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

Risk of Venous Thromboembolism in Patients Nursed at Home or in Long-Term Care Residential Facilities

Background. This study investigated the prevalence of and impact of risk factors for deep venous thrombosis (DVT) in patients with chronic diseases, bedridden or with greatly limited mobility, cared for at home or in long-term residential facilities. Methods. We enrolled 221 chronically ill patients, all over 18 years old, markedly or totally immobile, at home or in long-term care facilities. They were screened at the bedside by simplified compression ultrasound. Results. The prevalence of asymptomatic proximal DVT was 18% (95% CI 13–24%); there were no cases of symptomatic DVT or pulmonary embolism. The best model with at most four risk factors included: previous VTE, time of onset of reduced mobility, long-term residential care as opposed to home care and causes of reduced mobility. The risk of DVT for patients with reduced mobility due to cognitive impairment was about half that of patients with cognitive impairment/dementia. Conclusions. This is a first estimate of the prevalence of DVT among bedridden or low-mobility patients. Some of the risk factors that came to light, such as home care as opposed to long-term residential care and cognitive deficit as causes of reduced mobility, are not among those usually observed in acutely ill patients

Investigation on Dabigatran Etexilate and Worsening of Renal Function in Patients with Atrial fibrillation : the IDEA Study

BACKGROUND AND OBJECTIVES: Warfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-treated patients to assess the incidence of dabigatran-related nephropathy and to investigate the possible correlation between dabigatran plasma concentration (DPC) and worsening renal function. METHOD: One hundred and seven patients treated long term with dabigatran etexilate for non-valvular atrial fibrillation (NVAF) were followed up for 90 days. DPC, serum creatinine (SCr) and serum cystatin C were prospectively measured. Ninety five patients had complete follow-up data and were evaluable for primary endpoint. RESULTS: Eleven patients had supratherapeutic DPC, defined as DPC higher than 200 ng/ml at study enrolment, but at the end of follow-up no patient showed a persistent increase in SCr. No patients experienced acute kidney injury. CONCLUSIONS: Our study shows that no persistent renal detrimental effect is associated with dabigatran treatment. An increase in SCr during dabigatran treatment is reversible and it seems to be unrelated to dabigatran itself

Patterns of treatment with antiplatelet therapy after an acute coronary syndrome: Data from a large database in a community setting

Aims Current guidelines strongly recommend antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor (dual therapy) for patients with acute coronary syndrome (ACS). To better understand how antiplatelet treatment is prescribed in clinical practice, the aim of this study was to provide a more detailed description of real-world patients with and without antiplatelet treatment after an ACS, their outcomes at one-year follow-up and the related integrated cost. Methods The ReS database, including more than 12 million inhabitants, was evaluated. During the accrual period ACS patients discharged alive were identified on the basis of ICD-IX-CM code. Antiplatelet drug prescriptions and healthcare costs were analysed over one-year follow-up. Results In 2014, of the 25,129 patients discharged alive after an ACS, 5796 (23%) did not receive any antiplatelet therapy during the first month after hospital discharge. Among them, 3846 (66%) subjects were prescribed an antiplatelet drug subsequently, while 7.7% did not receive any antiplatelet treatment during the whole following year. Dual therapy in the subgroup of patients undergoing a revascularization procedure ( n = 8436) was prescribed to 79.2% of cases and to 46.1% ( n = 4009) of medically managed patients. The patients not treated with an antiplatelet treatment in the first month showed the highest one-year healthcare costs, mostly due to hospital re-admissions. Conclusions This analysis of a large patient community shows that a considerable proportion of patients remained untreated with antiplatelet treatment after an ACS event. A clearer characterization of these subjects can help to improve the adherence to the current guidelines and recommendations

A discussion about multi-axial fatigue criteria for NiTinol cardiovascular devices

Nickel-Titanium (NiTinol) alloys exploit a typical super-elastic behavior which makes them suitable for many biomedical applications, among which peripheral stenting, requiring the device being subjected to the high mobility of the lower limbs. Unfortunately, this complex environment can lead to the device fatigue fracture with likely other more severe complications, e.g. restenosis. Standards require to experimentally verify stent fatigue life behavior, without giving indications on how to select the loads to be applied for resembling most critical in-vivo conditions. Moreover, different multi-axial fatigue criteria have been originally developed for standard metals to predict the behavior under cyclic loads, but none of them is specifically formulated for NiTinol. This paper presents a numerical study having two aims: i) understanding how non-proportional loading conditions due to combination of axial compression, bending and torsion induced at each patient gait on the femoro-popliteal artery affects the implanted stent stress/strain distribution; ii) understanding how stent fatigue life prediction may be affected by the choice of the fatigue criteria. Accordingly, two different peripheral stent geometries, resembling commercial ones, were analysed under different sets of loading conditions. The cyclic deformations induced over the device structure by macroscopic loads are interpreted through four different fatigue approaches recently used in Nitinol fatigue analyses: Von Mises, Fatemi-Socie, Brown-Miller and Smith-Watson-Topper. The comparison between the outputs highlights that they are strongly influenced by the loading path, recognizing the major role in fatigue due to the combined torsional and bending actions. On the other hand, the choice of the fatigue criterion impacts on the fatigue life prediction

The Florence Psychiatric Interview

The Florence Psychiatric Interview (FPI) is an interviewing instrument for evaluating psychopathology in the community. The FPI is designed to be completed by clinical interviewers, and focuses on single episodes of illness where the symptoms are assessed and graded according to their severity on five-point scales. Psychiatric symptoms are evaluated regardless of their diagnostic collocation, and period and lifetime diagnoses may be generated by combining the episodes and using the appropriate algorithms (the information provided by the FPI covers the requirements of all the present diagnostic systems). Other aspects of psychiatric disorders that are usually ignored in other interviews are investigated (for example, costs of illness, use of health facilities, life events, and personality traits). Data on reliability (inter-rater agreement and test-retest reliability) and agreement with other instruments such as the Composite International Diagnostic Interview (CIDI) and the Structured Clinical Interview for the Diagnostic and Statistic Manual of Mental Disorders (SCID) seem encouraging. The FPI's ability to collect lifetime symptoms by combining episodes matches that of an interview (the CIDI) that uses the lifetime approach. Agreement between fully qualified psychiatrists and trained residents was excellent. The ability of the cases to recall symptoms experienced several years before was also acceptable. This instrument is therefore proposed for clinical studies at the epidemiological level. Copyright © 2001 Whurr Publishers Ltd

Prevalence of peripheral arterial disease in subjects with moderate cardiovascular risk: Italian results from the PANDORA study Data from PANDORA (Prevalence of peripheral Arterial disease in subjects with moderate CVD risk, with No overt vascular Diseases nor Diabetes mellitus)

<p>Abstract</p> <p>Background</p> <p>The PANDORA study has recently examined the prevalence of low ankle brachial index (ABI) in subjects with moderate risk of cardiovascular disease. This sub-analysis of the PANDORA study examines the prevalence of asymptomatic peripheral arterial disease (PAD), as determined by ABI, in Italian subjects presenting with moderate cardiovascular risk, in the absence of diabetes or overt vascular disease.</p> <p>Methods</p> <p>PANDORA is a non-interventional, cross-sectional study that was performed in 6 European countries, involving subjects with at least one cardiovascular (CV) risk factor. The primary objective was to evaluate the prevalence of asymptomatic PAD using ABI. For this post-hoc sub-analysis, data were extracted for subjects enrolled in Italy, comprising 51.5% (n = 5298) of subjects from the original PANDORA study. Secondary objectives were to establish the prevalence and treatment of CV risk factors.</p> <p>Results</p> <p>The mean age was 63.9 years and 22.9% (95% CI 21.7-24.0) of subjects presented with asymptomatic PAD. A range of risk factors comprising smoking, hypertension, low HDL-cholesterol, family history of coronary heart disease and habit of moderate-high alcohol intake were significantly associated with asymptomatic PAD (p < 0.0001). Statin treatment had the lowest incidence in Italian subjects. Furthermore, patients treated with statins were significantly less likely to have asymptomatic PAD than those who were not (p = 0.0001).</p> <p>Conclusions</p> <p>Asymptomatic PAD was highly prevalent in Italian subjects, the majority of whom were not candidates for ABI assessment according to current guidelines. Findings from this study suggest that these patients should be carefully examined in clinical practice and ABI measured so that therapeutic interventions known to decrease their CV risk may be offered.</p> <p>Trial registration number</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00689377">NCT00689377</a></p

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

Clinical experience with ipilimumab 3&#160;mg/kg: real-world efficacy and safety data from an expanded access programme cohort.

Ipilimumab improves survival in patients with advanced melanoma. The activity and safety of ipilimumab outside of a clinical trial was assessed in an expanded access programme (EAP).Ipilimumab was available upon physician request for patients aged 16 or over with pretreated stage III (unresectable)/IV melanoma, for whom no other therapeutic option was available. Patients received ipilimumab 3 mg/kg every 3 weeks for four doses. Patients with stable disease or an objective response to ipilimumab were eligible for retreatment upon disease progression. Tumour assessments were conducted at baseline and week 12. Patients were monitored for adverse events (AEs) within 3 to 4 days of each scheduled visit.Of 855 patients participating in the EAP in Italy, 833 were evaluable for response. Of these, 13\% had an objective immune response, and the immune-related disease control rate was 34\%. Median progression-free survival and overall survival were 3.7 and 7.2 months, respectively. Efficacy was independent of BRAF and NRAS mutational status. Overall, 33\% of patients reported an immune-related AE (irAE). The frequency of irAEs was not associated with response to ipilimumab.Outside of a clinical trial setting, ipilimumab is a feasible treatment option in patients with pretreated metastatic melanoma, regardless of BRAF and NRAS mutational status. Data from this large cohort of patients support clinical trial evidence that ipilimumab can induce durable disease control and long-term survival in patients who have failed to respond to prior treatment