Ana Lucía Arellano

Objectives: To describe the implementation of a multidisciplinary, ethically grounded hackathon as a model to develop and evaluate generative AI (GenAI) solutions for real-world clinical challenges within a hospital setting. Methods: The GenAI Health Hackathon (GAHH) organised at Hospital Clínic de Barcelona included 13 challenges were selected via an internal call based on clinical impact, feasibility and data availability. Participants accessed anonymised real-world data through a secure cloud environment. Teams employed large language models and retrieval-augmented generation to build prototypes addressing tasks such as clinical text structuring, decision support and workflow automation. Human-in-the-loop validation, explainability and regulatory safeguards were emphasised. Results: The hackathon yielded multiple AI prototypes tested on real data. Results varied: entity recognition reached 90.5% accuracy, summarisation >90% clinician concordance and nutritional models achieved F1 scores of 0.75–0.93. Lower scores (F1<0.52, Jaccard Index <0.4) were seen in complex reasoning or multilingual tasks. Bias was explored in 10 projects, with mitigations such as stratified sampling, prompt tuning, disclaimers and expert oversight. A transferable framework was proposed to replicate responsible GenAI hackathons in clinical contexts. Discussion: Interdisciplinary collaboration and real-world testing proved essential for aligning GenAI with clinical needs. The hackathon revealed challenges in bias, evaluation and integration but offered a transferable framework for responsible innovation under General Data Protection Regulation and the European Union Artificial Intelligence Act. Conclusions: The GAHH demonstrated that GenAI can be safely and effectively applied in healthcare with rigorous governance and interdisciplinary collaboration, offering a scalable model for responsible AI innovation.

The process of informed consent, a fundamental aspect of clinical research, involves providing research participants with information about a study and obtaining their voluntary agreement to participate. Its purpose is to safeguard the rights and welfare of participants by ensuring they comprehend the nature, potential benefits, and potential risks of the research, and can make an autonomous and informed decision about whether to participate. The history of informed consent in clinical research is relatively recent, beginning with the Nuremberg Code in 1947 and evolving through subsequent codes and laws such as the Declaration of Helsinki, the Belmont Report, the CIOMS guidelines, and the US Common Rule. There is a general ethical agreement on the structure and information that should be included in informed consent in order to ensure that participants have all the necessary information to make an informed decision. This chapter aims to provide an overview of significant historical milestones in the development of informed consent, current consensus on its structural features, and examples of situations where obtaining informed consent may pose a challenge, such as cluster-randomized clinical trials or decentralized clinical trials.

Drug-related deaths (DRDs) are a common cause of hospital death. Pharmacovigilance, either as spontaneous reporting or active surveillance, plays a key role in the detection and reporting of suspected adverse drug reactions (ADRs). We conducted a retrospective analysis of all DRDs spontaneously reported to a pharmacovigilance program of a tertiary hospital, by health care professionals. We compared these results to those of a previous retrospective study conducted in the same hospital from the hospital’s mortality registry. From 1460 spontaneous reported ADRs in a 10-year period, 73 (5%) were DRDs. The median age of DRD was 75 years (range 1 month–94) and 60.3% were men. The most frequent DRDs were hemorrhages (41.1%), followed by infections (17.8%). The most frequently involved drugs were anticoagulants and/or antithrombotic (30%), and antineoplastics (26.3%). When comparing both studies, spontaneous reporting detected more type B reactions (p < 0.001) and hospital-acquired DRD (p < 0.001); the number of concomitant drugs was higher (p = 0.0035); and the kind of ADR were different. The combination of several methods is mandatory to detect, assess, understand, and design strategies to prevent ADRs in a hospital setting, to ensure patient safety.

Aims: To determine the incidence of drug‐related deaths (DRD) in a university hospital in 2015, to describe their characteristics, and to discover risk factors of DRD.Methods: An analytic and retrospective cohort study. Patients with a death diagnosed predefined from a list of medical conditions potentially caused by drugs were the selected cases for further review. Causality assessment was evaluated by a local drug safety committee.Results: Out of 1135 inpatient deaths, 73 DRD were included (six were hospital‐acquired). The incidence of DRD of all hospital admissions was 0.34%, and the incidence of all deaths cases was 7%. Drugs were the cause of death in 38 patients (52%) and a contributive role in 35 (48%). The median age of DRD patients was 72 years (range 19–94) and 72.6% were men. The median hospital stay, Charlson score and number of drugs were 5 days, 2 points and seven drugs respectively. The most frequent DRD were cerebral haemorrhages and infections in drug‐immunosuppressed patients (32, 43.8%, each group). The most frequently involved drugs were antineoplastics and glucocorticosteroids (40% and 18%), and antithrombotics (33%); drug–drug interactions were present in 44% DRD. Sex, age and number of drugs were risk factors of DRD.Conclusions: Adverse drug reactions were a significant cause of death in hospitalized patients, mainly haemorrhages and infections precipitated by drug–drug interactions. Risk factors for DRD were sex, age and number of drugs. Preventable DRD and measures to avoid them should be accurately assessed in further studies.

Defects in drug metabolic pathways could explain why some patients have a history of multiple adverse drug reactions (ADR); therefore we aimed to analyze genetic polymorphisms in a patient with multiple ADR related to drugs with a common hepatic metabolic pathway through CYP2D6. We report a patient with psychosis and hypertension related to amitriptyline, tramadol, and duloxetine within a 2-year period. A pharmacogenetic test was performed to assess the causative role of the CYP2D6 enzyme, but did not demonstrate a metabolic deficiency. Although negative results in the reported case; typing for cytochrome P450 isoenzyme polymorphisms could be a useful diagnostic tool in some patients with a history of multiple ADR.

Background: Concurrent use of cannabis and alcohol is frequent. According different studies, the prevalence is among 20-34% depending on different samples studied. Objective: In contrast with the wide evidence available about neuropsychiatric effects associated to the use of cannabis or alcohol separately, there are few studies of the neuropsychiatric effects of their combination. Our aim was to review the literature regarding this topic. Conclusion: We performed a search in MEDLINE and from 114 potentially eligible studies, 27 were selected. Most of them studied the relation between cannabis and alcohol, and with them combined to other substances of abuse, but only a few considered their concurrent effect among mental disorders (ADHD, bipolar disorder) and neuropsychological performance. More research in the neuropsychiatric effects of the concomitant use of cannabis and alcohol is needed.

Background & Objective: Cannabis is the most widely used illicit drug. The two most important natural cannabinoids are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The THC content of cannabis has been increasing during the last years and recently appeared in the market as a series of synthetic cannabinoids with potent agonist activity. Recreational users frequently combine cannabis with other drugs of abuse as alcohol, amphetamines and derivatives, nicotine and cocaine. In addition, these subjects can be taking medicines for acute and chronic medical conditions. The increasing use of medicinal cannabis for chronic pain and neurological and psychiatric disorders can produce potential interactions with medications used for the symptomatic treatment of these or other diseases. Conclusion: THC and CBD are metabolized mainly in the liver by cytochrome P-450 isoenzymes (mainly CYP2Cs and CYP3A4). In vitro studies indicate that THC and CBD both inhibit CYP1A1, 1A2 and 1B1 enzymes, and recent studies have indicated that CBD is also a potent inhibitor of CYP2C19 and CYP3A4. Both cannabinoids may interact with other medications metabolized by the same pathway or by inducers/inhibitors of the isoenzymes. Cannabis produces sedation, impairs psychomotor performance, and increases blood pressure and heart rate. Pharmacodynamic interactions with other sedatives can potentiate the central effects but can be decreased by psychostimulants. This review focuses on the interactions between cannabinoids and alcohol, other drugs of abuse, and prescription medicines.

Nyaditum resae^® (NR) is a galenic preparation of heat-killed Mycobacterium manresensis, a new species of the fortuitum complex, that is found in drinkable water, and that has demonstrated to protect against the development of active TB in a murine experimental model that develop human-like lesions. Double-blind, randomized, placebo-controlled Clinical Trial (51 volunteers included). Two different doses of NR and a placebo were tested, the randomization was stratified by Latent Tuberculosis Infection (LTBI)-positive (n = 21) and LTBI-negative subjects (n = 30). Each subject received 14 drinkable daily doses for 2 weeks. All patients completed the study. The 46.3% of the overall reported adverse events (AE) were considered related to the investigational treatment. None of them were severe (94% were mild and 6% moderate). No statistical differences were found when comparing the median number of AE between the placebo group and both treatment groups. The most common AE reported were gastrointestinal events, most frequently mild abdominal pain and increase in stool frequency. Regarding the immunogenic response, both LTBI-negative and LTBI-positive volunteers treated with NR experienced a global increase on the Treg response, showed both in the population of CD25+CD39-, mainly effector Treg cells, or CD25+CD39+ memory PPD-specific Treg cells. This clinical trial demonstrates an excellent tolerability profile of NR linked to a significant increase in the population of specific effector and memory Tregs in the groups treated with NR in both LTBI-positive and negative subjects. NR shows a promising profile to be used to reduce the risk of active TB.