Abstract
BackgroundHeart failure (HF) is a complex chronic condition, leading to frequent hospitalization, decreased quality of life, and increased mortality. Current guidelines recommend that multidisciplinary care be provided in specialized HF clinics. A number of studies have demonstrated the effectiveness of these clinics; however, there is a wide range in the services provided across different clinics. This network meta-analysis will aim to identify the aspects of HF clinic care that are associated with the best outcomes: a reduction in mortality, hospitalization, and visits to emergency department (ED) and improvements to quality of life.MethodsRelevant electronic databases will be systematically searched to identify eligible studies. Controlled trials and observational cohort studies of adult (≥ 18 years of age) patients will be eligible for inclusion if they evaluate at least one component of guideline-based HF clinic care and report all-cause or HF-related mortality, hospitalizations, or ED visits or health-related quality of life assessed after a minimum follow-up of 30 days. Both controlled trials and observational studies will be included to allow us to compare the efficacy of the interventions in an ideal context versus their effectiveness in the real world. Two reviewers will independently perform both title and abstract full-text screenings and data abstraction. Study quality will be assessed through a modified Cochrane risk of bias tool for randomized controlled trials (RCTs) or the ROBINS-I tool for observational studies. The strength of evidence will be assessed using a modified Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system. Network meta-analysis methods will be applied to synthesize the evidence across included studies. To contrast findings between study designs, data from RCTs will be analyzed separately from non-randomized controlled trials and cohort studies. We will estimate both the probability that a particular component of care is the most effective and treatment effects for specified combinations of care.DiscussionTo our knowledge, this will be the first study to evaluate the comparative effectiveness of the different components of care offered in HF clinics. The findings from this systematic review will provide valuable insight about which components of HF clinic care are associated with improved outcomes, potentially informing clinical guidelines as well as the design of future care interventions in dedicated HF clinics.Systematic review registrationPROSPERO CRD42017058003
Highlights
Heart failure (HF) is a complex chronic condition associated with a high rate of comorbidity, significant impairment of quality of life, frequent hospitalization, progressive disability, and reduced survival [1,2,3]
(2019) 8:40 (Continued from previous page). To our knowledge, this will be the first study to evaluate the comparative effectiveness of the different components of care offered in HF clinics
The findings from this systematic review will provide valuable insight about which components of HF clinic care are associated with improved outcomes, potentially informing clinical guidelines as well as the design of future care interventions in dedicated HF clinics
Summary
This systematic review will be designed based on the Cochrane review methods [25] and will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [26]. Study designs This systematic review will include both randomized and non-randomized controlled trials and observational cohort studies evaluating at least one component, or any combination, of multidisciplinary HF clinic care with a defined intervention [18, 30,31,32]. In an approach similar to previous work evaluating the effectiveness of different components of psychological care for coronary heart disease [46], four increasingly complex models of the effects of the core components of HF clinic care will be fit for each outcome: Risk of bias and quality assessment We will use the modified Cochrane risk of bias tool [34] to assess the risk of bias in each included randomized controlled trial (RCT) in the following domains: random sequence generation, allocation concealment, blinding of outcome assessment, incomplete outcome data, and selective reporting. Sensitivity analyses including and excluding low-quality studies will be conducted to assess the effect of study quality on our findings
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