们不确定其对心力衰竭导致的死亡率的影响。基于这一有限证据,为获得额外有益结局所需治疗的人数(NNTB)为12(95%CI 9至126)。26项病例管理RCT报告了全因死亡率,低质量证据表明这些措施可能降低全因死亡率(RR 0.78,95%CI 0.68至0.90;NNTB 25,95%CI 17至54)。我们汇总了所有7项基于诊所的研究,低质量证据表明它们对全因死亡率可能几乎没有影响。对8项多学科研究的汇总分析给出了中等质量证据,表明这些措施可能降低全因死亡率(RR 0.67,95%CI 0.54至0.83;NNTB 17,95%CI 12至32)。我们汇总了12项病例管理研究中关于心力衰竭再入院的数据。中等质量证据表明它们可能降低心力衰竭再入院率(RR 0.64,95%CI 0.53至0.78;NNTB 8,95%CI 6至13)。我们只能汇总两项基于诊所的研究,中等质量证据表明基于诊所的干预措施与常规护理在心力衰竭再入院方面可能几乎没有差异(RR 1.01,95%CI 0.87至1.18)。对5项多学科干预措施的汇总分析给出了低质量证据,表明这些措施可能降低心力衰竭再入院风险(RR 0.68,95%CI 0.50至0.92;NNTB 11,95%CI 7至44)。对14项RCT的荟萃分析给出了中等质量证据,表明病例管理可能略微降低全因再入院率(RR 0.92,95%CI 0.83至1.01);每1000人中从491例降至451例(95%CI 407至495)。汇总4项基于诊所的RCT给出了低质量且有些异质性的证据,表明这些措施在全因再入院方面可能几乎没有差异(RR 0.90,95%CI 0.72至1.12)。来自5项RCT的低质量证据表明多学科干预措施可能略微降低全因再入院率(RR 0.85,95%CI 0.71至1.01);每1000人中从450例降至383例(95%CI 320至455)。病例管理和基于诊所的干预RCT均未报告不良反应。两项多学科干预措施报告未发生不良事件。中等质量的GRADE评估表明多学科干预措施与常规护理在不良反应方面可能几乎没有差异。生活质量报告普遍较差,失访率高。低质量证据意味着我们不确定病例管理和多学科干预措施对生活质量的影响。4项基于诊所的研究报告了生活质量,但由于报告方式不同,我们无法进行汇总。低质量证据表明基于诊所的干预措施在生活质量方面可能几乎没有差异。4个病例管理项目进行了成本效益分析,7个报告了成本数据。低质量证据表明这些措施可能降低成本且可能具有成本效益。两项基于诊所的研究报告了成本节约情况。低质量证据表明基于诊所的干预措施可能略微降低成本。来自一项多学科干预措施的低质量数据表明,从社会角度看这可能具有成本效益,但从卫生服务角度看则不然。
我们发现关于疾病管理项目对心力衰竭导致的死亡率的影响的证据有限,很少有研究报告这一结局。病例管理可能降低全因死亡率,多学科干预措施可能也降低全因死亡率,但基于诊所的干预措施对全因死亡率几乎没有影响。病例管理干预措施可能降低因心力衰竭或任何原因导致的再入院率。基于诊所的干预措施可能对心力衰竭再入院几乎没有影响,并且对任何原因导致的再入院可能也几乎没有差异。多学科干预措施可能降低因心力衰竭或任何原因导致的再入院风险。缺乏关于不良反应的证据,由于数据质量差,关于生活质量的结论仍不确定。研究地点和发生时间的差异妨碍了对成本和成本效益的综述尝试。改善生活质量的潜力是一个重要考虑因素,但报告仍然很差。未来试验中改进报告将加强这一与患者相关结局的证据。