The adoption of clinical pathways and the inclusion of likelihood ratios in the report: a controlled before and after study.

BACKGROUND: The aim of this study was to evaluate the consequence of the introduction of Clinical Pathways (CPs) and the inclusion of Likelihood Ratios (LRs) in test results instead of the reference intervals in the workload for the laboratory and in-patients. METHODS: A controlled before (2003) and after (2004, 2005, and 2006) study compared the exams requested using CPs instead of single exams for three pathologies (pulmonary embolism, acute myocardial infarction, and bile-pancreatic pathologies) in order to evaluate if this procedure is followed in clinical care and if it provides useful and accurate investigation for clinical care. Data were collected from the laboratory computer archive system over 3 years (2004 - 2006). RESULTS: The total number of requests decreased between the "before" and "after" 2004 and 2005. We found an increase (30% to 40%) in the requests of CPs. The percentage for each of the considered CPs showed a significant increase for the pulmonary embolism (EP) and bile-pancreatic pathologies: during the semesters monitored, we found an 80% increase in the request of these CPs. The percentage of acute myocardial infarction (AMI) CPs did not show a difference between the semesters compared. We also found an improvement in the diagnostic effectiveness: the concordance between the emergency department (ED) and ward diagnosis for EP increased. CONCLUSIONS: We demonstrated that this procedure is followed in clinical care for the three pathologies studied and that the use of CPs and LRs provide useful tools in making a more appropriate diagnosis. We demonstrated also that clinical audit is very important for monitoring. Audit is integral to good clinical practice and, in fact, aims to influence activity on a local level and is useful in maintaining best practice.

Platelet parameters in healthy and pathological pregnancy.

Changes in platelet count (PLT) are very important during pregnancy. Many platelet disorders occur during pregnancy and a reduction in PLT is the most common hemostasis abnormality identified, and this has important implications for mother and foetus. Many of these disorders share clinical and laboratory features, making accurate diagnosis difficult. The aim of this study was to establish reference intervals of platelet parameters for some of the more important pathologies associated to pregnancy (pre-eclampsia, gestational diabetes, autoimmune disorders, viral infections) using the automated hematology analyzer Sysmex XE-2100 and to evaluate the difference between healthy and pathological pregnancy. We enrolled in our study 100 pregnant women in the third trimester of pregnancy. The parameters analyzed included PLT, platelet distribution width, and mean platelet volume (MPV). We found statistically significant difference in PLT in pre-eclampsia, autoimmune disorders, and viral infections. Our results demonstrated also a statistically significant difference in MPV in pre-eclampsia and gestational diabetes. Our results allow the clinicians to detect hematologic change by simple complete blood count useful for the management of the pathological pregnancies. In conclusion, the overall picture of platelet disorders is extremely variegated, leading to numerous diagnostic and therapeutic problems whose solutions require close collaboration between clinicians and laboratory specialists.

Evaluation of nucleated red blood cells in the peripheral blood of hematological diseases.

BACKGROUND: Nucleated red blood cells (NRBCs) are present in the peripheral blood of several hematological and non-hematological conditions, usually associated with bad prognosis. The lack of an easy, rapid and reliable NRBCs count method did no't allow one to know the incidence of NRBCs and to quantify them: the count was usually done during the microscopic revision of a blood smear; this is the reason we found few studies on NRBCs automated count in the literature. The aim of this study was the evaluation of the presence and the quantification of NRBCs in some onco-hematological disorders. METHODS: This study analyzed 478 patients with the automated hematology analyzer Sysmex XE2100. The range of NRBCs were calculated in the peripheral blood at diagnosis, at hematological remission and during therapy. RESULTS: NRBCs are present in the peripheral blood of a high number of hematological diseases and are related to ineffective erythropoiesis or stress erythropoiesis or primary alterations of hematopoiesis. NRBCs were found in nearly all onco-hematological diseases at diagnosis, but not in all patients. NRBCs were frequently found during chemotherapy and absent at remission. CONCLUSIONS: To the authors' knowledge, this is the first study that gives a range for NRBCs count in the peripheral blood of these diseases.

Possibility of myelodysplastic syndromes screening using a complete blood automated cell count.

Diagnosis of MDS has changed during the last years because of the 2008 WHO classification. Complete blood cell count (CBC) is a very important tool both for diagnosis of MDS. The aim of this study was to evaluate if it is possible to use the abnormal signals produced by dysplastic cells to produce a flag "dysplasia" able to identify the patients needing further hematological investigations. The proposed flag has been tested in a large group of patients to evaluate the sensibility and specificity. We create 5 patterns of MDS. Our study demonstrated that the flag "dysplasia" is specific and sensible for MDS.

Reticulocyte count and reticulocyte maturation profile in human umbilical cord blood from healthy newborns.

Most fetal hematologic parameters show a significant relationship with gestational age: a linear increase is evident throughout gestation for several hematologic parameters. A few reports have described reference values for umbilical cord blood reticulocyte counts performed with automated hematology analyzers. Our aim was to use automated hematology analyzers (ADVIA 120; Siemens Healthcare Diagnostics) to establish reference intervals for reticulocyte parameters in cord blood from healthy newborns of 34 to 42 weeks of gestation. We also investigated whether differences in reticulocyte parameters exist between the sexes and between different weeks of gestation. We enrolled 98 healthy, appropriate for gestational age newborns. In term infants, the reticulocyte percentage, the absolute reticulocyte count, and the reticulocyte hemoglobin content decreased significantly as the gestational age increased, but the maturation subpopulations did not change significantly. We found no significant differences between the sexes. In conclusion, our results contribute to the establishment of reference intervals for cord blood from full-term newborns that are measured with an automated hematology analyzer.

Likelihood ratios reporting in a tertiary hospital emergency department; a pilot study.

The Emergency Department and the laboratory of our institution jointly developed simple Clinical Pathways for some important clinical conditions (pulmonary embolism, acute myocardial infarction, bile-pancreatic disease) and since May 2004 the positive and negative likelihood ratios have been added to the reports of the tests included in the clinical pathways. In the first semester 30% of clinicians adopted the new mode of tests requesting AMI, Pulmonary embolism and bile pancreatic clinical pathways, respectively, 24% 32% and 42%. According to a survey carried out in 2004 all the ED staff had knowledge of the project. A real partnership developed between the laboratory staff and Emergency Department physicians leading to the adoption of the Evidence Based Laboratory Medicine tools in the decision making process.

Nucleated red blood cells in term fetuses: reference values using an automated analyzer.

BACKGROUND: Nucleated red blood cells (NRBCs) are present in small numbers in the cord blood of healthy fetuses at birth. Acute and chronic stimuli, such as fetal hypoxia, cause increased circulating levels of NRBCs. Manual counting is presently the only way to quantify NRBCs, but it is time-consuming and inaccurate. Recently, automated approaches have been developed in order to quantify NRBCs. OBJECTIVES: Our aim was to compare manual vs. automated NRBC counting and derive reference values in umbilical cord blood samples from healthy term fetuses. METHODS: We analyzed blood samples from 131 healthy term fetuses by the automated approach and calculated reference values of NRBC counts as percentiles. To compare automated NRBC count with manual count we obtained umbilical cord blood samples from 50 further fetuses. RESULTS: Significant positive correlation was obtained between the two methods (r(2) = 0.988, Bland-Altman plot mean difference NRBCs/100 WBC: -0.590). The median for NRBCs/100 WBC was 3.05 (range 0-11.6) and the median for absolute NRBC counts x10(9)/l was 0.39 (range 0-1.8). CONCLUSIONS: We demonstrate that values obtained with the automated NRBC counting method are comparable to those obtained with the microscopic manual evaluation and give reference values for umbilical cord NRBCs at term that can be used in clinical practice.