Patient Safety Research Articles

Mining and disproportionality analysis of adverse events signals for naltrexone based on real-world data from the FAERS database

ABSTRACT Background This study aims to analyze adverse events (AEs) associated with naltrexone based on the FAERS database, providing a foundation for its safety monitoring. Research design and methods Disproportionality analysis methods, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms, were employed to quantify signals of naltrexone-related AEs. Results AEs related to naltrexone from the first quarter of 2013 to the fourth quarter of 2023 were extracted from the FAERS database for detailed analysis. Among a total of 41,757,311 reports 28,745 were directly associated with naltrexone, involving 27 organ systems. We identified 110 positive signals for AEs at the preferred term (PT) level using disproportionality analysis, which included known AEs such as agitation, depressed mood, sleep disorder, tremor, delirium, and decreased libido. Additionally, our findings suggested potential risks of restless legs syndrome, eosinophilic pneumonia, and otolithiasis, which were not mentioned in the drug’s label, thereby supplementing the existing safety information. Conclusions The analysis of the FAERS database identified AEs associated with naltrexone, contributing to the awareness of clinical practitioners and pharmacists regarding the drug-related risk signals. This awareness facilitates timely preventive and therapeutic measures, ensuring patient safety.

A review of human factors and infusion pumps: lessons for procurement

Integrating advanced technologies like medical devices in healthcare is crucial for addressing critical challenges, but patient safety must remain the top priority. In modern clinical settings, medical devices, such as infusion devices used to administer fluids and drugs, carry risks from use errors, requiring a focus on usability and human factors engineering (HFE). Despite the significance of integrating HFE into technology selection processes, it is often overlooked. A review of five key articles demonstrates how applying HFE principles in procurement strategies can enhance device usability and patient safety. Although designed to reduce medication errors, infusion devices can still cause over-infusion or delays, indicating the need for improved safety features that must be considered in the context of sociotechnical systems. The reviewed studies suggest incorporating HFE in design, purchasing, and implementation to address these issues. The studies highlight various HFE methodologies, showing a wide variation in design, deployment, interpretation, and reporting. This comprehensive examination underscores the importance of standardised evaluations to ensure safer and more effective medical devices, emphasizing the essential role of HFE in advancing patient safety within healthcare settings.

Usability evaluation and proposals for paediatric liquid medication containers

Japan’s universal health system allows free access to medical institutions and medical costs for children are often fully covered. While this is a good system, people are not always aware of the concept of self-medication and are less inclined to buy medication over the counter. The negative impacts of this can be inaccurate administration of medicine for people and their children. Professor Mikio Murata is a licensed pharmacist working on a project to investigate and research pharmaceutical containers, devices and packaging and drug delivery devices. The work will lead to improved containers, benefiting those administering and receiving medication. As paediatric prescriptions are often prepared by mixing different liquids and then dispensed by adding water to a measuring cup using markings on the liquid container, the process for a parent administering medicine to their child is cumbersome and it can be difficult to accurately measure medication. There is a need to decipher if the devices in use are fit-for-purpose and if there is a need for new methods for administering certain medicines to ensure the safety of patients. Further issues relate to the regulation of drug prices, with costs including necessary administration devices and packaging. This means pharmaceutical manufacturers may be reluctant to change packaging or containers after they have been launched due to the production line modifications that would be needed. Additionally, cost is often prioritised over user convenience as the cost of liquid and ointment containers used in pharmacies is borne by the pharmacy.

Moral sensitivity and attitudes towards patient safety among critical care nurses.

Patient safety is essential for healthcare quality and a global concern. The rapid advancement of medical technology presents ethical challenges for critical care nurses, who navigate complex decision-making processes. Given their close relationships with patients, nurses are uniquely positioned to address patient safety issues. Thus, enhancing nurses' moral sensitivity and ethical values is increasingly important. This study aims to explore the relationship between moral sensitivity and attitude towards patient safety in critical care nurses. This cross-sectional, descriptive-correlational study was conducted from June to September 2022 in three hospitals affiliated with Hamadan University of Medical Sciences in Iran. Participants were nurses in intensive care units (ICUs), selected via convenience sampling. A total of 382 nurses completed questionnaires assessing demographic information, moral sensitivity, and patient safety attitudes. Data analysis was performed using descriptive statistics, t-tests, ANOVA, Pearson's correlation, and multiple regression in SPSS 26.Ethical considerations: This research received ethical approval from the Ethics Committee of Hamadan University of Medical Sciences. Participants provided informed consent regarding the study's objectives, and their confidentiality was strictly upheld throughout the research. The nurses' average age and work experience were 38.6years and 12.4years, respectively. Mean scores for moral sensitivity and patient safety attitude were 81.65 ± 2.69 and 51.47 ± 2.21, indicating high levels and a significant positive correlation. Factors such as increasing age, work experience, fewer working hours, and completion of ethics training were linked to more positive attitudes towards patient safety (p < .05). Regression analysis showed that 42.8% of the variability in attitudes towards patient safety could be explained by moral sensitivity and demographic characteristics. This study highlights the relationship between moral sensitivity and patient safety attitudes among critical care nurses, emphasizing the importance of education, experience, and training in shaping ethical values. Enhancing moral sensitivity is vital for reducing risky behaviors and improving patient safety outcomes in critical care settings.

Ethical and Legal Implications of Healthcare Worker Shortages

The chronic shortage of healthcare workers presents significant ethical and legal challenges, particularly regarding the quality of patient care and safety. This paper explores the implications of healthcare worker shortages, focusing on their impact on labor cost, compromised patient care, increased medical errors, and rising malpractice claims. Healthcare institutions face legal risks when they fail to meet mandated staffing ratios, which can result in penalties, fines, and lawsuits. Furthermore, overworked staff, often subject to extended hours and excessive workloads, raise concerns about labor law violations, including non-compliance with mandatory rest periods and fair overtime compensation. The increased reliance on contract workers to fill staffing gaps also introduces legal challenges related to contract disputes, working conditions, and patient safety. Addressing these shortages is critical to preventing further harm to patients and mitigating legal liabilities for healthcare systems. This paper proposes a set of solutions, including legal mandates for minimum staffing ratios in critical care areas and incentives for recruitment and retention in underserved regions. These measures aim to reduce turnover, protect patient safety, and minimize legal risks. A holistic approach to workforce planning and policy reform is necessary to sustain safe staffing levels and ensure ethical standards of care are maintained across the healthcare system. Ultimately, addressing healthcare worker shortages is both a legal requirement and an ethical imperative to safeguard the future of patient care and the well-being of healthcare professionals.

Digital twin for the formal analysis of a depth of anesthesia controller

Effective management of depth of anesthesia (DoA) is crucial for patient safety in healthcare. Anesthesiologists typically adjust anesthetic dosages to maintain desired sedation, analgesia (pain relief), and muscle relaxation states. In this paper, we present a digital twin (DT) architecture for the formal modeling and verification of an infusion pump controller for DoA management. The DT incorporates a virtual patient model, an autonomous DoA controller adjusting the infusion rate of the anesthetic agent, i.e., propofol, a test-case manager, and a runtime verification monitor. Data exchange occurs via Ethernet frames. Challenges arise from noise in the Bispectral Index monitoring system readings and infusion rate measurements in clinical scenarios. To mitigate noise impact, we design a feedback controller that is robust against noise. We reason about DT performance by evaluating control specifications using a temporal-logic language within the context of our runtime verification tool.

Interval Analysis-Based Optimization: A Robust Model for Intensity-Modulated Radiotherapy (IMRT)

Background: Cancer remains one of the leading causes of mortality worldwide, with radiotherapy playing a crucial role in its treatment. Intensity-modulated radiotherapy (IMRT) enables precise dose delivery to tumors while sparing healthy tissues. However, geometric uncertainties such as patient positioning errors and anatomical deformations can compromise treatment accuracy. Traditional methods use safety margins, which may lead to excessive irradiation of healthy organs or insufficient tumor coverage. Robust optimization techniques, such as minimax approaches, attempt to address these uncertainties but can result in overly conservative treatment plans. This study introduces an interval analysis-based optimization model for IMRT, offering a more flexible approach to uncertainty management. Methods: The proposed model represents geometric uncertainties using interval dose influence matrices and incorporates Bertoluzza’s metric to balance tumor coverage and organ-at-risk (OAR) protection. The θ parameter allows controlled robustness modulation. The model was implemented in matRad, an open-source treatment planning system, and evaluated on five prostate cancer cases. Results were compared against traditional Planning Target Volume (PTV) and minimax robust optimization approaches. Results: The interval-based model improved tumor coverage by 5.8% while reducing bladder dose by 4.2% compared to PTV. In contrast, minimax robust optimization improved tumor coverage by 25.8% but increased bladder dose by 23.2%. The interval-based approach provided a better balance between tumor coverage and OAR protection, demonstrating its potential to enhance treatment effectiveness without excessive conservatism. Conclusions: This study presents a novel framework for IMRT planning that improves uncertainty management through interval analysis. By allowing adjustable robustness modulation, the proposed model enables more personalized and clinically adaptable treatment plans. These findings highlight the potential of interval analysis as a powerful tool for optimizing radiotherapy outcomes, balancing treatment efficacy and patient safety.

Prevalence and contributing factors of intravenous medication administration errors in emergency departments: a prospective observational study.

Medication administration in busy emergency departments (EDs) presents significant challenges due to the high-pressure environment and complexity of processes. Medication administration errors (MAEs) are a critical concern as they can severely impact patient safety and increase healthcare costs. Understanding the prevalence and underlying factors contributing to intravenous MAEs is essential for enhancing patient care and improving hospital services. This study aims to explore and measure the frequency of intravenous MAEs in EDs and identify factors contributing to these errors during their preparation and administration. This prospective study utilised the direct observation technique where the preparation and administration of 222 intravenous medications were observed in the EDs of two hospitals in Malaysia. Information on medication preparation, administration and other procedures were recorded. Error rates were calculated and multivariable logistic regression was conducted to identify factors contributing to intravenous MAEs. MAEs were detected in 83.3% (185/222) of the observed medications affecting 86.7% (124/143) patients. Among these, a total of 240 MAEs were identified, with the most common being wrong rate of administration (55.8%), wrong preparation technique (20.8%) and omission error (11.7%). Alimentary tract and metabolism medications accounted for the highest proportion of MAEs (52.0%), followed by anti-infective medications (21.7%) and nervous system medications (15.4%). Excluding wrong time errors reduced the error rate to 80.2% (178/222). Non-verbal orders and inadequate or absence of labelling were significantly associated with MAEs, while factors such as the complexity of preparations, working shift, experience and high-alert medications showed no significant associations. The study highlighted a high prevalence of intravenous MAEs in EDs. Non-verbal orders and inadequacy in labelling of medications were significant contributing factors to MAEs in the ED. Implementing an admixture labelling policy, comprehensive training programs, strict enforcement of existing guidelines and protocols through regular audits, establishing non-punitive error reporting system, and technological solutions where financially feasible are crucial for mitigating these errors to promote patient safety.

Patient and Family Involvement in Nursing Bedside Handover: A Qualitative Descriptive Study of Consumer Perceptions of Nursing Care

Background/Objectives: Patient and family involvement in bedside handover is a requirement of the national standards on patient safety and quality in Australia. To ensure patient-and-family-centred care, it is essential to understand how patients and families perceive their involvement in nursing bedside handover and what difficulties they face when participating. This study aimed to explore patient and family perceptions of their involvement in nursing bedside handover. Methods: We employed a qualitative descriptive study design with in-depth and semi-structured interviews. Using purposive and convenience sampling, 24 patients and family members were recruited from two adult hospitals in Western Australia between November 2021 and February 2022. The data were thematically analysed. Results: Participants had mixed experiences that overlapped with their individual perceptions, needs, and experiences. Their responses were grouped into three major themes with sub-themes: (1) discovering new nursing care approaches; (2) seeing the value of involvement in bedside handover; and (3) barriers hindering patient and family involvement in bedside handover. The findings revealed that patients and families valued their involvement in nursing bedside handover. However, several factors challenged their participation, including a lack of awareness about their right to participate, the timing of handovers, the nurse’s approach, and fear of asking questions. Conclusions: The findings serve as a guide for evidence-based practice and may significantly influence policy and practice in nursing bedside handover, potentially enhancing patient-and-family-centred care. While considered best practice, the consistent involvement of patients and their families in nursing bedside handover is not routinely achieved and is implemented to varying extents.

Burnout in modern-day health care: Where are we, and how can we markedly reduce it? A meta-narrative review from the EUREKA* project.

Burnout is disrupting the health care workforce, threatening the livelihoods of health care workers and the probability of safe and effective patient care. The aims of this study were to describe the evolution and gaps in burnout research and identify next steps to advance the field and reduce burnout. We formed a learning community of burnout scholars and Chief Wellness Officers, sought recent review articles for a meta-narrative synthesis of themes on health care worker burnout, and conducted focus groups with learning community members. In 1,425 systematic burnout studies found in a Medline database search of systematic reviews published since 2018, 68 were retained for analysis. Many focused on individual interventions (e.g., mindfulness), paying inconsistent attention to (a) what comprises burnout, (b) prevalence and contributors, (c) theories underlying it, (d) presence in marginalized populations, and (e) innovative research methods. There was consensus that burnout poses a global crisis, but there was no agreement on how to address it. Focus group participants noted that although burnout research is now "mainstream," health systems commit insufficient resources to addressing it. They proposed that emphasizing organizational finances and patient safety may make burnout a priority for health systems. Despite burnout's progressing unabated, many organizations do not employ known burnout indicators (worker dissatisfaction or turnover) as wellness metrics. Research into organizational contributors to burnout, rigorous evaluation of interventions, and organizational adoption of research findings into systemic action are urgently needed. A well-supported international research agenda is required to quickly move the field ahead and reduce or ultimately eliminate burnout.

Use of the measurement tools of TeamSTEPPS®: a scoping review

BackgroundTeamSTEPPS® (Team Strategies and Tools to Enhance Performance and Patient Safety) is an evidence-based program developed to train healthcare professionals working in any environment where communication and teamwork are important. Two questionnaires have been developed for the program: Teamwork Attitudes Questionnaire (T-TAQ) and Teamwork Perceptions Questionnaire (T-TPQ). The aim of this scoping review is to explore and describe the current research regarding those measurement tools across the health sciences education continuum, and consider where, when, how and with whom these tools are being used.MethodsThe study was conducted, planned, and reported according to the PRISMA-ScR checklist. PubMed and Web of Science databases were searched with the keyword, ″TeamSTEPPS″ in December 2023.ResultsForty-nine studies using any or both of T-TAQ and T-TPQ were considered eligible for this review. Twenty one of the studies were conducted with students, particularly nursing students; and twenty eight with health professionals, particularly nurses. TeamSTEPPS® training was conducted for both students and health professionals in 30 of the studies. T-TAQ was used in 26 of the studies; and T-TPQ in 17 studies. Both tools were used together in six of the studies. These measurement tools were applied to the students just before and after the training in 15 studies; and to the health professionals in five of the studies.ConclusionT-TAQ and T-TPQ were used in the studies involving the students and healthcare professionals with or without educational programs at all levels of healthcare education continuum and service, and were applied at various time intervals according to the aim of gathering data on the teamwork constructs seperately or holistically.

Analysis of Factors Affecting the Use of PPE (Personal Protective Equipment) in Nurses on the Prevention of Nosocomial Infections at Bina Kasih Hospital Medan

One of the efforts to provide labor protection for Occupational Safety and Health (K3) in hospitals is by providing Personal Protective Equipment. The purpose of this study is to analyze the factors that affect the use of PPE in Nurses in Bina Kasih Hospital Medan. This type of research includes quantitative research with a cross sectional approach. The population in this study was 152 nurses with a sample of 60 people based on the results of sample calculation using the Slovin formula. Data collection in the study used questionnaires and processed into SPSS with univariate, bivariate and multivariate analysis. The results of the study with the chi square statistical test found that the variables of age, working period, knowledge, attitude, availability of PPE, supervision and social support were related to the p&lt;sig value of α (0.05). Based on the results of the multivariate analysis, it is known that the most dominant variable influences, namely, the attitude variable (p=0.003, Exp(B) 14.931), namely attitude has an influence of 14.9 times on the use of PPE, the working period (p=0.004, Exp(B) 13.169), namely the working period has an influence of 13 times on the use of PPE, and social support (p=0.012 Exp(B) 8.592), namely social support has an influence of 8.5 times on the use of PPE. It can be concluded that the variables of working period, attitude and social support are the factors that most affect nurses in using PPE. It is recommended to Ananda Bekasi Hospital, especially to nurses, to always improve the performance of nursing care provided to patients by paying attention to the completeness of PPE in accordance with the SOPs that have been set by the work agency.

Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database

This study aims to monitor and identify adverse events (AEs) associated with cetuximab, a drug used to treat various late-stage (metastatic) tumors, to improve patient safety and guide drug use. This study retrospectively analyzed the cases reported in the FDA adverse event reporting system (FAERS) related to the application of cetuximab from 2013 Q1 to 2022 Q4. Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayesian geometric mean (EBGM) algorithms, were employed to quantify the signals of cetuximab-associated AEs. A total of 8364225 reports were contained in the FAERS database, of which 5186 reports of cetuximab were identified as ‘primary suspected (PS)’ AEs. The application of cetuximab resulted in AEs in 22 system organ classes (SOCs), which preserved 176 significant disproportionality preferred terms (PTs) through the computation of four algorithms. The main SOCs (Skin and subcutaneous tissue disorders, investigations, metabolism and nutrition disorders, and blood and lymphatic system disorders) accounted for 58.63%. Some AEs were not on the drug label: speech disorder, intervertebral discitis, glomerulonephritis rapidly progressive and disseminated intravascular coagulation. This study identified new signals of adverse drug reactions (ADRs) other than those mentioned in the specification associated with cetuximab, providing valuable insights into the relationship between ADRs and cetuximab use. The findings highlight the importance of continuous surveillance to detect and manage AEs effectively, ultimately improving patient safety during treatment with cetuximab.

Holistic Tri-Service Military Pathology: A Proposed Paradigm for Consolidation.

Historically, military anatomic pathology (AP) services have been significantly compartmentalized, with each branch independently executing its laboratory support mission. The result is redundant and costly duplication of nearly identical services in close geographic proximity. The duplication of AP services disperses the overall caseload, resulting in pathologist diagnostic acumen atrophy, excessive support personnel requirements, inadequate utilization of subspecialty expertise, and overall lower-quality patient care. Unlike many medical specialties, implementing AP services does not require direct patient interaction and is principally not as time-sensitive as other clinical laboratory testing. The practice of AP is conducive to a more consolidatory paradigm to achieve economies of scale. Pathology service unification would also afford the stationing of predominantly subspecialists at tertiary care centers to handle higher caseloads. Larger groups of pathologists increase patient safety enhancing peer-to-peer and subspeciality quality assurance processes during case review. Conversely, the nature of clinical pathology services requires a more widespread presence-even at the smaller, auxiliary clinics throughout the military health system. Clinical pathology services would also benefit from additional triservice cooperation including standardization of quality management processes, increased resource sharing, exchange, and cooperative contingency planning. Laboratory directorships also benefit from consolidating expertise, where pathologists could be physically located at a central site with remote oversight of laboratory services. Here, we propose a holistic triservice consolidation plan for military pathology to optimize resource utilization and ultimately realize the overarching strategic plan for military medicine set forth by the Defense Health Agency.

Resilience and risk: adding complexity-informed variables to patient-centered internal lean logistics in hospitals

The complexity of healthcare implies that hospital lean logistics demands resilience and has high stakes due to patient safety risks. Thus, three variables of lean logistics (route, routine, and rhythm – 3 Rs) should be complemented by two others (resilience and risk – 2Rs) that account for complexity. This paper presents a framework for assessing these 5Rs of internal lean logistics. It was conceived through a systematic review and interviews with experts. The framework use is illustrated through the study of the logistics of medications. It contributes to patient-centred internal lean logistics, indicating the key issues and how they relate to each other.

Hierarchical Deep Learning for Robust Cybersecurity in Multi-Cloud Healthcare Infrastructures

Patient safety is in danger because healthcare networks are more susceptible to cyberattacks as they become more intricate and linked. By altering data transmitted between various system components, malicious actors can hack into these networks. As cloud, edge, and IoT technologies become more widely used in contemporary healthcare systems, this difficulty is predicted to increase. This study presents a Combined Hybrid Deep Learning Framework with Layer Reuse for Cybersecurity (CHDLCY) to address this issue. This system is built to detect malicious actions that modify the metadata or payload of data flows across IoT gateways, edge, and core clouds quickly and precisely. The CHDLCY's is a unique design demanding less training time, while bigger models at the core cloud profit from a cutting-edge layer-merging method. The core cloud model is partially pre-trained by reusing layers from trained edge cloud models, which drastically reduces the number of training epochs required from 35 to 40 to just 6 to 8. Thorough tests demonstrated that CHDLCY not only accelerates the training phase but also achieves remarkable accuracy rates, ranging from 98% to 100%, in identifying cyber threats. The proposed approach offers a significant improvement over previous models in terms of training efficiency and generalizability to new datasets.

A qualitative exploration of midwives' and ambulance clinicians' experiences working together

Background/Aims Effective teamwork represents a significant component of high-quality maternity care. Midwives and ambulance clinicians are sometimes required to work together in the pre-hospital setting, but these interactions are not well documented or understood. This study aimed to explore the views and experiences of clinicians, to describe the barriers to and facilitators of effective teamwork in this context. Methods Focus group discussions and in-depth interviews were conducted with 30 London-based clinicians who had experience of providing emergency maternity care in the pre-hospital setting as part of a multidisciplinary team. Data were analysed thematically, informed by principles of grounded theory. Results Three overarching themes emerged: significance of the patient environment, reaching a shared mental model and interpersonal dynamics. Challenges included conflicting priorities and lack of understanding each other's roles and skillsets. Civility and multidisciplinary training were perceived as conducive to effective teamwork. Conclusions The findings provide insight to the factors that were perceived to impact teamwork in a pre-hospital maternity context. Actions to improve patient safety include increased partnership working between acute and ambulance trusts, including the provision of multidisciplinary training. Implications for practice Midwives and ambulance clinicians report a shared goal of a safe and positive experience for the families in their care. When working towards these outcomes, teams require leadership that acknowledges the various professional remits present.

Investigation of the Relationship Between Perceived Leadership Behaviours of Nurses and Hospital Safety Culture: A Study With the Structural Equation Model.

Work environments that support patient safety initiatives are important for quality service and patient outcomes. The relationship between the leadership behaviours of nurse managers and safety culture, which has the potential to support these initiatives, constitutes one of the most important knowledge gaps. The study aimed to determine the relationship between nurses' perceived leadership behaviours and hospital safety culture and the factors affecting them. We tested the theoretical model using structural equation modelling with the AMOS 21 program. The research was conducted with 134 nurses in two public hospitals in the south of Türkiye. Data were collected between October and December 2021 using the Leadership Behaviour Questionnaire and the Patient Safety Culture Hospital Questionnaire. Descriptive statistical analysis used to evaluate the data of the study. Structural equation modelling analysis and confirmatory factor analysis performed to test the research hypotheses. The study found that non-punitive attitudes towards the mistakes had a full mediating effect on overall perception of safety interaction with employee-oriented leadership and high-level hospital interventions (β = -0.510, 95% CI -1.006/-0.076), and change had partly mediating effect on overall perception of safety interaction with change-oriented leadership (β = -0.510, 95% CI -1.043/-0.053). It is clear that if nurse managers are to improve the staff's patient safety culture, they should develop change-oriented leadership skills by identifying adverse events and risks and motivating staff to learn from errors without taking punitive measures. In this context, healthcare organizations should evaluate the leadership qualities of managers. Managers at all levels can make plans to develop leadership behaviours that will play a facilitating role in improving patient safety.

Lepalvir: Biomaterial efficacy and safety for patients with acute ischemic stroke

Lepalvir: Biomaterial efficacy and safety for patients with acute ischemic stroke

Neoadjuvant immune checkpoint blockade in resectable hepatocellular carcinoma: A systematic review and meta-analyisis.

590 Background: Hepatocellular carcinoma (HCC) presents a significant therapeutic challenge due to its high recurrence rates after curative-intent resection. Neoadjuvant immune checkpoint blockade (ICB) has emerged as a promising strategy to improve tumor control by modulating the immune microenvironment prior to surgery. This systematic review and meta-analysis aim to assess the safety and efficacy of neoadjuvant ICB in improving clinical outcomes for patients with resectable HCC. Methods: A systematic search of PubMed, EMBASE, and Cochrane databases was conducted to identify clinical trials examining neoadjuvant ICB in resectable HCC. Primary endpoints included pathological complete response (pCR), major pathological response (mPR), overall response rate (ORR), and grade 3-4 treatment-related adverse events (TRAE). Prespecified subgroup analyses were conducted for studies combining ICB with tyrosine kinase inhibitors (TKIs) or dual ICB therapies. Pooled proportions were calculated using a random-effects model via the R package "meta." Inter-study heterogeneity was assessed using the I² statistic and test for subgroup differences were conducted. Results: Out of 1,321 studies screened, 14 clinical trials involving 252 patients with resectable HCC were included. Most studies were phase II trials (57%), and patient median age ranged from 57.5 to 68.0 years, with 88.3% of patients being male. The pooled prevalence of mPR was 32% (95% CI, 24–42%; I² = 9%)while pCR was achieved in 24% (95% CI, 17–34%; I² = 29%)of patients. The ORR was 27% (95% CI, 18–39%; I² = 49%), and severe adverse events (grade 3-4 TRAE) had a pooled prevalence of 24% (95% CI, 17–34%; I² = 16%). Subgroup analysis of trials combining ICB with TKIs showed an ORR 34% (95% CI, 20–55%; I² = 60%), an mPR rate of 27% (95% CI, 19–40%; I² = 0%), and a pCR rate of 20% (95% CI, 14–30%; I² = 0%). Dual ICB therapies demonstrated a higher mPR rate of 42% (95% CI, 26–67%; I² = 16%) and a pCR rate of 41% (95% CI, 29–59%; I² = 29%), but were associated with a higher incidence of severe TRAE (41%; 95% CI, 29–60%; I² = 0%). Conclusions: Neoadjuvant ICB demonstrates promising efficacy in resectable HCC, particularly when combined with TKIs or dual ICB therapies. While dual ICB enhances pathological response rates, it is associated with higher rates of severe TRAE. These results highlight the need of further studies to optimize combination strategies that balance efficacy and safety for patients with resectable HCC.