Indications, Utility and Appropriateness of Echocardiography in Outpatient Cardiology.

OBJECTIVE: Respect of "appropriateness" is considered an essential requirement, both on the clinical and the economic profile, and also as it helps to shorten the waiting list. However, only a few studies have dealt with the control of appropriateness in clinical practice, and most of them have focused only on hospital admissions and invasive procedures.
MATERIALS AND METHODS: INDICARD-out is a prospective, multicenter study carried out by A.R.C.A. (Associazioni Regionali Cardiologi Ambulatoriali) cardiologists from 13 Italian Regions, providing information on indications, utility and appropriateness of echocardiography in outpatient cardiology.
RESULTS: A total of 2110 prescriptions for echocardiogram were evaluated. Hypertension (23%) and the screening of asymptomatic subjects (17%) by far were the most frequent indications to echocardiography. Overall, 54% of the tests resulted appropriate, 30% were of uncertain appropriateness and 16% were inappropriate. Besides, 31% of the echocardiograms were not useful, and 28% were non pertinent for patient management. The vast majority of prescriptions (72%) came from non-cardiologist physicians (54% from general practitioners). The echocardiograms prescribed by cardiologists were significantly more appropriate, more useful and more pertinent than the tests prescribed by non-cardiologists.
CONCLUSIONS: The appropriateness, utility and pertinence of the echocardiography are still suboptimal in practice cardiology, especially when indicated by non-cardiologists. The cardiologist, from mere executor of tests prescribed and managed by other physicians, should gain the role of the clinician who takes care of all the cardiologic needs of the patient community.

INTRODUCTION

Echocardiography has had an impressive diffusion in clinical practice in the past few years, mainly because of the richness of the diagnostic information it provides, while maintaining a low risk to the patient by employing ultrasound technology, and also due to the low costs of echo examinations.[1] The availability of high quality and portable machines has allowed echocardiography to go beyond the frontiers of specialized centers, and made it a diagnostic tool currently performed in out-patient laboratories. With the increased diffusion, indications to echocardiography have progressively enlarged too.

In a context of availability of definite resources, such as the Public Health Care System, rapid increase in the demand of medical procedures yields a critical burden, both on the clinical management as well as the economic aspect. In the case of echocardiography, the availability of instruments and the operator’s knowledge, has been unable to match up the uncontrolled rise in the demand for the echo examinations. This vicious circle (more supply generates more demand) accounts for high global costs and long waiting lists of echocardiographic exams, and hence it raises the issue of the appropriateness of the indications for this procedure.

In two consensus documents published by the Italian Federation of Cardiology[2] and the Italian Society of Echocardiography,[3] respect of appropriateness is considered an essential requirement, both on the clinical (quality of medical care) and the economic profile, and also to shorten waiting lists. The appropriateness of medical interventions is usually defined by Scientific Societies through clinical guidelines. However, only a few studies have dealt with the control of appropriateness in clinical practice, and usually focusing on hospital admissions[45] and invasive procedures.[6789] The appropriateness of echocardiography has been investigated in three recent surveys.[101112] However, these surveys studied very selected populations, such as those enrolled from a single Italian region (Tuscany),[10] a single metropolitan area (Milan)[11] and a single hospital centre (Pontedera, Pisa).[12] To our best knowledge, no studies have been carried out till date on the appropriateness of echocardiography in a large, non selected, out-patient population, and our study presented in this paper would be the first of its kind.

In 2011, A.R.C.A. (Associazioni Regionali Cardiologi Ambulatoriali) carried out the INDICARD-out (INDIcazioni, percorsi assistenziali e appropriatezza in CARDiologia ambulatoriale) project, which aimed at investigating the activities of outpatient cardiology in Italy and, in particular, the appropriateness of non-invasive cardiological tests [exercise stress test, echocardiography, ambulatory electrocardiogram monitoring, vascular echography] in the outpatient population. INDICARD-out is a prospective, multicenter study conducted in a large population of patients selected by practice cardiologists from many Italian regions. In this paper, the results of the INDICARD-out study are reported in terms of the indications, utility and appropriateness of echocardiography.

MATERIALS AND METHODS

The INDICARD-out study has been carried out by the A.R.C.A. cardiologists operating in hospital or out-patient centers, and belonging to the National Health System (NHS) or in Private Accredited Structures (PAS). During one week of consecutive sampling, each investigator evaluated all prescriptions of echocardiograms made by another physician (general practitioner or other professionals) operating within the NHS. No case sampling from the private practice was allowed. Only echocardiogram prescriptions performed on non-hospitalized patients were accepted for the study.

The study was entirely managed through internet. Each investigator was provided with a specifically designed data-base (Excel format) for the collection of significant data, as shown in Figure 1.

Figure 1

Section of the data base (Excel format) utilized for data collection in the study

For each echo prescription, the following variables were evaluated and collected:

Prescribing physician: general practitioner, cardiologist, other professionals.

First echo examination or periodic monitoring.

Type of prescription: elective or urgent.

Completeness of prescription: a) isolated indication of required test; b) formulation of a presumptive diagnosis; c) formulation of a specific question.

Medical therapy followed by the patient: Known or unknown.

Indications to echocardiogram. The indications have been codified according to Italian Federation of Cardiology guidelines for appropriate use of non-invasive diagnostic methods.[13]

Appropriateness of prescription. According to Italian Federation of Cardiology guidelines,[13] the appropriateness has been graded as follows: class I: appropriate; class II: Uncertain appropriateness; class III: Inappropriate.

Result of the echocardiogram: normal or pathological.

Utility of the echocardiogram. The evaluation of utility was made by researchers according to Cochrane Collaboration definition:[14] “A medical test may be considered useful if it substantially changes the diagnostic pre-test probability, or if contributes to the implementation of an effective therapy”; in other words, the test is useful if it modifies the diagnostic or therapeutic approach of the patient.

Pertinence of the echocardiogram towards specific care needs of the patient. The assessment of pertinence, expressed by investigators before the test and independently from its results, was aimed to determine whether diagnostic power of the echocardiogram well agreed with the specific disease probability.

Patient management. Each investigator was asked to determine whether the patient’s (under consideration) overall clinical management had to be entitled to the cardiologist who performed the echocardiogram, or to another physician, in particular to the prescribing physician.

Statistical analysis

Chi-square test and Fischer’s exact test were utilized to assess statistical significance of the differences of association between appropriateness class, prescribing physician, utility, pertinence and result of the echocardiograms. A P < 0.05 was considered statistically significant. Continuous variables are expressed as mean ± standard deviation (SD).

RESULTS

Fifty-eight cardiologists, from 13 Italian regions, adhered to the echocardiography section of the INDICARD-out study. A homogeneous representation of the regions of northern (5 regions), central (4 regions) and southern (4 regions) Italy had been observed in the study.

Overall, 2110 prescriptions for echocardiogram were evaluated (mean age 60.4 ± 18 years; 1059 males, 1051 females). Out of 2110 echocardiograms, 756 (36%) were selected in hospital centers, 803 (38%) in PAS and 551 (26%) in out-patient centers. The vast majority of the echocardiograms (2001/2110; 95%) were prescribed as elective examination; and in only 109 cases (5%), an urgent test was required. Nearly half of all prescriptions (1012/2110; 48%) represented a periodic monitoring of tests already performed. With regard to the exhaustiveness of the prescription, it is interesting to note that only 147 prescriptions (7%) were correctly filled in (that is, reported required test, presumptive diagnosis and a specific question, as regulations require), and that in almost one-third of all prescriptions (594/2110; 28%) only the required test was mentioned. Further, the therapeutic regimen of the patient was unknown to the cardiologist who performed the test in 342/1610 cases (21%).

The indications to echocardiography, codified according to the Italian Federation of Cardiology guidelines,[13] are shown in Figure 2. Hypertension resulted by far the most frequent indication to echocardiography (22.9%), followed by the screening of asymptomatic subjects (16.8%). Among indications, frequent were also valvular heart diseases (12.8%), ischemic heart disease (8.9%) and cardiomyopathies (4.3%). Finally, a “not negligible” number of echocardiograms had been prescribed to investigate signs and symptoms, such as palpitations (8.2%), chest pain (7.6%), dyspnea and/or edema (6.6%) and heart bruits (4.2%). The less frequent indications included the pericardial (1.2%) and extracardiac diseases.

Figure 2

Indication to echocardiography, classified according to the Italian Federation of Cardiology guidelines (13)

The appropriateness of the 2110 echocardiograms evaluated in the study is shown in Figure 3. Overall, 1146 tests (54%) were appropriate (class I), 631 (30%) were of uncertain appropriateness (class II) and 333 (16%) were classified as inappropriate (class III).

Figure 3

Appropriateness of echocardiography. Class I: appropriate. Class II: uncertain appropriateness. Class III: inappropriate

Figure 4 shows the overall data of utility, pertinence and result of the tests as seen in our study. About two-thirds of the echocardiograms (1467, 69%) were considered useful for patient management while one-third (643, 31%) were judged as not useful. The assessment of pertinence provided similar data: 1524 tests (72%) were considered pertinent towards specific diagnostic question, while 586 tests (28%) were believed as non-pertinent. Further, with regard to the result, 1289 tests (61%) proved pathological while over one-third (821, 39%) provided a normal result.

Figure 4

Utility, pertinence and result of the echocardiograms

The appropriateness, utility, pertinence and result of echocardiography, according to each indication, are reported in Table 1. As evidenced in the table, the tests performed for screening asymptomatic subjects and for palpitations most frequently were inappropriate, not useful, non-pertinent and with normal results. Instead, the echocardiograms performed for valvular and ischemic heart disease, cardiomyopathies and pericardial disease, showed the best performances in terms of appropriateness, utility, pertinence and pathological result.

Table 1

Appropriateness, utility, pertinence and result of the tests according to each echocardiography indication

Indications	n (%)	Class I (%)	Class II (%)	Class III (%)	Useful (%)	Pertinent (%)	Pathological (%)
Screening in asymptomatics	354 (16.8)	48	21	31	58	63	34
Chest pain	160 (7.6)	27	52	21	61	63	45
Dyspnea/edema	139 (6.6)	53	27	20	71	79	63
Palpitations	172 (8.2)	40	12	48	52	57	41
Heart bruit	89 (4.2)	78	7	15	71	76	46
Valvular heart disease	271 (12.8)	63	31	6	82	83	89
Ischemic heart disease	187 (8.9)	66	31	3	74	76	78
Cardiomyopathy	91 (4.3)	65	34	1	86	85	76
Pericardial disease	25 (1.2)	84	12	4	84	84	68
Hypertension	484 (22.9)	60	34	6	72	73	70
Lung disease	32 (1.5)	53	38	9	75	62	53
Cerebral ischemia/stroke	25 (1.2)	72	16	12	76	92	48
Syncope	32 (1.5)	22	62	16	59	66	47
Aortic and great vessels disease	49 (2.3)	25	63	12	84	86	88

The utility, pertinence and result of the echocardiograms were also evaluated according to each appropriateness class. Figure 5 shows that appropriate tests (class I) were also more frequently useful (P < 0.0001), pertinent (P < 0.0001) and pathological (P < 0.0001), as compared with the tests of uncertain appropriateness (class II) and with inappropriate tests (class III).

Figure 5

Utility, pertinence and pathological result of the echocardiograms, according to each appropriateness class. Appropriate tests resulted significantly more useful, more pertinent and more frequently pathological, as compared to tests of uncertain appropriateness and with inappropriate tests.

The source of echo prescriptions is shown in Table 2. General practitioner was by far the largest prescribing physician (56%). Prescriptions came from a cardiologist in less than one-third of cases (28%) and even less frequently from other professionals. Figure 6 shows the appropriateness of the echocardiograms when prescribed by a cardiologist, as compared to tests prescribed by non-cardiologists. As evident in the figure, the echocardiograms prescribed by cardiologists resulted significantly more appropriate (P < 0.0001), more useful (P < 0.0001), more pertinent (P < 0.0001) and more frequently pathological (P < 0.0001) than the tests prescribed by non-cardiologists.

Table 2

Prescribing physician

General practitioner	1187	(56%)
Cardiologist	583	(28%)
Internal medicine physician	153	(7%)
Sport physician	56	(3%)
Surgeon	52	(2%)
Emergency department	23	(1%)
Other physician	56	(3%)

Figure 6

Appropriateness, utility, pertinence and result of echocardiography according to prescribing physician. The echocardiograms whose indications were carried by cardiologists resulted more appropriate, more useful, more pertinent and more frequently pathological as compared to tests with non cardiological indications

With regard to the clinical management of the patient undergoing echocardiography, it is extremely important to emphasize that the cardiologist was the referring physician of the patient in only 863/2110 (41%) of cases, and that in over half of the cases (1102/2110; 52%) clinical management of the patient was owned by the general practitioner.

DISCUSSION

INDICARD-out is the first study providing information on indications, appropriateness and utility of echocardiography in a large, non selected, out-patient population, really representative of the practice cardiology in Italy.

The main findings emerging from the study are: a) hypertension and the screening of apparently healthy subjects are the most frequent indications to echocardiography in practice cardiology; b) the appropriateness of echocardiography is poor, as almost half of the echocardiograms are definitely or probably inappropriate; c) utility and pertinence of echo examinations are suboptimal in clinical practice; d) the echocardiograms very frequently show no pathological findings; e) appropriateness, utility and pertinence of echocardiography are even more inadequate when indications are carried by non-cardiologist physicians; f) in more than a half of the cases, the cardiologist is the mere executor of tests whose result will be managed by other doctors.

The appropriateness of indications

The INDICARD-out study showed that only 54% of the echocardiograms performed in practice cardiology were appropriate. According to the Italian Federation of Cardiology guidelines,[13] 30% and 16% of echo examinations were considered as probably or definitely inappropriate, respectively.

With regards to the relationship between the indications and the appropriateness, the echocardiograms performed for established cardiovascular disease (valvular and ischemic heart disease, cardiomyopathy, pericardial disease and hypertension) resulted by far as the most appropriate indications (class I ranging between 60% and 84%). Nearly half of echo examinations were instead performed in patients without established cardiovascular disease. Among these indications, palpitations, screening of apparently healthy subjects and chest pain achieved the worst results of appropriateness (class I: 27% to 48%; class III: 21% to 48%).

The INDICARD-out results confirm and extend previous data on appropriateness of echocardiography obtained in populations with different and very specific characteristics of selection. In a multicentre ANMCO (Associazione Medici Cardiologi Ospedalieri) survey,[1015] performed in out-patients from hospitals of Tuscany, Lattanzi and coll[10] found an appropriateness rate much lower and worse than our results (class I: 43.6%), with relative and absolute inappropriateness of 36.8% and 19.6%, respectively. Similar results were obtained by Orsini and coll[12] in a single center, out-patient, hospital population (class I, II and III: 43%, 36% and 21%, respectively). These results are even more significant because they were obtained after a training program specifically targeted at prescribing physicians. Finally, in a population selected by eleven echocardiography laboratories of Milan city, Mantero and coll[11] found a higher incidence of appropriate examinations in hospitalized (class I: 65%; class III: 14%) than out-patients (class I: 40%; class III: 32%). Therefore, the INDICARD-out results revealed an echocardiography appropriateness slightly better, although still suboptimal, than single centers or single areas studies, probably because the latter were planned to confront with local realities of particular concern.

In clinical practice, the measure of appropriateness requires the comparison of observed cases of care with defined patterns of appropriate care. Several methods have been developed to define the appropriateness of medical procedures. The most widely used of these methods has been developed in the 80s by the RAND Corporation in collaboration with the University of California, Los Angeles.[161718] According to this method, a group of experts, based on scientific evidences, elaborates a scale from 1 to 9 for each potential indication to a medical procedure. The final score generates a scale of appropriateness: 1-3 (inappropriate); 4-6 (uncertain appropriateness); 7-9 (appropriate). Clinical guidelines issued by the Scientific Societies are a variant of the RAND method. In the INDICARD-out study, the appropriateness of echocardiography has been defined according to the Italian Federation of Cardiology guidelines.[13] Although recent international guidelines on echocardiography have been published, the opportunity of defining the appropriateness of non-invasive cardiologic tests with a unique guideline, such as the INDICARD-out project required, well matched the need of adherence to the Italian cardiologic practice.

Utility, pertinence and result of the echocardiograms

In the present study, nearly one-third of the echocardiograms was considered not useful for the diagnostic and therapeutic management of patients, i.e., unable to change pre-test probability of the disease or its therapeutic approach. Similar results were obtained with regard to the pertinence of the tests, since 28% of the echocardiograms were considered non pertinent with regard to the specific disease probability. The estimation of utility and pertinence of the tests, although linked to a precise definition,[14] were among the study variables most subjected to the investigator discretion. Nevertheless, a strong correlation between appropriateness, utility, pertinence and results of the echocardiograms was found. Actually, in the present study an appropriate test had a 78%-91% likelihood to be also pathological, pertinent and useful, as compared to a 19%-35% likelihood for inappropriate tests [Figure 5].

Another important finding emerging from this study is the high number of echocardiograms with normal results, almost approaching to 40% of the total number of tests. The rate of normal result of a test is one of the criteria utilized in the definition of quality standards for invasive diagnostic laboratories. According to the American College of Cardiology/Society for Cardiac Angiography and Intervention recommendations,[19] the rate of normal coronary angiograms should not exceed 20-27% of the diagnostic coronary arteriographies, because an excess of normal tests is likely to be an index of poor indications to the procedure. Although it is difficult to extend these observations and to set precise limits for non-invasive tests, the assessment of normality rate results should represent an important parameter for quality standards definition, as much as for non-invasive diagnostic laboratories.

Prescribing physician and appropriateness

In the INDICARD-out study, over 70% of the requests for echocardiography were made by non cardiologists. Among them, general practitioner was by far the largest prescribing physician (56% of prescriptions). In agreement with previous surveys,[101112] in our study the indications to echocardiography were carried by a cardiologist only in a minority of cases (28%). In addition, general practitioner was recognized as the referring physician for the patient submitted to echocardiography in over 50% of cases. In other words, the cardiologist is much more frequently a mere executor of tests prescribed by other doctors, and whose result will be managed by other than a clinician who takes care of cardiologic needs in the community.

Paradoxically, the largest prescribers were also the worst prescribers. Indeed, the echocardiograms requested by non-cardiologists were significantly less appropriate, less pertinent, less useful and more frequently normal, as compared to tests whose indications came from cardiologists [Figure 6]. However, it is also necessary to emphasize the absolute (8%) and relative (25%) inappropriateness of cardiologic prescriptions.

Waiting lists and appropriateness

The delay in access to health care is disliked by public opinion, however it is inevitable. The first consideration of health care managers is that the waiting list is a direct measure of the need of the people for medicals services, and that the size of the list is directly related to the need. The results of our study clearly contradict this consideration, as almost half of the subjects was waiting for a probably or definitely inappropriate test, and about one-third for a not useful and non-pertinent test.

Waiting lists depend on the dynamic balance between the demand and supply of services. Until now, the problem of waiting lists has been approached by health care managers in two ways: Visibility of the lists and enhancement of supply of services. The enhancement of supply (the so-called government of the supply) has been pursued by health managers through several ways (optimization of activities, budget objectives, incentive systems, incremental remunerated activity) that inevitably lead to an increase in operators workload and sanitary costs. Even more importantly, the results of this and previous studies[101215] clearly indicate that isolated enhancement of supply, without the control of appropriateness, is an inadequate tool for shortening waiting lists, since greater availability of supply automatically increases the demand, often for inappropriate exams. Although we cannot really aim at 100% appropriateness, simple removal of inappropriate tests, and a critical revision of those likely inappropriate, could significantly reduce the demand of tests, waiting lists and costs, according to unquestionable criteria, both in scientific and social terms.

How can we improve medical appropriateness?

The really effective way to simultaneously address the issues of quality of cares, waiting lists and costs, is the control of appropriateness of the demand. The government of the demand, however, is a complex and articulated strategy that primarily requires the knowledge of clinical guidelines and the development and sharing of diagnostic-therapeutic pathways among health care providers. The second essential requirement in the government of the demand is periodic monitoring of appropriateness of single medical procedures, in order to intervene and correct specific critical problems, through clinical audit, restrictions on prescribing of diagnostic tests, and incentive and disincentive of individual measures. Such methods, already in use in drug prescriptions, should also be extended to diagnostic exams as well.

Despite theoretical interest of both politicians and scientific societies,[2320] till date only a few studies have dealt with the monitoring of the appropriateness, and have largely focused on invasive procedures and hospital admissions. The assessment of appropriateness in practice requires contemporary knowledge of two kind of variables: Type of intervention/procedure performed (a-type information); and, patient/clinical setting on whom the intervention is performed (b-type information). Isolated a-type information, without knowledge of the clinical context (b-type information), precludes any assessment of appropriateness. Health authorities have pursued until now strategies to acquire isolated a-type information, and were able to estimate only the efficiency of the system, but not the appropriateness of provided care.

In a recent position paper by Società Italiana di Ecografia Cardiovascolare — SIEC, the importance of the appropriateness of use of echocardiography and of operators competence has been reaffirmed.[21] Scientific Societies, as well as the role in the development of guidelines, have the unique responsibility to assess their application in clinical practice.

CONCLUSIONS

The INDICARD-out study provided information on indications, utility and appropriateness of echocardiography in a large, non selected population, that was representative of the Italian outpatient cardiology. The study showed a poor appropriateness, suboptimal utility and pertinence of the echocardiograms, especially when indications were given by non-cardiologists. Despite increasing interest of both politicians and scientific societies, only a few studies have assessed the appropriateness of medical interventions in clinical practice. Control of appropriateness is essential, not only for quality care assurance, but also for limiting the costs of health services and shortening waiting lists. The cardiologist, from a mere executor of tests prescribed and managed by other doctors, should gain again the role of the clinician who takes care of the cardiologic needs of community.