Overactive bladder: results from patients treated by hyaluronic acid-chondroitin sulphate therapy.

BACKGROUND: Overactive bladder (OAB) is a chronic condition. This study was prompted by the need to fill the gap between medical treatment and advanced therapies allowing improvement in Quality of Life. The aim of the current study was to evaluate the association between treatment type (Ialuril®; IBSA Farmaceutici, Lodi, Italy; in combination with antimuscarinic or alone after drop-out of antimuscarinic, relative to antimuscarinic alone treatment) and functional outcomes (number of micturitions, pelvic pain, urinary incontinence, nocturia, urgency). METHODS: Of all patients newly diagnosed (January 2016 - January 2022) with OAB syndrome, we retrospectively identified 150 patients. They harbored three groups of 50 patients each: group 1 (antimuscarinic drug), group 2 (antimuscarinic drug + hyaluronic acid-chondroitin sulphate [HA-CS]), group 3 (antimuscarinic dropout patients). Univariable linear and logistic regression models were fitted for number and rates of incontinence, urgency, pelvic pain, nocturia, respectively. RESULTS: A significant mean reduction of 1.5 micturition (P=0.02) was recorded in group 2 compared to group 1. Conversely, no statistically significant mean difference was recorded in group 3 compared to group 1. Regarding pelvic pain, both group 2 and group 3 were associated with lower rate of pelvic pain (P<0.001). Regarding urgency, a statistically significant protective OR was recorded for group 2 (OR=0.39; P=0.04), compared to group 1. CONCLUSIONS: The combination therapy was associated with symptom improvement in antimuscarinic naïve OAB patients. Conversely in antimuscarinic dropped-out patients only pelvic pain improved with the HS-CA. No statistically significant differences were recorded for other functional outcomes, such as incontinence and nocturia.

Is a Low Dosage of Medical Cannabis Effective for Treating Pain Related to Fibromyalgia? A Pilot Study and Systematic Review.

Background and Objectives: Fibromyalgia is a multifaceted and frequently misunderstood chronic pain disease marked by widespread musculoskeletal pain and cognitive/somatic dysfunction. This trial aims to contribute to the existing knowledge on treating fibromyalgia (FM) with medical cannabis (Cannabis sativa L.) and explore a safer and more effective cannabis administration method. The goal is to provide evidence-based findings that can guide alternative treatment options for FM patients by assessing a pilot study. Materials and Methods: The trial was performed at the pain therapy unit of the San Carlo Hospital (Potenza, Italy) by administrating to 30 FM patients 100 mg/day of Bedrocan® (Bedrocan International, Veendam, The Netherlands) as a decoction. The Numerical Rating Scale (NRS) and SF-12 short-form health questionnaire were used to evaluate pain intensity and the quality of life at the beginning of the study and the 6th-month follow-up. A systematic review of all clinical studies investigating the use of cannabis to reduce FM was also undertaken to place this study in the context of the existing evidence base. Results: Pain intensity evaluated with the NRS lowered from a median of 8 [95% CI 7.66-8.54] at a baseline to a median of 4 (95% CI 3.28-4.79) after 6 months of follow-up (p-value < 0.001; t-test). Similarly, significant physical and mental state improvement, evaluated with the SF-12 questionnaire, was found in 96.67% and 82.33% of patients, respectively (95% CI 44.11-51.13 for the physical state, and 53.48-58.69 for mental state assessed after the 6th-month follow-up; p-value < 0.001; t-test). The systematic analysis of the literature identified 10 clinical trials concerning the treatment of fibromyalgia with cannabis. Conclusions: Considering results from the present pilot study and systematic review, it is possible to assume that medical cannabis may be considered an alternative therapy for FM patients who do not respond to conventional pharmacological therapy.

Antiplatelet Therapy for Elderly Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

The elderly represent an increasing proportion of patients presenting with acute coronary syndrome (ACS). Various data have shown that the benefits of percutaneous coronary revascularization are maintained in elderly patients presenting with ACS. Conversely, the management of antiplatelet therapy remains challenging and controversial, because older patients are usually at a high risk of both ischemia and bleeding. Moreover, the recommended ischemic and bleeding risk scores in patients with ACS were developed from studies with a low representation of older patients. New antiplatelet strategies have been developed, but their evidence in elderly patients is limited because they are usually underrepresented in randomized clinical trials due to their clinical complexity. The aim of this review is to summarize the different factors associated with increased ischemic and/or bleeding risk and the scientific evidence about the different antiplatelet strategies in elderly patients presenting with ACS and undergoing percutaneous coronary revascularization.

National programme for the reliability of ionizing radiation measurements based on inter-laboratory comparisons (ILCs): ILC n°2 'radiopharmaceutical activities'.

A national Inter-Laboratory Comparisons (ILCs) programme was organized in Italy in 2022 by the Italian National Institute of Ionizing Radiation Metrology (INMRI), belonging to ENEA (Italian National Agency for New Technologies, Energy and Sustainable Economic Development), under the auspices of the Ministry of Enterprises and Made in Italy (Mimit ex MiSe). Within this ILCs programme, six inter-laboratory comparisons were organized, including the ILC-2 which focused on activity measurements carried out with radionuclide calibrators commonly used in the nuclear medicine departments of the participants. The focus was on three short-lived radionuclides - 99mTc, 18F, 177Lu - commonly employed in nuclear medicine for both diagnostic and therapeutic purposes. All presented results were compared with the reference values provided by ENEA-INMRI to ensure the traceability of measurements to the national primary activity standards. The observed deviation from the reference values of the measured activity were mainly within ± 10% (100% for 18F, 91.7% for 99mTc, 100% for 177Lu). The En statistical estimator was used to assess the participants' ability to estimate uncertainty in the provided activity values. The obtained values revealed that, in certain instances, the involved laboratories did not achieve the correct results for En (with failure rates of 22.7%, 16.7%, 12.5% for 18F, 99mTc, 177Lu, respectively), despite deviations from the reference values falling within the ± 10%. The aim of ILC-2 was to harmonize the activity measurements in the country within the field of nuclear medicine for the specific radionuclides studied and enhance the measurement capabilities of the participants.

Is It Still Time for Safety Walkaround? Pilot Project Proposing a New Model and a Review of the Methodology.

Background and Objectives: Healthcare facilities are complex systems due to the interaction between different factors (human, environmental, management, and technological). As complexity increases, it is known that the possibility of error increases; therefore, it becomes essential to be able to analyze the processes that occur within these contexts to prevent their occurrence, which is the task of risk management. For this purpose, in this feasibility study, we chose to evaluate the application of a new safety walkaround (SWA) model. Materials and Methods: A multidisciplinary working group made up of experts was established and then the subsequent phases of the activity were divided into three stages, namely the initial meeting, the operational phase, and the final meeting, to investigate knowledge regarding patient safety before and subsequently through visits to the department: the correct compilation of the medical record, adherence to evidence-based medicine (EBM) practices, the overall health and the degree of burnout of the various healthcare professionals, as well as the perception of empathy of staff by patients. Results: This working group chose to start this pilot project in the vascular surgery ward, demonstrating the ability of the tool used to capture the different aspects it set out to collect. In detail, the new version of SWA proposed in this work has made it possible to identify risk situations and system vulnerabilities that have allowed the introduction of corrective tools; detect adherence to existing company procedures, reschedule training on these specific topics after reviewing, and possibly update the same procedures; record the patient experience about the doctor-patient relationship and communication to hypothesize thematic courses on the subject; evaluate workers' perception of their health conditions about work, and above all reassure operators that their well-being is in the interest of the management of the healthcare company, which is maintained. Conclusions: Therefore, the outcome of the present study demonstrates the versatility and ever-present usefulness of the SWA tool.

Risk Management and Patient Safety in the Artificial Intelligence Era: A Systematic Review.

BACKGROUND: Healthcare systems represent complex organizations within which multiple factors (physical environment, human factor, technological devices, quality of care) interconnect to form a dense network whose imbalance is potentially able to compromise patient safety. In this scenario, the need for hospitals to expand reactive and proactive clinical risk management programs is easily understood, and artificial intelligence fits well in this context. This systematic review aims to investigate the state of the art regarding the impact of AI on clinical risk management processes. To simplify the analysis of the review outcomes and to motivate future standardized comparisons with any subsequent studies, the findings of the present review will be grouped according to the possibility of applying AI in the prevention of the different incident type groups as defined by the ICPS. MATERIALS AND METHODS: On 3 November 2023, a systematic review of the literature according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was carried out using the SCOPUS and Medline (via PubMed) databases. A total of 297 articles were identified. After the selection process, 36 articles were included in the present systematic review. RESULTS AND DISCUSSION: The studies included in this review allowed for the identification of three main "incident type" domains: clinical process, healthcare-associated infection, and medication. Another relevant application of AI in clinical risk management concerns the topic of incident reporting. CONCLUSIONS: This review highlighted that AI can be applied transversely in various clinical contexts to enhance patient safety and facilitate the identification of errors. It appears to be a promising tool to improve clinical risk management, although its use requires human supervision and cannot completely replace human skills. To facilitate the analysis of the present review outcome and to enable comparison with future systematic reviews, it was deemed useful to refer to a pre-existing taxonomy for the identification of adverse events. However, the results of the present study highlighted the usefulness of AI not only for risk prevention in clinical practice, but also in improving the use of an essential risk identification tool, which is incident reporting. For this reason, the taxonomy of the areas of application of AI to clinical risk processes should include an additional class relating to risk identification and analysis tools. For this purpose, it was considered convenient to use ICPS classification.

Oxidative Stress in Sepsis: A Focus on Cardiac Pathology.

This study aims to analyze post-mortem human cardiac specimens, to verify and evaluate the existence or extent of oxidative stress in subjects whose cause of death has been traced to sepsis, through immunohistological oxidative/nitrosative stress markers. Indeed, in the present study, i-NOS, NOX2, and nitrotyrosine markers were higher expressed in the septic death group when compared to the control group, associated with also a significant increase in 8-OHdG, highlighting the pivotal role of oxidative stress in septic etiopathogenesis. In particular, 70% of cardiomyocyte nuclei from septic death specimens showed positivity for 8-OHdG. Furthermore, intense and massive NOX2-positive myocyte immunoreaction was noticed in the septic group, as nitrotyrosine immunostaining intense reaction was found in the cardiac cells. These results demonstrated a correlation between oxidative and nitrosative stress imbalance and the pathophysiology of cardiac dysfunction documented in cases of sepsis. Therefore, subsequent studies will focus on the expression of oxidative stress markers in other organs and tissues, as well as on the involvement of the intracellular pattern of apoptosis, to better clarify the complex pathogenesis of multi-organ failure, leading to support the rationale for including therapies targeting redox abnormalities in the management of septic patients.

The international reference system for beta-particle emitting radionuclides: Validation through the pilot study CCRI(II)-P1.Co-60.

The Bureau International des Poids et Mesures (BIPM) is developing a new transfer instrument to extend its centralized services for assessing the international equivalence of radioactive standards to new radionuclides. A liquid scintillation counter using the triple/double coincidence ratio method is being studied and tested in the CCRI(II)-P1.Co-60 pilot study. The pilot study, involving 13 participating laboratories with primary calibration capabilities, validated the approach against the original international reference system based on ionization chambers, which has been in operation since 1976. The results are in agreement and an accuracy suitable for purpose, below 5×10-4, is achieved. The pilot study also reveals an issue when impurities emitting low-energy electrons are present in the standard solution, which have a different impact on liquid scintillation counting compared to other primary measurement methods.

Focus on Prevention: Peripheral Arterial Disease and the Central Role of the Cardiologist.

Peripheral artery disease (PAD) is a manifestation of systemic atherosclerotic disease. PAD patients have a poor prognosis with an increased risk of cardiovascular (CV) events, including myocardial infarction (MI), stroke, limb ischemia and CV death; therefore, it is important to detect and treat PAD early. PAD and coronary artery disease (CAD) share a common pathogenesis and risk factors for development; therefore, cardiologists are in a unique position to screen, diagnosis and treat PAD. Moreover, PAD and CAD also share some treatment goals, including an aggressive modification of risk factors to reduce the risk of CV events. However, PAD remains an underdiagnosed and undertreated disease with medico-legal implications. As the role of cardiologists is expanding, the purpose of this review was to awaken the clinicians to the significance of PAD.

'Compressed Baby Head': A New 'Abusive Head Trauma' Entity?

BACKGROUND: Child abuse represents an important issue in the medico-legal and social context. In the last few decades, various aspects and mechanisms have been identified in child abuse case studies; however, constant research is needed in the field. With this paper, the authors will present a case of a new entity of Abusive Head Trauma that has come to the attention of medico-legal experts. DISCUSSION: The trauma analysis performed on the cranio-encephalic district of the baby revealed quite peculiar lesions that led the authors to exclude that the injuries had been solely caused by violent shaking of the baby's head, as suggested by Shaken Baby Syndrome. Instead, the authors hypothesised that another lesion mechanism had been added to this one, namely latero-lateral cranial compression. The comprehensive and exhaustive analysis of the case led the authors to present a new possible entity in child abuse trauma, namely 'Compressed Baby Head'. CONCLUSIONS: To the best of our knowledge, in the current literature, no similar clinical cases have ever been described. Thus, the case's uniqueness deserves to be brought to the attention of experts and the entire scientific community, as well as medical personnel, paediatricians, and reanimators. These professional figures are the first individuals who may encounter complex clinical cases such as the one presented in this paper; thus, they need to know how to properly manage the case and ensure protection for the abused infants and children.