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ISSN (Online) 2465-2628
Published by AboutScience Srl Homepage  [4 journals]
  • Altmetrics, Beamplots, Plum X Metrics and friends: discovering the new
           waypoints in the Science Metrics roadmap

    • Authors: Valeria Scotti
      Pages: 1 - 2
      PubDate: 2022-01-19
      DOI: 10.33393/ao.2022.2363
      Issue No: Vol. 9 (2022)
       
  • Health Policy Brief: i pilastri dell’Engagement in Emofilia

    • Authors: Guendalina Graffigna, Serena Barello, Caterina Bosio, Chiara Biasoli, Andrea Buzzi, Cristina Cassone, Luigi Ambroso, Patrizia Di Gregorio, Lorenzo Farace, Paola Giordano, Renato Marino, Irene Ricca, Angiola Rocino
      Pages: 3 - 9
      Abstract: About 5000 people in Italy suffer from hemophilia, the most common coagulation disorder. As for other chronic diseases, even in the case of hemophilia, the engagement of the patient is essential: the patients, in fact, must be empowered and helped to become strong partners of the care team and sensitized with respect to their rights and duties for the successful achievement of the goals set by their healthcare path. Hence the initiative to start a new research-intervention project in the field of hemophilia. The study had different phases of research: a first moment inspired by the principles of narrative medicine, aimed at collecting stories and narratives of patients with hemophilia related to the experience of the disease and therapy and expectations of active involvement in the relationship with the clinician. At the same time, among hematologists and patients has been surveyed the experience of therapeutical relationship and communication, to capture the aspects in which they feel effective and the areas of improvement and unmet needs. Subsequently, a workshop dedicated to patients and hematologists was organized to foster mutual awareness between these two targets and the formation of a better communication and relational skills of clinicians. The results of the project formed the basis for a policy brief document, aimed at disseminating recommendations to support better relationship and empathic communication between clinicians and patients.
      PubDate: 2022-01-19
      DOI: 10.33393/ao.2022.2319
      Issue No: Vol. 9 (2022)
       
  • Introducing the “How to …” review article series

    • Authors: Giacomo Bellani, Giulio Zuanetti
      Pages: 10 - 10
      PubDate: 2022-04-11
      DOI: 10.33393/ao.2022.2411
      Issue No: Vol. 9 (2022)
       
  • A mixed reality telemedicine system for collaborative ultrasound
           diagnostics and ultrasound-guided interventions

    • Authors: Stefan Maas, Peter Kopacsi, Peter Kovacs, Arnaud Bosteels
      Pages: 15 - 20
      Abstract: In acute care settings (emergency room [ER], intensive care unit [ICU], operating room [OR]), it is common for inexperienced physicians to have problems making an ultrasound (US) diagnosis, so they have to consult an expert. In this article, we would like to present a methodology by which geographically independent expert physicians can engage during an US examination through virtual and augmented reality. The expert can view the set-up and the US images obtained by the examiner and discuss the clinical case over video chat. In turn, s/he can advise on the proper positioning of the US transducer on the patient with the help of a virtual US transducer. This technology can be used to obtain experts’ opinion from a remote location, whether it is inside a hospital or many miles away. Similarly, it can be used for distant training; whatever the indication, it will lead to improved care. We discuss two different use cases inside an ER: US for a Focused Assessment with Sonography in Trauma (FAST) examination and US for the insertion of a central venous catheter (CVC). Currently, we position this technology to Technology Readiness Level 2, as the concept is formulated and the practical application is identified. The basic properties of algorithms are defined and the basic principles are coded. We performed experiments with parts of the technology in an artificial environment. We asked a doctor, Arnaud Bosteels, to review this method and create this article together.
      PubDate: 2022-04-20
      DOI: 10.33393/ao.2022.2394
      Issue No: Vol. 9 (2022)
       
  • Guideline proposal for pharma companies to manage pharmacovigilance
           activities in digital media

    • Authors: Daniela Bernardini, Ilenia Bocchi, Stefano Bonato, Davide Bottalico, Valentina Calderazzo, Carmela Casino, Gian Nicola Castiglione, Carla Cottone, Stefania Dellon, Ilaria Grisoni, Amanda Mattavelli, Giacomo Pirisino, Silvia Romano, Grazia Sirizzotti, Lisa Stagi, on behalf of the SIMeF Working Group
      Pages: 21 - 28
      Abstract: Internet has become a central part of our everyday lives. Digital media are integrated in our daily routines and play a critical role in the dissemination of public health information and disease prevention guidelines. For this reason, digital activities are becoming more and more impacting in pharma company activities and this is an increasing trend after the pandemic period. Managing digital activities from pharmacovigilance (PV) perspective may have challenges linked to correct assessment of the activities and application of PV rules: this was underlined in recent publications, where the need to have more specific guidelines linked to digital activities management was evidenced. Considering this scenario and the continuous evolution of the digital activities, the SIMEF PV working group decided to work on a proposal guideline to provide support to PV departments in pharma companies, suggesting a framework to manage sponsored digital activities (i.e., website, web apps, social media webpage, chatbots) impacting potential collection of adverse events (AEs). The purpose of this guideline is to provide useful instructions on how to manage PV requirements for digital activities, suggesting potential solutions for assessing initiatives, creating governance framework, conducting a correct vendor management, and suggesting practical approaches for AEs reporting and follow-up. The aim of this document is also to trigger a broader discussion among relevant stakeholders on which PV guidelines may be useful and appropriate considering this continuous evolving scenario.
      PubDate: 2022-04-21
      DOI: 10.33393/ao.2022.2401
      Issue No: Vol. 9 (2022)
       
  • Psoriasis at the time of COVID-19: results of an Italian survey on
           patients and caregivers

    • Authors: Valeria Dealessi, Giovanni Gigante, Claudia Leporati, Ugo G. Viora
      Pages: 29 - 35
      Abstract: Methods: A multiple-choice survey, addressing the first and the second waves of COVID-19 pandemic, was administered to psoriatic patients and their caregivers, to evaluate demographics, clinical data, patient’s perception and psychological impact with respect to the assistance received. Patient’s engagement was evaluated through Social Media interactions (reach and engagement of Facebook and Instagram about the website “La pelle conta”, lapellaconta.it). Results: Preliminary results of the survey spanned in the time period from 30/9/2020 to 11/3/2021. Out of 852 patients, 83% were women. Seventy-three percent of patients declared that living with the disease worsened during the pandemic, with the onset or exacerbation of anxiety, stress, sense of helplessness, sadness and distress. A worsening in the assistance from the healthcare system was reported by 54% of the psoriatic patients. Two hundred fifteen caregivers took part to the survey and 84% were women. During the pandemic, a worsening in the symptoms of the patients was noted by 69% of the caregivers, and they also experienced sense of helplessness, anxiety, stress, sadness and distress themselves. Conclusions: Although both the patients and the caregivers registered a worsening of symptoms and of quality of assistance and an increase of anxiety during the pandemic, in most of the cases the patients and their families were able to face difficulties, improving their relationship. The caregivers are central for patient assistance but they cannot be left alone.
      PubDate: 2022-05-05
      DOI: 10.33393/ao.2022.2393
      Issue No: Vol. 9 (2022)
       
  • Cost analysis comparison of rurioctocog alfa pegol compared to turoctocog
           alfa pegol in the prophylaxis of Haemophilia A in Italy

    • Authors: Federica Demma, Pierpaola Arpa
      Pages: 36 - 42
      Abstract: Background: Hemophilia-A is an X-linked genetic disorder arising from a mutation to the X chromosome and causing either a quantitative or qualitative deficiency in blood clotting factor-VIII (FVIII). Several recombinant extended half-life FVIII products (rFVIII-EHL) are in use in Italy for the treatment of hemophilia-A. Objective: To estimate the annual average cost of the prophylactic treatment of a patient with hemophilia-A in Italy with rurioctocog alfa pegol or turoctocog alfa pegol, with particular regard to potential dose adjustments as provided in the SPCs. Methods: The comparison between the two rFVIII-EHL, expressed in terms of average annual cost per patient treated, was conducted from the NHS perspective. The average annual consumption (IU/kg) of the two rFVIII-EHL was derived from the clinical trial of reference for in label prophylactic treatment. Adjustments of doses and administration intervals allowed in the SPCs were considered on the basis of the literature. The published ex-factory price considered for both rFVIII-EHL was € 0.72. A scenario analysis focused on possible dosing adjustments was conducted. Results: With regard to the average consumption associated with the posology in label, the average annual treatment cost is almost the same between the two rFVIII-EHL. Whereas taking into account the possible dose adjustments based on once-weekly administration, rurioctocog alfa pegol shows a considerably lower average annual treatment cost compared to turoctocog alfa pegol (– € 42,719). Conclusions: Rurioctocog alfa pegol would be the more sustainable option, based on the annual average cost, for the NHS in the prophylactic treatment of hemophilia-A.
      PubDate: 2022-06-06
      DOI: 10.33393/ao.2022.2405
      Issue No: Vol. 9 (2022)
       
  • New trends in clinical trials—between complexity and the need for
           renewal

    • Authors: Celeste Cagnazzo
      Pages: 42 - 44
      PubDate: 2022-06-21
      DOI: 10.33393/ao.2022.2437
      Issue No: Vol. 9 (2022)
       
  • What will remain of the Impact Factor'

    • Authors: Valeria Scotti
      Pages: 45 - 46
      Abstract: This year the new 2022 version of Clarivate’s impact factor profoundly changed the setup for some journals. Compli­cated by the pandemic, the introduction of early access into the tally of articles lead to the question of whether impact factors can still be considered the most important parameter for traditional bibliometric evaluations.
      PubDate: 2022-07-26
      DOI: 10.33393/ao.2022.2467
      Issue No: Vol. 9 (2022)
       
  • Classical and Point-of-Care tests in severe hemorrhage management

    • Authors: Paolo Simioni
      Pages: 47 - 51
      Abstract: Hemorrhage is defined as an acute loss of blood from the cardiovascular system. The hemostatic cascade (comprising the vasculature, coagulation factors, the fibrinolytic and the platelet systems) is the physiological mechanism meant to control this event. Coagulation assessment is fundamental in the monitoring and treatment of hemorrhage. Over the years several classical laboratory-based diagnostic tests have been developed for the management of severe hemorrhage, however their main downside is the time necessary to obtain a result, which can be significant (between 40 minutes and an hour) and therefore not be entirely representative of a fastchanging clinical picture. Based on this need of faster results, Point-of-Care tests have been developed and implemented, since they can represent a diagnostic tool that allows a reduction of the time interval before appropriate intervention. They rely on instruments able to determine blood clot formation in whole blood samples upon activation of coagulation with specific reagents, and activation of platelets upon exposure to different drugs. The present review proposes an overview of both the available Point-of-Care tests such as Thrombelastography, for the assessment of blood clot formation, Impedance Aggregometry, for the function of platelets, and those still under improvement or missing entirely.
      PubDate: 2022-07-31
      DOI: 10.33393/ao.2022.2433
      Issue No: Vol. 9 (2022)
       
  • Plasma, platelets and cryoprecipitates therapies

    • Authors: Vanessa Agostini
      Pages: 52 - 57
      Abstract: The present review gives an overview of the components, applications and risks of transfusion therapy. Fresh frozen plasma (FFP) transfusion is a widely used procedure both in a prophylactic and therapeutic context. In both scenarios the method of administration and the dosage are, improperly, the same; it is reported that in the clinical context FFP is inappropriately used in over 50% of cases.  According to different guidelines its only recommended use is in a condition of critical hemorrhage, as there is no evidence of positive outcomes in its prophylactic administration. Platelet concentrates (PCs) are broadly used to support patients with thrombocytopenia, whether it is pre or postoperative, or in intensive care medicine. The only consensus on its use is the prophylactic administration when the patient’s platelet count is lower than 10,000. Another use of PCs can be in reducing side effects and enhancing the effects of specific drugs, although this application is still complex. Cryoprecipitate usage in clinics is decreasing both due to its variable content of factors I, VIII, XIII and von Willebrand, and the amount of time necessary to obtain it. Of great importance in the transfusion therapy framework are the respiratory complications that can occur, such as Transfusion-Associated Cardiac Overload (TACO), Transfusion-Related Acute Lung Injury (TRALI), Transfusion-Associated Dyspnea (TAD) and transfusion-induced sepsis. The suggested procedure when any of these (and other) complications occur is to seek consultation from the transfusion medicine unit.
      PubDate: 2022-07-31
      DOI: 10.33393/ao.2022.2432
      Issue No: Vol. 9 (2022)
       
  • Sepsis-induced coagulopathy and disseminated intravascular coagulation

    • Authors: Antonino Giarratano
      Pages: 58 - 60
      Abstract: The definition of sepsis is usually associated to the innate immune system while instead, it is also connected to a response of the coagulation system, given that in septic patients thrombohemorrhagic events occur. The activation of the immune response and the recruitment of the coagulation system aim at the compartmentalization in the vascular stream of the response to the microorganism to avoid its spreading. This mechanism, as a side effect, exposes the organism to a variety of “dysregulations”. Disseminated Intravascular Coagulation (DIC) can present itself in septic patients with one of three different phenotypes: pro-coagulant, fibrinolytic and hemorrhagic. Associated to DIC, as it can be considered its predecessor, is Sepsis-Induced Coagulopathy (SIC) a prior, faster-evolving condition. International institutions have developed a scoring system to distinguish SIC from overt-DIC, which has the distinctive characteristics of a reduced platelet count in the initial stages and a higher INR value. Being a rapidly evolving condition SIC needs to be quickly diagnosed and treated; to this day no concrete recommendations exist regarding a therapeutic approach. Unfractionated heparin, antithrombin III, thrombomodulin and recombinant protein C have shown limited, or even non-existing, effects in SIC treatment, while the use of thromboelastography and thromboelastometry has represented a progress in the testing of coagulation-hemorrhagic conditions. The procedure to be followed is, besides microcirculation resuscitation, a prompt intervention with antibiotic treatment and the execution of a de-escalation protocol. Further studies are still necessary to define the most effective treatment for these conditions.
      PubDate: 2022-07-31
      DOI: 10.33393/ao.2022.2434
      Issue No: Vol. 9 (2022)
       
  • Major obstetric hemorrhage management

    • Authors: Maria Grazia Frigo
      Pages: 61 - 65
      Abstract: Postpartum hemorrhage (PPH) is to this day one of the leading causes of maternal death and its diagnosis is still highly subjective, as it relies on unprecise estimates of the amount of blood loss. There are three areas in which PPH outcomes can be improved: prevention, treatment and rescue. PPH can escalate to a graver clinical picture of Severe Acute Maternal Morbidity (SAMM) due to an inaccurate estimate of the blood loss, inability to identify an at-risk patient, delays in testing and availability of hemoderivatives, and lack of clear guidelines and interdisciplinary communication. Many factors can predispose to PPH and in clinical practice the many causes of its insurgence are summarized with the 4T formula: Tone (uterine atony), Trauma (laceration/hematoma), Tissue (retained tissue/invasive placenta), Thrombin (coagulation). Some precautions can be taken in preventing PPH such as the use of uterotonics, the administration of oxytocin, the timing of umbilical cord clamping, and the monitoring of anemia and the platelet to fibrinogen concentration ratio. In recent years studies have been published with the goal of leading PPH diagnosis and management through universal guidelines, point-of-care testing and interdisciplinary approaches. The proposed algorithms, albeit not yet validated, are useful in the clinical practice; similarly beneficial is the use of reliable predictive panels such as the Modified Early Obstetric Warning System.
      PubDate: 2022-07-31
      DOI: 10.33393/ao.2022.2426
      Issue No: Vol. 9 (2022)
       
  • Management of bleeding in cardiac surgery patients

    • Authors: Marco Ranucci
      Pages: 66 - 69
      Abstract: tbd
      PubDate: 2022-07-31
      DOI: 10.33393/ao.2022.2435
      Issue No: Vol. 9 (2022)
       
  • Coagulopathy and hemorrhage management in major abdominal surgery

    • Authors: Cristiano Piangatelli
      Pages: 70 - 72
      Abstract: Whilst some guidelines for hemorrhage management during major abdominal surgery have been written, evaluation of the patient’s basal condition remains the headmost factor. Firstly, an assessment to predict perioperative bleeding should be performed, although its prognostic ability is limited as it relies on the patient’s anamnesis and on standardized tests that can have a low predictive accuracy. Upon hemorrhage, monitoring the therapeutic window between hypovolemia and hypervolemia is of crucial importance. According to the guidelines, both a prompt stabilization of cardiac preload and goal-directed fluid therapy (with either colloids or crystalloids) are advised in case of both hypovolemia and hypervolemia. Plasma transfusion, instead, is discouraged for treatment of elevated (mild to moderate) International normalized ratio (INR), as it was shown to have minimal effects and increase the risk of infection. In summary, to define the weak link in the coagulation cascade and the etiopathogenesis of postoperative bleeding is necessary to rely on all available methodologies, such as standardized tests, Point-of-care tests and goal-directed therapies. This review gives an overview of the many factors that are to be monitored during surgical hemorrhage and a summary of the approaches to manage coagulopathy.
      PubDate: 2022-07-31
      DOI: 10.33393/ao.2022.2424
      Issue No: Vol. 9 (2022)
       
  • Coagulopathy and hemorrhage management in cirrhotic patients

    • Authors: Giandomenico Biancofiore
      Pages: 73 - 76
      Abstract: tbd
      PubDate: 2022-07-31
      DOI: 10.33393/ao.2022.2436
      Issue No: Vol. 9 (2022)
       
  • Trauma-induced coagulopathy management

    • Authors: Maria Grazia Bocci
      Pages: 77 - 82
      Abstract: In the last years significant progress has been made in the understanding and treatment of hemorrhage caused by trauma which (along with the advances made in early resuscitation, and critical care) has led to a reduction of “late” deaths, meaning those due to trauma-induced organ failure/sepsis. Depending on the case, trauma is usually characterized by a variable equilibrium between hypo and hypercoagulation, with a majority of hypercoagulation cases. Trauma-induced coagulopathy (TIC), instead, is not only characterized by a coagulation disorder but also a state of inflammation which increases the need for transfusions, the risk of multiorgan failure and thromboembolic complications. In this clinical picture, hemostatic resuscitation, damage control resuscitation and homeostasis maintenance have been shown to reduce mortality. According to guidelines, the heart of TIC treatment is an early individualised goal-directed treatment relying on coagulation support and thromboprophylactic strategies (administration of tranexamic acid, fibrinogen concentrate and packed red blood cells), platelet function monitoring and viscoelastic Point-of-care testing. The implementation of the protocol suggested by the guidelines has allowed a more effective support of coagulopathy and has led to a reduction in hemoderivatives usage, hospitalization time and the death rate in severely injured trauma patients. The aforementioned improvements in TIC management were explicitly confirmed by a multicentric study in which the year the guidelines were implemented was compared with a prior year when no specific protocol was executed.
      PubDate: 2022-07-31
      DOI: 10.33393/ao.2022.2425
      Issue No: Vol. 9 (2022)
       
  • Emicizumab in hemophilia A with inhibitors: clinical and economic impact
           of its use in a Cuban patient

    • Authors: Dunia Castillo-Gonzàles, Irianys Álvarez Sardiñas, Consuelo Macías Abraham, Alex G. Muñoz Bedoya
      Pages: 83 - 86
      Abstract: Introduction: The management of a patient with severe hemophilia A with inhibitors is a challenge for any healthcare professional. The present analysis shows the clinical and economic impact of the therapeutic approach in the most critical patient of the Cuban Hemophilia Cohort. Objective: To evaluate the economic and clinical impact of the implementation of Emicizumab therapy in the first Cuban patient. Case presentation: Adult patient who started to use recombinant activated factor VII episodically during adolescence when he was diagnosed with the presence of high-responding antibodies against factor VIII. During the years that he used this medication, he had recorded between 95 and 105 bleeds annually. In 2018, he presented with severe hemoperitoneum and was admitted to the intensive care unit with high doses of recombinant factor VII activated, multiple transfusions of packed red blood cells, and other care typical of a critically ill patient; his evolution was satisfactory. He started emicizumab prophylaxis 7 months after this event and is currently on Week 133 of treatment. He has not presented with further bleeding, nor has he reported adverse reactions to this treatment. The biannual cost savings for on-demand treatment and prophylaxis have been US $792,509.24. Conclusions: Emicizumab prophylaxis improved the patient’s quality of life and that of his family. From the perspective of the Cuban health system, the use of emicizumab in this clinical case was satisfactory and its experience will be analyzed in new patients.
      PubDate: 2022-09-05
      DOI: 10.33393/ao.2022.2438
      Issue No: Vol. 9 (2022)
       
  • A roadmap for building your scientific reputation on social media

    • Authors: Vittorio Iacovella
      Pages: 87 - 91
      Abstract: The wide adoption of online media for scholarly purposes triggered a rapid increase in the access to scientific information. This led to several outcomes, including considering internet as the main functional medium for disseminating knowledge. Here we briefly describe how this represented one of the foundations of the open access revolution and how this is connected to the development and circulation of alternative metrics for research outcomes. We then enumerate a list of practical suggestions on how to proceed when dealing with the online dissemination of research products, in order to build and maintain a scientific reputation on internet.
      PubDate: 2022-09-20
      DOI: 10.33393/ao.2022.2468
      Issue No: Vol. 9 (2022)
       
  • How to insert a PICC: practical tips for the intensive care physician

    • Authors: Stefano Elli, Giacomo Bellani, Alberto Lucchini
      Pages: 11 - 14
      Abstract: Peripherally inserted central catheters (PICCs) are central vascular access devices inserted via deep veins of the arm, also useful in critical care settings. The purpose of this article is to offer to a critical care clinician with good skills in central venous catheterization, but who has limited experience on PICC catheters, the basic information on how the procedure is performed and how to minimize the risks of complications or failure of the maneuver. The main technical steps and the main precautions to be taken during PICC placement will be analyzed, with reference to the differences compared to central catheterization. Specifically, the pre-procedural phase and the intraprocedural main steps of the maneuver will be analyzed. A dedicated Vascular Access Team is considered useful and desirable by the current literature, but when the use of the PICC proves useful or even mandatory, the intensive care physician skilled in central venous catheters can transfer skills from central to peripheral catheterization.
      PubDate: 2021-04-11
      DOI: 10.33393/ao.2022.2360
      Issue No: Vol. 9 (2021)
       
 
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