Introduction: worldwide, a large number of surgical procedures are performed daily for aesthetic purposes,often providing excellent outcomes in terms of appearance enhancement. However, these interventions are notexempt from adverse effects, including visible skin alterations such as hypertrophic scars and fibrosis, which maynegatively impact patients’ physical and emotional well-being.Case description: Three cases of patients with hypertrophic scars and/or fibrosis following surgical interventionswere treated using an injectable cocktail of recombinant enzymes. From the first treatment session, all patientsreported positive changes. Post-treatment evaluation showed improvements in tissue mobility, sensitivity, pain,and visible appearance of the affected areas. These physical improvements were accompanied by a noticeableenhancement in patients’ emotional state.Conclusions: Treatment with an injectable cocktail of recombinant enzymes may represent a beneficial therapeuticoption for managing hypertrophic scars and fibrosis after surgical interventions, contributing to both physicalrecovery and improved quality of life.
Recent reports on the unavailability of OpenEvidence in the European Union and the United Kingdom have renewed debate on artificial intelligence, medicine, and regulation. This case has often been interpreted as further evidence of Europe’s structural difficulty in supporting technological innovation. While this reading identifies a real problem, it is insufficient. The central question is not only how rapidly AI is adopted, but how safely, critically, and responsibly it is integrated into clinical practice. In the global regulatory landscape, the United States operates within a market-oriented ecosystem largely shaped by medical device regulation; China pursues a more centralized and state-driven strategy; and Europe relies on a risk-based regulatory framework. Yet healthcare AI cannot be assessed only through availability, competitiveness, or formal compliance. Its value depends on clinical validity, epistemic transparency, and compatibility with physicians’ professional duties. Clinically oriented AI systems, especially those based on curated sources and professional interfaces, may appear more reliable than general-purpose models. However, perceived reliability is not equivalent to clinical validity. Even retrieval-augmented systems can generate inaccurate citations, weak inferences, misleading syntheses, or recommendations expressed with greater certainty than the evidence permits. The distinctive danger is therefore not simply error, but error presented in the language of evidence. This paper argues against both uncritical adoption and reflexive prohibition. Safe medical AI requires technical robustness, proportionate regulation, institutional governance, independent validation, and specific physician training in critical use. The guiding principle remains deontological: artificial intelligence may support clinical reasoning, but it cannot assume professional responsibility.
Introduction: Metastatic colorectal cancer (mCRC) constitutes approximately 10% of all cancers globally and ranks as the second leading cause of cancer-related deaths. Management of refractory mCRC remains challenging due to pharmacological resistance and limited effective therapeutic options. Methods: This publication presents insights from a Delphi panel of Italian clinicians regarding mCRC therapeutic approaches, unmet medical needs, and fruquintinib’s potential clinical utility within existing treatment algorithms. The project, guided by four leading Italian oncology experts, involved two survey rounds among 14 oncologists, achieving consensus on 15 statements with a 100% response rate. Results: The expert panel identified critical epidemiological patterns in mCRC, with 20-25% of patients requiring further treatment after the failure of third-line therapy. The panel emphasized the clinical significance of fruquintinib’s efficacy and tolerability profile demonstrated in the FRESCO-2 trial. The experts unanimously endorsed fruquintinib as a new standard of care for adult mCRC patients who have progressed through available standard therapies. Conclusions: This recommendation is based on fruquintinib’s observed survival benefit and manageable toxicity profile, which facilitate improved treatment management and potentially enhance patient quality of life. The structured consensus approach validates these recommendations, providing practical guidance for optimizing outcomes as therapeutic options for mCRC continue to expand in complexity.
Introduction: Several factors influence the quality and appearance of the skin, including age, lifestyle, sun exposure, and certain conditions. These elements can have a significant negative impact on some individuals. As a result, esthetic medicine is increasingly sought after as a solution to counteract these effects, enhancing both appearance and self-esteem. The objective of the research was to observe the clinical and histological changes in the skin of five women with photoaging, hyperpigmentation, rhytidosis, or acne scars after a single application of recombinant enzymes. Methods: This longitudinal descriptive study was conducted on 5 women aged 47-65, randomly selected. Photographic records and biopsies were taken before and after the treatment. Results: Clinical results revealed a significant improvement in skin quality and texture, with reduced skin laxity and skin repositioning, as well as a decrease in hyperpigmented lesions and acne scars. Histologically, there was a reduction in hyperkeratosis and collagen basophilia, along with regeneration of elastic and collagen fibers, showing an increase in their integrity. Conclusion: A single dose of recombinant enzymes demonstrated improvement in skin quality both clinically and histologically in 100% of the patients, proving to be a safe, reliable, and easy-to-apply treatment. It achieved high levels of patient satisfaction, suggesting its potential to replace more invasive procedures.
Introduction: The European Medicines Agency (EMA) has updated its Reflection Paper on the use of Real-World Data (RWD) in Observational Studies (OS), emphasizing the regulatory importance of Real-World Evidence (RWE). Objectives: Summarize the main methodological recommendations of the EMA’s 2025 guidance, highlight challenges and opportunities for the use of RWD in regulatory contexts, and discuss implications for clinical researchers, with particular attention to the role of pharmacists. Discussion: The new guidance distinguishes descriptive from causal OS and endorses Target Trial Emulation (TTE) to improve causal inference in observational research. It stresses transparency, reproducibility, and rigorous data governance, while calling for robust strategies to manage bias and confounding. Pharmacists are recognized as key contributors to drug utilization research and post-marketing surveillance, ensuring data quality and interoperability and supporting the integration of RWE into regulatory decision-making. Conclusions: EMA’s roadmap affirms the value of RWE in strengthening regulatory science. Its implementation will require cultural change, technical expertise, and resource allocation, offering both challenges and opportunities for healthcare researchers, particularly pharmacists, to transform RWD into trusted evidence.
This review addresses the unique challenges of pediatric eosinophilic esophagitis (EoE) management, aiming to develop a comprehensive knowledge base, standardize therapeutic approaches, and explore new targeted biological treatments. A non-systematic literature review was conducted, complemented by two surveys: one for clinicians to validate current practices and another for the President of the Italian Association of Families Against Eosinophilic Esophagitis to assess disease burden. An expert panel discussed and validated the results. The study identified a prevalence of 32.9 per 100,000 in pediatric EoE in Italy, with only half of the cases accurately diagnosed and an average diagnostic delay of 18 months. Current treatments show limitations in long-term management, with 27.8% of patients proving ineligible, intolerant, or inadequately controlled. The Impact Score and SCOPE (Symptoms, Comprehensive Observation, Pathological Evaluation) approach were recommended for early diagnosis and treatment efficacy evaluation. Dupilumab emerged as a promising therapy for patients unresponsive to conventional treatments, demonstrating significantly higher rates of histological remission in children aged 1-11 years compared to placebo in clinical trials. This study provides a standardized approach to pediatric EoE management, emphasizing early diagnosis, multidisciplinary care, and targeted biological treatments. The findings highlight the need for increased awareness, standardized care pathways, and further research to address ongoing challenges in pediatric EoE management.
Introduction: Pathological scars, despite the achievements of modern medicine, are still a problem. Its prevalence can reach up to 50% in emergency surgeries. These scars can lead to physical complications, including impaired mobility, altered sensation, and discoloration, and may even cause pain. In this study, we explore the possibilities of using the combined drug of recombinant collagenase and lyase enzymes, and high molecular weight hyaluronic acid (HMWHA) pbserum HIGH in the treatment of pathological scars. Methods: patients of the main group received a course of intra-cicatricial injections of the drug, treatment results were assessed clinically, according to the Vancouver Scar Scale (VSS) and Observer Scar Assessment Scale (POSAS) scales, the results were compared morphologically with standard scars treatment methods (biopsies were taken before and after treatment). Results: Clinically, patients of the main group received a pronounced positive transformation of scar tissue in 6 weeks, statistical processing of data confirms the reliability of changes, morphological studies prove the normotrophic nature of the changes in the scars (including comparison with the control group). Conclusions: Remedy of recombinant collagenase and lyase enzymes in combination with HMWHA pbserum HIGH in the form of the course of intra-cicatricial injections is a safe and effective method of treating pathological scars.
Introduction: Hereditary angioedema (HEA) is a rare genetic disorder characterised by recurrent episodes of edema affecting various body districts. HEA therapy includes treatment of acute attacks and short- or long-term prophylaxis. Objective: To describe the main demographic and clinical characteristics of patients with HEA in real Italian clinical practice, as well as the use of pharmacological treatments, the use of healthcare resources and costs with particular reference to lanadelumab. Methods: From administrative databases of healthcare institutions for about 9 million patients, between January 2010 and September 2020, all-age HEA patients were identified through hospitalisation, exemption code or specific drugs. Demographic and clinical characteristics, medications prescribed for acute attacks and prophylaxis were described at inclusion. For patients treated with lanadelumab, the switching of dosing regimen from 2 to 4 weeks was examined. Healthcare resource utilisation and costs were assessed at one-year follow-up. Results: 258 patients with HEA were identified (~0.003% of the sample). Of them, 41.1% were male, and the mean age was 44.6 years; 80% of patients were treated for acute attacks, and 20% were on prophylaxis. In lanadelumab-treated, 85% started treatment with a 2-week regimen, and of them 75.8% switched to a 4-week regimen. For these patients, the estimated annual cost—calculated using the weighted average of patients who switched treatments—was €114,362. Conclusions: The data from this analysis on therapeutic management of HEA patients in the Italian clinical practice showed that, despite the limited number of patients treated with lanadelumab, many received one administration every 4 weeks, suggesting a good disease control.
Background: Pulmonary arterial hypertension (PAH) is a rare and progressive disease characterized by high mortality and a significant impact on quality of life. Despite therapeutic advances, considerable heterogeneity persists in Italy’s diagnostic and therapeutic pathways, leading to delays in diagnosis and disparities in access to care. Objective: With this work we aim to define a roadmap for a shared diagnostic, therapeutic, and care pathway for PAH in the Triveneto region, aiming to reduce management variability, improve continuity of care, and optimize the use of available resources. Methods: A multidisciplinary group of cardiologists, pulmonologists, and rheumatologists from Triveneto, along with a representative from the Pulmonary Hypertension Patients’ Association, convened in a series of meetings to discuss diagnostic and therapeutic pathways. Results: Early identification of PAH should be based on the classification of symptomatic patients into three main phenotypes (cardiac, pulmonary, and not better specified), followed by a specific diagnostic process based on updated hemodynamic criteria. Therapeutic strategies should be defined according to risk stratification, with clear guidelines for comorbidity management and monitoring through quality indicators (Key Performance Indicators) to assess the effectiveness of care pathways. Conclusions: The proposed roadmap represents a shared model for PAH management in the Triveneto region, promoting a multidisciplinary and integrated approach. Its adoption could enhance care quality, reduce regional disparities, and align with European guidelines, ultimately improving patient prognosis and quality of life.
Introduction: Alcohol-based hand sanitizers are used in healthcare settings, but their efficacy against both enveloped and non-enveloped viruses requires further investigation. Methods: In this study, viral suspensions composed by the test virus, an interfering substance, and the test product, were exposed to Amuchina Gel Xgerm (100 g of the product contains 74 g of ethanol 96%; Angelini Pharma S.p.A) at 80% dilution in water, according to the European Standard EN14476:2013+A2:2019 –quantitative suspension test for the evaluation of virucidal activity in the medical area– for chemical disinfectants and antiseptics, in the presence of bovine serum albumin 0.3 g/L. The residual viral titers were measured. Results: Sixty second exposures to the product determined a ≥4 log10 reduction of virus titer in all cases. For adenovirus type 5, human coxsakievirus, herpesvirus 1 and influenza virus A H1N1, a ≥4 log10 reduction of virus titer was obtained already after 30 s. Amuchina Gel Xgerm demonstrated effectiveness against seven virus families, including both enveloped and non-enveloped viruses. Conclusion: Amuchina Gel Xgerm is a preventive measure against infection spread in healthcare and community settings, contributing to improved healthcare management.
In Italy, breast cancer is the most frequently diagnosed cancer in women, with 55,900 new cases in 2023 (over 90% in the early stages). Due to the screening, early diagnosis and adjuvant treatment, these patients have a 5-years survival rate of 87% after the diagnosis. There are 834,154 women in Italy with a previous diagnosis of breast cancer: most of these women require a follow-up. The AIOM, ESMO and ASCO Guidelines recommend for early breast cancer (EBC) a clinical follow-up with only physical examination (and eliciting of symptoms) and an annual X-ray mammography, on the basis of the results of two randomized trials published in 1994 that showed no benefit in overall survival with intensive follow-up. However, an Italian survey reported the application by 80% of oncologists of an intensive follow-up based on the individual patient’s risk of recurrence. In fact, the oncologists believe that an early diagnosis of locoregional or distant recurrence may allow an early start of very effective therapies. In this lack of up-to-date scientific data, many questions about follow-up remain unanswered and the few ongoing studies will provide results in several years. Non-compliance with guideline recommendations leads to increased costs for the healthcare system. Furthermore, management varies widely from centre to centre with regard to guideline recommendations, resulting in inequalities between patients. For these reasons, the follow-up of breast cancer should be reconsidered. In the absence of recent scientific evidence, a multidisciplinary group of breast cancer experts has initiated a Consensus on the follow-up of EBC according to the mini-Delphi methodology. The project will be completed by the end of 2024.
The market placing of a medical device in compliance with the requirements of EU Regulation 2017/745 (Medical Device Regulation) demands advanced regulatory expertise and a high level of detail and depth, inevitably leading to significant human and time resources. In an era where Artificial Intelligence (AI) is already present in various aspects of daily life, the potential and opportunity to use AI tools in the scientific field, such as the CE marking process of medical devices, are being explored. This process consists of several phases and related activities, some of which have been chosen as significant examples to evaluate how and to what extent AI can add value in achieving their compliance. The article presents the overall results in terms of performance and reliability derived from generative AI tests using Large Language Models, such as ChatGPT, applied to some of the processes necessary for the market placing of a medical device. The method used focuses on the relationship between prompt quality and output quality, demonstrating the importance of prompt engineering in using these tools effectively alongside regulatory processes. It also emphasizes the need for end-users to have education, training, and understanding of the mechanisms of generative AI to optimize performance.
Introduction: The availability of increasingly accurate and high-performing Continuous Glucose Monitoring (CGM) systems today allows for the adoption of selection criteria based not only on clinical profiles but also on the preferences of people with diabetes. Methods: The “Dexcom ONE Experience” study aimed to investigate the initial user experiences with the Dexcom ONE CGM system in the real lives of people with diabetes undergoing insulin therapy, specifically early adopters (i.e., patients who first in Italy adopted Dexcom ONE CGM who have used the device for at least 30 days). Empirical evidence was collected, focusing primarily on usability, satisfaction, and impact on quality of life (QoL) of the system, through an online survey. All survey participants were insulin-treated patients, as indicated by CGM device recommendations. Results: Analysis was conducted on 300 completed surveys. 93% of respondents consider the device useful for diabetes management; 91% find it helps in more effectively managing therapy, while 88% report an improvement in health. 86% find it easy to learn how to use, and 93% plan to continue using it in the coming months. 74% believe the system to be highly reliable. The most recognized and utilized functions are data visibility on smartphones/receivers and glycaemic trend visibility. 70% of respondents express being “very or extremely satisfied” with the Dexcom ONE device experience (scoring 4/5), and 90% note a “positive or extremely positive” impact on their QoL from using the device. Conclusions: In conclusion, usability and satisfaction levels have proven to be high among early adopters of the Dexcom ONE CGM system.
The goals of Pharmacovigilance (PV) include early detection of new adverse reactions, broadening information on known reactions, identifying risk factors, comparing drug safety profiles, and effectively communicating safety information to healthcare professionals. In non-profit clinical research, PV activities often face challenges due to limited resources and training. An exploratory survey by the Italian Data Manager Group in 2022 highlighted critical issues in non-profit clinical trials, such as the lack of multidisciplinary support and insufficient training in PV. To strengthen PV in non-profit studies, continuous professional development and adequate resources are essential. Ensuring the presence of dedicated, well-trained professionals and promoting the use of updated tools and processes can significantly improve the management of PV activities, ultimately safeguarding patient health and maintaining high-quality research standards.
Background and aim: The ageing of the general population, with the increase in chronic diseases, poses the need for using technological innovation to face the growing healthcare needs. The present analysis applied the Activity-Based Costing tool in migraine patients followed at the IRCCS Mondino of Pavia to formalize and quantify the costs of the whole patient’s management process and to estimate the overall economic burden of migraine from the perspective of the National Health Service (NHS). Methods: A two-stage analysis was conducted. The first stage aimed at drawing patient’s pathway, defining all the possible activities and actors involved in the healthcare delivery and treatment for migraine at the IRCCS during year 2022. The second phase was the development of a model to estimate the costs of the entire process by pricing the individual activities. Results: The described model yielded an estimated total annual cost for the overall management of migraine of € 1,222,392, corresponding to a direct cost for a therapy of approximately 6 months per single patient of € 814. The most impactive items on the estimated annual expenditures were hospitalizations, followed by diagnostic examinations after follow-up visits and drugs dispensed by Hospital Pharmacy for home-administration (monoclonal antibodies). Conclusions: This analysis allowed detailing the single activities and resources used in migraine patient’s pathway and then estimating the direct costs sustained by the NHS. The model could be translated to other diseases for optimizing the diagnostic/therapeutic and economic management of assisted patients and improving healthcare resource allocation.
Background: Building a meaningful training program for musculoskeletal (MSK) specialists is a major undertaking to improve the clinicians’ skills and ultimately patients’ outcome. The purpose of this study was to gather direct information from attendants of a training program called IBSA International Academy – MSK Modules on the perceived benefit of such initiative. Methods: The IBSA International Academy has been developed during 2021 by IBSA’s Global Medical Affairs department with the involvement and support of an international faculty composed by experts in the field that has become the scientific Board of the Academy. More than 100 specialists from several European countries attended one or more modules focused on ultrasound (US) and US-guided infiltration and were asked to answer (a) a short survey just after the modules were completed and (b) a more detailed survey several weeks after their return to daily practice. Results: A total of 114 specialists from 12 European countries attended the academy. The post-module evaluation form was completed by 94 (82.4%) and the follow-up survey by 30 (26.3%) participants. Response rate was highest for specialists from Nordic countries (50.0%) and lowest from Balkan countries (11.1%). The overall feedback of the participants to the academy was overwhelmingly positive both immediately and medium–long term after return to daily practice. About 57% of responders indicated mastering US and 30% indicated a better understanding of the anatomy as a key learning outcome of the academy. The added value of networking between peers and of direct contact with the experts in the faculty was mentioned by 77% and 53% respectively.
Background: The availability of high-efficacy disease-modifying therapy (DMT), including natalizumab, improved treatment efficacy in adults with highly-active relapsing-remitting multiple sclerosis (RRMS). Natalizumab patent protection has expired, and the natalizumab biosimilar (Tyruko®) has been recently reimbursed by AIFA. As the price of natalizumab biosimilar is expected to be lower as compared with natalizumab originator’s price, a budget impact analysis was conducted to assess the economic impact associated to the introduction of natalizumab biosimilar for patients with highly-active RRMS. Methods: A budget impact model was developed, considering the INHS perspective and a 5-years time horizon. The number of patients treated with natalizumab was estimated based on historical natalizumab consumption data, disease prevalence rates and natalizumab market share. The budget impact population was divided into prevalent and incident patients. The model assumes that some patients in treatment with natalizumab originator will switch to natalizumab biosimilar and that some naïve patients will directly start treatment with natalizumab biosimilar. The ex-factory price of natalizumab originator (intravenous and subcutaneous) and biosimilar (intravenous) and the corresponding administration costs were included. All assumptions were validated by expert opinion. Results: Eligible population was estimated at 7,552, 7,779, 8,090, 8,494 and 8,834 in years 1, 2, 3, 4 and 5 respectively. The introduction of natalizumab biosimilar, considering a progressive increase in market share from 9.6% (year 1) to 40.5% (year 5), would provide an overall savings (5-years time horizon) over € 47 million to the INHS. The scenario analysis highlights that the lower treatment cost of biosimilar natalizumab compared to originator natalizumab would offset the higher cost associated with intravenous versus subcutaneous administration. Conclusion: Considering the results of this budget impact analysis, it is realistic to expect that the presence of biosimilar natalizumab will contribute to the sustainability of public pharmaceutical expenditure.
Considering the current and future therapeutic options that are or will be available in the adjuvant treatment of breast cancer, this document reports on the insights from two multi-regional expert meetings aimed at investigating possible problems of access to the treatment pathway involving the BRCA (BReast CAncer) test. The experts stated that the update of the AIOM guidelines (diagnostic and therapeutic innovations) will require a correction of clinicians’ behaviors and a partial reorganization of the current Integrated Care Pathways (ICPs). From this point of view, the update of the AIOM GLs could supply to Regions and, above all, to all cancer networks a valid rationale for starting a process of harmonization of ICPs aimed at guaranteeing the rapid access to treatments by improving the quality of the service provided by the National Health Service (SSN). To ensure to breast cancer patients a rapid access to the latest approved treatments, experts believe that it will be necessary to update the access pathway to genetic tests. This could lead to an increase in the use of genetic tests, creating one of the main organizational and economic challenge that regions and cancer networks will have to face.
