Professional liability in orthopaedics and traumatology in Italy.

BACKGROUND: Interest in medical errors has increased during the last few years owing to the number of medical malpractice claims. Reasons for the increasing number of claims may be related to patients' higher expectations, iatrogenic injury, and the growth of the legal services industry. Claims analysis provides helpful information in specialties in which a higher number of errors occur, highlighting areas where orthopaedic care might be improved. QUESTIONS/PURPOSES: We determined: (1) the number of claims involving orthopaedics and traumatology in Rome; (2) the risk of litigation in elective and trauma surgery; (3) the most common surgical procedures involved in claims and indemnity payments; (4) the time between the adverse medical event and the judgment date; and (5) issues related to informed consent. METHODS: We analyzed 1925 malpractice judgments decided in the Civil Court of Rome between 2004 and 2010. RESULTS: In total, 243 orthopaedics claims were filed, and in 75% of these cases surgeons were found liable; 149 (61%) of these resulted from elective surgery. Surgical teams were sued in 30 claims and found liable in 22. The total indemnity payment ordered was more than €12,350,000 (USD 16,190,000). THA and spinal surgery were the most common surgical procedures involved. Inadequate informed consent was reported in 5.3% of cases. CONCLUSIONS: Our study shows that careful medical examination, accurate documentation in medical records, and adequate informed consent might reduce the number of claims. We suggest monitoring of court judgments would be useful to develop prevention strategies to reduce claims.

Pharmacokinetics of colistin in cerebrospinal fluid after intraventricular administration of colistin methanesulfonate.

Intraventricular colistin, administered as colistin methanesulfonate (CMS), is the last resource for the treatment of central nervous system infections caused by panresistant Gram-negative bacteria. The doses and daily regimens vary considerably and are empirically chosen; the cerebrospinal fluid (CSF) pharmacokinetics of colistin after intraventricular administration of CMS has never been characterized. Nine patients (aged 18 to 73 years) were treated with intraventricular CMS (daily doses of 2.61 to 10.44 mg). Colistin concentrations were measured using a selective high-performance liquid chromatography (HPLC) assay. The population pharmacokinetics analysis was performed with the P-Pharm program. The pharmacokinetics of colistin could be best described by the one-compartment model. The estimated values (means ± standard deviations) of apparent CSF total clearance (CL/Fm, where Fm is the unknown fraction of CMS converted to colistin) and terminal half-life (t(1/2λ)) were 0.033 ± 0.014 liter/h and 7.8 ± 3.2 h, respectively, and the average time to the peak concentration was 3.7 ± 0.9 h. A positive correlation between CL/Fm and the amount of CSF drained (range 40 to 300 ml) was observed. When CMS was administered at doses of ≥5.22 mg/day, measured CSF concentrations of colistin were continuously above the MIC of 2 µg/ml, and measured values of trough concentration (C(trough)) ranged between 2.0 and 9.7 µg/ml. Microbiological cure was observed in 8/9 patients. Intraventricular administration of CMS at doses of ≥5.22 mg per day was appropriate in our patients, but since external CSF efflux is variable and can influence the clearance of colistin and its concentrations in CSF, the daily dose of 10 mg suggested by the Infectious Diseases Society of America may be more prudent.

Changing epidemiology of acute liver failure in Italy: a single-center experience over 25 years.

BACKGROUND: Acute liver failure (ALF) is a rare but often lethal syndrome. In Italy, recent data on its incidence and causes are lacking. We report here the epidemiological analysis of ALF cases observed in Campania, a Southern Italian region, over the last 25 years. METHODS: Medical records of ALF cases hospitalized from 1992 to 2018 were retrospectively analyzed. RESULTS: Two hundred ten ALF cases occurred during 1992-2018: 103 (49%) hepatitis B virus (HBV)-related (including 5 cases also infected with Delta virus), 39 (19%) from undetermined cause, 36 (17%) drug-induced, 11 (5%) Wilson's disease-associated, 8 (4%) hepatitis A virus (HAV)-related and 12 (6%) from other causes. Separate time-periods analysis of data showed a significant progressive decrease in ALF incidence mainly attributable to a decline of HBV and other viruses etiology. Already before 2010, HAV or Delta virus-related cases have no longer been observed. No hepatitis C or E virus-related ALF was detected through the study period. A progressive decrease in frequency of ALF due to undetermined causes or drug was also evident. CONCLUSIONS: A decrease in ALF incidence and a changing in its etiology were observed in Campania during 1992-2018. Both results were likely mainly due to 1991 introduction of HBV universal vaccination and may be considered generalizable nationwide.

Use of colistin in adult patients: A cross-sectional study.

OBJECTIVES: The aim of this study was to assess colistin use in a country endemic for multidrug-resistant Gram-negative bacteria (MDR-GNB). METHODS: Colistin prescription patterns were evaluated in 22 Italian centres. Factors associated with use of colistin in combination with other anti-MDR-GNB agents were also assessed. RESULTS: A total of 221 adults receiving colistin were included in the study. Their median age was 64 years (interquartile range 52-73 years) and 134 (61%) were male. Colistin was mostly administered intravenously (203/221; 92%) and mainly for targeted therapy (168/221; 76%). The most frequent indications for colistin therapy were bloodstream infection and lower respiratory tract infection. Intravenous colistin was administered in combination with at least another anti-MDR-GNB agent in 80% of cases (163/203). A loading dose of 9 MU of colistimethate was administered in 79% of patients receiving i.v. colistin and adequate maintenance doses in 85%. In multivariable analysis, empirical therapy [odds ratio (OR) = 3.25, 95% confidence interval (CI) 1.24-8.53;P = 0.017] and targeted therapy for carbapenem-resistant Enterobacterales infection (OR = 4.76, 95% CI 1.69-13.43; P = 0.003) were associated with use of colistin in combination with other agents, whilst chronic renal failure (OR = 0.39, 95% CI 0.17-0.88; P = 0.024) was associated with use of colistin monotherapy. CONCLUSION: Colistin remains an important option for severe MDR-GNB infections when other treatments are not available. Despite inherent difficulties in optimising its use owing to peculiar pharmacokinetic/pharmacodynamic characteristics, colistin was mostly used appropriately in a country endemic for MDR-GNB.

Syndrome of inappropriate anti-diuretic hormone secretion in cancer patients: results of the first multicenter Italian study.

BACKGROUND: Hyponatremia in cancer patients is often caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The aim of this observational multicenter study was to analyze the medical and economic implications of SIADH in this setting. METHODS: This study included 90 oncological patients from 28 Italian institutions that developed SIADH between January 2010 and September 2015. Data on clinical-pathological characteristics, anticancer therapies, hyponatremia, and related treatments were statistically analyzed. RESULTS: The majority were lung cancer patients (73%) with metastatic disease at the onset of hyponatremia (83%). A total of 76 patients (84%) were hospitalized because of SIADH and less than half (41%) received tolvaptan for SIADH treatment. The duration of hospitalization was significantly longer in patients who did not receive tolvaptan and in those who do not reach sodium normalization during hospitalization. Patients who experienced a second episode of hyponatremia following tolvaptan dose modification/discontinuation presented a significantly lower serum sodium value at the time of hospitalization and minimum sodium value during hospitalization compared with patients who had not experienced another episode. The severity of hyponatremia, defined as minimum sodium value during hospitalization with a cut-off value of 110 mmol/l, and not obtaining sodium correction during hospitalization significantly correlated with overall survival rate. CONCLUSIONS: Hyponatremia due to SIADH could result in longer hospitalization and in a decreased overall survival when not adequately treated, and tolvaptan represents an effective treatment with a potential effect of both improving overall survival and decreasing duration of hospitalization.

Intraoperative Neurological Monitoring With Evoked Potentials During Carotid Endarterectomy Versus Cooperative Patients Under General Anesthesia Technique: A Retrospective Study.

INTRODUCTION: The best technique to evaluate contralateral carotid flow during carotid endarterectomy (CEA) is still debated; an accurate detection of efficient contralateral blood flow can avoid unnecessary shunt placement and its complications. The aim of this retrospective observational study was to evaluate and compare the safety and efficacy of general anesthesia with motor-evoked potential and somatosensory-evoked potentials (mSSEP and tcMEP) versus cooperative patients under general anesthesia (CPGA) technique for CEA. Primary outcome was the rate of technical failure. The procedural time and shunt incidence between the 2 neuromonitoring strategies were also analyzed. PATIENTS AND METHODS: A total of 331 patients who consecutively underwent CEA were included (100 patients in the CPGA group and 231 in the mSSEP+tcMEP group). The anesthesia technique was customized according to the cerebral monitoring needs. Comparison between groups was performed along with risk analysis. RESULTS: Electrophysiological monitoring seems to be a safe and effective strategy of neuromonitoring during CEA. Compared with the CPGA technique, it ensures fewer technical failures, reduces surgical and anesthesiological time and, moreover, it may reduce shunt risk/incidence. The incidence of shunt between the CPGA group and mSSEP+tcMEP was statistically different (CPGA 12%, mSSEP+tcMEP 5.2%; P=0.02), and the relative risk reduction in the mSSEP+tcMEP group, compared with the CPGA group, was 0.57. CONCLUSIONS: mSSEP and tcMEP neuromonitoring was associated with less technical failure and procedural time than asleep-awake-asleep strategy. The evoked potential neuromonitoring may be an alternative technique to awake clinical assessment during CEA.

Performances of CPAP Devices With an Oronasal Mask.

BACKGROUND: The aim of this bench study was to investigate the performances of 8 devices for noninvasive CPAP. METHODS: Eight devices for noninvasive CPAP with an orofacial mask were studied: Ventumask, Ventumask 30, EasyVent, EasyVent Emergency, Compact Model II, Flowone, Superflow, Boussignac CPAP valve. Each device was tested at oxygen input flows from 5 to 20 L/min, and the output gas flow was measured in static conditions. Each device was evaluated during a eupneic and a tachypneic simulated breathing test. RESULTS: The gas output flow generated by each device increased with higher oxygen input flow; EasyVent and Flowone produced the highest output flow (P < .001). At the simulated eupneic breathing test, Superflow and EasyVent showed a more stable pressure swing at different PEEP levels, whereas the other masks had a greater swing, between 10 and 15 cm H2O PEEP (P = .002 for all pairwise comparisons). During the tachypneic breathing test, the pressure swing was stable with Flowone and EasyVent (P = .055), whereas it had increased with other masks (P = .002 for all pairwise comparisons). CONCLUSIONS: We found a significant variation in the performances of the 8 CPAP devices examined in this study. The technical characteristics and limitations of different CPAP devices should be considered when using in patients with hypoxemic acute respiratory failure.