What Is the Strength of Evidence for Heart Failure Disease-Management Programs?

Abstract

Heart failure (HF) disease-management programs are increasingly common. However, some large and recent trials of programs have not reported positive findings. There have also been parallel recent advances in reporting standards and theory around complex nonpharmacological interventions. These developments compel reconsideration in this Viewpoint of how research into HF-management programs should be evaluated, the quality, specificity, and usefulness of this evidence, and the recommendations for future research. Addressing the main determinants of intervention effectiveness by using the PICO (Patient, Intervention, Comparison, and Outcome) approach and the recent CONSORT (Consolidated Standards of Reporting Trials) statement on nonpharmacological trials, we will argue that in both current trials and meta-analyses, interventions and comparisons are not sufficiently well described; that complex programs have been excessively oversimplified; and that potentially salient differences in programs, populations, and settings are not incorporated into analyses. In preference to more general meta-analyses of programs, adequate descriptions are first needed of populations, interventions, comparisons, and outcomes in past and future trials. This could be achieved via a systematic survey of study authors based on the CONSORT statement. These more detailed data on studies should be incorporated into future meta-analyses of comparable trials and used with other techniques such as patient-based outcomes data and meta-regression. Although trials and meta-analyses continue to have potential to generate useful evidence, a more specific evidence base is needed to support the development of effective programs for different populations and settings.

Health-related quality of life determinants in outpatients with heart failure

“…Although samples used in other studies from the USA (8,25) and Spain (20) showed similar characteristics, most of the samples have considerably higher socio-economic and educational levels. In the future, we propose including this kind of population in a new study in order to improve our knowledge about that population's health.…”

“…Given the importance of HRQOL to patients, the adaptation of disease management interventions to support effective self-care of HF in Brazil is a priority (16)(17)24) . Programs to support self-care should include both patients and partners and examine ways to ensure that the many facets of these interventions are accessible and beneficial to patients with very low socioeconomic and educational levels (9,(24)(25) .…”

Applying Meta-Theory to Qualitative and Mixed-Methods Research

“…Meta-theories such as positivism struggle to subsume such demonstrable inconsistencies-and usually attribute the wide variability in findings to issues around method-notably intervention fidelity, study differences in populations, outcomes, and comparison groups (Clark et al, 2009). Seldom is ontology invoked.…”

Significance of education and self-management support for patients with chronic heart failure in family physician practice

“…From these earlier studies, major factors that may affect living with CHF and self-care include lack of knowledge, inadequate communication with providers, loss of social support, multiple co-morbidities, medication issues, physical limitations, loss of control, loss of meaningful activities, fear of getting worse, daily uncertainty, helplessness and the emotional impact of illness [13,14].…”