Publications by authors named "Anna Aprile"

38 Publications

The clinical legal medicine: a need for quality of care and patient's safety. A single center five-year experience.

Acta Biomed 2020 04 29;91(4):e2020090. Epub 2020 Apr 29.

Department of Molecular Medicine, Legal Medicine, University of Padua, Padua, Italy, Via Falloppio, 50, Padova, Italia..

Introduction: Clinical legal medicine is a branch of legal medicine that takes place in a clinical setting approaching the patient's bedside and using a particular attention not only for conceptual or normative references but also for every possible medical and social aspect.

Material And Methods: The requests of medico-legal opinions received by the Department of Legal Medicine of a large university hospital were retrospectively collected over a 5-years period. The analysis focused on the recurrence rate of the requests and the most common medico-legal issues to be solved in a clinical context, differentiating between adult and minor patients.

Results: The collected medico-legal advices amounted to 448. The most clearly involved clinical area was Medicine (54%) followed by Gynecology and Obstetrics (15.6%), Pediatrics and Surgery (10.7%). The requests concerning patient's self-determination in therapeutics choices, including refusal of proposed treatments, covered almost one-half of total casuistry. The designation of support administrator represented also a relevant issue (20.5%). In case of minors, the queries related to reporting crimes were three times higher than in adults, while the appointment of a support administrator was never requested.

Conclusion: Clinical legal medicine, through medico-legal advices, plays a primary role in contributing to the safeguarding of health and to the decision-making process of clinicians.
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http://dx.doi.org/10.23750/abm.v91i4.9373DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927498PMC
April 2020

The potential lethality of caput medusae.

Med Sci Law 2021 Jan 11:25802420986704. Epub 2021 Jan 11.

Department of Molecular Medicine, Legal Medicine, University of Padua, Italy.

While gastro-oesophageal varices commonly complicate portal hypertension and may be a life-threatening condition, fatal haemorrhaging from cirrhosis-related caput medusae has seldom been described in the scientific literature. This article documents a rare death due to the rupture of a varix in the umbilical area. This case raises a number of points for medico-legal discussion, such as the negative consequences of an erroneous cause of death in evaluating medical malpractice cases and the importance of a thorough external examination of the body in order to ensure this type of vascular lesion is not overlooked.
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http://dx.doi.org/10.1177/0025802420986704DOI Listing
January 2021

Colonization of and Plants by Is Strongly Reduced by the Exogenous Application of Tomato Systemin.

J Fungi (Basel) 2020 Dec 29;7(1). Epub 2020 Dec 29.

Department of Agricultural Sciences, University of Naples Federico II, Via Università 100, Portici, 80055 Naples, Italy.

Plant defense peptides are able to control immune barriers and represent a potential novel resource for crop protection. One of the best-characterized plant peptides is tomato Systemin (Sys) an octadecapeptide synthesized as part of a larger precursor protein. Upon pest attack, Sys interacts with a leucine-rich repeat receptor kinase, systemin receptor SYR, activating a complex intracellular signaling pathway that leads to the wound response. Here, we demonstrated, for the first time, that the direct delivery of the peptide to and plants protects from the agent of Grey mould (). The observed disease tolerance is associated with the increase of total soluble phenolic content, the activation of antioxidant enzymes, and the up-regulation of defense-related genes in plants treated with the peptide. Our results suggest that in treated plants, the biotic defense system is triggered by the Sys signaling pathway as a consequence of Sys interaction with a SYR-like receptor recently found in several plant species, including those under investigation. We propose that this biotechnological use of Sys, promoting defense responses against invaders, represents a useful tool to integrate into pest management programs for the development of novel strategies of crop protection.
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http://dx.doi.org/10.3390/jof7010015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824362PMC
December 2020

Take-Home Messages from the COVID-19 Pandemic: Strengths and Pitfalls of the Italian National Health Service from a Medico-Legal Point of View.

Healthcare (Basel) 2020 Dec 25;9(1). Epub 2020 Dec 25.

Department Experimental Medicine, University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.

The World Health Organization (WHO) declared the outbreak of the Coronavirus disease-2019 (COVID-19) infection a pandemic on 11 March 2020. As of the end of October 2020, there were 50 million cases of infection and over one million deaths recorded worldwide, over 45,000 of which occurred in Italy. In Italy, the demand for intensive care over the course of this pandemic crisis has been exceptionally high, resulting in a severe imbalance between the demand for and availability of the necessary resources. This paper focuses on elements of preventive medicine and medical treatments in emergency and non-emergency situations which, based on the international scientific literature, may prove to be useful to physicians on a behavioral level and avert professional liability problems. In order to achieve this objective, we have performed a search on MEDLINE to find published articles related to the risks associated with the pandemic that contain useful suggestions and strategies for mitigating risks and protecting the safety of the population. The results have been collocated in line with these specific study areas.
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http://dx.doi.org/10.3390/healthcare9010017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824087PMC
December 2020

Proposal for the application of a quality indicator to medico-legal consultations in the field of medical liability.

Curr Pharm Biotechnol 2020 Dec 10. Epub 2020 Dec 10.

Department of Molecular Medicine, Legal Medicine, University of Padua. Italy.

Introduction: In recent decades, the number of professional liability disputes has increased, especially in the civil sector. In these liability assessments, medico-legal experts have become the linchpin. Law No. 24/2017, concerning professional liability in Italy, requires that guidelines and best practices be established to identify the necessary elements for writing expert reports in the legal sector.

Materials And Methods: The authors have created a numerical indicator to be applied to 150 legal expert reports on professional liability, enabling them to evaluate the methodological quality of those reports. The results are then compared with the outcome of the legal proceedings in order to establish the suitability of this quality index for evaluating the work of medico-legal experts.

Results: Of the 150 reports considered, 14 were scored inadequate, 75 adequate and 31 good. These inadequate (according to the indicator) reports presented a higher probability of being scored inadequate in court proceedings, compared to the risk of inadequacy of all the reports OR 4.6 (95% CI 1.25 - 16.90). This probability significantly increased on comparing the inadequate reports with the adequate OR 5.6 (95% CI 1.28 - 24.41), and the inadequate with the good OR 7.73 (95% CI 1.50 - 39.87).

Discussion: Application of the proposed indicator is simple and produces a high-quality result, thus ensuring an accurate and tenable appraisal of methodological quality.

Conclusion: The indicator proposed serves as a useful starting point for creating the necessary methodological standards for medico-legal experts in the field of professional liability as recommended by Law No. 24/2017.
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http://dx.doi.org/10.2174/1389201021666201211104611DOI Listing
December 2020

The Motion of the Italian National Bioethics Committee on Aggressive Treatment towards Children with Limited Life Expectancy.

Healthcare (Basel) 2020 Nov 1;8(4). Epub 2020 Nov 1.

Department of Molecular Medicine, University of Padua, 35121 Padua, Italy.

The motion of the Italian National Bioethics Committee entitled "Aggressive treatment or therapeutic obstinacy on young children with limited life expectancy" comprises a premise that rejects therapeutic obstinacy and makes 12 recommendations. Recommendation no. 1 states the general rules: it ascribes a cardinal role to a shared care plan, it supports pain management therapy and pain relief, it opposes ineffective and disproportionate clinical treatment and defensive medicine. The other recommendations are correlated to the enacting of a national law establishing clinical ethics committees in paediatric hospitals; participation of parents and their fiduciaries in the decision-making processes; recourse to courts only as extrema ratio in the event of irremediable disagreement between the medical team and the family members; accompaniment at the end of life also through continuous deep sedation combined with pain therapy; access to palliative care; the need to reinforce research on pain and suffering in children; clinical trials and research studies conducted in children; the training of doctors, healthcare personnel and psychologists, to support parents in emotional and practical terms; the facilitation of the closeness of parents to children in extremely precarious clinical conditions; the relevant role of the associations of parents of sick children. Comments are made, in particular, about the innovative recommendations respectively relating to the adoption of care planning, the establishment, by law, of clinical ethics committees in paediatric hospitals and the limitation of recourse to courts-only as -in the event of irremediable disagreement between the medical team and the family members.
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http://dx.doi.org/10.3390/healthcare8040448DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7712670PMC
November 2020

How to communicate with families living in complete isolation.

BMJ Support Palliat Care 2020 Oct 15. Epub 2020 Oct 15.

Perioperative Medicine, Pain Therapy, ICU and Emergency Department, ASL2 - Chieti Pescara University, Chieti, Italy.

Importance: During the SARS-CoV-2 pandemic, a complete physical isolation has been worldwide introduced. The impossibility of visiting their loved ones during the hospital stay causes additional distress for families: in addition to the worries about clinical recovery, they may feel exclusion and powerlessness, anxiety, depression, mistrust in the care team and post-traumatic stress disorder. The impossibility of conducting the daily meetings with families poses a challenge for healthcare professionals.

Objective: This paper aims to delineate and share consensus statements in order to enable healthcare team to provide by telephone or video calls an optimal level of communication with patient's relatives under circumstances of complete isolation.

Evidence Review: PubMed, Cochrane Database of Systematic Reviews, Database of Abstracts and Reviews of Effectiveness and the AHCPR Clinical Guidelines and Evidence Reports were explored from 1999 to 2019. Exclusion criteria were: poor or absent relevance regarding the aim of the consensus statements, studies prior to 1999, non-English language. Since the present pandemic context is completely new, unexpected and unexplored, there are not randomised controlled trials regarding clinical communication in a setting of complete isolation. Thus, a multiprofessional taskforce of physicians, nurses, psychologists and legal experts, together with some family members and former intensive care unit patients was established by four Italian national scientific societies. Using an e-Delphi methodology, general and specific questions were posed, relevant topics were argumented, until arriving to delineate position statements and practical checklist, which were set and evaluated through an evidence-based consensus procedure.

Findings: Ten statements and two practical checklists for phone or video calls were drafted and evaluated; they are related to who, when, why and how family members must be given clinical information under circumstances of complete isolation.

Conclusions And Relevance: The statements and the checklists offer a structured methodology in order to ensure a good-quality communication between healthcare team and family members even in isolation, confirming that time dedicated to communication has to be intended as a time of care.
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http://dx.doi.org/10.1136/bmjspcare-2020-002633DOI Listing
October 2020

Seventeen-year Medical Professional Liability Experience in a Level III University Hospital.

Curr Pharm Biotechnol 2020 Oct 15. Epub 2020 Oct 15.

Department of Molecular Medicine, Legal Medicine, University of Padua, Padua. Italy.

Introduction: In recent decades, the number of medical professional liability disputes have grown exponentially, becoming a well-studied aspect of public healthcare. Legal medicine is an essential tool in managing this phenomenon.

Methods: This article reports the results of the analysis of disputes for medical professional liability in a Level III University Hospital in Italy. The study covers the time period from 01.01.2003 to 31.12.2019.

Results: 33% of claims have been compensated. Those claims fall within the following categories: 37% in the surgical field, 17% in the field of internal medicine and 35% in the emergency care field. As for the types of medical mistake, compensation was awarded in 30% of diagnostic error cases, 26% of therapeutic error cases, 47% of execution error cases and 55% of organizational deficiency cases.

Discussion: The difference in the rate of compensation between the various medical fields or types of error depends on specific medico-legal characteristics. The aim of advanced healthcare systems is to prevent medical liability disputes by analyzing this phenomenon and improving clinical risk management programs. In particular, according to our study, events related to organizational deficiencies are the most preventable. In addition, through the use of a dedicated reporting procedure, medico-legal analysis of malpractice cases may be the key to risk reduction.

Conclusion: Every major hospital should set up a medico-legal watchdog responsible for collecting and analyzing information on professional medical liability disputes in order to prevent and manage such events.
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http://dx.doi.org/10.2174/1389201021666201015145311DOI Listing
October 2020

Risk Management in the New Frontier of Professional Liability for Nosocomial Infection: Review of the Literature on Mycobacterium Chimaera.

Int J Environ Res Public Health 2020 10 7;17(19). Epub 2020 Oct 7.

Legal Medicine, Department of Molecular Medicine, University of Padua, Via G. Falloppio 50, 35121 Padua, Italy.

: (MC) is of recent origin and belongs to the large family of non-tuberculous mycobacteria. In recent years, it has shown a high infectious capacity via the aerosol produced by operating room equipment, such as heater-cooler units (HCU). The infection has a long latent period and high mortality rate. Genetic and epidemiological studies have shown that there is a clear link between the infection and a specific HCU model manufactured by LivaNova/Sorin. There is, therefore, a strong possibility that contamination occurs during device construction. The objective of this article is to describe the characteristics of this particular infection in view of the medico-legal implications on professional liability, specifically focusing on current evidence regarding contamination prevention. : we have analyzed the clinical characteristics and data from the autopsic investigations performed on a patient who died as a result of MC infection, in addition to analyzing all pertinent recommendation documents available internationally. We searched for all articles in the literature available on MEDLINE between 1995 and 30 July 2020, using the search words "Mycobacterium chimaera". We then analyzed those articles and reported only those that provide useful information regarding prevention techniques for containing dissemination and contamination. : the literature review produced 169 results that highlight the need to develop systems to mitigate and eliminate the risk of MC infection in operating rooms such as physical containment measures, e.g. device replacement, use of safe water, providing patients with information, and training healthcare professionals. : from a medico-legal viewpoint, this particular situation represents a new frontier of professional liability, which includes manufacturers of electromedical equipment. In order to comprehend the true extent of this silent global epidemic, the development of an organic, preventative monitoring system is essential.
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http://dx.doi.org/10.3390/ijerph17197328DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7579562PMC
October 2020

Mycobacterium Chimaera: Clinical and medico-legal considerations starting from a case of sudden acoustic damage.

Leg Med (Tokyo) 2020 Nov 7;47:101747. Epub 2020 Jul 7.

Legal Medicine, Department of Molecular Medicine, University-Hospital of Padova, Via Falloppio 50, 35121 Padova, Italy.

Mycobacterium Chimaera is a microorganism that can cause nosocomial infections particularly in patients undergoing cardiac surgery. The specific case presented herein shows an original clinical presentation of the infection: sudden unilateral deafness as a result of septic embolization. Medico-legal experts appointed by the court in a civil liability dispute analyzed the case and submitted their expert opinion. This article analyzes the peculiar and innovative aspect of professional liability that can be attributed to the healthcare facility and the manufacturer of the equipment used in the operating room from a medical-legal point of view.
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http://dx.doi.org/10.1016/j.legalmed.2020.101747DOI Listing
November 2020

Is the Italian consent to transfusion really informed? A medico-legal analysis between old ghosts and new evidence.

Transfus Apher Sci 2020 Oct 23;59(5):102823. Epub 2020 May 23.

Department of Molecular Medicine, Legal Medicine, University of Padua, Padua, Via Falloppio 50, 35121 Padua, Italy. Electronic address:

In healthcare systems of developed countries, obtaining informed consent is a necessary and fundamental requirement for the administration of any medical treatment. In Italy, for the administration of the recipient's informed consent for a blood transfusion, a pre-printed form is used in line with the Decree of the Ministry of Health dated 2 November 2015. This paper aims to analyse this form in light of the European legal provisions and following the enactment of Italian Law No. 219 of 2017 on informed consent and advance treatment directives. Our review shows that the structure of the form can be improved in light of the new direction provided by Italian law, the scientific advancement on transfusion risks, and the potential to reduce the use of blood components. Revising this form could be the opportune time to include written information on Patient Blood Management strategies. Though not exhaustive, this proposal may stimulate debate on the point and produce further contributions.
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http://dx.doi.org/10.1016/j.transci.2020.102823DOI Listing
October 2020

Patient blood management implementation in light of new Italian laws on patient's safety.

Transfus Apher Sci 2020 Aug 13;59(4):102811. Epub 2020 May 13.

Department of Molecular Medicine, Legal Medicine, University of Padua, Padua, Italy. Electronic address:

The present work aims to analyze the impact - from legal and medical perspective - of the recent Italian legislative provisions on the subject of healthcare safety, and how these affect current transfusion practices, also in light of the accumulation of evidence deriving from the implementation of the Patient Blood Management (PBM) program. The scientific evidence shows that PBM is a bundle of care that improves patient outcomes including mortality and morbidity, improves the quality of life of patients and the population, reduces healthcare costs and decreases consumption of blood components. These aspects should be largely sufficient to carry out an urgent implementation of PBM in Italian hospitals. However, it is now also possible to indicate a further incentive for implementation which is made up of medico-legal aspects and is characterized by the need to decrease the intrinsic risks of the use of blood products so as to protect doctors and hospitals from possible future medico-legal disputes regarding adverse transfusion events that could be effectively avoided.
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http://dx.doi.org/10.1016/j.transci.2020.102811DOI Listing
August 2020

Patient blood management: The best approach to transfusion medicine risk management.

Transfus Apher Sci 2020 Aug 27;59(4):102779. Epub 2020 Apr 27.

Department of Molecular Medicine, Legal Medicine, University of Padua, Padua, Italy. Electronic address:

In advanced health systems it is increasingly important to offer effective medical services that have high quality and safety standards. We present an overview of the direct hazards and the indirect hazards associated with blood transfusions. Our aim is to focus on the potential medico-legal impacts of these hazards in the context of clinical risk management, incorporating the accumulating evidence from Patient Blood Management programs. The direct or deterministic hazards of transfusion refer to scenarios where the mechanisms for post transfusion damage are clearly traceable to the blood transfused in a 1:1 cause and effect manner. The indirect hazards can be defined as probabilistic and are associated with transfusion through epidemiological studies. The implementation of Patient Blood Management programs demonstrates that the use of a blood transfusion is not always necessary or unavoidable but can be considered modifiable. Review of the literature confirms that transfusion should not be the default option to manage anemia or blood loss. Instead, accumulating evidence demonstrates that a patient-centred, proactive approach to managing a patient's own blood is the new standard of care. It thus follows, an adverse transfusion event, where the transfusion was avoidable through the application of patient blood management, may constitute a profile for medical professional medical negligence. In an effort to maximise patient safety, transfusion medicine practice culture needs to shift towards a patient blood management approach, with hospitals implementing it as an important tool to minimize the risks of allogeneic blood transfusion.
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http://dx.doi.org/10.1016/j.transci.2020.102779DOI Listing
August 2020

[Ethical, deontologic and legal considerations about SIAARTI Document "Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances".]

Recenti Prog Med 2020 Apr;111(4):212-222

Professore di medicina legale i.q., Università di Padova.

On 6 March 2020, the Italian Society of Anaesthesia Analgesia Resuscitation and Intensive care (SIAARTI) published the document "Clinical Ethics Recommendations for Admission to and Suspension of Intensive Care in Exceptional Conditions of Imbalance between Needs and Available Resources". The document, which aims to propose treatment decision-making criteria in the face of exceptional imbalances between health needs and available resources, has produced strong reactions, within the medical-scientific community, in the academic world, and in the media. In the current context of international public health emergency caused by the CoViD-19 epidemic, this work aims to explain the ethical, deontological and legal bases of the SIAARTI Document and to propose methodologic and argumentative integrations that are useful for understanding and placing in context the decision-making criteria proposed. The working group that contributed to the drafting of this paper agrees that it is appropriate that healthcare personnel, who is particularly committed to taking care of those who are currently in need of intensive or sub-intensive care, should benefit from clear operational indications that are useful to orient care and, at the same time, that the population should know in advance which criteria will guide the tragic choices that may fall on each one of us. This contribution therefore firstly reflects on the appropriateness of the SIAARTI standpoint and the objectives of the SIAARTI Document. It then turns to demonstrate how the recommendations it proposes can be framed within a shared interdisciplinary, ethical, deontological and legal perspective.
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http://dx.doi.org/10.1701/3347.33184DOI Listing
April 2020

Fibrinogen αC-regions are not directly involved in fibrin polymerization as evidenced by a "Double-Detroit" recombinant fibrinogen mutant and knobs-mimic peptides.

J Thromb Haemost 2020 04 29;18(4):802-814. Epub 2020 Jan 29.

Biopolimeri e Proteomica, IRCCS Ospedale Policlinico San Martino, Genova, Italy.

Background: Fibrin polymerization, following fibrinopeptides A and B (FpA, FpB) cleavage, relies on newly exposed α- and β-chains N-termini (GPR, GHR; A-, B-knobs, respectively) engaging preexistent a and b pockets in other fibrin(ogen) molecules' γ- and (B)β-chains C-terminal regions. A role for mostly disordered (A)α-chains C-terminal regions "bridging" between fibrin molecules/fibrils has been proposed.

Objectives: Fibrinogen Detroit is a clinically observed mutation (AαR19 → S) with nonengaging GPS A-knobs. By analogy, a similar Bβ-chain mutation, BβR17 → S, should produce nonengaging GHS B-knobs. A homozygous "Double-Detroit" mutant (AαR19 → S, BβR17 → S; DD-FG) was developed: with A-a and B-b engagements endogenously blocked, other interactions would become apparent.

Methods: DD-FG, wild-type recombinant (WT-FG), and human plasma (hp-FG) fibrinogen self-association was studied by turbidimetry coupled with fibrinopeptides release high-performance liquid chromatography (HPLC)/mass spectrometry analyses, and by light-scattering following size-exclusion chromatography (SE-HPLC).

Results: In contrast to WT-FG and hp-FG, DD-FG produced no turbidity increase, irrespective of thrombin concentration. The SE-HPLC profile of concentrated DD-FG was unaffected by thrombin treatment, and light-scattering, at lower concentration, showed no intensity and hydrodynamic radius changes. Compared with hp-FG, both WT-FG and DD-FG showed no FpA cleavage difference, while ~50% FpB was not recovered. Correspondingly, SDS-PAGE/Western-blots revealed partial Bβ-chain N-terminal and Aα-chain C-terminal degradation. Nevertheless, ~70% DD-FG molecules bearing (A)αC-regions potentially able to associate were available. Higher-concentration, nearly intact hp-FG with 500-fold molar excess GPRP-NH /GHRP-NH knobs-mimics experiments confirmed these no-association findings.

Conclusions: (A)αC-regions interactions appear too weak to assist native fibrin polymerization, at least without knobs engagement. Their role in all stages should be carefully reconsidered.
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http://dx.doi.org/10.1111/jth.14725DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186824PMC
April 2020

Fibrin gels entrapment of a doxorubicin-containing targeted polycyclodextrin: Evaluation of in vivo antitumor activity in orthotopic models of human neuroblastoma.

Toxicol Appl Pharmacol 2019 12 6;385:114811. Epub 2019 Nov 6.

UOS Biopolimeri e Proteomica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132 Genova, Italy.

In vivo local antitumor activity of fibrin gels (FBGs) loaded with the poly-cyclodextrin oCD-NH/Dox, compared to free Dox, was evaluated in two mouse orthotopic neuroblastoma (NB) models, after positioning of the releasing devices in the visceral space. FBGs were prepared at the fibrinogen (FG) concentrations of 22 and 40 mg/ml clotted in the presence of 0.81 mM/mg FG Ca and 1.32 U/mg FG thrombin. Our results indicate that FBGs loaded with oCD-NH/Dox and applied as neoadjuvant loco-regional treatment, show an antitumor activity significantly greater than that displayed by the same FBGs loaded with identical dose of Dox or after free Dox administered intra venous (iv). In particular, FBGs prepared at 40 mg/ml showed a slightly lower antitumor activity, although after their positioning we observed a significant initial reduction of tumor burden lasting for several days after gel implantation. FBGs at 22 mg/ml loaded with oCD-NH/Dox and applied after tumor removal (adjuvant treatment model) showed a significantly better antitumor activity than the iv administration of free Dox, with 90% tumor regrowth reduction compared to untreated controls. In all cases the weight loss post-treatment was limited after gel application, although in the adjuvant treatment the loss of body weight lasted longer than in the other treatment modality. In accordance with our recent published data on the low local toxic effects of FBGs, the present findings also underline an increase of the therapeutic index of Dox when locally administered through FBGs loaded with the oCD-NH/Dox complex.
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http://dx.doi.org/10.1016/j.taap.2019.114811DOI Listing
December 2019

The medico-legal assessment of aesthetic damage. A correlation analysis between experts and an operative proposal.

Leg Med (Tokyo) 2019 Sep 22;40:47-53. Epub 2019 Jul 22.

Department of Molecular Medicine - Legal Medicine, University of Padua, Via Falloppio, 50, Padua, Italy. Electronic address:

Aesthetic damage, defined as any detrimental modification of the individual morpho-functional exterior attributes, is difficult to assess, since the perception of its entity is rather subjective. This study aims to provide a medico-legal contribution to the assessment of this kind of damage. 60 photographic images, representing stabilized aesthetic damage, were collected and showed to 16 expert evaluators, who were required to exclusively quantify the objective component of the aesthetic impairment. The inter-observer agreement for the assessments was calculated using the Intraclass Correlation Coefficient (ICC). Looking into specific characteristics of both the injury and the damaged subject, the assessors were more consistent in quantifying the damage in male subjects (ICC 0.68) and in subjects aged over 50 years (ICC 0.81) as well as in assessing extensive damages (ICC 0.61) than those of mild severity (ICC 0.41). The assessment of impairments located in the facial area resulted in a high level of concordance (ICC 0.73), while damages located the head and neck regions presented the lowest concordance (ICC 0.35). The evaluators were more consistent in assessing the outcomes of burns (ICC 0.70). Regardless the various reasons underlying the different degree of concordance, these results and the high degree of the overall concordance (ICC 0.63) point out the skillfulness of medicolegal professionals to formulate a complex judgment as more objectively as possible. Finally, an operative proposal was outlined to guide medico-legal professionals or interns in evaluating the aesthetic damage as more objectively as possible.
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http://dx.doi.org/10.1016/j.legalmed.2019.07.006DOI Listing
September 2019

The contribution of legal medicine in clinical risk management.

BMC Health Serv Res 2019 Feb 1;19(1):85. Epub 2019 Feb 1.

Department of Molecular Medicine, Legal Medicine, University of Padua, Padua, Italy.

Background: In advanced health services, a main objective is to promote the culture of safety and clinical risk management. In this regard, the reporting of sentinel events fits within a perspective of error analysis, attempting to propose solutions aimed at preventing a new occurrence of the harmful event. The purpose of this study is to analyze the contribution of medico-legal litigation in the management of clinical risk and to propose an organizational model so as to coordinate the intervention of clinical risk management and medico-legal services.

Methods: Retrospective review of 206 cases of medico-legal litigation, settled against a Hospital of a North-eastern city in Italy from January 1, 2014 and December 31, 2015.

Results: Approximately 20% of cases, that are classifiable as "sentinel events", were not reported due to various factors. The reason that these events are under-reported is mainly due to the latency between the event itself and its manifestation as a serious damage to health as well as the discomfort in reporting the events of this kind, which is still widespread among healthcare workers. The systematic research of the available documentation for medico-legal purposes permits the acquisition of more information concerning the clinical event, thereby increasing the number and accuracy of the reports to the clinical risk unit.

Conclusion: The analysis of medico-legal litigation is a valid tool to enhance the reporting of "sentinel events". One possible proposal is the implementation of an organizational model to establish a rapid procedure for the reporting of sentinel events during the evaluation of medico-legal litigations.
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http://dx.doi.org/10.1186/s12913-018-3846-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6359867PMC
February 2019

Characterization of drug release from fibrin gels loaded with different pharmaceutical and experimental doxorubicin formulations.

Pharmacol Rep 2018 Aug 21;70(4):760-765. Epub 2018 Feb 21.

UOS Biopolimeri e Proteomica, Ospedale Policlinico San Martino, Genova, Italy.

Background: Local delivery of anticancer drugs represents a desirable type of treatment. Nevertheless, characteristics such as availability, biocompatibility, ease of operation, and efficacy sometimes represent difficult to overcome hurdles. Fibrin gels (FBGs) may be attractive biomaterials for local treatment when loaded with different chemotherapeutics or with polymer-anticancer-drug conjugates and nanoparticles. These components, linked together, might represent candidates to counteract local recurrences or reduce the volume of inoperable tumors. In the present study we analyzed the features of in vitro release of different formulations of doxorubicin (DOXO) from FBGs, and in vivo FBGs degradation.

Methods: In vitro DOXO release from FBGs was studied as a function of thrombin and Ca ion concentrations. DOXO was loaded in FBGs either alone or pre-incorporated in nanoparticles characterized by different physical features. The FBGs in vivo degradation was analyzed after sc or ip positioning.

Results: Our results suggest that each of the factors involved in the FBGs preparation may have different effects on drug release. In particular, the fibrinogen (FG) concentration and, above all, the DOXO formulation were found to have the greatest impact. Not surprisingly, we have also found a longer permanence in vivo of FBGs prepared at the highest thrombin, Ca ion, and FG concentrations.

Conclusions: The aim of this work was to study the effect of several conditions for preparing drug delivery systems based on FBGs loaded with different clinical or experimental formulations of DOXO. Our data identify some of these modalities that will be tested in vivo to evaluate their antitumor activity.
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http://dx.doi.org/10.1016/j.pharep.2018.02.014DOI Listing
August 2018

Certification ISO 9001 in clinical ethics consultation for improving quality and safety in healthcare.

Int J Qual Health Care 2018 Jul;30(6):486-491

Department of Molecular Medicine, University of Padova, Padova, Italy.

This paper refers to the quality management process of the Laboratory of Clinical Bioethics (LCB) of the University of Padua (Italy), which has obtained the quality certification to ISO 9001:2008, as a Clinical Ethics Support Service. Its activities consist mainly in clinical ethics consultations and training services, addressed to those who are called to decisions with ethical implications in the clinical setting, proposing a structured approach to identify and analyze the ethical issues that may loom in the relationships between health professionals and patients, and participating in their solution. The expected benefits of the application of ISO 9001 were mainly the following: to formalize the procedure adopted for clinical ethics consultation and training, to obtain a controlled management of documents, information and data, to ensure and demonstrate the quality of the provided activities and to make methods and organization publicly available. The main results which have been achieved with the 'quality management project' are summarized as follows: the enunciation of LCB Mission and Quality Policy; the drafting of the procedure by which clinical ethics consultation is provided; the formalization of members' skills and the adoption of relevant process and outcome indicators. Our experience may be useful in promoting accountability for the quality of ethics consultation services. We consider the certification process as a tool for transparent and reliable management of one of the most critical tasks in the current context of healthcare, motivating similar facilities to undertake similar pathways, with the aim to provide quality control on their activities.
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http://dx.doi.org/10.1093/intqhc/mzy047DOI Listing
July 2018

The utility of plastinates in court: a case of firearm homicide.

Forensic Sci Med Pathol 2018 06 24;14(2):216-220. Epub 2018 Feb 24.

Department of Neuroscience, Section of Human Anatomy, University of Padua, Padua, Italy.

Plastination is a technique renowned for its use in the preservation of human tissues or organs, and is mainly employed in anatomical training and in research regarding various scientific fields. The advantages of this method are related to the natural appearance, absence of odor, and easy-handling of the plastinated products. The use of plastinates in forensic sciences, their potential role in personal identification, and their usefulness in interpretation of post-mortem findings has been described, although literature on this topic is poor. The present paper is the first report of a firearm homicide where the brain of the victim was plastinated and presented in court as documentary evidence. Three dimensional examination of the brain during the trial allowed the judge to directly evaluate the pathway of the projectile and to compare it with the information that was presented based on depositions, post mortem data and police investigations, in a more straightforward manner. The important role played by plastination in the reported case in assisting with the final verdict could be a catalyst to extend the use of this technique to other criminal cases.
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http://dx.doi.org/10.1007/s12024-018-9958-xDOI Listing
June 2018

Disabling Outcomes After Peripheral Vascular Catheter Insertion in a Newborn Patient: A Case of Medical Liability?

Am J Case Rep 2017 Oct 23;18:1126-1129. Epub 2017 Oct 23.

Department of Molecular Medicine, University of Padova, Padova, Italy.

BACKGROUND The positioning of peripheral venous catheters (PVC) is an invasive procedure commonly performed in pediatrics hospital wards to obtain vascular access for the administration of fluids, medications and other intravenous (IV) therapies. Many studies exist about management of peripheral venous access in adults. On the contrary, scientific evidence on the management of this procedure in children and newborns, especially regarding the optimal duration of infusion and the possible related side effects, is still poor. To minimize the risk of phlebitis, the guidelines of the US Centers for Disease Control and Prevention suggest the replacement of the catheter every 72-96 hours in adult patients, while in pediatric patients the catheter can remain in place for the entire duration of the IV therapy, unless complications arise. CASE REPORT In the presented case, after the positioning of a PVC in a newborn, no clear signs/symptoms of phlebitis were registered before the sixth day and, despite the immediate removal of the catheter, the thrombotic process, secondary to phlebitis, was already occurring, causing serious and permanent disabling outcomes, susceptible to legal medical evaluation and financial compensation. CONCLUSIONS The knowledge of this case is particularly interesting to clinicians working in the field of neonatal care and to clinical risk management services inside hospital structures, since similar cases may be the source of requests for extremely high financial compensations due to medical liability.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5665609PMC
http://dx.doi.org/10.12659/ajcr.904736DOI Listing
October 2017

An unusual case of chronic cough: Professional liability in dentistry?

Respir Med Case Rep 2016 7;19:190-192. Epub 2016 Oct 7.

Department of Molecular Medicine, University of Padova, via Falloppio 50, 35121 Padova, Italy.

Foreign body aspiration (FBA) is a serious medical problem, also in dental practice. The case report describes the case of a patient who for 12 years has suffered from chronic cough as a result of the aspiration of a polymeric silicone resin fragment during a dental procedure. In November 2002, the patient was underwent dental care, and she points out that, when performing dental imprint, she had sensed that something "went down in the throat" but she was immediately reassured by the dentist. After lung CT was performed, the foreign body was identified and removed with benefit to the patient. The knowledge of this case report could be useful for dentists who perform dental impressions, to be aware of the fact that the material used is radiolucent e.g. cannot be seen on plan radiographs and it can be accidentally inhaled by the patient. The knowledge of the case is also important for doctors who come in contact with patients who previously underwent dental treatment, suffering from persistent cough, in the absence of positive radiological signs.
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http://dx.doi.org/10.1016/j.rmcr.2016.10.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5079355PMC
October 2016

Genital trauma and vaginal bleeding: is it a lapse of time issue? A case report of a prepubertal girl and review of the literature.

Int J Legal Med 2017 Jan 23;131(1):185-189. Epub 2016 Aug 23.

Department of Molecular Medicine-Legal Medicine, University of Padua, Padua, Italy.

Child victims of sexual abuse may present with physical findings whose interpretation requires the most exhaustive evaluation and an accurate collection of a detailed history. Genital bleeding is usually considered as an acute sign, related to a trauma that occurred shortly before its appearance. We report a case of a 34-month-old child who was referred to the emergency room with a significant vaginal hemorrhage, originating from a wide laceration of the posterior fourchette, and a negative history for accidental trauma. The characteristics of the lesion, compared to the temporal evolution of the healing process, and the witnesses' depositions led us to assume that the time elapsed between the abusive event and the physical examination was longer in respect to what had appeared at the first sight. The judicial reconstruction of the events confirmed our assumption, allowing the charge of the right abuse perpetrator. As the literature regarding this eventuality is very poor, we report this case to stress the importance for physicians to consider that an active bleeding may be the manifestation of a trauma that occurred very long before.
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http://dx.doi.org/10.1007/s00414-016-1440-2DOI Listing
January 2017

Fibrin gels loaded with cisplatin and cisplatin-hyaluronate complexes tested in a subcutaneous human melanoma model.

Invest New Drugs 2015 Dec 7;33(6):1151-61. Epub 2015 Oct 7.

U.O.S. Biopolimeri e Proteomica, IRCCS AOU San Martino-IST, Genova, Italy.

Fibrin gels are attractive biomaterials for local delivery of a variety of agents, from drugs to proteins. Similarly, polymer-anticancer-drug conjugates and nanoparticles are emerging as potential candidates for cancer treatment. Combining these different approaches, we have studied the efficacy of fibrin gels loaded with cisplatin (DDP) and a complex of DDP with hyaluronate (DDP-HA) for tumor growth inhibition in a melanoma model. Loaded gels prepared at relatively high fibrinogen concentration (22 mg/ml) showed good in vitro antiproliferative activities, prolonged release of the anticancer drug, and a long persistence (10-15 days) in vivo when implanted subcutaneously (sc) in immunodeficient mice. Gels loaded with DDP or DDP-HA containing 1/3 or even 1/6 of their systemic dose (6 mg/kg) and positioned under the tumor mass in mice bearing a sc human SK-Mel-28 tumor showed an antitumor activity better than that of the original parent compound given intraperitoneally (ip). Moreover, in an additional experiment in vivo, fibrin gels loaded with N-trimethyl chitosan-based nanoparticles containing a DDP-HA complex were assayed, resulting in a further 8 % improvement of anticancer activity, with lesser adverse systemic toxic effects. Taken together, these results suggest that the combination of fibrin gels and drugs complexed with suitable macromolecules holds great promise for loco-regional anticancer therapy of melanoma and other surgically removable cancer types.
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http://dx.doi.org/10.1007/s10637-015-0291-xDOI Listing
December 2015

Evaluating non-disclosure of errors and healthcare organization: a case of bioethics consultation.

Med Health Care Philos 2015 Nov;18(4):607-12

Fondazione Lanza, via Dante 55, 35139, Padua, Italy.

Sometimes medical errors should not be disclosed. We report a case of semen samples exchange, during a homologous artificial insemination procedure, where a bioethics consultation was required. The bioethics consultation addressed ethical and legal elements in play, supporting non-disclosure to some of the subjects involved. Through a proper methodology, gathering factual and juridical elements, a consultant can show when a moral dilemma between values and rights-privacy versus fatherhood, in our case-is unsubstantial, in a given context, because of the groundlessness of the value or the right itself. However, being the error elicited by organizational factors, a broader ethical pronouncement was needed. Under such circumstances, ethical evaluation should engage in a sort of 'ethical-based root-cause analysis', linking ethical principles to quality aims and showing the opportunity to integrate ethical methodology in healthcare management. From this perspective, errors may become an incentive to promote high-quality organizations, attending to the central value of person even through the organizational process.
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http://dx.doi.org/10.1007/s11019-015-9659-0DOI Listing
November 2015

Reflex anal dilatation: An observational study on non-abused children.

Forensic Sci Int 2014 May 20;238:22-5. Epub 2014 Feb 20.

Department of Environmental Medicine and Public Health - Legal Medicine, University of Padova, via Falloppio 50, Padova, 35121, Italy.

Objectives: Reflex anal dilatation (RAD) is considered as a possible sign of anal abuse,however studies evaluating its prevalence in non-abused children are limited. The aim of this study was to evaluate the prevalence of RAD in a convenience sample of children with no suspicion of abuse admitted to a Pediatric Emergency Department (PED).

Methods: Prospective observational study including children admitted to the PED of Padova, Italy, between January and June 2011. Patients with no suspicion of abuse and for whom ano-genital examination was part of their medical evaluation were included. Children were excluded if in critical clinical conditions or if any suspicion of abuse arose during medical evaluation. Presence/absence of RAD and of factors favoring its appearance were recorded for each patient.

Results: Two-hundred and thirty children (median age of 12 months, interquartile range 5-35 months) were finally included. A positive RAD was reported in 14 (6.1%, CI 95% 3.4-10). Only 3 patients (1.3%, CI 95% 0.3-3.7) showed a positive RAD in the absence of any predisposing factor.

Conclusions: RAD is an infrequent sign in non-abused children and it is particularly rare in the absence of any predisposing factor. Case-control studies are necessary to better clarify its diagnostic relevance.
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http://dx.doi.org/10.1016/j.forsciint.2014.02.010DOI Listing
May 2014

"Vaginal" bleeding in prepubertal age: a rare scaring riddle, a case of the urethral prolapse and review of the literature.

Forensic Sci Int 2011 Jul 17;210(1-3):e16-20. Epub 2011 May 17.

Legal Medicine Institute, Environmental & Public Health Department, University of Padua, Via Falloppio 50, 35121 Padua, Italy.

The entities responsible for isolated vaginal bleeding are a broad spectrum of diseases. Vaginal bleeding in a prepubertal child is always treated as an alarming symptom both by parents and professionals. Most often, one of the first hypotheses is that a sexual abuse may be occurred and the clinical work up is oriented to explore it and eventually confirm or substantiante another diagnosis. Among the possible differential diagnosis urethral prolapse has to be considered. We report the case of a 6 years-old Caucasian girl referred to our Service for a mild vaginal bleeding and with the suspicion of sexual abuse, excluded after the confirmation of the presence of urethral prolapse. The clinical picture and workup are described and compared with a review of the international literature on the issue.
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http://dx.doi.org/10.1016/j.forsciint.2011.04.017DOI Listing
July 2011