Paolo Carraro - Academia.edu (original) (raw)
Papers by Paolo Carraro
Biochimica Clinica, 2022
Introduction: during the current SARS-CoV-2 pandemic phase, the use of rapid diagnostic devices o... more Introduction: during the current SARS-CoV-2 pandemic phase, the use of rapid diagnostic devices outside the laboratory has expanded enormously, creating great opportunities but also new risks. Methods: the present observational study evaluated the type and frequency of errors of the extraanalytical phases through an active search on all unclear or ambiguous cases. 252 241 rapid antigenic tests performed outside the laboratory in different health facilities over a 132-day period were considered. The requests, the patient demographics and the results were later entered manually onto the Laboratory Information System (LIS). Results: through a number of data checks and internal reports, 2 556 cases of errors in the preexamination phase were recorded, with a relative frequency of 12,274 parts per million (ppm). The vast majority of errors were observed in this phase; these were due mainly to computer communication problems induced by human errors that made the loading of results or the issuing of the reports difficult. The remaining cases involving erroneous personal data or patient identification amounted to 16 (64 ppm), confirming the relative safety of this phase in decentralized analysis. The errors identified in the postexamination phase were 540, with a relative frequency of 2140 ppm. The assessment of the severity of the errors with Failure Mode and Effect Analysis (FMEA) allowed us to identify in particular, the attribution of the report to the wrong person (20 ppm) and the manual transcription of an incorrect result (20 ppm). Discussion: this study contributes to the comprehension of the critical issues connected to the Point of Care Testing and made it possible to establish corrective actions: improving staff training, choice of instruments with reading devices and establishing direct computer connection for the entering of the requests and results to the LIS.
Biochimica Clinica, Mar 1, 2011
The Journal of Emergency Medicine, 2015
Thyroid-stimulating hormone (TSH) has recently been introduced among the tests available to the E... more Thyroid-stimulating hormone (TSH) has recently been introduced among the tests available to the Emergency Department (ED) of our hospital. To evaluate the prevalence of TSH-level-dependent thyroid dysfunction and to assess the usefulness of urgent TSH testing in a series of emergency patients. We planned a single-center observational cross-sectional clinical study. We divided patients in groups according to their thyroid status using defined TSH decision levels. Previously diagnosed history of thyroid dysfunction and newly diagnosed thyroid dysfunctions were differentiated. Further, we analyzed the subset of emergency patients affected by atrial fibrillation (AF) due to the role of hyperthyroidism in AF pathogenesis. For each TSH request, we made a retrospective chart review to assess the usefulness of the test based on clinical efficacy and management efficiency indicators. The present study showed that, although the overall thyroid dysfunction rate was higher than in the general population, only a few newly diagnosed thyroid dysfunctions were found with limited clinical utility. We categorized urgent TSH requests as useful and not useful, by retrospective evaluation, and we identified and compared the main TSH testing clinical indications in the two groups. We found a positive impact of urgent TSH determination in emergency decision-making. Nevertheless, a stronger clinical impact could be achieved by improving request appropriateness and by targeting TSH testing to some clinical indications identified by the study. The work was considered a quality-improvement project by the Hospital Committee for Quality Management.
Giornale Italiano di Diabetologia e Metabolismo
Portable glucose meters must obviously provide reliable results for safe and effective treatment ... more Portable glucose meters must obviously provide reliable results for safe and effective treatment of diabetic patients and it is essential to verify their accuracy, precision and inadequacies. To improve the performance of blood glucose meters currently on the market, in 2013 the International Standardization Organization (ISO) issued new standards that must be applied widely in countries that recognize these standards, by 2016. Although home monitoring of blood glucose is recommended for glycemic control in diabetic patients, patients still have many difficulties that influence its proper use. These findings once again highlight the importance of selfmanagement training by the multi-disciplinary care team.
Thrombosis and haemostasis, 2003
The aim of the present study is to verify the relationship between peripheral artery disease (PAD... more The aim of the present study is to verify the relationship between peripheral artery disease (PAD) and some coagulation/fibrinolysis parameters in type 2 diabetic patients. Sixty-three type 2 diabetic patients, without PAD, were studied at baseline and after 4 years. Assessments included tissue-Plasminogen Activator (t-PA), Plasminogen Activator Inhibitor-1 antigen (PAI-1 Ag), Plasminogen Activator Inhibitor-1 activity (PAI-1 Act), Plasminogen (Pl), Fibrin peptide A (FPA), Fibrinogen (Fr), and the ankle/brachial pressure index (ABI). We observed a significant difference between diabetic patients and controls as regards tPA (11.8 +/- 5.4 vs. 6.6 +/- 3.0 ng/ml; p <0.05) and PAI-1 Act (17.8 +/- 9.2 vs. 11.7 +/- 6.6 ng/dl; p <0.005). After 4 years 13 diabetic patients became vasculopathic and, at baseline, had significantly lower tPA (8.9 +/- 4.8 vs. 12.5 +/- 5.3; p <0.011), and higher PAI-1 Ag (50.8 +/- 22.2 vs. 32 +/- 22.2; p <0.006), and PAI-1 Act values (24.1 +/- 9.5 vs....
La Rivista Italiana della Medicina di Laboratorio - Italian Journal of Laboratory Medicine, 2014
Clinical Chemistry, Feb 1, 2000
International journal of clinical & laboratory research, 1995
Diabetes Research and Clinical Practice, 1992
The aim of the present study was to investigate whether or not alterations of the plasma proteina... more The aim of the present study was to investigate whether or not alterations of the plasma proteinase-antiproteinase system were present in type 1 (insulin-dependent) diabetic patients and, if so, whether or not they were related to sex, age at onset and duration of the disease as well as to short- and long-term diabetic control. The plasma concentration of trypsin-like activity and two of the most important plasma serine proteinase inhibitors, alpha 1-antitrypsin and alpha 2-macroglobulin, were determined in 95 type 1 diabetic and 67 control subjects. The plasma concentration of alpha 1 antitrypsin was found to be markedly decreased (P < 0.001), whereas plasma alpha 2-macroglobulin and trypsin-like activity were increased in diabetics compared to controls (P = 0.009 and < 0.001, respectively). Sex also influenced the values of both proteinase inhibitors in diabetics, women showing higher values of plasma alpha 1-antitrypsin (P = 0.004) than men. In women, HbA1c was also positively correlated with blood glucose (P < 0.001), daily insulin dosage (P < 0.001), and trypsin-like activity of plasma (P = 0.02). On the contrary, in men, HbA1c appeared to be negatively correlated with plasma alpha 2-macroglobulin (P = 0.02). In addition to sex, age at onset (but not duration) of the disease revealed differences in plasma alpha 1-antitrypsin among diabetics, the lowest mean value of this inhibitor being present in men with age at onset below 15 years, who also showed a significant negative correlation between this inhibitor and HbA1c (P = 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)
Clinical Chemical Laboratory Medicine, 2000
Clinical Chemistry and Laboratory Medicine, 2000
Recent advances in the laboratory diagnostic approach to inherited thrombophilia call for an upda... more Recent advances in the laboratory diagnostic approach to inherited thrombophilia call for an update on laboratory strategies and organization. The present paper therefore deals in particular with: the panel test choice, timing and test appropriateness, and analytical methods in several clinical conditions. Specific recommendations are supported by the state-of-the-art in this branch.
Clinical Chemistry and Laboratory Medicine, 2000
Clinica Chimica Acta, 2009
Thrombosis Research, 2016
Direct oral anticoagulant (DOAC) intra- and inter-individual variability was previously reported,... more Direct oral anticoagulant (DOAC) intra- and inter-individual variability was previously reported, but its magnitude is still considered negligible for patient management. To evaluate inter- and intra-individual variability in real-world atrial fibrillation patients on dabigatran, rivaroxaban or apixaban in four Italian anticoagulation clinics and to assess the correlation between DOAC plasma concentration and creatinine-clearance (CrCl). A total of 330 consecutive patients were enrolled, of which 160 were on dabigatran (70 and 90 taking 150mg or 110mg twice-daily, respectively), 71 on rivaroxaban (37 and 34 taking 20mg or 15mg once-daily) and 99 on apixaban (73 and 26 taking 5mg or 2.5mg twice-daily). Blood was taken at trough and peak within the first month (15-25days) of treatment. Diluted-thrombin-time (dTT) calibrated for dabigatran and anti-FXa calibrated for rivaroxaban or apixaban was performed. Mean inter-individual variability expressed as overall CV values for all drugs was lower at peak (CV=46%) than at trough (CV=63%). Mean CV% intra-individual variability was 36.6% at trough and 34.0% at peak. Correlation with CrCl was poor for all drugs and only dabigatran at trough showed a significant correlation. This multicenter study confirms high DOAC inter-individual variability that cannot be explained by the rate of renal clearance to which the three DOAC were subjected since the correlation with CrCl was relatively poor. This poor correlation suggests caution in using CrCl as the sole laboratory parameter to indirectly evaluate residual circulating DOAC.
Artificial Organs, Sep 1, 2002
The International journal of artificial organs
The limited availability of human hepatocytes results in the use of animal cells in most bioartif... more The limited availability of human hepatocytes results in the use of animal cells in most bioartificial liver support devices. In the present work, clinically relevant liver specific metabolic activities were compared in rat, pig and human hepatocytes cultured on liver-derived biomatrix to optimize the expression of differentiated functions. Pig hepatocytes showed higher rates of diazepam metabolism (2.549+/-0.821 microg/h/million cells vs. 0.474+/-0.079 microg/h/million cells rats, p<0.005, and vs. 0.704+/-0.171 microg/h/million cells in man, p<0.005) and of bilirubin conjugation (21.60116+/-8.433237 micromoles/l/24 h vs. 6.786809+/-2.983758 in man, p<0.001 and vs. 9.956538+/-1.781016 micromoles/l/24 h in rats, p<0.005). Urea synthesis was similar in pig and in human hepatocytes (150+/-46.3 vs. 144.8+/-21.46 nmoles/h/million cells) and it was lower in rats (84.38+/-35.2; p<0.001 vs. man, p<0.02 vs. pig). High liver specific metabolic activities in cultured pig hepatocytes further support their use as a substitue for human cells in bioartificial liver devices.
Clinical Chemistry and Laboratory Medicine
Data on quality indicators (QIs) should be collected over time in order to identify and continuou... more Data on quality indicators (QIs) should be collected over time in order to identify and continuously monitor clinical laboratory performance and to improve patient safety by identifying and implementing effective interventions. The aim of the present study was to ascertain whether the utilization of a set of quality indicators over a 3-year period resulted in an improvement in the efficiency and effectiveness of an individual laboratory. Over a 3-year time interval (2009-2011), a series of 38 QIs covering all stages of the total testing process (21 in the pre-analytic, nine in the analytic and eight in the post-analytic phase) was monitored. On the basis of their patterns, QIs have been grouped into the following categories: [1] seven QIs of the pre-analytical phase and three of the intra-analytical phase with a significant trend and a significant linearity demonstrating an improvement over time; [2] 10 QIs of the pre-analytical and two of the intra-analytical phase with a significa...
The American journal of emergency medicine, Jan 16, 2015
The objective of this study is to determine the ways in which preanalytic factors related to phys... more The objective of this study is to determine the ways in which preanalytic factors related to physiologic status can affect the complete blood cell count (CBC) in patients referring to an emergency department (ED). Over a 1-year period, the results of hemoglobin (Hb) level and white blood cell (WBC) counts of the first CBC tests undertaken in consecutive patients (n = 11487) referring to the ED were compared with those obtained in the same patients at a second test undertaken within 24 hours of admission. A prospective evaluation of the same differences was made in another group (group 2) of 1025 consecutive ED patients, several clinical characteristics being taken into consideration. Mean Hb concentrations were higher in the first (range, 8.0-15.9 g/dL) than in the second test results (median overestimation, 0.4-0.8 g/dL; P < .0001). At multivariate analysis of results in group 2 patients, fluid administration (>0.5 L) and the presence of edema played a significant role in the...
Biochimica Clinica, 2022
Introduction: during the current SARS-CoV-2 pandemic phase, the use of rapid diagnostic devices o... more Introduction: during the current SARS-CoV-2 pandemic phase, the use of rapid diagnostic devices outside the laboratory has expanded enormously, creating great opportunities but also new risks. Methods: the present observational study evaluated the type and frequency of errors of the extraanalytical phases through an active search on all unclear or ambiguous cases. 252 241 rapid antigenic tests performed outside the laboratory in different health facilities over a 132-day period were considered. The requests, the patient demographics and the results were later entered manually onto the Laboratory Information System (LIS). Results: through a number of data checks and internal reports, 2 556 cases of errors in the preexamination phase were recorded, with a relative frequency of 12,274 parts per million (ppm). The vast majority of errors were observed in this phase; these were due mainly to computer communication problems induced by human errors that made the loading of results or the issuing of the reports difficult. The remaining cases involving erroneous personal data or patient identification amounted to 16 (64 ppm), confirming the relative safety of this phase in decentralized analysis. The errors identified in the postexamination phase were 540, with a relative frequency of 2140 ppm. The assessment of the severity of the errors with Failure Mode and Effect Analysis (FMEA) allowed us to identify in particular, the attribution of the report to the wrong person (20 ppm) and the manual transcription of an incorrect result (20 ppm). Discussion: this study contributes to the comprehension of the critical issues connected to the Point of Care Testing and made it possible to establish corrective actions: improving staff training, choice of instruments with reading devices and establishing direct computer connection for the entering of the requests and results to the LIS.
Biochimica Clinica, Mar 1, 2011
The Journal of Emergency Medicine, 2015
Thyroid-stimulating hormone (TSH) has recently been introduced among the tests available to the E... more Thyroid-stimulating hormone (TSH) has recently been introduced among the tests available to the Emergency Department (ED) of our hospital. To evaluate the prevalence of TSH-level-dependent thyroid dysfunction and to assess the usefulness of urgent TSH testing in a series of emergency patients. We planned a single-center observational cross-sectional clinical study. We divided patients in groups according to their thyroid status using defined TSH decision levels. Previously diagnosed history of thyroid dysfunction and newly diagnosed thyroid dysfunctions were differentiated. Further, we analyzed the subset of emergency patients affected by atrial fibrillation (AF) due to the role of hyperthyroidism in AF pathogenesis. For each TSH request, we made a retrospective chart review to assess the usefulness of the test based on clinical efficacy and management efficiency indicators. The present study showed that, although the overall thyroid dysfunction rate was higher than in the general population, only a few newly diagnosed thyroid dysfunctions were found with limited clinical utility. We categorized urgent TSH requests as useful and not useful, by retrospective evaluation, and we identified and compared the main TSH testing clinical indications in the two groups. We found a positive impact of urgent TSH determination in emergency decision-making. Nevertheless, a stronger clinical impact could be achieved by improving request appropriateness and by targeting TSH testing to some clinical indications identified by the study. The work was considered a quality-improvement project by the Hospital Committee for Quality Management.
Giornale Italiano di Diabetologia e Metabolismo
Portable glucose meters must obviously provide reliable results for safe and effective treatment ... more Portable glucose meters must obviously provide reliable results for safe and effective treatment of diabetic patients and it is essential to verify their accuracy, precision and inadequacies. To improve the performance of blood glucose meters currently on the market, in 2013 the International Standardization Organization (ISO) issued new standards that must be applied widely in countries that recognize these standards, by 2016. Although home monitoring of blood glucose is recommended for glycemic control in diabetic patients, patients still have many difficulties that influence its proper use. These findings once again highlight the importance of selfmanagement training by the multi-disciplinary care team.
Thrombosis and haemostasis, 2003
The aim of the present study is to verify the relationship between peripheral artery disease (PAD... more The aim of the present study is to verify the relationship between peripheral artery disease (PAD) and some coagulation/fibrinolysis parameters in type 2 diabetic patients. Sixty-three type 2 diabetic patients, without PAD, were studied at baseline and after 4 years. Assessments included tissue-Plasminogen Activator (t-PA), Plasminogen Activator Inhibitor-1 antigen (PAI-1 Ag), Plasminogen Activator Inhibitor-1 activity (PAI-1 Act), Plasminogen (Pl), Fibrin peptide A (FPA), Fibrinogen (Fr), and the ankle/brachial pressure index (ABI). We observed a significant difference between diabetic patients and controls as regards tPA (11.8 +/- 5.4 vs. 6.6 +/- 3.0 ng/ml; p <0.05) and PAI-1 Act (17.8 +/- 9.2 vs. 11.7 +/- 6.6 ng/dl; p <0.005). After 4 years 13 diabetic patients became vasculopathic and, at baseline, had significantly lower tPA (8.9 +/- 4.8 vs. 12.5 +/- 5.3; p <0.011), and higher PAI-1 Ag (50.8 +/- 22.2 vs. 32 +/- 22.2; p <0.006), and PAI-1 Act values (24.1 +/- 9.5 vs....
La Rivista Italiana della Medicina di Laboratorio - Italian Journal of Laboratory Medicine, 2014
Clinical Chemistry, Feb 1, 2000
International journal of clinical & laboratory research, 1995
Diabetes Research and Clinical Practice, 1992
The aim of the present study was to investigate whether or not alterations of the plasma proteina... more The aim of the present study was to investigate whether or not alterations of the plasma proteinase-antiproteinase system were present in type 1 (insulin-dependent) diabetic patients and, if so, whether or not they were related to sex, age at onset and duration of the disease as well as to short- and long-term diabetic control. The plasma concentration of trypsin-like activity and two of the most important plasma serine proteinase inhibitors, alpha 1-antitrypsin and alpha 2-macroglobulin, were determined in 95 type 1 diabetic and 67 control subjects. The plasma concentration of alpha 1 antitrypsin was found to be markedly decreased (P < 0.001), whereas plasma alpha 2-macroglobulin and trypsin-like activity were increased in diabetics compared to controls (P = 0.009 and < 0.001, respectively). Sex also influenced the values of both proteinase inhibitors in diabetics, women showing higher values of plasma alpha 1-antitrypsin (P = 0.004) than men. In women, HbA1c was also positively correlated with blood glucose (P < 0.001), daily insulin dosage (P < 0.001), and trypsin-like activity of plasma (P = 0.02). On the contrary, in men, HbA1c appeared to be negatively correlated with plasma alpha 2-macroglobulin (P = 0.02). In addition to sex, age at onset (but not duration) of the disease revealed differences in plasma alpha 1-antitrypsin among diabetics, the lowest mean value of this inhibitor being present in men with age at onset below 15 years, who also showed a significant negative correlation between this inhibitor and HbA1c (P = 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)
Clinical Chemical Laboratory Medicine, 2000
Clinical Chemistry and Laboratory Medicine, 2000
Recent advances in the laboratory diagnostic approach to inherited thrombophilia call for an upda... more Recent advances in the laboratory diagnostic approach to inherited thrombophilia call for an update on laboratory strategies and organization. The present paper therefore deals in particular with: the panel test choice, timing and test appropriateness, and analytical methods in several clinical conditions. Specific recommendations are supported by the state-of-the-art in this branch.
Clinical Chemistry and Laboratory Medicine, 2000
Clinica Chimica Acta, 2009
Thrombosis Research, 2016
Direct oral anticoagulant (DOAC) intra- and inter-individual variability was previously reported,... more Direct oral anticoagulant (DOAC) intra- and inter-individual variability was previously reported, but its magnitude is still considered negligible for patient management. To evaluate inter- and intra-individual variability in real-world atrial fibrillation patients on dabigatran, rivaroxaban or apixaban in four Italian anticoagulation clinics and to assess the correlation between DOAC plasma concentration and creatinine-clearance (CrCl). A total of 330 consecutive patients were enrolled, of which 160 were on dabigatran (70 and 90 taking 150mg or 110mg twice-daily, respectively), 71 on rivaroxaban (37 and 34 taking 20mg or 15mg once-daily) and 99 on apixaban (73 and 26 taking 5mg or 2.5mg twice-daily). Blood was taken at trough and peak within the first month (15-25days) of treatment. Diluted-thrombin-time (dTT) calibrated for dabigatran and anti-FXa calibrated for rivaroxaban or apixaban was performed. Mean inter-individual variability expressed as overall CV values for all drugs was lower at peak (CV=46%) than at trough (CV=63%). Mean CV% intra-individual variability was 36.6% at trough and 34.0% at peak. Correlation with CrCl was poor for all drugs and only dabigatran at trough showed a significant correlation. This multicenter study confirms high DOAC inter-individual variability that cannot be explained by the rate of renal clearance to which the three DOAC were subjected since the correlation with CrCl was relatively poor. This poor correlation suggests caution in using CrCl as the sole laboratory parameter to indirectly evaluate residual circulating DOAC.
Artificial Organs, Sep 1, 2002
The International journal of artificial organs
The limited availability of human hepatocytes results in the use of animal cells in most bioartif... more The limited availability of human hepatocytes results in the use of animal cells in most bioartificial liver support devices. In the present work, clinically relevant liver specific metabolic activities were compared in rat, pig and human hepatocytes cultured on liver-derived biomatrix to optimize the expression of differentiated functions. Pig hepatocytes showed higher rates of diazepam metabolism (2.549+/-0.821 microg/h/million cells vs. 0.474+/-0.079 microg/h/million cells rats, p<0.005, and vs. 0.704+/-0.171 microg/h/million cells in man, p<0.005) and of bilirubin conjugation (21.60116+/-8.433237 micromoles/l/24 h vs. 6.786809+/-2.983758 in man, p<0.001 and vs. 9.956538+/-1.781016 micromoles/l/24 h in rats, p<0.005). Urea synthesis was similar in pig and in human hepatocytes (150+/-46.3 vs. 144.8+/-21.46 nmoles/h/million cells) and it was lower in rats (84.38+/-35.2; p<0.001 vs. man, p<0.02 vs. pig). High liver specific metabolic activities in cultured pig hepatocytes further support their use as a substitue for human cells in bioartificial liver devices.
Clinical Chemistry and Laboratory Medicine
Data on quality indicators (QIs) should be collected over time in order to identify and continuou... more Data on quality indicators (QIs) should be collected over time in order to identify and continuously monitor clinical laboratory performance and to improve patient safety by identifying and implementing effective interventions. The aim of the present study was to ascertain whether the utilization of a set of quality indicators over a 3-year period resulted in an improvement in the efficiency and effectiveness of an individual laboratory. Over a 3-year time interval (2009-2011), a series of 38 QIs covering all stages of the total testing process (21 in the pre-analytic, nine in the analytic and eight in the post-analytic phase) was monitored. On the basis of their patterns, QIs have been grouped into the following categories: [1] seven QIs of the pre-analytical phase and three of the intra-analytical phase with a significant trend and a significant linearity demonstrating an improvement over time; [2] 10 QIs of the pre-analytical and two of the intra-analytical phase with a significa...
The American journal of emergency medicine, Jan 16, 2015
The objective of this study is to determine the ways in which preanalytic factors related to phys... more The objective of this study is to determine the ways in which preanalytic factors related to physiologic status can affect the complete blood cell count (CBC) in patients referring to an emergency department (ED). Over a 1-year period, the results of hemoglobin (Hb) level and white blood cell (WBC) counts of the first CBC tests undertaken in consecutive patients (n = 11487) referring to the ED were compared with those obtained in the same patients at a second test undertaken within 24 hours of admission. A prospective evaluation of the same differences was made in another group (group 2) of 1025 consecutive ED patients, several clinical characteristics being taken into consideration. Mean Hb concentrations were higher in the first (range, 8.0-15.9 g/dL) than in the second test results (median overestimation, 0.4-0.8 g/dL; P < .0001). At multivariate analysis of results in group 2 patients, fluid administration (>0.5 L) and the presence of edema played a significant role in the...