Il ruolo del Laboratorio di Microbiologia nella diagnosi delle malattie infettive

Ancora oggi il Laboratorio di Microbiologia clinica è un settore che ha meno usufruito dell’introduzione dell’automazione del processo analitico. Tra le competenze del Laboratorio di Microbiologia si annoverano il supporto alla diagnosi, al trattamento, alla prevenzione delle patologie infettive provocate sia da patogeni primari in soggetti immunocompetenti, sia da patogeni opportunisti o condizionati in soggetti con difese immunitarie compromesse. Il Laboratorio di Microbiologia clinica, per migliorare l’impatto clinico del risultato microbiologico dovrebbe fornire risultati accurati in tempi sempre più rapidi, possibilmente mediante anticipazioni telefoniche e soprattutto servendosi della rete. Infatti disponendo di un antibiogramma in tempi ridotti, si incide sulla scelta del farmaco antimicrobico, riducendo la spesa sanitaria, e allo stesso tempo, dove possibile, si incide sul tasso di mortalità. Il microbiologo deve sapersi confrontare continuamente con i colleghi medici su specifici aspetti, quali ad esempio il rapporto tra epidemiologia locale, resistenze e consumo di antibiotici, permettendo così di chiarire meglio le dinamiche alla base dei nuovi fenomeni di resistenza e consentendo di discutere le precauzioni da attuare per contrastarli. E’ ormai dimostrato che dove è già in vigore questo tipo di approccio, si è riusciti a contenere efficacemente numerosi fenomeni di diffusione delle resistenze, altrove invece molto estesi.Infatti il microbiologo clinico oggi è parte integrante nella gestione delle infezioni nosocomiali con capacità di consulenza e continua disponibilità ad evolversi e rinnovarsi, ed in più è in grado di gestire i processi analitici in modo da fornire risultati rilevanti sul piano clinico, comprensibili e sfruttabili dai colleghi medici. E' dunque indispensabile sottolineare il “nuovo ruolo” del Laboratorio di Microbiologia clinica, e di conseguenza del microbiologo, nella corretta gestione delle malattie infettive, partendo soprattutto da un idoneo trattamento del campione microbiologico indispensabile al corretto svolgimento della fase analitica nonché alla stessa interpretazione dei risultati

Effectiveness of a Hospital-Based Computerized Decision Support System on Clinician Recommendations and Patient Outcomes: A Randomized Clinical Trial.

IMPORTANCE: Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients. OBJECTIVE: To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care. DESIGN, SETTING, AND PARTICIPANTS: Open-label, parallel-group, randomized clinical trial among internal medicine wards of a large Italian general hospital. All analyses in this randomized clinical trial followed the intent-to-treat principle. Between November 1, 2015, and December 31, 2016, patients were randomly assigned to the intervention group, in which CDSS-generated reminders were displayed to physicians, or to the control group, in which reminders were generated but not shown. Data were analyzed between February 1 and July 31, 2018. INTERVENTIONS: Evidence-Based Medicine Electronic Decision Support (EBMEDS), a commercial CDSS covering a wide array of health conditions across specialties, was integrated into the hospital electronic health records to generate patient-specific recommendations. MAIN OUTCOMES AND MEASURES: The primary outcome was the resolution rate, the rate at which medical problems identified and alerted by the CDSS were addressed by a change in practice. Secondary outcomes included the length of hospital stay and in-hospital all-cause mortality. RESULTS: In this randomized clinical trial, 20 563 patients were admitted to the hospital. Of these, 6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control). The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men. In total, 28 394 reminders were generated throughout the course of the trial (median, 3 reminders per patient per hospital stay; interquartile range [IQR], 1-6). These messages led to a change in practice in approximately 4 of 100 patients. The resolution rate was 38.0% (95% CI, 37.2%-38.8%) in the intervention group and 33.7% (95% CI, 32.9%-34.4%) in the control group, corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ between the groups, with a median time of 8 days (IQR, 5-13 days) for the intervention group and a median time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not differ between early and late study periods. CONCLUSIONS AND RELEVANCE: An international commercial CDSS intervention marginally influenced routine practice in a general hospital, although the change did not statistically significantly affect patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02577198

Acute GVHD prophylaxis plus ATLG after myeloablative allogeneic haemopoietic peripheral blood stem-cell transplantation from HLA-identical siblings in patients with acute myeloid leukaemia in remission : final results of quality of life and long-term outcome analysis of a phase 3 randomised study

Background We previously showed that human anti-T-lymphocyte globulin (ATLG) plus ciclosporin and methotrexate given to patients with acute leukaemia in remission, having allogeneic haemopoietic stem-cell transplantation with peripheral blood stem cells from an HLA-identical sibling donor after myeloablative conditioning, significantly reduced 2-year chronic graft-versus-host disease (cGVHD) incidence and severity, without increasing disease relapse and infections, and improves cGVHD-free and relapse-free survival (cGRFS). The aim of an extended follow-up study was the assessment of long-term outcomes, which are, in this context, scarcely reported in the literature. We report unpublished data on quality of life (QoL) from the original study and the results of a follow-up extension. Methods In the original open-label study, patients with acute myeloid and lymphoblastic leukaemia in first or subsequent remission, having sibling HLA-identical allogeneic peripheral blood stem-cell transplantation, were randomly assigned (1:1) to receive ATLG plus standard GVHD prophylaxis with ciclosporin and short-term methotrexate (ATLG group) or standard GVHD prophylaxis without ATLG (non-ATLG group). Conditioning regimens were cyclophosphamide 120 mg/kg with either total body irradiation (12 Gy) or busulfan (12 . 8 mg/kg intravenously or 16 mg/kg orally), with or without etoposide (30-60 mg/kg). Randomisation was stratified according to centre and disease risk. The primary endpoint was cumulative incidence of cGVHD at 2 years. The primary and secondary endpoints, excluding QoL, have been published. QoL, assessed using European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-HDC29 questionnaires, was an unpublished secondary endpoint, which we now report here. A follow-up extension was then done, with the primary endpoint cumulative incidence of cGVHD. Enrolment has been completed for both studies. Findings In the original study, from Dec 14, 2006, to Feb 2, 2012, 161 patients were enrolled and 155 were randomly assigned to either the ATLG group (n=83) or to the non-ATLG group (n=72). In the follow-up study, which started on Feb 7, 2017, and was completed on June 30, 2017, 61 patients were included in the ATLG group and 53 were included in the non-ATLG group. Global health status showed a more favourable time course in the ATLG group compared with the non-ATLG group (p=0 . 02; treatment by visit interaction). ATLG was descriptively superior to non-ATLG at 24 months for physical function (points estimate -14.8 [95% CI -26.4 to-3.1]; p= 0.014) and social function (-19.1 [-38.0 to -0.2]; p=0.047), gastrointestinal side-effects (8 . 8 [2.5-15.1]; p=0 . 008) and effect on family (13.5 [1.2-25.8]; p=0.032). Extended follow-up (median 5 . 9 years [IQR 1.7-7.9]) confirmed a lower 5-year cGVHD incidence (30.0% [95% CI 21.4-41.9] vs 69.1% [59.1-80.1]; analysis for entire follow-up, p Interpretation The addition of ATLG to standard GVHD prophylaxis improves the probability of surviving without disease relapse and cGVHD after myeloablative peripheral blood stem-cell transplantation from an HLA-identical sibling donor for patients with acute leukaemia in remission. Further additional benefits are better QoL and shorter immunosuppressive treatment compared with standard GVHD prophylaxis without ATLG. Therefore, in this setting, ATLG plus standard GVHD prophylaxis should be preferred over the standard GVHD prophylaxis alone. Copyright (C) 2019 Elsevier Ltd. All rights reserved.Peer reviewe

Padua prediction score and IMPROVE score do predict in&#8209;hospital mortality in Internal Medicine patients

Padua prediction score (PPS) and IMPROVE bleeding score are validated tools for venous thromboembolism (VTE) risk assessment recommended by guidelines, albeit not frequently used. Some data suggest that a positive PPS and IMPROVE score may be were associated with early mortality in Internal Medicine patients. Aim of the study was to characterize the predictive ability on mortality of the two scores using two different populations, respectively, as derivation and validation cohort. The derivation cohort consisted of 1956 Internal Medicine patients admitted to La Spezia Hospital in 2013. 399 Internal Medicine patients admitted to Carate Brianza Hospital in 2016 constituted the validation cohort. PPS and IMPROVE scores were applied to each patient using their validated cutoffs. Frequency of positive PPS and mortality were significantly higher in La Spezia patients. In the derivation cohort, the positivity of at least one of the two scores was associated with a significantly higher mortality compared to both negative scores. Similar results were observed in the validation cohort. In the derivation cohort, the sensitivity of a positive PPS score in predicting mortality was 0.97 (0.94, 0.98) but the specificity was 0.21 (0.19, 0.23), the negative likelihood ratio being 0.15. Sensitivity and specificity of a positive IMPROVE gave specular findings but the positive likelihood ratio was 2.19. The accuracy data in the validation cohort were in the same direction. Both PPS and IMPROVE are associated with in-hospital mortality but their additional predictive accuracy is modest. It is unlikely that both scores could be useful in clinical practice to predict death in hospitalized Internal Medicine patients

A Comparative Assessment of Quality of Life in Patients with Multiple Myeloma Undergoing Autologous Stem Cell Transplantation Through an Outpatient and Inpatient Model

Outpatient autologous stem cell transplantation (ASCT) has proven to be feasible in terms of physical morbidity and mortality outcomes, but little data exist on the impact of this procedure on quality of life (QoL). The purpose of this prospective, observational, longitudinal cohort study was to compare the effects of inpatient (n = 76) and outpatient (n = 64) modes of care on QoL in patients with multiple myeloma who underwent ASCT. Patients were treated according to their preference for the inpatient or outpatient model. QoL was assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) at baseline (7 days before ASCT; T1) and at days +7 (T2) and +30 (T3) after ASCT. Overall, inpatients achieved higher mean values at each time point (86.05 ± 15.54 at T1, 89.23 ± 19.19 at T2, and 87.96 ± 13.6 at T3) compared with outpatients (85.62 ± 14.51 at T1, 87.42 ± 23.41 at T2, and 83.98 ± 20.2 at T3), although the differences did not reach statistical significance. Inpatients showed higher mean scores than outpatients in physical well-being (7.67 ± 5.7, 15.44 ± 6.34, and 12.96 ± 6.03, respectively, versus 5.89 ± 4.33, 13.92 ± 7.05, and 8.84 ± 6.33, respectively; P  .05). Mean scores on social/family well-being were significantly higher in the outpatient group compared with the inpatient group (22.93 ± 13.29, 21.14 ± 5.31, and 21.64 ± 4.58, respectively, versus 20.59 ± 3.79, 19.52 ± 5.12, and 20.01 ± 3.97, respectively; P = .003). There were no significant between-group differences with respect to functional well-being and emotional status. Among adults at a single institution undergoing ASCT for MM, the use of outpatient care compared with standard transplantation care did not result in improved QoL during transplantation. Further research is needed for replication and to assess longer-term outcomes and implications

Very low rate of readmission after an early discharge outpatient model for autografting in multiple myeloma patients: an Italian multicenter retrospective study

none18We analyzed the main modalities and clinical outcomes of the early discharge outpatient model in autologous stem cell transplantation (EDOM-ASCT) for multiple myeloma in Italy. EDOM-ASCT was employed in 382 patients, for a total of 522 procedures, between 1998 and 2012. Our study showed high homogeneity among centers in terms of inclusion criteria, supportive care, and in hospital readmission criteria. Overall, readmissions during the aplastic phase occurred in 98 of 522 transplantations (18.8%). The major extrahematological complication was neutropenic fever in 161 cases (30.8%), which required readmission in 76 cases. The incidence of severe World Health Organization grade 3 to 4 mucositis was 9.6%. By univariate analysis, fever, mucositis, altered renal function at diagnosis, second transplantation, and transplantation performed late in the course of the disease were significantly correlated with readmission, whereas fever, mucositis, altered renal function, and timing of transplantation remained the only independent predictors by multivariate analysis. Overall, transplantation-related mortality was 1.0%. No center effect was observed in this study (P = .36). The safety and low rate of readmission of the EDOM-ASCT in myeloma trial suggest that this strategy could be extended to other transplantation centers if a stringent patient selection and appropriate management are applied.Martino, Massimo; Montanari, Mauro; Ferrara, Felicetto; Ciceri, Fabio; Scortechini, Ilaria; Palmieri, Salvatore; Marktel, Sarah; Cimminiello, Michele; Messina, Giuseppe; Irrera, Giuseppe; Offidani, Massimo; Console, Giuseppe; Castagna, Luca; Milone, Giuseppe; Bruno, Benedetto; Tripepi, Giovanni; Lemoli, Roberto Massimo; Olivieri, AttilioMartino, Massimo; Montanari, Mauro; Ferrara, Felicetto; Ciceri, Fabio; Scortechini, Ilaria; Palmieri, Salvatore; Marktel, Sarah; Cimminiello, Michele; Messina, Giuseppe; Irrera, Giuseppe; Offidani, Massimo; Console, Giuseppe; Castagna, Luca; Milone, Giuseppe; Bruno, Benedetto; Tripepi, Giovanni; Lemoli, Roberto Massimo; Olivieri, Attili

Thromboprophylaxis with Low-Molecular-Weight Heparins: An Assessment of the Methodological Quality of Studies

Low-molecular-weight heparin (LMWH) represents the standard of care for prophylaxis of venous thromboembolism (VTE). We conducted a review of the evidence supporting the use of the different LMWHs employed in VTE prophylaxis, in different clinical settings, and analyzed its progression over time. To evaluate the standards of methodological quality of studies, we elaborated a quality assessment tool. By electronic databases, PubMed, MEDLINE, and Scopus databases, 249 articles deemed eligible for the analysis were selected. Several LMWHs did not have publications in all clinical settings. Extended duration of prophylaxis was documented only for a few LMWH. The quality score yielded statistically significant differences between the medians of the four settings (p\u2009=\u20090.0021) with a higher score in major orthopedic surgery (median, 16; 95% confidence interval [CI], 15-16) when compared with general surgery (median, 14; 95% CI, 13-14; p\u2009<\u20090.001). Median score for studies published after the year 1990 was higher than for those published earlier (p\u2009<\u20090.001). We conclude that the quality of the studies supporting LMWH for VTE prophylaxis in the different clinical settings is not homogeneous and inferior for studies performed before the year 1990. Clinical interchangeability of LMWHs in clinical practice remains a critical issue, and the selection of a product should be based on evidence available for each agent, and for each clinical indication derived from clinical trial

Mini IRENE - Deployable Heat Shield For Suborbital Flight Test

MINI Irene is the Flight Demonstrator of IRENE, a new-concept capsule with a variable geometry, originally conceived by ASI to widen the range of available platforms to retrieve payloads and/or data from low Earth orbit. This paper, after a short introduction of the patented IRENE deployable heat shield concept and benefits, shows the ongoing activities that will lead to the sub-orbital flight. The description is focused on the structural activities, both numerical and experimental), and on the avionic systems