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European Journal of Heart Failure 2005 7(5):768-779; doi:10.1016/j.ejheart.2005.01.018
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© 2005 European Society of Cardiology

The diagnosis of heart failure in European primary care: The IMPROVEMENT Programme survey of perception and practice

F.D. Richard Hobbs*, Jerzy Korewicki, John G.F. Cleland, Joanne Eastaugh, Nick Freemantle and on behalf of the IMPROVEMENT Investigators

Primary Care Clinical Sciences Building University of Birmingham, Birmingham B15 2TT, United Kingdom

* Corresponding author. E-mail address: f.d.r.hobbs{at}bham.ac.uk


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Objective: To examine European primary care physicians (PCPs) views on diagnosis of heart failure and compare perceptions with actual practice.

Design: Semi-structured PCP interviews and case note review on a random sample of heart failure patients.

Participants: 1363 primary care physicians from 14 countries and 11,062 patient notes.

Main outcome measures: Perceptions of PCPs compared to actual performance in heart failure (HF) diagnosis.

Results: Over 50% of patients with HF were above 70 years of age. Most subjects presented with typical clinical symptoms and objective signs of HF. In 50% of cases, HF was mainly diagnosed by PCPs. New York Heart Association classification was used by 50% of physicians. Electrocardiogram and chest X-ray were the most used diagnostic tests (90% and 84% respectively). PCPs considered echocardiography as having low diagnostic value, with only 48% routine usage. However, in actual practice echocardiography was used in 82% of diagnoses. Systolic dysfunction was observed in 51% HF subjects, but only 50% of physicians would differentiate systolic from diastolic heart failure.

Conclusions: There was low use of NYHA classification (which denotes symptom severity) and differentiation between systolic and diastolic causes (which determines treatment strategies).

Key Words: Heart failure • Diagnosis • Primary care • Survey

Received June 25, 2004; Revised October 29, 2004; Accepted January 27, 2005


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
Heart failure (HF) is a consequence of cardiac disease and/or changes in peripheral circulation, which results in pathological workload. Ischemic heart disease, either with or without hypertension as a comorbidity, is the most frequent cause of HF among patients in Europe. Heart failure is a common condition, with prevalence in the general population over the age of 45 of at least 2.3% [1]. The incidence of the condition is rising, [2], and is especially common in the elderly (15% of people over 85 suffer from heart failure) [1] and in at-risk groups [3]. Estimates suggest differences in etiology and frequency of HF between Western and Central Europe. The observed discrepancy in findings is likely due to greater prevalence of ischemic heart disease in Central and Eastern Europe compared with Western Hemisphere. The life expectancy in Western Europe is on the average 10 years longer, than in populations from Eastern and Central Europe [4–6]. Based on the epidemiological data, it is assumed that there are 20 million people in Europe (within its geographic limits) suffering from heart failure [7–10]. Increases in heart failure prevalence appear to be driven by increases in proportion of population that are elderly and, paradoxically, by improved management of patients with cardiovascular disease, expanding the number of patients surviving myocardial infarction but with damaged ventricles.

Heart failure has a major impact on health outcomes. Annual mortality in severe heart failure is around 60% [11]. In the general population, for all grades heart failure, 5-year mortality is 50–75% [12,13]. Morbidity in heart failure, as measured by symptom severity, quality of life, [14] need for consultation, treatment and hospital admission is considerable. In the UK, the reported 4.9% of admissions due to heart failure may extrapolate to up to 120,000 admissions per year nationally, [15] and admissions continue to rise [16,17]. For the last 20 years, there have been substantial advances in pharmacotherapy of heart failure. Angiotensin converting enzyme (ACE) inhibitors improve both morbidity and mortality in all grades of symptomatic heart failure due to LVSD, [18] and, in patients with asymptomatic LVSD, can delay or prevent progression to symptomatic heart failure [19,20]. More recently, the significant prognostic benefits of beta-blocker therapy in heart failure due to LVSD, [21,22] aldosterone receptor antagonists in severe heart failure, [23] and angiotensin receptor blockers in depressed systolic function heart failure, [24] have been demonstrated. However, since many patients with suspected heart failure do not receive any formal assessment of LV function, heart failure remains sub-optimally diagnosed and treated [25].

An essential element for treatment success is the reliable and precise diagnosis of heart failure. The major issue in the diagnosis of the disease relates to the criteria definition. Guidelines for the evaluation and management of heart failure are established in both the US (ACC/AHA [22] and Consensus Recommendations [26]) and Europe (ESC [9]). These state that the diagnosis of heart failure is justified when there are typical signs and symptoms of heart failure and myocardial dysfunction, confirmed by the objective evidence of cardiac dysfunction at rest (echocardiographic studies). In case of diagnostic uncertainty, a clinical response to treatment directed at heart failure is helpful in establishing the diagnosis. Simple and reliable diagnostic procedures are very important for primary care physicians, who are responsible for the early diagnosis of heart failure and implementation of adequate therapy.

The primary objective, of the IMPROVEMENT (IMprovement PROgram in eValuation and managEMENT of Heart Failure) study was to evaluate the current perception of heart failure and assess the management of such patients in routine clinical practice. The study was conducted in 14 countries across Europe, recruited from central, western and eastern parts. This paper reports on the diagnosis of heart failure by primary care physicians (PCPs).


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
Detailed design and methods of the IMPROVEMENT program were reported earlier [27,28]. Briefly, centres from 14 European countries participated in the study, with each country divided into 10 regions (5 rural and 5 urban). A consultant cardiologist was recruited to co-ordinate the study in each region. From routinely available lists, co-ordinators were responsible for contacting a random sample of primary care physicians, stratified according to age, gender and whether their office was in an urban or rural area. This process could be repeated if necessary to ensure that approximately 10 primary care physicians per region, 100 per country and 1400 physicians participated altogether.

Primary care physicians who consented to participate had an interview date set 6 weeks ahead and were asked to keep a log of all patients they saw with heart failure or who had a myocardial infarction, with or without heart failure. Interviewers, who were research nurses, medical students or other professional healthcare workers, were appointed in each region under the supervision of the regional co-ordinator. They were responsible for administering both the Perception and the Actual Practice Surveys, comprising a semi-structured standardised questionnaire, to the primary care physicians and, if more than the requisite number of patients had been entered on the log, for selecting at random six patients with heart failure and 3 additional patients with myocardial infarction (with or without heart failure). The protocol planned to record data from 900 patients per country and proximately 12,000 patients overall.

2.1. Study design and implementation, statistical methods
IMPROVEMENT was designed as an international study and methodology was planned and executed by the Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. This paper is based on the first of the planned 3 phases of investigation: evaluation of PCP perception regarding diagnosis and treatment of heart failure besides the assessment of actual practice.

These data provide information about the patterns of diagnostic procedures implemented by primary care physicians in the diagnosis of HF. Our results reflect the level of PCPs' knowledge regarding issues in heart failure diagnosis and, further, comparison between perception and practice. Since each country's health service organization also influences the patients' diagnostic course, independently of medical providers knowledge, our paper also describes the availability and limitation of access to diagnostic test procedures in different European countries [27–29].

The IMPROVEMENT of HF study was designed to achieve precision (lack of random error), and to achieve validity (lack of systematic error). Large sample sizes provide substantial protection from random error. In the binomial distribution, a probability of an event or observation of 0.5 is achieved with the greatest measurement error, which decreases in observations that move towards a probability of 0 or 1. Taking a probability of 0.5 as the ‘worst case—, the 95% confidence intervals around an observation, in a dataset containing 14,000 patients would be ±0.8%. For individual countries providing 500 observations the 95% confidence interval would be ±4.4%. Thus, as designed, the study provides statistically precise answers at every level. Random sampling of family practices plus screening for consecutive patients provides protection from systematic error [30].

Most statistical analyses planned and performed were simply descriptive, many involving subsets of patients for defined or specific characteristics. All analyses were conducted using SAS 6.12 or SAS 8.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
3.1. Primary care physicians (PCP) and patients
There were 1363 of 1400 planned primary care physicians who agreed to take part in this project. The highest percentage (47%) of participating physicians were doctors in the age group 41–50 years old (ranging from 10% in Turkey up to 72% in Italy). With regard to the gender of the primary care physician, significant discrepancies were detected between the different countries. In general, in countries from Eastern and Central Europe, 50% of PCPs were women, whereas in other countries this percentage varied from 7% in France up to 40% in Sweden. As planned by the study design, PCPs were recruited from urban and rural regions: in most countries 50% of physicians were from urban districts, with exception of France, Netherlands and United Kingdom, where most (78–100%) of them came from urban populations (Table 1).


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  		Table 1 Characteristics of primary care physicians and patients

 
Final analyses were based on the medical records of 11,062 patients (Table 1). On average, 54% of patients were above the age of 70 years (32% in Turkey, 36% in Russia reaching 77% in Sweden). Overall, women accounted for 45% of the population (Table 1). The majority of patients had clinical symptoms (i.e. dyspnea) along with objective signs of heart failure, thus fulfilling criteria for the diagnosis of heart failure according to ESC guidelines. Symptomatic disease was diagnosed in subjects with clinical signs and symptoms of heart failure confirmed by findings typical for systolic dysfunction, namely echocardiographic confirmed ejection fraction below 40%, poorly contracting left ventricle (LV), or enlarged LV. For recognition of asymptomatic heart failure (cardiac dysfunction), evidence of a reduced ejection fraction (<40%) was required, regardless of methods used.

Among registered patients, 12% were diagnosed with asymptomatic ventricular dysfunction. Patients with mild or moderate heart failure constituted 65%, while severe form was stated in 10%. The remaining 13% consisted of subjects who either were not diagnosed with heart failure or had died.

During the year preceding study recruitment, 4553 of registered patients were hospitalized. The most common cause of admission was heart failure either with or without acute myocardial infarction (57%). The highest percentage of ischemic cardiomyopathy was recorded in countries from Central and Eastern Europe (Russia 74%, Poland 65%, and Hungary 77%). Hypertension, as a co-morbidity or alone, was responsible for 42% of cases of heart failure. Pulmonary diseases (24%) and diabetes (18%) were the most commonly recognized co-existing diseases. At the same time atrial fibrillation was registered in 22% of participants [28].

3.2. Initial diagnosis of heart failure
Overall, in all of the countries, general practitioners or other primary care doctors made the initial diagnosis of heart failure in more than 50% cases (Table 2). However, substantial differences between the countries were observed, with highest percentage in Belgium and Germany, 65.3% and 68.4% respectively, and lowest in Great Britain and Czech Republic (27.9% and 37.4%). By contrast, initial diagnosis of heart failure was made relatively rarely by office-based cardiologists (on average below 5%).


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  		Table 2 Site of initial diagnosis of heart failure

 
3.3. Signs, symptoms and classification of heart failure
Primary care physicians stated that breathlessness (88–100%), orthopnoea (68–94%), ankle swelling and oedema were the most important symptoms of heart failure. These opinions were common among all PCPs, regardless of country. Physicians considered pulmonary crepitations (53–95%), cough (36–78%), elevated vein pressure (37–95%) and third heart sound (34–93%) were important signs and symptoms of heart failure, although this varied widely between countries. PCPs' general knowledge was not reflected in the audit of actual clinical practice: on average, breathlessness was recorded in 82%, orthopnoea in 37%, ankle swelling and oedema in 55% of study heart failure patients. Prevalence of remaining signs and symptoms ranged from 7% (third heart sound) to 39% (cough) (Table 3).


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  		Table 3 Perceived common signs and symptoms of heart failure and primary care physicians' usual classification of heart failure

 
The majority of primary care physicians (about 90%) used some kind of categorization to classify the progression of heart failure, however only 50% of them recorded in case notes the stages of heart failure progression (from 15% in Netherlands to 87% in Russia). On average, about half of the participating physician knew the classification of New York Heart Association (9% in Sweden to 77% in Poland). From those acquainted with the NYHA classification, most physicians reported using it in clinical practice, with the exception of PCPs in UK and Sweden (20% and 48% respectively). The rest of the physicians reported using a different, three steps assessment of heart failure—mild, moderate and severe. This type of classification was very popular among PCP in Sweden and UK (about 63%).

3.4. Diagnostic evaluation
Most of the participating physicians (about 90%) reported performing ECG tests in patients with heart failure and ECG results were recorded in 95% of analyzed case histories. Tracings were only regarded as normal in a small percentage of patients (1–6%), whereas the remainder were coded as abnormal. Ambulatory settings are often equipped to perform electrocardiography evaluation, and on average 30–40% of patients had their test performed on the out-patient basis. However, in France and Italy ECG this was less frequent (3.7% and 1% respectively). In France and Russia access to electrocardiography study was the easiest, about 70% of patients evaluated, whereas in other countries this percentage reached 30–40%. In most of cases, ECG study was performed at a local hospital, with usual waiting time reported as 48 h (Table 4).


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  		Table 4 Perceived and actual use of electrocardiography (ECG) in diagnosing heart failure

 
Most physicians (84%) reported arranging chest X-ray examination in patients with heart failure. About 28% of subjects with clinical diagnosis of heart failure had normal results. In most of the countries, chest X-ray was performed at local hospital and waiting time usually did not exceed 48 h (Table 5).


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  		Table 5 Perceived and actual use of chest X-ray to diagnose heart failure

 
In addition to clinical signs and symptoms, echocardiography is important in diagnosing heart failure. On average, 45% of PCPs' stated they referred their patients for ultrasound examination. There are substantial differences between the countries with regard to frequency of echocardiographic studies in this group of patients. In fact, observed percentages ranged from 10% in Netherlands, through 18% in Poland up to 65% in Belgium and 72% in France. Interestingly, there is discrepancy between physician—s answers in questionnaires, regarding the frequency of ordering of echocardiographic studies and actual results in case histories, which appeared in 82% of cases. No association between perception and every day practice was identified. Indeed, in the IMPROVEMENT study countries reporting low percentage of echocardiography ordered by PCPs, results of echocardiography were actually recorded in 84% and 69% of case notes (Table 6).


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  		Table 6 Perceived and actual use of echocardiography (echo) to diagnose heart failure

 
Normal results of ultrasound examination were noted in 8% of all cases, most often in case histories from PCPs in the Netherlands. On the other hand, left ventricle dysfunction (EF <40% or poorly contracting LV) was stated in 51% of subjects. The lowest percentage of echocardiographically confirmed heart failure was noted in case histories registered by PCP from UK, Turkey and Sweden, whereas highest numbers were found in data from Belgium, Italy and France (70%, 62% and 65%).

Systolic dysfunction was determined in only 50% of case notes reviewed. On questioning, only 46% of physician reported routinely distinguishing between systolic and diastolic forms of heart failure, while the rest did not know how to differentiate between systolic and diastolic dysfunction or were not aware of this concept. Those PCPs who identified systolic and diastolic heart failure, regarded echocardiography as crucial in diagnosis, followed by clinical signs and symptoms (Table 7).


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  		Table 7 Perceived differentiation by primary care physicians of systolic and diastolic heart failure

 
In the majority of participating countries echocardiography could be performed at the local hospital. Only in exceptional cases, was echocardiography possible within PCP practice (only in Germany and Russia). On average, waiting time for echocardiography was up to 1 month. Only in Belgium, in about 77% of cases, was echocardiography performed within 48 h from referral. In some countries, including Spain, Sweden, and the UK, most patients with heart failure (40%) waited to have the study done for 1–3 months.

3.5. Biochemical monitoring of creatinine and electrolytes
Current management of heart failure patients with angiotensin converting enzyme inhibitors requires regular checking of creatinine and electrolyte levels. Most PCPs reported running regular biochemical tests, mentioned above, in patients with heart failure. The exception was for patients from Russia, where 63% and 30% respectively had creatinine and electrolytes evaluation performed (Table 8).


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  		Table 8 Perceived and actual use of routine monitoring of creatinine and electrolytes

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
The IMPROVEMENT study represents the largest enquiry into European primary care physician perceptions and practice in heart failure diagnosis and treatment and confirms preliminary findings from a small survey of family doctor views regarding heart failure in six European countries [25]. Since outcomes in heart failure are linked to the stage of disease, then both early and accurate diagnosis are needed to guide appropriate treatment strategies. However, despite the need for accurate diagnosis, the IMPROVEMENT study confirms that many doctors in primary care still report that they rely on diagnosing heart failure on clinical grounds alone in most patients, as previously reported [25]. This finding is reinforced by the observations that most counties reported that the majority of patients were diagnosed with heart failure by their primary care physicians.

On the basis of European [9] and American [22] guidelines, diagnosing heart failure is not possible clinically since objective evidence of cardiac dysfunction is required, alongside the presence of appropriate symptoms, before a diagnosis is confirmed. Unfortunately, primary care physicians in Europe have variable and often delayed access to the most appropriate objective test namely echocardiography. As a consequence, doctors believe they need to rely on alternatives to echocardiography, such as the electrocardiograph (ECG) or chest X-ray, both tests perceived and actually used in most cases of heart failure in the IMPROVEMENT study. A normal ECG recording will, in most cases, exclude left ventricular dysfunction [31,32]. However, changes may be subtle and the lack of ECG interpretation skills may still require referral for specialist opinion. Another test often advocated [33], but with no supporting data for heart failure diagnosis, is the use of the chest X-ray. No data on the use of natriuretic peptide assays was volunteered in the IMPROVEMENT study.

Primary care physicians in Europe should not have to continue to rely on ECG or CXR for diagnosing heart failure. It is therefore not surprising that studies exploring the validity of a clinical diagnosis of heart failure in primary care, report high rates of misdiagnosis when patients are assessed against objective criteria (rates of 25–50% accuracy reported in different series) [3,34,35].

Improving the reliability of diagnosis is essential since determining the aetiology and stage of heart failure leads to different management choices, such as initiation of ACE inhibitors, [9,18,22] and β-blockers [9,21,22] in most patients with LVSD, spironolactone [23] in those cases with severe heart failure, or surgery where significant valve disease exists. These therapies improve symptoms, quality of life, disease prognosis, and reduce healthcare utilisation and costs. Furthermore, early diagnosis is needed, when there may be no symptoms, since treatment can delay or reverse disease progression [20]. Diagnostic methods may therefore need to encompass screening strategies, [3,36] as well as symptomatic case identification in the future.

The main limitation of the IMPROVEMENT study relates to the response rates, which were low in some countries. This may have lead to selection bias of physicians, with the responders being more motivated regarding cardiovascular disease and its management. It may also have been possible for doctors to have operated some selection in the heart failure cases listed for review, for example only selecting patients in whom they were more confident of the diagnosis. These patients may, therefore, have received greater diagnostic work-up. This may explain why more patients actually received an echocardiogram than physicians report was their usual use of the test. Therefore, these data probably best represent the perceptions of motivated primary care physicians.

To balance these study limitations, the number of doctors taking part was large, they were randomly allocated, and were geographically representative. Furthermore, despite these data probably representing better rather than average practice, there was repeated evidence of under-management. A strength of the study was the attempt to validate the doctors' perceptions of how they practiced against the actual data on diagnosis and treatment from the clinical case records.


   Acknowledgements
 
The IMPROVEMENT Programme was established under the Diagnostic Research Group of the Working Party on Heart Failure for the European Society of Cardiology. Investigators are Jerzy Korewicki, Richard Hobbs, John Cleland, Joanne Eastaugh, Alain Cohen-Solal, Juan Cosin Augilar, Rainer Dietz, Ferenc Follath, Nick Freemantle, Antonello Gavazzi, Hugo Madeira, Karl Swedberg, Wiek van Gilst, Istvan Preda, Jiri Widimski. The costs of conducting the survey and audit were supported by an unrestricted research grant from Servier.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 

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