Abstract
Background
The appropriateness of clinical laboratory use in hospital clinical practice is a very debated question. In fact diagnostic tests are essential tools for disease screening or diagnosis but at the same time they represent an important expenditure.
Methods
A quantitative study was conducted in an Italian general hospital with 535 beds and about 27,000 admissions per year. The sample was made of all patients discharged from the hospital with DRG 78 between the period 1 January 2005 and 31 December 2005.
Results
The Emergency Department (ED) discharged 2.9% (116/4009) of patients with pulmonary embolism diagnosis in the year 2005. The percentage of prescription inappropriateness inferred by analysis of all required tests by operative unit was 21.7% (950/4385). The approximate estimate of the economic value of unnecessarily required tests was of 3495€. Of these 96.5% (112/116) had enlisting criteria. All haematological and clinical-chemical tests (1295) concerning studied patients were analysed. About 70.4% (93/132) of d-dimer tests were ordered in ED. In the studied patients, unfractionated heparin was administered in 17.8% (20/112) of the cases, low-molecular weight heparin in 79.5% (89/112) and heparin therapy was not administered in 2.7% (three of 112).
Conclusion
This study uses a method to assess the quality of laboratory test orders using results as a tool to estimate the impact of economic resources devolved in executing inappropriate tests.
Introduction
The rising health-care expenditure, the continuous growth in the volume of laboratory tests and the observation of variations in laboratory testing practices have led to the critical assessment of routine laboratory utilization. It has been recognized that a reduction in the number of requests for laboratory tests, by improving the appropriateness of testing behaviour, is an essential part of quality improvement. 1
Appropriateness of clinical laboratory use in hospital clinical practice is a very debated question. In fact diagnostic tests are essential tools for disease screening, and diagnosis but at the same time they represent an important expenditure. 2 The increased use of laboratory investigations is a worldwide trend and several factors may be responsible: the increasing demand for care (owing to ageing of the population and increasing numbers of chronically ill people), the easier access to tests which in itself leads to ordering, the urge to make use of new technology, but also, higher standards of care, the guidelines which often recommend additional testing, and defensive behaviour. 3
Furthermore, continuing advances in the development of new medical treatments and more complex tests make it virtually certain that the future practice of medicine will be even more heavily dependent on laboratory medicine than it is today. 4
Many studies suggest wide variation in test ordering behaviour for seemingly similar indications. 5
Several factors may explain this variation: physicians' inability to estimate test performance characteristics, automatic adoption of routine protocols, low attention to previous test results in repeated tests, inaccurate interpretation of diagnostic results and rapid advances in diagnostic technology that makes it difficult for clinicians to stay abreast of the most effective testing strategies. 6
Moreover, once an abnormal test result is found, doctors may order further investigations, not realizing that 5% of test results on average exceed their reference ranges and a cascade of testing may result.
Interventions focused on overt examples of inappropriate testing might reduce costs while simultaneously improving quality. 3
The appropriateness of tests depends on the clinical context of the patient, the severity of the disorder, administrative necessities and many other factors. The definition of what is appropriate, or what is best practice in clinical use, therefore requires a consensus view within the profession in the context of each country's national health-care system. 5
The solution to many test-requesting problems will require a multifactorial approach. 6 There are many guidelines at the local, regional and national level for the use of specific tests, but guidelines alone have been shown to be the least productive way of effecting change. 7 Change will only be brought about with more innovative ways of presenting topics to busy doctors and nurses. The feedback of costing data has produced a substantial decrease in laboratory testing, but decreasing the cost of testing alone must not be the only goal and must be fully coupled with measures to support best practice. Computerized protocols have also been used successfully. 5 Education is a common approach to many of these interventions, although, as it has been delivered in different forms, from guidelines through lectures to outreach visits, the most successful educational approaches are not yet clear. 5
The aim of our study was to provide a model to analyse appropriateness of laboratory use to manage medical inpatients discharged with pulmonary embolism (PE) diagnosis.
Methods
The study was conducted in an Italian general hospital with 535 beds and 26,645 admissions per year (December 2005). In the initial phase we looked for the most frequent medical DRGs at discharge in 2007. The aim of this operation was to identify a medical DRG common to different hospital units and suitable for making a qualitative and quantitative comparison with respect to laboratory requests. PE (DRG 78; 5774€) was chosen as point of reference.
We considered patients with confirmed PE who fitted in the following inclusion criteria: 8,9
diagnosis certified throughout use of ventilation/perfusion lung scintigraphy with diagnostic reports of high probability of PE compared with chest X-rays or ventilation/perfusion scintigraphy or otherwise execution of pulmonary angiography; or execution of echocardiography with diagnostic report of PE; execution of ultrasonography of the legs positive for proximal deep venous thrombosis in patients with scintigraphy suggesting intermediate or low probability PE; high clinical probability in patients with scintigraphy suggesting intermediate probability PE.
Exclusion criteria were:
8,9
patients who died without having had scintigraphy, echocardiography or autopsy; patients with incomplete data.
We assessed these parameters:
mean number of blood laboratory tests ordered per patient on the basis of PE diagnosis by operative unit (OU); tests requested for patients admitted in the OU as routine profile; specific tests ordered for co-morbidities; specific tests for anticoagulant therapy monitoring; tests asked inappropriately; cost value of inappropriate prescriptions.
We defined as inappropriate:
all tests required without evidence of previous tests with abnormal values and/or of clinical conditions worsening during hospital stay (main disease or co-morbidities); all tests with out-of-range values that were not investigated further on.
We selected the list of patients discharged from the hospital with DRG 78 between the period 1 January 2005 to 31 December 2005. All of them were admitted through the Emergency Department (ED) and were discharged by the Internal Medicine Department, inside of two wards (Operative Unit A = OUA and Operative Unit B = OUB).
Patients' clinical chart consultation allowed us to:
Verify the correctness of the discharge diagnosis in used to recruit patients;
Collect sociodemographic and health characteristics for each patient (age, admission number, OU, date of admission and discharge, admission diagnosis, interventions executed, outcomes);
Collect data on co-morbidities present at the hospital access or diagnosed during the hospital stay, since they determine an increase of patient complexity that can promote further requests of laboratory tests unrelated to PE;
Verify anticoagulant therapy (drug type and dosage) administered to estimate appropriateness of monitoring it throughout laboratory tests.
We collected requests for haematological and chemical-clinical tests from laboratory database for the recruited patients. The hospital has a unique identifier for each single patient admitted.
We identified the patients' admission profile by unit as reported in Table 1.
Mean of blood tests number ordered stratified by OU
ESR denotes erythrocyte sedimentation rate formula includes tests on red blood cells, white blood cells, coagulation. ALT, alanine transaminase; AST, aspartate transaminase; LDH, lactate dehydrogenase; CK, creatinine kinase; CKMB, creatinine kinase-isoenzyme MB; INR, international normalized rate; aPTT, activated partial thromboplastin time. SD, standard deviation
*Tests included in access profile
† P < 0.05 between OUA and OUB
An abnormal test was defined as a test whose value is beyond the range identified by the Laboratory.
The correctness of the anticoagulant therapy monitoring was evaluated on the basis of recommendations provided by international guidelines. 10,11
The economic values of tests were estimated adopting a local Regional Scale of Charges (2006) for health-care services. 12
Data were analysed with SPSS version 12.0 (SPSS Inc., Chicago, IL, USA), and the chi-square test, Mann-Whitney test and Kruskal-Wallis test were used. A P value of <0.05 result was accepted as being statistically significant.
Results
In ED, 2.9% (116/4009) of patients were discharged with PE diagnosis in the year 2005. Of these, 96.5% (112/116) had enlisting criteria, 2.6% (three of 116) had incomplete data and 0.9% (one of 116) died before receiving a complete diagnosis.
Table 2 shows the demographic and clinical characteristics of the sample stratified by OU. Of the enlisted patients, 68.7% (77/112) were discharged from OUA. During hospital stay 8.9% (10/112) of the patients died. We did not find statistical differences between the two groups.
Characteristics of the population (n = 112)
OU, operative unit
All haematological and clinical-chemical tests (1295) concerning the patients studied were analysed. Of 1295 patients, (139) 10.7% came from ED, 52.5% (680/1295) from OUA and 36.8% (476/1295) from OUB. Table 2 shows the mean number of tests requested for each patient, stratified by OU.
The hospital admission for each patient occurred through the ED that ordered routine and specific laboratory tests to make a diagnosis (Table 3). Of 132, 93 (70.4%) d-dimer tests were prescribed in ED. D-dimer was not executed in 6.2% (seven of 112) of cases and in 17.9% (20/112) was repeated. The length of stay in ED was < 24 h in all patients. The transfer to OUA or OUB meant different access profiles with variable percentages for each test as described in Table 3.
Tests ordered at the time of admission in the OUs studied
ESR, erythrocyte sedimentation rate; ALT, alanine transaminase; AST, aspartate transaminase; LDH, lactate dehydrogenase; CK, creatine kinase; CK-MB, creatine kinase isoenzyme MB; INR, international normalized rate; aPTT, activated partial thromboplastin time; ED, emergency department; OU, operative unit
*Tests included in access profile
The analysis of specific test requests, i.e. for iron and ferritin, showed that in 36.6% (41/112) of patients the iron dosage was required without specific clinical indications.
The treatment of patients with PE should start with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH). In the patients studied, UFH was administered in 17.8% (20/112) of cases, LMWH in 79.5% (89/112) and in 2.7% (three of 112) heparin therapy was not administered. In long-term treatments, heparin therapy was switched from heparin to oral anticoagulant therapy in 61.6% (69/112) of patients.
To assess the correctness of therapy monitoring, specific tests requests were evaluated and INR (range 2–3) in particular was appropriated on the basis of international guidelines in 57.1% (420/736).
The percentage of prescription appropriateness inferred by analysis of all required tests by OU was 78.3% (3435/4385) and Table 4 shows that it was high in most of the tests considered in this study. In Table 5, the percentage of potential inappropriateness was split on the basis of the same assessment to differentiate two areas; the first where corrective interventions can be applied and the second where further investigations are needed.
Appropriateness of test prescription performed in operative units studied (expressed in percentage)
ESR, erythrocyte sedimentation rate; ALT, alanine transaminase; AST, aspartate transaminase; LDH, lactate dehydrogenase
*Includes tests repeated without evidence of previous tests with values out-of-range and tests out-of-range has not even been investigated
†Tests included in access profile
Percentage of potential inappropriate tests stratified by assessment criteria
ESR, erythrocyte sedimentation rate; ALT, alanine transaminase; AST, aspartate transaminase; LDH, lactate dehydrogenase
*Tests included in access profile
The approximate estimate of economic value of inappropriately required tests was of 3495€ (mean cost for each patient = 31.20€). If the estimate referred only to the first criteria of inappropriateness, the cost was 2499€ (mean cost for each patient = 22.31€) instead.
Discussion
This paper addresses an important topic about how the appropriateness of tests can be evaluated in complex clinical pathways. It advances a model of investigation based on identifying a significant disease subset and then carrying out in-depth review of the tests used throughout the patient pathway. It offers this as a generalizable model.
The percentage estimate of potentially inappropriate prescriptions is of 21.7% of laboratory tests, consistent with literature on this topic. 7 There were excessive requests related to tests present in access profiles. Repetitions of these tests are frequent both in the occasion of patient's transfer from ED to OU and within the OU. Repetitions are related to wrong behaviours caused by consolidated habits. Therefore, it is necessary to examine internal pathways in order to elaborate patient-oriented access profiles including useful tests that improve outcomes.
Consideration of the severity and complexity of cases was strictly necessary to evaluate the performance of OU. The case-mix acts as a complex variable that incorporates elements as severity of the main diagnosis, sociodemographic factors and co-morbidities. The last ones are important parameters that are able to influence various outcomes of hospital care (e.g. mean length of stay, grade of tolerance with regard to medical procedures, clinical response to therapy). The type and number of co-morbidities can influence clinical decisions concerning the planning of the most suitable treatment for patient.
The first phase of the study was the collection and analysis of the cases in the OU studied, performed through the assessment of the informative sources. The methodology used in the study was based on the assessment of patients' chart review fundamental in the process of evaluation of health-care quality. The limit of this method was a long time spent in collecting data. Nevertheless, if this method is adopted in projects aimed at assessing and improving specific patients' diagnostic pathways, it allows consents a timing discussion of instrumental tests and laboratory requests through focus groups.
Data analysis did not show statistically significant differences among demographic and clinical characteristics of patients discharged by the two OUs. This finding was a positive factor for the study goal aimed to evaluate an important aspect of quality concerning inpatients.
The laboratory tests represent decisive element especially in a severe pathology-like PE because they confirm the diagnostic suspect, monitor the disease progression and define and control the therapeutic treatment. Therefore their appropriateness becomes an essential tool that leads to good outcomes without being advantageous both for the patient and for the health system.
The tests required at the patient's access or uses as monitoring profiles on all patients represent one area where an incorrect use of laboratory is made. The physicians think that the use of laboratory tests is indispensable to patients' assessment, for they are able to reveal preclinical diseases not even previously suspected with anamnesis and/or physical examination. These theories should be supported by a cost-effectiveness analysis. In fact, the direct consequence of executing profiles characterized by a high number of generic tests followed by other tests ordered to verify the values out of range, is an increase of total hospital costs without further advantage on outcomes. Sometimes hospital stay is in fact prolonged owing to verify out-of-range data. 3
The analysis of data showed the presence of non-homogeneous access profiles even in similar contexts. Some biochemical parameters are important to check metabolism (i.e. glucose), organ function (i.e. creatinine/kidney, alanine transaminase, bilirubin/liver) homeostasis (i.e. sodium, potassium) but it is not clear if a generic assessment, on other districts or functions is useful. The request of simultaneous dosage of urea and creatinine is not justified to assess kidney function because urea is significantly influenced by metabolism of proteins and concentration of extracellular fluids. 13 As far as other analytes are concerned it is not useful to introduce them in the profiles both for variability related to lifestyle (gamma glutamyl transferase) and for biological interindividual variability, particularly for some parameters like iron, or for non-specific borderline changes (total proteins, lactate dehydrogenase). 14
The analysis of test orders in inpatients showed requests whose meaning is restricted to few clinical cases, like chlorine. It was required in a high percentage of cases (65% of patients recovered in OUB) even if it was not included in the profile. Similar considerations can be made on simultaneous dosage of iron and ferritin that are appropriate only in specific pathologies such as haemochromatosis and anaemias. D-dimer is the internationally recommended test on guidelines for the exclusion of PE diagnosis. Its levels can also be high in elderly patients, maybe consequent to less movement and presence of atherosclerosis. Its low specificity in elderly population makes it an unreliable test for excluding PE if it is not associated with other investigations. Certainly, its dosage is inappropriate out of the ED. Therefore, its repetition is not useful for patient management. 10,11,15
Data on monitoring anticoagulant therapy showed a higher number of OU test requests compared with international guidelines. It is also remarkable that there are not enough studies on safety assessment in the use of LMWH in subjects with haemorrhage risk (elderly people, patients with kidney disease, overweight patients). 16
Although the potential economic saving is only 22€ per case, this study shows the importance of the laboratory in pathways involving inpatients. The appropriateness is a fundamental aid for physicians to make correct decisions on patient health.
Conclusions
Improvement in laboratory use is a crucial aspect of quality concerning hospital pathways. The medical direction should guarantee high levels of efficacy and effectiveness and should discourage an inappropriate use of laboratory tests by physicians (both overuse and underuse). Striving for this implies the adoption of combined strategies, i.e. clinical governance tools: continuous education, dissemination and implementation of guidelines, management audit. Therefore, administrative interventions such as the replacement of the laboratory test request form and the feedback of data through monthly activity reports are important tools together with continuous audit among professionals to assess the results of the actions undertaken. 1,17,18
This study uses a method to assess the quality of laboratory test orders using results as a tool to estimate the impact of economic resources devolved in executing inappropriate tests. Its use in different hospital contexts is linked with the presence of easily accessible laboratory tests database, allowing an easy extrapolation of data for statistical analysis.
