QJM Advance Access originally published online on January 17, 2005
QJM 2005 98(2):127-138; doi:10.1093/qjmed/hci019
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QJM vol. 98 no. 2 © Association of Physicians 2005; all rights reserved.
Factors influencing medical treatment of heart failure patients in Spanish internal medicine departments: a national survey
From the Departments of Internal Medicine, 1Requena General Hospital, Valencia, 2Gregorio Marañon Hospital, Madrid, 3Costa del Sol Foundation Hospital, Málaga, 4Son Dureta Hospital, Palma de Mallorca, and 5Reina Sofía Hospital, Córdoba, Spain
Received 22 June 2004 and in revised form 2 November 2004
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Summary |
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Background: The medical management of heart failure (HF) in clinical practice varies considerably by country and by medical specialty.
Aim: To assess the treatment of HF patients admitted to Internal Medicine departments, and to evaluate out-patient management prior to admission, by specialty.
Design: Prospective cross-sectional multi-centre survey.
Methods: Of 55 randomly selected Spanish hospitals, 51 agreed to participate. All patients (n = 2145) consecutively admitted for decompensated HF to the Departments of Internal Medicine of these hospitals, over 5 months, were included. Twenty variables were analysed, including aspects relating to out-patient management prior to admission.
Results: Mean ± SD age was 77.2 ± 10.5 years, 57.3% were female, 47% had systolic dysfunction. Prescriptions at discharge: loop diuretics 85.6%, spironolactone 29.8%, ACEIs 65.8%, beta-blockers 8.7%, cardiac glycosides 39%. At admission, 86% already had a diagnosis of HF. Of these, 53% (older patients and more women) were being treated on an out-patient basis by primary care physicians. Primary care physicians requested fewer echocardiograms than internists (38% vs. 69%, p<0.001) and prescribed fewer drugs (ACEIs 40% vs. 54%, p<0.001; spironolactone 15% vs. 23%, p<0.05; beta-blockers 6% vs. 13%, p<0.01). The internists treated more incapacitated patients than the cardiologists (p<0.001), prescribed more high-dose ACEIs (20% vs. 13%, p<0.01) and spironolactone (26% vs. 20%, p<0.05), and fewer anticoagulants (32% vs. 39%, p<0.05).
Discussion: Patients admitted to medical departments with HF are different to those found in clinical trials. Their management is currently suboptimal. Differences in treatment between internists and cardiologists appear to be accounted for by differences in the patients they treat.
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Introduction |
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Heart failure (HF) is a syndrome that represents the ultimate clinical outcome of cardiac disorders in general, and has a mortality as high as that associated with cancer: 50–60% at 5 years after diagnosis.1 In Europe, the estimated prevalence of HF is 0.4–2%, and the incidence increases with age, reaching over 30 cases/1000 individuals/year in the population >75 years of age. HF is responsible for a large number of prolonged and recurrent hospitalizations, representing 1–2% of global health care costs.2–4
In the last 20 years, new drugs have been developed that have drastically affected treatment of the disease. Angiotensin-converting-enzyme inhibitors (ACEIs), increase patient survival, reduce the number of hospitalizations, and improve the functional class and quality of life of patients, compared to treatment with the classical drugs (diuretics and digitalis).5 Beta-blockers (BBs) afford important additional benefit for patients who have already been treated with diuretics, digoxin and ACEIs, with a reduction in mortality of 
30–35%.6 A study has also shown that spironolactone affords further improvement in New York Heart Association (NYHA) functional class III or IV patients treated with all the above-mentioned drugs.7
However, many clinical studies conducted in different countries have shown the prescription of all these drugs to be low, and the doses administered are moreover insufficient,8–15 despite the diffusion of clinical practice guidelines,16–20 thereby denying patients demonstrated benefits that improve both survival and quality of life.
Most patients diagnosed with HF are elderly, and present with important associated disorders.21–23 As a result, many of them are treated by primary care physicians on an out-patient basis, and by internists when admitted to hospital. In recent years, a series of studies has revealed differences in the management of HF in-patients that depend on the specialty of the physician in charge of treatment.24–29
This study is part of a larger multicentre project conducted in the Internal Medicine Departments of hospitals throughout Spain,30 with the purpose of determining the clinical and management approaches adopted by Spanish internists in caring for their patients with HF. As such, it constitutes the first study of this kind in Spain. Its objectives were: (i) to determine adhesion on the part of Spanish internists to the clinical practice guidelines for HF in patients admitted to their departments with this diagnosis; and (ii) to investigate whether differences exist in the out-patient management provided, prior to admission, by different specialists (primary care physicians, internists or cardiologists) among patients previously diagnosed with HF who are admitted to a Department of Internal Medicine.
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Methods |
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This was a prospective cross-sectional multi-centre study. A 55 acute patient hospitals were selected through randomized sampling stratified by centre size (<250 beds; 200–500; 500–1000; and >1000 beds) and the number of hospitals found in each region of the country, based on data from the Spanish Ministry of Health.31 In Spain, health care is divided into areas. Each area possesses primary care centres, with a number of patients assigned to each primary care physician, and a community hospital for the admission of all patients belonging to the area and the provision of specialized out-patient care. Moreover, there are high-technology hospitals that serve as reference centres for the community hospitals belonging to several areas. This organization allows identification of the primary care or specialized physician assigned to each patient, with access to the case history.
Our study included all patients consecutively admitted to the Department of Internal Medicine with a principal or secondary diagnosis of HF at discharge (based on Internal Classification of Diseases ICD-9-CM coding 428.0, 428.1, 428.9, 402.01, 402.11, 402.91, 404.01, 404.11, 404.91), and assigned exclusively to the care of internists.
All included patients were required to meet (all) the Framingham criteria for the diagnosis of HF,32 and to give their consent to participate. Patients for whom rigorous collection of pre-admission data was not possible, or who were referred from one physician specialty to other during this period, were excluded. The inclusion period lasted 5 months, from 1 October 2000 to 28 February 2001. The investigators (an internist assigned in each hospital) collected the hospitalization data from the clinical record and a direct patient interview if necessary, while the pre-admission information was obtained by telephone interview of the patient personal physician, written reports from the latter, or the out-patient clinical records.
The data were introduced in a database developed by the Heart Failure Working Group of the Spanish Society of Internal Medicine through prior consensus. The variables considered in the present substudy were: patient age; sex; marital status; social support (living alone, with the family or in a home for the elderly); cultural level (illiterate, primary, middle and higher education); physical incapacitation according to the Red Cross scale validated for elderly Spanish people33,34 (0, capable of self-care; 1, walks with difficulty; 2, needs help, walks with a cane; 3, occasional incontinence; 4, dependent on others for daily life activities, with incontinence; 5, immobile in bed); mental incapacitation assessed by the Red Cross scale validated for elderly Spanish people35 (0, normal; 1, mild memory impairment with normal conversation; 2, moderate memory impairment, with mild character and orientation alterations; 3, severe memory and orientation impairment, with behavioural disorders; 4, complete disorientation, dementia; 5, advanced dementia, vegetative state); associated diseases or factors (arterial hypertension, diabetes mellitus, obesity, chronic pulmonary disease, chronic renal failure, chronic liver disease, chronic neurological disease, hypercholesterolaemia, smoking, alcohol abuse) with previously defined criteria for each; stable phase NYHA functional class; HF aetiology according to attending physician criterion (arterial hypertension, ischaemic heart disease, valve pathology, idiopathic dilated, restrictive or toxic myocardiopathy); aetiology (established or undetermined before and during admission), based on attending physician criterion; echocardiography (performed or not, before and during admission); left ventricular ejection fraction (EF) (>45%, 45–30%, <30%); specialty of the physician supervising HF out-patient management if the patient had been diagnosed with HF before study admission (family physician, internist or cardiologist); the number of months elapsed from the diagnosis of HF; pharmacological treatment prescribed by the supervising physician before study admission of the patient (diuretics, ACEIs at appropriate doses (defined as those shown to reduce mortality in clinical trials: captopril 150–300 mg/day, enalapril 20–40 mg/day, lisinopril 30–35 mg/day, ramipril 10 mg/day, trandolapril 4 mg/day) or low doses (when such doses are not reached), BB, spironolactone, digitalis, angiotensin receptor antagonists (ARA II), amiodarone, nitrates, anticoagulants and amlodipine); pharmacological treatment prescribed at discharge; non-pharmacological treatment indicated at discharge (diet, exercise, avoidance of tobacco or alcohol, prevention of infections); existence of potential contraindications to ACEIs (renal failure (creatinine >3 mg/dl), arterial hypotension, serum potassium >5 mEq/l, bilateral renal arterial stenosis, intolerance or adverse reactions); total number of drugs prescribed per patient, including those indicated for other diseases; number of previous admissions in the last year due to HF; code and size of the hospital.
SPSS version 8.0 was used to analyse the results. Continuous variables, expressed as the mean and SD, were compared with the Student t-test for independent samples, while the categorical, expressed as percentages, were compared using the 
2 test. When the samples were related (treatment prior admission and at discharge) the McNemar type test was used. The relations between continuous and categorical variables were in turn analysed with the Pearson correlation (r) and Spearman test (rho). Logistic regression multivariate analyses were also carried out for each of the drugs prescribed at discharge as dependent variable. Independent variables associated to dependent variable with p<0.15 in the univariate analysis were incorporated a forward stepwise multivariate analysis. Previously, an evaluation was made of the existence of confounding or interactive effects between independents variables and their possible colinearity. The Pearson correlation test was used to study the association between continuous parameters, with the Spearman ordinal correlation test for analysing colinearity between categorical variables. Among all the variables presenting r or rho >0.4 the parameter presenting the greatest significance in the prior univariate analysis was selected.
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Results |
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Fifty-five hospitals were selected. Four of them refused to participate. Thus, the study was carried out in 51 hospitals (39% with <250 beds; 21% with 250–500 beds; 22% with 500–1000 beds; and 18% with >1000 beds), representative of the centres found in Spain.
A total of 2145 patients were included in the study (mean age 77.2 ± 10.5 years, with a 57.3% predominance of women). Most patients presented a basal NYHA functional class of II or III, and the most common cause of heart disease was arterial hypertension. Echocardiography was performed in 75% of the patients, ejection fraction being preserved in 53% of cases. Forty-five percent had undergone at least one hospital admission in the previous year.30 A total of 1848 patients (86%) had been diagnosed with HF before actual study admission. Six percent of patients (n = 127) died during hospitalization.
Management of hospitalized patients
Table 1 shows the differences between the medication used by the patients prior to admission and those prescribed at discharge, according to the stable-phase NYHA functional class. The percentage of patients receiving diuretics upon admission was directly proportional to the functional class (except with regard to class IV), and increased significantly at discharge in all cases (except class IV, in which practically no percentage change was observed). This greater HF severity patient group was not significantly older than the rest, and did not present more associated disorders or polymedication. Patients with previously undiagnosed HF (n = 297) had received diuretics (85%) and ACEIs (22%) prior to admission.
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The reasons for contraindicating ACEIs administration were: hypotension in 3.1% of patients, hyperkalaemia in 1.6%, renal failure in 3.6%, and bilateral renal arterial stenosis in 0.2%. These patients were excluded from the study.
Digitalis and anticoagulant use increased significantly in functional classes I and II, related to the existence of atrial fibrillation and valve disease (rho = 0.487, p<0.0001 and rho = 0.339, p<0.0001, respectively). Nitrate prescription likewise increased in correlation to ischaemic heart disease (rho = 0.434, p<0.0001).
Over half of the subjects had a preserved EF. Most were women (68%). Seventy-two percent presented with hypertension and/or diabetes (33%); 15% had supraventricular tachyarrhythmias, and 9% valve disease.
Prior to hospital admission, echocardiography was performed in 994 patients. The patients known to have a reduced ejection fraction (<45%) received more diuretics (p<0.005), spironolactone (p<0.0001), low dose ACEIs (p<0.0001), digoxin (p<0.0001) and nitrates (p<0.0001) than those with a normal ejection fraction. At discharge, 1543 patients had a echocardiogram (Table 2). Those with a reduced ejection fraction received significantly more spironolactone (p<0.01), ACEIs (p<0.0001) and nitrates (p<0.005). Digoxin, nitrates and anticoagulants were increased at discharge compared to admission in all patients, particularly among those with a normal ejection fraction.
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Patients aged >80 years were discriminated against regarding drug prescription at discharge (Table 3). They received comparatively fewer drugs in general, with the exceptions of diuretics, digoxin and nitrate. Significantly, only a small proportion of the oldest patients were given anticoagulants, this group presenting a higher prevalence of atrial fibrillation than the younger patients (49% vs. 46% in the 65–80 years age group, and 35% in those aged <65 years). On average, patients aged >80 received fewer drugs at discharge than patients in the 65–80 years and <65 years age groups (2.9 ± 1.4 vs. 3.3 ± 1.5 and 3.4 ± 1.5, respectively), had fewer associated diseases (2.1 ± 1.1 vs. 2.7 ± 1.4 and 2.7 ± 1.5), and had comparatively greater physical (1.8 ± 0.9 vs. 1.2 ± 0.4 and 1.1 ± 0.6) and mental (1.1 ± 0.6 vs. 0.8 ± 0.5 and 0.4 ± 0.3) incapacitation. Mortality was greater (8.6% vs. 5% and 1.8%), while no differences were recorded in either functional class or ejection fraction.
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Table 4 shows the variables that, as independent predictors, influenced prescription of each of the different drugs at discharge, following multivariate analysis involving all the factors shown to exhibit significance by univariate analysis. The prescription of diuretics and spironolactone were only influenced by their prescription prior to admission; ACEIs by the ejection fraction depressed; BB by ischaemic heart disease and, in the negative sense, by the severity of the NYHA functional class; anticoagulants by atrial fibrillation and, in the negative sense, by age >75 years and the severity of NYHA functional class. Two small hospitals showed significantly better adhesion to practice guidelines in the univariate analysis, but this difference disappeared on multivariate analysis.
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The non-pharmacological recommendations comprised dietary measures in 78% of the global patient series, avoidance of smoking in 51% of the smokers (10% of the total patient series) and of alcohol consumption in 50% of the alcoholics (4% of the total patients), physical exercise in 19%, and the prevention of infection in 16%.
Characteristics and management of out-patients according to physician specialty
The majority of patients (86%) had been diagnosed with HF before study admission, and were in the care of a physician (primary care 53%, cardiologists 29%, internists 17%), with a mean follow-up of 9.3 ± 2.1 months. The patients managed by primary-care physicians prior to admission were older, with a greater proportion of women, and had undergone fewer echocardiographic studies than the patients treated by cardiologists and internists. Moreover, the cause underlying HF was comparatively less often known in the primary care setting. Patients cared for by primary care physicians and internists had greater physical and mental incapacitation than those seen by cardiologists (Tables 5 and 6).
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There were no differences in the number of associated diseases among the three medical specialties, primary physicians caring for patients with an average of 2.5 ± 1.3 pathologies vs. 2.7 ± 1.3 and 2.4 ± 1.4 for internists and cardiologists, respectively).
Table 7 shows the treatments received by the patients prior to admission to the Internal Medicine departments. The internists advised a greater percentage of diuretics, spironolactone and ACEIs at appropriate doses than the cardiologists, while both professional categories prescribed significantly more of these drugs than the primary care physicians.
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While beta-blockers were little-prescribed by all three professional groups, they were administered more often by the internists and cardiologists, no differences being observed between the two. Patient age was inversely correlated to BB use. Accordingly, 15.2% of the patients aged <65 years received these drugs, vs. 9.8% of those aged 65–80 years, and 5.3% of those aged >80 years (p<0.01 among the three groups).
Anticoagulants were prescribed more often by cardiologists than by internists, and both specialty groups prescribed them more frequently than the primary care physicians, the difference remained statistically significant after fitting for the presence of atrial fibrillation or valve disease.
The mean overall number of drugs prescribed showed no significant differences among the three professional categories (primary care 5.3 ± 2.7, internal medicine 6.2 ± 2.1, and cardiology 6.1 ± 2.7).
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Discussion |
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The present study is the first multicentre, nationwide survey of the Spanish HF population admitted to Internal Medicine departments, and shows that drug prescription practice improved significantly during admission, although remaining far from levels advised in clinical practice guidelines. Globally, 85.6% of patients were receiving loop diuretics at discharge, while 68% were using ACEIs (30% at appropriate dosage), 29.8% spironolactone, 39% digitalis and 8.7% beta-blockers.
On analysing the out-patient management of the disease by cardiologists, internists and primary care physicians in relation to patients diagnosed with HF before the actual study admission, no clinically relevant differences were seen between cardiologists and internists, whose patients presented similar clinical characteristics. In comparison, the patients treated by primary care physicians were older, with increased incapacitation, a lesser percentage of echocardiographic studies, and fewer of the drugs recommended by clinical guidelines, compared with the patients treated by cardiologists or internists.
Internist management of hospitalized patients
As in most studies, we may have overestimated the diagnosis of HF, since echocardiography was only performed in 75% of the patients, and no data concerning diastolic dysfunction were required of those cases with a preserved ejection fraction. Although the Framingham criteria32 are not validated for use in clinical practice, they were selected for our study with the purpose of minimizing diagnostic error and avoiding the bias associated with the selection of patients with echocardiographic criteria of HF.
The situation in our survey was better than average as regards ACEI prescription, compared with the results of the Euroheart study36 (68% vs. 56.4% of the patients admitted to general medical departments) and in terms of the use of spironolactone (29.8% vs. 23.6%), but much worse in relation to beta-blockers (8.7% vs. 26.3%).
Under multivariate analysis, ACEIs prescription depended chiefly on reduced ejection fraction, with no influence from factors such as male sex, younger patient age or ischaemic heart disease. This is in contrast to the Euroheart study or an extensive review of 37 articles documenting ACEI use in patients with HF,37 where preserved systolic function did not significantly influence ACEIs prescription, in the absence of evidence suggesting that it reduces morbidity and mortality in diastolic HF.
Patient age constitutes an influencing factor in relation to lesser drug prescription in all studies, as a result of the greater comorbidity and polypharmaceutical regimens found in older patients.38,39 However, in our study the oldest patients (>80 years) did not suffer more diseases or receive more drugs for other pathologies, although they presented greater physical and mental incapacitation, and also greater mortality. In our study these patients were likewise undertreated, compared to those aged >80, except for diuretics, low-dose ACEIs, nitrates and digitalis.
The statistics regarding the use of beta-blockers in Spain are the lowest in Europe.36 A number of years have passed since they were first included in the clinical guidelines for all HF functional classes. Spironolactone has only shown its beneficial effects in a more recent study, and in patients administered ACEIs and beta-blockers, NYHA III or IV. Nevertheless, it is much more widely used than beta-blockers, at least in our setting. The side-effects attributed to beta-blockers are no greater than those associated with spironolactone. The fact that for many years beta-blockers were contraindicated for HF, and that spironolactone was commonly used a few decades ago to enhance the action of loop diuretics, may have influenced this situation. In fact, it is used in asymptomatic patients in stable condition, where it may not yet be of benefit. It is also possible that the need for careful beta-blocker titration conditions an excessive health care burden which negatively influences the decision to use these drugs, when considering that most patients managed for HF are not comparable to those patients included in clinical trials. A recent study shows that of the 100 patients eligible to commence carvedilol therapy at a district general hospital setting, 16% had contra-indications to initiate the therapy, 11.5% failed the first dose and only 6.6% achieved ‘target dose’.40
Non-pharmacological measures were seldom recommended in our study, agreeing with the few studies published to date on this basic part of HF therapy.41 In fact, none of the previously mentioned studies of HF management considered this aspect of treatment. Although solid evidence of the efficacy of such measures is lacking, the data reflected in the literature, and also generalized professional opinion, suffice to consider them an important cause of patient decompensation, readmission and progressive clinical deterioration.
Characteristics and management of out-patients according to physician specialty
Several studies have examined differences in management of out-patients with HF between cardiologists and primary care physicians, 42,43 showing that their management differed, but that the case-mix also varied. Limited data exist about the differences among general practitioners, internists and cardiologists,44,45 all based on self-reported practices without the analysis of demographic and clinical characteristics of patients. To our knowledge, no study has yet compared the management of patients by cardiologists and internists in the out-hospital setting when the patient clinical profile is similar. Our study has a series of limitations. Firstly, the data were retrospectively collected, though the information came from the physicians or clinical records. Secondly, a clear patient selection bias exists, since only those admitted to Internal Medicine were analysed. Nevertheless, this bias offers the advantage of studying the population of patients who are typically admitted to medical departments throughout the world,31 thus minimizing confusion on analysing the different treatments provided by the specialists. On the other hand, we do not know anything about the patients who were not admitted, and it is possible that the patients who require admission are treated sub-optimally irrespective of who is treating them. Lastly, the diagnosis of HF prior to the actual study admission may be erroneous, since it is based on physician opinion. However, this is also an important limitation in most other studies, due to the lack of diagnostic criteria for the syndrome.
Our results show that when the subgroup of patients, who due to their clinical profile are usually treated in internal medicine departments, are managed on an out-patient basis prior to admission, few relevant differences in management of the syndrome are observed between the two medical specialties. Internists see patients with greater physical and mental incapacitation, a greater percentage of hospital admissions, and a greater number of cases in which arterial hypertension is the underlying cause. In comparison, cardiologists tend to see more cases in whom ischaemic heart disease is the cause of HF. No differences are recorded in the number of echocardiographic studies made or in the drugs administered, with the exception that internists are more inclined to prescribe high dose ACEIs (probably as a result of the greater prevalence of hypertension in their setting) and fewer anticoagulants (probably due to the greater incapacitation of the patients seen by internists).
Our study also confirms that more than half of Spanish patients with HF are managed by primary care physicians on an out-patient basis, and that this professional group adheres even less to the established clinical guidelines than do the specialists, great variability having been described in this respect among different countries.47,48 The reasons for these differences are not clear. On one hand, they may be due to a different patient clinical profile. In this context, the present study shows that patients followed-up on by primary care physicians differ from those managed by specialists, with a greater presence of women, more advanced patient age, greater physical and mental incapacitation, and a larger proportion of neurological disorders that complicate mobility. A second consideration is the existence of a lack of confidence in the firm diagnosis of HF common to all the professionals, but stronger in the case of primary care where there is less access to complementary explorations (especially echocardiography). This was the situation in our case, since echocardiography was only available for application in 38% of the patients. In effect, echocardiography poses accessibility problems, particularly for primary care physicians, and local factors also contribute to explaining the limited number of echocardiographic studies, such as the availability of cardiologists, the number of systems in operation, and the existence of waiting lists that lead to bias in patient selection. In this context, the more elderly and more ill patients, and cases involving increased dependency on others for daily life activities, tend to be relegated—a situation found in most countries.47,48 An increase in the availability of systems and the adoption of certain alternative approaches (such as the performance of echocardiographic studies by health care technicians) may help improve the situation. On the other hand, there seems to be less familiarity among primary care physicians with the relevant scientific evidence, which is widely perceived as constituting a complex and rapidly changing field,49,50 and more scepticism as to the usefulness of drugs in patients with normal systolic function, or their applicability to patients who are usually elderly and already seriously ill. No studies have evaluated the quality of life of these patients subjected to explorations and treatments that in theory will improve their prognosis, since they are presumed to be amenable to the same measures applied to patients enrolled in clinical trials, despite the fact that the latter have considerably different profiles. The urgent adoption of new multidisciplinary strategies seems indicated, with the adoption of new organizational and including the education and participation of both the patients and various health care professionals. Such measures are cost-effective and reduce hospital admissions,51 although no data are yet available regarding possible improvements in patient quality of life or mortality.
In conclusion, the management of patients with HF presenting with the typical indications for hospital admission in the event of decompensation is suboptimal in Spain, particularly as regards treatment with beta-blockers. Until results are obtained from clinical trials demonstrating the same benefit in patients of this type as in the patients found in current clinical trials, it is necessary to improve the application of available evidence in the form of multidisciplinary and imaginative treatment strategies.
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Footnotes |
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Address correspondence to Dr P. Román-Sánchez, Hospital General de Requena, Paraje Casablanca s/n, 46340 Valencia, Spain. e-mail: gilroman{at}terra.es
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References |
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