Informed consent and biological agents in rheumatology and internal medicine.

BACKGROUND: The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules called biological agents. The increasing experience with biological agents has raised concerns about safety and efficacy issues that need to be discussed in the informed consent acquisition process. METHODS: The authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures. RESULTS: No studies specifically addressed the issue of informed consent in patients receiving biological agents. Several studies reported data about off-label use of biological agents usually with no obvious attention to informed consent shortcomings. CONCLUSION: The reported association between biological agents and serious infections or malignancies, including reactivation of latent tuberculosis, needs specific disclosure in informed consent acquisition, together with information about the possible efficacy in clinical contexts often characterized by resistance to previous treatments. Ethical and clinical issues bound to the need for experimenting with new agents with potentially serious adverse effects deserve specific attention. Studies aimed at evaluating mental capacity to consent in subjects receiving biological agents are required.

Improving Healthcare Workers' Adherence to Surgical Safety Checklist: The Impact of a Short Training.

BACKGROUND: Although surgery is essential in healthcare, a significant number of patients suffer unfair harm while undergoing surgery. Many of these originate from failures in non-technical aspects, especially communication among operators. A surgical safety checklist is a simple tool that helps to reduce surgical adverse events, but even if it is fast to fill out, its compilation is often neglected by the healthcare workers because of unprepared cultural background. The present study aims to value the efficacy of a free intervention, such as a short training about risk management and safety checklist, to improve checklist adherence. METHODS: In March 2019, the medical and nursing staff of the General Surgical Unit attended a two-lesson theoretical training concerning surgical safety and risk management tools such as the surgical safety checklist. The authors compared the completeness of the surgical checklists after and before the training, considering the same period (2 months) for both groups. RESULT: The surgical safety checklists were present in 198 cases (70.97%) before the intervention and 231 cases (96.25%) after that. After the training, the compilation adherence increased for every different type of healthcare worker of the unit (surgeons, nurses, anesthetists, and scrab nurses). Furthermore, a longer hospitalization was associated with a higher surgical checklist adherence by the operators. CONCLUSIONS: The results showed that a free and simple intervention, such as a two-lesson training, significantly stimulated the correct use of the surgical safety checklist. Moreover, the checklist adherence increased even for the operators who did not attend the training, maybe because of the positive influence of the colleagues' positive behaviors. As the results were promising with only two theoretical lessons, much more can be done to build a new safety culture in healthcare.

Incident Reporting System in an Italian University Hospital: A New Tool for Improving Patient Safety.

Clinical risk management constitutes a central element in the healthcare systems in relation to the reverberation that it establishes, and as regards the optimization of clinical outcomes for the patient. The starting point for a right clinical risk management is represented by the identification of non-conforming results. The aim of the study is to carry out a systematic analysis of all data received in the first three years of adoption of a reporting system, revealing the strengths and weaknesses. The results emerged showed an increasing trend in the number of total records. Notably, 86.0% of the records came from the medical category. Moreover, 41.0% of the records reported the possible preventive measures that could have averted the event and in 30% of the reports are hints to be put in place to avoid the repetition of the events. The second experimental phase is categorizing the events reported. Implementing the reporting system, it would guarantee a virtuous cycle of learning, training and reallocation of resources. By sensitizing health workers to a correct use of the incident reporting system, it could become a virtuous error learning system. All this would lead to a reduction in litigation and an implementation of the therapeutic doctor-patient alliance.

A Case of Lethal Idiopathic Plasmacytic Lymphadenopathy with Polyclonal Hypergammaglobulinemia: A Medical Challenge for the Forensic Pathologist.

A rare case of lethal idiopathic plasmacytic lymphadenopathy (IPL) with polyclonal hyperimmunoglobulinemia with chronic renal failure is described. A 40-year-old woman who had suffered from upper airways disease was admitted to the Emergency Room with acute renal failure and hypergammaglobulinemia. She developed pericardial effusion, a pruritic rash, splenomegaly and fell into a coma after 6 days. Multiple myeloma, infection, collagenopathy, and coagulopathy were ruled out. Finally, a form of malignant hypergammapathy was suspected. At autopsy, lymph nodes were infiltrated by polyclonal plasma cells and lymphocytes, with erythrophagocytosis features; immunohistochemistry confirmed the plasma cells (CD138+), with a prevalence of kappa-positive cells, B (CD20+) and T (CD3+) cells. Kidneys showed advanced glomerulosclerosis containing similar infiltrates. The cause of death was IPL with polyclonal hypergammaglobulinemia and advanced renal failure. Similar cases are unusual, and possible medical liability associated with failure to diagnose and treat idiopathic plasmacytic lymphadenopathy deserves discussion and further studies.

Complete cardiac rupture associated with closed chest cardiac massage: case report and review of the literature.

Chest skeletal injuries are the most frequent complications of external chest massage (ECM) during cardiopulmonary resuscitation, but heart and great vessels lacerations that are indeed very rare. We report the case of a 35-year-old workman who collapsed and underwent ECM by his co-workers for almost 30 min. At autopsy, no external injuries, fractures or bruises of the ribs or sternum, were observed. A hemopericardium with a rupture of the heart was found, with no signs of pre-existent cardiac disease. Bruises of thoracic aortic wall, lung petechiae, a contusion of the liver, and bruises of lumbar muscles were found. The cause of death was due to sudden cardiac death with an extensive cardiac rupture. This is an unusual report of massive heart damage without any skeletal or muscle chest injuries, secondary to cardiopulmonary resuscitation. This kind of cardiac lesions may be considered when thoracic­abdominal trauma, or medical history, is unclear.

Postmortem bone marrow analysis in forensic science: study of 73 cases and review of the literature.

In forensic sciences, bone marrow (BM) is an alternative matrix in postmortem toxicology because of its good resistance to autolysis and contaminations. Nevertheless, few studies have been focused on postmortem BM morphological changes after pathological stimuli. We examined 73 BM samples from forensic autopsies; causes of death were both natural and traumatic. BM samples were collected from the sternum by needle aspiration and biopsy; in selected cases, immunohistochemistry was performed. Few autolytic changes were found; BM cellularity decreased with increasing age and postmortem interval. Notable cell changes were detected in 45 cases (61.64%): neoplastic (n=4), and non-neoplastic BM findings (n=41), including multiorgan failure/sepsis (n=26), myelodisplastic-like conditions (n=11), and anaphylactic reactions (n=4). The results showed that BM cellularity supported circumstantial and autopsy findings, suggesting that BM samples could be a useful tool in forensic science applications.

Nasal ciliary motility: a new tool in estimating the time of death.

Determination of time since death is one of the most difficult and crucial issue in forensic medicine. Apart from body cooling, which is commonly used in the early postmortem interval (PMI), supravital reactions are the most interesting postmortem changes for time of death estimation. Nasal ciliary motility has been occasionally observed in postmortem period although no studies have focused on this phenomenon for forensic purposes. We aimed to evaluate the diagnostic usefulness of ciliary motility as a potential tool in estimating the time of death. Specimens of ciliated epithelium from 100 consecutive cadavers were obtained by scraping the nasal mucosa at three different postmortem intervals. The samples were then smeared on a slide, and an in vitro evaluation of ciliary movement was analyzed by phase-contrast microscopy. A postmortem nasal ciliary motility was observed, and a statistically significant relationship between decreasing ciliary movements and increasing postmortem interval was detected even in presence of putrefactive changes of nasal ultrastructure integrity. Some peculiar causes of death seem to influence ciliary motility in the early PMI, while no significant correlations with sex or age were observed. According to the results of this study, postmortem evaluation of nasal ciliary motility may be a bona fide and a feasible option for estimating the time of death.

An unusual death of a masochist: Accident or suicide?

"Autoerotic asphyxia" typically involves an individual hanging or ligature, resulting in self-induced oxygen deprivation brought about by neck compression during sexual activity. Little about the so-called "atypical forms" of autoerotic asphyxia, which also involve compression of the chest or abdomen, has been published in forensic literature. When death results from such practices, they are usually deemed accidental, however, suicide or homicide must also be considered. The authors present a single case of accidental fatal asphyxia by the simultaneous compression of the neck, chest, and abdomen using a chair-bed. The victim was known to have had masochistic tendencies. In order to confirm the hypothesis of accidental death, the results of crime scene investigations, and autopsy findings, including histological and toxicological analysis, are summarized here.

Multidrug poisoning involving nicotine and tramadol.

A fatal case of multidrug poisoning by tramadol and nicotine is reported. Tramadol is a centrally acting analgesic used in the treatment of moderate to severe acute or chronic pain. Nicotine, a lipid-soluble alkaloid, is one of the most readily available drugs in modern society. A 46-year-old man was found dead in his bed, and a suicide note was discovered near the body. He had 25 transdermal nicotine patches attached to his thorax and abdomen. Two half emptied bottles were found on the bedside table; the toxicological examination revealed that they contained tobacco and nicotine as well as other drugs such as diphenhydramine. At autopsy, areas of fresh and old myocardial infarction as well as diffuse pulmonary congestion and edema were present. The tramadol concentration was 6.6 microg/mL in femoral venous blood, while levels of nicotine and its primary metabolite cotinine were determined to be 0.6 and 2.0 microg/mL in femoral venous blood. Based on these results, we determined the cause of death to be cardiorespiratory failure induced by the additive effects of tramadol and nicotine shortly after consumption.

Death due to ingestion of nicotine-containing solution: case report and review of the literature.

Nicotine, a lipid-soluble alkaloid obtained from the dried leaves of Nicotiana, is most frequently encountered in tobacco products for smoking, chewing or sniffing as well as in a limited number of pesticides. Though nicotine is one of the most toxic drugs of abuse, it has rarely led to fatalities. Sudden death can be caused by cardiovascular arrest, respiratory muscle paralysis and/or central respiratory failure. A 42-year-old man was found dead by his wife. He was lying on the floor, next to a box containing many empty bottles of beer and vodka. Some labeled chemical bottles found at the scene contained various substances, including nicotine and brucine. Gross examination of the organs at autopsy revealed no specific findings. The toxicological examination failed to disclose any lethal toxic agents other than a high concentration of nicotine and its primary metabolite cotinine in femoral venous blood (2.2 microg/mL). Blood alcohol was determined to be 2.1 g/L in femoral venous blood. Only a paucity of fatal cases of nicotine poisoning has been reported in the literature so far.

Post-mortem Peyer's patches: their potential application in forensic medicine.

Pro-inflammatory mediators hold important functions in human body in response to infection, trauma and vascular disease. However, their action is down regulated by the release of anti-inflammatory cytokines, thus restoring a balance which reflects the immune status of a given individual. Recent studies have stressed out the importance of circulating levels of cytokines for forensic purposes even if there is a lack of studies regarding the role of post-mortem mucosa-associated lymphoid tissue. In this respect, Peyer's patches (PP), represent one of the most important immunological site of the body and the major component of the gut -associated lymphoid tissue. The aim of this study was to evaluate post-mortem PP immune response in 40 serial autopsy cases of people who died from natural and traumatic death. The study examined spontaneous release of the following cytokines by fresh isolated PP cells: interleukin (IL)-12, tumor necrosis factor (TNF)-alpha, IL-10, IL-6, IL-1 beta, and IL-8. Results will show that higher levels of TNF-alpha, IL-6, IL-1 beta, and IL-8 are statistically correlated with the traumatic death group. From a forensic point of view these data demonstrate that fundamental lymphoid organs, such as PP, may have a potential in diagnosing the cause of death.