Heart failure disease management programmes show inconsistent benefits across trials, with 40% of negative findings being spun into affirmative results rather than used to understand complexity.
Heart failure disease management programmes were developed from the mid-1990s to improve outcomes via education, support, and optimization of medicine regimens. Programmes were mostly targeted to patients after a previous hospitalization for heart failure. Support was often provided from various types of interdisciplinary teams via combinations of hospital-based clinics, home-based services, and telephone or remote electronic support providing a range of different content. From the start, evidence of the positive effects of programmes was encouraging. The earliest trial1 reported a 56% decrease in hospital admission after 90 days. Since then, more than 40 trials of different kinds of heart failure disease management programmes and more than 15 meta-analyses have been published. These systematic reviews identified that programmes improved all-cause re-hospitalization (9/11 reviews), heart failure-related hospitalization (8/9 reviews), and all-cause mortality (6/12 reviews). Accordingly, with seemingly strong and consistent evidence, international support for programmes has grown rapidly. Clinical guidelines recommend that providers make programmes available widely.2 However, several large and good quality recent trials have found only small or no benefits from programmes.3,4 From the Netherlands, one of the largest trials to date— COACH5—identified no differences over usual care from either a home-visit heart failure disease management programme in low intensity (4 visits) or high intensity (20 visits) forms. A very large Medicare-funded trial6 of nine programmes for patients with heart failure and diabetes across the USA (n = 30 000) found no benefits for hospitalization, mortality, patient satisfaction, care experience, self-care or mental/physical functioning, and costs far exceeded benefits. These findings should not be used to reduce support for programmes but do raise important questions about why programme outcomes vary.3,4 First, trial results are likely to be somewhat inconsistent because individual trials tend to be underpowered. That said, some of the larger trials are those with negative findings. Inconsistent effects from programmes can be attributed to positive elements of trial design such as atypically good usual care in comparison groups rather than biases, reporting inadequacies, or actual differences in programme effect size.7 Attribution to positive factors is reasonable but risks bias via the selective interpretation of negative results. This tendency is not uncommon: a recent systematic review of trials with negative results8 found that in 40% of cases, negative findings are ‘spun’ into affirmative results. To avoid bias, instead of downplaying or dismissing the significance of variations in findings, these should be acknowledged and explanations sought.9 Complexity should rather be incorporated into the questions posed about programmes. Instead of seeking a definitive ‘type’(s) of programme, research should examine how different types of programmes affect outcomes in different settings22 and the influence of the values and behaviours of providers and patients. This search for ‘what programme works for whom, when and why’ is an important and constructive new direction in chronic disease interventions.22 Negative findings are as useful as positive ones for developing evidence on how programmes work or do not work for people in different settings, to facilitate changes in outcomes.22 Programmes are not seen as ‘failing’ if they are not found to be beneficial but are viewed as important sources for learning about what influences programme outcomes. By better addressing the complexity of programmes, knowledge will increase about why programme outcomes vary and which programme designs are most suitable for different settings. This more nuanced evidence base is more useful because evidence that is most likely to be used by health decision-makers is that which contains comprehensive details of programme design characteristics, but also matches recommendations to particular settings, populations, and resources.34 Improved support for programmes is likely to increase when research takes more account of the influence of settings and is then more useful to decision-makers.34 This movement towards complexity is not then threatening to the future of programmes—on the contrary—it will improve the quality and usefulness of evidence and lead to more widespread utilization of programmes. A.M.C. receives career award support from Alberta Heritage Foundation for Medical Research and the Canadian Institutes for Health Research. Conflict of interest: none declared.
Clark et al. (Fri,) conducted a editorial in Heart failure. Heart failure disease management programmes was evaluated. Heart failure disease management programmes show inconsistent benefits across trials, with 40% of negative findings being spun into affirmative results rather than used to understand complexity.