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OBJECTIVE: Selective fetal growth restriction (sFGR) occurs in monochorionic twin pregnancies when unequal placental sharing leads to restriction in the growth of just one twin. Management options include laser separation of the fetal circulations, selective reduction or expectant management, but what constitutes the best treatment is not yet known. New trials in this area are urgently needed but, in this rare and complex group, maximizing the relevance and utility of clinical research design and outputs is paramount. A core outcome set ensures standardized outcome collection and reporting in future research. The objective of this study was to develop a core outcome set for studies evaluating treatments for sFGR in monochorionic twins. METHODS: An international steering group of clinicians, researchers and patients with experience of sFGR was established to oversee the process of development of a core outcome set for studies investigating the management of sFGR. Outcomes reported in the literature were identified through a systematic review and informed the design of a three-round Delphi survey. Clinicians, researchers, and patients and family representatives participated in the survey. Outcomes were scored on a Likert scale from 1 (limited importance for making a decision) to 9 (critical for making a decision). Consensus was defined a priori as a Likert score of ≥ 8 in the third round of the Delphi survey. Participants were then invited to take part in an international meeting of stakeholders in which the modified nominal group technique was used to consider the consensus outcomes and agree on a final core outcome set. RESULTS: Ninety-six outcomes were identified from 39 studies in the systematic review. One hundred and three participants from 23 countries completed the first round of the Delphi survey, of whom 88 completed all three rounds. Twenty-nine outcomes met the a priori criteria for consensus and, along with six additional outcomes, were prioritized in a consensus development meeting, using the modified nominal group technique. Twenty-five stakeholders participated in this meeting, including researchers (n = 3), fetal medicine specialists (n = 3), obstetricians (n = 2), neonatologists (n = 3), midwives (n = 4), parents and family members (n = 6), patient group representatives (n = 3), and a sonographer. Eleven core outcomes were agreed upon. These were live birth, gestational age at birth, birth weight, intertwin birth-weight discordance, death of surviving twin after death of cotwin, loss during pregnancy or before final hospital discharge, parental stress, procedure-related adverse maternal outcome, length of neonatal stay in hospital, neurological abnormality on postnatal imaging and childhood disability. CONCLUSIONS: This core outcome set for studies investigating the management of sFGR represents the consensus of a large and diverse group of international collaborators. Use of these outcomes in future trials should help to increase the clinical relevance of research on this condition. Consensus agreement on core outcome definitions and measures is now required. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. ispartof: ULTRASOUND IN OBSTETRICS & GYNECOLOGY vol:55 issue:5 pages:652-660 ispartof: location:England status: published

ObjectiveThe aim of this study was to determine whether glutamic acid decarboxylase antibody (GADA) titer and other clinical parameters could define the risk of progression to insulin therapy in latent autoimmune diabetes in adults (LADA) patients during a 7-year follow-up.MethodsThis study involved 220 LADA and 430 type 2 diabetes subjects followed up for 7 years from the time of GADA screening to evaluate their progression toward insulin therapy. Kaplan–Meier curves and multivariate logistic regression analysis were performed to identify the markers capable of influencing this progression.ResultsDuring the follow-up, the drop out was 4% in both groups. A total of 119 (56.1%) out of 212 LADA patients required insulin during the 7 years of follow-up. The Kaplan–Meier plots showed that 74/104 (71.1%) of high GADA titer required insulin compared with 45/108 (41.6%) of low GADA titer and with 86/412 (20.9%) of type 2 diabetes (P2and IA-2ICand zinc transporter 8 (ZnT8) positivity were also shown as the markers of faster progression (PPPConclusionsHigh GADA titer, BMI ≤ 25, ZnT8 and IA-2ICpositivity and sulfonylurea treatment, in the first year from diagnosis, significantly increase the progression toward insulin requirement in LADA patients.

From January 28th to February 10th, 2008 the Italian Society of Cardiac Rehabilitation and Prevention (GICR) conducted a national web-based survey aimed to provide specific and updated information on organization and core components of cardiac rehabilitation (CR) in Italy, and to describe, both in residential and out-patient settings, indications for CR, clinical characteristics of referred patients, risk profile, performed diagnostic procedures, exercise and educational programme, treatments and arrangements for the follow-up [1, 2]. The ISYDE-2008 is a multicenter, longitudinal, prospective observation study whose design was previously described [1, 2].

Introduction. Folic acid (FA) supplementation is recommended worldwide in the periconceptional period for the prevention of neural tube defects. Due to its involvement in a number of cellular processes, its role in other pregnancy outcomes such as miscarriage, recurrent miscarriage, low birth weight, preterm birth (PTB), preeclampsia, abruptio placentae, and stillbirth has been investigated. PTB is a leading cause of perinatal mortality and morbidity; therefore its association with FA supplementation is of major interest. The analysis of a small number of randomized clinical trials (RCTs) has not found a beneficial role of FA in reducing the rate of PTBs.Aim of the Study. The aim of this review was to examine the results from recent observational studies about the effect of FA supplementation on PTB.Materials and Methods. We carried out a search on Medline and by manual search of the observational studies from 2009 onwards that analyzed the rate of PTB in patients who received supplementation with FA before and/or throughout pregnancy.Results. The results from recent observational studies suggest a slight reduction of PTBs that is not consistent with the results from RCTs. Further research is needed to better understand the role of FA supplementation before and during pregnancy in PTB.

To compare pain associated with vaginal dinoprostone pessary vs. gel for induction of labor in women with an unfavorable cervix.A randomized controlled trial in a large academic public general hospital. A total of 52 nulliparous women of gestational age ≥ 38 weeks, with Bishop score ≤ 4 and intact membranes were allocated either to a controlled-release vaginal dinoprostone pessary or repeat doses of vaginal dinoprostone gel. Pain was recorded hourly from early induction until the onset of labor.Mean pain experienced by women belonging to the two groups differed significantly (p0.01). Women in the controlled-release device group were also significantly more often severe pain-free than women receiving gel (p0.05). Both methods had similar rates of oxytocin infusion and vaginal deliveries.The two induction procedures should be considered equivalent as far as ripening the cervix and initiating labor. In view of this finding, the low Bishop score should be considered an indication to prefer the controlled-release device, since it reduces pain thereby improving the physical and emotional wellbeing of the parturient.

Background A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the ‘conscious target’: patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs. Methods/Design A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses. Discussion This ‘educational research’ project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake. Trial registration number Clinicaltrials.gov #NCT01360346

Latent autoimmune diabetes in adults (LADA) includes a heterogeneous population wherein, based on glutamic acid decarboxylase antibody (GADA) titer, different subgroups of subjects can be identified. OBJECTIVE: The aim of the present study was to evaluate GADA titer-related risk for β-cell and other organ-specific autoimmunity in LADA subjects. METHODS: Adult-onset autoimmune diabetes subjects (n=236) and type 2 diabetes (T2DM) subjects (n=450) were characterized for protein tyrosine phosphatase (IA-2IC and IA-2(256-760)), zinc transporter 8 (ZnT8), thyroid peroxidase, (TPO), steroid 21-hydroxylase (21-OH), tissue transglutaminase (tTG), and antiparietal cell (APC) antibodies. RESULTS: High GADA titer compared to low GADA titer showed a significantly higher prevalence of IA-2IC, IA-2(256-760), ZnT8, TPO, and APC antibodies (P≤0.04 for all comparison). 21-OH antibodies were detected in 3.4% of high GADA titer. A significant decreasing trend was observed from high GADA to low GADA and to T2DM subjects for IA-2(256-760), ZnT8, TPO, tTG, and APC antibodies (P for trend≤0.001). TPO was the only antibody showing a different prevalence between gender; low GADA titer and T2DM female patients had a higher frequency of TPO antibody compared to males (P=0.0004 and P=0.0006, respectively), where the presence of high GADA titer conferred an odds ratio of 8.6 for TPO compared to low GADA titer. After subdividing high and low GADA titer subjects according to the number of antibodies, we observed that 73.3% of high GADA titer subjects were positive for at least one or more antibodies, compared to 38.3% of low GADA titer (P

Background: Hypertensive disorders in pregnancy (HDP) are associated with altered maternal haemodynamics, which can be investigated using non-invasive methodologies.Objective: To assess maternal ha...

Background Secondary prevention is not adequately implemented after myocardial infarction (MI). We assessed the effect on quality of care and prognosis of a long-term, relatively intensive rehabilitation strategy after MI. Methods We conducted a multicenter, randomized controlled trial in patients following standard post-MI cardiac rehabilitation, comparing a long-term, reinforced, multifactorial educational and behavioral intervention with usual care. A total of 3241 patients with recent MI were randomized to a 3-year multifactorial continued educational and behavioral program (intervention group; n = 1620) or usual care (control group; n = 1621). The combination of cardiovascular (CV) mortality, nonfatal MI, nonfatal stroke, and hospitalization for angina pectoris, heart failure, or urgent revascularization procedure was the primary end point. Other end points were major CV events, major cardiac and cerebrovascular events, lifestyle habits, and drug prescriptions. Results End point events occurred in 556 patients (17.2%). Compared with usual care, the intensive intervention did not decrease the primary end point significantly (16.1% vs 18.2%; hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.74-1.04). However, the intensive intervention decreased several secondary end points: CV mortality plus nonfatal MI and stroke (3.2% vs 4.8%; HR, 0.67; 95% CI, 0.47-0.95), cardiac death plus nonfatal myocardial infarction (2.5% vs 4.0%; HR, 0.64; 95% CI, 0.43-0.94), and nonfatal MI (1.4% vs 2.7%; HR, 0.52; 95% CI, 0.31-0.86). A marked improvement in lifestyle habits (ie, exercise, diet, psychosocial stress, less deterioration of body weight control) and in prescription of drugs for secondary prevention was seen in the intervention group. Conclusion The GOSPEL Study is the first trial to our knowledge to demonstrate that a multifactorial, continued reinforced intervention up to 3 years after rehabilitation following MI is effective in decreasing the risk of several important CV outcomes, particularly nonfatal MI, although the overall effect is small. Trial Registration ClinicalTrials.gov Identifier:NCT00421876

Background: Patients with septic shock by multidrug resistant (MDR) microorganism maybe considered a specific population of critical patients at very high risk of death in whom the effects of standard sepsis treatment has never been assessed. The objective of this retrospective analysis was to evaluate the risk factors for 30-day mortality and the impact of sepsis management in patients with septic shock caused by MDR bacteria. Methods: Patients with septic shock by MDR bacteria admitted to the mixed intensive care unit (ICU) of Modena University Hospital during a 6-year period were studied. The clinical and microbiological characteristics and sepsis treatments provided were analyzed and compared between survivors (S) and nonsurvivors (NS) at 30 days after septic shock appearance. Results: Ninety-four patients were studied. All therapeutic interventions applied to patients during their ICU stay did not show statistical significance between S and NS groups, except for administration of immunoglobulin M (IgM) preparation which were provided more frequently in S group ( P < .05). At the multivariate adjusted analysis, preexisting cancer (odds ratio [OR] = 2.965) and Acinetobacter baumannii infections (OR = 3.197) were independently correlated with an increased risk of 30-day mortality, whereas treatment with IgM preparation was protective (OR = 0.283). Conclusions: This retrospective study showed that in patients with septic shock caused by MDR bacteria, history of cancer and infection sustained by A baumannii increase the risk of mortality and that standard sepsis treatments do not seem to provide any protective effect. Adjunctive therapy with IgM preparation seems to be beneficial, but further appropriate studies are needed to confirm the results observed.

In previous papers, we have argued that a close connection may exist between the discontinuous northward displacement of the Adria plate and the spatio-temporal distribution of major earthquakes in the periAdriatic regions [1]-[3]. In particular, five seismic sequences are tentatively recognized in the post 1400 A.D. seismic history, each characterized by a progressive migration of major shocks along the eastern (Hellenides, Dinarides), western (Apennines) and northern (Eastern Southern Alps) boundaries of Adria. In this work, we describe an attempt at gaining insights into the short-term evolution of the strain field that underlies the migration of seismicity in the Apennine belt. The results of this study suggest that seismicity in the study area is mainly conditioned by the fact that the outer (Adriatic) sector of the Apennine belt, driven by the Adria plate, is moving faster than the inner (Tyrrhenian) belt. This kinematics is consistent with the observed Pleistocene deformation pattern and the velocity field inferred by GPS data. The spatio-temporal distribution of major shocks during the last still ongoing seismic sequence (post 1930) suggests that at present the probability of next major shocks is highest in the Northern Apennines. Within this area, we suggest that seismic hazard is higher in the zones located around the outer sector of the Romagna-Marche-Umbria units (RMU), since that wedge is undergoing an accelerated relative motion with respect to the inner Apennine belt. This hypothesis may also account for the pattern of background seismicity in the Northern Apennines. This last activity might indicate that the Upper Tiber Valley fault system is the most resisted boundary sector of the RMU mobile wedge, implying an higher probability of major earthquakes.

BACKGROUND: The performances of 2 noninvasive CPAP systems (high flow and low flow air-entrainment masks) were compared to the Boussignac valve in 3 different scenarios. METHODS: Scenario 1: pneumatic lung simulator with a tachypnea pattern (tidal volume 800 mL at 40 breaths/ min). Scenario 2: Ten healthy subjects studied during tidal breaths and tachypnea. Scenario 3: Twenty ICU subjects enrolled for a noninvasive CPAP session. Differences between set and effective CPAP level and F IO2 , as well as the lowest airway pressure and the pressure swing around the imposed CPAP level, were analyzed. The lowest airway pressure and swing were correlated to the pressure-time product (area of the airway pressure curve below the CPAP level) measured with the simulator. PaO2 was a subject’s further performance index. RESULTS: Lung simulator: Boussignac FIO2 was 0.54, even if supplied with pure oxygen. The air-entrainment masks had higher swing than the Boussignac (P .007). Pressure-time product correlated better with pressure swing (Spearman correlation coefficient [] 0.97) than with lowest airway pressure ( 0.92). In healthy subjects, thehigh-flowair-entrainmentmaskshowedlowerdifferencebetweensetandeffectiveFIO2 (P

The geodetic data acquired in the last 10 years by a fairly dense network of permanent GPS stations located in Central and Northern Italy are used to reconstruct the present horizontal velocity field in the study area and to evaluate the coseismic and postseismic effects of the recent L’Aquila earthquake (April 6, 2009 Mw = 6.3). The distribution of geodetic velocities indicates that during the observation period the outer Adriatic sector of the Central and Northern Apennines has moved faster than the surrounding zones. It is pointed out that this short term kinematic behaviour is compatible with the long term kinematics indicated by the post-early Pleistocene deformation pattern observed in the central Mediterranean area. The short term kinematic pattern in the Central Apennines has been perturbed by the L’Aquila earthquake. The daily position time series of the sites located within 140 km from the epicentre show a coseismic offset followed by a non linear time dependent displacement which gradually vanishes in 1–3 months, after which the trend of daily positions seems to become linear again. The non linear transient phase has been modelled by a decaying exponential function, possibly connected with postseismic viscoelastic relaxation. The displacements developed during this last phase are rather different from coseismic displacements. Also, the velocities tentatively deduced from the postseismic linear trends (observed for about 17 months) show quite different orientations with respect to both coseismic and short term postseismic displacements. This evidence suggests that the tectonic processes which developed in the Central Apennines after the L’Aquila event were complex, possibly related to shallow afterslip, deeper aseismic slip and viscoelastic relaxation of the lower crust and/or uppermost mantle.

In pseudophakic eyes, isolated total aniridia after nonperforating blunt trauma, without any apparent dehiscence or extension of the cataract incision, has been rarely reported in the literature. 1-5 Here we describe a case of posttraumatic massive hyphema followed by complete aniridia in a patient who had undergone cataract surgery 18 months before. A comprehensive diagnostic assessment, including ultrasound biomicroscopy (UBM; ie, 50-MHz single-element mechanical sector scanner) was performed within few days of hyphema reabsorption. To our knowledge, UBM findings of this condition have not been documented previously.

PURPOSE. To report the spectral domain (SD) findings in a retinal fold secondary to vitrectomy surgery. METHODS. A 57-year-old man presented 1 month after vitrectomy surgery with gas injection (C(3)F(8) 6%) in his left eye for treatment of a macula-on retinal detachment and was noted to have a retinal fold in the superior aspect of the macula. Complete ocular examination, fundus photography, fluorescein angiography, autofluorescence, and SD optical coherence tomography (OCT) were performed. RESULTS. Spectral domain OCT revealed a slightly hyperreflective lesion in the outer retina, which occupied a discontinuity in the inner segment-outer segment junction and extended superiorly with apparent indentation of the overlying retinal layers. CONCLUSIONS. This case illustrates how SD OCT may be useful in describing the morphologic substrate of retinal fold after retinal surgery.