Appropriate Prescriptions Mean Better Outcomes: How Can We Improve Ourselves?

This article refers to ‘Physicians’ guideline adherence is associated with long-term heart failure mortality in outpatients with heart failure with reduced ejection fraction: the QUALIFY international registry' by M. Komajda et al., published in this issue on pages 921–929. For patients with heart failure (HF) and reduced ejection fraction (HFrEF), current international guidelines clearly and strongly recommend the prescription of a set of drugs and devices that have been well demonstrated by randomized clinical trials as able to improve patients' outcomes.1, 2 The adoption in clinical practice of these recommended treatments was probably one of the most important reasons for reduction in mortality of HF patients over the last couple of decades.3, 4 New studies that test additional or substitutive treatment strategies are obviously necessary (and some of these are actually ongoing), but programmes to increase the adherence of physicians to current guidelines seem to be also extremely important. These programmes are based on observations that level of adherence to recommended prescriptions is associated with mortality and morbidity reductions in HF patients.5-7 However, these observations are generally limited to the most traditional drugs (renin−angiotensin system blockers and β-adrenergic blockers), to western countries, to a relatively short-term period of follow-up or to not always taking into account the prescribed dosages of the drugs. In this issue of the Journal, the study by Komajda et al.8 overcomes some of these limitations as: (i) it was conducted in 36 countries over five continents with different economical levels and healthcare systems; (ii) it included patients of different ethnicities; (iii) it utilized an adherence score that took into account not only prescriptions but also dosages of all the recommended drugs (renin−angiotensin system blockers, β-adrenergic blockers, mineralocorticoid receptor antagonists and ivabradine); and (iv) it evaluated the patients' outcomes over a relatively long period of follow-up (18 months). In addition, statistical analysis, aimed to demonstrate independent association between adherence of prescriptions and patients' outcomes, should be considered to be particularly robust as the applied methodology appropriately considered the competing risk of death. Komajda et al.8 concluded that adherence is independently associated with a lower risk of death due to HF and of the combined outcome measure of HF hospitalizations or cardiovascular death. The weaknesses, in part acknowledged by the authors, are related to the young age of the patient population, surely not representative of patients with HF in real clinical practice, the suboptimal completeness of follow-up information, and also that there is no information on the reasons why recommended drugs were not prescribed or prescribed at low dosages. This kind of information could have modified the real rate of adherence of prescriptions to guidelines. This study reliably reinforces the concept that the widespread application in practice of the treatments, shown to be ‘life saving’ by well conducted and convincing randomized clinical trials and, for this reason, strongly recommended by current international guidelines, can modify the outcomes' profiles of patients with HFrEF. The question is: how to concretely improve the process of incorporation of the guideline recommendations into clinical practice, not only by HF specialists but also by general cardiologists and by internal medicine doctors and geriatricians, who very frequently have to deal with this kind of serious clinical condition? Publication and diffusion of guidelines is, of course, a mandatory process including the organization of ad hoc conventions of different health professionals describing and discussing these in detail. These strategies are necessary, but surely not sufficient, as demonstrated by the level of adherence to guidelines shown by observations of medical behaviours adopted in real-world practice.9, 10 Recently, different approaches to increase drug adherence, with the aim of improving outcomes of patients with chronic cardiovascular conditions, have been formally tested in randomized studies involving pharmacists and lay people (such as those working in barber shops). These new technologies with variable results almost never had hard endpoints as the primary objective of the study.11-13 This type of study should be encouraged and financially supported by public institutions or charities, because private funding from companies of drugs or devices is generally not easily obtained, as a specific therapeutic tool is not the object of the study. Even if clear evidence of a beneficial effect of an implementation strategy was demonstrated by a trial on hard endpoints, the application in practice could be very difficult due to different health structure characteristics, national healthcare systems or cultural-socio-economic conditions. In other words, it is difficult to apply a specific single recipe to any local context. Another strategy, probably more effective and easier to be implemented in a large setting of different local conditions, is initiatives similar to that applied in the USA, the ‘Get With The Guidelines’ programme,14 or that applied in Sweden, the ‘SWEDEHEART’ project.15 These systems of continuous data collection for quality improvement and research through on-line reporting of data carried out during regular health care of health professionals are focused on the processes of care and outcomes of common cardiovascular diseases, including HF, and related interventions. They have an established track records of quality improvement and high-impact research, as documented by different publications. The most important component of the success is the establishment of a culture of dedicated, non-selective, continuous registration of detailed patient and procedural characteristics and outcomes by ordinary healthcare personnel. The second most important component of these initiatives is a reliable, user-friendly informatics infrastructure. The Swedish example also adds the possibility to include in the system an application for prospective registry-based randomized clinical trials. These trials may be also combined with the conventional accumulation of complete follow-up information using the so-called administrative flows of data. In this context, it will be also possible to implement studies, based on data collection through electronic health records, on comparative evaluation of different approaches aimed to improve adherence to recommended treatments for chronic cardiovascular clinical conditions such as HF. The methodology of the ‘registry trials’ for this kind of evaluation might be the most efficient approach, reducing the complexity and the costs of these studies. The diffusion of these systems of continuous data collection, possibly in a large number of countries, seems to be one of the most efficient ways to narrow the gap between both guideline recommendations and appropriate prescriptions in daily clinical practice with the final goal to improve outcomes of patients with HF and, as a consequence, to reduce the socio-economic burden of this very serious clinical condition. A successful and concrete realization of such projects could be obtained just with the collaboration of different stakeholders, health professionals, patients and health authorities. The manuscript of Komajda et al.8 once more documented that drugs do not work if we do not prescribe them. Scientific associations of specialists, such as the European Society of Cardiology, could be the catalysts of initiatives aimed at more concretely incorporating their guidelines into clinical practice, providing the appropriate infrastructure with a common set of variables, with shared definitions, for the continuous collection of data useful to monitor (and benchmark) the most relevant recommendations of guidelines. Conflict of interest: A.P.M. has no conflict of interest to disclose with respect to the present manuscript. Outside the present work he received honoraria for participation in committees of studies sponsored by Bayer, Novartis and Fresenius.